Notice2023-16560
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals Under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability
Primary source
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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Single- Entity Versions of Previously Approved Antiretrovirals under PEPFAR." The draft guidance describes circumstances under which an applicant may be eligible for a barrier-to-innovation waiver under the Prescription Drug User Fee Act (PDUFA) for certain new drug applications (NDAs) for single-entity (SE) antiretroviral (ARV) and fixed-combination (FC) ARV drug products for the treatment or prevention of human immunodeficiency virus-one (HIV-1). The draft guidance is also intended to help applicants request a barrier-to-innovation waiver under those circumstances.
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 51322-51323]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16560]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1635]
Prescription Drug User Fee Act Waivers, Reductions, and Refunds
for Fixed-Combinations and Single-Entity Versions of Previously
Approved Antiretrovirals 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Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled ``PDUFA
Waivers, Reductions, and Refunds for Fixed-Combinations and Single-
Entity Versions of Previously Approved Antiretrovirals under PEPFAR.''
The draft guidance describes circumstances under which an applicant may
be eligible for a barrier-to-innovation waiver under the Prescription
Drug User Fee Act (PDUFA) for certain new drug applications (NDAs) for
single-entity (SE) antiretroviral (ARV) and fixed-combination (FC) ARV
drug products for the treatment or prevention of human immunodeficiency
virus-one (HIV-1). The draft guidance is also intended to help
applicants request a barrier-to-innovation waiver under those
circumstances.
DATES: Submit either electronic or written comments on the draft
guidance by October 2, 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-2018-D-1635 for ``PDUFA Waivers, Reductions, and Refunds for Fixed-
Combinations and Single-Entity Versions of Previously Approved
Antiretrovirals 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.
[[Page 51323]]
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 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: Sophia Park, Division of User Fee
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10001 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-7900, <a href="/cdn-cgi/l/email-protection#d09394958293bfbcbcb5b3a4b9bfbea390b6b4b1feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="b7f4f3f2e5f4d8dbdbd2d4c3ded8d9c4f7d1d3d699dfdfc499d0d8c1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``PDUFA Waivers, Reductions, and Refunds for Fixed-
Combinations and Single-Entity Versions of Previously Approved
Antiretrovirals under PEPFAR.'' This draft guidance is proposed as a
revision of the guidance for industry entitled ``User Fee Waivers for
FDC and Co-Packaged HIV Drugs for PEPFAR,'' issued February 2007. The
draft guidance describes circumstances under which an applicant may be
eligible for a barrier-to-innovation waiver under PDUFA for certain
NDAs for SE ARV and FC ARV drug products for the treatment of HIV-1.
When final, this guidance will supersede the guidance for industry
entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for
PEPFAR,'' issued February 2007.
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 ``PDUFA
Waivers, Reductions, and Refunds for Fixed-Combinations and Single-
Entity Versions of Previously Approved Antiretrovirals 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 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 FDA's guidance entitled ``Prescription Drug User Fee
Act Waivers, Reductions, and Refunds for Drug and Biological Products''
associated with requesting waivers of user fees (including PEPFAR
waivers) has been approved under OMB control number 0910-0693. The
collection of information in completing and submitting FDA Form FDA
3397 (Prescription Drug User Fee Coversheet) has been approved under
OMB control number 0910-0297. The collection of information in 21 CFR
part 314 for submission of a new drug application has been approved
under OMB control number 0910-0001.
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. 2023-16560 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P
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