Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records, 66856-66858 [2023-21252]
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66856
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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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’’).
PO 00000
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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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Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
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, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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
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
SUPPLEMENTARY INFORMATION:
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.
Adverse Experience Reporting For
Licensed Biological Products; and
General Records—21 CFR Part 600
OMB Control Number 0910–0308—
Extension
This information collection helps
support implementation of statutory and
regulatory authorities that govern
adverse experience reporting. Under the
Public Health Service Act (PHS Act) (42
U.S.C. 262), FDA may only approve a
biologics license application for a
biological product that is safe, pure, and
potent. When a biological product is
approved and enters the market, the
product is introduced to a larger patient
population in settings different from
clinical trials. New information
generated during the postmarketing
period offers further insight into the
benefits and risks of the product, and
evaluation of this information is
important to ensure its safe use.
Regulations implementing adverse
experience reporting (AER)
requirements applicable to biological
products are codified in part 600 (21
CFR part 600). Regulations applicable to
combination products subject to
regulations in part 600 are found in part
4 (21 CFR part 4)—Regulation of
Combination Products. The collections
of information are intended to enable
FDA to take actions necessary for the
protection of the public health in
response to reports of adverse
experiences related to biologics licensed
under any provision of section 351 of
the PHS Act.
To assist respondents with the
reporting provisions of the information
collection, FDA has created both paperbased and electronic forms. Information
may be submitted electronically through
MEDWATCH or the Vaccine Adverse
Experience Reporting System (VAERS).
AER reports are filed using the
MEDWATCH Form FDA–3500A
(approved under OMB control numbers
0910–0291 and 0910–0645) or the
VAERS–1. Both versions of the forms
and instructions are available from the
internet at https://vaers.hhs.gov/. The
forms may also be downloaded,
completed, and submitted to the Agency
by mail or facsimile.
For operational efficiency, on March
20, 2023, we requested, and OMB has
approved, the addition of burden
attributable to provisions set forth in
part 4, subpart B, previously included in
OMB control number 0910–0834. When
information regarding an event that
involves a death or serious injury, or an
adverse event, associated with the use of
the combination product is received by
the product sponsor, the information
must be provided to the other
constituent part applicant(s) no later
than 5 calendar days after receipt under
§ 4.103. Relatedly, § 4.104 explains how
and where to submit reports.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—BIOLOGICAL PRODUCTS 1
Number of
respondents
ddrumheller on DSK120RN23PROD with NOTICES1
21 CFR section; activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
600.80(c)(1), 600.80(d), and 600.80(e); postmarketing 15-day Alert Reports
600.82; notification of discontinuance or interruption in manufacturing ...........
600.80(c)(2); Periodic Adverse Experience Reports ........................................
600.81; distribution reports ...............................................................................
600.80(h)(2), 600.81(b)(2), and 600.90; waiver requests .................................
109
23
109
172
35
3,806.95
1.435
3,697
5.727
1.886
414,958
33
402,973
985
66
1
2
28
1
1
414,958
66
11,283,244
985
66
Total ...........................................................................................................
..........................
..........................
........................
........................
11,699,319
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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66858
Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—BIOLOGICAL PRODUCTS 1
Number of
recordkeepers
21 CFR section; activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeper
(in hours)
Total hours
600.12; 2 Maintenance of Records ....................................................................
600.12(b)(2); Recall Records ............................................................................
600.80(c)(1) and 600.80(k); AER Records .......................................................
131
216
109
40.145
3.4028
7,503.95
5,259
735
817,931
32
24
1
168,288
17,640
817,931
Total ...........................................................................................................
..........................
..........................
........................
........................
1,003,859
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN—COMBINATION PRODUCTS 1
Number of
respondents
21 CFR section; activity
4.102, 4.103, 4.104, 4.105; Postmarketing Safety Reporting for Combination
Products, including associated reports and sharing information with other
constituent part applicants.
1 There
11
Average
burden per
disclosure
(in hours)
Total annual
disclosures
18
198
Total
hours
0.35 (21 minutes) ...
69
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this information
collection has changed since the last
OMB approval. The reporting and
recordkeeping burden has increased
mostly due to an increase in the number
of AER reports submitted to FDA and
the associated recordkeeping with these
reports. We have also added burden we
believe attributable to post marketing
safety reporting and attendant
recordkeeping and disclosures, as
required under part 4, subpart B.
Dated: September 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–21252 Filed 9–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meetings
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
disclosures
per respondents
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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. 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.
VerDate Sep<11>2014
18:09 Sep 27, 2023
Jkt 259001
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Renewal of Centers of Biomedical
Research Excellence (COBRE) (Phase 2).
Date: November 7–8, 2023.
Time: 9:30 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Nina Sidorova, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, MSC 6200, Room 3AN18–01,
Bethesda, Maryland 20892, 301–594–3663,
sidorova@nigms.nih.gov.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of MOSAIC K99/R00
applications.
Date: November 9, 2023.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Rebecca H. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, MSC 6200, Room 3AN12B,
Bethesda, Maryland 20892, 301–594–2771,
johnsonrh@nigms.nih.gov.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of Support for Research
Excellence (SuRE) Program (R16).
Date: November 17, 2023.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
PO 00000
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Contact Person: Rebecca H. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, MSC 6200, Room 3AN12B,
Bethesda, Maryland 20892, 301–594–2771,
johnsonrh@nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: September 22, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–21154 Filed 9–27–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 1009 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. 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: Heart, Lung, and
Blood Initial Review Group; NHLBI
E:\FR\FM\28SEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66856-66858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21252]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3847]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Adverse Experience Reporting for Licensed Biological
Products; and General Records
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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
information applicable to required adverse experience reporting for
licensed biological products, and general records associated with the
manufacture and distribution of biological products.
DATES: Submit either electronic or written comments on the collection
of information by November 27, 2023.
ADDRESSES: 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.
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-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
[[Page 66857]]
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, 10A63, 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 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.
Adverse Experience Reporting For Licensed Biological Products; and
General Records--21 CFR Part 600
OMB Control Number 0910-0308--Extension
This information collection helps support implementation of
statutory and regulatory authorities that govern adverse experience
reporting. Under the Public Health Service Act (PHS Act) (42 U.S.C.
262), FDA may only approve a biologics license application for a
biological product that is safe, pure, and potent. When a biological
product is approved and enters the market, the product is introduced to
a larger patient population in settings different from clinical trials.
New information generated during the postmarketing period offers
further insight into the benefits and risks of the product, and
evaluation of this information is important to ensure its safe use.
Regulations implementing adverse experience reporting (AER)
requirements applicable to biological products are codified in part 600
(21 CFR part 600). Regulations applicable to combination products
subject to regulations in part 600 are found in part 4 (21 CFR part
4)--Regulation of Combination Products. The collections of information
are intended to enable FDA to take actions necessary for the protection
of the public health in response to reports of adverse experiences
related to biologics licensed under any provision of section 351 of the
PHS Act.
To assist respondents with the reporting provisions of the
information collection, FDA has created both paper-based and electronic
forms. Information may be submitted electronically through MEDWATCH or
the Vaccine Adverse Experience Reporting System (VAERS). AER reports
are filed using the MEDWATCH Form FDA-3500A (approved under OMB control
numbers 0910-0291 and 0910-0645) or the VAERS-1. Both versions of the
forms and instructions are available from the internet at https://vaers.hhs.gov/. The forms may also be downloaded, completed, and
submitted to the Agency by mail or facsimile.
For operational efficiency, on March 20, 2023, we requested, and
OMB has approved, the addition of burden attributable to provisions set
forth in part 4, subpart B, previously included in OMB control number
0910-0834. When information regarding an event that involves a death or
serious injury, or an adverse event, associated with the use of the
combination product is received by the product sponsor, the information
must be provided to the other constituent part applicant(s) no later
than 5 calendar days after receipt under Sec. 4.103. Relatedly, Sec.
4.104 explains how and where to submit reports.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden--Biological Products \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section; activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
600.80(c)(1), 600.80(d), and 109 3,806.95 414,958 1 414,958
600.80(e); postmarketing 15-
day Alert Reports............
600.82; notification of 23 1.435 33 2 66
discontinuance or
interruption in manufacturing
600.80(c)(2); Periodic Adverse 109 3,697 402,973 28 11,283,244
Experience Reports...........
600.81; distribution reports.. 172 5.727 985 1 985
600.80(h)(2), 600.81(b)(2), 35 1.886 66 1 66
and 600.90; waiver requests..
---------------------------------------------------------------------------------
Total..................... ............... ............... .............. .............. 11,699,319
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 66858]]
Table 2--Estimated Annual Reporting Burden--Biological Products \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
21 CFR section; activity recordkeepers records per records recordkeeper Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
600.12; \2\ Maintenance of 131 40.145 5,259 32 168,288
Records......................
600.12(b)(2); Recall Records.. 216 3.4028 735 24 17,640
600.80(c)(1) and 600.80(k); 109 7,503.95 817,931 1 817,931
AER Records..................
---------------------------------------------------------------------------------
Total..................... ............... ............... .............. .............. 1,003,859
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The recordkeeping requirements in Sec. 610.18(b) are included in the estimate for Sec. 600.12.
Table 3--Estimated Annual Reporting Burden--Combination Products \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per Total
respondents respondents disclosures disclosure (in hours) hours
----------------------------------------------------------------------------------------------------------------
4.102, 4.103, 4.104, 4.105; 11 18 198 0.35 (21 minutes).... 69
Postmarketing Safety
Reporting for Combination
Products, including
associated reports and
sharing information with
other constituent part
applicants.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden for this information collection has changed since the
last OMB approval. The reporting and recordkeeping burden has increased
mostly due to an increase in the number of AER reports submitted to FDA
and the associated recordkeeping with these reports. We have also added
burden we believe attributable to post marketing safety reporting and
attendant recordkeeping and disclosures, as required under part 4,
subpart B.
Dated: September 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21252 Filed 9-27-23; 8:45 am]
BILLING CODE 4164-01-P
