Page images
PDF
EPUB

(c) The requestor will be notified in termine whether individuals hav writing of ATSDR's determination that exposed to hazardous substance either a health assessment will be per- degree to which such exposure b formed, a health assessment will not be curred, and any possible health e performed, or that further information resulting from such exposure. concerning the facility or release is re- (b) Should ATSDR decide, in i1 quired before a decision can be made cretion, to conduct a health whether a health assessment will be study, it will notify the parties as performed.

ified in $90.6. (d) If a health assessment is not initiated in response to a request from the 8 90.8 Conduct of health assess public, ATSDR shall provide a written

and health effects studies. explanation to the requestor of why a (a) Any interested person or pe health assessment is not appropriate. may submit data or informatic

ATSDR for it to consider in its co: 890.6 Notification of determination to

of a health assessment or a heall conduct a health assessment in re

fects study. In performing a healt sponse to a request from the public.

sessment or a health effects 8 (a) Following a determination by ATSDR will consider data and info ATSDR to conduct a health assessment tion it has independently generata in response to a request from the pub- received from other parties, suc lic, ATSDR shall notify in writing, at a EPA, other Federal agencies, State minimum, the following parties of its local governmental agencies, i intent to perform a health assessment:

nesses, citizen organizations, and is (1) The U.S. Environmental Protec- munity groups. tion Agency;

(b) ATSDR may determine it 18 (2) The appropriate State government essary to conduct a site visit in environmental agency;

nection with a health assessment. (3) The appropriate State and local health effects study. The ATSDR5 health departments;

resentative may allow the partici; (4) The requestor;

tion of any person in the site (5) The owner or operator of the facil- which he or she, at his or her dised ity of concern, if their identity is read- tion, determines will aid in the condily available to ATSDR.

of the health assessment or health In addition, ATSDR will notify, in

fects study. writing or by telephone, other poten- (c) In the event that the informat tially responsible parties, if their iden- necessary to perform a health asst tity is readily available to ATSDR. ment or health effects study 18

(b) At its discretion, ATSDR may no- readily available from other sourc tify any other persons which it feels ATSDR may arrange for sampling may be affected by the release or have additional data gathering at a facil information pertaining to the release.

or release for the limited purpose of

termining the existence of current 8 90.7 Decision to conduct health ef- potential health problems.

fects study. (a) ATSDR may decide, in its discre

890.9 Public health advisory. tion, based upon the results of a health ATSDR may issue a public health a assessment or other available informa- visory based on the findings of a heal tion, to conduct a health effects study assessment, health effects, study, for a particular site or sites. Such a de- other ATSDR involvement. cision may,

in

appropriate circumstances, be made prior to the com

890.10 Notice and comment period. pletion of a health assessment for a Following internal review by ATSD. site or sites. When deciding whether to and external peer review of a dral conduct a health effects study, ATSDR final report of the results of a healt will consider such factors as the results effects study, ATSDR will publish a no and recommendations of a health as- tice that the draft final report is avail sessment for the site or sites and the able for public review

and comment. Al need for additional information to de- a minimum, the notice shall be pub

ex

is at least one newspaper of gen- or particular part thereof (other than atribution in the local where the health or safety effects data), to which s located. The notice shall de- any officer, employee, or representa

bor copies of the draft final re- tive of ATSDR has access under this at the health effects study can be part if made public would divulge insed and set a reasonable time pe- formation entitled to protection under

interested persons to submit the Trade Secrets Act (18 U.S.C. 1906), rests

concerning the study. such information or particular portion DR may, at its discretion, respond thereof shall be considered confidential ting to comments it receives. in accordance with the purposes of that

section, except that such record, re1 Reporting of results of health

port, document, or information may be seguments and health effects stud

disclosed to other officers, employees,

or authorized representatives of the ATSDR shall provide a report of United States concerned with carrying insults of a health assessment or

out statutorily mandated duties. d effects study to EPA, the appro

(c) In submitting data to ATSDR, a * State and local governmental

person may designate the data which cies, any person requesting

such person believes is entitled to proDDR to conduct the health assess

tection under paragraph (b) of this secand parties potentially respon

tion and submit such designated data for the release, if their identity is

separately from other data submitted atly available to ATSDR. In addi

under this part. A designation under such reports shall be available to araberal public upon request.

this paragraph shall be made in writing

to the Administrator. However, should A in the event that ATSDR or its resentatives conduct medical

ATSDR at any time question such desmations of individuals in the course

ignation, not less than 15 days notice bealth effects study and the exam

to the person sumitting the informa

tion shall be given of the intention to kion reveals a positive significant

remove such trade secret designation utical finding, the individual, and a

from such information. The person pician if designated by the individwill be promptly notified of that

may submit a request to the Adminis

trator to reconsider this intention and dicant medical finding by ATSDR. A summary of the findings of all

may provide additional information in al examinations for each individ

support of the trade secret designation.

The Administrator shall notify the per31. be sent by ATSDR to that indi

son in writing of the decision which 0 All studies and results of research

will become effective no sooner than 15 sardacted under this part (other than

days after the date of such notice. the assessments) shall be reported

$90.13 Recordkeeping requirements. tr adopted only after appropriate peer

(a) ATSDR shall maintain a record of

all health assessments and health efP.12 Confidentiality of information. fects studies. The Administrator shall, A) ATSDR shall consider any medi

at his or her discretion, determine the information in individually identi

contents of the record. At a minimum, able form to be confidential informa

the record shall include: Noe and shall release such information (1) The final ATSDR report of the us in accordance with the Privacy health assessment or health effects Bet (5 U.S.C. 552a) or other applicable study;

(2) Nonconfidential data and other in6) As provided under section 104(e)(7) formation upon which that report is CERCLA, any records, reports, or in- based or which was considered by kamation obtained from any person

ATSDR; under this section shall be available to (3) Nonconfidential data or other inide public, except that upon a showing formation submitted by interested perberisfactory to ATSDR by any person sons pertaining to the health assessBat records, reports, or information, ment or health effects study;

[ocr errors]

Tederal law.

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-10 lanta, Georgia.

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

(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

[ocr errors][merged small][ocr errors]

SUBCHAPTER 1-(RESERVED)
SUBCHAPTER J-VACCINES

PART 100-VACCINE INJURY insurance policy is $158.00 per month. COMPENSATION

This amount will be revised to reflect the changes in the medical care compo

nent of the Consumer Price Index (All 01 Applicability.

Urban Consumers, U.S. City Average), 1023 Average cost of a health insurance pol- published by the United States Bureau ley.

of Labor Statistics, plus 2 percent per 13 Vaccine injury table.

year. The revised amounts will be efAUTHORITY: Sec. 215 of the Public Health fective upon their delivery by the SecStrice Act (42 U.S.C. 216); sec. 2115 of the retary to the United States Claims 5 Act, 100 Stat. 3767, as amended (42

Court, and the amounts will be pubS.C. 30022-15); $100.3, the Vaccine Injury

lished in a notice in the FEDERAL REGTable, issued under sec. 312 of Pub. L. 99 660, 0 Stat. 3779 (42 U.S.C. 30028-1 note) and sec.

ISTER from time to time as determined 14(c) of the PHS Act (42 U.S.C. 300aa-14(c)). by the Secretary.

(57 FR 28099, June 24, 1992, as amended at 60 100.1 Applicability.

FR 7693, Feb. 8. 1995)
This part applies to the National
Vaccine Injury Compensation Program

$ 100.3 Vaccine injury table. VICP) under subtitle 2 of title XXI of (a) In accordance with section 312(b) the Public Health Service (PHS) Act. of the National Childhood Vaccine In0 FR 7693, Feb. 8, 1995)

jury Act of 1986, title III of Pub. L. 99

660, 100 Stat. 3779 (42 U.S.C. 300a8-1 1100.2 Average cost of a health insur- note) and section 2114(c) of the Public ance policy.

Health Service Act (42 U.S.C. 30028For purposes of determining the 14(c)), the following is a table of vacmount of compensation under the

cines, the injuries, disabilities, illVICP, section 2115(a)(3)(B) of the PHS nesses, conditions, and deaths resulting Act, 42 U.S.C. 300aa.15(a)(3)(B), provides from the administration of such vacthat certain individuals are entitled to cines, and the time period in which the receive an amount reflecting lost earn- first symptom or manifestation of s, less certain deductions. One of onset or of the significant aggravation de deductions is the average cost of a of such injuries, disabilities, illnesses, bealth insurance policy, as determined conditions, and deaths is to occur after by the Secretary of Health and Human vaccine administration for purposes of Services. The Secretary has deter- receiving compensation under the Promined that the average cost of a health gram:

VACCINE INJURY TABLE

Itiness, disability, injury or condition covered

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

cant aggravation after vaccine administra

tion

LOTP; 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

4 hours. B. Encephalopathy (or encephalitis)

72 hours. C. Any sequela (including death) of an illness, disability, injury, or condition reterred Not applicable.

to above which illness, disability, injury, or condition arose within the time period

prescribed. IL (a). Measles, mumps, nubella, or any vaccine containing any of the foregoing as a component A. Anaphylaxis or anaphylactic shock

4 hours.

VACCINE INJURY TABLE Continued

Time period for first symptom mandestation of onset ord

sig llness, disability, injury or condition covered

cant apravedon atter vaccine admin

son 8. Encephalocatry for ercephalitis)

5-15 days (not less than 5 days

not more than 15 days) torr stos, muros, ruboke, or any cine containing any of the

going as a component C. Presidual seizure disorder in accordance with subsection (D)(3)

515 days (not less than 5 days not more than 15 days) for a

sies, mumps, noole a my cine containing any of the

going as a component D. Any sequela (including death) of an iness, disability, injury. Or condition referred Not applicable

to above which üness, disability, injury, or condition arose within the time period

prescribed. IL (D). In the case of measies, mumps, rubella (MMA), measies, nobela (MR) or rubella vacaines only. A. Chronic arthritis

42 days. B. Any sequela (including death) of an iness, disability, injury, or condition referred Not applicable

to above which iness, disabiity, injury, or condition arose within the time period

prescribed.
IN. Poio Vaccine (other than Inactivated Polio Vaccine):
A. Paralytic Polio
In a non-immunodeficient recipient

30 days.
In an immunodeficient recipient ...

6 months. In a vaccine associated community case

Not applicable. B. Any acute complication or sequela (including death) of an illness, disability, injury. Not applicable * ar condition referred to above which iness, disability, injury, or condition arose

within the time period prescribed. N. Inactivated Polio Vaccines A. Anaphylaxis or anaphylactic shock ..

4 hours. 8. Any acute complication or sequela (including death) of an illness, disability, injury. Not applicable.

ar condition referred to above which illness, disability, injury, or condition arose within the time period prescribed.

[ocr errors]

(b) Qualifications and aids to interpre- edema of the hypopharynx, epiglottis, tation. The following qualifications and larynx, or trchea and minimal findings aids to interpretation shall apply to of eosinophilia in the liver, spleen and the Vaccine Injury Table in paragraph lungs. When death occurs within mid-21 (a) of this section:

utes of exposure and without signs of (1) Anaphylaxis and anaphylactic respiratory distress, there may not be shock. For purposes of paragraph (a) of significant pathologic findings. this section, Anaphylaxis

and

(2) Encephalopathy. For purposes of anaphylactic shock mean an acute, se- paragraph (a) of this section, a vaccine vere, and potentially lethal systemic recipient shall be considered to have allergic reaction. Most cases resolve suffered an encephalopathy only if such without sequelae. Signs and symptoms recipient manifests, within the applicabegin minutes to a few hours after ex- ble period, an injury meeting the deposure. Death, if it occurs, usually re- scription below sults from airway obstruction caused encephalopathy, and then a chronic by laryngeal edema or bronchospasm encephalopathy persists in such person and may be associated with cardio- for more than 6 months beyond the vascular collapse. Other significant date of vaccination. clinical signs and symptoms may in- (1) An acute encephalopathy is one clude the following: Cyanosis, hypo- that is sufficiently severe so as to retension, bradycardia, tachycardia, ar- quire hospitalization. rhythmia, edema of the pharynx and/or (A) For children less than 18 months of trachea and/or larynx with stridor and age who present without an associated dyspnea. Autopsy findings may include seizure event, an acute encephalopathy acute emphysema which results from is indicated by a significantly delower respiratory tract obstruction, creased level of consciousness lasting

of

an

acute

[ocr errors]
« PreviousContinue »