51166 Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Notices 

12This 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/hhsguidance-documents//prep-act-guidance.pdf (last 

visited Jan. 24, 2021). 

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

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 

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 


tkelley on DSK125TN23PROD with NOTICES
Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Notices 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, 

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 

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. 

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, 

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) 


tkelley on DSK125TN23PROD with NOTICES