[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60686-60688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19081]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-3370]


Post-Warning Letter Meetings Under the Generic Drug User Fee Act; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Post-
Warning Letter Meetings Under GDUFA.'' This draft guidance provides 
information on the implementation of the Post-Warning Letter Meeting 
process for certain drug manufacturing facilities, a program 
enhancement agreed upon by the Agency and industry as part of the 
negotiations relating to the reauthorization of the Generic Drug User 
Fee Amendments (GDUFA), as described in ``GDUFA Reauthorization 
Performance Goals and Program Enhancements Fiscal Years 2023-2027'' 
(GDUFA III commitment letter). Specifically, this draft guidance 
describes the process detailed in the GDUFA III commitment letter for 
how an eligible facility may request a Post-Warning Letter Meeting with 
FDA regarding the facility's ongoing remediation efforts to current 
good manufacturing practice (CGMP) deficiencies described in a warning 
letter, how to prepare and submit a complete meeting package, and how 
FDA intends to conduct the Post-Warning Letter Meeting.

DATES: Submit either electronic or written comments on the draft 
guidance by October 5, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 60687]]

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-2023-D-3370 for ``Post-Warning Letter Meeting Under GDUFA.'' 
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 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.

FOR FURTHER INFORMATION CONTACT: Rebecca Frey-Cooper, Office of 
Manufacturing Quality, Center for Drug Evaluation and Research (HFD-
003), Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 240-402-4127.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Post-Warning Letter Meetings under GDUFA.'' This draft 
guidance provides information on the implementation of the Post-Warning 
Letter Meeting process, a program enhancement agreed upon by the Agency 
and industry as part of the negotiations relating to the 
reauthorization of GDUFA, as described in ``GDUFA Reauthorization 
Performance Goals and Program Enhancements Fiscal Years 2023-2027'' 
(GDUFA III Commitment Letter). Specifically, this draft guidance 
describes the process in the GDUFA III commitment letter for how an 
eligible facility may request a Post-Warning Letter Meeting with FDA 
regarding the facility's ongoing remediation efforts to current good 
manufacturing practice (CGMP) deficiencies described in a warning 
letter, how to prepare and submit a complete meeting package, and how 
FDA intends to conduct the Post-Warning Letter Meeting.
    The Generic Drug User Fee Amendments of 2012 (GDUFA I) amended the 
FD&C Act to authorize FDA to assess and collect user fees to provide 
FDA with additional resources to help ensure patients have access to 
quality, affordable, safe, and effective generic drugs. GDUFA fee 
resources bring greater predictability and timeliness to the review of 
generic drug applications. GDUFA has been reauthorized every 5 years to 
continue FDA's ability to assess and collect GDUFA fees, and this user 
fee program has been reauthorized twice since GDUFA I, most recently in 
the Generic Drug User Fee Amendments of 2022. As described in the GDUFA 
III Commitment Letter applicable to this latest reauthorization, FDA 
has agreed to performance goals and program enhancements regarding 
aspects of the generic drug assessment program that build on previous 
authorizations of GDUFA. New enhancements to the program are designed 
to maximize the efficiency and utility of each assessment cycle, with 
the intent of reducing the number of assessment cycles for ANDAs and 
facilitating timely access to generic medicines for American patients.
    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 ``Post-Warning 
Letter Meetings Under GDUFA.'' 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. The 
previously approved

[[Page 60688]]

collections of information are subject to review by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 (PRA) 
(44 U.S.C. 3501-3521). The collections of information in 21 CFR part 
314 have been approved under OMB control number 0910-0001. The 
collections of information in 21 CFR parts 210 and 211 pertaining to 
current good manufacturing practice has been approved under OMB control 
number 0910-0139. The collections of information in 21 CFR part 11 for 
electronic records and electronic signatures have been approved under 
OMB control number 0910-0303. The collections of information pertaining 
to the submissions of GDUFA III commitment letter, meetings related to 
generic drug development, and the Generic Drug User Fee Program have 
been approved under OMB control number 0910-0727.

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: August 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19081 Filed 9-1-23; 8:45 am]
BILLING CODE 4164-01-P