National Biodefense Science Board, 4628-4629 [2022-01764]
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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]
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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]
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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:
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18:03 Jan 27, 2022
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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
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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/
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28JAN1
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
nbsb. Members of the public may
provide written comments or submit
questions for consideration by the NBSB
at any time via email to NBSB@hhs.gov.
Additionally, the NBSB invites
stakeholders to request up to seven
minutes to address the Board in-person
during the meeting. The Board is
interested in hearing from anyone
involved in, or who represents, a
relevant biomedical, biodefense, or
health security industry; serves as
faculty or conducts research at an
academic institution; occupies a
relevant health profession or works for
a hospital system or health care
consumer organization; or who serves in
a relevant state, Tribal, territorial, or
local government agency. Requests to
provide remarks to the NBSB during the
public meeting must be sent to NBSB@
hhs.gov by March 1, 2022. In that
request, please provide the speaker’s
name, title, and position, with a brief
description of the topic that they will
address. The number of speakers and
topics will be based on relevance to the
mission of the NBSB and amount of
time available on the agenda. The
charter of the NBSB may be reviewed on
the ASPR/NBSB website. Topics and
presentations with an obvious
commercial bias, to include any form of
advertising, marketing, or solicitation,
will not be accepted.
FOR FURTHER INFORMATION CONTACT:
CAPT Christopher L. Perdue, MD, MPH,
NBSB Designated Federal Official,
Washington, DC, NBSB@hhs.gov.
Dawn O’Connell,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2022–01764 Filed 1–27–22; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jspears on DSK121TN23PROD with NOTICES1
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
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18:03 Jan 27, 2022
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proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC–SBIR PHS
2022–1 Phase I: Adjuvant Development for
Vaccines and for Autoimmune and Allergic
Diseases (Topic 105).
Date: February 18, 2022.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G51,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Thomas F. Conway, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G51, Rockville, MD
20852, 240–507–9685, thomas.conway@
nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC–SBIR PHS
2022–1 Phase II: Adjuvant Development for
Vaccines and for Autoimmune and Allergic
Diseases (Topic 105).
Date: February 18, 2022.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G51,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Thomas F. Conway, Ph.D.,
Scientific Review Officer, Scientific Review,
Program Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G51, Rockville, MD
20852, 240–507–9685, thomas.conway@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: January 25, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–01746 Filed 1–27–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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
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4629
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: National Institute of
General Medical Sciences Special Emphasis
Panel; NIGMS Review of SuRE First
Applications.
Date: March 22, 2022.
Time: 10:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 45 Center Drive, Bethesda,
MD 20892 (Video Meeting).
Contact Person: Tracy Koretsky, 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 3AN.12F,
Bethesda, MD 20892, 301 594 2886,
tracy.koretsky@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.859, Biomedical Research and
Research Training, National Institutes of
Health, HHS)
Dated: January 24, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–01741 Filed 1–27–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) 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.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; NIDA
UE5: Research Education Course in Product
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]]>Agencies
[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4628-4629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01764]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Biodefense Science Board
AGENCY: Office of the Assistant Secretary for Preparedness and Response
(ASPR), Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Biodefense Science Board (NBSB or the Board) is
authorized under Section 319M of the 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 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/
[[Page 4629]]
nbsb. Members of the public may provide written comments or submit
questions for consideration by the NBSB at any time via email to
[email protected].
Additionally, the NBSB invites stakeholders to request up to seven
minutes to address the Board in-person during the meeting. The Board is
interested in hearing from anyone involved in, or who represents, a
relevant biomedical, biodefense, or health security industry; serves as
faculty or conducts research at an academic institution; occupies a
relevant health profession or works for a hospital system or health
care consumer organization; or who serves in a relevant state, Tribal,
territorial, or local government agency. Requests to provide remarks to
the NBSB during the public meeting must be sent to [email protected] by
March 1, 2022. In that request, please provide the speaker's name,
title, and position, with a brief description of the topic that they
will address. The number of speakers and topics will be based on
relevance to the mission of the NBSB and amount of time available on
the agenda. The charter of the NBSB may be reviewed on the ASPR/NBSB
website. Topics and presentations with an obvious commercial bias, to
include any form of advertising, marketing, or solicitation, will not
be accepted.
FOR FURTHER INFORMATION CONTACT: CAPT Christopher L. Perdue, MD, MPH,
NBSB Designated Federal Official, Washington, DC, [email protected].
Dawn O'Connell,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2022-01764 Filed 1-27-22; 8:45 am]
BILLING CODE 4150-37-P
