[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51325-51326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0301]


Fixed-Combinations and Single-Entity Versions of Previously 
Approved Antiretrovirals for the Treatment or Prevention of Human 
Immunodeficiency Virus-One Under the President's Emergency Plan for 
Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Fixed-
Combinations and Single-Entity Versions of Previously Approved 
Antiretrovirals for the Treatment or Prevention of HIV-1 Under 
PEPFAR.'' This draft guidance provides recommendations for applications 
for single-entity antiretroviral (ARV) and ARV fixed-combination (FC) 
drug products for the treatment or prevention of human immunodeficiency 
virus-one (HIV-1) infection that are intended for procurement under the 
President's Emergency Plan for AIDS Relief (PEPFAR). Specifically, this 
draft guidance addresses versions of ARV drug products for which the 
individual ARV drug product components are already FDA-approved and for 
which substantial evidence of safety and efficacy of the specific drug 
product or combination drug product already exists. When finalized, 
this draft guidance will replace the previous final guidance for 
industry entitled ``Fixed Dose Combinations, Co-Packaged Drug Products, 
and Single-Entity Versions of Previously Approved Antiretrovirals for 
the Treatment of HIV'' issued in October 2006.

DATES: Submit either electronic or written comments on the draft 
guidance by November 1, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2004-D-0301 for ``Fixed-Combinations and Single-Entity Versions of 
Previously Approved Antiretrovirals for the Treatment of HIV-1 Under 
PEPFAR.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive

[[Page 51326]]

label to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

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

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Fixed-Combinations and Single-Entity Versions of Previously 
Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under 
PEPFAR.'' This draft guidance provides recommendations for applications 
for single-entity ARV and ARV FC drug products for the treatment of 
HIV-1 infection that are intended for procurement under PEPFAR. 
Specifically, this draft guidance addresses versions of ARV drug 
products for which the individual ARV drug product components are 
already FDA-approved and for which substantial evidence of safety and 
efficacy of the specific drug product or combination drug product 
already exists. The draft guidance discusses regulatory procedures 
relevant to such applications and recommendations on how to identify 
and address common issues. The recommendations in this draft guidance 
primarily focus on the tentative approval of marketing applications 
intended for procurement under PEPFAR, where there are patent or 
exclusivity barriers to final marketing approval.
    When finalized, this draft guidance will replace the previous final 
guidance for industry entitled ``Fixed Dose Combinations and Single-
Entity Versions of Previously Approved Antiretrovirals for the 
Treatment of HIV,'' issued October 18, 2006 (71 FR 61483). Important 
changes in this draft guidance compared to the 2006 final version 
include the following:
     Addition of information about ARV drug products for 
prevention of HIV-1 infection.
     Deletion of references to co-packaged products and focus 
on single-entity ARV and ARV FC drug products currently most needed 
under PEPFAR.
     Inclusion of a subsection that describes the processes for 
making changes to applications after tentative approval.
     Addition of updated descriptions of regulatory 
requirements and procedures in the main text of the document and 
deletion of Attachments A, B, and C.
     Addition of updated information, for example, in the 
section on chemistry, manufacturing, and controls, to be consistent 
with other guidances for industry released after 2006.
    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 current thinking of FDA on ``Fixed-
Combinations and Single-Entity Versions of Previously Approved 
Antiretrovirals for the Treatment or Prevention of HIV-1 Under 
PEPFAR.'' 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. Paperwork Reduction Act of 1995

    While this draft guidance contains no collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 312 for the submission of investigational 
new drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 for the 
submission of new drug applications, abbreviated new drug applications 
and supplemental applications have been approved under OMB control 
number 0910-0001. The collections of information for the submission of 
controlled correspondence related to generic drug development have been 
approved under OMB control number 0910-0797. The collections of 
information pertaining to Prescription Drug User Fee Program have been 
approved under OMB control number 0910-0297. The collections of 
information pertaining to Generic Drug User Fee Program have been 
approved under 0910-0727. The collections of information related to 
expedited review programs for serious conditions have been approved 
under OMB control number 0910-0765. The collections of information for 
the submission of postmarketing adverse drug experience reporting have 
been approved under OMB control number 0910-0230. The collections of 
information in 21 CFR parts 210 and 211 pertaining to current good 
manufacturing practice have been approved under OMB control number 
0910-0139. The collections of information in 21 CFR 201.57 for the 
submission of prescription drug product labeling have been approved 
under OMB control number 0910-0572. The collections of information 
pertaining to good clinical practice have been approved under OMB 
control number 0910-0843.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16557 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P