73314 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 

to the bill-payment or bill history 

services that consumers actually signed 

up for.) 

Parts IV through VIII of the proposed 

order are reporting and compliance 

provisions. Part IV requires 

PaymentsMD to retain documents 

relating to its compliance with the 

order. The order requires that 

PaymentsMD retain all of the 

documents for a five-year period. Part V 

requires dissemination of the order now 

and in the future to all current and 

future subsidiaries, principals, officers, 

directors, and managers, and to persons 

with responsibilities relating to the 

subject matter of the order. Part VI 

ensures notification to the FTC of 

changes in corporate status. Part VII 

mandates that PaymentsMD submit a 

compliance report to the FTC within 60 

days, and periodically thereafter as 

requested. Part VIII is a provision 

‘‘sunsetting’’ the order after twenty (20) 

years, with certain exceptions. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2014–28969 Filed 12–9–14; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Ebola Virus Disease Vaccines 

ACTION: Notice of Declaration under the 

Public Readiness and Emergency 

Preparedness Act. 

SUMMARY: The Secretary is issuing a 

declaration pursuant to section 319F–3 

of the Public Health Service Act (42 

U.S.C. 247d–6d) to provide liability 

protection for activities related to Ebola 

Virus Disease Vaccines consistent with 

the terms of the declaration. 

DATES: The declaration is effective as of 

December 3, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Lurie, MD, MSPH, 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 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

Background 

The Public Readiness and Emergency 

Preparedness Act (‘‘PREP Act’’) 

authorizes the Secretary of Health and 

Human Services (‘‘the Secretary’’) to 

issue a declaration to provide liability 

immunity to certain individuals and 

entities (‘‘Covered Persons’’) against any 

claim of loss caused by, arising out of, 

relating to, or resulting from the 

administration or use of medical 

countermeasures (‘‘Covered 

Countermeasures’’), except for claims 

that meet the PREP Act’s definition of 

willful misconduct. Using this 

authority, the Secretary is issuing a 

declaration to provide liability 

immunity to Covered Persons for 

activities related to the Covered 

Countermeasures, Ebola Virus Disease 

Vaccines as listed in Section VI of the 

Declaration, 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, & Cosmetic (FD&C) Act to provide 

new emergency authorities for 

dispensing 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 (the 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. 

The Ebola virus causes an acute, 

serious illness that is often fatal. Since 

March 2014, West Africa has been 

experiencing the largest and most 

complex Ebola outbreak since the Ebola 

virus was first discovered in 1976, 

affecting populations in multiple West 

African Countries and travelers from 

West Africa to the United States and 

other countries. The World Health 

Organization has declared the Ebola 

Virus Disease Outbreak as a Public 

Health Emergency of International 

Concern (PHEIC) under the framework 

of the International Health Regulations 

(2005). 

Unless otherwise noted, all statutory 

citations below are to the U.S. Code. 

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 Ebola 

virus and the resulting disease may in 

the future constitute a public health 

emergency. 

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 she 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. 

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 

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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 United States. 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 

who is 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 

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 exempted 

under the FD&C Act for use as an 

investigational drug or device that 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 ten years after the 

Department’s determination that 

procurement of the countermeasure is 

appropriate. 

Section VI lists the Ebola Virus 

Disease Vaccines that are Covered 

Countermeasures. 

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 Public Health Service 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 declaration states that 

liability immunity is afforded to 

Covered Persons for Recommended 

Activities related to: 

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(a) Present or future Federal contracts, 

cooperative agreements, grants, other 

transactions, interagency agreements, or 

memoranda of understanding or other 

Federal agreements; or (b) Activities 

authorized in accordance with the 

public health and medical response of 

the Authority Having Jurisdiction to 

prescribe, administer, deliver, distribute 

or dispense the Covered 

Countermeasures following a 

declaration of an emergency. 

Section VII 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. 

For governmental program planners 

only, liability immunity is afforded only 

to the extent they 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. 

This last limitation on distribution is 

intended to deter program planners that 

are government entities from seizing 

privately held stockpiles of Covered 

Countermeasures. It does not apply to 

any other Covered Persons, including 

other program planners who are not 

government 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 

of the countermeasure. In Section VIII, 

the Secretary states that the disease 

threat for which she recommends 

administration or use of the Covered 

Countermeasures is Ebola virus disease. 

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 

use by an individual of a Covered 

Countermeasure consistent with the 

terms of a declaration issued under the 

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 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 West 

Africa. 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. 

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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 explains the 

effective time periods for different 

means of distribution of Covered 

Countermeasures. 

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 

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. 

Section XIII provides for twelve (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 Strategic 

National Stockpile during the effective 

period of the declaration. 

Section XIV, Countermeasures Injury 

Compensation Program 

Section 319F–4 of the PREP Act 

authorizes a 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 if countermeasures are 

administered or used outside the United 

States, 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 United States 

may not be eligible for CICP benefits. 

Section XV, Amendments 

The Secretary may amend any portion 

of a declaration through publication in 

the Federal Register. 

Declaration 

Declaration, Public Readiness and 

Emergency Preparedness Act Coverage 

for Ebola Virus 

Disease Vaccines 

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 Ebola 

virus and the resulting disease or 

conditions may in the future constitute 

a public health emergency. 

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 

United States. 

In addition, I have determined that 

the following additional persons are 

qualified persons: (a) Any person 

authorized in accordance with the 

public health and medical emergency 

response of the Authority Having 

Jurisdiction, as described in section VII 

below, to prescribe, administer, deliver, 

distribute or dispense the Covered 

Countermeasures, and their officials, 

agents, employees, contractors and 

volunteers, following a declaration of 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; (c) any 

person authorized to prescribe, 

administer, or dispense Covered 

Countermeasures using Emergency Use 

Instructions or under an order issued in 

accordance with Section 564A of the 

FD&C Act. 

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 Ebola Virus Disease Vaccines: 

(1) Recombinant Replication Deficient 

Chimpanzee Adenovirus Type 3- 

Vectored Ebola Zaire Vaccine (ChAd3– 

EBO–Z) GlaxoSmithKline [GSK code 

name GSK3390107A] 

(2) BPSC1001 (rVSV–ZEBOV–GP) 

BioProtection Services Corporation, 

subsidiary of Newlink Genetics; and 

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(3) Ad26.ZEBOV/MVA–BN-Filo 

(MVA-mBN226B) Janssen Corporation, 

subsidiary of Johnson & Johnson/

Bavarian Nordic. 

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 related to: 

(a) Present or future Federal contracts, 

cooperative agreements, grants, other 

transactions, interagency agreements, 

memoranda of understanding, or other 

Federal agreements; 

or 

(b) Activities authorized in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction to prescribe, 

administer, deliver, distribute or 

dispense the Covered Countermeasures 

following a declaration of an emergency. 

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; 

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 

virus disease. 

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 through means of 

distribution, as identified in Section 

VII(a) of this Declaration, other than in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction begins on the date 

of signature and extends for twelve (12) 

months from that date. 

Liability immunity for Covered 

Countermeasures administered and 

used in accordance with the public 

health and medical response of the 

Authority Having Jurisdiction begins 

with a declaration and lasts through (1) 

the final day the emergency declaration 

is in effect or (2) twelve (12) months 

from the date of signature, whichever 

occurs first. 

XIII. Additional Time Period of 

Coverage 

42 U.S.C. 247d–6d(b)(3)(B) and (C) 

I have determined that an additional 

twelve (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 a 

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 (‘‘HRSA’’), 

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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 73319 

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) 

Any amendments to this declaration 

will be published in the Federal 

Register. 

Authority: 42 U.S.C. 247d–6d. 

Dated: December 3, 2014. 

Sylvia M. Burwell, 

Secretary. 

[FR Doc. 2014–28856 Filed 12–9–14; 8:45 am] 

BILLING CODE 4150–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

Federal Health IT Strategic Plan: 2015– 

2020 Open Comment Period 

AGENCY: ONC, HHS. 

ACTION: Notice. 

Authority: Section 3001(c)(3) of the Public 

Health Service Act. 

SUMMARY: Section 3001(c)(3) of the 

Public Health Service Act, as added by 

the Health Information Technology for 

Economic and Clinical Health (HITECH) 

Act, requires the National Coordinator 

for Health Information Technology 

(ONC) to update the Federal Health IT 

Strategic Plan (developed June 3, 2008; 

last updated on September 15, 2011) in 

consultation with other appropriate 

federal agencies and in collaboration 

with private and public entities. The 

Plan was developed in collaboration 

across multiple federal agencies, and 

ONC will seek input on the draft Plan 

from the private sector through the 

Health IT Policy Committee. This notice 

serves to announce that the public 

comment period for the Federal Health 

IT Strategic Plan is open through 

Tuesday, February 6 at 5:00 p.m. 

(Eastern). ONC welcomes and 

encourages all comments from the 

public regarding the Plan. 

In order for your comments to be read 

and considered, you must submit your 

comment via http://www.healthit.gov/

policy-researchers-implementers/

strategic-plan-public-comments. 

FOR FURTHER INFORMATION CONTACT: 

Matthew Swain, Program Analyst in the 

Office of Planning, Evaluation, and 

Analysis, matthew.swain@hhs.gov, 

202.205.3754. 

Dated: December 4, 2014. 

Matthew Swain, 

Program Analyst, Office of Planning, 

Evaluation, and Analysis, Office of the 

National Coordinator for Health Information 

Technology (ONC), Office of the Secretary 

(OS). 

[FR Doc. 2014–28855 Filed 12–9–14; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Mine Safety and Health Research 

Advisory Committee; Notice of Charter 

Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the Mine 

Safety and Health Research Advisory 

Committee, Centers for Disease Control 

and Prevention, Department of Health 

and Human Services, has been renewed 

for a 2-year period through November 

30, 2016. 

For information, contact Jeffrey H. 

Welsh, B.A., Designated Federal Officer, 

Mine Safety and Health Research 

Advisory Committee, Centers for 

Disease Control and Prevention, 

Department of Health and Human 

Services, 626 Cochrans Mill Road, 

Mailstop P05, Pittsburgh, Pennsylvania 

15236, Telephone (412) 386–4040 or fax 

(412) 386–6614. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Claudette Grant, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2014–28933 Filed 12–9–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

The Centers for Disease Control (CDC)/ 

Health Resources and Services 

Administration (HRSA) Advisory 

Committee on HIV, Viral Hepatitis and 

STD Prevention and Treatment; Notice 

of Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the CDC/ 

HRSA Advisory Committee on HIV, 

Viral Hepatitis and STD Prevention and 

Treatment, Department of Health and 

Human Services, has been renewed for 

a 2-year period through November 25, 

2016. 

Contact Person for More Information: 

Johnathan Mermin, M.D., M.P.H., 

Designated Federal Officer, CDC/HRSA 

Advisory Committee on HIV, Viral 

Hepatitis and STD Prevention and 

Treatment, Department of Health and 

Human Services, CDC, 1600 Clifton 

Road NE., Mailstop E07, Atlanta, 

Georgia 30333, telephone (404) 639– 

8000 or fax (404) 639–8600. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Claudette Grant, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2014–28932 Filed 12–9–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Head Start Impact Study 

Participants Beyond 8th Grade. 

OMB No.: 0970–0229. 

Description: The Administration for 

Children and Families (ACF) within the 

Department of Health and Human 

Services (HHS) will collect follow-up 

information from children and families 

in the Head Start Impact Study. In 

anticipation of conducting a future 

follow-up for the study, ACF will collect 

information necessary to identify 

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