EXECUTIVE OFFICE OF THE PRESIDENT 

 OFFICE OF MANAGEMENT AND BUDGET 

WASHINGTON, D.C. 20503 

 

 THE DIRECTOR 

January 18, 2007 

M-07-07 M-07-07 

MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS 

 AND AGENCIES 

FROM: Rob Portman 

SUBJECT: Issuance of OMB’s “Final Bulletin for Agency Good Guidance 

Practices” 

The Office of Management and Budget (OMB) today issued a bulletin applicable 

to all departments and agencies entitled “Final Bulletin for Agency Good Guidance Practices.” 

This Bulletin establishes policies and procedures for the development, issuance, and use of 

significant guidance documents by Executive Branch departments and agencies and is intended 

to increase the quality and transparency of agency guidance practices and the significant 

guidance documents produced through them. 

to all departments and agencies entitled “Final Bulletin for Agency Good Guidance Practices.” 

This Bulletin establishes policies and procedures for the development, issuance, and use of 

significant guidance documents by Executive Branch departments and agencies and is intended 

to increase the quality and transparency of agency guidance practices and the significant 

guidance documents produced through them. 

This Bulletin is one aspect of a larger OMB effort to ensure and maximize the quality, 

utility, objectivity and integrity of information disseminated by Federal agencies, pursuant to the 

Information Quality Act. 

This Bulletin is one aspect of a larger OMB effort to ensure and maximize the quality, 

utility, objectivity and integrity of information disseminated by Federal agencies, pursuant to the 

Information Quality Act. 

This Bulletin has benefited from extensive public and agency comments received on a draft 

released by OMB on November 23, 2005. 

If your staff has questions about this guidance, please contact Margaret Malanoski at (202) 

395-3122 or Margaret_A._Malanoski@omb.eop.gov. 

Attachment 
Bulletin No. 07-02 

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. 

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 Fed. 

Reg. 71,866 (November 30, 2005). Upon request, OMB extended the public comment 

period from December 23, 2005 to January 9, 2006. 70 Fed. Reg. 76,333 (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. 

DATE: 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, 

N.W., 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

 

 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. 

 

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. § 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, ANon-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., § 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 FiftyEighth 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 websites 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). 

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”). 

2
 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: 

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 

 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 

 

4 Id., at 72. 

5 Appalachian Power, 208 F.3d at 1019. 

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 76,333 

3
request for comments on problematic guidance9

 and its other requests for regulatory 

reform nominations in 200110 and 2004.11 This Bulletin and recent amendments to 

Executive Order 12866 respond to these problems.12 

 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, 

 

(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 22,041 (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 7,987 (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. 

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). 

4
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. 

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. 

The Requirements of the Final Bulletin and Response to Public Comments

 

A. Overview

 

16 See FDA, “Administrative Practices and Procedures; Good Guidance Practices,” 65 FR 7321, 7322-23 

(proposed Feb. 14, 2000). 

17 21 C.F.R. § 10.115; 65 FR 56,468 (Sept. 19, 2000). 

18 Pub. L. No. 106-554, § 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, § 2(b). 

20 Id. 

5
 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 

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 C.F.R. § 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 

6
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 

7
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 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 

8
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 

9
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 noticeand-comment procedures of § 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 § 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 § IV. 

However, if such guidance documents are “significant,” then they are subject to the other 

requirements of 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 

 

21 See U.S. Office of Management and Budget’s Government-wide Information Quality Guidelines, 67 FR 

8452, 8454, 8460 (Feb. 22, 2002). 

10
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 

11
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, prelitigation, 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. 

 

 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, § II(2)(h) clarifies that, given their legally nonbinding nature, significant 

guidance documents should not include mandatory language such as “shall,” “must,” 

 

22 See FDA’s Good Guidance Practices, 21 C.F.R. § 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.” 

12
“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 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. 

 

 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 

 

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. 

13
 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 website a list of all of an agency's significant guidance documents. 

Under § III(1)(a), agencies will maintain a current electronic list of all significant 

guidance documents on their websites in a manner consistent with OMB policies for 

agency public websites and information dissemination.24 To assist the public in locating 

such electronic lists, they should be maintained on an agency’s website – or as a link on 

an agency’s website to the electronic list posted on a component or subagency’s website -

- 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 websites. 

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 websites with the goal of making 

all of their significant guidance documents currently in effect publicly available on their 

websites by the effective date of this Bulletin.25 Other requirements of this Bulletin, such 

as § 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 website 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. 

 Under § 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 listserve or 

 

24 U.S. Office of Management and Budget, Memorandum M-05-04, “Policies for Federal Agency Public 

Websites” (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

25 In this regard, we note that under the Electronic Freedom of Information Act Amendments of 1996, 

agencies have been posting on their websites statements of general policy and interpretations of general 

applicability. See 5 U.S.C. § 552(a)(2). 

14
similar mechanism for members of the public who would like to be notified by email 

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 

 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 

website 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. 

 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 

 

26 Regulations.gov is available at http://www.Regulations.gov/fdmspublic/component/main. 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 

15
comment before adoption, it need not do so again upon issuance of the significant 

guidance document.28

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, § 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 website. 

E. Notice and Comment on Economically Significant Guidance Documents 

 Under § 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 websites and information dissemination, 

the agency must post the draft on its website, 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. 

 

opportunity for comment. See Office of Federal Contract Compliance Programs, “Guidelines for SelfEvaluation 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). 

29 Federal agency public websites 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). 

16
 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 website 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 website. 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 § 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 severe weather conditions. Even if such notices or advisories 

had an economically significant impact, subjecting them to the notice-and-comment 

17
procedures of Section IV would not be feasible or appropriate. An agency may discuss 

with OMB other exceptions that are consistent with § IV(2). 

 Though economically significant guidance documents that fall under the 

exemption in § 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

 

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. 

 

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. 

18
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, § 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, § 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 

19
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, § 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, § 

3). 

II. Basic Agency Standards for Significant Guidance Documents. 

1. Approval Procedures: 

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. 

20
III. Public Access and Feedback for Significant Guidance Documents. 

1. Internet Access: 

a. Each agency shall maintain on its website -- or as a link on an agency’s 

website to the electronic list posted on a component or subagency’s website -- 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 

website 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 website 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 website, 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 website 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 

21
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. 

22