[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Notices]
[Pages 1923-1924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Generic Drug User Fee Amendments; Draft Guidance for Industry; 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announcing the availability of a draft guidance for industry entitled 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This draft guidance provides recommendations on the procedures for 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 This draft guidance 
revises the draft guidance of the same title issued in October 2017.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DATES: Submit either electronic or written comments on the draft 
guidance by March 11, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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proposed collection of information in the draft guidance by March 11, 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:
     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-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 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 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, [email protected]; 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, 
[email protected].

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.

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    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 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: 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