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Regulatory Reviews' which was released on May 11, 2009. 

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Report to the Chairman, Committee on Oversight and Government Reform, 
House of Representatives: 

United States Government Accountability Office: 
GAO: 

April 2009: 

Federal Rulemaking: 

Improvements Needed to Monitoring and Evaluation of Rules Development 
as Well as to the Transparency of OMB Regulatory Reviews: 

GAO-09-205: 

GAO Highlights: 

Highlights of GAO-09-205, a report to the Chairman, Committee on 
Oversight and Government Reform, House of Representatives. 

Why GAO Did This Study: 

Regulation is one of the principal tools that the government uses to 
implement public policy. As part of the rulemaking process federal 
agencies must comply with an increasing number of procedural and 
analytical requirements. GAO was asked to examine how broadly 
applicable rulemaking requirements cumulatively have affected (1) 
agencies' rulemaking processes, in particular including effects of 
requirements added to the process since 2003, and (2) transparency of 
the Office of Information and Regulatory Affairs (OIRA) regulatory 
review process. To address these objectives, GAO reviewed selected 
rules issued between January 2006 and May 2008 and associated dockets 
and also interviewed knowledgeable agency and OIRA officials. 

What GAO Found: 

The agencies GAO reviewed had little data on the time and resources 
used to comply with regulatory requirements making it difficult to 
evaluate the effects of these requirements on rulemaking. All the 
agencies set milestones for regulatory development. During our review, 
only the Department of Transportation (DOT) provided data showing that 
it tracked and reported on milestones, but EPA and FDA provided similar 
information in their agency comments. The agencies GAO reviewed also 
could provide little systematic data on the resources they used—such as 
staff hours, contract costs, and other expenses—in developing rules. 
DOT and SEC have attempted to identify staff time expended on 
individual rules but are encountering difficulties generating usable 
and reliable data. Despite the challenges they have encountered in 
attempting to track time and resources in rulemaking, agency officials 
identified potential benefits to the management of their processes if 
they had such information to evaluate. Systematic tracking and 
reporting by agencies on their schedules and milestones would also be 
consistent with internal control standards. 

Our review of 139 major rules including 16 case-study rules revealed 
that most triggered analytical requirements under the Paperwork 
Reduction Act (PRA), Regulatory Flexibility Act (RFA), and Executive 
Order 12866, but few other requirements. Agency officials reported that 
requirements added to the rulemaking process by the Office of 
Management and Budget (OMB) since 2003 sometimes required a learning 
period when first implemented, but their agencies either already 
performed the added requirements or recognized the revisions as best 
practices. The officials instead identified long-standing requirements 
of the PRA and the RFA as generally requiring a more significant 
investment of resources. Based on the limited information available, 
the average time needed to complete a rulemaking across our 16 case-
study rules was about 4 years, with a range from about 1 year to nearly 
14 years, but there was considerable variation among agencies and 
rules.  

OIRA’s reviews of agencies’ draft rules often resulted in changes. Of 
12 case-study rules subject to OIRA review, 10 resulted in changes, 
about half of which included changes to the regulatory text. Agencies 
used various methods to document OIRA’s reviews, which generally met 
disclosure requirements, but the transparency of this documentation 
could be improved. In particular, some prior issues persist, such as 
uneven attribution of changes made during the OIRA review period and 
differing interpretations regarding which changes are “substantive” and 
thus require documentation. Out of eight prior GAO recommendations to 
improve the transparency OIRA has implemented only one—to clarify 
information posted about meetings with outside parties regarding draft 
rules under OIRA review. 

What GAO Recommends: 

GAO recommends that, consistent with internal control standards, the 
Environmental Protection Agency (EPA), Food and Drug Administration 
(FDA), and Securities and Exchange Commission (SEC) track and evaluate 
actual performance versus targeted milestones for developing 
significant rules to identify process improvement opportunities. GAO 
also recommends that OMB should provide additional guidance to agencies 
to improve transparency and documentation of the OIRA review process. 
In comments on a draft of this report, SEC and OMB generally agreed 
with our recommendations. EPA and FDA said they believe they already 
have such tracking systems. 

View [hyperlink, http://www.gao.gov/products/GAO-09-205] or key 
components. For more information, contact Denise M. Fantone at (202) 
512-6806 or Fantoned@gao.gov. 

Contents: 

Letter: 

Results in Brief: 

Background: 

Agencies Have Limited Data on the Time and Resources Used to Address 
Regulatory Requirements in Their Rulemaking Processes: 

OIRA's Role in the Rulemaking Process Could Be More Transparent: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Summary of Common Regulatory Requirements: 

Appendix II: Case Studies of 16 Selected Rules: 

Appendix III: Examples of OIRA Review Documentation: 

Appendix IV: Comments from the Office of Management and Budget: 

Appendix V: Comments from the Securities and Exchange Commission: 

Appendix VI: Comments from the Department of Health and Human Services, 
Food and Drug Administration: 

Appendix VII: Comments from the Environmental Protection Agency: 

Appendix VIII: GAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Tables: 

Table 1: Rulemaking Requirements Generally Applicable to Major Rules: 

Table 2: Classification of OIRA Review Changes to Case-Study Rules: 

Table 3: Documentation of OIRA Reviews for Case-Study Rules: 

Figures: 

Figure 1: Basic Phases of Rulemaking Processes: 

Figure 2: Rulemaking Timelines from Initiation to Final Rule for 16 
Case Studies: 

Figure 3: Percentage of 139 Major Rules That Triggered Rulemaking 
Requirements: 

Figure 4: Number of 16 Case-Study Rules That Triggered Rulemaking 
Requirements: 

Figure 5: NHTSA Summary Memorandum Identifying OIRA Review Changes: 

Figure 6: FAA Standard Form to Indicate the Nature of OIRA Review 
Changes: 

Figure 7: EPA Use of Redline/Strikeout Method to Document OIRA Review 
Changes: 

Abbreviations: 

ANPRM: Advance Notice of Proposed Rulemaking: 

APA: Administrative Procedure Act: 

CAA: Clean Air Act: 

CAFE: corporate average fuel economy: 

CDER: Center for Drug Evaluation and Research: 

CF: Division of Corporation Finance: 

CFSAN: Center for Food Safety and Applied Nutrition: 

CRA: Congressional Review Act: 

DOT: Department of Transportation: 

EDGAR: Electronic Data Gathering, Analysis, and Retrieval System: 

EDR: event data recorder: 

EPA: Environmental Protection Agency: 

FAA: Federal Aviation Administration: 

FACA: Federal Advisory Committee Act: 

FDA: Food and Drug Administration: 

FRDTS: Federal Register Document Tracking System: 

GACT: generally available control technologies or management practices: 

ICI: Investment Company Institute: 

IM: Division of Investment Management: 

IQA: Information Quality Act: 

LDR: Labor Distribution Reporting: 

MACT: maximum achievable control technologies: 

NEPA: National Environmental Policy Act: 

NHTSA: National Highway Traffic Safety Administration: 

NRA: Negotiated Rulemaking Act of 1990: 

NTTAA: National Technology Transfer and Advancement Act: 

OAR: Office of Air and Radiation: 

OIRA: Office of Information and Regulatory Affairs: 

OMB: Office of Management and Budget: 

OST: Office of the Secretary of Transportation: 

OW: Office of Water: 

PRA: Paperwork Reduction Act: 

RAPIDS: Rule and Policy Information Development System: 

RFA: Regulatory Flexibility Act of 1980: 

RIN: Regulation Identifier Number: 

SBREFA: Small Business Regulatory Enforcement Fairness Act: 

SDWA: Safe Drinking Water Act Amendments of 1996: 

SEC: Securities and Exchange Commission: 

UMRA: Unfunded Mandates Reform Act of 1995: 

XBRLe: eXtensible Business Reporting Language: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

April 20, 2009: 

The Honorable Edolphus Towns: 
Chairman: 
Committee on Oversight and Government Reform: 
House of Representatives: 

Dear Mr. Chairman: 

Regulation is one of the principal tools that the government uses to 
implement public policy. Federal regulations affect many aspects of 
citizens' lives, whether addressing issues featured in the headlines of 
the past year, such as the safety of the food supply and the health of 
the housing and financial markets, or other long-standing goals such as 
environmental protection and workplace and transportation accident 
prevention. Regulations also help ensure the effective distribution of 
funds under a range of programs including Medicare, Medicaid, Social 
Security, agricultural support, and disaster assistance programs. 
Underlying federal regulatory actions is the long-standing rulemaking 
process established by the Administrative Procedure Act (APA).[Footnote 
1] 

As part of that process, Congresses and Presidents have required 
agencies to comply with an increasing number of procedural and 
analytical requirements prior to issuing a rule. Some requirements 
apply only to cabinet departments and independent agencies, while 
others also apply to independent regulatory agencies.[Footnote 2] The 
goals of these requirements include promoting public participation in 
rulemaking, reducing regulatory burdens, requiring more rigorous 
regulatory analysis, and enhancing oversight of agencies' rulemaking. 
As we have previously reported, these requirements entail a wide range 
of procedural, consultative, and analytical actions on the part of the 
agencies.[Footnote 3] For example, the Regulatory Flexibility Act (RFA) 
requires agencies to examine the impact of their rules on small 
entities. The Paperwork Reduction Act (PRA) requires agencies to 
provide public notice, solicit comments, and request approval by the 
Office of Management and Budget (OMB) before imposing new information 
collection requirements. Executive Order 12866 directs agencies (other 
than independent regulatory agencies) to assess costs and benefits of 
available regulatory alternatives and to submit significant rules to 
OMB's Office of Information and Regulatory Affairs (OIRA) for review 
before they are published. (See appendix I for a summary of agencies' 
responsibilities under broadly applicable regulatory requirements 
relevant to the rules we reviewed for this report.) 

In the past, Congress has asked us to review the implementation of 
specific rulemaking requirements.[Footnote 4] For this report, you 
asked us to examine how broadly applicable rulemaking requirements 
cumulatively have affected (1) agencies' rulemaking processes and (2) 
the transparency of the OIRA review process.[Footnote 5] Specifically, 
you asked us to address the following aspects of the rulemaking 
process: 

* To the extent that information is available, how have changes in 
requirements since 2003 affected the complexity, cost, and length of 
the rulemaking process? 

* How long do agencies take to issue rules? 

* What requirements must an agency comply with to issue a major rule? 

* What effect do agency interactions with OMB have on rulemaking? 

To address the first and second questions, we primarily relied on 
reviews of 16 case studies and interviews with officials from 
regulatory agencies and OMB. We chose a case-study approach because 
agency officials informed us during initial meetings that little 
systematic information existed within agencies on the time, staffing, 
and contracting costs associated with the development of individual 
rules or the required analyses that support rulemakings. To identify 
the rules for our case studies, we relied on our Federal Rules 
Database.[Footnote 6] The database includes information such as the 
type of rule (major or nonmajor),[Footnote 7] priority of the rule (for 
example, whether it is a significant rule), and the publication date of 
the rule. We drew a sample from final rules issued from January 2006 
through May 2008, to increase the likelihood that the rules chosen were 
affected by changes in regulatory requirements since 2003 and for which 
the staff who were involved would be available to discuss the 
rulemaking process.[Footnote 8] We randomly selected 16 major or other 
significant final rules from executive branch agencies responsible for 
health, safety, and environmental regulations and an independent 
regulatory agency for purposes of comparison.[Footnote 9] We examined 
two case-study rules each from the Department of Transportation's (DOT) 
Federal Aviation Administration (FAA) and National Highway Traffic 
Safety Administration (NHTSA), the Environmental Protection Agency's 
(EPA) Office of Air and Radiation (OAR) and Office of Water (OW), the 
Food and Drug Administration's (FDA) Center for Drug Evaluation and 
Research (CDER) and Center for Food Safety and Applied Nutrition 
(CFSAN), and the Securities and Exchange Commission's (SEC) Division of 
Corporation Finance (CF) and Division of Investment Management (IM). 
Although these agencies and offices are not equivalent 
organizationally, we treated them as such for purposes of this report 
to obtain comparable volumes of major and significant final rules in 
our selection process. The agencies, offices, and sample of rules that 
we assessed are not representative of all regulatory agencies and all 
rules. 

We reviewed the agencies' regulatory dockets for each rule selected 
using a standardized data collection instrument and discussed what we 
found with knowledgeable agency officials and OMB. We defined "changes 
in requirements" as changes that OMB identified as significant in its 
September 2003 revision of OMB Circular No. A-4,[Footnote 10] which 
provides guidance on conducting regulatory analysis, and also OMB's 
December 2004 Final Information Quality Bulletin for Peer Review. 
[Footnote 11] These changes were implemented since our 2003 report on 
OMB's role in the rulemaking process.[Footnote 12] 

To answer the third question, we reviewed the statutory and executive 
requirements broadly applicable to rulemaking. We also analyzed the 139 
major rules, as defined by the Congressional Review Act (CRA), issued 
from January 2006 through May 2008 to be consistent with the time 
period used for selection of our case studies. To identify the rules, 
we again relied on our Federal Rules Database. Based on our tests of 
the data in the database, including confirming the quality control 
steps used to ensure completeness of the database and tracing database 
information back to source documents, we determined that these data 
were sufficiently reliable for the purposes of this report. To identify 
the requirements that were discussed and that were triggered by the 
major rules, we reviewed the relevant GAO major rule report on the rule 
and the published final rule.[Footnote 13] 

To answer the fourth question, we analyzed the information collected 
above and reviewed the dockets of the 12 selected case-study rules from 
DOT, EPA, and FDA relying on the same basic methodology we previously 
used to report on OMB's role in and affect on rulemaking--reviewing 
documents from agencies' and OMB's dockets and interviewing officials 
to obtain information about the regulatory review process for selected 
rules. We chose these rules because all were subject to review by OMB/ 
OIRA under Executive Order 12866 and the transparency requirements 
under the order. The other 4 case-study rules were not subject to OIRA 
review because SEC is an independent regulatory agency. As part of the 
fourth question, you also asked us to review the status of GAO 
recommendations from GAO-03-929 on improving the transparency of OIRA's 
regulatory review process. To report on the status of those 
recommendations, we relied on information from our annual update of 
open recommendations and interviews with OMB officials. 

For reporting purposes, we discuss our findings on the first three 
questions in objective one--the effects of rulemaking requirements on 
agencies' rulemaking processes, including the complexity, cost, and 
length of their processes. Our findings related to the fourth question 
and updated findings from our 2003 report are discussed in objective 
two--the transparency of OMB's role in the regulatory review process. 
We conducted our review from August 2008 through February 2009 in 
accordance with generally accepted government auditing standards. Those 
standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

Results in Brief: 

During the course of our review, the case-study agencies provided 
little data on the time and resources required to develop rules or 
comply with broadly applicable regulatory requirements, making it 
difficult to evaluate the effects of the requirements on the rulemaking 
process. During our review, we found that all the agencies set 
milestones for regulatory development, but only DOT provided data that 
showed it routinely tracked these milestones. In comments on our draft 
report, EPA and FDA subsequently provided some documentation and data 
that showed that these agencies also routinely tracked milestones. 
Based on the limited information available at the time of our review, 
the average time needed to complete a rulemaking across our 16 case- 
study rules was about 4 years, with a range from about 1 year to nearly 
14 years, but there was considerable variation among agencies and 
rules. The agencies also could provide little systematic data on the 
resources they use, such as staff hours, contract costs, and other 
expenses, in developing individual rulemakings. DOT and SEC have 
attempted to identify staff time expended on individual rules but are 
encountering difficulties generating usable and reliable data. Despite 
the challenges they have encountered in attempting to track time and 
resources in rulemaking, agency officials identified potential benefits 
to the management of their processes if they had such information. 
Systematic tracking and reporting by agencies on their schedules and 
milestones would also be consistent with internal control standards. 

When issuing major rules, all agencies must comply with broadly 
applicable statutory requirements, and agencies other than independent 
regulatory agencies are also subject to requirements in executive 
orders. However, an agency may not need to include specific analyses if 
the substance of the rule or exceptions and thresholds in the 
requirement lead the agency to determine that a specific rule did not 
trigger the requirement. Our review of 139 major rules and 16 case- 
study rules showed that most triggered analytical requirements under 
the PRA, the RFA, and (except for independent regulatory agencies such 
as SEC) Executive Order 12866, but few other analytical requirements. 
Agency officials reported that requirements added to the rulemaking 
process by OMB since 2003 that include more rigorous assessment of 
economically significant rules sometimes involved a learning period 
when first implemented, but their agencies either already performed the 
added requirements or recognized the revisions as best practices. The 
officials instead identified the long-standing requirements of the PRA 
and the RFA as generally requiring a more significant investment of 
resources. 

OIRA's reviews of agencies' draft rules often resulted in changes to 
the rules, but there are opportunities to improve the transparency of 
OIRA's reviews. OIRA reviewed 12 of our 16 case-study rules under 
Executive Order 12866; SEC's rules are not reviewed by OIRA. OIRA's 
reviews resulted in changes to 10 of the 12 rules. Further, we 
determined that changes to 5 of the rules (1 DOT, 3 EPA, and 1 FDA) 
were significant in that they included changes to the regulatory text 
of the rule. For example, one change to the draft text of a FDA rule on 
dietary supplements reduced the requirement to save reserve samples 
from 3 years to 2 years. Agencies used varying methods to document 
OIRA's review of their draft rules, and their documentation generally 
met the executive order's requirements to disclose materials they 
provided to OIRA and substantive changes made during OIRA's review but 
could be improved for greater transparency. In particular, there was 
uneven attribution of the sources of changes made during the OIRA 
review period and differing interpretations regarding which changes are 
"substantive" and thus require documentation. We previously made eight 
recommendations to improve the transparency of the OIRA regulatory 
review process, but OIRA implemented only one of those recommendations, 
that is, to clarify information that OIRA posts about meetings with 
nonfederal parties regarding draft rules under OIRA review. OIRA did 
not implement the remaining seven recommendations, for example to apply 
transparency requirements to both formal and informal OIRA review 
periods and to encourage agencies to use best practice methods to 
document changes made to rules after submission to OIRA. 

To be consistent with internal controls for information in managing 
agency operations, we recommend that for significant rules FDA and SEC 
routinely track major milestones in regulatory development and report 
internally and externally when major milestones are reached against 
established targets. EPA, FDA, and SEC should also evaluate actual 
performance versus the targeted milestones and when they are different, 
determine why. If the administration retains Executive Order 12866 or 
establishes similar requirements, we recommend that to improve 
transparency of the review process OIRA should (1) instruct agencies to 
clearly state in final rules whether the agencies made substantive 
changes as a result of the OIRA reviews, (2) define what types of 
changes made as a result of the OIRA review process are "substantive" 
and need to be publicly identified, (3) direct agencies to clearly 
attribute those changes made at the suggestion or recommendation of 
OIRA, and (4) standardize how agencies label documentation of these 
changes in public rulemaking dockets. 

SEC, EPA, FDA, and OMB commented on the recommendations. With regard to 
the two recommendations directed to the rulemaking agencies, SEC stated 
that the Commission will consider our recommendations, and both EPA and 
FDA provided new information on their tracking systems and data. We 
note, however, that we had requested this information during our review 
to address our second research question, but the information was not 
forthcoming. Also, they did not provide this information at the 
conclusion of our review either in response to our statements of facts 
to the agencies or at our exit conference with the agencies. Because 
this information was not provided at the time of our review, we did not 
have the opportunity to discuss how the information is used, whether it 
is useful, and, most importantly, if it could be used to respond to our 
report objectives. We did not audit the new information provided 
because of an approaching deadline for OMB to provide recommendations 
to the President for a new executive order on federal agency regulatory 
review. With regard to our four recommendations to OMB, the agency 
stated that these recommendations have merit and warrant further 
consideration. In particular, OMB stated that it will give full 
consideration to our recommendations as the agency finalizes its own 
recommendations to the President for a new executive order on 
regulatory review. 

Background: 

Regulatory agencies have authority and responsibility for developing 
and issuing regulations. The basic process by which all federal 
agencies develop and issue regulations is spelled out in the APA. 
[Footnote 14] This act establishes procedures and broadly applicable 
federal requirements for informal rulemaking, also known as notice and 
comment rulemaking.[Footnote 15] Among other things, the APA generally 
requires agencies to publish a notice of proposed rulemaking in the 
Federal Register.[Footnote 16] After giving interested persons an 
opportunity to comment on the proposed rule by providing "written data, 
views, or arguments," the agency may then publish the final rule. In 
addition to the requirements under the APA, an agency may also need to 
comply with requirements imposed by other statutes. The APA has been in 
place for more than 60 years, but most other statutory requirements on 
rulemaking have been imposed more recently. 

OMB is responsible for the coordinated review of agency rulemaking to 
ensure that regulations are consistent with applicable law, the 
President's priorities, and the principles set forth in executive 
orders, and that decisions made by one agency do not conflict with the 
policies or actions taken or planned by another agency. OMB also 
provides guidance to agencies. Some form of centralized review of rules 
by the Executive Office of the President has existed for over 30 years. 
OIRA was created within OMB by the PRA and given substantive 
responsibilities for reviewing and approving agencies' information 
collection requests. Since 1981, various executive orders also gave 
OIRA substantive regulatory review responsibilities. OIRA's current 
regulatory review responsibilities are detailed in Executive Order 
12866 related to regulatory planning and review. The order states that 
OIRA is to be the "repository of expertise concerning regulatory 
issues." 

Under Executive Order 12866, OIRA reviews agencies' significant 
regulatory actions and is generally required to complete its review 
within 90 days after an agency formally submits a draft regulation. 
Each agency provides OIRA a list of its planned regulatory actions, 
indicating those that the agency believes are significant. After 
receipt of this list, the Administrator of OIRA may also notify the 
agency that OIRA has determined that a planned regulation is a 
significant regulatory action within the meaning of the Executive 
Order.[Footnote 17] The order defines significant regulatory actions as 
those that are likely to result in a rule that may: 

1. have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities; 

2. create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; 

3. materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or: 

4. raise novel legal or policy issues arising out of legal mandates, 
the President's priorities, or the principles set forth in Executive 
Order 12866. 

The order further directs executive branch agencies to conduct a 
regulatory analysis for economically significant regulations (generally 
those rules that have an annual effect on the economy of $100 million 
or more).[Footnote 18] OIRA historical data show that since 1994 (the 
first full calendar year that Executive Order 12866 was in effect), 
approximately 15 percent of the rules that OIRA reviewed were 
economically significant. For other significant rules, the order 
requires agencies to provide an assessment of the potential costs and 
benefits of the rule. The executive order also contains several 
transparency provisions that require both OIRA and agencies to disclose 
certain information about the OIRA review process. For example, the 
order requires agencies to publicly identify substantive changes made 
to the draft at OIRA's suggestion, and it requires OIRA to disclose 
information about communications between OIRA and persons not employed 
by the executive branch pertinent to rules under OIRA's review. The 
transparency requirements are discussed in more detail later in this 
report. 

In addition to the responsibilities that OIRA exercises, OMB also 
provides guidance to agencies on regulatory requirements. In 2003, for 
example, OMB issued revised analytical guidelines for agencies to use 
in assessing the regulatory impact of economically significant 
regulations in OMB Circular No. A-4.[Footnote 19] In issuing the 
guidelines, OMB cited several significant changes from its previous 
economic guidance. They included placing a greater emphasis on cost- 
effectiveness analysis, using formal probability analysis to assess 
uncertainty for rules with more than a billion-dollar annual impact on 
the economy, and conducting a more systematic evaluation of qualitative 
as well as quantified benefits and costs.[Footnote 20] In addition, 
OMB's guidelines recommend that agencies estimate net benefits using a 
range of discount rates instead of a single discount rate.[Footnote 21] 
In 2004, OMB issued its Final Information Quality Bulletin for Peer 
Review, which established governmentwide guidance for conducting peer 
reviews of government science documents. The bulletin directs agencies, 
including independent regulatory agencies, to subject "influential 
scientific information," such as original data and formal analytic 
models used in regulatory impact assessments, to an appropriate level 
of peer review. 

New administrations generally reexamine the rulemaking process and 
OMB's role in the process. Most recently, in a memorandum of January 
30, 2009, President Obama directed the Director of OMB, in consultation 
with representatives of regulatory agencies, to produce within 100 days 
a set of recommendations for a new executive order on federal 
regulatory review.[Footnote 22] The memorandum stated that the 
recommendations should offer suggestions for, among other things, the 
relationship between OIRA and the agencies; provide guidance on 
disclosure and transparency; encourage public participation in agency 
regulatory processes; offer suggestions on the role of cost-benefit 
analysis; address the role of distributional considerations, fairness, 
and concern for the interests of future generations; identify methods 
of ensuring that regulatory review does not produce undue delay; 
clarify the role of the behavioral sciences in formulating regulatory 
policy; and identify the best tools for achieving public goals through 
the regulatory process. 

Agencies Have Limited Data on the Time and Resources Used to Address 
Regulatory Requirements in Their Rulemaking Processes: 

All agencies' rulemaking processes share three basic steps or phases: 
initiation of rulemaking actions, development of proposed rules, and 
development of final rules. Built into agencies' rulemaking processes 
are opportunities for internal and external deliberations and reviews. 
Figure 1 provides an overview of these regulatory development steps. 

Figure 1: Basic Phases of Rulemaking Processes: 

[Refer to PDF for image: illustration] 

Initiate action: 

Source of rule initiation: 
Identify action: Sources of rule initiation: 
* External; 
* Internal; 
* Statutory. 

Prioritization, planning, and approval: 
* Manage, prioritize, plan, and approve rulemaking; 
* Determine anticipated issues; 
* Ensure stakeholder input; 
* Outline plan for development. 

Develop proposed action: 

Identify issues and gather data: 
* Determine process/work groups; 
* Determine needed analysis; 
* Optional agency procedures (e.g., ANPRM). 

Develop preamble and rule language: 
* Statutory and executive order requirements; 
* Initial internal and external agency deliberation. 

Internal and external agency review: 
* Develop and select options; 
* Internal and external deliberation and approval processes. 

Publish proposed rule: 
* Sign and publish notice of proposed rule in Federal Register; 
* Stakeholder outreach. 

Develop final action: 

Receive and review comment: 
* Manage public comments on proposed rule; 
* Review and consider public comments. 

Finalize preamble and rule language: 
* Statutory and executive order requirements; 
* Optional agency procedures (e.g., supplemental proposal). 

Internal and external agency review: 
* Internal and external deliberation and approval processes. 

Publish final rule: 
* Publish final rules in Federal Register; 
* Stakeholder outreach. 

Source: EPA. 

Note: ANPRM is Advance Notice of Proposed Rulemaking. 

[End of figure] 

During initiation, agency officials identify issues that may 
potentially result in a rulemaking. Potential rulemakings may result 
from statutory requirements or issues identified through external 
sources (for example, public hearings or petitions from the regulated 
community) or internal sources (for example, management agendas). 
During this phase, agencies gather information that would allow them to 
determine whether a rulemaking is needed and to identify potential 
regulatory options. At this time, the agencies will also identify the 
resources needed for the rulemaking and may draft concept documents to 
present to agency management that summarize the issues, present the 
regulatory options, and identify needed resources.[Footnote 23] Agency 
officials reported that this initial work on a rule is of indeterminate 
length and sometimes constitutes a major portion of the process. While 
the point at which a rulemaking officially commences may vary by agency 
and rule, as a general matter, rulemaking begins only after management 
receives, reviews, and approves the concept document.[Footnote 24] At 
the latest, according to OIRA, the rulemaking will officially commence 
when agency officials assign a Regulation Identifier Number (RIN) for 
the proposed rule. 

The second phase of the rulemaking process starts when an agency begins 
developing the proposed rule. During this phase, an agency will draft 
the rule, including the preamble (which is the portion of the rule that 
informs the public of the supporting reasons and purpose of the final 
rule) and the rule language. The agency will also begin to address 
analytical and procedural requirements in this phase. Agency officials 
pointed out that these initial analyses form the basis for other 
analyses completed later in the process, including those prepared to 
address statutory and executive order requirements. Agency officials 
stated that development of a rule is a coordinated effort, with 
economists, lawyers, and policy and subject matter experts contributing 
to individual rulemakings. Also built into this phase are opportunities 
for internal and external deliberations and reviews, including official 
management approval. OIRA may be involved informally at any point 
during the process. For each rule identified by the agency as, or 
determined by the Administrator of OIRA to be, a significant regulatory 
action, the agency submits the rule to OIRA for formal review-- 
including the coordination of interagency review. After OIRA completes 
its review and the agency incorporates resulting changes, the agency 
publishes the proposed rule in the Federal Register for public 
comments. 

In the third phase of the process, the development of the final rule, 
the agency repeats, as needed, the steps used during the development of 
the proposed rule. Once the comment period closes, the agency responds 
to the comments either by modifying the rule to incorporate the 
comments or by addressing the comments in the final rule. This phase 
also includes opportunities for internal and external review. Again, if 
the agency determines that the rule is significant or at OIRA's 
request, the agency submits the rule to OIRA for review before 
publication of the final rule. In the event that OIRA's review results 
in a change to the final rule, the agency will revise the rule before 
publishing it in the Federal Register. Officials noted that addressing 
analytical and procedural requirements is faster with a draft of the 
proposed rule in hand, but analyses may need to be modified if public 
comments change the rule substantially. The final rule as published in 
the Federal Register includes the date that the rule becomes effective. 

While the agencies share these basic process steps, there are inter-and 
intra-agency variations in the management of the rulemaking process. 
For example, EPA's OW generally designates one rulemaking team member 
as the point of contact through the development of the rule. Officials 
at FDA stated that their point of contact may change during the course 
of the rulemaking based on the rule's development phase; as the office 
working on the rule within the agency changes so does the point of 
contact. Agencies also have differing numbers of required internal 
reviews, and they may complete tasks within a phase in a different 
sequence. 

Agencies Identified Milestones for Regulatory Development: 

Officials we met with described agency-specific processes for 
regulatory development and addressing the procedural and analytical 
requirements that applied to their respective rulemakings. These 
included identification of "milestones," significant events or stages 
in the agency-specific process. Officials also identified some 
milestones common to the rulemaking process that apply across the 
federal government, such as publishing the proposed and final rule. In 
addition, officials at the agencies we spoke with identified the 
following agency-specific internal milestones in their regulatory 
development process. 

* DOT officials at FAA and NHTSA identified common milestones, 
including development of a draft concept, management reviews within 
administrations, review by the Secretary's Office, and external review. 

* EPA identified 14 milestones for nonroutine rulemakings from 
initiation to publication of the proposed rule, including assigning a 
working group, development and approval of an Analytic Blueprint and 
management reviews.[Footnote 25] After the proposed rule is published, 
EPA tracks an additional 4 to 5 milestones to develop the final rule. 

* FDA officials emphasized that regulatory development is similar 
throughout FDA. CFSAN and CDER used milestones such as assigning a 
working group, drafting, and conducting analyses and management 
clearances. 

* SEC officials stated that CF and IM identified as common milestones 
generation (typically including public input), drafting, and approval 
by the commissioners. 

During the course of our review, only DOT provided us with data that 
showed it routinely tracked these milestones. In comments on our draft 
report, EPA and FDA subsequently provided some documentation and data 
that showed that these agencies also routinely tracked milestones. 
However, we had requested this information during our review to address 
our second research question, but the information was not forthcoming. 
Also, they did not provide this information at the conclusion of our 
review either in response to our statements of facts to the agencies or 
at our exit conference with the agencies. Because this information was 
not provided at the time of our review, we did not have the opportunity 
to discuss how the information is used, whether it is useful, and, most 
importantly, if it could be used to respond to our report objectives. 
We did not audit the new information provided because of an approaching 
deadline for OMB to provide recommendations to the President for a new 
executive order on federal agency regulatory review. 

DOT sets target dates for major milestones, such as when the rule is 
scheduled to move to OIRA for review. The agency uses the Rulemaking 
Management System to monitor both the target and actual dates for these 
major milestones in the development of rules for internal management 
decision-making purposes. This allows DOT regulatory development staff 
and managers to identify a rule's status and determine if the rule is 
on or behind schedule, based on target dates. Some of the information 
captured in the system includes the stage of the rulemaking (proposed 
rule, final rule), a schedule of milestones with target and actual 
dates, and an explanation for any delay. For significant regulatory 
actions, DOT makes some milestone tracking information publicly 
available through the Report on DOT Significant Rulemakings available 
on the agency's web site. Among the objectives that DOT officials 
attributed to their tracking and reporting efforts were that they 
provide opportunities to assess their schedule estimates and improve 
internal and external accountability. An official noted, for example, 
that tracking and posting the information helped the agency identify 
best estimates of schedules. 

EPA uses an internal tracking database--Rule and Policy Information and 
Development System (RAPIDS)--that contains both projected and actual 
dates for meeting major milestones in rule development. This database 
provides background information and a timetable on each stage of the 
rulemaking, including a schedule of the milestones with both projected 
and actual dates. EPA uses the data in RAPIDS to develop management 
reports used by EPA managers and executives as a planning and tracking 
tool. The reports also serve as a tool to improve the regulatory 
development process. EPA makes this tracking information available to 
the public on a quarterly basis. 

FDA also tracks regulatory milestones through its Federal Register 
Document Tracking System (FRDTS). FRDTS is an internal, Web-based 
integrated system that allows FDA to track the preparation and approval 
process of documents to be submitted to the Federal Register for 
publication. Tracking the rulemaking approval process is done for all 
rulemakings, however the system only tracks milestones for the latter 
stages of the rulemaking's development and clearing process. FDA 
management uses the information in FRDTS as one tool in the management 
of its regulatory development process. 

SEC did not have such systematic tracking and reporting of its 
scheduled and actual regulatory milestones. However, implementing such 
a system is consistent with standards for internal control.[Footnote 
26] According to the standards, for an agency to run and control its 
operations, it must have relevant, reliable information relating to 
external as well as internal events. Moreover, an acknowledged expert 
on the regulatory process has stated that a myriad of formal 
requirements and political expectations requires sophisticated 
management of the rulemaking process.[Footnote 27] Among other 
functional requirements, he noted that scheduling and budgeting for 
rulemaking are useful tools for officials to manage regulation 
development and control the resources needed to complete a rule. 
[Footnote 28] Monitoring and assessing actual performance against 
planned targets, identifying reasons for missed targets, and adjusting 
resource requirements to fit conditions based on actual experience are 
among the ways that agencies could use their rulemaking plans and 
milestones as management control and accountability tools. 

Length of Time Required to Issue a Rule Varies by Agency and Rule with 
Few Common Characteristics: 

We found variation in length of time required for the development and 
issuance of final rules both within and among agencies. In general, 
agency officials agreed that the publication of the final rule marked 
the end of the rulemaking process.[Footnote 29] In contrast, 
identifying when a rulemaking begins is less definite. All agencies 
identified milestones that marked the initiation of a rulemaking in 
their agencies, but also asserted that agency staff sometimes worked on 
certain issues related to the rulemaking years before commencement of 
the actual rulemaking, either as part of earlier, related rulemakings 
or policy development for the rule. Based on agency milestones, 
officials we spoke with at three of the four agencies provided 
estimates for the length of time for an average rulemaking. FDA 
officials estimated that a straightforward rulemaking may take up to 3˝ 
to nearly 4 years from initiation to final publication. DOT officials 
estimated approximately 1-˝ years from the end of the public comment 
period following the publication of the proposed rule to final rule. 
SEC officials estimated that some rules are completed within 6 months 
of publication of a proposed rule to final rule. EPA officials declined 
to provide an estimate for an average rulemaking at their agency, 
stating that there is too much variation. However, some agency 
officials emphasized that the average time required to issue any given 
rule could vary from these estimates, as illustrated by the 16 case- 
study rules we reviewed (see figure 2). 

Figure 2: Rulemaking Timelines from Initiation to Final Rule for 16 
Case Studies: 

[Refer to PDF for image: stacked horizontal bar chart] 

Case Study: DOT: Air tour safety; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 1.75 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 3.33 years; 
Total: 5.08 years. 

Case Study: DOT: Human space flight requirements; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 0.92 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 1 years; 
Total: 1.92 years. 

Case Study: DOT: Event data recorders; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 1.67 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 2.17 years; 
Total: 2.84 years. 

Case Study: DOT: Fuel economy-light trucks; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 1.67 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 0.67 years; 
Total: 2.34 years. 

Case Study: EPA: Ethylene oxide emissions; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 3.67 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 0.5 years; 
Total: 4.17 years. 

Case Study: EPA: Hazardous air pollutants; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 4.33 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 0.5 years; 
Total: 4.83 years. 

Case Study: EPA: Disinfection byproducts 2; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 4 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 2.42 years; 
Total: 6.42 years. 

Case Study: EPA: Surface water treatment 2; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 4 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 2.42 years; 
Total: 6.42 years. 

Case Study: FDA: Dietary supplements; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 6.08 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 4.25 years; 
Total: 10.33 years. 

Case Study: FDA: Lean nutrient claims; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 1.83 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 1.17 years; 
Total: 3.0 years. 

Case Study: FDA: Ozone depleting substances[A]; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 0.92 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 0 years; 
Total: 0.92 years. 

Case Study: FDA: Physician labeling; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 8.83 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 5.08 years; 
Total: 5.91 years. 

Case Study: SEC: Electronic shareholder forums; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 0.25 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 0.42 years; 
Total: 0.67 years. 

Case Study: SEC: Internet proxies; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 0.75 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 1.08 years; 
Total: 1.83 years. 

Case Study: SEC: Mutual fund data reporting; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 0.67 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 0.42 years; 
Total: 1.09 years. 

Case Study: SEC: Mutual fund redemption fees; 
Initiated action to publication of proposed rule (Phase I and Phase II 
of rulemaking)[B]: 1 years; 
Publication of proposed rule to publication of final rule (Phase III of 
rulemaking): 0.58 years; 
Total: 1.58 years. 

Source: GAO analysis. 		 

[A] FDA's Ozone Depleting Substances was a direct final rule, and as 
such, FDA published a proposed and final rule on the same day. 

[B] Initiation was based on agencies' best estimates of when they 
initiated the rules. Also, because of the ambiguity in the early stages 
of rulemaking--only the end of Phase II of rulemaking, publication of a 
proposed rule, has a clearly defined milestone--we did not distinguish 
between the first two phases of rulemaking. 

[End of figure] 

Using two rulemaking milestones common among federal agencies-- 
publication in the Federal Register of the proposed rule and 
publication of the final rule--the length of time for our 16 case-study 
rules ranged from approximately half a year (SEC's Mutual Fund Data 
Reporting rule) to nearly 5 years (FDA's Physician Labeling rule). As 
an illustration of the time investment in regulatory development--as 
measured from agency-specific internal milestones--the entire 
rulemaking process for the same two rules ranged from slightly over 1 
year to 13 years, respectively. Overall the average time from 
initiation to final publication of a rule for our 16 case-study rules 
was just over 4 years, with the average time for the 4 SEC rules just 
over 1 year, the DOT rules taking an average of just over 3 years, and 
the EPA and FDA rules taking longer than the overall average at 5-1/2 
and 7 years, respectively. For most of our case study rules, the time 
to develop the proposed rule was at least as much as the time between 
publication of the proposed and final rules. We also found that the 
complexity or magnitude of a major rule also did not explain all or 
most variation, as some case-study rules that were not major took 
nearly as long or longer to be published. (For more detailed 
information about the timelines for each of the case-study rules, see 
appendix II.) 

During our review we identified multiple factors that influence the 
time needed to issue a rule, including: 

* the complexity of the issues addressed by the rulemakings; 

* prioritizations set by agency management that can change when other 
priorities, such as new congressional mandates, arise; and: 

* the amount of internal and external review required at the different 
phases of the rulemaking process. 

Some agency officials said that rulemaking for complex topics or for 
rules that raise new issues typically takes longer to complete than for 
routine rules. Rules that are a management priority or have a statutory 
or judicial deadline may move more quickly through the rulemaking 
process, while other rules may be set aside as agency staff members 
work on other things. Also, rules that require OIRA and interagency 
review typically need additional time for the external review process 
and, according to some agency officials, trigger additional internal 
scrutiny. The priorities and the pace of rulemaking have also been 
affected during transitions in presidential administrations. Since 
1948, the amount of rulemaking activity has increased in the last 
months of every outgoing administration when the party in control of 
the White House changed. During every recent transition involving a 
change in the party controlling the White House since 1981, this has 
been followed by the incoming administration recommending that agencies 
delay effective dates for reconsideration of rules published at the end 
of the previous administration.[Footnote 30] 

Agencies Have Limited Information on Resources Used in Regulatory 
Development: 

There is little rule-specific tracking of resources used in regulatory 
development. Agency officials were unable to identify the staffing or 
other resources (such as contracting costs associated with preparing 
expert analyses or convening public meetings) for regulatory 
development for all rules or for the limited number of case-study 
rules. As noted above, internal control standards call for relevant, 
reliable and timely information. Regarding staffing, such management 
information was not available from agencies we audited. Officials were 
able to generally describe how they staff rulemaking, noting that 
rulemaking is a coordinated effort, with many individuals from 
throughout the agency contributing to specific rulemakings. However, 
none of the agencies routinely tracked staff time associated with 
rulemakings or were able to provide records of staff time devoted to 
case-study rulemakings or supporting analyses. Moreover, agency 
officials stated that because many staff within the agencies with 
different job functions--attorneys, economists, programs staff, as well 
as regulatory developers--contribute to individual rules, they could 
not provide after-the-fact estimates. 

However, based on their experiences, the agencies' officials identified 
ways they have explored using existing agency information for purposes 
of improving management of the rulemaking process. For example, 
according to a DOT official responsible for rulemaking, having reliable 
data on how long it takes to publish a proposed rule and identifying 
where the time is spent is critically important for reengineering the 
process. The official also pointed out that while the agency knows that 
the time of some support staff is all devoted to rulemaking, there is 
no data for tracking core program offices' involvement in technical and 
lead roles in the rulemaking process. The official noted that these 
data could help determine how much of certain staff members' time is 
reasonable and how many additional staff days would be needed to speed 
up the process. EPA officials stated that they use the tracking 
information in the agency's RAPIDS system to help identify best 
practices as well as identify those actions that need corrective 
measures. FDA officials stated that they track the rulemaking process 
from a project management perspective. According to these officials, 
this allows the agency to identify areas that appear to "logjam" the 
process and to develop mechanisms that would improve the rulemaking 
process. In addition, FDA officials stated that agency management meets 
to discuss the major milestones reported in the FRDTS to identify areas 
of improvement in the regulatory development process. SEC officials 
also track some data from a project management perspective. Officials 
stated that the former SEC Chairman was interested in knowing how long 
it takes to conduct economic analyses. During the course of our review, 
EPA, FDA, and SEC did not document these claims or provide specific 
examples of how this information was used to improve their rulemaking 
process. However, in response to our draft report, the EPA and FDA 
provided both documentation and examples to support the information 
provided above. 

Agency officials described additional details about their tracking 
efforts and the limitations of this information. One DOT agency, FAA, 
is working on a system, called Labor Distribution Reporting (LDR) that 
allows all FAA managers and employees to better understand staff 
resources required for achieving agency goals and objectives. However, 
using LDR to assess the staff time devoted to rulemaking has proven 
challenging for FAA officials responsible for rulemaking activity. 
Those officials said that the data generated by LDR have not been 
reliable and the information does not necessarily track rulemaking 
activity as distinct from other staff responsibilities. Additionally, 
attempts to aggregate LDR information by rule proved unwieldy as these 
costs are embedded in agency-wide systems that capture information at a 
higher level and for multiple purposes. FAA is reengineering its use of 
LDR by consolidating and simplifying the codes used with the goal of 
providing managers with reliable information on how staff time is used 
and how it contributes to meeting agency performance targets. SEC's CF 
also tried to do more detailed staff time coding for each rulemaking 
project but has now instituted more generic tracking by category of 
activity. A CF official also pointed out that CF's coding does not 
cover all groups within SEC that contribute to rulemaking projects. 
Another SEC official from the Division of Trading and Markets 
identified a similar tracking challenge. Although the division has 
specific rulemaking offices organized by subject area, not all the work 
done by these offices is related to rulemaking. 

Similarly, there is limited information available regarding contract 
costs. At three of the agencies in our case study--DOT, FDA, and SEC-- 
analytical and procedural requirements typically are addressed in-house 
by agency staff. One agency, EPA, regularly supplements in-house staff 
responsible for regulatory development by hiring contractors to conduct 
analyses as part of the regulatory development process. The agency does 
not track these costs by rulemaking; however, EPA officials were able 
to identify some of the costs associated with regulatory development 
for four case-study rules. For the two major OW rules--the Surface 
Water Treatment 2 rule and the Disinfection Byproducts 2 rule--the 
costs related to expert advisory panels, public meetings, travel, and 
regulatory analyses for the microbial pathogens and disinfection 
byproducts cluster of rules (that includes a total of seven rules 
including the two case study rules) were more than $13 million. As 
mentioned above, EPA did not track the costs of each of these rules 
separately throughout the course of rule development. Identified costs 
for the two nonmajor rules--the Ethylene Oxide Emissions rule and the 
Hazardous Air Pollutants rule--were less, $100,000 and $780,000, 
respectively. EPA officials told us that funding for regulatory 
analyses comes from a central budget within the program developing the 
rule. 

As stated earlier, while it is difficult to pinpoint when the 
initiation phase of rulemaking begins, agency officials reported that 
developing proposed rules constitutes a significant portion of 
regulatory development, so that much of the resource investment in a 
rulemaking occurs prior to publication of the proposed rule. For 
example, NHTSA's Fuel Economy-Light Trucks rule was just one in a 
series of related rulemakings that dated back to the 1970s, informed by 
decades of work by that agency. Also, EPA's Disinfection Byproducts 2 
rule and the Surface Water Treatment 2 rule were based on the work of 
an expert panel convened under the Federal Advisory Committee Act years 
before these rules were proposed. Another example mentioned by EPA 
officials was a stormwater management rule for the oil and gas industry 
that supplemented and was partially based on an earlier nationwide, 
multi-industry rulemaking. 

Reviews of published rules or rulemaking dockets provide little 
information on the resources and level of effort needed for agencies to 
comply with specific rulemaking requirements. As pointed out by DOT 
officials, neither the text of the rule nor the materials in the 
agency's rulemaking docket might indicate all of the resources and the 
decision-making process that the agency performed to make such 
determinations. Specifically, they noted that dockets would not 
necessarily include copies of the underlying analyses if the agency 
concluded that the rule did not trigger that requirement. Also, each 
requirement that a rule triggers does not necessarily require 
preparation of a separate analysis. Agencies can use some analyses to 
address more than one requirement (for example, using one benefit-cost 
analysis to address multiple analytical requirements). 

Even if costs and resources were tracked at the individual rule level, 
the resources used to meet general rulemaking requirements would still 
need to be captured to provide a complete picture. Rulemaking is an 
integral part of agency business, and it would be hard to separate all 
that is done for rulemaking from what also contributes to other 
operational and policy decisions. Further, given the many other demands 
on scarce agency resources, the resources that would be needed to 
develop reliable tracking data on individual rules or requirements must 
be weighed against other investments. 

Many of the Rules GAO Reviewed Triggered Few of the Broadly Applicable 
Rulemaking Requirements: 

When issuing major rules, agencies must generally comply with the APA 
and a number of other broadly applicable procedural and analytical 
requirements specified in law. However, one statutory requirement, the 
Unfunded Mandates Reform Act of 1995 (UMRA), does not apply to 
independent regulatory agencies. EPA and the Occupational Safety and 
Health Administration must also comply with a requirement to convene a 
small business advocacy review panel under the Small Business 
Regulatory Enforcement Fairness Act if their rules would have a 
significant economic impact on a substantial number of small entities-
-business or governmental.[Footnote 31] Further, agencies other than 
independent regulatory agencies are also subject to requirements in 
executive orders. In addition to the broadly applicable requirements, 
agencies may need to comply with agency-or program-specific 
requirements established by other statutes. 

Table 1 lists the 17 broadly applicable statutes and executive orders 
with rulemaking requirements that were cited by 10 or more major rules 
that we reviewed for this report.[Footnote 32] For each we provide a 
high-level characterization of agencies' responsibilities under the 
requirement. (Appendix I provides additional information about these 
requirements.) 

Table 1: Rulemaking Requirements Generally Applicable to Major Rules: 

Requirements applicable to rules of all agencies: 

Source of requirements: Administrative Procedure Act; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Procedures required for informal rulemaking, 
also known as notice-and-comment rulemaking. 

Source of requirements: Congressional Review Act; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Submission of rules to Congress for review. 

Source of requirements: Endangered Species Act; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Analysis of impact on endangered or 
threatened species. 

Source of requirements: National Environmental Policy Act; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Analysis of environmental impacts. 

Source of requirements: National Technology Transfer and Advancement 
Act; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Use of voluntary consensus standards. 

Source of requirements: Paperwork Reduction Act; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Analysis of paperwork burden and submission 
to OIRA for approval of new information collections. 

Source of requirements: Regulatory Flexibility Act; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Consideration of regulatory alternatives to 
lessen the burden on small entities. 

Requirements applicable to rules of cabinet departments and independent 
agencies, but not to rules of independent regulatory agencies: 

Source of requirements: Unfunded Mandates Reform Act; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Analysis of costs and benefits of federal 
mandates and consideration of alternatives. 

Source of requirements: Executive Order 12372; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Consultation with state and local elected 
officials. 

Source of requirements: Executive Order 12630; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Analysis of impact on constitutionally 
protected property rights. 

Source of requirements: Executive Order 12866; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Submission of significant rules for OIRA 
review and analysis of costs, benefits, and regulatory alternatives. 

Source of requirements: Executive Order 12898; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Consideration of environmental justice impact 
on minority and low-income populations. 

Source of requirements: Executive Order 12988; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Ensuring clarity of regulatory language 
regarding legal rights and obligations. 

Source of requirements: Executive Order 13045; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Evaluation of environmental health or safety 
effects on children. 

Source of requirements: Executive Order 13132; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Consultation with state and local officials 
on federalism implications. 

Source of requirements: Executive Order 13175; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Consultation with Indian tribal governments. 

Source of requirements: Executive Order 13211; 
Characterization of agencies' responsibilities: Requirements applicable 
to rules of all agencies: Analysis of effects on energy supply, 
distribution, or use. 

Source: GAO. 

[End of table] 

Our review of the 139 major rules published from January 2006 through 
May 2008 showed that many of the procedural and analytical requirements 
that generally apply to the agencies were not triggered by specific 
rules. An agency may not need to include specific analyses if the 
substance of the rule or exceptions, exclusions, and thresholds in the 
requirement lead the agency to determine that the requirement was not 
triggered by a specific rule. For example, if the substance of a rule 
includes no new information collections, the agency would not have to 
estimate burden hours under the PRA. Exceptions and exclusions can be 
either categorical or statute specific. As an example of a categorical 
exception, the APA notice-and-comment requirements do not apply to any 
rule regarding a military or foreign affairs function of the United 
States. Also, the RFA and UMRA requirements do not apply if a rule was 
exempt from the APA notice-and-comment requirements. An example of a 
statute-specific exemption is section 1601(c) of the Farm Security and 
Rural Investment Act of 2002 that generally exempted rules issued by 
the Department of Agriculture's Commodity Credit Corporation from the 
APA and the PRA requirements.[Footnote 33] The applicability of certain 
requirements is also limited by threshold provisions. For example, 
agencies only need to prepare UMRA "written statements" for rules that 
the agencies believe include a federal intergovernmental or private 
sector mandate that may result in expenditures of $100 million or more 
(adjusted for inflation) in any year.[Footnote 34] Taken as a whole, an 
agency may need to work through a series of determinations for each 
rule under each requirement regarding substance, exceptions, and 
thresholds.[Footnote 35] 

In the 139 major rules we reviewed, the agencies mentioned at least 29 
different broadly applicable requirements, but most rules actually 
triggered only a handful of the requirements. Our review of the major 
rules showed that in addition to the procedural requirements under the 
APA and the CRA, the only analytical requirements triggered by 45 
percent or more of all rules were the PRA, the RFA, and Executive Order 
12866. Collectively, however, the requirements resulted in agencies 
providing at least some information on the costs, benefits, or both 
associated with 91 percent of the major rules.[Footnote 36] Agencies 
also frequently cited the UMRA and Executive Order 13132 related to 
federalism, but the rules seldom triggered those requirements. Figure 3 
illustrates how often the agencies stated that their rules triggered 
the most commonly cited analytical requirements, according to our major 
rules reports. 

Figure 3: Percentage of 139 Major Rules That Triggered Rulemaking 
Requirements: 

[Refer to PDF for image: vertical bar graph] 

Statute: Paperwork Reduction Act: 66%; 
Statute: Regulatory Flexibility Act: 45%; 
Statute: Unfunded Mandates Reform Act: 17%; 
Executive Order: E.O. 12866 (regulatory review): 84%; 
Executive Order: E.O. 13132 (federalism): 5%. 

Source: GAO analysis. 

Note: Other requirements were triggered by less than 5 percent of the 
major rules reviewed. 

[End of figure] 

Similarly, the 16 case-study rules that we reviewed triggered some, but 
not all, of the broadly applicable requirements. All 16 of the rules 
discussed requirements under the PRA and the RFA, but only 11 triggered 
a PRA analysis and 10 an RFA analysis. Except for the rules promulgated 
by SEC, all of the rules discussed UMRA and Executive Order 13132 
requirements; however, only 4 rules triggered an UMRA analysis and 3 a 
federalism analysis. The 4 case-study rules from DOT, EPA, and FDA that 
were economically significant rules also included quantitative cost- 
benefit analyses required under Executive Order 12866. Figure 4 
illustrates how often the agencies stated that the case-study rules 
triggered the most commonly cited analytical requirements. (See the 
case studies in appendix II for further details on the regulatory 
requirements addressed by each rule.) 

Figure 4: Number of 16 Case-Study Rules That Triggered Rulemaking 
Requirements: 

[Refer to PDF for image: vertical bar graph] 

Statute: Paperwork Reduction Act: 
Number of case-study rules: 11. 

Statute: Regulatory Flexibility Act: 
Number of case-study rules: 10. 

Statute: Unfunded Mandates Reform Act: 
Number of case-study rules: 4. 

Executive Order: E.O. 12866 (regulatory review): 
Number of case-study rules: 12. 

Executive Order: E.O. 13132 (federalism): 
Number of case-study rules: 3. 

Source: GAO analysis. 

Note: UMRA, Executive Order 12866, and Executive Order 13132 do not 
apply to the 4 SEC rules because SEC is an independent regulatory 
agency. 

[End of figure] 

Agencies Reported That Recent Regulatory Requirements Presented Some 
Challenges Initially: 

Agency officials from case-study agencies reported that in some 
instances, the new requirements imposed by OMB since 2003 were 
challenging initially, requiring additional time and resources. 
However, some officials noted that these recent requirements reflected 
practices that some agencies had already adopted. For example, FDA had 
routinely circulated the regulatory impact analyses of economically 
significant rules for peer review before submitting the rules to OMB 
prior to the 2004 issuance of the Peer Review Bulletin and while these 
regulatory impact analyses are excluded from the requirements of the 
Bulletin, FDA continues to circulate them for peer review. FDA 
officials agreed that the revised OMB Circular No. A-4 helped to 
clarify expectations for their economic analyses and in some cases 
resulted in less time needed for OMB review and greater confidence in 
the regulatory choices. 

Initially incorporating certain aspects of the new requirement for 
formal probability analysis to assess uncertainty lengthened the 
rulemaking process for one agency. NHTSA officials reported that prior 
to issuance of revised Circular No. A-4--which requires formal 
probability analysis to assess uncertainty for rules with more than a 
billion-dollar annual impact on the economy--NHTSA used a simpler form 
of uncertainty analysis, called sensitivity analysis, rather than the 
more formal probability analysis. When NHTSA performed its first 
probability analysis under OMB Circular No. A-4, it took several weeks 
to complete and required contracting resources outside the agency--not 
a typical practice for NHTSA. In addition, to meet its statutory 
deadline, the agency sent the rule to OIRA for review before completing 
the probability analysis. In contrast, EPA had incorporated probability 
analysis into its regulatory development process on a case-by-case 
basis prior to the issuance of Circular No. A-4 and therefore did not 
find that requirement challenging. 

Officials from case-study agencies identified two long-standing 
analytical and procedural requirements, the PRA regarding information 
collections and the RFA regarding analysis of rules' effects on small 
entities, as having had more significant effects on time and resources 
than the more recent requirements. Some officials said that these 
requirements add time to the rulemaking process and may even work at 
cross-purposes during the course of regulatory development. Agency 
officials at FDA and SEC reported that compliance with the PRA 
information collection requirements may add a year or more to the 
timeline of regulatory development. As a result, rather than gather new 
information to support a rulemaking, agency officials will sometimes 
rely on existing information, information available from a more limited 
number of sources, or information gathered through public notices. This 
can make it more difficult to determine the effect of a regulation on 
small entities that may not be represented by a small sample of 
interested parties or respond to public notices. FDA officials stated 
that the agency posts on its Web site a "Dear Colleague" letter 
alerting the small business community to the rulemakings listed in the 
semi-annual Unified Agenda and Regulatory Plan that may affect small 
business. This letter explains how to contact the agency and encourages 
small businesses to become involved early in the rulemaking process. 
However, it can still be difficult to determine the effect of a 
regulation on small entities. According to the agency officials, this 
requires agencies to either move forward with available information or 
go through time-consuming approvals for information collections under 
the PRA. 

OIRA's Role in the Rulemaking Process Could Be More Transparent: 

Our review of 12 DOT, EPA, and FDA rules submitted to OIRA for formal 
review under Executive Order 12866 indicated that for 10 of the 12 
rules, the agencies identified OIRA changes to the rules. Using the 
same basic methodology as in our 2003 report on the effect of OIRA's 
review process, we used a variety of information sources (such as 
agency and OIRA docket materials and interviews with agency officials) 
to classify the most significant level of changes attributed to OIRA's 
review.[Footnote 37] For each of the 12 rules, we classified the level 
of OIRA changes into one of the following three categories: 

* Significant changes. Rules in which the most significant changes 
affected the scope, impact, or estimated costs and benefits of the 
rules as originally submitted to OIRA. Usually, these changes were made 
to the regulatory language that would appear in the Code of Federal 
Regulations and is legally binding. For example, in an FDA rule on 
dietary supplements, OIRA suggested a change in the regulatory language 
to reduce the number of years required to save a reserve sample. 
However, revisions to a cost-benefit analysis could also be significant 
because they affect the reported impact of a rule. 

* Other material changes. Rules in which the most significant changes 
resulted in the addition or deletion of material in the explanatory 
preamble section of the rule. For example, in a DOT rule on event data 
recorders, OIRA suggested a change in the explanatory language 
clarifying that crash investigators and researchers are able to 
download data from the recorders. 

* Minor or no OIRA changes. Rules in which there were no changes made 
to the draft rule, the most significant changes attributed to OIRA's 
suggestions resulted in editorial or other minor revisions, or any 
changes in the rule prior to publication were not at the suggestion of 
OIRA. 

As shown in table 2, we determined that OIRA suggested "significant" 
changes for 4 of the 12 case-study rules submitted for Executive Order 
12866 reviews, "other material" changes for 4 of the rules, and "minor" 
changes for 2 of the rules. OIRA did not suggest any changes for the 
remaining 2 rules. Of the 4 rules that had significant changes, 2 were 
rules developed and promulgated by EPA and 1 each by DOT and FDA. In 
addition 3 of the 4 rules with significant changes were major rules. 
(See the case studies in appendix II for further details on the changes 
made to rules reviewed by OIRA.) 

Table 2: Classification of OIRA Review Changes to Case-Study Rules: 

Agency rule: DOT/FAA; Air Tour Safety; 
Most significant OIRA review period changes: Significant changes; 
Examples of OIRA review changes: Change to regulatory text: 
Clarification that annual events limit is either four charitable events 
or nonprofit events, not four of each; Change to preamble: Addition of 
chart explaining changes proposed by rule from existing regulation. 
Clarification of difference between "Operation Specification" and 
"Letter of Authorization." 

Agency rule: DOT/FAA; Human Space Flight; Requirements; 
Most significant OIRA review period changes: Minor or no changes; 
Examples of OIRA review changes: The agency did not consider OIRA's 
changes significant. 

Agency rule: DOT/NHTSA; Fuel Economy-Light Trucks; (major rule); 
Most significant OIRA review period changes: Minor or no changes; 
Examples of OIRA review changes: The agency did not consider OIRA's 
changes significant. 

Agency rule: DOT/NHTSA; Event Data Recorders; 
Most significant OIRA review period changes: Other material changes; 
Examples of OIRA review changes: Changes to preamble: Language change 
related to ensuring that crash investigators and researchers are able 
to download data from the recorders. Addition to the owner's manual of 
a sentence advising owners that a recorder does not store or collect 
personal information. 

Agency rule: EPA/AR; Ethylene Oxide Emissions; 
Most significant OIRA review period changes: Other material changes; 
Examples of OIRA review changes: Changes to preamble: Language change 
that mentions how EPA could adopt a "mixed approach and issue generally 
available control technologies or management practices (GACT) standards 
for certain emission points and required maximum achievable control 
technologies (MACT) standards for other emission points. In addition, 
there is language change regarding cancer risks to individuals exposed 
to emissions from regulated source. 

Agency rule: EPA/AR; Hazardous Air Pollutants; 
Most significant OIRA review period changes: Other material changes; 
Examples of OIRA review changes: Changes to preamble: Related section 
specifying periodic determinations of pertinent technical factors. 
Added language to provide a more balanced discussion of rationale for 
selecting "no control." Requested EPA expand its discussion on risks 
reduced by emission controls. 

Agency rule: EPA/OW; Disinfection Byproducts 2; (major rule); 
Most significant OIRA review period changes: Significant changes; 
Examples of OIRA review changes: Changes to regulatory text: Changed 
repeat compliance monitoring to apply only when more than eight 
monitoring locations were required, rather than four. Removed 
additional requirements for repeat monitoring. 

Agency rule: EPA/OW; Surface Water Treatment 2; (major rule); 
Most significant OIRA review period changes: Significant changes; 
Examples of OIRA review changes: Change to regulatory text: Addition of 
notification of violation requirements for public water systems. 
Modification of regulatory section on provision of additional 
circumstances under which data can be grandfathered under state 
approval; Change to preamble: Indication that regulated systems may 
assume state approval of monitoring locations if explicit approval is 
not forthcoming. 

Agency rule: FDA/CDER; Physician Labeling; 
Most significant OIRA review period changes: Other material changes; 
Examples of OIRA review changes: Changes to preamble: Deletion of a PRA-
related estimate of the number of respondents. Altered the number of 
affected pharmaceutical firms that could be considered small 
businesses. 

Agency rule: FDA/CDER; Ozone Depleting Substances; 
Most significant OIRA review period changes: Minor or no changes; 
Examples of OIRA review changes: No changes suggested by OIRA. 

Agency rule: FDA/CFSAN; Dietary Supplements; (major rule); 
Most significant OIRA review period changes: Significant changes; 
Examples of OIRA review changes: Change to regulatory text: Requirement 
in the draft rule to save reserve samples for 3 years was changed to 2 
years; Change to regulatory impact analysis: Added text justifying the 
rulemaking and additional description of calculations of costs 
associated with illness and injury associated with contaminated or 
mislabeled dietary supplements. 

Agency rule: FDA/CFSAN; Lean Nutrient Claims; 
Most significant OIRA review period changes: Minor or no changes; 
Examples of OIRA review changes: No changes suggested by OIRA. 

Source: GAO analysis. 

[End of table] 

Documentation of OIRA Review Was Sometimes Incomplete: 

Executive Order 12866 requires both agencies and OIRA to disclose to 
the public certain information about OIRA's regulatory reviews. After 
the regulatory action has been published in the Federal Register or 
otherwise issued to the public, an agency is required to: 

1. make available to the public the information provided to OIRA in 
accordance with the executive order;[Footnote 38] 

2. identify for the public, in a complete, clear, and simple manner, 
the substantive changes between the draft submitted to OIRA and the 
action subsequently announced; and: 

3. identify for the public those changes in the regulatory action that 
were made at the suggestion or recommendation of OIRA.[Footnote 39] 

The order requires OIRA to maintain a publicly available log that 
includes the following information pertinent to rules under OIRA's 
review: 

1. the status of rules submitted for OIRA review, 

2. a notation of all written communications received by OIRA from 
persons not employed by the executive branch, and: 

3. information about oral communications between OIRA and persons not 
employed by the executive branch. 

After the rule has been published or otherwise issued to the public (or 
the agency has announced its decision to not publish or issue the 
rule), OIRA is required to make available to the public all documents 
exchanged between OIRA and the agency during the review by OIRA. 
[Footnote 40] An OIRA official also pointed out that OIRA does not 
monitor, on a rule-by-rule basis, compliance by rulemaking agencies 
with their disclosure obligations under Executive Order 12866. 

The case-study agencies generally met the executive order's 
requirements to disclose materials they provided to OIRA and 
substantive changes made during OIRA's review. In contrast to our study 
in 2003, all the agencies we reviewed for this report had documentation 
of OIRA's reviews. However, the documentation could be improved for 
greater transparency. Executive Order 12866 does not specify how 
agencies should document the changes made to draft rules after their 
submission to OIRA, nor is there any governmentwide guidance that 
directs agencies on how to do so. Nonetheless, some of the 
documentation on OIRA's changes was very clear, but in other cases 
additional efforts were required to interpret the information. As we 
found in 2003, the agencies did not always clearly attribute changes 
made at the suggestion of OIRA, and agencies' interpretations were not 
necessarily consistent regarding what constitutes a substantive change 
that should be documented to comply with the executive order 
transparency requirements. For example, different departments within 
one agency had varied interpretations, with one office only considering 
those changes made to regulatory text as substantive. Table 3 provides 
summary information about the type and nature of agencies' 
documentation to address Executive Order 12866 transparency 
requirements for the 12 case-study rules reviewed by OIRA. (See 
appendix III for examples of agencies' OIRA review documentation.) 

Table 3: Documentation of OIRA Reviews for Case-Study Rules: 

Agency rule: DOT/FAA; Air Tour Safety; 
Source of OIRA review documentation: Online public rulemaking docket 
(regulations.gov)[A]; 
How agency documented OIRA review: Memo to internal file; 
Whether publicly available documentation attributed source(s) of 
changes made to rule: No. 

Agency rule: DOT/FAA; Human Space Flight; Requirements; 
Source of OIRA review documentation: Testimonial evidence from 
officials; 
How agency documented OIRA review: N/A (no substantive changes); 
Whether publicly available documentation attributed source(s) of 
changes made to rule: N/A (no substantive changes). 

Agency rule: DOT/NHTSA; Fuel Economy - Light Trucks; (major rule); 
Source of OIRA review documentation: Testimonial evidence from 
officials; 
How agency documented OIRA review: N/A (no substantive changes); 
Whether publicly available documentation attributed source(s) of 
changes made to rule: N/A (no substantive changes). 

Agency rule: DOT/NHTSA; Event Data Recorders; 
Source of OIRA review documentation: Online public rulemaking docket 
(regulations.gov); 
How agency documented OIRA review: Memo to file in docket; 
Whether publicly available documentation attributed source(s) of 
changes made to rule: Yes. 

Agency rule: EPA/OAR; Ethylene Oxide Emissions; 
Source of OIRA review documentation: Online public rulemaking docket 
(regulations.gov); 
How agency documented OIRA review: Redline/strikeout document(s) in 
docket; 
Whether publicly available documentation attributed source(s) of 
changes made to rule: Yes. 

Agency rule: EPA/OAR; Hazardous Air Pollutants; 
Source of OIRA review documentation: Online public rulemaking docket 
(regulations.gov); 
How agency documented OIRA review: Redline/strikeout and e-mails in 
docket; 
Whether publicly available documentation attributed source(s) of 
changes made to rule: Yes. 

Agency rule: EPA/OW; Disinfection Byproducts 2; (major rule); 
Source of OIRA review documentation: Online public rulemaking docket 
(regulations.gov); 
How agency documented OIRA review: Redline/strikeout and check box form 
in docket; 
Whether publicly available documentation attributed source(s) of 
changes made to rule: No. 

Agency rule: EPA/OW; Surface Water Treatment 2; (major rule); 
Source of OIRA review documentation: Online public rulemaking docket 
(regulations.gov); 
How agency documented OIRA review: Redline/strikeout, check box memo to 
the file in docket; 
Whether publicly available documentation attributed source(s) of 
changes made to rule: No. 

Agency rule: FDA/CDER; Physician Labeling Rule; 
Source of OIRA review documentation: Online public rulemaking docket 
(regulations.gov); 
How agency documented OIRA review: Redline/strikeout (changed pages 
consolidated) in docket; 
Whether publicly available documentation attributed source(s) of 
changes made to rule: Yes. 

Agency rule: FDA/CDER; Ozone Depleting Substances; 
Source of OIRA review documentation: OIRA regulatory review Web site 
[hyperlink, http://www.reginfo.gov]; 
How agency documented OIRA review: N/A - Rule classified as "consistent 
without change"; 
Whether publicly available documentation attributed source(s) of 
changes made to rule: N/A (no changes). 

Agency rule: FDA/CFSAN; Dietary Supplements; (major rule); 
Source of OIRA review documentation: Paper docket at FDA because of 
difficulties using online docket; 
How agency documented OIRA review: Redline/strikeout in docket (62 
documents); 
Whether publicly available documentation attributed source(s) of 
changes made to rule: No. 

Agency rule: FDA/CFSAN Lean Nutrient Claims; 
Source of OIRA review documentation: Online public rulemaking docket 
[hyperlink, http://www.regulations.gov]; 
How agency documented OIRA review: Note to file (with an unchanged rule 
draft); 
Whether publicly available documentation attributed source(s) of 
changes made to rule: N/A (no changes). 

Source: GAO analysis. 

[A] Added to the docket subsequent to our review. 

[End of table] 

As we also found in 2003, agencies sometimes included more information 
about OIRA's review than required, and we found such information useful 
to more clearly explain what had occurred. For example, EPA included 
copies of messages from OIRA outlining suggested changes to draft rules 
under review. EPA also included a memo to the docket summarizing the 
subjects discussed with OIRA at a meeting about one of the case-study 
rules. In the case of one rule that was unchanged by OIRA, FDA's docket 
included both an annotated copy of the rule returned to FDA and a memo 
to the file noting that there were no changes to the draft rule. 

In general, compared to our review in 2003, we found it more difficult 
to find agencies' documentation of OIRA's regulatory reviews, primarily 
because of difficulties using the search capabilities in the 
centralized electronic Federal Docket Management System under 
[hyperlink, http://www.regulations.gov]. Using the advanced docket 
search function as instructed by the Web site user information to first 
find the rule, we searched by the rule title, the RIN, and the rule 
Docket ID independently and as they appeared in the published version 
of the final rule in the Federal Register. Using those criteria, we 
were able to find all four of the DOT case-study rules submitted for 
OIRA review but only one each of the 4 FDA rules and 4 EPA rules. We 
chose to use paper dockets when the opportunity presented itself for 
the FDA case study rules.[Footnote 41] 

Agencies' labeling practices also sometimes made it difficult to find 
the relevant documentation about OIRA's reviews. Out of 12 dockets, we 
were able to identify 5 of the 10 changed rules and 1 of the 2 
unchanged rules by searching the docket Web pages for "12866," "OIRA," 
and "OMB." In addition, while the agencies' published rules stated that 
the rules had been reviewed by OIRA under Executive Order 12866, most 
of the rules did not identify whether substantive changes had been made 
during the OIRA review period (and therefore documentation of the 
changes should be included in the rulemaking docket). Although there is 
no requirement for agencies to do so, including such additional 
information would be consistent with how agencies discuss other 
rulemaking requirements in published rules and potentially help readers 
navigate the docket. Such information, for example, would more clearly 
have identified which of our case-study rules' dockets should include 
documentation of OIRA review changes. 

In response to the disclosure requirements placed on OIRA by Executive 
Order 12866, OIRA's meeting logs indicated that parties not employed by 
the executive branch initiated meetings with OIRA regarding 7 of the 12 
case-study rules, but we do not know what influence meeting discussions 
had on OIRA recommendations because there is no requirement for OIRA to 
disclose the substance of the meetings. OIRA logged a total of 10 
meetings, but 2 of the meetings each concerned 2 rules. Three of these 
meetings occurred before formal submission of the draft rule for OIRA 
review. There were meetings on all 4 EPA case-study rules. As we found 
during our review in 2003, most of the nonfederal parties appeared to 
be representatives of regulated entities. In all but 2 of the meetings, 
the agency issuing the regulation was represented. 

OIRA Implemented Only One of Eight Prior GAO Recommendations to Improve 
Transparency of the Regulatory Review Process: 

In our 2003 report on the OMB/OIRA regulatory review process, we made 
eight recommendations to the Director of OMB to improve the 
transparency of the process.[Footnote 42] OMB implemented our 
recommendation to improve the clarity of OIRA's meeting log to better 
identify participants in OMB meetings with external parties on rules 
under review by disclosing the affiliations of participants. In some 
cases, the log also identified the clients represented. 

However, OIRA did not agree with the seven remaining recommendations in 
the 2003 report and did not implement those recommendations. We 
recommended that OIRA should do the following: 

1. Define the transparency requirements applicable to the agencies and 
OIRA in Executive Order 12866 in such a way that they include not only 
the formal review period, but also the informal review period when OIRA 
says it can have its most important impact on agencies' rules. 

2. Change OIRA's database to clearly differentiate within the 
"consistent with change" outcome category which rules were 
substantively changed at OIRA's suggestion or recommendation and which 
were changed in other ways and for other reasons. 

3. Reexamine OIRA's current policy that only documents exchanged by 
OIRA branch chiefs and above need to be disclosed because most of the 
documents that are exchanged while rules are under review at OIRA are 
exchanged between agency staff and OIRA desk officers. 

4. Establish procedures whereby either OIRA or the agencies disclose 
the reason why rules are withdrawn from OIRA review. 

5. Define the types of "substantive" changes during the OIRA review 
process that agencies should disclose as including not only changes 
made to the regulatory text but also other, noneditorial changes that 
could ultimately affect the rules' application (for example, 
explanations supporting the choice of one alternative over another and 
solicitations of comments on the estimated benefits and costs of 
regulatory options). 

6. Instruct agencies to put information about changes made in a rule 
after submission for OIRA's review and those made at OIRA's suggestion 
or recommendation in the agencies' public rulemaking dockets, and to do 
so within a reasonable period after the rules have been published. 

7. Encourage agencies to use "best practice" methods of documentation 
that clearly describe those changes. 

We discussed the status of these open recommendations with OIRA 
representatives annually since 2003 and also as part of this review, 
and they confirmed that OIRA had not subsequently implemented any of 
the seven remaining recommendations. As discussed above, our current 
review indicated that there are still opportunities to improve 
transparency for some of these topics, such as better identification of 
when agencies made substantive changes to their rules as a result of 
the OIRA review process, attributing the sources of changes made during 
the review period, and clarifying the definition of substantive 
changes. Other issues covered by our 2003 recommendations--such as OIRA 
informal reviews and disclosing why rules are withdrawn from OIRA 
review--did not arise during this review, but this may reflect the 
nature of the specific rules we reviewed and our more limited sample of 
case studies. 

Conclusions: 

Federal regulatory agencies issue many rules to ensure public health 
and safety, protect the environment, and facilitate the effective 
functioning of financial markets, among other goals. Because these 
rules can affect so many aspects of citizens' lives, it is crucial that 
rules be carefully developed and considered and that rulemaking 
procedures be effective and transparent. To further such goals, 
Congresses and Presidents have placed many procedural and analytical 
requirements on the rulemaking process over the years. While we and 
others have reported on agencies' implementation of individual 
requirements, there has been little analysis of the cumulative effects 
these requirements have on agencies' rulemaking processes. 

Our study of broadly applicable requirements illustrated the 
difficulties of evaluating the effects of regulatory requirements on 
the rulemaking process with limited data. To the extent that agencies 
had information for selected rules, it showed considerable variation in 
the time required for issuing final rules that could not be explained 
by the number of regulatory requirements, few of which were triggered. 
Moreover, the complexity or magnitude of a major rule also did not 
explain all or most variation, as some case-study rules were not major 
and took nearly as long or longer to be published. This raises the 
question of what factors can account for the variations in rule 
development. While our findings point to better use of existing 
estimates and plans to identify opportunities to improve the rulemaking 
process, agencies also recognized more can be done and, in some cases, 
have taken steps to answer this question. 

We found that early in their rulemaking processes each agency 
identified the key milestones it needed to accomplish to produce a 
final rule. During the course of our review, only DOT provided data 
that it routinely tracked these milestones and reported internally and 
externally on the status of milestones for development of the agency's 
significant rules. However, in comments on our draft report, EPA and 
FDA subsequently provided some documentation and data on their tracking 
and reporting of milestones. Although there is no right time for how 
long a rulemaking should take, monitoring actual versus estimated 
performance enables agency managers to identify steps in the rulemaking 
process that account for substantial development time and provides 
information necessary to further evaluate whether the time was well 
spent. Although not all factors are within an agency's control, some 
are. Agency officials we spoke with identified several potential 
benefits to monitoring and reporting, including better scheduling and 
increased internal and external accountability. This is also consistent 
with the internal control standard that an agency must have relevant, 
reliable information relating to external as well as internal events. 
Additionally, officials in three of the four agencies we audited said 
they would benefit from a better understanding of how staff resources 
are used, even though agencies' efforts so far have produced limited 
results. Information on only one element in the rulemaking process-- 
length of time--cannot answer whether an agency is managing well. 
However, such information can provide insights into the process, such 
as when it contributed to our efforts to determine the relative burden 
of various regulatory requirements. 

Our review of major and case-study rules indicated that the majority of 
the rules triggered only a few of the rulemaking requirements. The 
requirements that rules most often triggered are among the longest 
standing and broadly applicable--the PRA, the RFA, and centralized OIRA 
review under Executive Order 12866. The PRA and the RFA generally apply 
to all agencies and rules, and officials from each of the agencies 
where we conducted case studies cited those requirements as ones that 
consistently added time to the rulemaking process and required 
investments of agency resources. Similarly, under Executive Order 
12866, we observed that a relatively small portion of rules submitted 
to OIRA for review have economic consequences significant enough to 
trigger the most rigorous analytical requirements, so any burden of 
compliance with those requirements is not very widespread. The majority 
of rules submitted for OIRA review (around 85 percent historically) are 
significant for reasons other than their economic impact. 

The case-study agencies generally met the executive order's 
requirements to disclose materials they provided for OIRA's review and 
substantive changes made during OIRA's review. For those case-study 
agencies and rules subject to OIRA review, some agency practices were 
more effective than others in communicating review results. 
Transparency problems that we identified in the past persist, such as 
incomplete attribution of changes and inconsistent definitions of 
substantive changes among and within agencies. Also, unlike when 
addressing other regulatory requirements--where agencies typically note 
in the published rule whether the rule triggered the requirements-
-the agencies did not clearly identify in their final rules when 
substantive changes had been made during the OIRA review period. OIRA, 
as the agency responsible for providing oversight and guidance to 
agencies on regulatory matters, is the principal entity in a position 
to ensure consistent compliance across agencies if the administration 
retains transparency requirements regarding regulatory review. 

Recommendations for Executive Action: 

We are making six recommendations to improve the monitoring and 
evaluation of rules development and the transparency of the review 
process. 

To be consistent with internal controls for information in managing 
agency operations, we recommend that for significant rules the 
Commissioner of FDA and the Chairman of SEC routinely track major 
milestones in regulatory development and report internally and 
externally when major milestones are reached against established 
targets. The Administrator of EPA, the Commissioner of FDA, and the 
Chairman of SEC should each also evaluate actual performance versus the 
targeted milestones and when they are different determine why. 

If the current administration retains Executive Order 12866, or 
establishes similar transparency requirements, we recommend that the 
Director of OMB, through the Administrator of OIRA, take the following 
four actions to more consistently implement the order's requirement to 
provide information to the public "in a complete, clear, and simple 
manner": 

* define in guidance what types of changes made as a result of the OIRA 
review process are substantive and need to be publicly identified, 

* instruct agencies to clearly attribute those changes "made at the 
suggestion or recommendation of OIRA," 

* direct agencies to clearly state in final rules whether they made 
substantive changes as a result of the OIRA reviews, and: 

* standardize how agencies label documentation of these changes in 
public rulemaking dockets. 

Agency Comments and Our Evaluation: 

We provided a draft of this report to the Department of Health and 
Human Services (HHS), DOT, EPA, SEC, and OMB. We received written 
comments from HHS/FDA, EPA, SEC, and OMB which are summarized below and 
reprinted in appendices IV through VII. However, because EPA and FDA 
provided new information as part of agency comments, we did not analyze 
the information provided and conduct follow-up discussions with agency 
officials prior to publication of this report. We note that we had 
asked for this information during our review and the agencies did not 
provide at that time. Also, they did not provide this information at 
the conclusion of our review either in response to our statements of 
facts to the agencies or at our exit conference with the agencies. DOT 
provided only technical comments. With regard to the two 
recommendations directed to the rulemaking agencies, SEC stated that 
the Commission is committed to evaluating and improving all of it 
processes and will consider our recommendations as part of that 
process. 

With regard to our recommendation that for significant rules agencies 
routinely track major milestones in regulatory development and report 
internally and externally when major milestones are reached against 
established targets, FDA commented that the scope of this 
recommendation should be more narrow and flexible. Specifically, FDA 
commented that: (1) the scope of tracking should be limited to only 
economically significant rules because FDA cannot predict with 
certainty what rules OMB will consider otherwise significant until 
close to rule clearance, (2) alternative tracking approaches should be 
permitted since FDA has the FRDTS that tracks the progress of all its 
Federal Register documents through the latter stages of the agency's 
development and clearance process, and (3) routine reporting on when 
major milestones are met should only be internal because reporting 
externally may mislead stakeholders and prompt inquiries that draw 
resources away from the agency's ability to complete regulations. 

While we agree that some flexibility is necessary, we disagree about 
narrowing the scope of our recommendation. For example, regarding FDA's 
proposal to narrow the scope to only economically significant rules, in 
this report we note that about 85 percent of all significant rules are 
not economically significant, so such a limitation would drop the bulk 
of the agency's regulatory activity. Further, with regard to FDA's 
point that it is uncertain what rules OMB will deem significant, in 
this report we stated that under Executive Order 12866 the agency, not 
OMB, has the primary responsibility to first identify which rules are 
significant. Therefore, FDA should be aware of many if not most of the 
rules that are deemed significant in its inventory. For those rules 
that OMB deems significant only at the latter stages of rulemaking, we 
recognize that tracking might have to begin at that stage. Regarding 
FDA's second point, we did not recommend one particular system and 
recognize that the information in FRDTS provides tracking data on 
milestones. However, we note that these data are limited to the latter 
stages of the rulemaking process. Because our review showed that the 
earlier developmental stages of a rule could be a significant portion 
of time spent in regulatory development, there is value in also 
tracking milestones in the earlier stages. Regarding FDA's third point, 
it is still important to report some information externally as well as 
internally to improve the transparency and accountability of the 
agency's rulemaking process. Further, we believe that FDA's concern 
about the impact that reporting some information externally could have 
on agency resources is overstated. None of the agencies we met with 
during this review identified responding to public inquiries as a major 
factor affecting resources and timeliness. Also, there is nothing that 
precludes agencies from providing reasons for delays when externally 
reporting this information to reduce the volume of public inquiries. 
Therefore, we kept this recommendation addressed to FDA. 

With regard to our second recommendation that agencies should also 
evaluate actual performance versus the targeted milestones, FDA stated 
that the agency is already engaged in quality improvement efforts for 
its rulemaking process. Specifically, FDA said that its Policy Council 
has quarterly meetings with the agency components and the agency 
periodically reviews its rulemaking processes to see if changes are 
needed. Also, FDA noted that 12 such reviews have been completed since 
1981, and identified two recent pilot projects resulting from these 
reviews. However, although FDA said the agency conducted general 
evaluations and provided some examples, FDA did not provide information 
showing that the agency had specifically evaluated the issue 
highlighted in our recommendation. To the extent that FDA has not, we 
would still recommend that they specifically evaluate the reasons for 
any discrepancies between projected and actual milestones for their 
significant rulemakings. Therefore, we kept this recommendation 
addressed to FDA. We revised the body of the report where appropriate 
in response to the additional information FDA provided in its comments. 

Regarding our recommendation that agencies routinely track major 
milestones and report internally and externally when major milestones 
are reached, EPA clarified that the agency currently tracks key 
milestones associated with the rulemaking process and reports this 
information internally and externally. Specifically, EPA cited RAPIDS, 
an internal tracking system that monitors cross-agency involvement and 
senior management reviews. EPA also cited three primary sources for 
external reporting, specifically its use of Action Initiation Lists, 
the Semiannual Regulatory Agenda, and a quarterly report which they 
subsequently identified as EPAStat.[Footnote 43] 

Based on the new information and subsequent documentation that we 
requested from EPA in response to the agency's comments, we concur that 
EPA has a tracking system and internal and external reporting 
mechanisms that appear to address our recommendation. Therefore, we 
removed this recommendation to EPA. For example, EPA's RAPIDS tracks 
information on numerous milestones on all phases of the rulemaking 
process. Further, RAPIDS tracks information on rules that are both 
economically significant and significant. Similarly, with regard to 
internal and external reporting, EPA cited three main sources the 
agency uses for external reporting of milestones. We modified the body 
of the report to incorporate the new information. We note, however, 
that we had requested this information during our review and, because 
the information was not provided at the time of our review, we did not 
have the opportunity to discuss how the information is used, whether it 
is useful, and, most importantly, if it could be used to respond to our 
report objectives. We did audit the new information provided because of 
the approaching deadline for OMB to provide recommendations to the 
President for a new executive order on federal agency regulatory 
review. 

While not specifically addressing our second recommendation that 
agencies should also evaluate actual performance versus the targeted 
milestones, EPA comments indicated that agency executives and managers 
routinely meet to review milestones on key regulations and review 
program performance. Specifically, EPA noted that actions that are 
completed on time or early are used by the agency as examples of best 
practices and actions that are off-track are identified early and 
corrective steps are taken to expedite their completion. Because we 
were unaware of this system or its use at the time of our review, we 
could not determine whether EPA specifically evaluated discrepancies 
between projected and actual milestones to determine reasons why and 
took corrective actions. No evidence was provided to draw a conclusion. 
Therefore, we kept this recommendation addressed to EPA. 

With regard to our four recommendations to OMB to more consistently 
implement the Executive Order 12866 requirement that agencies provide 
information to the public in a complete, clear, and simple manner, OMB 
stated that these recommendations have merit and warrant further 
consideration. In particular, OMB stated that it will give full 
consideration to the report and its recommendations as the agency 
finalizes its recommendations to the President for a new Executive 
Order on regulatory review. OMB also said that the report will remind 
rulemaking agencies of their responsibility to identify in a complete, 
clear, and simple manner the substantive changes between the draft rule 
submitted to OIRA for review and the action subsequently announced, and 
to identify those changes in the regulatory action that were made at 
the suggestion or recommendation of OIRA. 

We also received technical comments and clarifications which we 
incorporated into this report, where appropriate. EPA provided a 
substantive technical comment regarding our classifications of the 
level of OIRA changes for three of the case study rules. In light of 
the clarifying comments EPA provided, we revised our classification of 
the Ethylene Oxide Emissions rule from "significant changes" to "other 
material changes." However we did not reclassify the other two EPA 
rules because the changes suggested would not be consistent with the 
methodology and criteria we used in this and prior reviews of the OIRA 
regulatory review process. 

As agreed with your office, unless you publicly announce the contents 
of this report earlier, we plan no further distribution until 30 days 
from the report date. At that time, we will send copies to appropriate 
congressional committees, the Secretary of Health and Human Services, 
the Secretary of Transportation, the Administrator of EPA, the Chairman 
of SEC, and the Director of OMB. The report also will be available at 
no charge on the GAO Web site at [hyperlink, http://www.gao.gov]. 

If you or your staff members have any questions about this report, 
please contact me at (202) 512-6806 or fantoned@gao.gov. Contact points 
for our Offices of Congressional Relations and Public Affairs may be 
found on the last page of this report. GAO staff who made major 
contributions to this report are listed in appendix VIII. 

Sincerely yours, 

Signed by: 

Denise M. Fantone: 
Director: 
Strategic Issues: 

[End of section] 

Appendix I: Summary of Common Regulatory Requirements: 

In this appendix, we provide information on commonly applicable 
regulatory requirements established by statutes and executive orders. 
We included those requirements identified by 10 or more of the rules we 
reviewed for this report or that were relevant to our case-study rules. 
We list the requirements within each major section (statutory 
requirements and executive orders) in chronological order. For each 
requirement, the following paragraphs summarize the general purpose, 
applicability and requirements imposed by the initiatives that were 
relevant to the rules we examined for this report. 

Statutory Requirements: 

Administrative Procedure Act: 

The Administrative Procedure Act (APA) was enacted in 1946 and 
established the basic framework of administrative law governing federal 
agency action, including rulemaking.[Footnote 44] Section 553 of Title 
5, United States Code, governs "notice-and-comment" rulemaking, also 
referred to as "informal" or "APA rulemaking." Section 553 generally 
requires (1) publication of a notice of proposed rulemaking, (2) 
opportunity for public participation in the rulemaking by submission of 
written comments, and (3) publication of a final rule and accompanying 
statement of basis and purpose not less than 30 days before the rule's 
effective date. Congresses and Presidents have taken a number of 
actions to refine and reform this regulatory process since the APA was 
enacted. 

National Environmental Policy Act of 1969: 

The National Environmental Policy Act (NEPA) requires agencies to 
consider the potential impact on the environment of federal agency 
action, including regulations.[Footnote 45] NEPA directs all agencies 
of the federal government to include in proposals for "major Federal 
actions significantly affecting the quality of the human environment" a 
detailed environmental impact statement addressing certain listed 
subjects and applying substantive criteria set forth in the Act. 
[Footnote 46] 

Federal Advisory Committee Act: 

The Federal Advisory Committee Act (FACA) regulates the formation and 
operation of advisory committees by federal agencies.[Footnote 47] 
Advisory committees, normally comprising of experts in the regulatory 
field involved, representatives of affected interest groups, and 
representatives of federal and state agencies, generally advise 
agencies on the content of rulemaking or on issues while the rulemaking 
is in progress. Some statutes require the agencies to use advisory 
committees, and others authorize but do not require their use.[Footnote 
48] 

Endangered Species Act of 1973: 

The Endangered Species Act seeks to protect species of animals against 
threats to their continuing existence caused by man.[Footnote 49] Under 
section 7 of the Act, each federal agency, "in consultation with and 
with the assistance of the Secretary" of the Interior shall ensure that 
any regulation issued by that agency not jeopardize the continued 
existence of any endangered or threatened species. 16 U.S.C. § 
1536(a)(2). 

Regulatory Flexibility Act: 

The Regulatory Flexibility Act (RFA) was enacted in response to 
concerns about the effect that federal regulations can have on small 
entities.[Footnote 50] The RFA requires independent and other 
regulatory agencies to assess the impact of their rules on "small 
entities," defined as including small businesses, small governmental 
jurisdictions, and certain small not-for-profit organizations. Under 
the RFA, an agency must prepare an initial regulatory flexibility 
analysis at the time proposed rules are issued, unless the head of the 
agency certifies that the proposed rule would not have a "significant 
economic impact upon a substantial number of small entities." 5 U.S.C. 
§ 605(b). The analysis must include a consideration of regulatory 
alternatives that accomplish the stated objectives of the proposed rule 
and that minimize any significant impact on such entities. However, the 
RFA only requires consideration of such alternatives and an explanation 
of why alternatives were rejected; the Act does not mandate any 
particular outcome in rulemaking. After the comment period on the 
proposed rule is closed, the agency must either certify a lack of 
impact, or prepare a final regulatory flexibility analysis, which among 
other things, responds to issues raised by public comments on the 
initial regulatory flexibility analysis. The agencies must make the 
final analysis available to the public and publish the analysis or a 
summary of it in the Federal Register. The Act also requires agencies 
to ensure that small entities have an opportunity to participate in the 
rulemaking process and requires the Chief Counsel of the Small Business 
Administration's Office of Advocacy to monitor agencies' compliance. 
The RFA applies only to rules for which an agency publishes a notice of 
proposed rulemaking (or promulgates a final interpretative rule 
involving the internal revenue laws of the United States), and it does 
not apply to ratemaking. 

Paperwork Reduction Act of 1980: 

The Paperwork Reduction Act (PRA) requires agencies to justify any 
collection of information from the public to minimize the paperwork 
burden they impose and to maximize the practical utility of the 
information collected.[Footnote 51] The Act applies to independent and 
other regulatory agencies. Under the PRA, agencies are required to 
submit all proposed information collections to the Office of 
Information and Regulatory Affairs (OIRA) in the Office of Management 
and Budget (OMB).[Footnote 52] Information collections generally cover 
information obtained from more than ten sources.[Footnote 53] In their 
submissions, agencies must establish the need and intended use of the 
information, estimate the burden that the collection will impose on 
respondents, and show that the collection is the least burdensome way 
to gather the information. Generally, the public must be given a chance 
to comment on proposed collections of information. 44 U.S.C. § 3506(c), 
5 C.F.R. § 1320.11. At the final rulemaking stage, no additional public 
notice and opportunity for comment is required, although OMB may direct 
the agency to publish a notice in the Federal Register notifying the 
public of OMB review. 

Negotiated Rulemaking Act of 1990: 

The Negotiated Rulemaking of 1990 (NRA) established a statutory 
framework for agency use of negotiated rulemaking to formulate proposed 
regulations.[Footnote 54] The NRA supplements the rulemaking provisions 
of the APA, clarifying the authority of federal agencies to conduct 
negotiated rulemaking. Generally, in a negotiated rulemaking, 
representatives of the agency and the various affected interest groups 
get together and negotiate the text of a proposed rule. 

Unfunded Mandates Reform Act of 1995: 

The Unfunded Mandates Reform Act (UMRA) was enacted to address concerns 
about federal statutes and regulations that require nonfederal parties 
to expend resources to achieve legislative goals without being provided 
funding to cover the costs.[Footnote 55] UMRA generates information 
about the nature and size of potential federal mandates but does not 
preclude the implementation of such mandates. UMRA applies to proposed 
federal mandates in both legislation and regulations, but it does not 
apply to rules published by independent regulatory agencies. With 
regard to the regulatory process, UMRA generally requires federal 
agencies to prepare a written statement containing a "qualitative and 
quantitative assessment of the anticipated costs and benefits" for any 
rule that includes a federal mandate that may result in the expenditure 
of $100 million or more in any 1 year by state, local, and tribal 
governments in the aggregate, or by the private sector.[Footnote 56] 
For such rules, agencies are to identify and consider a reasonable 
number of regulatory alternatives and from those select the least 
costly, most cost-effective, or least burdensome alternative that 
achieves the objectives of the rule (or explain why that alternative 
was not selected). UMRA also includes a consultation requirement; 
agencies must develop a process to permit elected officers of state, 
local, and tribal governments (or their designees) to provide input in 
the development of regulatory proposals containing significant 
intergovernmental mandates. UMRA applies only to rules for which an 
agency publishes a notice of proposed rulemaking. 

National Technology Transfer and Advancement Act of 1995: 

The National Technology Transfer and Advancement Act (NTTAA) directs 
federal agencies to use voluntary consensus standards in their 
regulatory activities unless the agency provides Congress, through OMB, 
with an explanation of why using these standards would be inconsistent 
with applicable law or otherwise impracticable.[Footnote 57] Voluntary 
consensus standards are technical standards (e.g., specifications of 
materials, performance, design, or operation; test methods; sampling 
procedures; and related management systems practices) that are 
developed or adopted by voluntary consensus standards bodies. 

Small Business Regulatory Enforcement Fairness Act: 

Congress amended the RFA in 1996 by enacting the Small Business 
Regulatory Enforcement Fairness Act (SBREFA).[Footnote 58] SBREFA 
included judicial review of compliance with the RFA. SBREFA requires 
agencies to develop one or more compliance guides for each final rule 
or group of related final rules for which the agency is required to 
prepare a regulatory flexibility analysis. SBREFA also requires the 
Environmental Protection Agency and the Occupational Safety and Health 
Administration to convene advocacy review panels before publishing an 
initial regulatory flexibility analysis. 

Congressional Review Act: 

The Congressional Review Act (CRA) was enacted as part of SBREFA in 
1996 to better ensure that Congress has an opportunity to review, and 
possibly reject, rules before they become effective.[Footnote 59] CRA 
established expedited procedures by which members of Congress may 
disapprove agencies' rules by introducing a resolution of disapproval 
that, if adopted by both Houses of Congress and signed by the 
President, can nullify an agency's rule. CRA applies to rules issued by 
independent and other regulatory agencies. CRA requires agencies to 
file final rules with both Congress and GAO before the rules can become 
effective. GAO's role under CRA is to provide Congress with a report on 
each major rule (for example, rules with a $100 million impact on the 
economy) including GAO's assessment of the issuing agency's compliance 
with the procedural steps required by various acts and executive orders 
governing the rulemaking process. 

Information Quality Act: 

In 2000, the Information Quality Act (IQA) was added as an amendment to 
the PRA.[Footnote 60] IQA applies to the same agencies that are subject 
to the PRA; the Act applies to independent and other regulatory 
agencies. The IQA requires every agency to issue guidelines, with OMB 
oversight, to ensure and maximize the quality, objectivity, utility, 
and integrity of information disseminated by the agency. Agencies must 
also establish administrative mechanisms allowing affected persons to 
seek and obtain correction of information maintained and disseminated 
by the agency. 

On December 16, 2004, OMB issued the Information Quality Bulletin for 
Peer Review under the IQA and other authority.[Footnote 61] The 
Bulletin establishes minimum standards for when peer review is required 
for scientific information, including stricter minimum standards for 
the peer review of "highly influential" scientific assessments. The 
Bulletin also establishes the types of peer review that should be 
considered by agencies in different circumstances. The Bulletin applies 
to independent and other regulatory agencies. Agencies must conduct any 
required peer reviews early enough to allow the agency to plan its 
regulatory approaches. "When an information product is a critical 
component of rule-making, it is important to obtain peer review before 
the agency announces its regulatory options so that any technical 
corrections can be made before the agency becomes invested in a 
specific approach or the positions of interest groups have hardened." 
70 Fed. Reg. 2668. The result of a peer review is a report, which 
agencies must consider making available to potential commenters in the 
rulemaking process. "If an agency relies on influential scientific 
information or a highly influential scientific assessment...the agency 
shall include in the administrative record for that action a 
certification that explains how the agency has complied with the 
requirements of this Bulletin." 70 Fed. Reg. 2673. 

E-Government Act of 2002: 

The E-Government Act of 2002 was intended to enhance the management and 
promotion of electronic government services and processes.[Footnote 62] 
With regard to the regulatory process, the Act requires agencies, to 
the extent practicable, to accept public comments on proposed rules by 
electronic means and to ensure that publicly accessible federal Web 
sites contain electronic dockets for their proposed rules, including 
all comments submitted on the rules and other relevant materials. 

Executive Orders: 

In addition to congressional regulatory reform initiatives enacted in 
statutes, presidential initiatives have a key role in the regulatory 
process. In fact, centralized review of agencies' regulations within 
the Executive Office of the President has been part of the rulemaking 
process for more than 30 years. 

Executive Order 12372 - Intergovernmental Review of Federal Programs: 

This executive order generally requires federal agencies to consult 
with state and local elected officials on regulations involving Federal 
financial assistance or Federal development that would have an impact 
on State and local finances.[Footnote 63] 

Executive Order 12630 - Governmental Actions and Interference with 
Constitutionally Protected Property Rights: 

This executive order requires agencies to limit interference with 
private property rights protected under the Fifth Amendment to the 
Constitution.[Footnote 64] Agencies must include an analysis of the 
impact of proposed regulations on property rights in its submissions to 
OMB. 

Executive Order 12866 - Regulatory Planning and Review: 

The formal process by which OIRA currently reviews agencies' proposed 
rules and final rules is essentially unchanged since Executive Order 
12866 was issued in 1993.[Footnote 65] Under Executive Order 12866, 
OIRA reviews significant proposed and final rules from agencies, other 
than independent regulatory agencies, before they are published in the 
Federal Register. 

The executive order states, among other things, that agencies should 
assess all costs and benefits of available regulatory alternatives, 
including both quantitative and qualitative measures. It also provides 
that agencies should generally select regulatory approaches that 
maximize net benefits (unless a statute requires another approach). 
Among other principles, the executive order encourages agencies to 
tailor regulations to impose the least burden on society needed to 
achieve the regulatory objectives. The executive order also established 
agency and OIRA responsibilities in the review of regulations, 
including transparency requirements. OIRA provides guidance to federal 
agencies on implementing the requirements of the executive order, such 
as guidance on preparing economic analyses required for significant 
rules in OMB Circular No. A-4. 

OMB Circular No. A-4: 

On September 17, 2003, OMB issued OMB Circular No. A-4, Regulatory 
Analysis, which is a guide for preparing the economic analysis of 
significant regulatory action called for by the Executive Order. 
[Footnote 66] OMB designed the guidelines to help agencies conduct 
"good regulatory analyses" and to standardize the way that benefits and 
costs of regulations are measured and reported. The guidelines define a 
good regulatory analysis as one that includes a statement of the need 
for the proposed regulation, an assessment of alternatives, and an 
evaluation of the benefits and costs of the alternatives. The 
guidelines state that the motivation of the evaluation is to learn if 
the benefits of an action are likely to justify the costs, or discover 
which of the possible alternatives would be the most cost-effective. 
According to OIRA, this Circular contains several significant changes 
from previous OMB guidance, including (1) more emphasis on cost-
effectiveness analysis, (2) formal probability analysis for rules with 
more than a billion-dollar impact on the economy and (3) more 
systematic evaluation of qualitative as well as quantified benefits and 
costs. 

Executive Order 12898 - Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations: 

This executive order requires each agency to develop an "environmental 
justice strategy...that identifies and addresses disproportionately 
high and adverse human health or environmental effects of its programs, 
policies, and activities on minority populations and low-income 
populations."[Footnote 67] Each agency must identify rules that should 
be revised to meet the objectives of the executive order. 

Executive Order 12988 - Civil Justice Reform: 

This executive order requires agencies to draft regulations in a manner 
that will reduce needless litigation by ensuring the clarity of 
regulatory language regarding legal rights and obligations.[Footnote 
68] For example, the order requires agencies to draft regulations that 
provide a clear legal standard for affected conduct rather than a 
general standard, and promote simplification and burden reduction. 

Executive Order 13045 - Protection of Children from Environmental 
Health Risks and Safety Risks: 

This executive order requires that agencies issuing "economically 
significant" rules that also concern an environmental health risk or 
safety risk that an agency has reason to believe may disproportionately 
affect children must submit to OIRA an evaluation of the environmental 
health or safety effects of the planned regulation on 
children.[Footnote 69] Agencies must also include an explanation of why 
the planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the agencies. 

Executive Order 13132 - Federalism: 

This executive order requires agencies to prepare a federalism summary 
impact statement for actions that have federalism implications. 
[Footnote 70] Specifically, it provides that "no agency shall 
promulgate any regulation that has federalism implications, [or] that 
imposes substantial direct compliance costs on state and local 
governments," unless the agency (1) has consulted with state and local 
officials early in the process, (2) submitted to OMB copies of any 
written communications from such officials, and (3) published in the 
preamble of the rule "a federalism summary impact statement" describing 
the consultations, "a summary of the nature of [state and local] 
concerns and the agency's position supporting the need to issue the 
regulations, and a statement of the extent to which the concerns of 
State and local officials have been met." 

Executive Order 13175 - Consultation and Coordination with Indian 
Tribal Governments: 

This executive order provides that "no agency shall promulgate any 
regulation that has tribal implications" unless the agency (1) has 
consulted with tribal officials early in the process, (2) submitted to 
OMB copies of any written communications from such officials, and (3) 
published in the preamble of the rule "a tribal summary impact 
statement" describing the consultations, "a summary of the nature of 
their concerns and the agency's position supporting the need to issue 
the regulation, and a statement of the extent to which the concerns of 
tribal officials have been met."[Footnote 71] On issues relating to 
tribal self-government, tribal trust resources, or Indian tribal treaty 
and other rights, each agency should explore and, where appropriate, 
use consensual mechanisms for developing regulations, including 
negotiated rulemaking. 

Executive Order 13211 - Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use: 

This executive order requires agencies to prepare and submit to OMB a 
"Statement of Energy Effects" for significant energy actions.[Footnote 
72] The statement must cover the regulation's "adverse effects on 
energy supply, distribution, or use (including a shortfall in supply, 
price increases, and increased use of foreign supplies)" and reasonable 
alternatives and their effects. The "Statement of Energy Effects" must 
be published (or summarized) in the related proposed and final rule. 

[End of section] 

Appendix II: Case Studies of 16 Selected Rules: 

This appendix provides case studies on 16 final rules published between 
January 2006 and May 2008 that we reviewed for this report. At the 
beginning of each case study the official rule title as published in 
the Federal Register is followed by a short title that we used to 
identify the rule in the body of our report. The body of each case 
study includes identifying information, a brief summary or synopsis of 
the rule, a discussion of the regulatory requirements addressed in the 
final rule, a summary of the changes to the rule resulting from reviews 
of the draft rule by the Office of Management and Budget's (OMB) Office 
of Information and Regulatory Affairs (OIRA) (if applicable), and a 
timeline of important events in the course of the rulemaking. 

* Identifying Information. Identifies the responsible federal agency, 
and other unique identifying information, such as the Regulation 
Identifier Number (RIN), the citation in the Federal Register of the 
final rule, and the docket number in [hyperlink, 
http://www.regulations.gov]. 

* Rule Synopsis. Provides summary information about the substance and 
effects of the rule, such as the intent or purpose of the rule, a brief 
discussion of the rule's origin, rulemaking history, or regulatory 
authority upon which the rule was created. 

* Regulatory Requirements Addressed in the Final Rule. Identifies 
generally-applicable rulemaking requirements discussed by the agency in 
the final rule as published in the Federal Register and either what 
additional actions were taken to comply with the triggered requirement 
or why the requirement was not triggered. For economically significant 
rules that triggered the requirement under Executive Order 12866, we 
identified if the agency prepared a cost-benefit analysis, and if 
applicable, we also summarize the actions the agency took to address 
recent changes to regulatory requirements made by OMB since 2003. 

* Changes Resulting from OIRA Review. Describes changes to rules that 
were recommended by OIRA during OIRA's review of the rulemaking under 
Executive Order 12866. 

* Timeline. Identifies key dates such as the dates OIRA received and 
completed its reviews, the publication dates of the proposed and final 
rules in the Federal Register, the date the public comment period 
ended, and other dates mentioned or tracked by agency officials. 

National Air Tour Safety Standards (Air Tour Safety): 

Identifying Information: 

* Agency: Department of Transportation, Federal Aviation 
Administration: 

* Rule classification: Other Significant: 

* RIN: 2120-AF07: 

* Federal Register citation: 72 Fed. Reg. 6884: 

* Regulations.gov docket number: FAA-1998-4521: 

* Date of final rule: February 13, 2007: 

Rule Synopsis: 

The rule sets safety standards governing commercial air tours. The 
objective of the rule is to provide a higher and uniform level of 
safety for all commercial air tours. The rule includes provisions 
requiring that passengers be briefed on safety procedures, such as 
opening exits, exiting the aircraft, and using life preservers. It 
requires that passengers in helicopters and planes operating over open 
water wear life preservers, and that helicopters operating over open 
water be equipped to float. It also gives relief from drug and alcohol 
testing for four air tour charity events per year, and increases the 
required prior flight time for pilots in those events from 200 to 500 
hours. Air tours frequently take place in heavy air traffic and in 
areas geographically limited in size with dangerous natural 
obstructions. Better oversight of the industry was recommended by the 
National Transportation Safety Board, reports of the Department of 
Transportation (DOT) Inspector General, and GAO. 

Regulatory Requirements Addressed in the Final Rule: 

FAA discussed the following generally-applicable statutes and executive 
orders in the final rule: 

* NEPA: FAA concluded that the rule qualified for a categorical 
exclusion from NEPA and that the rule does not involve any significant 
impacts to the human environment. 

* PRA: The rule included new information collections for which FAA 
completed and submitted an Information Collection Request to OIRA for 
approval. 

* RFA: FAA determined that the rule will have a significant economic 
impact on a substantial number of small entities and prepared a final 
regulatory flexibility analysis. 

* Trade Agreements Act: FAA assessed the potential effect of the rule 
and determined that it would have only a domestic impact and therefore 
no effect on any international trade-sensitive activity. 

* UMRA: FAA determined that the rule would not result in any 1-year 
expenditure by state, local, and tribal governments, in the aggregate, 
or by the private sector that would meet or exceed the relevant 
threshold of $128.1 million. 

* Executive Order 12866 (Regulatory Planning and Review): FAA 
identified the rule as a significant regulatory action as defined by 
the executive order because it raised novel policy issues. FAA 
conducted an economic analysis and submitted the rule to OIRA for 
review. 

* Executive Order 13132 (Federalism): FAA determined that the rule did 
not have a substantial direct effect on the states, on the relationship 
between the national government and the states, or on the balance of 
power and responsibilities among the various levels of government. 
Therefore, FAA concluded that the rule did not have federalism 
implications. 

* Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use): FAA 
determined that the rule was not a significant energy action under the 
executive order because it was not likely to have a significant adverse 
effect on the supply, distribution, or use of energy. 

Changes Resulting from OIRA Review: 

There was a significant change to the regulatory text. The rule 
language was changed to clarify that four charitable or non-profit 
events, with no event lasting more than 3 consecutive days, was the 
limit, rather than four of each in one calendar year. There were also a 
number of other material changes to the rule. OIRA requested the 
addition of a chart or matrix explaining the changes made by this rule. 
OIRA requested the inclusion of an explanation of the policy of a four- 
event limit on charity and nonprofit event flights. OIRA questioned the 
source used for support of a requirement that pilots flying charity, 
nonprofit or community event flights have 500 hours total flying time. 
FAA added an explanation to the rule. OIRA requested clarification of 
differences between "Operations Specification" and a "Letter of 
Authorization." FAA rewrote the rule section to clarify the 
differences. OIRA requested FAA more fully explain the effect of the 
rule on operations at the Grand Canyon. FAA added three sentences to 
the preamble. OIRA changed the rule at both the proposed and final rule 
stages. 

Timeline: 

* January 2, 2002: Preliminary team concurrence on proposed rule. 

* January 2, 2002: Economic evaluation of proposed rule. 

* November 2, 2002: Final team concurrence on proposed rule. 

* December 9, 2002: Director's concurrence on proposed rule. 

* January 8, 2003: First internal level concurrence on proposed rule. 

* January 30, 2003: Second FAA internal level concurrence on proposed 
rule. 

* February 5, 2003: Draft proposed rule transmitted to the Office of 
the Secretary of Transportation (OST). 

* July 8, 2003: OST approved draft proposed rule. 

* July 10, 2003: OIRA received draft proposed rule. 

* October 7, 2003: OIRA completed review of proposed. 

* October 9, 2003: Issuance of proposed rule. 

* October 22, 2003: Proposed rule published in the Federal Register. 

* October 21, 2005: Preliminary team concurrence on final rule. 

* November 21, 2005: Principal's briefing on final rule. 

* January 19, 2006: Economic evaluation of final rule. 

* March 27, 2006: Final team concurrence on final rule. 

* April 5, 2006: Director's concurrence on final rule. 

* April 6, 2006: First internal level concurrence on final rule. 

* April 25, 2006: Second FAA internal level concurrence on final rule. 

* April 27, 2006: Transmittal to the OST of final rule. 

* August 16, 2006: OST approval of draft final rule. 

* August 16, 2006: Transmittal to OIRA of final rule. 

* September 21, 2006: Meeting between OIRA and nonfederal parties 
regarding the rule. 

* November 7, 2006: OIRA approval of final rule. 

* December 22, 2006: Issuance of final rule. 

* February 13, 2007: Final rule published in the Federal Register. 

Human Space Flight Requirements for Crew and Space Flight Participants 
(Human Space Flight Requirements): 

Identifying Information: 

* Agency: Department of Transportation, Federal Aviation 
Administration: 

* Rule classification: Other Significant: 

* RIN: 2120-AI57: 

* Federal Register citation: 71 Fed. Reg. 75,616: 

* Regulations.gov docket number: FAA-2005-23449: 

* Date of final rule: December 15, 2006: 

Rule Synopsis: 

The rule establishes requirements for human space flight, with the 
intent of providing an acceptable level of safety to the general public 
and ensuring individuals on board are aware of the risks associated 
with launch and reentry. The rule sets training and medical standards 
for the crew, and requires the operator to inform each space flight 
participant in writing of the risks of launch and reentry. Security 
requirements in the rule prevent participants from carrying certain 
items on board, and safety requirements in the rule require 
participants be trained before flight on how to respond to an emergency 
situation. 

Regulatory Requirements Addressed in the Final Rule: 

FAA discussed the following generally-applicable statutes and executive 
orders in the final rule: 

* NEPA: FAA concluded that the rule qualified for a categorical 
exclusion from the requirement for preparation of an environmental 
assessment or environmental impact statement. 

* PRA: The rule included new information collections for which FAA 
completed and submitted an Information Collection Request to OIRA for 
approval. 

* RFA: The FAA Administrator certified that the rule will not have a 
significant economic impact on a substantial number of small entities. 

* Trade Agreements Act: FAA assessed the potential effect of the rule 
and determined that it will impose the same costs on domestic and 
international entities and thus has a neutral trade impact. 

* UMRA: FAA determined that the rule would not result in any 1-year 
expenditure by state, local and tribal governments, in the aggregate, 
or by the private sector that would meet or exceed the relevant 
threshold of $120.7 million. 

* Executive Order 12866 (Regulatory Planning and Review): FAA 
identified the rule as a significant regulatory action as defined by 
the executive order because it raised novel policy issues. FAA 
conducted an economic analysis and submitted the rule to OIRA for 
review. 

* Executive Order 13132 (Federalism): FAA determined that the rule did 
not have a substantial direct effect on the states, on the relationship 
between the national government and the states, or the balance of power 
and responsibilities among the various levels of government. Therefore, 
FAA concluded that the rule did not have federalism implications. 

* Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use): FAA 
determined that the rule was not a significant energy action under the 
executive order because it was not likely to have a significant adverse 
effect on the supply, distribution, or use of energy. 

Changes Resulting from OIRA Review: 

There were no substantive changes to this rule resulting from OIRA 
review. 

Timeline: 

* March 22, 2005: Preliminary team concurrence on proposed rule. 

* April 25, 2005: Economic evaluation of proposed rule. 

* April 29, 2005: Principal's briefing on proposed rule. 

* May 31, 2005: Final team concurrence on proposed rule. 

* June 17, 2005: Director's concurrence on proposed rule. 

* July 12, 2005: Legal concurrence on proposed rule. 

* July 24, 2005: Office of the FAA Administrator concurrence on 
proposed rule. 

* July 28, 2005: Proposed rule transmitted to OST. 

* September 23, 2005: OST approval of proposed rule. 

* September 28, 2005: OIRA received draft proposed rule. 

* December 22, 2005: OIRA completed review of draft proposed rule 
without change. 

* December 22, 2005: Issuance of proposed rule. 

* December 29, 2005: Proposed rule published in the Federal Register. 

* March 24, 2006: Preliminary team concurrence on final rule. 

* April 6, 2006: Economic evaluation of final rule. 

* April 27, 2006: Final team concurrence on final rule. 

* May 5, 2006: Director's concurrence on final rule. 

* May 26, 2006: Final rule transmitted to OST. 

* August 29, 2006: OST approval of final rule. 

* August 29 2006: OIRA received draft final rule. 

* November 9, 2006: OIRA completed review of draft final rule without 
change. 

* December 1, 2006: Issuance of final rule. 

* December 15, 2006: Final rule published in the Federal Register. 

Light Trucks, Average Fuel Economy; Model Years 2008-2011 (Fuel Economy-
Light Trucks): 

Identifying Information: 

* Agency: Department of Transportation, National Highway Traffic Safety 
Administration: 

* Rule classification: Major, Economically Significant: 

* RIN: 2127-AJ61: 

* Federal Register citation: 71 Fed. Reg. 17,566: 

* Regulations.gov docket number: NHTSA-2005-22223 (proposed rule); 
NHTSA-2006-24309 (final rule): 

* Date of final rule: April 6, 2006: 

Rule Synopsis: 

The rule reforms the structure of the corporate average fuel economy 
(CAFE) program for light trucks and establishes higher CAFE standards 
for model years 2008 through 2011. While this rule was proposed in 2005 
and finalized in 2006, it was preceded by a series of rules 
establishing fuel economy standards for light trucks (i.e., non- 
passenger automobiles) that date back to the 1970s. The rule was 
mandated by the Energy Policy Conservation Act of 1975. 

Regulatory Requirements Addressed in the Final Rule: 

NHTSA discussed the following generally-applicable statutes and 
executive orders in the final rule: 

* NEPA: NHTSA prepared an environmental assessment for the rule and 
concluded that the rule will not have a significant effect on the 
quality of the human environment. 

* NTTAA: NHTSA consulted with voluntary consensus standards bodies and 
incorporated industry standards and definitions, such as an industry 
standard on light truck footprint. 

* PRA: The rule included new information collections for which NHTSA 
completed and submitted an Information Collection Request to OIRA for 
approval. 

* RFA: NHTSA's Deputy Administrator certified that the rule did not 
have a significant economic impact on a substantial number of small 
entities. 

* UMRA: NHTSA determined that the rule would not result in any 1-year 
expenditure by state, local and tribal governments, in the aggregate, 
of more than $115 million, but would result in the expenditure of that 
magnitude by the private sector. NHTSA concluded that it was required 
by statute to set standards at the maximum feasible level achievable by 
manufacturers, and thus could not consider regulatory alternatives. 

* Executive Order 12866 (Regulatory Planning and Review): NHTSA 
identified the rule as a significant regulatory action as defined by 
the executive order because of its economic significance. Therefore, 
NHTSA conducted an economic analysis and submitted the rule to OIRA for 
review. 

* Executive Order 12988 (Civil Justice Reform): NHTSA determined that 
the rule does not have any retroactive effect. 

* Executive Order 13045 (Protection of Children from Environmental 
Health Risks and Safety Risks): NHTSA determined that the rule does not 
have a disproportionate effect on children. 

* Executive Order 13132 (Federalism): NHTSA stated that the statutory 
authorization for the rule has a broad preemption provision, and 
therefore, the agency was required to establish these standards by law. 

* Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use): NHTSA 
determined that the rule would not have any adverse energy effects. 

* OMB Peer Review Bulletin: NHTSA convened a panel of three external 
experts to review the model used in the rule. The peer review reports 
and the agency's response to reviews were included in the rulemaking 
docket. 

Recent Analytic Requirements Addressed: 

NHTSA's regulatory impact analysis addressed two of the four analytical 
changes in the OMB economic guidelines that GAO reviewed for this 
study. For example, the agency assessed uncertainty using a formal 
probability analysis and discounted potential future benefits and costs 
using discount rates of 7 percent and 3 percent, as directed by the OMB 
guidelines. Agency officials said that conducting the probability 
analysis was time-consuming, requiring one full-time analyst about 6 
weeks to complete. In addition, the officials said, the probability 
analysis was conducted after the agency had selected the preferred 
regulatory alternative, and as a result, the analysis was not used for 
decision-making purposes. The agency did not evaluate qualitative and 
quantitative benefits and costs because it monetized all the key 
impacts and the agency's analysis did not emphasize cost-effectiveness. 

Changes Resulting from OIRA Review: 

NHTSA did not consider substantive any of the changes made to either 
the draft proposed or draft final rules during the formal review 
period, and thus did not docket a record of changes made during the 
OIRA review period. 

Timeline: 

* 1974: DOT/EPA reported to Congress on motor vehicle fuel economy 
standards. 

* 1975: Energy Policy Conservation Act of 1975 enacted. 

* December 29, 2003: NHTSA issued an Advanced Notice of Proposed 
Rulemaking under a different RIN (2127-AJ17) soliciting comments on the 
structure of the CAFE program and an intent to reform the light truck 
CAFE program. 

* July 26, 2005: OIRA received the draft proposed rule. 

* August 22, 2005: OIRA completed review of the draft proposed rule 
with change. 

* August 30, 2005: Proposed rule published in the Federal Register. 

* March 14, 2006: OIRA staff met with outside parties to discuss this 
rule. 

* March 23, 2006: OIRA received the draft final rule. 

* March 28, 2006: OIRA completed review of the draft final rule 
consistent with change. 

* April 6, 2006: Final rule published in the Federal Register. 

Event Data Recorders: 

Identifying Information: 

* Agency: Department of Transportation, National Highway Traffic Safety 
Administration: 

* Rule classification: Other Significant: 

* RIN: 2127-AI72: 

* Federal Register citation: 71 Fed. Reg. 50,998: 

* Regulations.gov docket number: NHTSA-2004-18029 (proposed rule); 
NHTSA-2006-25666 (final rule): 

* Date of final rule: August 28, 2006: 

Rule Synopsis: 

The rule establishes standards for the auto industry practice of 
installing event data recorders (EDR) in passenger cars and other light 
vehicles. The intent of the rule is to standardize data obtained 
through EDRs so that data may be most effective and ensure that EDR 
infrastructure develops to provide a foundation for automatic crash 
notification. The rule requires a minimum set of specified data 
elements, standardizes data format, helps ensure crash survivability of 
an EDR and its data, and ensures commercial availability of tools 
necessary to enable crash investigators to retrieve data from the EDR. 
The rule also requires vehicle manufacturers to describe the function 
and capability of an EDR in the owner's manual of any vehicle equipped 
with an EDR to ensure public awareness. NHTSA promulgated the rule 
following years of study by NHTSA and the National Transportation 
Safety Board, and after having received three citizen petitions. 

Regulatory Requirements Addressed in the Final Rule: 

NHTSA discussed the following generally-applicable statutes and 
executive orders in the final rule: 

* NEPA: NHTSA determined that the rule will not have any significant 
impact on the quality of the human environment. 

* NTTAA: NHTSA adopted voluntary consensus standards where practicable. 

* PRA: The rule did not contain any new information collection 
requests. 

* RFA: NHTSA's Administrator certified that the rule would not have a 
significant economic impact on a substantial number of small entities. 

* UMRA: NHTSA determined that the rule would not result in the 
expenditure by state, local, or tribal governments, in the aggregate, 
or by the private sector, of more than the annual threshold of $118 
million. 

* Executive Order 12866 (Regulatory Planning and Review): NHTSA 
identified the rule as a significant regulatory action as defined by 
the executive order. NHTSA conducted an economic analysis and submitted 
the rule to OIRA for review. 

* Executive Order 12988 (Civil Justice Reform): NHTSA stated that the 
rule specified its preemptive effect in clear language. 

* Executive Order 13045 (Protection of Children from Environmental 
Health Risks and Safety Risks): NHTSA concluded that because the rule 
is not economically significant and does not involve health and safety 
risks that disproportionately affect children, no further analysis was 
necessary under this executive order. 

* Executive Order 13132 (Federalism): NHTSA concluded that general 
principles of preemption law would operate so as to displace any 
conflicting state law or regulation. 

Changes Resulting from OIRA Review: 

As documented by the agency in memorandums included in the public 
docket, OIRA suggested changes to both the proposed and final rule that 
NHTSA officials incorporated into the published versions of the rules. 
NHTSA incorporated OIRA suggested language to the proposed rule 
preamble related to ensuring that crash investigators and researchers 
are able to obtain the capability of downloading data from the EDR. 
Similarly, NHTSA changed, at OIRA's suggestion, the owner's manual 
statement in the text of the proposed rule to include a sentence 
advising owners that an EDR does not store or collect personal 
information. NHTSA incorporated additional OIRA suggestions to the 
final rule, adding to or clarifying the policy discussion in the 
preamble, including adding clarifying language to the federalism 
discussion. NHTSA incorporated OIRA changes to the owner's manual 
statement in the final rule text, explaining that parties with special 
equipment, including law enforcement officials, can access information 
in an EDR if they have access to the vehicle, and that they may group 
EDR data with personal information regularly collected in the course of 
a criminal investigation. 

Timeline: 

* 1991: NHTSA began to examine EDRs as part of the Special Crash 
Investigations Program. 

* November 9, 1998: NHTSA denied petition for rulemaking on EDRs. 

* June 2, 1999: NHTSA denied second petition for rulemaking on EDRs. 

* 2001: NHTSA received a third petition for rulemaking on EDRs. 

* October 11, 2002: NHTSA published request for comment on the future 
role of EDRs in motor vehicles. 

* March 9, 2004: OIRA received the draft proposed rule. 

* June 3, 2004: OIRA completed review of draft proposed rule consistent 
with change. 

* December 2003: Preliminary regulatory evaluation completed. 

* June 14, 2004: Proposed rule published in the Federal Register. 

* April 11, 2006: OIRA received draft final rule. 

* July 2006: Final regulatory evaluation completed. 

* August 17, 2006: OIRA completed review of draft final rule consistent 
with change. 

* August 28, 2006: Final rule published in the Federal Register. 

Ethylene Oxide Emissions Standards for Sterilization Facilities 
(Ethylene Oxide Emissions): 

Identifying Information: 

* Agency: Environmental Protection Agency, Office of Air and Radiation: 

* Rule classification: Other Significant: 

* RIN: 2060-AK09: 

* Federal Register citation: 71 Fed. Reg. 17,712: 

* Regulations.gov docket number: EPA-HQ-OAR-2003-0197: 

* Date of final rule: April 7, 2006: 

Rule Synopsis: 

The rule resulted from the periodic evaluation of the emission 
standards for ethylene oxide emissions from sterilization facilities. 
In the proposed rule, EPA decided not to impose more stringent emission 
standards, determining that additional controls at existing sources 
would achieve, at best, minimal emission reduction at a very high cost. 
The Clean Air Act requires EPA to assess the risk posed by ethylene 
oxide emissions and set more stringent standards as it deems necessary 
within 8 years of initially setting standards, taking into account 
developments in practices, processes, and control technologies. 

Regulatory Requirements Addressed in the Final Rule: 

EPA discussed the following generally-applicable statutes and executive 
orders in the final rule: 

* CRA: EPA filed the rule with the Congress and the Comptroller 
General. 

* NTTAA: The rule does not involve any technical standards. 

* PRA: The rule does not impose any new information collection 
requests. 

* RFA: EPA determined that the rule would not have a significant 
economic impact on a substantial number of small entities. 

* UMRA: EPA determined that the rule would not result in expenditures 
of $100 million or more to state, local, and tribal governments, in the 
aggregate, or to the private sector in any one year. 

* Executive Order 12866 (Regulatory Planning and Review): OMB deemed 
the rule a significant regulatory action as defined by the executive 
order. Therefore, EPA submitted the rule to OMB for review. 

* Executive Order 13045 (Protection of Children from Environmental 
Health Risks and Safety Risks): EPA "did not have reason to believe" 
that the environmental health or safety risks addressed by this rule 
presented a disproportionate risk to children. 

* Executive Order 13132 (Federalism): EPA determined that the final 
rule did not have a substantial direct effects on the states, on the 
national government and the states, or on the distribution of power and 
responsibilities among the various levels of government. EPA concluded 
that the rule did not have federalism implications. 

* Executive Order 13175 (Consultation and Coordination with Indian 
Tribal Governments): EPA determined that the rule would not have 
substantial direct effects on tribal governments, on the relationship 
between the federal government and Indian tribes, or on the 
distribution of power and responsibilities between the federal 
government and Indian tribes. 

* Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use): EPA 
determined that the rule would not likely have a significant adverse 
effect on the supply, distribution, or use of energy. 

Changes Resulting from OIRA Review: 

An OIRA-initiated change included generally available control 
technologies or management practices (GACT) in addition to maximum 
achievable control technologies or management practices (MACT) for area 
sources of ethylene oxide. Both are standards EPA can use for 
controlling emissions of ethylene oxide for area sources. Major sources 
are required to use MACT to control emissions. In the proposed rule 
OIRA specified that the CAA provides that "EPA is not required to 
conduct any review under section 112(f) of the CAA or promulgate any 
emissions limitations under that subsection for any source listed 
pursuant to section 112(c)(3), for which EPA has issued GACT standards. 
Thus, although EPA has discretion to conduct a residual risk review 
under section 112(f) for area sources for which it has established 
GACT, it is not required to do so." OIRA specified that EPA's residual 
risk review is required for each CAA section 112(d) source category, 
except area source categories for which EPA issued a GACT standard. 

While addressing Executive Order 13045, "Protection of Children from 
Environmental Health and Safety Risks," EPA stated that "The public is 
invited to submit or identify peer reviewed studies and data, of which 
the agency may not be aware, that assessed the results of early life 
exposure to ethylene oxide commercial sterilization facility 
emissions." During OIRA review this sentence was deleted. 

EPA had written that if cancer risks to individuals exposed to 
emissions from a regulated source are found above a threshold specified 
in the CAA, "we must promulgate residual risk standards for the source 
category (or subcategory) which provide an ample margin of safety." 
OIRA rewrote the sentence to read "we must decide whether additional 
reductions are necessary to provide an ample margin of safety." 
Similarly, EPA wrote that in the same circumstance, "we must also adopt 
more stringent standards to prevent an adverse environmental effect." 
The quotation changed during OIRA review to read "we must determine 
whether more stringent standards are necessary to prevent an adverse 
environmental effect." 

Timeline: 

* December 6, 1994: Original emission standards rule published. 

* 1997: EPA began developing the methodology for conducting a residual 
risk assessment. 

* Late 1990s: EPA convened groups to consider changing the technologies 
used for ethylene emission control. 

* February 13, 2002: EPA assigned a Start Action Number. 

* August 3, 2005: OIRA received the draft proposed rule. 

* September 27, 2005: OIRA completed review of the draft proposed rule. 

* October 24, 2005: The proposed rule is published in the Federal 
Register. 

* March 22, 2006: OIRA met with nonfederal parties regarding the rule. 

* March 23, 2006: OIRA received the draft final rule. 

* March 31, 2006: OIRA completed review of the draft final rule. 

* April 7, 2006: The final rule was published in the Federal Register. 

National Emission Standards for Organic Hazardous Air Pollutants from 
the Synthetic Organic Chemical Manufacturing Industry (Hazardous Air 
Pollutants): 

Identifying Information: 

* Agency: Environmental Protection Agency, Office of Air and Radiation: 

* Rule classification: Other Significant: 

* RIN: 2060-AK14: 

* Federal Register citation: 71 Fed. Reg. 76,603: 

* Regulations.gov docket number: EPA-HQ-OAR-2005-0475: 

* Date of final rule: December 21, 2006: 

Rule Synopsis: 

The rule established that the original National Emission Standards for 
Organic Hazardous Air Pollutants for the synthetic organic chemical 
manufacturing industry set in 1994 would mostly remain unchanged. 
Although the rule does not impose further controls on the synthetic 
organic chemical manufacturing industry, it does amend certain aspects 
of the existing regulations. The CAA directs EPA to evaluate the 
remaining risk presented by major sources of emissions of hazardous air 
pollutants 8 years after promulgation of technology-based standards to 
determine if the standards provide an ample margin of safety to protect 
public health. The Act also directs EPA to review all standards 
regulating hazardous air pollutants every 8 years and revise them as 
necessary, taking into account developments in practices, processes, 
and control technologies. 

Regulatory Requirements Addressed in the Final Rule: 

EPA discussed the following generally-applicable statutes and executive 
orders in the final rule: 

* CRA: EPA filed the final rule with Congress and the Comptroller 
General. 

* NTTAA: The rule does not involve any voluntary consensus standards. 

* PRA: The rule does not impose any new information collection 
requests. 

* RFA: EPA determined that the rule would not have a significant 
economic impact on a substantial number of small entities. 

* UMRA: EPA determined that the rule does not contain a federal mandate 
that may result in expenditures of $100 million or more on state, 
local, and tribal governments, in the aggregate, or the private sector 
in any one year. 

* Executive Order 12866 (Regulatory Planning and Review): OMB deemed 
the rule a significant regulatory action as defined by the executive 
order because it raised novel legal and policy issues. Therefore, EPA 
submitted the rule to OMB for review. 

* Executive Order 12898 (Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations): One of 
EPA's environmental justice priorities is to reduce exposure to air 
toxics. In the proposed rule, EPA requested comment on the implications 
of this priority since some regulated facilities are located near 
minority and low-income populations. EPA received one comment regarding 
this environmental justice concern that it addressed in the final rule. 

* Executive Order 13045 (Protection of Children from Environmental 
Health and Safety Risks): EPA "did not have reason to believe" that the 
environmental health or safety risks addressed by the rule presented a 
disproportionate risk to children. 

* Executive Order 13132 (Federalism): EPA determined that the rule did 
not have a substantial direct effect on the states, on the relationship 
between the national government and the states, or on the balance of 
power and responsibilities among the various levels of government. 
Therefore, EPA concluded that the rule did not have federalism 
implications. 

* Executive Order 13175 (Consultation and Coordination with Indian 
Tribal Governments): EPA determined that the rule does not have tribal 
implications. 

* Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use): EPA 
determined that the rule would not likely have a significant adverse 
effect on the supply, distribution, or use of energy. 

Changes Resulting from OIRA Review: 

OIRA made several substantive changes to the explanatory text of the 
preamble. OIRA cut a section specifying periodic determinations of 
pertinent technical factors. It deleted a statement that assumptions 
made in the study design did not fully capture the relatively higher 
exposure seen by children. It requested additional and more balanced 
discussion of the rationale for selecting "no control," and requested 
that EPA specify a sample size and expand its discussion on risks 
reduced by emission controls. It deleted a section describing some 
costs of the regulation and ways for EPA to avoid those costs. OIRA 
review resulted in EPA deleting a sentence asserting that it was 
required by the CAA under a particular set of circumstances to 
promulgate residual risk standards. 

Timeline: 

* February 14, 2002: EPA assigned a Start Action Number. 

* March 16, 2006: OIRA received draft proposed rule. 

* March 22, 2006: OIRA met with nonfederal parties regarding the rule. 

* May 31, 2006: OIRA completed review of proposed rule. 

* June 14, 2006: Proposed rule published in the Federal Register. 

* December 11, 2006: OIRA received draft final rule. 

* December 14, 2006: OIRA completed review of draft final rule. 

* December 21, 2006: Final rule was published in the Federal Register. 

National Primary Drinking Water Regulations: Stage 2 Disinfectants and 
Disinfection Byproducts Rule (Disinfection Byproducts 2): 

Identifying Information: 

* Agency: Environmental Protection Agency, Office of Water: 

* Rule classification: Major, Significant: 

* RIN: 2040-AD38: 

* Federal Register citation: 71 Fed. Reg. 388: 

* Regulations.gov docket number: EPA-HQ-OW-2002-0043: 

* Date of final rule: January 4, 2006: 

Rule Synopsis: 

The rule is intended to help public water systems deliver safe water 
with the benefits of disinfection but with fewer risks from 
disinfection byproducts. Certain disinfectants used to treat drinking 
water are known to create byproducts posing potential reproductive, 
developmental, and cancer risks to humans. Authorized by the Safe 
Drinking Water Act Amendments of 1996 (SDWA), the rule is one of a 
series of rules, including the Surface Water Treatment 2 rule, intended 
to improve the quality of drinking water provided by public water 
systems throughout the United States. EPA's first rulemaking on 
disinfection byproducts was promulgated in 1979. Because of the complex 
and far-reaching implications of the rule, as well as the relationship 
between the Disinfection Byproducts 2 rule and the Surface Water 
Treatment 2 rule, EPA convened a FACA panel to help develop the 
policies in the rule. 

Regulatory Requirements Addressed in the Final Rule: 

EPA discussed the following generally-applicable statutes and executive 
orders in the final rule: 

* NTTAA: EPA adopted voluntary consensus standards for monitoring the 
levels of disinfection byproducts. 

* PRA: The rule contained new information collection requirements for 
which EPA completed and submitted an Information Collection Request to 
OIRA for approval. 

* RFA: EPA certified that the rule would not have a significant 
economic impact on a substantial number of small entities. EPA 
conducted a SBREFA advocacy review panel. 

* UMRA: EPA determined that the rule may contain a mandate resulting in 
annual expenditures of more than $100 million for state, local, and 
tribal governments, or the private sector. EPA prepared an UMRA 
analysis, which included a consideration of the regulatory 
alternatives. 

* Executive Order 12866 (Regulatory Planning and Review): EPA 
identified the rule as a significant regulatory action as defined by 
the executive order. Therefore, EPA conducted an economic analysis and 
submitted the rule to OIRA for review. 

* Executive Order 12898 (Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations): EPA 
consulted with minority and low-income stakeholders. EPA determined 
that since the rule applies uniformly to all communities, the health 
protections provided are equal across all minority and income groups 
served by systems regulated by the rule. 

* Executive Order 13045 (Protection of Children from Environmental 
Health Risks and Safety Risks): EPA concluded that "it has reason to 
believe that the environmental health or safety risk...addressed by 
this [rule] may have a disproportionate effect on children. EPA 
believes that the [rule] will result in greater risk reduction for 
children than for the general population." 

* Executive Order 13132 (Federalism): EPA determined that the rule did 
not have federalism implications because it will not have substantial 
direct effects on the states, on the relationship between the states 
and federal government, or the distribution of power and 
responsibilities among various levels of government. 

* Executive Order 13175 (Consultation and Coordination with Indian 
Tribal Governments): EPA concluded that the final rule may have tribal 
implications because it may impose substantial direct compliance costs 
on tribal governments and the federal government will not provide the 
funds necessary to pay those costs. A detailed estimate of the tribal 
impact was included in the rule. 

* Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use): EPA 
determined that the rule is not likely to have a significant adverse 
effect on the supply, distribution, or use of energy. 

Recent Analytic Requirements Addressed: 

EPA's regulatory impact analysis addressed the four analytical changes 
in the OMB economic guidelines that we reviewed for this study. For 
example, the agency analyzed cost-effectiveness, discounted potential 
benefits and costs using discount rates of 7 percent and 3 percent, 
evaluated potential qualitative and quantitative benefits and costs, 
and conducted a probability analysis to assess the uncertainty 
associated with some potential impacts. Agency officials said that they 
assessed the cost-effectiveness of the regulatory alternatives in the 
rule because the OMB guidelines require it but that the three other 
analyses were conducted because the agency had already adopted them as 
best practices. The officials estimated that the cost-effectiveness 
analysis required from 1 to 2 months to complete, partly because the 
agency had not yet developed guidance for analyzing the cost- 
effectiveness of health-related rules. In addition, agency officials 
said that the cost-effectiveness analysis was only of limited use for 
selecting a final regulatory alternative. 

Changes Resulting from OIRA Review: 

The copy of the draft final rule in the docket shows changes throughout 
to both the preamble and the rule text itself. Some appear to be 
strictly editorial, and others appear to have substantive effect. One 
significant change to the rule text itself is in the section on 
compliance monitoring requirements. The requirement to repeat 
monitoring is changed to apply only when more than eight monitoring 
locations are required, rather than four required monitoring locations. 
Additional requirements for repeat monitoring have been removed. 
Changes to the preamble include the addition of a description of 
variances and exemptions in place of a statement that the rule would be 
updated "upon completion of affordability discussions with OMB." EPA's 
Executive Order 12866 compliance form for the rule, docketed with the 
OMB review of the draft of the final rule, describes the OMB changes as 
not substantive. 

Timeline: 

* November 29, 1979: The Total Trihalomethanes Rule, the first 
regulation of disinfection byproducts, was published. 

* Fall 1992: EPA convened an advisory committee to address the issue of 
disinfection and disinfectant byproducts and pathogen control issues; 
this led to the first Disinfection Byproducts rule. 

* Spring 1993: A Cryptosporidium outbreak in Milwaukee, Wisconsin, 
sickened over 400,000 people, roughly 50 percent of users of the 
municipal drinking water system. 

* 1996: The SDWA required EPA to establish new standards for treatment 
of drinking water and the byproducts of the water treatment process. 

* 1997: EPA convened a federal advisory committee to finalize SDWA 
rulemakings, including the Disinfection Byproducts 2 rule and Interim 
Enhanced Surface Water Treatment rule. 

* December 16, 1998: The first Disinfection Byproducts rule was 
published in the Federal Register. 

* March 1999 to July 2000: EPA reconvened the federal advisory 
committee to provide technical input on additional SDWA rulemakings, 
including the Disinfection Byproducts 2 rule and the Surface Water 
Treatment 2 rule. 

* August 6, 1999: EPA assigned a Start Action Number for the 
rulemaking. 

* Late 1999: EPA initiated the pre-panel stages of a SBREFA advocacy 
review panel. 

* June 23, 2000: Advocacy review panel completed. 

* September 2000: Federal advisory committee members signed Agreement 
in Principle stating consensus of the group. 

* December 29, 2000: Federal advisory committee Agreement in Principle 
was published in the Federal Register. 

* January 16, 2001: Revisions to the first Disinfection Byproducts 
rulemaking were published in the Federal Register. 

* October 17, 2001: EPA published pre-proposal draft of Disinfection 
Byproducts 2 rule preamble and regulatory language on the agency Web 
site for public comment on whether the draft was consistent with 
federal advisory committee recommendations. 

* July 2003: The agency completed the regulatory impact analysis for 
proposed rule. 

* August 18, 2003: The proposed rule was published in the Federal 
Register. 

* February 2005: EPA received notice of intent to sue. 

* April 14, 2005: OMB staff met with outside parties to discuss several 
rules by the EPA Office of Water, including this rule. 

* August 26, 2005: OMB received the draft final rule. 

* November 2005: EPA entered into settlement agreement to complete the 
rule by December 2005. 

* November 23, 2005: OMB completed review of draft final rule with 
change. 

* December 2005: EPA completed the regulatory impact analysis for final 
rule. 

* December 15, 2005: EPA Administrator signed the final rule. 

* January 4, 2006: The final rule was published in the Federal 
Register. 

National Primary Drinking Water Regulations: Long Term 2 Enhanced 
Surface Water Treatment Rule (Surface Water Treatment 2): 

Identifying Information: 

* Agency: Environmental Protection Agency, Office of Water: 

* Rule classification: Major, Economically Significant: 

* RIN: 2040-AD37: 

* Federal Register citation: 71 Fed. Reg. 654: 

* Regulations.gov docket number: EPA-HQ-OW-2002-0039: 

* Date of final rule: January 5, 2006: 

Rule Synopsis: 

The rule is intended to protect public health against Cryptosporidium 
and other microbial pathogens in drinking water. Cryptosporidium is 
highly resistant to chemical disinfectants and can cause acute illness 
and death for people with weakened immune systems. Authorized by SDWA, 
the rule was one of a series of rules, including the Disinfection 
Byproducts 2 rule, intended to improve the quality of drinking water 
supplied by public water systems throughout the United States. Because 
of the complex and far-reaching implications of the rule, as well as 
the relationship between the Disinfection Byproducts 2 rule and the 
rule, EPA convened a FACA panel to help develop the policies in the 
rule. 

Regulatory Requirements Addressed in the Final Rule: 

EPA discussed the following generally-applicable statutes and executive 
orders in the final rule: 

* NTTAA: EPA adopted voluntary standards for monitoring the levels of 
one pathogen. 

* PRA: The rule contained new information collection requirements for 
which EPA completed and submitted an Information Collection Request to 
OIRA for approval. 

* RFA: EPA certified that the rule would not have a significant 
economic impact on a substantial number of small entities. EPA 
conducted a SBREFA advocacy review panel. 

* UMRA: EPA determined that the rule may contain a mandate resulting in 
annual expenditures of more than $100 million for state, local, and 
tribal governments, in the aggregate, or the private sector. EPA 
prepared an UMRA analysis, which included a consideration of the 
regulatory alternatives. 

* Executive Order 12866 (Regulatory Planning and Review): EPA 
identified the rule as a significant regulatory action as defined in 
the executive order because of its economic significance. Therefore, 
EPA conducted an economic analysis and submitted the rule to OIRA for 
review. 

* Executive Order 12898 (Federal Actions to Address Environmental 
Justice in Minority Populations or Low-Income Populations): EPA 
determined that since the rule applies uniformly to all communities, 
the health protections provided are equal across all minority and 
income groups served by systems regulated by the rule. 

* Executive Order 13045 (Protection of Children from Environmental 
Health Risks and Safety Risks): EPA determined that the rule was 
economically significant and that the environmental risks addressed by 
the rule may have a disproportionate effect on children. 

* Executive Order 13132 (Federalism): EPA concluded that the rule may 
have federalism implications because it may impose substantial direct 
costs on state or local governments, and the federal government will 
not provide the funds to pay those costs. 

* Executive Order 13175 (Consultation and Coordination with Indian 
Tribal Governments): EPA concluded that the rule may have tribal 
implications because it may impose substantial direct compliance costs 
on tribal governments, and the federal government will not provide the 
funds necessary to pay those costs. 

* Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use): EPA 
determined that the rule is not likely to have a significant adverse 
effect on the supply, distribution, or use of energy. 

Recent Analytical Requirement Addressed: 

EPA's regulatory impact analysis addressed the four analytical changes 
in the OMB economic guidelines that we reviewed for this study. The 
agency analyzed cost-effectiveness, discounted potential benefits and 
costs using discount rates of 7 percent and 3 percent, evaluated 
potential qualitative and quantitative benefits and costs, and 
conducted a probability analysis to assess the uncertainty associated 
with some potential impacts. Agency officials said that they assessed 
the cost-effectiveness of the regulatory alternatives in the rule 
because the OMB guidelines require it but that the three other analyses 
were conducted because the agency had already adopted them as best 
practices. The officials estimated that the cost-effectiveness analysis 
required from 1 to 2 months to complete, partly because the agency had 
not yet developed guidance for analyzing the cost-effectiveness of 
health-related rules. In addition, agency officials said that the cost- 
effectiveness analysis was only of limited use for selecting a final 
regulatory alternative. 

Changes Resulting from OIRA Review: 

According to OMB's public database, OMB received the draft final rule 
on March 31, 2005, and review was complete on June 22, 2005. The rule 
was subsequently published "consistent with change." EPA's Executive 
Order 12866 compliance form for the rule, docketed with the OMB review 
of the draft of the final rule, describes the OMB changes as not 
substantive. The reviewed copy of the draft final rule shows changes 
throughout the draft rule to both the preamble and the rule text 
itself. Some appear to be strictly editorial, and others appear to have 
substantive effect. Two significant changes to the rule text itself are 
addition of notification of violation requirements for public water 
systems in section 141.211 of the rule and changes to section 141.703 
that provide additional circumstances under which data can be 
grandfathered under state approval. Changes to the preamble include 
indication that regulated systems may assume state approval of 
monitoring locations if explicit state approval is not forthcoming. 

Timeline: 

* Fall 1992: EPA convened an advisory committee to address the issue of 
disinfection and disinfectant byproducts and pathogen control issues; 
this led to the first Disinfection Byproducts rule. 

* Spring 1993: A Cryptosporidium outbreak in Milwaukee, Wisconsin, 
sickened 400,000 people, roughly 50 percent of users of the municipal 
drinking water system. 

* August 9, 1999: EPA assigned Start Action Number for the rulemaking. 

* 1996: The SDWA authorized EPA to establish new treatment standards 
for drinking water and byproducts of the water treatment process. 

* 1997: EPA convened an issue-specific federal advisory committee to 
develop SDWA rulemakings, including Stage 1 DBP Rule and Interim 
Surface Water Treatment Rule. 

* December 16, 1998: Interim Enhanced Surface Water Treatment Rule was 
published in the Federal Register. 

* March 1999 to September 2000: EPA reconvened the federal advisory 
committee to provide technical input on additional SDWA rulemakings, 
including the Long Term 2 Rule. 

* Late 1999: EPA initiated the pre-panel stages of a SBREFA advocacy 
review panel. 

* June 23, 2000: Advocacy review panel completed. 

* September 2000: Federal advisory committee members signed Agreement 
in Principle stating consensus of the group. 

* December 29, 2000: Federal advisory committee Agreement in Principle 
was published in the Federal Register. 

* January 16, 2001: Revisions to Interim Enhanced Surface Water 
Treatment rulemaking were published in the Federal Register. 

* October 17, 2001: EPA published pre-proposal draft of Long Term 2 
Rule preamble and regulatory language on the agency Web site for public 
comment. 

* January 14, 2002: The Long Term 1 Rule was published in the Federal 
Register. 

* December 18, 2002: OIRA received the draft proposed rule. 

* March 18, 2003: OIRA completed review of the draft proposed rule with 
change. 

* June 2003: The agency completed the regulatory impact analysis for 
proposed rule. 

* August 11, 2003: The proposed rule was published in the Federal 
Register. 

* February 2005: EPA received notice of intent to sue. 

* March 31, 2005: OMB received the draft final rule. 

* April 14, 2005: OMB staff met with outside parties to discuss several 
rules by the EPA Office of Water, including this rule. 

* June 22, 2005: OMB completed review of draft final rule with change. 

* November 2005: EPA entered into settlement agreement to complete the 
rule by December 2005. 

* December 2005: The agency completed the regulatory impact analysis 
for final rule. 

* December 15, 2005: Final rule was signed. 

* January 5, 2006: The final rule published in the Federal Register. 

Requirements on Content and Format of Labeling for Human Prescription 
Drug and Biological Products (Physician Labeling): 

Identifying Information: 

* Agency: Food and Drug Administration, Center for Drug Evaluation and 
Research: 

* Rule classification: Other Significant: 

* RIN: 0910-AA94: 

* Federal Register citation: 71 Fed. Reg. 3922: 

* Regulations.gov docket number: FDA-2000-N-0044: 

* Date of final rule: January 24, 2006: 

Rule Synopsis: 

The rule revises the requirements for the format and content of 
labeling for human prescription drugs and biological products, the 
information physicians use to learn about and prescribe these products. 
The rule governs physician drug labeling which takes the form of 
package inserts. Package inserts are used as the basis for a large 
uniform prescription drug manual called The Physician's Desk Reference. 
FDA stated that the intent of the rule is to enhance the safe and 
effective use of prescription drug products and to reduce the number of 
adverse reactions resulting from medication errors caused by 
misunderstood or incorrectly applied drug information. Specifically, 
revisions require the labeling of new and recently approved products to 
include highlights of prescribing information and a table of contents, 
exclude less important and include more important content, meet new 
minimum graphical requirements, be accompanied by all applicable 
patient labeling approved by FDA, and clarify certain prescribing 
requirements. 

Regulatory Requirements Addressed in the Final Rule: 

FDA discussed the following generally-applicable statutes and executive 
orders in the final rule: 

* NEPA: FDA determined that the rule does not have a significant effect 
on the human environment. 

* PRA: The rule included new information collections for which FDA 
completed and submitted an Information Collection Request to OIRA for 
approval. 

* RFA: FDA believes that the final rule would not have a significant 
impact on most small entities in this industry, but it is possible that 
a few small firms may be significantly affected by the final rule. FDA 
included a final regulatory flexibility analysis in the final rule. 

* UMRA: FDA determined that the rule would not result in any 1-year 
expenditure by state, local and tribal governments, in the aggregate, 
or by the private sector that would meet or exceed the relevant 
threshold of $115 million. 

* Executive Order 12866 (Regulatory Planning and Review): FDA 
identified the rule as a significant regulatory action as defined by 
the executive order. FDA conducted an economic analysis and submitted 
the rule to OIRA for review. 

* Executive Order 12988 (Civil Justice Reform): FDA determined that the 
rule does not have any retroactive effect. 

* Executive Order 13132 (Federalism): FDA stated that certain state- 
level product liability claims would conflict with federal law or 
frustrate the purpose of federal regulation. FDA described six 
categories of product liability claims that the agency believed would 
be preempted by FDA's regulation of prescription drug labeling. 

Changes Resulting from OIRA Review: 

FDA deleted at OIRA's suggestion an estimate of the number of people 
who would submit applications for new drugs and a table detailing the 
estimated reporting burden for those subject to FDA's information 
collection request. FDA at OIRA's suggestion also increased the number 
of affected pharmaceutical firms that could be considered small. We 
found in FDA's docket, documentation of OIRA's review for the final 
rule but not for the proposed rule. We assume none was required for the 
proposed rule as, according to OIRA's [hyperlink, 
http://www.reginfo.gov], it was not changed by OIRA review. 

Timeline: 

* Before 1992: CDER received feedback from physicians in the field that 
prescription drug labeling required revision. 

* 1992: CDER convened the first focus group on the issue. 

* August 2, 2000: OIRA received draft proposed rule. 

* December 14, 2000: OIRA completed review of the draft proposed rule 
without change. 

* December 22, 2000: The proposed rule was published in the Federal 
Register. 

* August 2003: The draft final rule approved by CDER. 

* October 2003: The rule was sent to the Office of Chief Counsel, which 
performed a federalism analysis. 

* November 2004: The rule received FDA approval and was sent to the 
Department of Health and Human Services and OMB simultaneously. 

* January 10, 2005: OIRA received the draft final rule. 

* April 1, 2005: FDA withdrew the rule from OIRA review at OIRA's 
request. 

* April 8, 2005: FDA resubmitted the rule for OIRA review. 

* January 17, 2006: OIRA completed its review of the final rule with 
change. 

* January 24, 2006: The final rule was published in the Federal 
Register. 

Use of Ozone Depleting Substances; Removal of Essential Use 
Designations (Ozone Depleting Substances): 

Identifying Information: 

* Agency: Food and Drug Administration, Center for Drug Evaluation and 
Research: 

* Rule classification: Other Significant: 

* RIN: 0910-AF93: 

* Federal Register citation: 71 Fed. Reg. 70,870: 

* Regulations.gov docket number: FDA-2006-N-0169: 

* Date of final rule: December 7, 2006: 

Rule Synopsis: 

The Clean Air Act required that FDA, in consultation with EPA, 
determine whether an FDA-regulated product that released ozone- 
depleting substances was essential. The rule removes the "essential 
use" designations granted previously by FDA for seven products emitting 
ozone-depleting substances from pressurized containers. As none of the 
seven products were being marketed in the United States, the rule 
removed unnecessary essential use designations. The products were 
granted the designation by a previous FDA rule, which also stated that 
if essential use products were no longer marketed in the United States, 
the designation could be withdrawn. 

Regulatory Requirements Addressed in the Final Rule: 

FDA discussed the following generally-applicable statutes and executive 
orders in the final rule: 

* NEPA: FDA conducted an environmental assessment and considered 
potential impacts. FDA concluded that an environmental impact statement 
was not required. 

* PRA: The rule does not impose any new information collection 
requests. 

* RFA: FDA certified that the rule would not have a significant 
economic impact on a substantial number of small entities. 

* UMRA: FDA did not expect the rule to result in any 1-year expenditure 
that would meet or exceed the relevant threshold of $118 million. 

* Executive Order 12866 (Regulatory Planning and Review): FDA believed 
that the rule was not a significant regulatory action as defined by 
this executive order. However, OMB requested the rule for review 
because of its international implications. 

* Executive Order 13132 (Federalism): FDA determined that the rule did 
not contain policies that have federalism implications. 

Changes Resulting from OIRA Review: 

Under Executive Order 12866, FDA did not consider the rule significant 
regulatory action as defined by the executive order. However, FDA 
believed that OMB would want to review the rule because of the rule's 
implications to the Montreal Protocol (Treaty) that included agency 
obligations to EPA as stated in the treaty, and also amendments to the 
Clean Air Act. OIRA did not suggest any changes to the rule during the 
formal OMB review period. 

Timeline: 

* Early 2006: CDER began drafting the direct-to-final rule. 

* May 2006: CDER approval process began. 

* July 2006: Economic analysis completed. 

* August 2006: Rule approved by CDER's Office of Regulatory Policy. 

* September 2006: Rule approved by CDER Director. 

* October 2006: Rule approved by Chief Counsel and management at FDA. 

* October 23, 2006: OIRA received draft final rule. 

* November 28, 2006: OIRA completed review of draft final rule with no 
change. 

* December 2006: Direct-to-final rule published in the Federal 
Register. 

Current Good Manufacturing Practice in Manufacturing, Packaging, 
Labeling, or Holding Operations for Dietary Supplements (Dietary 
Supplements): 

Identifying Information: 

* Agency: Food and Drug Administration, Center for Food Safety and 
Applied Nutrition: 

* Rule classification: Major, Economically Significant: 

* RIN: 0910-AB88: 

* Federal Register citation: 72 Fed. Reg. 34,752: 

* Regulations.gov docket number: FDA-1996-N-0028: 

* Date of final rule: June 25, 2007: 

Rule Synopsis: 

The rule establishes the minimum current good manufacturing practice 
for manufacturing, packaging, labeling, and holding dietary 
supplements.[Footnote 73] FDA was authorized by the Dietary Supplement 
Health and Education Act of 1994 to prescribe by regulation good 
manufacturing practices for dietary supplements. FDA published an 
Advance Notice of Proposed Rulemaking on February 6, 1997 in the 
Federal Register. 62 Fed. Reg. 5700. FDA published a proposed rule in 
the Federal Register on March 13, 2003. 

Regulatory Requirements Addressed in the Final Rule: 

FDA discussed the following statutory and regulatory requirements in 
the final rule: 

* NEPA: FDA determined that the final rule did not trigger the 
requirements of NEPA because the action is of a type that does not 
individually or cumulatively have a significant effect on the human 
environment. 

* PRA: The rule included new information collections for which FDA 
completed and submitted an Information Collection Request to OIRA for 
approval. 

* RFA: FDA determined that the rule will have a significant economic 
impact on a substantial number of small entities and prepared a final 
regulatory flexibility analysis. 

* UMRA: FDA determined that the rule may contain a mandate resulting in 
annual expenditures of more than $122 million for state, local, and 
tribal governments, or the private sector. FDA prepared an UMRA 
analysis, which included a consideration of the rule's effects on 
future costs. 

* Executive Order 12866 (Regulatory Planning and Review): FDA 
identified the rule as a significant regulatory action as defined by 
the executive order because of its economic significance. Therefore, 
FDA conducted an economic analysis and submitted the rule to OIRA for 
review. 

* Executive Order 13132 (Federalism): FDA determined that the rule did 
not have a substantial direct effect on the states, on the relationship 
between the national government and the states, or on the balance of 
power and responsibilities among the various levels of government. FDA 
concluded that the rule did not have federalism implications. 

Recent Analytic Requirements Addressed: 

FDA's regulatory impact analysis for the final rule included the four 
analytical changes in OMB Circular No. A-4 that we reviewed for this 
study. For example, the agency analyzed cost-effectiveness and 
evaluated some qualitative impacts, discounted future benefits and 
costs using discount rates of 3 percent and 7 percent, and conducted a 
probability analysis to assess the uncertainty associated with some 
potential impacts. FDA officials said that they used the two discount 
rates because of Circular No. A-4 but added that they have always 
followed OMB guidelines on discount rates. The officials could not 
recall whether the cost-effectiveness analysis was conducted 
specifically because of Circular No. A-4, but indicated that it is 
currently an agency best practice. The officials added that 
systematically evaluating qualitative impacts and using probability 
analysis to analyze uncertainty are also agency best practices. For 
example, the officials said that they analyzed uncertainty using a 
probability analysis because it is a best practice when there is a 
large degree of uncertainty about the estimated benefits and costs. 
According to these officials, OMB Circular No. A-4 is useful because it 
made transparent what OMB reviewers expect for analytical support on 
economically significant rules and, more generally, because it serves 
as a blueprint for conducting a regulatory impact analysis. 

Changes Resulting from OIRA Review: 

FDA made changes at the suggestion of OIRA to both the preamble and the 
regulatory text. FDA sent draft versions of the final rule to OIRA 
twice, once in October 2005 and again in June 2006. FDA staff stated 
that the rule was not returned by OIRA, but rather as a result of 
discussions, FDA staff made a number of changes and sent a second draft 
of the rule to OIRA. Our review of both copies of the draft final rule 
reviewed by OIRA as docketed by FDA found edits to the rule, both to 
the preamble and the rule itself. For example, in addition to editorial 
changes, changes to the draft rule text show that a requirement in the 
rule to save reserve samples for 3 years was changed to 2 years. This 
change is also reflected in the preamble language. Changes to the 
regulatory impact analysis--included with the rule in its entirety in 
keeping with FDA practice--show additions of text justifying the 
rulemaking and additional descriptions of calculations of costs 
associated with illness and injury resulting from contaminated or 
mislabeled dietary supplements. We found documentation of the final 
stage of OMB review on both drafts sent to OMB during that stage. 

Timeline: 

* October 25, 1994: Dietary Supplement Health and Education Act of 
1994, Pub. L. No. 103-417, was enacted, granting FDA authority to 
prescribe good manufacturing practices for dietary supplements by 
regulation. 

* November 1995: Industry group requested that FDA consider a 
rulemaking on good manufacturing practices for dietary supplements. 

* February 6, 1997: An Advance Notice of Proposed Rulemaking was 
published in the Federal Register. 

* 1998-1999: FDA management considered and committed to a rulemaking. 

* 1999: FDA undertook a series of outreach activities, including public 
meetings and tours of dietary supplement manufacturing facilities. 

* October 4, 2002: OIRA received the draft proposed rule. 

* January 16, 2003: OIRA completed review of the draft proposed rule 
with change. 

* March 13, 2003: The proposed rule was published in the Federal 
Register. 

* October 25, 2005: OIRA received the draft final rule. 

* November 29, 2005, October 4, 2006, and November 16, 2006: OIRA staff 
met with outside parties to discuss this rule. 

* May 8, 2007: OIRA completed review of draft final rule with change. 

* June 25, 2007: Final rule was published in the Federal Register, and 
FDA published an interim final rule on a process for requesting 
exemption from the dietary supplement current good manufacturing 
practices requirement for 100 percent identity testing of dietary 
ingredients. 

Food Labeling: Nutrient Content Claims, Expansion of the Nutrient 
Content Claim "Lean" (Lean Nutrient Claims): 

Identifying Information: 

* Agency: Food and Drug Administration, Center for Food Safety and 
Applied Nutrition: 

* Rule classification: Other Significant: 

* RIN: 0910-ZA27: 

* Federal Register citation: 72 Fed. Reg. 1455: 

* Regulations.gov docket number: FDA-2004-P-0008: 

* Date of final rule: January 12, 2007: 

Rule Synopsis: 

The rule amends FDA's food labeling regulations to allow the use of the 
word "lean" more frequently by including it for use with "mixed dishes 
not measurable with a cup" that fulfill certain criteria for fat and 
cholesterol content.[Footnote 74] The intent was to provide reliable 
information that would assist consumers in maintaining healthy dietary 
practices. The rule was promulgated in response to a petition by Nestlé 
Corporation requesting that the category "mixed dishes not measurable 
with a cup" be included among those that can be called "lean." 

Regulatory Requirements Addressed in the Final Rule: 

FDA discussed the following generally-applicable statutes and executive 
orders in the final rule: 

* NEPA: FDA determined that the final rule did not trigger the 
requirements of NEPA because the action is of a type that does not 
individually or cumulatively have a significant effect on the human 
environment. 

* RFA: FDA certified that the rule would not have a significant 
economic impact on a substantial number of small entities. 

* PRA: The rule did not contain any new information collection 
requests. 

* UMRA: FDA did not expect the rule to result in any 1-year expenditure 
by state, local, and tribal governments, in the aggregate, or by the 
private sector, that would meet or exceed the relevant threshold of 
$122 million. 

* Executive Order 12866 (Regulatory Planning and Review): FDA 
determined that the rule was not a significant regulatory action as 
defined by the executive order. However, OMB considered the rule a 
significant regulatory action. Therefore, FDA submitted the rule to 
OIRA for review. 

* Executive Order 13132 (Federalism): FDA determined that the rule 
would have a preemptive effect on state law, but concluded that the 
preemptive effect of the rule is consistent with Executive Order 13132. 

Changes Resulting from OIRA Review: 

After 100 days of formal OMB review, the final rule was not changed by 
OMB. 

Timeline: 

* January 9, 2004: Nestlé submitted the petition for the rulemaking. 

* April 22, 2004: FDA filed the Nestlé petition for comprehensive 
review. 

* November 25, 2005: Proposed rule published in the Federal Register. 

* February 16, 2006: FDA notified state health commissioners, state 
agricultural commissioners, food program directors, and FDA field 
personnel and drug program directors of the intended amendment. 

* September 12, 2006: OIRA received draft final rule. 

* December 21, 2006: OIRA completed review of the draft final rule with 
no change. 

* January 12, 2007: Final rule published in the Federal Register. 

Electronic Shareholder Forums: 

Identifying Information: 

* Agency: Securities and Exchange Commission, Division of Corporation 
Finance: 

* Rule classification: Not applicable: 

* RIN: 3235-AJ92: 

* Federal Register citation: 73 Fed. Reg. 4450: 

* Regulations.gov docket number: SEC-2007-1058 (proposed rule); SEC- 
2008-0133 (final rule): 

* Date of final rule: January 25, 2008: 

Rule Synopsis: 

The rule encourages the use of online shareholder forums. It removes 
legal ambiguity and both real and perceived impediments to private 
sector experimentation with the use of the Internet for communication. 
SEC stated that such communication technology can potentially better 
vindicate shareholders' rights, for example, to elect directors and 
improve discussions on a variety of subjects that are now considered 
only periodically and indirectly through the proxy process. The rule 
gives liability protection to parties maintaining or operating an 
electronic shareholder forum. 

Regulatory Requirements Addressed in the Final Rule: 

SEC discussed the following generally-applicable statutes in the final 
rule: 

* RFA: SEC analyzed whether the rule would have a significant economic 
impact on a substantial number of small entities and prepared both an 
initial and final regulatory flexibility analysis. 

* PRA: The rule did not include any new information collection 
requirements. 

Changes Resulting from OIRA Review: 

As an independent regulatory agency, SEC is not subject to OIRA 
regulatory review under Executive Order 12866. 

Timeline: 

* 2006: Lawsuit resulted in court decision concerning proxies. 

* May 7, 24, and 25, 2007: SEC hosted three proxy roundtables to gather 
information from a wide of variety of parties interested in proxy 
issues. 

* July 12, 2007: Staff formally recommended proposed rule for SEC 
consideration. 

* July 27, 2007: At an open meeting, SEC approved issuance of proposed 
rule. 

* August 3, 2007: Proposed rule was published in the Federal Register. 

* November 16, 2007: Staff formally recommended adopting final rule to 
SEC. 

* November 28, 2007: At an open meeting, SEC approved issuance of final 
rule. 

* January 25, 2008: Final rule was published in Federal Register. 

Internet Availability of Proxy Materials (Internet Proxies): 

Identifying Information: 

* Agency: Securities and Exchange Commission, Division of Corporation 
Finance: 

* Rule classification: Major: 

* RIN: 3235-AJ47: 

* Federal Register citation: 72 Fed. Reg. 4148: 

* Regulations.gov docket number: SEC-2005-0386 (proposed); SEC-2007- 
0134 (final): 

* Date of final rule: January 29, 2007: 

Rule Synopsis: 

The rule provides an alternative method of providing proxy materials to 
shareholders by posting the materials on an Internet site and notifying 
shareholders of their availability. The rule is voluntary, and issuers 
of securities are not required to offer shareholders an electronic 
distribution option. 

Regulatory Requirements Addressed in the Final Rule: 

SEC discussed the following generally-applicable statutory requirements 
in the final rule: 

* PRA: The rule included new information collections for which SEC 
completed and submitted an Information Collection Request to OIRA for 
approval. 

* RFA: SEC analyzed whether the rule would have a significant economic 
impact on a substantial number of small entities and prepared an 
initial and final regulatory flexibility analysis. 

Changes Resulting from OIRA Review: 

As an independent regulatory agency, SEC is not subject to OIRA 
regulatory review under Executive Order 12866. 

Timeline: 

* Spring 2005: SEC regulatory development staff began drafting the 
proposed rule. 

* November 14, 2005: Staff formally recommended that SEC approve 
proposed rule. 

* November 29, 2005: SEC approved issuance of proposed rule at an open 
meeting. 

* December 15, 2005: The proposed rule was published in the Federal 
Register. 

* November 27, 2006: Staff formally recommended adopting final rule for 
SEC consideration. 

* December 13, 2006: SEC approved issuance of final rule at an open 
meeting. 

* January 29, 2007: The final rule was published in the Federal 
Register. 

Extension of Interactive Data Voluntary Reporting Program on the EDGAR 
System to Include Mutual Fund Risk/Return Summary Information (Mutual 
Fund Data Reporting): 

Identifying Information: 

* Agency: Securities and Exchange Commission, Division of Investment 
Management: 

* Rule classification: Not applicable: 

* RIN: 3235-AJ59: 

* Federal Register citation: 72 Fed. Reg. 39,290: 

* Regulations.gov docket number: SEC-2007-0220 (proposed rule); SEC- 
2007-0958 (final rule): 

* Date of final rule: July 17, 2007: 

Rule Synopsis: 

The rule encourages mutual funds to participate in a voluntary 
reporting program to tag selected risk/return data in a standard format 
in eXtensible Business Reporting Language (XBRL). According to the 
preamble, "with almost half of all U.S. households owning mutual 
funds...improving the quality of mutual fund disclosure is important to 
millions of Americans." When tagged in XBRL, the data become 
interactive and can be retrieved, searched, or analyzed by software 
applications in an automated fashion. The rule encourages voluntary 
participation in a program of electronically tagging risk/return 
information by mutual funds, so that SEC can evaluate the usefulness of 
such tagging to interested parties. Information submitted would be 
included in the Electronic Data Gathering, Analysis, and Retrieval 
System (EDGAR) filings. 

Regulatory Requirements Addressed in the Final Rule: 

SEC discussed the following generally-applicable statutes in the final 
rule: 

* PRA The rule included new information collections for which SEC 
completed and submitted an Information Collection Request to OIRA for 
approval. 

* RFA: SEC analyzed whether the rule would have a significant economic 
impact on a substantial number of small entities and prepared both an 
initial and final regulatory flexibility analysis. 

Changes Resulting from OIRA Review: 

As an independent regulatory agency, SEC is not subject to OIRA 
regulatory review under Executive Order 12866. 

Timeline: 

* March 2006: ICI announced an initiative to create a taxonomy of 
interactive data tags for the risk/return summary. 

* June 12, 2006: SEC held a public roundtable on the use of interactive 
data for mutual funds. 

* September 24, 2006: First draft of ICI tags distributed to working 
group for comment; SEC staff provided comments on draft taxonomy over 
next several weeks. 

* January 4, 2007: ICI released the XBRL tags to the public. 

* January 18, 2007: Staff formally recommended proposing release for 
SEC consideration. 

* January 31, 2007: SEC approved issuance of proposed rule. 

* February 12, 2007: Proposed rule published in the Federal Register. 

* May 16, 2007: ICI submitted taxonomy to XBRL International for 
acknowledgment. 

* June 6, 2007: Staff formally recommended adopting final rule for SEC. 

* June 20, 2007: SEC approved issuance of final rule at an open 
meeting. 

* July 17, 2007: Final rule was published in the Federal Register. 

Mutual Fund Redemption Fees Identifying Information (Mutual Fund 
Redemption Fees): 

Identifying Information: 

* Agency: Securities and Exchange Commission, Division of Investment 
Management: 

* Rule classification: Major: 

* RIN: 3235-AJ51: 

* Federal Register citation: 71 Fed. Reg. 58,257: 

* Regulations.gov docket number: SEC-2006-0292 (proposed rule); SEC- 
2006-1284 (final rule): 

* Date of final rule: October 3, 2006: 

Rule Synopsis: 

The rule amends SEC Rule 22c-2, which permits registered open-end 
investment companies (funds) to impose a redemption fee of up to 2 
percent on the redemption of fund shares. The rule is intended to allow 
funds to recoup some of the direct and indirect costs of frequent 
trading and to reduce the dilution of fund shares. The rule also 
requires that the fund, regardless of whether it imposes a redemption 
fee, enter into a written agreement with each of its intermediaries 
(such as broker-dealers or retirement plan administrators) under which 
the intermediaries must provide the fund, upon request, information 
about the identity of shareholders and information about their 
transactions in fund shares. These amendments are designed to address 
certain technical issues that arose after the rule was adopted and 
reduce the cost of compliance to both funds and financial 
intermediaries. 

Regulatory Requirements Addressed in the Final Rule: 

SEC discussed the following generally-applicable statutory requirements 
in the final rule: 

* PRA: The rule included new information collections for which SEC 
completed and submitted an Information Collection Request to OIRA for 
approval. 

* RFA: SEC analyzed whether the rule would have a significant economic 
impact on a substantial number of small entities and prepared both an 
initial and final regulatory flexibility analysis. 

Changes Resulting from OIRA Review: 

As an independent regulatory agency, SEC is not subject to OIRA 
regulatory review under Executive Order 12866. 

Timeline: 

* March 11, 2005: SEC adopted rule 22c-2 under the Investment Company 
Act; in the final notice, SEC solicited additional comment on 22c-2. 

* February 3, 2006: Staff formally recommended that SEC amend Rule 
22c-2. 

* February 28, 2006: SEC approved issuance of proposed amendments to 
Rule 22c-2. 

* March 7, 2006: The proposed amended rule was published in the Federal 
Register. 

* September 1, 2006: Staff formally recommended that SEC adopt amended 
rule. 

* September 27, 2006: SEC approved issuance of final rule. 

* October 3, 2006: The final rule was published in the Federal 
Register. 

This appendix presents examples of different methods that agencies used 
to document the OIRA review process under Executive Order 12866 in 
their rulemaking dockets (See figures 5, 6, and 7.) 

[End of section] 

Appendix III: Examples of OIRA Review Documentation: 

Figure 5: NHTSA Summary Memorandum Identifying OIRA Review Changes: 

[Refer to PDF for image: letter] 

U.S. Department of Transportation: 
National Highway Traffic Safety Administration: 

Memorandum: 

Date: March 10, 2009: 

Subject: Revisions to Regulatory Action on Event Data Recorders (EDRs): 

From: [Signed by] Eric Stas: 
Attorney-Advisor, Office of the Chief Counsel: 
National Highway Traffic Safety Administration (NHTSA): 

To: U.S. DOT Docket Management System: 
Docket NHTSA-2006-25666-455: 

Section 6(a)(3)(E) of Executive Order 12866, "Regulatory Planning and 
Review," requires agencies to identify the substantive changes between 
a draft regulatory action suubmitted to the Office of Management and 
Budget (OMB) for review and the action subsequently announced. 

Changes to the EDR Final Rule: 

At the suggestion of OMB, NHTSA modified the draft EDR final rule as 
follows: 

* Added a discussion regarding why the agency anticipates that EDRs 
will require collection of vehicle identification number (VIN) 
information, how the agency typically safeguards such information, and 
why VIN information is not a 'record' or part of a 'system of records' 
under the Privacy Act of 1974 (see Section III.B and Section IV.H.7). 

* Clarified that the regulation of in-vehicle subscription services 
(e.g., ones designed to link the vehicle with a dispatcher of emergency 
medical personnel or roadside assistance) is outside the scope of the 
present EDR rulemaking. However, the agency stated its expectation that 
consumers are generally made aware at the time of sale as to the 
continued availability of such services for a fee (see Section IV.B.*). 

* Clarified the agency's position on the preemptive effect of the EDR 
final rule (e.g., updated the discussion of State EDR laws, which 
increased number during the course of the agencies development of the 
final rule, and of how the rule would impact those existing Stare laws 
(see Section IV.B.()). 

* Added language to the required owner's manual statement to explain 
that parties permitted to obtain access to EDR data (such as law 
enforcement officials) may be able to combine such data with other 
types of personally-identifying information routinely acquired during a 
crash investigation (see paragraph 563.11 of the regulatory text of the 
final.... 

Changes to the EDR Final Regulatory Evaluation (FRE): 

At the suggestion of OMB, NHTSA modified the FRE as follows: 

* Revised Tables IV-3 and IV-4 to reflect the fact that for some 
manufacturers whose products do not currently meet all of the 
requirements of the EDR final rule, there may be certain computer, 
paperwork, and compliance costs associated with conforming their 
vehicles to the new requirements. However, the agency continues to 
believe that those costs would be de minimis. Accordingly, for those 
items, we substituted an estimate of "negligible" cost for the draft 
final rule's estimate of"$O" (see Chapter IV). 

Source: NHTSA. 

[End of figure] 

Figure 6: FAA Standard Form to Indicate the Nature of OIRA Review 
Changes: 

[Refer to PDF for image: document] 

Federal Aviation Administration: 
Compliance With E.O. 12866: 

Section 6(a)(3)(E) of E.O. 12866 requires agencies to identify for the 
public, in a complete, clear, and simple manner, those changes in a 
regulatory action made at the suggestion or recommendation of the 
Office of Information and Regulatory Affairs (OIRA), Office of 
Management and Budget. Place a copy of this form in the docket and in 
the project folder. 

Title of Rulemaking: Enhanced Airworthiness Program for Airplane 
Systems/Fuel Tank Safety (EAPAS/FTS): 

Regulatory Identification Number: 2120-AI31: 

[Empty]: OIRA did not review the rulemaking document. 

[Empty]: OIRA reviewed the rulemaking document, but did not suggest or 
recommend any changes. 

[Check]: OIRA reviewed the rulemaking document, and we have documented 
the changes we made at OIRA's suggestion or recommendation in an 
attachment to this sheet. 

Signature of Analyst: [Illegible] 

Date: January 2, 2008: 

Attachment: 

Source: FAA. 

[End of figure] 

Figure 7: EPA Use of Redline/Strikeout Method to Document OIRA Review 
Changes: 

[Refer to PDF for image: document] 

Word Perfect Document Compare Summary: 

Original document: C:\Documents and Settings\epa\My Documents\Preamble\ 
Old Drafts\Stage2preamble_OMB_082205.wpd. 

Revised document: C:\Documents and Settings\epa\My Documents\Preamble\ 
Old Drafts\Stage2preamble_final_121405.wpd. 

Deletions are shown with the following attributes and color: 

[Strikeout] Blue RGB(0,0,255): 

Deleted text is shown as full text. 

Insertions are shown with the following attributes and color: 

Double underline; Redline; Red RGB(255,0,0). 

Moved blocks are marked in the new location, and only referenced in the 
old location. Moved blocks are shown in the following color: 

Orange RGB(255,200,0). 

The document was marked with 984 Deletions, 870 Insertions, 1 Move. 

Source Water Type: Subpart II; 
Population Size Category: less than 500; 
Monitoring Frequency[1]: per year; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 2; 
Distribution System Monitoring Location: Highest TTHM Locations: 1; 
Distribution System Monitoring Location: Highest HAA5 Locations: 1; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 0. 

Source Water Type: Subpart II; 
Population Size Category: 500-3,300; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 2; 
Distribution System Monitoring Location: Highest TTHM Locations: 1; 
Distribution System Monitoring Location: Highest HAA5 Locations: 1; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 0. 

Source Water Type: Subpart II; 
Population Size Category: 3,301-9,999; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 2; 
Distribution System Monitoring Location: Highest TTHM Locations: 1; 
Distribution System Monitoring Location: Highest HAA5 Locations: 1; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 0. 

Source Water Type: Subpart II; 
Population Size Category: 10,000-49,999; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 4; 
Distribution System Monitoring Location: Highest TTHM Locations: 2; 
Distribution System Monitoring Location: Highest HAA5 Locations: 1; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 1. 

Source Water Type: Subpart II; 
Population Size Category: 50,000-249,999; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 8; 
Distribution System Monitoring Location: Highest TTHM Locations: 3; 
Distribution System Monitoring Location: Highest HAA5 Locations: 3; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 2. 

Source Water Type: Subpart II; 
Population Size Category: 250,000-999,999; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 12; 
Distribution System Monitoring Location: Highest TTHM Locations: 5; 
Distribution System Monitoring Location: Highest HAA5 Locations: 4; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 3. 

Source Water Type: Subpart II; 
Population Size Category: 1,000,000-4,999,999; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 16; 
Distribution System Monitoring Location: Highest TTHM Locations: 6; 
Distribution System Monitoring Location: Highest HAA5 Locations: 6; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 4. 

Source Water Type: Subpart II; 
Population Size Category: greater than 5,000,000; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 20; 
Distribution System Monitoring Location: Highest TTHM Locations: 8; 
Distribution System Monitoring Location: Highest HAA5 Locations: 7; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 5. 

Source Water Type: Ground Water; 
Population Size Category: less than 500; 
Monitoring Frequency[1]: per year; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 2; 
Distribution System Monitoring Location: Highest TTHM Locations: 1; 
Distribution System Monitoring Location: Highest HAA5 Locations: 1; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 0. 

Source Water Type: Ground Water; 
Population Size Category: 500-9,999; 
Monitoring Frequency[1]: per year; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 2; 
Distribution System Monitoring Location: Highest TTHM Locations: 1; 
Distribution System Monitoring Location: Highest HAA5 Locations: 1; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 0. 

Source Water Type: Ground Water; 
Population Size Category: 10,000-99,999; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 4; 
Distribution System Monitoring Location: Highest TTHM Locations: 2; 
Distribution System Monitoring Location: Highest HAA5 Locations: 1; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 1. 

Source Water Type: Ground Water; 
Population Size Category: 100,000-499,999; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 6; 
Distribution System Monitoring Location: Highest TTHM Locations: 3; 
Distribution System Monitoring Location: Highest HAA5 Locations: 2; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 1. 

Source Water Type: Ground Water; 
Population Size Category: greater than 500,000; 
Monitoring Frequency[1]: per quarter; 
Distribution System Monitoring Location: Total per monitoring 
period[2]: 8; 
Distribution System Monitoring Location: Highest TTHM Locations: 3; 
Distribution System Monitoring Location: Highest HAA5 Locations: 3; 
Distribution System Monitoring Location: Existing Subpart L Compliance 
Locations: 2. 

[1] All systems must [strikeout: dual sample set] [insert: monitor] 
during month of highest DBP concentrations. 

[2] System [strikeout: is] [insert: on manual monitoring and subpart H 
systems serving 500-3,300 are] required to take individual TTHM and 
HAA5 samples (instead of a dual sample set) at the locations with the 
highest TTHM and HAA5 concentrations, respectively. Only one location 
with a dual sample set per monitoring period is needed if highest TTHM 
and HAA5 concentrations occur at the same location [insert, and month, 
if monitored annually.] 

(c) Your must recommend subpart V compliance monitoring locations based 
on standard monitoring results, system specific study results, and 
subpart L compliance monitoring results. You must follow the protocol 
in paragraphs (c)(1) through [strikeout: (4)] [insert (8) of this 
section.] If required to monitor at more than [strikeout: four] 
[insert: eight] locations, you must repeat the protocol as necessary. 
[strikeout: alternating between locations with the highest HAA5 LRAA 
and the highest TTHM LRAA not previously selected as a subpart V 
monitoring location for choosing locations under paragraph (c)(3) and 
(c)(4).] If you do not have exiting subpart L compliance.... 

Source: EPA. 

[End of figure] 

[End of section] 

Appendix IV: Comments from the Office of Management and Budget: 

Executive Office Of The President: 
Office Of Management And Budget: 
Washington, D.C. 20503: 

April 7, 2009: 

Ms. Denise M. Fantone: 
Director, Strategic Issues: 
Government Accountability Office: 
441 G Street, NW: 
Washington, DC 20548: 

Dear Ms. Fantone: 

Thank you for your letter of February 27, 2009, to Director Orszag in 
which you provided a draft copy of your report Federal Rulemaking 
Improvements Needed to Monitoring and Evaluation of Rules Development 
as well as to the Transparency of OMB Regulatory Review (Report), and 
offered us the opportunity to provide comments on the draft report. 
Because it is the Office of Information and Regulatory Affairs (OIRA) 
within the Office of Management and Budget (OMB) that oversees 
implementation of Executive Order I2866 (EO I2866) governing regulatory 
review, Director Orszag has asked that I respond to your letter. 

We have reviewed the report carefully, particularly those portions 
pertaining to OMB review of draft regulations pursuant to EO 12866 and 
the recommendations on how OIRA could make the review process more 
transparent. Our comments below relate primarily to the report's 
findings and recommendations regarding OMB's role in the regulatory 
review process. 

First let me say that we appreciate your finding that the rulemaking 
agencies studied by GAO generally complied with their obligation under 
EO 12866 to disclose materials that they provided for, and substantive 
changes to the draft rule that occurred during, OIRA review. (Report at 
p. 39.) However, we have also noted the concerns in the draft report 
regarding certain transparency issues related to the disclosures that 
are made by rulemaking agencies pursuant to EO 12866. (Report at p. 
40.) In this regard, OIRA does not monitor, on a rule-by-rule basis, 
compliance by rulemaking agencies with their disclosure obligations 
under EO I2866. (As you know, OIRA is subject to its own disclosure 
requirements under both EO I2866 and OIRA's Memorandum of October I8, 
200I on "OIRA Disclosure.") However, your report will remind rulemaking 
agencies of their responsibility under EO I2866 - once the regulation 
has been published in the Federal Register or otherwise made available 
to the public - to identify in a complete, clear, and simple manner the 
substantive changes between the draft rule submitted to OIRA for review 
and the action subsequently announced, and to identify those changes in 
the regulatory action that were made at the suggestion or 
recommendation of OIRA. 

On page 40 of the draft report you recommend that the Director of OMB, 
through the Administrator of OIRA, take the following four actions to 
more consistently implement the EO's requirement that the agencies 
provide information to the public in a complete, clear, and simple 
manner: 

* define in guidance what types of changes made. as a result of the 
OIRA review process arc substantive and need to be publicly identified, 

* instruct agencies to clearly attribute those changes "made at the 
suggestion or recommendation of OIRA," 

* direct agencies to clearly state in final rules whether they made 
substantive changes as a result of the OIRA reviews, and, 

* standardize how agencies label documentation of these changes in 
public rulemaking dockets. 

We believe these recommendations have merit and warrant further 
consideration. OIRA takes seriously the disclosure requirements of EO 
12866, and OIRA remains committed to a high level of transparency in 
the regulatory review process. 

We would like to bring to your attention that, on January 30, 2009, 
President Obama issued a Memorandum for the Heads of Executive 
Departments and Agencies on "Regulatory Review" (74 FR 5977; February 
3, 2000). In his Memorandum, the President directed the OMB Director, 
in consultation with representatives of regulatory agencies, to produce 
within I00 days a set of recommendations for a new EO on Federal agency 
regulatory review. The President directed that these recommendations, 
among other things: "offer suggestions for the relationship between 
OIRA and the agencies; provide guidance on disclosure and transparency; 
encourage public participation in agency regulatory processes; offer 
suggestions on the role of cost-benefit analysis; address the role of 
distributional considerations, fairness, and concern for the interests 
of future generations; identify methods of ensuring that regulatory 
review does not produce undue delay; clarify the role of the behavioral 
sciences in formulating regulatory policy; and identify the best tools 
for achieving public goals through the regulatory process." 

Since then, OIRA has been reaching out to agencies to solicit 
recommendations for revising the regulatory review process, consistent 
with the President's Memorandum. In addition, on February 26, 2009, OMB 
published a notice in the Federal Register (74 FR 8819) inviting public 
comment on how to improve the regulatory review process and the 
principles governing the development of regulation. We have received 
over I00 comments in response to this notice. These comments are 
available to the public at [hyperlink, 
http://www.reginfo.gov/public/jsp/EO/fedReaReview/publicCommcnts.jsp]. 
In addition, we have also met with various stakeholder groups to obtain 
their input and have posted a record of these meetings at the same 
website address (along with any written materials provided at these 
meetings). 

Thank you again for the opportunity to comment on the draft report. We 
very much appreciate GAO's draft findings and recommendations for 
improving the regulatory review process, particularly in the area of 
government transparency, one of the key concerns identified by the 
President in his January 30 Memorandum. The President also underscored 
the importance of transparency in his Memorandum of January 2I, 2009, 
"Transparency and Open Government" (74 FR 4685; January 26, 2009). We 
will give full consideration to the report and its recommendations as 
we finalize our recommendations to the President for a new Executive 
Order on regulatory review. 

Sincerely, 

Signed by: 
Kevin F. Neyland
Acting Administrator: 
Office of Information and Regulatory Affairs: 

[End of section] 

Appendix V: Comments from the Securities and Exchange Commission: 

United States Securities And Exchange Commission: 
The Chairman: 
Washington, D.C. 20549: 

March 20, 2009: 

Timothy A. Bober: 
Assistant Director, Strategic Issues: 
United States Government Accountability Office: 
441 G Street, NW: 
Washington, DC 20548: 

Dear Mr. Bober, 

Thank you for transmitting the GAO's draft report: "Improvements Needed 
to Monitoring and Evaluation of Rules Development as well as to the 
Transparency of OMB Regulatory Reviews." We were happy to participate 
in your review and appreciate the opportunity to comment. We have 
transmitted separately a few specific comments on factual portions of 
the report concerning the SEC that we believe should be amended for 
accuracy. 

The SEC strives for an open and efficient rulemaking process that 
affords the public a full opportunity to comment. I am committed to 
evaluating all the Commission's processes and looking for ways in which 
they can be improved. I appreciate and take seriously any suggestions 
as to ways in which we can gain efficiencies in our rulemaking process. 
It is always important for as to think about how we might do a better 
job, and we will consider your recommendations as part of that 
evaluation. 

Sincerely, 

Signed by: 

Mary L. Schapiro: 
Chairman: 

[End of section] 

Appendix VI: Comments from the Department of Health and Human Services, 
Food and Drug Administration: 

Department Of Health & Human Services: 
Food and Drug Administration: 
Silver Spring, MD 20993: 

Date: March 19, 2009: 

To: Acting Assistant Secretary for Legislation: 

From: Chief of Staff, FDA: 

Subject: FDA's General Comments to GAO's Draft Report Entitled, Federal 
Rulemaking - Improvements Needed to Monitoring and Evaluation of Rules 
Development as Well as to the Transparency of OMB Regulatory Reviews 
(GAO-09-205): 

FDA is providing the attached general comments to the U.S. Government 
Accountability Office's draft report entitled: Federal Rulemaking - 
Improvements Needed to Monitoring and Evaluation of Rules Development 
as Well as to the Transparency of OMB Regulatory Reviews (GAO-09-205). 

FDA appreciates the opportunity to review and comment on this draft 
report before it is published. 

Signed by: 

Susan C. Winkler, R.Ph., Esq. 

Attachment: 

[End of letter] 

FDA's General Comments to the U.S. Government Accountability Office's 
(GAO) Draft Report Entitled, Improvements Needed to Monitoring and 
Evaluation of Rules Development as Well as to the Transparency of OMB 
Regulatory Reviews: 

The Food and Drug Administration (FDA) welcomes the opportunity to 
comment on GAO's draft report. This document responds to the three 
recommendations made by GAO to FDA, the Environmental Protection Agency 
(EPA), and the Securities and Exchange Commission (SEC). 

GAO Recommendations: 

To be consistent with internal controls for information in managing 
agency operations, GAO recommends that for significant rules, the 
Administrator of EPA, the Commissioner of FDA, and the Chairman of SEC 
take the following actions: 

1. Routinely track major milestones in regulatory development: 

FDA believes that only "economically significant" rules should be 
tracked. Even with this more narrow scope, the recommendation would be 
difficult to implement. FDA cannot predict with certainty which rules 
OMB considers to be significant until the rule is close to final agency 
clearance, and FDA does not know the number of rules deemed by OMB to 
be significant. 

In addition, alternative approaches should be permitted. For example, 
FDA maintains a database, the Federal Register Document Tracking System 
(FRDTS), to track the progress of all its Federal Register documents 
through the latter stages of the agency's development and clearance 
process. For potentially significant regulations, the agency not only 
uses the FRDTS, but also develops work plans, and holds quarterly 
planning meetings with all parties involved in the regulations process, 
to keep abreast of progress, problems and possible delays. In addition, 
the agency instituted a Policy Council which is comprised of all senior 
agency officials involved in the regulations development process. The 
Policy Council meets once a month, providing the opportunity to report 
to FDA senior management on the progress of meeting major milestones. 

2. Report internally and externally when major milestones are reached 
against established targets: 

FDA already reports internally when major milestones are reached. As 
mentioned above, FDA holds quarterly and monthly meetings where major 
milestones are discussed and reported. At its monthly meetings, the FDA 
Policy Council discusses priorities, resources, and any other issues 
that impact the agency regulation development process. For example, the 
Policy Council discusses competing priorities and tries to reach 
consensus on overall agency priorities. The Policy Council serves as a 
venue to disseminate information on new regulatory requirements such as 
new statutes and Executive Orders. Moreover, the Policy Council 
discusses the allocation of agency resources needed for significant 
regulations. 

FDA advises against routinely reporting externally when major 
milestones are met. Reporting on when major milestones are met as 
compared to established targets may mislead stakeholders and 
incorrectly suggest that the agency is not working diligently on the 
completion of a particular regulation. This reporting may result in 
follow-up inquiries from interested parties, and responding to such 
inquiries draws resources away from completing the regulation. Although 
establishing timeframes upfront for completing a regulation is helpful, 
it is not uncommon for deadlines to be revisited in light of public 
health emergencies, changes in priorities in response to public health 
needs, evolving policy considerations, and the many steps that must be 
taken to complete and clear a rule, e.g., the various statutory 
requirements that must be addressed. 

3) Evaluate actual performance versus the targeted milestones to 
determine whether differences are explainable or, if not, if there is a 
need for further management reviews: 

FDA already engages in quality improvement efforts for its rulemaking 
process. In addition to quarterly regulations meetings with each agency 
component and the FDA Policy Council meetings, FDA periodically reviews 
its regulations development and clearance process to see if changes are 
needed to improve the efficiency and timeliness. Since 1981, 12 such 
reviews have been conducted and recommended improvements implemented. 
Recent improvements include piloting the use of digital signatures for 
clearing regulations to reduce the time it takes to clear and publish 
regulations in the Federal Register, and piloting the use of a 
standardized questionnaire on a wild platform to reduce the time it 
takes to develop an economic analysis for a rule. 

[End of section] 

Appendix VII: Comments from the Environmental Protection Agency: 

United States Environmental Protection Agency: 
Office Of Policy, Economics And Innovation: 
Washington, D.C. 20460: 
Internet Address (URL):[hyperlink, http://www.epa.gov] 

March 20, 2009: 

Ms. Denise M. Fantone: 
Director, Strategic Issues: 
United States Government Accountability Office: 
Washington, D.C. 20548: 

Dear Ms. Fantone: 

Thank you for providing us the opportunity to comment on the final 
draft report entitled Federal Rulemaking: Improvements Needed to 
Monitoring and Evaluation of Rules Development as well as to the 
Transparency of OMB Regulatory Reviews (GAO-09-205). EPA appreciates 
GAO's efforts, despite the short timeframe for review, to evaluate how 
changes in broad rulemaking requirements have cumulatively affected: 
(1) the agencies' rulemaking process; and (2) the transparency of OMB 
regulatory reviews. 

We agree with GAO that the small sample size used in the report may not 
be representative of all regulatory agencies or all rules within a 
specific agency. As you know, EPA develops over 450 final regulations 
in a given year. These regulatory actions vary tremendously from 
technical amendments consisting of several pages of preamble and rule 
text to regulations with supporting documents consisting of hundreds of 
pages. Additionally, the development process itself may differ 
considerably. Thus, the four EPA case studies are not entirely 
representative of the range of regulatory development in the agency. 
For example, two out of the four EPA case studies (Stage 2 Disinfection 
Byproducts Rule and Longterm 2 Surface Water Treatment Rule) were 
developed using an "advisory committee process," which involves outside 
stakeholders in most aspects of developing the rule and supporting 
data. This approach can result in a long, intense, and very public 
development process. This advisory committee rule development process 
is less frequently used than the usual notice and comment rulemaking 
process. Therefore, drawing recommendations from such a small sample of 
rules could be misleading. 

EPA would like to make several corrections to the current draft report. 
GAO recommends that agencies routinely track major milestones in 
regulatory development and report internally and externally when major 
milestones are reached against established targets. EPA would like to 
clarify that the agency currently does track key milestones associated 
with the rulemaking process. This information has been reported 
internally and externally. The draft report does not reflect the 
agency's efforts in monitoring the regulatory process. The following 
data provide information to clarify the systems and processes the 
Agency uses to track and report on process milestones. 

* EPA has a well-established, agency-wide process for rule development, 
referred to as the Action Development Process (ADP). GAO specifically 
notes on page I5 of the report that EPA tracks 14 milestones as it 
develops a proposed rule under the ADP. After the proposed rule is 
published, EPA routinely tracks 4-5 additional milestones to develop 
the final rule. 

* EPA has an internal tracking system, Rule and Policy Information 
Development System (RAPIDS), which monitors cross-Agency involvement 
and senior management reviews to ensure timely decisions. In RAPIDS, 
EPA routinely tracks milestones in regulatory development by projecting 
dates for achieving milestones and subsequently recording actual dates 
of completion. Actual dates may differ from projected dates for based 
on a variety of management decisions and resource requirements. The ADP 
is flexible and programs can adjust milestone dates to address evolving 
priorities. 

* EPA uses data in RAPIDS, complemented by additional information, to 
develop regulatory management reports that are provided to EPA managers 
and executives as a forward-looking planning and tracking tool and as a 
means to improve the flow of communication between and among program 
managers. 

* EPA executives and managers routinely meet to review milestones on 
key regulations, review program performance, and identify best 
practices. During the study period, the EPA Deputy Administrator met, 
at approximately 6-week intervals, with program executives and 
specifically tracked the attainment of regulation development 
milestones for several dozen priority actions. Regulations were tracked 
against an agreed upon schedule for a standard set of development 
milestones. Actions that are completed on time or early are used by EPA 
as examples of best practices. Actions that are off-track are 
identified early and corrective steps are taken to expedite their 
completion. This data was reviewed weekly at senior staff meetings and 
reported to the public quarterly. 

* As you are aware, twice a year, the Agency publishes all the agency's 
planned actions which are currently under development or review through 
EPA's Semiannual Regulatory Agenda. This regulatory agenda provides the 
public updated information on the important external milestones and 
even highlights those actions in the early pre-rule stages. 

* EPA is committed to furthering transparency and has instituted the 
practice of providing on-line information to the public as soon as the 
Agency begins development of a new rule. EPA is using Action Initiation 
Lists to notify the public about new rules and other regulatory 
actions. AILS are posted on the EPA Web site at the end of each month 
and describe the actions that were approved for commencement. (AILS are 
found at [hyperlink, http://www.epa.gov/lawsregs/search/ail.html]). 

EPA notes that OMB is currently soliciting comments from agencies and 
the public on the topic of OMB regulatory review. EPA is developing its 
response. 

Again, we appreciate the opportunity to comment on this report and 
would be happy to discuss the comments further if needed. Should you 
have any questions, please contact Bobbie Trent, our GAO liaison at 202-
566-0983. 

Sincerely, 

Signed by: 

Louise P. Wise: 
Acting Associate Administrator: 
Office of Policy, Economics and innovation: 

Enclosure: 

[End of section] 

Appendix VIII: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Denise M. Fantone, (202) 512-6806 or fantoned@gao.gov: 

Acknowledgements: 

In addition to the contact named above, Timothy Bober, Assistant 
Director; Timothy Guinane; Edward Leslie; Andrea Levine; James McTigue, 
Susan Offutt, Melanie Pappasian; Jacquelyn Pontious; Robert Powers; 
Joseph Santiago; Wesley Sholtes; William Trancucci, Michael Volpe; 
Gregory Wilmoth; and Diana Zinkl made key contributions to this report. 

[End of section] 

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2009. 

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Process Limit the Usefulness and Credibility of EPA's Integrated Risk 
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2008. 

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Rulemaking Information. [hyperlink, 
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6, 2007. 

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2007. 

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2006. 

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http://www.gao.gov/products/GAO-05-939T]. Washington, D.C.: July 27, 
2005. 

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Measures. [hyperlink, http://www.gao.gov/products/GAO-05-796SP]. 
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Government Burden on Public. [hyperlink, 
http://www.gao.gov/products/GAO-05-424]. Washington, D.C.: May 20, 
2005. 

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and Options for Improvement. [hyperlink, 
http://www.gao.gov/products/GAO-05-454]. Washington, D.C.: March 31, 
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http://www.gao.gov/products/GAO-04-637]. Washington, D.C.: May 12, 
2004. 

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Transparency of Those Reviews. [hyperlink, 
http://www.gao.gov/products/GAO-03-929]. Washington, D.C.: September 
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Other Agencies. [hyperlink, http://www.gao.gov/products/GAO-01-852T]. 
Washington, D.C.: June 14, 2001. 

Regulatory Flexibility Act: Implementation in EPA Program Offices and 
Proposed Lead Rule. [hyperlink, 
http://www.gao.gov/products/GAO/GGD-00-193]. Washington, D.C.: 
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[End of section] 

Footnotes: 

[1] Pub. L. No. 404, 60 Stat. 237 (1946), codified in 1966 in scattered 
sections of title 5, United States Code. 

[2] "Independent agencies" refers to agencies that answer directly to 
the President but are not part of cabinet departments, such as the 
Environmental Protection Agency (EPA). 

"Independent regulatory agencies" refers to the boards and commissions 
identified as such in the Paperwork Reduction Act (44 U.S.C. § 
3502(5)), such as the Securities and Exchange Commission. 

[3] See GAO, Federal Rulemaking: Procedural and Analytical Requirements 
at OSHA and Other Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-01-852T] (Washington, D.C.: June 14, 
2001). See also the Related GAO Products section at the end of this 
report. 

[4] See GAO, Federal Rulemaking: Past Reviews and Emerging Trends 
Suggest Issues That Merit Congressional Attention, [hyperlink, 
http://www.gao.gov/products/GAO-06-228T] (Washington, D.C.: Nov. 1, 
2005), for a summary of the main findings from reports and testimonies 
we prepared during the past decade. Although we found benefits 
associated with individual rulemaking requirements--such as encouraging 
greater public participation and enhancing the transparency of the 
rulemaking process--we also found that they were often less effective 
than intended. 

[5] We did not examine the effects of agency-or program-specific 
requirements on the issuance of regulations, such as EPA's issuance of 
regulations under the Clean Air Act (see, for example, 42 U.S.C. § 
7607). 

[6] The Congressional Review Act (CRA) requires agencies to file rules 
with Congress and the Comptroller General before the rules can become 
effective. 5 U.S.C. § 801(a)(1)(A). To compile information on all the 
rules submitted under the CRA, GAO established a database and created a 
standardized submission form to allow more consistent information 
collection. The Federal Rules Database is publicly available at 
[hyperlink, http://www.gao.gov] under Legal Products. 

[7] As defined by CRA, a major rule is generally a rule that the OIRA 
Administrator finds has resulted in or is likely to result in (1) an 
annual effect on the economy of $100 million or more, (2) a major 
increase in costs or prices, or (3) significant adverse effects on 
competition, employment, investment, productivity, or innovation. 5 
U.S.C. § 804(2). This is similar, but not identical to, the definition 
of an economically significant rule under Executive Order 12866 on 
regulatory planning and review. 

[8] From January 2006 through May 2008, federal agencies issued over 
7,000 rules. 

[9] As defined in the Introduction to The Regulatory Plan and the 
Unified Agenda of Federal Regulatory and Deregulatory Actions, "other 
significant" rules are those that are not economically significant but 
are considered significant by the agency. This category includes rules 
that the agency anticipates will be reviewed under Executive Order 
12866 or rules that are a priority of the agency head. 

[10] OMB's New Guidelines for the Conduct of Regulatory Analysis, which 
was issued on September 17, 2003, became effective for economically 
significant proposed rules on January 1, 2004, and for economically 
significant final rules on January 1, 2005. 

[11] Office of Management and Budget, Memorandum for Heads of 
Departments and Agencies on Issuance of OMB's Final Information Quality 
Bulletin for Peer Review (Dec. 16, 2004). 

[12] GAO, Rulemaking: OMB's Role in Reviews of Agencies' Draft Rules 
and the Transparency of Those Reviews, [hyperlink, 
http://www.gao.gov/products/GAO-03-929] (Washington, D.C.: Sept. 22, 
2003). 

[13] GAO's primary role under CRA is to provide Congress with a report 
on each major rule containing our assessment of whether the 
promulgating federal agency's submissions indicate that it has complied 
with the procedural steps required by various statutes and executive 
orders governing rulemaking, such as preparation of a cost-benefit 
analysis, the PRA, the RFA, and Executive Order 12866. 5 U.S.C. § 
801(a)(2)(A). 

[14] Certain rulemakings are governed, however, by agency-or program- 
specific statutory requirements. For example, certain EPA rulemakings 
implementing the Clean Air Act are subject to the more specific 
procedural requirements of the Clean Air Act in lieu of the APA 
provisions that would otherwise apply. See 42 U.S.C. § 7607. 

[15] The APA describes two types of rulemaking, formal and informal. 
Formal rulemaking includes a trial-type on-the-record proceeding. Most 
federal agencies use the informal rulemaking procedures outlined in 5 
U.S.C. § 553. 

[16] The APA includes exceptions to notice and comment procedures for 
categories of rules such as those dealing with military or foreign 
affairs and agency management or personnel. 5 U.S.C. § 553(a). APA 
requirements to publish a proposed rule generally do not apply when an 
agency finds, for "good cause," that those procedures are 
"impracticable, unnecessary, or contrary to the public interest." 5 
U.S.C. § 553(b). 

[17] The Administrator of OIRA may also waive review of any planned 
regulatory action designated by the agency as significant. 

[18] Regulatory analysis, such as benefit-cost analysis, is a tool 
regulatory agencies use to anticipate and evaluate the likely 
consequences of rules. 

[19] Although independent regulatory agencies, such as SEC, are not 
subject to Executive Order 12866 and Circular No. A-4, they may be 
directed to consider the economic effect of their rulemakings by 
various statutes. 

[20] Office of Information and Regulatory Affairs, "Memorandum for The 
President's Management Council on OMB's Circular No. A-4, New 
Guidelines for the Conduct of Regulatory Analysis" (Mar. 2, 2004). 

[21] Discounting is used to make comparable the benefits and costs that 
occur in different time periods. In general, a higher discount rate 
gives less weight to benefits and costs occurring in the future 
compared to the present. The new guidelines recommend that agencies use 
7 percent and 3 percent. Previous guidance recommended using 7 percent 
and encouraged the use of sensitivity analysis to assess the effect of 
alternative discount rates. 

[22] 74 Fed. Reg. 5977 (Feb. 3, 2009). 

[23] EPA's concept document is called an analytic blueprint that 
identifies the types of regulatory analyses needed for the rulemaking 
and ensures that the agency allocates the resources needed throughout 
the rulemaking process. 

[24] EPA's rulemaking officially begins once the agency assigns a start 
action number, that is prior to when management receives, reviews, and 
approves the analytic blueprint. 

[25] EPA has three classes, or "tiers," of rulemakings. Only the two 
higher-priority classes are required to follow this process. Most, but 
not all, significant rules would go through this process. 

[26] GAO, Standards for Internal Control in the Federal Government 
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1] 
(Washington, D.C.: November 1999). 

[27] Cornelius M. Kerwin, The Management of Regulation Development: Out 
of the Shadows (Washington, D.C.: IBM Center for The Business of 
Government, 2007), 11. 

[28] Ibid., p. 20. 

[29] OIRA officials pointed out that a rulemaking that is later subject 
to a judicial challenge may not have "ended" with final publication. 

[30] For the most recent transition, see 74 Fed. Reg. 4435 (Jan. 26, 
2009). See also GAO, Regulatory Review: Delay of Effective Dates of 
Final Rules Subject to the Administration's January 20, 2001, 
Memorandum, GAO-02-370R (Washington, D.C.: Feb. 15, 2002). 

[31] 5 U.S.C. § 609. 

[32] When discussing or displaying information on multiple requirements 
in this report, we have followed the convention of listing statutes 
first followed by executive orders. 

[33] 7 U.S.C. § 7991(c). 

[34] The dollar threshold for 2008 was approximately $133 million. 

[35] See GAO, Unfunded Mandates: Analysis of Reform Act Coverage, 
[hyperlink, http://www.gao.gov/products/GAO-04-637] (Washington, D.C.: 
May 12, 2004), for an illustration of the complex multistep process 
needed to determine whether UMRA is triggered. In that report, we noted 
that there are 14 definitional exceptions, exclusions, or other 
restrictions applicable to the identification of federal mandates in 
rules. 

[36] Information on the cost-benefit analysis, if any, that was 
prepared for a rule is one of the mandated elements of our major rule 
reports under CRA. However, this element reflects requirements from 
various statutory or executive orders, rather than any one requirement. 

[37] [hyperlink, http://www.gao.gov/products/GAO-03-929]. 

[38] For all significant rules this information includes, for example, 
the text of the draft regulation provided to OIRA and an assessment of 
the potential costs and benefits. For economically significant rules, 
the information must also include the underlying analysis of benefits 
and costs (quantified to the extent feasible). 

[39] According to OIRA representatives, the requirement for agencies to 
document changes made at the suggestion or recommendation of OIRA only 
applies to changes made after draft rules are formally submitted to 
OIRA for review. 

[40] According to OIRA representatives, the requirement to make 
available "all documents exchanged between OIRA and the agency" issuing 
the regulation only applies to exchanges made by OIRA staff at the 
branch chief level and above, not documents exchanged between OIRA desk 
officers and staff in regulatory agencies. 

[41] At the time of our review, FDA was transitioning to 
regulations.gov and had both paper and online dockets available for its 
rules. 

[42] [hyperlink, http://www.gao.gov/products/GAO-03-929]. 

[43] The Semiannual Regulatory Agenda is also known as the Unified 
Agenda of Federal Regulatory and Deregulatory Actions. 

[44] Pub. L. No. 404, 60 Stat. 237, ch. 324, §§ 1-12 (1946), codified 
by Pub. L. No. 89-554 (1996) in 5 U.S.C. §§ 551-559, 701-706, 1305, 
3105, 3344, 5372, 7521. 

[45] Pub. L. No. 91-190, 83 Stat. 852 (1970), codified at 42 U.S.C. §§ 
4321-4347. 

[46] 42 U.S.C. § 4332. 

[47] Pub. L. No. 92-463, 86 Stat. 770 (1972) (codified at 5 U.S.C. 
appendix 2). 

[48] The Occupational Safety and Health Act of 1970, for example, 
authorizes, but does not require, the use of advisory committees for 
establishing certain safety and health standards. 29 U.S.C. § 656. 

[49] Pub. L. No. 93-205, 87 Stat. 884 (1973). 

[50] Pub. L. No. 96-354, 94 Stat. 1164 (1980), codified as amended at 5 
U.S.C. §§ 601-612. 

[51] The PRA was originally enacted into law in 1980, Pub. L. No. 96-
511, 94 Stat. 2812 (1980). It was reauthorized with minor amendments in 
1986, Pub. L. No. 99-591, 100 Stat. 3341 (1986), and was reauthorized a 
second time with more significant changes in 1995, Pub. L. No. 104-13, 
109 Stat. 163 (1995). 44 U.S.C. §§ 3501-3520. 

[52] 44 U.S.C. § 3504. 

[53] The PRA generally defines a "collection of information" as the 
obtaining or disclosure of facts or opinions by or for an agency from 
ten or more nonfederal persons. 44 U.S.C. § 3502(3). Many information 
collections, recordkeeping requirements, and third-party disclosures 
are contained in or are authorized by regulations as monitoring or 
enforcement tools, while others appear in separate written 
questionnaires for purposes of developing the regulation. 

[54] Pub. L. No. 101-648, 104 Stat. 4969 (1990), codified at 5 U.S.C. 
§§ 561-570. The NRA was permanently reauthorized by the Administrative 
Dispute Resolution Act of 1996, Pub. L. No. 104-320, § 11, 110 Stat. 
2870, 3873 (1996). 

[55] Pub. L. No. 104-4, 109 Stat. 48 (1995) (codified in scattered 
sections of title 2 of the United States Code). 

[56] The dollar thresholds in UMRA are in 1996 dollars and are adjusted 
annually for inflation. 

[57] Pub. L. No. 104-113, 110 Stat. 775 (1995). 

[58] Pub. L. No. 104-121, Title II, 110 Stat. 857(1996) (codified in 
scattered sections of title 5 of the United States Code). 

[59] 5 U.S.C. §§ 801-808. 

[60] Consolidated Appropriations Act of 2001, Pub. L. No. 106-554, § 
515, 114 Stat. 2763, 2763A-152,codified at 44 U.S.C. § 3516 note. 

[61] 70 Fed. Reg. 2664 (Jan. 14, 2005). 

[62] Pub. L. No. 107-347, 116 Stat. 2899 (2002), codified at 44 U.S.C. 
§ 3501 note. 

[63] 47 Fed. Reg. 30,959 (July 14, 1982). 

[64] 53 Fed. Reg. 8859 (Mar. 15, 1988). 

[65] 58 Fed. Reg. 51,735 (Sept. 30, 1993). 

[66] Available at [hyperlink, 
http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf]. 

[67] 59 Fed. Reg. 7629 (Feb. 11, 1994). 

[68] 61 Fed. Reg. 4729 (Feb. 5, 1996). 

[69] 62 Fed. Reg. 19,885 (Apr. 21, 1997). 

[70] 64 Fed. Reg. 43,255 (Aug. 4, 1999). 

[71] 65 Fed. Reg. 67,249 (Nov. 6, 2000). 

[72] 66 Fed. Reg. 28,355 (May 18, 2001). 

[73] For more information on FDA's dietary supplements program see GAO, 
Dietary Supplements: FDA Should Take Further Actions to Improve 
Oversight and Consumer Understanding, [hyperlink, 
http://www.gao.gov/products/GAO-09-250] (Washington, D.C.: Jan. 29, 
2009). 

[74] For more information on FDA's food labeling program see GAO, Food 
Labeling: FDA Needs to Better Leverage Resources, Improve Oversight, 
and Effective Use Available Data to Help Consumers Select Healthy 
Foods, [hyperlink, http://www.gao.gov/products/GAO-08-597] (Washington, 
D.C.: Sept. 9, 2008). 

[End of section] 

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