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(4) The protocol for the health effects study;

(5) A list of the individuals responsible for external peer review of the report of a health effects study, their comments, and ATSDR's response to the comments; and

(6) For health effects study, the notice announcing the availability of a draft final report for public review and comment, all comments received in response to the notice, and any responses to the comments by ATSDR.

(b) The record may contain a confidential portion which shall include all information determined to be confidential by the Administrator under this part.

(c) The Administrator may determine other documents are appropriate for inclusion in the record for health assessments or health effects studies.

(d) Predecisional documents, including draft documents, are not documents upon which ATSDR bases its conclusions in health assessments or health effects studies, and are not usu

ally included in the record for healt assessments or health effects studies.

(e) The record for ATSDR health a sessments and health effects studie will be available for review, upon pric request, at ATSDR headquarters in A lanta, Georgia.

(f) Nothing in this section is intende to imply that ATSDR's decisions t conduct health assessments or healt effects studies, or the reports of healt assessments or health effects studie are subject to judicial review.

$90.14 Documentation and cost recov ery.

(a) During all phases of ATSDI health assessments and health effect studies, documentation shall be com pleted and maintained to form th basis for cost recovery, as specified i section 107 of CERCLA.

(b) Where appropriate, the informa tion and reports compiled by ATSDF pertaining to costs shall be forwarded to the appropriate EPA regional office for cost recovery purposes.

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Sec.

SUBCHAPTER I—(RESERVED)
SUBCHAPTER J-VACCINES

PART 100-VACCINE INJURY COMPENSATION

01 Applicability.

10.2 Average cost of a health insurance policy.

M3 Vaccine injury table.

AUTHORITY: Sec. 215 of the Public Health Sice Act (42 U.S.C. 216); sec. 2115 of the Act, 100 Stat. 3767, as amended (42 CS.C. 300aa-15); $100.3, the Vaccine Injury Table, issued under sec. 312 of Pub. L. 99-660, 100 Stat. 3779 (42 U.S.C. 300aa-1 note) and sec. 14(c) of the PHS Act (42 U.S.C. 300aa-14(c)).

1100.1 Applicability.

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

30 FR 7693, Feb. 8, 1995]

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 earn8, less certain deductions. One of deductions is the average cost of a health insurance policy, as determined by the Secretary of Health and Human Services. The Secretary has determined that the average cost of a health

insurance policy is $158.00 per month. This amount will be revised to reflect the changes in the medical care component of the Consumer Price Index (All Urban Consumers, U.S. City Average), published by the United States Bureau of Labor Statistics, plus 2 percent per year. The revised amounts will be effective upon their delivery by the Secretary to the United States Claims Court, and the amounts will be published in a notice in the FEDERAL REGISTER from time to time as determined by the Secretary.

[57 FR 28099, June 24, 1992, as amended at 60 FR 7693, Feb. 8, 1995]

§ 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. 99660, 100 Stat. 3779 (42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health Service Act (42 U.S.C. 300aa14(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

Illness, disability, injury or condition covered

LDTP; P; DT; Td; or Tetanus Toxoid; or in any combination with Polio; or any Other Vaccine Containing Whole Cell Pertussis Bacteria, Extracted or Partial Cell Pertussis Bacteria, or Specific Pertussis Antigen(s):

A. Anaphylaxis or anaphylactic shock

B. Encephalopathy (or encephalitis)

Time period for first symptom or manifestation of onset or of significant

aggravation after vaccine administration

4 hours.

C. Any 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.

Il (a). Measles, mumps, rubella, or any vaccine containing any of the foregoing as a component:

A. Anaphylaxis or anaphylactic shock

72 hours. Not applicable.

4 hours.

VACCINE INJURY TABLE-Continued

liness, disability, injury or condition covered

B. Encephalopathy (or encephalitis)

C. Residual seizure disorder in accordance with subsection (b)(3)

D. Any 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.

II. (b). In the case of measles, mumps, rubella (MMR), measles, rubella (MR) or rubella vaccines only:

A. Chronic arthritis.

B. Any 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. Polio Vaccine (other than Inactivated Polio Vaccine):

A. Paralytic Polio

In a non-immunodeficient recipient

In an immunodeficient recipient

In a vaccine associated community case.

B. Any acute 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. Inactivated Polio Vaccine:

A. Anaphylaxis or anaphylactic shock

B. Any acute 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.

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(b) Qualifications and aids to interpretation. The following qualifications and aids to interpretation shall apply to the Vaccine Injury Table in 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.

(1) An acute encephalopathy is one that is sufficiently severe so as to require hospitalization.

(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

r at least 24 hours. Those children than 18 months of age who present lowing a seizure shall be viewed as ving an acute encephalopathy if eir significantly decreased level of sciousness persists beyond 24 hours nd cannot be attributed to a postictal ate (seizure) or medication.

B) For adults and children 18 months age or older, an acute encephalopathy one that persists for at least 24 hours and characterized by at least two of the following:

AA significant change in mental that is not medication related; pecifically a confusional state, or a delirium, or a psychosis;

2) A significantly decreased level of consciousness, which is independent of 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 acephalopathy in any age group. (D) A "significantly decreased level consciousness" is indicated by the esence of at least one of the followclinical signs for at least 24 hours greater (see paragraphs (b)(2)(1)(A) and (b)(2)(1)(B) of this section for applicable timeframes):

(1)Decreased or absent response to vironment (responds, if at all, only loud voice or painful stimuli);

2) Decreased or absent eye contact does not fix gaze upon family members rother individuals); or

(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; 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.

any

(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) Residual Seizure Disorder. (i) A petitioner may be considered to have suffered a residual seizure disorder for purposes of paragraph (a) of this section, if the first seizure or convulsion occurred 5-15 days (not less than 5 days and not more than 15 days) after administration of the vaccine and 2 or more additional distinct seizure or convulsion episodes occurred within 1 year after the administration of the vaccine which were unaccompanied by fever (defined as a rectal temperature equal to or greater than 101.0 degrees Fahrenheit or an oral temperature equal to

or greater than 100 tegrees Fahrous arthritis for more than 6 m ennett). A distinct seizure or convul- following vaccination. sion episode s ruinantly ierized is inbinding all seizure or convulsive actyity xeuring within a 14-cur period. inless competent and palified expert neuroicca estimony s resented co the contrary in a particular case.

For purposes of paragraph a; of this section, à pectioner shall not be considered to have surfered a residual seizure sorter. f the petioner surfered a seizure rovision accom amed by lever defined as a rectal temperature equal or greater than (DL) regrees Firencest or an orai Temperature equal to or greater than 100.) isgrees Firencest before the arta by arter he surmstracion of the vaccine involved

4) Secure and contusion. For pur poses of paragrapes 2. 2 and 3) of ans section. he terms seizure" and convulsion nclude nyociame, gen eralized come-ciome grand mal), and simple and complex parnai seizures. Absence pect mai seizures shall not

re considerer và 22 on so forth in the Tadie. Jersing movements or staring episodes one are 100 80essartly in nutcacion i seizure accv

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(ii) For purposes of paragraph ( this section, the following shall n considered as chronic arthritis: XA culoskeletal disorders such as di A connective tissue diseases (inclu but not limited to rheumatoid ar as. Juvenile rheumatoid arthritis, temic lupus erythematosus, syst sclerosis, mixed connective tissue ease. polymyositis/dermatomyo necrotizing vasculitis vasculopathies and Sjogren's & irome), jegenerative joint disease, fectious agents other than rub whether by direct invasion or aë immune reaction), metabolic and et mine iseases, trauma, neoplasms, ta ropathic disorders, bone and cartila isorders and arthritis associated w ankylosing spondylitis. psoriasis, dammatory bowel disease, Reite syndrome, or blood disorders.

di) Arthralgia (joint pain) or st ness without joint swelling shall not viewed as chronic arthritis for purpo Ji paragraph (a) of this section.

c3fective tate provisions. The Tal of injuries set forth in paragraph (a) his section appites to petitions f compensation under the Program fil with the United States Court of Fe ersi Claims on or after March 10, 199 The Qualifications and Aids to Intel precacion set forth in paragraph (b) ¢. this section apply to petitions file with the United States Court of Fed ersi Claims on or after March 10, 199 The pections for compensation file with the United States Court of Fed ersi Claims before March 10, 1996 shal be governed by section 1143) (initia Table and section 114(b) (initia "Qualification and Aids to Interpreta on of the Public Health Service Act as in erfect on February 8, 1996. 60 FS 1694, Feb. 8. 1996)

PART 110-(RESERVED)

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