[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Pages 50088-50089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1633]


Soliciting Public Comment on Appendix A of the Food and Drug 
Administration's July 2018 Guidance Entitled ``Abbreviated New Drug 
Application Submissions--Amendments To Abbreviated New Drug 
Applications Under Generic Drug User Fee Amendments;'' Notice; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the establishment of a docket to solicit comments on the 
content of Appendix A in the July 2018 guidance for industry entitled 
``ANDA Submissions--Amendments to Abbreviated New Drug Applications 
Under GDUFA'' (ANDA Amendments Guidance). We are soliciting comments on 
the content of Appendix A. The Agency is taking this action to fulfill 
the Agency's commitment described in section IX.B. of the GDUFA 
Reauthorization Performance Goals and Program Enhancements Fiscal Years 
2023-2027 Commitment Letter (GDUFA III Commitment Letter).

DATES: Either electronic or written comments must be submitted by 
October 14, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 14, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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:

[[Page 50089]]

     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-2022-N-1633 for ``Soliciting Public Comment on Appendix A of FDA's 
July 2018 Guidance Entitled `ANDA Submissions--Amendments to 
Abbreviated New Drug Applications Under GDUFA'; Notice; Establishment 
of a Public Docket; Request for Comments.'' 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.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Office of Generic 
Drugs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver 
Spring, MD 20993-0002, 301-796-3471.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed the Generic Drug User Fee 
Amendments (GDUFA I) into law. GDUFA must be reauthorized every 5 years 
so FDA can continue to assess and collect GDUFA fees, and was most 
recently authorized in the FDA Reauthorization Act of 2017, Public Law 
115-52 (GDUFA II) on August 18, 2017, for fiscal years 2018-2022. In a 
joint effort in anticipation of GDUFA reauthorization in 2022, the 
Agency and representatives from the generic drug industry negotiated 
the draft agreement reflected in the GDUFA III Commitment Letter.\1\ 
Specifically, FDA agreed to performance goals and program enhancements 
regarding aspects of the generic drug assessment program that build on 
the GDUFA program established and enhanced through previous 
authorizations. 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 abbreviated new 
drug applications (ANDAs) and facilitating timely access to quality, 
affordable, safe, and effective generic medicines.
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    \1\ See ``GDUFA Reauthorization Performance Goals and Program 
Enhancements Fiscal Years 2023-2027,'' available at https://www.fda.gov/media/153631/download.
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    In the GDUFA III Commitment Letter, FDA agreed to issue a Federal 
Register notice on or before April 30, 2023, to solicit public comment 
on the content of Appendix A in the ANDA Amendments Guidance.\2\ The 
ANDA Amendments Guidance describes amendment classifications (``major'' 
or ``minor'' amendments) and categories (amendments subject to 
``priority'' or ``standard'' review goals) and explains how amendment 
submission classification and category may affect an amendment's 
performance goal date. The guidance superseded a 2001 guidance entitled 
``Major, Minor, and Telephone Amendments to Abbreviated New Drug 
Applications'' (2001 guidance), which contained descriptions of major 
and minor amendments; however, these descriptions were considered 
during GDUFA II negotiations and were incorporated into the GDUFA II 
Commitment Letter.\3\ Accordingly, the ANDA Amendments Guidance 
incorporates the descriptions from the 2001 guidance, and provides 
further description of these amendments, including general descriptions 
and examples of the types of deficiencies that would classify an 
applicant's response to these deficiencies as a major or minor 
amendment. Appendix A in the ANDA amendments guidance (Appendix A: 
Major Deficiencies) is a non-exhaustive list of examples of 
deficiencies that the FDA may consider major.
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    \2\ See the guidance for industry entitled ``ANDA Submissions--
Amendments to Abbreviated New Drug Applications Under GDUFA,'' 
available at https://www.fda.gov/media/89258/download.
    \3\ See ``GDUFA Reauthorization Performance Goals and Program 
Enhancements Fiscal Years 2018-2022,'' available at https://www.fda.gov/media/101052/download.
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    With this notice, FDA is seeking comments on the examples of major 
deficiencies listed in Appendix A of the ANDA amendments guidance, as 
well as comment on how any proposed revisions to that list could be 
beneficial to industry in understanding ANDA amendment classification.

II. Paperwork Reduction Act of 1995

    This notice contains no new collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

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: August 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17414 Filed 8-12-22; 8:45 am]
BILLING CODE 4164-01-P


