[Federal Register Volume 65, Number 216 (Tuesday, November 7, 2000)]
[Notices]
[Page 66757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28521]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1563]


Draft Guidance for Industry on Carcinogenicity Study Protocol 
Submissions; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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availability of a draft guidance for industry entitled 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DATES: Submit written comments on the draft guidance by February 5, 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ADDRESSES: Copies of this draft guidance for industry are available on 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written requests for single copies of the draft guidance to the Drug 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 Submit written comments on the draft guidance 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draft guidance for industry entitled ``Carcinogenicity Study Protocol 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 The draft guidance describes the kind of information the 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.
[FR Doc. 00-28521 Filed 11-6-00; 8:45 am]
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