Notice2022-26412
Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Draft Guidance for Industry; Availability
Primary source
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Published
December 5, 2022
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions." For purposes of implementing the Generic Drug User Fee Amendments of 2022 (GDUFA III), the Pre-Submission Facility Correspondence (PFC) process was revised as part of the performance goals and program enhancements agreed to by FDA and industry, as described in the GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III commitment letter). FDA assesses facility information submitted in a PFC to inform the Agency's decision regarding the need for facility inspections that support assessment of the abbreviated new drug application (ANDA). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned ANDA submission for priority ANDAs, allowing the Agency more time to make preapproval inspection decisions. A PFC meeting the conditions outlined in the revised draft guidance will qualify the ANDA for a shorter, 8- month priority review goal. This revised draft guidance describes the content, timing, and assessment of a complete and accurate PFC for purposes of GDUFA III. Additionally, this revised draft guidance provides information on the Agency's rationale for and current approach to assessing a PFC and replaces the previous draft guidance for industry, "ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence)," issued in November 2017.
Full Text
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<title>Federal Register, Volume 87 Issue 232 (Monday, December 5, 2022)</title>
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[Federal Register Volume 87, Number 232 (Monday, December 5, 2022)]
[Notices]
[Pages 74425-74426]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26412]
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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; 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 revised draft guidance for industry entitled
``ANDAs: Pre-Submission Facility Correspondence Related to Prioritized
Generic Drug Submissions.'' For purposes of implementing the Generic
Drug User Fee Amendments of 2022 (GDUFA III), the Pre-Submission
Facility Correspondence (PFC) process was revised as part of the
performance goals and program enhancements agreed to by FDA and
industry, as described in the GDUFA Reauthorization Performance Goals
and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III
commitment letter). FDA assesses facility information submitted in a
PFC to inform the Agency's decision regarding the need for facility
inspections that support assessment of the abbreviated new drug
application (ANDA). A complete and accurate PFC allows the Agency to
begin the facility assessment process in advance of the planned ANDA
submission for priority ANDAs, allowing the Agency more time to make
preapproval inspection decisions. A PFC meeting the conditions outlined
in the revised draft guidance will qualify the ANDA for a shorter, 8-
month priority review goal. This revised draft guidance describes the
content, timing, and assessment of a complete and accurate PFC for
purposes of GDUFA III. Additionally, this revised draft guidance
provides information on the Agency's rationale for and current approach
to assessing a PFC and replaces the previous draft guidance for
industry, ``ANDAs: Pre-Submission of Facility Information Related to
Prioritized Generic Drug Applications (Pre-Submission Facility
Correspondence),'' issued in November 2017.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 6, 2023. Submit either electronic or written comments
concerning the collection of information proposed in the draft guidance
by February 3, 2023.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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-2017-D-3101 for ``ANDAs: Pre-Submission Facility Correspondence
Related to Prioritized Generic Drug Submissions.'' 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
[[Page 74426]]
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: Ranjani Prabhakara, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, rm. 6648, Silver Spring, MD 20993, 240-402-
4652.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``ANDAs: Pre-Submission Facility Correspondence
Related to Prioritized Generic Drug Submissions.'' This guidance
replaces the draft guidance for industry ``ANDAs: Pre-Submission of
Facility Information Related to Prioritized Generic Drug Applications
(Pre-Submission Facility Correspondence),'' issued in November 2017.
The PFC is a mechanism under which FDA assesses facility
information submitted in a PFC to inform the Agency's decision
regarding the need for facility inspections that support assessment of
priority ANDAs, prior approval supplements (PASs), PAS amendments, and
ANDA amendments (collectively referred to herein as ANDAs). Under the
performance goals and program enhancements described in the GDUFA III
commitment letter, FDA agreed to a shorter 8-month goal date for action
on such priority generic drug submissions if a PFC meets specified
conditions.
A complete and accurate PFC allows the Agency to begin the facility
assessment process in advance of the planned ANDA submission for
priority ANDAs. This lead time provides the Agency the opportunity to
determine whether facility inspections will be needed, and, when they
are, to initiate inspection planning earlier in the assessment of a
priority ANDA, helping the Agency to meet the shorter priority review
goal timeframe.
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent 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. 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 collections of
information are subject to review by OMB under the PRA. 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 have been
approved under OMB control number 0910-0727.
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: November 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26412 Filed 12-2-22; 8:45 am]
BILLING CODE 4164-01-P
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