Document ID: FDA-2013-D-0589-0011
Agency: fda
Document Type: Notice
Title: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral
Drugs for Treatment; Guidance for Industry; Availability
Posted Date: 2015-11-03T05:00Z

[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67761-67762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27935]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Human Immunodeficiency Virus-1 Infection: Developing 
Antiretroviral Drugs for Treatment; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a 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 and therapeutic biologic 
products for the treatment of HIV-1 infection.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-0589 for ``Human Immunodeficiency Virus-1 Infection: 
Developing Antiretroviral Drugs for Treatment; Guidance for Industry; 
Availability.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, 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 guidance document.

[[Page 67762]]

FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Human Immunodeficiency Virus-1 Infection: Developing 
Antiretroviral Drugs for Treatment.'' This guidance assists sponsors in 
all phases of drug development including nonclinical development, early 
phases of clinical development, phase 3 protocol designs, and endpoints 
for the treatment of HIV. This guidance specifically addresses HIV drug 
development in populations in need of additional HIV drugs for 
maintaining HIV suppression including trial designs for heavily 
treatment-experienced patients (multiple-drug-resistant patients with 
few remaining options); use of early virologic assessments as primary 
endpoints in trials evaluating antiretroviral drugs in heavily 
treatment-experienced patients; recommended trial durations based on 
medical need; and risk-benefit in the targeted patient population.
    This guidance finalizes the draft guidance of the same name 
published in the Federal Register June 5, 2013 (78 FR 33848), and 
replaces the guidance for industry entitled ``Antiretroviral Drugs 
Using Plasma HIV RNA Measurements--Clinical Considerations for 
Accelerated and Traditional Approval'' issued October 2002.
    The public comments received on the draft guidance have been 
considered and the guidance has been revised to: (1) Clarify 
definitions of treatment-na[iuml]ve and treatment-experienced patient 
categories with respect to both drug susceptibility and clinical 
history; (2) add recommendations for trial designs that investigate 
switching treatment regimens in patients who are suppressed on current 
therapy; and (3) briefly discuss recommendations for labeling claims 
for safety endpoints.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on developing antiretroviral drugs for the 
treatment of HIV infection. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it 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 OMB control number 0910-0014, the collections of information in 
21 CFR part 314 have been approved under OMB control number 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 OMB control number 
0910-0581.

III. Electronic Access

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

    Dated: October 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27935 Filed 11-2-15; 8:45 am]
 BILLING CODE 4164-01-P