[Federal Register Volume 89, Number 161 (Tuesday, August 20, 2024)]
[Notices]
[Pages 67446-67447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18636]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0044]


Product-Specific Guidance Meetings Between the Food and Drug 
Administration and Abbreviated New Drug Application Applicants Under 
the Generic Drug User Fee Amendments; 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 final guidance for industry entitled ``Product-
Specific Guidance Meetings Between FDA and ANDA Applicants Under 
GDUFA.'' This guidance provides recommendations to industry on product-
specific guidance (PSG) meetings between FDA and a prospective 
applicant preparing to submit to FDA, or an applicant that has 
submitted to FDA, an abbreviated new drug application (ANDA) under the 
Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, this 
guidance provides information on requesting and conducting PSG meetings 
with FDA (i.e., pre-submission PSG teleconferences, post-submission PSG 
teleconferences, pre-submission PSG meetings, and post-submission PSG 
meetings), as contemplated in the Generic Drug User Fee Amendments 
(GDUFA) Reauthorization Performance Goals and Program Enhancements 
Fiscal Years 2023-2027 (GDUFA III commitment letter). This guidance 
provides procedures that will promote well-managed PSG meetings and 
help ensure that such meetings are scheduled and conducted in 
accordance with the time frames set forth in the GDUFA III commitment 
letter. This guidance finalizes the draft guidance for industry of the 
same title issued on February 21, 2023.

DATES: The announcement of the guidance is published in the Federal 
Register on August 20, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-0044 for ``Product-Specific Guidance Meetings Between FDA 
and ANDA Applicants 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: David Coppersmith, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring MD 20993-0002, 301-
796-9193.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Product-Specific Guidance Meetings Between FDA and ANDA 
Applicants Under GDUFA.'' 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 the Agency with resources to help ensure patients 
have access to quality, safe, and effective generic drugs. GDUFA fee 
resources bring

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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 two times since GDUFA I, most recently in 
the Generic Drug User Fee Amendments of 2022 (GDUFA III). As described 
in the GDUFA III commitment letter applicable to this latest 
reauthorization, FDA 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.
    To receive approval for an ANDA submitted under section 505(j) of 
the FD&C Act (21 U.S.C. 355(j)), an applicant generally must 
demonstrate, among other things, that its proposed drug product is 
bioequivalent to the reference listed drug (RLD). As noted in 21 CFR 
320.24, in vivo methods, in vitro methods, or both can be used to 
establish bioequivalence (BE). FDA recommends that applicants consult 
published PSGs when considering an appropriate BE study and/or other 
studies for a proposed drug product. PSGs provide recommendations for 
developing generic drug products and describe FDA's current thinking on 
the evidence needed to demonstrate that an ANDA is therapeutically 
equivalent to the specific RLD product.
    As described in the GDUFA III commitment letter, FDA agreed to 
certain performance goals, including time frames and procedures for 
scheduling and conducting: (1) PSG teleconferences to provide feedback 
on the potential impact of a new or revised PSG on the applicant's 
development program; and (2) pre-submission PSG meetings and post-
submission PSG meetings to provide a forum in which the applicant can 
discuss the scientific rationale for an approach other than the 
approach recommended in a new or revised PSG to ensure that the 
approach complies with the relevant statutes and regulations.
    This guidance finalizes the draft guidance of the same title issued 
on February 21, 2023 (88 FR 10523). FDA considered comments received on 
the draft guidance as the guidance was finalized. Changes from the 
draft to the final guidance include updates to clarify when applicants 
can submit PSG teleconference and PSG meeting requests, the topics that 
applicants can discuss during PSG teleconferences and PSG meetings, and 
when applicants should utilize other pathways to seek FDA's feedback. 
In addition, FDA made editorial changes to improve clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Product-Specific Guidance Meetings Between 
FDA and ANDA Applicants 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 (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
pertaining to the submissions of controlled correspondence, GDUFA III 
meetings related to generic drug development, and the Generic Drug User 
Fee Program have been approved under OMB control number 0910-0727. The 
collections of information in 21 CFR part 314 have been approved under 
OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the 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 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18636 Filed 8-19-24; 8:45 am]
BILLING CODE 4164-01-P