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

monthly adjustment amounts (IRMAA) 

made by the Social Security 

Administration (SSA). 

The Medicare claim, organization 

determination, coverage determination, 

and at-risk determination appeals 

processes consist of four levels of 

administrative review, and a fifth level 

of review with the Federal district 

courts after administrative remedies 

under HHS regulations have been 

exhausted. The first two levels of review 

are administered by the Centers for 

Medicare & Medicaid Services (CMS) 

and conducted by Medicare contractors 

for claim appeals, by MAOs and an 

Independent Review Entity (IRE) for 

Part C organization determination 

appeals, or by PDPSs and an IRE for Part 

D coverage determination and at-risk 

determination appeals. The third level 

of review is administered by OMHA and 

conducted by Administrative Law 

Judges and attorney adjudicators. The 

fourth level of review is administered by 

the HHS Departmental Appeals Board 

(DAB) and conducted by the Medicare 

Appeals Council (Council). In addition, 

OMHA and the DAB administer the 

second and third levels of appeal, 

respectively, for Medicare eligibility, 

entitlement, Part B late enrollment 

penalty, and IRMAA reconsiderations 

made by SSA; a fourth level of review 

with the Federal district courts is 

available after administrative remedies 

within SSA and HHS have been 

exhausted. 

Sections 1869, 1155, 1876(c)(5)(B), 

1852(g)(5), and 1860D–4(h) of the Act 

are implemented through the 

regulations at 42 CFR part 405 subparts 

I and J; part 417, subpart Q; part 422, 

subpart M; part 423, subparts M and U; 

and part 478, subpart B. As noted above, 

OMHA administers the nationwide 

Administrative Law Judge hearing 

program in accordance with these 

statutes and applicable regulations. To 

help ensure nationwide consistency in 

that effort, OMHA established a manual, 

the OCPM. Through the OCPM, the 

OMHA Chief Administrative Law Judge 

establishes the day-to-day procedures 

for carrying out adjudicative functions, 

in accordance with applicable statutes, 

regulations, and OMHA directives. The 

OCPM provides direction for processing 

appeals at the OMHA level of 

adjudication for Medicare Part A and B 

claims; Part C organization 

determinations; Part D coverage 

determinations and at-risk 

determinations; and SSA eligibility and 

entitlement, Part B late enrollment 

penalty, and IRMAA determinations. 

Section 1871(c) of the Act requires 

that the Secretary publish a list of all 

Medicare manual instructions, 

interpretive rules, statements of policy, 

and guidelines of general applicability 

not issued as regulations at least every 

three months in the Federal Register. 

II. Format for the Quarterly Issuance 

Notices 

This quarterly notice provides the 

specific updates to the OCPM that have 

occurred in the three-month period of 

October through December 2018. A 

hyperlink to the available chapters on 

the OMHA website is provided below. 

The OMHA website contains the most 

current, up-to-date chapters and 

revisions to chapters, and will be 

available earlier than we publish our 

quarterly notice. We believe the OMHA 

website provides more timely access to 

the current OCPM chapters for those 

involved in the Medicare claim; 

organization, coverage, and at-risk 

determination; and entitlement appeals 

processes. We also believe the website 

offers the public a more convenient tool 

for real time access to current OCPM 

provisions. In addition, OMHA has a 

listserv to which the public can 

subscribe to receive notification of 

certain updates to the OMHA website, 

including when new or revised OCPM 

chapters are posted. If accessing the 

OMHA website proves to be difficult, 

the contact person listed above can 

provide the information. 

III. How To Use the Notice 

This notice lists the OCPM chapters 

and subjects published during the 

quarter covered by the notice so the 

reader may determine whether any are 

of particular interest. We expect this 

notice to be used in concert with future 

published notices. The OCPM can be 

accessed at https://www.hhs.gov/about/ 

agencies/omha/the-appeals-process/ 

case-processing-manual/index.html. 

IV. OCPM Releases for October 

Through December 2018 

The OCPM is used by OMHA 

adjudicators and staff to administer the 

OMHA program. It offers day-to-day 

operating instructions, policies, and 

procedures based on statutes and 

regulations, and OMHA directives. 

The following is a list and description 

of OCPM provisions that were revised in 

the three-month period of October 

through December 2018. This 

information is available on our website 

at https://www.hhs.gov/about/agencies/ 

omha/the-appeals-process/caseprocessing-manual/index.html. 

OCPM Chapter 17: Dismissals 

Chapter 17, Dismissals. This chapter 

addresses the reasons an OMHA 

adjudicator may dismiss a request for 

hearing or a request for review of a CMS 

contractor’s dismissal of a request for a 

reconsideration, the contents of a 

dismissal order and its associated 

notice, and the effect of a dismissal. 

This chapter also addresses a party’s 

rights to appeal a dismissal and an 

adjudicator’s authority to vacate his or 

her own dismissal. 

OCPM Chapter 18: Requests for 

Information and Remands 

Chapter 18, Requests for Information 

and Remands. When authorized by the 

applicable regulations, OMHA 

adjudicators may use requests for 

information and remands to obtain 

information that is missing from an 

appeal, or request that a prior 

adjudicating entity take an action or 

issue a new appeal determination. In 

addition, an appellant and CMS or a 

CMS contractor in a Part A, B, or C 

appeal; an enrollee and CMS, the IRE, 

or a PDPS in a Part D appeal; or an 

appellant and SSA in an appeal of an 

SSA reconsideration may jointly request 

that a case be remanded to the prior 

adjudicator. This chapter describes the 

circumstances in which an OMHA 

adjudicator may issue a request for 

information or remand, and the 

requirements for requesting that an 

OMHA adjudicator remand a case. In 

addition, this chapter describes the right 

of a party, CMS, a CMS contractor, a 

PDPS, or SSA to request that the OMHA 

Chief Administrative Law Judge or a 

designee review a remand and, if it was 

not authorized by regulation, vacate the 

remand order. 

Dated: January 22, 2019. 

Jason M. Green, 

Chief Advisor, Office of Medicare Hearings 

and Appeals. 

[FR Doc. 2019–00564 Filed 1–30–19; 8:45 am] 

BILLING CODE 4150–46–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Ebola Virus Disease Vaccines— 

Amendment 

ACTION: Notice of Amendment to the 

December 3, 2014, Declaration under 

the Public Readiness and Emergency 

Preparedness Act for Ebola Virus 

Disease Vaccines, as amended. 

SUMMARY: The Secretary is amending the 

Declaration issued pursuant to the 

Public Health Service Act on December 

3, 2014, as amended on December 1, 

2015 and December 2, 2016, to update 

the term ‘‘Ebola Virus Disease’’ to 


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‘‘Ebola disease’’ (EBOD) throughout the 

declaration and to clarify the definition 

of EBOD. The amendment also expands 

the Covered Countermeasures beyond 

the three vaccines 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 Declaration 

issued pursuant to section 319F–3 of the 

Public Health Service Act on December 

3, 2014 (79 FR 73314), as amended on 

December 1, 2015 (80 FR 76541) and 

December 2, 2016 (81 FR 89471), 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 three 

vaccines 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 

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 

vaccines 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 

three vaccines 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 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 

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 Western African 

countries and travelers from Western 

Africa to the U.S. and other countries. 

In 2014, 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 makes 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 

vaccines 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. 


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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 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 

vaccines against viruses and variants of 

all viruses of the Ebolavirus 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. 

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. 

Section VI. Covered Countermeasures 

As noted above, section III describes 

the Secretary’s Recommended Activities 

for which liability immunity is in effect. 

This section 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 


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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 vaccines 

that are Covered Countermeasures. The 

Secretary is expanding the types of 

Covered Countermeasures covered 

under this Declaration to include 

monovalent or multivalent ebolavirus or 

filovirus vaccine types against any 

single or combinations of the pathogens 

resulting in EBOD as defined in Section 

I of this Declaration, all components and 

constituent materials of these vaccines, 

and all devices and their constituent 

components used in the administration 

of these vaccines: 

(1) Inactivated virus vaccines 

(2) Live-attenuated vaccines 

(3) mRNA vaccines 

(4) DNA vaccines 

(5) Subunit vaccines 

(6) Peptide and/or polysaccharide and/ 

or conjugate vaccines 

(7) Virion-like particles vaccines 

(8) Nanoparticle vaccines 

(9) Recombinant vaccines 

(10) Viral vector-based vaccines 

This change is intended to expand the 

types of EBOD vaccines that are 

included as Covered Countermeasures 

consistent with the terms of this 

declaration, including the limitations 

stated in Section VII of this Declaration. 

The Declaration continues coverage for 

EBOD vaccines previously afforded 

under this declaration: (1) 

‘‘Recombinant Replication Deficient 

Chimpanzee Adenovirus Type 3– 

Vectored Ebola Zaire Vaccine’’ (ChAd3– 

EBO–Z); (2) ‘‘Recombinant Vesicular 

Stomatitis Virus-vectored vaccine 

expressing EBOV–Zaire glycoprotein’’ 

(rVSV–ZEBOV–GP), and; (3) 

‘‘Ad26.ZEBOV/MVA–BN–Filo’’ (MVA– 

mBN226B), and extends coverage to 

encompass all categories of EBOD 

vaccines. 

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 specifies that the term 

‘‘directly supported’’ in this Declaration 

means that the U. S. has provided some 

form of tangible support such as 

supplies, funds, products, technical 

assistance, or staffing. 

The Secretary is amending the 

Declaration to delete the limitation 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 an emergency. In 

accordance with the PREP Act, 

termination of this limitation has only 

future effect, and does not alter coverage 

provided under the Declaration prior to 

the effective date of this amendment. 

However, we do not believe that this 

amendment substantively alters liability 

protections previously afforded under 

the Declaration, given that the 

Declaration previously only covered 

specific EBOD vaccines that were 

directly supported by the U.S. Federal 

Government. The amendments to 

Sections VI and VII of this Declaration 

are intended to expand coverage under 

the Declaration to all categories of EBOD 

vaccines but retain the limitation to 

those EBOD vaccines that are directly 

supported by the U.S. Federal 

Government. We note that the 

Declaration still covers activities 

authorized in accordance with the 

public health and medical response of 

the Authority Having Jurisdiction to 

prescribe, administer, deliver, 

distribute, or dispense EBOD vaccines 

following a declaration of an emergency 

when the activities also involve Covered 

Countermeasures directly supported by 

the U.S. Federal Government. 

Accordingly, individuals carrying out 

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 are still 

listed as qualified persons under 

Section V of the declaration. Section V 

also defines the terms ‘‘Authority 

Having Jurisdiction’’ and ‘‘Declaration 

of an emergency.’’ We have specified in 

the definition that Authorities having 

jurisdiction include federal, state, local, 

and tribal authorities and institutions or 

organizations acting on behalf of those 

governmental entities. 

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 


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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 PREP Act are losses 

caused by, arising out of, relating to or 

resulting from the administration to or 

use by an individual of a Covered 

Countermeasure consistent with the 

terms of a Declaration issued under the 

PREP Act. Under the Secretary’s 

definition, these liability claims are 

precluded if they 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 PREP Act precludes, for 

example, liability claims alleging 

negligence by a manufacturer in creating 

a vaccine, 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 slip and 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: (1) 

To manufacturers and distributors 

without regard to whether the 

countermeasure is used by or 

administered to this population; and (2) 

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 XI. 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 is amended to 

extend the effective time period for 

distribution of Covered 

Countermeasures consistent with 

Section VII of this Declaration through 

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 Stockpile. 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. 


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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 any 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 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 

US, 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 

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 

Declaration issued December 3, 2014 (79 

FR 73314). The first amendment was 

issued December 1, 2015 (80 FR 76541). 

The second amendment was issued 

December 2, 2016 (81 FR 89471). The 

Secretary may amend any portion of this 

Declaration through publication in the 

Federal Register. 

Republished Declaration 

Declaration, as Amended, for Public 

Readiness and Emergency Preparedness 

Act Coverage for Ebola Disease Vaccines 

This Declaration amends and 

republishes the December 3, 2014, 

Declaration, as amended on December 1, 

2015 and December 2, 2016, for 

coverage under the Public Readiness 

and Emergency Preparedness (‘‘PREP’’) 

Act for Ebola Disease Vaccines. To the 

extent any term of the December 3, 

2014, Declaration, as amended on 

December 1, 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, under the conditions 

stated in this Declaration, the 

manufacture, testing, development, 

distribution, administration, and use of 

the Covered Countermeasures. 

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; or (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 vaccines: 

All monovalent or multivalent 

ebolavirus or filovirus vaccine types 

against any single or combinations of 

the pathogens resulting in EBOD as 

defined in Section I of this Declaration, 

all components and constituent 

materials of these vaccines, and all 

devices and their constituent 


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components used in the administration 

of these vaccines: 

(1) Inactivated virus vaccines 

(2) Live-attenuated vaccines 

(3) mRNA vaccines 

(4) DNA vaccines 

(5) Subunit vaccines 

(6) Peptide and/or polysaccharide and/ 

or conjugate vaccines 

(7) Virion-like particles vaccines 

(8) Nanoparticle vaccines 

(9) Recombinant vaccines 

(10) Viral vector-based vaccines 

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. 

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 December 3, 

2014, 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 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. 

Authority: 42 U.S.C. 247d–6d. 

Dated: January 24, 2019. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2019–00260 Filed 1–30–19; 8:45 am] 

BILLING CODE 4150–37–P 


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