[Title 42 CFR J]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[Subchapter J - VACCINES]
[From the U.S. Government Printing Office]


42PUBLIC HEALTH12008-10-012008-10-01falseVACCINESJSUBCHAPTER JPUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
                          SUBCHAPTER J_VACCINES



PART 100_VACCINE INJURY COMPENSATION--Table of Contents




Sec.
100.1 Applicability.
100.2 Average cost of a health insurance policy.
100.3 Vaccine injury table.

    Authority: Secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-3782 
(42 U.S.C. 300aa-1 note); sec. 2114(c) and (e) of the PHS Act (42 U.S.C. 
300aa-14(c) and (e)); sec. 2115(a)(3)(B) of the PHS Act (42 U.S.C. 
300aa-15(a)(3)(B)); sec. 904(b) of Pub. L. 105-34, 111 Stat. 873; sec. 
1503 of Pub. L. 105-277, 112 Stat. 2681-741; and sec. 523(a) of Pub. L. 
106-170, 113 Stat. 1927-1928.



Sec. 100.1  Applicability.

    This part applies to the National Vaccine Injury Compensation 
Program (VICP) under subtitle 2 of title XXI of the Public Health 
Service (PHS) Act.

[60 FR 7693, Feb. 8, 1995]



Sec. 100.2  Average cost of a health insurance policy.

    For purposes of determining the amount of compensation under the 
VICP, section 2115(a)(3)(B) of the PHS Act, 42 U.S.C. 300aa-15(a)(3)(B), 
provides that certain individuals are entitled to receive an amount 
reflecting lost earnings, less certain deductions. One of the deductions 
is the average cost of a health insurance policy, as determined by the 
Secretary. The Secretary has determined that the average cost of a 
health insurance policy is $363.12 for 2006. This figure is calculated 
periodically (generally on an annual basis) using the most recent 
Medical Expenditure Panel Survey-Insurance Component (MEPS-IC) data 
available as the baseline for the average monthly cost of a health 
insurance policy. This baseline is adjusted by the annual percentage 
increase/decrease obtained from the most recent annual Kaiser Family 
Foundation and Health Research and Educational Trust (KFF/HRET) Employer 
Health Benefits survey or other authoritative source that may be more 
accurate or appropriate in the future. The revised amount will be 
effective upon its delivery by the Secretary to the United States Court 
of Federal Claims, and the amount will be published as a notice in the 
Federal Register periodically (generally on an annual basis).

[72 FR 36612, July 5, 2007]



Sec. 100.3  Vaccine injury table.

    (a) In accordance with section 312(b) of the National Childhood 
Vaccine Injury Act of 1986, title III of Pub. L. 99-660, 100 Stat. 3779 
(42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health 
Service Act (42 U.S.C. 300aa-14(c)), the following is a table of 
vaccines, the injuries, disabilities, illnesses, conditions, and deaths 
resulting from the administration of such vaccines, and the time period 
in which the first symptom or manifestation of onset or of the 
significant aggravation of such injuries, disabilities, illnesses, 
conditions, and deaths is to occur after vaccine administration for 
purposes of receiving compensation under the Program:

                          Vaccine Injury Table
------------------------------------------------------------------------
                                                       Time period for
                                                      first symptom or
                                                      manifestation of
                              Illness, disability,       onset or of
           Vaccine             injury or condition       significant
                                     covered          aggravation after
                                                           vaccine
                                                       administration
------------------------------------------------------------------------
I. Vaccines containing        A. Anaphylaxis or     4 hours.
 tetanus toxoid (e.g., DTaP,   anaphylactic shock.  2-28 days.
 DTP, DT, Td, or TT).         B. Brachial Neuritis
                              C. Any acute          Not applicable.
                               complication or
                               sequela (including
                               death) of an
                               illness,
                               disability, injury,
                               or condition
                               referred to above
                               which illness,
                               disability, injury,
                               or condition arose
                               within the time
                               period prescribed.

[[Page 613]]

 
II. Vaccines containing       A. Anaphylaxis or     4 hours.
 whole cell pertussis          anaphylactic shock.  72 hours.
 bacteria, extracted or       B. Encephalopathy     Not applicable.
 partial cell pertussis        (or encephalitis).
 bacteria, or specific        C. Any acute
 pertussis antigen(s) (e.g.,   complication or
 DTP, DTaP, P, DTP-Hib).       sequela (including
                               death) of an
                               illness,
                               disability, injury,
                               or condition
                               referred to above
                               which illness,
                               disability, injury,
                               or condition arose
                               within the time
                               period prescribed.
III. Measles, mumps, and      A. Anaphylaxis or     4 hours.
 rubella vaccine or any of     anaphylactic shock.  5-15 days (not less
 its components (e.g., MMR,   B. Encephalopathy      than 5 days and not
 MR, M, R).                    (or encephalitis).    more than 15 days).
                              C. Any acute          Not applicable.
                               complication or
                               sequela (including
                               death) of an
                               illness,
                               disability, injury,
                               or condition
                               referred to above
                               which illness,
                               disability, injury,
                               or condition arose
                               within the time
                               period prescribed.
IV. Vaccines containing       A. Chronic arthritis  7-42 days.
 rubella virus (e.g., MMR,    B. Any acute          Not applicable.
 MR, R).                       complication or
                               sequela (including
                               death) of an
                               illness,
                               disability, injury,
                               or condition
                               referred to above
                               which illness,
                               disability, injury,
                               or condition arose
                               within the time
                               period prescribed.
V. Vaccines containing        A. Thrombocytopenic   7-30 days.
 measles virus (e.g., MMR,     purpura.             6 months.
 MR, M).                      B. Vaccine-Strain
                               Measles Viral
                               Infection in an
                               immunodeficient
                               recipient.
                              C. Any acute          Not applicable.
                               complication or
                               sequela (including
                               death) of an
                               illness,
                               disability, injury,
                               or condition
                               referred to above
                               which illness,
                               disability, injury,
                               or condition arose
                               within the time
                               period prescribed.
VI. Vaccines containing       A. Paralytic Polio
 polio live virus (OPV).
                                --in a non-         30 days.
                                 immunodeficient
                                 recipient.
                                --in an             6 months.
                                 immunodeficient
                                 recipient.
                                --in a vaccine      Not applicable.
                                 associated
                                 community case.
                              B. Vaccine-Strain
                               Polio Viral
                               Infection
                                --in a non-         30 days.
                                 immunodeficient
                                 recipient.
                                --in an             6 months.
                                 immunodeficient
                                 recipient.
                                --in a vaccine      Not applicable.
                                 associated
                                 community case.
                              C. Any acute          Not applicable.
                               complication or
                               sequela (including
                               death) of an
                               illness,
                               disability, injury,
                               or condition
                               referred to above
                               which illness,
                               disability, injury,
                               or condition arose
                               within the time
                               period prescribed.
VII. Vaccines containing      A. Anaphylaxis or     4 hours
 polio inactivated virus       anaphylactic shock.
 (e.g., IPV).
                              B. Any acute          Not applicable.
                               complication or
                               sequela (including
                               death of an
                               illness,
                               disability, injury,
                               or condition
                               referred to above
                               which illness,
                               disability, injury,
                               or condition arose
                               within the time
                               period prescribed..
VIII. Hepatitis B. vaccines.  A. Anaphylaxis or     4 hours.
                               anaphylactic shock.
                              B. Any acute          Not applicable.
                               complication or
                               sequela (including
                               death) of an
                               illness,
                               disability, injury,
                               or condition
                               referred to above
                               which illness,
                               disability, injury,
                               or condition arose
                               within the time
                               period prescribed.
IX. Hemophilus influenzae     No Condition          Not applicable.
 type b polysaccharide         Specified.
 conjugate vaccines.
X. Varicella vaccine........  No Condition          Not applicable.
                               Specified.
XI. Rotavirus vaccine.......  No condition          Not applicable.
                               specified.

[[Page 614]]

 
XII. Vaccines containing      Intussusception.....  0-30 days.
 live, oral, rhesus-based
 rotavirus.
XIII. Pneumococcal conjugate  No condition          Not applicable.
 vaccines.                     specified..
XIV. Any new vaccine          No Condition          Not applicable.
 recommended by the Centers    Specified.
 for Disease Control and
 Prevention for routine
 administration to children,
 after publication by the
 Secretary of a notice of
 coverage.
------------------------------------------------------------------------

    (b) Qualifications and aids to interpretation. The following 
qualifications and aids to interpretation shall apply to the Vaccine 
Injury Table to paragraph (a) of this section:
    (1) Anaphylaxis and anaphylactic shock. For purposes of paragraph 
(a) of this section, Anaphylaxis and anaphylactic shock mean an acute, 
severe, and potentially lethal systemic allergic reaction. Most cases 
resolve without sequelae. Signs and symptoms begin minutes to a few 
hours after exposure. Death, if it occurs, usually results from airway 
obstruction caused by laryngeal edema or bronchospasm and may be 
associated with cardiovascular collapse. Other significant clinical 
signs and symptoms may include the following: Cyanosis, hypotension, 
bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or 
trachea and/or larynx with stridor and dyspnea. Autopsy findings may 
include acute emphysema which results from lower respiratory tract 
obstruction, edema of the hypopharynx, epiglottis, larynx, or trchea and 
minimal findings of eosinophilia in the liver, spleen and lungs. When 
death occurs within minutes of exposure and without signs of respiratory 
distress, there may not be significant pathologic findings.
    (2) Encephalopathy. For purposes of paragraph (a) of this section, a 
vaccine recipient shall be considered to have suffered an encephalopathy 
only if such recipient manifests, within the applicable period, an 
injury meeting the description below of an acute encephalopathy, and 
then a chronic encephalopathy persists in such person for more than 6 
months beyond the date of vaccination.
    (i) An acute encephalopathy is one that is sufficiently severe so as 
to require hospitalization (whether or not hospitalization occurred).
    (A) For children less than 18 months of age who present without an 
associated seizure event, an acute encephalopathy is indicated by a 
significantly decreased level of consciousness lasting for at least 24 
hours. Those children less than 18 months of age who present following a 
seizure shall be viewed as having an acute encephalopathy if their 
significantly decreased level of consciousness persists beyond 24 hours 
and cannot be attributed to a postictal state (seizure) or medication.
    (B) For adults and children 18 months of age or older, an acute 
encephalopathy is one that persists for at least 24 hours and 
characterized by at least two of the following:
    (1) A significant change in mental status that is not medication 
related; specifically a confusional state, or a delirium, or a 
psychosis;
    (2) A significantly decreased level of consciousness, which is 
independent of a seizure and cannot be attributed to the effects of 
medication; and
    (3) A seizure associated with loss of consciousness.
    (C) Increased intracranial pressure may be a clinical feature of 
acute encephalopathy in any age group.
    (D) A ``significantly decreased level of consciousness'' is 
indicated by the presence of at least one of the following clinical 
signs for at least 24 hours or greater (see paragraphs (b)(2)(i)(A) and 
(b)(2)(i)(B) of this section for applicable timeframes):
    (1) Decreased or absent response to environment (responds, if at 
all, only to loud voice or painful stimuli);
    (2) Decreased or absent eye contact (does not fix gaze upon family 
members or other individuals); or

[[Page 615]]

    (3) Inconsistent or absent responses to external stimuli (does not 
recognize familiar people or things).
    (E) The following clinical features alone, or in combination, do not 
demonstrate an acute encephalopathy or a significant change in either 
mental status or level of consciousness as described above: Sleepiness, 
irritability (fussiness), high-pitched and unusual screaming, persistent 
inconsolable crying, and bulging fontanelle. Seizures in themselves are 
not sufficient to constitute a diagnosis of encephalopathy. In the 
absence of other evidence of an acute encephalopathy, seizures shall not 
be viewed as the first symptom or manifestation of the onset of an acute 
encephalopathy.
    (ii) Chronic Encephalopathy occurs when a change in mental or 
neurologic status, first manifested during the applicable time period, 
persists for a period of at least 6 months from the date of vaccination. 
Individuals who return to a normal neurologic state after the acute 
encephalopathy shall not be presumed to have suffered residual 
neurologic damage from that event; any subsequent chronic encephalopathy 
shall not be presumed to be a sequela of the acute encephalopathy. If a 
preponderance of the evidence indicates that a child's chronic 
encephalopathy is secondary to genetic, prenatal or perinatal factors, 
that chronic encephalopathy shall not be considered to be a condition 
set forth in the Table.
    (iii) An encephalopathy shall not be considered to be a condition 
set forth in the Table if in a proceeding on a petition, it is shown by 
a preponderance of the evidence that the encephalopathy was caused by an 
infection, a toxin, a metabolic disturbance, a structural lesion, a 
genetic disorder or trauma (without regard to whether the cause of the 
infection, toxin, trauma, metabolic disturbance, structural lesion or 
genetic disorder is known). If at the time a decision is made on a 
petition filed under section 2111(b) of the Act for a vaccine-related 
injury or death, it is not possible to determine the cause by a 
preponderance of the evidence of an encephalopathy, the encephalopathy 
shall be considered to be a condition set forth in the Table.
    (iv) In determining whether or not an encephalopathy is a condition 
set forth in the Table, the Court shall consider the entire medical 
record.
    (3) [Reserved]
    (4) Seizure and convulsion. For purposes of paragraphs (b) (2) of 
this section, the terms, ``seizure'' and ``convulsion'' include 
myoclonic, generalized tonic-clonic (grand mal), and simple and complex 
partial seizures. Absence (petit mal) seizures shall not be considered 
to be a condition set forth in the Table. Jerking movements or staring 
episodes alone are not necessarily an indication of seizure activity.
    (5) Sequela. The term ``sequela'' means a condition or event which 
was actually caused by a condition listed in the Vaccine Injury Table.
    (6) Chronic Arthritis. (i) For purposes of paragraph (a) of this 
section, chronic arthritis may be found in a person with no history in 
the 3 years prior to vaccination of arthropathy (joint disease) on the 
basis of:
    (A) Medical documentation, recorded within 30 days after the onset, 
of objective signs of acute arthritis (joint swelling) that occurred 
between 7 and 42 days after a rubella vaccination;
    (B) Medical documentation (recorded within 3 years after the onset 
of acute arthritis) of the persistence of objective signs of 
intermittent or continuous arthritis for more than 6 months following 
vaccination; and
    (C) Medical documentation of an antibody response to the rubella 
virus.
    (ii) For purposes of paragraph (a) of this section, the following 
shall not be considered as chronic arthritis: Musculoskeletal disorders 
such as diffuse connective tissue diseases (including but not limited to 
rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus 
erythematosus, systemic sclerosis, mixed connective tissue disease, 
polymyositis/determatomyositis, fibromyalgia, necrotizing vascultitis 
and vasculopathies and Sjogren's Syndrome), degenerative joint disease, 
infectious agents other than rubella (whether by direct invasion or as 
an immune reaction) metabolic and endocrine diseases, trauma, neoplasms, 
neuropathic disorders, bone and cartilage disorders and arthritis 
associated with

[[Page 616]]

ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's 
syndrome, or blood disorders.
    (iii) Arthralgia (joint pain) or stiffness without joint swelling 
shall not be viewed as chronic arthritis for purposes of paragraph (a) 
of this section.
    (7) Brachial neuritis. (i) This term is defined as dysfunction 
limited to the upper extremity nerve plexus (i.e., its trunks, 
divisions, or cords) without involvement of other peripheral (e.g., 
nerve roots or a single peripheral nerve) or central (e.g., spinal cord) 
nervous system structures. A deep, steady, often severe aching pain in 
the shoulder and upper arm usually heralds onset of the condition. The 
pain is followed in days or weeks by weakness and atrophy in upper 
extremity muscle groups. Sensory loss may accompany the motor deficits, 
but is generally a less notable clinical feature. The neuritis, or 
plexopathy, may be present on the same side as or the opposite side of 
the injection; it is sometimes bilateral, affecting both upper 
extremities.
    (ii) Weakness is required before the diagnosis can be made. Motor, 
sensory, and reflex findings on physical examination and the results of 
nerve conduction and electromyographic studies must be consistent in 
confirming that dysfunction is attributable to the brachial plexus. The 
condition should thereby be distinguishable from conditions that may 
give rise to dysfunction of nerve roots (i.e., radiculopathies) and 
peripheral nerves (i.e., including multiple monoeuropathies), as well as 
other peripheral and central nervous system structures (e.g., cranial 
neuropathies and myelopathies).
    (8) Thrombocytopenic purpura. This term is defined by a serum 
platelet count less than 50,000/mm3. Thrombocytopenic purpura does not 
include cases of thrombocytopenia associated with other causes such as 
hypersplenism, autoimmune disorders (including alloantibodies from 
previous transfusions) myelodysplasias, lymphoproliferative disorders, 
congenital thrombocytopenia or hemolytic uremic syndrome. This does not 
include cases of immune (formerly called idiopathic) thrombocytopenic 
purpura (ITP) that are mediated, for example, by viral or fungal 
infections, toxins or drugs. Thrombocytopenic purpura does not include 
cases of thrombocytopenia associated with disseminated intravascular 
coagulation, as observed with bacterial and viral infections. Viral 
infections include, for example, those infections secondary to Epstein 
Barr virus, cytomegalovirus, hepatitis A and B, rhinovirus, human 
immunodeficiency virus (HIV), adenovirus, and dengue virus. An 
antecedent viral infection may be demonstrated by clinical signs and 
symptoms and need not be confirmed by culture or serologic testing. Bone 
marrow examination, if performed, must reveal a normal or an increased 
number of megakaryocytes in an otherwise normal marrow.
    (9) Vaccine-strain measles viral infection. This term is defined as 
a disease caused by the vaccine-strain that should be determined by 
vaccine-specific monoclonal antibody or polymerase chain reaction tests.
    (10) Vaccine-strain polio viral infection. This term is defined as a 
disease caused by poliovirus that is isolated from the affected tissue 
and should be determined to be the vaccine-strain by oligonucleotide or 
polymerase chain reaction. Isolation of poliovirus from the stool is not 
sufficient to establish a tissue specific infection or disease caused by 
vaccine-strain poliovirus.
    (c) Coverage provisions. (1) Except as provided in paragraph (c)(2), 
(3) or (4) of this section, the revised Table of Injuries set forth in 
paragraph (a) of this section and the Qualifications and Aids to 
Interpretation set forth in paragraph (b) of this section apply to 
petitions for compensation under the Program filed with the United 
States Court of Federal Claims on or after March 24, 1997. Petitions for 
compensation filed before such date shall be governed by section 2114(a) 
and (b) of the Public Health Service Act as in effect on January 1, 
1995, or by Sec. 100.3 as in effect on March 10, 1995 (see 60 FR 7678, 
et seq., February 8, 1995), as applicable.
    (2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, and X 
of the Table) are included in the Table as of August 6, 1997.
    (3) Rotavirus vaccines (Item XI of the Table) are included in the 
Table as of October 22, 1998. Vaccines containing live, oral, rhesus-
based rotavirus (Item

[[Page 617]]

XII of the Table) are included in the Table as of October 22, 1998, 
provided that they were administered on or before August 26, 2002.
    (4) Pneumococcal conjugate vaccines (Item XIII of the Table) are 
included in the Table as of December 18, 1999.
    (5) Other new vaccines (Item XIV of the Table) will be included in 
the Table as of the effective date of a tax enacted to provide funds for 
compensation paid with respect to such vaccines. An amendment to this 
section will be published in the Federal Register to announce the 
effective date of such a tax.

[60 FR 7694, Feb. 8, 1995, as amended at 62 FR 7688, Feb. 20, 1997; 62 
FR 10626, Mar. 7, 1997; 63 FR 25778, May 11, 1998; 64 FR 40518, July 27, 
1999; 67 FR 48559, July 25, 2002]



PART 102_SMALLPOX COMPENSATION PROGRAM--Table of Contents




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.
102.22-102.29 [Reserved]

                      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 the 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 benefits 
          determinations.
102.91 Secretary's review authority.
102.92 No additional judicial or administrative review of determinations 
          made under this part.


[[Page 618]]


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

    Source: 68 FR 51497, Aug. 27, 2003, unless otherwise noted.



                      Subpart A_General Provisions

    Source: 68 FR 70093, Dec. 16, 2003, unless otherwise noted.



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 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) Child means any natural, illegitimate, adopted, or posthumous 
child or stepchild of a deceased smallpox vaccine recipient or vaccinia 
contact who, at the time of the recipient or contact's death is:
    (1) 18 years of age or under; or
    (2) Over 18 years of age and a student as defined in section 8101 of 
title 5, United States Code; or
    (3) Over 18 years of age and incapable of self-support because of 
physical or mental disability.
    (f) Contact case means a case in which a person developed an initial 
vaccinial lesion or vaccinial infection through an

[[Page 619]]

exposure other than being vaccinated him/herself.
    (g) 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.
    (h) 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:
    (i) 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
    (ii) 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.
    (i) 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).
    (j) Dependent means a person who would be considered a dependent by 
the Internal Revenue Service.
    (k) Disapproval means a decision by the Secretary that the requester 
will not be paid benefits under the Program.
    (l) Effective period of the Declaration means the time span 
specified in the Declaration, as amended by the Secretary.
    (m) 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.
    (n) 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.
    (o) Injury means an injury (including death), disability, illness, 
or condition.
    (p) Legally incompetent means a person who is considered to lack 
legal capacity under applicable State law.
    (q) Program means the Smallpox Vaccine Injury Compensation Program.
    (r) 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.
    (s) 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.
    (t) Request Form means the form designated by the Secretary as the 
request form for purposes of this part.
    (u) 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.
    (v) 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.
    (w) 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.
    (x) Smallpox (Vaccinia) Vaccine Injury Table or Table or Table of 
Injuries means the table of injuries included at Sec. 102.21,

[[Page 620]]

including the definitions and requirements set forth at Sec. 102.21(b).
    (y) 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.
    (z) State means any State of the United States of America, the 
District of Columbia, United States territories, commonwealths, and 
possessions, the Republic of the Marshall Islands, the Republic of 
Palau, and the Federated States of Micronesia.
    (aa) Survivor means a survivor of a deceased smallpox vaccine 
recipient or vaccinia contact meeting the requirements of Sec. 102.11.
    (bb) 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.
    (cc) 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:
    (i) 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
    (ii) 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.

[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004, as amended at 71 
FR 29810, May 24, 2006]



             Subpart B_Persons Eligible To Receive Benefits

    Source: 68 FR 70093, Dec. 16, 2003, unless otherwise noted.



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

[[Page 621]]

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

[[Page 622]]

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 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., the first symptom or manifestation of 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.

[68 FR 70093, Dec. 16, 2003, as amended at 71 FR 29810, May 26, 2006]

[[Page 623]]



Sec. 102.21  Smallpox (Vaccinia) Vaccine Injury Table.

                                  (a) Smallpox (Vaccinia) Vaccine Injury Table
----------------------------------------------------------------------------------------------------------------
                                          Time interval for first symptom or manifestation of onset of injury
                                         after: (1) administration of smallpox (vaccinia) vaccine in recipients
 Injury (illness, disability, injury,   (R); or (2) exposure to vaccinia in contacts (C). Please note that these
            or condition)               time intervals do not refer to time periods for the date of diagnosis of
                                                                      the injury.
----------------------------------------------------------------------------------------------------------------
1. Significant Local Skin Reaction...  R or C: 1-21 days.
2. Stevens-Johnson Syndrome..........  R or C: 1-21 days.
3. Inadvertent Inoculation...........  R or C: 1-21 days.
4. Generalized Vaccinia..............  R or C: 1-21 days.
5. Eczema Vaccinatum.................  R or C: 1-21 days.
6. Progressive Vaccinia..............  R or C: 1-21 days.
7. Postvaccinial Encephalopathy,       R or C: 1-21 days.
 Encephalitis or Encephalomyelitis.
8. Fetal Vaccinia....................  Maternal R or C: any time in gestation until 7 days after birth.
9. Secondary Infection...............  R or C: 0-30 days.
10. Anaphylaxis or Anaphylactic Shock  R: 0-4 hours.
                                       C: Not Covered.
11. Vaccinial Myocarditis,             R or C: 1-21 days.
 Pericarditis, or Myopericarditis.
12. Death resulting from an injury     R or C: No time interval specified.
 referred to above in which the
 injury arose within the time
 interval referred to above (except
 as specifically provided in
 specified paragraph (b) of this
 section).
----------------------------------------------------------------------------------------------------------------

    (b) Table definitions and requirements. The Table Definitions that 
follow shall apply to, define and describe the scope of, and be read in 
conjunction with paragraph (a) of this section.
    (1) Significant local skin reaction--(i) Definition. Significant 
local skin reaction is, for purposes of the Table, an unexpected and 
extreme response at the vaccination or inoculation site that results in 
a significant scar that is serious enough to require surgical 
intervention. The onset of this injury is the initial skin lesion at the 
vaccination or inoculation site that generally occurs with smallpox 
vaccinations or inoculations. Minor scarring or minor local reactions do 
not constitute a Table injury. Even a robust take, defined as an area of 
redness at the vaccination site that exceeds 7.5 cm in diameter with 
associated swelling, warmth and pain, in general is considered an 
expected response to the vaccination or inoculation. A robust take does 
not in itself constitute a Table injury, even when the redness and 
swelling involves the entire upper arm with associated enlargement and 
tenderness of the glands (lymph nodes) in the underarm (axilla).
    (ii) Table requirements. A Table injury for a significant local skin 
reaction in a recipient or contact requires sufficient evidence in the 
medical records of the occurrence of a significant local skin reaction 
at the vaccination or inoculation site and a permanent, disfiguring scar 
that resulted from the significant local skin reaction. The scar must be 
of sufficient severity to require surgical intervention to correct a 
significant cosmetic (e.g., keloid) or functional (e.g., contracture) 
deformity and such surgery must be included in the treatment plan 
documented in the medical records.
    (2) Stevens-Johnson Syndrome (SJS)--(i) Definition. SJS (sometimes 
called erythema multiforme major) is an acute hypersensitivity reaction 
that affects skin, mucous membranes, and sometimes internal organs 
(systemic toxicity). For purposes of the Table, both skin and mucous 
membrane rash or lesions must be present and the rash or lesions may not 
cover less than ten percent of body surface area. In SJS, mucosal 
involvement generally predominates. Mucosal lesions generally occur at 
more than one location and manifest as painful lesions in sites such as 
the mouth or eyes. Skin rash or lesions in SJS usually consist of red 
raised areas (erythematous macules), blisters, and ulcerations.
    (ii) Table requirements. A Table injury for SJS in a recipient or 
contact requires sufficient evidence in the medical records of the 
occurrence of SJS.

[[Page 624]]

The SJS, or related complications, must be of sufficient severity to 
require inpatient hospitalization.
    (3) Inadvertent Inoculation (II)--(i) Definition. II is the spread 
of vaccinia virus from an existing vaccination or inoculation site to a 
second location usually by scratching the vaccination or inoculation 
site and subsequently spreading the virus, which produces a new 
vaccinial lesion on the same person. Alternatively, II is the spread of 
vaccinia virus from an existing vaccination or inoculation site to 
another person usually by scratching an existing vaccination or 
inoculation site and subsequently spreading the virus, resulting in a 
contact case.
    (ii) Table requirements. A Table injury for II in a recipient or 
contact requires sufficient evidence in the medical records of the 
occurrence of II and the occurrence of one of the following:
    (A) Eye lesions, e.g., vaccinial keratitis or vaccinial blepharitis, 
that resulted from II and that led to a permanent sequela, e.g., 
decrease in visual acuity;
    (B) Permanent and disfiguring scar(s) that resulted from II. The 
scar(s) must be of sufficient severity to require surgical intervention 
to correct a significant cosmetic (e.g., keloid) or functional (e.g., 
contracture) deformity and such surgery must be included in the 
treatment plan documented in the medical records; or
    (C) Acute II or related complications of sufficient severity to 
require inpatient hospitalization.
    (4) Generalized Vaccinia (GV)--(i) Definition. GV is a vaccinial 
infection that occurs from the spread of vaccinia from an existing 
vaccination or inoculation site to otherwise normal skin, resulting in 
multiple new areas of vaccinial rash or lesions. The vaccinia is 
believed to be spread through the blood. The rash or lesions are 
characterized by multiple blisters (vesicles or pustules) that generally 
evolve in a similar sequence or manner as the original vaccination or 
inoculation site.
    (ii) Table requirements. A Table injury for GV in a recipient or 
contact requires sufficient evidence in the medical records of the 
occurrence of GV and the occurrence of one of the following:
    (A) Permanent and disfiguring scar(s) that resulted from GV. The 
scar(s) must be of sufficient severity to require surgical intervention 
to correct a significant cosmetic (e.g., keloid) or functional (e.g., 
contracture) deformity and such surgery must be included in the 
treatment plan documented in the medical records; or
    (B) Acute GV or related complications of sufficient severity to 
require inpatient hospitalization.
    (5) Eczema Vaccinatum (EV)--(i) Definition. EV is the transmission 
or the spread of vaccinia virus from a vaccination or inoculation site 
to skin that has been affected by, or is currently affected with, eczema 
or atopic dermatitis. EV is characterized by lesions that include 
multiple blisters (vesicles or pustules), which generally evolve in a 
similar sequence or manner as the original vaccination or inoculation 
site. The lesions may come together to form larger lesions. Lesions may 
also spread to patches of skin that have never been involved with eczema 
or atopic dermatitis. A person with EV may be quite ill with signs and 
symptoms that involve the whole body (systemic illness), such as fever, 
malaise, or enlarged glands (lymph nodes).
    (ii) Table requirements. A Table injury for EV in a recipient or 
contact requires sufficient evidence in the medical records of the 
occurrence of EV and the occurrence of one of the following:
    (A) Permanent and disfiguring scar(s) that resulted from EV. The 
scar(s) must be of sufficient severity to require surgical intervention 
to correct a significant cosmetic (e.g., keloid) or functional (e.g., 
contracture) deformity and such surgery must be included in the 
treatment plan documented in the medical records; or
    (B) Acute EV or related complications of sufficient severity to 
require inpatient hospitalization.
    (6) Progressive Vaccinia (PV)--(i) Definition. PV is the failure to 
initiate the healing process in an initial vaccination or inoculation 
site by 21 days after exposure to vaccinia with progressive ulceration 
or necrosis at the vaccination or inoculation site leading to a

[[Page 625]]

large destructive ulcer. PV is seen in people with an impaired immune 
system (immunocompromised) and is characterized by a complete or near 
complete lack of inflammation or absence of inflammatory cells in the 
dermis of the skin at the vaccination or inoculation site. The diagnosis 
of PV may be made before 21 days after exposure, especially in a known 
immunocompromised individual who develops a lesion at the vaccination or 
inoculation site. PV may spread through the blood to any location in the 
body. Any person who initiates a significant healing process of the 
vaccination or inoculation site by 21 days after receipt of the smallpox 
vaccine or exposure to vaccinia does not have PV.
    (ii) Table requirements. A Table injury for PV in a recipient or 
contact requires sufficient evidence in the medical records of the 
occurrence of PV and the occurrence of one of the following:
    (A) Permanent and disfiguring scar(s) that resulted from PV. The 
scar(s) must be of sufficient severity to require surgical intervention 
to correct a significant cosmetic (e.g., keloid) or functional (e.g., 
contracture) deformity and such surgery must be included in the 
treatment plan documented in the medical records; or
    (B) Acute PV or related complications of sufficient severity to 
require inpatient hospitalization.
    (7) Postvaccinial Encephalopathy, Encephalitis or Encephalomyelitis 
(PVEM)--(i) Definition. PVEM is, for the purposes of the Table, an 
autoimmune central nervous system injury. In rare cases, the vaccinia 
virus is isolated from the central nervous system. Manifestations 
usually occur abruptly and may include fever, vomiting, loss of appetite 
(anorexia), headache, general malaise, impaired consciousness, 
confusion, disorientation, delirium, drowsiness, seizures, language 
difficulties (aphasia), coma, muscular incoordination (ataxia), urinary 
incontinence, urinary retention, and clinical signs consistent with 
inflammation of the spinal cord (myelitis) such as paralysis or 
meningismus. Long term central nervous system impairments such as 
paralysis, seizure disorders, or developmental delays are known to occur 
as sequelae of the acute PVEM. No clinical criteria, radiographic 
findings, or laboratory tests are specific for the diagnosis of PVEM.
    (ii) Table requirements. A Table injury for PVEM in a recipient or 
contact requires sufficient evidence in the medical records of the 
occurrence of acute PVEM. The acute PVEM or related complications must 
be of sufficient severity to require inpatient hospitalization.
    (8) Fetal Vaccinia (FV)--(i) Definition. FV is an intrauterine 
vaccinial infection subsequent to vaccinia vaccination or inoculation of 
the mother that results from the placental transmission of the vaccinia 
virus during any time in the pregnancy. FV manifests as multiple skin 
lesions or organ involvement and may result in significant scarring or 
death. FV skin lesions are similar to those seen in GV or PV and the 
lesions may come together to form larger lesions. Congenital 
malformations, other than those described above, are not Table injuries.
    (ii) Table requirements. A Table injury for FV requires sufficient 
evidence in the medical records of the occurrence of the FV. The 
occurrence of the FV or related complications must be of sufficient 
severity to require inpatient hospitalization or result in permanent and 
disfiguring scar(s). In addition, a Table injury for FV requires one of 
the following:
    (A) A maternal history of vaccinial vaccination or inoculation, with 
the occurrence of vaccinial skin or mucous membrane lesions within the 
incubation period for vaccinia during the pregnancy in a maternal 
recipient or contact; or
    (B) Isolation of vaccinia from intrauterine or neonatal tissue.
    (9) Secondary Infection (SI)--(i) Definition. SI is, for purposes of 
the Table, a non-vaccinial bacterial, fungal, or viral infection at the 
site of a vaccinial skin or mucous membrane lesion. SI occurs because 
the blister formation or ulceration that is part of the normal 
progression of a vaccinial skin or mucous membrane lesion disrupts the 
surface of the skin or mucous membrane, allowing potential germs to 
invade and infect the vaccinial skin or mucous

[[Page 626]]

membrane lesion leading to significant illness requiring 
hospitalization.
    (ii) Table requirements. A Table injury for SI in a recipient or 
contact requires sufficient evidence in the medical records of the 
occurrence of SI. The acute SI or related complications must be of 
sufficient severity to require inpatient hospitalization.
    (10) Anaphylaxis or Anaphylactic shock--(i) Definition. Anaphylaxis 
or anaphylactic shock is, for purposes of the Table, as an acute, 
severe, and potentially lethal systemic allergic reaction to a component 
of the smallpox vaccine.
    (ii) Table requirements. A Table injury for anaphylaxis or 
anaphylactic shock in a recipient requires sufficient evidence in the 
medical records of the occurrence of an acute anaphylaxis or 
anaphylactic shock. The anaphylaxis or anaphylactic shock must be of 
sufficient severity to require inpatient hospitalization. Anaphylaxis or 
anaphylactic shock is not a Table injury for contacts.
    (11) Vaccinial Myocarditis, Pericarditis, or Myopericarditis (MP)--
(i) Definition. MP is, for purposes of the Table, vaccinial myocarditis, 
pericarditis, or myopericarditis. Myocarditis is defined as an 
inflammation of the heart muscle (myocardium). Pericarditis is defined 
as an inflammation of the covering of the heart (pericardium). 
Myopericarditis is defined as an inflammation of both the heart muscle 
and its covering. The inflammation associated with MP may range in 
severity from very mild (subclinical) to life threatening. In many mild 
cases, myocarditis is diagnosed solely by transient electrocardiographic 
(EKG) abnormalities (e.g., ST segment and T wave changes), increased 
cardiac enzymes, or mild echocardiographic abnormalities. Arrhythmias, 
abnormal heart sounds, heart failure, and death may occur in more severe 
cases. Pericarditis generally manifests with chest pain, abnormal heart 
sounds (pericardial friction rub), EKG abnormalities (e.g., ST segment 
and T wave changes), and/or increased fluid accumulation around the 
heart.
    (ii) Table requirements. A Table injury for MP in a recipient or 
contact requires sufficient evidence in the medical records of the 
occurrence of acute MP. The acute MP (or related complications) must be 
of sufficient severity to require inpatient hospitalization. A death 
resulting from MP requires sufficient microscopic (histopathologic) 
evidence of MP or its sequela in heart tissue.
    (c) Glossary for purposes of this section.
    (1) Blister or vesicle means a circumscribed, elevated skin or 
mucous membrane lesion containing an accumulation of fluid.
    (2) Contact means a person who developed a vaccinial lesion or 
infection through inoculation (and not vaccination).
    (3) Exposure period means the span of time during which vaccinia 
virus can be transmitted from a vaccine recipient shedding vaccinia or 
through a contact case shedding vaccinia.
    (4) Inoculation means transmission of and infection with the 
vaccinia virus through a means other than smallpox vaccination. Spread 
(inoculation) of vaccinia virus may occur in two ways: either self-
inoculation in which the vaccinia virus is spread from the vaccinial 
lesion at the vaccination site to one or more areas on the same person 
or person-to-person inoculation when the vaccinia virus is spread to 
another person, a contact.
    (5) Inoculation site means the skin or mucous membrane surface where 
the vaccinia virus entered the body through means other than 
vaccination.
    (6) Lesion means a pathologic change.
    (7) Pustule means a circumscribed, elevated skin or mucous membrane 
lesion containing an accumulation of white blood cells.
    (8) Recipient means a person to whom the smallpox vaccine was 
administered.
    (9) Ulceration means a specific skin or mucous membrane lesion 
characterized by erosion of the skin or mucous membrane surface.
    (10) Vaccination means the administration and receipt of the 
smallpox (vaccinia) vaccine, and not through contact.
    (11) Vaccination site means the skin surface where the vaccinia 
virus entered the body through vaccination.

[68 FR 70093, Dec. 16, 2003, as amended at 71 FR 29808, May 24, 2006]

[[Page 627]]



Sec. Sec. 102.22-102.29  [Reserved]



                      Subpart D_Available Benefits

    Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.



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.

[[Page 628]]



Sec. 102.32  Benefits for lost employment income.

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

[[Page 629]]

her legal guardian or life insurance benefits on behalf of the 
dependent(s)).



            Subpart E_Procedures for Filing Request Packages

    Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.



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, Healthcare Systems Bureau, Health Resources 
and Services Administration, Parklawn Building, Room 11C-06, 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, Healthcare 
Systems Bureau, Health Resources and Services Administration, Parklawn 
Building, Room 11C-06, 5600 Fishers Lane, Rockville, Maryland 20857.
    (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.''

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29810, May 24, 2006]



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, Healthcare Systems Bureau, 
Health Resources and Services Administration, Parklawn Building, Room 
11C-06, 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, Healthcare Systems Bureau, Health Resources and Services 
Administration, Parklawn Building, Room 11C-06, 5600 Fishers Lane, 
Rockville, Maryland 20857.

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29810, May 24, 2006]



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 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

[[Page 630]]

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

[[Page 631]]

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 or reimbursement for representatives' fees or costs. 
The Act does not authorize the Secretary to pay, or reimburse for, any 
fees or costs associated with the requester's use of a personal 
representative under this Program, including those of an attorney.

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29811, May 24, 2006]



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 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

[[Page 632]]

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

    Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.



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:
    (i) 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
    (ii) Was administered a smallpox vaccine pursuant to an approved 
smallpox emergency response plan during the effective period of the 
Declaration.

[[Page 633]]

    (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)(i)-(ii) 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.

[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004]



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 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

[[Page 634]]

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 vaccinia 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

    Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.



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-

[[Page 635]]

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 
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

[[Page 636]]

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 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

[[Page 637]]

requester's estate under applicable State law.



                  Subpart H_Secretarial Determinations

    Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.



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

[[Page 638]]

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

    Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.



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.
    (i) 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 at the time the 
covered injury was sustained.
    (ii) 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.

[[Page 639]]

    (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.

[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004]



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

[[Page 640]]

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:
    (i) If no other eligible survivors are of equal priority to receive 
death benefits, the Secretary will pay a death benefit in an amount 
calculated under the alternative calculation to the aggregate of the 
dependents on whose behalf the election was filed; and
    (ii) If other eligible survivors are of equal priority to receive 
death benefits as the dependents receiving death benefits under the 
alternative calculation, the Secretary will pay the other eligible 
survivors a proportionate amount of the death benefit available and 
calculated under the standard calculation. In such circumstances, the 
Secretary will pay the aggregate of the dependents receiving a death 
benefit under the alternative calculation a proportionate share of the 
benefits available under that calculation (in place of the proportionate 
share of the death benefit that would be available under the standard 
calculation). For example, if a deceased 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 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

[[Page 641]]

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:
    (i) The maximum payment of death benefits that may be made on behalf 
of the aggregate of the dependents in any one year is $50,000;
    (ii) All payments made under this paragraph will stop once the 
youngest of the dependents reaches the age of 18.
    (3) Reductions for other coverage. The total amount of death 
benefits provided under the alternative calculation will be reduced so 
that the total amount of payments made (or expected to be made) under 
obligations described in paragraph (d)(3)(i) of this section, together 
with the death benefits paid under the alternative calculation, is not 
greater than the amount of payments described in paragraph (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.
    (i) The amount of death benefits paid under the alternative 
calculation will be reduced for all payments made, or expected to be 
made in the future, by any third-party payor for:
    (A) Compensation for the deceased person's loss of employment income 
on behalf of the dependents or their legal guardian(s);
    (B) 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
    (C) Life insurance benefits on behalf of the dependents.
    (ii) 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

[[Page 642]]

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.

[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004]



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 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 Secretary. 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.

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29811, May 24, 2006]



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

[[Page 643]]

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

    Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.



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, Healthcare Systems Bureau, Health Resources and 
Services Administration, 5600 Fishers Lane, Room 12-105, Rockville, 
Maryland 20857.
    (2) Letters sent through a commercial carrier or private courier 
service must be sent to the Associate Administrator, Healthcare Systems 
Bureau, Parklawn Building, Room 12-105, 5600 Fishers Lane, Rockville, 
Maryland 20857.
    (c) Reconsideration process. When the Associate Administrator of the 
Healthcare Systems 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.

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29811, May 24, 2006]



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

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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 unless the President specifically directs otherwise.

                           PART 110 [RESERVED]

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