80 FR 67761 - Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 212 (November 3, 2015)

Page Range		67761-67762
FR Document		2015-27935

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.

Federal Register, Volume 80 Issue 212 (Tuesday, November 3, 2015)

[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67761-67762]
From the Federal Register Online [www.thefederalregister.org]
[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

67762 Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices

FOR FURTHER INFORMATION CONTACT: II. The Paperwork Reduction Act of OMB, Attn: FDA Desk Officer, FAX:
Jeffrey Murray, Center for Drug 1995 202–395–7285, or emailed to oira_
Evaluation and Research, Food and This guidance refers to previously submission@omb.eop.gov. All
Drug Administration, 10903 New approved collections of information that comments should be identified with the
Hampshire Ave., Bldg. 22, Rm. 6360, are subject to review by the Office of OMB control number 0910–0393. Also
Silver Spring, MD 20993–0002, 301– Management and Budget under the include the FDA docket number found
796–1500. Paperwork Reduction Act of 1995 (44 in brackets in the heading of this
SUPPLEMENTARY INFORMATION: U.S.C. 3501–3520). The collections of document.
I. Background information in 21 CFR part 312 have FOR FURTHER INFORMATION CONTACT: FDA
been approved under OMB control PRA Staff, Office of Operations, Food
FDA is announcing the availability of number 0910–0014, the collections of and Drug Administration, 8455
a guidance for industry entitled information in 21 CFR part 314 have Colesville Rd., COLE–14526, Silver
‘‘Human Immunodeficiency Virus-1 been approved under OMB control Spring, MD 20993–0002, PRAStaff@
Infection: Developing Antiretroviral number 0910–0001, and the collections fda.hhs.gov.
Drugs for Treatment.’’ This guidance of information referred to in the
assists sponsors in all phases of drug guidance for industry entitled SUPPLEMENTARY INFORMATION: In
development including nonclinical ‘‘Establishment and Operation of compliance with 44 U.S.C. 3507, FDA
development, early phases of clinical Clinical Trial Data Monitoring has submitted the following proposed
development, phase 3 protocol designs, Committees’’ have been approved under collection of information to OMB for
and endpoints for the treatment of HIV. OMB control number 0910–0581. review and clearance.
This guidance specifically addresses Prescription Drug Product Labeling;
HIV drug development in populations III. Electronic Access
Medication Guide Requirements OMB
in need of additional HIV drugs for Persons with access to the Internet Control Number 0910–0393—Extension
maintaining HIV suppression including may obtain the guidance at either
trial designs for heavily treatment- http://www.fda.gov/Drugs/Guidance FDA regulations require the
experienced patients (multiple-drug- ComplianceRegulatoryInformation/ distribution of patient labeling, called
resistant patients with few remaining Guidances/default.htm or http:// Medication Guides, for certain
options); use of early virologic www.regulations.gov. prescription human drug and biological
assessments as primary endpoints in products used primarily on an
Dated: October 28, 2015.
trials evaluating antiretroviral drugs in outpatient basis that pose a serious and
Leslie Kux,
heavily treatment-experienced patients; significant public health concern
Associate Commissioner for Policy. requiring distribution of FDA approved
recommended trial durations based on
[FR Doc. 2015–27935 Filed 11–2–15; 8:45 am] patient medication information. These
medical need; and risk-benefit in the
targeted patient population. BILLING CODE 4164–01–P Medication Guides inform patients
This guidance finalizes the draft about the most important information
guidance of the same name published in they should know about these products
DEPARTMENT OF HEALTH AND in order to use them safely and
the Federal Register June 5, 2013 (78 FR
HUMAN SERVICES effectively. Included is information such
33848), and replaces the guidance for
industry entitled ‘‘Antiretroviral Drugs as the drug’s approved uses,
Food and Drug Administration
Using Plasma HIV RNA contraindications, adverse drug
Measurements—Clinical Considerations [Docket No. FDA–2011–N–0902] reactions, and cautions for specific
for Accelerated and Traditional populations, with a focus on why the
Agency Information Collection particular product requires a Medication
Approval’’ issued October 2002.
Activities; Proposed Collection; Guide. These regulations are intended to
The public comments received on the
Submission for Office of Management improve the public health by providing
draft guidance have been considered
and Budget Review; Prescription Drug information necessary for patients to use
and the guidance has been revised to:
Product Labeling; Medication Guide certain medication safely and
(1) Clarify definitions of treatment-naı̈ve
Requirements effectively.
and treatment-experienced patient
categories with respect to both drug AGENCY: Food and Drug Administration, The regulations contain the following
susceptibility and clinical history; (2) HHS. reporting requirements that are subject
add recommendations for trial designs ACTION: Notice. to the PRA:
that investigate switching treatment • 21 CFR 208.20—Applicants must
regimens in patients who are SUMMARY: The Food and Drug submit draft Medication Guides for FDA
suppressed on current therapy; and (3) Administration (FDA) is announcing approval according to the prescribed
briefly discuss recommendations for that a proposed collection of content and format.
labeling claims for safety endpoints. information has been submitted to the • 21 CFR 314.70(b)(3)(ii) and 21 CFR
This guidance is being issued Office of Management and Budget 601.12(f)—Application holders must
consistent with FDA’s good guidance (OMB) for review and clearance under submit changes to Medication Guides to
practices regulation (21 CFR 10.115). the Paperwork Reduction Act of 1995 FDA for prior approval as supplements
The guidance represents the current (the PRA). to their applications.
DATES: Fax written comments on the • 21 CFR 208.24(c)—Each distributor
mstockstill on DSK4VPTVN1PROD with NOTICES

thinking of FDA on developing
antiretroviral drugs for the treatment of collection of information by December or packer that receives Medication
HIV infection. It does not establish any 3, 2015. Guides, or the means to produce
rights for any person and is not binding ADDRESSES: To ensure that comments on Medication Guides, from a manufacturer
on FDA or the public. You can use an the information collection are received, under paragraph (b) of this section shall
alternative approach if it satisfies the OMB recommends that written provide those Medication Guides to
requirements of the applicable statutes comments be faxed to the Office of each authorized dispenser to whom it
and regulations. Information and Regulatory Affairs, ships a container of drug product.

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Document Created: 2018-03-01 11:33:08
Document Modified: 2018-03-01 11:33:08

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		Submit either electronic or written comments on Agency guidances at any time.
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.
FR Citation		80 FR 67761

80 FR 67761 - Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 212 (November 3, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration