Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38701 

occurred in the three-month period of 

April through June 2018. A hyperlink to 

the available chapters on the OMHA 

website is provided below. The OMHA 

website contains the most current, upto-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 and 

coverage 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. 

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. 

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. Reorganization and Revision of the 

OCPM 

OMHA is in the process of 

restructuring, reorganizing, and 

reformatting the OCPM to make it more 

user friendly. As part of this ongoing 

process, we are drafting new OCPM 

chapters and revising existing OCPM 

chapters to conform to the new format. 

Previously, the OCPM contained 

separate divisions for each Medicare 

part, and most chapters were repeated 

in each division. New and revised 

chapters provide information pertaining 

to all appeals arising under all Medicare 

parts. Plain language is used where 

possible and guidance is provided in a 

user-friendly, question-and-answer 

format. The manual is also being revised 

to reflect regulatory changes made by 

the final rule that was published in the 

January 17, 2017 Federal Register and 

became effective on March 20, 2017 (82 

FR 4974). New and revised chapters can 

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

about/agencies/omha/the-appealsprocess/case-processing-manual/ 

index.html. Unless inconsistent with a 

statute, regulation, or other controlling 

authority, provisions of chapters that 

were published before May 10, 2018, 

remain in effect until revised, and can 

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

about/agencies/omha/the-appealsprocess/case-processing-manual/2017/ 

index.html. 

IV. OCPM Releases for April Through 

June 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 new OCPM provisions and the 

subject matter. For future quarterly 

notices, we will list only the specific 

updates to the list of manual provisions 

that have occurred in the covered 3- 

month period. This information is 

available on our website at https://

www.hhs.gov/about/agencies/omha/theappeals-process/case-processingmanual/index.html. 

OCPM Chapter 1: Manual Overview, 

Definition, and Governance 

Chapter 1, Manual Overview, 

Definition, Governance. This chapter 

describes the OCPM’s purpose and 

organization. It also describes how to 

navigate the OCPM, and when and how 

to cite an OCPM provision as an 

authority in an action issued by an 

OMHA adjudicator. 

OMHA receives a variety of appeals, 

as discussed in section I above. This 

chapter describes when a specific 

OCPM provision may be read to apply 

to all or certain types of appeals, and 

describes OCPM conventions for citing 

to statutory, regulatory, and other 

applicable authorities. In addition, this 

chapter describes the process for 

updating an OCPM chapter, as well as 

how to determine when a revision was 

issued or became effective, and how to 

access prior versions of a chapter. 

OCPM Chapter 19: Closing the Case 

Chapter 19, Closing the Case. Timely 

notice of the disposition and closing of 

a case, in compliance with applicable 

laws and policy, is important to ensure 

that effectuation of a decision, or other 

necessary actions, can be undertaken by 

the parties to the appeal, CMS, CMS 

contractors, plans, SSA, or the Council. 

Receipt of the disposition package also 

governs the timing for parties to file an 

appeal, and for the Council to initiate a 

review of a case on its own motion. In 

addition, the timely transfer of the 

administrative record helps ensure 

effectuation can occur, SSA, CMS, or 

CMS contractors can refer cases for 

review by the Council, and the record 

can be transitioned to storage. This 

revised chapter describes the necessary 

steps to timely and accurately close 

appeals pending at OMHA. 

OCPM Chapter 20: Post-Adjudication 

Actions 

Chapter 20, Post-Adjudication 

Actions. This new chapter describes the 

various potential actions that may occur 

after an OMHA adjudicator issues a 

decision, dismissal, or remand, and the 

procedures for responding to such 

actions. These actions include requests 

to correct a clerical error, reopen a 

decision, vacate a dismissal, or review 

a remand issued by an OMHA 

adjudicator. OMHA adjudicators take 

action to grant or deny such a request, 

and in some instances may initiate an 

action on their own motion. 

In addition, parties may seek Council 

review of decisions and dismissals. 

CMS and its contractors, or SSA, may 

also refer decisions and dismissals to 

the Council for possible own motion 

review. The chapter also describes 

actions the Council may take on an 

appealed or referred case, including 

remanding the case to OMHA. 

Dated: July 23, 2018. 

Amanda M. Axeen, 

Acting Chief Advisor, Office of Medicare 

Hearings and Appeals. 

[FR Doc. 2018–16860 Filed 8–6–18; 8:45 am] 

BILLING CODE 4150–46–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Declaration Under the Public 

Readiness and Emergency 

Preparedness Act for Zika Virus 

Vaccines 

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Secretary is amending a 

Declaration pursuant to the Public 

Health Service Act to provide liability 

immunity protection for activities 

related to Zika virus vaccines consistent 

with the terms of the Declaration. 

DATES: The declaration is effective as of 

August 1, 2018. 


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1CDC Zika case reporting; https://www.cdc.gov/ 

zika/reporting/2018-case-counts.html, accessed 

23July2018, 1630. 

FOR FURTHER INFORMATION CONTACT: 

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

Assistant Secretary for Preparedness 

and Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue 

SW, Washington, DC 20201; Telephone: 

202–205–2882. 

SUPPLEMENTARY INFORMATION: The 

Public Readiness and Emergency 

Preparedness Act (PREP Act) authorizes 

the Secretary of Health and Human 

Services (the Secretary) to issue a 

Declaration to provide liability 

immunity to certain individuals and 

entities (Covered Persons) against any 

claim of loss caused by, arising out of, 

relating to, or resulting from the 

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, 

effective August 1, 2016 (82 FR 10365 

(February 10, 2017)), Acting Secretary 

Norris Cochran issued a Declaration to 

provide liability immunity to Covered 

Persons for activities related to the 

Covered Countermeasures, Zika virus 

vaccines as listed in Section VI of the 

Declaration, consistent with the terms of 

the Declaration. The Secretary is 

amending the August 1, 2016 

Declaration to extend the effective time 

period of the declaration through 

December 31, 2022 and to clarify and 

add to the list of covered 

countermeasures to include all Zika 

virus vaccine types and technologies. 

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 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. Zika virus is a mosquito-borne 

flavivirus that usually causes mild 

symptoms but has been determined to 

cause microcephaly and other severe 

brain abnormalities in fetuses and 

infants born to women infected with 

Zika virus before birth. Zika virus has 

also been associated with other adverse 

pregnancy outcomes, including 

miscarriage, stillbirth, and congenital 

Zika syndrome, and is linked to 

Guillain-Barre Syndrome. Beginning in 

2015, Brazil experienced the largest 

outbreak of disease caused by Zika 

infection since its discovery in Uganda 

in 1947. On February 1, 2016, the World 

Health Organization (WHO) determined 

that microcephaly cases and other 

neurologic disorders reported in Brazil 

constituted a Public Health Emergency 

of International Concern (PHEIC) in 

accordance with the International 

Health Regulations (IHR). Since 2015, 

Zika virus has been detected in nations 

throughout the world. In the United 

States, traveler-associated cases have 

been identified in all the states, and 

local transmission of Zika virus is 

occurring in Puerto Rico; American 

Samoa; areas of Miami, Florida; and 

Texas. On August 12, 2016, former 

Secretary Sylvia M. Burwell determined 

that a public health emergency of 

national significance existed within the 

Commonwealth of Puerto Rico relating 

to pregnant women and children born to 

pregnant women with Zika. Former 

Secretary Burwell renewed that 

determination on November 4, 2016; 

Acting Secretary Norris Cochran 

renewed that determination on January 

31, 2017; and former Secretary Thomas 

E. Price renewed that declaration on 

April 28, 2017. The Secretary’s public 

health emergency declaration expired 

on July 26, 2017. On November 18, 

2016, the WHO Director-General 

declared the end of the PHEIC based on 

recommendations of the WHO 

Emergency Committee that Zika virus 

and associated consequences no longer 

represent a PHEIC as defined under the 

IHR, but remain a significant enduring 

public health challenge requiring 

intense action that should be escalated 

into a sustained program of work with 

dedicated resources to address the longterm nature of the disease and its 

associated consequences. In 2018, cases 

continue to be reported throughout the 

U.S. states and territories of laboratoryconfirmed Zika virus disease in 

individuals returning from travel to 

affected areas, or presumed local 

mosquito-borne transmission, or other 

modes of transmission.1

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 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 Zika 

virus and the resulting disease may 

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 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 


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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 

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 the parents, subsidiaries, affiliates, 

successors, and assigns of a 

manufacturer. 

A distributor means a person or entity 

engaged in the distribution of drugs, 

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 

Covered 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 Covered 

Countermeasures for which the 

Secretary has recommended such 

activities. The PREP Act states that a 

‘‘Covered Countermeasure’’ must be: A 

‘‘qualified pandemic or epidemic 

product,’’ or a ‘‘security 

countermeasure,’’ as described 

immediately below; or a drug, biological 

product or device authorized for 

emergency use in accordance with 

Sections 564, 564A, or 564B of the 

FD&C Act. 

A qualified pandemic or epidemic 

product means a drug or device, as 

defined in the FD&C Act or a biological 

product, as defined in the PHS Act that 

is: (i) Manufactured, used, designed, 

developed, modified, licensed or 

procured to diagnose, mitigate, prevent, 

treat, or cure a pandemic or epidemic or 

limit the harm such a pandemic or 

epidemic might otherwise cause; (ii) 

manufactured, used, designed, 

developed, modified, licensed, or 

procured to diagnose, mitigate, prevent, 

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

by such a drug, biological product, or 

device; (iii) or a product or technology 

intended to enhance the use or effect of 

such a drug, biological product, or 

device. 

A security countermeasure is a drug 

or device, as defined in the FD&C Act 

or a biological product, as defined in the 

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

determines to be a priority to diagnose, 

mitigate, prevent, or treat harm from any 

biological, chemical, radiological, or 

nuclear agent identified as a material 

threat by the Secretary of Homeland 

Security, or (b) to diagnose, mitigate, 

prevent, or treat harm from a condition 

that may result in adverse health 

consequences or death and may be 

caused by administering a drug, 

biological product, or device against 

such an agent; and (ii) is determined by 

the Secretary of Health and Human 

Services to be a necessary 

countermeasure to protect public health. 

To be a Covered Countermeasure, 

qualified pandemic or epidemic 

products or security countermeasures 

also must be approved or cleared under 

the FD&C Act; licensed under the PHS 

Act; or authorized for emergency use 

under Sections 564, 564A, or 564B of 

the FD&C Act. 

A qualified pandemic or epidemic 

product also may be a Covered 

Countermeasure when it is subject to an 

exemption (that is, it is permitted to be 

used under an Investigational Drug 

Application or an Investigational Device 

Exemption) under the FD&C Act and is 

the object of research for possible use 

for diagnosis, mitigation, prevention, 

treatment, or cure, or to limit harm of 

a pandemic or epidemic or serious or 

life-threatening condition caused by 

such a drug or device. 

A security countermeasure also may 

be a Covered Countermeasure if it may 

reasonably be determined to qualify for 

approval or licensing within 10 years 

after the Department’s determination 

that procurement of the countermeasure 

is appropriate. 

Section VI lists Zika virus vaccines 

that are Covered Countermeasures. The 

Secretary is amending the list of 

vaccines by: Deleting ‘‘whole particle’’ 

from the first category of vaccines listed 

to clarify that the category includes all 

inactivated virus vaccines; adding ‘‘and/ 

or polysaccharide and/or conjugate’’ to 

the sixth category of vaccines listed to 

include these types of peptide vaccine; 

and adding a new ninth category, 

‘‘recombinant vaccines’’ to include any 

Zika virus vaccines using this type of 

technology. 

Section VI also refers to the statutory 

definitions of Covered Countermeasures 


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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: (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 he recommends 

administration or use of the Covered 

Countermeasures is Zika virus. 

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 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 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 


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countries 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 extends the 

effective period for different means of 

distribution of Covered 

Countermeasures through December 31, 

2022. 

Section XIII, Additional Time Period of 

Coverage 

The Secretary must specify a date 

after the ending date of the effective 

time 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. 

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 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 this Declaration through publication 

in the Federal Register. 

Declaration 

Declaration for Public Readiness and 

Emergency Preparedness Act Coverage 

for Zika Virus 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 Zika 

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 


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38706 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 

Authorization in accordance with 

Section 564 of the FD&C Act; (c) any 

person authorized to prescribe, 

administer, or dispense Covered 

Countermeasures in accordance with 

Section 564A of the FD&C Act. 

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 Zika virus vaccines, 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) Virus-like particles vaccines 

(8) Nanoparticle vaccines 

(9) Recombinant 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 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 Zika 

virus. 

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 and extends through 

December 31, 2022. 

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) December 31, 2022, 

whichever occurs first. 

XIII. Additional Time Period of 

Coverage 

42 U.S.C. 247d–6d(b)(3)(B) and (C) 

I have determined that an additional 

12 months of liability protection is 

reasonable to allow for the 

manufacturer(s) to arrange for 

disposition of the Covered 

Countermeasure, including return of the 

Covered Countermeasures to the 

manufacturer, and for Covered Persons 

to take such other actions as are 

appropriate to limit the administration 

or use of the Covered Countermeasures. 

Covered Countermeasures obtained 

for the SNS during the effective period 

of this Declaration are covered through 

the date of administration or use 

pursuant to a distribution or release 

from the SNS. 

XIV. Countermeasures Injury 

Compensation Program 

42 U.S.C 247d–6e 

The PREP Act authorizes the 

Countermeasures Injury Compensation 


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Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38707 

Program (CICP) to provide benefits to 

certain individuals or estates of 

individuals who sustain a covered 

serious physical injury as the direct 

result of the administration or use of the 

Covered Countermeasures, and benefits 

to certain survivors of individuals who 

die as a direct result of the 

administration or use of the Covered 

Countermeasures. The causal 

connection between the countermeasure 

and the serious physical injury must be 

supported by compelling, reliable, valid, 

medical and scientific evidence in order 

for the individual to be considered for 

compensation. The CICP is 

administered by the Health Resources 

and Services Administration, within the 

Department of Health and Human 

Services. Information about the CICP is 

available at the toll-free number 1–855– 

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

XV. Amendments 

42 U.S.C. 247d–6d(b)(4) 

Amendments to this Declaration will 

be published in the Federal Register. 

Authority: 42 U.S.C. 247d–6d. 

Dated: August 1, 2018. 

Alex M. Azar II 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2018–16856 Filed 8–6–18; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Initial Review Group; Clinical Aging 

Review Committee NIA–C. 

Date: September 27–28, 2018. 

Time: 3:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Rd., Bethesda, MD 20814. 

Contact Person: Alicja L. Markowska, 

Ph.D., DSC, National Institute on Aging, 

National Institutes of Health, Gateway 

Building 2C212, 7201 Wisconsin Avenue, 

Bethesda, MD 20892, 301–496–9666, 

markowsa@nia.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: August 1, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–16787 Filed 8–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information may be obtained 

by emailing the indicated licensing 

contact at the National Heart, Lung, and 

Blood, Office of Technology Transfer 

and Development Office of Technology 

Transfer, 31 Center Drive Room 4A29, 

MSC2479, Bethesda, MD 20892–2479; 

telephone: 301–402–5579. A signed 

Confidential Disclosure Agreement may 

be required to receive any unpublished 

information. 

SUPPLEMENTARY INFORMATION: This 

notice is in accordance with 35 U.S.C. 

209 and 37 CFR part 404 to achieve 

commercialization of results of 

federally-funded research and 

development. 

Technology description follows. 

Neuroendocrine Tumor Evans Blue 

Containing Radiotherapeutics 

The invention pertains to a 

radiotherapeutic against neuroendocrine 

tumors that express somatostatin 

receptor. Radionuclide therapies 

directed against tumors that express 

somatostatin receptors (SSTRs) have 

proven effective for the treatment of 

advanced, low- to intermediate-grade 

neuroendocrine tumors. The subject 

radiotherapeutic covered by the subject 

patent estate includes a somatostatin 

(SST) peptide derivative like octreotate 

(TATE), conjugated to an Evans Blue 

(EB) analog, and further chelated via 

DOTA to therapeutic radionuclide177Lu, 

a beta emitter. The EB analog reversibly 

binds to circulating serum albumin and 

improves the pharmacokinetics of SST 

peptide derivatives and reduce peptidereceptor radionuclide therapy toxicity. 

EB analog conjugated to octreotate (EB– 

DOTATATE) has been shown by the 

inventors to provide reversible albumin 

binding in vivo and extended half-life in 

circulation. When EB–TATE is slowly 

released into the tumor 

microenvironment, tumor uptake and 

internalization into SSTR positive 

tumors resulted in delivery of 

radioactive particles and tumor cell 

killing. EB–TATE displayed 

significantly more favorable 

pharmacokinetics than TATE alone by 

achieving higher tumor to non-tumor 

penetration as evidenced by positron 

emission tomography. 

Potential Commercial Applications: 

• Cancer therapeutics 

• Higher stability/Lower toxicity 

Development Stage: 

• Early stage 

Inventors: Xiaoyuan Chen and Orit 

Jacobson Weiss (both of NIBIB). 

Intellectual Property: HHS Reference 

No. E–150–2016–1; International Patent 

Application PCT/US2017/031696. 

Licensing Contact: Michael 

Shmilovich, Esq, CLP; 301–435–5019; 

shmilovm@mail.nih.gov. 

Dated: July 20, 2018. 

Michael Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2018–16839 Filed 8–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Treatment of Type I Diabetes 

and its Comorbidities 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Heart, Lung and 

Blood Institute (NHLBI), National 

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant of an exclusive 

patent License to Inversago Pharma, 

Inc., located in Montreal, Quebec, 

Canada, to practice the inventions 

embodied in the patent applications 


daltland on DSKBBV9HB2PROD with NOTICES