[Federal Register Volume 75, Number 199 (Friday, October 15, 2010)]
[Rules and Regulations]
[Pages 63656-63688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25110]



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Part IV





Department of Health and Human Services





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42 CFR Part 110



Countermeasures Injury Compensation Program (CICP): Administrative 
Implementation, Interim Final Rule; Final Rule

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

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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.

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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 toll-free 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

[[Page 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[supreg] and Relenza[supreg] 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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Summary of the Regulation

Summary of Available Benefits (Sec.  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 Sec.  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 Sec.  110.32 and cover lost employment income incurred as a 
result of a covered injury or its health complications. Death benefits 
are described in Sec.  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 
Sec.  110.33, death benefits are available under standard or 
alternative calculations depending upon the eligible survivors.
    As explained in Sec.  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 Sec.  
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 third-party 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-of-pocket 
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 (Sec.  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 Sec.  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 Sec.  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 Sec.  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[supreg] and Relenza[supreg] 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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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[supreg] and 
Relenza[supreg], 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[supreg] and Relenza[supreg] 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

[[Page 63660]]

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 Sec.  110.3(n) themselves, except that the pregnant 
women need not suffer a covered injury as required by Sec.  
110.3(n)(2). As provided for in Sec.  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 Sec.  110.3(bb) and described 
in Sec.  110.11. Categories of eligible survivors and the priority of 
such survivors to receive benefits from the Program are discussed below 
in relation to Sec.  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 (Sec.  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).

[[Page 63661]]

    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 Sec.  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, Sec.  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 Sec.  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 Sec.  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 Sec.  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, Sec.  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

[[Page 63662]]

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 (Sec.  110.20)

    Covered injuries are defined in Sec.  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 pre-existing 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 (Sec.  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

[[Page 63663]]

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 Sec.  110.20(d), requesters with such 
claims may need to submit sufficient relevant medical documentation or 
scientific evidence (such as studies published in peer-reviewed 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 (Sec.  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 (Sec.  110.31 and Sec.  
110.80)

    Medical benefits that may be available under the Program are 
described in Sec.  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

[[Page 63664]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  110.31(c), requesters are expected to make good 
faith efforts to pursue medical benefits and services from their 
primary payers. Further, Sec.  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 Sec.  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 
third-party payer with an obligation to pay for or provide the medical 
services or items.

Lost Employment Income--Summary and Calculation (Sec.  110.32 and Sec.  
110.81)

    Lost employment income benefits that may be available under the 
Program appear in Sec.  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 Sec.  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 Sec.  
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

[[Page 63665]]

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 Sec.  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 Sec.  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 Sec.  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 66\2/3\ 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 (Sec.  110.11, Sec.  110.33, 
and Sec.  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 Sec.  110.11 (eligible 
survivors and their priority to receive death benefits), Sec.  110.33 
(general description of death benefits) and Sec.  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 Sec.  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 Sec.  
110.82(c). This method is based upon the deceased person's

[[Page 63666]]

employment income at the time of the covered injury.

Filing a Request Package (Sec.  110.40-Sec.  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 Sec.  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 (Sec.  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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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

[[Page 63667]]

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 Sec.  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 
Sec.  110.42(f) is an additional and alternative filing period to the 
one afforded to all potential requesters under Sec.  110.42(a). 
Therefore, persons who would be eligible to use the filing deadline 
described in Sec.  110.42(f) could rely on the deadline provided under 
Sec.  110.42(a) or Sec.  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 Sec.  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 Sec.  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 Sec.  110.42(a).

Deadlines for Submitting Documentation (Sec.  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 Sec.  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 Sec.  110.50 and Sec. Sec.  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 Sec. Sec.  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 (Sec.  110.44)

    Requesters do not need to retain the services of lawyers to pursue 
benefits under this Program. However, as provided in Sec.  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 Sec.  
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 Sec.  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 
Sec.  100.63.
    As explained above, although legal representation is permitted, it 
is not needed for filing for Program benefits. As described in Sec.  
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 (Sec.  110.45)

    If there are multiple survivors, then each survivor may submit 
Request

[[Page 63668]]

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 (Sec.  110.46)

    The filing of amendments to previously filed Request Packages is 
discussed in Sec.  110.46. As explained in Sec.  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 Sec.  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 (Sec.  110.50-Sec.  
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 (Sec.  110.50)

    The phrase ``medical records'' is defined in Sec.  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

[[Page 63669]]

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 Sec.  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 Sec.  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 Sec.  110.50(d), the Secretary may determine that 
particular records described in Sec.  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 Sec.  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 
(Sec.  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 Sec.  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 Sec.  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 
Sec.  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 Sec.  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 (Sec.  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 Sec.  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

[[Page 63670]]

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, Sec.  
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 (Sec.  
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 Sec.  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 
(Sec.  110.60-Sec.  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 Sec.  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 Sec. Sec.  
110.60, 110.61, and 110.62. As set forth in Sec.  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 Sec.  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 
Sec.  110.82(b) or are choosing a death benefit under the alternative 
calculation described in Sec.  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 third-party payers (described fully in the death benefits 
calculation section of this preamble and set forth in Sec.  
110.82(d)(3)(A)). Survivors seeking death benefits also must submit 
other documentation described in Sec.  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 Sec.  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 
(Sec.  110.70-Sec.  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 Sec.  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 Sec.  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

[[Page 63671]]

discretion to accept a letter meeting the requirements set out in Sec.  
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 
Sec.  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 Sec.  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 Sec.  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 Sec.  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 (Sec.  110.83)

    The Secretary's options in paying all benefits under the Program 
are described in Sec.  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 Sec.  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 Sec.  110.83(a), lump sum payments will generally 
be made through electronic funds transfers to requesters' accounts. 
Under Sec.  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 Sec.  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 (Sec.  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 Sec.  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 third-party 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 (Sec.  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

[[Page 63672]]

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 Sec.  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 
(Sec.  110.91, Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 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[reg] and Relenza[reg] 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:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Number of     Responses per      Hourly       Total burden                     Total hour
                          Form                              respondents     respondent       response          hours         Wage rate         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                      2,520               1               1           2,520           18.72          47,174
 Information Form.......................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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

[[Page 63674]]

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-Barr[eacute] 
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 State-purchased 
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 mid-level 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

[[Page 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[supreg], Relenza[supreg], 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.

0
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


Sec.  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.

[[Page 63676]]

Sec.  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 
Sec.  110.31.
    (2) Lost employment income incurred as a result of a covered 
injury, as described in Sec.  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 Sec.  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 Sec.  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.


Sec.  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 Sec.  
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 Sec.  
110.31, lost employment income described in Sec.  110.32, and/or 
payment to certain survivors of death benefits described in Sec.  
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 Sec.  
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 
Sec.  110.20(b), and determined by the Secretary in accordance with 
Sec.  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 Sec.  110.3(g).

[[Page 63677]]

    (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 Sec.  
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 Sec.  
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 Sec.  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 Sec.  
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


Sec.  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 Sec.  
110.3(n);
    (2) Survivors, as described in Sec.  110.3(cc) and Sec.  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 Sec.  110.42. Amendments to previously 
filed Request Packages and the filing deadlines for such amendments are 
described in Sec.  110.46.
    (c) The benefits available to different categories of requesters 
are described in Sec.  110.30.


Sec.  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

[[Page 63678]]

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 Sec.  110.82(c), and is not eligible to 
receive death benefits under the standard calculation described in 
Sec.  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


Sec.  110.20  How to establish a covered injury.

    (a) General. Only serious injuries, as described in Sec.  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 Sec.  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


Sec.  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.


Sec.  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

[[Page 63679]]

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 Sec.  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 Sec.  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.


Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  110.82.


Sec.  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 Sec.  110.82. As provided in 
Sec.  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 Sec.  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 Sec.  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 Sec.  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);

[[Page 63680]]

    (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


Sec.  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.


Sec.  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 hand-delivered. 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.


Sec.  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, Sec.  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).


Sec.  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 Sec.  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.


Sec.  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

[[Page 63681]]

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 Sec.  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.


Sec.  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.


Sec.  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 Sec.  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


Sec.  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 Sec.  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

[[Page 63682]]

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.


Sec.  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 Sec.  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 
Sec.  110.3(g), in accordance with the requirements set forth in Sec.  
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.


Sec.  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 Sec.  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 Sec.  
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 re-
submitted; 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 Sec.  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 Sec.  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]


Sec.  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 Sec.  
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

[[Page 63683]]

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


Sec.  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 third-party 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 third-party 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 
third-party 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]


Sec.  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 Sec.  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 third-party 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]

[[Page 63684]]

Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  110.82(c), in 
place of proportional benefits available under the standard calculation 
as described in Sec.  110.82(b). Written selections are described in 
Sec.  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 Sec.  
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 third-party 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.


Sec.  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, 
Sec. Sec.  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 Sec.  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 Sec.  110.83(b), the Program reserves the right to 
waive this requirement for good cause.

Subpart H--Secretarial Determinations


Sec.  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.


Sec.  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.


Sec.  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.

[[Page 63685]]

    (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.


Sec.  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 Sec.  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).


Sec.  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 
Sec.  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 Sec.  110.90.

Subpart I--Calculation and Payment of Benefits


Sec.  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 Sec.  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 Sec.  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 Sec. Sec.  
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.


Sec.  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 Sec.  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 66\2/3\ 
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.

[[Page 63686]]

    (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 Sec.  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 Sec.  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 66\2/3\ 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.


Sec.  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 Sec.  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

[[Page 63687]]

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.


Sec.  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 Sec.  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 Sec. Sec.  
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

[[Page 63688]]

until the Secretary makes a final benefits determination.


Sec.  110.84   The Secretary's right to recover benefits paid under 
this Program from third-party 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 third-party payment(s).

Subpart J--Reconsideration of the Secretary's Determinations


Sec.  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 Sec.  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.


Sec.  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.


Sec.  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


Sec.  110.100  [Reserved]

[FR Doc. 2010-25110 Filed 10-14-10; 8:45 am]
BILLING CODE 4165-15-P