3432 Federal Register / Vol. 72, No. 16 / Thursday, January 25, 2007 / Notices 

1U.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). 

2See, 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, ‘‘NonBinding 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 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). 

3See 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’’). 

4 Id., at 72. 

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

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 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

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. 

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


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6See, 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). 

7See, e.g., note 2, supra. 

8U.S. Office of Management and Budget, 

‘‘Proposed Bulletin for Good Guidance Practices,’’

70 FR 76333 (Dec. 23, 2005). 

9See note 1, supra. 

10U.S. Office of Management and Budget, Draft 

Report to Congress on the Costs and Benefits of 

Federal Regulations, 66 FR 22041 (May 2, 2001). 

11U.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). 

12President 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. 

13See, e.g., note 2, supra. 

14Notice, ‘‘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). 

16See 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). 

18Pub. L. 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). 

19Executive Order 12866, as further amended, 

§ 2(b). 

20 Id. 

Concern about whether agencies are 

properly observing the notice-andcomment 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-andcomment 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

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. 

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 

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 nonbinding 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 factspecific 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 § IV. However, if such guidance 

documents are ‘‘significant,’’ then they 

are subject to the other requirements of 


ycherry on PROD1PC64 with NOTICES
3436 Federal Register / Vol. 72, No. 16 / Thursday, January 25, 2007 / Notices 

21See U.S. Office of Management and Budget’s 

Government-wide Information Quality Guidelines, 

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

22See 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.’’

23As 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. 

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

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. 

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 


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Federal Register / Vol. 72, No. 16 / Thursday, January 25, 2007 / Notices 3437 

24U.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. 

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). 

26Regulations.gov is available at http:// 

www.Regulations.gov/fdmspublic/component/main. 

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 

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. 

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. 

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

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. 


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3438 Federal Register / Vol. 72, No. 16 / Thursday, January 25, 2007 / Notices 

27For 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). 

28See, 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). 

29Federal agency public Web sites must be 

designed to make information and services fully 

available to individuals with disabilities. For 

additional information, see: http://www.accessboard.gov/index.htm; see also Rehabilitation Act, 

29 U.S.C. 701, 794, 794d. 

30See U.S. Office of Management and Budget, 

‘‘Final Information Quality Bulletin For Peer 

Review,’’ 70 FR 2664 (Jan. 14, 2005). 

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. Preadoption 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-andcomment 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

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. 

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 § 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 


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Federal Register / Vol. 72, No. 16 / Thursday, January 25, 2007 / Notices 3439 

31The 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. 

severe weather conditions. Even if such 

notices or advisories had an 

economically significant impact, 

subjecting them to the notice-andcomment 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-andcomment 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. 

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: 


ycherry on PROD1PC64 with NOTICES
3440 Federal Register / Vol. 72, No. 16 / Thursday, January 25, 2007 / Notices 

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 

SECURITIES AND EXCHANGE 

COMMISSION 

[Investment Company Act Release No. 

27668; 812–13201] 

Hercules Technology Growth Capital, 

Inc.; Notice of Application 

January 19, 2007. 

AGENCY: Securities and Exchange 

Commission (the ‘‘Commission’’). 

ACTION: Notice of an application for an 

order under section 61(a)(3)(B) of the 

Investment Company Act of 1940 (the 

‘‘Act’’). 

SUMMARY OF APPLICATION: Applicant, 

Hercules Technology Growth Capital, 

Inc. (‘‘HTGC’’), requests an order 

approving a proposal to issue options to 

purchase HTGC’s common stock 

(‘‘Common Stock’’) to directors who are 

not officers or employees of HTGC 

(‘‘Eligible Directors’’) pursuant to 

HTGC’s 2006 Non-employee Director 

Plan (the ‘‘Plan’’). 

FILING DATES: The application was filed 

on June 21, 2005 and amended on 

December 12, 2006. 

Hearing or Notification of Hearing: An 

order granting the application will be 

issued unless the Commission orders a 

hearing. Interested persons may request 

a hearing by writing to the 

Commission’s Secretary and serving 

applicant with a copy of the request, 

personally or by mail. Hearing requests 

should be received by the Commission 

by 5:30 p.m. on February 13, 2007, and 


ycherry on PROD1PC64 with NOTICES