Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices 757 

these health professions programs is 

collected in the HRSA Performance 

Report for Grants and Cooperative 

Agreements. Specific performance 

measurement requirements for each 

program may be found on the HRSA 

website at https://bhw.hrsa.gov/grants/ 

reportonyourgrant. Data collection 

activities consist of two reports—an 

annual progress report and annual 

performance report—that are submitted 

by awardees to comply with statutory 

and programmatic requirements for 

performance measurement and 

evaluation (including specific Title III, 

VII and VIII requirements), as well as 

the Government Performance and 

Results Act of 1993 (GPRA) and the 

GPRA Modernization Act of 2010 

requirements. The performance 

measures were last revised in 2016 to 

ensure they addressed programmatic 

changes, met evolving program 

management needs, and responded to 

emerging workforce concerns. As these 

changes successfully enabled BHW to 

demonstrate accurate outputs and 

outcomes associated with the health 

professions programs, BHW will 

continue with its current performance 

management strategy and make only 

minor changes that reflect new HHS and 

HRSA priorities with the addition of a 

question asking awardees how many 

trainees received training in telehealth, 

substance use treatment, and/or 

medication-assisted treatment. 

Need and Proposed Use of the 

Information: The purpose of the 

proposed data collection is to continue 

analysis and reporting of awardee 

training activities and educational 

programs, identify intended practice 

locations and report outcomes of funded 

initiatives. Data collected from these 

grant programs will also provide a 

description of the program activities of 

approximately 1,500 reporting grantees 

to inform policymakers on the barriers, 

opportunities, and outcomes involved 

in health care workforce development. 

The proposed measures focus on five 

key outcomes: (1) Increasing the 

workforce supply of well-educated 

practitioners in needed professions; (2) 

increasing the number of practitioners 

that practice in underserved and rural 

areas; (3) enhancing the quality of 

education; (4) increasing the 

recruitment, training, and placement of 

under-represented groups in the health 

workforce; and (5) supporting 

educational infrastructure to increase 

the capacity to train more health 

professionals in high demand areas. 

Likely Respondents: Respondents are 

awardees of BHW health professions 

grant programs. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel to be able to respond to a 

collection of information; to search data 

sources; to complete and review the 

collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

Direct Financial Support Program ....................................... 500 1 500 3.1 1,550 

Infrastructure Program ......................................................... 100 1 100 4.5 450 

Multipurpose or Hybrid Program .......................................... 900 1 900 4.3 3,870 

Total .............................................................................. 1,500 ........................ 1,500 ........................ 5,870 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2019–00402 Filed 1–30–19; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Ebola Virus Disease Therapeutics— 

Amendment 

ACTION: Notice of Amendment to the 

February 27, 2015, Declaration under 

the Public Readiness and Emergency 

Preparedness Act for Ebola Virus 

Disease Therapeutics, as amended. 

SUMMARY: The Secretary is amending the 

February 27, 2015, Declaration issued 

pursuant to the Public Health Service 

Act, amended December 9, 2015 and 

December 2, 2016, to update the term 

‘‘Ebola Virus Disease’’ to ‘‘Ebola 

disease’’ (EBOD) throughout the 

declaration and to clarify the definition 

of EBOD. The amendment also expands 

the Covered Countermeasures beyond 

the single therapeutic listed in prior 

declarations but limit coverage to 

Covered Countermeasures that are 

directly supported by the United States 

(U.S.) Federal Government, consistent 

with the terms of the Declaration, and 

is republishing the Declaration in its 

entirety as amended. 

DATES: The Amended Declaration is 

applicable beginning December 1, 2018. 

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 

Secretary is amending the February 27, 

2015, Declaration issued pursuant to the 

Public Health Service Act, amended 

December 9, 2015 (80 FR 76536) and 

December 2, 2016, (81 FR 89476) to 

extend the effective time period through 

December 31, 2023; to update the term 

‘‘Ebola Virus Disease’’ to ‘‘Ebola 

disease’’ (EBOD) throughout the 

declaration and to clarify the definition 

of EBOD; and to expand the Covered 

Countermeasures beyond the single 

therapeutic listed in prior declarations 

but limit coverage to Covered 

Countermeasures that are directly 

supported by the United States (U.S.) 

Federal Government, consistent with 

the terms of the Declaration, and is 

republishing the Declaration in its 

entirety as amended. 

The Public Readiness and Emergency 

Preparedness Act (PREP Act) authorizes 

the Secretary of Health and Human 

Services to issue a Declaration to 


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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 administration or use 

of medical countermeasures (Covered 

Countermeasures), except for claims 

that meet the PREP Act’s definition of 

willful misconduct. The Secretary may, 

through publication in the Federal 

Register, amend any portion of a 

Declaration. Using this authority, the 

Secretary is amending the Declaration 

that provides liability immunity to 

Covered Persons for activities related to 

the 

Covered Countermeasures, EBOD 

therapeutics as listed in Section VI of 

the Declaration to extend the effective 

time period through December 31, 2023; 

to update the term used to identify the 

disease and clarify the definition of 

‘‘Ebola disease’’; and to expand the 

Covered Countermeasures beyond the 

single therapeutic listed in prior 

declarations but limit coverage to 

Covered Countermeasures that are 

directly supported by the U.S. Federal 

Government, consistent with the terms 

of this Declaration. 

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 in the U.S. 

Code as 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 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 

products. 

Ebola disease is a severe and often 

fatal illness in humans caused by 

several highly virulent viruses that are 

members of the family Filoviridae. 

Disease in people has been observed 

due to four viruses classified in a 

filoviral genus currently called 

Ebolavirus—Bundibugyo virus, Ebola 

virus, Sudan virus, and Taı ̈ Forest virus. 

With an average EBOD case fatality rate 

of around 42 percent, ebolaviruses pose 

a high risk to public health and national 

security. 

From 2013 to 2016, Western Africa 

experienced the largest EBOD outbreak 

since the first two ebolaviruses (Ebola 

virus and Sudan virus) were discovered 

in 1976, and the unprecedented size of 

the outbreak complicated global health 

response. The outbreak affected 

populations in multiple Western 

African countries and travelers from 

Western Africa to the U.S. and other 

countries. The World Health 

Organization (WHO) declared the EBOD 

outbreak as a Public Health Emergency 

of International Concern under the 

framework of the International Health 

Regulations (2005). In March 2016, 

WHO determined that the EBOD 

outbreak no longer constituted a Public 

Health Emergency of International 

Concern but emphasized the crucial 

need for continued support to prevent, 

detect, and respond rapidly to any new 

EBOD outbreak in Western Africa. 

During the 2013 to 2016 outbreak 

widespread transmission was limited to 

Western African countries; however, 

ebolaviruses present a real threat to 

national security, because the U.S. 

experienced travel-associated cases of 

EBOD diagnosed within U.S. borders 

and transmission to health care workers 

within U.S. borders. The recurrent but 

unpredictable and variable nature of 

EBOD outbreaks and the transmission 

profile make ebolaviruses threats to the 

public health security of the American 

people, requiring vigilance and a 

continuing need for development of 

medical countermeasures. 

Ebola disease is an ongoing public 

health risk, as the Democratic Republic 

of the Congo (COD) continues to 

experience EBOD outbreaks and there is 

a risk of extension to surrounding 

countries. Days after announcing the 

end of the outbreak of EBOD from April 

to July of 2018 in COD’s E ́ quateur 

Province, the COD Ministry of Health 

declared a new EBOD outbreak in NordKivu Province on August 1, 2018. The 

Ministry of Health, WHO and U.S. 

Government partners are responding to 

this incident as new cases occur across 

the densely populated province. As 

demonstrated by the 2013–2016 EBOD 

outbreak, that resulted in disease in 

several Americans including 

transmission within the U.S., the risk to 

the U.S. population from EBOD 

outbreaks in Africa presents a national 

health security issue. Thus, there is a 

continuing need for development of 

therapeutics against EBOD. 

Unless otherwise noted, all statutory 

citations below are to the U.S. Code. 

To be consistent with the most 

current World Health Organization 

International Classification of Diseases, 

the Secretary is amending the 

declaration throughout to use the term 

EBOD to refer to the disease, health 

condition or threat to health that 

constitutes or may constitute a public 

health emergency. This change in 

terminology is not intended to have any 

substantive effect on coverage under the 

amended Declaration. 

Section I. Determination of Public 

Health Emergency or Credible Risk of 

Future Public Health Emergency 

Before issuing a Declaration under the 

PREP Act, the Secretary is required to 

determine that a disease or other health 

condition or threat to health constitutes 

a public health emergency or that there 

is a credible risk that the disease, 

condition, or threat may in the future 

constitute such an emergency. This 

determination is separate and apart from 

a Declaration issued by the Secretary 

under section 319 of the PHS Act that 

a disease or disorder presents a public 

health emergency or that a public health 

emergency, including significant 

outbreaks of infectious diseases or 

bioterrorist attacks, otherwise exists, or 

other Declarations or determinations 

made under other authorities of the 

Secretary. Accordingly, in Section I, the 

Secretary determines that there is a 

credible risk that the spread of 

ebolaviruses and the resulting disease 

may constitute a public health 

emergency. 

In section I, the Secretary also amends 

the Declaration to clarify the definition 

of Ebola disease, providing that for the 

purposes of this Declaration, Ebola 

disease (EBOD) is defined as the illness 

resulting from infection by the following 

viruses of the filoviral Ebolavirus genus: 

• Bundibugyo virus 

• Ebola virus 

• Sudan virus 

• Taı ̈ Forest virus 

• ebolaviruses with undefined 

pathogenicity in humans 

This amendment is intended to clarify 

that the Declaration covers EBOD and 

all therapeutics against viruses and 

variants of all viruses of the Ebolavirus 


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genus consistent with the terms of the 

Declaration. 

Section II. Factors Considered 

In deciding whether and under what 

circumstances to issue a Declaration 

with respect to a Covered 

Countermeasure, the Secretary must 

consider 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 

countermeasure. In Section II, the 

Secretary states that he has considered 

these factors. 

Section III. Recommended Activities 

The Secretary must recommend the 

activities for which the PREP Act’s 

liability immunity is in effect. These 

activities may include, under conditions 

as the Secretary may specify, the 

manufacture, testing, development, 

distribution, administration, or use of 

one or more Covered Countermeasures 

(‘‘Recommended Activities’’). In Section 

III, the Secretary recommends activities 

for which the immunity is in effect 

under the conditions stated in the 

Declaration. The Secretary is amending 

the Declaration to remove the condition 

that Recommended Activities only 

include those that relate to clinical trials 

permitted to proceed after review by the 

Food and Drug Administration (FDA) 

that administer or use the Covered 

Countermeasure under an 

investigational new drug application 

(IND). This amendment continues that 

coverage, and expands liability 

immunity beyond activities related to 

clinical trials permitted to proceed after 

review by the FDA, that administer or 

use the Covered Countermeasure under 

an IND. Section VI of the Declaration 

retains the limitation that Covered 

Countermeasures are limited to those 

activities involving Covered 

Countermeasures directly supported by 

the U.S. Federal Government. 

Section IV. Liability Immunity 

The Secretary must also state that 

liability protections available under the 

PREP Act are in effect with respect to 

the Recommended Activities. These 

liability protections provide that 

‘‘[s]ubject to other provisions of [the 

PREP Act], a covered person shall be 

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 to or use by an 

individual of a covered countermeasure 

if a Declaration . . . has been issued 

with respect to such countermeasure.’’ 

In Section IV, the Secretary states that 

liability protections are in effect with 

respect to the Recommended Activities. 

Section V. Covered Persons 

The PREP Act’s liability immunity 

applies to ‘‘Covered Persons’’ with 

respect to administration or use of a 

Covered Countermeasure. The term 

‘‘Covered Persons’’ has a specific 

meaning and is defined in the PREP Act 

to include manufacturers, distributors, 

program planners, and qualified 

persons, and their officials, agents, and 

employees, and the U.S. The PREP Act 

further defines the terms 

‘‘manufacturer,’’ ‘‘distributor,’’ 

‘‘program planner,’’ and ‘‘qualified 

person’’ as described below. 

A manufacturer includes a contractor 

or subcontractor of a manufacturer; a 

supplier or licenser of any product, 

intellectual property, service, research 

tool or component or other article used 

in the design, development, clinical 

testing, investigation or manufacturing 

of a Covered Countermeasure; and any 

or all of the parents, subsidiaries, 

affiliates, successors, and assigns of a 

manufacturer. 

A distributor means a person or entity 

engaged in the distribution of drug, 

biologics, or devices, including but not 

limited to: Manufacturers; repackers; 

common carriers; contract carriers; air 

carriers; own-label distributors; privatelabel distributors; jobbers; brokers; 

warehouses and wholesale drug 

warehouses; independent wholesale 

drug traders; and retail pharmacies. 

A program planner means a state or 

local government, including an Indian 

tribe; a person employed by the state or 

local government; or other person who 

supervises or administers a program 

with respect to the administration, 

dispensing, distribution, provision, or 

use of a Covered Countermeasure, 

including a person who establishes 

requirements, provides policy guidance, 

or supplies technical or scientific advice 

or assistance or provides a facility to 

administer or use a Covered 

Countermeasure in accordance with the 

Secretary’s Declaration. Under this 

definition, a private-sector employer or 

community group or other ‘‘person’’ can 

be a program planner when it carries out 

the described activities. 

A qualified person means a licensed 

health professional or other individual 

authorized to prescribe, administer, or 

dispense Covered Countermeasures 

under the law of the state in which the 

countermeasure was prescribed, 

administered, or dispensed; or a person 

within a category of persons identified 

as qualified in the Secretary’s 

Declaration. Under this definition, the 

Secretary can describe in the 

Declaration other qualified persons, 

such as volunteers, who are Covered 

Persons. Section V describes other 

qualified persons covered by this 

Declaration. 

The PREP Act also defines the word 

‘‘person’’ as used in the Act: A person 

includes an individual, partnership, 

corporation, association, entity, or 

public or private corporation, including 

a federal, state, or local government 

agency or department. Section V 

describes Covered Persons under the 

Declaration, including Qualified 

Persons. 

The Secretary is amending the 

Declaration to include the following as 

qualified persons: (a) Any person 

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, and their 

officials, agents, employees, contractors 

and volunteers, following a Declaration 

of an emergency; (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; and (c) any 

person authorized to prescribe, 

administer, or dispense Covered 

Countermeasures in accordance with 

Section 564A of the FD&C Act. In 

addition, the Secretary is amending the 

declaration to remove the following 

category of qualified persons: Any 

person authorized to prescribe, 

administer, or dispense the Covered 

Countermeasures or who is otherwise 

authorized to perform an activity to 

carry out clinical trials permitted to 

proceed after FDA review that 

administer or use the Covered 

Countermeasure under an IND and that 

are directly supported by the U.S. These 

changes are intended to expand 

qualified persons to those who may 

administer Covered Countermeasures 

directly supported by the U.S. Federal 

Government in an emergency response, 

or under an Emergency Use 

Authorization issued by the FDA or 

other emergency authority of the FDA, 

and to any individuals carrying out 

activities under clinical trials within the 

scope of the statutory definitions 

provided in this section that involve 

countermeasures directly supported by 

the U.S. 

Section VI. Covered Countermeasures 

As noted above, section III describes 

the Secretary’s Recommended Activities 


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for which liability immunity is in effect. 

Section VI identifies the 

countermeasures for which the 

Secretary has recommended such 

activities. The PREP Act states that a 

Covered Countermeasure must be: A 

‘‘qualified pandemic or epidemic 

product,’’ or a ‘‘security 

countermeasure,’’ as described 

immediately below; or a drug, biological 

product or device authorized for 

emergency use in accordance with 

sections 564, 564A, or 564B of the FD&C 

Act. 

A qualified pandemic or epidemic 

product means a drug or device, as 

defined in the FD&C Act or a biological 

product, as defined in the PHS Act that 

is: (i) Manufactured, used, designed, 

developed, modified, licensed or 

procured to diagnose, mitigate, prevent, 

treat, or cure a pandemic or epidemic or 

limit the harm such a pandemic or 

epidemic might otherwise cause; (ii) 

manufactured, used, designed, 

developed, modified, licensed, or 

procured to diagnose, mitigate, prevent, 

treat, or cure a serious or lifethreatening disease or condition caused 

by such a drug, biological product, or 

device; (iii) or a product or technology 

intended to enhance the use or effect of 

such a drug, biological product, or 

device. 

A security countermeasure is a drug 

or device, as defined in the FD&C Act 

or a biological product, as defined in the 

PHS Act that: (i)(a) The Secretary 

determines to be a priority to diagnose, 

mitigate, prevent, or treat harm from any 

biological, chemical, radiological, or 

nuclear agent identified as a material 

threat by the Secretary of Homeland 

Security, or (b) to diagnose, mitigate, 

prevent, or treat harm from a condition 

that may result in adverse health 

consequences or death and may be 

caused by administering a drug, 

biological product, or device against 

such an agent; and (ii) is determined by 

the Secretary of Health and Human 

Services to be a necessary 

countermeasure to protect public health. 

To be a Covered Countermeasure, 

qualified pandemic or epidemic 

products or security countermeasures 

also must be approved or cleared under 

the FD&C Act; licensed under the PHS 

Act; or authorized for emergency use 

under sections 564, 564A, or 564B of the 

FD&C Act. 

A qualified pandemic or epidemic 

product also may be a Covered 

Countermeasure when it is subject to an 

exemption (that is, it is permitted to be 

used under an Investigational Drug 

Application or an Investigational Device 

Exemption) under the FD&C Act and is 

the object of research for possible use 

for diagnosis, mitigation, prevention, 

treatment, or cure, or to limit harm of 

a pandemic or epidemic or serious or 

life-threatening condition caused by 

such a drug or device. A security 

countermeasure also may be a Covered 

Countermeasure if it may reasonably be 

determined to qualify for approval or 

licensing within 10 years after the 

Department’s determination that 

procurement of the countermeasure is 

appropriate. 

Section VI lists the EBOD therapeutics 

that are Covered Countermeasures. The 

Secretary is expanding the types of 

Covered Countermeasures covered 

under this Declaration to include classes 

or categories of therapeutics for 

mitigation or treatment of EBOD as 

defined in section I of this Declaration, 

including all components and 

constituent materials of these 

therapeutics, and all devices and their 

constituent components used in the 

administration of these therapeutics. 

This change is intended to expand the 

types of EBOD therapeutics that are 

included as Covered Countermeasures 

consistent with the terms of this 

Declaration, including the limitations 

stated in the Section VII of this 

Declaration. The Declaration continues 

coverage for EBOD therapeutics 

previously covered under this 

declaration, ZMapp® monoclonal 

antibody therapeutic, and extends 

coverage to encompass all categories of 

EBOD therapeutics. 

Section VI also refers to the statutory 

definitions of Covered Countermeasures 

to make clear that these statutory 

definitions limit the scope of Covered 

Countermeasures. Specifically, the 

Declaration notes that Covered 

Countermeasures must be ‘‘ ‘qualified 

pandemic or epidemic products’, or 

‘security countermeasures’, or drugs, 

biological products, or devices 

authorized for investigational or 

emergency use, as those terms are 

defined in the PREP Act, the FD&C Act, 

and the PHS Act.’’ 

Section VII. Limitations on Distribution 

The Secretary may specify that 

liability immunity is in effect only to 

Covered Countermeasures obtained 

through a particular means of 

distribution. The Secretary is amending 

the Declaration to state that liability 

immunity is afforded to Covered 

Persons for Recommended Activities 

involving Covered Countermeasures 

that are directly supported by the U.S. 

Federal Government through past, 

present or future federal contracts, 

cooperative agreements, grants, other 

transactions, interagency agreements, or 

memoranda of understanding or other 

federal agreements or arrangements. The 

Secretary defines the term ‘‘directly 

support’’ to mean that the U.S. has 

provided some form of tangible support 

such as supplies, funds, products, 

technical assistance, or staffing. 

This amendment is intended to 

expand liability immunity beyond the 

prior limitation to activities that are 

related to clinical trials permitted to 

proceed after FDA review that 

administer or use the Covered 

Countermeasure under an IND, but the 

amendment retains the limitation that 

the activities must be directly supported 

by the U.S. Federal Government as 

described and defined in this section. 

Section VIII. Category of Disease, 

Health Condition, or Threat 

The Secretary must identify, for each 

Covered Countermeasure, the categories 

of diseases, health conditions, or threats 

to health for which the Secretary 

recommends the administration or use 

of the countermeasure. In Section VIII, 

the Secretary states that the disease 

threat for which he recommends 

administration or use of the Covered 

Countermeasures is EBOD. 

Section IX. Administration of Covered 

Countermeasures 

The PREP Act does not explicitly 

define the term ‘‘administration’’ but 

does assign the Secretary the 

responsibility to provide relevant 

conditions in the Declaration. In Section 

IX, the Secretary defines 

‘‘Administration of a Covered 

Countermeasure’’: 

Administration of a 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 purpose of distributing and 

dispensing countermeasures. 

The definition of ‘‘administration’’ 

extends only to physical provision of a 

countermeasure to a recipient, such as 

vaccination or handing drugs to 

patients, and to activities related to 

management and operation of programs 

and locations for providing 

countermeasures to recipients, such as 

decisions and actions involving security 

and queuing, but only insofar as those 

activities directly relate to the 

countermeasure activities. Claims for 

which Covered Persons are provided 

immunity under the Act are losses 

caused by, arising out of, relating to, or 

resulting from the administration to or 


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use by an individual of a Covered 

Countermeasure consistent with Act. 

Under the Secretary’s definition; these 

liability claims are precluded if the 

claims allege an injury caused by 

physical provision of a countermeasure 

to a recipient, or if the claims are 

directly due to conditions of delivery, 

distribution, dispensing, or management 

and operation of countermeasure 

programs at distribution and dispensing 

sites. 

Thus, it is the Secretary’s 

interpretation that, when a Declaration 

is in effect, the Act precludes, for 

example, liability claims alleging 

negligence by a manufacturer in creating 

a therapeutic, or negligence by a health 

care provider in prescribing the wrong 

dose, absent willful misconduct. 

Likewise, the Act precludes a liability 

claim relating to the management and 

operation of a countermeasure 

distribution program or site, such as a 

slip-and-fall injury or vehicle collision 

by a recipient receiving a 

countermeasure at a retail store serving 

as an administration or dispensing 

location that alleges, for example, lax 

security or chaotic crowd control. 

However, a liability claim alleging an 

injury occurring at the site that was not 

directly related to the countermeasure 

activities is not covered, such as a slipand-fall with no direct connection to the 

countermeasure’s administration or use. 

In each case, whether immunity is 

applicable will depend on the particular 

facts and circumstances. 

Section X. Population 

The Secretary must identify, for each 

Covered Countermeasure specified in a 

Declaration, the population or 

populations of individuals for which 

liability immunity is in effect with 

respect to administration or use of the 

countermeasure. This section explains 

which individuals should use the 

countermeasure or to whom the 

countermeasure should be 

administered—in short, those who 

should be vaccinated or take a drug or 

other countermeasure. Section X 

provides that the population includes 

‘‘any individual who uses or who is 

administered a Covered Countermeasure 

in accordance with the Declaration.’’ 

In addition, the PREP Act specifies 

that liability immunity is afforded to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered to this 

population and to program planners and 

qualified persons when the 

countermeasure is either used by or 

administered to this population or the 

program planner or qualified person 

reasonably could have believed the 

recipient was in this population. 

Section X includes these statutory 

conditions in the Declaration for clarity. 

Section X. Geographic Area 

The Secretary must identify, for each 

Covered Countermeasure specified in 

the Declaration, the geographic area or 

areas for which liability immunity is in 

effect with respect to administration or 

use of the countermeasure, including, as 

appropriate, whether the Declaration 

applies only to individuals physically 

present in the area or, in addition, 

applies to individuals who have a 

described connection to the area. 

Section XI provides that liability 

immunity is afforded for the 

administration or use of a Covered 

Countermeasure without geographic 

limitation. This could include claims 

related to administration or use in 

Africa or other locations outside the 

U.S. It is possible that claims may arise 

in regard to administration or use of the 

Covered Countermeasures outside the 

U.S. that may be resolved under U.S. 

law. 

In addition, the PREP Act specifies 

that liability immunity is afforded: (1) 

To manufacturers and distributors 

without regard to whether the 

countermeasure is used by or 

administered to individuals in the 

geographic areas; and (2) to program 

planners and qualified persons when 

the countermeasure is either used or 

administered in the geographic areas or 

the program planner or qualified person 

reasonably could have believed the 

countermeasure was used or 

administered in the areas. Section XI 

includes these statutory conditions in 

the Declaration for clarity. 

Section XII. Effective Time Period 

The Secretary must identify for each 

Covered Countermeasure the period or 

periods during which liability immunity 

is in effect, designated by dates, 

milestones, or other description of 

events, including factors specified in the 

PREP Act. Section XII identifies the 

effective time period. Section XII is 

amended to extend the effective time 

period to December 31, 2023. 

Section XIII. Additional Time Period of 

Coverage 

The Secretary must specify a date 

after the ending date of the effective 

period of the Declaration that is 

reasonable for manufacturers to arrange 

for disposition of the Covered 

Countermeasure, including return of the 

product to the manufacturer, and for 

other Covered Persons to take 

appropriate actions to limit 

administration or use of the Covered 

Countermeasure. In addition, the PREP 

Act specifies that for Covered 

Countermeasures that are subject to a 

Declaration at the time they are obtained 

for the Strategic National Stockpile 

(SNS) under 42 U.S.C. 247d–6b(a), the 

effective period of the Declaration 

extends through the time the 

countermeasure is used or administered 

pursuant to a distribution or release 

from the SNS. Liability immunity under 

the provisions of the PREP Act and the 

conditions of the Declaration continues 

during these additional time periods. 

Thus, liability immunity is afforded 

during the ‘‘Effective Time Period,’’ 

described under XII of the Declaration, 

plus the ‘‘Additional Time Period’’ 

described under section XIII of the 

Declaration. 

Section XIII provides for 12 months as 

the additional time period of coverage 

after expiration of the Declaration. 

Section XIII also explains the extended 

coverage that applies to products 

obtained for the SNS during the 

effective period of the Declaration. 

Section XIV. Countermeasures Injury 

Compensation Program 

Section 319F–4 of the PREP Act 

authorizes the Countermeasures Injury 

Compensation Program (CICP) to 

provide benefits to eligible individuals 

who sustain a serious physical injury or 

die as a direct result of the 

administration or use of a Covered 

Countermeasure. Compensation under 

the CICP for an injury directly caused by 

a Covered Countermeasure is based on 

the requirements set forth in this 

Declaration, the administrative rules for 

the Program, and the statute. To show 

direct causation between a Covered 

Countermeasure and a serious physical 

injury, the statute requires ‘‘compelling, 

reliable, valid, medical and scientific 

evidence.’’ The administrative rules for 

the Program further explain the 

necessary requirements for eligibility 

under the CICP. Please note that by 

statute, requirements for compensation 

under the CICP may not always align 

with the requirements for liability 

immunity provided under the PREP Act. 

Section XIV, ‘‘Countermeasures Injury 

Compensation Program,’’ explains the 

types of injury and standard of evidence 

needed to be considered for 

compensation under the CICP. 

Further, the administrative rules for 

the CICP specify that if countermeasures 

are administered or used outside the 

U.S., only otherwise eligible individuals 

at American embassies, military 

installations abroad (such as military 

bases, ships, and camps) or at North 

Atlantic Treaty Organization (NATO) 

installations (subject to the NATO 


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Status of Forces Agreement) where 

American servicemen and 

servicewomen are stationed may be 

considered for CICP benefits. Other 

individuals outside the U.S. may not be 

eligible for CICP benefits. 

Section XV. Amendments 

This is the third amendment to the 

February 27, 2015, Declaration (80 FR 

73314). The first amendment was issued 

December 9, 2015 (80 FR 76536), the 

second amendment was issued 

December 2, 2016 (81 FR 89476). The 

Secretary may amend any portion of a 

Declaration through publication in the 

Federal Register. 

Republished Declaration 

Declaration, as Amended, Public 

Readiness and Emergency 

Preparedness Act Coverage for Ebola 

Disease Therapeutics 

This Declaration amends and 

republishes the February 27, 2015 for 

coverage under the Public Readiness 

and Emergency Preparedness (PREP) 

Act for Ebola Disease Therapeutics, as 

amended December 9, 2015 and 

December 2, 2016. To the extent any 

term of the February 27, 2015 

Declaration, as amended on December 9, 

2015 and December 2, 2016, is 

inconsistent with any provision of this 

Republished Declaration, the terms of 

this Republished Declaration are 

controlling. 

I. Determination of Public Health 

Emergency or Credible Risk of Future 

Public Health Emergency 

42 U.S.C. 247d–6d(b)(1) 

I have determined that there is a 

credible risk that the spread of 

ebolaviruses and the resulting disease or 

conditions, constituting EBOD may in 

the future constitute a public health 

emergency. For the purposes of this 

Declaration, EBOD is the illness 

resulting from infection by viruses of 

any of the following viruses of the 

Ebolavirus genus: 

• Bundibugyo virus 

• Ebola virus 

• Sudan virus 

• Taı ̈ Forest virus 

• ebolaviruses with undefined 

pathogenicity in humans 

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 the manufacture, 

testing, development, distribution, 

administration, and use of the Covered 

Countermeasures under the conditions 

stated in this Declaration. 

IV. Liability Immunity 

42 U.S.C. 247d–6d(a), 247d–6d(b)(1) 

Liability immunity as prescribed in 

the PREP Act and conditions stated in 

this Declaration is 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 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 

U.S. 

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 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; (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; and (c) any 

person authorized to prescribe, 

administer, or dispense Covered 

Countermeasures in accordance with 

Section 564A of the FD&C Act. 

i. 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. 

ii. 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. 

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 the 

following EBOD therapeutics: 

All classes or categories of 

therapeutics for mitigation or treatment 

of EBOD as defined in section I of this 

Declaration, including all components 

and constituent materials of these 

therapeutics, and all devices and their 

constituent components used in the 

administration of these therapeutics. 

Covered Countermeasures must be 

‘‘qualified pandemic or epidemic 

products,’’ or ‘‘security 

countermeasures,’’ or drugs, biological 

products, or devices authorized for 

investigational or emergency use, as 

those terms are defined in the PREP Act, 

the FD&C Act, and the Public Health 

Service Act. 

VII. Limitations on Distribution 

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

I have determined that liability 

immunity is afforded to Covered 

Persons only for Recommended 

Activities involving Covered 

Countermeasures that are directly 

supported by the U.S. Federal 

Government, through past, present or 

future federal contracts, cooperative 

agreements, grants, other transactions, 

interagency agreements, memoranda of 

understanding, or other federal 

agreements or arrangements. The term 

‘‘directly supported’’ in this Declaration 

means that the U.S Federal Government 

has provided some form of tangible 

support such as supplies, funds, 

products, technical assistance, or 

staffing. 

I have also determined that for 

governmental program planners only, 

liability immunity is afforded only to 

the extent such program planners obtain 

Covered Countermeasures through 

voluntary means, such as (1) donation; 

(2) commercial sale; (3) deployment of 

Covered Countermeasures from federal 

stockpiles; or (4) deployment of 

donated, purchased, or otherwise 

voluntarily obtained Covered 

Countermeasures from state, local, or 

private stockpiles. 


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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 Ebola 

disease (EBOD). 

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 purpose of distributing and 

dispensing countermeasures. 

X. Population 

42 U.S.C. 247d–6d(a)(4), 247d– 

6d(b)(2)(C) 

The populations of individuals 

include any individual who uses or is 

administered the Covered 

Countermeasures in accordance with 

this Declaration. 

Liability immunity is afforded to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered to this 

population; liability immunity is 

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 immunity is afforded for the 

administration or use of a Covered 

Countermeasure without geographic 

limitation. 

Liability immunity is afforded to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered in any 

designated geographic area; liability 

immunity is 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. 

XII. Effective Time Period 

42 U.S.C. 247d–6d(b)(2)(B) 

Liability immunity for Covered 

Countermeasures began on February 27, 

2015 and extends through December 31, 

2023. 

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 Strategic National Stockpile 

(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 (toll-free) or http://

www.hrsa.gov/cicp/. 

XV. Amendments 

42 U.S.C. 247d–6d(b)(4) 

Any amendments to this Declaration 

will be published in the Federal 

Register. 

Authority: 42 U.S.C. 247d–6d. 

Dated: January 24, 2019. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2019–00261 Filed 1–30–19; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[OMHA–1803–N] 

Medicare Program; Administrative Law 

Judge Hearing Program for Medicare 

Claim and Entitlement Appeals; 

Quarterly Listing of Program 

Issuances—October Through 

December 2018 

AGENCY: Office of Medicare Hearings 

and Appeals (OMHA), HHS. 

ACTION: Notice. 

SUMMARY: This quarterly notice lists the 

OMHA Case Processing Manual (OCPM) 

instructions that were published from 

October through December 2018. This 

manual standardizes the day-to-day 

procedures for carrying out adjudicative 

functions, in accordance with 

applicable statutes, regulations, and 

OMHA directives, and gives OMHA 

staff direction for processing appeals at 

the OMHA level of adjudication. 

FOR FURTHER INFORMATION CONTACT: 

Jason Green, by telephone at (571) 777– 

2723, or by email at jason.green@

hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Office of Medicare Hearings and 

Appeals (OMHA), a staff division within 

the Office of the Secretary within the 

U.S. Department of Health and Human 

Services (HHS), administers the 

nationwide Administrative Law Judge 

hearing program for Medicare claim; 

organization, coverage, and at-risk 

determination; and entitlement appeals 

under sections 1869, 1155, 

1876(c)(5)(B), 1852(g)(5), and 1860D– 

4(h) of the Social Security Act (the Act). 

OMHA ensures that Medicare 

beneficiaries and the providers and 

suppliers that furnish items or services 

to Medicare beneficiaries, as well as 

Medicare Advantage organizations 

(MAOs), Medicaid State agencies, and 

applicable plans, have a fair and 

impartial forum to address 

disagreements with Medicare coverage 

and payment determinations made by 

Medicare contractors, MAOs, or Part D 

plan sponsors (PDPSs), and 

determinations related to Medicare 

eligibility and entitlement, Part B late 

enrollment penalty, and income-related 


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