[Federal Register: January 25, 2007 (Volume 72, Number 16)]
[Notices]
[Page 3432-3440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja07-80]
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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 http://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: http://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: http://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 http://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: http://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 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 (see Executive Order 12866, as further
amended, section 3).
II. Basic Agency Standards for Significant Guidance Documents
1. Approval Procedures:
[[Page 3440]]
a. Each agency shall develop or have written procedures for the
approval of significant guidance documents. Those procedures shall
ensure that the issuance of significant guidance documents is approved
by appropriate senior agency officials.
b. Agency employees should not depart from significant guidance
documents without appropriate justification and supervisory
concurrence.
2. Standard Elements: Each significant guidance document shall:
a. Include the term ``guidance'' or its functional equivalent;
b. Identify the agenc(ies) or office(s) issuing the document;
c. Identify the activity to which and the persons to whom the
significant guidance document applies;
d. Include the date of issuance;
e. Note if it is a revision to a previously issued guidance
document and, if so, identify the document that it replaces;
f. Provide the title of the document, and any document
identification number, if one exists;
g. Include the citation to the statutory provision or regulation
(in Code of Federal Regulations format) which it applies to or
interprets; and
h. 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 agency consideration
of positions advanced by affected private parties.
III. Public Access and Feedback for Significant Guidance Documents
1. Internet Access:
a. Each agency shall maintain on its 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--a current list of its significant guidance
documents in effect. The list shall include the name of each
significant guidance document, any document identification number, and
issuance and revision dates. The agency shall provide a link from the
current list to each significant guidance document that is in effect.
New significant guidance documents and their Web site links shall be
added promptly to this list, no later than 30 days from the date of
issuance.
b. The list shall identify significant guidance documents that have
been added, revised or withdrawn in the past year.
2. Public Feedback:
a. Each agency shall establish and clearly advertise on its Web
site a means for the public to submit comments electronically on
significant guidance documents, and to submit a request electronically
for issuance, reconsideration, modification, or rescission of
significant guidance documents. Public comments under these procedures
are for the benefit of the agency, and no formal response to comments
by the agency is required by this Bulletin.
b. Each agency shall 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 significant
guidance document as a binding requirement. The agency shall provide,
on its Web site, the name and contact information for the office(s).
IV. Notice and Public Comment for Economically Significant Guidance
Documents
1. In General: Except as provided in Section IV(2), when an agency
prepares a draft of an economically significant guidance document, the
agency shall:
a. Publish a notice in the Federal Register announcing that the
draft document is available;
b. Post the draft document on the Internet and make it publicly
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);
c. Invite public comment on the draft document; and
d. Prepare and post on the agency's Web site a response-to-comments
document.
2. Exemptions: An agency head, in consultation with the OIRA
Administrator, may identify a particular economically significant
guidance document or category of such documents for which the
procedures of this Section are not feasible or appropriate.
V. 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 deadline, the agency shall, to
the extent practicable, schedule its proceedings so as to permit
sufficient time to comply with this Bulletin.
VI. 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.
VII. Effective Date
The requirements of this Bulletin shall take effect 180 days after
its 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.
Dated: January 18, 2007.
Steven D. Aitken,
Acting Administrator, Office of Information and Regulatory Affairs.
[FR Doc. E7-1066 Filed 1-24-07; 8:45 am]
BILLING CODE 3110-01-P