Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Draft Guidance for Industry; Availability, 74425-74426 [2022-26412]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 87, Number 232 (Monday, December 5, 2022)]
[Notices]
[Pages 74425-74426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Correspondence Related to Prioritized Generic Drug Submissions; Draft 
Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled 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in the revised draft guidance will qualify the ANDA for a shorter, 8-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 This revised draft guidance describes the 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 Additionally, this revised draft guidance 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to assessing a PFC and replaces the previous draft guidance for 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:
     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-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 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

[[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 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: 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