Meeting of the National Vaccine Advisory Committee, 73061-73062 [2020-25243]
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Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices
information on the number of clients
and immediate household members
tested for COVID–19, the number of
clients newly diagnosed (or presumed
positive) with COVID–19, the
cumulative number of clients with
COVID–19, the number of clients who
received services in each RWHAP
service category (identified in Policy
Clarification Notice 16–02 RWHAP
Services: Eligible Individuals and
Allowable Uses of Funds), and the types
of services provided using telehealth
technology in the CDR. The information
obtained in this module will assist
HRSA in understanding how CARES
Act RWHAP funding is being used to
support RWHAP clients and immediate
household members and ensure that
HRSA is compliant with federal
reporting requirements.
Likely Respondents: All RWHAP
providers (e.g., recipients or
subrecipients) who receive CARES Act
RWHAP funding.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
CDR Module ........................................................................
2,045
12
24,540
3.2
78,528
Total ..............................................................................
2,045
........................
24,540
........................
78,528
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–25219 Filed 11–13–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
ACTION:
Notice.
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the National Vaccine Advisory
Committee (NVAC) will hold a virtual
meeting. The meeting will be open to
the public and public comment will be
heard during the meeting.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
VerDate Sep<11>2014
20:13 Nov 13, 2020
Jkt 253001
The meeting will be held
December 4, 2020. The confirmed
meeting times and agenda will be
posted on the NVAC website at https://
www.hhs.gov/nvpo/nvac/meetings/
index.html as soon as they become
available.
ADDRESSES: Instructions regarding
attending this meeting will be posted
online at: https://www.hhs.gov/nvpo/
nvac/meetings/ at least one
week prior to the meeting. Preregistration is required for those who
wish to attend the meeting or participate
in public comment. Please register at
https://www.hhs.gov/nvpo/nvac/
meetings/.
FOR FURTHER INFORMATION CONTACT: Ann
Aikin, Acting Designated Federal
Officer, at the Office of Infectious
Disease and HIV/AIDS Policy, U.S.
Department of Health and Human
Services, Mary E. Switzer Building,
Room L618, 330 C Street SW,
Washington, DC 20024. Email: nvac@
hhs.gov. Phone: 202–695–9742.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of HHS was mandated to
establish the National Vaccine Program
to achieve optimal prevention of human
infectious diseases through
immunization and to achieve optimal
prevention against adverse reactions to
vaccines. The NVAC was established to
provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
DATES:
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serves as Director of the National
Vaccine Program.
During this NVAC meeting, NVAC
will hear presentations to support the
recent charge from Admiral Brett P.
Giroir, MD, the Assistant Secretary for
Health and Director of the National
Vaccine Program, and respond to the
following question: The FDA standards
for approval and licensure of vaccines
for COVID–19 addresses safety and
effectiveness and encourages inclusion
of minorities, the elderly, pregnant
women, and people with medical
comorbidities in clinical trials. In
particular, for COVID–19 vaccines, I am
interested in the approach the nation
should take in regard to vaccination of
children, given that there will be
relatively little data on children from
some of the early clinical trials? As
context, the case fatality rate for
children under age 18 is .02%. What is
the appropriate approach, and timing,
of generating the needed data and
proceeding to potential childhood
vaccination as we move forward? The
NVAC will also review a draft report of
the response to the full charge. Please
note that agenda items are subject to
change, as priorities dictate. Information
on the final meeting agenda will be
posted prior to the meeting on the
NVAC website: https://www.hhs.gov/
nvpo/nvac/.
Members of the public will have the
opportunity to provide comment at the
NVAC meeting during the public
comment period designated on the
agenda. Public comments made during
the meeting will be limited to three
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73062
Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices
minutes per person to ensure time is
allotted for all those wishing to speak.
Individuals are also welcome to submit
written comments in advance. Written
comments should not exceed three
pages in length. Individuals submitting
comments should email their written
comments or their request to provide a
comment during the meeting to nvac@
hhs.gov at least five business days prior
to the meeting.
Dated: October 27, 2020.
Ann Aikin,
Acting Designated Federal Official, Office of
the Assistant Secretary for Health.
[FR Doc. 2020–25243 Filed 11–13–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
jbell on DSKJLSW7X2PROD with NOTICES
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. 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: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Acquired Immunodeficiency
Syndrome Research Review Committee
Acquired Immunodeficiency Syndrome
Research Review Committee (AIDS).
Date: December 9–10, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G21,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Robert C. Unfer, PhD.,
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 3G21, Rockville, MD
20852, (240) 669–5035, robert.unfer@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
VerDate Sep<11>2014
20:13 Nov 13, 2020
Jkt 253001
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: November 9, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: November 9, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–25190 Filed 11–13–20; 8:45 am]
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[FR Doc. 2020–25185 Filed 11–13–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Secretary; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Muscular Dystrophy
Coordinating Committee (MDCC).
The meeting will be open to the
public. Individuals who plan to
participate and need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the Contact Person listed
below in advance of the meeting.
Name of Committee: Muscular Dystrophy
Coordinating Committee.
Date: December 16, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: The purpose of this meeting is to
bring together committee members,
representing government agencies, patient
advocacy groups, other voluntary health
organizations, and patients and their families
to update one another on progress relevant to
the Action Plan for the Muscular Dystrophies
and to coordinate activities and discuss gaps
and opportunities leading to better
understanding of the muscular dystrophies,
advances in treatments, and improvements in
patients’ and their families’ lives. The agenda
for this meeting is available on the MDCC
website: https://www.mdcc.nih.gov/
Meetings_Events/december-16-2020.
Registration: To register, please go to:
https://roseliassociates.zoomgov.com/
webinar/register/WN_ztgxOEmQPKtTSwCXWyk1w.
Webcast Live: https://videocast.nih.gov/.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Glen Nuckolls, Ph.D.,
Program Director, National Institute of
Neurological, Disorders and Stroke (NINDS),
NIH, 6001 Executive Blvd., Rm 2203,
Bethesda, MD 20892, 301–496–5876, MDCC@
nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
More information can be found on the
Muscular Dystrophy Coordinating Committee
home page: https://mdcc.nih.gov/.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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. 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
Allergy and Infectious Diseases Special
Emphasis Panel; NIH Support for
Conferences and Scientific Meetings (Parent
R13 Clinical Trial Not Allowed).
Date: December 8–10, 2020.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F43,
Rockville, MD 20892, (Virtual Meeting).
Contact Person: Kelly Y. Poe, Ph.D.,
Deputy Director, 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
3F43, Bethesda, MD 20892–9834, (240) 669–
5036, poeky@mail.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: November 9, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–25187 Filed 11–13–20; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 85, Number 221 (Monday, November 16, 2020)]
[Notices]
[Pages 73061-73062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25243]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the National Vaccine Advisory Committee
AGENCY: Office of Infectious Disease and HIV/AIDS Policy, Office of the
Assistant Secretary for Health, Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the
Department of Health and Human Services (HHS) is hereby giving notice
that the National Vaccine Advisory Committee (NVAC) will hold a virtual
meeting. The meeting will be open to the public and public comment will
be heard during the meeting.
DATES: The meeting will be held December 4, 2020. The confirmed meeting
times and agenda will be posted on the NVAC website at https://www.hhs.gov/nvpo/nvac/meetings/ as soon as they become
available.
ADDRESSES: Instructions regarding attending this meeting will be posted
online at: https://www.hhs.gov/nvpo/nvac/meetings/ at least
one week prior to the meeting. Pre-registration is required for those
who wish to attend the meeting or participate in public comment. Please
register at https://www.hhs.gov/nvpo/nvac/meetings/.
FOR FURTHER INFORMATION CONTACT: Ann Aikin, Acting Designated Federal
Officer, at the Office of Infectious Disease and HIV/AIDS Policy, U.S.
Department of Health and Human Services, Mary E. Switzer Building, Room
L618, 330 C Street SW, Washington, DC 20024. Email: [email protected].
Phone: 202-695-9742.
SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public
Health Service Act (42 U.S.C. 300aa-1), the Secretary of HHS was
mandated to establish the National Vaccine Program to achieve optimal
prevention of human infectious diseases through immunization and to
achieve optimal prevention against adverse reactions to vaccines. The
NVAC was established to provide advice and make recommendations to the
Director of the National Vaccine Program on matters related to the
Program's responsibilities. The Assistant Secretary for Health serves
as Director of the National Vaccine Program.
During this NVAC meeting, NVAC will hear presentations to support
the recent charge from Admiral Brett P. Giroir, MD, the Assistant
Secretary for Health and Director of the National Vaccine Program, and
respond to the following question: The FDA standards for approval and
licensure of vaccines for COVID-19 addresses safety and effectiveness
and encourages inclusion of minorities, the elderly, pregnant women,
and people with medical comorbidities in clinical trials. In
particular, for COVID-19 vaccines, I am interested in the approach the
nation should take in regard to vaccination of children, given that
there will be relatively little data on children from some of the early
clinical trials? As context, the case fatality rate for children under
age 18 is .02%. What is the appropriate approach, and timing, of
generating the needed data and proceeding to potential childhood
vaccination as we move forward? The NVAC will also review a draft
report of the response to the full charge. Please note that agenda
items are subject to change, as priorities dictate. Information on the
final meeting agenda will be posted prior to the meeting on the NVAC
website: https://www.hhs.gov/nvpo/nvac/.
Members of the public will have the opportunity to provide comment
at the NVAC meeting during the public comment period designated on the
agenda. Public comments made during the meeting will be limited to
three
[[Page 73062]]
minutes per person to ensure time is allotted for all those wishing to
speak. Individuals are also welcome to submit written comments in
advance. Written comments should not exceed three pages in length.
Individuals submitting comments should email their written comments or
their request to provide a comment during the meeting to [email protected]
at least five business days prior to the meeting.
Dated: October 27, 2020.
Ann Aikin,
Acting Designated Federal Official, Office of the Assistant Secretary
for Health.
[FR Doc. 2020-25243 Filed 11-13-20; 8:45 am]
BILLING CODE 4150-44-P
