[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]


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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.

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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 http://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: http://www.hhs.gov/nvpo/nvac/meetings/index.html 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 http://www.hhs.gov/nvpo/nvac/meetings/index.html.

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: http://www.hhs.gov/nvpo/nvac/index.html.
    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]
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