[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10]
 
[Page 86-87]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
 
                      Subpart A--General Provisions
 
Sec.
10.1  Scope.
10.3  Definitions.
10.10  Summaries of administrative practices and procedures.
10.19  Waiver, suspension, or modification of procedural requirements.
 
              Subpart B--General Administrative Procedures
 
10.20  Submission of documents to Dockets Management Branch; computation 
          of time; availability for public disclosure.
10.25  Initiation of administrative proceedings.
10.30  Citizen petition.
10.33  Administrative reconsideration of action.
10.35  Administrative stay of action.
10.40  Promulgation of regulations for the efficient enforcement of the 
          law.
10.45  Court review of final administrative action; exhaustion of 
          administrative remedies.
10.50  Promulgation of regulations and orders after an opportunity for a 
          formal evidentiary public hearing.
10.55  Separation of functions; ex parte communications.
10.60  Referral by court.
10.65  Meetings and correspondence.
10.70  Documentation of significant decisions in administrative file.
10.75  Internal agency review of decisions.
10.80  Dissemination of draft Federal Register notices and regulations.
 
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10.85  Advisory opinions.
10.90  Food and Drug Administration regulations, recommendations, and 
          agreements.
10.95  Participation in outside standard-setting activities.
10.100  Public calendar.
10.105  Representation by an organization.
10.110  Settlement proposals.
10.115  Good guidance practices.
 
     Subpart C--Electronic Media Coverage of Public Administrative 
             Proceedings; Guideline on Policy and Procedures
 
10.200  Scope.
10.203  Definitions.
10.204  General.
10.205  Electronic media coverage of public administrative proceedings.
10.206  Procedures for electronic media coverage of agency public 
          administrative proceedings.
 
    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.
 
    Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.115]
 
[Page 113-117]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
              Subpart B--General Administrative Procedures
 
Sec. 10.115  Good guidance practices.
 
    (a) What are good guidance practices? Good guidance practices 
(GGP's) are FDA's policies and procedures for developing, issuing, and 
using guidance documents.
    (b) What is a guidance document?
 
[[Page 114]]
 
    (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, labeling, promotion, 
manufacturing, and testing of regulated products; the processing, 
content, and evaluation or 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 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 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 can provide input on guidance documents that FDA is 
developing under the procedures described in paragraph (g) of this 
section.
    (2) You can suggest areas for guidance document development. Your 
suggestions should address why a guidance document is necessary.
    (3) You can submit drafts of proposed guidance documents for FDA to 
consider. When you do so, you should mark the document "Guidance 
Document Submission" and submit it to Dockets Management Branch (HFA-
305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    (4) You can, at any time, suggest that FDA revise or withdraw an 
already existing guidance document. Your suggestion should address why 
the guidance document should be revised or withdrawn and, if applicable, 
how it should be revised.
    (5) Once a year, FDA will publish, both in the Federal Register and 
on the Internet, a list of possible topics for future guidance document 
development or revision during the next year. You can comment on this 
list (e.g., by
 
[[Page 115]]
 
suggesting alternatives or making recommendations on the topics that FDA 
is considering).
    (6) To participate in the development and issuance of guidance 
documents through one of the mechanisms described in paragraphs (f)(1), 
(f)(2), or (f)(4) of this section, you should contact the center or 
office that is responsible for the regulatory activity covered by the 
guidance document.
    (7) If FDA agrees to draft or revise a guidance document, under a 
suggestion made under paragraphs (f)(1), (f)(2), (f)(3) or (f)(4) of 
this section, you can 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 
can seek or accept early input from individuals or groups outside the 
agency. For example, FDA can 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 can:
    (A) Hold 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, 
FDA will 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) Immediately implement the guidance document; 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) Immediately implement the guidance document, unless FDA 
indicates otherwise when the document is made available; and
    (C) Invite your comment on the Level 2 guidance document. Paragraph 
(h) of this section tells you how to submit your comments.
 
[[Page 116]]
 
    (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 can 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) Prominently display 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
    (vii) 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.
    (3) When issuing draft guidance documents that are the product of 
international negotiations (e.g., guidances resulting from the 
International Conference on Harmonisation), FDA need not apply 
paragraphs (i)(1) and (i)(2) of this section. However, any final 
guidance document issued according to this provision must contain the 
elements in paragraphs (i)(1) and (i)(2) of this section.
    (j) Who, within FDA, can approve issuance of guidance documents? 
Each center and office must have written 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?
    (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 on the Internet a current list of all guidance 
documents. New documents will be added to this list within 30 days of 
issuance.
    (2) Once a year, FDA will publish in the Federal Register its 
comprehensive list of guidance documents. The comprehensive list will 
identify documents that have been added to the list or withdrawn from 
the list since the previous comprehensive list.
 
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    (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. You can also contact the center or office ombudsman for 
assistance in resolving the issue. If you are unable to resolve the 
issue at the center or office level 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.
 
[65 FR 56477, Sept. 19, 2000]