79190 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Lubna Merchant, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4418, 

Silver Spring, MD 20993–0002, 301– 

796–5162, or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Best 

Practices in Developing Proprietary 

Names for Human Prescription Drug 

Products.’’ This guidance describes best 

practices to help minimize proprietary 

name-related medication errors and 

otherwise avoid adoption of proprietary 

names that contribute to violations of 

the FD&C Act and its implementing 

regulations. This guidance also 

describes the framework FDA uses in 

evaluating proprietary names that 

sponsors could use before submitting 

names for FDA review if they wish. 

FDA has long recognized the 

importance of proprietary name 

confusion as a potential cause of 

medication errors and has addressed 

this issue repeatedly in recent decades. 

Our focus has been to develop and 

communicate to sponsors a systematic, 

standardized, and transparent approach 

to proprietary name evaluation within 

the product development, review, and 

approval process. 

In the Federal Register of May 29, 

2014 (79 FR 30852), FDA announced the 

availability of a draft guidance entitled 

‘‘Best Practices in Developing 

Proprietary Names for Drugs.’’ The 

guidance announced in this notice 

finalizes the draft guidance issued in 

May 2014. The Agency has carefully 

reviewed and considered the comments 

it received in developing this final 

version of the guidance. 

FDA received several comments on 

the guidance and revised the guidance 

in response to these comments. The 

revisions include (a) adding a note in 

the section discussing the United States 

Adopted Name (USAN) stating that FDA 

will no longer object to the use of twoletter USAN stems in names for 

products that do not share any 

association with the stem in question; 

(b) streamlining the name simulation 

study section based on the feedback 

received; (c) providing clarifications to 

the section that discusses medical 

abbreviations, modifiers, and 

computational methods; (d) separating 

the content pertaining to 

nonprescription proprietary names and 

issuing separate guidance to address the 

name development process for 

nonprescription drugs; (e) revising the 

misbranding discussion for greater 

clarity and included information on one 

possible study methodology that 

sponsors may consider to test proposed 

names for misbranding concerns; and (f) 

adding certain definitions and specific 

criteria for prescreening proprietary 

name candidates and updating 

definitions in the glossary and clarified 

terminology where needed. FDA also 

revised the document throughout to 

ensure consistency in terminology, 

clarified section headings, and 

reordered information for clarity where 

applicable. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of a draft guidance entitled 

‘‘Best Practices in Developing 

Proprietary Names for Human 

Nonprescription Drug Products.’’ That 

draft guidance is issued in response to 

industry stakeholders’ requests to 

specifically address the approaches for 

naming of human nonprescription drug 

products. The draft guidance is being 

issued to provide greater clarity on the 

considerations applicable to 

nonprescription drug products. 

The guidance announced in this 

notice is being issued consistent with 

FDA’s good guidance practices 

regulation (21 CFR 10.115). The 

guidance represents the current thinking 

of FDA on ‘‘Best Practices in Developing 

Proprietary Names for Human 

Prescription Drug Products.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001, and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// 

www.regulations.gov. 

Dated: December 4, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27058 Filed 12–8–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Fourth Amendment to the Declaration 

Under the Public Readiness and 

Emergency Preparedness Act for 

Medical Countermeasures Against 

COVID–19 and Republication of the 

Declaration 

ACTION: Notice of Amendment and 

Republished Declaration. 

SUMMARY: The Secretary issues this 

amendment pursuant to section 319F–3 

of the Public Health Service Act to 

amend his March 10, 2020 Declaration 

Under the Public Readiness and 

Emergency Preparedness Act for 

Medical Countermeasures Against 

COVID–19. 

DATES: The amendments to the 

Declaration are applicable as of 

February 4, 2020, except as otherwise 

specified in Section XII. 

FOR FURTHER INFORMATION CONTACT: 

Robert P. Kadlec, MD, MTM&H, MS, 

Assistant Secretary for Preparedness 

and Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79191 

1 85 FR 15198 (Mar. 17, 2020). 

2 85 FR 21012 (Apr. 15, 2020). 

3 85 FR 35100 (June 8, 2020). 

4 85 FR 52136 (Aug. 24, 2020). 

5See, e.g., Advisory Opinion on the Public 

Readiness and Emergency Preparedness Act and the 

March 10, 2020 Declaration under the Act, Apr. 17, 

2020, as Modified on May 19, 2020, available at 

https://www.hhs.gov/guidance/sites/default/files/

hhs-guidance-documents/prep-act-advisoryopinion-hhs-ogc.pdf (last visited Dec. 1, 2020); 

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 Dec. 1, 2020); Advisory Opinion 20–03 on 

the Public Readiness and Emergency Preparedness 

Act and the Secretary’s Declaration under the Act, 

Oct. 22, 2020, as Modified on Oct. 23, 2020, 

available at https://www.hhs.gov/guidance/sites/ 

default/files/hhs-guidance-documents/AO3.1.2_

Updated_FINAL_SIGNED_10.23.20.pdf (last visited 

Dec. 1, 2020); Advisory Opinion 20–04 on the 

Public Readiness and Emergency Preparedness Act 

and the Secretary’s Declaration under the Act, Oct. 

22, 2020, as Modified on Oct. 23, 2020, available 

at https://www.hhs.gov/guidance/sites/default/files/ 

hhs-guidance-documents/AO%204.2_Updated_

FINAL_SIGNED_10.23.20.pdf (last visited Dec. 1, 

2020). 

6See, 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/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19- 

tests.pdf (last visited Dec. 1, 2020); 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 

Dec. 1, 2020); 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 Dec. 1, 2020); 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/sites/ 

default/files/prep-act-guidance.pdf (last visited 

Dec. 1, 2020); 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-authorizationpharmacies-administering-coveredcountermeasures.pdf (last visited Dec. 1, 2020) 

(collectively, OASH PREP Act Authorizations). 

7 ‘‘Telehealth, telemedicine, and related terms 

generally refer to the exchange of medical 

information from one site to another through 

electronic communication to improve a patient’s 

health.’’ Medicare Telemedicine Health Care 

Provider Fact Sheet, Mar. 17, 2020, available at 

https://www.cms.gov/newsroom/fact-sheets/

medicare-telemedicine-health-care-provider-factsheet (last visited on Dec. 2, 2020). For the 

Declaration and the Fourth Amendment, the term 

‘‘telehealth’’ includes telehealth, telemedicine, and 

related terms as described by the Centers for 

Medicare & Medicaid (CMS). 

SW, Washington, DC 20201; Telephone: 

202–205–2882. 

SUPPLEMENTARY INFORMATION: The 

Public Readiness and Emergency 

Preparedness (PREP) Act, 42 U.S.C. 

247d–6d et. seq., authorizes the 

Secretary of Health and Human Services 

(the Secretary) to issue a declaration to 

provide liability protections 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 

certain medical countermeasures 

(Covered Countermeasures), except for 

claims involving ‘‘willful misconduct,’’ 

as defined in the PREP Act. Such 

declarations are subject to amendment 

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 AllHazards 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 Covered Countermeasures under 

the PREP Act. 

On January 31, 2020, the Secretary 

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 to the Coronavirus 

Disease 2019 (COVID–19) outbreak, 

which subsequently became a global 

pandemic. Pursuant to section 319 of 

the PHS Act, the Secretary renewed that 

declaration on April 21, 2020, July 23, 

2020, and October 2, 2020. On March 

10, 2020, the Secretary issued a 

declaration under the PREP Act for 

medical countermeasures against 

COVID–19.1 On April 10, the Secretary 

amended the Declaration to extend 

liability protections to Covered 

Countermeasures authorized under the 

CARES Act.2 On June 4, the Secretary 

amended the Declaration to clarify that 

Covered Countermeasures under the 

Declaration include qualified pandemic 

and epidemic products that limit the 

harm that COVID–19 might otherwise 

cause.3 On August 19, the Secretary 

amended the Declaration to add 

additional categories of Qualified 

Persons and to amend the category of 

disease, health condition, or threat for 

which he recommends the 

administration or use of Covered 

Countermeasures.4

The Secretary now further amends the 

Declaration pursuant to section 319F–3 

of the Public Health Service Act. This 

Fourth Amendment to the Declaration: 

(a) Clarifies that the Declaration must 

be construed in accordance with the 

Department of Health and Human 

Services (HHS) Office of the General 

Counsel (OGC) Advisory Opinions on 

the Public Readiness and Emergency 

Preparedness Act and the Declaration 

(Advisory Opinions).5 The Declaration 

incorporates the Advisory Opinions for 

that purpose. 

(b) Incorporates authorizations that 

the HHS Office of the Assistant 

Secretary for Health (OASH) has issued 

as an Authority Having Jurisdiction.6

(c) Adds an additional category of 

Qualified Persons under Section V of 

the Declaration and 42 U.S.C. 247d– 

6d(i)(8)(B), i.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 permitted to 

practice.7

(d) Modifies and clarifies the training 

requirements for certain licensed 

pharmacists and pharmacy interns to 

administer certain routine childhood or 

COVID–19 vaccinations. 

(e) Makes explicit that Section VI 

covers all qualified pandemic and 

epidemic products under the PREP Act. 

(f) Adds a third method of 

distribution under Section VII of the 

Declaration and 42 U.S.C. 247d–6d(a)(5) 

that would provide liability protections 

for, among other things, additional 

private-distribution channels. 

(g) Makes explicit in Section IX that 

there can be situations where not 

administering a covered countermeasure 

to a particular individual can fall within 

the PREP Act and this Declaration’s 

liability protections. 

(h) Makes explicit in Section XI that 

there are substantial federal legal and 

policy issues, and substantial federal 

legal and policy interests, in having a 

unified, whole-of-nation response to the 

COVID–19 pandemic among federal, 

state, local, and private-sector entities. 

The world is facing an unprecedented 

pandemic. To effectively respond, there 

must be a more consistent pathway for 

Covered Persons to manufacture, 

distribute, administer or use Covered 

Countermeasures across the nation and 

the world. 


jbell on DSKJLSW7X2PROD with NOTICES
79192 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

8 In addition, the Fourth Amendment makes 

certain non-substantive changes. Those should not 

be interpreted to change any substantive provisions. 9See, e.g., Advisory Opinion on the Public 

Readiness and Emergency Preparedness Act and the 

March 10, 2020 Declaration under the Act, Apr. 17, 

2020, as Modified on May 19, 2020, available at 

https://www.hhs.gov/guidance/sites/default/files/ 

hhs-guidance-documents/prep-act-advisoryopinion-hhs-ogc.pdf (last visited Dec. 1, 2020); 

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 Dec. 1, 2020); Advisory Opinion 20–03 on 

the Public Readiness and Emergency Preparedness 

Act and the Secretary’s Declaration under the Act, 

Oct. 22, 2020, as Modified on Oct. 23, 2020, 

available at https://www.hhs.gov/guidance/sites/ 

default/files/hhs-guidance-documents/AO3.1.2_

Updated_FINAL_SIGNED_10.23.20.pdf (last visited 

Dec. 1, 2020); Advisory Opinion 20–04 on the 

Public Readiness and Emergency Preparedness Act 

and the Secretary’s Declaration under the Act, Oct. 

22, 2020, as Modified on Oct. 23, 2020, available 

at https://www.hhs.gov/guidance/sites/default/files/ 

hhs-guidance-documents/AO%204.2_Updated_

FINAL_SIGNED_10.23.20.pdf (last visited Dec. 1, 

2020). 

10Using Telehealth to Expand Access to Essential 

Health Services during the COVID–19 Pandemic, 

CDC, updated June 10, 2020, available at https://

www.cdc.gov/coronavirus/2019-ncov/hcp/ 

telehealth.html (last visited Dec. 1, 2020). 

11Medicare Telemedicine Health Care Provider 

Fact Sheet, Mar. 17, 2020, available at https://

www.cms.gov/newsroom/fact-sheets/medicaretelemedicine-health-care-provider-fact-sheet (last 

visited Dec. 1, 2020). 

12See, e.g., Trump Administration Drives 

Telehealth Services in Medicaid and Medicare, 

CMS, Oct. 14, 2020, available at https://

www.cms.gov/newsroom/press-releases/trumpadministration-drives-telehealth-services-medicaidand-medicare (last visited Dec. 1, 2020); Secretary 

Azar Announces Historic Expansion of Telehealth 

Access to Combat COVID–19, Mar. 17, 2020, 

available at https://www.hhs.gov/about/news/2020/ 

03/17/secretary-azar-announces-historicexpansion-of-telehealth-access-to-combat-covid19.html (last visited Nov. 30, 2020); OIG Policy 

Statement Regarding Physicians and Other 

Practitioners That Reduce or Waive Amounts Owed 

by Federal Health Care Program Beneficiaries for 

Telehealth Services During the 2019 Novel 

Coronavirus (COVID–19) Outbreak, Mar. 17, 2020, 

available at https://oig.hhs.gov/fraud/docs/ 

alertsandbulletins/2020/policy-telehealth-2020.pdf 

(last visited Nov. 30, 2020). 

13OCR Announces Notification of Enforcement 

Discretion for Telehealth Remote Communications 

During the COVID–19 Nationwide Public Health 

Emergency, Mar. 17, 2020, available at https://

www.hhs.gov/about/news/2020/03/17/ocrannounces-notification-of-enforcement-discretionfor-telehealth-remote-communications-during-thecovid-19.html (last visited Dec. 1, 2020). The PREP 

Act does not provide immunity against federal 

enforcement actions brought by the federal 

government. We refer to this exercise of 

(i) Revises the effective time period of 

the Declaration in light of the 

amendments to the Declaration.8

The Secretary republishes the 

Declaration, as amended, in full. Unless 

otherwise noted, all statutory citations 

are to the U.S. Code. 

Description of This Amendment 

Declaration 

The Declaration has fifteen sections 

describing PREP Act coverage for 

medical countermeasures against 

COVID–19. OGC has issued Advisory 

Opinions interpreting the PREP Act and 

reflecting the Secretary’s interpretation 

of the Declaration.9 The Secretary now 

amends the Declaration to clarify that 

the Declaration must be construed in 

accordance with the Advisory Opinions. 

The Secretary expressly incorporates the 

Advisory Opinions for that purpose. 

Section V. Covered Persons 

Section V of the Declaration describes 

Covered Persons, including additional 

qualified persons identified by the 

Secretary, as required under the PREP 

Act. The Secretary amends Section V to 

specify an additional category of 

qualified persons. Specifically, 

healthcare personnel who are permitted 

to order and administer a Covered 

Countermeasure through telehealth in a 

state may do so for patients in another 

state so long as the healthcare personnel 

comply with the legal requirements of 

the state in which the healthcare 

personnel are permitted to order and 

administer the Covered Countermeasure 

by means of telehealth. 

Telehealth is widely recognized as a 

valuable tool to promote public health 

during this pandemic. According to the 

Centers for Disease Control and 

Prevention (CDC), 

Telehealth services can facilitate public 

health mitigation strategies during this 

pandemic by increasing social distancing. 

These services can be a safer option for 

[healthcare personnel (HCP)] and patients by 

reducing potential infectious exposures. 

They can reduce the strain on healthcare 

systems by minimizing the surge of patient 

demand on facilities and reduce the use of 

[personal protective equipment (PPE)] by 

healthcare providers. 

Maintaining continuity of care to the extent 

possible can avoid additional negative 

consequences from delayed preventive, 

chronic, or routine care. Remote access to 

healthcare services may increase 

participation for those who are medically or 

socially vulnerable or who do not have ready 

access to providers. Remote access can also 

help preserve the patient-provider 

relationship at times when an in-person visit 

is not practical or feasible. Telehealth 

services can be used to: 

• Screen patients who may have symptoms 

of COVID–19 and refer as appropriate 

• Provide low-risk urgent care for nonCOVID–19 conditions, identify those persons 

who may need additional medical 

consultation or assessment, and refer as 

appropriate 

• Access primary care providers and 

specialists, including mental and behavioral 

health, for chronic health conditions and 

medication management 

• Provide coaching and support for 

patients managing chronic health conditions, 

including weight management and nutrition 

counseling 

• Participate in physical therapy, 

occupational therapy, and other modalities as 

a hybrid approach to in-person care for 

optimal health 

• Monitor clinical signs of certain chronic 

medical conditions (e.g., blood pressure, 

blood glucose, other remote assessments) 

• Engage in case management for patients 

who have difficulty accessing care (e.g., those 

who live in very rural settings, older adults, 

those with limited mobility) 

• Follow up with patients after 

hospitalization 

• Deliver advance care planning and 

counseling to patients and caregivers to 

document preferences if a life-threatening 

event or medical crisis occurs 

• Provide non-emergent care to residents 

in long-term care facilities 

• Provide education and training for HCP 

through peer-to-peer professional medical 

consultations (inpatient or outpatient) that 

are not locally available, particularly in rural 

areas.10

Similarly, CMS has stressed the 

importance of telehealth during this 

pandemic: 

Telehealth, telemedicine, and related terms 

generally refer to the exchange of medical 

information from one site to another through 

electronic communication to improve a 

patient’s health. Innovative uses of this kind 

of technology in the provision of healthcare 

is increasing. And with the emergence of the 

virus causing the disease COVID–19, there is 

an urgency to expand the use of technology 

to help people who need routine care, and 

keep vulnerable beneficiaries and 

beneficiaries with mild symptoms in their 

homes while maintaining access to the care 

they need. Limiting community spread of the 

virus, as well as limiting the exposure to 

other patients and staff members will slow 

viral spread.11

Accordingly, CMS and other HHS 

components has substantially expanded 

the scope of services paid under 

Medicare when furnished using 

telehealth technologies during this 

pandemic. 

Other HHS components have also 

taken steps to expand the use of 

telehealth during the pandemic.12

Moreover, to expand the use of 

telehealth during this pandemic, the 

Office for Civil Rights (OCR) at HHS is 

exercising enforcement discretion and 

will not impose penalties for 

noncompliance with the regulatory 

requirements under the Health 

Insurance Portability and 

Accountability Act (HIPAA) Rules 

against covered healthcare providers 

that serve patients through everyday 

communications technologies during 

the COVID–19 nationwide public health 

emergency.13 This exercise of discretion 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79193 

enforcement discretion as another example of the 

Department’s desire to support the expanded use of 

telehealth during this pandemic. 

14 Id. 

15See, e.g., 2020 Alaska Laws Ch. 10 (S.B. 241) 

Sec. 7 (healthcare provider can perform telehealth 

if, among other things, ‘‘the health care provider is 

licensed, permitted, or certified to provide 

healthcare services in another jurisdiction and is in 

good standing in the jurisdiction that issued the 

license, permit, or certification’’); CT Exec. Order 

No. 7G, Sec. 5(b), Mar. 19, 2020, available at https:// 

portal.ct.gov/-/media/Office-of-the-Governor/

Executive-Orders/Lamont-Executive-Orders/ 

Executive-Order-No-7G.pdf (last visited Dec. 1, 

2020) (‘‘Subsection (a)(12)’s requirements for the 

licensure, certification or registration of telehealth 

providers shall be suspended for such telehealth 

providers that are Medicaid enrolled providers or 

in-network providers for commercial fully insured 

health insurance providing telehealth services to 

patients’’); Fl. Emerg. Order, DOH No. 20–002, In 

Re: Suspension of Statutes, Rules, and Orders, 

Made Necessary by COVID–19, Mar. 16, 2020, 

available at http://www.flhealthsource.gov/pdf/

emergencyorder-20-002.pdf?inf_contact_

key=c1be7c474d297aa416752a23d269

4901680f8914173f9191b1c0223e68310bb1 (last 

visited Dec. 1, 2020) (‘‘For purposes of preparing 

for, responding to, and mitigating any effect of 

COVID–19, health care professionals not licensed in 

this state may provide health care services to a 

patient licensed in this state using telehealth, 

notwithstanding the requirements of section 

456.47(4)(a) through (c), (h), and (i), Florida Statutes 

. . . . This exemption shall apply only to the 

following out of state health care professionals 

holding a valid, clear, and unrestricted license in 

another state or territory in the United States who 

are not currently under investigation or prosecution 

in any disciplinary proceeding in any of the states 

in which they hold a license: physicians, 

osteopathic physicians, physician assistants, and 

advanced practice registered nurses.’’); IA Emer. 

Dec., Sec. 39 (Nov. 10, 2020), available at https:// 

governor.iowa.gov/sites/default/files/documents/ 

Public%20Health%20Proclamation%20- 

%202020.11.10.pdf (last visited Dec. 1, 2020) 

(temporarily suspending any statute or rule defining 

a doctor or medical staff as ‘‘requiring all doctors 

and medical staff be licensed to practice in this 

state, to the extent that individual is licensed to 

practice in another state’’); NH Emer. Order # 15 

Pursuant to Exec. Order 2020–4, Sec. 1, Mar. 23, 

2020, available at https://www.governor.nh.gov/ 

sites/g/files/ehbemt336/files/documents/ 

emergency-order-15.pdf (last visited Dec. 1, 2020) 

(‘‘any out-of-state medical provider whose 

profession is licensed within this State shall be 

allowed to perform any medically necessary service 

as if the medical provider were licensed to perform 

such service within the state of New Hampshire 

subject to,’’ among other things, the medical 

provider being ‘‘licensed and in good standing in 

another United States jurisdiction’’). 

16Advisory 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 Dec. 1, 2020). 

17See, 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/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19- 

tests.pdf (last visited Dec. 1, 2020); 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 

Dec. 1, 2020); 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 Dec. 1, 2020); 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/sites/ 

default/files/prep-act-guidance.pdf (last visited 

Dec. 1, 2020); 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-authorizationpharmacies-administering-coveredcountermeasures.pdf (last visited Dec. 1, 2020). 

applies to widely available 

communications apps, such as 

FaceTime or Skype, when used in good 

faith for any telehealth treatment or 

diagnostic purpose, regardless of 

whether the telehealth service is 

directly related to COVID–19.14

Many states have authorized out-ofstate healthcare personnel to deliver 

telehealth services to in-state patients, 

either generally or in the context of 

COVID–19.15

To help maximize the utility of 

telehealth, the Secretary declares that 

the term ‘‘qualified person’’ under 42 

U.S.C. 247d–6d(i)(8)(B) includes 

healthcare personnel using telehealth to 

order or administer Covered 

Countermeasures for patients in a state 

other than the state where the 

healthcare personnel are permitted to 

practice. When ordering and 

administering Covered Countermeasures 

through telehealth to patients in a state 

where the healthcare personnel are not 

already permitted to do so, the 

healthcare personnel must comply with 

all requirements for ordering and 

administering Covered Countermeasures 

to patients through telehealth in the 

state where the healthcare personnel are 

licensed or otherwise permitted to 

practice. Any state law that prohibits or 

effectively prohibits such a qualified 

person from ordering and administering 

Covered Countermeasures through 

telehealth is preempted.16 Nothing in 

this Declaration shall preempt state laws 

that permit additional persons to deliver 

telehealth services. 

The Secretary also amends Section V 

to include several examples of Covered 

Persons who are Qualified Persons, 

because they are authorized in 

accordance with the public health and 

medical emergency response of the 

Authority Having Jurisdiction to 

prescribe, administer, deliver, distribute 

or dispense the Covered 

Countermeasures. Those examples 

include certain pharmacists, pharmacy 

interns, and pharmacy technicians who 

order or administer certain COVID–19 

tests and certain vaccines.17 These 

examples are not an exclusive or 

exhaustive list of persons who are 

qualified persons identified by the 

Secretary in Section V. 

The Secretary also amends Section V 

to make explicit that the requirement in 

that section for certain qualified persons 

to have a current certificate in basic 

cardiopulmonary resuscitation 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 Accreditation Council for Pharmacy 

Education (ACPE), or the Accreditation 

Council for Continuing Medical 

Education. 

The Secretary also amends Section 

V’s training requirements for licensed 

pharmacists to order and administer 

certain childhood or COVID–19 

vaccines. To order and administer 

vaccines, the licensed pharmacist must 

have completed the immunization 

training that the licensing State requires 

in order for pharmacists to 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. 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. 

Other than the basic cardiopulmonary 

resuscitation requirement and the 

practical training program requirement, 

this Amendment does not change the 

requirements for a pharmacist, 

pharmacy intern, or pharmacy 

technician to be a ‘‘qualified person’’ 

under 42 U.S.C. 247d–6d(i)(8)(B) who 

can order or administer childhood or 

COVID–19 vaccines pursuant to the 

Declaration. 

Section VI. Covered Countermeasures 

The Secretary amends Section VI to 

make explicit that Section VI covers all 

qualified pandemic and epidemic 

products under the PREP Act. 


jbell on DSKJLSW7X2PROD with NOTICES
79194 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

18See 85 FR 52136 (Aug. 24, 2020). 

Section VII. Limitations on Distribution 

The Secretary may specify that 

liability protections are in effect only for 

Covered Countermeasures obtained 

through a particular means of 

distribution. The Declaration previously 

stated that liability immunity is afforded 

to Covered Persons only for 

Recommended Activities related to (a) 

present or future federal contracts, 

cooperative agreements, grants, other 

transactions, interagency agreements, or 

memoranda of understanding or other 

federal agreements; or (b) activities 

authorized in accordance with the 

public health and medical response of 

the Authority Having Jurisdiction to 

prescribe, administer, deliver, 

distribute, or dispense the Covered 

Countermeasures following a 

declaration of an emergency. 

COVID–19 is an unprecedented global 

challenge that requires a whole-ofnation response that utilizes federal-, 

state-, and local- distribution channels 

as well as private-distribution channels. 

Given the broad scale of this pandemic, 

the Secretary amends the Declaration to 

extend PREP Act coverage to additional 

private-distribution channels, as set 

forth below. 

The amended Section VII adds that 

PREP Act liability protections also 

extend to Covered Persons for 

Recommended Activities that are 

related to any Covered Countermeasure 

that is: 

(a) Licensed, approved, cleared, or 

authorized by the Food and Drug 

Administration (FDA) (or that is 

permitted to be used under an 

Investigational New Drug Application or 

an Investigational Device Exemption) 

under the Federal Food, Drug, and 

Cosmetic (FD&C) Act or Public Health 

Service (PHS) Act to treat, diagnose, 

cure, prevent, mitigate or limit the harm 

from COVID–19, or the transmission of 

SARS–CoV–2 or a virus mutating 

therefrom; or 

(b) a respiratory protective device 

approved by the National Institute for 

Occupational Safety and Health 

(NIOSH) under 42 CFR part 84, or any 

successor regulations, that the Secretary 

determines to be a priority for use 

during a public health emergency 

declared under section 319 of the PHS 

Act to prevent, mitigate, or limit the 

harm from, COVID–19, or the 

transmission of SARS–CoV–2 or a virus 

mutating therefrom. 

To qualify for this third distribution 

channel (but not necessarily to qualify 

for the other distribution channels), a 

Covered Person must manufacture, test, 

develop, distribute, administer, or use 

the Covered Countermeasure pursuant 

to the FDA licensure, approval, 

clearance, or authorization (or pursuant 

to an Investigational New Drug 

Application or Investigational Device 

Exemption), or the NIOSH approval. 

This third distribution channel may 

extend PREP Act coverage when there is 

no federal agreement or authorization in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction to prescribe, 

administer, deliver, distribute or 

dispense the Covered Countermeasures 

following a declaration of an emergency. 

For example, a manufacturer, 

distributor, program planner, or 

qualified person engages in 

manufacturing, testing, development, 

distribution, administration, or use of a 

COVID–19 test pursuant to an FDA 

Emergency Use Authorization for that 

COVID–19 test. If the Covered Person 

satisfies all other requirements of the 

PREP Act and Declaration, there will be 

PREP Act coverage even if there is no 

federal agreement to cover those 

activities and those activities are not 

part of the authorized activity of an 

Authority Having Jurisdiction. 

Section IX. Administration of Covered 

Countermeasures 

The Secretary amends Section IX to 

make explicit that there can be 

situations where not administering a 

covered countermeasure to a particular 

individual can fall within the PREP Act 

and this Declaration’s liability 

protections. 

Section XI. Geographic Area 

The Secretary makes explicit in 

Section XI that there are substantial 

federal legal and policy issues, and 

substantial federal legal and policy 

interests within the meaning of Grable 

& Sons Metal Products, Inc. v. Darue 

Eng’g. & Mf’g., 545 U.S. 308 (2005), in 

having a unified, whole-of-nation 

response to the COVID–19 pandemic 

among federal, state, local, and privatesector entities. The world is facing an 

unprecedented global pandemic. To 

effectively respond, there must be a 

more consistent pathway for Covered 

Persons to manufacture, distribute, 

administer or use Covered 

Countermeasures across the nation and 

the world. Thus, there are substantial 

federal legal and policy issues, and 

substantial federal legal and policy 

interests within the meaning of Grable 

& Sons Metal Products, Inc. v. Darue 

Eng’g. & Mf’g., 545 U.S. 308 (2005), in 

having a uniform interpretation of the 

PREP Act. Under the PREP Act, the sole 

exception to the immunity from suit and 

liability of covered persons is an 

exclusive Federal cause of action against 

a Covered Person for death or serious 

physical injury proximately caused by 

willful misconduct by such Covered 

Person. In all other cases, an injured 

party’s exclusive remedy is an 

administrative remedy under section 

319F–4 of the PHS Act. Through the 

PREP Act, Congress delegated to me the 

authority to strike the appropriate 

Federal-state balance with respect to 

particular Covered Countermeasures 

through PREP Act declarations. 

Section XII. Effective Time Period 

The Secretary amends Section XII to 

provide that 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, begins with a ‘‘Declaration 

of Emergency,’’ as 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, PREP Act 

coverage began on August 24, 2020), 

and lasts through (a) the final day the 

Declaration of Emergency is in effect, or 

(b) October 1, 2024, whichever occurs 

first. This change is to conform the text 

of the Declaration to the Third 

Amendment.18

The Secretary also amends Section XII 

to provide that liability protections for 

all Covered Countermeasures identified 

in Section VII(c) of this Declaration 

begins on the date of this amended 

Declaration and lasts through (a) the 

final day the Declaration of Emergency 

is in effect, or (b) October 1, 2024, 

whichever occurs first. Because the 

Secretary is adding Section VII(c) to the 

Declaration in this Amendment, Section 

XII provides that Section VII(c) is 

effective as of the date this amended 

Declaration is published. 

Additional Amendments 

The Secretary also makes other, nonsubstantive amendments. 

Declaration, as Amended, for Public 

Readiness and Emergency 

Preparedness Act Coverage for Medical 

Countermeasures Against COVID–19 

To the extent any term previously in 

the Declaration, including its 

amendments, is inconsistent with any 

provision of this Republished 

Declaration, the terms of this 

Republished Declaration are controlling. 

This Declaration must be construed in 

accordance with the Advisory Opinions 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79195 

19See, e.g., Advisory Opinion on the Public 

Readiness and Emergency Preparedness Act and the 

March 10, 2020 Declaration under the Act, Apr. 17, 

2020, as Modified on May 19, 2020, available at 

https://www.hhs.gov/guidance/sites/default/files/ 

hhs-guidance-documents/prep-act-advisoryopinion-hhs-ogc.pdf (last visited Dec. 1, 2020); 

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 Dec. 1, 2020); Advisory Opinion 20–03 on 

the Public Readiness and Emergency Preparedness 

Act and the Secretary’s Declaration under the Act, 

Oct. 22, 2020, as Modified on Oct. 23, 2020, 

available at https://www.hhs.gov/guidance/sites/

default/files/hhs-guidance-documents/AO3.1.2_

Updated_FINAL_SIGNED_10.23.20.pdf (last visited 

Dec. 1, 2020); Advisory Opinion 20–04 on the 

Public Readiness and Emergency Preparedness Act 

and the Secretary’s Declaration under the Act, Oct. 

22, 2020, as Modified on Oct. 23, 2020, available 

at https://www.hhs.gov/guidance/sites/default/files/ 

hhs-guidance-documents/AO%204.2_Updated_

FINAL_SIGNED_10.23.20.pdf (last visited Dec. 1, 

2020). This is not to suggest that other PREP Act 

declarations should be construed in a manner 

contrary to the interpretation provided in the 

Advisory Opinions. 

20See, 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/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19- 

tests.pdf (last visited Dec. 1, 2020); 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 

Dec. 1, 2020); 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 Dec. 1, 2020); 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/sites/ 

default/files/prep-act-guidance.pdf (last visited 

Dec. 1, 2020); 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-authorizationpharmacies-administering-coveredcountermeasures.pdf (last visited Dec. 1, 2020) 

(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. 

21Some 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 Dec. 

1, 2020). 

of the Office of the General Counsel 

(Advisory Opinions). I incorporate those 

Advisory Opinions as part of this 

Declaration.19 This Declaration is a 

‘‘requirement’’ under the PREP Act. 

I. Determination of Public Health 

Emergency 

42 U.S.C. 247d–6d(b)(1) 

I have determined that the spread of 

SARS–CoV–2 or a virus mutating 

therefrom and the resulting disease 

COVID–19 constitutes a public health 

emergency. I further determine that use 

of any respiratory protective device 

approved by NIOSH under 42 CFR part 

84, or any successor regulations, is a 

priority for use during the public health 

emergency that I declared on January 

31, 2020 under section 319 of the PHS 

Act for the entire United States to aid in 

the response of the nation’s healthcare 

community to the COVID–19 outbreak. 

II. Factors Considered 

42 U.S.C. 247d–6d(b)(6) 

I have considered the desirability of 

encouraging the design, development, 

clinical testing, or investigation, 

manufacture, labeling, distribution, 

formulation, packaging, marketing, 

promotion, sale, purchase, donation, 

dispensing, prescribing, administration, 

licensing, and use of the Covered 

Countermeasures. 

III. Recommended Activities 

42 U.S.C. 247d–6d(b)(1) 

I recommend, under the conditions 

stated in this Declaration, the 

manufacture, testing, development, 

distribution, administration, and use of 

the Covered Countermeasures. 

IV. Liability Protections 

42 U.S.C. 247d–6d(a), 247d–6d(b)(1) 

Liability protections as prescribed in 

the PREP Act and conditions stated in 

this Declaration are in effect for the 

Recommended Activities described in 

Section III. 

V. Covered Persons 

42 U.S.C. 247d–6d(i)(2), (3), (4), (6), 

(8)(A) and (B) 

Covered Persons who are afforded 

liability protections under this 

Declaration are ‘‘manufacturers,’’ 

‘‘distributors,’’ ‘‘program planners,’’ and 

‘‘qualified persons,’’ as those terms are 

defined in the PREP Act; their officials, 

agents, and employees; and the United 

States. 

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 

Emergency, as that term is defined in 

Section VII of this Declaration; 20

(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), 21 (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) FDAauthorized 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 


jbell on DSKJLSW7X2PROD with NOTICES
79196 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

22This 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 Dec. 1, 2020); 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/sites/default/files/prep-actguidance.pdf (last visited Dec. 1, 2020). 

23See, 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-guidancedocuments/advisory-opinion-20-02-hhs-ogc-prepact.pdf (last visited Dec. 1, 2020). 

Council for Pharmacy Education (ACPE) 

to order and administer vaccines. Such 

a training program must include handson 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; 22

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; and 

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. 

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.23

Nothing in this Declaration shall 

preempt state laws that permit 

additional persons to deliver telehealth 

services. 

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. 

VI. Covered Countermeasures 

42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. 

247d–6d(i)(1) and (7) 

Covered Countermeasures are: 

(a) Any antiviral, any drug, any 

biologic, any diagnostic, any other 

device, any respiratory protective 

device, or any vaccine manufactured, 

used, designed, developed, modified, 

licensed, or procured: 

i. To diagnose, mitigate, prevent, treat, 

or cure COVID–19, or the transmission 

of SARS–CoV–2 or a virus mutating 

therefrom; or 

ii. to limit the harm that COVID–19, 

or the transmission of SARS–CoV–2 or 

a virus mutating therefrom, might 

otherwise cause; 

(b) a product manufactured, used, 

designed, developed, modified, 

licensed, or procured to diagnose, 

mitigate, prevent, treat, or cure a serious 

or life-threatening disease or condition 

caused by a product described in 

paragraph (a) above; 

(c) a product or technology intended 

to enhance the use or effect of a product 

described in paragraph (a) or (b) above; 

or 

(d) any device used in the 

administration of any such product, and 

all components and constituent 

materials of any such product. 

To be a Covered Countermeasure 

under the Declaration, a product must 

also meet 42 U.S.C. 247d–6d(i)(1)’s 

definition of ‘‘Covered 

Countermeasure.’’ 

VII. Limitations on Distribution 

42 U.S.C. 247d–6d(a)(5) and (b)(2)(E) 

I have determined that liability 

protections are afforded to Covered 

Persons only for Recommended 

Activities involving: 

(a) Covered Countermeasures that are 

related to present or future federal 

contracts, cooperative agreements, 

grants, other transactions, interagency 

agreements, memoranda of 

understanding, or other federal 

agreements; 

(b) Covered Countermeasures that are 

related to activities authorized in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction to prescribe, 

administer, deliver, distribute or 

dispense the Covered Countermeasures 

following a Declaration of Emergency; 

or 

(c) Covered Countermeasures that are: 

i. Licensed, approved, cleared, or 

authorized by the FDA (or that are 

permitted to be used under an 

Investigational New Drug Application or 

an Investigational Device Exemption) 

under the FD&C Act or PHS Act to treat, 

diagnose, cure, prevent, mitigate, or 

limit the harm from COVID–19, or the 

transmission of SARS–CoV–2 or a virus 

mutating therefrom; or 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79197 

24For simplicity, this example assumes a patient 

only requires one dose of the vaccine. 

ii. a respiratory protective device 

approved by NIOSH under 42 CFR part 

84, or any successor regulations, that the 

Secretary determines to be a priority for 

use during a public health emergency 

declared under section 319 of the PHS 

Act to prevent, mitigate, or limit the 

harm from COVID–19, or the 

transmission of SARS–CoV–2 or a virus 

mutating therefrom. 

To qualify for this third distribution 

channel, a Covered Person must 

manufacture, test, develop, distribute, 

administer, or use the Covered 

Countermeasure pursuant to the FDA 

licensure, approval, clearance, or 

authorization (or pursuant to an 

Investigational New Drug Application or 

Investigational Device Exemption), or 

the NIOSH approval. 

As used in this Declaration, the terms 

‘‘Authority Having Jurisdiction’’ and 

‘‘Declaration of Emergency’’ have the 

following meanings: 

(a) The Authority Having Jurisdiction 

means the public agency or its delegate 

that has legal responsibility and 

authority for responding to an incident, 

based on political or geographical (e.g., 

city, county, tribal, state, or federal 

boundary lines) or functional (e.g., law 

enforcement, public health) range or 

sphere of authority. 

(b) A Declaration of Emergency means 

any declaration by any authorized local, 

regional, state, or federal official of an 

emergency specific to events that 

indicate an immediate need to 

administer and use the Covered 

Countermeasures, with the exception of 

a federal declaration in support of an 

Emergency Use Authorization under 

Section 564 of the FD&C Act unless 

such declaration specifies otherwise. 

I have also determined that, for 

governmental program planners only, 

liability protections are afforded only to 

the extent such program planners obtain 

Covered Countermeasures through 

voluntary means, such as (a) donation; 

(b) commercial sale; (c) deployment of 

Covered Countermeasures from federal 

stockpiles; or (d) deployment of 

donated, purchased, or otherwise 

voluntarily obtained Covered 

Countermeasures from state, local, or 

private stockpiles. 

VIII. Category of Disease, Health 

Condition, or Threat 

42 U.S.C. 247d–6d(b)(2)(A) 

The category of disease, health 

condition, or threat for which I 

recommend the administration or use of 

the Covered Countermeasures is not 

only COVID–19 caused by SARS–CoV– 

2, or a virus mutating therefrom, but 

also other diseases, health conditions, or 

threats that may have been caused by 

COVID–19, SARS–CoV–2, or a virus 

mutating therefrom, including the 

decrease in the rate of childhood 

immunizations, which will lead to an 

increase in the rate of infectious 

diseases. 

IX. Administration of Covered 

Countermeasures 

42 U.S.C. 247d–6d(a)(2)(B) 

Administration of the Covered 

Countermeasure means physical 

provision of the countermeasures to 

recipients, or activities and decisions 

directly relating to public and private 

delivery, distribution and dispensing of 

the countermeasures to recipients, 

management and operation of 

countermeasure programs, or 

management and operation of locations 

for the purpose of distributing and 

dispensing countermeasures. 

Where there are limited Covered 

Countermeasures, not administering a 

Covered Countermeasure to one 

individual in order to administer it to 

another individual can constitute 

‘‘relating to . . . the administration to 

. . . an individual’’ under 42 U.S.C. 

247d–6d. For example, consider a 

situation where there is only one dose 24

of a COVID–19 vaccine, and a person in 

a vulnerable population and a person in 

a less vulnerable population both 

request it from a healthcare 

professional. In that situation, the 

healthcare professional administers the 

one dose to the person who is more 

vulnerable to COVID–19. In that 

circumstance, the failure to administer 

the COVID–19 vaccine to the person in 

a less-vulnerable population ‘‘relat[es] 

to . . . the administration to’’ the 

person in a vulnerable population. The 

person in the vulnerable population was 

able to receive the vaccine only because 

it was not administered to the person in 

the less-vulnerable population. 

Prioritization or purposeful allocation of 

a Covered Countermeasure, particularly 

if done in accordance with a public 

health authority’s directive, can fall 

within the PREP Act and this 

Declaration’s liability protections. 

X. Population 

42 U.S.C. 247d–6d(a)(4), 247d– 

6d(b)(2)(C) 

The populations of individuals to 

whom the liability protections of this 

Declaration extend include any 

individual who uses or is administered 

the Covered Countermeasures in 

accordance with this Declaration. 

Liability protections are afforded to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered to this 

population; liability protections are 

afforded to program planners and 

qualified persons when the 

countermeasure is used by or 

administered to this population, or the 

program planner or qualified person 

reasonably could have believed the 

recipient was in this population. 

XI. Geographic Area 

42 U.S.C. 247d–6d(a)(4), 247d– 

6d(b)(2)(D) 

Liability protections are afforded for 

the administration or use of a Covered 

Countermeasure without geographic 

limitation. 

Liability protections are afforded to 

manufacturers and distributors without 

regard to whether the Covered 

Countermeasure is used by or 

administered in any designated 

geographic area; liability protections are 

afforded to program planners and 

qualified persons when the 

countermeasure is used by or 

administered in any designated 

geographic area, or the program planner 

or qualified person reasonably could 

have believed the recipient was in that 

geographic area. 

COVID–19 is a global challenge that 

requires a whole-of-nation response. 

There are substantial federal legal and 

policy issues, and substantial federal 

legal and policy interests within the 

meaning of Grable & Sons Metal 

Products, Inc. v. Darue Eng’g. & Mf’g., 

545 U.S. 308 (2005), in having a unified, 

whole-of-nation response to the COVID– 

19 pandemic among federal, state, local, 

and private-sector entities. The world is 

facing an unprecedented pandemic. To 

effectively respond, there must be a 

more consistent pathway for Covered 

Persons to manufacture, distribute, 

administer or use Covered 

Countermeasures across the nation and 

the world. Thus, there are substantial 

federal legal and policy issues, and 

substantial federal legal and policy 

interests within the meaning of Grable 

& Sons Metal Products, Inc. v. Darue 

Eng’g. & Mf’g., 545 U.S. 308 (2005), in 

having a uniform interpretation of the 

PREP Act. Under the PREP Act, the sole 

exception to the immunity from suit and 

liability of covered persons under the 

PREP Act is an exclusive Federal cause 

of action against a covered person for 

death or serious physical injury 

proximately caused by willful 

misconduct by such covered person. In 

all other cases, an injured party’s 

exclusive remedy is an administrative 


jbell on DSKJLSW7X2PROD with NOTICES
79198 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

25 42 U.S.C. 247d–6d(b)(7) provides that ‘‘[n]o 

court of the United States, or of any State, shall 

have subject matter jurisdiction to review, whether 

by mandamus or otherwise, any action by the 

Secretary under this subsection.’’ 

remedy under section 319F–4 of the 

PHS Act. Through the PREP Act, 

Congress delegated to me the authority 

to strike the appropriate Federal-state 

balance with respect to particular 

Covered Countermeasures through PREP 

Act declarations.25

XII. Effective Time Period 

42 U.S.C. 247d–6d(b)(2)(B) 

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 the 

date of this amended Declaration and 

last through (a) the final day the 

Declaration of Emergency is in effect, or 

(b) October 1, 2024, whichever occurs 

first. 

XIII. Additional Time Period of 

Coverage 

42 U.S.C. 247d–6d(b)(3)(B) and (C) 

I have determined that an additional 

12 months of liability protection is 

reasonable to allow for the 

manufacturer(s) to arrange for 

disposition of the Covered 

Countermeasure, including return of the 

Covered Countermeasures to the 

manufacturer, and for Covered Persons 

to take such other actions as are 

appropriate to limit the administration 

or use of the Covered Countermeasures. 

Covered Countermeasures obtained 

for the SNS during the effective period 

of this Declaration are covered through 

the date of administration or use 

pursuant to a distribution or release 

from the SNS. 

XIV. Countermeasures Injury 

Compensation Program 

42 U.S.C 247d–6e 

The PREP Act authorizes the 

Countermeasures Injury Compensation 

Program (CICP) to provide benefits to 

certain individuals or estates of 

individuals who sustain a covered 

serious physical injury as the direct 

result of the administration or use of the 

Covered Countermeasures, and benefits 

to certain survivors of individuals who 

die as a direct result of the 

administration or use of the Covered 

Countermeasures. The causal 

connection between the countermeasure 

and the serious physical injury must be 

supported by compelling, reliable, valid, 

medical and scientific evidence in order 

for the individual to be considered for 

compensation. The CICP is 

administered by the Health Resources 

and Services Administration, within the 

Department of Health and Human 

Services. Information about the CICP is 

available at the toll-free number 1–855– 

266–2427 or http://www.hrsa.gov/cicp/. 

XV. Amendments 

42 U.S.C. 247d–6d(b)(4) 

Amendments to this Declaration will 

be published in the Federal Register, as 

warranted. 

Authority: 42 U.S.C. 247d–6d. 

Dated: December 3, 2020. 

Alex M. Azar II, 

Secretary of Health and Human Services. 

[FR Doc. 2020–26977 Filed 12–8–20; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Declaration Under the Public 

Readiness and Emergency 

Preparedness Act for 

Countermeasures Against 

Marburgvirus and/or Marburg Disease 

SUMMARY: The Secretary is issuing this 

Declaration pursuant to section 319F–3 

of the Public Health Service Act to 

provide limited immunity for activities 

related to countermeasures against 

marburgvirus and/or Marburg disease. 

DATES: The Declaration is effective as of 

November 25, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Robert P. Kadlec, MD, MTM&H, MS, 

Assistant Secretary for Preparedness 

and Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue 

SW, Washington, DC 20201; Telephone: 

202–205–2882. 

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. This 

Declaration is subject to amendment 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. 

The Pandemic and All-Hazards 

Preparedness Reauthorization Act 

(PAHPRA), Public Law 113–5, was 

enacted on March 13, 2013. Among 

other things, PAHPRA added sections 

564A and 564B to the Federal Food, 

Drug, and Cosmetic (FD&C) Act to 

provide new authorities for the 

emergency use of approved products in 

emergencies and products held for 

emergency use. PAHPRA accordingly 

amended the definitions of ‘‘Covered 

Countermeasures’’ and ‘‘qualified 

pandemic and epidemic products’’ in 

Section 319F–3 of the Public Health 

Service Act (PREP Act provisions), so 

that products made available under 

these new FD&C Act authorities could 

be covered under PREP Act 

Declarations. PAHPRA also extended 

the definition of qualified pandemic and 

epidemic products that may be covered 

under a PREP Act Declaration to include 

products or technologies intended to 

enhance the use or effect of a drug, 

biological product, or device used 

against the pandemic or epidemic or 

against adverse events from these 


jbell on DSKJLSW7X2PROD with NOTICES