[Federal Register: November 29, 2004 (Volume 69, Number 228)]
[Notices]
[Page 69374-69375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no04-49]
-----------------------------------------------------------------------
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Draft Guidance for Industry on the Role of Human Immunodeficiency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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Role of HIV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draft guidance is intended to assist sponsors in the clinical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 Specifically, the draft guidance addresses the role of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 The draft guidance is also intended to serve as a focus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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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access to the draft guidance document.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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
BILLING CODE 4160-01-S