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period, called the project period, lly be for 3-5 years. Generally, the grant will initially 1 year and subsequent continuwards will also be for 1 year at A grantee must submit a sepaapplication to have the support ed for each subsequent year.

regarding continuation and the funding level of such will be of such factors as the e's progress and management ces, and the availability of funds. I cases, continuation awards redetermination by the Secretary continued funding is in the best est of the Federal Government. Neither the approval of any appli

nor the award of any grant mits or obligates the Federal Govent in any way to make any addisupplemental, continuation, or Award with respect to any aped application or portion of an apred application.

How may a grantee use grant funds?

grantee shall only spend funds it ves under this part according to approved application and budget, suthorizing legislation, the terms

and conditions of the grant award, the applicable cost principles specified in subpart Q of 45 CFR part 74, and the regulations of this part.

$87.9 Which other HHS regulations apply?

Several other regulations apply to grants under this part. These include, but are not limited to:

42 CFR part 50, subpart D-Public Health Service grant appeals procedure

45 CFR part 16-Procedures of the Departmental Grant Appeals Board

45 CFR part 46-Protection of human subjects

45 CFR part 74-Administration of grants 45 CFR part 75-Informal grant appeals procedures

45 CFR part 80-Nondiscrimination under programs receiving Federal assistance through the Department of Health and Human Services effectuation of title VI of the Civil Rights Act of 1964

45 CFR part 81-Practice and procedure for hearing under part 80 of this Title

45 CFR part 84-Nondiscrimination on the basis of handicap in programs and activities receiving or benefiting from Federal financial assistance

45 CFR part 91-Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance [49 FR 38117, Sept. 27, 1984]

SUBCHAPTER H-HEALTH ASSESSMENTS AND HEALL FECTS STUDIES OF HAZARDOUS SUBSTANCES REI AND FACILITIES

PART 90-ADMINISTRATIVE FUNC- stances and Disease Registry
TIONS, PRACTICES, AND PROCE
DURES

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90.1 Purpose and applicability.

The provisions of this part set forth the policies and procedures of the Agency for Toxic Substances and Disease Registry (ATSDR) with respect to its conduct of health assessments and health effects studies under section 104/1) of Comprehensive Environmental Response, Compensation, and Liability Act, as amended by the Superfund Amendments and Reauthorization Act of 1986, and section 3019 of the Resource Conservation and Recovery Act. These provisions apply to ATSDR, as well as its contractors, agents, and those carrying out health assessments and health effects studies pursuant to agreements with ATSDR, such as other Federal agencies and States.

890.2 Definitions.

Administrator means the Administrator of the Agency for Toxic Sub

ATSDR means the Agency fo Substances and Disease Registr be Health Service, U.S. Depart Health and Human Services.

a Cove

CERCLA means the Compre Environmental Response, Cor tion, and Liability Act of 1 US.C. 9601 et seq., Pub. L. 960 amended by the Superfund ments and Reauthorization Act 1 (Pub. L. 99-499).

EPA means the U.S. Environ Protection Agency.

for

Facility is defined in 42 U.S.C. { Hazardous substance is defined U.S.C. 9601(14). In addition, the includes any pollutant or contan which the Administrator determi appropriate for the purposes of Cese ing out his or her responsibilities CERCLA

Health assessment means the evit tion of data and information on the lease of hazardous substances inter environment in order to assess anyt rent or future impact on public he develop health advisories or other ommendations, and identify studiere actions needed to evaluate and r gate or prevent human health effect

Health effects study means resea investigation, or study performed ATSDR or other parties pursuant t agreement with ATSDR to evalu the health effects of exposure to t ardous substances at specific sit This term includes, but is not limi to, epidemiological studies, expost and disease registries, and health s veillance programs. This term does L include health assessments.

Owner or operator is defined in U.S.C. 9601(20).

Peer review means review for s entific quality by a panel consisting no less than three nor more than seve members, who shall be disintereste scientific experts selected by the Ad ministrator of ATSDR on the basis their reputation for scientific objectiv ity and the lack of institutional ties

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submitted with a request for a health assessment.

(c) Each request for a health assessment should include, where possible:

(1) Any other information pertaining to the facility or release, such as the nature and amount of the hazardous substances of concern or the identities of parties believed to be potentially responsible for the release;

(2) Potential pathways for human exposure, including a description of the media contaminated (e.g. soil, groundwater, air, etc.);

(3) The demographic nature and proximity of the potentially affected human population; and

(4) Other Federal, State, or local governmental agencies which were notified or that investigated the facility or release.

(d) This data collection has been reviewed and approved by OMB in accordance with the Paperwork Reduction Act and assigned the control number 0920-0204.

§ 90.5 Acting on requests.

under

(a) Upon receipt of a request for a health assessment submitted this part, ATSDR will determine, in its discretion, whether or not there is a reasonable basis to justify conducting a health assessment. ATSDR will base this determination on, among other factors:

(1) Whether individuals have been exposed to a hazardous substance, for which the probable source of such exposure is a release;

(2) The location, concentration, and toxicity of the hazardous substances; (3) The potential for further human exposure;

(4) The recommendations of other governmental agencies; and

(5) The ATSDR resources available and other ATSDR priorities, such as its responsibilities to conduct other health assessments and health effects studies.

(b) Where appropriate, ATSDR will request information from other Federal, State, and local governmental agencies, as well as other persons, pertaining to a facility or release which is the subject of a request from the public to ATSDR to conduct a health assessment.

(c) The requestor will be notified in writing of ATSDR's determination that either a health assessment will be performed, a health assessment will not be performed, or that further information concerning the facility or release is required before a decision can be made whether a health assessment will be performed.

(d) If a health assessment is not initiated in response to a request from the public, ATSDR shall provide a written explanation to the requestor of why a health assessment is not appropriate. $90.6 Notification of determination to conduct a health assessment in response to a request from the public. (a) Following a determination by ATSDR to conduct a health assessment in response to a request from the public, ATSDR shall notify in writing, at a minimum, the following parties of its intent to perform a health assessment: (1) The U.S. Environmental Protection Agency;

(2) The appropriate State government environmental agency;

(3) The appropriate State and local health departments;

(4) The requestor;

(5) The owner or operator of the facility of concern, if their identity is readily available to ATSDR.

In addition, ATSDR will notify, in writing or by telephone, other potentially responsible parties, if their identity is readily available to ATSDR.

(b) At its discretion, ATSDR may notify any other persons which it feels may be affected by the release or have information pertaining to the release. 890.7 Decision to conduct health effects study.

(a) ATSDR may decide, in its discretion, based upon the results of a health assessment or other available information, to conduct a health effects study for a particular site or sites. Such a decision may, in appropriate circumstances, be made prior to the completion of a health assessment for a site or sites. When deciding whether to conduct a health effects study, ATSDR will consider such factors as the results and recommendations of a health assessment for the site or sites and the need for additional information to de

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(a) Any interested person or pe may submit data or informati ATSDR for it to consider in its co of a health assessment or a heal fects study. In performing a healtel sessment or a health effects s ATSDR will consider data and info tion it has independently generatet received from other parties, suc EPA, other Federal agencies, State local governmental agencies, nesses, citizen organizations, and c munity groups.

(b) ATSDR may determine it is essary to conduct a site visit in nection with a health assessment health effects study. The ATSDR resentative may allow the partic tion of any person in the site v which he or she, at his or her dist tion, determines will aid in the cond of the health assessment or health fects study.

(c) In the event that the informat necessary to perform a health asse ment or health effects study is : readily available from other sourc ATSDR may arrange for sampling additional data gathering at a facil or release for the limited purpose of termining the existence of current potential health problems.

§ 90.9 Public health advisory.

ATSDR may issue a public health a visory based on the findings of a heal assessment, health effects, study, other ATSDR involvement.

§ 90.10 Notice and comment period.

Following internal review by ATSD and external peer review of a dra final report of the results of a healt effects study, ATSDR will publish a no tice that the draft final report is avail able for public review and comment. A a minimum, the notice shall be pub

in at least one newspaper of gentribution in the local where the located. The notice shall dehow copies of the draft final reof the health effects study can be med and set a reasonable time per interested persons to submit ments concerning the study. DR may, at its discretion, respond ating to comments it receives.

Reporting of results of health sessments and health effects stud

ATSDR shall provide a report of sults of a health assessment or th effects study to EPA, the approState and local governmental cies, any person requesting SOR to conduct the health assessand parties potentially responfor the release, if their identity is sily available to ATSDR. In addisuch reports shall be available to eneral public upon request.

In the event that ATSDR or its sentatives conduct medical exnations of individuals in the course health effects study and the examtion reveals a positive significant dical finding, the individual, and a Kician if designated by the individwill be promptly notified of that icant medical finding by ATSDR. A summary of the findings of all tal examinations for each individbe sent by ATSDR to that indi

All studies and results of research dcted under this part (other than ith assessments) shall be reported adopted only after appropriate peer view.

12 Confidentiality of information.

ATSDR shall consider any mediinformation in individually identible form to be confidential informaan and shall release such information nly in accordance with the Privacy Act (5 U.S.C. 552a) or other applicable Federal law.

(b) As provided under section 104(e)(7) of CERCLA, any records, reports, or information obtained from any person ander this section shall be available to the public, except that upon a showing Satisfactory to ATSDR by any person that records, reports, or information,

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. 1905), 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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