Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification To Accompany Drug, Biological Product, and Device Applications or Submissions, 10104-10106 [2021-03243]
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10104
Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–03234 Filed 2–17–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0275]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Certification To
Accompany Drug, Biological Product,
and Device Applications or
Submissions
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 March 22,
2021.
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 0910–0616. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
jbell on DSKJLSW7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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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Jkt 253001
Certification To Accompany Drug,
Biological Product, and Device
Applications or Submissions (Form
FDA 3674)
OMB Control Number 0910–0616—
Extension
The information required under
section 402(j)(5)(B) of the Public Health
Service Act (PHS Act) (42 U.S.C.
282(j)(5)(B)) is submitted in the form of
a certification, Form FDA 3674, which
accompanies applications and
submissions currently submitted to FDA
and already approved by OMB. The
OMB control numbers and expiration
dates for those applications and
submissions are: 21 CFR parts 312 and
314 (human drugs), OMB control
number 0910–0014, expiring March 31,
2022, and OMB control number 0910–
0001, expiring March 31, 2021; 21 CFR
parts 312 and 601 (biological products),
OMB control number 0910–0014,
expiring March 31, 2022, and OMB
control number 0910–0338, expiring
February 28, 2023; 21 CFR parts 807 and
814 (devices), OMB control number
0910–0120, expiring June 30, 2020, and
OMB control number 0910–0231,
expiring March 31, 2023.
Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110–85)
amended the PHS Act by adding section
402(j). The provisions broadened the
scope of clinical trials subject to
submitting information and required
additional information to be submitted
to the clinical trials databank (https://
clinicaltrials.gov/) (FDA has verified the
website address, but FDA is not
responsible for any subsequent changes
to the website after this document
publishes in the Federal Register)
previously established by the National
Institutes of Health (NIH)/National
Library of Medicine. This includes
expanded information on applicable
clinical trials and summary information
on the results of certain clinical trials.
The provisions include responsibilities
for FDA as well as several amendments
to the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
One provision, section 402(j)(5)(B) of
the PHS Act, requires that a certification
accompany human drug, biological, and
device product submissions made to
FDA. Specifically, at the time of
submission of an application under
sections 505, 515, or 520(m) of the
FD&C Act (21 U.S.C. 355, 360e, or
360j(m)), or under section 351 of the
PHS Act (42 U.S.C. 262), or submission
of a report under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)), such
application or submission must be
accompanied by a certification, Form
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
FDA 3674, that all applicable
requirements of section 402(j) of the
PHS Act have been met. Where
available, such certification must
include the appropriate National
Clinical Trial (NCT) numbers that are
assigned upon submission of required
information to the NIH databank at
https://clinicaltrials.gov/.
The proposed extension of the
collection of information is necessary to
satisfy the previously mentioned
statutory requirement. The importance
of obtaining these data relates to
adherence to the legal requirements for
submissions to the clinical trials registry
and results data bank and ensuring that
individuals and organizations
submitting applications or reports to
FDA under the listed provisions of the
FD&C Act or the PHS Act adhere to the
appropriate legal and regulatory
requirements for certifying to having
complied with those requirements. The
failure to submit the certification
required by section 402(j)(5)(B) of the
PHS Act, and the knowing submission
of a false certification, are both
prohibited acts under section 301 of the
FD&C Act (21 U.S.C. 331). Violations are
subject to civil money penalties. Form
FDA 3674 provides a convenient
mechanism for sponsors/applicants/
submitters to satisfy the certification
requirements of the statutory provision.
To assist sponsors/applicants/
submitters in understanding the
statutory requirements associated with
Form FDA 3674, we have provided a
guidance available at: https://
www.fda.gov/RegulatoryInformation/
Guidances/ucm125335.htm. This
guidance recommends the applications
and submissions FDA considers should
be accompanied by the certification
form, Form FDA 3674. The applications
and submissions identified in the
guidance are reflected in the burden
analysis. FDA last updated this
guidance in 2017.
Investigational New Drug
Applications. FDA’s Center for Drug
Evaluation and Research (CDER)
received 1,661 investigational new drug
applications (INDs) and 11,328 clinical
protocol IND amendments in calendar
year (CY) 2019. CDER anticipates that
IND and clinical protocol amendment
submission rates will remain at or near
this level in the near future.
FDA’s Center for Biologics Evaluation
and Research (CBER) received 639 new
INDs and 581 clinical protocol IND
amendments in CY 2019. CBER
anticipates that IND and clinical
protocol amendment submission rates
will remain at or near this level in the
near future. The estimated total number
of submissions (new INDs and new
E:\FR\FM\18FEN1.SGM
18FEN1
Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
protocol submissions) subject to
mandatory certification requirements
under section 402(j)(5)(B) of the PHS
Act, is 12,989 for CDER plus 1,220 for
CBER, or 14,209 submissions per year.
The minutes per response is the
estimated number of minutes that a
respondent would spend preparing the
information to be submitted to FDA
under section 402(j)(5)(B) of the PHS
Act, including the time it takes to enter
the necessary information on the form.
Based on its experience with current
submissions, FDA estimates that
approximately 15 minutes on average
would be needed per response for
certifications that accompany IND
applications and clinical protocol
amendment submissions. It is assumed
that most submissions to investigational
applications will reference only a few
protocols for which the sponsor/
applicant/submitter has obtained a NCT
number from https://clinicaltrials.gov/
prior to making the submission to FDA.
It is also assumed that the sponsor/
applicant/submitter has electronic
capabilities allowing them to retrieve
the information necessary to complete
the form in an efficient manner.
Marketing Applications/Submissions.
In CY 2019, CDER and CBER received
252 new drug applications (NDA)/
biologics license applications (BLA)/
premarket approvals (PMA)/
resubmissions and 701 NDA/BLA
amendments for which certifications are
needed. CDER and CBER received 295
efficacy supplements/resubmissions to
previously approved NDAs/BLAs in CY
2019. CDER and CBER received 893
abbreviated new drug applications
(ANDAs) in CY 2019. CDER received
765 bioequivalence amendments/
supplements in CY 2019. CDER and
CBER anticipate that new drug/biologic
applications/resubmissions and efficacy
supplement submission rates will
remain at or near this level in the near
future.
FDA’s Center for Devices and
Radiological Health (CDRH) received a
total of 324 new applications for PMA,
510(k) submissions containing clinical
information, PMA supplements,
applications for humanitarian device
exemptions (HDE) and amendments in
10105
CY 2019. CDRH anticipates that
application, amendment, supplement,
and annual report submission rates will
remain at or near this level in the near
future.
Based on its experience reviewing
NDAs, BLAs, PMAs, HDEs, 510(k)s, and
ANDAs and experience with current
submissions of Form FDA 3674, FDA
estimates that approximately 45 minutes
on average would be needed per
response for certifications which
accompany NDA, BLA, PMA, HDE,
510(k), and ANDA marketing
applications and submissions. It is
assumed that the sponsor/applicant/
submitter has electronic capabilities
allowing them to retrieve the
information necessary to complete the
form in an efficient manner.
In the Federal Register of May 14,
2020 (85 FR 28955), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
(investigational
applications)
FDA; center activity
Number of
respondents
(marketing
applications)
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
CDER
New Applications (IND) .................................
Clinical Protocol Amendments (IND) .............
New Marketing Applications/Resubmissions
(NDA/BLA).
Clinical Amendments to Marketing Applications.
Efficacy Supplements/Resubmissions ...........
Abbreviated New Drug Applications
(ANDA)—Original Applications.
ANDA Bioequivalence Supplements/Amendments.
1,661
11,328
........................
........................
........................
220
1
1
1
1,661
11,328
220
0.25 (15 minutes) ...
0.25 (15 minutes) ...
0.75 (45 minutes) ...
415
2,832
165
........................
701
1
701
0.75 (45 minutes) ...
526
........................
........................
257
892
1
1
257
892
0.75 (45 minutes) ..
0.75 (45 minutes) ...
193
669
........................
765
1
765
0.75 (45 minutes) ...
573
639
581
........................
........................
........................
32
1
1
1
639
581
32
0.25 (15 minutes) ..
0.25 (15 minutes) ...
0.75 (45 minutes) ..
160
145
24
........................
0
1
0
0.75 (45 minutes) ..
0
........................
38
1
38
0.75 (45 minutes) ...
28
........................
1
1
1
0.75 (45 minutes) ..
1
........................
0
1
0
0.75 (45 minutes) ..
0
........................
324
1
324
0.75 (45 minutes) ..
243
........................
........................
........................
..................
................................
5,974
CBER
jbell on DSKJLSW7X2PROD with NOTICES
New Applications (IND) .................................
Clinical Protocol Amendments (IND) .............
New Marketing Applications/Resubmissions
(NDA/BLA/PMA).
Clinical Amendments to Marketing Applications.
Efficacy Supplements/Resubmissions (BLA
only).
Abbreviated New Drug Applications
(ANDA)—Original Applications.
ANDA Bioequivalence Supplements/Amendments.
CDRH
New Marketing Applications (includes PMAs,
HDEs, Supplements and 510(k)s expected
to contain clinical data).
Total ...............................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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10106
Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03243 Filed 2–17–21; 8:45 am]
BILLING CODE 4164–01–P
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–03232 Filed 2–17–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
jbell on DSKJLSW7X2PROD with NOTICES
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
SIP21–007, Epilepsy Incidence and
Etiology: Important Information for
Public Health Prevention and Health
Promotion in the US Community.
Date: May 11, 2021.
Time: 11:00 a.m.–6:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Jaya
Raman, Ph.D., Scientific Review Officer,
National Center for Chronic Disease
Prevention and Health Promotion, CDC,
4770 Buford Highway, Mailstop S107–8,
Atlanta, Georgia 30341, Telephone (770)
488–6511, JRaman@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
VerDate Sep<11>2014
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Jkt 253001
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at: https://
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
SUPPLEMENTARY INFORMATION:
[Document Identifier: CMS–10733]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by March 22, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
DATES:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
William Parham at (410) 786–4669.
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined 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 publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Data
Management Plan Self-Attestation
Questionnaire (DMP SAQ); Use: The
Privacy Act of 1974 allows for
discretionary releases of data
maintained in Privacy Act protected
systems of records under § 552a(b)
(Conditions of Disclosure). The mandate
to account for disclosures of data under
the Privacy Act is found at
§ 552a(c)(Accounting of Certain
Disclosures). This section states that
certain information must be maintained
regarding disclosures made by each
agency. This information is: Date,
Nature, Purpose, and Name/Address of
Recipient. Section 552a(e) sets the
overall Agency Requirements that each
agency must meet in order to maintain
records under the Privacy Act. The Data
Use Agreement (DUA) form is needed as
part of the review of each CMS data
request to ensure compliance with the
requirements of the Privacy Act for
disclosures that contain PII.
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]]>Agencies
[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10104-10106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03243]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0275]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Certification To
Accompany Drug, Biological Product, and Device Applications or
Submissions
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 March 22, 2021.
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 0910-0616. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Certification To Accompany Drug, Biological Product, and Device
Applications or Submissions (Form FDA 3674)
OMB Control Number 0910-0616--Extension
The information required under section 402(j)(5)(B) of the Public
Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) is submitted in
the form of a certification, Form FDA 3674, which accompanies
applications and submissions currently submitted to FDA and already
approved by OMB. The OMB control numbers and expiration dates for those
applications and submissions are: 21 CFR parts 312 and 314 (human
drugs), OMB control number 0910-0014, expiring March 31, 2022, and OMB
control number 0910-0001, expiring March 31, 2021; 21 CFR parts 312 and
601 (biological products), OMB control number 0910-0014, expiring March
31, 2022, and OMB control number 0910-0338, expiring February 28, 2023;
21 CFR parts 807 and 814 (devices), OMB control number 0910-0120,
expiring June 30, 2020, and OMB control number 0910-0231, expiring
March 31, 2023.
Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110-85) amended the PHS Act by adding section
402(j). The provisions broadened the scope of clinical trials subject
to submitting information and required additional information to be
submitted to the clinical trials databank (https://clinicaltrials.gov/)
(FDA has verified the website address, but FDA is not responsible for
any subsequent changes to the website after this document publishes in
the Federal Register) previously established by the National Institutes
of Health (NIH)/National Library of Medicine. This includes expanded
information on applicable clinical trials and summary information on
the results of certain clinical trials. The provisions include
responsibilities for FDA as well as several amendments to the Federal
Food, Drug, and Cosmetic Act (FD&C Act).
One provision, section 402(j)(5)(B) of the PHS Act, requires that a
certification accompany human drug, biological, and device product
submissions made to FDA. Specifically, at the time of submission of an
application under sections 505, 515, or 520(m) of the FD&C Act (21
U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42
U.S.C. 262), or submission of a report under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)), such application or submission must be
accompanied by a certification, Form FDA 3674, that all applicable
requirements of section 402(j) of the PHS Act have been met. Where
available, such certification must include the appropriate National
Clinical Trial (NCT) numbers that are assigned upon submission of
required information to the NIH databank at https://clinicaltrials.gov/
.
The proposed extension of the collection of information is
necessary to satisfy the previously mentioned statutory requirement.
The importance of obtaining these data relates to adherence to the
legal requirements for submissions to the clinical trials registry and
results data bank and ensuring that individuals and organizations
submitting applications or reports to FDA under the listed provisions
of the FD&C Act or the PHS Act adhere to the appropriate legal and
regulatory requirements for certifying to having complied with those
requirements. The failure to submit the certification required by
section 402(j)(5)(B) of the PHS Act, and the knowing submission of a
false certification, are both prohibited acts under section 301 of the
FD&C Act (21 U.S.C. 331). Violations are subject to civil money
penalties. Form FDA 3674 provides a convenient mechanism for sponsors/
applicants/submitters to satisfy the certification requirements of the
statutory provision.
To assist sponsors/applicants/submitters in understanding the
statutory requirements associated with Form FDA 3674, we have provided
a guidance available at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. This guidance recommends the applications and
submissions FDA considers should be accompanied by the certification
form, Form FDA 3674. The applications and submissions identified in the
guidance are reflected in the burden analysis. FDA last updated this
guidance in 2017.
Investigational New Drug Applications. FDA's Center for Drug
Evaluation and Research (CDER) received 1,661 investigational new drug
applications (INDs) and 11,328 clinical protocol IND amendments in
calendar year (CY) 2019. CDER anticipates that IND and clinical
protocol amendment submission rates will remain at or near this level
in the near future.
FDA's Center for Biologics Evaluation and Research (CBER) received
639 new INDs and 581 clinical protocol IND amendments in CY 2019. CBER
anticipates that IND and clinical protocol amendment submission rates
will remain at or near this level in the near future. The estimated
total number of submissions (new INDs and new
[[Page 10105]]
protocol submissions) subject to mandatory certification requirements
under section 402(j)(5)(B) of the PHS Act, is 12,989 for CDER plus
1,220 for CBER, or 14,209 submissions per year. The minutes per
response is the estimated number of minutes that a respondent would
spend preparing the information to be submitted to FDA under section
402(j)(5)(B) of the PHS Act, including the time it takes to enter the
necessary information on the form.
Based on its experience with current submissions, FDA estimates
that approximately 15 minutes on average would be needed per response
for certifications that accompany IND applications and clinical
protocol amendment submissions. It is assumed that most submissions to
investigational applications will reference only a few protocols for
which the sponsor/applicant/submitter has obtained a NCT number from
https://clinicaltrials.gov/ prior to making the submission to FDA. It
is also assumed that the sponsor/applicant/submitter has electronic
capabilities allowing them to retrieve the information necessary to
complete the form in an efficient manner.
Marketing Applications/Submissions. In CY 2019, CDER and CBER
received 252 new drug applications (NDA)/biologics license applications
(BLA)/premarket approvals (PMA)/resubmissions and 701 NDA/BLA
amendments for which certifications are needed. CDER and CBER received
295 efficacy supplements/resubmissions to previously approved NDAs/BLAs
in CY 2019. CDER and CBER received 893 abbreviated new drug
applications (ANDAs) in CY 2019. CDER received 765 bioequivalence
amendments/supplements in CY 2019. CDER and CBER anticipate that new
drug/biologic applications/resubmissions and efficacy supplement
submission rates will remain at or near this level in the near future.
FDA's Center for Devices and Radiological Health (CDRH) received a
total of 324 new applications for PMA, 510(k) submissions containing
clinical information, PMA supplements, applications for humanitarian
device exemptions (HDE) and amendments in CY 2019. CDRH anticipates
that application, amendment, supplement, and annual report submission
rates will remain at or near this level in the near future.
Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s,
and ANDAs and experience with current submissions of Form FDA 3674, FDA
estimates that approximately 45 minutes on average would be needed per
response for certifications which accompany NDA, BLA, PMA, HDE, 510(k),
and ANDA marketing applications and submissions. It is assumed that the
sponsor/applicant/submitter has electronic capabilities allowing them
to retrieve the information necessary to complete the form in an
efficient manner.
In the Federal Register of May 14, 2020 (85 FR 28955), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of
respondents respondents Number of Total Total
FDA; center activity (investigational (marketing responses per annual Average burden per response hours
applications) applications) respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)................... 1,661 .............. 1 1,661 0.25 (15 minutes)................... 415
Clinical Protocol Amendments (IND)....... 11,328 .............. 1 11,328 0.25 (15 minutes)................... 2,832
New Marketing Applications/Resubmissions ................ 220 1 220 0.75 (45 minutes)................... 165
(NDA/BLA).
Clinical Amendments to Marketing ................ 701 1 701 0.75 (45 minutes)................... 526
Applications.
Efficacy Supplements/Resubmissions....... ................ 257 1 257 0.75 (45 minutes)................... 193
Abbreviated New Drug Applications (ANDA)-- ................ 892 1 892 0.75 (45 minutes)................... 669
Original Applications.
ANDA Bioequivalence Supplements/ ................ 765 1 765 0.75 (45 minutes)................... 573
Amendments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)................... 639 .............. 1 639 0.25 (15 minutes)................... 160
Clinical Protocol Amendments (IND)....... 581 .............. 1 581 0.25 (15 minutes)................... 145
New Marketing Applications/Resubmissions ................ 32 1 32 0.75 (45 minutes)................... 24
(NDA/BLA/PMA).
Clinical Amendments to Marketing ................ 0 1 0 0.75 (45 minutes)................... 0
Applications.
Efficacy Supplements/Resubmissions (BLA ................ 38 1 38 0.75 (45 minutes)................... 28
only).
Abbreviated New Drug Applications (ANDA)-- ................ 1 1 1 0.75 (45 minutes)................... 1
Original Applications.
ANDA Bioequivalence Supplements/ ................ 0 1 0 0.75 (45 minutes)................... 0
Amendments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH
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New Marketing Applications (includes ................ 324 1 324 0.75 (45 minutes)................... 243
PMAs, HDEs, Supplements and 510(k)s
expected to contain clinical data).
Total.................................... ................ .............. .............. .......... .................................... 5,974
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 10106]]
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03243 Filed 2-17-21; 8:45 am]
BILLING CODE 4164-01-P
