[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10523-10525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03517]


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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 Applicants 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Drug User Fee Act; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Product-
Specific Guidance Meetings Between FDA and ANDA Applicants Under 
GDUFA.'' This draft guidance provides recommendations to industry on 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 Specifically, this draft 
guidance provides information on requesting and conducting PSG meetings 
with FDA (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 
draft guidance is intended to provide procedures that will promote 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.

DATES: Submit either electronic or written comments on the draft 
guidance by April 24, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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://

[[Page 10524]]

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 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: 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 draft guidance for industry 
entitled ``Product-Specific Guidance Meetings Between FDA and ANDA 
Applicants Under GDUFA.'' The Generic Drug User Fee Amendments (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, affordable, safe, and effective generic drugs. GDUFA 
fee resources bring greater predictability and timeliness to the review 
of generic drug applications. GDUFA must be 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 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.
    To receive approval for an ANDA submitted under section 505(j) of 
the FD&C Act, 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 and/or 
in vitro methods 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 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 the PSG to ensure 
that the approach complies with the relevant statutes and regulations.
    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 ``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

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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 collection of 
information are subject to review by OMB under the PRA. The collections 
of information pertaining to the submissions of controlled 
correspondence, GDUFA III commitment letter, and meetings related to 
generic drug development have been approved under OMB control number 
0910-0797. The collections of information pertaining to 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 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: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03517 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P