Notice2023-03517
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Between the Food and Drug Administration and Abbreviated New Drug Applicants Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability
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Published
February 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Product- Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA." This draft guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA or an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 Specifically, this draft guidance provides information on requesting and conducting PSG meetings with FDA (PSG teleconferences, pre-submission PSG meetings, and post- submission PSG meetings),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 This draft guidance is intended to provide procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with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.
Full Text
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<title>Federal Register, Volume 88 Issue 34 (Tuesday, February 21, 2023)</title>
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[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10523-10525]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Drug User Fee Act; Draft Guidance for Industry; Availability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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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