[Federal Register Volume 69, Number 231 (Thursday, December 2, 2004)]
[Notices]
[Page 70153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26533]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0493]


Draft Guidance for Industry on Recommended Approaches to 
Integration of Genetic Toxicology Study Results; 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availability of a draft guidance for industry entitled ``Recommended 
Approaches to Integration of Genetic Toxicology Study Results.'' This 
draft guidance is intended to inform industry on how the Center for 
Drug Evaluation and Research (CDER) views positive findings in genetic 
toxicology assays, and to provide recommendations to industry on how to 
proceed in assuring safety of healthy subjects or patients when results 
in genotoxicity studies suggest a potential cancer or genetic hazard.

DATES: Submit written or electronic comments on the draft guidance by 
January 31, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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 INFORMATIONsection for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: David Jacobson-Kram, Center for Drug 
Evaluation and Research (HFD-024), Food and Drug Administration, 5515 
Security Lane, Rockville, MD 20852, 301-443-5346.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Recommended Approaches to Integration of Genetic Toxicology 
Study Results.'' Risk for carcinogenesis is usually determined in 
rodent assays, in either 2-year studies or shorter-term studies using 
alternative models (ICH S1B). Regulatory decisions involving both 
single- and repeat-dose clinical studies are discussed in this 
guidance. Pharmaceuticals administered through oral, intravenous, 
topical, and other routes, as appropriate, are subject to this 
guidance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on recommended 
approaches to integration of genetic toxicology study results. 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 submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two paper copies of mailed comments are to be submitted, except that 
individuals may submit one paper 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 Division of Dockets Management 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 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: November 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26533 Filed 12-1-04; 8:45 am]
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