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, 15999-16001 [2024-04715]
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Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
Dated: February 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Applications for FDA Approval To
Market a New Drug—21 CFR Part 314
[FR Doc. 2024–04722 Filed 3–5–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by April 5,
2024.
DATES:
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.
ADDRESSES:
ddrumheller on DSK120RN23PROD with NOTICES1
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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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
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://
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15999
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.
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
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16000
Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
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
(§ 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.
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
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
209
514
1
1.31
4.02
1
3
26.55
1
21
857
153
627
13,647
1
24 ..................................
480 ................................
2 ....................................
16 ..................................
80 ..................................
300 ................................
504
411,360
306
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
0.5 (30 minutes) ...........
0.5
ddrumheller on DSK120RN23PROD with NOTICES1
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 ......................................................
Subpart D
314.101(a)—NDA or ANDA filing over protest ..............................................
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Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
16001
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section
Number of
respondents
Number of
responses per
respondent
54
1.98
107
0.5 (30 minutes) ...........
53.5
314.107(e)—notification of court actions or written consent to approval ......
Total annual
responses
Average burden per
response
(in hours)
Total
hours
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 .......................
CPA Requests for NDA/Biologics License Application Products ..................
491
1,335
2
1,024
1,836
69
1
2.05
18.71
1
9.67
6.04
5.84
1
1,005
24,979
2
6,851
11,097
403
1
61 ..................................
8 ....................................
8 ....................................
6 ....................................
4 ....................................
120 ................................
5 ....................................
61,305
199,832
16
41,106
44,388
48,360
5
Total ........................................................................................................
....................
........................
........................
.......................................
3,476,650
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 § 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.
I. Background
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2390]
Notice of the Denial of a Hearing
Request Regarding a Proposal To
Refuse To Approve a Supplemental
New Drug Application for HETLIOZ
(Tasimelteon)
AGENCY:
Food and Drug Administration,
HHS.
ddrumheller on DSK120RN23PROD with NOTICES1
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of the
decision to deny a request for a hearing
regarding the proposal of the Center for
Drug Evaluation and Research (CDER) to
refuse to approve the supplemental new
drug application (sNDA) 205677–004,
submitted by Vanda Pharmaceuticals,
SUMMARY:
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Inc. (Vanda), for HETLIOZ (tasimelteon)
capsules, 20 milligrams (mg), for the
treatment of jet lag disorder. The
decision, which also refuses approval of
sNDA 205677–004, is available in the
docket identified by the number in the
heading of this document.
DATES: The decision was published in
the docket on March 1, 2024.
FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring,
MD 20993, 240–402–5931.
SUPPLEMENTARY INFORMATION:
On January 31, 2014, FDA approved
new drug application (NDA) 205677 for
HETLIOZ (tasimelteon) for treatment of
non-24-hour sleep-wake disorder, a
circadian-rhythm disorder that
disproportionately afflicts individuals
who are totally blind. On October 16,
2018, Vanda submitted the
supplemental NDA (sNDA) that is the
subject at issue here: sNDA 205677–004
for HETLIOZ (tasimelteon) capsules, 20
mg, proposing to add a new indication
for the treatment of jet lag disorder. On
December 1, 2020, FDA approved NDA
214517 for HETLIOZ (tasimelteon)
suspension for the treatment of
nighttime sleep disturbances in
pediatric patients with Smith-Magenis
Syndrome, a rare genetic
neurodevelopment disorder.
On July 1, 2022, Vanda requested an
opportunity for a hearing under 21 CFR
314.110(b)(3) on whether there are
grounds under section 505(d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(d)) for denying approval
of sNDA 205677–004 for the treatment
of jet lag disorder. On August 29, 2022,
CDER notified Vanda by registered mail,
providing it with a notice of opportunity
for a hearing (NOOH) on a proposal to
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refuse to approve sNDA 205677–004.
The NOOH was subsequently published
in the Federal Register of October 11,
2022 (87 FR 61337).
On November 10, 2022, Vanda filed a
notice of participation and requested a
hearing and, on December 12, 2022,
submitted information, data, and
analyses in support of that request. On
June 12, 2023, CDER submitted a
proposed order denying Vanda’s request
for a hearing and refusing to approve the
sNDA. On August 11, 2023, Vanda
responded to CDER’s proposed order.
On September 8, 2023, CDER submitted
a reply, which included a revised
proposed order.
After considering the parties’
submissions, on March 1, 2024, FDA
issued a decision denying Vanda’s
request for a hearing on CDER’s
proposal to refuse approval and refusing
to approve sNDA 205677–004.
II. Electronic Access
Persons with access to the internet
may obtain the final decision at https://
www.regulations.gov/docket/FDA-2022N-2390. The final decision and other
documents pertaining to the refusal to
approve HETLIOZ (sNDA 205677–004)
are available at https://
www.regulations.gov under the docket
number found in brackets in the
heading of this document.
Dated: March 1, 2024.
Namandje´ N. Bumpus,
Principal Deputy Commissioner.
[FR Doc. 2024–04735 Filed 3–5–24; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
