Notice2022-17414
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
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Published
August 15, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 87 Issue 156 (Monday, August 15, 2022)</title>
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[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Pages 50088-50089]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<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:
[[Page 50089]]
<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-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 <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.
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 <a href="https://www.fda.gov/media/153631/download">https://www.fda.gov/media/153631/download</a>.
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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 <a href="https://www.fda.gov/media/89258/download">https://www.fda.gov/media/89258/download</a>.
\3\ See ``GDUFA Reauthorization Performance Goals and Program
Enhancements Fiscal Years 2018-2022,'' available at <a href="https://www.fda.gov/media/101052/download">https://www.fda.gov/media/101052/download</a>.
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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 <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: 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
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