Notice2023-21256
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug
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Published
September 28, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with applications for FDA approval to market a new drug or generic drug.
Full Text
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<title>Federal Register, Volume 88 Issue 187 (Thursday, September 28, 2023)</title>
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[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66853-66856]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21256]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2030]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Application for Food and Drug Administration Approval
To Market a New Drug
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with applications for FDA approval to market a new drug or
generic drug.
DATES: Either electronic or written comments on the collection of
information must be submitted by November 27, 2023.
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 November 27, 2023. 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:
<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-2020-N-2030 for ``Application for Food and Drug Administration
Approval to Market a New Drug.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#ca9a988b99beabacac8aacaeabe4a2a2b9e4ada5bc"><span class="__cf_email__" data-cfemail="712123302205101717311715105f1919025f161e07">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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
[[Page 66854]]
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, including each proposed extension
of an existing 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--21 CFR Part 314
OMB Control Number 0910-0001--Revision
This information collection supports implementation of statutory
and regulatory authorities that govern new drugs. Under section 505(a)
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
355(a)), a new drug may not be commercially marketed in the United
States unless an approval of an application filed with FDA under
section 505(b) or (j) of the FD&C Act is effective with respect to such
drug. We have issued regulations in part 314 (21 CFR part 314) that
establish procedures and requirements for applications submitted in
accordance with section 505 of the FD&C Act. The regulations in subpart
A (Sec. Sec. 314.1 through 314.3) set forth general provisions, while
regulations in subparts B and C (Sec. Sec. 314.50 through 314.99) set
forth content and format requirements for new drug applications (NDAs)
and abbreviated new drug applications (ANDAs) respectively. The
regulations include requirements for the submission of specific data
elements along with patent information, pediatric use information,
supplements and amendments, proposed labeling, and specific
postmarketing reports (PMRs). Respondents to the information collection
are sponsors of these applications.
Regulations in subpart D (Sec. Sec. 314.100 through 314.170)
explain Agency actions on applications and set forth timeframes for FDA
review. The information collection includes provisions established
through our Agency user fee programs, most recently authorized under
the FDA User Fee Reauthorization Act of 2022. These provisions pertain
to performance goals, expedited programs, review transparency,
communications with FDA, dispute resolution, drug safety enhancements,
and the allocation of Agency resources to align with these program
objectives as agreed to with our stakeholders and set forth in our
``User Fee Performance Goals for Fiscal Years 2023-2027'' Commitment
Letters, which are available from our website at <a href="https://www.fda.gov">https://www.fda.gov</a>
along with more information about specific FDA user fee programs.
Included among the provisions in subpart G (Sec. Sec. 314.410
through 314.445), Sec. 314.420 covers information to include in drug
master files (DMFs). To assist respondents to this information
collection we have prepared templates, guidance, forms, and resources
available from our website at <a href="https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs">https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs</a>. We have developed Form
FDA 3938 and accompanying instructions on submitting DMFs in accordance
with the applicable regulations. We are revising Form FDA 3898 and the
accompanying instructions to allow for multiple selections of
submission types and to clarify the number of digits to be entered for
the holder and establishment registration numbers.
In accordance with Sec. 314.445, we also develop Agency guidance
documents to assist respondents in complying with provisions in part
314. These guidance documents are issued consistent with our good
guidance practice regulations at 21 CFR 10.115. To search available FDA
guidance documents, visit our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
Applications submitted in accordance with subpart H (Sec. Sec.
314.500 through 314.560) pertain to accelerated approval of new drugs
for serious or life-threatening illnesses.
Information collection and associated burden for the submissions in
subpart I (Sec. Sec. 314.600 through 314.650) pertain to approval of
certain new drugs when human efficacy studies are not ethical or
feasible. The regulations provide for the submission of specific data
elements, animal studies of safety and efficacy to establish likely
clinical benefit in humans and upon approval of the drug product,
additional requirements and/or restrictions to ensure safe use of the
product. Additional PMRs, safety reporting, and promotional material as
well as requirements for withdrawal of these human drug applications,
and FDA termination of requirements for these human drug applications
are included in Sec. Sec. 314.620 through 314.650. The estimated
burden for these human drug applications is included in the reported
submissions and burden under general human drug applications, Sec.
314.50, and other specific regulations in the table for human drug
application requirements in general.
Finally, we are also revising the collection to include the
submission of information pursuant to the CREATES Act (enacted as part
of the Further Consolidated Appropriations Act of 2020 (21 U.S.C. 355-
1(1) and 355-2)). Under the CREATES Act, developers of potential drug
and biological products are enabled to use the CREATES pathway to
obtain samples of brand products that are needed to support their
applications. Relevant products include those submitted in generic drug
applications under section 505(j) of the FD&C Act and NDAs submitted
under section 505(b)(2) of the FD&C Act, and biosimilar products
submitted under section 351(k) of the Public Health Service Act as
amended by the Biologics Price Competition and Innovation Act of 2009.
One of the requirements for using the CREATES pathway for products that
are subject to a Risk Evaluation and Mitigation Strategy with elements
to assure safe use is to obtain a Covered Product Authorization (CPA)
from FDA (21 U.S.C. 355-2(b)(2)). New information collection burden for
CPAs for new drug and biologic applications is included in the burden
table below.
To assist respondents to the information collection we have
developed the following forms:
[[Page 66855]]
<bullet> Form FDA 356h (and instructions): Application to Market a New
or Abbreviated New Drug or Biologic for Human Use
<bullet> Form FDA 2252 (and instructions): Transmittal of Annual
Reports for Drugs and Biologics for Human Use (Sec. 314.81)
<bullet> Form FDA 2253 (and instructions): Transmittal of
Advertisements and Promotional Labeling for Drugs and Biologics for
Human Use
<bullet> Forms FDA 3331/3331a (and instructions): Field Alert Reports
<bullet> Form FDA 3542 (and instructions): Patent Information Submitted
Upon and After Approval of an NDA or Supplement
<bullet> FDA 3542a (and instructions): Patent Information Submitted
with the Filing of an NDA, Amendment, or Supplement
<bullet> Revised Form FDA 3938 (and revised instruction): DMF
submission
<bullet> Form FDA 3988 (and instruction): Transmittal of post marketing
requirements (PMR)/postmarketing commitments (PMC) submissions for
Drugs and Biologics
<bullet> Form FDA 3989 (and instruction): Transmittal of PMR/PMC Annual
Status Report Information
Individuals requesting printed forms are instructed to contact the FDA
Forms Manager by email at <a href="/cdn-cgi/l/email-protection#75131a07180618141b14121007351a165b1311145b121a03"><span class="__cf_email__" data-cfemail="167079647b657b7778777173645679753870727738717960">[email protected]</span></a>. Certain fees may be
applicable.
Information collection pertaining to hearings and other
administrative proceedings covered in 21 CFR subpart E are approved
under OMB control number 0910-0191. Unless otherwise noted, information
collection pertaining to postmarket safety reporting and associated
recordkeeping is approved under OMB control numbers 0910-0230 and 0910-
0291.
Respondents for this information collection include pharmaceutical
industry entities who contribute to the preparation and marketing of
pharmaceutical products to the U.S. public.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden per response (in hours) Total hours
respondents respondent responses
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Subpart B
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314.50(a)-(l)--Content and format of a 505(b)(1) 85 1.42 121 1,921....................................... 232,441
or 505(b)(2) application.
314.50(i)(1)--Patent certifications: Form FDA 170 6.55 1,113 10.......................................... 11,130
3542.
314.50(i)(1)--Patent certifications: Form FDA 1 1 1 15.......................................... 15
3542a.
314.50(i)(6)--Amended patent certifications..... 73 4.33 316 2........................................... 632
314.52(a), (b), and (e)--NDAs--Notice of 15 3 45 15.......................................... 675
noninfringement of patent certification.
314.52(c)--Noninfringement of patent 22 3 66 0.33 (20 minutes)........................... 22
certification notice content.
314.53(f)(1)--Correction of patent information 7 1.14 8 10.......................................... 80
errors by persons other than the NDA holder.
314.53(f)(2)--Correction of patent information 8 1.13 9 1........................................... 9
errors by the NDA holder.
314.60--Amendments to unapproved NDA, supplement 269 7.22 1,942 80.......................................... 155,360
or resubmission.
314.60(f)--Patent certifications for unapproved 6 1 6 2........................................... 12
applications.
314.65--Withdrawal of unapproved applications... 20 1.05 21 2........................................... 42
314.70 and 314.71--Supplements and other changes 501 5.13 2,570 150......................................... 385,500
to approved application.
314.72--Changes of ownership of NDAs............ 73 1.67 122 2........................................... 244
314.81--Other PMR 314.81(b)(1) [3331 and 3331a 532 18.5 9,834 8........................................... 78,672
field alert reports and follow-ups].
314.81(b)(2)--[Form FDA 2252]--Annual reports... 692 4.46 3,090 40.......................................... 123,600
314.81(b)(2)--[Form FDA 2253]--Promotional 310 121 37,508 2........................................... 75,016
labeling.
314.81(b)(2)(vii) Form FDA 3988--PMR/PMC........ 737 0.87 642 24.......................................... 15,408
314.81(b)(2)(vii) Form FDA 3989--PMR/PMC Annual 737 0.29 216 24.......................................... 5,184
Status Report for Drugs and Biologics.
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Subpart C
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314.93--Suitability Petitions................... 16 1.31 21 24.......................................... 504
314.94(a) and (d)--ANDA content................. 213 4.02 857 480......................................... 411,360
314.94(a)(12)(viii)--Amended patent 153 1 153 2........................................... 306
certifications before approval of ANDA.
314.95(c)--Noninfringement of patents (ANDAs)... 209 3 627 16.......................................... 10,032
314.96(a)(1)--Amendments to unapproved ANDAs.... 514 26.55 13,647 80.......................................... 1,091,760
314.96(c)--Amendment for pharmaceutical 1 1 1 300......................................... 300
equivalent to a listed drug other than
reference listed drug.
314.96(d)--Patent certification requirements.... 100 1 100 2........................................... 200
314.97--Supplements and other changes to ANDAs.. 343 17.57 6,027 80.......................................... 482,160
314.97(b)--Supplements to ANDA for 1 1 1 300......................................... 300
pharmaceutical equivalent to a listed drug
other than RLD.
314.99(a)--ANDA Applicants: Withdrawal of 58 2.41 140 2........................................... 280
unapproved ANDAs.
314.99(a)--ANDA Transfer of ownership........... 137 1.24 170 2........................................... 340
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Subpart D
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314.101(a)--NDA or ANDA filing over protest..... 1 1 1 0.5 (30 minutes)............................ 0.5
314.107(e)--notification of court actions or 54 1.98 107 0.5 (30 minutes)............................ 53.5
written consent to approval.
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Subparts G, H, and I
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314.420--Drug Master Files--original Form FDA 491 2.05 1,005 61.......................................... 61,305
3938.
DMF Amendments--Technical....................... 1,335 18.71 24,979 8........................................... 199,832
DMF Amendments--REMS............................ 2 1 2 8........................................... 16
DM Amendments--administrative................... 1,024 9.67 6,851 6........................................... 41,106
DMFs--Annual reports............................ 1,836 6.04 11,097 4........................................... 44,388
314.550--Promotional material and subpart H 69 5.84 403 120......................................... 48,360
applications \2\.
[[Page 66856]]
CPA Requests for NDA/Biologics License 1 1 1 5........................................... 5
Application Products.
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Total....................................... ........... .............. .............. ............................................ 3,476,650
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\1\ Total burden hours have been rounded.
\2\ We have included burden attendant to subpart H applications activity in our estimate of burden associated with Sec. 314.50.
Our estimated burden for the information collection reflects an
overall decrease of 642,293.5 hours. The reporting period for this
information collection renewal includes the 3 years of the COVID-19
pandemic. We attribute this adjustment to a decrease in the number of
submissions received during the public health emergency. We anticipate
that the numbers of submissions to FDA will return to pre-pandemic
levels as economic activity recovers. We also attribute a portion of
the burden adjustment to improved operational efficiencies with regard
to Agency data systems and digital submission processes.
Dated: September 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21256 Filed 9-27-23; 8:45 am]
BILLING CODE 4164-01-P
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