Sixth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 9516-9520 [2021-03106]

Download as PDF 9516 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers Activity; 21 CFR part Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours Multiple distributor data and distributor tracking records— 821.30(c)(2) and (d) ......................................................... 22,000 1 22,000 1 22,000 Total .............................................................................. ........................ ........................ ........................ ........................ 592,276 1 There are no capital costs or operating and maintenance costs associated with this collection of information. burden. 2 One-time TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents Activity; 21 CFR part Acquisition of tracked devices and final distributor data— 821.30(a) and (b) ............................................................. Multiple distributor data and distributor tracking records— 821.30(c)(2) and (d) ......................................................... Total .............................................................................. 1 There Dated: February 9, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–03017 Filed 2–12–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Sixth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 Notice of amendment. The Acting Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration. SUMMARY: This amendment to the Declaration is effective as of February 16, 2021. DATES: khammond on DSKJM1Z7X2PROD with NOTICES Total annual disclosures Average burden per disclosure Total hours 22,000 1 22,000 1 22,000 1,100 1 1,100 1 1,100 ........................ ........................ ........................ ........................ 23,100 are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimate for this information collection has not changed since the last OMB approval. ACTION: Number of disclosures per respondent L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health andHuman Services, 200 Independence Avenue FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 18:04 Feb 12, 2021 Jkt 253001 SW, Washington, DC 20201; 202–260– 0365, paige.ezernack@hhs.gov. SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving ‘‘willful misconduct’’ as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109– 148, Division C, section 2. It amended the Public Health Service (PHS) Act, adding section 319F–3, which addresses liability immunity, and section 319F–4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d–6d and 42 U.S.C. 247d–6e, respectively. Section 319F–3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116–136, enacted on March 27, 2020, to expand Countermeasures under the PREP Act. On January 31, 2020, former Secretary, Alex M. Azar II, declared a PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID–19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, and January 21, 2021. On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against COVID–19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID–19 might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, August 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary’s Declaration and E:\FR\FM\16FEN1.SGM 16FEN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices authorizations issued by the Department’s Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond; added an additional category of qualified persons under Section V of the Declaration; made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act; added a third method of distribution to provide liability protections for, among other things, private distribution channels; made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration’s liability protections; made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID– 19 pandemic among federal, state, local, and private-sector entities; revised the effective time period of the Declaration; and republished the declaration in full. (85 FR 79190 December 9, 2020). On January 28, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID–19 vaccines that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021). The Acting Secretary now amends section V of the Declaration to add a new subsection (h) to add an additional category of qualified persons covered under the PREP Act, and thus authorizes: (h) Any Federal government employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government employees, contractors, or volunteers are qualified persons if the following requirement is met: The executive department or agency by or for which the Federal employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such employees, contractors, or volunteers are authorized to carry out under this declaration. VerDate Sep<11>2014 17:04 Feb 12, 2021 Jkt 253001 Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a ‘‘qualified person’’ is a ‘‘covered person.’’ Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. ‘‘Qualified person’’ includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) ‘‘a person within a category of persons so identified in a declaration by the Secretary’’ under subsection (b) of the PREP Act. 42 U.S.C. 247d–6d(i)(8) By this amendment to the Declaration, the Acting Secretary identifies an additional category of persons who are qualified persons under section 247d– 6d(i)(8)(B): Federal employees, contractors and volunteers authorized by their Department or agency to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of their duties or responsibilities. The Acting Secretary has determined that there is an urgent need to expand the pool of available COVID–19 vaccinators in order to respond effectively to the pandemic. As vaccine supply is made more widely available over the coming months, health care system capacity and the vaccination workforce are likely to become increasingly strained throughout the Nation. The United States is deploying federal personnel, contractors and volunteers to assist in the national COVID–19 vaccination program. While the United States is a covered person under the PREP Act and the Declaration, this amendment clarifies that federal employees, contractors and volunteers are also qualified persons authorized by the Secretary to prescribe, dispense, or administer covered countermeasures, consistent with the terms and conditions of the Declaration. As qualified persons, these employees, contractors and volunteers will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration in addition to the protection that is afforded to the United States as a covered person. Second, to the extent PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 9517 that any State law that would otherwise prohibit the employees, contractors, or volunteers who are a ‘‘qualified person’’ from prescribing, dispensing, or administering COVID–19 vaccines or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are ‘‘qualified persons’’ under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID–19 diagnostic tests.1 The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as ‘‘qualified persons’’ would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of ‘‘qualified persons’’ specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F–3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law. The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by COVID–19 as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID–19 vaccination program. 1 Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https://www.hhs.gov/ guidance/sites/default/files/hhs-guidancedocuments/prep-act-advisory-opinion-hhs-ogc.pdf/ (last visited Jan. 24, 2021). See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2020, available at: https://www.justice.gov/sites/ default/files/opinions/attachments/2021/01/19/ 2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021). E:\FR\FM\16FEN1.SGM 16FEN1 9518 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID–19. Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID–19, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, and as amended on February 2, 2021, is further amended pursuant to section 319F–3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (December 9, 2020). 1. Covered Persons, section V, delete in full and replace with: V. Covered Persons khammond on DSKJM1Z7X2PROD with NOTICES 42 U.S.C. 247d–6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are ‘‘manufacturers,’’ ‘‘distributors,’’ ‘‘program planners,’’ ‘‘qualified persons,’’ and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. ‘‘Order’’ as used herein and in guidance issued by the Office of the Assistant Secretary for Health 2 means a provider medication order, which includes prescribing of vaccines, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons: (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; 3 2 See Guidance for Licensed Pharmacists, COVID– 19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19tests.pdf (last visited Jan. 24, 2021); 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-pharmacistsand-pharmacy-interns-regarding-covid-19-vaccinesimmunity.pdf (last visited Jan. 24, 2021). 3 See, e.g., Guidance for Licensed Pharmacists, COVID–19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https:// VerDate Sep<11>2014 17:04 Feb 12, 2021 Jkt 253001 (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; (c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act; (d) A State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy),4 (1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule or (2) FDA www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19tests.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for COVID–19 Screening Tests at Nursing Homes, Assisted-Living Facilities, LongTerm-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/guidance/sites/default/files/ hhs-guidance-documents/prep-act-coverage-forscreening-in-congregate-settings.pdf (last visited Jan. 24, 2021); 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/hhsguidance-documents//licensed-pharmacists-andpharmacy-interns-regarding-covid-19-vaccinesimmunity.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-guidance-documents//prepact-guidance.pdf (last visited Jan. 24, 2021); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/ guidance/sites/default/files/hhs-guidancedocuments//prep-act-authorization-pharmaciesadministering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH PREP Act Authorizations). Nothing herein shall suggest that, for purposes of the Declaration, the foregoing are the only persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. 4 Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, ‘‘State-licensed or registered intern’’ (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. See 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 at 2, available at https://www.hhs.gov/ guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf (last visited Jan. 24, 2021). PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 authorized or FDA licensed COVID –19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met: i. The vaccine must be authorized, approved, or licensed by the FDA; ii. In the case of a COVID–19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID–19 vaccine recommendation(s). iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule; iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines; v. The licensed or registered pharmacy intern 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 vaccines, and the recognition and treatment of emergency reactions to vaccines; vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; 5 5 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, 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:// E:\FR\FM\16FEN1.SGM 16FEN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period; viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s 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; ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and x. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID– 19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID– 19 vaccine(s). (e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.6 www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021). 6 See, e.g.,Advisory Opinion 20–02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents/ VerDate Sep<11>2014 17:04 Feb 12, 2021 Jkt 253001 Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. (f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID–19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID–19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: (i) Documentation of completion of the Centers for Disease Control and Prevention COVID–19 (CDC) Vaccine Training Modules 7 and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID– 19 vaccine(s) to be administered; and (g) Any physician, advanced practice registered nurse, registered nurse, or practical nurse who has held an active license or certification to prescribe, dispense, or administer vaccines under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID–19 vaccination effort by a federal, State, local, Tribal or territorial authority or by an institution in which the COVID–19 advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021). 7 See COVID–19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/ training.html. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 9519 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to (i) documentation of completion of the Centers for Disease Control and Prevention COVID–19 Vaccine Training Modules and (ii) documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID–19 vaccine(s) to be administered. (h) Any Federal government employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government employees, contractors, or volunteers are qualified persons if the following requirement is met: The executive department or agency by or for which the Federal employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited ien scope than the activities such employees, contractors, or volunteers are authorized to carry out under this declaration. 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. E:\FR\FM\16FEN1.SGM 16FEN1 9520 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 2. Effective Time Period, Section XII, Add to the End of the Section: Liability protections for Qualified Persons under sections V(f) and V(d) of the declaration begin on February 8, 2021 and last through October 1, 2024. Authority: 42 U.S.C. 247d–6d. Norris Cochran, Acting Secretary, Department of Health and Human Services. [FR Doc. 2021–03106 Filed 2–11–21; 4:15 pm] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Epstein-Barr Virus Antibody That Blocks Fusion And Neutralizes Virus Infection of B Cells Description of Technology Epstein-Barr virus (EBV) is the most common cause of infectious mononucleosis and is associated with nearly 200,000 cancers and 140,000 deaths each year. EBV-associated cancers include Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, Burkitt B cell lymphoma, and EBV post-transplant lymphoproliferative disease. The latent VerDate Sep<11>2014 17:04 Feb 12, 2021 Jkt 253001 reservoir for EBV in the body is the B lymphocyte. Thus, blocking B cell infection is important for reducing EBVrelated disease. EBV can infect both B cells and epithelial cells; however, the method of entry differs between these two cell types. To initiate B cell infection, EBV glycoprotein 350 (gp350) binds to compliment receptor 2 (CR2; also known as CD21), followed by binding of glycoprotein 42 (gp42) to HLA class II molecules, which triggers fusion of EBV with the B cell, allowing virus entry into the cell. Fusion also requires the EBV proteins gH/gL, which are found complexed with gp42 as a heterotrimer, and gB. Infection of epithelial cells is initiated by the binding of the EBV protein BMRF2 to cellular integrins, followed by binding of gH/gL to ephrin receptor A2 and integrins, which triggers fusion by EBV gB. Monoclonal antibodies that specifically bind EBV gp42 are described by this invention. The gp42specific antibodies are capable of neutralizing EBV infection and inhibiting fusion of EBV with B cells. The monoclonal antibodies can be used for the treatment or prophylaxis of EBV infection, prevention of EBV-associated disease or infection in immunocompromised subjects, diagnosis of EBV infection, and detection of EBV in a biological sample. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. Potential Commercial Applications • • • • Viral diagnostics Viral therapeutics Viral prophylaxis Vaccine research Competitive Advantages • Ease of manufacture • Strongly neutralizing antibodies • Alternative to EBV vaccines Development Stage • In vivo data assessment (animal) Inventors: Jeffrey Cohen (NIAID), Wei Bu (NIAID), Nathan Board (NIAID), Kennichi Dowdell (NIAID). Intellectual Property: HHS Reference No. E–020–2020–0—U.S. Provisional Application No. 62/979,070, filed February 20, 2020. Licensing Contact: Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 interested in collaborative research to further develop, evaluate, or commercialize for development of a vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. Dated: January 28, 2021. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2021–03045 Filed 2–12–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; 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 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: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Renal RC2 Applications. Date: March 19, 2021. Time: 3:30 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ryan G. Morris, Ph.D., Scientific Review Officer, Review Branch, Division of Extramural Activities, NIDDK, National Institutes of Health, 6707 Democracy Boulevard, Room 7015, Bethesda, MD 20892–2542, 301–594–4721, ryan.morris@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) E:\FR\FM\16FEN1.SGM 16FEN1

Agencies

[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9516-9520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Sixth Amendment to Declaration Under the Public Readiness and 
Emergency Preparedness Act for Medical Countermeasures Against COVID-19

ACTION: Notice of amendment.

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SUMMARY: The Acting Secretary issues this amendment pursuant to section 
319F-3 of the Public Health Service Act to add additional categories of 
Qualified Persons authorized to prescribe, dispense, and administer 
covered countermeasures under section VI of this Declaration.

DATES: This amendment to the Declaration is effective as of February 
16, 2021.

FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Office of the 
Assistant Secretary for Preparedness and Response, Office of the 
Secretary, Department of Health andHuman Services, 200 Independence 
Avenue SW, Washington, DC 20201; 202-260-0365, [email protected].

SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency 
Preparedness Act (PREP Act) authorizes the Secretary of Health and 
Human Services (the Secretary) to issue a Declaration to provide 
liability immunity to certain individuals and entities (Covered 
Persons) against any claim of loss caused by, arising out of, relating 
to, or resulting from the manufacture, distribution, administration, or 
use of medical countermeasures (Covered Countermeasures), except for 
claims involving ``willful misconduct'' as defined in the PREP Act. 
Under the PREP Act, a Declaration may be amended as circumstances 
warrant.
    The PREP Act was enacted on December 30, 2005, as Public Law 109-
148, Division C, section 2. It amended the Public Health Service (PHS) 
Act, adding section 319F-3, which addresses liability immunity, and 
section 319F-4, which creates a compensation program. These sections 
are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. 
Section 319F-3 of the PHS Act has been amended by the Pandemic and All-
Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, 
enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic 
Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to 
expand Countermeasures under the PREP Act.
    On January 31, 2020, former Secretary, Alex M. Azar II, declared a 
public health emergency pursuant to section 319 of the PHS Act, 42 
U.S.C. 247d, effective January 27, 2020, for the entire United States 
to aid in the response of the nation's health care community to the 
COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the 
Secretary renewed that declaration effective on April 26, 2020, July 
25, 2020, October 23, 2020, and January 21, 2021.
    On March 10, 2020, former Secretary Azar issued a Declaration under 
the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, 
Mar. 17, 2020) (the Declaration). On April 10, the former Secretary 
amended the Declaration under the PREP Act to extend liability immunity 
to covered countermeasures authorized under the CARES Act (85 FR 21012, 
Apr. 15, 2020). On June 4, the former Secretary amended the Declaration 
to clarify that covered countermeasures under the Declaration include 
qualified countermeasures that limit the harm COVID-19 might otherwise 
cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary 
amended the declaration to add additional categories of Qualified 
Persons and amend the category of disease, health condition, or threat 
for which he recommended the administration or use of the Covered 
Countermeasures. (85 FR 52136, August 24, 2020). On December 3, 2020, 
the former Secretary amended the declaration to incorporate Advisory 
Opinions of the General Counsel interpreting the PREP Act and the 
Secretary's Declaration and

[[Page 9517]]

authorizations issued by the Department's Office of the Assistant 
Secretary for Health as an Authority Having Jurisdiction to respond; 
added an additional category of qualified persons under Section V of 
the Declaration; made explicit that the Declaration covers all 
qualified pandemic and epidemic products as defined under the PREP Act; 
added a third method of distribution to provide liability protections 
for, among other things, private distribution channels; made explicit 
that there can be situations where not administering a covered 
countermeasure to a particular individual can fall within the PREP Act 
and the Declaration's liability protections; made explicit that there 
are substantive federal legal and policy issues and interests in having 
a unified whole-of-nation response to the COVID-19 pandemic among 
federal, state, local, and private-sector entities; revised the 
effective time period of the Declaration; and republished the 
declaration in full. (85 FR 79190 December 9, 2020). On January 28, 
2021, the Acting Secretary amended the Declaration to add additional 
categories of Qualified Persons authorized to prescribe, dispense, and 
administer COVID-19 vaccines that are covered countermeasures under the 
Declaration (86 FR 7872, February 2, 2021).
    The Acting Secretary now amends section V of the Declaration to add 
a new subsection (h) to add an additional category of qualified persons 
covered under the PREP Act, and thus authorizes:
    (h) Any Federal government employee, contractor, or volunteer who 
prescribes, administers, delivers, distributes or dispenses a Covered 
Countermeasure. Such Federal government employees, contractors, or 
volunteers are qualified persons if the following requirement is met: 
The executive department or agency by or for which the Federal 
employee, contractor, or volunteer is employed, contracts, or 
volunteers has authorized or could authorize that employee, contractor, 
or volunteer to prescribe, administer, deliver, distribute, or dispense 
the Covered Countermeasure as any part of the duties or 
responsibilities of that employee, contractor, or volunteer, even if 
those authorized duties or responsibilities ordinarily would not extend 
to members of the public or otherwise would be more limited in scope 
than the activities such employees, contractors, or volunteers are 
authorized to carry out under this declaration.

Description of This Amendment by Section

Section V. Covered Persons

    Under the PREP Act and the Declaration, a ``qualified person'' is a 
``covered person.'' Subject to certain limitations, a covered person is 
immune from suit and liability under Federal and State law with respect 
to all claims for loss caused by, arising out of, relating to, or 
resulting from the administration or use of a covered countermeasure if 
a declaration under the PREP Act has been issued with respect to such 
countermeasure. ``Qualified person'' includes (A) a licensed health 
professional or other individual who is authorized to prescribe, 
administer, or dispense such countermeasures under the law of the State 
in which the countermeasure was prescribed, administered, or dispensed; 
or (B) ``a person within a category of persons so identified in a 
declaration by the Secretary'' under subsection (b) of the PREP Act. 42 
U.S.C. 247d-6d(i)(8)
    By this amendment to the Declaration, the Acting Secretary 
identifies an additional category of persons who are qualified persons 
under section 247d-6d(i)(8)(B): Federal employees, contractors and 
volunteers authorized by their Department or agency to prescribe, 
administer, deliver, distribute, or dispense the Covered Countermeasure 
as any part of their duties or responsibilities.
    The Acting Secretary has determined that there is an urgent need to 
expand the pool of available COVID-19 vaccinators in order to respond 
effectively to the pandemic. As vaccine supply is made more widely 
available over the coming months, health care system capacity and the 
vaccination workforce are likely to become increasingly strained 
throughout the Nation. The United States is deploying federal 
personnel, contractors and volunteers to assist in the national COVID-
19 vaccination program. While the United States is a covered person 
under the PREP Act and the Declaration, this amendment clarifies that 
federal employees, contractors and volunteers are also qualified 
persons authorized by the Secretary to prescribe, dispense, or 
administer covered countermeasures, consistent with the terms and 
conditions of the Declaration.
    As qualified persons, these employees, contractors and volunteers 
will be afforded liability protections in accordance with the PREP Act 
and the terms of this amended Declaration in addition to the protection 
that is afforded to the United States as a covered person. Second, to 
the extent that any State law that would otherwise prohibit the 
employees, contractors, or volunteers who are a ``qualified person'' 
from prescribing, dispensing, or administering COVID-19 vaccines or 
other Covered Countermeasures, such law is preempted. On May 19, 2020, 
the Office of the General Counsel issued an advisory opinion concluding 
that, because licensed pharmacists are ``qualified persons'' under this 
declaration, the PREP Act preempts state law that would otherwise 
prohibit such pharmacists from ordering and administering authorized 
COVID-19 diagnostic tests.\1\ The opinion relied in part on the fact 
that the Congressional delegation of authority to the Secretary under 
the PREP Act to specify a class of persons, beyond those who are 
authorized to administer a covered countermeasure under State law, as 
``qualified persons'' would be rendered a nullity in the absence of 
such preemption. This opinion is incorporated by reference into this 
declaration. Based on the reasoning set forth in the May 19, 2020 
advisory opinion, any State law that would otherwise prohibit a member 
of any of the classes of ``qualified persons'' specified in this 
declaration from administering a covered countermeasure is likewise 
preempted. In accordance with section 319F-3(i)(8)(A) of the Public 
Health Service Act, a State remains free to expand the universe of 
individuals authorized to administer covered countermeasures within its 
jurisdiction under State law.
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    \1\ Department of Health and Human Services General Counsel 
Advisory Opinion on the Public Readiness and Emergency Preparedness 
Act, May 19, 2020, available at: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-advisory-opinion-hhs-ogc.pdf/ (last visited Jan. 24, 2021). See also, Department of 
Justice Office of Legal Counsel Advisory Opinion for Robert P. 
Charrow, General Counsel of the Department of Health and Human 
Services, January 12, 2020, available at: https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021).
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    The plain language of the PREP Act makes clear that there is 
preemption of state law as described above. Furthermore, preemption of 
State law is justified to respond to the nation-wide public health 
emergency caused by COVID-19 as it will enable States to quickly expand 
the vaccination workforce with additional qualified healthcare 
professionals where State or local requirements might otherwise inhibit 
or delay allowing these healthcare professionals to participate in the 
COVID-19 vaccination program.

[[Page 9518]]

Amendments to Declaration

    Amended Declaration for Public Readiness and Emergency Preparedness 
Act Coverage for medical countermeasures against COVID-19.
    Section V of the March 10, 2020 Declaration under the PREP Act for 
medical countermeasures against COVID-19, as amended April 10, 2020, 
June 4, 2020, August 19, 2020, as amended and republished on December 
3, 2020, and as amended on February 2, 2021, is further amended 
pursuant to section 319F-3(b)(4) of the PHS Act as described below. All 
other sections of the Declaration remain in effect as republished at 85 
FR 79190 (December 9, 2020).
    1. Covered Persons, section V, delete in full and replace with:
V. Covered Persons
42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)
    Covered Persons who are afforded liability immunity under this 
Declaration are ``manufacturers,'' ``distributors,'' ``program 
planners,'' ``qualified persons,'' and their officials, agents, and 
employees, as those terms are defined in the PREP Act, and the United 
States. ``Order'' as used herein and in guidance issued by the Office 
of the Assistant Secretary for Health \2\ means a provider medication 
order, which includes prescribing of vaccines, or a laboratory order, 
which includes prescribing laboratory orders, if required. In addition, 
I have determined that the following additional persons are qualified 
persons:
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    \2\ See Guidance for Licensed Pharmacists, COVID-19 Testing, and 
Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at 
https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); 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-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 
2021).
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    (a) Any person authorized in accordance with the public health and 
medical emergency response of the Authority Having Jurisdiction, as 
described in Section VII below, to prescribe, administer, deliver, 
distribute or dispense the Covered Countermeasures, and their 
officials, agents, employees, contractors and volunteers, following a 
Declaration of an Emergency, as that term is defined in Section VII of 
this Declaration; \3\
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    \3\ See, e.g., Guidance for Licensed Pharmacists, COVID-19 
Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, 
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance 
for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, 
Assisted-Living Facilities, Long-Term-Care Facilities, and other 
Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf (last 
visited Jan. 24, 2021); 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-interns-regarding-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-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021); PREP Act 
Authorization for Pharmacies Distributing and Administering Certain 
Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH 
PREP Act Authorizations). Nothing herein shall suggest that, for 
purposes of the Declaration, the foregoing are the only persons 
authorized in accordance with the public health and medical 
emergency response of the Authority Having Jurisdiction.
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    (b) Any person authorized to prescribe, administer, or dispense the 
Covered Countermeasures or who is otherwise authorized to perform an 
activity under an Emergency Use Authorization in accordance with 
Section 564 of the FD&C Act;
    (c) Any person authorized to prescribe, administer, or dispense 
Covered Countermeasures in accordance with Section 564A of the FD&C 
Act;
    (d) A State-licensed pharmacist who orders and administers, and 
pharmacy interns who administer (if the pharmacy intern acts under the 
supervision of such pharmacist and the pharmacy intern is licensed or 
registered by his or her State board of pharmacy),\4\ (1) vaccines that 
the Advisory Committee on Immunization Practices (ACIP) recommends to 
persons ages three through 18 according to ACIP's standard immunization 
schedule or (2) FDA authorized or FDA licensed COVID -19 vaccines to 
persons ages three or older. Such State-licensed pharmacists and the 
State-licensed or registered interns under their supervision are 
qualified persons only if the following requirements are met:
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    \4\ Some states do not require pharmacy interns to be licensed 
or registered by the state board of pharmacy. As used herein, 
``State-licensed or registered intern'' (or equivalent phrases) 
refers to pharmacy interns authorized by the state or board of 
pharmacy in the state in which the practical pharmacy internship 
occurs. The authorization can, but need not, take the form of a 
license from, or registration with, the State board of pharmacy. See 
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 at 2, 
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 
2021).
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    i. The vaccine must be authorized, approved, or licensed by the 
FDA;
    ii. In the case of a COVID-19 vaccine, the vaccination must be 
ordered and administered according to ACIP's COVID-19 vaccine 
recommendation(s).
    iii. In the case of a childhood vaccine, the vaccination must be 
ordered and administered according to ACIP's standard immunization 
schedule;
    iv. The licensed pharmacist must have completed the immunization 
training that the licensing State requires in order for pharmacists to 
order and administer vaccines. If the State does not specify training 
requirements for the licensed pharmacist to order and administer 
vaccines, the licensed pharmacist must complete a vaccination training 
program of at least 20 hours that is approved by the Accreditation 
Council for Pharmacy Education (ACPE) to order and administer vaccines. 
Such a training program must include hands on injection technique, 
clinical evaluation of indications and contraindications of vaccines, 
and the recognition and treatment of emergency reactions to vaccines;
    v. The licensed or registered pharmacy intern 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 vaccines, and the recognition 
and treatment of emergency reactions to vaccines;
    vi. The licensed pharmacist and licensed or registered pharmacy 
intern must have a current certificate in basic cardiopulmonary 
resuscitation; \5\
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    \5\ 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, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-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-guidance-documents//prep-act-guidance.pdf (last 
visited Jan. 24, 2021).

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[[Page 9519]]

    vii. The licensed pharmacist must complete a minimum of two hours 
of ACPE-approved, immunization-related continuing pharmacy education 
during each State licensing period;
    viii. The licensed pharmacist must comply with recordkeeping and 
reporting requirements of the jurisdiction in which he or she 
administers vaccines, including informing the patient's 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;
    ix. The licensed pharmacist must inform his or her childhood-
vaccination patients and the adult caregiver accompanying the child of 
the importance of a well-child visit with a pediatrician or other 
licensed primary care provider and refer patients as appropriate; and
    x. The licensed pharmacist and the licensed or registered pharmacy 
intern must comply with any applicable requirements (or conditions of 
use) as set forth in the Centers for Disease Control and Prevention 
(CDC) COVID-19 vaccination provider agreement and any other federal 
requirements that apply to the administration of COVID-19 vaccine(s).
    (e) Healthcare personnel using telehealth to order or administer 
Covered Countermeasures for patients in a state other than the state 
where the healthcare personnel are licensed or otherwise permitted to 
practice. When ordering and administering Covered Countermeasures by 
means of telehealth to patients in a state where the healthcare 
personnel are not already permitted to practice, the healthcare 
personnel must comply with all requirements for ordering and 
administering Covered Countermeasures to patients by means of 
telehealth in the state where the healthcare personnel are permitted to 
practice. Any state law that prohibits or effectively prohibits such a 
qualified person from ordering and administering Covered 
Countermeasures by means of telehealth is preempted.\6\ Nothing in this 
Declaration shall preempt state laws that permit additional persons to 
deliver telehealth services.
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    \6\ See, e.g.,Advisory Opinion 20-02 on the Public Readiness and 
Emergency Preparedness Act and the Secretary's Declaration under the 
Act, May 19, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021).
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    (f) Any healthcare professional or other individual who holds an 
active license or certification permitting the person to prescribe, 
dispense, or administer vaccines under the law of any State as of the 
effective date of this amendment, or as authorized under the section 
V(d) of this Declaration, who prescribes, dispenses, or administers 
COVID-19 vaccines that are Covered Countermeasures under section VI of 
this Declaration in any jurisdiction where the PREP Act applies, other 
than the State in which the license or certification is held, in 
association with a COVID-19 vaccination effort by a federal, State, 
local Tribal or territorial authority or by an institution in the State 
in which the COVID-19 vaccine covered countermeasure is administered, 
so long as the license or certification of the healthcare professional 
has not been suspended or restricted by any licensing authority, 
surrendered while under suspension, discipline or investigation by a 
licensing authority or surrendered following an arrest, and the 
individual is not on the List of Excluded Individuals/Entities 
maintained by the Office of Inspector General, subject to: (i) 
Documentation of completion of the Centers for Disease Control and 
Prevention COVID-19 (CDC) Vaccine Training Modules \7\ and, for 
healthcare providers who are not currently practicing, documentation of 
an observation period by a currently practicing healthcare professional 
adequately experienced in vaccination who confirms competency of the 
healthcare provider in preparation and administration of the particular 
COVID-19 vaccine(s) to be administered; and
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    \7\ See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/training.html.
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    (g) Any physician, advanced practice registered nurse, registered 
nurse, or practical nurse who has held an active license or 
certification to prescribe, dispense, or administer vaccines under the 
law of any State within the last five years, which is inactive, expired 
or lapsed, who prescribes, dispenses, or administers COVID-19 vaccines 
that are Covered Countermeasures under section VI of this Declaration 
in any jurisdiction where the PREP Act applies in association with a 
COVID-19 vaccination effort by a federal, State, local, Tribal or 
territorial authority or by an institution in which the COVID-19 
vaccine covered countermeasure is administered, so long as the license 
or certification was active and in good standing prior to the date it 
went inactive, expired or lapsed and was not revoked by the licensing 
authority, surrendered while under suspension, discipline or 
investigation by a licensing authority or surrendered following an 
arrest, and the individual is not on the List of Excluded Individuals/
Entities maintained by the Office of Inspector General, subject to (i) 
documentation of completion of the Centers for Disease Control and 
Prevention COVID-19 Vaccine Training Modules and (ii) documentation of 
an observation period by a currently practicing healthcare professional 
adequately experienced in vaccination who confirms competency of the 
healthcare provider in preparation and administration of the particular 
COVID-19 vaccine(s) to be administered.
    (h) Any Federal government employee, contractor, or volunteer who 
prescribes, administers, delivers, distributes or dispenses a Covered 
Countermeasure. Such Federal government employees, contractors, or 
volunteers are qualified persons if the following requirement is met: 
The executive department or agency by or for which the Federal 
employee, contractor, or volunteer is employed, contracts, or 
volunteers has authorized or could authorize that employee, contractor, 
or volunteer to prescribe, administer, deliver, distribute, or dispense 
the Covered Countermeasure as any part of the duties or 
responsibilities of that employee, contractor, or volunteer, even if 
those authorized duties or responsibilities ordinarily would not extend 
to members of the public or otherwise would be more limited ien scope 
than the activities such employees, contractors, or volunteers are 
authorized to carry out under this declaration.
    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.

[[Page 9520]]

2. Effective Time Period, Section XII, Add to the End of the Section:
    Liability protections for Qualified Persons under sections V(f) and 
V(d) of the declaration begin on February 8, 2021 and last through 
October 1, 2024.

    Authority: 42 U.S.C. 247d-6d.

Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-03106 Filed 2-11-21; 4:15 pm]
BILLING CODE 4150-37-P
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