[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60686-60688]
[FR Doc No: 2023-19081]

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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Draft Guidance for Industry; Availability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.

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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the availability of a draft guidance for industry entitled ``Post-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 This draft guidance provides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 Specifically, this draft guidance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DATES: Submit either electronic or written comments on the draft
guidance by October 5, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:

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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    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,<PHONE_NUMBER>.

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

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


1 of 4 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING November 30 December 1, 2004 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: 703 305 5805 Docket Number: OPP 2004 0320 Dimethoate: Issues Related to Hazard and Dose Response Assessment FIFRA SAP Chair Stephen M. Roberts, Ph. D. Professor and Program Director Center for Environmental and Human Toxicology University of Florida, Box 110885 Building 471, Mowry Road Gainesville, FL 32611 0885 Designated Federal Official Myrta R. Christian, M. S. FIFRA Scientific Advisory Panel Office of Science Coordination and Policy U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, N. W. ( 7201M) EPA East Building Washington, D. C. 20460 Phone: 202 564 8498 Fax: 202 564 8382 christian. myrta@ epa. gov FIFRA Scientific Advisory Panel Members Janice Elaine Chambers, Ph. D. William L. Giles Distinguished Professor & Director College of Veterinary Medicine Mississippi State University Wise Center Spring Street Mississippi State, MS 39762 6100 H. Christopher Frey, Ph. D. Professor, Civil Engineering North Carolina State University 208 Mann Hall, Campus Box 7908 2500 Stinson Drive Raleigh, NC 27695 7908 Stuart Handwerger, M. D. Professor of Pediatrics, University of Cincinnati Children's Hospital Medical Center 3333 Burnet Avenue Cincinnati, OH 45229 3039 2 of 4 Steven G. Heeringa, Ph. D. Research Scientist & Director for Statistical Design Institute for Social Research, University of Michigan P. O. Box 1248 Ann Arbor, MI 48106 1248 Gary Isom, Ph. D. Professor of Toxicology School of Pharmacy & Pharmacal Sciences Purdue University 575 Stadium Mall Drive West Lafayette, IN 47907 2091 Kenneth Portier, Ph. D. Associate Professor, Statistics Institute of Food and Agricultural Sciences University of Florida 522 McCarty Hall, C. P. O. BOX 110339 Gainesville, FL 32611 0339 FQPA Science Review Board Members William Brimijoin, Ph. D. Chair, Pharmacology Mayo Clinic and Medical School 200 1st Street, SW Rochester, MN 55905 001 Thomas F. X. Collins, Ph. D., Fellow, ATS Chief, Developmental/ Reproductive Toxicology And Immunotoxicology Branch U. S. Food and Drug Administration CFSAN, HFS 025 8301 Muirkirk Road Laurel, MD 20708 Deborah Cory Slechta, Ph. D. Environmental and Occupational Health Sciences Institute Robert Wood Johnson Medical School University of Medicine and Dentistry of New Jersey and Rutgers State University, 170 Freylinghuysen Road, Room 235 Piscataway, NJ 08854 Lawrence Fischer, Ph. D. Center for Integrative Toxicology C 231 Holden Hall Michigan State University East Lansing, MI 48824 3 of 4 Paul Foster, Ph. D., Senior Research Fellow National Institute of Environmental Health Sciences PO Box 12233 ( MD E1 06) 111 TW Alexander Drive Research Triangle Park, NC 27709 Bettina M. Francis, Ph. D. Associate Professor, Department of Entomology University of Illinois at Urbana Champaign 320 Morrill Hall, 505 S. Goodwin Avenue Urbana, IL 61801 Gaylia Jean Harry, Ph. D. Neurotoxicology Group Leader National Institute of Environmental Health Sciences 111 Alexander Drive Research Triangle Park, NC 27709 Pamela J. Lein, Ph. D. Scientist, Center for Research on Occupational & Environmental Toxicology Oregon Health & Science University L606, SW Sam Jackson Park Road Portland, OR 97239 Peter Macdonald, D. Phil. Professor of Mathematics and Statistics McMaster University, Hamilton Hall 218 1280 Main St. West Hamilton, Ontario, Canada L8S 4K1 Isaac N. Pessah, Ph. D. Department of Molecular Biosciences Director, Center for Children's Environmental Health and Disease Prevention University of California One Shields Avenue Davis, CA 95616 Carey Pope, Ph. D. Professor of Toxicology & Physiological Sciences Oklahoma State University 264 McElroy Hall Stillwater, OK 74078 Nu May Ruby Reed, Ph. D., D. A. B. T. Staff Toxicologist, Pesticide Regulation California Environmental Protection Agency 1001 I. Street 4 of 4 Sacramento, CA 95812 4015 Jim E. Riviere, D. V. M., Ph. D. Burroughs Wellcome Fund Distinguished Professor and Director Center for Chemical Toxicology Research and Pharmacokinetics Department of Population Health and Pathobiology College of Veterinary Medicine North Carolina State University 4700 Hillsborough St. Raleigh, NC 27606