[Federal Register Volume 69, Number 228 (Monday, November 29, 2004)]
[Notices]
[Pages 69374-69375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26272]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0484]


Draft Guidance for Industry on the Role of Human Immunodeficiency 
Virus Drug Resistance Testing in Antiretroviral Drug Development; 
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availability of a draft guidance for industry entitled ``Role of HIV 
Drug Resistance Testing in Antiretroviral Drug Development.'' This 
draft guidance is intended to assist sponsors in the clinical 
development of drugs for the treatment of human immunodeficiency virus 
(HIV) infection. Specifically, the draft guidance addresses the role of 
HIV resistance testing during antiretroviral drug development and 
postmarketing. The draft guidance is also intended to serve as a focus 
for continued discussions among the Division of Antiviral Drug Product 
(DAVDP) in FDA's Center for Drug Evaluation and Research, 
pharmaceutical sponsors, the academic community, and the public.

DATES: Submit written or electronic comments on the draft guidance by 
February 28, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jeffrey S. Murray, or Kimberly A. 
Struble Center for Drug Evaluation and Research (HFD-530), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2330.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Role of HIV Drug Resistance Testing in Antiretroviral Drug 
Development.'' This draft guidance addresses the role of HIV resistance 
testing during antiretroviral drug development and postmarketing. The 
draft guidance is based on the following: (1) A 2-day session of the 
Antiviral Drug Product advisory committee convened November 2 and 3, 
1999, to address issues relating to HIV resistance testing; (2) the 
DAVDP's experience with reviewing resistance data for antiretroviral 
drugs; and (3) input from pharmaceutical sponsors and the HIV 
community.
    The draft guidance discusses the nonclinical studies (mechanism of 
action; antiviral activity in vitro; cytotoxicity/therapeutic index; 
and the effects of serum protein binding on antiviral activity) we 
recommend be completed prior to the initiation of phase 1 clinical 
studies in HIV-infected patients. In addition, the draft guidance 
addresses the use of resistance testing in the clinical phases of drug 
development and recommends the type of information that should be 
collected and the types of analyses that should be conducted to 
characterize an antiretroviral's resistance profile. The draft guidance 
also reviews the role of resistance testing in initial activity and 
dose-finding, for study enrollment criteria, for background regimen 
selection, and to establish an indication. Included in this draft 
guidance are two appendices: (1) A template for submitting HIV 
resistance data and (2) information on the genetic threshold for 
resistance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the agency's current thinking on the role of HIV resistance 
testing in antiretroviral drug development. 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.

[[Page 69375]]

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of mailed 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 Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under the OMB 
control number 0910-0014 (until January 31, 2006).

IV. 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 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26272 Filed 11-26-04; 8:45 am]
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