Notice2023-16557
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of Human Immunodeficiency Virus-One Under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability
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Published
August 3, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under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 This draft guidance provides recommendations for applications for single-entity antiretroviral (ARV) and ARV fixed-combination (FC) drug products for the treatment or prevention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 Specifically, this draft guidance addresses versions of ARV drug products for which the individual ARV drug product components are already FDA-approved and for which substantial evidence of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 When finalized, this draft guidance will replace the previous final guidance for industry entitled "Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously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.
Full Text
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<title>Federal Register, Volume 88 Issue 148 (Thursday, August 3, 2023)</title>
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[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51325-51326]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry;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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Addition of information about ARV drug products for
prevention of HIV-1 infection.
<bullet> Deletion of references to co-packaged products and focus
on single-entity ARV and ARV FC drug products currently most needed
under PEPFAR.
<bullet> Inclusion of a subsection that describes the processes for
making changes to applications after tentative approval.
<bullet> Addition of updated descriptions of regulatory
requirements and procedures in the main text of the document and
deletion of Attachments A, B, and C.
<bullet> 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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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