63656 Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 110 

RIN 0906–AA83 

Countermeasures Injury 

Compensation Program (CICP): 

Administrative Implementation, Interim 

Final Rule 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Interim final rule with request 

for comments. 

SUMMARY: The Public Readiness and 

Emergency Preparedness Act (PREP Act) 

authorizes the Secretary of Health and 

Human Services (the Secretary) to 

establish the Countermeasures Injury 

Compensation Program (CICP or 

Program). The Department of Health and 

Human Services (HHS) is issuing this 

interim final rule with request for 

comments in order to establish 

administrative policies, procedures, and 

requirements for the CICP. This Program 

is designed to provide benefits to certain 

persons who sustain serious physical 

injuries or death as a direct result of 

administration or use of covered 

countermeasures identified by the 

Secretary in declarations issued under 

the PREP Act. In addition, the Secretary 

may provide death benefits to certain 

survivors of individuals who died as the 

direct result of such covered injuries or 

their health complications. The 

Secretary is seeking public comments 

on this interim final rule. 

DATES: This regulation is effective on 

October 15, 2010. Written one 

comments must be submitted on or 

before December 14, 2010. The 

Secretary will consider the comments 

received and will decide whether to 

amend the current procedures and 

requirements based on such comments. 

ADDRESSES: You may submit comments 

in one of three ways, as listed below. 

The first is the preferred method. Please 

submit your comments in only of these 

ways, so that no duplicates are received. 

1. Federal eRulemaking Portal. You 

may submit comments electronically to 

http://www.regulations.gov. Click on the 

link ‘‘Submit electronic comments on 

HRSA regulations with an open 

comment period.’’ Submit your actual 

comments as an attachment to your 

message or cover letter. (Attachments 

should be in Microsoft Word or 

WordPerfect; however, we prefer 

Microsoft Word.) 

2. By regular, express or overnight 

mail. You may mail written comments 

to the following address only: Health 

Resources and Services Administration, 

Department of Health and Human 

Services, Attention: HRSA Regulations 

Officer, Parklawn Building Rm. 14A–11, 

5600 Fishers Lane, Rockville, MD 

20857. Please allow sufficient time for 

mailed comments to be received before 

the close of the comment period. 

3. Delivery by hand (in person or by 

courier). If you prefer, you may deliver 

your written comments before the close 

of the comment period to the same 

address: Parklawn Building Room 14A– 

11, 5600 Fishers Lane, Rockville, MD 

20857. Please call in advance to 

schedule your arrival with one of our 

HRSA Regulations Office staff members 

at telephone number (301) 443–1785. 

Because of staffing and resource 

limitations, and to ensure that no 

comments are misplaced, we cannot 

accept comments by facsimile (FAX) 

transmission. 

In commenting, please refer to file 

code [HRSA–2010–0006]. Comments 

received on a timely basis will be 

available for public inspection as they 

are received, beginning approximately 3 

weeks after publication of this Notice, in 

Room 14–05 of the Health Resources 

and Services Administration’s offices at 

5600 Fishers Lane, Rockville, MD., on 

Monday through Friday of each week 

from 8:30 a.m. to 5 p.m. (phone: 301– 

443–1785). 

FOR FURTHER INFORMATION CONTACT: Dr. 

Vito Caserta, Director, Countermeasures 

Injury Compensation Program, 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

Parklawn Building, Room 11C–26, 5600 

Fishers Lane, Rockville, MD 20857. 

Phone calls can be directed to (888) 

ASK–HRSA (275–4772). This is a tollfree number. 

SUPPLEMENTARY INFORMATION: 

Background 

This regulation administratively 

establishes the compensation program 

authorized by the Public Readiness and 

Emergency Preparedness Act (the PREP 

Act) which added new authorities under 

sections 319F–3 and 319F–4 of the 

Public Health Service Act, as amended 

(PHS Act) (42 U.S.C. 247d–6d, 247d– 

6e). The PREP Act, which was enacted 

as part of the Department of Defense, 

Emergency Supplemental 

Appropriations to Address Hurricanes 

in the Gulf of Mexico, and Pandemic 

Influenza Act of 2006 (Pub. L. 109–148) 

on December 30, 2005, confers broad 

liability protections to covered persons 

and authorizes compensation to eligible 

individuals who sustain serious 

physical injuries or deaths as the direct 

result of the administration or use of a 

covered countermeasure for a disease, 

condition, or threat that the Secretary of 

Health and Human Services (the 

Secretary) determines either constitutes 

a current public health emergency, or 

there is a credible risk that the disease, 

condition, or threat may in the future 

constitute such an emergency. This 

determination is identified in a 

declaration issued by the Secretary 

under the PREP Act. 

Both the liability protections and the 

compensation authorized under the 

PREP Act are invoked by declarations 

issued by the Secretary (hereinafter 

PREP Act declarations or declarations) 

(section 319F–3(b) of the PHS Act (42 

U.S.C. 247d–6d(b)). Through the 

issuance of such PREP Act declarations, 

the Secretary makes a determination 

that a disease, condition, or other 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. In such declarations, the 

Secretary recommends targeted liability 

immunity for persons or entities 

involved in the manufacture, testing, 

development, distribution, dispensing, 

administration, and/or use of a covered 

countermeasure for the disease, threat, 

or condition specified. Each Secretarial 

declaration specifies, for each covered 

countermeasure identified in the 

declaration: (a) The category or 

categories of diseases, health conditions, 

or threats to health for which the 

Secretary recommends the 

administration or use of the covered 

countermeasure; (b) the period or 

periods during which the liability 

protections are in effect (for example, 

from a certain date through a future 

date, or other descriptions of events that 

would trigger the application of the 

liability protections); (c) the population 

or populations for whom the Secretary 

recommends the administration or use 

of the covered countermeasure (for 

example, the entire population during a 

pandemic period); and (d) the 

geographic area or areas for which the 

liability protections are in effect (e.g., no 

geographic limitation, a certain region of 

the United States). In addition, the 

Secretary can provide whether the 

liability protections are only available 

for specified distribution methods (for 

example, the liability protections shall 

only be in effect if the countermeasures 

are obtained through a voluntary means 

of distribution). The Secretary may 

change any component of a declaration 

by amendment. 

The Secretary publishes all PREP Act 

declarations, and amendments to such 

declarations, in the Federal Register. In 

addition, they are generally posted on 

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Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 63657 

the Department’s Web site at http:// 

www.hhs.gov/disasters/discussion/ 

planners/prepact/ and on the Program’s 

Web site at http://www.hrsa.gov/ 

countermeasurescomp/. As of April 

2010, the Secretary had published 

declarations with respect to the 

following countermeasures: (1) 

Pandemic influenza vaccines 

(including, but not limited to the 

influenza A H1N1 2009 monovalent 

vaccine which will be hereafter referred 

to as the 2009 H1N1 vaccine); (2) 

anthrax countermeasures; (3) botulism 

countermeasures; (4) the influenza 

antiviral drugs Tamiflu® and Relenza®

when used for pandemic purposes; (5) 

smallpox countermeasures; (6) acute 

radiation syndrome countermeasures; 

(7) pandemic influenza diagnostics, 

personal respiratory devices, and 

respiratory support devices; and (8) the 

influenza antiviral drug peramivir when 

used to treat pandemic H1N1 2009 

influenza (which will be hereafter 

referred to as 2009 H1N1). Several of 

these declarations have been amended, 

some on multiple occasions. 

‘‘Covered countermeasure’’ is a term of 

art defined in the PREP Act and 

includes three categories (section 319F– 

3(i)(1) of the PHS Act (42 U.S.C. 247d– 

6d(i)(1)). The first category, consisting of 

‘‘qualified pandemic or epidemic 

product[s],’’ is defined in section 319F– 

3(i)(7) of the PHS Act (42 U.S.C. 247d– 

6d(i)(7)). This category includes 

products (drugs, biological products, 

and devices) manufactured, used, 

designed, developed, modified, 

licensed, or procured to diagnose, 

mitigate, prevent, treat, or cure a 

pandemic or epidemic or to limit the 

harm such pandemic or epidemic might 

otherwise cause. The category also 

extends to products used to diagnose, 

mitigate, prevent, treat, or cure a serious 

or life-threatening disease or condition 

caused by a ‘‘qualified pandemic or 

epidemic product.’’ In order to qualify, 

a drug, biological product, or device 

must be: (1) Approved or cleared under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) or licensed under the PHS 

Act; (2) the subject of research for 

possible use and subject to an 

exemption under sections 505(i) or 

520(g) of the FFDCA; or (3) covered 

under an emergency use authorization 

(in accordance with section 564 of the 

FFDCA). 

The second category includes 

‘‘security countermeasure[s].’’ A security 

countermeasure, defined in section 

319F–2(c)(1)(B) of the PHS Act (42 

U.S.C. 247d–6b(c)(1)(B), is a drug, 

biological product, or device that the 

Secretary determines: (1) Is a priority to 

diagnose, mitigate, prevent, or treat 

harm either from an agent identified as 

a material threat or from a condition 

that may result in injuries or deaths and 

may be caused by administering a drug, 

biological product, or device against 

such an agent; (2) is a necessary 

countermeasure; and (3) is approved or 

cleared under the FFDCA or licensed 

under the PHS Act or will likely be 

approved, cleared or licensed within 

eight years or is authorized for 

emergency use under section 564 of the 

FFDCA. 

The final category consists of 

products subject to emergency use 

authorizations. This category extends to 

drugs (as defined in section 201(g)(1) of 

the FFDCA, 21 U.S.C. 321(g)(1)), 

biological products (as defined in 

section 351(i) of the PHS Act (42 U.S.C. 

262), or devices (as defined in section 

201(h) of the FFDCA, 21 U.S.C. 321(h)) 

that are authorized for emergency use in 

accordance with section 564 of the 

FFDCA. 

In order to be eligible for the liability 

protections of the PREP Act or to receive 

benefits under the compensation 

provisions of the PREP Act, a covered 

countermeasure must meet one of these 

three categories and must also be 

identified by the Secretary in a PREP 

Act declaration. As explained above, the 

liability protections afforded by the 

PREP Act are tied to Secretarial 

declarations. The PREP Act’s liability 

protections are broad, covering, for 

example, the manufacture, testing, 

development, distribution, dispensing, 

administration or use of the designated 

covered countermeasure (absent willful 

misconduct as defined in section 319F– 

3(c)(1) of the PHS Act (42 U.S.C. 247d– 

6d(c)(1)). The immunity from suit 

afforded by the PREP Act applies to any 

claim for loss that has a causal 

relationship with the administration to 

or use by an individual of a covered 

countermeasure, including a causal 

relationship with the design, 

development, clinical testing or 

investigation, manufacture, labeling, 

distribution, formulation, packaging, 

marketing, promotion, sale purchase, 

donation, dispensing, prescribing, 

administration, licensing, or use of such 

countermeasure[s] (section 319F– 

3(a)(2)(B) of the PHS Act (42 U.S.C. 

247d–6d(a)(2)(B)). For more information 

about the liability protections afforded 

to covered persons under the PREP Act, 

questions and answers are available on 

the Department’s Web site at http:// 

www.hhs.gov/disasters/emergency/ 

manmadedisasters/bioterorism/ 

medication-vaccine-qa.html and http:// 

www.hhs.gov/disasters/discussion/ 

planners/prepact/prepact-h1n1.html. 

In addition to establishing the PREP 

Act’s liability protections for covered 

persons, the PREP Act authorizes the 

Secretary to establish a program to 

provide compensation to eligible 

individuals for certain covered injuries 

sustained as the direct result of the 

administration or use of a covered 

countermeasure identified in a PREP 

Act declaration. The Secretary delegated 

the authority to operate the 

compensation program described in 

section 319F–4 of the PHS Act (42 

U.S.C. 247d–6e) to the Administrator of 

the Health Resources and Services 

Administration (HRSA) on November 8, 

2006. Pursuant to this delegation of 

authority, HRSA established and 

administers the Countermeasures Injury 

Compensation Program (hereinafter 

CICP or Program). 

Under the CICP, certain persons may 

be eligible for benefits for covered 

injuries, described below, sustained as a 

direct result of the administration or use 

of covered countermeasures. The PREP 

Act stipulates that the CICP will follow, 

with very limited exceptions, the 

Smallpox Vaccine Injury Compensation 

Program (SVICP) for eligibility and 

compensation determinations (section 

319F–4(b)(4) of the PHS Act (42 U.S.C. 

247d–6e(b)(4)). In addition, the 

elements of compensation are almost 

identical to those available under the 

SVICP (section 319F–4(b)(2) of the PHS 

Act (42 U.S.C. 247d–6e(b)(2)). The 

SVICP was established under the 

Smallpox Emergency Personnel 

Protection Act of 2003 (SEPPA) and its 

implementing regulations are available 

at 42 CFR part 102. Specifically, the 

PREP Act provides that (with limited 

exceptions) the CICP is to follow the 

SEPPA, the SVICP regulations 

implementing the SEPPA, and such 

additional or alternate regulations as the 

Secretary may promulgate for purposes 

of this section (section 319F–4(b)(4) of 

the PHS Act (42 U.S.C. 247d–6e(b)(4)). 

The Secretary is issuing this interim 

final rule under that authority. 

As authorized under the PREP Act, 

the Secretary is herein, at 42 CFR part 

110, establishing the procedures and 

requirements governing the CICP. As 

explained below, the Secretary is 

issuing this regulation as an interim 

final rule, to be effective on October 15, 

2010. However, the Secretary is seeking 

public comments on these procedures 

and requirements and may change 

provisions of this regulation upon 

review of the comments received. 

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63658 Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 

Summary of the Regulation 

Summary of Available Benefits (§ 110.2) 

The benefits available under this 

Program are medical benefits, benefits 

for lost employment income, and 

survivor death benefits. Medical 

benefits are described more fully in 

§ 110.31 and include payment or 

reimbursement for medical services and 

items that the Secretary determines are 

reasonable and necessary to diagnose or 

treat a covered injury and to diagnose, 

treat, or prevent its health 

complications. Benefits for lost 

employment income are described more 

fully in § 110.32 and cover lost 

employment income incurred as a result 

of a covered injury or its health 

complications. Death benefits are 

described in § 110.33 and provide 

payments to survivors if the Secretary 

determines that the death of the injured 

countermeasure recipient was the direct 

result of a covered injury. As described 

in § 110.33, death benefits are available 

under standard or alternative 

calculations depending upon the 

eligible survivors. 

As explained in § 110.2(b), the PREP 

Act, based upon provisions included in 

the SEPPA, establishes that the 

government generally is a secondary 

payer for benefits available under the 

Program. For example, death benefits 

paid under the alternative calculation in 

§ 110.82(c) are secondary to death and 

disability benefits under the Public 

Safety Officers’ Benefits (PSOB) 

Program (a program within the United 

States Department of Justice that 

provides payments to public safety 

officers and their survivors, including 

death benefits for officers killed in the 

line of duty). 

Benefits under the Program usually 

will only be paid after the requester has 

in good faith attempted to obtain all 

other available coverage from all thirdparty payers with an obligation to pay 

for or provide such benefits. Requesters 

generally must provide the names of all 

other third party payers that have 

already provided benefits, that are 

expected to do so in the future, or that 

may have a legal or contractual 

obligation to do so. These payers 

include, but are not limited to: 

insurance companies, workers’ 

compensation programs, the Federal 

Employees’ Compensation Act (FECA) 

Program, military treatment facilities 

(MTFs), the Department of Veterans 

Affairs, or the PSOB Program. If such a 

third-party payer has paid for or 

provided the type of benefits requested 

under this Program, the Secretary will 

only pay such benefits in an amount 

necessary to supplement the payments 

already provided so that the requester 

does not have unreimbursed out-ofpocket expenses. For example, if a 

requester determined to be eligible for 

medical benefits incurred $10,000 in 

reasonable and necessary medical 

expenses resulting from a covered injury 

and the requester’s health insurance 

company (a third-party payer) has paid 

$5,000 for the covered medical benefits 

and services, the Program would 

reimburse the requester $5,000 

(representing the amount the requester 

is entitled to under this Program, 

reduced by the amount paid or payable 

by third-party payers). As explained 

later, upon payment of benefits under 

the Program, the Secretary will be 

subrogated to the rights of the requester 

and may assert a claim against any 

third-party payer with a legal or 

contractual obligation to pay for, or 

provide, such benefits. 

Eligible Requesters (§ 110.10) 

There are three categories of eligible 

requesters under the Program: (1) 

Injured countermeasure recipients; (2) 

survivors of deceased injured 

countermeasure recipients who died as 

a direct result of the administration or 

use of a covered countermeasure; and 

(3) executors or administrators on behalf 

of the estates of deceased injured 

countermeasure recipients (regardless of 

their cause of death). 

Injured Countermeasure Recipients 

The first category of requesters, an 

‘‘injured countermeasure recipient’’ is 

defined in § 110.3(n) as an individual: 

(1) Who, with respect to 

administration or use of a covered 

countermeasure pursuant to a 

Secretarial declaration: 

(A) Meets the specifications of the 

pertinent declaration; or 

(B) Is administered or uses a covered 

countermeasure in a good faith belief 

that he or she meets the specifications 

of the pertinent declaration; and 

(2) Sustained a covered injury as 

defined in § 110.3(g). 

(3) If a covered countermeasure is 

administered to, or used by, a pregnant 

woman in accordance with paragraphs 

(1)(A) or (1)(B), any child from that 

pregnancy who survives birth is an 

injured countermeasure recipient if the 

child is born with, or later sustains, a 

covered injury (as defined in section 

110.3(g)) as the direct result of the 

covered countermeasure’s 

administration to, or use by, the mother 

during her pregnancy. 

Thus, the eligibility requirements for 

injured countermeasure recipients may 

vary based on the terms of the PREP Act 

declaration issued with respect to the 

particular covered countermeasure. For 

example, all of the declarations issued 

to date, which are subject to change, 

include specific limitations in Category 

I, entitled ‘‘Covered Countermeasures.’’ 

The amended PREP Act declaration for 

pandemic influenza vaccines specifies 

that the liability immunity afforded 

under the PREP Act ‘‘shall only be in 

effect with respect to: (1) Present or 

future Federal contracts, cooperative 

agreements, grants, interagency 

agreements, or memoranda of 

understanding for vaccines against 

pandemic influenza A viruses with 

pandemic potential used and 

administered in accordance with this 

Declaration, and (2) activities 

authorized in accordance with the 

public health and medical response of 

the Authority Having Jurisdiction to 

prescribe, administer, deliver, distribute 

or dispense the pandemic 

countermeasures following a declaration 

of an emergency, as defined in section 

IX below’’ (74 FR 51153 (Oct. 5, 2009)). 

This document defines an Authority 

Having Jurisdiction as ‘‘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 or authority.’’ Id. 

Thus, the immunity protections (and 

the benefits available under the CICP) 

are contingent upon either requirement 

(and not necessarily both) being 

satisfied. With respect to each requester 

who received a covered countermeasure 

identified in a declaration with such 

language, the Secretary will have to 

consider whether the administration or 

use of a covered countermeasure met 

either of the requirements set forth 

above or whether there was a good faith 

belief of such at the time of the 

administration or use in order to 

determine whether the person identified 

as an injured countermeasure recipient 

meets the requirements of § 110.3(n)(1). 

In the case of 2009 H1N1 vaccines, this 

inquiry will generally be simple, given 

that all such vaccines distributed in the 

United States were purchased under 

contract by the Federal Government 

(satisfying the first requirement quoted 

above). 

The amended PREP Act declaration 

for the influenza antivirals Tamiflu®

and Relenza® contains similar 

limitations to those described above in 

its section entitled ‘‘Covered 

Countermeasures.’’ Specifically, the 

amended PREP Act declaration provides 

that the liability immunity afforded 

under the PREP Act ‘‘shall only be in 

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Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 63659 

effect with respect to: (1) Present or 

future Federal contracts, cooperative 

agreements, grants, interagency 

agreements, or memoranda of 

understanding involving 

countermeasures that are used and 

administered in accordance with this 

declaration, and (2) 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 Countermeasure 

following a declaration of an emergency, 

as defined in section IX below’’ (73 FR 

61861 (Oct. 17, 2008), amended by 74 

FR 29213 (June 19, 2009)). The 

declaration, like other PREP Act 

declarations, goes on to define ‘‘the 

Authority Having Jurisdiction,’’ and the 

‘‘Declaration of Emergency.’’ Many 

administrations or uses of pandemic 

influenza antivirals in the current 2009 

H1N1 outbreak will certainly meet the 

first requirement (e.g., antivirals from 

the Strategic National Stockpile are 

under Federal contracts). A more 

complicated analysis may be required 

with respect to other administrations or 

uses to determine whether the alternate 

requirement (the Authority Having 

Jurisdiction requirement) was satisfied 

in particular circumstances. In order for 

the Authority Having Jurisdiction 

requirement to apply, the authorized 

activities must follow a declaration of 

emergency, as defined in the applicable 

declaration. With respect to the 

declaration for Tamiflu® and Relenza®, 

a ‘‘Declaration of Emergency’’ is defined 

as ‘‘[a] 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 pandemic 

countermeasures, with the exception of 

a Federal declaration in support of an 

emergency use authorization under 

section 564 of the FFDCA unless such 

declaration specifies otherwise’’ (73 FR 

at 61863, section IX (definitions)). The 

same declaration defines the ‘‘Authority 

Having Jurisdiction’’ as ‘‘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).’’ Id. Thus, the 

Authority Having Jurisdiction can vary 

depending upon the circumstances. The 

Secretary, in an amendment to the PREP 

Act declaration for the influenza 

antivirals Tamiflu® and Relenza® for 

pandemic use, shared her determination 

that the risk of the spread of 2009 H1N1 

viruses and resulting disease constitutes 

a public health emergency (74 FR 29213 

(June 19, 2009), amending 73 FR 61861 

(Oct. 17, 2008)). Prior to the issuance of 

the PREP Act Declaration, the Acting 

Secretary, pursuant to the authority 

vested in him under section 319 of the 

Public Health Service Act, 42 U.S.C. 

247d, issued a determination that a 

public health emergency existed 

nationwide involving H1N1 influenza 

that affected or has significant potential 

to affect national security. This 

determination was subsequently 

renewed by the current Secretary. Thus, 

with respect to covered 

countermeasures used in connection 

with the 2009 H1N1 virus, the Secretary 

has issued a declaration of emergency 

sufficient to invoke the ‘‘Authority 

Having Jurisdiction’’ requirement in 

declarations published to date. 

Although the Authority Having 

Jurisdiction requirement was 

intentionally worded broadly to account 

for the complexities of our national 

public health and emergency response 

systems (in which the Federal 

Government, States, localities, tribes, 

and the private sector play important 

roles), the Secretary wishes to provide 

some additional guidance to enable 

individuals who have been 

administered or used covered 

countermeasures to assess their 

potential eligibility for CICP benefits as 

injured countermeasure recipients. In 

the Secretary’s view, 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 

countermeasure will apply primarily in 

two contexts. Under the first scenario, 

authorized activities would include 

activities associated with the 

administration or use of covered 

countermeasures that were prescribed, 

administered, delivered, distributed, or 

dispensed by healthcare providers and 

others specifically authorized to do so 

under an agreement, memorandum of 

understanding, standard operating 

procedure, or other formal arrangement 

with an Authority Having Jurisdiction 

following the declaration of an 

emergency. In this way, the Authority 

Having Jurisdiction requirement would 

extend to individuals receiving medical 

care from private healthcare providers 

and institutions provided that the 

provider or institution is charged, 

through some sort of formal 

arrangement, by an Authority Having 

Jurisdiction with carrying out such 

activities as part of the public sector’s 

response. 

Under the second scenario, activities 

authorized in accordance with the 

public health and medical response of 

the Authority Having Jurisdiction would 

include covered countermeasures 

administered or used in accordance 

with the written recommendations of an 

Authority Having Jurisdiction following 

the declaration of an emergency. For 

example, if a local public health agency 

recommends that all persons with a 

certain high-risk condition who contract 

the 2009 H1N1 virus receive a particular 

course of treatment with an influenza 

antiviral identified in a PREP Act 

declaration following the declaration of 

emergency for the associated disease, 

then individuals who use such 

medications based on their doctors’ 

compliance with such recommendations 

would qualify as activities authorized 

by the Authority Having Jurisdiction. 

Likewise, the Centers for Disease 

Control and Prevention (CDC) issued 

interim recommendations for the use of 

influenza antivirals for pandemic 

purposes. See e.g., ‘‘Updated Interim 

Recommendations for the Use of 

Antiviral Medications in the Treatment 

and Prevention of Influenza for the 

2009–2010 Season’’ (available at http:// 

www.cdc.gov/H1N1flu/ 

recommendations.htm). If an individual 

used an influenza antiviral for 

pandemic purposes covered by a PREP 

Act declaration because his or her 

physician prescribed the covered 

countermeasure in accordance with the 

CDC’s recommendations, then such use 

would meet the Authority Having 

Jurisdiction requirement because the 

physician’s actions would constitute 

activities authorized by the Authority 

Having Jurisdiction (in this case, the 

CDC). Given the complexity of the 

health care delivery system and the 

numerous and diverse products already 

identified as covered countermeasures 

in PREP Act declarations, an analysis of 

whether particular specifications 

included in declarations will 

necessarily be declaration-specific and 

fact-specific. The Secretary notes that in 

certain cases, a patient being 

administered or using a covered 

countermeasure as a result of a 

healthcare provider’s independent 

medical judgment, and not because the 

patient necessarily falls within a 

targeted group identified in an 

Authority Having Jurisdiction’s 

recommendations, may qualify as an 

activity authorized by an Authority 

Having Jurisdiction because 

recommendations issued by such 

authorities often take into account the 

need for healthcare providers to use 

independent clinical judgment with 

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63660 Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 

respect to the use or administration of 

covered countermeasures with respect 

to each patient. The Secretary does not 

wish to interfere with such independent 

clinical judgments. 

Although this discussion of the 

Authority Having Jurisdiction 

requirement used in declarations to date 

is intended to assist potential requesters 

with the CICP, whether a particular 

recipient was administered or used a 

covered countermeasure in accordance 

with a particular PREP Act declaration 

will be dependent on the language 

included in the pertinent declaration, as 

well as the specific circumstances 

involved. 

Administrations and Uses in Pregnant 

Women 

Section 110.3(n)(3) addresses certain 

circumstances in which a pregnant 

woman is administered or uses a 

covered countermeasure. This provision 

applies to women when their 

administration or use of a covered 

countermeasure satisfies all of the terms 

of a PREP Act declaration (or if there 

was good faith belief of such). Thus, it 

applies to women who meet the 

definition of an injured countermeasure 

recipient under § 110.3(n) themselves, 

except that the pregnant women need 

not suffer a covered injury as required 

by § 110.3(n)(2). As provided for in 

§ 110.3(n)(3), a child can qualify as an 

injured countermeasure recipient if the 

child survives birth, and is born with, 

or later sustains, a covered injury as the 

direct result of the mother’s 

administration or use of a covered 

countermeasure during pregnancy. Such 

a child’s eligibility for compensation 

under the Program is dependent upon 

the mother being administered, or using, 

a covered countermeasure under the 

terms of a declaration (or based on a 

good faith belief of such) and upon the 

child sustaining a covered injury as a 

result (regardless of whether the mother 

sustained a covered injury). Absent such 

a clarification, and in light of the 

breadth of the PREP Act’s liability 

protections (see e.g., section 319F– 

3(a)(1)–(2)), such a child might be 

barred from pursuing litigation against a 

covered person (e.g., a vaccine 

manufacturer) for an allegedly related 

injury (absent willful misconduct) 

without being afforded compensation 

otherwise available under the CICP. 

This is not the Secretary’s intention. 

Eligibility of children for 

compensation under this Program does 

not depend upon whether the covered 

person (e.g., doctor administering the 

vaccine) or the mother knew that she 

was pregnant at the time the covered 

countermeasure was administered or 

used. 

Other Requesters 

The second category of requesters, 

survivors of a deceased injured 

countermeasure recipient, is defined in 

§ 110.3(bb) and described in § 110.11. 

Categories of eligible survivors and the 

priority of such survivors to receive 

benefits from the Program are discussed 

below in relation to § 110.33, which 

addresses death benefits (the only type 

of benefit survivors are eligible to 

receive). 

The third category of requesters 

encompasses the estates of deceased 

injured countermeasure recipients, 

through their executors or 

administrators. These are individuals 

who are authorized to act on behalf of 

the deceased injured countermeasure 

recipient’s estate under applicable State 

law. Estates of deceased injured 

countermeasure recipients are not 

eligible for death benefits, but they may 

be able to receive the medical and/or 

lost employment income benefits which 

the injured countermeasure recipient 

would have been paid by the Program 

prior to death, but had not received in 

full during his or her lifetime. 

Members of the Uniformed Services and 

Eligibility for Benefits Under the CICP 

Members of the Uniformed Services 

may be eligible for benefits under the 

CICP. The term Uniformed Services 

means the armed forces, the 

Commissioned Corps of the National 

Oceanic and Atmospheric 

Administration and the Commissioned 

Corps of the Public Health Service. Such 

individuals are subject to the same 

eligibility requirements as civilians. The 

fact that they are members of the 

military or a Uniformed Service does 

not preclude them from receiving 

benefits under the CICP if they are 

otherwise eligible. However, given that 

the CICP is the payer of last resort 

(including after any medical care, lost 

wages, or other benefits provided by the 

United States Government or other 

third-party payers), the amount of 

benefits available under the CICP may 

be minimal because of the benefits they 

are entitled to by virtue of their status 

as members of the Uniformed Services. 

Territorial Limitations 

Section 319F–4(b)(1) of the PHS Act 

provides that CICP benefits are only 

available to eligible individuals if their 

covered injury is caused by a covered 

countermeasure administered or used 

pursuant to a declaration issued by the 

Secretary under 42 U.S.C. 247d–6d(b) 

(or in a good faith belief of such). One 

of the provisions that the PREP Act 

directs the Secretary to establish in each 

declaration is the ‘‘geographic area or 

areas’’ in which liability immunity 

under the Act is in effect ‘‘with respect 

to the administration or use of the 

[covered] countermeasure’’ (section 

319F–3(b)(2)(D) of the PHS Act (42 

U.S.C. 247d–6d(b)(2)(D)). The Secretary 

has the discretion to specify in a 

declaration that liability immunity 

applies ‘‘without geographic limitation,’’ 

and also to determine ‘‘whether the 

declaration applies only to individuals 

physically present in such areas or also 

to individuals who have a connection to 

such areas, which connection is 

described in the declaration.’’ Id. 

Although each declaration is unique 

and all are subject to amendment 

through publication in the Federal 

Register, the PREP Act declarations 

published to date provide no geographic 

limitation and generally apply to any 

populations that use or are administered 

the countermeasures in accordance with 

the terms of the declarations. As long as 

other eligibility requirements are 

satisfied, CICP benefits may be paid 

without regard to United States 

citizenship. 

The Secretary’s intent is to provide 

clear guidance to potential requesters 

injured by the administration or use of 

a covered countermeasure. Therefore, 

she has determined that, solely for the 

purpose of administering the CICP, 

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. 

Individuals not in one of these 

categories may not be eligible for 

benefits under the Program. 

Survivors (§ 110.11) 

Section 110.11 describes the 

categories of eligible survivors in the 

event that the injured countermeasure 

recipient dies. Survivors may be eligible 

to receive death benefits under the 

Program if the Secretary determines that 

the otherwise eligible injured 

countermeasure recipient sustained a 

covered injury and died as a direct 

result of the injury. Thus, if the 

Secretary determines that the injured 

countermeasure recipient died of a 

cause unrelated to the covered injury, 

survivors are not eligible to receive 

death benefits (regardless of the 

seriousness of the covered injury). 

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With limited exceptions, the CICP 

follows the requirements of the PSOB 

Program with respect to the categories of 

eligible survivors (known in the PSOB 

Program as beneficiaries) and the order 

of priority for payments of death 

benefits. The order of priority for 

survivors to receive death benefits 

under the Program is subject to future 

changes made to the PSOB Program 

concerning eligible survivors and their 

priority to receive death benefits. 

Currently, the categories of eligible 

survivors under the PSOB Program are 

as follows: 

(1) Surviving spouses; 

(2) Surviving eligible children (as 

defined in § 110.3(e)). This definition is 

based on the definition of ‘‘child’’ within 

the PSOB. Currently, a surviving child 

is considered eligible under the PSOB 

Program if he or she is an individual 

who is a natural, illegitimate, adopted, 

or posthumous child, or stepchild, of 

the deceased person and, at the time of 

that individual’s death, is 18 years of 

age or younger (i.e., has not reached 

19th birthday), or between 19 and 22 

years of age and a full-time student, or 

is older than 18 years of age and 

incapable of self-support because of 

physical or mental disability. For 

clarity, § 110.3(e) defines a stepchild, 

based on the PSOB’s definition of a 

stepchild, and a posthumous child (a 

child born after the death of a parent). 

(3) Individuals designated by the 

deceased person as the beneficiaries 

under the deceased person’s most 

recently executed life insurance policy; 

or 

(4) Surviving parents (of deceased 

children or adults). 

Such survivors, as defined under the 

PSOB Program, are also eligible 

survivors under this Program. 

The PREP Act, following the SEPPA, 

included two additional categories of 

survivors under this Program who are 

not eligible survivors under the PSOB 

Program: 

(5) Legal guardians of deceased 

minors without surviving parents; and 

(6) Surviving dependents who are 

younger than the age of 18 (have not 

reached their 18th birthday). This 

category could include children who 

also meet the requirements of category 

2 above (surviving eligible children). 

However, it also includes persons who 

would not qualify as surviving eligible 

children (for example, a nephew who 

was supported by the deceased injured 

countermeasure recipient, but who was 

not adopted). Persons who satisfy both 

category 6 and category 2 (surviving 

eligible children) may be able to choose 

between death benefits under the 

standard calculation and death benefits 

under the alternative calculation. 

As discussed below, special criteria 

apply to the final category of eligible 

survivors. Under current practices, in 

the event that a deceased injured 

countermeasure recipient is survived by 

a spouse and eligible children, the 

spouse will receive 50 percent of the 

death benefit and the children will 

divide the remaining 50 percent equally. 

If there are no surviving eligible 

children, then the spouse receives the 

entire benefit; if there is no surviving 

spouse, then the children divide the 

benefit in equal shares. In the event that 

the deceased injured countermeasure 

recipient is not survived by a spouse or 

children, the individual designated by 

the deceased injured countermeasure 

recipient as the beneficiary under his or 

her most recently executed life 

insurance policy receives the death 

benefit. If there is no life insurance 

policy or no surviving designated 

beneficiary under such a policy, the 

parents, if living, divide the death 

benefit in equal shares. If none of these 

categories of survivors exists, the legal 

guardian of a deceased minor (who was 

an injured countermeasure recipient) 

with no living parent will receive the 

death benefit, if applicable. As 

explained in § 110.11(b)(5), surviving 

dependents younger than the age of 18 

(category 6 above) have the same 

priority as surviving eligible children 

(category 2 above). 

Only the legal guardians of persons 

qualifying both as surviving eligible 

children (category 2 above) and as 

dependents younger than the age of 18 

(category 6 above) can choose between 

a proportional death benefit under the 

standard and the alternative methods of 

payment for death benefits, described in 

detail in § 110.82. Survivors eligible 

under the PSOB Program’s categories of 

survivors (e.g., spouses, parents, certain 

insurance designees, and surviving 

eligible children) who do not qualify as 

dependent minors are only covered 

under the standard death benefit 

calculation. Dependents who are minors 

and who do not qualify under another 

category of eligible survivors (under the 

example given above, a nephew who 

was supported by the deceased injured 

countermeasure recipient, but never 

adopted) are only covered by the 

alternative method of payment. In the 

event that survivors are eligible for 

death benefits under the Program, 

Program staff will be able to assist 

families concerning the standard and 

alternative calculation of death benefits 

once a determination is made 

concerning eligibility. 

Serious Physical Injuries 

As set forth in § 110.20(b), and 

pursuant to section 319F–4(e)(3) of the 

PHS Act, only serious physical injuries 

or deaths are covered by the Program 

(42 U.S.C. 247d–6e(e)(3)). The definition 

of a serious physical injury included in 

the liability provisions of the PREP Act 

apply only to those provisions and to 

lawsuits pursuing claims of willful 

misconduct. Congress did not mandate 

that the same definition apply within 

the CICP. Under the definition 

pertaining to the liability provisions of 

the PREP Act, a serious physical injury 

is defined as an injury that (a) is life 

threatening; (b) results in permanent 

impairment of a body function or 

permanent damage to a body structure; 

or (c) necessitates medical or surgical 

intervention to preclude permanent 

impairment of a body function or 

permanent damage to a body structure 

(section 319F–3(i)(10) of the PHS Act 

(42 U.S.C. 247d–6d(i)(10)). Under the 

CICP, § 110.20 clarifies that physical 

biochemical alterations leading to 

physical changes and serious functional 

abnormalities at the cellular or tissue 

level in any bodily function may, in 

certain circumstances, be considered 

serious physical injuries. As a general 

matter, only injuries that warranted 

hospitalization (whether or not the 

person was actually hospitalized) or 

injuries that led to a significant loss of 

function or disability (whether or not 

hospitalization was warranted) will be 

considered serious physical injuries. 

Hereafter serious physical injuries will 

be referred to as serious injuries. This 

includes instances in which there may 

be no measurable anatomic or structural 

change in the affected tissue or organ, 

but there is an abnormal functional 

change. For example, many psychiatric 

conditions are caused by abnormal 

neurotransmitter levels in key portions 

of the central nervous system. Thus, it 

is possible that certain serious 

psychiatric conditions may qualify as 

serious physical injuries if the 

psychiatric conditions are a 

manifestation of a physical biochemical 

abnormality in neurotransmitter level or 

type caused by a covered 

countermeasure. One way of 

determining that an abnormal physical 

change in neurotransmitter level is 

causing the injury would be a clinical 

challenge that demonstrates a positive 

clinical response to a medication that is 

designed to restore the balance of 

appropriate neurotransmitters necessary 

for normal function in an injured 

countermeasure recipient. However, 

minor injuries do not meet this 

definition. For example, covered 

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injuries do not include common and 

expected skin reactions (such as 

localized swelling or warmth that is not 

of sufficient severity to warrant 

hospitalization and that does not lead to 

a significant loss of function or 

disability) or expected minor scarring at 

the vaccination site (as occurs 

commonly with smallpox vaccinations). 

Unlike under the VICP, the effects of 

an injury need not last for a certain 

period of time (or result in inpatient 

hospitalization or surgical intervention) 

for it to be considered a serious injury 

under the CICP. Therefore, some injured 

countermeasure recipients may be able 

to show that they sustained a serious 

injury which resolved within a 

relatively short time-frame (for example, 

a person who sustains a serious injury 

as the direct result of a covered 

countermeasure which is successfully 

treated after two weeks of 

hospitalization). 

The Secretary will consider the 

unique circumstances of each injury 

claimed and will make determinations 

on a case-by-case basis as to whether 

particular injuries can be considered 

serious injuries. 

Injuries Sustained as a Direct Result of 

a Disease, and Not of a Covered 

Countermeasure 

Section 110.20(e) makes clear that an 

injury sustained as the direct result of 

a disease (or health condition or threat 

to health) for which the Secretary 

recommended the administration or use 

of a covered countermeasure in a PREP 

Act declaration is not a covered injury. 

Thus, if an injury was caused by a 

disease, and not as a direct result of the 

administration or use of a covered 

countermeasure, it cannot qualify as a 

covered injury. If a covered 

countermeasure is ineffective in 

preventing or treating a disease and an 

individual suffers the disease, an injury 

resulting from the disease would not be 

a covered injury because the injury 

results from the disease and not from 

the administration or use of the covered 

countermeasure. Two examples may be 

illustrative. Under the first example, an 

individual receives the 2009 H1N1 

vaccine and then goes on to develop 

2009 H1N1 influenza because the 

person failed to develop an immune 

response to the vaccine. Currently, no 

vaccine achieves 100% efficacy in 

stimulating a protective immune 

response in the population. This is 

sometimes referred to as failure of 

vaccine efficacy. If a vaccine recipient 

suffers a serious complication as the 

result of contracting the circulating 2009 

H1N1 virus, and not as the result of the 

2009 H1N1 vaccine or another covered 

countermeasure, such injury will not 

qualify as a covered injury because it 

results from the disease itself and would 

have occurred even if the vaccine had 

not been administered. Under a second 

example, a person suffering from serious 

complications as a result of contracting 

the 2009 H1N1 virus is put on a 

ventilator that qualifies as a covered 

countermeasure under a PREP Act 

declaration. The ventilator malfunctions 

and the individual suffers a serious 

health injury as a result of the ventilator 

malfunction. Such an injury may qualify 

as a covered injury because it would 

result from the use of a covered 

countermeasure (a ventilator) and not 

directly from the underlying 2009 H1N1 

disease. In considering whether an 

injury results from the administration or 

use of a covered countermeasure, as 

opposed to the disease itself, the 

Secretary will evaluate whether the 

injury directly resulted from a 

component or a function of the covered 

countermeasure (in which case, the 

injury may qualify as a covered injury) 

as opposed to the disease itself (in 

which case, the injury cannot qualify as 

a covered injury even if a covered 

countermeasure was administered or 

used, but was ineffective). Some 

covered countermeasures may contain 

attenuated live organisms, such as 

intranasal 2009 H1N1 vaccine or 

smallpox vaccine. Despite attenuation, 

serious infections can rarely be caused 

by these types of countermeasures. A 

serious injury resulting from this type of 

infection (as a result of vaccination) in 

an injured countermeasure recipient 

could qualify as a covered injury 

because it would directly result from the 

administration or use of a covered 

countermeasure. 

With limited exceptions, the PREP 

Act provides that the CICP’s procedures 

for determining eligibility, whether 

eligible persons have sustained covered 

injuries, whether compensation may be 

available, and the amount of such 

compensation shall be the same as those 

authorized by the SEPPA and 

implemented in the SVICP. One of these 

exceptions pertains to individuals who 

were eligible to apply under the SVICP 

as a ‘‘contact case’’ based on accidental 

vaccinia inoculation. The PREP Act 

makes clear that individuals who 

contract a disease as a result of contact 

with a person who used or was 

administered a covered countermeasure 

(or other close contacts) may not pursue 

claims under the CICP for any resulting 

injuries (sections 319F–4(b)(4), (e)(2), 

and (e)(5) of the PHS Act (42 U.S.C. 

247d–6e(b)(4), (e)(2), and (e)(5)). Thus, 

although it is possible that in some 

circumstances, individuals may suffer 

injuries as a result of diseases 

contracted after exposure to individuals 

because of their use or administration of 

covered countermeasures (for example, 

a person who contracts vaccinia after 

close contact with another person who 

was administered a smallpox vaccine 

that qualifies as a covered 

countermeasure), such contacts cannot 

pursue benefits under the CICP for such 

injuries. Contracting a disease in such a 

manner is extremely rare and will 

generally only be possible with vaccines 

containing live viruses. 

How To Establish a Covered Injury 

(§ 110.20) 

Covered injuries are defined in 

§ 110.3(g) and are set out in Subpart C 

of this rule. Covered injuries are defined 

as serious injuries (or deaths) sustained 

by injured countermeasure recipients 

that the Secretary determines are either: 

(1) An injury meeting the requirements 

of a Countermeasure Injury Table 

(Table), discussed below; or (2) an 

injury that is, in fact, the direct result of 

the administration or use of a covered 

countermeasure. The latter requirement 

includes serious aggravations of preexisting conditions if such aggravations 

were caused by a covered 

countermeasure (e.g., a seizure disorder 

that is proven, to the satisfaction of the 

Secretary, to have been made 

significantly more serious as the direct 

result of the administration or use of the 

countermeasure). All requesters 

(including survivors and executors or 

administrators of the estate of a 

deceased countermeasure recipient) 

must demonstrate that an injured 

countermeasure recipient sustained a 

covered injury in order to be eligible for 

any benefits under the CICP. 

Table Injuries 

Section 110.20(c) discusses Table 

injuries. As noted above, one way that 

requesters can demonstrate that they 

sustained a covered injury is by 

demonstrating that they sustained an 

injury listed on a Countermeasure Injury 

Table (Table) within the time interval 

set forth on the Table, as set out in 

Subpart K (§ 110.100 et seq.) of this rule. 

In accordance with the PREP Act 

(following the SEPPA), an injured 

countermeasure recipient shall be 

presumed to have sustained a covered 

injury as the direct result of the 

administration of a covered 

countermeasure if the requester submits 

sufficient documentation demonstrating 

that the injured countermeasure 

recipient sustained an injury included 

on a Table, with the onset of the first 

sign or symptom within the time 

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interval specified on the Table. The 

injury must also meet the Table’s 

definitions and requirements, which 

will be described under Subpart K. In 

such circumstances, the Secretary will 

presume, solely for purposes of the 

Program, that the injured 

countermeasure recipient’s injury was 

caused by the covered countermeasure 

(absent another cause, as described 

below). Such a requester need not 

actually demonstrate that the covered 

countermeasure caused the underlying 

injury, only that an injury listed on the 

Table (and meeting the Table’s 

definition) was sustained and that it 

first manifested itself within the time 

interval listed. 

In directing the Secretary to establish 

a Table with such a presumption, 

Congress did not direct the Secretary to 

make this presumption conclusive. In 

the Secretary’s view, it would be 

inconsistent with the purposes of the 

PREP Act to do so. For this reason, 

based on her review of the submitted 

documentation and other relevant 

evidence, and consistent with the 

regulations implementing the SVICP, 

the Secretary may determine that an 

injury meeting the Table requirements 

was actually caused by other factors and 

was not caused by the covered 

countermeasure (e.g., if the Secretary 

determined that the medical records 

demonstrated that an individual’s injury 

of encephalopathy, a type of brain 

injury, was caused by a car accident that 

occurred after a covered countermeasure 

was used, and neither the 

encephalopathy nor the car accident 

was caused by the covered 

countermeasure itself). In these 

circumstances, which we expect to 

occur rarely, the Secretary could rebut 

a Table presumption of causation and 

decide that the requester not be afforded 

the presumption of a Table injury. 

The Secretary is authorized under the 

PREP Act to issue Table(s) for each 

covered countermeasure identified in a 

PREP Act declaration. According to the 

PREP Act, the Secretary may only 

identify such covered injuries, for 

purposes of inclusion on a Table, in 

circumstances where the Secretary 

determines, based on ‘‘compelling, 

reliable, valid, medical and scientific 

evidence that administration or use of 

the covered countermeasure directly 

caused such covered injury’’ (section 

319F–4(b)(5)(A) of the PHS Act (42 

U.S.C. 247d–6e(b)(5)(A)). The Secretary 

plans on reviewing the available 

scientific evidence concerning covered 

countermeasures identified in PREP Act 

declarations and to issue such Tables, 

when appropriate, through rulemaking. 

In an effort to administratively 

implement the Program as soon as 

possible, the Secretary is not including 

such Tables within this rulemaking, but 

should such Tables be issued in the 

future, she will do so as amendments to 

this rule. 

Non-Table Injuries 

Section 110.20(c) discusses non-Table 

injuries. Certain requesters who are 

unable to demonstrate a Table injury 

may still be able to show that they 

sustained a covered injury. Such 

requesters may include those who 

believe that an injury included on a 

Table was sustained, but who did not 

meet all the Table requirements (e.g., 

the onset of the injury did not occur 

within the required time interval 

included on the Table) or those whose 

injuries are not included on a Table. To 

establish a covered injury in such 

circumstances, the Secretary must 

determine that the injury sustained was 

the direct result of the administration or 

use of a covered countermeasure. Under 

the PREP Act, the Secretary may only 

make such determinations based on 

compelling, reliable, valid, medical and 

scientific evidence (section 319F–4(b)(4) 

of the PHS Act (42 U.S.C. 247d– 

6e(b)(4)). As described in § 110.20(d), 

requesters with such claims may need to 

submit sufficient relevant medical 

documentation or scientific evidence 

(such as studies published in peerreviewed medical literature). In 

evaluating such claims, the Secretary 

will take into consideration relevant 

medical and scientific evidence, 

including relevant medical records. As 

provided under the PREP Act, this 

determination is not reviewable by any 

court (section 319F–4(b)(5)(C) of the 

PHS Act (42 U.S.C. 247d–6e(b)(5)(C)). 

Temporal association between 

administration or use of the covered 

countermeasure and onset of the injury 

(i.e., the injury occurs a certain time 

after the administration or use) is not 

sufficient, by itself, to prove that an 

injury is the direct result of a covered 

countermeasure. 

Benefits Available to Different 

Categories of Requesters (§ 110.30) 

An eligible requester who is an 

injured countermeasure recipient may 

be eligible to receive medical benefits, 

benefits for lost employment income, or 

both, as long as he or she provides the 

appropriate documentation. For 

example, such requesters must submit 

documentation showing that they have 

incurred unreimbursable, reasonable, 

and necessary medical expenses as a 

result of a covered injury or its health 

complications to receive medical 

benefits, and documentation showing 

that they lost employment income as a 

result of a covered injury or its health 

complications for a specified period in 

order to receive benefits for lost 

employment income. Such 

documentation requirements are 

discussed later in this rule. 

An eligible requester who is a 

survivor of an otherwise eligible 

deceased injured countermeasure 

recipient can only receive a death 

benefit as a survivor, and no other 

benefits. Such death benefits are only 

available if the survivors demonstrate to 

the satisfaction of the Secretary that the 

death was caused by the covered injury 

or its health complications. 

The estate of an otherwise eligible 

deceased injured countermeasure 

recipient may be eligible to receive 

medical benefits, benefits for lost 

employment income, or both if such 

benefits were accrued, but were not paid 

in full, during the deceased person’s 

lifetime. Such benefits may be available 

regardless of the cause of death. 

However, the estate would not be 

eligible to receive payments for benefits 

that were not accrued during the 

deceased person’s lifetime. For example, 

the estate would not be entitled to 

benefits for projected lost employment 

income that the injured countermeasure 

recipient might have earned if he or she 

had not died. In addition, the estate 

would not be eligible for death benefits, 

as those benefits are only available to 

survivors. 

Medical Benefits—Summary and 

Calculation (§ 110.31 and § 110.80) 

Medical benefits that may be available 

under the Program are described in 

§ 110.31. Under the PREP Act, the 

medical benefits that shall be provided 

have the same elements and shall be in 

the same amount as those prescribed by 

section 264 of the PHS Act (the relevant 

provision of the SEPPA) (42 U.S.C. 

239c). They include payment(s) or 

reimbursement for medical services and 

medical items that the Secretary 

determines are reasonable and necessary 

for the diagnosis or treatment of a 

covered injury, or for the diagnosis, 

treatment, or prevention of the injury’s 

direct health complications. Past, 

current, and expected future medical 

services and items may be included in 

medical benefits. The Secretary is 

authorized to pay for medical services 

or items in an effort to cure, counteract, 

or minimize the effects of any covered 

injury (or its health complications), or to 

give relief, reduce the degree or the 

period of disability, or aid in lessening 

the amount of benefits to an injured 

countermeasure recipient. As an 

example, the CICP may purchase a 

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health insurance policy for an injured 

countermeasure recipient, which would 

have the benefit of providing care to the 

injured countermeasure recipient over 

the course of years or a lifetime and the 

attendant benefit of being an efficient 

use of Federally-appropriated funds (as 

compared with direct payments for the 

services and items covered by the 

purchased health insurance policy). 

In making determinations about 

which medical services and items 

provided in the past were reasonable 

and necessary, the Secretary may 

consider whether those medical services 

and items were prescribed or 

recommended by a healthcare provider. 

In considering benefits for future 

medical services and items, the 

Secretary may consider statements by 

healthcare providers with expertise in 

the medical issues involved (for 

example, a statement by a treating 

neurologist concerning services and 

items likely to be needed to address 

neurological issues) concerning those 

services and items that appear likely to 

be needed in the future to diagnose or 

treat the covered injury or its health 

complications. However, the Secretary 

is not bound by such statements. In 

addition, the Secretary may consider 

whether the services and items are 

within the standard of care for the 

injured countermeasure recipient’s 

medical condition. 

As set forth in § 110.31(b), for a 

requester to receive medical benefits for 

a health complication of a covered 

injury, the health complication must 

have resulted from the covered injury or 

its treatment and must not be more 

likely due to other factors or conditions. 

Examples of health complications 

include ill effects that stem from the 

covered injury, an adverse reaction to a 

prescribed medication or as a result of 

a diagnostic test used in connection 

with a covered injury, or a complication 

of a surgical procedure used to treat the 

covered injury. 

As explained in § 110.31(d), if an 

injured countermeasure recipient dies 

before filing with, or being fully paid by, 

the Program, the deceased person’s 

estate may be eligible for benefits for the 

cost of medical services and/or items 

accrued during his or her lifetime as a 

result of the covered injury or its health 

complications provided such payments 

and expenses were not paid in full by 

a third party during the deceased 

injured countermeasure recipient’s 

lifetime. Because such payments are for 

medical expenses accrued as a result of 

a covered injury while the injured 

countermeasure recipient was alive, the 

cause of death does not have to be 

related to the covered injury for these 

medical benefits to be paid to the estate. 

The calculation of medical benefits is 

described in § 110.80. There are no caps 

on medical benefits. However, the 

Secretary may limit the payment of such 

benefits to the amounts (costs) she 

considers reasonable for those services 

and items that she considers reasonable 

and necessary. In addition, payment of 

medical benefits or reimbursement of 

costs for medical services and items by 

the Program is secondary to the 

obligations of any third-party payer, 

such as the United States (except for 

payment of benefits under this 

Program), State or local government 

entities, private insurance carriers, 

employers, or any other third-party 

payers that may have an obligation to 

pay for or provide medical benefits. 

Because the Program is a secondary 

payer, requesters are required to make 

good faith efforts to pursue medical 

benefits from their primary payers. For 

example, the Program will generally not 

pay for medical benefits that are paid or 

payable by the injured countermeasure 

recipient’s medical insurance. As 

explained in § 110.31(c), requesters are 

expected to make good faith efforts to 

pursue medical benefits and services 

from their primary payers. Further, 

§ 110.2(b) explains that the benefits 

available under the CICP usually will 

only be paid after the requester has in 

good faith attempted to obtain all other 

available coverage from third-party 

payers with an obligation to pay for or 

provide such benefits. Thus, the 

Secretary has the discretion not to pay 

medical benefits if a requester has not 

made such good faith attempts. 

When the Secretary has determined 

that the requester is eligible for medical 

benefits and the documentation needed 

to compute the amount is available, she 

will do the following, consistent with 

the calculations described in § 110.80: 

(1) Determine which medical 

expenses that have been submitted are 

reasonable and necessary to diagnose or 

treat a covered injury or to diagnose, 

treat, or prevent its health 

complications. 

(2) Compute all those reasonable 

medical expenses, including medical 

services and items provided in the past, 

and anticipated future medical 

expenses. 

(3) Deduct from the computation the 

total amount paid, or payable, by all 

other third-party payers. 

This will be the basis for the 

Program’s payment. For example: an 

eligible injured countermeasure 

recipient incurred $5,000 in reasonable 

and necessary medical expenses. If the 

individual’s insurance company paid 

$3,000, and the individual is 

responsible for the $2,000 balance (due 

to deductibles and co-payments), then 

the Secretary will pay a medical benefit 

of $2,000. 

As explained elsewhere in this 

preamble, the Secretary may make a 

payment of medical benefits and later 

pursue such a payment from a thirdparty payer with an obligation to pay for 

or provide the medical services or items. 

Lost Employment Income—Summary 

and Calculation (§ 110.32 and § 110.81) 

Lost employment income benefits that 

may be available under the Program 

appear in § 110.32. Under the PREP Act, 

compensation for lost employment 

income under this Program shall have 

the same elements and shall be in the 

same amount as prescribed by section 

265 of the PHS Act (the relevant 

provision of the SEPPA) (42 U.S.C. 

239d). The CICP will provide benefits 

for lost employment income (secondary 

to other benefits that may be available 

to the requester), subject to limitations 

described in § 110.81(c), based on the 

number of days of work that the injured 

person lost as a result of the covered 

injury or its health complications 

(including diagnosis and treatment), and 

supported by the degree of disability or 

injury, medical and employment 

records. 

These benefits are a percentage of the 

employment income lost at the time of 

injury, due to the covered injury or its 

health complications, and are based on 

the number of eligible work days for 

which such income was lost. 

Employment income means the injured 

person’s gross employment income at 

the time of injury. Lost work days do 

not have to be consecutive, and partial 

days of lost work are included in the 

calculation. For example, if an 

individual’s work day is eight hours and 

he or she missed four hours a day for 

doctors’ appointments on two different 

days, the eight hours of work missed 

may be considered one total day of lost 

wages. As described in § 110.32(c), a 

day in which an individual used paid 

leave (e.g., sick leave or vacation leave) 

in order to be paid for lost work will not 

be considered a day for which 

employment income was lost and will 

not be used in calculating benefits for 

lost employment income. The only 

exception to this rule is in a case where 

the injured person reimburses the 

employer for the wages paid and the 

employer restores the paid leave taken 

so it is available for future use, thus 

putting the injured countermeasure 

recipient back in the same position as if 

he or she had not used paid leave on the 

lost work day. The Secretary has the 

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discretion to consider the 

reasonableness of the number of work 

days (or partial work days) lost as a 

result of a covered injury or its health 

complications in this calculation, as 

well as the severity of the covered injury 

as demonstrated by the medical records, 

and to consider alternative work 

schedules in determining the number of 

work days lost. 

Under the PREP Act, following the 

SEPPA, the Program cannot pay for the 

first five days of lost employment 

income resulting from a covered injury 

or its health complications, unless the 

injured countermeasure recipient lost 

employment income for ten or more 

work days (in which case, all of the lost 

work days will be included in the 

calculation). For this reason, if an 

individual lost a total of four days (or 

fewer) of employment income as a result 

of a covered injury, he or she will not 

be eligible for any benefits for lost 

employment income. An injured 

countermeasure recipient will be 

compensated for ten or more days of 

work lost if he or she lost employment 

income for those days as a result of the 

covered injury (or its health 

complications). If the number of days of 

lost employment income due to the 

covered injury (or its health 

complications) is fewer than ten, the 

Secretary will reduce the number of lost 

work days by five days. 

The calculation of benefits for lost 

employment income is described in 

§ 110.81. The annual cap on benefits for 

lost employment income is $50,000. A 

requester may use documents such as 

pay slips, earning and leave statements, 

and other documents concerning the 

injured individual’s salary, to document 

his or her employment income. 

Pursuant to the PREP Act (incorporating 

the SEPPA), the lost employment 

income benefit terminates once the 

injured countermeasure recipient 

reaches the age of 65. Benefits that 

represent future lost employment 

income will be adjusted to account for 

inflation. It is important to note that 

future lost employment income will be 

calculated based on an individual’s 

gross employment income at the time 

the covered injury was sustained 

(except for the inflation adjustment 

provided for in this regulation) and will 

not be based on an individual’s 

anticipated future employment income. 

The lifetime cap for the lost 

employment income benefit is equal to 

the amount of the death benefit 

available under the PSOB Program in 

the same fiscal year in which the 

lifetime cap is reached (currently 

$311,810, but subject to change each 

fiscal year). However, this lifetime 

limitation does not apply if the 

Secretary determines that an individual 

has a covered injury considered to be a 

total and permanent disability under 

section 216(i) of the Social Security Act. 

For this reason, an injured 

countermeasure recipient determined by 

the Secretary to have a permanent and 

total disability may be eligible to receive 

up to $50,000 a year until he or she 

reaches the age of 65, without regard to 

the lifetime cap. 

As is the case for medical benefits, if 

an injured countermeasure recipient 

dies before filing for, or being fully paid, 

benefits for lost employment income 

incurred during his or her lifetime as a 

result of a covered injury or its health 

complications, the executor or 

administrator of that person’s estate may 

file for such benefits on behalf of the 

estate. Because this payment is made for 

loss of employment income that accrued 

while the injured person was alive, the 

death does not have to be related to the 

covered injury for these benefits to be 

paid. However, no such lost 

employment income may be paid after 

the receipt, by the survivor or survivors 

of a deceased injured countermeasure 

recipient, of death benefits under 

§ 110.82. 

Once the Secretary has determined 

that she has all the information 

necessary to compute lost employment 

income, the calculation will be made as 

follows, as set out in § 110.81: 

(1) The Secretary will make a 

calculation concerning the number of 

lost work days that are reasonable based 

on the degree of injury or disability. 

(A) If the injured countermeasure 

recipient lost five days or fewer of 

employment income, then no benefits 

for lost employment income will be 

paid. 

(B) If the injured countermeasure 

recipient lost six to nine days of 

employment income, then the Secretary 

will subtract five days from the number 

of lost work days for which lost 

employment income can be paid. 

(C) If the injured countermeasure 

recipient lost ten or more days of 

employment income, then every lost 

work day will be counted in calculating 

the lost employment income benefit. 

(2) The Secretary will multiply the 

injured countermeasure recipient’s daily 

gross employment income (including 

income from self-employment) at the 

time of the covered injury by the 

number of lost work days (as computed 

above). This figure will be adjusted to 

account for inflation, as appropriate. 

(3) The Secretary will compute 75 

percent of the lost employment income 

if the injured countermeasure recipient 

had one or more dependents (at the time 

of the covered injury) or 662⁄3 percent of 

the lost employment income if there 

were no dependents (at the time of the 

covered injury). This calculation will 

serve as the basis for the lost 

employment income benefit. 

(4) The amount of payment will be 

reduced by any benefit that the 

requester is entitled to receive from a 

third-party payer (e.g., a workers’ 

compensation program). However, the 

Secretary may make a payment of lost 

employment income and later pursue 

such a payment from a third-party payer 

with an obligation to pay for or provide 

the benefit (e.g., the Secretary can pay 

a benefit for lost employment income to 

a requester with a claim pending in a 

State workers’ compensation program, 

and then has a right to recover such a 

payment from the employee or the State 

if its program determines that such a 

benefit is due the requester). 

(5) The payments made will be 

subject to an annual cap of $50,000. 

(6) The benefits paid in lost 

employment income will be subject to a 

lifetime cap, as discussed above, unless 

the Secretary determines that a 

requester has a covered injury 

considered to be a total and permanent 

disability under section 216(i) of the 

Social Security Act. 

Death Benefits—Summary and 

Calculation (§ 110.11, § 110.33, and 

§ 110.82) 

Certain survivors of injured 

countermeasure recipients who died as 

a direct result of a covered injury or its 

health complications may be eligible for 

death benefits, as set out in § 110.11 

(eligible survivors and their priority to 

receive death benefits), § 110.33 (general 

description of death benefits) and 

§ 110.82 (calculation of death benefits). 

Under the PREP Act, compensation 

for death benefits has the same elements 

and shall be in the same amount as 

prescribed by section 266 of the PHS 

Act (the relevant section of the SEPPA) 

(42 U.S.C. 239e). Thus, in accordance 

with the PREP Act (incorporating 

SEPPA), death benefits under the CICP 

may be available under one of two 

different calculations: the ‘‘standard 

calculation’’ or the ‘‘alternative 

calculation.’’ The ‘‘standard calculation’’ 

is a lump-sum payment to eligible 

survivors and is described in 

§ 110.82(b). In general, this method is 

based on the death benefit available 

under the PSOB Program. The 

‘‘alternative calculation’’ is only 

available to surviving dependents who 

are younger than the age of 18, as 

described in § 110.82(c). This method is 

based upon the deceased person’s 

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employment income at the time of the 

covered injury. 

Filing a Request Package (§ 110.40– 

§ 102.41) 

A Countermeasures Injury 

Compensation Program Request for 

Benefits Form (hereinafter ‘‘Request 

Form’’) will be available from the 

Program. In order for a requester to have 

his or her Request for Benefits reviewed 

by the Program, the requester must 

submit, at a minimum, a completed 

Request Form (or a Letter of Intent to 

file a Request Form, described below) 

postmarked within the filing deadlines 

established by this regulation. If 

requesters choose to use a commercial 

carrier such as Federal Express, United 

Parcel Service, Emery, etc., or a private 

delivery service, in the absence of a 

postmark, the date that the Request 

Form or Request Package is marked as 

received by the delivery service will be 

considered the equivalent of a postmark. 

Requesters must send their Request 

Forms and all supporting 

documentation (the Request Package) to 

the address listed in § 110.41. To avoid 

any delays in implementing the 

Program, the Program will not accept 

Request Forms or Request Packages 

electronically at this time. However, the 

Program will publish a notice in the 

future if electronic filing becomes 

available. Once the Program assigns a 

case number to a requester, all related 

correspondence should reference the 

assigned case number. 

Filing Deadlines (§ 110.42) 

Under the PREP Act, the filing 

deadlines that applied under SEPPA are 

mandatory with respect to Request 

Forms filed with this Program. For that 

reason, injured countermeasure 

recipients have one year from the date 

of the administration or use of a covered 

countermeasure to submit a Request 

Form (or Letter of Intent to file a 

Request Form, as described in 

§ 110.42(b)). For covered 

countermeasures used or administered 

over a period of time (for example, 

antibiotics taken daily for seven days), 

the filing deadline is one year from the 

latest administration or use associated 

with the covered injury. For vaccines 

administered in more than one dose on 

different dates (for example, 2009 H1N1 

vaccines given in two doses one month 

apart), the filing deadline is one year 

from the date of the vaccine 

administration associated with the 

injury. Because the PREP Act, 

incorporating SEPPA, refers to requests 

based on the administration or use of 

the countermeasure, the filing deadline 

that applies to Request Forms filed by 

injured countermeasure recipients is the 

same filing deadline that applies to 

Request Forms filed by the survivors or 

the representatives of the estates of 

deceased injured countermeasure 

recipients. This one-year filing deadline 

is absolute, regardless of when the first 

symptoms of the injury occur or when 

individuals suspect that the injury may 

have been caused by a covered 

countermeasure. Likewise, the one-year 

filing deadline applies to injuries 

sustained by a child described in 

section 110.3(n)(3) (a child under 

certain circumstances whose covered 

injuries were the direct result of a 

covered countermeasure’s 

administration to, or use by, the mother 

of the child when she was pregnant 

with that child). The filing deadline for 

a Request for Benefits to compensate a 

child qualifying as an injured 

countermeasure recipient under section 

110.3(n)(3) is one year from the date of 

administration or use of the covered 

countermeasure during the mother’s 

pregnancy. Pursuant to statute, the date 

of the child’s birth, the date the injury 

is discovered, or the date the injury is 

diagnosed is not the basis of 

determining the filing deadline. 

This one-year filing deadline does not 

apply to amendments to previously 

filed Request Forms. As explained later 

in the discussion of § 110.46, if an 

injured countermeasure recipient filed a 

Request Form within the filing deadline 

and later dies, his or her survivor(s) (or 

the representative of his or her estate) 

may later amend the original Request 

Package outside of the filing deadline 

(because the original Request Form was 

timely filed). 

As described in § 110.42(b), requesters 

may meet the Program’s filing deadline 

by filing a Letter of Intent to file a 

Request Form within the governing 

filing deadline. This mechanism is 

available to ensure that persons with 

potential claims will have a means of 

meeting the Program’s filing deadline 

even if all of the pertinent documents 

(e.g., administrative regulation, Request 

Forms and Instructions) are not yet 

available. The Program previously 

notified the public of the ability to file 

Letters of Intent even before the 

Program’s regulations are published and 

the Program’s forms and instructions are 

available. The Program has made this 

information available on HRSA’s Web 

site. Thus, if a requester files a Letter of 

Intent to file within one year of 

administration or use of the covered 

countermeasure that is thought to have 

caused the injury, then the requester has 

met the filing deadline. The Program 

has already received several such 

letters. All requesters who file a Letter 

of Intent should file a Request Form as 

soon as possible after the Request Form 

becomes available. 

As set forth in § 110.42(d), Request 

Forms (or Letters of Intent) not filed 

within the governing filing deadline 

will not be processed, and the requester 

will not be eligible for any Program 

benefits. 

Section 110.42(e) also provides for 

‘‘constructive receipt’’ of Request Forms, 

at the Secretary’s discretion. When a 

requester files a legal action with the 

Federal Government (e.g., a claim filed 

pursuant to the Federal Tort Claims Act 

(FTCA) or a petition for compensation 

with the VICP) that concerns an alleged 

injury resulting from the administration 

or use of a covered countermeasure, 

then the Secretary may consider the 

filing of such a legal action (whether an 

administrative action or a lawsuit) to be 

‘‘constructive receipt’’ of a Request Form 

or Letter of Intent filed under the CICP, 

for the purposes of determining the 

filing date. Given the one-year statute of 

limitations for this Program and the fact 

that not all potentially eligible persons 

may be aware of the Program, the 

Department may offer such constructive 

receipt in appropriate circumstances to 

ensure that claims or lawsuits filed 

concerning injuries or deaths allegedly 

resulting from CICP covered 

countermeasures will be considered by 

the CICP. Thus, if an individual files a 

VICP claim concerning an injury 

allegedly sustained as the result of a 

covered countermeasure and such legal 

action is filed in the United States Court 

of Federal Claims within one year of its 

administration or use, the Secretary has 

the discretion to decide that the claim 

was ‘‘constructively received’’ by the 

Government on the date that such action 

is filed in court. Despite the Secretary’s 

ability to consider certain submissions 

as timely filings for the Program relying 

on such ‘‘constructive receipt,’’ there is 

no guarantee that the Secretary will 

follow this approach in particular cases, 

and potential requesters must file 

Request Forms (or Letters of Intent) 

within the appropriate Program filing 

deadline in order to be assured of timely 

filing with the Program. 

Section 110.42(f) describes an 

additional filing deadline available to 

certain requesters with respect to 

injuries added to Covered 

Countermeasures Injury Tables. 

Through this regulation, the Secretary is 

reserving Subpart K of this part for 

Covered Countermeasures Injury Tables, 

described above. In order to publish this 

regulation as soon as possible, the 

Secretary will publish such Tables 

separately. However, because those 

Tables will later be included in this 

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regulation and this part, any initial 

publications of such Tables or 

subsequent modifications to such Tables 

will be considered amendments to this 

regulation. As described in § 110.42(e), 

in the event that the Secretary issues a 

new Covered Countermeasure Injury 

Table, or amends a previously 

published Table, requesters will have an 

extended filing deadline based on the 

effective date of the Table amendment. 

However, this extended filing deadline 

will only apply to requesters if the Table 

amendment enables a person who could 

not establish a Table injury before the 

amendment to establish such an injury. 

As a hypothetical example, if the 

Secretary amends this regulation in the 

future by adding a Table for the 2009 

H1N1 vaccine and the Secretary 

includes an associated injury of 

anaphylaxis, any person who meets the 

Table requirements for an injury of 

anaphylaxis after receiving the 2009 

H1N1 vaccine (i.e., suffered the injury of 

anaphylaxis according to any 

definitions included on the Table, and 

suffered the onset of the injury within 

the time frame listed on the Table after 

the vaccine administration) would have 

one year from the effective date of the 

Table change adding the injury of 

anaphylaxis to file a Request Form. 

Such an individual will be afforded this 

alternative filing deadline because this 

Table change would enable this 

potential requester to establish a Table 

injury. For such persons, this alternative 

filing deadline applies regardless of 

whether the requesters previously filed 

a Request Form with the Program. The 

filing deadline provided under 

§ 110.42(f) is an additional and 

alternative filing period to the one 

afforded to all potential requesters 

under § 110.42(a). Therefore, persons 

who would be eligible to use the filing 

deadline described in § 110.42(f) could 

rely on the deadline provided under 

§ 110.42(a) or § 110.42(f). Depending on 

the factual circumstances, it is possible 

that one or the other deadline could 

provide a potential requester with a 

longer period in which to file a Request 

Form. This additional filing deadline is 

authorized by the PREP Act’s 

incorporation of SEPPA’s filing 

deadlines for Table amendments. We 

expect that the filing deadline described 

in § 110.42(f) may make benefits 

available to individuals who would 

otherwise be time-barred with respect to 

injuries for which new scientific 

evidence becomes available linking a 

particular covered countermeasure with 

a particular injury. 

It is important to note that the 

additional filing deadline described in 

§ 110.42(f) is only available to persons 

who are provided with the presumption 

of causation of a Table injury by virtue 

of changes made to a Table. Persons 

who sustained other injuries or who do 

not meet all of the requirements for such 

a Table injury (for example, the 

definition included on the Table, and 

the time-frame for onset included on the 

Table) will not be afforded an additional 

one year filing deadline based on the 

effective date of the Table change. 

Because the Table change would not 

enable such individuals to establish a 

Table injury, they would be subject to 

the standard filing deadline described in 

§ 110.42(a). 

Deadlines for Submitting 

Documentation (§ 110.43) 

As described above, a requester will 

meet the filing deadline requirement by 

submitting a completed and signed 

Request Form (or Letter of Intent) within 

the filing deadline set forth in § 110.42, 

with documentation to follow at a later 

date. Although the Secretary will accept 

documentation required to make 

eligibility determinations (i.e., 

documentation described in § 110.50 

and §§ 110.51, 110.52, and 110.53 

depending upon the nature of the 

Request) at the time the Request Form 

is filed, requesters need not submit such 

documentation at that time. Submitting 

eligibility documentation as soon as 

possible will enable the Secretary to 

make a prompt eligibility determination. 

The documentation necessary to make 

benefits determinations (i.e., 

documentation described in §§ 110.60, 

110.61, 110.62, and 110.63, depending 

on the type of benefits sought) need not 

be filed until a requester has been 

notified by the Secretary that the 

requester is eligible for Program 

benefits. However, the Secretary will 

accept such documentation if submitted 

at an earlier date. 

After filing a Request Form (or Letter 

of Intent) within the filing deadline, a 

requester must update the Request 

Package to reflect new information as it 

becomes available. For example, 

requesters have an obligation to arrange 

with their healthcare providers to 

submit copies of medical records as they 

are generated. 

Legal or Personal Representatives of 

Requesters (§ 110.44) 

Requesters do not need to retain the 

services of lawyers to pursue benefits 

under this Program. However, as 

provided in § 110.44(a), requesters may 

have a legal or personal representative 

(e.g., lawyer, guardian, family member, 

or friend) submit the Request Form (or 

Letter of Intent) and/or Request Package 

on their behalf. In certain 

circumstances, described below, 

requesters may be required to have a 

legal or personal representative file on 

their behalf. All representatives filing on 

behalf of requesters will be bound by 

the obligations and documentation 

requirements that apply to the requester. 

For example, if this regulation requires 

a requester to submit his or her medical 

records, the requester’s representative 

would be required to submit those 

records on behalf of the requester. If a 

requester has a legal or personal 

representative, the Program will 

generally direct all communications to 

the representative unless the Program is 

advised that the representation has 

stopped. However, as described in 

§ 110.40(a), the Secretary reserves the 

right to contact the requester directly if 

necessary (e.g., in circumstances in 

which the Secretary is unable to contact 

the representative). The Secretary also 

reserves the right to contact requesters 

at a later date to conduct a follow-up 

survey to help determine improvements 

in the ability of the Program to meet the 

needs of requesters. 

As described in § 110.44(b), a legally 

competent requester may use a 

representative to submit a Request 

Package on his or her behalf. In such 

circumstances, the requester must 

indicate on the Request Form that he or 

she has authorized the representative to 

submit the Request Package on his or 

her behalf. 

Requesters who are minors or adults 

who do not have legal capacity to 

receive payments (i.e., adults 

determined to be legally incompetent by 

a court having jurisdiction) are required 

to have the assistance of a representative 

(who does not need to be a lawyer). 

Representatives of requesters who are 

minors (excepting emancipated minors), 

or adults determined by a court not to 

have legal capacity to receive payments, 

are required to submit specific 

documentation, in addition to the 

documentation generally required of 

requesters, which is described in 

§ 100.63. 

As explained above, although legal 

representation is permitted, it is not 

needed for filing for Program benefits. 

As described in § 110.44(d), the Program 

will not be responsible for the payment 

or reimbursement of any fees for the 

services of legal or personal 

representatives or for any associated 

costs. The authorizing statute does not 

permit the Program to pay any 

attorney’s fees or related costs. 

Multiple Survivors (§ 110.45) 

If there are multiple survivors, then 

each survivor may submit Request 

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Forms separately or the group of 

survivors may submit one Request Form 

together. Multiple survivors are not 

required to file separate supporting 

documentation; rather, they may submit 

one complete set of supporting 

documentation on behalf of all 

survivors. 

Amendments to Request Packages 

(§ 110.46) 

The filing of amendments to 

previously filed Request Packages is 

discussed in § 110.46. As explained in 

§ 110.46(a), all requesters may amend 

their documentation concerning 

eligibility until the Secretary makes an 

eligibility determination. After that 

time, the Secretary will not accept 

additional documentation concerning 

eligibility (except amendments filed by 

survivors or the estates of deceased 

countermeasure recipients, discussed 

below). 

After the Secretary makes a benefits 

determination (e.g., determines that no 

benefits may be awarded because all 

eligible benefits have been paid by other 

third party payers, or determines that a 

requester is entitled to benefits and sets 

the amount of the award), the 

determination is final and the Secretary 

will not accept new benefits 

documentation regarding that covered 

injury (except amendments filed by 

survivors or the estates of deceased 

countermeasure recipients, discussed 

below). The Secretary believes that 

benefits determinations must have 

finality. The Secretary will do her best 

to assess the appropriate level of 

benefits based on the information before 

her at the time of the benefits 

determination. In certain circumstances, 

such determinations may be based on 

the Secretary’s assessment of the likely 

future needs of a requester. For 

example, a medical benefits award will 

be based, in part, on the Secretary’s best 

judgment as to the anticipated future 

course of an injured countermeasure 

recipient’s illness. Because reopening 

such benefits decisions would create an 

unreasonable administrative burden and 

would prevent finality, the Secretary 

will not consider new evidence 

concerning the appropriate level or type 

of benefits after the benefits 

determination has been made. If another 

approach were pursued, the Secretary 

could be in the position of revisiting 

benefits every time a requester’s medical 

condition or insurance coverage altered, 

even slightly. The Program is not in a 

position to constantly re-evaluate such 

determinations. 

Although new documentation cannot 

be submitted after a determination has 

been made, applicants have a right to 

seek reconsideration of an unfavorable 

eligibility or benefits decision (Section 

110.90). 

Section 110.46(b) addresses 

amendments filed by requesters who are 

survivors. If an injured countermeasure 

recipient filed a Request Package, but 

later dies, his or her survivors may 

amend the Request Package by filing a 

new Request Form. A survivor filing 

such an amended request will only be 

entitled to benefits under the Program if 

the original Request Form (filed by or on 

behalf of the injured countermeasure 

recipient, his or her estate, or other 

survivors) was filed within the 

applicable one year filing deadline. If 

such an amendment is filed, all of the 

documentation submitted with the 

original Request Package will be 

considered part of the amended Request 

Package and the survivor need not 

resubmit such documentation. If the 

injured countermeasure recipient (or his 

or her estate) never filed a Request 

Package, a Request Form filed by a 

survivor would be considered the 

beginning of a new Request Package and 

not an amendment to a previously filed 

Request Package. As set forth in 

§ 110.46(b), survivors must file an 

amendment to a Request Package if 

there is a change in the eligible 

survivors (for example, the spouse of an 

injured countermeasure recipient dies). 

Section 110.46(c) addresses 

amendments filed by the executor or 

administrator of the estate of a deceased 

injured countermeasure recipient. If an 

injured countermeasure recipient filed a 

Request Package, but later dies before all 

benefits are paid by the Program, the 

executor or administrator of his or her 

estate may amend the Request Package 

by filing a new Request Form. The estate 

will only be entitled to receive benefits 

under the Program if the original 

Request Form (previously filed by or on 

behalf of the injured countermeasure 

recipient or his or her survivor(s)) was 

filed within the applicable one-year 

filing deadline. If such an amendment is 

filed, all of the documentation 

submitted with the original Request 

Package will be considered part of the 

amended Request Package and the 

executor or administrator of the estate 

need not resubmit such documentation. 

If the injured countermeasure recipient 

(or his or her survivor(s)) never filed a 

Request Package, a Request Form filed 

by the executor or administrator of his 

or her estate would be considered the 

beginning of a new Request Package and 

not an amendment to a previously filed 

Request Package. 

Requesters are responsible for 

notifying the Program of any changes in 

circumstances that may have an impact 

on the Secretary’s eligibility and 

benefits determinations. 

Documentation Required To Be Deemed 

Eligible (§ 110.50–§ 110.54) 

Requesters or their representatives 

must submit appropriate documentation 

sufficient to enable the Secretary to 

determine whether requesters are 

eligible for Program benefits. The 

documentation required will vary 

somewhat depending on whether the 

requester is filing as an injured 

countermeasure recipient, survivor, or 

estate (through the executor or 

administrator). 

Medical Records Necessary To 

Determine Whether a Covered Injury 

Was Sustained (§ 110.50) 

The phrase ‘‘medical records’’ is 

defined in § 110.3(p), which provides 

that ‘‘medical records’’ for purposes of 

this part means ‘‘documentation 

associated with primary care, hospital 

in-patient and out-patient care, 

speciality consultations, and diagnostic 

testing and results.’’ 

Because all Request Packages filed 

with the Program, including those filed 

by survivors or executors or 

administrators of the estates of deceased 

persons, must relate back to an injured 

countermeasure recipient who sustained 

a covered injury, all requesters must 

submit medical records sufficient to 

demonstrate to the Secretary that a 

covered injury was sustained by the 

injured countermeasure recipient. 

Section 110.50(a) describes the medical 

records that are generally required in 

order for a requester to establish that a 

covered injury was sustained. The 

Secretary will use the records 

submitted, as well as any other available 

evidence, to evaluate if an injury 

appearing in a Table (and meeting the 

requirements of a Table) was sustained 

or if an injury was otherwise sustained 

as the direct result of the administration 

or use of a covered countermeasure. The 

Program will consider copies of medical 

records to be the same as the original 

records. Section 110.50 sets forth all of 

the medical records necessary for the 

Secretary to determine whether a 

covered injury was sustained. 

As a general matter, the Secretary 

expects to receive medical records 

directly from healthcare providers. The 

Secretary requires that requesters sign 

an Authorization for Use or Disclosure 

of Health Information Form 

(Authorization for Health Information 

Form), available from the Program, for 

each applicable healthcare provider 

authorizing the release of the requested 

medical records directly to the Program 

and send copies of each of these 

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Authorization for Health Information 

Forms to the Program. Section 110.50(b) 

explains that requesters may submit any 

additional medical documentation that 

they believe supports their Request 

Packages. The Program will not expect 

such documentation. The medical 

records described in § 110.50(a) 

generally will be sufficient for the 

Program to make a covered injury 

determination. As an example of the 

type of documentation described in 

§ 110.50(a), a requester may submit 

scientific evidence such as a scientific 

research article in order to demonstrate 

that an injury was directly caused by the 

administration or use of a covered 

countermeasure. In making covered 

injury determinations, the Secretary 

may consider the scientific evidence 

available (e.g., published articles 

concerning a relationship between the 

countermeasure and an injury) and 

consult with qualified medical experts. 

Section 110.50(c) addresses 

circumstances in which certain medical 

records are unavailable to a requester 

(e.g., a medical office has closed, 

records have been destroyed due to a 

natural disaster, a requester is unable to 

afford the costs charged by a provider to 

copy and release medical records). In 

these cases, the requester must provide 

a statement describing the reasons for 

the records’ unavailability and the 

reasonable efforts the requester has 

made to provide them. The Secretary 

may, at her discretion, accept such a 

statement from the requester instead of 

the required medical records, if the 

circumstances so warrant. In addition, 

the Secretary may, at her discretion, 

obtain the records directly from 

healthcare providers on the requester’s 

behalf. 

As described in § 110.50(d), the 

Secretary may determine that particular 

records described in § 110.50(a) are not 

necessary for particular requesters (for 

example, if certain medical records 

provide the same information as other 

records that are submitted) or that 

additional medical records may be 

required in order to make a covered 

injury determination. For example, the 

Secretary generally requires all medical 

records for one year prior to the 

administration or use of a covered 

countermeasure as necessary to indicate 

the injured countermeasure recipient’s 

pre-existing medical history. Based on 

her review of such documents, however, 

the Secretary may require additional 

information concerning a condition that 

was pre-existing prior to the injured 

countermeasure recipient’s 

administration or use of a covered 

countermeasure to determine the most 

likely cause of the covered injury. Also, 

depending on the circumstances of the 

administration or use of the covered 

countermeasure and the specifications 

of the relevant PREP Act declaration, 

the Secretary may need additional 

information concerning the 

circumstances of the administration or 

use of the covered countermeasure to 

determine whether the specifications of 

the declaration were satisfied (or that a 

good faith belief of such existed). The 

Secretary will notify requesters in such 

circumstances. 

If an injured countermeasure recipient 

died, and his or her survivors seek a 

death benefit under the Program, the 

Secretary will need to review the 

medical records to determine whether 

the death was the direct result of a 

covered injury. As explained in 

§ 110.52(c), the medical records 

reviewed for this purpose may be the 

same as those submitted for the covered 

injury determination. 

Documentation an Injured 

Countermeasure Recipient Must Submit 

for the Secretary To Make a 

Determination of Eligibility for Program 

Benefits (§ 110.51) 

Section 110.51 sets forth all of the 

documentation an injured 

countermeasure recipient must submit 

in order for an eligibility determination 

to be made. First, the requester (or his 

or her representative) must submit a 

Request Form. Second, requesters must 

submit records sufficient to demonstrate 

that the injured countermeasure 

recipient was administered or used a 

covered countermeasure (e.g., medical 

records, vaccination records, records 

from an employer or public health 

authority). Third, a requester must 

submit the medical records described in 

§ 110.50 sufficient to show that the 

injured countermeasure recipient 

sustained a covered injury. Fourth, a 

requester should submit a copy of each 

signed Authorization for Health 

Information Form for each healthcare 

provider authorizing providers to 

release medical records directly to the 

Program. As described in § 110.51(b), 

the Secretary has the discretion to 

determine that a requester need not 

submit a copy of such signed 

Authorization for Health Information 

Form with respect to each healthcare 

provider in all circumstances. Finally, 

as described in § 110.51(b), a requester 

may be required to submit additional 

documentation as required by the 

Secretary. For example, as a general 

matter, the information provided on the 

Request Form, together with other 

documentation submitted with respect 

to other requirements, will be sufficient 

for the Secretary to make a 

determination as to whether the injured 

countermeasure recipient was 

administered or used a covered 

countermeasure in accordance with all 

of the terms of a Secretarial declaration 

(including administration or use during 

the effective period of the declaration) 

or in a good faith belief that the 

administration or use met all of the 

terms of a declaration. However, in 

certain circumstances, the Secretary 

may require requesters to submit 

additional documentation in order to 

make an eligibility determination. In 

appropriate circumstances, the 

Secretary may determine that all of the 

records described in § 110.51 will not be 

required for a particular injured 

countermeasure recipient. In such 

circumstances, the Secretary will notify 

the requester of such. 

Documentation a Survivor Must Submit 

for the Secretary To Make a 

Determination of Eligibility for Death 

Benefits (§ 110.52) 

Section 110.52 describes the 

documentation that a survivor must 

submit for an eligibility determination 

to be made with respect to survivor 

death benefits. With the exception of a 

Request Form, discussed below, there is 

no need to duplicate documentation 

already submitted (by an injured 

countermeasure recipient during his or 

her lifetime, by the executor or 

administrator of his or her estate after 

death, or by another survivor). With 

respect to all requests for death benefits 

(payable only to survivors), at least one 

survivor must file a Request Form. This 

is true even if the injured 

countermeasure recipient already 

submitted a Request Form and the 

survivor(s) are amending the previously 

filed Request Package. Section 110.52 

makes clear that all of the 

documentation required for injured 

countermeasure recipients must be filed 

for an eligibility determination to be 

made with respect to death benefits. 

Additional documentation is also 

required (e.g., a death certificate for the 

injured countermeasure recipient, 

medical records demonstrating that the 

death was the direct result of a covered 

injury, documentation showing that the 

requester is an eligible survivor). As 

provided in § 110.52(a)(2), the Secretary 

has the discretion to accept other 

documentation that the injured 

countermeasure recipient is deceased if 

the death certificate is unavailable and 

the Secretary is satisfied with a letter 

submitted by the requester concerning 

the reasons for the unavailability of the 

certificate. The Secretary expects that 

this will be a rare occurrence. In 

addition, in the place provided on the 

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Request Form, a survivor filing a 

Request Form must verify that there are 

no other eligible survivors or that other 

eligible survivors exist (together with 

information about such survivors). As 

noted above, § 110.11 describes eligible 

survivors for purposes of death benefits 

and the priorities of survivorship. 

Documentation the Executor or 

Administrator of the Estate of a 

Deceased Injured Countermeasure 

Recipient Must Submit for the Secretary 

To Make a Determination of Eligibility 

for Benefits to the Estate (§ 110.53) 

The executor or administrator of the 

estate of a deceased injured 

countermeasure recipient, seeking 

benefits under the Program on behalf of 

the estate, must submit a completed and 

signed Request Form. This is true even 

if the injured countermeasure recipient 

or a survivor already submitted a 

Request Form and the executor or 

administrator of the estate is amending 

the previously filed Request Package. In 

addition, a death certificate for the 

injured countermeasure recipient is 

required. As provided in § 110.53(b), the 

Secretary has the discretion to accept 

other documentation showing that the 

injured countermeasure recipient is 

deceased if the death certificate is 

unavailable and the Secretary is 

satisfied with a letter submitted by the 

executor or administrator concerning 

the reasons for the unavailability of the 

certificate. The Secretary expects that 

this will be a rare occurrence. Although 

the estate may receive benefits 

regardless of whether or not the death 

resulted from a covered injury, the 

Secretary may require documentation 

concerning the death in cases in which 

eligibility has not yet been determined. 

For example, the Secretary may require 

such documentation to help determine 

whether an injury was caused by the 

administration or use of a covered 

countermeasure, as opposed to an 

underlying health condition that might 

be apparent at death. No death benefits 

are awarded to the estate. Finally, 

documentation showing that the 

individual is the executor or 

administrator of the deceased injured 

countermeasure recipient’s estate (e.g., a 

court order or letters of administration) 

is required. 

Documentation Required for the 

Secretary To Determine Program 

Benefits (§ 110.60–§ 110.63) 

In addition to the documentation 

requesters must submit for the Secretary 

to make eligibility determinations 

(including the determination that a 

covered injury was sustained), 

requesters must submit documentation 

to enable the Program to calculate the 

type and amount of benefits available. 

Because the benefits available under the 

Program are secondary to benefits 

received or receivable from third-party 

payers, it may be possible that certain 

requesters who are deemed eligible will 

not receive benefits from the Program. 

Sections 110.60–110.63 describe the 

documentation that is required for 

requesters seeking particular types of 

benefits. 

Although the Program will accept 

such documentation at any time after a 

Request Form is filed, a requester need 

not submit any of the documentation 

pertaining to benefits until the Secretary 

has informed the requester that he or 

she is eligible under the Program. The 

submission of benefits documentation is 

described in § 110.43(b) and is designed 

to ease the documentary burden on 

requesters who do not know whether or 

not they will be deemed eligible. 

In order to calculate the amount of 

each type of benefit available, the 

Program requires requesters to provide 

documentation of every third-party 

payer that may have paid for or 

provided the benefits requested, or that 

may have an obligation to do so. The 

information required concerning such 

third-party payers with respect to each 

type of benefit available under the 

Program is described in §§ 110.60, 

110.61, and 110.62. As set forth in 

§ 110.60(a)(3), a requester may need to 

give consent for the Program to 

communicate directly with third-party 

payers. 

Requesters seeking medical benefits 

must also submit documentation 

concerning the amount paid or expected 

to be paid by such third-party payers for 

the medical services or items for which 

payment is being sought under the 

Program. Third-party payers of medical 

benefits include, but are not limited to, 

medical insurance, Medicaid, Medicare, 

and any other source of medical 

reimbursement. An example of the 

documentation necessary to satisfy this 

requirement is an Explanation of 

Benefits form issued by the injured 

countermeasure recipient’s health 

insurance company. 

Third-party payers of benefits for lost 

employment income include, but are 

not limited to, the injured 

countermeasure recipient’s employer, 

disability insurance, workers’ 

compensation programs, and the 

Department of Veterans Affairs. In order 

to satisfy his or her obligations under 

§ 110.61, an injured countermeasure 

recipient may need to submit 

documentation including his or her 

earnings and leave statements, 

information concerning the number of 

hours in the requester’s standard work 

day, as well as documentation 

concerning any programs or payments 

for lost wages. 

Survivors seeking death benefits will 

have to submit different documentation 

concerning third-party payers 

depending on whether they are seeking 

death benefits under the standard 

calculation described in § 110.82(b) or 

are choosing a death benefit under the 

alternative calculation described in 

§ 110.82(c). For example, survivors 

seeking a death benefit under the 

standard calculation must submit 

documentation concerning PSOB 

Program death and disability benefits. 

The legal guardian of survivors seeking 

a death benefit under the alternative 

calculation must submit documentation 

concerning existing or potential thirdparty payers (described fully in the 

death benefits calculation section of this 

preamble and set forth in 

§ 110.82(d)(3)(A)). Survivors seeking 

death benefits also must submit other 

documentation described in § 110.62. 

Before payments will be made, the 

representatives of requesters who are 

minors or adults who lack legal capacity 

to receive payments must submit 

additional documentation described in 

§ 110.63. Because some of this 

documentation may be time-consuming 

to obtain (e.g., obtaining a court decree 

establishing a guardianship of the estate 

for an adult who lacks legal capacity), 

the requester may wait until a benefits 

calculation has been made, and a 

written approval has been issued, before 

submitting such documentation. 

Determinations the Secretary Must 

Make Before Benefits Can Be Paid 

(§ 110.70–§ 110.74) 

When the Secretary receives a 

completed and signed Request Form or 

Request Package postmarked within the 

filing deadline, she will conduct two 

separate reviews, as described in 

§ 110.70. First, she will determine 

whether the requester is eligible for 

Program benefits. Second, the Secretary 

will determine the type and amount of 

any benefits that may be paid. 

If the Request Package does not 

include sufficient documentation to 

determine eligibility, the Secretary will 

send written notice to the requester (or 

his or her representative) identifying the 

documentation that is needed, as 

provided for in § 110.71. The requester 

will be given 60 days to submit the 

required documentation. If, after 

reasonable efforts to obtain the 

documents, the documentation remains 

unavailable, the requester must submit 

a letter explaining the circumstances to 

the Secretary. The Secretary also has the 

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discretion to accept a letter meeting the 

requirements set out in § 110.71 as a 

substitute for the unavailable 

documentation. 

If the Secretary determines that a 

requester is not eligible for benefits 

under the Program, she will inform the 

requester (or his or her representative) 

of the disapproval in writing. As 

described in § 110.72(a), the Secretary 

will provide information as to the 

options available to the requester, 

including the requester’s right to seek 

reconsideration of the eligibility 

decision. 

If the Secretary determines that a 

requester meets the eligibility 

requirements, she will notify the 

requester in writing of this decision, at 

which point the Secretary will review 

the Request Package in order to 

calculate the type and amount of the 

benefits. If the Request Package does not 

have sufficient documentation for the 

Secretary to calculate the amount of the 

benefits, the Secretary will notify the 

requester in writing of the 

documentation she requires to complete 

the calculation. As with the eligibility 

documentation, the requester will be 

given 60 days to submit the required 

documentation or provide a letter 

setting forth the circumstances that 

make the records unavailable. Again, 

the Secretary may accept a letter 

meeting the requirements set forth in 

§ 110.71 as a substitute for the 

unavailable documentation. Once the 

Secretary has sufficient documentation 

to calculate a requester’s benefits, the 

Secretary will complete this calculation. 

As set out in § 110.73, once the 

Secretary has calculated the amount of 

the benefits and determined that 

payment is to be made, she will inform 

the requester of the approval in writing 

and then initiate payment. Under 

§ 110.74, if the Secretary disapproves a 

Request, which the Secretary may do at 

any time, she will so notify the 

requester (or his or her representative) 

in writing and provide information as to 

the requester’s right to seek 

reconsideration of the Secretary’s 

decision. 

Payment of All Benefits Under the 

Program (§ 110.83) 

The Secretary’s options in paying all 

benefits under the Program are 

described in § 110.83. The Secretary 

makes all payment decisions, consistent 

with applicable law, and unilaterally 

determines the method of payment. If 

the Secretary determines that there is a 

reasonable likelihood that payments of 

medical benefits, benefits for lost 

employment income, or death benefits 

paid under the alternative calculation 

(described in § 110.82(c)) will be 

required for a period in excess of a year 

from the date the Secretary determines 

that the requester is eligible for such 

benefits, the Secretary may pay such 

benefits through a lump-sum payment, 

a trust such as a U.S. grantor 

reversionary trust, annuity or medical 

insurance policy, or appropriate 

structured settlement agreement (or a 

combination of these methods), 

provided they are actuarially 

determined to have a value equal to the 

present value of the projected total 

amount of such benefits that the 

requester is eligible to receive. 

As described in § 110.83(a), lump sum 

payments will generally be made 

through electronic funds transfers to 

requesters’ accounts. Under § 110.83(b), 

if a requester is a minor, the payment 

will be made on the minor’s behalf to 

the account of the minor’s legal 

guardian (generally, the minor’s parent). 

The legal guardians of minor requesters 

under this Program will be required to 

use the payments for the benefit of the 

minor. Such legal guardians are subject 

to applicable State law requirements 

concerning payments made on behalf of 

minors (e.g., become the guardian of the 

minor’s estate or establish an account 

with State court supervision, if required 

by State law). Such legal guardians are 

also required to provide to the Secretary 

documentation of guardianship or 

conservatorship; however, the Secretary 

may waive this requirement for good 

cause. Section 110.83(b) describes the 

requirements pertaining to lump sum 

payments made on behalf of adults who 

lack the legal capacity to receive 

payments. 

As provided in § 110.83(c), the 

Secretary may choose to make interim 

payments of benefits under the Program 

(in other words, issue a payment for a 

certain type or portion of Program 

benefit prior to making the final benefits 

payment) to give certain benefits to a 

requester more quickly than would 

otherwise be possible. For example, the 

Secretary may pay medical benefits for 

past services or items to an eligible 

requester whose covered injury has 

resulted in substantial medical bills 

before making the final determination 

concerning the payment of future 

medical benefits. In certain cases, the 

Secretary may make an interim payment 

of benefits even before a final eligibility 

or benefits determination is made. The 

Secretary expects such instances to be 

rare, and the requester in such 

circumstances must agree to repay the 

Secretary for any benefits later 

determined to be unavailable under the 

Program. 

The Tax Consequences of Receiving 

Benefits from the Program 

The Secretary is asking the Internal 

Revenue Service (IRS) to provide 

prompt guidance on the tax 

consequences of receiving benefits 

under the Program. The Program will 

share this guidance as soon as it is 

received. 

The Secretary’s Right To Recover 

Benefits Paid Under this Program From 

Third-Party Payers (§ 110.84) 

As described above, the payment of 

benefits under this Program is 

secondary to benefits available from 

other third-party payers. The category of 

third-party payers that have primary 

responsibility to pay for or provide such 

benefits is different for each type of 

benefit available under this Program. 

Such third-party payers are discussed in 

the sections of the preamble concerning 

the different types of benefits. As 

described in § 110.84, after the Secretary 

pays benefits under this Program, she 

will be subrogated to the rights of the 

requester, meaning that the Secretary 

may assert a claim against any thirdparty payer with a legal or contractual 

obligation to pay for, or provide, such 

benefits. The Secretary may recover 

from such a third-party payer the 

amount of benefits the third-party payer 

has (or had) an obligation to pay for (or 

provide) or may recover them from the 

requester if they were paid to the 

requester. For example, if the Secretary 

pays a requester $10,000 in benefits for 

lost employment income under this 

Program and a State workers’ 

compensation program later determines 

that it is obliged to pay the requester 

$5,000 in workers’ compensation 

benefits, the Secretary may pursue a 

claim against the State for $5,000 

(because the Secretary, as the secondary 

payer, would only be obligated to pay 

the requester $5,000 in benefits for lost 

employment income). No benefits paid 

under this Program are subject to any 

lien by any third-party payer. 

Reconsideration of the Secretary’s 

Eligibility and Benefits Determinations 

(§ 110.90) 

Every individual who has filed a 

Request Package and has received a 

determination by the Secretary either 

disapproving eligibility for benefits or 

denying a category or amount of benefits 

requested has a right to seek 

reconsideration of the Secretary’s 

determination(s). However, no 

reconsiderations may be filed 

concerning the mechanisms of payment. 

Although such initial determinations 

are characterized as Secretarial 

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determinations, this decision-making 

authority will be delegated to the 

Program. The requester or his or her 

representative must send a letter seeking 

reconsideration to the Associate 

Administrator, Healthcare Systems 

Bureau, Health Resources and Services 

Administration, at the address provided 

in § 110.90(b). The letter must be 

received by the Department within 60 

calendar days of the date of the 

Department’s determination letter. The 

letter should state the reasons why the 

determination should be reconsidered. 

No new documentation may be 

included with this letter. 

The Associate Administrator, 

Healthcare Systems Bureau, will 

convene a panel to review all cases 

seeking reconsideration. The panel will 

consist of qualified individuals who are 

independent of the Program. The panel 

will review the documentation that was 

before the Secretary at the time of the 

determination (and will not consider 

any new documentation submitted by 

the requester). 

After reviewing the record, the panel 

will make a recommendation to the 

Associate Administrator, Healthcare 

Systems Bureau, who will then make a 

final determination as to whether or not 

the requester is eligible for benefits or as 

to the type and/or amount of benefits 

that may be paid. The Associate 

Administrator will inform the requester 

or his or her representative in writing of 

the determination(s) and of the reasons. 

This decision will be considered the 

Secretary’s final action on the issue for 

which reconsideration was sought. 

Requesters may not seek review of such 

a decision. 

If the Associate Administrator’s final 

decision is that a requester who was 

determined to be ineligible for benefits 

is, in fact, eligible, then the Secretary 

will make a determination as to the type 

and amount of benefits to be paid. The 

requester then has a right to seek 

reconsideration of the Secretary’s 

determination on that issue. 

Secretary’s Review Authority and No 

Additional Judicial or Administrative 

Review of Determinations Made Under 

This Regulation (§ 110.91, § 110.92) 

In accordance with section 262(f)(1) of 

the PHS Act (SEPPA) (42 U.S.C. 

239a(f)(1)) and as described in § 110.91, 

the PREP Act authorizes the Secretary to 

review at any time, on her own motion 

or on application, any determination 

made concerning eligibility, and the 

calculation and amount of benefits 

under the Program and authorizes the 

Secretary to affirm, vacate, or modify 

such determination in any manner the 

Secretary deems appropriate. The 

decision of whether to engage in such a 

review rests within the complete 

discretion of the Secretary. 

However, as explained in § 110.92, 

once the Secretary has made a final 

decision as to eligibility or type or 

amount of benefits and the requester has 

exercised his or her right to 

reconsideration, the PREP Act, 

referencing section 262(f)(2) of the PHS 

Act (SEPPA) (42 U.S.C. 239a(f)(2)), does 

not allow any further review of that 

decision by any court or administrative 

body (unless the President specifically 

directs further administrative review). 

Given this broad statutory prohibition 

against further review, no determination 

made under this part (including, but not 

limited to, eligibility determinations, 

benefits calculations, payment 

decisions, and reconsideration 

decisions) will be subject to any review 

by Federal or State courts. 

Finally, there is also no judicial 

review of the Secretary’s determinations 

establishing or amending a Covered 

Countermeasure Injury Table. 

Justification for Omitting Notice of 

Proposed Rulemaking and for Waiver of 

Delayed Effective Date 

Through the enactment of the PREP 

Act, the Secretary was authorized to 

establish and administer the Program. 

Congress authorized the Secretary to 

issue regulations implementing the 

PREP Act as the Secretary deems 

reasonable and necessary. In accordance 

with that statutory authority, the 

Secretary is herein establishing the 

procedures and requirements to govern 

the Program. 

In addition, the Secretary has 

determined, under 5 U.S.C. 553(b), that 

it is contrary to the public interest to 

follow proposed rulemaking procedures 

(i.e., issuing a proposed rule, with an 

accompanying solicitation of public 

comments) before issuance of these 

regulations, because such a process 

might delay the continuing 

implementation of the President’s plan 

to protect the population of the United 

States against public health pandemic, 

epidemic, or security threats. The 

sooner this regulation is in effect, the 

sooner the Program can be implemented 

and potential requesters who may have 

been seriously injured by a covered 

countermeasure will be able to be 

considered for medical and lost 

employment income benefits. Further, 

survivors of those who they believe 

have died as a result of a covered 

countermeasure will be able to apply for 

death benefits. Once this implementing 

regulation is in effect, the Secretary 

expects individuals who believe that 

they may be eligible for benefits under 

the Program will file requests for such 

benefits within a short time frame since 

Letters of Intent to request benefits have 

already been filed with the Program. In 

addition, publishing this regulation 

promptly is necessary to make the 

remedies afforded by this Program 

available to potential requesters as soon 

as possible given the governing one year 

filing deadline. As noted above, the 

Secretary has made every effort to 

enable those who suffer covered injuries 

as the result of covered countermeasures 

to have an opportunity to apply for 

benefits under this Program. As 

described above, to the extent that 

scientific evidence linking a covered 

countermeasure to an injury becomes 

available and such injury is added to a 

Table, potential requesters will be able 

to take advantage of an alternative filing 

deadline, which may increase the 

likelihood that their Request Forms will 

be timely filed. In addition, the 

Secretary may rely upon constructive 

receipt of filing, as described in 

§ 110.42(e). The Secretary further 

believes that her omission of a Notice of 

Proposed Rulemaking and delay of the 

effective date of this regulation is 

warranted given that most of the 

eligibility and benefits criteria under 

this Program are the same as those 

included in the SVICP’s administrative 

implementation regulations—42 CFR 

part 102. Public comments with respect 

to those regulations were solicited, 

received, and considered by the 

Secretary. For the same reasons, the 

Secretary has determined that there is 

good cause to waive a delay in the rule’s 

effective date. Nonetheless, as noted 

above, comments on the procedures and 

requirements in this interim final rule 

will be accepted at the above listed 

address for a period of 60 days 

following the rule’s publication in the 

Federal Register. Thus, although the 

rule is effective immediately upon 

publication, the Secretary will consider 

the comments received and, based on 

them, may amend the procedures and/ 

or requirements pertaining to this 

Program. 

Economic and Regulatory Impact 

Unfunded Mandates Reform Act of 

1995: The Secretary has determined that 

this interim final rule will not have 

effects on State, local, and tribal 

governments and on the private sector 

such as to require consultation under 

the Unfunded Mandates Reform Act of 

1995. 

Federalism Impact Statement: The 

Secretary has also reviewed this rule in 

accordance with Executive Order 13132 

regarding federalism, and has 

determined that it does not have 

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Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 63673 

‘‘federalism implications.’’ The rule does 

not ‘‘have substantial direct effects on 

the states, or on the relationship 

between the national government and 

the states, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

Impact on Family Well-Being: This 

interim final rule will not adversely 

affect the following elements of family 

well-being: Family safety, family 

stability, marital commitment; parental 

rights in the education, nurture and 

supervision of their children; family 

functioning, disposable income or 

poverty; or the behavior and personal 

responsibility of youth, as determined 

under section 654(c) of the Treasury and 

General Government Appropriations 

Act of 1999. In fact, this interim final 

rule may have a positive impact on the 

disposable income and poverty 

elements of family well-being to the 

extent that families of injured persons 

(and of other persons deemed eligible to 

receive benefits under this part) receive, 

or are helped by, medical, lost 

employment income, and/or death 

benefits paid under this part without 

imposing a corresponding burden on 

them. 

Impact of the New Rule: In this 

interim final rule, the Secretary 

establishes the procedures and 

requirements applicable to requesters 

filing for benefits available under the 

Program. This interim final rule is based 

on the PREP Act. It will have the effect 

of enabling certain eligible individuals 

who sustained covered injuries as the 

direct result of receiving a covered 

countermeasure under the Secretary’s 

declaration, to receive benefits under 

the Program. In the event that an 

otherwise eligible injured 

countermeasure recipient has died, his 

or her estate and/or survivors may be 

entitled to certain benefits. This interim 

final rule sets out the eligibility 

requirements that apply to the Program, 

how benefits will be calculated, and the 

documentation that must be submitted. 

Paperwork Reduction Act of 1995: 

Collection of Information: The 

Countermeasures Injury Compensation 

Program 

Description of Respondents: The 

respondents will be individuals who 

sustain serious injuries as a direct result 

of the administration or use of covered 

countermeasures (i.e., injured 

countermeasure recipients) identified by 

the Secretary in declarations issued 

under the PREP Act. In addition, 

respondents may also be certain 

survivors of individuals who died as the 

direct result of their covered injuries or 

their health complications (i.e., eligible 

survivors of deceased injured 

countermeasure recipients) and/or the 

estates of deceased injured 

countermeasure recipients. Examples of 

currently covered countermeasures are: 

the 2009 H1N1 vaccine, the influenza 

antiviral drugs Tamiflu® and Relenza® 

when used for pandemic purposes, 

pandemic influenza diagnostics, 

personal respiratory devices (e.g., N–95 

filtering facepiece respirators to prevent 

the spread of the 2009 H1N1 virus), and 

respiratory support devices (e.g., 

ventilators used for life support for 

critically ill patients with respiratory 

failure due to infection with 2009 H1N1 

virus), the influenza intravenous 

antiviral drug peramivir when used to 

treat infection with 2009 H1N1, and 

certain anthrax, smallpox, botulism, and 

acute radiation syndrome 

countermeasures. 

Estimated Annual Reporting: The 

estimated annual reporting for this data 

collection is a total of five hours for 

reviewing and completing the 

Countermeasures Injury Compensation 

Program Request for Benefits Form 

(Request Form) and the 

Countermeasures Injury Compensation 

Program Authorization for Use or 

Disclosure of Health Information Form 

(Authorization for Health Information 

Form) as well as the time to obtain and 

provide medical and financial 

documentation for eligibility and the 

computation of benefits. The 

respondents listed above will complete 

the Request Form to inform the CICP of 

their contact information (e.g., name, 

address), and the dates and the 

circumstances under which a covered 

countermeasure was administered or 

used. After submitting the Request 

Form, the eligible respondents listed 

above will complete the Authorization 

for Health Information Form to request 

that medical records be sent to the CICP. 

The wage rate is the October 2009 

average hourly earnings from the Bureau 

of Labor Statistics, U.S. Department of 

Labor. The estimated annual response 

burden is as follows: 

Form Number of 

respondents 

Responses 

per 

respondent 

Hourly 

response 

Total burden 

hours Wage rate Total hour cost 

Request for Benefits Form and Supporting Documentation ......................... 2,520 1 5 12,600 $18.72 $235,872 

Authorization for Use or Disclosure of 

Health Information Form ...................... 2,520 1 1 2,520 18.72 47,174 

As a result of the 2009 H1N1 

influenza outbreak, this is the first time 

that covered countermeasures identified 

in PREP Act declarations are being 

distributed, administered, and used in 

the general population of the United 

States. This is also the first time that the 

strain of 2009 H1N1 virus has circulated 

in the United States and worldwide, and 

the first time that a specific influenza 

vaccine is available to prevent its 

illness. In light of these factors, the 

incidence of potential adverse events 

associated with this vaccine cannot be 

predicted. However, as the same 

technology is utilized in the production 

of seasonal influenza vaccine, the rate of 

vaccine-associated adverse events is not 

expected to be any different than for 

seasonal influenza vaccine. Since the 

behavior of the 2009 H1N1 virus may be 

unpredictable and the number of people 

who will get the 2009 H1N1 vaccine is 

unknown, the CICP estimates of the 

number of Request for Benefits Forms 

that will be filed are predicated on 

currently available information. The 

CICP expects that individuals with 

severe injuries are more likely to file 

requests for benefits since they may 

have incurred more unreimbursable 

medical expenses and have more lost 

employment income than individuals 

alleging less serious injuries (for whom 

the benefits available under the CICP 

may be limited). Therefore, the 

estimates of Requests for Benefits 

assumes that a larger percentage of the 

more seriously injured will file for 

Request Packages. 

According to the Centers for Disease 

Control and Prevention (CDC) 127 

million doses of 2009 H1N1 vaccine had 

been distributed to public health 

agencies and healthcare providers in the 

United States as of May 28, 2010. 

Currently, it is estimated that 

approximately 90 million Americans 

have been vaccinated, although the 

precise number is not known. As of May 

29, 2010, the Vaccine Adverse Reporting 

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63674 Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 

System (VAERS) has received 11,180 

reports related to 2009 H1N1 

vaccination. The vast majority (92.2%) 

of adverse events reported to VAERS 

after receiving the 2009 H1N1 vaccine 

have not involved serious health 

problems or outcomes (e.g., they 

encompass events such as soreness at 

the vaccine injection site). Of the 11,180 

reports, 868 (7.7 percent) were reports 

that involved what would be considered 

serious health events as defined by 

VAERS. The number of these reports is 

similar to those historically seen after 

distribution of a similar number of 

seasonal flu vaccine doses. Among the 

11,180 reports of adverse events, there 

were 60 reports of deaths. The 60 

VAERS reports that involve deaths are 

under review by CDC, the Food and 

Drug Administration (FDA) and the 

States in which the reported deaths 

occurred. VAERS has received 143 

reports of Guillain-Barre ́ Syndrome 

(GBS), for which follow-up assessments 

are under way. In the United States, 

about 80–160 cases of GBS are expected 

to occur each week, regardless of 

vaccination. VAERS is a national 

passive reporting system for vaccine 

adverse events managed by both CDC 

and the Food and Drug Administration 

(FDA) in which reports are submitted 

voluntarily by people who think an 

adverse event occurred after 

vaccination. VAERS accepts reports 

from all sources. VAERS is useful as a 

signal detection system to monitor for 

potential vaccine safety problems. 

As outlined above, VAERS has 

received 868 serious reports and 10,312 

nonserious reports. Very little 2009 

H1N1 vaccine is currently being 

administered so it can be assumed these 

numbers may increase slightly but will 

not change significantly. The CICP 

expects 75 percent (or 651) of these 

reports to result in Requests for Benefits 

filed with the CICP, and about 5 percent 

(or 516) of the reports of less serious 

injuries to result in Requests for Benefits 

with the CICP, for a total of 1,167 

Requests. 

In April 2009 there were an estimated 

50 million courses of FDA approved 

antiviral drugs in the Strategic National 

Stockpile (SNS). Eleven million of these 

50 million were distributed to project 

areas (i.e., all U.S. States, territories and 

jurisdictions). An additional 23 million 

courses of antiviral drugs were 

purchased by project areas and held as 

part of State stockpiles available for 

distribution to the local level if needed. 

Assuming all the antiviral drugs 

provided by the SNS (approximately 11 

million courses) and the Statepurchased antiviral drugs 

(approximately 23 million courses) were 

distributed to the local level and 

dispensed, the CICP expects that 

approximately 672 Request for Benefits 

Forms will be filed concerning serious 

injuries allegedly resulting from covered 

antivirals. Based on estimates by CICP 

staff, the incidence of very serious 

injuries from antivirals may be 2 in 10 

million (10 cases) for anaphylaxis, 1 in 

1 million (50 cases) for Toxic Epidermal 

Necrolysis/Stevens Johnson Syndrome, 

and 10 in 1 million (500 cases) for 

bronchospasms. The incidence of less 

serious injuries from antivirals is 1 in 1 

million (50 cases) for skin reactions and 

100 in 1 million (5,000 cases) for 

vomiting. The CICP estimates that 75 

percent of 560 (or 420) of the 

individuals alleging serious injuries as a 

result of antivirals qualifying as covered 

countermeasures will file requests for 

benefits with the CICP. However, the 

CICP expects that only 5 percent of 

5,050 (or 252) of the individuals alleging 

less serious injuries will file Request 

Packages with the CICP because the 

benefits available to them may be 

limited. 

Certain ventilators used for life 

support of critically ill patients with 

2009 H1N1 infection are covered 

countermeasures. Critically ill patients 

with pneumonia and respiratory failure 

due to 2009 H1N1 infection require 

invasive mechanical ventilators to assist 

them with breathing. Many critically ill 

2009 H1N1 patients in the intensive 

care unit require invasive mechanical 

ventilation for several weeks. Prolonged 

ventilator use is associated with serious 

adverse events such as Ventilator 

Associated Pneumonia (VAP), which 

has a high mortality rate. The CDC 

estimates that between 183,000 and 

378,000 H1N1-related hospitalizations 

occurred from April 2009 to January 16, 

2010. The mid-level in this range of 

2009 H1N1-related hospitalizations is 

about 257,000. CDC further estimates 

the 2009 H1N1-related deaths which 

occurred between April 2009 and 

January 16, 2010 to be between 8,330 

and 17,160. The mid-level in this range 

of 2009 H1N1-related deaths is about 

11,690. (The CICP expects that these 

individuals were hospitalized before 

their deaths). The CICP estimates that 5 

percent of the mid-level (or 12,850) of 

the individuals hospitalized ended up 

in the intensive care unit and 25 percent 

(or 3,213) of them were placed on 

ventilators. About 10 percent of the 

3,213 (or 321) got VAP, and the CICP 

estimates that 5% (or 16) will file 

Requests for Benefits. Using the midlevel range for H1N1-related deaths, the 

CICP estimates that 25 percent (or 2,922) 

were placed on ventilators and about 10 

percent (or 292) of them got VAP. The 

CICP estimated that 5 percent (or 15) of 

the survivors or the estates of those that 

have died as a result of the 2009 H1N1 

virus may submit Requests for Benefits 

alleging that a death was caused by a 

ventilator. Whether such requests will 

result in the receipt of benefits depends 

on many factors, including whether the 

administration or use of such ventilators 

met the requirements of the applicable 

PREP Act declaration (or that a good 

faith belief of such existed) and whether 

it is demonstrated that a covered injury 

was sustained. 

A total of 85 million N–95 filtering 

facepiece respirators were distributed to 

project areas, with an initial distribution 

of 25 million occurring in April 2009, 

and a second distribution of 60 million 

occurring in October, 2009. However, it 

is impossible to estimate how many 

were actually distributed by individual 

project areas. 

In 2009, the Department of Defense 

(DoD) provided smallpox vaccinations 

to 176,068 persons which is about four 

times the number of civilians (39,566) 

that received the smallpox vaccine 

between January 2003 and June 2004 

when healthcare and emergency 

workers were receiving the vaccine to 

prepare to respond to emergency 

situations. Approximately 65 of the 

39,566 civilians filed requests for 

benefits with the Smallpox Vaccine 

Injury Compensation Program (SVICP), 

which ended in January 2008, for 

injuries that they sustained after being 

administered the smallpox vaccine. The 

CICP is using the experience with the 

SVICP to derive its estimates of the 

number of requests for benefits that may 

be filed with the CICP for injuries from 

the smallpox vaccine. The CICP 

estimates that since four times as many 

military personnel receied this vaccine 

as civilians, about four times as many 

individuals who filed claims with the 

SVICP will file claims with the CICP 

(because military personnel were 

generally not eligible to receive benefits 

under the SVICP, but may be eligible to 

receive benefits under the CICP). 

Therefore, the CICP estimates that about 

260 Requests for Benefits for injuries 

from the smallpox vaccine will be filed. 

In 2009, DoD immunized 224,057 

individuals with anthrax vaccinations. 

Since the anthrax vaccine is as 

reactogenetic as the smallpox vaccine, 

the SVICP experience is used to derive 

the estimates of the number of request 

for benefits that will be filed with the 

CICP for injuries from the anthrax 

vaccine. About six times the number of 

military personnel (224,057) received 

the anthrax vaccine as healthcare and 

emergency workers who received the 

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Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 63675 

smallpox vaccine per year. Therefore, 

the CICP estimates that about 6 times as 

many individuals who filed claims with 

the SVICP will file claims relating to the 

anthrax vaccine with the CICP. The 

CICP estimates that about 390 requests 

for benefits for injuries from the anthrax 

vaccine will be filed. It is important to 

note that these estimates do not reflect 

the Secretary’s assessment of the actual 

number of serious injuries or deaths 

resulting from the covered 

countermeasures described here. 

VAERS is a passive reporting system 

and has inherent limitations. Although 

it is a useful resource to generate 

hypotheses, it cannot be relied on to 

reach conclusions concerning the 

numbers of serious injuries or deaths 

actually resulting from particular 

vaccines. Moreover, even if the injuries 

are indeed serious and are determined 

by the Secretary to have resulted from 

a covered countermeasure, requesters 

with the CICP may still be deemed 

ineligible for benefits (for example, the 

person using a covered countermeasure 

may not have satisfied all of the 

specifications of the pertinent PREP Act 

declaration, the Request Form might 

have been filed outside of the one-year 

filing deadline). 

Comments on this information 

collection activity should be sent to 

OMB Desk Officer, Office of 

Management and Budget, Room 10235, 

New Executive Office Building, 725 

17th Street, NW., Washington, DC 

20053; Fax: (202) 395–3888. 

List of Subjects in 42 CFR Part 110 

Benefits, Biologics, Compensation, 

Immunization, Public Health, 

Pandemic, Countermeasures, Pandemic 

Influenza, 2009 H1N1 Vaccine, 

Influenza Antivirals, Tamiflu®, 

Relenza®, Peramivir, Pandemic 

Influenza Diagnostics, Personal 

Respiratory Devices, N–95 Filtering 

Facepiece Respirators, Respiratory 

Support Devices, Ventilators, Anthrax, 

Smallpox, Botulism, Acute Radiation 

Syndrome. 

Dated: July 2, 2010. 

Mary K. Wakefield, 

Administrator, Health Resources and Services 

Administration. 

Approved: July 12, 2010. 

Kathleen Sebelius, 

Secretary. 

■ For the reasons stated in the preamble, 

the Department amends title 42 of the 

CFR by adding part 110 to read as 

follows: 

PART 110—COUNTERMEASURES 

INJURY COMPENSATION PROGRAM 

Subpart A—General Provisions 

Sec. 

110.1 Purpose. 

110.2 Summary of available benefits. 

110.3 Definitions. 

Subpart B—Persons Eligible To Receive 

Benefits 

110.10 Eligible requesters. 

110.11 Survivors. 

Subpart C—Covered Injuries 

110.20 How to establish a covered injury. 

Subpart D—Available Benefits 

110.30 Benefits available to different 

categories of requesters under this 

Program. 

110.31 Medical benefits. 

110.32 Benefits for lost employment 

income. 

110.33 Death benefits. 

Subpart E—Procedures for Filing Request 

Packages 

110.40 How to obtain forms and 

instructions. 

110.41 How to file a Request Package. 

110.42 Deadlines for filing Request Forms. 

110.43 Deadlines for submitting 

documentation. 

110.44 Legal or personal representatives of 

requesters. 

110.45 Multiple survivors. 

110.46 Amending a request package. 

Subpart F—Documentation Required for the 

Secretary To Determine Eligibility 

110.50 Medical records necessary for the 

Secretary to determine whether a 

covered injury was sustained. 

110.51 Documentation an injured 

countermeasure recipient must submit 

for the Secretary to make a determination 

of eligibility for Program benefits. 

110.52 Documentation a survivor must 

submit for the Secretary to make a 

determination of eligibility for death 

benefits. 

110.53 Documentation the executor or 

administrator of the estate of a deceased 

injured countermeasure recipient must 

submit for the Secretary to make a 

determination of eligibility for benefits to 

the estate. 

Subpart G—Documentation Required for 

the Secretary To Determine Program 

Benefits 

110.60 Documentation a requester who is 

determined to be eligible must submit for 

the Secretary to make a determination of 

medical benefits. 

110.61 Documentation a requester who is 

determined to be eligible must submit for 

the Secretary to make a determination of 

lost employment income benefits. 

110.62 Documentation a requester who is 

determined to be an eligible survivor 

must submit for the Secretary to make a 

determination of death benefits. 

110.63 Documentation a legal or personal 

representative must submit when filing 

on behalf of a minor or on behalf of an 

adult who lacks legal capacity to receive 

payment of benefits. 

Subpart H—Secretarial Determinations 

110.70 Determinations the Secretary must 

make before benefits can be paid. 

110.71 Insufficient documentation for 

eligibility and benefits determinations. 

110.72 Sufficient documentation for 

eligibility and benefits determinations. 

110.73 Approval of benefits. 

110.74 Disapproval of benefits. 

Subpart I—Calculation and Payment of 

Benefits 

110.80 Calculation of medical benefits. 

110.81 Calculation of benefits for lost 

employment income. 

110.82 Calculation of death benefits. 

110.83 Payment of all benefits. 

110.84 The Secretary’s right to recover 

benefits paid under this Program from 

third-party payers. 

Subpart J—Reconsideration of the 

Secretary’s Determinations 

110.90 Reconsideration of the Secretary’s 

eligibility and benefits determinations. 

110.91 Secretary’s review authority. 

110.92 No additional judicial or 

administrative review of determinations 

made under this part. 

Subpart K—Covered Countermeasures 

Injury Tables 

110.100 [Reserved] 

Authority: 42 U.S.C. 247d–6e. 

Subpart A—General Provisions 

§ 110.1 Purpose. 

This part implements the Public 

Readiness and Emergency Preparedness 

Act (PREP Act), which amended the 

Public Health Service Act (herein after 

‘‘PHS Act’’ or ‘‘the Act’’) by including 

section 319F–3, and section 319F–4 

entitled ‘‘Covered Countermeasure 

Process.’’ Section 319F–4 of the PHS Act 

directs the Secretary of Health and 

Human Services, following issuance of 

a declaration under section 319F–3(b), 

to establish procedures for the 

Countermeasures Injury Compensation 

Program (herein after ‘‘CICP’’ or ‘‘the 

Program’’) to provide medical and lost 

employment income benefits to certain 

individuals who sustained a covered 

injury as the direct result of the 

administration or use of a covered 

countermeasure consistent with a 

declaration issued pursuant to section 

319F–3(b), or in the good faith belief 

that administration or use of the covered 

countermeasure was consistent with a 

declaration. Also, if the Secretary 

determines that an individual died as a 

direct result of a covered injury, the Act 

provides for certain survivors of that 

individual to receive death benefits. 

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63676 Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 

§ 110.2 Summary of available benefits. 

(a) The Act authorizes three forms of 

benefits to, or on behalf of, requesters 

determined to be eligible by the 

Secretary: 

(1) Payment or reimbursement for 

reasonable and necessary medical 

services and items to diagnose or treat 

a covered injury, or to diagnose, treat, or 

prevent its health complications, as 

described in § 110.31. 

(2) Lost employment income incurred 

as a result of a covered injury, as 

described in § 110.32. 

(3) Death benefits to certain survivors 

if the Secretary determines that the 

death of the injured countermeasure 

recipient was the direct result of a 

covered injury, as described in § 110.33. 

(b) In general, the benefits paid under 

the Program, are secondary to any 

obligation of any third-party payer to 

provide or pay for such benefits. The 

benefits available under the CICP 

usually will be paid only after the 

requester has in good faith attempted to 

obtain all other available coverage from 

all third-party payers with an obligation 

to pay for or provide such benefits (e.g., 

medical insurance for medical services 

or items, workers’ compensation 

program(s) for lost employment 

income). However, as provided in 

§ 110.84, the Secretary has the 

discretion to pay benefits under this 

Program before a potential third-party 

payer makes a determination on the 

availability of similar benefits and has 

the right to later pursue a claim against 

any third-party payer with a legal or 

contractual obligation to pay for, or 

provide, such benefits. 

§ 110.3 Definitions. 

This section defines certain words 

and phrases found throughout this part. 

(a) Act or PHS Act means the Public 

Health Service Act, as amended. 

(b) Alternative calculation means the 

calculation used in § 110.82(c) of this 

part for the death benefit available to 

dependents younger than 18 years old at 

the time of payment. 

(c) Approval means a decision by the 

Secretary or her designee that the 

requester is eligible for benefits under 

the Program. 

(d) Benefits means payments and/or 

compensation for reasonable and 

necessary medical expenses or 

provision of services described in 

§ 110.31, lost employment income 

described in § 110.32, and/or payment 

to certain survivors of death benefits 

described in § 110.33. 

(e)(1) Child means any natural, 

illegitimate, adopted, posthumous child, 

or stepchild of a deceased injured 

countermeasure recipient who, at the 

time of the countermeasure recipient’s 

death is: 

(i) 18 years of age or younger; or 

(ii) Between 19 and 22 years of age 

and a full-time student; or 

(iii) Incapable of self-support due to a 

physical or mental disability. 

(2) Posthumous child means a child 

born after the death of the parent. 

(3) Stepchild means a child of an 

injured countermeasure recipient’s 

spouse but who is not the child of the 

injured countermeasure recipient. For a 

stepchild to be eligible for survivor 

death benefits under the Program, the 

stepchild’s parent must have been 

married to the injured countermeasure 

recipient at the time of that injured 

countermeasure recipient’s death, and 

the stepchild must have been supported 

by the injured countermeasure 

recipient. 

(f) Covered Countermeasure means 

the term that is defined in section 319F– 

3(i)(1) of the PHS Act and described in 

a declaration issued under section 

319F–3(b) of the PHS Act (42 U.S.C. 

247d–6d(i)(I),(b)). To be a covered 

countermeasure for purposes of this 

part, the countermeasure must have 

been administered or used pursuant to 

the terms of a declaration, or in a good 

faith belief of such; and 

(1) Administered or used within a 

State (as defined in § 110.3(aa)), or 

otherwise in the territory of the United 

States; or 

(2) Administered to, or used by, 

otherwise eligible individuals— 

(i) At American embassies or military 

installations abroad (such as military 

bases, ships, and camps); or 

(ii) At North Atlantic Treaty 

Organization (NATO) installations 

(subject to the NATO Status Agreement) 

where American servicemen and 

servicewomen are stationed. 

(g) Covered injury means death, or a 

serious injury as described in 

§ 110.20(b), and determined by the 

Secretary in accordance with § 110.20 of 

this part, to be: 

(1) An injury meeting the 

requirements of a Covered 

Countermeasures Injury Table, which is 

presumed to be the direct result of the 

administration or use of a covered 

countermeasure unless the Secretary 

determines there is another more likely 

cause; or 

(2) An injury (or its health 

complications) that is the direct result of 

the administration or use of a covered 

countermeasure. This includes serious 

aggravation caused by a covered 

countermeasure of a pre-existing 

condition. 

(h) Declaration means a 

recommendation issued by the Secretary 

under section 319F–3(b) of the PHS Act 

(42 U.S.C. 247d–6d(b)), for the 

manufacture, testing, development, 

distribution, administration, or use of 

one or more covered countermeasures, 

following her determination that a 

specific disease, condition, or threat 

represents a public health emergency or 

a credible risk of a future public health 

emergency. 

(i) Dependent means, for purposes of 

lost employment income benefits, a 

person whom the Internal Revenue 

Service would consider to be the injured 

countermeasure recipient’s dependent 

at the time the covered injury was 

sustained. For purposes of survivor 

death benefits, dependent means a 

person whom the Internal Revenue 

Service would consider to be the 

deceased injured countermeasure 

recipient’s dependent at the time the 

covered injury was sustained, and who 

is younger than the age of 18 at the time 

of filing the Request Form. 

(j) Disapproval means a decision by 

the Secretary that the individual 

requesting benefits is not eligible to 

receive benefits under the Program for 

the specified injury that is the basis of 

the Request for Benefits. 

(k) Effective period of the declaration 

means the time span specified in a 

declaration, or as amended by the 

Secretary. 

(l) Federal Employees’ Compensation 

Act (FECA) Program means the workers’ 

compensation benefits program for 

civilian officers and employees of the 

Federal Government established under 5 

U.S.C. 8101 et seq. as amended, and 

implemented by the United States 

Department of Labor in regulations 

codified at 20 CFR part 10, as amended. 

(m) Healthcare provider means an 

individual licensed, certified, or 

registered by an appropriate authority 

and who is qualified and authorized to 

provide health care services, such as 

diagnosing and treating physical or 

mental health conditions, prescribing 

medications, and providing primary 

and/or specialty care. 

(n) Injured countermeasure recipient 

means an individual: 

(1) Who, with respect to 

administration or use of a covered 

countermeasure pursuant to a 

Secretarial declaration: 

(i) Meets the specifications of the 

pertinent declaration; or 

(ii) Is administered or uses a covered 

countermeasure in a good faith belief 

that he or she is in a category described 

by paragraph (1)(i) of this definition; 

and 

(2) Sustained a covered injury as 

defined in § 110.3(g). 

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(3) If a covered countermeasure is 

administered to, or used by, a pregnant 

woman in accordance with paragraphs 

(1)(i) or (1)(ii) of this definition, any 

child from that pregnancy who survives 

birth is an injured countermeasure 

recipient if the child is born with, or 

later sustains, a covered injury (as 

defined in section 110.3(g)) as the direct 

result of the covered countermeasure’s 

administration to, or use by, the mother 

during her pregnancy. 

(o) Lacks legal capacity means legally 

incompetent to receive payment(s) of 

benefits, as determined under 

applicable law. 

(p) Medical records means 

documentation associated with primary 

care, hospital in-patient and out-patient 

care, specialty consultations, and 

diagnostic testing and results. 

(q) Payer of last resort means that the 

Program pays benefits secondary to all 

other public and private third-party 

payers who have an obligation to pay for 

such benefits. 

(r) Program means the 

Countermeasures Injury Compensation 

Program (CICP). 

(s) PREP Act means the Public 

Readiness and Emergency Preparedness 

Act, codified as sections 319F–3 and 

319F–4 of the PHS Act (42 U.S.C. 247d– 

6d, 42 U.S.C. 247d–6e). 

(t) Public Safety Officers’ Benefits 

(PSOB) Program means the Program 

established under Subpart 1 of part L of 

title I of the Omnibus Crime Control and 

Safe Streets Act of 1968 (42 U.S.C. 3796 

et seq.), as amended, and implemented 

by the United States Department of 

Justice in regulations codified at 28 CFR 

part 32, as amended. 

(u) Representative (legal or personal) 

means someone other than the person 

for whom Program benefits are sought, 

and who is authorized to file the 

Request Package on the requester’s 

behalf pursuant to § 110.44. 

(v) Requester means an injured 

countermeasure recipient, or survivor, 

or the estate of a deceased injured 

countermeasure recipient (through the 

executor or administrator of the estate) 

who files a Request Package for Program 

benefits, or on whose behalf a Request 

Package is filed, under this part. 

(w) Request Form or Request for 

Benefits Form means the document 

designated by the Secretary for applying 

for Program benefits under this part. 

(x) Request Package means the 

Request Form, all documentation 

submitted by, or on behalf of, the 

requester, and all documentation 

obtained by the Secretary as authorized 

by, or on behalf of, the requester for 

determinations of Program eligibility 

and benefits under this part. 

(y) Secretary means the Secretary of 

Health and Human Services and any 

other officer or employee of the 

Department of Health and Human 

Services to whom the authority 

conferred on the Secretary under the 

PREP Act has been delegated. 

(z) Serious injury means serious 

physical injury. Physical biochemical 

alterations leading to physical changes 

and serious functional abnormalities at 

the cellular or tissue level in any bodily 

function may, in certain circumstances, 

be considered serious injuries. As a 

general matter, only injuries that 

warranted hospitalization (whether or 

not the person was actually 

hospitalized) or injuries that led to a 

significant loss of function or disability 

(whether or not hospitalization was 

warranted) will be considered serious 

injuries. 

(aa) Standard calculation means the 

calculation used in § 110.82(b) of this 

part for the death benefit available to all 

eligible survivors (other than surviving 

dependents younger than the age of 18 

who do not fit the definition of ‘‘child’’ 

under § 110.3(e)). 

(bb) State means any State of the 

United States of America, the District of 

Columbia, United States territories, 

commonwealths, and possessions, the 

Republic of the Marshall Islands, the 

Republic of Palau, and the Federated 

States of Micronesia. 

(cc) Survivor means a person meeting 

the requirements of § 110.11 with 

respect to a deceased injured 

countermeasure recipient who died as a 

direct result of a covered injury. 

(dd) Table or Table of Injuries means 

a Table of Covered Countermeasure 

Injuries to be included under Subpart K 

of this part, including the definitions 

and requirements set out therein. 

(ee) Third-party payer means the 

United States (other than for payments 

of benefits under this Program) or any 

other third party, including but not 

limited to, any State or local 

governmental entity, private insurance 

carrier, or employer, any public or 

private entity with a legal or contractual 

obligation to pay for or provide benefits. 

The Program is the payer of last resort. 

Subpart B—Persons Eligible To 

Receive Benefits 

§ 110.10 Eligible requesters. 

(a) The following requesters may, as 

determined by the Secretary, be eligible 

to receive benefits from this Program: 

(1) Injured countermeasure recipients, 

as described in § 110.3(n); 

(2) Survivors, as described in 

§ 110.3(cc) and § 110.11; or 

(3) Estates of deceased injured 

countermeasure recipients through 

individuals authorized to act on behalf 

of the deceased injured countermeasure 

recipient’s estate under applicable State 

law (i.e., executors or administrators). 

(b) If a countermeasure recipient dies, 

his or her survivor(s) and/or the 

executor or administrator of his or her 

estate may file a new Request Package 

(or Request Package(s)) or amend a 

previously filed Request Package. A new 

Request Package may be filed whether 

or not a Request Package was previously 

submitted by, or on behalf of, the 

deceased injured countermeasure 

recipient, but must be filed within the 

filing deadlines described in § 110.42. 

Amendments to previously filed 

Request Packages and the filing 

deadlines for such amendments are 

described in § 110.46. 

(c) The benefits available to different 

categories of requesters are described in 

§ 110.30. 

§ 110.11 Survivors. 

(a) Survivors of injured 

countermeasure recipients who died as 

the direct result of a covered injury. If 

the Secretary determines that an injured 

countermeasure recipient died as the 

direct result of a covered injury (or 

injuries), his or her survivor(s) may be 

eligible for death benefits. 

(b) Survivors who may be eligible to 

receive benefits and the order of priority 

for benefits. (1) The Act uses the same 

categories of survivors and order of 

priority for benefits as established and 

defined by the PSOB Program, except as 

provided in paragraphs (b)(3), (4), and 

(5) of this section. 

(2) The PSOB Program’s categories of 

survivors (known in the PSOB Program 

as beneficiaries) and order of priority for 

receipt of death benefits are detailed 

under subpart 1 of part L of title I of the 

Omnibus Crime Control and Safe Streets 

Act of 1968 (42 U.S.C. 3796 et seq.), as 

amended, as implemented in 28 CFR 

part 32. 

(3) In the PSOB Program, the person 

who is survived must have satisfied the 

eligibility requirements for a deceased 

public safety officer, whereas the person 

who is survived under this Program 

must be a deceased injured 

countermeasure recipient who would 

otherwise have been eligible under this 

part. 

(4) Unlike the PSOB Program, if there 

are no survivors eligible to receive death 

benefits under the PSOB Program (as set 

forth in paragraph (b)(2) of this section), 

the legal guardian of a deceased minor 

who was a countermeasure recipient 

may be eligible as a survivor under this 

Program. Such legal guardianship must 

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be determined by a court of competent 

jurisdiction under applicable State law. 

(5) A surviving dependent younger 

than the age of 18 whose legal guardian 

opts to receive a death benefit under the 

alternative calculation on the 

dependent’s behalf will have the same 

priority as surviving eligible children 

under the PSOB Program (consistent 

with paragraph (b)(2) of this section) 

even if the dependent is not the 

surviving eligible child of the deceased 

countermeasure recipient for purposes 

of the PSOB Program. However, such a 

dependent may only be eligible to 

receive benefits under the alternative 

death benefits calculation, described in 

§ 110.82(c), and is not eligible to receive 

death benefits under the standard 

calculation described in § 110.82(b). 

Death benefits paid under the 

alternative calculation will be paid to 

the dependents’ legal guardian(s) on 

behalf of all such dependents. 

(6) Any change in the order of priority 

of survivors or of the eligible category of 

survivors under the PSOB Program shall 

apply to requesters seeking death 

benefits under this Program on the 

effective date of the change, even prior 

to any corresponding amendment to this 

part. Such changes will apply to 

Request Packages pending with the 

Program on the effective date of the 

change, as well as to Requests filed after 

that date. 

Subpart C—Covered Injuries 

§ 110.20 How to establish a covered injury. 

(a) General. Only serious injuries, as 

described in § 110.3(z), or deaths are 

covered under the Program. In order to 

be eligible for benefits under the 

Program, a requester must submit 

documentation showing that a covered 

injury, as described in § 110.3(g), was 

sustained as the direct result of the 

administration or use of a covered 

countermeasure pursuant to the terms of 

a declaration under section 319F–3(b) of 

the PHS Act (including administration 

or use during the effective period of the 

declaration) or as the direct result of the 

administration or use of a covered 

countermeasure in a good faith belief 

that it was administered or used 

pursuant to the terms of a declaration 

(including administration or use during 

the effective period of the declaration). 

A requester can establish that a covered 

injury was sustained by demonstrating 

to the Secretary that a Table injury 

occurred, as described in paragraph (c) 

of this section. In the alternative, a 

requester can establish that an injury 

was actually caused by a covered 

countermeasure, as described in 

paragraph (d) of this section. The 

Secretary may obtain the opinions of 

qualified medical experts in making 

determinations concerning covered 

injuries. 

(b) Table injuries. A Table lists and 

explains injuries that, based on 

compelling, reliable, valid, medical and 

scientific evidence, are presumed to be 

caused by a covered countermeasure, 

and the time periods in which the onset 

(i.e., first sign or symptom) of these 

injuries must occur after administration 

or use of the covered countermeasures. 

If an injury occurred within the listed 

time periods, and at the level of severity 

required, there is a rebuttable 

presumption that the covered 

countermeasure was the cause of the 

injury. A Table is accompanied by 

Qualifications and Aids to 

Interpretation which provide an 

explanation of the injuries listed on a 

Table. A requester may establish that a 

covered injury occurred by 

demonstrating that the countermeasure 

recipient sustained an injury listed on a 

Table, within the time interval defined 

by the Table’s Definitions and 

Requirements. In such circumstances, 

the requester need not demonstrate the 

cause of the injury because the Secretary 

will presume, only for purposes of 

making determinations under this 

Subpart, that the injury was the direct 

result of the administration or use of a 

covered countermeasure. Even if the 

Table requirements are satisfied, 

however, an injury will not be 

considered a covered injury if the 

Secretary determines, based on her 

review of the evidence, that a source 

other than the countermeasure more 

likely caused the injury. In such 

circumstances, the Table presumption 

of causation will be rebutted. 

(c) Injuries for which causation must 

be shown (non-Table injuries). If an 

injury is not included on a Table or if 

the injury does not meet the 

requirements set out for an injury that 

is listed on a Table (e.g., the first sign 

or symptom of the injury did not occur 

within the time interval specified on the 

Table), the requester must demonstrate 

that the injury occurred as the direct 

result of the administration or use of a 

covered countermeasure. Such proof 

must be based on compelling, reliable, 

valid, medical and scientific evidence. 

Temporal association between receipt of 

the countermeasure and onset of the 

injury is not sufficient by itself to prove 

that the countermeasure caused the 

injury. 

(d) Injuries resulting from the 

underlying condition for which the 

countermeasure was administered or 

used. An injury sustained as the direct 

result of the covered condition or 

disease for which the countermeasure 

was administered or used, and not as 

the direct result of the administration or 

use of the covered countermeasure, is 

not a covered injury (e.g., if the covered 

countermeasure is ineffective in treating 

or preventing the underlying condition 

or disease). 

Subpart D—Available Benefits 

§ 110.30 Benefits available to different 

categories of requesters under this 

Program. 

(a) Benefits available to injured 

countermeasure recipients. A requester 

who is an injured countermeasure 

recipient may be eligible to receive 

either medical benefits or benefits for 

lost employment income, or both. 

(b) Benefits available to survivors. A 

requester who is an eligible survivor of 

a deceased injured countermeasure 

recipient may be eligible to receive a 

death benefit if the death was caused by 

the covered injury or its health 

complications. 

(c) Benefits available to estates of 

deceased injured countermeasure 

recipients. The estate of an otherwise 

eligible deceased injured 

countermeasure recipient may be 

eligible to receive medical benefits or 

benefits for lost employment income, or 

both, if such benefits were accrued 

during the deceased countermeasure 

recipient’s lifetime, or at the time of 

death, as a result of a covered injury or 

its health complications, but have not 

yet been paid in full by the Program. 

Such medical benefits and benefits for 

lost employment income may be 

available regardless of the cause of 

death. The estate of the deceased 

injured countermeasure recipient may 

not receive a death benefit. Death 

benefits are only available to certain 

survivors. 

§ 110.31 Medical benefits. 

(a) Injured countermeasure recipients 

may receive payments or 

reimbursements for medical services 

and items that the Secretary determines 

to be reasonable and necessary to 

diagnose or treat a covered injury, or to 

diagnose, treat, or prevent the health 

complications of a covered injury. The 

Secretary may pay for such medical 

services and items in an effort to cure, 

counteract, or minimize the effects of 

any covered injury, or any health 

complication of a covered injury, or to 

give relief, reduce the degree or the 

period of disability, or aid in lessening 

the amount of benefits to a requester 

(e.g., a surgical procedure that lessens 

the amount of time and expense for the 

treatment of a covered injury). The 

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Secretary may make such payments or 

reimbursements if reasonable and 

necessary medical services and items 

have already been provided or if they 

are likely to be needed in the future. In 

making determinations about which 

medical services and items are 

reasonable and necessary, the Secretary 

may consider whether those medical 

services and items were prescribed or 

recommended by a healthcare provider, 

and may consider whether the 

applicable service or item is within the 

standard of care for that condition. 

(b) To receive medical benefits for the 

health complications of a covered 

injury, a requester must demonstrate 

that the complications are the direct 

result of the covered injury. Examples of 

health complications include, but are 

not limited to, ill-effects that stem from 

the covered injury, an adverse reaction 

to a prescribed medication or as a result 

of a diagnostic test used in connection 

with a covered injury, or a complication 

of a surgical procedure used to treat a 

covered injury. 

(c) The calculation of medical benefits 

available under this Program is 

described in § 110.80. Although there 

are no caps on medical benefits, the 

Secretary may limit payments to the 

amounts that she determines are 

reasonable for services and items 

considered reasonable and necessary. 

All payment or reimbursement for 

medical services and items is secondary 

to any obligation of any third-party 

payer to pay for or provide such services 

or items to the requester. As provided in 

§ 110.84, the Secretary retains the right 

to recover medical benefits paid by the 

Program to requesters if third-party 

payers are obligated to provide those 

benefits. Requesters are expected to 

make good faith efforts to pursue 

medical benefits and services from their 

primary payers. The Secretary reserves 

the right to disapprove medical benefits 

if the requester fails to do so. 

(d) The Secretary may make payments 

of medical benefits or reimbursements 

of medical expenses described in this 

section to the estate of a deceased 

injured countermeasure recipient as 

long as such payments or expenses were 

accrued during the deceased injured 

countermeasure recipient’s lifetime, or 

at the time of death, as the result of the 

covered injury or its health 

complications, and were not paid in full 

by the Program before the deceased 

injured countermeasure recipient died. 

§ 110.32 Benefits for lost employment 

income. 

(a) Requesters who are determined to 

be eligible for Program benefits as 

injured countermeasure recipients may 

be able to receive benefits for loss of 

employment income incurred as a result 

of a covered injury (or its health 

complications, as described in 

§ 110.31(b)). Compensation for lost 

wages is paid as a percentage of the 

amount of employment income earned 

at the time of injury and lost as the 

result of the covered injury or its health 

complications. The period of time 

requested for lost employment income 

benefits must be supported by the 

severity of the covered injury as 

demonstrated by the medical and 

employment records. 

(b) The method and amount of 

benefits for lost employment income are 

described in § 110.81. Benefits for lost 

employment income will be adjusted if 

there are fewer than ten days of lost 

employment income. Pursuant to law, 

and as described in § 110.81, benefits 

provided for lost employment income 

may also be adjusted for annual and 

lifetime caps. Payment of benefits for 

lost employment income is secondary to 

any obligation of any third-party payer 

to pay for lost employment income or to 

provide disability or retirement benefits 

to the requester. It is the obligation of 

requesters to follow all specified 

procedures to apply for and acquire 

third-party benefits. The Secretary has 

the discretion to disapprove lost 

employment income benefits if the 

requester fails to do so. As provided in 

§ 110.84, the Secretary reserves the right 

to recover lost employment income 

benefits paid by the Program to 

requesters if third-party payers are 

obligated to provide those benefits. 

(c) The Secretary does not require an 

individual to use paid leave (e.g., sick 

leave or vacation leave) for lost work 

days. However, if an individual uses 

paid leave for lost work days, the 

Secretary will not consider those days to 

be days of lost employment income 

unless the individual reimburses the 

employer for the paid leave taken and 

the employer restores the leave that was 

used. This puts the individual back in 

the same position as if he or she had not 

used paid leave for the lost work days. 

(d) The Secretary may pay benefits for 

lost employment income to the estate of 

a deceased injured countermeasure 

recipient as long as such benefits were 

accrued during the deceased injured 

countermeasure recipient’s lifetime as 

the result of a covered injury or its 

health complications, and were not paid 

in full by the Program before the 

deceased injured countermeasure 

recipient died. However, no such lost 

employment income may be paid after 

the receipt, by the survivor or survivors 

of a deceased injured countermeasure 

recipient, of death benefits under 

§ 110.82. 

§ 110.33 Death benefits. 

(a) Eligible survivors may be able to 

receive a death benefit under this 

Program if the Secretary determines that 

an otherwise eligible countermeasure 

recipient sustained a covered injury and 

died as a direct result of the injury or 

its health complications. The method 

and amount of death benefits are 

described in § 110.82. As provided in 

§ 110.84, the Secretary retains the right 

to recover death benefits paid by the 

Program if third-party payers are 

obligated to provide those benefits. 

There are two different calculations for 

death benefits: the standard calculation 

and the alternative calculation. 

(b) The standard calculation, 

described in § 110.82(b), is based upon 

the death benefit available under the 

PSOB Program and is available to all 

eligible survivors with one exception 

(surviving dependents younger than the 

age of 18 who do not fit the definition 

of ‘‘child’’ under § 110.3(e)). In the event 

that death benefits were paid under the 

PSOB Program with respect to the 

deceased injured countermeasure 

recipient, no death benefits may be paid 

under the standard calculation. In 

addition, death benefits under this 

standard calculation are secondary to 

disability benefits under the PSOB 

Program. If a disability benefit was paid 

under the PSOB Program, the amount of 

that disability benefit would be 

deducted from benefits payable under 

the standard calculation. 

(c) The alternative calculation, 

described in § 110.82(c), is based on the 

injured countermeasure recipient’s 

employment income at the time of the 

covered injury. Payment under this 

calculation is only available to surviving 

dependents who are younger than the 

age of 18 at the time of payment. The 

legal guardian(s) of such surviving 

dependents must select the death 

benefit as calculated under this 

alternative calculation before it will be 

paid. Annual and lifetime caps may 

apply. The payment of a death benefit 

as calculated under this alternative 

calculation is secondary to other 

benefits paid or payable with respect to 

the deceased injured countermeasure 

recipient, namely: 

(1) Compensation for loss of 

employment income (except for lost 

employment income under this 

Program); 

(2) Death or disability benefits (i.e., 

payments including, but not limited to, 

those under the PSOB Program) on 

behalf of the dependent(s) or their legal 

guardian(s); 

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(3) Retirement benefits on behalf of 

the dependent(s) or their legal 

guardians; or 

(4) Life insurance benefits on behalf of 

the dependent(s). 

Subpart E—Procedures for Filing 

Request Packages 

§ 110.40 How to obtain forms and 

instructions. 

(a) Copies of all necessary forms and 

instructions will be available: 

(1) By writing to the Countermeasures 

Injury Compensation Program, 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

Parklawn Building, Room 11C–26, 5600 

Fishers Lane, Rockville, MD 20857. 

(2) By calling 1–888–ASK–HRSA. 

This is a toll-free number. 

(3) By downloading them from the 

Internet at http://www.hrsa.gov/ 

countermeasurescomp/. Click on the 

link to ‘‘Forms and Instructions.’’ 

(b) Before reviewing a Request for 

Benefits, the Secretary will assign a case 

number to the Request for Benefits and 

so inform the requester (or his or her 

representative) in writing. All 

correspondence to the requester (or his 

or her representative) about a specific 

Request for Benefits will be referenced 

by this case number. 

§ 110.41 How to file a Request Package. 

A Request Package comprises all the 

forms and documentation that are 

submitted to enable the Secretary to 

determine eligibility and calculate 

benefits. Request Packages may be 

submitted through the U.S. Postal 

Service, commercial carrier, or private 

courier service. The Countermeasures 

Injury Compensation Program will not 

accept Request Packages that are handdelivered. Electronic submissions are 

not currently accepted, but may be in 

the future. The Program will publish a 

notice if electronic filing becomes 

available. Requesters (or their 

representatives) should send all forms 

and documentation to the 

Countermeasures Injury Compensation 

Program, Healthcare Systems Bureau, 

Health Resources and Services 

Administration, Parklawn Building, 

Room 11C–26, 5600 Fishers Lane, 

Rockville, MD 20857. All 

documentation to the Program must 

include the case number once one has 

been assigned to the requester. 

§ 110.42 Deadlines for filing Request 

Forms. 

(a) General. All Request Forms (or 

Letters of Intent, described in paragraph 

(b) of this section) must be filed within 

one year of the date of the 

administration or use of a covered 

countermeasure that is alleged to have 

caused the injury. If no previous 

Request Form (or Letter of Intent) has 

been filed, this deadline also applies to 

survivor(s) of an injured 

countermeasure recipient who is 

deceased, and to the executor or 

administrator of his or her estate. If a 

Request Form (or Letter of Intent) was 

previously filed, § 110.46 describes 

amendments to Request Packages. 

(b) Letters of Intent. Until Request 

Forms and Instructions are available, 

requesters must file a Letter of Intent to 

File, in order to establish that their 

Requests for Benefits are timely filed 

within the one-year deadline. Directions 

for submitting a Letter of Intent (to file) 

are available on the Program’s Web site 

at http://www.hrsa.gov/ 

countermeasurescomp/ or by calling 1– 

888–ASK–HRSA. Even once Request 

Forms are available, the Secretary has 

the discretion to accept Letters of Intent 

(to file) for purposes of meeting the 

filing deadline. However, when Request 

Forms and Instructions are available, all 

requesters who have submitted Letters 

of Intent must still file Request Forms as 

soon as possible. 

(c) Determination of proper filing. The 

filing date is the date the Request Form 

(or Letter of Intent) is postmarked. A 

legibly dated receipt from a commercial 

carrier, a private courier service, or the 

U.S. Postal Service will be considered 

equivalent to a postmark. If and when 

Request Forms are accepted 

electronically, the filing date is the date 

the Request Form is submitted 

electronically. A Request Form will not 

be considered filed unless it has been 

completed (to the fullest extent 

possible) and signed by the requester or 

his or her personal or legal 

representative. After filing a Request 

Form within the governing filing 

deadline, a requester must update the 

Request Package to reflect new 

information as it becomes available (e.g., 

copies of medical records generated 

after the initial submission of the 

Request Package). 

(d) Request Forms not filed within the 

one-year deadline. If the Secretary 

determines that a Request Form or 

Letter of Intent was not filed within the 

governing filing deadline set out in this 

section, the Request Form (or Letter of 

Intent) will not be processed and the 

requester will not be eligible for benefits 

under this Program. 

(e) Constructive receipt. The Secretary 

reserves the right to consider a legal 

claim filed with the Federal 

Government (e.g., a Federal Tort Claims 

Act claim or a petition with the National 

Vaccine Injury Compensation Program) 

concerning an alleged injury resulting 

from the administration or use of a 

covered countermeasure to be a filing of 

a Request Form or Letter of Intent for 

purposes of determining the filing date 

under this Program. The date of such 

constructive filing will be the official 

filing date of the action, i.e., when all 

applicable requirements for proper 

filing in that forum have been met. 

(f) Request Forms (or amendments to 

Request Forms) based on initial 

publication of a Table of Injuries or 

modifications to an existing Table. The 

Secretary may publish a new Table (or 

Tables) by amendment(s) to subpart K of 

this part. The effect of such a new Table 

or amendment may enable a requester 

who previously could not establish a 

Table injury to do so. In such 

circumstances, the requester must file a 

new Request Form if one was previously 

submitted and eligibility was denied or 

if one was not previously submitted 

within one year after the effective date 

of the establishment of, or amendment 

to, the Table. If the Secretary has not 

made a determination, she will 

automatically review any pending 

Request Forms in light of the new or 

amended Table(s). 

§ 110.43 Deadlines for submitting 

documentation. 

(a) Documentation for eligibility 

determinations. A requester will satisfy 

the filing deadline as long as the signed 

Request Form is completed (to the 

fullest extent possible) and submitted 

within the governing filing deadline 

described in § 110.42. The Secretary 

generally will not begin review of a 

requester’s eligibility until all the 

documentation necessary to make this 

determination has been submitted. 

(b) Documentation for benefits 

determinations. Although the Secretary 

will accept documentation required to 

make benefits determinations (i.e., 

calculate benefits available, if any) at 

the time the Request Form is filed or 

any time thereafter, requesters need not 

submit such documentation until they 

have been notified that the Secretary has 

determined eligibility. The Secretary 

will not generally begin review of the 

benefits available to a requester until the 

documentation necessary to make a 

benefits determination has been 

submitted. 

§ 110.44 Legal or personal representatives 

of requesters. 

(a) Generally. Persons other than a 

requester (e.g., a lawyer, guardian, 

family member, friend) may file a 

Request Package on a requester’s behalf 

as his or her legal or personal 

representative. A requester need not use 

the services of a lawyer to apply for 

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benefits under this Program. A legal 

representative, or a personal 

representative (who does not need to be 

a lawyer) is only required, as described 

in this section, for requesters who are 

minors or adults who lack legal capacity 

to receive payment of benefits. In the 

event that a legal or personal 

representative files on behalf of a 

requester, the representative will be 

bound by the obligations and 

documentation requirements that apply 

to the requester (e.g., if a requester is 

required to submit employment records, 

the representative must file the 

requester’s employment records). The 

representative must also satisfy the 

requirements specific to representatives 

set out in this part. If a requester has a 

representative, the Program will 

generally direct all communications to 

the representative. However, the 

Secretary reserves the right of the 

Program to contact the requester directly 

if necessary, and to conduct a follow-up 

survey to determine the ability of the 

Program to meet requesters’ needs. 

(b) Legal or personal representatives 

of legally competent adults. A requester 

who is a legally competent adult may 

use a legal or personal representative to 

submit a Request Package on his or her 

behalf. In such circumstances, the 

requester must indicate on the Request 

Form that he or she is authorizing the 

representative to seek benefits under 

this Program on his or her behalf. 

(c) Legal or personal representatives 

of minors and adults who lack legal 

capacity to receive payment of benefits. 

A requester who is a minor or an adult 

who lacks legal capacity to receive 

payment of benefits must use a legal or 

personal representative to apply for 

benefits under this Program on his or 

her behalf. In such circumstances, the 

representative must indicate, in the 

place provided on the Request Form, 

that the requester is a minor or an adult 

who lacks legal capacity to receive 

payment of benefits and that the 

representative is filing on behalf of the 

requester. In addition, before the 

requester will be paid by the Program, 

the representative must submit the 

documentation described in § 110.63. A 

minor who is emancipated, as 

determined by a court of competent 

jurisdiction, does not need a legal or 

personal representative to file a Request 

Form or Request Package on his or her 

behalf. 

(d) No payment or reimbursement for 

legal or personal representatives’ fees or 

costs. The Act does not authorize the 

Secretary to pay for, or reimburse, any 

fees or costs associated with the 

requester’s use of the services of a legal 

or personal representative under this 

Program, including those of an attorney. 

§ 110.45 Multiple survivors. 

Multiple survivors of the same 

deceased injured countermeasure 

recipient may file Request Forms 

separately or together. Multiple 

survivors may also submit one set of any 

required documentation on behalf of all 

of the requesting survivors as long as 

such documentation is identical for 

each survivor. 

§ 110.46 Amending a Request Package. 

(a) Generally. All requesters may 

amend their documentation concerning 

eligibility up to the time the Secretary 

has made an eligibility determination. 

Requesters are expected to submit 

additional medical records as they 

become available. Requesters also may 

amend their information or 

documentation concerning the 

calculation of benefits until the 

Secretary has made a benefits 

determination. Once an eligibility 

determination has been made, the 

Secretary will not accept additional 

documentation concerning eligibility, 

except as described in paragraphs (b) 

and (c) of this section. Once a benefits 

determination has been made, the 

Secretary will not accept additional 

documentation regarding the type or 

amount of benefits for that covered 

injury, except as described in 

paragraphs (b) and (c) of this section. 

(b) Requesters who are survivors. If an 

injured countermeasure recipient 

submitted a Request Form within the 

filing deadline, but subsequently dies, 

or the executor or administrator timely 

filed on behalf of the estate, the 

survivor(s) may amend the previously 

filed Request Package at any time by 

filing a new Request Form in order to 

be considered for death benefits. Such 

an amendment can be filed regardless of 

whether the Secretary made an 

eligibility determination or paid benefits 

with respect to the deceased injured 

countermeasure recipient’s Request 

Package. However, a survivor filing an 

amendment to a previously filed 

Request Package may only be eligible for 

benefits if the previously filed Request 

Package was filed within the governing 

filing deadline. All documentation that 

has already been submitted with respect 

to the deceased injured countermeasure 

recipient will be considered part of the 

survivor requester’s Request Package, 

and he or she is not required to resubmit 

such documentation. Survivor 

requesters must also file an amendment 

to a Request Package if there is a change 

in the order of priority of survivors, as 

described in § 110.11. 

(c) Requests in which the benefits are 

sought for the estate of a deceased 

injured countermeasure recipient. If an 

injured countermeasure recipient 

submitted a Request Form within the 

filing deadline, but subsequently dies 

before all due benefits are paid by the 

Program, the executor or administrator 

of his or her estate may amend his or 

her Request Package at any time in order 

for the estate to be considered for 

benefits. This opportunity to amend 

applies also if the Request Form was 

timely filed by a survivor. Such an 

amendment can be filed regardless of 

whether the Secretary made an 

eligibility determination or paid benefits 

with respect to the deceased injured 

countermeasure recipient’s Request 

Package. However, the executor or 

administrator of the deceased injured 

countermeasure recipient’s estate filing 

an amendment to a previously filed 

Request Package may only be eligible to 

receive benefits on behalf of the estate 

if the previously filed Request Package 

was filed within the governing deadline. 

All documentation that has already been 

submitted with respect to the deceased 

injured countermeasure recipient will 

be considered part of that person’s 

Request Package, and the executor or 

administrator of the estate is not 

required to resubmit such 

documentation. 

Subpart F—Documentation Required 

for the Secretary To Determine 

Eligibility 

§ 110.50 Medical records necessary for the 

Secretary to determine whether a covered 

injury was sustained. 

(a) In order to determine whether an 

injured countermeasure recipient 

sustained a covered injury, a requester 

must arrange for his or her medical 

providers to submit to the Program the 

following medical records, as defined in 

§ 110.3(p): 

(1) All medical records documenting 

medical visits, procedures, 

consultations, and test results that 

occurred on or after the date of 

administration or use of the covered 

countermeasure; and 

(2) All hospital records, including the 

admission history and physical 

examination, the discharge summary, all 

physician subspecialty consultation 

reports, all physician and nursing 

progress notes, and all test results that 

occurred on or after the date of 

administration or use of the covered 

countermeasure; and 

(3) All medical records for one year 

prior to administration or use of the 

covered countermeasure as necessary to 

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indicate an injured countermeasure 

recipient’s pre-existing medical history. 

(b) A requester may submit additional 

medical documentation that he or she 

believes will support the Request 

Package. Although generally not 

required if a Table injury was sustained, 

a requester may introduce additional 

medical documentation or scientific 

evidence in order to establish that an 

injury was caused by a covered 

countermeasure. Letters from treating 

physicians may be submitted as 

additional evidence, but may not 

substitute for the medical 

documentation required in paragraph (a) 

of this section. 

(c) If certain medical records listed in 

paragraph (a) of this section are 

unavailable to the Program after the 

requester has made reasonable efforts to 

facilitate the records being sent to the 

Program, the requester must submit a 

statement describing the reasons for the 

records’ unavailability and the efforts he 

or she has made to arrange for the health 

care providers to submit them. The 

Secretary has the discretion to accept 

this statement in place of the 

unavailable medical records. In this 

circumstance, the Secretary may attempt 

to obtain the records on the requester’s 

behalf. 

(d) In certain circumstances, the 

Secretary may require additional 

records to make a determination that a 

covered injury was sustained (e.g., 

medical records more than one year 

prior to the date of administration or use 

of the covered countermeasure) or may 

determine that certain records described 

in paragraph (a) of this section are not 

necessary for an eligibility 

determination. 

(e) Although the Secretary prefers to 

receive medical records directly from 

healthcare providers, she has the 

discretion to accept them from the 

requester. 

§ 110.51 Documentation an injured 

countermeasure recipient must submit for 

the Secretary to make a determination of 

eligibility for Program benefits. 

(a) An injured countermeasure 

recipient (or his or her legal or personal 

representative) must submit all of the 

following documentation in order for 

the Secretary to make a determination of 

eligibility: 

(1) A completed and signed Request 

Form submitted within the filing 

deadline described in § 110.42; and 

(2) Records sufficient to demonstrate 

that the injured countermeasure 

recipient used or was administered a 

covered countermeasure; and 

(3) Records sufficient to demonstrate 

that the injured countermeasure 

recipient sustained a covered injury, as 

defined in § 110.3(g), in accordance 

with the requirements set forth in 

§ 110.50; and 

(4) A copy of each signed 

Authorization for Health Information 

Form authorizing the release of records 

to the Program that was sent by the 

requester to each healthcare provider 

instructing that the records be submitted 

directly to the Program. 

(b) In certain circumstances, some of 

the above documentation may not be 

required, or additional documentation 

may be required, in which case the 

Secretary will so notify the requester. 

For example, the Secretary may require 

records sufficient to demonstrate that 

the injured countermeasure recipient 

was administered or used a covered 

countermeasure in accordance with the 

provisions of a Secretarial declaration, 

or in the good faith belief that it was so 

administered or used, if she is unable to 

determine this from the records 

submitted. In order to meet the 

specifications of a declaration, some 

individuals will need to show that the 

activity giving rise to the injury (i.e., 

administration or use of the covered 

countermeasure) was authorized in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction, as defined in the 

pertinent declaration, to prescribe, 

administer, deliver, distribute or 

dispense the covered countermeasure 

following a declaration of an emergency, 

as defined in the pertinent declaration. 

For purposes of this part, this 

requirement can be satisfied by showing 

that the covered countermeasure was 

administered or used following the 

declaration of an emergency, as defined 

in the pertinent declaration, by an 

Authority Having Jurisdiction, as 

defined in the pertinent declaration 

either: 

(1) Pursuant to a written agreement or 

other formal arrangement with an 

Authority Having Jurisdiction; or 

(2) In accordance with the written 

recommendations of an Authority 

Having Jurisdiction. 

§ 110.52 Documentation a survivor must 

submit for the Secretary to make a 

determination of eligibility for death 

benefits. 

(a) A requester who is a survivor 

under § 110.11 must submit the 

following documentation in order for a 

determination of eligibility for a death 

benefit to be made: 

(1) All of the documentation required 

for individuals in § 110.51. There is no 

need to duplicate documentation 

already submitted to satisfy the 

requirements of other subparts in this 

part. For example, if the deceased 

injured countermeasure recipient had 

previously filed, the documentation 

submitted does not have to be resubmitted; and 

(2) A death certificate for the deceased 

countermeasure recipient. If a death 

certificate is unavailable, the requester 

must submit a letter providing the 

reasons for its unavailability. The 

Secretary has the discretion to accept 

other documentation as evidence that 

the injured countermeasure recipient is 

deceased; and 

(3) Medical records sufficient to 

establish that the deceased injured 

countermeasure recipient died as the 

result of the covered injury or its health 

complications. Such medical records 

may be the same as those required 

under § 110.50. If an autopsy was 

performed, the requester must submit a 

complete copy of the final autopsy 

report; and 

(4) Documentation showing that the 

requester is an eligible survivor, 

pursuant to § 110.11 (e.g., birth 

certificate or marriage certificate); and 

(5) Verification, on the place provided 

on the Request Form, either that there 

are no other eligible survivors (e.g., for 

surviving eligible children, that there is 

no surviving spouse, no other surviving 

eligible children, and no other surviving 

dependents younger than the age of 18 

who may be eligible for the death 

benefit under the alternative 

calculation) or that other eligible 

survivors exist (along with the 

information known about such 

survivors). Section 110.11 describes 

eligible survivors and the priorities of 

survivorship; and 

(6) Even if a Request Form had 

previously been filed by the injured 

countermeasure recipient, the 

survivor(s) must submit a new Request 

Form. 

(b) [Reserved] 

§ 110.53 Documentation the executor or 

administrator of the estate of a deceased 

injured countermeasure recipient must 

submit for the Secretary to make a 

determination of eligibility for benefits to 

the estate. 

(a) The executor or administrator of 

the estate of a deceased injured 

countermeasure recipient must submit 

the following documentation in order 

for a determination of eligibility for 

benefits to the estate to be made: 

(1) All of the documentation required 

for individuals in § 110.51; 

(2) A death certificate for the deceased 

injured countermeasure recipient. If a 

death certificate is unavailable, the 

executor or administrator must submit a 

letter providing the reasons for its 

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unavailability. The Secretary has the 

discretion to accept other 

documentation as evidence that the 

injured countermeasure recipient is 

deceased; and 

(3) Documentation showing that the 

individual is the executor or 

administrator of the estate of the 

deceased injured countermeasure 

recipient, e.g., Letter of Administration 

issued by a court of competent 

jurisdiction; and 

(4) Even if a Request Form had 

previously been filed by the injured 

countermeasure recipient, the executor 

or administrator of the estate must 

submit a new Request Form. 

(b) [Reserved] 

Subpart G—Documentation Required 

for the Secretary To Determine 

Program Benefits 

§ 110.60 Documentation a requester who 

is determined to be eligible must submit for 

the Secretary to make a determination of 

medical benefits. 

(a) A requester determined by the 

Secretary to be eligible for Program 

benefits and who seeks payment or 

reimbursement for medical services or 

items must provide the following, in 

addition to the documentation 

submitted under subpart F of this part: 

(1) List of third-party payers. The 

requester must submit a list of all thirdparty payers that may have an obligation 

to pay for or provide any medical 

services or items to the injured 

countermeasure recipient for which 

payment or reimbursement is being 

sought under this Program. Such thirdparty payers may include, but are not 

limited to, health maintenance 

organizations, health insurance 

companies, workers’ compensation 

programs, Medicare, Medicaid, 

Department of Veterans Affairs, military 

treatment facilities (MTFs), and any 

other entities obligated to provide 

medical services or items or reimburse 

individuals for medical expenses. Such 

a list must include the injured 

countermeasure recipient’s account 

numbers and other applicable 

information. If the requester knows of 

no such third-party payer, he or she 

must so certify in writing. If the 

requester becomes aware that a thirdparty payer may have such an 

obligation, the requester must inform 

the Secretary within ten business days 

of becoming aware of this information, 

even after benefits have been paid by 

the Program. 

(2) Documents for medical services or 

items provided since the onset of the 

covered injury. A requester seeking 

payment or reimbursement for medical 

services or items already provided for a 

covered injury or its health 

complications must submit an itemized 

statement from each healthcare provider 

or entity (e.g., clinic, hospital, doctor, or 

pharmacy) and third-party payer listing 

the services or items provided to 

diagnose or treat the covered injury or 

its health complications and the 

amounts paid or expected to be paid by 

third parties for such services or items 

(e.g., an Explanation of Benefits from 

the individual’s health insurance 

company). If no third-party payer has an 

obligation to pay for or provide such 

services or items, the requester must so 

certify in writing and submit an 

itemized list of the services or items 

provided (including the total cost of 

such services or items). To assist the 

Secretary in making a determination as 

to whether such services or items were 

reasonable and necessary to diagnose or 

treat a covered injury, or to diagnose, 

treat, or prevent its health 

complications, the requester may 

submit, in addition to the required 

medical records, documentation 

showing that a health-care provider 

prescribed or recommended such 

services or items. The medical records 

must support the requested services and 

items. 

(3) Documents for medical services 

and items expected to be provided in 

the future. A requester seeking 

payments for medical services or items 

resulting from a covered injury or its 

health complications expected to be 

provided in the future must submit a 

statement from each healthcare provider 

(e.g., a treating neurologist for 

neurological issues and a treating 

cardiologist for cardiac issues) 

describing those services and items that 

appear likely to be needed to diagnose 

or treat the covered injury, or to 

diagnose, treat, or prevent its health 

complications, in the future. The 

medical records must support the 

requested services and items. A 

requester must submit documentation, if 

available, concerning the likely cost of, 

and the amount expected to be covered 

by third-party payers for, such services 

or items. Consent for the Program to 

communicate directly with the 

healthcare providers may also be 

required. 

(b) [Reserved] 

§ 110.61 Documentation a requester who 

is determined to be eligible must submit for 

the Secretary to make a determination of 

lost employment income benefits. 

(a) A requester determined by the 

Secretary to be eligible for Program 

benefits and who seeks benefits for lost 

employment income must provide, in 

addition to the documentation 

submitted under subpart F of this part, 

documentation describing: 

(1) The number of days (including 

partial days) of work missed by the 

injured countermeasure recipient as a 

result of the covered injury or its health 

complications for which employment 

income was lost (e.g., time sheet from 

the relevant pay period(s) showing work 

days missed). As stated in § 110.32(c), 

days for which an individual used paid 

leave will be considered days of work 

for which employment income was 

received and, therefore, would not 

qualify for lost employment income 

benefits. However, if the injured 

countermeasure recipient reimburses 

the employer for the paid leave taken 

and the employer restores the leave that 

was used, the individual may be eligible 

for lost employment income benefits for 

those days; and 

(2) The injured countermeasure 

recipient’s gross employment income at 

the time the covered injury was 

sustained (e.g., the individual’s Federal 

tax return or pay stub(s) from all 

employers at the time of the covered 

injury); and 

(3) Whether the injured 

countermeasure recipient had one or 

more dependents at the time the 

covered injury was sustained (e.g., the 

individual’s Federal tax return at the 

time of the covered injury); and 

(4) A list of all third-party payers that 

have paid, or that may be obligated to 

pay, benefits to the injured 

countermeasure recipient for loss of 

employment income or provide 

disability and/or retirement benefits for 

which payment or reimbursement is 

being sought under this Program (e.g., 

State workers’ compensation programs, 

disability insurance programs, Uniform 

Services Retirement Board 

determinations, Department of Veterans 

Affairs determinations, etc.). A requester 

must submit documentation, if 

available, concerning the amount of 

such payments or benefits paid or 

payable to, or on behalf of, the injured 

countermeasure recipient by third-party 

payers. If the requester knows of no 

such third-party payer, he or she must 

so certify in writing. If, at any time, the 

requester becomes aware that a thirdparty payer may have such an 

obligation, the requester must inform 

the Secretary within ten business days 

of becoming aware of this information, 

even after benefits have been paid by 

the Program. 

(b) [Reserved] 

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63684 Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 

§ 110.62 Documentation a requester who 

is determined to be an eligible survivor 

must submit for the Secretary to make a 

determination of death benefits. 

(a) A requester determined by the 

Secretary to be an eligible survivor and 

who seeks a death benefit under 

§ 110.82(b) (the standard calculation) 

must provide, in addition to the 

documentation submitted under subpart 

F of this part, a written certification 

informing the Secretary whether a 

disability or death benefit was paid or 

payable under the PSOB Program with 

respect to the deceased injured 

countermeasure recipient. If such 

benefit was provided, the requester 

must submit documentation showing 

the amount of the benefit paid by the 

PSOB Program. If the deceased injured 

countermeasure recipient was covered 

under the PSOB and no such benefit 

was, or will be provided, the 

certification must explain whether any 

survivors are eligible for a death benefit 

under the PSOB Program and, if so, 

whether a death benefit may be paid or 

payable under the PSOB Program. 

(b) The legal guardian seeking a death 

benefit under § 110.82(c) (the alternative 

calculation) on behalf of a dependent 

younger than the age of 18 determined 

by the Secretary to be an eligible 

survivor must provide, in addition to 

the documentation submitted under 

Subpart F of this part, the following: 

(1) Documentation showing that the 

deceased injured countermeasure 

recipient is survived by one or more 

dependents younger than the age of 18. 

Such documentation must show the 

date of birth of all such dependents 

(e.g., copies of birth certificates); 

(2) Documentation showing that the 

requester is the legal guardian of all of 

the dependents described in paragraph 

(b)(1) of this section, as required under 

§ 110.63(a). If multiple dependents have 

different legal guardians, the legal 

guardian of each of the dependents must 

submit such documentation; 

(3) A written selection by each legal 

guardian, on behalf of all of the 

dependents described in paragraph 

(b)(1) of this section for whom he or she 

is the legal guardian, to receive 

proportional death benefits under the 

alternative calculation as described in 

§ 110.82(c), in place of proportional 

benefits available under the standard 

calculation as described in § 110.82(b). 

Written selections are described in 

§ 110.82(c)(1); 

(4) Documentation showing the 

deceased injured countermeasure 

recipient’s gross employment income at 

the time the covered injury was 

sustained (e.g., the decedent’s Federal 

tax return or pay stub(s) from all 

employers at the time of the covered 

injury); and 

(5) A description of all third-party 

payers that have paid for, or that may 

be required to pay for, the benefits 

described in § 110.82(c)(3)(i). This 

description must include the amount of 

such benefits that have been paid or that 

may be paid in the future. If the 

representative knows of no such thirdparty payer, he or she must so certify in 

writing. If, at any time, the 

representative becomes aware that a 

third-party payer may have such an 

obligation, he or she must inform the 

Secretary within ten business days of 

becoming aware of this information, 

even after benefits have been paid by 

the Program. 

§ 110.63 Documentation a legal or 

personal representative must submit when 

filing on behalf of a minor or on behalf of 

an adult who lacks legal capacity to receive 

payment of benefits. 

Before benefits will be paid by the 

Program to an eligible requester who is 

a minor or an adult who lacks legal 

capacity to receive payment of benefits, 

his or her legal or personal 

representative must submit the 

following, in addition to the 

documentation required under Subpart 

F of this part and, as applicable, 

§§ 110.60–110.62: 

(a) For an eligible requester who is a 

minor: 

(1) Documentation showing that the 

requester is a minor (e.g., birth 

certificate); and 

(2) Documentation showing that the 

representative is the legal guardian of 

the property or estate of the minor (e.g., 

appointment of guardianship by a court 

of competent jurisdiction). If a minor 

has more than one legal guardian, this 

documentation is required only of one 

legal guardian. In the alternative, 

documentation showing that the minor 

is considered emancipated under 

applicable State law. In accordance with 

§ 110.83(b), the Program reserves the 

right to waive the requirement of 

documentation of guardianship for good 

cause. 

(b) For an eligible requester who is an 

adult who lacks legal capacity to receive 

payment of benefits: 

(1) Documentation showing that the 

requester is an adult who lacks this legal 

capacity (e.g., declaration of legal 

incapacity issued by a court of 

competent jurisdiction, or comparable 

documentation); and 

(2) A decree by a court of competent 

jurisdiction establishing a guardianship 

or conservatorship of the requester’s 

estate under applicable State law, or 

durable power of attorney, if applicable. 

In accordance with § 110.83(b), the 

Program reserves the right to waive this 

requirement for good cause. 

Subpart H—Secretarial Determinations 

§ 110.70 Determinations the Secretary 

must make before benefits can be paid. 

Before the Secretary will pay benefits 

under this Program, she must determine 

that: 

(a) The requester or his or her 

representative submitted a completed 

and signed Request Form within the 

governing filing deadline; and 

(b) The requester meets the eligibility 

requirements set out in this part 

(including a determination that a 

covered injury was sustained); and 

(c) The requester is entitled to receive 

benefits from the Program. In making 

this determination, the Secretary will 

decide the type(s) and amounts of 

benefits that will be paid to the 

requester. 

§ 110.71 Insufficient documentation for 

eligibility and benefits determinations. 

In the event that there is insufficient 

documentation in the Request Package 

for the Secretary to make the applicable 

determinations under this part, the 

Secretary will so notify the requester, or 

his or her representative. The requester 

will be given 60 calendar days from the 

date of the Secretary’s notification to 

submit the required documentation. If 

the requester is unable to provide the 

additional documentation, he or she 

may provide a written explanation of 

the reason(s) that the requested 

documentation is unavailable and the 

efforts the requester has made to obtain 

the documents. The Secretary may 

accept such a statement in place of the 

required documentation or disapprove 

the Request for Benefits due to 

insufficient documentation. If 

insufficient documentation is submitted 

in response to the Secretary’s letter, the 

Secretary may disapprove the Request 

for Benefits. 

§ 110.72 Sufficient documentation for 

eligibility and benefits determinations. 

(a) Eligibility determinations. When 

the Secretary determines that there is 

sufficient documentation in the Request 

Package to evaluate a requester’s 

eligibility, she will begin the review to 

determine whether the requester is 

eligible for Program benefits. If the 

Secretary determines that the requester 

is not eligible, the Secretary will inform 

the requester (or his or her 

representative) in writing of the 

disapproval, and the right to 

reconsideration of the determination, as 

described in subpart J. 

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(b) Benefits determinations. If the 

Secretary determines that the requester 

is eligible for benefits, she will, after 

receiving adequate documentation from 

the requester for a benefits 

determination, either calculate the 

amount and types of benefits, as 

described in subpart I of this part, or 

request additional documentation in 

order to calculate the benefits that can 

be paid (e.g., an Explanation of Benefits 

from the requester’s health insurance 

company, if none was submitted). As 

provided in subpart J, requesters have 

the right to reconsideration of the 

Secretary’s determination of the 

category and amount of benefits payable 

under the Program. 

(c) Additional documentation 

required. At any time after a Request 

Form has been filed, the Secretary may 

ask a requester to supplement or amend 

the Request Package by providing 

additional information or 

documentation. 

§ 110.73 Approval of benefits. 

When the Secretary has determined 

that benefits will be paid to a requester 

and has calculated the type and amount 

of such benefits, she will so notify the 

requester (or his or her representative) 

in writing. The Secretary will make 

payments in accordance with § 110.83. 

Once all benefits have been paid, the 

Request Package can no longer be 

amended (except for survivor benefits). 

The payment determination will 

constitute final agency action with 

regard to the particular countermeasure 

injury that is the subject of the Request 

for Benefits and payment (i.e., the 

Request for Benefits is closed with 

regard to the injury that is the basis of 

the payment of benefits). 

§ 110.74 Disapproval of benefits. 

(a) If the Secretary determines that a 

requester is not eligible for payments 

under the Program, the Secretary will 

disapprove the Request for Benefits and 

provide the requester, or his or her 

representative, with written notice of 

the basis for the disapproval, and the 

right to reconsideration of the 

determination, as provided in § 110.90. 

(b) The Secretary may disapprove a 

Request for Benefits even before the 

requester has submitted all the required 

documentation (e.g., the Secretary may 

determine that a requester did not meet 

the filing deadline, or that a covered 

countermeasure was not used or 

administered). 

(c) The Secretary may re-open a 

disapproved Request for Benefits on her 

own accord should medical or scientific 

evidence later become available to 

justify a re-determination of the 

disapproval of eligibility or payments. 

In extraordinary circumstances, to be 

determined at the Secretary’s discretion, 

she may re-open a disapproved Request 

for Benefits even after the requester has 

exercised the right to reconsideration 

and the disapproval determination has 

been upheld in accordance with the 

procedures set out in § 110.90. 

Subpart I—Calculation and Payment of 

Benefits 

§ 110.80 Calculation of medical benefits. 

In calculating medical benefits, the 

Secretary will take into consideration all 

reasonable costs for reasonable and 

necessary medical items and services to 

diagnose or treat a countermeasure 

recipient’s covered injury, or to 

diagnose, treat, or prevent its health 

complications, as described in § 110.31. 

The Secretary will consider and may 

rely upon benefits documentation 

submitted by the requester (e.g., bills, 

Explanation of Benefits, and cost-related 

documentation to support the expenses 

relating to the covered injury or its 

health complications), as required by 

§ 110.60. The Secretary will make such 

payments only to the extent that such 

costs were not, and will not be, paid by 

any third-party payer and only if no 

third-party payer had or has an 

obligation to pay for or provide such 

services or items to the requester, except 

as provided in §§ 110.83(c) and 110.84. 

There are no caps on the benefits for 

reasonable and necessary medical 

expenses that may be provided under 

the Program. 

§ 110.81 Calculation of benefits for lost 

employment income. 

(a) Primary calculation. Benefits 

under this section may be paid for days 

of work lost as a result of a covered 

injury or its health complications if the 

injured countermeasure recipient lost 

employment income for the lost work 

days as reasonable based on the degree 

of injury or disability. As stated in 

§ 110.32(c), days for which an 

individual used paid leave will be 

considered days of work for which 

employment income was received and, 

therefore, would not qualify for lost 

employment income benefits. However, 

if the injured countermeasure recipient 

reimburses the employer for the paid 

leave taken and the employer restores 

the leave that was used, the individual 

may be eligible for lost employment 

income benefits for those days; 

(1) The Secretary will calculate the 

rate of benefits to be paid for the lost 

work days based on the injured 

countermeasure recipient’s gross 

employment income, which includes 

income from self-employment, at the 

time he or she sustained the covered 

injury. The Secretary may not, except 

with respect to injured individuals who 

are minors, consider projected future 

earnings in this calculation. 

(i) For an injured countermeasure 

recipient with no dependents at the 

time the covered injury was sustained, 

the benefits are 662⁄3 percent of the 

individual’s gross employment income 

at the time of injury. 

(ii) For an injured countermeasure 

recipient with one or more dependents 

at the time the covered injury was 

sustained, the benefits are 75 percent of 

the individual’s gross employment 

income at the time of injury; and 

(iii) In the case of an injured 

countermeasure recipient who is a 

minor, the Secretary may consider the 

provisions of 5 U.S.C. 8113 (authorizing 

the FECA Program), and any 

implementing regulations, in 

determining the amount of payments 

under this section and the 

circumstances under which such 

payments are reasonable and necessary. 

(b) Adjustment for inflation. Benefits 

for lost employment income paid under 

the Program that represent future lost 

employment income will be adjusted 

annually to account for inflation. 

(c) Limitations on benefits paid. The 

Secretary will reduce the benefits 

calculated under paragraphs (a) and (b) 

of this section according to the 

limitations described in this paragraph 

(c): 

(1) Number of lost work days. An 

injured countermeasure recipient will 

be compensated for ten or more days of 

work lost if he or she lost employment 

income for those days as a result of the 

covered injury (or its health 

complications). If the number of days of 

lost employment income due to the 

covered injury (or its health 

complications) is fewer than ten, the 

Secretary will reduce the number of lost 

work days by five days. If the injured 

countermeasure recipient lost 

employment income for a period of five 

days or fewer, no benefits for lost 

employment income will be paid. Lost 

work days do not need to be 

consecutive. Partial days of lost 

employment income may be aggregated 

to calculate the total number of lost 

work days. The Secretary has the 

discretion to consider the 

reasonableness of the number of work 

days (or partial work days) lost as a 

result of a covered injury or its health 

complications in this calculation, and to 

consider alternative work schedules in 

determining the number of work days 

lost. 

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(2) Annual limitation. The maximum 

amount that an injured countermeasure 

recipient may receive in any one year in 

benefits for lost employment income 

under this Program is $50,000. 

(3) Lifetime limitation. The maximum 

amount that an injured countermeasure 

recipient can receive during his or her 

lifetime in benefits for lost employment 

income under this Program is the 

amount of the death benefit calculated 

under the PSOB Program in the same 

fiscal year as the year in which this 

lifetime cap is reached. This amount is 

the maximum death benefit payable to 

survivors under this Program using the 

standard calculation described in 

§ 110.82(b). However, this lifetime cap 

does not apply if the Secretary 

determines that the countermeasure 

recipient has a covered injury (or 

injuries) meeting the definition of 

‘‘disability’’ in section 216(i) of the 

Social Security Act, 42 U.S.C. 416(i). 

(4) Termination of payments. The 

Secretary will not pay benefits for lost 

employment income after the injured 

countermeasure recipient reaches the 

age of 65. 

(d) Reductions for other coverage. 

From the amount of benefits calculated 

under paragraphs (a), (b), and (c) of this 

section, the Secretary will make 

reductions: 

(1) For all payments made, or 

expected to be made in the future, to the 

injured countermeasure recipient for 

compensation of lost employment 

income or disability or retirement 

benefits, by any third-party payer in 

relation to the covered injury or its 

health complications, consistent with 

§ 110.32(b); and 

(2) So that the total amount of benefits 

for lost employment income paid to an 

injured countermeasure recipient under 

this Program, together with the total 

amounts paid (or payable) by third-party 

payers, as described in paragraph (d)(1) 

of this section, does not exceed 662⁄3

percent (or 75 percent, if the injured 

countermeasure recipient had at least 

one dependent at the time the covered 

injury was sustained) of his or her 

employment income at the time of the 

covered injury for the lost work days. 

(3) If an injured countermeasure 

recipient receives a lump-sum payment 

from any third-party payer under any 

obligation described in paragraph (d)(1) 

of this section, the Secretary shall 

consider such a payment to be received 

over a period of years, rather than in a 

single year. The Secretary has discretion 

as to how to apportion such payments 

over multiple years. 

§ 110.82 Calculation of death benefits. 

(a) General. (1) If the legal guardian(s) 

of dependents younger than 18 years of 

age does not file a written selection to 

receive death benefits under the 

alternative calculation, as described in 

paragraph (c)(1) of this section, or if the 

Secretary does not approve such a 

selection, the Secretary will pay 

proportionate death benefits under the 

standard calculation to all of the eligible 

survivors with priority to receive death 

benefits under the standard calculation, 

as described in § 110.33(b) and 

paragraph (b) of this section. 

(2) If the Secretary approves a written 

selection to receive benefits under the 

alternative calculation, as described in 

paragraph (c)(1) of this section: 

(i) If no other eligible survivors are of 

equal priority to receive death benefits, 

the Secretary will pay a death benefit in 

an amount calculated under the 

alternative calculation to the aggregate 

of the dependents on whose behalf the 

election was filed; and 

(ii) If other eligible survivors are of 

equal priority to receive death benefits 

as the dependents receiving death 

benefits under the alternative 

calculation, the Secretary will pay the 

other eligible survivors a proportionate 

amount of the death benefit available 

and calculated under the standard 

calculation. In such circumstances, the 

Secretary will pay the aggregate of the 

dependents receiving a death benefit 

under the alternative calculation a 

proportionate share of the benefits 

available under that calculation (in 

place of the proportionate share of the 

death benefit that would be available 

under the standard calculation). For 

example, if a deceased countermeasure 

recipient is survived by a dependent ten 

year-old child and a spouse who is not 

the child’s legal guardian (e.g., the 

dependent child’s parents were the 

deceased injured countermeasure 

recipient and his or her former spouse), 

the current surviving spouse would be 

able to receive his or her share of the 

death benefit under the standard 

calculation, and the dependent child’s 

legal guardian, on behalf of the minor, 

would receive either the child’s 

proportionate share of the death benefit 

under the standard calculation or the 

child’s proportionate share of the death 

benefit available under the alternative 

calculation (if the legal guardian filed a 

written selection for such a death 

benefit and the Secretary approved the 

selection). 

(b) Standard calculation of death 

benefits. (1) The maximum death benefit 

available under the standard calculation 

of death benefits (described in this 

paragraph) is the amount of the 

comparable death benefit calculated 

under the PSOB Program in the same 

fiscal year in which the injured 

countermeasure recipient died 

(regardless of whether the PSOB 

Program reduces the amount of its death 

benefits because of a limit in 

appropriations). 

(2) No death benefit will be paid 

under the standard calculation if a death 

benefit is paid, or if survivors are 

eligible to receive a death benefit, under 

the PSOB Program with respect to the 

deceased injured countermeasure 

recipient. 

(3) The death benefit will not be 

reduced under the standard calculation 

if a total and permanent disability 

benefit has been, or will be paid under 

the PSOB Program with respect to the 

deceased injured countermeasure 

recipient. However, the death benefit 

will be reduced if a temporary and 

partial disability benefit has been, or 

will be paid under the PSOB Program 

with respect to that individual. If the 

PSOB Program disability benefit paid 

was reduced because of a limitation on 

appropriations, a death benefit will be 

available under the standard calculation 

to the extent necessary to ensure that 

the total amount of disability benefits 

paid under the PSOB Program, together 

with the amount of death benefits paid 

under the standard calculation, equals 

the amount of the death benefit 

described in paragraph (b)(1) of this 

section. 

(4) Under the standard calculation, 

death benefits will be paid in a lump 

sum. 

(c) Alternative calculation of death 

benefits available to surviving 

dependents younger than the age of 18. 

If a deceased countermeasure recipient 

had at least one dependent who is 

younger than the age of 18 (and will be 

younger than the age of 18 at the time 

of the payment), the legal guardian(s) of 

all such dependents may request 

benefits under the alternative 

calculation described in this paragraph. 

To receive such a benefit, the legal 

guardian, on behalf of all such 

dependents for whom he or she is the 

legal guardian, must file a selection to 

receive benefits under the alternative 

calculation, as described in paragraph 

(c)(1) of this section, and the Secretary 

must approve such selection. If multiple 

dependents have different legal 

guardians, each legal guardian is 

responsible for requesting benefits 

under the standard calculation or for 

filing a selection for a death benefit 

under the alternative calculation. If a 

single dependent has more than one 

legal guardian, one legal guardian may 

file the selection. Payments made under 

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the alternative calculation will be made 

to the legal guardian(s) of all of the 

dependents on behalf of all of those 

dependents until they reach the age of 

18. 

(1) Selection of benefits under the 

alternative calculation. Before a 

payment of a death benefit will be 

approved under the alternative 

calculation, the legal guardian(s) of the 

dependents for whom he or she is the 

legal guardian must file a written 

selection, on behalf of all such 

dependents, to receive a death benefit 

under the alternative calculation. If such 

a selection is approved by the Secretary, 

these dependents will be paid a 

proportionate share of the death benefit 

under the alternative calculation in 

place of the proportionate share of 

benefits that would otherwise be 

available to them under the standard 

calculation. 

(2) Amount of payments. The 

maximum death benefit available under 

this paragraph is 75 percent of the 

deceased injured countermeasure 

recipient’s income (including income 

from self-employment) at the time he or 

she sustained the covered injury that 

resulted in death, adjusted to account 

for inflation, except as follows: 

(i) The maximum payment of death 

benefits that may be made on behalf of 

the aggregate of the dependents in any 

one year is $50,000; 

(ii) All payments made under this 

paragraph will stop once the youngest of 

the dependents reaches the age of 18. 

(3) Reductions for other coverage. The 

total amount of death benefits provided 

under the alternative calculation 

(described in this paragraph) will be 

reduced so that the total amount of 

payments made (or expected to be 

made) under obligations described in 

paragraph (c)(3)(i) of this section, 

together with the death benefits paid 

under the alternative calculation, is not 

greater than the amount of payments 

described in paragraph (c)(2) of this 

section. In other words, the total amount 

of death benefits paid to dependents 

under the alternative calculation may be 

reduced if third-party payers have paid 

(or are expected to pay) for certain 

benefits so that such dependents will 

receive a total sum (combining the death 

benefit under the alternative calculation 

and the actual and expected benefits 

covered by third-party payers) that is 

not greater than the death benefit that 

would be available under the alternative 

calculation if there were no third-party 

payer(s) to pay such benefits. The total 

amount of death benefits will not be 

reduced by lost employment income 

paid by the Program. 

(i) The amount of death benefits paid 

under the alternative calculation will be 

reduced for all payments made, or 

expected to be made in the future, by 

any third-party payer for: 

(A) Compensation for the deceased 

countermeasure recipient’s loss of 

employment income on behalf of the 

dependents or their legal guardians(s) 

(but not any lost employment income 

benefits paid by the Program); 

(B) Disability, retirement, or death 

benefits in relation to the deceased 

countermeasure recipient (including, 

but not limited to, death and disability 

benefits under the PSOB Program) on 

behalf of the dependents or their legal 

guardian(s); and 

(C) Life insurance benefits on behalf 

of the dependents; 

(4) Timing of payments. Payments 

made under this paragraph will be made 

on an annual basis, beginning from the 

time of the initial payment, to the legal 

guardian(s) on behalf of the aggregate of 

the dependents receiving the payment. 

In the year in which the youngest 

dependent reaches the age of 18, 

payments under this section will be 

paid on a pro rata basis for the period 

of time before that dependent reaches 

the age of 18. Once a dependent reaches 

the age of 18, the payments under this 

alternative calculation will no longer be 

made on his or her behalf. Because 

payments under the alternative 

calculation are to be made on behalf of 

dependents who are younger than the 

age of 18, if a dependent meets this 

requirement at the time of filing of the 

Request Form, but reaches the age of 18 

(or is older than 18 years of age) at the 

time of the initial payment, no payment 

will be made to the dependent’s legal 

guardian on his or her behalf under the 

alternative calculation. 

§ 110.83 Payment of all benefits. 

(a) The Secretary determines the 

mechanism of payment of Program 

benefits. She may choose to pay any 

benefits under this Program through 

lump-sum payments. If the Secretary 

determines that there is a reasonable 

likelihood that the payments of medical 

benefits, benefits for lost employment 

income, or death benefits paid under the 

alternative calculation (described in 

§ 110.82(c)) will be required for a period 

in excess of one year from the date the 

Secretary determines the requester is 

eligible for such benefits, payments may 

be made through a lump-sum payment, 

the purchase of an annuity or medical 

insurance policy, establishment of a 

trust (including a U.S. grantor 

reversionary trust) or execution of an 

appropriate structured settlement 

agreement, at the Secretary’s discretion. 

Payments, annuities, policies, or 

agreements must be actuarially 

determined to have a value equal to the 

present value of the projected total 

amount of benefits that the requester is 

eligible to receive under §§ 110.80, 

110.81, and 110.82. Lump sum 

payments will be made through an 

electronic funds transfer to an account 

of the requester. 

(b) If the requester is a minor, the 

payment will be made on the minor’s 

behalf to the account of the legal 

guardian of the estate or property of the 

minor. In accepting such payments, the 

legal guardian of a minor requester is 

obligated to use the funds for the benefit 

of the minor and to take any actions 

necessary to comply with State law 

requirements pertaining to such 

payments. If the requester is an adult 

who lacks the legal capacity to receive 

payment(s), the legal guardian must 

establish a guardianship or 

conservatorship of the estate account 

with court oversight, in accordance with 

State law, and payment will be made to 

that account. Documentation of 

guardianship (or conservatorship) is 

required for requesters who are minors 

or adults who lack legal capacity unless 

the Secretary waives this requirement 

for good cause. 

(c) The Secretary has the discretion to 

make interim payments of benefits 

under this Program, even before a final 

determination as to the type(s) and total 

amount of benefits that will be paid. 

Interim payments will be made only in 

exceptional cases. The Secretary may, 

for example, make an interim payment 

of medical benefits that have been 

calculated before a final determination 

on benefits for lost employment income 

is completed, or of past medical benefits 

that have been calculated before a final 

calculation of future medical benefits is 

completed. The Secretary may make an 

interim payment even before a final 

eligibility or benefits determination is 

made (e.g., if a piece of documentation 

has not been obtained because a person 

with a severe countermeasure-related 

injury is hospitalized, but all other 

documentation is consistent with the 

requester meeting the eligibility 

requirements). If such a requester’s 

documentation is incomplete, the 

requester must submit the required 

documentation within the time-frame 

determined by the Secretary. The 

requester must agree that he or she will 

be obligated to repay the Secretary such 

benefits in the event that a Program 

payment is later determined to be 

incorrect. Any payments made on an 

interim basis will not entitle a requester 

to seek reconsideration of the 

Secretary’s decision on these benefits 

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until the Secretary makes a final 

benefits determination. 

§ 110.84 The Secretary’s right to recover 

benefits paid under this Program from thirdparty payers. 

Upon payment of benefits under this 

Program, the Secretary will be 

subrogated to the rights of the requester 

and may assert a claim against any 

third-party payer with a legal or 

contractual obligation to pay for (or 

provide) such benefits and may recover 

from such third-party payer(s) the 

amount of benefits paid up to the 

amount of benefits the third-party payer 

has or had an obligation to pay for (or 

provide). In other words, the Secretary 

may pay benefits before the requester 

receives a payment from a third-party 

payer in certain circumstances. In those 

circumstances, the Secretary has a right 

to be reimbursed by the third-party 

payer. The circumstances in which the 

Secretary may assert this right include 

those in which the Secretary pays 

benefits under this Program to a 

requester before a final decision is made 

that a third-party payer has an 

obligation to pay such benefits to the 

requester. Requesters receiving benefits 

under this Program (or their 

representatives) shall assist the 

Secretary in recovering such benefits. In 

the event that a requester receives a 

benefit from a third-party payer after 

receiving the same type of benefits from 

the Secretary under this Program, the 

Secretary has a right to recover from the 

requester the amount of the benefit(s) 

received. The requester must notify and 

reimburse the Program within ten 

business days of receiving the thirdparty payment(s). 

Subpart J—Reconsideration of the 

Secretary’s Determinations 

§ 110.90 Reconsideration of the 

Secretary’s eligibility and benefits 

determinations. 

(a) Right of reconsideration. A 

requester has the right to seek 

reconsideration of the Secretary’s 

determination that he or she is not 

eligible for Program benefits. In 

addition, a requester who asserts that 

the amount of the benefits paid (or the 

fact that certain benefits were not paid 

or payable) is incorrect may also seek 

reconsideration. A requester may not 

seek reconsideration of the Secretary’s 

decision as to the mechanism of 

payment. Requests for reconsideration 

must be in writing, describe the 

reason(s) why the decision should be 

reconsidered, and be postmarked within 

60 calendar days of the date of the 

Secretary’s decision on the Request for 

Benefits. Because no new 

documentation will be considered in the 

reconsideration process, the 

reconsideration request may not include 

or refer to any documentation that was 

not before the Secretary at the time of 

her determination. 

(b) Letters seeking reconsideration. A 

requester, or his or her representative, 

may send the letter seeking 

reconsideration through the U.S. Postal 

Service, commercial carrier, or a private 

courier service. The Secretary will not 

accept reconsideration requests 

delivered by hand. Electronic 

submissions of letters seeking 

reconsideration are not currently 

accepted, but may be accepted in the 

future. The Program will publish a 

notice if an electronic method becomes 

available. Letters sent through the U.S. 

Postal Service, commercial carrier or 

private courier service must be sent to 

the Associate Administrator, Healthcare 

Systems Bureau, Health Resources and 

Services Administration, 5600 Fishers 

Lane, Room 12–105, Rockville, 

Maryland 20857. 

(c) Reconsideration process. When the 

Associate Administrator of the 

Healthcare Systems Bureau (the 

Associate Administrator), receives a 

request for reconsideration, a qualified 

panel, independent of the Program, will 

be convened to review the Secretary’s 

determination. The panel will base its 

recommendation on the documentation 

before the Secretary when the 

determination was made. The panel will 

perform its own review and make its 

own findings, which will be submitted 

to the Associate Administrator. The 

Associate Administrator will then 

review the panel’s recommendation(s) 

and make a final determination, which 

will be sent to the requester (or his or 

her representative). This will be the 

Secretary’s final action on the request 

for reconsideration and will be 

considered the Secretary’s final 

determination on the request for 

Program benefits with regard to the 

injury that is the subject of that Request 

Package. Requesters may not seek 

review of a decision made on 

reconsideration. 

(d) Effect of reconsideration on 

amending a Request Package. As stated 

in § 110.46, a Request Package cannot be 

amended after exhaustion of the 

reconsideration process, except for 

amendments by survivors seeking death 

benefits or executors or administrators 

on behalf of an estate. 

§ 110.91 Secretary’s review authority. 

Under section 319F–4(b)(4) of the 

Public Health Service Act (42 U.S.C. 

247d–6e(b)(4)) (referencing section 262 

of the PHS Act (42 U.S.C. 239a)), the 

Secretary may, at any time, on her own 

motion or on application, review any 

determination made under this part 

(including, but not limited to, 

determinations concerning eligibility, 

entitlement to benefits, and the 

calculation of amount of benefits under 

the Program). Upon review, the 

Secretary may affirm, vacate, or modify 

the determination in any manner the 

Secretary deems appropriate. 

§ 110.92 No additional judicial or 

administrative review of determinations 

made under this part. 

(a) Under section 319F–4(b)(4) of the 

PHS Act (42 U.S.C. 247d–6e(b)(4)) 

(referencing section 262 of the PHS Act 

(42 U.S.C. 239a)), no judicial review of 

the Secretary’s actions concerning 

eligibility and benefits determinations 

under this part (including, but not 

limited to, determinations concerning 

eligibility, the type or amount of 

benefits, and the method of payment of 

benefits) is permitted. In addition, no 

further administrative review of such 

actions are permitted unless the 

President specifically directs otherwise. 

(b) Under section 319F–4(b)(5)(c) of 

the PHS Act (42 U.S.C. 247d– 

6e(b)(5)(c)), no judicial review of the 

Secretary’s actions in establishing or 

amending a Table (or Tables) for 

purposes of this part (which include, 

but are not limited to, identifying 

injuries on a Table (or choosing not to 

identify injuries on a Table), 

establishing time-frames or definitions 

for Table injuries, and amending a 

Table) is permitted. 

Subpart K—Covered Countermeasures 

Injury Tables 

§ 110.100 [Reserved] 

[FR Doc. 2010–25110 Filed 10–14–10; 8:45 am] 

BILLING CODE 4165–15–P 

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