[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25306-25308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10922]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-3101]
Abbreviated New Drug Applications: Pre-Submission Facility
Correspondence Related to Prioritized Generic Drug Submissions;
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 ``ANDAs:
Pre-Submission Facility Correspondence Related to Prioritized Generic
Drug Submissions.'' This guidance describes the facility information to
be submitted in a pre-submission facility correspondence (PFC) and how
FDA will use this information to set a review goal for a priority
abbreviated new drug application (ANDA). This guidance incorporates a
program enhancement agreed upon by the Agency and industry as part of
the negotiations relating to reauthorization of the Generic Drug User
Fee Amendments (GDUFA) and as described in ``GDUFA Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2023-2027''
(GDUFA III commitment letter). This guidance finalizes for
implementation the draft guidance of the same title issued on December
5, 2022.
DATES: The announcement of the guidance is published in the Federal
Register on June 16, 2025.
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://
[[Page 25307]]
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-2017-D-3101 for ``ANDAs: Pre-Submission Facility Correspondence
Related to Prioritized Generic Drug Submissions; Guidance for
Industry.'' 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: Ranjani Prabhakara, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 240-
402-4652, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``ANDAs: Pre-Submission Facility Correspondence Related to
Prioritized Generic Drug Submissions.'' This guidance provides
information to applicants on how FDA intends to assign a goal date
based on the content, timing, and assessment of a PFC submitted prior
to a priority ANDA under section 505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).
The commitments negotiated under the Generic Drug User Fee
Amendments of 2022 (GDUFA III) introduced several changes intended to
further streamline the PFC process, which was originally negotiated
under the Generic Drug User Fee Amendments of 2017 (GDUFA II). Changes
to the PFC process introduced in the GDUFA III commitment letter
include revisions to the content and format of the facility information
that should be submitted in a complete and accurate PFC and increased
flexibility when changes are made between the PFC and ANDA. FDA
considered the applicability of Executive Order 14192, per Office of
Management and Budget (OMB) guidance in M-25-20, and finds this action
to be deregulatory in nature.
This guidance finalizes the draft guidance entitled ``ANDAs: Pre-
Submission Facility Correspondence Related to Prioritized Generic Drug
Submissions'' issued on December 5, 2022 (87 FR 74425). FDA considered
comments received on the draft guidance as the guidance was finalized.
Editorial changes were made to improve clarity about the information to
include in a PFC.
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 ``ANDAs: Pre-Submission Facility
Correspondence Related to Prioritized Generic Drug Submissions.'' 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
OMB under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521). The collections of information in 21 CFR 314 have been approved
under OMB control number 0910-0001. The collections of information in
21 CFR part 210 and 211 (Current Good Manufacturing Practice) have been
approved under OMB control number 0910-0139. The collections of
information relating to Form FDA 356h have been approved under OMB
control number 0910-0338. The collections of information relating to
Form FDA 3794, the Generic Drug User Fee Cover Sheet, have been
approved under OMB control number 0910-0727.
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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: June 10, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10922 Filed 6-13-25; 8:45 am]
BILLING CODE 4164-01-P