National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 51166-51167 [2021-19759]
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Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Notices
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qualified persons only if the following
requirements are met:
ix. The COVID–19 therapeutic must
be authorized, approved, or licensed by
the FDA;
x. In the case of a licensed pharmacist
ordering a COVID–19 therapeutic, the
therapeutic must be ordered for
subcutaneous, intramuscular, or oral
administration and in accordance with
the FDA approval, authorization, or
licensing;
xi. In the case of licensed
pharmacists, qualified pharmacy
technicians, and licensed or registered
pharmacy interns administering the
COVID–19 therapeutic, the therapeutic
must be administered subcutaneously,
intramuscularly, or orally in accordance
with the FDA approval, authorization,
or licensing;
xii. In the case of qualified pharmacy
technicians, the supervising pharmacist
must be readily and immediately
available to the qualified pharmacy
technician;
xiii. In the case of COVID–19
therapeutics administered through
intramuscular or subcutaneous
injections, the licensed pharmacist,
licensed or registered pharmacy intern
and qualified pharmacy technician must
complete a practical training program
that is approved by the ACPE. This
training program must include hands-on
injection technique, clinical evaluation
of indications and contraindications of
COVID–19 therapeutics, the recognition
and treatment of emergency reactions to
COVID–19 therapeutics, and any
additional training required in the FDA
approval, authorization, or licensing;
xiv. The licensed pharmacist, licensed
or registered pharmacy intern and
qualified pharmacy technician must
have a current certificate in basic
cardiopulmonary resuscitation; 12
12 This requirement is satisfied by, among other
things, a certification in basic cardiopulmonary
resuscitation by an online program that has
received accreditation from the American Nurses
Credentialing Center, the ACPE, or the
Accreditation Council for Continuing Medical
Education. The phrase ‘‘current certificate in basic
cardiopulmonary resuscitation,’’ when used in the
September 3, 2020 or October 20, 2020 OASH
authorizations, shall be interpreted the same way.
See Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID–19 Vaccines
and Immunity under the PREP Act, OASH
Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID–19 Vaccines and
Immunity under the PREP Act, OASH, Sept. 3,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents//
licensed-pharmacists-and-pharmacy-internsregarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act
Coverage for Qualified Pharmacy Technicians and
State-Authorized Pharmacy Interns for Childhood
Vaccines, COVID–19 Vaccines, and COVID–19
Testing, OASH, Oct. 20, 2020, available at https://
www.hhs.gov/guidance/sites/default/files/hhs-
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21:55 Sep 13, 2021
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xv. The licensed pharmacist must
comply with recordkeeping and
reporting requirements of the
jurisdiction in which he or she
administers COVID–19 therapeutics,
including informing the patient’s
primary-care provider when available
and complying with requirements with
respect to reporting adverse events;
xvi. The licensed pharmacist, the
licensed or registered pharmacy intern
and the qualified pharmacy technician
must comply with any applicable
requirements (or conditions of use) that
apply to the administration of COVID–
19 therapeutics.
Nothing in this Declaration shall be
construed to affect the National Vaccine
Injury Compensation Program,
including an injured party’s ability to
obtain compensation under that
program. Covered countermeasures that
are subject to the National Vaccine
Injury Compensation Program
authorized under 42 U.S.C. 300aa–10 et
seq. are covered under this Declaration
for the purposes of liability immunity
and injury compensation only to the
extent that injury compensation is not
provided under that Program. All other
terms and conditions of the Declaration
apply to such covered countermeasures.
2. Effective Time Period, section XII,
delete in full and replace with:
Liability protections for any
respiratory protective device approved
by NIOSH under 42 CFR part 84, or any
successor regulations, through the
means of distribution identified in
Section VII(a) of this Declaration, begin
on March 27, 2020 and extend through
October 1, 2024.
Liability protections for all other
Covered Countermeasures identified in
Section VI of this Declaration, through
means of distribution identified in
Section VII(a) of this Declaration, begin
on February 4, 2020 and extend through
October 1, 2024.
Liability protections for all Covered
Countermeasures administered and
used in accordance with the public
health and medical response of the
Authority Having Jurisdiction, as
identified in Section VII(b) of this
Declaration, begin with a Declaration of
Emergency as that term is defined in
Section VII (except that, with respect to
qualified persons who order or
administer a routine childhood
vaccination that ACIP recommends to
persons ages three through 18 according
to ACIP’s standard immunization
schedule, liability protections began on
August 24, 2020), and last through (a)
the final day the Declaration of
guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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Emergency is in effect, or (b) October 1,
2024, whichever occurs first.
Liability protections for all Covered
Countermeasures identified in Section
VII(c) of this Declaration begin on
December 9, 2020 and last through (a)
the final day the Declaration of
Emergency is in effect or (b) October 1,
2024 whichever occurs first.
Liability protections for Qualified
Persons under section V(d) of the
Declaration who are qualified pharmacy
technicians and interns to seasonal
influenza vaccine to persons aged 19
and older begin on August 4, 2021.
Liability protections for Qualified
Persons under section V(f) of the
Declaration begin on February 2, 2021,
and last through October 1, 2024.
Liability protections for Qualified
Persons under section V(g) of the
Declaration begin on February 16, 2021,
and last through October 1, 2024.
Liability protections for Qualified
Persons who are physicians, advanced
practice registered nurses, registered
nurses, or practical nurses under section
V(h) of the Declaration begins on
February 2, 2021 and last through
October 1, 2024, with additional
conditions effective as of March 11,
2021and liability protections for all
other Qualified persons under section
V(h) begins on March 11, 2021 and last
through October 1, 2024.
Liability protections for Qualified
Persons under section V(i) of the
Declaration who are licensed
pharmacists to order and administer and
qualified pharmacy technicians and
licensed or registered pharmacy interns
to administer COVID–19 therapeutics
begin on September 9, 2021.
Authority: 42 U.S.C. 247d–6d.
Dated: September 9, 2021.
Xavier Becerra,
Secretary, U.S. Department of Health and
Human Services.
[FR Doc. 2021–19790 Filed 9–9–21; 4:15 pm]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; 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
E:\FR\FM\14SEN1.SGM
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Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Notices
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: Heart, Lung, and
Blood Initial Review Group; Clinical Trials
Review Study Section.
Date: October 28–29, 2021.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6705
Rockledge Drive, Bethesda, MD 20817
(Virtual Meeting).
Contact Person: Keary A Cope, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, National Institutes of Health,
6705 Rockledge Drive, Room 209–A,
Bethesda, MD 20892–7924, (301) 827–7912,
copeka@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 8, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–19759 Filed 9–13–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
tkelley on DSK125TN23PROD with NOTICES
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: Center for Scientific
Review Special Emphasis Panel; ImmunoOncology Research.
Date: October 14–15, 2021.
Time: 9:00 a.m. to 8:00 p.m.
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Maria Elena CardenasCorona, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20817, 301–867–5309, maria.cardenascorona@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 19–
367: Maximizing Investigators’ Research
Award.
Date: October 14, 2021.
Time: 3:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Anita Szajek, Scientific
Review Officer, Center for Scientific Review,
6701 Rockledge Drive, Bethesda, MD 20892,
301–827–6276, anita.szajek@nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Lung Injury, Repair, and Remodeling
Study Section.
Date: October 18–19, 2021.
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 Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Ghenima Dirami, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4122,
MSC 7814, Bethesda, MD 20892, 240–498–
7546, diramig@csr.nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Molecular Neuropharmacology and Signaling Study Section.
Date: October 18–19, 2021.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Vanessa S. Boyce, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 4016F,
MSC 7812, Bethesda, MD 20892, (301) 435–
0908, boycevs@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Health Promotion in Communities Study
Section.
Date: October 18–19, 2021.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Helena Eryam Dagadu,
MPH, Ph.D., Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3137,
PO 00000
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51167
Bethesda, MD 20892, 301–435–1266,
dagaduhe@csr.nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Cancer Immunopathology and
Immunotherapy Study Section.
Date: October 18–19, 2021.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Zhang-Zhi Hu, M.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6186,
MSC 7804, Bethesda, MD 20892, (301) 594–
2414, huzhuang@csr.nih.gov.
Name of Committee: Infectious Diseases
and Immunology A Integrated Review Group;
Bacterial Pathogenesis Study Section.
Date: October 18–19, 2021.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Marci Scidmore, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192,
MSC 7808, Bethesda, MD 20892, 301–435–
1149, marci.scidmore@nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Cancer Biomarkers Study Section.
Date: October 18–19, 2021.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Lawrence Ka-Yun Ng,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6152,
MSC 7804, Bethesda, MD 20892, 301–357–
9318, ngkl@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Brain Injury and Neurovascular
Pathologies Study Section.
Date: October 18–19, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Alexander Yakovlev,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5206,
MSC 7846, Bethesda, MD 20892, 301–435–
1254, yakovleva@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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]]>Agencies
[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Pages 51166-51167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19759]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; 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
[[Page 51167]]
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: Heart, Lung, and Blood Initial Review Group;
Clinical Trials Review Study Section.
Date: October 28-29, 2021.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6705 Rockledge Drive,
Bethesda, MD 20817 (Virtual Meeting).
Contact Person: Keary A Cope, Ph.D., Scientific Review Officer,
Office of Scientific Review/DERA, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6705 Rockledge Drive, Room
209-A, Bethesda, MD 20892-7924, (301) 827-7912, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: September 8, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-19759 Filed 9-13-21; 8:45 am]
BILLING CODE 4140-01-P
