[Federal Register Volume 65, Number 30 (Monday, February 14, 2000)]
[Proposed Rules]
[Pages 7321-7330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3344]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10, 14, 19, and 25

[Docket No. 99N-4783]


Administrative Practices and Procedures; Good Guidance Practices

Agency: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its administrative regulations to codify its policies and procedures 
for the development, issuance, and use of guidance documents. This 
action is necessary in order to comply with requirements of the Food 
and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA 
codifies certain parts of the agency's current ``Good Guidance 
Practices'' (GGP's) and directs the agency to issue a regulation that 
is consistent with the Federal Food, Drug, and Cosmetic Act (the act) 
and that specifies FDA's policies and procedures for the development, 
issuance, and use of guidance documents. The intended effect of this 
regulation is to make the agency's procedures for development, 
issuance, and use of guidance documents clear to the public.

DATES: Submit written comments and recommendations by May 1, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lisa L. Barclay, Office of Policy (HF-
22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3370.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The Presidential Memorandum on Plain Language issued on June 1, 
1998, directs FDA to ensure that all of its documents are clear and 
easy-to-read. Part of achieving that goal involves having readers of a 
regulation feel that it is speaking directly to them. The agency has 
attempted to incorporate plain language concepts through the use of 
pronouns and other plain language in this regulation as much as 
possible. For example, the agency will be using the term ``you'' to 
refer to all affected parties outside of the agency. For purposes of 
this regulation, ``you'' and ``public'' are used interchangeably. The 
agency would like your comments on how effectively it has used plain 
language in this regulation, and whether this has made the document 
more clear and easy to understand.

II. History

    In May 1995, the Indiana Medical Device Manufacturer's Council 
filed a citizen's petition with the agency, which requested, among 
other things, that FDA establish greater controls over the initiation, 
development, and issuance of guidance documents to assure the 
appropriate level of meaningful public participation. In response to 
this petition, the agency issued a proposed guidance document that set 
forth the agency's position on how it would proceed in the future with 
respect to guidance document development, issuance, and use (61 FR 
9181, March 7, 1996).
    The agency invited public comment on its proposal, and on April 26, 
1996, the agency held a public meeting to discuss it. After reviewing 
and considering all of the comments received during the meeting and the 
public comment period, the agency finalized its procedures. In the 
Federal Register of February 27, 1997 (62 FR 8961), FDA published a 
notice announcing the agency's GGP's guidance document (the 1997 GGP 
document).
    The 1997 GGP document provided a definition of guidance; 
established a standard way of naming guidance documents; described the 
legal effect of guidance documents; established practices for 
developing guidance documents and receiving public input; established 
ways for making guidance documents available to the public; and 
provided information concerning the agency's existing appeals processes 
for disputes regarding guidance documents.
    On November 21, 1997, the President signed FDAMA into law (Public 
Law No. 105-115). Section 405 of FDAMA, which added section 701(h) to 
the act (21 U.S.C. 371(h)), establishes certain aspects of the 1997 GGP 
document as the law. It also directs the agency to evaluate the 
effectiveness of the 1997 GGP document and then develop and issue 
regulations specifying its policies and procedures for the development, 
issuance, and use of guidance documents. The agency conducted an 
internal evaluation of the effectiveness of the 1997 GGP document and 
now is proposing changes to its existing part 10 (21 CFR part 10) 
regulations to clarify its procedures for development, issuance, and 
use of guidance documents. The proposal, in large part, tracks the 1997 
GGP document. As discussed below in part V.A of this document, any 
changes from the 1997 GGP document that FDA is proposing are based on 
the language in FDAMA, or FDA's internal evaluation of GGP's. Your 
comments on the proposal will help FDA further evaluate the 
effectiveness of its 1997 GGP document.

III. 1997 GGP Document

    The 1997 GGP document issued by the agency in February 1997 
provided a great deal of information regarding the agency's procedures 
for the development, issuance, and use of guidance documents. Below is 
a brief overview of the key parts of the 1997 GGP document.
    First, the 1997 GGP document explained its purpose. The purpose of 
GGP's is to ensure that agency guidance

[[Page 7322]]

documents are developed with the proper amount of your participation, 
that you have easy access to guidance documents, and that guidance 
documents are not treated as binding requirements on you or on FDA. The 
agency also wanted to ensure that every part of the agency followed 
these policies and procedures the same way.
    The 1997 GGP document also clarified what does and does not 
constitute a guidance document, and it provided examples.
    The 1997 GGP document stated that guidance documents themselves do 
not create rights or responsibilities under the law, and guidance 
documents are not legally binding on you or on the agency. Instead, 
guidance documents explain how the agency believes the law applies to 
certain regulated activities. The 1997 GGP document also noted, 
however, that a guidance document represents the agency's current 
thinking on the subject addressed in the document, and it is intended 
to ensure consistency in the application of laws and regulations. 
Therefore, FDA supervisors will take steps to ensure that their 
employees do not make determinations that are different from what is in 
a guidance document without appropriate justification and supervisory 
concurrence.
    The 1997 GGP document described several different ways that the 
agency receives your input regarding guidance documents before, during, 
and after a document's development. The 1997 GGP document also 
described the internal FDA clearance process for guidance documents.
    Under the 1997 GGP document, the agency adopted a two-level 
approach to the development of guidance documents. Level 1 guidance 
documents were defined as those documents directed primarily to 
applicants/sponsors or other members of the regulated industry that set 
forth first interpretations of statutory or regulatory requirements, 
changes in interpretation or policy that are of more than a minor 
nature, unusually complex scientific issues, or highly controversial 
issues. Level 2 guidance documents included all other documents.
    For a Level 1 guidance document, which the agency defined as 
generally more controversial or new, FDA calls for public input, in 
most cases, before the document goes into effect. For a Level 2 
document, which is generally less novel or controversial in nature, FDA 
calls for your comments when the document is issued.
    The 1997 GGP document established certain standard elements that 
are included in all guidance documents, including: A standard way of 
referring to guidance documents; a statement of nonbinding effect; the 
absence of any language implying that the document is mandatory; and 
other standard information, such as date of issuance and whether a 
document is draft or final.
    The 1997 GGP document also clarified that FDA will educate and 
train all current and new FDA employees involved in the development, 
issuance, and use of guidance documents about the agency's GGP's and 
will monitor staff to ensure that they are appropriately following 
GGP's. The GGP guidance also stated that the agency would evaluate 
whether GGP's are achieving their purpose. According to the 1997 GGP 
document, lists of guidance documents and the documents themselves will 
be available to you. The agency will maintain and update this list.
    Finally, the 1997 GGP document described an appeals process that 
provides you with an opportunity to raise an issue regarding whether 
FDA staff have followed GGP's.

IV. Statutory Requirements Under FDAMA

    Section 701(h) of the act (21 U.S.C. 371(h)) codifies certain parts 
of the 1997 GGP document. Section 701(h)(1)(A) of the act requires the 
agency to develop guidance documents with public participation and to 
ensure that information identifying the existence of such documents and 
the documents themselves are made available to you both in written form 
and, as feasible, through electronic means.
    Section 701(h)(1)(A) of the act further explains that guidance 
documents shall not create or confer any rights for or on any person, 
although they represent the views of the agency on matters within its 
jurisdiction.
    Section 701(h)(1)(B) of the act states that guidance documents 
shall not be binding on the agency, and that the agency shall ensure 
that its employees do not deviate from such guidances without 
appropriate justification and supervisory concurrence. Under the 
statute, the agency is required to: (1) Provide training to employees 
on how to develop and use guidance documents, and (2) monitor the 
development and issuance of guidance documents.
    For certain categories of guidance documents, the statute requires 
that the agency ensure public participation in their development prior 
to implementation. (See section 701(h)(1)(C) of the act.) These 
categories include documents that: (1) Set forth initial 
interpretations of a statute or regulation; (2) contain changes in 
interpretation or policy that are of more than a minor nature; (3) 
contain complex scientific issues; or (4) contain highly controversial 
issues. Prior public participation is required for these categories of 
documents unless the agency determines that such prior public 
participation is not feasible or appropriate. In such cases, the agency 
is required to provide for public comment upon implementation and to 
consider any comments received.
    For guidance documents that set forth existing practices or minor 
changes in policy, section 701(h)(1)(D) of the act requires the agency 
to provide you with an opportunity to comment upon implementation.
    Section 701(h)(2) of the act requires the agency to ensure uniform 
nomenclature for guidance documents and uniform internal procedures for 
approval of guidance documents. The agency is also required to ensure 
that new and revised guidance documents are properly dated and indicate 
the nonbinding nature of the documents. The statute also requires the 
agency to conduct periodic reviews of all guidance documents and, where 
appropriate, revise such documents.
    Section 701(h)(3) of the act requires the agency to maintain a list 
of guidance documents which must be kept electronically, updated, and 
published periodically in the Federal Register. FDA must also make 
copies of the guidance documents available to the public.
    Section 701(h)(4) of the act requires the agency to have an 
effective appeals mechanism to address complaints that FDA is not 
developing and using guidance documents in accordance with this 
provision of the law.
    Finally, section 701(h)(5) of the act requires the agency to 
evaluate the effectiveness of the 1997 GGP document and then to issue 
regulations specifying its policies and procedures for developing, 
issuing, and using guidance documents by July 1, 2000.

V. Proposed Regulations

A. Overview

    To evaluate the strengths and weaknesses of its GGP's as required 
by FDAMA, and as stated in its 1997 GGP document, the agency conducted 
an informal internal survey. The survey solicited information regarding 
FDA employees' views on the effectiveness of GGP's and questioned 
whether FDA employees had received complaints regarding the agency's 
development, issuance, and use of guidance documents since the 
development of

[[Page 7323]]

GGP's. This internal review found that the agency's GGP's have 
generally been beneficial and effective in standardizing the agency's 
procedures for development, issuance, and use of guidance documents, 
and that FDA employees have generally been following GGP's.
    As a result of the FDAMA provision and FDA's internal survey, FDA 
is proposing certain minor changes to the procedures described in its 
1997 GGP document. These changes and the reasons for them will be 
discussed below. As part of its continuing effort to evaluate and 
improve the development, issuance, and use of guidance documents, the 
agency is inviting public comment not only on the specific provisions 
described in the proposed regulation, but also on the 1997 GGP 
document. FDA is interested in hearing how you view the effectiveness 
of the procedures described in the 1997 GGP document.

B. Definitions

    Proposed Sec. 10.115(a) explains that ``Good Guidance Practices 
(GGP's) set forth FDA's policies and procedures for developing, 
issuing, and using guidance documents.''
    Proposed Sec. 10.115(b)(1) defines the term ``guidance document.'' 
While FDAMA did not explicitly require that the agency define the term 
``guidance document,'' the agency did so in the 1997 GGP document and 
has found that a definition helps to increase clarity for affected 
parties within and outside of the agency. To eliminate certain 
redundancies, the agency has modified that definition and included it 
in this proposed regulation. The agency defines guidance documents as 
those prepared for FDA staff, applicants/sponsors, and the public that 
describe the agency's interpretation of or policy on a regulatory 
issue.
    The proposed regulation states that guidance documents include, but 
are not limited to, documents that relate to: (1) The design, 
production, manufacturing, and testing of regulated products; (2) the 
processing, content, and evaluation/approval of submissions; and (3) 
inspection and enforcement policies.
    In addition, the agency is clarifying what is not a guidance 
document. As discussed in the 1997 GGP document, documents that would 
fall into the nonguidance category include: (1) Those relating to 
internal FDA procedures, (2) agency reports, (3) general information 
documents provided to consumers and health professionals, (4) speeches, 
(5) journal articles and editorials, (6) media interviews, (7) press 
materials, (8) warning letters, or (9) other communications directed to 
individual persons or firms.
    In clarifying what is not a guidance document, the proposal has 
added general information documents provided to health professionals 
and memoranda of understanding. General information documents for 
health professionals would include documents such as ``Dear Health 
Professional'' letters. These documents, like general information 
documents provided to consumers, might describe a public health alert 
or emergency. In addition, FDA has added memoranda of understanding to 
the list of documents that would not be considered guidance documents 
because memoranda of understanding are agreements that FDA makes with 
other Federal or State government organizations in order to determine 
who will enforce certain laws. These documents do not articulate agency 
policy, and therefore they fall outside the definition of a guidance 
document.
    In defining guidance documents, the agency recognizes that there 
are certain documents directed to its own staff that also would provide 
guidance to you. The agency, therefore, considers those documents to be 
guidance documents. However, among FDA's internal documents, there is 
another category of documents that describe FDA's day-to-day business. 
While such documents might be interesting to you, they do not fall 
within the definition of guidance documents. Examples of such documents 
could include: Staff guides regarding personnel information or leave 
policies or directives on how to route documents for review within the 
agency.
    Consistent with the distinction drawn in section 701(h)(1)(C) of 
the act, the agency is proposing in Sec. 10.115(c) to define two levels 
of guidance documents, which, as discussed below, will be subject to 
different levels of public participation before issuance. This is the 
same approach that the agency took in the 1997 GGP document. Level 1 
guidance documents include guidance documents that: (1) Set forth 
initial interpretations of statutory or regulatory requirements; (2) 
set forth changes in interpretation or policy that are of more than a 
minor nature; (3) discuss complex scientific issues; or (4) cover 
highly controversial issues. As discussed below, for Level 1 documents, 
the agency is generally required by the statute to ensure public 
participation in their development prior to implementation.
    In contrast, Level 2 documents are guidance documents that set 
forth existing practices or minor changes in interpretation or policy. 
Level 2 guidance documents include all guidance documents that are not 
classified as Level 1. As discussed below, according to the statute, 
for Level 2 documents, the agency is not required to seek comments from 
you before publication of the document, but the agency must provide for 
your comment upon implementation.
    As discussed above, proposed Sec. 10.115(c)(3) defines ``you'' as 
all affected parties outside of the agency. ``You'' does not refer to 
agency employees because the procedures they must follow under GGP's 
are different than the procedures that you would follow; e.g., FDA 
employees follow different procedures when they would like to deviate 
from a guidance document. Under this proposed regulation, ``you'' and 
``public'' are used interchangeably.

C. Legal Effect of Guidance Documents

    Consistent with section 701(h)(1)(A) and (h)(1)(B) of the act, 
proposed Sec. 10.115(d) describes the nonbinding effect of guidance 
documents. Specifically, it provides that guidance documents do not 
establish legally enforceable rights or responsibilities. They do not 
legally bind you or the agency.
    Proposed Sec. 10.115(d) further provides that you may choose to use 
an approach other than the one set forth in a guidance document. 
However, the alternative approach must comply with the relevant 
statutes and regulations. If you would like to choose an alternate 
approach, FDA is willing to discuss that approach with you to ensure 
that it complies with all relevant laws and regulations.
    The proposed regulation also clarifies that although guidance 
documents do not legally bind FDA, they represent the agency's current 
thinking. Therefore, FDA employees may depart from guidance documents 
only with appropriate justification and supervisory concurrence.
    Because the agency's issuance of GGP's is an attempt to make its 
processes for initially communicating new or different regulatory 
expectations to a broad public audience consistent across the agency, 
proposed Sec. 10.115(e) clarifies that FDA should not use other methods 
or documents to informally provide this information. Consistent with 
the 1997 GGP document, the agency is proposing that GGP's must be 
followed whenever interpretations of law or policy that are not readily 
apparent from the statute or regulations

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are first communicated to a broad public audience.

D. Public Participation in the Development and Issuance of Guidance

    Section 701(h)(1)(A) of the act requires FDA to develop guidance 
documents with your participation. Proposed Sec. 10.115(f) describes 
how you may participate in the development and issuance of FDA's 
guidance documents. These mechanisms for your input include: (1) 
Suggestions for areas of guidance document development; (2) submission 
of drafts of guidance documents to FDA for consideration; (3) 
suggestions about revisions of an existing guidance document; (4) 
submission of comments on an annual list of possible topics for future 
FDA guidance documents; and (5) submission of comments on specific 
proposed and final guidance documents.
    The 1997 GGP document stated that the agency would issue its list 
of possible topics for future FDA guidance document development or 
revision twice a year. However, given its experience with GGP's thus 
far, the agency has determined that publishing the list once a year 
would be more workable and just as informative. If the agency were to 
publish such a list semiannually, it would likely publish essentially 
the same list twice.
    The 1997 GGP document also provided that FDA would not be bound by 
its list of possible topics for future FDA guidance documents. In other 
words, FDA would not be required to issue a guidance document on every 
topic identified in that list. Similarly, FDA would not be stopped from 
issuing a guidance document on a topic not identified on the list. FDA 
will apply that same principle to the annual list.
    If you want FDA to draft a guidance document on a particular issue 
or to revise an existing guidance document, you should contact the 
Center or Office that is responsible for the regulatory activity 
covered by the guidance document. For purposes of this regulation, FDA 
is using the term ``office'' to refer to offices that are agency 
components comparable to a Center, e.g. Office of the Commissioner, 
Office of Regulatory Affairs, or Office of the Chief Counsel, not 
offices with a given Center. You should include a statement explaining 
why the new or revised document is necessary. If FDA agrees to draft or 
revise a guidance document, it will follow the procedures described in 
proposed Sec. 10.115(g).
    Proposed Sec. 10.115(g) describes the agency's procedures for the 
development and issuance of a guidance document. These procedures are 
similar to those described in the 1997 GGP document. As stated above in 
proposed Sec. 10.115(c), the agency will determine, depending on its 
content, whether each guidance document is a Level 1 or Level 2 
document.
1. Level 1 Procedures
    Proposed Sec. 10.115(g)(1) describes the procedures for developing 
and issuing most Level 1 guidance documents. Under proposed 
Sec. 10.115(g)(1), before FDA drafts a Level 1 guidance document, FDA 
may seek or accept early input from individuals or groups outside the 
agency. For example, FDA may do this by participating in or holding 
meetings and workshops.
    After FDA prepares a draft of a Level 1 guidance document, FDA will 
publish a notice in the Federal Register announcing that the draft 
guidance document is available. FDA will post the draft on the Internet 
and make it available in hard copy. FDA will invite your comments on 
the draft guidance document. Procedures for submission of your comments 
on guidance documents are described in proposed Sec. 10.115(h).
    After it prepares a draft of a Level 1 guidance document, FDA may 
also hold additional public meetings or workshops, or it may present 
the draft guidance document to an advisory committee for review.
    After providing an opportunity for your comment on a draft Level 1 
guidance document, FDA will review any comments it has received. FDA 
will prepare the final version of the guidance document that 
incorporates suggested changes, when appropriate. FDA then will publish 
a notice in the Federal Register announcing that the guidance document 
is available. FDA will post the guidance document on the Internet and 
make it available in hard copy. As discussed in the 1997 GGP document, 
when FDA issues a final guidance document, FDA is not obligated to 
address each comment specifically.
    After providing an opportunity for comment, FDA may decide that it 
is appropriate to issue another draft of the guidance document. In this 
case, FDA will 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. FDA would then proceed to issue a final version 
of the guidance document in the manner described above.
    Proposed Sec. 10.115(g)(1) is consistent with the 1997 GGP 
document. Minor changes have been made to clarify the types of early 
input that FDA may accept. In addition, FDA has clarified that it does 
not post a separate notice of availability of a guidance document on 
the Internet, but rather it posts the actual guidance document on the 
Internet. Copies of the Federal Register notices of availability are 
available on the Internet at http://www.fda.gov.
    Section 701(h)(1)(C) of the act provides that the agency is not 
required to seek your comment before it implements a Level 1 guidance 
document if your prior participation is not feasible or appropriate. 
Proposed Sec. 10.115(g)(2) mirrors the words of the statute. In the 
1997 GGP document, the agency provided that it would not seek your 
comment before implementing a Level 1 guidance document if: (1) There 
are public health reasons for immediate implementation of the guidance 
document; (2) there is a statutory requirement, executive order, or 
court order that requires immediate implementation; or (3) the guidance 
document presents a less burdensome policy that is consistent with 
public health. The agency plans to continue to apply the same three 
exceptions, but it reserves the authority to provide for other 
exceptions that are consistent with section 701(h)(1)(C) of the act, if 
the need arises.
    Proposed Sec. 10.115(g)(3) describes the procedures that FDA will 
use for developing and issuing Level 1 guidance documents that fall 
under the exception discussed above. For that certain small class of 
guidance documents, FDA will: (1) Publish a notice in the Federal 
Register announcing that the guidance document is available; (2) post 
the guidance document on the Internet and make it available in hard 
copy; and (3) seek your comment when it issues or publishes the 
guidance document. If FDA receives comments on one of the excepted 
guidance documents, FDA will review those comments and revise the 
guidance document, when appropriate.
2. Level 2 Procedures
    Proposed Sec. 10.115(g)(4) describes the procedures for developing 
and issuing Level 2 guidance documents, as defined in 
Sec. 10.115(c)(2). As set forth in section 701(h)(1)(D)of the act, FDA 
may implement a Level 2 guidance document at the same time that it 
issues the document and solicits public comment. After it prepares a 
Level 2 guidance document, FDA will publish the guidance document on 
the Internet and provide an opportunity for your comment at that time. 
Similar to the procedures for Level 1, if FDA receives comments on a 
Level 2 guidance document, FDA will review those comments and revise 
the document,

[[Page 7325]]

when appropriate. FDA may also, at its discretion, seek public comment 
before it implements a Level 2 guidance document.
    You will know when a Level 2 guidance document has been issued 
because it will be posted on the Internet. In addition, FDA's 
electronic comprehensive list will be updated within 30 days of 
issuance and FDA's annual Federal Register list will identify all 
guidance documents that have been issued since the previous list was 
published.
    In an effort to make the agency's guidance document development 
process as open as possible, proposed Sec. 10.115(g)(5) provides that 
you may submit comments on any guidance document (Level 1 or Level 2, 
draft or final) at any time. FDA will review all of the comments that 
it receives and will revise guidance documents in response to your 
comments, when appropriate. When draft Level 1 guidance documents are 
issued under proposed Sec. 10.115(g)(1), and when Level 1 guidance 
documents are issued under proposed Sec. 10.115(g)(3), there will be a 
period of time established for the receipt of comments. All comments 
received during that period will be reviewed and considered 
immediately. Comments received after the closing date of the specified 
comment period will be reviewed as soon as possible and issues raised 
in those comments may be addressed in a future revision of the 
document, as the agency deems appropriate.
    Proposed Sec. 10.115(h) tells you how to submit comments on 
guidance documents. If you choose to submit comments on a guidance 
document, you must send them to the Dockets Management Branch. The 
comments submitted should identify the docket number on the guidance 
document, if such a docket number exists. For documents that do not 
have a docket number assigned, the comments should refer to the title 
of the document. Once comments have been received on a guidance 
document, the Dockets Management Branch will establish a docket for 
that document, and all additional comments will be routed to that 
docket. Comments will be available to the public in accordance with 
FDA's regulations at Sec. 10.20(j).
    Such comments will be available at the Dockets Management Branch, 
and, when feasible, on the Internet. In its 1997 GGP document, the 
agency directed all comments on Level 1 documents to the Dockets 
Management Branch, and comments on all Level 2 documents to the 
document's originating office. Based on its internal review, the agency 
has decided that it can better track comments if they are all submitted 
to the docket, as proposed in Sec. 10.115(h).

E. FDA's Internal Procedures

    Consistent with section 701(h)(2) of the act and the 1997 GGP 
document, proposed Sec. 10.115(i) describes the standard elements that 
must be included in each guidance document. The agency is proposing 
that all guidance documents: (1) Include the term ``guidance;'' (2) 
identify the Center or Office issuing the document; (3) identify the 
activity and people to which the document applies; (4) include a 
statement of the document's nonbinding effect; (5) include the date of 
issuance; note if it is a revision to a previously issued guidance 
document and identify the document that it replaces; and (6) contain 
the word ``draft'' if the document is a draft guidance document.
    Historically, FDA has issued regulatory guidance to its field staff 
through documents called Compliance Policy Guides (CPG's), and those 
documents have come to be recognized by that name. Therefore, the 
agency will continue to issue CPG's, but each CPG will also include the 
term ``guidance'' in its subtitle in order to clarify that it does fall 
within the definition of a guidance document.
    Consistent with the 1997 GGP document, the statement of nonbinding 
effect will generally read as follows: ``This guidance document 
represents the agency's current thinking on * * *. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statute and regulations.''
    Proposed Sec. 10.115(i)(2) also provides that, due to the 
nonbinding nature of guidance documents, certain mandatory language 
cannot be included in guidance documents, unless the agency is using 
these words to describe a statutory or regulatory requirement. Examples 
of such language includes words like ``shall,'' ``must,'' ``required,'' 
or ``requirement.''
    Consistent with section 701(h)(2) of the act, proposed 
Sec. 10.115(j) provides that all FDA Centers and Offices must have 
procedures for the internal clearance of guidance documents that ensure 
that this responsibility is given to the appropriate senior agency 
officials. Under the 1997 GGP document, an Office Director in a Center 
or an Office of Regulatory Affairs equivalent or higher approves a 
Level 1 guidance before it goes out to the public in draft or final. 
The Office of Chief Counsel approves a draft or final guidance document 
that describes new legal interpretations. The Office of Policy approves 
the release of a draft or final guidance document that describes 
significant changes in agency policy.
    Under the 1997 GGP document, an official at Division Director level 
or higher approves a Level 2 guidance document before it goes out to 
the public. Because, by definition, Level 2 documents are less 
controversial or novel, the clearance of a Level 2 guidance document 
does not usually involve as many senior agency officials.
    FDA's current plan is to keep the minimum sign off procedures 
described in the 1997 GGP document. The agency is not including them in 
its proposal because it does not think it is appropriate to describe 
these internal procedures in a regulation. Moreover, some Centers or 
Offices have chosen to have their guidance document sign-off take place 
at a level that is higher than that described in the 1997 GGP document. 
Nothing in this regulation will affect that practice.
    Proposed Sec. 10.115(k) describes procedures for FDA review and 
revision of existing guidance documents. Under these procedures, the 
agency will review periodically existing guidance documents to 
determine whether they need to be changed or withdrawn. When 
significant changes are made to the statute or regulations, the agency 
will review and, if appropriate, revise guidance documents relating to 
that changed statute or regulation. In addition, your comments may at 
any time suggest that FDA revise a guidance document. Those suggestions 
should address why the guidance document should be revised and how it 
should be revised.
    Proposed Sec. 10.115(l) describes procedures for how the agency 
plans to ensure consistent application of GGP's. Under these 
procedures, all current and new FDA employees involved in the 
development, issuance, or application of guidance documents will be 
trained regarding the agency's GGP's.
    In addition, on a regular basis, FDA Centers and Offices will 
monitor the development, issuance, and use of guidance documents to 
ensure that employees are following good guidance practices.
    The 1997 GGP document provided that the agency would educate the 
public about the legal effect of guidance and that FDA staff should 
take the opportunity to state and explain the legal effect of guidance 
when speaking to the public about guidance

[[Page 7326]]

documents. Although the agency believes that the 1997 GGP document, the 
inclusion of the statement of the nobinding effect on all guidance 
documents, and the FDA public pronouncements about the legal effect of 
guidance have made great strides in educating the public about the 
legal effect of guidance, the agency believes that it is important that 
these education efforts continue. Therefore, as part of its employee 
training, FDA will direct its employees to continue educating the 
public about the nonbinding effect of guidance.

F. Public Access to Guidance Documents

    Section 701(h)(1)(A) of the act requires FDA to ensure that 
information about the existence of guidance documents and guidance 
documents themselves are made available to you in written form, and, as 
feasible, through electronic means. Proposed Sec. 10.115(m) and (n) 
incorporate that requirement.
    Proposed Sec. 10.115(m) provides that FDA will make copies 
available in hard copy and, as feasible, through the Internet. All new 
recently issued guidance documents have been made available through the 
Internet, but there are some documents that were issued prior to 
issuance of the 1997 GGP document that are not available in an 
electronic version that can be easily included on the Internet.
    Proposed Sec. 10.115(n) tells you how you can get a list of all of 
FDA's guidance documents. Under proposed Sec. 10.115(n), FDA will 
maintain a current list of all guidance documents on the Internet at 
www.fda.gov/opacom/morechoices/industry/guidedc.htm. New documents will 
be added to this list within 30 days of issuance. Although the agency 
recognizes that the Internet is an a easy and efficient tool for 
distribution of public information, it will continue to make its 
guidance document list available through the Federal Register. Once a 
year, FDA will publish a comprehensive list of guidance documents in 
the Federal Register.
    In the 1997 GGP document, the agency stated that it would provide 
quarterly updates to the annual comprehensive Federal Register list. 
However, the agency has been unable to issue timely updates. The agency 
believes that the annual Federal Register list plus the current list on 
the Internet is more workable for the agency and is consistent with the 
statutory requirement. However, the agency would like to receive your 
comments on this proposed change.
    FDA's guidance document lists will include: (1) The name of the 
guidance document, issuance and revision dates; and (2) information on 
how to obtain copies of the document.

G. Dispute Resolution

    Section 701(h)(4) of the act requires the agency to have adequate 
procedures in place to address complaints regarding the development and 
use of guidance documents. Proposed Sec. 10.115(o) describes such 
procedures. If you believe that someone at FDA did not follow the 
procedures in Sec. 10115(o) or that someone at FDA treated a guidance 
document as a binding requirement, you should contact that person's 
supervisor in the Center or Office that issued the guidance document. 
If the issue cannot be resolved at that level, you should contact the 
next highest supervisor. If the issue still remains unresolved at the 
level of the Center or Office Director or if you feel that you are not 
making progress by going through the chain of command, you may ask the 
Office of the Chief Mediator and Ombudsman to become involved.

H. Conforming Changes

    The agency is also proposing conforming changes to its regulations 
at Sec. 10.90(b) that describe the agency's procedures for guidelines. 
For many years, the agency issued documents articulating regulatory 
guidance that were referred to as ``guidelines.'' However, since the 
development of GGP's, the agency has moved to referring to all 
documents that provide you with guidance as ``guidance documents.'' To 
make these regulations consistent, the agency is proposing to revise 
Sec. 10.90(b) to eliminate reference to the term guideline, and instead 
cross-reference the procedures for development, issuance, and use of 
guidance documents at Sec. 10.115. In addition, the agency is proposing 
to make conforming changes throughout parts 10, 14, 19, and 25 (21 CFR 
parts 14, 19, and 25) to ensure that the term ``guidance document'' 
replaces the term ``guideline,'' as appropriate.

VI. Comments Received by the Agency

    After the passage of FDAMA, the agency was faced with a large 
burden in the implementation of the new statute. In an effort to make 
the agency's processes more open and transparent, as well as to solicit 
your input on how various FDAMA provisions should be implemented, the 
agency issued a notice in the Federal Register establishing special 
FDAMA dockets (63 FR 40719, July 30, 1998). These dockets, which were 
assigned to specific provisions of the statute, allowed you to submit 
comments or proposals to the agency regarding how the provisions should 
be implemented.
    The agency received one such comment on section 405 of FDAMA. The 
comment raised several suggestions as to how this provision should be 
implemented. These suggestions and FDA's responses are discussed below.
    1. The comment suggested that FDA solicit input before it 
solidifies its views on an approach for a new guidance.
    The agency agrees that it is important to solicit your input at the 
earliest possible time. That is why it is proposing to create several 
mechanisms for your early input, including: (1) An opportunity to 
suggest new or revised guidance, (2) notification that it is 
considering new or revised guidance, (3) notification that it is 
issuing certain guidance documents, and (4) the ability to hold 
meetings or workshops before a draft document is developed. In 
addition, the reason that FDA solicits comments on a guidance document 
is because its views are not solidified, and the agency seeks your 
input regarding decisions about what final guidance documents will 
contain.
    2. The comment noted that the legislative history accompanying 
section 405 of FDAMA stated that Congress ``intends that FDA will waive 
[the] requirement for prior public participation only in rare and 
extraordinary circumstances where there is a compelling rationale.'' 
The comment reads this standard to mean situations involving a public 
health emergency.
    The agency does not interpret this exception so narrowly. In the 
1997 GGP document, the agency provided limited exceptions to the prior 
public participation requirement, including situations where: (1) There 
are public health reasons for immediate implementation of the guidance 
document; (2) there is a statutory requirement, executive order, or 
court order that requires immediate implementation; or (3) the guidance 
document presents a less burdensome policy that is consistent with 
public health. The agency continues to believe that these exceptions 
are both consistent with the intent of Congress in FDAMA and necessary 
for the timely issuance of important guidance documents.
    3. The comment suggested that the agency accept input on whether a 
planned guidance document involves a significant or minor change in 
policy, i.e., whether it is a Level 1 or Level 2 guidance document. 
Again, the agency welcomes your input on all of its guidance documents, 
including

[[Page 7327]]

comment regarding whether the documents have been appropriately 
classified as Level 1 or Level 2.
    FDA will review comments received about designation as a Level 1 or 
Level 2 document, but in the interest of issuing guidance in a timely 
manner, the agency does not believe that it is necessarily beneficial 
to systematically receive comment on all of these designations prior to 
issuance of guidance documents.
    4. The comment noted that section 405 of FDAMA provided that FDA 
employees should not deviate from guidance documents without 
appropriate justification and supervisory concurrence. Therefore, the 
comment requests that FDA provide a requester with written notice when 
it determines to deviate from a guidance document, and state the given 
reasons for such deviation.
    While the agency completely agrees that FDA employees should not 
deviate from guidance without appropriate justification and supervisory 
concurrence, it disagrees that it should provide the requester with 
written notice stating the reasons for such deviations. However, the 
agency will, upon request, explain why it is deviating from the 
guidance at the time that it makes its decision to do so.
    Moreover, if a requester disagrees with how a guidance document has 
been applied, or not applied, FDA has an appeals process set up for 
requesters to raise concerns.
    5. The comment noted the importance of training FDA staff on how to 
develop and use guidance documents in a manner consistent with section 
405 of the statute, and recommends that the agency should collaborate 
with industry and other stakeholders on training, where appropriate.
    The agency agrees with this comment, and has numerous mechanisms in 
place to train FDA employees effectively about the appropriate 
development and use of guidance documents. In addition, the agency 
recognizes the importance of collaboration with its stakeholders. While 
the agency welcomes your suggestions about how its training could be 
most effective, the agency believes that FDA should conduct its own 
training of FDA staff.
    6. The comment suggested that FDA should work to ensure consistency 
in the application of guidance documents across the Centers.
    The agency agrees and will work to ensure consistent application of 
guidance documents by receiving comment from around the agency 
regarding certain cross-cutting guidance documents, and ensuring 
appropriate clearance by various Centers or Offices, if they are 
affected by the guidance document. The focus of GGP's is to achieve 
this goal, and the agency believes that the proposed regulations seek 
to address concerns about consistent application of guidance across the 
agency.
    7. The comment noted that the statute requires that FDA ensure that 
an effective appeals mechanism be in place to address complaints about 
the development or use of guidance documents. The comment suggested 
that the agency be committed to resolve these disputes as quickly and 
amicably as possible through the cooperative exchange of views, in 
accordance with current dispute resolution policies. In addition, the 
comment requested that when multiple requesters raise complaints in a 
particular area, it should trigger a special inquiry by senior agency 
policy staff, and renewed training, if appropriate.
    The agency agrees with this comment. FDA will seek to resolve 
disputes quickly and efficiently. When multiple problems arise, FDA 
will engage senior policy officials in the dispute, and will retrain 
staff, when appropriate.
    8. The comment noted the importance of FDA's periodic review of 
existing guidance documents, with revisions made to those documents, as 
necessary. It suggested that FDA set up a system for periodic review 
that fosters individual accountability for updating guidance documents. 
The comment suggested that such a process might include soliciting 
public input as quickly as possible, accepting proposals from the 
public on guidance documents, and responding in writing to all such 
proposals within 60 days.
    The agency agrees that it should conduct periodic reviews of 
guidance documents, but reserves the discretion to set up an informal 
system for this review process. Because of resource constraints and in 
the interest of issuing all guidance documents in a timely manner, the 
agency declines to require itself to respond in writing to suggested 
guidance proposals within a given timeframe. However, the agency is 
committed to ensuring that guidance documents are updated and revised 
as frequently as necessary, and to reviewing public input regarding 
those potential revisions. The agency is also committed to reviewing 
all of your proposals submitted for future regulatory guidance, but 
declines to set up a system whereby all written proposals are responded 
to in writing.
    9. Lastly, the comment stated that section 405 of FDAMA makes clear 
that FDA should not develop or modify policies and procedures through 
informal mechanisms such as speeches or statements at meetings that it 
has not previously dealt with through regulation or prior guidances.
    The agency agrees with this comment. The fundamental premise behind 
GGP's is increased consistency in the development, issuance, and use of 
guidance documents; ensuring consistency of procedures is the goal of 
the proposed regulations. The agency is committed to ensuring that 
these principles are upheld, and urges you to notify FDA if you become 
aware of FDA employees first communicating agency policy through 
informal mechanisms such as speeches or statements at meetings.

VII. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement would be required.

VIII. Analysis of Impact

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612), 
and under the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Unless an agency 
certifies that a rule will not have a significant economic impact on a 
substantial number of small entities, the Regulatory Flexibility Act 
requires an analysis of regulatory options that would minimize any 
significant impact of a rule on small entities. The Unfunded Mandates 
Reform Act requires that agencies prepare an assessment of anticipated 
costs and benefits before proposing any rule that may result in an 
annual expenditure by State, local, and tribal governments, in the 
aggregate, or by the private sector, of $100 million (adjusted annually 
for inflation).
    The agency believes that this proposed rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
This proposed rule does not impose any mandates on State, local, or 
tribal governments, nor is it a significant

[[Page 7328]]

regulatory action under the Unfunded Mandates Reform Act. Furthermore, 
the agency certifies that this proposed rule will not have a 
significant economic impact on a substantial number of small entities. 
Therefore, under the Regulatory Flexibility Act, no further regulatory 
flexibility analysis is required.

IX. Paperwork Reduction Act of 1995

    FDA concludes that this proposed regulation would impose no 
reporting or recordkeeping requirements. Therefore, clearance by the 
Office of Management and Budget under the Paperwork Reduction Act of 
1995 is not required.

X. Comments

    Interested persons may, on or before May 1, 2000, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

List of Subjects

21 CFR Part 10

    Administrative practices and procedures, News media, Good Guidance 
Practices.

21 CFR Part 14

    Administrative practices and procedures, Advisory committees, Color 
additives, Drugs, Radiation protection.

21 CFR Part 19

    Conflict of interests.

21 CFR Part 25

    Environmental impact statements, Foreign relations, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that 21 CFR parts 10, 
14, 19, and 25 be amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

    1. The authority citation for 21 CFR part 10 continues to read as 
follows:

    Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.


Secs. 10.20, 10.45, and 10.85  [Amended]

    2. In 21 CFR part 10, remove the words ``guideline'' and 
``guidelines'' wherever they appear and add in their place the words 
``guidance document'' and ``guidance documents'', respectively, in the 
following places:
    a. Section 10.20(j)(1)(v),
    b. Section 10.45(d), and
    c. Section 10.85(d)(5).
    3. In Sec. 10.90, remove the words ``guideline'' and ``guidelines'' 
wherever they appear and add in their place the words ``guidance 
document'' and ``guidance documents'', respectively, and revise the 
section heading and paragraph (b) to read as follows:


Sec. 10.90  Food and Drug Administration regulations, guidance 
documents, recommendations, and agreements.

* * * * *
    (b) Guidance documents. FDA guidance documents, as that term is 
defined in Sec. 10.115, will be developed, issued, and used according 
to the requirements at Sec. 10.115.
* * * * *
    4. Add Sec. 10.115 to subpart B to read as follows:


Sec. 10.115  Good Guidance Practices.

    (a) What are good guidance practices? Good guidance practices 
(GGP's) set forth FDA's policies and procedures for developing, 
issuing, and using guidance documents.
    (b) How is the term ``guidance document'' defined?
    (1) Guidance documents are documents prepared for FDA staff, 
applicants/sponsors, and the public that describe the agency's 
interpretation of or policy on a regulatory issue.
    (2) Guidance documents include, but are not limited to, documents 
that relate to: The design, production, manufacturing, and testing of 
regulated products; the processing, content, and evaluation/approval of 
submissions; and inspection and enforcement policies.
    (3) Guidance documents do not include: Documents relating to 
internal FDA procedures, agency reports, general information documents 
provided to consumers or health professionals, speeches, journal 
articles and editorials, media interviews, press materials, warning 
letters, memoranda of understanding, or other communications directed 
to individual persons or firms.
    (c) What other terms have a special meaning?
    (1) ``Level 1 guidance documents'' include guidance documents that:
    (i) Set forth initial interpretations of statutory or regulatory 
requirements,
    (ii) Set forth changes in interpretation or policy that are of more 
than a minor nature,
    (iii) Include complex scientific issues, or
    (iv) Cover highly controversial issues.
    (2) ``Level 2 guidance documents'' are guidance documents that set 
forth existing practices or minor changes in interpretation or policy. 
Level 2 guidance documents include all guidance documents that are not 
classified as Level 1.
    (3) ``You'' refers to all affected parties outside of FDA.
    (d) Are you or FDA required to follow a guidance document?
    (1) No. Guidance documents do not establish legally enforceable 
rights or responsibilities. They do not legally bind the public or FDA.
    (2) You may choose to use an approach other than the one set forth 
in a guidance document. However, your alternative approach must comply 
with the relevant statutes and regulations. FDA is willing to discuss 
an alternative approach with you to ensure that it complies with the 
relevant statutes and regulations.
    (3) Although guidance documents do not legally bind FDA, they 
represent the agency's current thinking. Therefore, FDA employees may 
depart from guidance documents only with appropriate justification and 
supervisory concurrence.
    (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 may not use documents and 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 GGP's 
must be followed whenever regulatory expectations that are not readily 
apparent from the statute or regulations are first communicated to a 
broad public audience.
    (f) How can you participate in the development and issuance of 
guidance documents?
    (1) You may provide input on guidance documents that FDA is 
developing under the procedures described in paragraph (g) of this 
section.
    (2) You may suggest areas for guidance document development. Your 
suggestions should address why a guidance document is necessary. You 
may also submit drafts of guidance documents to FDA to consider.
    (3) You may, at any time, suggest that FDA revise an already 
existing guidance

[[Page 7329]]

document. Your suggestion should address why the guidance document 
should be revised and how it should be revised.
    (4) Once a year, FDA will publish, in both the Federal Register and 
on the Internet, a list of possible topics for future guidance document 
development or revision during the next year. You may comment on this 
list (e.g., by suggesting alternatives or recommendations about the 
topics that FDA is considering).
    (5) To participate in the development and issuance of guidance 
documents through one of the mechanisms described in paragraph (f)(1), 
(f)(2), or (f)(3) of this section, you should contact the Center or 
Office that is responsible for the regulatory activity covered by the 
guidance document.
    (6) If FDA agrees to draft or revise a guidance document, under a 
suggestion made under paragraph (f)(1), (f)(2), or (f)(3) of this 
section, you may participate in the development of that guidance 
document under the procedures described in paragraph (g) of this 
section.
    (g) What are FDA's procedures for developing and issuing guidance 
documents?
    (1) FDA's procedures for the development and issuance of Level 1 
guidance documents are as follows:
    (i) Before FDA prepares a draft of a Level 1 guidance document, FDA 
may seek or accept early input from individuals or groups outside the 
agency. For example, FDA may do this by participating in or holding 
public meetings and workshops.
    (ii) After FDA prepares a draft of a Level 1 guidance document, FDA 
will:
    (A) Publish a notice in the Federal Register announcing that the 
draft guidance document is available;
    (B) Post the draft guidance document on the Internet and make it 
available in hard copy; and
    (C) Invite your comment on the draft guidance document. Paragraph 
(h) of this section tells you how to submit your comments.
    (iii) After FDA prepares a draft of a Level 1 guidance document, 
FDA also may:
    (A) Hold additional public meetings or workshops; or
    (B) Present the draft guidance document to an advisory committee 
for review.
    (iv) After providing an opportunity for public comment on a Level 1 
guidance document, FDA will:
    (A) Review any comments received and prepare the final version of 
the guidance document that incorporates suggested changes, when 
appropriate;
    (B) Publish a notice in the Federal Register announcing that the 
guidance document is available;
    (C) Post the guidance document on the Internet and make it 
available in hard copy; and
    (D) Implement the guidance document.
    (v) After providing an opportunity for comment, FDA may decide that 
it should issue another draft of the guidance document. In this case, 
you should follow the steps in paragraphs (g)(1)(ii), (g)(1)(iii), and 
(g)(1)(iv) of this section.
    (2) FDA will not seek your comment before it implements a Level 1 
guidance document if the agency determines that prior public 
participation is not feasible or appropriate.
    (3) FDA will use the following procedures for developing and 
issuing Level 1 guidance documents under the circumstances described in 
paragraph (g)(2) of this section.
    (i) After FDA prepares a guidance document, FDA will:
    (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;
    (C) Implement the guidance document when it is made available; and
    (D) Invite your comment when it issues or publishes the guidance 
document. Paragraph (h) of this section tells you how to submit your 
comments.
    (ii) If FDA receives comments on the guidance document, FDA will 
review those comments and revise the guidance document when 
appropriate.
    (4) FDA will use the following procedures for developing and 
issuing Level 2 guidance documents:
    (i) After it prepares a guidance document, FDA will:
    (A) Post the guidance document on the Internet and make it 
available in hard copy;
    (B) Implement the guidance document when it is made available, 
unless FDA indicates otherwise; and
    (C) Invite your comment on the Level 2 guidance document. Paragraph 
(h) of this section tells you how to submit your comments.
    (ii) If FDA receives comments on the guidance document, FDA will 
review those comments and revise the document when appropriate. If a 
version is revised, the new version will be placed on the Internet.
    (5) You may comment on any guidance document at any time. Paragraph 
(h) of this section tells you how to submit your comments. FDA will 
revise guidance documents in response to your comments when 
appropriate.
    (h) How should you submit comments on a guidance document?
    (1) If you choose to submit comments on any guidance document under 
paragraph (g) of this section, you must send them to the Dockets 
Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.
    (2) Comments should identify the docket number on the guidance 
document, if such a docket number exists. For documents without a 
docket number, the title of the guidance document should be included.
    (3) Comments will be available to the public in accordance with 
FDA's regulations on submission of documents to the Dockets Management 
Branch specified in Sec. 10.20(j).
    (i) What standard elements must FDA include in a guidance document?
    (1) A guidance document must:
    (i) Include the term ``guidance,''
    (ii) Identify the Center(s) or Office(s) issuing the document,
    (iii) Identify the activity to which and the people to whom the 
document applies,
    (iv) Include a statement of the document's nonbinding effect,
    (v) Include the date of issuance,
    (vi) Note if it is a revision to a previously issued guidance and 
identify the document that it replaces, and
    (vi) Contain the word ``draft'' if the document is a draft 
guidance.
    (2) Guidance documents must not include mandatory language such as 
``shall,'' ``must,'' ``required,'' or ``requirement,'' unless FDA is 
using these words to describe a statutory or regulatory requirement.
    (j) Who, within FDA, can approve issuance of guidance documents? 
Each Center and Office must have in place appropriate procedures for 
the approval of guidance documents. Those procedures must ensure that 
issuance of all documents is approved by appropriate senior FDA 
officials.
    (k) How will FDA review and revise existing guidance documents?
    (1) The agency will periodically review existing guidance documents 
to determine whether they need to be changed or withdrawn.
    (2) When significant changes are made to the statute or 
regulations, the agency will review and, if appropriate, revise 
guidance documents relating to that changed statute or regulation.
    (3) As discussed in paragraph (f)(3) of this section, you may at 
any time suggest that FDA revise a guidance document.
    (l) How will FDA ensure that FDA staff are following GGP's?

[[Page 7330]]

    (1) All current and new FDA employees involved in the development, 
issuance, or application of guidance documents will be trained 
regarding the agency's GGP's.
    (2) FDA Centers and Offices will monitor the development and 
issuance of guidance documents to ensure that GGP's are being followed.
    (m) How can you get copies of FDA's guidance documents? FDA will 
make copies available in hard copy and as feasible, through the 
Internet.
    (n) How will FDA keep you informed of the guidance documents that 
are available?
    (1) FDA will maintain a current list of all guidance documents on 
the Internet. New documents will be added to this list within 30 days 
of issuance.
    (2) Once a year, FDA will publish its comprehensive list of 
guidance documents in the Federal Register. The comprehensive list will 
identify documents that have been added to the list or withdrawn from 
the list since the previous comprehensive list.
    (3) FDA's guidance document lists will include the name of the 
guidance document, issuance and revision dates, and information on how 
to obtain copies of the document.
    (o) What can you do if you believe that someone at FDA is not 
following these GGP's? If you believe that someone at FDA did not 
follow the procedures in this section or that someone at FDA treated a 
guidance document as a binding requirement, you should contact that 
person's supervisor in the Center or Office that issued the guidance 
document. If the issue cannot be resolved, you should contact the next 
highest supervisor. If you are unable to resolve the issue at the level 
of the Center/Office Director or if you feel that you are not making 
progress by going through the chain of command, you may ask the Office 
of the Chief Mediator and Ombudsman to become involved.

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

    5. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority: 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 42 
U.S.C. 201, 262, 263b, 264; 15 U.S.C. 1451-1461; 5 U.S.C. App. 2; 28 
U.S.C. 2112.


Secs. 14.27 and 14.33  [Amended]

    6. In 21 CFR part 14, remove the word ``guidelines'' and add in its 
place the word ``guidance documents'' in the following places:
    a. Section 14.27(b)(3) and
    b. Section 14.33(c).

PART 19--STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST

    7. The authority citation for 21 CFR part 19 continues to read as 
follows:

    Authority: 21 U.S.C. 371.


Sec. 19.10  [Amended]

    8. In Sec. 19.10(c), remove the word ``guidelines'' and add in its 
place the word ``guidance documents''.

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

    9. The authority citation for 21 CFR part 25 continues to read as 
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR 
1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR 
1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR 1980 Comp., 
p. 356-360.


Sec. 25.30  [Amended]

    10. In Sec. 25.30(h), remove the word ``guidelines'' and add in its 
place the word ``guidance documents''.

    Dated: February 8, 2000.
Margaret Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-3344 Filed 2-11-00; 8:45 am]
BILLING CODE 4160-01-F