[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 15999-16001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 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

[[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:

 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 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.
                                                 -------------------------------------------------------------------------------------------------------
    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