[Federal Register Volume 67, Number 100 (Thursday, May 23, 2002)]
[Notices]
[Page 36198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1563]


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 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 (CDER) relies on when evaluating protocols for animal 
carcinogenicity studies.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), 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 guidance to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Robert E. Osterberg, Center for Drug 
Evaluation and Research (HFD-24), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5476.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Carcinogenicity Study Protocol Submissions.'' In conjunction 
with the reauthorization of the Prescription Drug User Fee Act of 1992 
(PDUFA), FDA agreed to specific performance goals (PDUFA goals) for 
activities associated with the development and review of products in 
human drug applications. The PDUFA goals related to special protocol 
assessment and agreement provide that, upon request, FDA will evaluate 
within 45 calendar 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 guidance is intended to facilitate the agency's review 
of protocols for animal carcinogenicity studies by informing sponsors 
of the types of information the agency relies on during its evaluation 
of such protocols. A draft guidance of the same name was made available 
for public comment in a notice published in the Federal Register of 
November 7, 2000 (65 FR 66757). This guidance contains only minor 
changes for clarification.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The 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.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the guidance to the Dockets Management Branch (address 
above). 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 
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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-12872 Filed 5-22-02; 8:45 am]
BILLING CODE 4160-01-S