Document ID: FDA-2018-D-1635-0004
Agency: fda
Document Type: Notice
Title: 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Previously Approved Antiretrovirals Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability
Posted Date: 2023-08-03T04:00Z

[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51322-51323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``PDUFA 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The draft guidance describes circumstances under which an applicant may 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 The draft guidance is also intended to help 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DATES: Submit either electronic or written comments on the draft 
guidance by October 2, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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.

[[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, [email protected].

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 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. 2023-16560 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P