
[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66853-66856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 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.

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, 
[email protected].

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 https://www.fda.gov 
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 https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs. 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    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]]


 Form FDA 356h (and instructions): Application to Market a New 
or Abbreviated New Drug or Biologic for Human Use
 Form FDA 2252 (and instructions): Transmittal of Annual 
Reports for Drugs and Biologics for Human Use (Sec.  314.81)
 Form FDA 2253 (and instructions): Transmittal of 
Advertisements and Promotional Labeling for Drugs and Biologics for 
Human Use
 Forms FDA 3331/3331a (and instructions): Field Alert Reports
 Form FDA 3542 (and instructions): Patent Information Submitted 
Upon and After Approval of an NDA or Supplement
 FDA 3542a (and instructions): Patent Information Submitted 
with the Filing of an NDA, Amendment, or Supplement
 Revised Form FDA 3938 (and revised instruction): DMF 
submission
 Form FDA 3988 (and instruction): Transmittal of post marketing 
requirements (PMR)/postmarketing commitments (PMC) submissions for 
Drugs and Biologics
 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 [email protected]. 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.
                                                 -------------------------------------------------------------------------------------------------------
    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


