Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records, 17858-17859 [2024-05222]
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17858
Federal Register / Vol. 89, No. 49 / Tuesday, March 12, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Total annual
responses
Average burden per response
Total hours
607.22(b); Written waiver request ........................
1
1
1
1 ....................................
1
Total .....................................................................
........................
........................
........................
.......................................
1,460
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
control number for this information
collection is 0910–0308. Also include
the FDA docket number found in
brackets in the heading of this
document.
Based on our evaluation of calendar
year 2022 data from CBER’s Blood
Establishment Registration and Product
Listing system, we have adjusted the
currently approved burden estimate we
attribute to establishment registration
and product listing to reflect a decrease
in product listing updates and an
increase in the number of initial
registrations. Our estimated burden for
the information collection reflects an
overall decrease of 36 hours.
FOR FURTHER INFORMATION CONTACT:
Dated: March 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
Adverse Experience Reporting for
Licensed Biological Products; and
General Records—21 CFR Part 600
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
OMB Control Number 0910–0308—
Extension
[Docket No. FDA–2023–N–3847]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 11,
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
SUMMARY:
VerDate Sep<11>2014
19:36 Mar 11, 2024
Jkt 262001
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.
[FR Doc. 2024–05215 Filed 3–11–24; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR Section; activity
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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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.
In the Federal Register of September
28, 2023 (88 FR 66856), we published a
60-day notice requesting public
comment on the proposed collection of
information. We received one comment
regarding our estimate of 28 hours per
response for periodic adverse
experience reports. The comment
suggested we lower that estimate but
provided no data or explanation in
support of the proposed reduction.
While we have therefore made no
adjustment in our burden estimate, we
encourage further comment regarding a
basis for assessing burden for the scope
of information collection activity
covered by the applicable regulations
and associated forms.
Respondents: Respondents to this
collection of information are
manufacturers of biological products
(including blood and blood
E:\FR\FM\12MRN1.SGM
12MRN1
17859
Federal Register / Vol. 89, No. 49 / Tuesday, March 12, 2024 / Notices
components) and any person whose
name appears on the label of a licensed
biological product.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—BIOLOGICAL PRODUCTS 1
Number of
respondents
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.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—BIOLOGICAL PRODUCTS 1
Number of
recordkeepers
21 CFR Section; activity
Numbers 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
2
There are no capital costs or operating and maintenance costs associated with this collection of information.
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
11
Total annual
disclosures
18
198
Average burden per disclosure
(in hours)
0.35 (21 minutes) ............................................
Total hours
69
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: March 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05222 Filed 3–11–24; 8:45 am]
BILLING CODE 4164–01–P
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
disclosures per
respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Department of Health and
Human Services, Office of the Secretary,
AGENCY:
VerDate Sep<11>2014
19:36 Mar 11, 2024
Jkt 262001
Office of the Assistant Secretary for
Health.
ACTION:
Notice of a meeting.
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Service is hereby giving notice that the
Presidential Advisory Council on HIV/
AIDS (PACHA or the Council) will
convene the 80th full council meeting
on Wednesday, March 27–Thursday,
March 28, 2024. The meeting will be
open to the public and there will be a
public comment session during the
meeting; pre-registration is required to
provide public comment. To pre-register
to provide public comment, please send
an email to PACHA@hhs.gov and
include your name, organization, and
title by close of business Monday,
March 18, 2024. If you decide you
would like to provide public comment
but do not pre-register, you may submit
your written statement by emailing
PACHA@hhs.gov by close of business
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Thursday, April 4, 2024. The meeting
agenda will be posted on the PACHA
page on HIV.gov at https://www.hiv.gov/
federal-response/pacha/about-pacha
prior to the meeting.
DATES: The meeting will convene on
Wednesday, March 27, 2024 from
approximately 10:00 a.m. (Eastern)
–7:00 p.m. (Eastern) and Thursday,
March 28, 2024 from approximately
10:00 a.m. (Eastern) to 4:45 p.m.
(Eastern).
Texas Southern University,
3100 Cleburne Avenue, Houston, TX
77004. To attend the meeting virtually,
please visit www.hhs.gov/live.
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, MPA, Senior
Management Analyst, at PACHA@
hhs.gov or Caroline.Talev@hhs.gov.
Additional information can be obtained
by accessing the Council’s page on the
HIV.gov site at www.hiv.gov/pacha.
SUPPLEMENTARY INFORMATION: PACHA
was established by Executive Order
12963, dated June 14, 1995, as amended
ADDRESSES:
E:\FR\FM\12MRN1.SGM
12MRN1
]]>Agencies
[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17858-17859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05222]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3847]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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, Agency, or we) 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 11, 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 0910-0308. 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.
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.
In the Federal Register of September 28, 2023 (88 FR 66856), we
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment regarding our
estimate of 28 hours per response for periodic adverse experience
reports. The comment suggested we lower that estimate but provided no
data or explanation in support of the proposed reduction. While we have
therefore made no adjustment in our burden estimate, we encourage
further comment regarding a basis for assessing burden for the scope of
information collection activity covered by the applicable regulations
and associated forms.
Respondents: Respondents to this collection of information are
manufacturers of biological products (including blood and blood
[[Page 17859]]
components) and any person whose name appears on the label of a
licensed biological product.
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.
Table 2--Estimated Annual Reporting Burden--Biological Products \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Numbers 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 Average burden
21 CFR Section; activity Number of disclosures per Total annual per disclosure Total hours
respondents respondents disclosures (in hours)
----------------------------------------------------------------------------------------------------------------
4.102, 4.103, 4.104, 4.105; 11 18 198 0.35 (21 69
Postmarketing Safety minutes).
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: March 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05222 Filed 3-11-24; 8:45 am]
BILLING CODE 4164-01-P
