FDA Guidance

FDA Administrative Practices and Procedures

Good Guidance Practices 

0217-FDA GGP

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule

The Food and Drug Administration (FDA) is amending its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary to comply with requirements of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).

The Modernization Act codified certain parts of the agency’s current ‘‘Good Guidance Practices’’ (GGP’s) and directed the agency to issue a regulation consistent with the act 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: This rule is effective October 19, 2000

Background

Under section 405 of the Modernization Act (Public Law 105-115), statutory provisions on guidance documents were added to the Federal Food, Drug, and Cosmetic Act (the act) in section 701(h) (21 U.S.C. 371(h)). In the Federal Register of February 14, 2000 (65 FR 7321), we (FDA) proposed changes to our existing part 10 (21 CFR part 10)  regulations to clarify our procedures for the development, issuance, and use of guidance documents. Interested parties were given until May 1, 2000, to comment on the proposal.

Description of the Final Rule

Comments and Agency Response We received 18 comments on the proposed rule, largely from trade organizations.

The comments we received generally supported the policies and procedures described in the GGP’s.

General Comment (Comment 1) One comment recommended that we include in this preamble a list of generally accepted principles of a good guidance document. The comment nominated several principles for inclusion on the list.

We decline to develop a list of generally accepted principles of a “good” guidance document because we believe that the procedures described in Sec. 10.115 reflect generally accepted principles for developing, issuing, and using guidance documents. For example, a good guidance document represents our current thinking on a matter and clearly states that it does not establish legally enforceable requirements. We expect each guidance document developed, issued, and used under the rule to have the characteristics of a good guidance document.

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Last Updated: 2015-08-09