Document ID: FDA-2013-D-0589-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection:  Developing Antiretroviral Drugs for Treatment; Availability
Posted Date: 2013-06-05T04:00Z

[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33848-33849]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13288]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0589]

Draft Guidance for Industry on Human Immunodeficiency Virus-1 
Infection: Developing Antiretroviral Drugs for Treatment; 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availability of a draft guidance for industry entitled ``Human 
Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for 
Treatment.'' The purpose of this guidance is to assist sponsors in all 
phases of development of antiretroviral drugs for the treatment of HIV. 
This draft guidance revises the guidance for industry entitled 
``Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical 
Considerations

[[Page 33849]]

for Accelerated and Traditional Approval'' issued in October 2002.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 5, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6370, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Human Immunodeficiency Virus-1 Infection: Developing 
Antiretroviral Drugs for Treatment.'' This guidance revises the 
guidance for industry entitled ``Antiretroviral Drugs Using Plasma HIV-
RNA Measurements--Clinical Considerations for Accelerated and 
Traditional Approval'' issued in October 2002. Significant changes from 
the 2002 version include: (1) More details on nonclinical development 
of antiretroviral drugs; (2) a greater emphasis on recommended trial 
designs for HIV-1 infected heavily treatment-experienced patients 
(those with multiple-drug, resistant virus and few remaining 
therapeutic options); (3) use of a primary endpoint evaluating early 
virologic changes for studies in heavily treatment-experienced 
patients; and (4) use of the traditional approval pathway for initial 
approval of all antiretrovirals with primary analysis time points 
dependent on the indication sought instead of an accelerated approval 
pathway followed by traditional approval. Longer term trials may be 
appropriate for patients who are treatment-na[iuml]ve or have limited 
prior experience, whereas shorter term trials may be appropriate for 
patients with limited treatment options.
    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 developing 
antiretroviral drugs for the treatment of HIV-1 infection. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR part 312 have been approved 
under 0910-0014, the collections of information in 21 CFR part 314 have 
been approved under 0910-0001, and the collections of information 
referred to in the guidance for industry entitled ``Establishment and 
Operation of Clinical Trial Data Monitoring Committees'' have been 
approved under 0910-0581.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13288 Filed 6-4-13; 8:45 am]
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