Notice2024-00403
Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Published
January 11, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Requests for Reconsideration at the Division Level Under GDUFA." This draft guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This draft guidance revises the draft guidance of the same title issued in October 2017. This revision is being issued to reflect the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA) and to clarify what matters are appropriate for requests for reconsideration.
Full Text
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<title>Federal Register, Volume 89 Issue 8 (Thursday, January 11, 2024)</title>
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[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Notices]
[Pages 1923-1924]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00403]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5868]
Requests for Reconsideration at the Division Level Under the
Generic Drug User Fee Amendments; Draft Guidance for Industry;
Availability; Agency Information Collection Activities; Proposed
Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Requests for Reconsideration at the Division Level Under GDUFA.''
This draft guidance provides recommendations on the procedures for
applicants of abbreviated new drug applications (ANDAs) that wish to
pursue a request for reconsideration within the review discipline at
the division level or original signatory authority. This draft guidance
revises the draft guidance of the same title issued in October 2017.
This revision is being issued to reflect the most recent
reauthorization of the Generic Drug User Fee Amendments (GDUFA) and to
clarify what matters are appropriate for requests for reconsideration.
DATES: Submit either electronic or written comments on the draft
guidance by March 11, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by March 11,
2024.
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-5868 for ``Requests for Reconsideration at the Division
Level Under GDUFA.'' 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 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: With regard to the draft guidance:
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver
Spring, MD 20903, 240-695-3412, <a href="/cdn-cgi/l/email-protection#2d604c5f59454c03634a585448436d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="420f2330362a236c0c25373b272c022426236c2a2a316c252d34">[email protected]</span></a>; With regard
to the proposed collection of information: Duong T (Diane) Nhu, Office
of Operations, Food and Drug Administration, Three White Flint North,
10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-402-3953,
<a href="/cdn-cgi/l/email-protection#3d6d6f7c6e495c5b5b7d5b595c1355554e135a524b"><span class="__cf_email__" data-cfemail="8bdbd9cad8ffeaededcbedefeaa5e3e3f8a5ece4fd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Requests for Reconsideration at the Division Level Under
GDUFA.'' This draft guidance provides recommendations on the procedures
for applicants of ANDAs that wish to pursue a request for
reconsideration within the review discipline at the division level or
original signatory authority. Requests within the scope of this
guidance document should concern certain actions that relate to an ANDA
and have scientific significance.
[[Page 1924]]
During the assessment of an ANDA, FDA considers important issues
that are central to product evaluation. Sometimes, an applicant may
disagree with FDA, and because these disagreements often involve
intricate matters, it is critical to have procedures in place to ensure
open and prompt consideration of an applicant's concern(s). The
procedures and policies described in this guidance are intended to
formalize FDA's current and historical practices and to continue to
promote rapid and fair resolution of eligible requests between an
applicant and FDA. This draft guidance revises the draft guidance of
the same title issued on October 12, 2017 (82 FR 47531). This revision
is being issued to reflect the most recent reauthorization of GDUFA in
the Continuing Appropriations and Ukraine Supplemental Appropriations
Act, 2023 (Division F, Title III, Pub. L. 117-180, 136 Stat. 2155), and
to clarify what matters are appropriate for requests for
reconsideration.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Requests for
Reconsideration at the Division Level Under GDUFA.'' 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
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Applications for FDA Approval To Market a New Drug
OMB Control Number 0910-0001--Revision
The information collection request supports the Agency's draft
guidance entitled, ``Requests for Reconsideration at the Division Level
Under GDUFA.'' As discussed in section I of this notice, this draft
guidance provides information to respondents regarding procedures for
submitting requests for reconsideration, including details on the
content and format of the submission. Respondents to the collection of
information are applicants of ANDAs. Based on available data with
regard to similar information collections, FDA's Center for Drug
Evaluation and Research will receive approximately 310 requests for
reconsideration annually from 155 respondents. Because we estimate it
will take 5 hours to prepare a request for reconsideration, we estimate
it will take an average of 1,550 total hours annually for respondents
to prepare and submit requests for reconsideration.
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
Section of guidance/reporting activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
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Section IV: Procedures for Submitting and Responding to a Request 155 2 310 5 1,550
for Reconsideration...............................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
This draft guidance refers to previously approved FDA collections
of information found in FDA regulations. The collections of information
in 21 CFR part 314 have been approved under OMB control number 0910-
0001. The collections of information pertaining to the GDUFA III
commitment letter, meetings related to generic drug development, and
the Generic Drug User Fee Program 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: January 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00403 Filed 1-10-24; 8:45 am]
BILLING CODE 4164-01-P
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