Meeting of the National Vaccine Advisory Committee, 29951-29952 [2020-10656]
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Federal Register / Vol. 85, No. 97 / Tuesday, May 19, 2020 / Notices
247d(a)(2)). However, the
recommendations and processes
described in the guidance are expected
to assist the Agency more broadly in its
continued efforts to assist sponsors in
the clinical development of drugs for
the treatment of COVID–19 beyond the
termination of the COVID–19 public
health emergency and reflect the
Agency’s current thinking on this issue.
Therefore, within 60 days following the
termination of the public health
emergency, FDA intends to revise and
replace this guidance with any
appropriate changes based on comments
received on this guidance and the
Agency’s experience with
implementation.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘COVID–19:
Developing Drugs and Biological
Products for Treatment or Prevention.’’
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
The guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). Under the PRA, Federal
Agencies must obtain approval from
OMB for each collection of information
they conduct or sponsor. ‘‘Collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party.
This guidance refers to previously
approved FDA collections of
information. These collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR parts 312 and
320 have been approved under OMB
control number 0910–0014; the
collections of information in 21 CFR
part 58 regarding good laboratory
practice for nonclinical laboratory
studies have been approved under OMB
control number 0910–0119; the
collections of information in 21 CFR
parts 50 and 56 have been approved
under OMB control number 0910–0130;
the collections of information in 21 CFR
part 320 have been approved under
VerDate Sep<11>2014
17:57 May 18, 2020
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OMB control number 0910–0291; the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338; the
collections of information in FDA’s draft
guidance for industry entitled ‘‘Formal
Meetings Between FDA and Sponsors
and Applicants of Prescription Drug
User Fee Act Products’’ have been
approved under OMB control number
0910–0429; the collections of
information in FDA’s final guidance for
clinical trial sponsors entitled
‘‘Establishment and Operation of
Clinical Trial Data Monitoring
Committees’’ have been approved under
OMB control number 0910–0581; and
the collections of information in FDA’s
final guidance for industry entitled
‘‘Oversight of Clinical Investigations—A
Risk-Based Approach to Monitoring’’
have been approved under OMB control
number 0910–0733.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/
emergency-preparedness-and-response/
mcm-issues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders, or https://
www.regulations.gov.
Dated: May 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10635 Filed 5–18–20; 8:45 am]
BILLING CODE 4164–01–P
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.
ACTION: Notice.
AGENCY:
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 on
Tuesday, June 9, 2020. If needed,
SUMMARY:
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29951
additional sessions and may be added
on Wednesday, June 10, 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. 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. Telephone: 202–795–7611.
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 the June 2020 NVAC meeting,
sessions will focus on coronavirus
vaccine development, reimbursement
and changes in billing and coverage
with updates from members. 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
minutes per person to ensure time is
allotted for all those wishing to speak.
Individuals are also welcome to submit
written comments. Written comments
should not exceed three pages in length.
Individuals submitting written
comments should email their comments
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29952
Federal Register / Vol. 85, No. 97 / Tuesday, May 19, 2020 / Notices
to nvac@hhs.gov at least five business
days prior to the meeting.
Dated: May 13, 2020.
Ann Aikin,
Acting Designated Federal Official, Office of
the Assistant Secretary for Health.
[FR Doc. 2020–10656 Filed 5–18–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice of meeting.
AGENCY:
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 be
holding the 67th full Council meeting
utilizing virtual technology. The
meeting will be open to the public; a
public comment session will be held
during the meeting. Pre-registration is
required for both public participation
and comment.
Individuals who wish to participate in
the meeting and/or provide public
comment should pre-register by sending
an email to PACHA@hhs.gov.
Individuals will be required to provide
their name, organization, and email
address to pre-register. Agenda items
will include discussing the 2019 novel
coronavirus (COVID–19) and the impact
on people living with, or at risk of, HIV
and implementing the Ending the HIV
Epidemic initiative post COVID–19. The
meeting agenda will be posted on the
PACHA website at https://www.hiv.gov/
federal-response/pacha/about-pacha as
soon as it becomes available.
DATES: The meeting will be held on
Monday, June 1, 2020, from
approximately 2:00 p.m. to 5:00 p.m.
(ET) and on Tuesday, June 2, 2020 from
approximately 2:00 p.m. to 5:00 p.m.
(ET). This meeting will be conducted
utilizing virtual technology.
ADDRESSES: Instructions regarding
attending this meeting virtually will be
posted one week prior to the meeting at:
https://www.hiv.gov/federal-response/
pacha/about-pacha.
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, MPA, Public Health
Analyst, Presidential Advisory Council
on HIV/AIDS, 330 C Street SW, Room
L609A, Washington, DC 20024; (202)
SUMMARY:
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795–7622 or PACHA@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
by Executive Order 13009, dated June
14, 1996 and is currently operating
under the authority given in Executive
Order 13889, dated September 27, 2019.
The Council was established to provide
advice, information, and
recommendations to the Secretary
regarding programs and policies
intended to promote effective
prevention and care of HIV infection
and AIDS. The functions of the Council
are solely advisory in nature.
The Council consists of not more than
25 members. Council members are
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
and AIDS, public health, global health,
philanthropy, marketing or business, as
well as other national leaders held in
high esteem from other sectors of
society. Council members are appointed
by the Secretary or designee, in
consultation with the White House.
Dated: May 13, 2020.
B. Kaye Hayes,
Principal Deputy Director, Office of Infectious
Disease and HIV/AIDS Policy, Office of the
Assistant Secretary for Health.
[FR Doc. 2020–10639 Filed 5–18–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Acute Neural Injury and Epilepsy
Study Section.
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Date: June 18–19, 2020.
Time: 8:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Paula Elyse Schauwecker,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5201,
Bethesda, MD 20892, 301–760–8207,
schauweckerpe@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Nursing and Related Clinical Sciences Study
Section.
Date: June 22–23, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Preethy Nayar, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3156,
Bethesda, MD 20892, 301–402–4469,
nayarp2@csr.nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Drug Discovery and Molecular
Pharmacology Study Section.
Date: June 22–23, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Jeffrey Smiley, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6194,
MSC 7804, Bethesda, MD 20892, 301–594–
7945, smileyja@csr.nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Cancer, Heart, and Sleep Epidemiology B
Study Section.
Date: June 22–23, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Gianina Ramona
Dumitrescu, Ph.D., MPH, Scientific Review
Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 4193–C, Bethesda, MD 28092,
301–827–0696, dumitrescurg@csr.nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Neurotransporters, Receptors,
and Calcium Signaling Study Section.
Date: June 23, 2020.
Time: 8:30 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
E:\FR\FM\19MYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 97 (Tuesday, May 19, 2020)]
[Notices]
[Pages 29951-29952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10656]
-----------------------------------------------------------------------
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 on Tuesday, June 9, 2020. If needed,
additional sessions and may be added on Wednesday, June 10, 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].
Telephone: 202-795-7611.
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 the June 2020 NVAC meeting, sessions will focus on
coronavirus vaccine development, reimbursement and changes in billing
and coverage with updates from members. 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 minutes per person to ensure time is allotted for all those
wishing to speak. Individuals are also welcome to submit written
comments. Written comments should not exceed three pages in length.
Individuals submitting written comments should email their comments
[[Page 29952]]
to [email protected] at least five business days prior to the meeting.
Dated: May 13, 2020.
Ann Aikin,
Acting Designated Federal Official, Office of the Assistant Secretary
for Health.
[FR Doc. 2020-10656 Filed 5-18-20; 8:45 am]
BILLING CODE 4150-44-P
