[Federal Register: May 23, 2002 (Volume 67, Number 100)]
[Notices]
[Page 36198]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my02-73]
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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