Notice2024-04715
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
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Published
March 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 89 Issue 45 (Wednesday, March 6, 2024)</title>
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[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 15999-16001]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04715]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2030]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by April 5, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0001. Also include the FDA docket
number found in brackets in the heading of this document.
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#2b7b796a785f4a4d4d6b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="68383a293b1c090e0e280e0c094600001b460f071e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
[[Page 16000]]
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)). Included in our estimated burden is effort
we attribute to information collection activities associated with CPAs.
To assist respondents to the information collection we have
developed the following forms:
<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#6a0c05180719070b040b0d0f182a2529442c2e2b442d253c"><span class="__cf_email__" data-cfemail="e88e879a859b858986898f8d9aa8a7abc6aeaca9c6afa7be">[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 to the information collection are pharmaceutical
industry entities who contribute to the preparation and marketing of
pharmaceutical products regulated by the FDA.
In the Federal Register of September 28, 2023 (88 FR 66853), we
published a notice inviting public comment on the proposed collection
of information. No comments were received.
We estimate the burden of the 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 pharmaceutical 1 1 1 300......................................... 300
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
[[Page 16001]]
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\.
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: February 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04715 Filed 3-5-24; 8:45 am]
BILLING CODE 4164-01-P
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