[Federal Register Volume 68, Number 241 (Tuesday, December 16, 2003)]
[Rules and Regulations]
[Pages 70080-70106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30790]



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Part II





Department of Health and Human Services





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Health Resources and Services Administration



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42 CFR Part 102



Smallpox Vaccine Injury Compensation Program: Administrative 
Implementation; Interim Final Rule

  Federal Register / Vol. 68, No. 241 / Tuesday, December 16, 2003 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 102

RIN 0906-AA61


Smallpox Vaccine Injury Compensation Program: Administrative 
Implementation

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Interim final rule.

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SUMMARY: The Smallpox Emergency Personnel Protection Act of 2003 
(SEPPA), authorizes the Secretary of Health and Human Services (the 
Secretary), to establish the Smallpox Vaccine Injury Compensation 
Program (``the Program''). This program is designed to provide benefits 
and/or compensation to certain persons harmed as a direct result of 
receiving smallpox covered countermeasures, including the smallpox 
vaccine, or as a direct result of contracting vaccinia through certain 
accidental exposures. In addition, the Secretary may provide death 
benefits to certain survivors of individuals who died as the direct 
result of these injuries.
    On August 27, 2003, the Secretary published an interim final rule 
that set out a Smallpox (Vaccinia) Vaccine Injury Table (``the 
Table''). The table includes adverse effects (including injuries, 
disabilities, conditions, and deaths) within specific time periods that 
shall be presumed to result from the receipt of, or exposure to, the 
smallpox vaccine. The Secretary will use this table, as well as the 
procedures set out in this regulation, in deciding whether persons are 
eligible to receive benefits under the program.
    In this interim final rule, the Secretary is setting out the 
administrative policies, procedures, and requirements governing the 
program, as authorized by the SEPPA. The Secretary is seeking public 
comment on this interim final rule.

DATES: This regulation is effective on December 16, 2003. Written 
comments must be submitted on or before February 17, 2004. The 
Secretary will consider the comments received and will decide whether 
to amend the current procedures and requirements based on such 
comments.

ADDRESSES: All written comments concerning this interim final rule 
should be submitted to the Director, Smallpox Vaccine Injury 
Compensation Program, Special Programs Bureau, Health Resources and 
Services Administration, Parklawn Building, Room 16C-17, 5600 Fishers 
Lane, Rockville, MD 20857. Express and courier mail should be sent to 
the Director, Smallpox Vaccine Injury Compensation Program, Special 
Programs Bureau, Health Resources and Services Administration, 4350 
East-West Highway, 10th Floor, Bethesda, Maryland 20814. Electronic 
comments should be sent to [email protected]. Comments received will be 
available for public inspection at the Smallpox Vaccine Injury 
Compensation Program Office, Special Programs Bureau, Health Resources 
and Services Administration, 4350 East-West Highway, 10th Floor, 
Bethesda, Maryland 20814, between the hours of 8:30 a.m. and 5 p.m. on 
Federal government workdays.

FOR FURTHER INFORMATION CONTACT: Paul T. Clark, Director, Smallpox 
Vaccine Injury Compensation Program, telephone 1-888-496-0338. This is 
a toll-free number. Electronic inquiries should be sent to 
[email protected]. Interested parties may also wish to consult the 
program's Web site at http://www.hrsa.gov/smallpoxinjury.

SUPPLEMENTARY INFORMATION:

Background

    Before it was eradicated, smallpox (variola) was a serious illness 
that manifested as outbreaks of either variola major with death rates 
of greater than 20% or variola minor with death rates of almost 1%. The 
smallpox (vaccinia) vaccine (referred to in this rule as the ``smallpox 
vaccine'') contains a live vaccinia virus that induces immunity to 
smallpox infection, but does not lead to variola infection or disease. 
Vaccinia virus is an orthopox type virus that is different from, but 
related to, the smallpox virus. The smallpox vaccine was an essential 
tool for the successful global eradication of the smallpox virus, 
announced by the World Health Organization in 1980. Despite such 
eradication, concern exists that terrorists may have access to the 
smallpox virus.
    On December 13, 2002, the President announced a plan to protect the 
population of the United States against the threat of a possible 
smallpox attack. This plan was based on heightened concerns, in the 
wake of the attacks of September and October 2001, that terrorists may 
have access to the smallpox virus and may attempt to use it against the 
population of the United States and government facilities abroad. Under 
this plan, which the Secretary is actively working to implement, State 
and local governments have formed smallpox emergency response plans to 
facilitate the provision of critical services to the population of the 
United States in the event of a smallpox virus attack.
    To further the President's plan, the Secretary issued a Declaration 
Regarding Administration of Smallpox Countermeasures on January 24, 
2003 (68 FR 4212). This Declaration was issued pursuant to statutory 
authority, 42 U.S.C. 233(p)(2)(A), which was enacted by the Homeland 
Security Act of 2002, Pub. L. 107-296, 116 Stat. 2135. In this 
Declaration, the Secretary stated that ``a potential bioterrorist 
incident makes it advisable to administer, on a voluntary basis, 
covered countermeasures specified * * * for prevention or treatment of 
smallpox or control or treatment of adverse events related to smallpox 
vaccination, to [specified] categories of individuals * * *.'' The 
specific ``covered countermeasures'' described in the Declaration are 
smallpox vaccines, cidofovir and its derivatives, and Vaccinia Immune 
Globulin. The categories of persons to whom the Secretary recommended 
the administration of such covered countermeasures, on a voluntary 
basis, included certain health care workers, certain public safety 
personnel, other members of smallpox emergency response plans 
identified by State or local government entities or the Department of 
Health and Human Services, and certain personnel associated with 
specific Federal facilities abroad. The Secretary recommended that such 
persons receive the smallpox vaccine to ensure the immediate 
mobilization of smallpox emergency response personnel who would provide 
critical services to the population of the United States in the event 
of a smallpox virus attack. The Secretary's Declaration became 
effective on January 24, 2003, and will remain effective until January 
23, 2004, unless the Secretary extends or shortens that time period by 
amendment.
    Under the Smallpox Vaccine Injury Compensation Program authorized 
by the SEPPA, certain persons may be entitled to benefits (defined as 
benefits and/or compensation) for covered injuries, described below, 
suffered as a direct result of the administration of smallpox covered 
countermeasures (including the smallpox vaccine) or accidental vaccinia 
inoculation. Specifically, the SEPPA authorizes the Secretary to make 
the benefits available to two categories of eligible persons who 
sustained covered injuries, provided

[[Page 70081]]

they meet the legal requirements (e.g., filing deadlines).
    The first category, ``smallpox vaccine recipients,'' includes 
certain persons who volunteer for, and are selected to be members of, a 
smallpox emergency response plan, are vaccinated with a smallpox 
vaccine under such a plan, and sustain covered injuries. The second 
category, vaccinia contacts, includes certain persons who have covered 
injuries as the direct result of exposure to vaccinia through contact 
with certain persons who received the smallpox vaccine or with the 
contacts of such recipients. In addition, if a person in either 
category dies, his or her survivors or his or her estate may be 
eligible for selected benefits under this program in certain 
circumstances.
    The benefits available under the program include compensation for 
medical care, lost employment income, and survivor death benefits. To 
be considered for program benefits, requesters (i.e., smallpox vaccine 
recipients, vaccinia contacts, survivors, or the representatives of the 
estates of deceased smallpox vaccine recipients or vaccinia contacts), 
or persons filing on their behalf as their representatives, must file a 
Request Form and the documentation required under this regulation to 
show that they are eligible.
    As mandated under the SEPPA, the Secretary is herein, at 42 CFR 
part 102, establishing the procedures and requirements governing the 
program. At this time, the Secretary is seeking public comments on 
these procedures and requirements.

Summary of the Regulation

Summary of Available Benefits and Secondary Nature of Benefits (Sec.  
102.2, Sec.  102.84)

    The benefits available under this program are medical benefits, 
benefits for lost employment income, and survivor death benefits.
    As explained in Sec.  102.2(b), the SEPPA establishes that the 
government is a secondary payor for most benefits available under the 
program. Thus, benefits paid under this program are generally secondary 
to any obligation of any third-party payor, described in Sec.  
102.3(aa), to pay for or provide such benefits. Requesters generally 
must provide the names of all other third-party payors that have 
already provided benefits, that are expected to do so in the future, or 
that may have a duty to do so. These payers include, but are not 
limited to: insurance companies, workers' compensation programs, the 
Federal Employees' Compensation Act (FECA) Program, or the Public 
Safety Officers' Benefit (PSOB) Program, a program within the United 
States Department of Justice that provides payments to public safety 
officers and their survivors, including death payments for officers 
killed in the line of duty. If such a third-party payor 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. For example, if a requester 
were otherwise entitled to $10,000 in medical benefits from this 
program and the requester's health insurance company (a third-party 
payor) has paid $5,000 for the covered medical benefits and services, 
the program would pay the requester $5,000 (the amount the requester is 
entitled to under this program, reduced by the amount the requester is 
entitled to from third-party payors). As explained later in the 
preamble, upon payment of benefits under the Smallpox Vaccine Injury 
Compensation Program, the Secretary will be subrogated to the rights of 
the requester and may assert a claim against any third-party payor with 
a legal or contractual obligation to pay for, or provide, such 
benefits.
Description of Eligible Requesters (Sec.  102.10(a))
    (1) Smallpox vaccine recipients, as defined in Sec.  102.3(y).
    A person who has received a smallpox vaccine is only considered a 
``smallpox vaccine recipient,'' for purposes of this program, if he or 
she meets the criteria described in this regulation. Specifically, he 
or she must have been in a covered occupation (including health care 
workers, law enforcement officers, public safety personnel, and 
supporting personnel), received a smallpox vaccine as a participant in 
an approved smallpox emergency response plan, and sustained a covered 
injury, described later in this preamble. The exact requirements for 
smallpox vaccine recipients are set forth in Sec.  102.3(x). For 
example, this regulation provides that, in order to be eligible, a 
smallpox vaccine recipient must have received the smallpox vaccine 
between January 24, 2003, and January 23, 2004, unless the period is 
extended by the Secretary. In order to be covered by the program, a 
smallpox vaccine recipient must also have volunteered for and been 
selected to be a member of a smallpox emergency response plan before 
the time that the Secretary publicly announces that an active case of 
smallpox has been identified anywhere in the world. For this reason, 
persons who become members of smallpox emergency response plans in 
order to respond to a case of smallpox that has already occurred will 
not be considered ``smallpox vaccine recipients.'' Likewise, persons 
who receive the smallpox vaccine as members of the military or members 
of the public who receive the smallpox vaccine voluntarily, and not as 
part of an approved smallpox emergency response plan, are not entitled 
to benefits under the program.
    (2) Vaccinia contact, as defined in Sec.  102.3(bb).
    The SEPPA imposes specific restrictions as to which persons who 
have contracted vaccinia from another person may be eligible for 
benefits under this program. The specific requirements pertaining to 
vaccinia contacts are set forth in Sec.  102.3(bb). As explained in 
that section, vaccinia contacts are only eligible for benefits under 
this program if they can show that they contracted vaccinia as a result 
of contact with a person who either meets the definition of a smallpox 
vaccine recipient (except that the vaccine recipient does not need to 
sustain a covered injury) or who was accidentally inoculated by such a 
person. For this reason, if the source of a contact's exposure to 
vaccinia is a person who received a smallpox vaccine other than under 
an approved smallpox emergency response plan, the contact would not 
fall within the regulation's definition of a ``vaccinia contact'' and 
would not be eligible for benefits under the program. For example, the 
contacts of members of the military and State Department personnel who 
receive the smallpox vaccine for their employment, but not as part of 
an approved smallpox emergency response plan, would not be entitled to 
benefits under this program. Likewise, the contacts of members of the 
general public who receive the smallpox vaccine voluntarily, and not as 
part of an approved smallpox emergency response plan, would not be 
covered under this program. In addition, vaccinia contacts must have 
contracted vaccinia during the effective period of the Declaration 
(between January 24, 2003, and January 23, 2004, unless extended by the 
Secretary), or within 30 days after the end of such period, and must 
have sustained a covered injury.
    (3) Certain survivors of deceased smallpox vaccine recipients or 
vaccinia contacts, as defined in Sec.  102.3(z).
    Categories of eligible survivors and the priority of such survivors 
to receive benefits from the program are discussed in the section of 
this preamble concerning death benefits (the only type of benefit 
survivors are eligible to receive).

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    (4) Representatives of estates of deceased smallpox vaccine 
recipients or vaccinia contacts.
    Representatives of estates of deceased smallpox vaccine recipients 
or vaccinia contacts may file Request Packages with the program as long 
as they are seeking benefits on behalf of the deceased person's estate.
Benefits Available to Different Categories of Requesters (Sec.  102.30)
    An eligible requester who is a smallpox vaccine recipient or a 
vaccinia contact may be entitled to receive either medical benefits or 
benefits for lost employment income or both as long as they provide the 
proper documentation. For example, such requesters must submit 
documentation showing that they have out-of-pocket reasonable and 
necessary medical expenses as a result of a covered injury or its 
health complications in order to receive medical benefits, and 
documentation showing that they lost employment income as a result of a 
covered injury or its health complications in order to receive benefits 
for lost employment income. Such documentation requirements are 
discussed later in this preamble.
    An eligible requester who is the survivor of a deceased smallpox 
vaccine recipient or vaccinia contact may be entitled to receive a 
death benefit.
    The estate of a deceased smallpox vaccine recipient or vaccinia 
contact may be eligible to receive medical benefits or benefits for 
lost employment income or both if such benefits were accrued during the 
deceased person's lifetime as a direct result of a covered injury or 
its health complications, but were not paid during the deceased 
person's lifetime. 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 person might 
have accrued if he or she had not died.
Covered Injuries (Sec.  102.20--Sec.  102.21)
    Covered injuries are defined in Sec.  102.3(g) and set out in 
subpart C of this rule. Covered injuries are those injuries in smallpox 
vaccine recipients or vaccinia contacts that the Secretary determines 
are more likely than not (i.e., by a preponderance of the evidence) the 
direct result of the administration of a covered countermeasure 
(including a smallpox vaccine) or of vaccinia acquired through 
accidental vaccinia inoculation. Because even survivors of, and 
representatives of estates of, deceased smallpox vaccine recipients and 
vaccinia contacts must demonstrate that the deceased person sustained a 
covered injury, a requester will not be deemed eligible for benefits 
under the program unless the Secretary determines that an eligible 
smallpox vaccine recipient or vaccinia contact sustained a covered 
injury.
    One way that requesters can demonstrate that they sustained a 
covered injury is by demonstrating that they sustained an injury listed 
on the Smallpox (Vaccinia) Vaccine Injury Table (the table) within the 
required time interval, as set out in Sec.  102.21. In accordance with 
the SEPPA, a smallpox vaccine recipient or vaccinia contact shall be 
presumed to have sustained a covered injury as the direct result of the 
administration of, or exposure to, the smallpox vaccine if the 
requester submits sufficient documentation demonstrating that he or she 
sustained an injury included on the table, with the onset of the first 
symptom or manifestation within the time interval specified on the 
table. The injury must also meet the table's definitions and 
requirements, set forth in Sec.  102.21(b). In such circumstances, the 
Secretary will presume, solely for purposes of the program, that the 
smallpox vaccine recipient or vaccinia contact's injury was caused by 
the smallpox vaccine or exposure to vaccinia. Such a requester need not 
actually demonstrate that the vaccine (or the vaccinia contracted from 
accidental vaccinia inoculation) caused the underlying injury, only 
that an injury listed on the table 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 SEPPA to make this presumption 
absolutely conclusive. For this reason, based on his review of the 
submitted documentation and other relevant evidence, the Secretary may 
determine that an injury meeting the table requirements was more likely 
than not (i.e., by a preponderance of the evidence) caused by other 
factors and was not caused by the smallpox vaccine or exposure to 
vaccinia (e.g., if the Secretary determined that the medical records 
demonstrated that an individual's injury of encephalopathy was caused 
by a car accident that occurred post-vaccination and not by the 
smallpox vaccine or exposure to vaccinia). In these circumstances, 
which we expect to occur rarely, the Secretary could rebut the table 
presumption and decide that the requester may not be entitled to 
benefits under the program.
    Requesters who believe they sustained an injury included on the 
table, but did not meet all the table requirements (e.g., the first 
manifestation of the injury did not become apparent within the required 
time interval), or requesters who believe they sustained an injury not 
included on the table, may still be able to demonstrate that the injury 
is one that is covered under the program. In order to establish a 
covered injury, such requesters may need to submit sufficient relevant 
medical documentation (such as isolation of vaccinia from the injured 
part of the body) or scientific evidence (such as results of studies 
published in peer-reviewed medical literature). In order to establish a 
covered injury, the Secretary, upon review of this evidence, must 
conclude that, more likely than not, the injury was actually caused by 
the administration of a covered countermeasure or by vaccinia through 
accidental inoculation during the time periods set forth by law. In 
other words, in evaluating such claims, the Secretary will employ a 
preponderance of the evidence standard, taking into consideration all 
relevant medical and scientific evidence, including all relevant 
medical records. As provided under the SEPPA, this determination, as 
with all other actions by the Secretary under this Act, is not 
reviewable by any court.
    Any injury that the Secretary considers minor is not a covered 
injury. For example, covered injuries do not include expected skin 
reactions or expected minor scarring at the vaccination or inoculation 
site. No benefits will be paid for these reactions, as stated in Sec.  
102.20(b).
Medical Benefits--Summary and Calculation (Sec.  102.31 and Sec.  
102.80)
    Medical benefits that may be available under the program are 
described in Sec.  102.31. 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 its direct health complications (sequelae). Past, current, 
and expected future medical services and items may be included in 
medical benefits.
    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 health care practitioner. In considering benefits for

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future medical services and items, the Secretary will consider 
statements by health care practitioners 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.
    In order for a requester to receive medical benefits for a health 
complication, the health complication must have resulted from the 
covered injury and not be more likely due to other factors or 
conditions. Examples of health complications include complications of a 
covered injury that occur as part of the natural course of the 
underlying disease, an adverse reaction to a prescribed medication or 
diagnostic test used in connection with a covered injury, or a 
complication of a surgical procedure used to treat the injury.
    If a smallpox vaccine recipient or vaccinia contact dies before 
filing for, or being paid, benefits for the cost of medical services or 
items accrued during his or her lifetime as a result of a covered 
injury or its health complications, the deceased person's estate may be 
paid such medical benefits. Because such payments are for medical 
expenses accrued as a result of a covered injury while the injured 
person was alive, the cause of death does not have to be related to the 
covered injury for these medical benefits to be paid.
    The calculation of medical benefits is described in Sec.  102.80. 
There are no caps on medical benefits. However, the Secretary may limit 
the payment of such benefits to the amounts he considers reasonable for 
those services and items he 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 payor, 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 payors that may have a statutory or contractual obligation to pay 
for or provide medical benefits.
    When the Secretary has determined that the requester is eligible 
for medical benefits and that all of the documentation is available by 
which he can compute the amount, he will do the following, consistent 
with the calculations described in Sec.  102.80:
    (1) Determine which medical expenses that have been submitted are 
reasonable and necessary to diagnose or treat a covered injury or 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 his computation the total amount paid, or payable, 
by all other third-party payors. This will be the basis for the 
program's payment. For example: An eligible, injured individual 
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 the preamble, the Secretary may make a 
payment of medical benefits and later pursue such a payment from a 
third-party payor with an obligation to pay for or provide the medical 
services or items.
Lost Employment Income--Summary and Calculation (Sec.  102.32 and Sec.  
102.81)
    Lost employment income benefits that may be available under the 
program are set out in Sec.  102.32. The program will provide benefits 
for lost employment income (secondary to other benefits that may be 
available to the requester) 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). These benefits are a 
percentage of the employment income lost and are based on the number of 
eligible work days for which such income was lost. Employment income 
includes the injured person's gross employment income. The 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 workday 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 will 
be considered one total day of lost work. As described in Sec.  
102.32(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 in which the injured person's 
employer restores the paid leave taken and puts the requester in the 
same position as if he or she had not used paid leave on the lost work 
day (i.e., treats the employee as if he or she did not take paid leave 
by taking back the payments made when the leave was used and giving 
back the leave to the employee for future use).
    Under 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 individual lost employment income for 
10 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 of employment income as a result of a covered 
injury, he or she will not be eligible for any benefits for lost 
employment income.
    The calculation of benefits for lost employment income is described 
in Sec.  102.81. The annual cap on benefits for lost employment income 
for a requester 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 and benefits, to document his or her 
employment income. The benefit terminates once the requester reaches 
the age of 65. Benefits that represent future lost employment income 
will be adjusted to account for inflation. It is important to remember 
that future lost employment income will be calculated based on an 
individual's 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 this 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 
approximately $262,100, but subject to change). 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, a requester deemed to have a permanent and total disability by 
the Secretary may be eligible to receive up to $50,000 a year until he 
or she reaches the age of 65.
    As with medical benefits, if a smallpox vaccine recipient or 
vaccinia contact dies before filing for, or being paid, benefits for 
lost employment income incurred during his or her lifetime as a result 
of a covered injury or its health complications, the representative 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

[[Page 70084]]

was alive, the death does not have to be related to the covered injury 
for these benefits to be paid.
    Once the Secretary has determined that he has all the information 
necessary to compute lost employment income, the calculation will be 
made as follows, as set out in Sec.  102.81:
    (1) If the eligible individual lost five days or fewer of 
employment income, then there will be no benefits for lost employment 
income.
    (2) If the eligible individual lost six to nine days of employment 
income, then the Secretary will subtract five days from the number of 
lost work days; if the eligible individual lost 10 or more days of 
employment income, then every lost work day will be counted.
    (3) The Secretary will multiply the injured individual'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.
    (4) The Secretary will compute 75% of the lost employment income if 
the injured individual had one or more dependents (at the time of the 
covered injury) or 66 2/3% 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.
    (5) The amount of payment will be reduced by any benefit that the 
requester is entitled to receive from a third-party payor (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 payor 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 State if its program determines that such a benefit is due the 
requester).
    (6) The payments made will be subject to an annual cap of $50,000. 
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.
    No State law workers' compensation lien may be maintained on any 
benefit for lost employment income paid under this program.
Death Benefits--Summary and Calculation (Sec.  102.11, Sec.  102.33, 
and Sec.  102.82)
    Certain survivors of smallpox vaccine recipients or vaccinia 
contacts 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.  
102.11 (eligible survivors and their priority to receive death 
benefits), Sec.  102.33 (general description of death benefits) and 
Sec.  102.82 (calculation of death benefits).
    The SEPPA provides that death benefits under this program may be 
available under two different calculations. The ``standard 
calculation'' is a lump-sum payment to eligible survivors and is 
described in Sec.  102.82(c). 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.  102.82(d). This method is 
based upon the deceased person's employment income at the time of the 
covered injury.
Eligible Survivors and Priorities for Receiving Death Benefits
    With limited exceptions, the Smallpox Vaccine Injury Compensation 
Program 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 
to them. The order of priority for survivors to receive death benefits 
under the program is subject to changes made in the future under 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; (3) individuals designated by the deceased person as the 
beneficiaries under the deceased person's most recently executed life 
insurance policy; and (4) surviving parents. Such survivors, as defined 
under the PSOB Program, are also eligible survivors under this program. 
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 
is 18 years of age or younger, or between 19 and 23 years of age and a 
full-time student, or is over 18 years of age and incapable of self-
support because of physical or mental disability.
    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 (some of whom 
may also fall within the category of surviving eligible children). As 
discussed below, special criteria apply to the final category of 
eligible survivors.
    Under current practices, in the event that the deceased eligible 
individual is survived by a spouse and eligible children, the spouse 
will receive 50% of the death benefit and the children will divide the 
remaining 50% 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 individual has no surviving spouse or 
children, the individual designated by the deceased individual as the 
beneficiary under his or her most recently executed life insurance 
policy will receive the death benefit. If there is no life insurance 
policy or no surviving designated beneficiary under such a policy, the 
parents will divide the death benefit in equal shares. If none of these 
categories of survivors exists, the legal guardian of a deceased minor 
(who was a smallpox vaccine recipient or vaccinia contact) with no 
living parent will receive the death benefit, if applicable. As 
explained in Sec.  102.11(b)(5), surviving dependents younger than the 
age of 18 will have the same priority as surviving eligible children.
    Only the legal guardians of persons qualifying both as surviving 
eligible children under the PSOB Program and as dependents younger than 
the age of 18 can choose between a proportional death benefit under the 
standard and the alternative methods of payment. 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 calculation. Dependents who are minors and who do not qualify 
under another category of eligible survivors (for example, eligible 
surviving children of the deceased) are only covered by the alternative 
method of payment.
Death Benefits Under the Standard Calculation, Described in Sec.  
102.82(c)
    Under the ``standard calculation,'' the amount of the death benefit 
that can be paid under the program in a particular

[[Page 70085]]

fiscal year will equal the amount of the death benefit available under 
the PSOB Program in the same fiscal year (without regard to any 
reduction in PSOB Program death benefits due to a limitation in 
appropriations). The amount of the PSOB Program death benefit, which is 
subject to change, is currently approximately $262,100. Survivors who 
already collected, or are eligible to collect, death benefits under the 
PSOB Program are not eligible to receive Smallpox Vaccine Injury 
Compensation Program death benefits under the standard calculation. 
Survivors receiving a death benefit under the standard calculation from 
this program will receive the difference between any disability benefit 
paid under the PSOB Program and the death benefit available under the 
standard calculation if the PSOB Program disability benefit was 
underpaid due to a limitation in appropriations.
    Death benefits under the standard calculation will be reduced by 
the amount of lost employment income benefits that were paid under this 
program either to the deceased individual during his or her lifetime, 
or to his or her estate after death. For example, if a smallpox vaccine 
recipient received $40,000 from the program during his lifetime in 
benefits for lost employment income and later died, his survivors would 
be entitled to receive a total of approximately $222,100 in this fiscal 
year (the approximate $262,100 death benefit, minus the $40,000 in 
benefits for lost employment income paid to the injured person during 
his lifetime).
Death Benefits Under the Alternative Calculation, Described in Sec.  
102.82(d)
    Payments made under the ``alternative calculation'' of death 
benefits are based on the deceased person's employment income at the 
time he or she sustained the covered injury. Under this calculation, 
75% of the deceased person's employment income (determined in the same 
manner as employment income for purposes of lost employment income 
benefits) at the time he or she sustained the covered injury resulting 
in death will be paid annually until the youngest of the dependents 
reaches the age of 18. However, the maximum annual amount that may be 
paid to dependents (in total) under the alternative calculation is 
$50,000. No lifetime caps apply to death benefits under this 
alternative calculation.
    Death benefits under this alternative calculation are available 
only to surviving dependents who are younger than the age of 18. In 
order for such surviving dependents to receive payments under the 
alternative calculation as opposed to the standard calculation, the 
legal guardian of all the dependents younger than the age of 18 must 
choose to receive a proportionate share of the benefits under this 
calculation on their behalf, as described in Sec.  102.82(d)(1). In the 
event that multiple dependents have different legal guardians, each 
legal guardian is responsible for choosing the calculation of death 
benefits on behalf of the dependents of whom he or she is the legal 
guardian. For this reason, the legal guardian of several individuals 
who qualify both as surviving dependents younger than the age of 18 and 
as surviving eligible children cannot select a death benefit under the 
standard calculation for some of those dependents and a death benefit 
under the alternative calculation for other dependents. For those 
survivors who are eligible for a death benefit under both calculations, 
the particular circumstances (e.g., the age of the survivors, the 
employment income of the deceased person at the time of the covered 
injury) will determine which method of calculation will provide the 
greatest financial benefit.
    If dependent survivors choose to receive death benefits under the 
alternative calculation, no death benefits will be paid to those 
dependents under the standard calculation. However, such payments would 
not preclude other eligible survivors of equal priority from receiving 
a proportionate death benefit under the standard calculation. For 
example, if a deceased smallpox recipient or vaccinia contact is 
survived by two dependents younger than the age of 18 from a prior 
marriage and by a spouse who is not the legal guardian of the 
dependents, the legal guardian of the two dependents could choose to 
receive a 50% share of the death benefit for the dependent children 
under the alternative calculation and the surviving spouse would still 
be able to receive his or her 50% share of the death benefit under the 
standard calculation. As another example, if a deceased smallpox 
recipient is survived by two minor, dependent children, one whose 
living parent is the deceased person's surviving spouse and another 
whose living parent is the deceased person's former spouse, the 
surviving spouse could receive a 50% share of the death benefit under 
the standard calculation and each of the dependent children would be 
eligible for a proportionate share (25%) of the death benefit available 
under the standard calculation or the alternative calculation, as 
determined by the children's respective legal guardians. Although the 
Program will generally apportion death benefits among multiple eligible 
survivors, it will not do so on behalf of dependents receiving death 
benefits under the alternative calculation if the dependents share the 
same legal guardian (because such payments would be made to the legal 
guardian on behalf of all of the dependents for whom he or she is the 
legal guardian). The legal guardian would be expected to apportion the 
award appropriately.
    Death benefits paid to survivors under this alternative calculation 
are secondary to all payments made, or expected to be made in the 
future, by any third party payor for: (i) Compensation for the deceased 
person's loss of employment income on behalf of the dependents 
receiving death benefits under the alternative calculation, or their 
legal guardian(s); (ii) disability, retirement, or death benefits in 
relation to the deceased person on behalf of the dependents receiving 
death benefits under the alternative calculation, or their legal 
guardian(s); and (iii) life insurance benefits on behalf of the 
dependents receiving death benefits under the alternative calculation. 
Such secondary benefits are described in Sec.  102.83(d)(3)(A). 
Reductions will not be made if such benefits were paid to other persons 
(for example, if a retirement benefit was paid to the surviving spouse 
who is not the dependents' legal guardian, no deduction would be made 
to the dependents' death benefit to account for the benefit the spouse 
received). In calculating such reductions, the Secretary will have 
discretion to apportion over multiple years any lump-sum third-party 
payments. The Secretary has a right to recover benefits paid under this 
program from third-party payors that have an obligation to pay for or 
provide such benefits.
    As with other determinations made under this regulation, any 
determination concerning the calculation and payment of death benefits 
is not subject to any judicial review.
Filing a Request Package (Sec.  102.40-Sec.  102.41)
    A Smallpox Vaccine Injury Compensation Request Form (hereinafter 
``Request Form'') available from the program and all the eligibility 
and benefits documentation comprise the Smallpox Vaccine Injury 
Compensation Request Package (hereinafter ``Request Package''). In 
order for a requester to have his or her request reviewed by the 
program, the

[[Page 70086]]

requester must submit, at a minimum, a completed Request Form 
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 Request Packages to the applicable address listed in 
Sec.  102.41.
Representatives of Requesters (Sec.  102.44)
    This program has been designed so that requesters do not need to 
retain the services of lawyers to pursue benefits under this program. 
However, as provided in Sec.  102.44, requesters may have a legal or 
personal representative submit the Request Form and/or Request Package 
on their behalf. A legally competent requester must certify 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 
legally incompetent adults will require the assistance of a 
representative (who does not need to be a lawyer). Representatives of 
requesters who are minors or adults determined by a court to be legally 
incompetent are required to submit specific documentation, in addition 
to the documentation generally required of requesters, which is 
described in Sec.  102.63. The representative of a requester is 
required to submit the documents that would ordinarily be required of 
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 the same records on behalf of the requester.
    The Secretary will direct all correspondence to, and communicate 
exclusively with, a requester's representative unless the Secretary is 
advised that the representation has stopped. As explained above, 
although legal representation is permitted, it is not needed for filing 
for program benefits. As described in Sec.  102.44(d), the Secretary 
will not be responsible for the payment of any fees for the services of 
legal or personal representatives or for any associated costs.
Filing Deadlines (Sec.  102.42)
    Smallpox vaccine recipients who have a covered injury have one year 
from the date of a smallpox vaccination administered during the 
effective period of the Declaration (between January 24, 2003, and 
January 23, 2004, unless the Secretary extends the time period) to 
submit a Request Form. This deadline applies even if the requester's 
injury was the direct result of a covered countermeasure other than the 
smallpox vaccine (e.g., cidofovir) that was administered after the 
vaccine administration. Vaccinia contacts have two years to submit 
their Request Forms from the date of the onset of the covered injury, 
as documented in their medical records. Because the SEPPA, in its 
discussion of filing deadlines, refers to requests based on the 
administration of the smallpox vaccine and requests based on accidental 
vaccinia inoculation, the filing deadlines that apply to Request Forms 
filed by smallpox vaccine recipients or vaccinia contacts are the same 
filing deadlines that apply to Request Forms filed by the survivors or 
the representatives of the estates of deceased smallpox vaccine 
recipients and vaccinia contacts. However, as explained later in the 
preamble, if a smallpox vaccine recipient or vaccinia contact filed a 
timely Request Form and later died, his or her survivors (or the 
representative of his or her estate) could file an amendment to that 
Request Package outside of the filing deadline. Because the 
administration of smallpox covered countermeasures other than the 
smallpox vaccine (cidofovir and its derivatives or Vaccinia Immune 
Globulin), in the context of this program, generally relates back to 
complications arising from the administration of the smallpox vaccine 
or of accidental vaccinia inoculation, the filing deadlines set forth 
in Sec.  102.42 extend to the administration of such other covered 
countermeasures.
    In the event that the Secretary amends the Table of Injuries, 
requesters have an extended filing deadline, based on the effective 
date of the table amendment, which will be published in the Federal 
Register. However, the extended filing deadline only applies if the 
table amendment enables a person who could not establish a table injury 
before the amendment to establish such an injury.
    To speed the review of eligibility, requesters should file all 
documentation required for eligibility determinations by the filing 
deadline. However, a requester will meet the filing deadline 
requirement by submitting only the completed and signed Request Form by 
that deadline, with documentation to follow. Request Forms not filed 
within the governing filing deadline will not be processed, and the 
requester will not be considered for any program benefits.
Amendments to Request Packages (Sec.  102.46)
    The filing of amendments to previously filed Request Packages is 
discussed in Sec.  102.46. As explained in that section, if a smallpox 
vaccine recipient or vaccinia contact filed a Request Package, but 
later dies, his or her survivors or the representative of his or her 
estate may amend the Request Package. However, a requester filing such 
an amended request will only be entitled to benefits under the program 
if the original Request Form (filed by the smallpox vaccine recipient, 
vaccinia contact, or representative) was filed within the applicable 
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 or 
estate representative need not resubmit such documentation. 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 Needed for the Secretary To Determine Eligibility (Sec.  
102.50-Sec.  102.54)
    Requesters or their representatives must submit appropriate 
documentation to allow the Secretary to determine if the requesters are 
eligible for program benefits. The documentation required will vary 
somewhat depending on whether the requester is filing as a smallpox 
vaccine recipient, vaccinia contact, survivor, or representative of an 
estate.
Medical Records Required of All Requesters To Establish a Covered 
Injury (Sec.  102.50)
    Because all Request Packages filed with the program, including 
those filed by survivors or representatives of the estates of deceased 
persons, must relate back to a smallpox vaccine recipient or vaccinia 
contact who sustained a covered injury, all requesters must submit 
medical records sufficient to demonstrate to the Secretary that a 
covered injury was sustained by a smallpox vaccine recipient or a 
vaccinia contact. Section 102.50(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 either 
whether an injury set out in the table and meeting the table's 
requirements was sustained or whether an injury was sustained as the 
direct result of

[[Page 70087]]

receiving a covered countermeasure (including a smallpox vaccine) or of 
contracting vaccinia through accidental exposure. The program will 
consider copies of medical records to be the same as the original 
records.
    Although the medical records described in Sec.  102.50(a) are those 
that will generally be required for all requesters, requesters may also 
submit additional documentation, as provided for under Sec.  102.50(b). 
As described in Sec.  102.50(d), the Secretary may determine that 
particular records described in Sec.  102.50(a) are not necessary for 
particular requesters (for example, if certain medical records provide 
the exact same information as other records that are submitted) or that 
additional records may be required in order to make a covered injury 
determination (for example, in cases in which a preexisting condition 
may be the cause of the current injury).
    If certain medical records are unavailable to a requester, the 
requester must submit a statement describing the reasons for the 
records' unavailability and the reasonable efforts the requester has 
made to obtain them. The Secretary may, at his discretion, accept such 
a statement from the requester instead of the required medical records, 
if the circumstances so warrant, as set forth in Sec.  102.50(c).
    If a smallpox vaccine recipient or vaccinia contact 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.  
102.53(d), the medical records reviewed for this purpose may be the 
same as those submitted for the covered injury determination.
    In making covered injury determinations, the Secretary may consider 
all of the scientific evidence available (e.g., published articles 
concerning a relationship between the smallpox vaccine and an injury) 
and consult with qualified medical experts.
Documentation a Smallpox Vaccine Recipient Must Submit To Be Deemed 
Eligible (Sec.  102.51)
    As described above, a smallpox vaccine recipient must submit 
medical records that are sufficient to show that he or she sustained a 
covered injury, including medical records produced after the 
vaccination from all hospitals, clinics, or providers. In order to show 
eligibility, such a requester must also submit a completed and signed 
Request Form and the documentation described in Sec.  102.51. As noted 
in Sec.  102.51(b), a requester may submit a certification form, 
available from the program, completed by the entity (e.g., State 
government, private employer) that participated in the administration 
of the smallpox vaccine or other covered countermeasure to the smallpox 
vaccine recipient as part of a smallpox emergency response plan in 
place of documentation otherwise required concerning the requester's 
participation in, and receipt of the smallpox vaccine under, an 
approved smallpox emergency response plan.
Documentation a Vaccinia Contact Must Submit To Be Deemed Eligible 
(Sec.  102.52)
    A requester who is a vaccinia contact must submit a completed and 
signed Request Form and the documentation described in Sec.  102.52. 
Among the required documentation is documentation identifying the 
individual who was the source of the accidental vaccinia inoculation. 
However, if such documentation is unavailable, for example, if the 
source of the exposure to vaccinia is unknown, the Secretary has the 
discretion to accept other documentation providing evidence of the 
source of such exposure. For example, the Secretary may accept an 
affidavit signed by the requester explaining the circumstances under 
which he or she contracted the vaccinia. If this information is 
supportive of the vaccinia contact contracting vaccinia from a smallpox 
vaccine recipient (as defined in this regulation, except that the 
recipient need not sustain a covered injury) or from the contact of 
such a person, the Secretary may accept such an affidavit in place of 
the required documentation.
Documentation a Survivor Must Submit To Be Deemed Eligible (Sec.  
102.53)
    A requester who is a survivor of a deceased smallpox vaccine 
recipient or vaccinia contact must submit a completed and signed 
Request Form, the documentation discussed above that the deceased 
person would have had to submit if he or she were alive at the time of 
filing, and the documentation required of survivor requesters. These 
requirements are described in Sec.  102.53.
Documentation a Representative of a Deceased Person's Estate Must 
Submit for the Estate To Be Deemed Eligible (Sec.  102.54)
    A requester who is the representative of the estate of a deceased 
smallpox vaccine recipient or vaccinia contact, seeking benefits under 
the program on behalf of the estate, must submit a completed and signed 
Request Form, the documentation discussed above that the deceased 
person would have had to submit if he or she were alive at the time of 
filing, and the documentation required of requesters who are estate 
representatives. These requirements are described in Sec.  102.54.
Documentation Needed for the Secretary To Calculate Benefits (Sec.  
102.60-Sec.  102.63)
    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 generally secondary to benefits received from third-party 
payors, it may be possible that certain requesters who are deemed 
eligible will not receive benefits from the program. Sections 102.60-
102.63 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.  102.43(b) 
and is designed to ease the documentary burden on requesters who do not 
know whether or not they will be deemed eligible. Requesters need not 
submit benefits documentation until they have been notified by the 
Secretary that they are eligible.
    In order to calculate the amount of each type of benefit available, 
the program requires requesters to provide documentation of every 
third-party payor 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 payors with respect to each type 
of benefit available under the program is described in Sec.  102.60-
Sec.  102.62.
    Requesters seeking medical benefits must also submit documentation 
concerning the amount paid or expected to be paid by such third-party 
payors for the medical services or items for which payment is being 
sought under the program. Third-party payors of medical benefits 
include, but are not limited to, medical insurance, Medicaid, Medicare, 
and any other source of medical recompense. An example of the 
documentation necessary to satisfy this requirement is an Explanation 
of

[[Page 70088]]

Benefits form issued by the requester's health insurance company.
    Third-party payors of benefits for lost employment income include, 
but are not limited to, the requester's employer, disability insurance, 
and workers' compensation programs. In order to satisfy his or her 
obligations under Sec.  102.61, a requester 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 lost work benefits 
programs or payments.
    Requesters seeking death benefits will have to submit different 
documentation concerning third-party payors depending on whether they 
are seeking death benefits under the standard calculation described in 
Sec.  102.82(c) or are choosing a death benefit under the alternative 
calculation described in Sec.  102.82(d). 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 a broader 
group of existing or potential third-party payors (described fully in 
the death benefits calculation section of this preamble and set forth 
in Sec.  102.83(d)(3)(A)). Requesters seeking death benefits must 
submit other documentation described in Sec.  102.62.
    Before payments will be made, the representatives of requesters who 
are minors or legally incompetent adults must submit additional 
documentation described in Sec.  102.63. Because some of this 
documentation may be time-consuming to obtain (e.g., obtaining a court 
decree establishing a guardianship of the estate for a legally 
incompetent adult), the requester can wait until a benefits calculation 
has been made, and a written approval has been issued, before 
submitting such documentation.
Determinations the Secretary Will Make (Sec.  102.70-Sec.  102.74)
    When the Secretary receives a completed and signed Request Form or 
Request Package postmarked in the appropriate time frame, he will 
conduct two separate reviews, as described in Sec.  102.70. First, he 
will determine whether the requester is eligible. Second, the Secretary 
will determine the type and amount of benefits that may be paid (if 
any).
    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.  102.71. 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 discretion 
to accept a letter meeting the requirements set out in Sec.  102.71 as 
a substitute for the unavailable documentation. Once the Secretary has 
sufficient documentation to make an eligibility determination, he will 
make that decision in a timely manner.
    If the Secretary determines that a requester is not eligible for 
benefits under the program, he will inform the requester (or his or her 
representative) of the disapproval in writing. As described in Sec.  
102.72(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, he 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 he 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.  102.71 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 in a timely manner.
    As set out in Sec.  102.73, once the Secretary has calculated the 
amount of the benefits and determined that payment is to be made, he 
will inform the requester of the approval in writing and then initiate 
payment. Under Sec.  102.74, if the Secretary disapproves a request, 
which the Secretary may do at any time, he will so notify the requester 
(or his or her representative) in writing and provide information as to 
the options available to the requester, including the requester's right 
to seek reconsideration of the Secretary's decision.
Payment of All Benefits Under the Program (Sec.  102.83)
    The Secretary's options in paying all benefits under the program 
are described in Sec.  102.83. 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.  102.82(d)) 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, annuity or medical insurance 
policy, or appropriate structured settlement agreement, as long as the 
payment, annuity, policy, or agreement is 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.  102.83(b), lump sum payments will generally 
be made through electronic funds transfers to requesters' accounts. If 
a requester is a minor, the payment will be transferred 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). In administering this program, consistent with 
the practice of the PSOB Program in paying death benefits on behalf of 
minors, the Secretary will not require proof that the legal guardian 
has taken such actions. Section 102.83(b) describes the requirements 
pertaining to lump sum payments made on behalf of adults considered 
legally incompetent.
    As provided in Sec.  102.83(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) in order to get 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

[[Page 70089]]

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 
improper.
The Tax Consequences of Receiving Benefits From the Program
    The Secretary has asked the Internal Revenue Service (IRS) to 
provide prompt guidance on the tax consequences of receiving benefits 
under SEPPA. The IRS intends to publish guidance before the end of the 
year that will give requesters who receive benefits under the program 
the information they would need to meet any Federal tax 
responsibilities. The IRS has committed to working with the Secretary 
to ensure that requesters have ready access to the tax information and 
assistance with any additional questions they may have.
The Secretary's Right To Recover Benefits Paid Under the Program From 
Third-Party Payors (Sec.  102.84)
    As described elsewhere in this preamble, the payment of benefits 
under this program is generally secondary to benefits available from 
other third-party payors. The category of third-party payors 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 
payors are discussed in the sections of the preamble concerning the 
different types of benefits. As described in Sec.  102.84, after the 
Secretary pays benefits under this program, he will be subrogated to 
the rights of the requester, meaning that the Secretary may assert a 
claim against any third-party payor with a legal or contractual 
obligation to pay for, or provide, such benefits. The Secretary may 
recover from such a third-party payor the amount of benefits the third-
party payor has or had an obligation to pay for or provide. 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 the $5,000 (because the Secretary, as the 
secondary payor, would only be obligated to pay the requester $5,000 in 
benefits for lost employment income). Any benefits paid under this 
program are not subject to any lien by any primary third-party payor.
The Reconsideration Process (Sec.  102.90)
    Every individual who has filed a Request Package and has received a 
determination by the Secretary either denying eligibility for benefits 
or denying a category or amount of benefits requested, has a right to 
seek reconsideration of the Secretary's determination(s). Although such 
initial determinations are characterized as Secretarial determinations, 
this decision-making authority will be delegated to the Smallpox 
Vaccine Injury Compensation Program Office. The requester or his or her 
representative must send a letter seeking reconsideration to the 
Associate Administrator, Special Programs Bureau, Health Resources and 
Services Administration, at the address provided in Sec.  102.90(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 Secretary should reconsider his decision. No 
new documentation can be included with this letter.
    The Associate Administrator, Special Programs Bureau, will convene 
a panel to review all cases seeking reconsideration. The panel will 
consist of qualified individuals who are independent of the Smallpox 
Vaccine Injury Compensation Program Office. The panel will review the 
Request Package 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 case, the panel will make a recommendation to 
the Associate Administrator, Special Programs 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 Further Review of Determinations 
Made Under This Regulation (Sec.  102.91, Sec.  102.92)
    As described in Sec.  102.91, the SEPPA authorizes the Secretary to 
review at any time, and at his own motion or on application, any 
determination made concerning eligibility, entitlement to benefits, and 
the calculation and payment of benefits under the Program and 
authorizes the Secretary to affirm, vacate, or modify such 
determination in any manner the Secretary deems appropriate.
    As explained in Sec.  102.92, 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, section 
262(f)(2) of the Public Health Service Act 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.
Justification for Omitting Notice of Proposed Rulemaking and for Waiver 
of Delayed Effective Date
    Through the enactment by the SEPPA of part C, Title II of the 
Public Health Service Act (PHS Act), the Secretary was authorized to 
establish and administer the Smallpox Vaccine Injury Compensation 
Program. Congress authorized the Secretary to issue regulations 
implementing the SEPPA as the Secretary deems reasonable and necessary, 
and provided that the initial implementing regulations could be 
published by interim final rule. 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 the threat of a smallpox attack. A significant 
element of this plan, which is also an important priority

[[Page 70090]]

of the Secretary, is the increased voluntary participation of persons 
in smallpox emergency response plans throughout the nation, which 
includes voluntary immunization with the smallpox vaccine. The sooner 
this regulation is in effect, the sooner the program is implemented and 
the sooner potential requesters will be able to assess their 
eligibility to receive benefits from the program. Once this 
implementing regulation is in effect, the Secretary expects individuals 
who believe that they may be entitled to benefits under the program 
will file requests for such benefits within a short time frame. In 
addition, publishing this regulation promptly is necessary given that 
the governing filing deadlines, as applied to particular requesters, 
will begin to occur within a short period of time.
    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 set forth 
in this interim final rule will be accepted at the above listed address 
for a period of 60 days following the publication of the rule 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
    Regulatory Flexibility Act and Executive Order 12866. Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when rulemaking is necessary, to 
select regulatory approaches that provide the greatest net benefits 
(including potential economic, environmental, public health, safety 
distributive and equity effects). In addition, under the Regulatory 
Flexibility Act of 1980 (RFA), if a rule has a significant economic 
effect on a substantial number of small entities, the Secretary must 
specifically consider the economic effect of a rule on small entities 
and analyze regulatory options that could lessen the impact of the 
rule.
    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, of costs, of benefits, of incentives, of 
equity, and of available information. Regulations must meet certain 
standards, such as avoiding an unnecessary burden. Regulations that are 
``significant'' because of cost, adverse effects on the economy, 
inconsistency with other agency actions, effects on the budget, or 
novel legal or policy issues, require special analysis.
    The Secretary has determined that minimal resources are required to 
implement the provisions included in this regulation. Therefore, in 
accordance with the RFA, and the Small Business Regulatory Enforcement 
Fairness Act of 1996, which amended the RFA, the Secretary certifies 
that this rule will not have a significant impact on a substantial 
number of small entities. Specifically, both the benefits and the 
burdens associated with this interim final rule will go almost entirely 
to individuals who are filing as requesters with the program. Any 
burdens on small entities associated with the implementation of this 
final rule (e.g., completing a certification form concerning a smallpox 
vaccine recipient who was vaccinated under the auspices of a small 
entity as part of a smallpox emergency response plan, providing records 
to requesters seeking to comply with the regulation's documentation 
requirements) will be minimal in nature. Moreover, the number of small 
entities affected in this way will be very small in number.
    The Secretary has also determined that this proposed rule does not 
meet the criteria for a major rule as defined by Executive Order 12866 
and would have no major effect on the economy or Federal expenditures. 
We have determined that the proposed rule is not a ``major rule'' 
within the meaning of the statute providing for Congressional Review of 
Agency Rulemaking, 5 U.S.C. 801.
    Nonetheless, the Secretary believes that a discussion of the 
factors that led to the creation of the smallpox vaccination plan and 
of the Smallpox Vaccine Injury Compensation Program, as well as the 
likely impact of both programs, is warranted. As described earlier in 
this preamble, prior to its eradication, smallpox (variola) was a 
serious illness that manifested either as outbreaks of variola major 
with death rates of greater than 20% or variola minor with death rates 
approaching 1%. Those who survived were frequently left with 
significant disabilities, such as blindness. Smallpox vaccine was an 
essential tool for the successful global eradication of smallpox, 
announced by the World Health Organization in 1980. Despite such 
eradication, concern exists that terrorists may have access to the 
smallpox virus.
    On December 13, 2002, the President announced a plan to protect the 
population of the United States against the threat of a possible 
smallpox attack. This plan was based on heightened concerns, in the 
wake of the attacks of September and October 2001, that terrorists may 
have access to the smallpox virus and may attempt to use it against the 
population of the United States and government facilities abroad. Under 
this plan, which the Secretary is actively working to implement, State 
and local governments have formed volunteer smallpox emergency response 
teams that will be prepared to provide critical services to the 
population of the United States in the event of a smallpox virus 
attack.
    In furtherance of the President's plan, and as described earlier, 
the Secretary issued a Declaration Regarding Administration of Smallpox 
Countermeasures on January 24, 2003. In this Declaration, the Secretary 
stated that ``a potential bioterrorist incident makes it advisable to 
administer, on a voluntary basis, covered countermeasures specified * * 
* for prevention or treatment of smallpox [(virus infection)] or 
control or treatment of adverse events related to smallpox vaccination, 
to [specified] categories of individuals * * *.'' The specific 
``covered countermeasures'' described in the Declaration are smallpox 
vaccines, cidofovir and derivatives thereof, and Vaccinia Immune 
Globulin. The categories of persons to whom the Secretary recommended 
the administration of such covered countermeasures, on a voluntary 
basis, included certain health care workers, members of smallpox 
emergency response plans identified by State or local government 
entities or the Department of Health and Human Services, certain public 
safety personnel, and certain personnel associated with specific 
Federal facilities abroad. The Secretary recommended that such persons 
receive the smallpox vaccine to ensure that essential personnel would 
be able to mobilize immediately and provide critical services to the 
population of the United States in the event of a smallpox virus 
attack.
    As already stated, the SEPPA was enacted on April 30, 2003. This 
statute authorized the Secretary to establish the Smallpox Vaccine 
Injury Compensation Program (the program). This program has been 
appropriated $42 million for the administration of the program and the 
payment of benefits under the program. The purpose of the program is to 
provide benefits to eligible members of smallpox emergency response 
plans who sustain a covered injury as the result of receiving the 
smallpox vaccine (or other smallpox covered countermeasures). In 
addition, certain persons who come in contact with a vaccinated member 
of a smallpox

[[Page 70091]]

emergency response plan (or the contact of such a person) and sustain a 
covered injury may be eligible for benefits. As noted above, death 
benefits are also available to survivors of individuals whose death 
resulted directly from a covered injury.
    The availability of benefits to injured persons (and certain 
survivors, in the case of death) under this program was considered an 
important step in the implementation of the Administration's smallpox 
vaccination plan and in the nation's preparedness to face potential 
terrorist events involving the smallpox virus. Prior to the enactment 
of the SEPPA, and the establishment of this program, eligible smallpox 
vaccine recipients and vaccinia contacts were only entitled to benefits 
for medical care or for lost employment income related to covered 
injuries that were otherwise available from other third-party payors 
(e.g., State workers' compensation programs). In addition, pursuant to 
the Homeland Security Act of 2002, certain smallpox vaccine recipients 
and vaccinia contacts could pursue legal actions relating to covered 
injuries under the Federal Torts Claims Act (FTCA). The latter option 
was limited insofar as awards under the FTCA are available only to the 
extent that negligence can be shown in relation to the vaccine 
production or administration. The SEPPA expanded the benefits available 
to eligible smallpox vaccine recipients and vaccinia contacts through 
the establishment of a no-fault administrative compensation program 
that supplements the benefits available from other third-party payors.
    The Administration has worked to remove other disincentives to 
smallpox vaccination through approved smallpox emergency response plans 
(e.g., providing appropriate guidelines for pre-vaccination screening 
for potential contraindications, engaging in post-vaccination 
surveillance and data collection).
    Because it is impossible to quantify the risk of potential 
terrorist incidents involving the smallpox virus, it is impossible to 
assess the contribution that a group of first responders vaccinated 
with the smallpox vaccine through smallpox emergency response plans 
will provide to the population of the United States. In making benefits 
available to eligible individuals, the Administration is removing a 
disincentive that may be a barrier against first responders and others 
receiving the smallpox vaccination as participants in approved smallpox 
emergency response plans. In removing this disincentive, the program is 
likely to increase the nation's preparedness in the face of 
uncertainty. In addition, the establishment of the program ensures that 
individuals who sustain covered injuries as the direct result of such 
vaccinations (or of other smallpox covered countermeasures) or of 
accidental vaccinia inoculation will be afforded appropriate benefits, 
including payment for related medical services and items.
    As of September 2003, approximately 38,400 vaccinations have been 
administered to civilians under approved smallpox emergency response 
plans. Of those, approximately 800 have reported medical injuries to 
the CDC through the Vaccine Adverse Events Reporting System (VAERS). 
Such reports have included three fatalities and 92 serious injuries. 
Some of those who have reported injuries may not be eligible for the 
Smallpox Vaccine Injury Compensation Program, either because the injury 
is not covered by the Act (e.g., because the injury is excluded as a 
minor injury or because the injury is neither listed on the table nor 
is there evidence linking the smallpox vaccine to the occurrence of the 
injury) or because the individual is not eligible under the SEPPA 
(e.g., the requester received the smallpox vaccine, but not as a 
participant in an approved smallpox emergency response plan). 
Nevertheless, these recorded injuries indicate a possible injury rate 
of about 2% of the vaccinated population.
    The $42 million appropriated to the Program, in addition to 
covering administrative costs, was projected by Congress to cover the 
provision of benefits to eligible requesters. This figure was reached 
after consideration of the projected number of covered injuries and 
related deaths, projected medical costs related to the covered 
injuries, and the projected number of lost work days resulting from 
such covered injuries. The fact that program benefits are generally 
only available if such benefits are not available from other third-
party payors (e.g., medical benefits will not be paid for medical 
services or items if a requester's health insurance company has an 
obligation to pay for or provide such services or items), or are 
generally only available in an amount necessary to supplement benefits 
available from third-party payors, was also considered.
    It should be noted that the smallpox vaccination program that was 
being considered by Congress and the Administration when the $42 
million appropriation was made contemplated that up to 2-3 million 
individuals could be vaccinated through approved smallpox emergency 
response plans if individuals representing all of the occupations 
described in the SEPPA (including health care workers, firefighters, 
and public safety personnel) fully participated in the smallpox 
vaccination program. The number of individuals who have received the 
smallpox vaccine under approved smallpox emergency response plans to 
date is substantially smaller than the number of such vaccinees that 
were considered possible if the smallpox vaccination program reached 
full participation. As of September 2003, approximately 38,400 
vaccinations were administered under approved smallpox emergency 
response plans. For this reason, the number of individuals eligible to 
receive benefits under the program may in fact be a small percentage of 
the numbers originally considered. Given that the number of individuals 
who have volunteered to receive the smallpox vaccine under approved 
smallpox emergency response plans is significantly smaller than the 
total number of potential vaccinees likely considered in devising the 
$42 million appropriation, the program expects the adverse events 
associated with the smallpox vaccination program and the amount of 
benefits paid by the program (which will depend, on large part, upon 
the amount of medical services and items, as well as lost employment 
income, relating to covered injuries) to be similarly smaller than what 
was considered in calculating the $42 million appropriation. Of course, 
this expectation may change over time depending upon many factors, 
including the number of volunteers who receive the smallpox vaccine 
under approved smallpox emergency response plans in the future, as well 
as new scientific findings concerning the existence of causal 
relationships between particular medical conditions and the smallpox 
vaccine (as well as other covered countermeasures and vaccinia 
contracted through accidental exposure).
    In establishing the procedures described in this regulation, the 
Secretary has made operational decisions that will assist eligible 
requesters to receive benefits in a prompt and fair manner. For 
example, requesters are not required to obtain the services of an 
attorney in order to obtain benefits under the program, but are 
permitted to appoint a representative to assist them in filing a 
Request Package if this will be helpful to the requester.
    In addition, the Secretary has made an effort to be flexible in 
circumstances in which a requester is unable to submit documentation 
that would otherwise be required in order to establish eligibility and 
entitlement to benefits. For

[[Page 70092]]

example, if a requester has made a good faith effort to obtain medical 
records, but is unable to access such records (e.g., if a physician's 
practice is no longer in business), the Secretary may choose to accept 
a statement by the requester describing the reasons for the records' 
unavailability and the reasonable efforts the requester has made to 
obtain them in place of the unavailable medical records. Likewise, if a 
vaccinia contact is unable to identify the source of his or her 
exposure to vaccinia, this interim final rule enables the requester to 
submit an affidavit explaining the circumstances under which he or she 
contracted the vaccinia. If this information is consistent with the 
vaccinia contact contracting vaccinia from an eligible vaccinee or the 
contact of such a person (e.g., the vaccinia contact works in a 
hospital and was in close contact with several individuals who received 
the smallpox vaccine under an approved smallpox emergency response plan 
and, to the best of his or her knowledge, was not in close contact with 
any person who received the smallpox vaccine outside such a plan), the 
Secretary may accept such an affidavit in place of the required 
documentation.
    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 ``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, 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 SEPPA. 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, or as a direct result of vaccinia contracted through 
accidental vaccinia inoculation in the case of certain vaccinia 
contacts, to receive benefits under the program. In the event that an 
otherwise eligible smallpox vaccine recipient or vaccinia contact 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, and the documentation that must be 
submitted.
    Paperwork Reduction Act of 1995. In accordance with section 
3506(c)(2)(A) of the Paperwork Reduction Act (PRA) of 1995, the 
Department is required to solicit public comments, and receive final 
Office of Management and Budget (OMB) approval, on any information 
collection requirements set forth in rulemaking. As indicated, in order 
to implement the SEPPA, certain information is required as set forth in 
Sec. Sec.  102.50-102.63 of this rule.
    In accordance with the PRA, we have submitted and obtained OMB 
approval on this data collection and reporting of this information. An 
emergency review was needed before the expiration of the normal time 
limits under OMB's regulations at 5 CFR part 1320, to ensure the timely 
availability of data as necessary to ensure the provision of benefits 
to eligible petitioners. Delaying the data collection would delay 
implementation of the statutory purpose of providing benefits to 
eligible individuals who sustained covered injuries, particularly 
because the statutory filing deadlines for certain eligible requesters 
may occur as early as January 2004. Implementing this regulation and 
providing benefits as soon as possible will ensure that the intent of 
SEPPA in making these benefits to eligible individuals will be 
implemented, to the extent possible. OMB has approved this collection, 
with a 180-day approval period. During this period, we will publish a 
separate Federal Register notice announcing the initiation of an 
extensive 60-day agency review and public comment period on the 
requirements set forth.
    Collection of Information: The Smallpox Vaccine Injury Compensation 
Program.
    Description of Respondents: Individuals who are members of smallpox 
emergency response plans who received a smallpox vaccine and sustained 
a covered injury from it or from other covered countermeasures. 
Individuals who were injured by vaccinia from contact with a vaccinated 
member of a smallpox emergency response plan or other vaccinia contacts 
also qualify. In addition, some survivors of smallpox vaccine 
recipients or of vaccinia contacts may be eligible for death benefits 
and the estates of such deceased persons may receive certain benefits.
    Estimated Annual Reporting: The estimated annual reporting for this 
data collection is a total of six hours for reviewing and completing 
the Smallpox Vaccine Injury Compensation Request Form as well as the 
time to obtain and provide medical and financial documentation for 
eligibility and the computation of benefits. The estimated annual 
response burden is as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Number of      Responses per                      Total burden
                       Form                           respondents       respondent    Hourly response       hours          Wage rate     Total hour cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request Form and Supporting Documentation.........            1,250                1                5            6,250           $37.50         $234,375
Certification.....................................            1,250                1                1            1,250            37.50           46,875
                                                   -----------------------------------------------------------------------------------------------------
    Total.........................................            2,500  ...............  ...............            7,500  ...............          281,250
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 70093]]

    According to CDC's Vaccine Adverse Event Reporting System (VAERS), 
there are reports of three fatalities and 92 serious injuries (out of 
approximately 800 total reported injuries) based on the administration 
of approximately 38,400 smallpox vaccinations to volunteers within the 
civilian sector (as of September 2003). The program recognizes the 
difficulty inherent in predicting the number of individuals who will 
file for benefits under approved smallpox emergency response plans. 
Nonetheless, with the anticipation of additional individuals receiving 
the smallpox vaccine, plus a number of potential contact cases, the 
program predicts that there may be up to 1,250 requesters. It is 
important to note that a large number of such requesters filing Request 
Forms with the program may not be eligible for payments under the 
program for a variety of reasons (e.g., they sustained minor injuries 
that do not qualify as covered injuries, the Secretary determines that 
their injuries do not qualify as table injuries and that there is 
insufficient evidence to establish causation, they received the 
smallpox vaccine outside of an approved smallpox emergency response 
plan, or they did not file their Request Form within the governing 
filing deadlines).
    The annual burden estimate includes the time required to review and 
complete the Request Form as well as the time to obtain and provide 
further documentation necessary for eligibility and benefits 
determinations. Comments on this information collection activity should 
be sent to Lauren Wittenberg, OMB Desk Officer, Office of Management 
and Budget, Room 10235, New Executive Office Building, 725 17th Street, 
NW., Washington, DC 20053; FAX: (202) 395-6974.

List of Subjects in 42 CFR Part 102

    Benefits, Biologics, Compensation, Immunization, Public health, 
Smallpox, Vaccinia.

    Dated: October 27, 2003.
Elizabeth M. Duke,
Administrator, Health Resources and Services Administration.

    Approved: December 8, 2003.
Tommy G. Thompson,
Secretary.

0
For the reasons stated above, the Department of Health and Human 
Services amends part 102 of 42 CFR as follows:
0
1. The authority section for part 102 is revised to read as follows:

    Authority: 42 U.S.C. 216, 42 U.S.C. 239-239h.


0
2. In part 102, add sections 102.1--102.20 to read as follows:

PART 102--SMALLPOX VACCINE INJURY COMPENSATION PROGRAM

Subpart A--General Provisions
Sec.
102.1 Purpose.
102.2 Summary of available benefits.
102.3 Definitions.
Subpart B--Persons Eligible to Receive Benefits
102.10 Eligible requesters.
102.11 Survivors.
Subpart C--Covered Injuries
102.20 How to establish a covered injury.
102.21 Smallpox (Vaccinia) Vaccine Injury Table.
Subpart D--Available Benefits
102.30 Benefits available to different categories of requesters 
under this program.
102.31 Medical benefits.
102.32 Benefits for lost employment income.
102.33 Death benefits.
Subpart E--Procedures for Filing Request Packages
102.40 How to obtain forms and instructions.
102.41 How to file a request package.
102.42 Deadlines for filing request forms.
102.43 Deadlines for submitting documentation.
102.44 Representatives of requesters.
102.45 Multiple survivors.
102.46 Amending a request package.
Subpart F--Required Documentation To Be Deemed Eligible
102.50 Medical records necessary to establish that a covered injury 
was sustained.
102.51 Documentation a smallpox vaccine recipient must submit to be 
deemed eligible by the Secretary.
102.52 Documentation a vaccinia contact must submit to be deemed 
eligible by the Secretary.
102.53 Documentation a survivor must submit to be deemed eligible by 
the Secretary.
102.54 Documentation a representative of the estate of a deceased 
smallpox vaccine recipient or vaccinia contact must submit to be 
deemed eligible by the Secretary.
Subpart G--Required Documentation for Eligible Requesters to Receive 
Benefits
102.60 Documentation an eligible requester seeking medical benefits 
must submit.
102.61 Documentation an eligible requester seeking benefits for lost 
employment income must submit.
102.62 Documentation an eligible requester seeking a death benefit 
must submit.
102.63 Documentation a representative filing on behalf of an 
eligible requester who is a minor or a legally incompetent adult 
must submit.
Subpart H--Secretarial Determinations
102.70 Determinations the Secretary must make before benefits can be 
paid.
102.71 Insufficient documentation for eligibility and benefits 
determinations.
102.72 Sufficient documentation for eligibility and benefits 
determinations.
102.73 Approval of benefits.
102.74 Disapproval of benefits.
Subpart I--Calculation and Payment of Benefits
102.80 Calculation of medical benefits.
102.81 Calculation of benefits for lost employment income.
102.82 Calculation of death benefits.
102.83 Payment of all benefits.
102.84 The Secretary's right to recover benefits paid under this 
program from third-party payors.
Subpart J--Reconsideration of the Secretary's Determinations.
102.90 Reconsideration of the Secretary's eligibility and/or 
benefits determinations.
102.91 Secretary's review authority.
102.92 No additional judicial or administrative review of 
determinations.

Subpart A--General Provisions


Sec.  102.1  Purpose.

    This part implements Section 2 of the Smallpox Emergency Personnel 
Protection Act of 2003 (the Act). The Act directs the Secretary of 
Health and Human Services to establish procedures for providing 
benefits to certain individuals who sustained a covered injury as the 
direct result of the administration of the smallpox vaccine or other 
covered countermeasure, and to certain individuals who sustained a 
covered injury as the direct result of accidental vaccinia inoculation 
through contact with certain persons vaccinated with the smallpox 
vaccine or with individuals accidentally inoculated by them. Also, if 
the Secretary determines that an individual died as a result of a 
covered injury, the Act provides for certain survivors of that 
individual to receive death benefits.


Sec.  102.2  Summary of available benefits.

    (a) The Act authorizes three forms of benefits to requesters deemed 
eligible by the Secretary:
    (1) Payment or reimbursement for reasonable and necessary medical 
services and items to diagnose or treat a covered injury or its health 
complications, as described in Sec.  102.31.
    (2) Lost employment income incurred as a result of a covered 
injury, as described in Sec.  102.32.
    (3) Death payments to survivors if the Secretary determines that 
the death of the smallpox vaccine recipient or vaccinia contact was the 
direct result of

[[Page 70094]]

a covered injury, as described in Sec.  102.33.
    (b) The benefits paid under the Program, with the exception of 
death benefits paid under Sec.  102.82(c), are secondary to any 
obligation of any third-party payor to pay for such benefits. Death 
benefits paid under Sec.  102.82(c) are secondary to death and 
disability benefits under the PSOB Program. The benefits paid under the 
Program usually will only be paid after the requester has pursued all 
other available coverage from all third-party payors with an obligation 
to pay for or provide such benefits (e.g., medical insurance for 
medical items, workers' compensation program(s) for lost employment 
income). However, as provided in Sec.  102.84, the Secretary has the 
discretion to pay benefits under this Program before a potential third-
party payor makes a determination on the availability of similar 
benefits and has the right to later pursue a claim against any third-
party payor with a legal or contractual obligation to pay for, or 
provide, such benefits.


Sec.  102.3  Definitions.

    This section defines certain words and phrases found throughout 
this part. Words and phrases that are used only in limited situations 
are defined in specific sections of this part.
    (a) Accidental vaccinia inoculation means the transfer of vaccinia 
virus from an existing vaccination site (the skin surface where the 
vaccinia virus entered the body through vaccination) or inoculation 
site (the skin or mucous membrane surface where the vaccinia virus 
entered the body through means other than vaccination) on a person to a 
second person, resulting in a contact case.
    (b) Act means the Smallpox Emergency Personnel Protection Act of 
2003, Pub. L. 108-20, 117 Stat. 638.
    (c) Approval means a decision by the Secretary that the requester 
will be paid benefits under the Program.
    (d) Benefits means benefits and/or compensation.
    (e) Contact case means a case in which a person developed an 
initial vaccinial lesion or vaccinial infection through an exposure 
other than being vaccinated him/herself.
    (f) Covered countermeasure means smallpox (vaccinia) vaccines, 
cidofovir and its derivatives, or Vaccinia Immune Globulin, when used 
to prevent or treat the smallpox disease or control or treat the 
adverse effects of vaccinia vaccination or inoculation or of the 
administration of another countermeasure.
    (g) Covered injury means an injury determined by the Secretary, in 
accordance with subpart C of this part, to be:
    (1) An injury meeting the requirements of the Table, which is 
presumed to be the direct result of the administration of a smallpox 
vaccine or accidental vaccinia inoculation; or
    (2) More likely than not, the direct result of:
    (A) The administration of a covered countermeasure (including the 
smallpox vaccine) during the effective period of the Declaration, in 
the case of a smallpox vaccine recipient; or
    (B) Vaccinia contracted through accidental vaccinia inoculation 
(and not the result of receiving a smallpox vaccine) during the 
effective period of the Declaration (or within 30 days after the end of 
such period), in the case of a vaccinia contact.
    (h) Declaration means the Declaration Regarding Administration of 
Smallpox Countermeasures issued by the Secretary on January 24, 2003, 
and published in the Federal Register on January 28, 2003 (68 FR 4212).
    (i) Dependent means a person who would be considered a dependent by 
the Internal Revenue Service.
    (j) Disapproval means a decision by the Secretary that the 
requester will not be paid benefits under the Program.
    (k) Effective period of the Declaration means the time span 
specified in the Declaration (January 24, 2003 until and including 
January 23, 2004), unless extended by the Secretary.
    (l) FECA Program means the workers' compensation benefits program 
for civilian officers and employees of the Federal Government 
established under the Federal Employees' Compensation Act (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) Health care practitioner means a health care provider licensed 
by a State and authorized to diagnose and prescribe medications and 
other treatments or authorized to provide primary or specialty care.
    (n) Injury means an injury (including death), disability, illness, 
or condition.
    (o) Legally incompetent means a person who is considered to lack 
legal capacity under applicable State law.
    (p) Program means the Smallpox Vaccine Injury Compensation Program.
    (q) Public Safety Officers' Benefits Program (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.
    (r) Requester means a smallpox vaccine recipient, vaccinia contact, 
survivor, or representative of the estate of a deceased smallpox 
vaccine recipient or vaccinia contact (on behalf of the estate) who 
files a Request Package, or on whose behalf a Request Package is filed, 
under this part.
    (s) Request Form means the form designated by the Secretary as the 
request form for purposes of this part.
    (t) 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 eligibility and benefits under this 
part.
    (u) 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 involved has been delegated.
    (v) Smallpox emergency response plan means a State, local, or 
Department of Health and Human Services plan, approved by the 
Secretary, detailing actions to be taken in preparation for a possible 
smallpox-related emergency during the period prior to the 
identification of an active case of smallpox either within or outside 
the United States.
    (w) Smallpox (Vaccinia) Vaccine Injury Table or Table or Table of 
Injuries means the table of injuries included at Sec.  102.21, 
including the definitions and requirements set forth at Sec.  
102.21(b).
    (x) Smallpox vaccine recipient means a person:
    (1) Who has been a health care worker, law enforcement officer, 
firefighter, security personnel, emergency medical personnel, other 
public safety personnel, or support personnel for such occupational 
specialties who has volunteered and been selected to be a member of a 
smallpox emergency response plan prior to the time at which the 
Secretary publicly announces that an active case of smallpox has been 
identified within or outside of the United States;
    (2) Who is or will be functioning in a role identified in a 
smallpox emergency response plan;
    (3) To whom a smallpox vaccine is administered pursuant to a 
smallpox emergency response plan during the effective period of the 
Declaration; and
    (4) Who sustained a covered injury.
    (y) State means any State of the United States of America, the 
District of Columbia, United States territories,

[[Page 70095]]

commonwealths, and possessions, the Republic of the Marshall Islands, 
the Republic of Palau, and the Federated States of Micronesia.
    (z) Survivor means a survivor of a deceased smallpox vaccine 
recipient or vaccinia contact meeting the requirements of Sec.  102.11.
    (aa) Third-party payor means the United States (other than for 
payments of benefits under this Program) or any other third-party, 
including any State or local governmental entity, private insurance 
carrier, or employer, with a legal or contractual obligation to pay for 
or provide benefits.
    (bb) Vaccinia contact means an individual who:
    (1) Contracted vaccinia during the effective period of the 
Declaration (or within 30 days after the end of such period);
    (2) Prior to contracting vaccinia, was accidentally inoculated by a 
person:
    (A) Meeting the criteria set forth in Sec.  102.3(x)(1)-(3) (a 
person meeting the definition of a smallpox vaccine recipient, except 
for the requirement that the person sustained a covered injury); or
    (B) Who was accidentally inoculated by a person meeting the 
criteria set forth in Sec.  102.3(x)(1)-(3) (a person meeting the 
definition of a smallpox vaccine recipient, except for the requirement 
that the person sustained a covered injury); and
    (3) Sustained a covered injury.

Subpart B--Persons Eligible To Receive Benefits


Sec.  102.10  Eligible requesters.

    (a) The following requesters may, as determined by the Secretary, 
be eligible to receive benefits from this Program:
    (1) Smallpox vaccine recipients, as described in Sec.  102.3(x);
    (2) Vaccinia contacts, as described in Sec.  102.3(bb); or
    (3) Survivors, as described in Sec.  102.3(z) and Sec.  102.11.
    (4) Representatives of the estates of deceased smallpox vaccine 
recipients or vaccinia contacts (i.e., individuals authorized to act on 
behalf of the deceased person's estate under applicable state law, such 
as an executor).
    (b) If a smallpox vaccine recipient or vaccinia contact dies, his 
or her survivor(s) or the representative 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 person, but must be filed within the filing deadlines 
described in Sec.  102.42. Amendments to previously filed Request 
Packages and the filing deadlines for such amendments are described in 
Sec.  102.46.
    (c) The benefits available to different categories of requesters 
are described in Sec.  102.30.


Sec.  102.11  Survivors.

    (a) Survivors of individuals who died as the direct result of a 
covered injury. If the Secretary determines that a smallpox vaccine 
recipient or vaccinia contact 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 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), (b)(4), and (b)(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, as amended.
    (3) In the PSOB Program, the person who is survived must satisfy 
the eligibility requirements for a deceased public safety officer, 
whereas the person who is survived under this Program must be a 
deceased smallpox vaccine recipient or vaccinia contact 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 smallpox vaccine recipient or vaccinia contact may be 
eligible as a survivor under this Program. Such legal guardianship must 
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 person 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.  102.82(d), and is not eligible to receive death benefits under 
the standard calculation described in Sec.  102.82(c). Because death 
benefits paid under the alternative calculation will be paid to the 
dependents' legal guardian(s) on behalf of all such dependents, the 
Secretary will not divide or apportion such benefits among the 
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.  102.20  How to establish a covered injury.

    (a) General. In order to receive benefits under the Program, a 
requester must submit documentation showing that a covered injury, as 
described in Sec.  102.3(g), was sustained. 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 or accidental vaccinia 
inoculation, as described in paragraph (d) of this section. The 
Secretary will consider all relevant medical and scientific evidence, 
such as medical records and documentation submitted by the requester, 
when determining whether a covered injury was established. In addition, 
the Secretary may obtain the views of qualified medical experts in 
making determinations concerning covered injuries. As set forth in the 
definition of covered countermeasures, if a covered injury is related 
to the administration of a covered countermeasure, the countermeasure 
must have been administered to prevent or treat the smallpox disease or 
to control or treat the adverse effects of vaccinia vaccination or 
inoculation or of the administration of another countermeasure. The 
time periods described in this part for receiving a covered 
countermeasure (during the effective period of the Declaration) or for 
vaccinia contracted from accidental vaccinia inoculation (during the 
effective period of the Declaration or within 30 days after the end of 
such

[[Page 70096]]

period) in relation to a covered injury must also be met.
    (b) Minor injuries. Any injuries that the Secretary deems minor 
will not be considered covered injuries. Minor injuries include 
expected and routine responses to the smallpox vaccine, other covered 
countermeasures, or accidental vaccinia inoculation that are not severe 
(e.g., minor scarring or minor local reactions, for instance a mild 
systemic illness with a generalized maculopapular rash that resolves 
quickly).
    (c) Table injuries. A requester may establish that a covered injury 
occurred by demonstrating that a smallpox vaccine recipient or vaccinia 
contact sustained an injury listed on the Smallpox (Vaccinia) Vaccine 
Injury Table, set forth in Sec.  120.21, within the time interval 
listed on the Table and as defined by the Table's Definitions and 
Requirements, set forth in Sec.  120.21(b). 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 of a smallpox vaccine or exposure to vaccinia. Even if 
the Table requirements are satisfied, however, an injury will not be 
considered a covered injury if the Secretary determines, based upon his 
review of the evidence, that a source other than the smallpox vaccine 
or exposure to vaccinia more likely than not caused the injury. In such 
circumstances, the Table presumption will be rebutted.
    (d) Injuries for which causation must be proven. If an injury is 
not included on the Table or if a requester is unable to meet all of 
the Table requirements with respect to an injury included on the Table 
(e.g., onset of the injury within the time interval included on the 
Table), a requester may establish a covered injury by proving 
causation. To establish that a covered countermeasure or accidental 
vaccinia inoculation caused an injury, the requester must demonstrate, 
by a preponderance of the evidence (more likely than not), that:
    (1) In the case of a smallpox vaccine recipient, he or she 
sustained an injury as the direct result of the administration of a 
covered countermeasure (including the smallpox vaccine) during the 
effective period of the Declaration; or
    (2) In the case of a vaccinia contact, he or she sustained an 
injury as the direct result of vaccinia contracted through accidental 
vaccinia inoculation from a person described in Sec.  102.3(bb)(2) (a 
person meeting the definition of a smallpox vaccine recipient, except 
that the person need not sustain a covered injury, or the contact of 
such a person), and not as the result of receiving a smallpox vaccine. 
Such vaccinia must have been contracted during the effective period of 
the Declaration (or within 30 days after the end of such period). The 
Secretary will consider an injury that resulted from the administration 
of a covered countermeasure (other than the smallpox vaccine) to be the 
direct result of vaccinia contracted through accidental vaccinia 
inoculation if the covered countermeasure was administered as a result 
of such vaccinia.


Sec. Sec.  102.22-102.29  [Reserved]

    3. In part 102, reserve Sec. Sec.  102.22-102.29.


Sec. Sec.  102.30-102.91  [Added]

    4. In part 102, add sections 102.30-102.91 to read as follows:

Subpart D--Available Benefits


Sec.  102.30  Benefits available to different categories of requesters 
under this Program.

    (a) Benefits available to smallpox vaccine recipients and vaccinia 
contacts.
    A requester who is an eligible smallpox vaccine recipient or 
vaccinia contact may be entitled 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 smallpox vaccine recipient or vaccinia contact may be 
entitled to receive a death benefit.
    (c) Benefits available to estates of deceased smallpox vaccine 
recipients or vaccinia contacts. The estate of an otherwise eligible 
deceased smallpox vaccine recipient or vaccinia contact may be eligible 
to receive medical benefits or benefits for lost employment income, or 
both, if such benefits were accrued during the deceased person's 
lifetime as a result of a covered injury or its health complications, 
but were not paid while the deceased person was living. Such medical 
benefits and benefits for lost employment income may be available 
regardless of whether the death was the direct result of a covered 
injury or an unrelated factor. The estate of a deceased smallpox 
vaccine recipient or vaccinia contact may not receive a death benefit.


Sec.  102.31  Medical benefits.

    (a) Smallpox vaccine recipients and vaccinia contacts 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 a health complication of a covered injury 
(i.e., sequela). 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 monthly 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 Secretary may make such payments or 
reimbursements if the medical services and items have already been 
provided or if they are likely to be provided 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 health care 
practitioner.
    (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, complications of a 
covered injury that occur as part of the natural course of the 
underlying disease, an adverse reaction to a prescribed medication or 
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.  102.80. Although there are no caps on 
medical benefits available under this Program, the Secretary may limit 
payments to the amount he deems reasonable for those services and items 
he considers reasonable and necessary. All payment or reimbursement for 
medical services and items is secondary to any obligation of any third-
party payor to pay for or provide such services or items to the 
requester. As provided in Sec.  102.84, the Secretary retains the right 
to recover medical benefits paid to requesters by third-party payors.
    (d) The Secretary may make payments or reimbursements of medical 
benefits to the estate of a deceased smallpox vaccine recipient or 
vaccinia contact as long as such benefits were accrued during the 
deceased person's lifetime as the result of a covered injury or its 
health complications and were not paid during the deceased person's 
lifetime.


Sec.  102.32  Benefits for lost employment income.

    (a) Requesters who are smallpox vaccine recipients or vaccinia 
contacts

[[Page 70097]]

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.  102.31(b)). These benefits are a percentage of the 
employment income lost due to the covered injury or its health 
complications.
    (b) The method and amount of benefits for lost employment income 
are described in Sec.  102.81. Benefits for lost employment income will 
be adjusted if there are fewer than 10 days of lost employment income. 
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 payor to pay 
for lost employment income or to provide disability or retirement 
benefits to the requester. As provided in Sec.  102.84, the Secretary 
retains the right to recover benefits for lost employment income paid 
to requesters from third-party payors.
    (c) The Secretary is not requiring an individual to use paid leave 
(e.g., sick leave or vacation leave) to be paid for lost work days. 
However, if an individual uses such paid leave in order to be paid for 
lost work days, the Secretary will not consider the days in which such 
leave was used to be days of lost employment income, unless the 
individual's employer restores the leave that was used. By restoring 
paid leave, an employer puts the individual in the same position as if 
he or she had not used paid leave on the lost work day (i.e., takes 
back the payments made when the leave was taken and gives back the 
leave to the employee for future use).
    (d) The Secretary may pay benefits for lost employment income to 
the estate of a deceased smallpox vaccine recipient or vaccinia contact 
as long as such benefits were accrued during the deceased person's 
lifetime as the result of a covered injury or its health complications 
and were not paid to the deceased person during his or her lifetime.


Sec.  102.33  Death benefits.

    (a) Eligible survivors may be able to receive a death benefit under 
this Program if the Secretary determines that an otherwise eligible 
deceased smallpox vaccine recipient or vaccinia contact sustained a 
covered injury and died as a direct result of the injury. Annual and 
lifetime caps may apply to the death benefits provided. The method and 
amount of death benefits are described in Sec.  102.82. As provided in 
Sec.  102.84, the Secretary retains the right to recover death benefits 
paid to requesters from third-party payors. Death benefits may be paid 
under two different calculations.
    (b) The standard calculation, described in Sec.  102.82(c), is 
based upon the death benefit available under the PSOB Program and is 
available to all eligible survivors (except for surviving dependents 
younger than the age of 18 who are not also surviving eligible 
children). In the event that death benefits were paid under the PSOB 
Program with respect to the deceased person, 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. Any death benefit paid under the standard calculation 
will be reduced by the total amount of benefits for lost employment 
income paid to the smallpox vaccine recipient or vaccinia contact 
during his or her lifetime and to his or her estate after death.
    (c) The alternative calculation, described in Sec.  102.82(c), is 
calculated based on the person's employment income at the time of the 
covered injury. This calculation is only available to surviving 
dependents who are younger than the age of 18. The legal guardian(s) of 
such surviving dependents must select the death benefit as calculated 
under this alternative calculation before it will be paid. The payment 
of a death benefit as calculated under this alternative calculation is 
secondary to other benefits received (compensation for loss of 
employment income, death benefits (including PSOB Program death 
benefits), disability benefits, or retirement benefits on behalf of the 
dependent(s) or his or her legal guardian or life insurance benefits on 
behalf of the dependent(s)).

Subpart E--Procedures for Filing Request Packages


Sec.  102.40  How to obtain forms and instructions.

    Interested parties may obtain copies of all necessary forms and 
instructions by sending a letter through the U.S. Postal Service, 
commercial carrier, or private courier service, by telephone, or by 
downloading them from the Program's website.
    (a) If using the U.S. Postal Service, interested parties should 
send letters asking for forms and instructions to the Smallpox Vaccine 
Injury Compensation Program Office, Special Programs Bureau, Health 
Resources and Services Administration, Parklawn Building, Room 16C-17, 
5600 Fishers Lane, Rockville, MD 20857.
    (b) If using a commercial carrier or private courier service, 
interested parties should send letters asking for forms and 
instructions to the Smallpox Vaccine Injury Compensation Program 
Office, Special Programs Bureau, Health Resources and Services 
Administration, 4350 East-West Highway, 10th Floor, Bethesda, Maryland 
20814.
    (c) For forms and instructions, interested parties can call (888) 
496-0338. This is a toll-free number.
    (d) Interested parties can download forms and instructions from the 
Internet at http://www.hrsa.gov/smallpoxinjury. Click on the link to 
``Forms and Instructions.''


Sec.  102.41  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 payments. Request Packages may be filed through the U.S. 
Postal Service, commercial carrier, or private courier service. The 
Smallpox Vaccine Injury Compensation Program Office will not accept 
Request Packages electronically or by hand-delivery.
    (a) If using the U.S. Postal Service, requesters (or their 
representatives) should send all forms and documentation to the 
Smallpox Vaccine Injury Compensation Program Office, Special Programs 
Bureau, Health Resources and Services Administration, Parklawn 
Building, Room 16C-17, 5600 Fishers Lane, Rockville, MD 20857.
    (b) If using a commercial carrier or private courier service, 
requesters (or their representatives) should send all forms and 
documentation to the Smallpox Vaccine Injury Compensation Program 
Office, Special Programs Bureau, Health Resources and Services 
Administration, 4350 East-West Highway, 10th Floor, Bethesda, Maryland 
20814.


Sec.  102.42  Deadlines for Filing Request Forms.

    (a) General. Filing deadlines vary depending on whether the injured 
individual is a smallpox vaccine recipient or a vaccinia contact. In 
all cases, the filing date is the date the Request Form is postmarked. 
A legibly dated receipt from a commercial carrier, a private courier 
service, or the U.S. Postal Service (e.g., the date that a commercial 
carrier places on the package at the time of drop-off) will be 
considered equivalent to a postmark. 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 representative. 
After filing a Request

[[Page 70098]]

Form within the governing filing deadline, a requester can and should 
update the Request Form to reflect new information.
    (b) Request forms not filed within deadline. If the Secretary 
determines that a Request Form was not filed within the governing 
filing deadline set out in this section, the Request Form will not be 
processed and the requester will not be entitled to any benefits under 
this Program.
    (c) Smallpox vaccine recipients. All Request Forms filed by, or on 
behalf of, a smallpox vaccine recipient must be filed within one year 
of the date of the administration of a smallpox vaccine to the smallpox 
vaccine recipient. This deadline also applies to a deceased smallpox 
vaccine recipient's survivor(s) and the representative of his or her 
estate. This deadline applies to Request Forms concerning injuries 
resulting from the administration of a smallpox vaccine or other 
covered countermeasures.
    (d) Vaccinia contacts. All Request Forms filed by, or on behalf of, 
a vaccinia contact must be filed within two years after the date of the 
first symptom or manifestation of onset of the covered injury in the 
vaccinia contact. This deadline also applies to a deceased vaccinia 
contact's survivor(s) and the representative of his or her estate. This 
deadline applies to Request Forms concerning injuries resulting from 
vaccinia contracted through accidental vaccinia inoculation or from the 
administration of covered countermeasures (other than the smallpox 
vaccine) as a result of such accidental vaccinia inoculation.
    (e) Request forms (or amendments to request forms) based on 
modifications to the table of injuries. The Secretary may amend the 
Table set forth in Sec.  102.21. The effect of such an amendment may 
enable a requester who previously could not establish a Table injury to 
establish a Table injury. In such circumstances, the requester must 
file a new Request Form or an amendment to a previously filed Request 
Form as follows:
    (1) If the injured person is a smallpox vaccine recipient, within 
one year after the effective date of the amendment to the Table; or
    (2) If the injured person is a vaccinia contact, within two years 
after the effective date of the amendment to the Table.


Sec.  102.43  Deadlines for submitting documentation.

    (a) Documentation for eligibility determinations. All eligibility 
documentation required by the Program should be filed together with the 
Request Form. However, if this is not possible, 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.  102.42. The Secretary will 
not generally begin his review of a requester's eligibility until the 
documentation necessary for the Secretary to make this determination 
has been submitted. All such documentation must be submitted before the 
Program terminates.
    (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 his review of the benefits available to a requester until the 
documentation necessary for the Secretary to make a benefits 
determination has been submitted. All such documentation must be 
submitted before the Program terminates.


Sec.  102.44  Representatives of requesters.

    (a) Persons other than a requester (e.g., a lawyer, guardian, 
friend) may file a Request Package on a requester's behalf as his or 
her representative. A requester need not use the services of a lawyer 
to secure benefits under this Program. A representative (who does not 
need to be a lawyer) is only required, as described in this section, 
for requesters who are minors or legally incompetent adults. In the 
event that a 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 forth in this 
regulation. If a requester has a representative, all communications 
from the Secretary will be directed exclusively to the representative.
    (b) Representatives of legally competent adults. A requester who is 
a legally competent adult may use a representative to submit a Request 
Package on his or her behalf. In such circumstances, the requester must 
certify on the Request Form that he or she is authorizing the 
representative to pursue benefits under this Program on his or her 
behalf.
    (c) Representatives of minors and legally incompetent adults. A 
requester who is a minor or a legally incompetent adult must use a 
representative to pursue benefits under this Program on his or her 
behalf. In such circumstances, the representative must certify, in the 
place provided on the Request Form, that the requester is a minor or a 
legally incompetent adult 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.  102.63.
    (d) No payment for attorneys' fees or costs. Because it is not 
necessary to hire a lawyer to obtain benefits under this Program and 
because attorneys' fees or other fees and costs to representatives are 
not covered under the Act, the Secretary will not reimburse such fees 
or costs.


Sec.  102.45  Multiple survivors.

    Multiple survivors of the same smallpox vaccine recipient or 
vaccinia contact 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.  102.46  Amending a request package.

    (a) Generally. All requesters may amend their documentation 
concerning eligibility until the Secretary has made an eligibility 
determination. Requesters also may amend their information or 
documentation concerning the calculation of benefits until the 
Secretary has made a benefits determination. The Secretary may, at his 
discretion, accept eligibility or benefits documents even after 
eligibility or benefits determinations have been made (e.g., the 
Secretary may accept new documents concerning eligibility after 
determining that a requester is ineligible and may use such documents 
to reevaluate the earlier eligibility determination). However, such new 
documentation will not be used in any reconsideration regarding the 
initial determination. The Secretary will not consider any 
documentation submitted after the Program terminates.
    (b) Requesters who are survivors. If a smallpox vaccine recipient 
or vaccinia contact submitted a Request Form within the filing 
deadline, but subsequently dies, his or her survivor(s) may amend his 
or her Request Package at any time before the Program terminates in 
order to be considered

[[Page 70099]]

eligible 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 person's Request Package. 
However, a survivor filing an amendment to a previously filed Request 
Package may only be entitled to 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 person 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.  102.11. Such an amendment may be filed 
at any time before the Program terminates.
    (c) Requests in which benefits are sought by the estate of a 
deceased smallpox vaccine recipient or vaccinia contact. If a smallpox 
vaccine recipient or vaccinia contact submitted a Request Form within 
the filing deadline, but subsequently dies, a representative of his or 
her estate may amend his or her Request Package at any time before the 
Program terminates in order to be considered eligible for benefits. 
Such an amendment can be filed regardless of whether the Secretary made 
an eligibility determination or paid benefits with respect to the 
deceased person's Request Package. However, a representative of an 
estate filing an amendment to a previously filed Request Package may 
only be entitled to benefits if the previously filed Request Package 
was filed within the governing filing deadline. All required 
documentation that has already been submitted with respect to the 
deceased person will be considered part of the amended Request Package, 
and the representative of the estate is not required to resubmit such 
documentation.

Subpart F--Required Documentation To Be Deemed Eligible


Sec.  102.50  Medical records necessary to establish that a covered 
injury was sustained.

    (a) In order to establish that a smallpox vaccine recipient or 
vaccinia contact sustained a covered injury, a requester must submit 
the following medical records:
    (1) All physician, clinic, or hospital outpatient medical records 
documenting medical visits, consultations, and test results that 
occurred on or after the date of the smallpox vaccination or exposure 
to vaccinia; and
    (2) All inpatient hospital medical records, including the admission 
history and physical examination, the discharge summary, all physician 
subspecialty consultation reports, all progress notes, and all test 
results that occurred on or after the date of the smallpox vaccination 
or exposure to vaccinia.
    (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 need to 
introduce additional medical documentation or scientific evidence in 
order to establish that an injury was caused by a covered 
countermeasure (including the smallpox vaccine) or vaccinia contracted 
through accidental vaccinia inoculation.
    (c) If certain medical records listed in paragraph (a) of this 
section are unavailable to the requester after he or she has made 
reasonable efforts to obtain the records, the requester must submit a 
statement describing the reasons for the records' unavailability and 
the efforts he or she has taken to obtain the records. The Secretary 
has the discretion to accept such a statement in place of the 
unavailable medical records. In this circumstance, the Secretary may 
require an authorization from the requester (or his or her 
representative) to try to obtain the records on his or her behalf.
    (d) In certain circumstances, the Secretary may require additional 
medical records to make a determination that a covered injury was 
sustained (e.g., medical records prior to the date of vaccination or 
accidental vaccinia exposure) or may determine that certain records 
described in paragraph (a) of this section are not necessary for an 
eligibility determination (e.g., records that are duplicative of other 
records submitted). If the Program requests additional medical records 
(or information) from a requester's health care practitioner, then the 
requester may use a release form in order to have the medical records 
sent directly to the Program.


Sec.  102.51  Documentation a smallpox vaccine recipient must submit to 
be deemed eligible by the Secretary.

    (a) A smallpox vaccine recipient must submit the following 
documentation in order to be deemed eligible by the Secretary:
    (1) A completed (to the fullest extent possible) and signed Request 
Form.
    (2) Documentation demonstrating that the requester:
    (A) Is a health care worker, law enforcement officer, firefighter, 
security personnel, emergency medical personnel, other public safety 
personnel, or support personnel for such occupational specialties who 
has volunteered and been selected to be a member of a smallpox 
emergency response plan prior to the time at which the Secretary 
publicly announces that an active case of smallpox has been identified 
within or outside of the United States and that the requester is or 
will be functioning in a role identified in a smallpox emergency 
response plan; and
    (B) Was administered a smallpox vaccine pursuant to an approved 
smallpox emergency response plan during the effective period of the 
Declaration.
    (3) If the requester's injury relates to the administration of 
cidofovir or its derivatives or Vaccinia Immune Globulin, and not the 
smallpox vaccine, documentation demonstrating that the requester was 
administered such a covered countermeasure during the effective period 
of the Declaration.
    (4) Medical records sufficient to demonstrate that the requester 
sustained a covered injury, as described in Sec.  102.3(g), in 
accordance with the requirements set forth in Sec.  102.50.
    (b) As an alternative to the documentation described in paragraphs 
(a)(2)(A)-(B) of this section (documentation concerning a vaccine 
recipient's participation in, and receipt of the smallpox vaccine 
under, an approved smallpox emergency response plan), a requester may 
submit a certification, by a Federal, State, or local government entity 
or private health care entity participating in the administration of 
covered countermeasures through a smallpox emergency response plan, 
that the requester is a person described in Sec.  102.3(x)(1)-(3) (a 
person meeting the definition of a smallpox vaccine recipient, except 
for the requirement that the person sustained a covered injury). A 
certification form that may be used for this purpose is available from 
the Program.


Sec.  102.52  Documentation a vaccinia contact must submit to be deemed 
eligible by the Secretary.

    A requester who is a vaccinia contact must submit the following 
documentation in order to be deemed eligible by the Secretary:
    (a) A completed (to the fullest extent possible) and signed Request 
Form;
    (b) Documentation identifying the individual who was the source of 
the accidental vaccinia inoculation. This

[[Page 70100]]

documentation must demonstrate that the source of the vaccinia was an 
individual described in Sec.  102.3(x)(1)-(3) (a person meeting the 
definition of a smallpox vaccine recipient, except for the requirement 
that the person sustained a covered injury) or an individual who was 
accidentally inoculated by an individual described in Sec.  
102.3(x)(1)-(3) (a person meeting the definition of a smallpox vaccine 
recipient, except for the requirement that the person sustained a 
covered injury). If the requester is unable to provide the identity of 
the person who was the source of the accidental exposure, he or she 
must explain in writing both why this criterion cannot be met and the 
circumstances of the accidental vaccinia inoculation that support an 
individual described above as the source of the accidental vaccinia 
inoculation. The Secretary has the discretion to accept the requester's 
statement as evidence of the requester's source of exposure; and
    (c) Medical records sufficient to demonstrate that the requester 
contracted vaccinia during the effective period of the Declaration (or 
within 30 days thereafter) and sustained a covered injury, as described 
in Sec.  102.3(g), in accordance with the requirements set forth in 
Sec.  102.50. These records must be consistent with the requester 
contracting vaccinia after the accidental vaccinia inoculation 
described in paragraph (b) of this section.


Sec.  102.53  Documentation a survivor must submit to be deemed 
eligible by the Secretary.

    A requester who is a survivor must submit the following 
documentation in order to be deemed eligible by the Secretary:
    (a) A completed (to the fullest extent possible) and signed Request 
Form;
    (b) All of the documentation required in:
    (1) Section 102.51(a)(2)-(4) (documentation requirements for 
smallpox vaccine recipients), in the case of a deceased smallpox 
vaccine recipient. The survivor requester may submit a certification, 
as described in Sec.  102.51(b) in the place of the documentation 
described in Sec.  102.51(a)(2) (documentation concerning a vaccine 
recipient's participation in, and receipt of the smallpox vaccine 
under, an approved smallpox emergency response plan); or
    (2) Section 102.52(b)-(d) (documentation requirements for vaccinia 
contacts), in the case of a deceased vaccinia contact;
    (c) A death certificate for the deceased smallpox vaccine recipient 
or vaccinia contact. 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 smallpox recipient or vaccinia 
contact is deceased;
    (d) Medical records sufficient to demonstrate that the deceased 
smallpox vaccine recipient or vaccinia contact died as the result of 
the covered injury. Such medical records may be the same as those 
required under Sec.  102.50. If an autopsy was performed on the 
deceased smallpox vaccine recipient or vaccinia contact, the requester 
must submit a complete copy of the final autopsy report.
    (e) Documentation showing that the requester is an eligible 
survivor, pursuant to Sec.  102.11 (e.g., birth certificate or marriage 
certificate); and
    (f) A certification, on the place provided on the Request Form, 
either that there are no other eligible survivors (e.g., for surviving 
eligible children, a certification 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 
102.11 lists eligible survivors and the priorities of survivorship.


Sec.  102.54  Documentation the representative of the estate of a 
deceased smallpox vaccine recipient or vaccine contact must submit to 
be deemed eligible by the Secretary.

    A requester who is the representative of the estate of a deceased 
smallpox vaccine recipient or vaccinia contact must submit the 
following documentation in order for the estate to be deemed eligible 
by the Secretary:
    (a) A completed (to the fullest extent possible) and signed Request 
Form;
    (b) All of the documentation required in:
    (1) Section 102.51(a)(2)-(4) (documentation requirements for 
smallpox vaccine recipients), in the case of a deceased smallpox 
vaccine recipient. The requester may submit a certification, as 
described in Sec.  102.51(b) in the place of the documentation 
described in Sec.  102.51(a)(2) (documentation concerning a vaccine 
recipient's participation in, and receipt of the smallpox vaccine 
under, an approved smallpox emergency response plan); or
    (2) Section 102.52(b)-(d) (documentation requirements for vaccinia 
contacts), in the case of a deceased vaccinia contact;
    (c) A death certificate for the deceased smallpox vaccine recipient 
or vaccinia contact. 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 smallpox recipient or vaccinia 
contact is deceased; and
    (d) Documentation showing that the requester is the representative 
of the estate of the deceased smallpox vaccine recipient or vaccinia 
contact.

Subpart G--Required Documentation for Eligible Requesters to 
Receive Benefits


Sec.  102.60  Documentation an eligible requester seeking medical 
benefits must submit.

    A requester deemed eligible by the Secretary who seeks payment or 
reimbursement for medical services or items must submit the following, 
in addition to the documentation submitted under subpart F:
    (a) List of third-party payors. The requester must submit a list of 
all third-party payors that may have an obligation to pay for or 
provide any medical services or items for which payment or 
reimbursement is being sought under this Program. Such third-party 
payors may include, but are not limited to, health maintenance 
organizations, health insurance companies, Medicare, Medicaid, and 
other entities obligated to provide medical services or items or 
recompense individuals for medical expenses. Such a list must include 
the individual's account numbers and other applicable information. If 
the requester knows of no such third-party payor, he or she must 
certify to that fact. If the requester becomes aware that a third-party 
payor may have such an obligation, the requester must inform the 
Secretary within 10 business days of becoming aware of this 
information.
    (b) Documents for medical services or items provided in the past. A 
requester seeking payment or reimbursement for medical services or 
items provided in the past must submit an itemized statement from each 
health care entity (e.g., clinic, hospital, doctor, or pharmacy) and 
third-party payor 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

[[Page 70101]]

company). If no third-party payor has an obligation to pay for or 
provide such services or items, the requester must certify to that fact 
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 its health complications, the requester may submit, in 
addition to the required medical records, documentation showing that a 
health care practitioner prescribed or recommended such services or 
items. The medical records must support the requested services and 
items;
    (c) Documents for medical services and items expected to be 
provided in the future. A requester seeking payments for medical 
services or items expected to be provided in the future must submit a 
statement from one or more health care practitioner(s) (e.g., a 
treating neurologist for neurologic issues and a treating cardiologist 
for cardiologic issues) describing those services and items that appear 
likely to be needed to diagnose or treat the covered injury or 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 paid by third-party payors for, such services or 
items.


Sec.  102.61  Documentation an eligible requester seeking benefits for 
lost employment income must submit.

    A requester deemed eligible by the Secretary who seeks benefits for 
lost employment income from the Program must submit, in addition to the 
documentation submitted under subpart F, documentation describing:
    (a) The number of days (including partial days) of work missed by 
the smallpox vaccine recipient or vaccinia contact as a result of the 
covered injury or its health complications for which employment income 
was lost (e.g., time sheet from pay period reflecting work days 
missed). As stated in Sec.  102.32(c), days for which an individual 
used paid leave in order to be paid for lost work will be considered 
days of work for which employment income was received (unless the 
individual's employer restores the leave that was used by putting the 
individual in the same position as if he or she had not used paid 
leave);
    (b) The smallpox vaccine recipient or vaccinia contact's gross 
employment income at the time the covered injury was sustained (e.g., 
the individual's most recent Federal tax return or a pay stub from the 
time of the covered injury);
    (c) Whether the smallpox vaccine recipient or vaccinia contact had 
one or more dependents at the time the covered injury was sustained 
(e.g., the individual's most recent Federal tax return); and
    (d) All third-party payors that have paid for or that may be 
required to pay the requester benefits for loss of employment income or 
provide disability and retirement benefits for which payment or 
reimbursement is being sought under this Program (e.g., State workers' 
compensation programs, disability insurance programs, etc.). A 
requester must submit documentation, if available, concerning the 
amount of such payments or benefits expected to be paid by third-party 
payors. If the requester knows of no such third-party payor, he or she 
must certify to that fact. If, at any time, the requester becomes aware 
that a third-party payor may have such an obligation, the requester 
must inform the Secretary within 10 business days of becoming aware of 
this information.


Sec.  102.62  Documentation an eligible requester seeking a death 
benefit must submit.

    (a) A requester deemed an eligible survivor by the Secretary who 
seeks a death benefit under Sec.  102.82(c) must submit, in addition to 
the documentation submitted under subpart F, a certification informing 
the Secretary whether a disability or death benefit was paid under the 
PSOB Program with respect to the deceased smallpox vaccine recipient or 
vaccinia contact. If such a benefit(s) was provided, the requester must 
submit documentation showing the amount of the benefit(s) provided by 
the PSOB Program. If no such benefits were provided, the certification 
must explain whether any survivors are eligible for a death benefit 
under the PSOB Program and, if so, whether death benefits have been 
sought under the PSOB Program.
    (b) A representative seeking a death benefit under Sec.  102.82(d) 
on behalf of a dependent requester younger than the age of 18 deemed an 
eligible survivor by the Secretary must submit, in addition to the 
documentation submitted under subpart F, the following:
    (1) Documentation showing that the deceased smallpox vaccine 
recipient or vaccinia contact 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) 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.  102.82(d), in 
place of proportional benefits available under the standard calculation 
as described in Sec.  102.82(c). Written selections are described in 
Sec.  102.82(d)(1).
    (3) 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.  102.63(b). If multiple dependents have 
different legal guardians, the legal guardian of each dependent(s) must 
submit such documentation;
    (4) Documentation showing the deceased smallpox vaccine recipient 
or vaccinia contact's gross employment income at the time the covered 
injury was sustained (e.g., the decedent's most recent Federal tax 
return or a pay stub from the time of the covered injury); and
    (5) A description of all third-party payors that have paid for or 
that may be required to pay for the benefits described in Sec.  
102.82(d)(3)(A). This description must include the amount of such 
benefits that have been paid or that may be authorized to be paid in 
the future. If the representative knows of no such third-party payor, 
he or she must certify to that fact. If, at any time, the 
representative becomes aware that a third-party payor may have such an 
obligation, he or she must inform the Secretary within 10 business days 
of becoming aware of this information.


Sec.  102.63  Documentation a representative filing on behalf of an 
eligible requester who is a minor or a legally incompetent adult must 
submit.

    Before benefits will be paid under by the Program to an eligible 
requester who is a minor or legally incompetent adult, his or her 
representative must submit, in addition to the documentation submitted 
under subpart F and under Sec. Sec.  102.60-102.62, the following:
    (a) Documentation showing that the requester is:
    (1) A minor (e.g., birth certificate); or
    (2) A legally incompetent adult (e.g., court decree of 
incompetency); and
    (b) Documentation showing that:
    (1) In the case of a minor, the requester is the legal guardian of 
the minor (e.g., birth certificates for parents who are legal guardians 
or, for other legal guardians, a decree by a court of competent 
jurisdiction establishing the legal guardianship of a person other

[[Page 70102]]

than the minor's parents under applicable State law). If a minor has 
more than one legal guardian, this information is required only of one 
legal guardian; or
    (2) In the case of a legally incompetent adult, a decree by a court 
of competent jurisdiction establishing a guardianship or 
conservatorship of the requester's estate under applicable State law.

Subpart H--Secretarial Determinations


Sec.  102.70  Determinations the Secretary must make before benefits 
can be paid.

    (a) Before reviewing a Request Package, the Secretary will assign a 
Program number to the Request Package 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 
Package will be referenced by this Program number.
    (b) Before the Secretary will pay benefits under this Program, he 
must determine that:
    (1) The requester or his or her representative submitted a 
completed (to the fullest extent possible) and signed Request Form 
within the governing filing deadline;
    (2) The requester meets the eligibility requirements set out in 
this part (including a determination that a covered injury was 
sustained); and
    (3) 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.
    (c) Once the Secretary has sufficient documentation to make an 
eligibility or benefits determination, he will make the decision in a 
timely manner.


Sec.  102.71  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 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 write to the Secretary and explain the 
reason that the requested documentation is unavailable and the efforts 
the requester has taken to obtain the documents. The Secretary may 
accept such a letter in place of the required documentation or 
disapprove the request due to insufficient documentation. If no 
documentation is submitted in response to the Secretary's letter, the 
Secretary may disapprove the request. The Secretary also may require an 
authorization from the requester (or his or her representative) to try 
to obtain required documentation on his or her behalf.


Sec.  102.72  Sufficient documentation for eligibility and benefits 
determinations.

    (a) Eligibility determinations. When the Secretary determines that 
there is sufficient documentation in the Request Package to conduct an 
evaluation of a requester's eligibility, he will begin the review to 
determine whether the requester is eligible. 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 options available to the requester, including 
reconsideration.
    (b) Benefits determinations. If the Secretary determines that the 
requester is eligible for benefits, he will, after receiving 
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 insurance company if none was provided).
    (c) Additional documentation required. At any time after a Request 
Form has been filed, the Secretary may direct a requester to supplement 
or amend the Request Package by providing additional information or 
documentation.


Sec.  102.73  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, he 
will notify the requester (or his or her representative) in writing. 
The Secretary will make payments in accordance with Sec.  102.83.


Sec.  102.74  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 and provide the requester, or his or her representative, with a 
written notice of the basis for the disapproval and the options 
available to the requester, including reconsideration.
    (b) The Secretary may disapprove a request at any time, even before 
the requester has submitted required documentation (e.g., the Secretary 
may determine that a requester did not meet the filing deadline, even 
before required documentation is submitted or reviewed).

Subpart I--Calculation and Payment of Benefits


Sec.  102.80  Calculation of medical benefits.

    In calculating medical benefits, the Secretary will take into 
consideration all reasonable costs for those medical items and services 
that are reasonable and necessary to diagnose or treat a smallpox 
vaccine recipient or vaccinia contact's covered injury or its health 
complications, as described in Sec.  102.31. 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.  102.60. The Secretary 
will make such payments only to the extent that such costs were not, 
and will not be, paid by any third-party payor and only if no third-
party payor had or has an obligation to provide such services or items 
to the requester, except as provided in Sec.  103.83(c) and Sec.  
103.84. There are no caps on medical benefits that may be provided 
under the Program.


Sec.  102.81  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 smallpox vaccine recipient or vaccinia contact 
lost employment income for the lost work days. As described in Sec.  
102.32(c), days in which an individual used paid leave (including 
vacation and sick leave) for lost work days will not be considered days 
for which the individual lost employment income (unless the 
individual's employer restores the leave taken by putting the employee 
in the same position as if he or she had not used paid leave).
    (1) The Secretary will calculate the rate of benefits to be paid 
for the lost work days based on the smallpox vaccine recipient or 
vaccinia contact'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.
    (A) For a smallpox vaccine recipient or vaccinia contact with no 
dependents at the time the covered injury was sustained, the benefits 
are 66\2/3\% of the individual's gross employment income

[[Page 70103]]

at the time the covered injury was sustained.
    (B) For a smallpox vaccine recipient or vaccinia contact with one 
or more dependents at the time the covered injury was sustained, the 
benefits are 75% of the individual's gross employment income at the 
time the covered injury was sustained; and
    (2) In the case of a smallpox vaccine recipient or vaccinia contact 
who is a minor, the Secretary may consider the provisions of 5 U.S.C. 
8113 (part of the statute 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:
    (1) Annual limitation. The maximum amount that a requester can 
receive in any one year in benefits for lost employment income under 
this Program is $50,000;
    (2) Lifetime limitation. The maximum amount that a requester 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.  102.82(c). However, this lifetime cap does not apply 
if the Secretary determines that the smallpox vaccine recipient or 
vaccinia contact 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); and
    (3) Number of lost work days. A requester 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 5 days. If the 
smallpox vaccine recipient or vaccinia contact lost employment income 
for a period of 5 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 work days (or partial work days) lost as a result 
of a covered injury or its health complications in this calculation.
    (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 requester for compensation of lost employment income or disability 
or retirement benefits, by any third-party payor in relation to the 
covered injury or its health complications, consistent with Sec.  
102.32(b); and
    (2) So that the total amount of benefits for lost employment income 
paid to a requester under this Program, together with the total amounts 
paid (or payable) by third-party payors, as described in paragraph 
(d)(1) of this section, does not exceed 66\2/3\% (or 75%, if the 
smallpox vaccine recipient or vaccinia contact 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. If a requester receives a lump-sum payment from any third-party 
payor, under any obligation described in paragraph (d)(1) of this 
section, the Secretary will deem 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; 
and
    (e) Termination of payments. The Secretary will not pay benefits 
for lost employment income after the requester reaches the age of 65.


Sec.  102.82  Calculation of death benefits.

    (a) Definitions. For purposes of this section:
    (1) Alternative calculation means the calculation used under 
paragraph (d) of this section for the death benefit available to 
dependents.
    (2) Deceased person means an otherwise eligible deceased smallpox 
vaccine recipient or vaccinia contact; and
    (3) Dependent means a person whom the Internal Revenue Service 
would have considered the deceased person'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.
    (4) Standard calculation means the calculation used under paragraph 
(c) of this section for the death benefit available to all eligible 
survivors (other than dependents who do not meet another category of 
eligible survivors, such as surviving eligible children).
    (b) 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 
(d)(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.  102.11(b).
    (2) If the Secretary approves a written selection to receive 
benefits under the alternative calculation, as described in paragraph 
(d)(1) of this section:
    (A) 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
    (B) 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 smallpox vaccine 
recipient is survived by a dependent 10-year old child and a spouse who 
is not the child's legal guardian (e.g., the dependent child's parents 
were the deceased person and his or her former spouse), the 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).
    (c) Standard calculation of death benefits. (1) The maximum death 
benefit available under the standard calculation of death benefits is 
the amount of the

[[Page 70104]]

comparable death benefit calculated under the PSOB Program in the same 
fiscal year as the year in which the death benefit under the standard 
calculation is paid under this Program (without regard to any reduction 
under the PSOB Program attributable to a limitation in appropriations), 
reduced by the total amount of benefits for lost employment income paid 
under this Program to the deceased person during his or her lifetime 
and to his or her estate after death.
    (2) No death benefit will be paid under the standard calculation if 
a death benefit has been paid, or if survivors are eligible to receive 
a death benefit, under the PSOB Program with respect to the deceased 
person.
    (3) No death benefit will be paid under the standard calculation if 
a disability benefit has been paid under the PSOB Program with respect 
to the deceased person. However, 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 (c)(1) of this section.
    (4) Death benefits will be paid under the standard calculation in a 
lump sum.
    (d) Alternative calculation of death benefits available to 
surviving dependents younger than the age of 18. If a deceased smallpox 
vaccine recipient or vaccinia contact 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 (d)(1) of this section. 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 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 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% of the deceased person'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 (as 
appropriate), except as follows:
    (A) 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;
    (B) 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 will be reduced so 
that the total amount of payments made (or expected to be made) under 
obligations described in paragraph (d)(3)(A) of this section, together 
with the death benefits paid under the alternative calculation, is not 
greater than the amount of payments described in paragraph (d)(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 payors have paid (or are expected to pay) for certain 
benefits so that such dependents will receive a total sum (combining 
the death benefit paid under the alternative calculation and the actual 
and expected benefits paid for by third-party payors) that is not 
greater than the death benefit that would be available under the 
alternative calculation if no third-party payor existed to pay such 
benefits.
    (A) 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 payor for:
    (i) Compensation for the deceased person's loss of employment 
income on behalf of the dependents or their legal guardian(s);
    (ii) Disability, retirement, or death benefits in relation to the 
deceased person (including, but not limited to, death and disability 
benefits under the PSOB Program) on behalf of the dependents or their 
legal guardian(s); and
    (iii) Life insurance benefits on behalf of the dependents.
    (B) In calculating such reductions, the Secretary will deem any 
lump-sum payment made by a third-party payor under any obligation 
described in paragraph (d)(3)(A) of this section, as 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.
    (4) Timing of payments. Payments made under this paragraph will be 
made on an annual basis, beginning at 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.  102.83  Payment of all benefits.

    (a) The Secretary may 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.  102.82(d)) will be required 
for a period in excess of one year from the date the Secretary 
determines the requester is eligible for such benefits, the Secretary 
may make a lump-sum payment, purchase an annuity or medical insurance 
policy, or execute an appropriate structured settlement agreement, 
provided that such payment, annuity, policy, or agreement is 
actuarially determined to have a value equal to the present value of 
the projected total amount of benefits that

[[Page 70105]]

the requester is eligible to receive under Sec. Sec.  102.80, 102.81, 
and 102.82(d).
    (b) Lump sum payments will be made through an electronic funds 
transfer to an account of the requester. However, if the requester is a 
minor, the payment will be made to the account of his or her legal 
guardian on behalf of the minor. In accepting such payments, the legal 
guardian of a minor requester is obliged 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 
a legally incompetent adult, 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.
    (c) The Secretary may, at his discretion, make interim payments of 
benefits under this Program, even before he makes a final determination 
as to the total type and total amount of benefits that will be paid. 
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, in his discretion, 
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 vaccine-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 requester. Such a 
requester must agree that he or she will be obliged to repay the 
Secretary such benefits in the event that such payments are later 
determined to be inappropriate. Any payments made on an interim basis 
will not entitle a requester to seek reconsideration of the Secretary's 
decision on these benefits until the Secretary makes a complete 
benefits determination.


Sec.  102.84  The Secretary's right to recover benefits paid under this 
program from third-party payors.

    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 payor with a legal or contractual obligation to 
pay for (or provide) such benefits and may recover from such third-
party payor(s) the amount of benefits paid up to the amount of benefits 
the third-party payor 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 payor in specific circumstances. 
In those circumstances, the Secretary has a right to be reimbursed by 
the third-party payor. 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 payor 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 payor after receiving the same type of benefits from the 
Secretary under this Program, the Secretary has a right to recover the 
amount of the benefits awarded from the requester.

Subpart J--Reconsideration of the Secretary's Determinations


Sec.  102.90  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 payment. In addition, a requester who asserts that the 
amount of the benefits paid by the Secretary (or the fact that certain 
benefits were not paid or payable) is incorrect may also seek 
reconsideration. Letters seeking 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. Because no new documentation will be 
considered in the reconsideration process, the letter seeking 
reconsideration may not include or refer to any documentation that was 
not before the Secretary at the time of his initial determination.
    (b) Letters seeking reconsideration. A requester, or his or her 
representative, may send a letter seeking reconsideration through the 
U.S. Postal Service, commercial carrier, or a private courier service. 
The Secretary will not accept letters seeking reconsideration 
electronically or by hand-delivery.
    (1) Letters sent through the U.S. Postal Service must be sent to 
the Associate Administrator, Special Programs Bureau, Health Resources 
and Services Administration, 5600 Fishers Lane, Room 16C-17, Rockville, 
Maryland 20857.
    (2) Letters sent through a commercial carrier or private courier 
service must be sent to the Associate Administrator, Special Programs 
Bureau, Health Resources and Services Administration, 4350 East-West 
Highway, 10th Floor, Bethesda, Maryland 20814.
    (c) Reconsideration process. When the Associate Administrator of 
the Special Programs Bureau (the Associate Administrator), receives a 
letter seeking reconsideration, a qualified panel will be convened, 
independent of the Program, to review the Secretary's initial 
determination. The panel will base its recommendation on the 
documentation before the Secretary when the initial determination(s) 
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 letter seeking reconsideration and will be considered the 
Secretary's final determination on the request. Requesters may not seek 
review of a decision made on reconsideration.


Sec.  102.91  Secretary's review authority.

    Under section 262(f)(1) of the Public Health Service Act (42 U.S.C. 
239a(f)(1)), the Secretary may, at any time, review on his own motion 
or on application, any determination made under this part (including, 
but not limited to, determinations concerning eligibility, entitlement 
to benefits, and the calculation and payment of benefits under the 
Program). Upon review of such a determination, the Secretary may 
affirm, vacate, or modify the determination in any manner the Secretary 
deems appropriate.


Sec.  102.92  No additional judicial or administrative review of 
determinations made under this part.

    Under section 262(f)(2) of the Public Health Service Act (42 U.S.C. 
239a(f)(2)), no further judicial review of the Secretary's actions 
under this part (including, but not limited to, eligibility 
determinations, the calculation of benefits, and determinations about 
the method of payment of benefits) is permitted. In addition, no 
further administrative review of the Secretary's actions under this 
part is permitted

[[Page 70106]]

unless the President specifically directs otherwise.
[FR Doc. 03-30790 Filed 12-12-03; 8:45 am]
BILLING CODE 4165-15-P