Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 4628 [2022-01692]
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4628
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Written procedures; 589.2000(e)(1)(iv) ......................
300
1
300
14
4,200
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number
of recordkeepers on inspectional data.
Based on a review of the information
collection since our last request for
OMB approval we have adjusted our
burden estimate, which has resulted in
a decrease to the currently approved
burden. Review of our inspection data
suggests that the number of facilities
that need to conduct these separation
practices is gradually decreasing,
therefore we have decreased the number
of facilities who must comply, as well
as the total number of hours needed to
comply with this burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
SUMMARY:
Food and Drug Administration
[Docket Nos. FDA–2011–N–0742;
FDA–2018–N–0180; FDA–2019–N–2854;
FDA–2021–N–0515; FDA–2014–N–1960;
FDA–2017–D–6069; and FDA–2019–N–3325]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
[FR Doc. 2022–01731 Filed 1–27–22; 8:45 am]
BILLING CODE 4164–01–P
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution ............................................
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications ................
Premarket Tobacco Product Applications and Recordkeeping Requirements .......................................................
Postmarketing Adverse Experience Reporting and Recordkeeping .......................................................................
MedWatch: Adverse Event and Product Experience Reporting System (Paper Based) .......................................
De Novo Classification Process (Evaluation of Automatic Class III Designation) ..................................................
Laboratory Accreditation for Analyses of Foods .....................................................................................................
Dated: January 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01692 Filed 1–27–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
jspears on DSK121TN23PROD with NOTICES1
AGENCY:
The National Biodefense
Science Board (NBSB or the Board) is
authorized under Section 319M of the
SUMMARY:
VerDate Sep<11>2014
18:03 Jan 27, 2022
Jkt 256001
Public Health Service (PHS) Act, as
added by Section 402 of the Pandemic
and All-Hazards Preparedness Act of
2006 and amended by Section 404 of the
Pandemic and All-Hazards
Preparedness Reauthorization Act. The
Board is governed by the Federal
Advisory Committee Act, which sets
forth standards for the formation and
use of advisory committees. The NBSB
provides expert advice and guidance on
scientific, technical, and other matters
of special interest to the Department of
Health and Human Services (HHS)
regarding current and future chemical,
biological, nuclear, and radiological
agents, whether naturally occurring,
accidental, or deliberate. Authority to
manage and operate the NBSB,
including to receive advice and
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
0910–0045
0910–0810
0910–0879
0910–0230
0910–0291
0910–0844
0910–0898
Date approval
expires
12/31/2024
12/31/2024
12/31/2024
1/31/2025
1/31/2025
1/31/2025
1/31/2025
recommendations from the Board, has
been delegated by the Secretary of HHS
to the Assistant Secretary for
Preparedness and Response (ASPR). The
NBSB will meet in public (virtually) on
March 7, 2022, beginning at 12:30 p.m.
Eastern time. ASPR invites stakeholders
and the general public to attend and
participate as appropriate. A detailed
agenda and instructions to register to
attend the meeting will be available on
the NBSB meeting website https://
www.phe.gov/nbsb.
Procedures for Public Participation:
Members of the public may attend the
meeting via a toll-free phone number or
Zoom teleconference, which requires
pre-registration. The meeting link to
pre-register will be posted on the
meeting website https://www.phe.gov/
E:\FR\FM\28JAN1.SGM
28JAN1
]]>Agencies
[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Page 4628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01692]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-N-0742; FDA-2018-N-0180; FDA-2019-N-2854; FDA-
2021-N-0515; FDA-2014-N-1960; FDA-2017-D-6069; and FDA-2019-N-3325]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Registration of Producers of Drugs and 0910-0045 12/31/2024
Listing of Drugs in Commercial
Distribution...........................
Generic Clearance for the Collection of 0910-0810 12/31/2024
Qualitative Data on Tobacco Products
and Communications.....................
Premarket Tobacco Product Applications 0910-0879 12/31/2024
and Recordkeeping Requirements.........
Postmarketing Adverse Experience 0910-0230 1/31/2025
Reporting and Recordkeeping............
MedWatch: Adverse Event and Product 0910-0291 1/31/2025
Experience Reporting System (Paper
Based).................................
De Novo Classification Process 0910-0844 1/31/2025
(Evaluation of Automatic Class III
Designation)...........................
Laboratory Accreditation for Analyses of 0910-0898 1/31/2025
Foods..................................
------------------------------------------------------------------------
Dated: January 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01692 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P
