00-28521. Draft Guidance for Industry on Carcinogenicity Study Protocol Submissions; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Carcinogenicity Study Protocol Submissions.” This document is intended to provide guidance on the types of information the Center for Drug Evaluation and Research relies on when evaluating protocols for animal carcinogenicity studies.

DATES:

Submit written comments on the draft guidance by February 5, 2000. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Copies of this draft guidance for industry are available on the Internet at http://www.fda.gov/​cder/​guidance/​index.htm. Submit written requests for single copies of the draft guidance to the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Joseph J. DeGeorge, Center for Drug Evaluation and Research (HFD-24), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5476.

SUPPLEMENTARY INFORMATION:

FDA is announcing the availability of a draft guidance for industry entitled “Carcinogenicity Study Protocol Submissions.” The draft guidance describes the kind of information the agency relies on when evaluating special protocols for animal carcinogenicity studies.

The Prescription Drug User Fee Act of 1992 (PDUFA) was reauthorized in November 1997 (PDUFA 2). In conjunction with PDUFA 2, FDA agreed to specific performance goals (PDUFA goals) for activities associated with the development and review of products in human drug applications as defined in section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)). The PDUFA goals for special protocol assessment and agreement provide that, upon request, FDA will evaluate within 45 days certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsor. Protocols for animal carcinogenicity studies are eligible for this special protocol assessment. This draft guidance is intended to facilitate the agency's review of animal carcinogenicity study protocols.

This draft guidance is being issued consistent with FDA's good guidance practices (65 FR 56468, September 19, 2000). The draft guidance represents the agency's current thinking on carcinogenicity study protocol submissions. 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 statutes and regulations.

Interested persons may submit to the Dockets Management Branch (address above) written comments on the draft guidance. 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. The draft guidance and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.