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person involved in the con- submitted with a request for a health dhe study or research under re- assessment.

(c) Each request for a health assessmeans an individual, firm, ment should include, where possible: stion, association, partnership, (1) Any other information pertaining ziom, joint venture, commercial to the facility or release, such as the

United States Government, nature and amount of the hazardous municipality, commission, polit- substances of concern or the identities abdivision of a State, Indian of parties believed to be potentially rearany interstate body.

sponsible for the release; tant or contaminant is defined in (2) Potential pathways for human exC. $501(33).

posure, including a description of the kealth advisory is a statement media contaminated (e.g. soil, groundEDR containing a finding that a water, air, etc.); poses a significant risk to

(3) The demographic nature and proxhealth and recommending imity of the potentially affected res to be taken to reduce expo human population; and und eliminate or substantially

(4) Other Federal, State, or local govste the significant risk to human ernmental agencies which were noti

fied or that investigated the facility or ease is defined in 42 U.S.C. 9601(22). release. Procedures for

requesting

(d) This data collection has been rewalth assessments.

viewed and approved by OMB in accord

ance with the Paperwork Reduction ATSDR will accept requests to

Act and assigned the control number mm health assessments for a par

0920_0204. facility or release from any pergroup of persons.

$ 90.5 Acting on requests. All requests to ATSDR to perform 2 assessments should be addressed

(a) Upon receipt of a request for a Assistant Administrator, Agency

health assessment submitted under Toric Substances and Disease Reg

this part, ATSDR will determine, in its 1500 Clifton Road NE., Atlanta,

discretion, whether or not there is a reasonable basis to justify conducting

a health assessment. ATSDR will base Contents of requests for health this determination on, among other misments.

factors: Bach request for a health assess

(1) Whether individuals have been exshall contain:

posed to a hazardous substance, for The name, address (including zip which the probable source of such expoand telephone number of the

sure is a release;

(2) The location, concentration, and The organization or group the

toxicity of the hazardous substances; miestor represents, if any;

(3) The potential for further human The name, location, and descrip exposure; of the facility or release of con

(4) The recommendations of other

governmental agencies; and 9 A statement providing informa- (5) The ATSDR resources available Hea that individuals have been exposed and other ATSDR priorities, such as its

hazardous substance and that the responsibilities to conduct other health Robable source is a release, or suffi- assessments and health effects studies. Lent information to allow the Admin- (b) Where appropriate, ATSDR will strator to make such a finding;

request information from other FedA statement requesting ATSDR to eral, State, and local governmental perform a health assessment.

agencies, as well as other persons, perW At his or her discretion, consist- taining to a facility or release which is at with the requirements of CERCLA, the subject of a request from the public the Administrator may decide not to to ATSDR to conduct a health assessrequire the preceding information be ment.

restor;

(c) The requestor will be notified in termine whether individuals hay writing of ATSDR's determination that exposed to hazardous substanc either a health assessment will be per- degree to which such exposure 1 formed, a health assessment will not be curred, and any possible health performed, or that further information resulting from such exposure. concerning the facility or release is re- (b) Should ATSDR decide, in quired before a decision can be made cretion, to conduct a health whether a health assessment will be study, it will notify the parties a performed.

ified in 890.6. (d) If a health assessment is not initiated in response to a request from the 8 90.8 Conduct of health anses public, ATSDR shall provide a written

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

ATSDR for it to consider in its ci 8 90.6 Notification of determination to

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

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

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

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

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

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

resentative may allow the parti (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 dit ity of concern, if their identity is read- tion, determines will aid in the con ily available to ATSDR.

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

fects study. writing or by telephone, other poten- (c) In the event that the informa tially responsible parties, if their iden- necessary to perform a health as tity is readily available to ATSDR. ment or health effects study is (b) At its discretion, ATSDR may no

readily available from other sour 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 fact 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 assessment or other available informa- visory based on the findings of a hea 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

8 90.10 Notice and comment period. pletion of a health assessment for a Following internal review by ATS. site or sites. When deciding whether to and external peer review of a dry conduct a health effects study, ATSDR final report of the results of a heal will consider such factors as the results effects study, ATSDR will publish & 1 and recommendations of a health as- tice that the draft final report is ava sessment for the site or sites and the able for public review and comment.. need for additional information to de- a minimum, the notice shall be pu

in at least one newspaper of genistribution in the local where the located. The notice shall delow copies of the draft final reIn the health effects study can be sed and set a reasonable time pefor interested persons to submit rents concerning the study. s may, at its discretion, respond ting to comments it receives. I Reporting of results of health sweatments and health effects stud

ATSDR shall provide a report of Insults of a health assessment or d effects study to EPA, the approState and local governmental

any person requesting DR to conduct the health assessE and parties potentially respona for the release, if their identity is y available to ATSDR. In addisuch reports shall be available to general public upon request. In the event that ATSDR or its nasentatives conduct medical excations of individuals in the course bealth effects study and the examon reveals a positive significant tical finding, the individual, and a freician if designated by the individ

Fill be promptly notified of that Dicant medical finding by ATSDR. A summary of the findings of all Sal examinations for each individtl be sent by ATSDR to that indi

or particular part thereof (other than health or safety effects data), to which any officer, employee, or representative of ATSDR has access under this part if made public would divulge information entitled to protection under the Trade Secrets Act (18 U.S.C. 1906), such information or particular portion thereof shall be considered confidential in accordance with the purposes of that section, except that such record, report, document, or information may be disclosed to other officers, employees, or authorized representatives of the United States concerned with carrying out statutorily mandated duties.

(c) In submitting data to ATSDR, a person may designate the data which such person believes is entitled to protection under paragraph (b) of this section and submit such designated data separately from other data submitted under this part. A designation under this paragraph shall be made in writing to the Administrator. However, should ATSDR at any time question such designation, not less than 15 days notice to the person sumitting the information shall be given of the intention to remove such trade secret designation from such information. The person may submit a request to the Administrator to reconsider this intention and may provide additional information in support of the trade secret designation. The Administrator shall notify the person in writing of the decision which will become effective no sooner than 15 days after the date of such notice. $90.13 Recordkeeping requirements.

(a) ATSDR shall maintain a record of all health assessments and health effects studies. The Administrator shall, at his or her discretion, determine the contents of the record. At a minimum, the record shall include:

(1) The final ATSDR report of the health assessment or health effects study;

(2) Nonconfidential data and other information upon which that report is based or which was considered by ATSDR;

(3) Nonconfidential data or other information submitted by interested persons pertaining to the health assessment or health effects study;

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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 hes assessments or health effects studie

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

(1) Nothing in this section is inten to imply that ATSDR's decisions conduct health assessments or hea effects studies, or the reports of hea assessments or health effects stud are subject to judicial review. 8 90.14 Documentation and cost rec

ery. (a) During all phases of ATSL health assessments and health effec studies, documentation shall be co pleted and maintained to form ti basis for cost recovery, as specified section 107 of CERCLA.

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

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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 101 Applicability.

Urban Consumers, U.S. City Average), 10.3 Average cost of a health insurance pol- published by the United States Bureau

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 SecErice Act (42 U.S.C. 216); sec. 2115 of the retary to the United States Claims

Act, 100 Stat. 3767, as amended (42 18.C. 30024-15); $100.3, the Vaccine Injury

Court, and the amounts will be pubTable, issued under sec. 312 of Pub. L. 99 660,

lished in a notice in the FEDERAL REG1. Stat. 3779 (42 U.S.C. 30048-1 note) and sec.

ISTER from time to time as determined E}{{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
Faccine Injury Compensation Program

8 100.3 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 InFR 7693, Feb. 8, 1995)

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

660, 100 Stat. 3779 (42 U.S.C. 30048-1 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. 3000,Por purposes of determining the 14(c)), the following is a table of vacamount of compensation under the cines, the injuries, disabilities, illVICP, section 2116(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 Isceive an amount reflecting lost earn- first symptom or manifestation of 148, less certain deductions. One of onset or of the significant aggravation se 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

Time period for first symptom or

manifestation of onset or of signifiIllness, disability, injury or condition covered

cant
aggravation after vaccine administra-

tion
DTP, P: DT; Td; or Tetanus Toxoid; or in any combination with Polio; or any other
Vascine 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 referred Not applicable. to above which illness, disability, injury, or condition arose within the time period

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

4 hours.

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