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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 health assessments or health effects studies.

(e) The record for ATSDR health assessments and health effects studies will be available for review, upon prior request, at ATSDR headquarters in Atlanta, Georgia.

(f) Nothing in this section is intended to imply that ATSDR's decisions to conduct health assessments or health effects studies, or the reports of health assessments or health effects studies, are subject to judicial review.

890.14 Documentation and cost recovery.

(a) During all phases of ATSDR health assessments and health effects studies, documentation shall be completed and maintained to form the basis for cost recovery, as specified in section 107 of CERCLA.

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

Sec.

SUBCHAPTER J-VACCINES

PART 100-VACCINE INJURY COMPENSATION

100.1 Applicability.

100.2 Average cost of a health insurance policy.

100.3 Vaccine injury table.

AUTHORITY: Sec. 215 of the Public Health Service Act (42 U.S.C. 216); sec. 2115 of the PHS Act, 100 Stat. 3767, as revised (42 U.S.C. 300aa-15); $100.3, Vaccine Injury Table, issued under secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-3782 (42 U.S.C. 300aa-1 note) and sec. 2114(c) and (e) of the PHS Act, 100 Stat. 3766 and 107 Stat. 645 (42 U.S.C. 300aa-14(c) and (e); and sec. 904(b) of Pub. L. 105-34, 111 Stat. 873).

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mined 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 cov-
ered

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Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration

4 hours. 2-28 days. Not applicable.

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IV. Vaccines containing rubella virus (e.g., A. Chronic arthritis
MMR, MR, R).

B. Any acute complication or sequela
(including death) of an illness, disabil-
ity, injury, or condition referred to
above which illness, disability, injury,
or condition arose within the time pe-
riod prescribed.

V. Vaccines containing measles virus A. Thrombocytopenic purpura ....
(e.g., MMR, MR, M).

B. Vaccine-Strain Measles Viral Infection
in an immunodeficient recipient.

Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration

4 hours.

72 hours.
Not applicable.

4 hours.

5-15 days (not less than 5 days and not

more than 15 days).

Not applicable.

7-42 days.
Not applicable.

7-30 days.
6 months.

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C. Any acute complication or sequela❘ Not applicable.
(including death) of an illness, disabil-
ity, injury, or condition referred to
above which illness, disability, injury,
or condition arose within the time pe-
riod prescribed.

VII. Vaccines containing polio inactivated A. Anaphylaxis or anaphylactic shock
virus (e.g., IPV).

VIII. Hepatitis B. vaccines

4 hours

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Vaccine

VACCINE INJURY TABLE-Continued

IX. Hemophilus influenzae type b polysaccharide vaccines (unconjugated, PRP vaccines).

Illness, disability, injury or condition covered

A. Early-onset Hib disease
B. Any acute complication or sequela
(including death) of an illness, disabil-
ity, injury, or condition referred to
above which illness, disability, injury,
or condition arose within the time pe-
›riod prescribed.

X. Hemophilus influenzae type b poly- No Condition Specified

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(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.

179-168 0-98--21

(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

(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 pre

sumed 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 encephalopathy was caused by an infection, a toxin, a metabolic disturbance,

the

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 100.0 degrees Fahrenheit). A distinct seizure or convulsion episode is ordinarily defined as including all seizure or convulsive activity occurring within a 24-hour period, unless competent and qualified expert neurological testimony is presented to the contrary in a particular case.

(ii) For purposes of paragraph (a) of this section, a petitioner shall not be considered to have suffered a residual seizure disorder, if the petitioner suffered a seizure or convulsion 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 100.0 degrees Fahrenheit) before the fifth day after the administration of the vaccine involved.

(4) Seizure and convulsion. For purposes of paragraphs (b) (2) and (3) 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

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