Federal Register - August 4, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices
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podiatry, optometry or veterinary student with appropriate training in administering vaccines as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers COVID19
vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID19 vaccine covered countermeasure is administered;
Subject to the following requirements:
i. The vaccine must be authorized, approved, or licensed by the FDA;
ii. Vaccination must be ordered and administered according to ACIPs COVID19
vaccine recommendations;
iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention COVID19 Vaccine Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID19 vaccines;
iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID19 vaccines to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID19 vaccines;
v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; 13
vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patients 13 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 COVID19 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, COVID19 Vaccines, and COVID19
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.
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primary-care provider when available, submitting the required immunization information to the State or local immunization information system vaccine registry, complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and vii. The healthcare professionals and students comply with any applicable requirements or conditions of use as set forth in the Centers for Disease Control and Prevention CDC COVID19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID19 vaccines.
Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured partys 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 VIIa 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 VIIa 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 VIIb 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 ACIPs 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 VIIc 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 Vd of the Declaration who are qualified pharmacy technicians and interns to administer seasonal influenza vaccine to
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persons aged 19 and older begin on August 4, 2021.
Liability protections for Qualified Persons under section Vf of the Declaration begin on February 2, 2021, and last through October 1, 2024.
Liability protections for Qualified Persons under section Vg 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 Vh 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 Vh begins on March 11, 2021 and last through October 1, 2024.
Authority: 42 U.S.C. 247d6d.
Dated: July 30, 2021.
Xavier Becerra, Secretary, Department of Health and Human Services.
FR Doc. 202116681 Filed 8221; 11:15 am BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health Fogarty International Center; Notice of Meeting Pursuant to section 10d of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Fogarty International Center Advisory Board.
The meeting will be open to the public via online meeting. Individuals who plan to attend 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.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552bc4 and 552bc6, 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: Fogarty International Center Advisory Board.
Date: September 910, 2021.
Closed: September 09, 2021, 12:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
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