Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug, 66853-66856 [2023-21256]
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Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
name of the technology for which they
will be presenting.
Registration for attendees not
presenting at the meeting is not
required.
IV. Collection of Information
This document does not impose
information collection requirements,
that is, reporting, recordkeeping, or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35).
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Chyana Woodyard, who is
the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–21186 Filed 9–27–23; 8:45 am]
BILLING CODE 4120–01–P
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.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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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
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66853
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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
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Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
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
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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 (§§ 314.1 through 314.3) set
forth general provisions, while
regulations in subparts B and C
(§§ 314.50 through 314.99) set forth
content and format requirements for
new drug applications (NDAs) and
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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 (§§ 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 (§§ 314.410 through 314.445),
§ 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-submissionrequirements/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 § 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-fdaguidance-documents.
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Applications submitted in accordance
with subpart H (§§ 314.500 through
314.560) pertain to accelerated approval
of new drugs for serious or lifethreatening illnesses.
Information collection and associated
burden for the submissions in subpart I
(§§ 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 §§ 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,
§ 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:
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Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
• 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
(§ 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 formsmanager@
oc.fda.gov. Certain fees may be
applicable.
66855
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
Number of
respondents
21 CFR section
Number of
responses per
respondent
Average burden
per response
(in hours)
Total annual
responses
Total hours
Subpart B
314.50(a)–(l)—Content and format of a 505(b)(1) or 505(b)(2) application ..
314.50(i)(1)—Patent certifications: Form FDA 3542 .....................................
314.50(i)(1)—Patent certifications: Form FDA 3542a ...................................
314.50(i)(6)—Amended patent certifications .................................................
314.52(a), (b), and (e)—NDAs—Notice of noninfringement of patent certification.
314.52(c)—Noninfringement of patent certification notice content ................
314.53(f)(1)—Correction of patent information errors by persons other than
the NDA holder.
314.53(f)(2)—Correction of patent information errors by the NDA holder ....
314.60—Amendments to unapproved NDA, supplement or resubmission ...
314.60(f)—Patent certifications for unapproved applications ........................
314.65—Withdrawal of unapproved applications ..........................................
314.70 and 314.71—Supplements and other changes to approved application.
314.72—Changes of ownership of NDAs ......................................................
314.81—Other PMR 314.81(b)(1) [3331 and 3331a field alert reports and
follow-ups].
314.81(b)(2)—[Form FDA 2252]—Annual reports .........................................
314.81(b)(2)—[Form FDA 2253]—Promotional labeling ................................
314.81(b)(2)(vii) Form FDA 3988—PMR/PMC ..............................................
314.81(b)(2)(vii) Form FDA 3989—PMR/PMC Annual Status Report for
Drugs and Biologics.
85
170
1
73
15
1.42
6.55
1
4.33
3
121
1,113
1
316
45
1,921 .............................
10 ..................................
15 ..................................
2 ....................................
15 ..................................
232,441
11,130
15
632
675
22
7
3
1.14
66
8
0.33 (20 minutes) .........
10 ..................................
22
80
8
269
6
20
501
1.13
7.22
1
1.05
5.13
9
1,942
6
21
2,570
1 ....................................
80 ..................................
2 ....................................
2 ....................................
150 ................................
9
155,360
12
42
385,500
73
532
1.67
18.5
122
9,834
2 ....................................
8 ....................................
244
78,672
692
310
737
737
4.46
121
0.87
0.29
3,090
37,508
642
216
40 ..................................
2 ....................................
24 ..................................
24 ..................................
123,600
75,016
15,408
5,184
16
213
153
1.31
4.02
1
21
857
153
24 ..................................
480 ................................
2 ....................................
504
411,360
306
209
514
1
3
26.55
1
627
13,647
1
16 ..................................
80 ..................................
300 ................................
10,032
1,091,760
300
100
343
1
1
17.57
1
100
6,027
1
2 ....................................
80 ..................................
300 ................................
200
482,160
300
58
137
2.41
1.24
140
170
2 ....................................
2 ....................................
280
340
1
1.98
1
107
0.5 (30 minutes) ...........
0.5 (30 minutes) ...........
0.5
53.5
2.05
18.71
1
9.67
6.04
5.84
1,005
24,979
2
6,851
11,097
403
61 ..................................
8 ....................................
8 ....................................
6 ....................................
4 ....................................
120 ................................
61,305
199,832
16
41,106
44,388
48,360
Subpart C
314.93—Suitability Petitions ..........................................................................
314.94(a) and (d)—ANDA content .................................................................
314.94(a)(12)(viii)—Amended patent certifications before approval of
ANDA.
314.95(c)—Noninfringement of patents (ANDAs) ..........................................
314.96(a)(1)—Amendments to unapproved ANDAs .....................................
314.96(c)—Amendment for pharmaceutical equivalent to a listed drug
other than reference listed drug.
314.96(d)—Patent certification requirements ................................................
314.97—Supplements and other changes to ANDAs ...................................
314.97(b)—Supplements to ANDA for pharmaceutical equivalent to a listed
drug other than RLD.
314.99(a)—ANDA Applicants: Withdrawal of unapproved ANDAs ...............
314.99(a)—ANDA Transfer of ownership ......................................................
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Subpart D
314.101(a)—NDA or ANDA filing over protest ..............................................
314.107(e)—notification of court actions or written consent to approval ......
1
54
Subparts G, H, and I
314.420—Drug Master Files—original Form FDA 3938 ................................
DMF Amendments—Technical ......................................................................
DMF Amendments—REMS ...........................................................................
DM Amendments—administrative ..................................................................
DMFs—Annual reports ...................................................................................
314.550—Promotional material and subpart H applications 2 .......................
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2
1,024
1,836
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Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section
Number of
respondents
Number of
responses per
respondent
1
1
CPA Requests for NDA/Biologics License Application Products ..................
Total ........................................................................................................
1 Total
Average burden
per response
(in hours)
Total annual
responses
1
Total hours
5 ....................................
5
I.................... I........................ I........................ I.......................................
3,476,650
burden hours have been rounded.
2 We have included burden attendant to subpart H applications activity in our estimate of burden associated with § 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 prepandemic 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2023–N–3847]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 the proposed
extension of the collection of
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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18:09 Sep 27, 2023
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Submit either electronic or
written comments on the collection of
information by November 27, 2023.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 27,
2023. 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 postmarked or the delivery
service acceptance receipt is on or
before that date.
ADDRESSES:
Electronic Submissions
Food and Drug Administration
AGENCY:
information applicable to required
adverse experience reporting for
licensed biological products, and
general records associated with the
manufacture and distribution of
biological products.
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’’).
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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–
2023–N–3847 for ‘‘Adverse Experience
Reporting for Licensed Biological
Products; and General Records.’’
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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
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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
