Final Bulletin for Agency Good Guidance Practices, 3432-3440 [E7-1066]

Agencies

• Office of Management and Budget
• Management and Budget Office

[Federal Register Volume 72, Number 16 (Thursday, January 25, 2007)]
[Notices]
[Pages 3432-3440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1066]



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OFFICE OF MANAGEMENT AND BUDGET


Final Bulletin for Agency Good Guidance Practices

AGENCY: Office of Management and Budget, Executive Office of the 
President.

ACTION: Final bulletin.

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SUMMARY: The Office of Management and Budget (OMB) is publishing a 
final Bulletin entitled, ``Agency Good Guidance Practices,'' which 
establishes policies and procedures for the development, issuance, and 
use of significant guidance documents by Executive Branch departments 
and agencies. This Bulletin is intended to increase the quality and 
transparency of agency guidance practices and the significant guidance 
documents produced through them.
    On November 23, 2005, OMB proposed a draft Bulletin for public 
comment. 70 FR 71866 (November 30, 2005). Upon request, OMB extended 
the public comment period from December 23, 2005 to January 9, 2006. 70 
FR 76333 (December 23, 2005). OMB received 31 comments on the proposal 
from diverse public and private stakeholders (see https://
www.whitehouse.gov/omb/inforeg/good_guid/c-index.html) and input from 
Federal agencies. The final Bulletin includes refinements developed 
through the public comment process and interagency deliberations.

DATES: The effective date of this Bulletin is 180 days after its 
publication in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Margaret Malanoski, Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
725 17th Street, NW., New Executive Office Building, Room 10202, 
Washington, DC 20503. Telephone (202) 395-3122.

SUPPLEMENTARY INFORMATION:

Introduction

    As the scope and complexity of regulatory programs have grown, 
agencies increasingly have relied on guidance documents to inform the 
public and to provide direction to their staffs. As the impact of 
guidance documents on the public has grown, so too, has the need for 
good guidance practices--clear and consistent agency practices for 
developing, issuing, and using guidance documents.
    OMB is responsible both for promoting good management practices and 
for overseeing and coordinating the Administration's regulatory policy. 
Since early in the Bush Administration, OMB has been concerned about 
the proper development and use of agency guidance documents. In its 
2002 draft annual Report to Congress on the Costs and Benefits of 
Regulations, OMB discussed this issue and solicited public comments 
regarding problematic guidance practices and specific examples of 
guidance documents in need of reform.\1\ OMB has been particularly 
concerned that agency guidance practices should be more transparent, 
consistent and accountable. Such concerns also have been raised by 
other authorities, including Congress and the courts.\2\
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    \1\ U.S. Office of Management and Budget, Draft Report to 
Congress on the Costs and Benefits of Federal Regulations, 67 FR 
15,014, 15,034-35 (March 28, 2002).
    \2\ See, e.g., Food and Drug Administration Modernization Act of 
1997, 21 U.S.C. Sec.  371(h) (establishing FDA good guidance 
practices as law); ``Food and Drug Administration Modernization and 
Accountability Act of 1997,'' S. Rep. 105-43, at 26 (1997) (raising 
concerns about public knowledge of, and access to, FDA guidance 
documents, lack of a systematic process for adoption of guidance 
documents and for allowing public input, and inconsistency in the 
use of guidance documents); House Committee on Government Reform, 
``Non-Binding Legal Effect of Agency Guidance Documents,'' H. Rep. 
106-1009 (106th Cong., 2d Sess. 2000) (criticizing ``back-door'' 
regulation); the Congressional Accountability for Regulatory 
Information Act, H.R. 3521, 106th Cong., Sec.  4 (2000) (proposing 
to require agencies to notify the public of the non-binding effect 
of guidance documents); Gen. Elec. Co. v. EPA, 290 F.3d 377 (D.C. 
Cir. 2002) (striking down PCB risk assessment guidance as 
legislative rule requiring notice and comment); Appalachian Power 
Co. v. EPA, 208 F.3d 1015 (D.C. Cir. 2000) (striking down emissions 
monitoring guidance as legislative rule requiring notice and 
comment); Chamber of Commerce v. Dep't of Labor, 174 F.3d 206 (D.C. 
Cir. 1999) (striking down OSHA Directive as legislative rule 
requiring notice and comment); Administrative Conference of the 
United States, Rec. 92-2, 1 C.F.R. 305.92-2 (1992) (agencies should 
afford the public a fair opportunity to challenge the legality or 
wisdom of policy statements and to suggest alternative choices); 
American Bar Association, Annual Report Including Proceedings of the 
Fifty-Eighth Annual Meeting, August 10-11, 1993, Vol. 118, No. 2, at 
57 (``the American Bar Association recommends that: Before an agency 
adopts a nonlegislative rule that is likely to have a significant 
impact on the public, the agency provide an opportunity for members 
of the public to comment on the proposed rule and to recommend 
alternative policies or interpretations, provided that it is 
practical to do so; when nonlegislative rules are adopted without 
prior public participation, immediately following adoption, the 
agency afford the public an opportunity for post-adoption comment 
and give notice of this opportunity.''); 3 American Bar Association, 
``Recommendation on Federal Agency Web Pages'' (August 2001) 
(agencies should maximize the availability and searchability of 
existing law and policy on their Web sites and include their 
governing statutes, rules and regulations, and all important 
policies, interpretations, and other like matters on which members 
of the public are likely to request).
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    In its 2002 Report to Congress, OMB recognized the enormous value 
of agency guidance documents in general. Well-designed guidance 
documents serve many important or even critical functions in regulatory 
programs.\3\ Agencies may provide helpful guidance to interpret 
existing law through an interpretive rule or to clarify how they 
tentatively will treat or enforce a governing legal norm through a 
policy statement. Guidance documents, used properly, can channel the 
discretion of agency employees, increase efficiency, and enhance 
fairness by providing the public clear notice of the line between 
permissible and impermissible conduct while ensuring equal treatment of 
similarly situated parties.
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    \3\ See U.S. Office of Management and Budget, Stimulating 
Smarter Regulation: 2002 Report to Congress on the Costs and 
Benefits of Regulations and Unfunded Mandates on State, Local and 
Tribal Entities, 72-74 (2002) (hereinafter ``2002 Report to 
Congress'').
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    Experience has shown, however, that guidance documents also may be 
poorly designed or improperly implemented. At the same time, guidance 
documents may not receive the benefit of careful consideration accorded 
under the procedures for regulatory development and review.\4\ These 
procedures include: (1) Internal agency review by a senior agency 
official; (2) public participation, including notice and comment under 
the Administrative Procedure Act (APA); (3) justification for the rule, 
including a statement of basis and purpose under the APA and various 
analyses under Executive Order 12866 (as further amended), the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act; (4) 
interagency review through OMB; (5) Congressional oversight; and (6) 
judicial review. Because it is procedurally easier to issue guidance 
documents, there also may be an incentive for regulators to issue 
guidance documents in lieu of regulations. As the D.C. Circuit observed 
in Appalachian Power:
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    \4\ Id., at 72.

    The phenomenon we see in this case is familiar. Congress passes 
a broadly worded statute. The agency follows with regulations 
containing broad language, open-ended phrases, ambiguous standards 
and the like. Then as years pass, the agency issues circulars or 
guidance or memoranda, explaining, interpreting, defining and often 
expanding the commands in regulations. One guidance document may 
yield another and then another and so on. Several words in a 
regulation may spawn hundreds of pages of text as the agency offers 
more and more detail regarding what its regulations demand of 
regulated entities. Law is made, without notice and comment, without 
public participation, and without publication in the Federal 
Register or the Code of Federal Regulations.\5\
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    \5\ Appalachian Power, 208 F.3d at 1019.


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    Concern about whether agencies are properly observing the notice-
and-comment requirements of the APA has received significant attention. 
The courts, Congress, and other authorities have emphasized that rules 
which do not merely interpret existing law or announce tentative policy 
positions but which establish new policy positions that the agency 
treats as binding must comply with the APA's notice-and-comment 
requirements, regardless of how they initially are labeled.\6\ More 
general concerns also have been raised that agency guidance practices 
should be better informed and more transparent, fair and 
accountable.\7\ Poorly designed or misused guidance documents can 
impose significant costs or limit the freedom of the public. OMB has 
received comments raising these concerns and providing specific 
examples in response to its proposed Bulletin,\8\ its 2002 request for 
comments on problematic guidance \9\ and its other requests for 
regulatory reform nominations in 2001 \10\ and 2004.\11\ This Bulletin 
and recent amendments to Executive Order 12866 respond to these 
problems.\12\
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    \6\ See, e.g., Appalachian Power; Gen. Elec. Co.; Chamber of 
Commerce; House Committee on Government Reform, ``Non-Binding Legal 
Effect of Agency Guidance Documents''; ACUS Rec. 92-2, supra note 2; 
Robert A. Anthony, ``Interpretive Rules, Policy Statements, 
Guidances, Manuals and the Like--Should Federal Agencies Use Them to 
Bind the Public?'' 41 Duke L.J. 1311 (1992).
    \7\ See, e.g., note 2, supra.
    \8\ U.S. Office of Management and Budget, ``Proposed Bulletin 
for Good Guidance Practices,'' 70 FR 76333 (Dec. 23, 2005).
    \9\ See note 1, supra.
    \10\ U.S. Office of Management and Budget, Draft Report to 
Congress on the Costs and Benefits of Federal Regulations, 66 FR 
22041 (May 2, 2001).
    \11\ U.S. Office of Management and Budget, Draft Report to 
Congress on the Costs and Benefits of Federal Regulations, 69 FR 
7987 (Feb. 20, 2004); see also U.S. Office of Management and Budget, 
Validating Regulatory Analysis: 2005 Report to Congress on the Costs 
and Benefits of Federal Regulations and Unfunded Mandates on State, 
Local and Tribal Entities 107-125 (2005).
    \12\ President Bush recently signed Executive Order 13422, 
``Further Amendment to Executive Order 12866 on Regulatory Planning 
and Review.'' Among other things, E.O. 13422 addresses the potential 
need for interagency review of certain significant guidance 
documents by clarifying OMB's authority to have advance notice of, 
and to review, agency guidance documents.
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    This Bulletin on ``Agency Good Guidance Practices'' sets forth 
general policies and procedures for developing, issuing and using 
guidance documents. The purpose of Good Guidance Practices (GGP) is to 
ensure that guidance documents of Executive Branch departments and 
agencies are: Developed with appropriate review and public 
participation, accessible and transparent to the public, of high 
quality, and not improperly treated as legally binding requirements. 
Moreover, GGP clarify what does and does not constitute a guidance 
document to provide greater clarity to the public. All offices in an 
agency should follow these policies and procedures.
    There is a strong foundation for establishing standards for the 
initiation, development, and issuance of guidance documents to raise 
their quality and transparency. The former Administrative Conference of 
the United States (ACUS), for example, developed recommendations for 
the development and use of agency guidance documents.\13\ In 1997, the 
Food and Drug Administration (FDA) created a guidance document 
distilling its good guidance practices (GGP).\14\ Congress then 
established certain aspects of the 1997 GGP document as the law in the 
Food and Drug Administration Modernization Act of 1997 (FDAMA; Public 
Law No. 105-115).\15\ The FDAMA also directed FDA to evaluate the 
effectiveness of the 1997 GGP document and then to develop and issue 
regulations specifying FDA's policies and procedures for the 
development, issuance, and use of guidance documents. FDA conducted an 
internal evaluation soliciting FDA employees' views on the 
effectiveness of GGP and asking whether FDA employees had received 
complaints regarding the agency's development, issuance, and use of 
guidance documents since the development of GGP. FDA found that its GGP 
had been beneficial and effective in standardizing the agency's 
procedures for development, issuance, and use of guidance documents, 
and that FDA employees had generally been following GGP.\16\ FDA then 
made some changes to its existing procedures to clarify its GGP.\17\ 
The provisions of the FDAMA and FDA's implementing regulations, as well 
as the ACUS recommendations, informed the development of this 
government-wide Bulletin.
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    \13\ See, e.g., note 2, supra.
    \14\ Notice, ``The Food and Drug Administration's Development, 
Issuance, and Use of Guidance Documents,'' 62 FR 8961 (Feb. 27, 
1997).
    \15\ 21 U.S.C. 371(h).
    \16\ See FDA, ``Administrative Practices and Procedures; Good 
Guidance Practices,'' 65 FR 7321, 7322-23 (proposed Feb. 14, 2000).
    \17\ 21 CFR 10.115; 65 FR 56468 (Sept. 19, 2000).
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Legal Authority for This Bulletin

    This Bulletin is issued under statutory authority, Executive Order, 
and OMB's general authorities to oversee and coordinate the rulemaking 
process. In what is commonly known as the Information Quality Act, 
Congress directed OMB to issue guidelines to ``provide policy and 
procedural guidance to Federal agencies for ensuring and maximizing the 
quality, utility, objectivity and integrity of information disseminated 
by Federal agencies.\18\ Moreover, Executive Order 13422, ``Further 
Amendment to Executive Order 12866 on Regulatory Planning and Review,'' 
recently clarified OMB's authority to oversee agency guidance 
documents. As further amended, Executive Order 12866 affirms that 
``[c]oordinated review of agency rulemaking is necessary to ensure that 
regulations and guidance documents are consistent with applicable law, 
the President's priorities, and the principles set forth in this 
Executive order,'' and the Order assigns that responsibility to 
OMB.\19\ E.O. 12866 also establishes OMB's Office of Information and 
Regulatory Affairs as ``the repository of expertise concerning 
regulatory issues, including methodologies and procedures that affect 
more than one agency.'' \20\ Finally, OMB has additional authorities to 
oversee the agencies in the administration of their programs.
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    \18\ Pub. L. 106-554, Sec.  515(a) (2000). The Information 
Quality Act was developed as a supplement to the Paperwork Reduction 
Act, 44 U.S.C. 3501 et seq., which requires OMB, among other things, 
to ``develop and oversee implementation of policies, principles, 
standards, and guidelines to--(1) Apply to Federal agency 
dissemination of public information, regardless of the form or 
format in which such information is disseminated; and (2) promote 
public access to public information and fulfill the purposes of this 
subchapter, including through the effective use of information 
technology.'' 44 U.S.C. 3504(d).
    \19\ Executive Order 12866, as further amended, Sec.  2(b).
    \20\ Id.
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The Requirements of the Final Bulletin and Response to Public Comments

A. Overview

    This Bulletin establishes: a definition of a significant guidance 
document; standard elements for significant guidance documents; 
practices for developing and using significant guidance documents; 
requirements for agencies to enable the public to comment on 
significant guidance documents or request that they be created, 
reconsidered, modified or rescinded; and ways for making guidance 
documents available to the public. These requirements should be 
interpreted and implemented in a manner that, consistent with the goals 
of improving the quality, accountability and transparency of agency 
guidance documents, provides sufficient flexibility for agencies to 
take those

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actions necessary to accomplish their essential missions.

B. Definitions

    Section I provides definitions for the purposes of this Bulletin. 
Several terms are identical to or based on those in FDA's GGP 
regulations, 21 CFR 10.115; the Paperwork Reduction Act, 44 U.S.C. 3501 
et seq.; Executive Order 12866, as further amended; and OMB's 
Government-wide Information Quality Guidelines, 67 FR 8452 (Feb. 22, 
2002).
    Section I(1) provides that the term ``Administrator'' means the 
Administrator of the Office of Information and Regulatory Affairs 
(OIRA) in the Office of Management and Budget.
    Section I(2) provides that the term ``agency'' has the same meaning 
as it has under the Paperwork Reduction Act, 44 U.S.C. 3502(1), other 
than those entities considered to be independent agencies, as defined 
in 44 U.S.C. 3502(5).
    Section I(3) defines the term ``guidance document'' as an agency 
statement of general applicability and future effect, other than a 
regulatory action (as defined in Executive Order 12866, as further 
amended), that sets forth a policy on a statutory, regulatory, or 
technical issue or an interpretation of a statutory or regulatory 
issue. This definition is used to comport with definitions used in 
Executive Order 12866, as further amended. Nothing in this Bulletin is 
intended to indicate that a guidance document can impose a legally 
binding requirement.
    Guidance documents often come in a variety of formats and names, 
including interpretive memoranda, policy statements, guidances, 
manuals, circulars, memoranda, bulletins, advisories, and the like. 
Guidance documents include, but are not limited to, agency 
interpretations or policies that relate to: the design, production, 
manufacturing, control, remediation, testing, analysis or assessment of 
products and substances, and the processing, content, and evaluation/
approval of submissions or applications, as well as compliance guides. 
Guidance documents do not include solely scientific research. Although 
a document that simply summarizes the protocol and conclusions of a 
specific research project (such as a clinical trial funded by the 
National Institutes of Health) would not qualify as a guidance 
document, such research may be the basis of a guidance document (such 
as the HHS/USDA ``Dietary Guidelines for Americans,'' which provides 
guidance to Americans on what constitutes a healthy diet).
    Some commenters raised the concern that the term ``guidance 
document'' reflected too narrow a focus on written materials alone. 
While the final Bulletin adopts the commonly used term ``guidance 
document,'' the definition is not limited only to written guidance 
materials and should not be so construed. OMB recognizes that agencies 
are experimenting with offering guidance in new and innovative formats, 
such as video or audio tapes, or interactive web-based software. The 
definition of ``guidance document'' encompasses all guidance materials, 
regardless of format. It is not the intent of this Bulletin to 
discourage the development of promising alternative means to offer 
guidance to the public and regulated entities.
    A number of commenters raised concerns that the definition of 
``significant guidance document'' in the proposed Bulletin was too 
broad in some respects. In particular, the proposed definition included 
guidance that set forth initial interpretations of statutory and 
regulatory requirements and changes in interpretation or policy. The 
definition in the proposed Bulletin was adapted from the definition of 
``Level 1 guidance documents'' in FDA's GGP regulations.
    Upon consideration of the comments, the need for clarity, and the 
broad application of this Bulletin to diverse agencies, the definition 
of ``significant guidance document'' has been changed. Section I(4) 
defines the term ``significant guidance document'' as a guidance 
document disseminated to regulated entities or the general public that 
may reasonably be anticipated to: (i) Lead to 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; or (ii) Create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
or (iii) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or (iv) Raise novel legal or policy issues arising out of 
legal mandates, the President's priorities, or the principles set forth 
in Executive Order 12866, as further amended. Under the Bulletin, 
significant guidance documents include interpretive rules of general 
applicability and statements of general policy that have the effects 
described in Section I(4)(i)-(iv).
    The general definition of ``significant guidance document'' in the 
final Bulletin adopts the definition in Executive Order 13422, which 
recently amended Executive Order 12866 to clarify OMB's role in 
overseeing and coordinating significant guidance documents. This 
definition, in turn, closely tracks the general definition of 
``significant regulatory action'' in E.O. 12866, as further amended. 
One advantage of this definition is that agencies have years of 
experience in the regulatory context applying the parallel definition 
of ``significant regulatory action'' under E.O. 12866, as further 
amended. However, a few important changes were made to the definition 
used in E.O. 12866, as further amended, to make it better suited for 
guidance. For example, in recognition of the non-binding nature of 
guidance the words ``may reasonably be anticipated to'' preface all 
four prongs of the ``significant guidance document'' definition. This 
prefatory language makes clear that the impacts of guidance often will 
be more indirect and attenuated than binding legislative rules.
    Section I(4) also clarifies what is not a ``significant guidance 
document'' under this Bulletin. For purposes of this Bulletin, 
documents that would not be considered significant guidance documents 
include: Legal advisory opinions for internal Executive Branch use and 
not for release (such as Department of Justice Office of Legal Counsel 
opinions); briefs and other positions taken by agencies in 
investigations, pre-litigation, litigation, or other enforcement 
proceedings; speeches; editorials; media interviews; press materials; 
Congressional correspondence; guidances that pertain to a military or 
foreign affairs function of the United States (other than guidance on 
procurement or the import or export of non-defense articles and 
services); grant solicitations; warning letters; case or investigatory 
letters responding to complaints involving fact-specific 
determinations; purely internal agency policies; guidances that pertain 
to the use, operation or control of a government facility; and internal 
operational guidances directed solely to other Federal agencies 
(including Office of Personnel Management personnel issuances, General 
Services Administration Federal Travel Regulation bulletins, and most 
of the National Archives and Records Administration's records 
management bulletins). The Bulletin also exempts speeches of agency 
officials.
    Information collections, discretionary grant application packages, 
and compliance monitoring reports also are not significant guidance 
documents. Though the Bulletin does not cover

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guidance documents that pertain to the use, operation, or control of a 
Federal facility, it does cover generally applicable instructions to 
contractors. Section I(4) also provides that an agency head, in 
consultation and concurrence with the OIRA Administrator, may exempt 
one or more categories of significant guidance documents from the 
requirements of the Bulletin.
    The definition of guidance document covers agency statements of 
``general applicability'' and ``future effect,'' and accordingly, the 
Bulletin does not cover documents that result from an adjudicative 
decision. We construe ``future effects'' as intended (and likely 
beneficial) impacts due to voluntary compliance with a guidance 
document. Moreover, since a significant guidance document is an agency 
statement of ``general applicability,'' correspondence such as opinion 
letters or letters of interpretation prepared for or in response to an 
inquiry from an individual person or entity would not be considered a 
significant guidance document, unless the correspondence is reasonably 
anticipated to have precedential effect and a substantial impact on 
regulated entities or the public. Thus, this Bulletin should not 
inhibit the beneficial practice of agencies providing informal guidance 
to help specific parties. If the agency compiles and publishes informal 
determinations to provide guidance to, and with a substantial impact 
on, regulated industries, then this Bulletin would apply. Guidance 
documents are considered ``significant'' when they have a broad and 
substantial impact on regulated entities, the public or other Federal 
agencies. For example, a guidance document that had a substantial 
impact on another Federal agency, by interfering with its ability to 
carry out its mission or imposing substantial burdens, would be 
significant under Section I(4)(ii) and perhaps could trigger Section 
I(5) as well.
    In general, guidance documents that concern routine matters would 
not be ``significant.'' Among an agency's internal guidance documents, 
there are many categories that would not constitute significant 
guidance documents. There is a broad category of documents that may 
describe the agency's day-to-day business. Though such documents might 
be of interest to the public, they do not fall within the definition of 
significant guidance documents for the purposes of this Bulletin. More 
generally, there are internal guidance documents that bind agency 
employees with respect to matters that do not directly or substantially 
impact regulated entities. For example, an agency may issue guidance to 
field offices directing them to maintain electronic data files of 
complaints regarding regulated entities.
    Section I(5) states that the term ``economically significant 
guidance document'' means a significant guidance document that ``may 
reasonably be anticipated to lead to'' an annual effect on the economy 
of $100 million or more or adversely affect in a material way the 
economy or a sector of the economy. The relevant economic impacts 
include those that may be imposed by Federal agencies, State, or local 
governments, or foreign governments that affect the U.S. economy, as 
well as impacts that could arise from private sector conduct. The 
definition of economically significant guidance document tracks only 
the part of the definition of significant guidance document in Section 
I(4)(i) related to substantial economic impacts. This clarifies that 
the definition of ``economically significant guidance document'' 
includes only a relatively narrow category of significant guidance 
documents. This definition enables agencies to determine which 
interpretive rules of general applicability or statements of general 
policy might be so consequential as to merit advance notice-and-comment 
and a response-to-comments document--and which do not. Accordingly, the 
definition of economically significant guidance document includes 
economic impacts that rise to $100 million in any one year or adversely 
affect the economy or a sector of the economy.
    The definition of economically significant guidance document also 
departs in other ways from the language describing an economically 
significant regulatory action in Section 3(f)(1) of E.O. 12866, as 
further amended. A number of commenters on the proposed Bulletin raised 
questions about how a guidance document--which is not legally binding--
could have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy or a sector of the 
economy. As other commenters recognized, although guidance may not be 
legally binding, there are situations in which it may reasonably be 
anticipated that a guidance document could lead parties to alter their 
conduct in a manner that would have such an economically significant 
impact.
    Guidance can have coercive effects or lead parties to alter their 
conduct. For example, under a statute or regulation that would allow a 
range of actions to be eligible for a permit or other desired agency 
action, a guidance document might specify fast track treatment for a 
particular narrow form of behavior but subject other behavior to a 
burdensome application process with an uncertain likelihood of success. 
Even if not legally binding, such guidance could affect behavior in a 
way that might lead to an economically significant impact. Similarly, 
an agency might make a pronouncement about the conditions under which 
it believes a particular substance or product is unsafe. While not 
legally binding, such a statement could reasonably be anticipated to 
lead to changes in behavior by the private sector or governmental 
authorities such that it would lead to a significant economic effect. 
Unless the guidance document is exempted due to an emergency or other 
appropriate consideration, the agency should observe the notice-and-
comment procedures of section IV.
    In recognition of the non-binding nature of guidance documents, the 
Bulletin's definition of economically significant guidance document 
differs in key respects from the definition of an economically 
significant regulatory action in section 3(f)(1) of E.O. 12866, as 
further amended. First, as described above, the words ``may reasonably 
be anticipated to'' are included in the definition. Second, the 
definition of economically significant guidance document contemplates 
that the guidance document could ``lead to'' (as opposed to ``have'') 
an economically significant effect. This language makes clear that the 
impacts of guidance documents often will be more indirect and dependent 
on third-party decisions and conduct than is the case with binding 
legislative rules. This language also reflects a recognition that, as 
various commenters noted, guidance documents often will not be amenable 
to formal economic analysis of the kind that is prepared for an 
economically significant regulatory action. Accordingly, this Bulletin 
does not require agencies to conduct a formal regulatory impact 
analysis to guide their judgments about whether a guidance document is 
economically significant.
    The definition of ``economically significant guidance document'' 
excludes guidance documents on Federal expenditures and receipts. 
Therefore, guidance documents on Federal budget expenditures (e.g., 
entitlement programs) and taxes (the administration or collection of 
taxes, tax credits, or duties) are not subject to the requirements for 
notice and comment and a response to comments document in Sec.  IV. 
However, if such guidance documents are ``significant,'' then they are 
subject to the other requirements of

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this Bulletin, including the transparency and approval provisions.
    Section I(6) states that the term ``disseminated'' means prepared 
by the agency and distributed to the public or regulated entities. 
Dissemination does not include distribution limited to government 
employees; intra-or interagency use or sharing of government 
information; and responses to requests for agency records under the 
Freedom of Information Act, the Privacy Act, the Federal Advisory 
Committee Act or other similar law.\21\
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    \21\ See U.S. Office of Management and Budget's Government-wide 
Information Quality Guidelines, 67 FR 8452, 8454, 8460 (Feb. 22, 
2002).
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    Consistent with Executive Order 12866, as further amended, Section 
I(7) defines the term ``regulatory action'' as any substantive action 
by an agency (normally published in the Federal Register) that 
promulgates or is expected to lead to the promulgation of a final 
regulation, including notices of inquiry, advance notices of inquiry 
and notices of proposed rulemaking.
    Section I(8) defines the term ``regulation,'' consistent with 
Executive Order 12866, as further amended, as an agency statement of 
general applicability and future effect, which the agency intends to 
have the force and effect of law, that is designed to implement, 
interpret, or prescribe law or policy or to describe the procedure or 
practice requirements of an agency.

C. Basic Agency Standards

    Section II describes basic agency standards for significant 
guidance documents.
1. Agency Approval Procedures
    Section II(1)(a) directs each agency to develop or have written 
procedures for the internal clearance of significant guidance documents 
no later than the effective date of this Bulletin. Those procedures 
should ensure that issuance of significant guidance documents is 
approved by appropriate agency officials. Currently at FDA the Director 
in a Center or an Office of Regulatory Affairs equivalent or higher 
approves a significant guidance document before it is distributed to 
the public in draft or final form. Depending on the nature of specific 
agency guidance documents, these procedures may require approval or 
concurrence by other components within an agency. For example, if 
guidance is provided on compliance with an agency regulation, we would 
anticipate that the agency's approval procedures would ensure 
appropriate coordination with other agency components that have a stake 
in the regulation's implementation, such as the General Counsel's 
office and the component responsible for development and issuance of 
the regulation.
    Section II(1)(b) states that agency employees should not depart 
from significant agency guidance documents without appropriate 
justification and supervisory concurrence. It is not the intent of this 
Bulletin to inhibit the flexibility needed by agency officials to 
depart appropriately from significant guidance documents by rigidly 
requiring concurrence only by very high-level officials. Section 
II(1)(a) also is not intended to bind an agency to exercise its 
discretion only in accordance with a general policy where the agency is 
within the range of discretion contemplated by the significant guidance 
document.
    Agencies are to follow GGP when providing important policy 
direction on a broad scale. This includes when an agency communicates, 
informally or indirectly, new or different regulatory expectations to a 
broad public audience for the first time, including regulatory 
expectations different from guidance issued prior to this Bulletin.\22\ 
This does not limit the agency's ability to respond to questions as to 
how an established policy applies to a specific situation or to answer 
questions about areas that may lack established policy (although such 
questions may signal the need to develop guidance in that area). This 
requirement also does not apply to positions taken by agencies in 
litigation, pre-litigation, or investigations, or in any way affect 
their authority to communicate their views in court or other 
enforcement proceedings. This requirement also is not intended to 
restrict the authority of agency General Counsels or the Department of 
Justice Office of Legal Counsel to provide legal interpretations of 
statutory and regulatory requirements.
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    \22\ See FDA's Good Guidance Practices, 21 CFR 10.115(e): ``Can 
FDA use means other than a guidance document to communicate new 
agency policy or a new regulatory approach to a broad public 
audience? The agency must not use documents or other means of 
communication that are excluded from the definition of guidance 
document to informally communicate new or different regulatory 
expectations to a broad public audience for the first time. These 
GGPs must be followed whenever regulatory expectations that are not 
readily apparent from the statute or regulations are first 
communicated to a broad public audience.''
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    Agencies also should ensure consistent application of GGP. 
Employees involved in the development, issuance, or application of 
significant guidance documents should be trained regarding the agency's 
GGP, particularly the principles of Section II(2). In addition, agency 
offices should monitor the development, issuance and use of significant 
guidance documents to ensure that employees are following GGP.
2. Standard Elements
    Section II(2) establishes basic requirements for significant 
guidance documents. They must: (i) Include the term ``guidance'' or its 
functional equivalent; (ii) Identify the agenc(ies) or office(s) 
issuing the document; (iii) Identify the activity to which and the 
persons to whom the document applies; (iv) Include the date of 
issuance; (v) Note if it is a revision to a previously issued guidance 
document and, if so, identify the guidance that it replaces; (vi) 
Provide the title of the guidance and any document identification 
number, if one exists; and (vii) include the citation to the statutory 
provision or regulation (in Code of Federal Regulations format) which 
it applies to or interprets.
    In implementing this Bulletin, particularly Section II(2)(e), 
agencies should be diligent to identify for the public whether there is 
previous guidance on an issue, and, if so, to clarify whether that 
guidance document is repealed by the new significant guidance document 
completely, and if not, to specify what provisions in the previous 
guidance document remain in effect. Superseded guidance documents that 
remain available for historical purposes should be stamped or otherwise 
prominently identified as superseded. Draft significant guidance 
documents that are being made available for pre-adoption notice and 
comment should include a prominent ``draft'' notation. As existing 
significant guidance documents are revised, they should be updated to 
comply with this Bulletin.
    Finally, Section II(2)(h) clarifies that, given their legally 
nonbinding nature, significant guidance documents should not include 
mandatory language such as ``shall,'' ``must,'' ``required'' or 
``requirement,'' unless the agency is using these words to describe a 
statutory or regulatory requirement, or the language is addressed to 
agency staff and will not foreclose consideration by the agency of 
positions advanced by affected private parties.\23\ For example, a 
guidance document may explain how the agency believes a statute or

[[Page 3437]]

regulation applies to certain regulated activities. Before a 
significant guidance document is issued or revised, it should be 
reviewed to ensure that improper mandatory language has not been used. 
As some commenters noted, while a guidance document cannot legally 
bind, agencies can appropriately bind their employees to abide by 
agency policy as a matter of their supervisory powers over such 
employees without undertaking pre-adoption notice and comment 
rulemaking. As a practical matter, agencies also may describe laws of 
nature, scientific principles, and technical requirements in mandatory 
terms so long as it is clear that the guidance document itself does not 
impose legally enforceable rights or obligations.
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    \23\ As the courts have held, see supra note 2, agencies need to 
follow statutory rulemaking requirements, such as those of the APA, 
to issue documents with legally binding effect, i.e., legislative 
rules. One benefit of GGP for an agency is that the agency's review 
process will help to identify any draft guidance documents that 
instead should be promulgated through the rulemaking process.
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    A significant guidance document should aim to communicate 
effectively to the public about the legal effect of the guidance and 
the consequences for the public of adopting an alternative approach. 
For example, a significant guidance document could be captioned with 
the following disclaimer under appropriate circumstances:

    ``This [draft] guidance, [when finalized, will] represent[s] the 
[Agency's] current thinking on this topic. It does not create or 
confer any rights for or on any person or operate to bind the 
public. You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and 
regulations. If you want to discuss an alternative approach (you are 
not required to do so), you may contact the [Agency] staff 
responsible for implementing this guidance. If you cannot identify 
the appropriate [Agency] staff, call the appropriate number listed 
on the title page of this guidance.''

    When an agency determines it would be appropriate, the agency 
should use this or a similar disclaimer. Agency staff should similarly 
describe the legal effect of significant guidance documents when 
speaking to the public about them.

D. Public Access and Feedback

    Section III describes public access procedures related to the 
development and issuance of significant guidance documents.
1. Internet Access
    Section III directs agencies to ensure that information about the 
existence of significant guidance documents and the significant 
guidance documents themselves are made available to the public in 
electronic form. Section III(1) enables the public to obtain from an 
agency's Web site a list of all of an agency's significant guidance 
documents. Under section III(1)(a), agencies will maintain a current 
electronic list of all significant guidance documents on their Web 
sites in a manner consistent with OMB policies for agency public Web 
sites and information dissemination.\24\ To assist the public in 
locating such electronic lists, they should be maintained on an 
agency's Web site--or as a link on an agency's Web site to the 
electronic list posted on a component or subagency's Web site--in a 
quickly and easily identifiable manner (e.g., as part of or in close 
visual proximity to the agency's list of regulations and proposed 
regulations). New documents will be added to this list within 30 days 
from the date of issuance. The agency list of significant guidance 
documents will include: the name of the significant guidance document, 
any docket number, and issuance and revision dates. As agencies develop 
or revise significant guidance documents, they should organize and 
catalogue their significant guidance documents to ensure users can 
easily browse, search for, and retrieve significant guidance documents 
on their Web sites.
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    \24\ U.S. Office of Management and Budget, Memorandum M-05-04, 
``Policies for Federal Agency Public Web sites'' (Dec. 17, 2004), 
available at: https://www.whitehouse.gov/omb/memoranda/fy2005/m05-
04.pdf; U.S. Office of Management and Budget, Memorandum M-06-02, 
``Improving Public Access to and Dissemination of Government 
Information and Using the Federal Enterprise Architecture Data 
Reference Model'' (Dec. 16, 2005), available at: https://
www.whitehouse.gov/omb/memoranda/fy2006/m06-02.pdf.
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    The agency shall provide a link from the list to each significant 
guidance document (including any appendices or attachments) that 
currently is in effect. Many recently issued guidance documents have 
been made available on the Internet, but there are some documents that 
are not now available in this way. Agencies should begin posting those 
significant guidance documents on their Web sites with the goal of 
making all of their significant guidance documents currently in effect 
publicly available on their Web sites by the effective date of this 
Bulletin.\25\ Other requirements of this Bulletin, such as section 
II(2) (Standard Elements), apply only to significant guidance documents 
issued or amended after the effective date of the Bulletin. For such 
significant guidance documents (including economically significant 
guidance documents), agencies should provide, to the extent appropriate 
and feasible, a Web site link from the significant guidance document to 
the public comments filed on it. This would enable interested 
stakeholders and the general public to understand the various 
viewpoints on the significant guidance documents.
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    \25\ In this regard, we note that under the Electronic Freedom 
of Information Act Amendments of 1996, agencies have been posting on 
their Web sites statements of general policy and interpretations of 
general applicability. See 5 U.S.C. 552(a)(2).
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    Under section III(1)(b), the significant guidance list will 
identify those significant guidance documents that were issued, revised 
or withdrawn within the past year. Agencies are encouraged, to the 
extent appropriate and feasible, to offer a list serve or similar 
mechanism for members of the public who would like to be notified by e-
mail each time an agency issues its annual update of significant 
guidance documents. To further assist users in better understanding 
agency guidance and its relationship to current or proposed Federal 
regulations, agencies also should link their significant guidance 
document lists to Regulations.gov.\26\
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    \26\ Regulations.gov is available at https://www.Regulations.gov/
fdmspublic/component/main.
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2. Public Feedback
    Section III(2) requires each agency to have adequate procedures for 
public comments on significant guidance documents and to address 
complaints regarding the development and use of significant guidance 
documents. Not later than 180 days from the publication of this 
Bulletin, each agency shall establish and clearly advertise on its Web 
site a means for the public to submit electronically comments on 
significant guidance documents, and to request electronically that 
significant guidance documents be issued, reconsidered, modified or 
rescinded. The public may state their view that specific guidance 
documents are ``significant'' or ``economically significant'' and 
therefore are subject to the applicable requirements of this Bulletin. 
At any time, the public also may request that an agency modify or 
rescind an existing significant guidance document. Such requests should 
specify why and how the significant guidance document should be 
rescinded or revised.
    Public comments submitted under these procedures on significant 
guidance documents are for the benefit of the agency, and this Bulletin 
does not require a formal response to comments (of course, agencies 
must comply with any applicable statutory requirements to respond, and 
this Bulletin does not alter those requirements). In some cases, the 
agency, in consultation with the Administrator of OMB's Office of 
Information and Regulatory Affairs, may in its discretion decide to 
address public comments by updating or altering the significant 
guidance document.

[[Page 3438]]

    Although this Bulletin does not require agencies to provide notice 
and an opportunity for public comment on all significant guidance 
documents before they are adopted, it is often beneficial for an agency 
to do so when they determine that it is practical. Pre-adoption notice-
and-comment can be most helpful for significant guidance documents that 
are particularly complex, novel, consequential, or controversial. 
Agencies also are encouraged to consider observing notice-and-comment 
procedures for interpretive significant guidance documents that 
effectively would extend the scope of the jurisdiction the agency will 
exercise, alter the obligations or liabilities of private parties, or 
modify the terms under which the agency will grant entitlements. As it 
does for legislative rules, providing pre-adoption opportunity for 
comment on significant guidance documents can increase the quality of 
the guidance and provide for greater public confidence in and 
acceptance of the ultimate agency judgments. For these reasons, 
agencies sometimes follow the notice-and-comment procedures of the APA 
even when doing so is not legally required.\27\ Of course, where an 
agency provides for notice and comment before adoption, it need not do 
so again upon issuance of the significant guidance document.\28\
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    \27\For example, in developing its guidelines for self-
evaluation of compensation practices regarding systemic compensation 
discrimination, the Department of Labor provided for pre-adoption 
notice and opportunity for comment. See Office of Federal Contract 
Compliance Programs, ``Guidelines for Self-Evaluation of 
Compensation Practices for Compliance with Nondiscrimination 
Requirements of Executive Order 11246 with Respect to Systemic 
Compensation Discrimination,'' 69 FR 67,252 (Nov. 16, 2004).
    \28\ See, e.g., Office of Federal Procurement Policy Act, 41 
U.S.C. 418(b) (providing for pre-adoption notice and comment for 
procurement policies with a significant effect or cost).
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    Many commenters expressed the desire for a better way to resolve 
concerns about agency guidance documents and adherence to good guidance 
practices. To help resolve public concerns over problematic guidance 
documents, section III(2)(b) requires each agency to designate an 
office (or offices) to receive and address complaints by the public 
that the agency is not following the procedures in this Bulletin or is 
improperly treating a guidance document as a binding requirement. The 
public also could turn to this office to request that the agency 
classify a guidance as ``significant'' or ``economically significant'' 
for purposes of this Bulletin. The agency shall provide the name and 
contact information for the office(s) on its Web site.

E. Notice and Comment on Economically Significant Guidance Documents

    Under section IV, after the agency prepares a draft of an 
economically significant guidance document, the agency must publish a 
notice in the Federal Register announcing that the draft guidance 
document is available for comment. In a manner consistent with OMB 
policies for agency public Web sites and information dissemination, the 
agency must post the draft on its Web site, make it publicly available 
in hard copy, and ensure that persons with disabilities can reasonably 
access and comment on the guidance development process.\29\ If the 
guidance document is not in a format that permits such electronic 
posting with reasonable efforts, the agency should notify the public 
how they can review the guidance document. When inviting public 
comments on the draft guidance document, the agency will propose a 
period of time for the receipt of comments and make the comments 
available to the public for review. The agency also may hold public 
meetings or workshops on a draft guidance document, or present it for 
review to an advisory committee or, as required or appropriate, to a 
peer review committee.\30\ In some cases, the agency may, in its 
discretion, seek early public input even before it prepares the draft 
of an economically significant guidance document. For example, the 
agency could convene or participate in meetings or workshops.
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    \29\ Federal agency public Web sites must be designed to make 
information and services fully available to individuals with 
disabilities. For additional information, see: https://www.access-
board.gov/index.htm; see also Rehabilitation Act, 29 U.S.C. 701, 
794, 794d.
    \30\ See U.S. Office of Management and Budget, ``Final 
Information Quality Bulletin For Peer Review,'' 70 FR 2664 (Jan. 14, 
2005).
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    After reviewing comments on a draft, the agency should incorporate 
suggested changes, when appropriate, into the final version of the 
economically significant guidance document. The agency then should 
publish a notice in the Federal Register announcing that the 
significant guidance document is available. The agency must post the 
significant guidance document on the Internet and make it available in 
hard copy. The agency also must prepare a robust response-to-comments 
document and make it publicly available. Though these procedures are 
similar to APA notice-and-comment requirements, this Bulletin in no way 
alters (nor is it intended to interpret) the APA requirements for 
legislative rules under 5 U.S.C. 553.
    Prior to or upon announcing the availability of the draft guidance 
document, the agency should establish a public docket. Public comments 
submitted on an economically significant guidance document should be 
sent to the agency's docket. The comments submitted should identify the 
docket number on the guidance document (if such a docket number 
exists), as well as the title of the document. Comments should be 
available to the public at the docket and, when feasible, on the 
Internet. Agencies should provide a link on their Web site from the 
guidance document to the public comments as well as the response to 
comments document.
    After providing an opportunity for comment, an agency may decide, 
in its discretion, that it is appropriate to issue another draft of the 
significant guidance document. The agency may again solicit comment by 
publishing a notice in the Federal Register, posting a draft on the 
Internet and making the draft available in hard copy. The agency then 
would proceed to issue a final version of the guidance document in the 
manner described above. Copies of the Federal Register notices of 
availability should be available on the agency's Web site. In addition, 
the response-to-comments document should address the additional 
comments received on the revised draft.
    An agency head, in consultation and concurrence with the OIRA 
Administrator, may identify a particular significant guidance document 
or class of guidance documents for which the procedures of this Section 
are not feasible and appropriate. Under Sec.  IV, the agency is not 
required to seek public comment before it implements an economically 
significant guidance document if prior public participation is not 
feasible or appropriate. It may not be feasible or appropriate for an 
agency to seek public comment before issuing an economically 
significant guidance document if there is a public health, safety, 
environmental or other emergency requiring immediate issuance of the 
guidance document, or there is a statutory requirement or court order 
that requires immediate issuance. Another type of situation is 
presented by guidance documents that, while important, are issued in a 
routine and frequent manner. For example, one commenter raised concerns 
that the National Weather Service not only frequently reports on 
weather and air conditions but also gives consumers guidance, such as 
heat advisories, on the best course of action to take in

[[Page 3439]]

severe weather conditions. Even if such notices or advisories had an 
economically significant impact, subjecting them to the notice-and-
comment procedures of Section IV would not be feasible or appropriate. 
An agency may discuss with OMB other exceptions that are consistent 
with section IV(2).
    Though economically significant guidance documents that fall under 
the exemption in section IV(2) are not required to undergo the full 
notice-and-comment procedures, the agency should: (a) Publish a notice 
in the Federal Register announcing that the guidance document is 
available; (b) post the guidance document on the Internet and make it 
available in hard copy (or notify the public how they can review the 
guidance document if it is not in a format that permits such electronic 
posting with reasonable efforts); and (c) seek public comment when it 
issues or publishes the guidance document. If the agency receives 
comments on an excepted guidance document, the agency should review 
those comments and revise the guidance document when appropriate. 
However, the agency is not required to provide post-promulgation 
notice-and-comment if such procedures are not feasible or appropriate.

F. Emergencies

    In emergency situations or when an agency is obligated by law to 
act more quickly than normal review procedures allow, the agency shall 
notify OIRA as soon as possible and, to the extent practicable, comply 
with this Bulletin. For those significant guidance documents that are 
governed by a statutory or court-imposed deadlines, the agency shall, 
to the extent practicable, schedule its proceedings so as to permit 
sufficient time to comply with this Bulletin.

G. Judicial Review

    This Bulletin is intended to improve the internal management of the 
Executive Branch and is not intended to, and does not, create any right 
or benefit, substantive or procedural, enforceable at law or in equity, 
against the United States, its agencies or other entities, its officers 
or employees, or any other person.\31\
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    \31\ The provisions of this Bulletin, and an agency's compliance 
or noncompliance with the Bulletin's requirements, are not intended 
to, and should not, alter the deference that agency interpretations 
of laws and regulations should appropriately be given.
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H. Effective Date

    The requirements of this Bulletin shall take effect 180 days after 
publication in the Federal Register except that agencies will have 210 
days to comply with requirements for significant guidance documents 
promulgated on or before the date of publication of this Bulletin.

Bulletin for Agency Good Guidance Practices

I. Definitions

    For purposes of this Bulletin--
    1. The term ``Administrator'' means the Administrator of the Office 
of Information and Regulatory Affairs in the Office of Management and 
Budget (OIRA).
    2. The term ``agency'' has the same meaning it has under the 
Paperwork Reduction Act, 44 U.S.C. 3502(1), other than those considered 
to be independent regulatory agencies, as defined in 44 U.S.C. 3502(5).
    3. The term ``guidance document'' means an agency statement of 
general applicability and future effect, other than a regulatory action 
(as defined in Executive Order 12866, as further amended, section 
3(g)), that sets forth a policy on a statutory, regulatory or technical 
issue or an interpretation of a statutory or regulatory issue.
    4. The term ``significant guidance document''--
    a. Means (as defined in Executive Order 12866, as further amended, 
section 3(h)) a guidance document disseminated to regulated entities or 
the general public that may reasonably be anticipated to:
    (i) Lead to 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;
    (ii) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (iii) Materially alter the budgetary impact of entitlements, 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or
    (iv) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
Executive Order 12866, as further amended.
    b. Does not include legal advisory opinions for internal Executive 
Branch use and not for release (such as Department of Justice Office of 
Legal Counsel opinions); briefs and other positions taken by agencies 
in investigations, pre-litigation, litigation, or other enforcement 
proceedings (nor does this Bulletin in any other way affect an agency's 
authority to communicate its views in court or in other enforcement 
proceedings); speeches; editorials; media interviews; press materials; 
Congressional correspondence; guidance documents that pertain to a 
military or foreign affairs function of the United States (other than 
guidance on procurement or the import or export of non-defense articles 
and services); grant solicitations; warning letters; case or 
investigatory letters responding to complaints involving fact-specific 
determinations; purely internal agency policies; guidance documents 
that pertain to the use, operation or control of a government facility; 
internal guidance documents directed solely to other Federal agencies; 
and any other category of significant guidance documents exempted by an 
agency head in consultation with the OIRA Administrator.
    5. The term ``economically significant guidance document'' means a 
significant guidance document that may reasonably be anticipated to 
lead to an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy or a sector of the 
economy, except that economically significant guidance documents do not 
include guidance documents on Federal expenditures and receipts.
    6. The term ``disseminated'' means prepared by the agency and 
distributed to the public or regulated entities. Dissemination does not 
include distribution limited to government employees; intra- or 
interagency use or sharing of government information; and responses to 
requests for agency records under the Freedom of Information Act, the 
Privacy Act, the Federal Advisory Committee Act or other similar laws.
    7. The term ``regulatory action'' means any substantive action by 
an agency (normally published in the Federal Register) that promulgates 
or is expected to lead to the promulgation of a final regulation, 
including notices of inquiry, advance notices of inquiry and notices of 
proposed rulemaking (see Executive Order 12866, as further amended, 
section 3).
    8. The term ``regulation'' means an agency statement of general 
applicability and future effect, which the agency intends to