Research Program for Exposure-Dose Reconstruction

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 98027]

Research Program for Exposure-Dose Reconstruction

Introduction

The Agency for Toxic Substances and Disease Registry (ATSDR)

announces the availability of fiscal year (FY) 1998 funds for a

continuation of a cooperative agreement research program for exposure-

dose reconstruction. The purpose of the program is to reconstruct,

estimate, predict, and evaluate exposures to widely varying contaminant

concentrations, exposure frequencies, and exposure durations, with

widely varying emission characteristics that can be found at National

Priorities List (NPL) sites, Resource Conservation and Recovery Act

(RCRA) facilities, and other sites or facilities where a hazardous

substance has been released into the environment.

ATSDR is committed to achieving the health promotion and disease

prevention objectives of Healthy People 2000, a national activity to

reduce morbidity and mortality and improve the quality of life. This

announcement is related to the priority area of Environmental Health.

(For ordering a copy of Healthy People 2000, see the section Where to

Obtain Additional Information.)

Authority

This program is authorized under section 104(i)(1)(E) of the

Comprehensive Environmental Response, Compensation, and Liability Act

(CERCLA) of 1980, as amended by the Superfund Amendments and

Reauthorization Act (SARA) of 1986 [42 U.S.C. 9604(i)(1)(E)] and

section 3019 (b) (c) of the Resource Conservation and Recovery Act

(RCRA), as amended (Hazardous and Solid Waste Amendments of 1984) [42

U.S.C. 6939a(b) and (c)].

Smoke-Free Workplace

ATSDR strongly encourages all grant and cooperative agreement

recipients to provide a smoke-free workplace and promote the non-use of

all tobacco products, and Public Law 103-227, the Pro Children Act of

1994, prohibits smoking in certain facilities that receive Federal

funds in which education, library, day care, health care, and early

childhood development services are provided to children.

Eligible Applicants

Eligible applicants are the official public health agencies of the

States or their bona fide agents or instrumentalities. This includes

the District of Columbia, American Samoa, the Commonwealth of Puerto

Rico, the Virgin Islands, the Federated States of Micronesia, Guam, the

Northern Mariana Islands, the Republic of the Marshall Islands, the

Republic of Palau, and federally recognized Indian Tribal governments.

State organizations, including State universities, State colleges, and

State research institutions, must affirmatively establish that they

meet their respective State's legislative definition of a State entity

or political subdivision to be considered an eligible applicant.

Availability of Funds

Approximately $300,000 is available in FY 1998 to fund one award.

It is expected that the award will begin on or about September 30,

1998, for a 12-month budget period and a project period of up to 5

years. The funding estimate may vary and is subject to change.

Continuation awards within the project period will be made on the

basis of satisfactory progress and the availability of funds.

Use of Funds

Funds may be expended for reasonable program purposes, such as

personnel, travel, supplies and services. Funds for contractual

services may be requested. However, the awardee, as the direct and

primary recipient of ATSDR cooperative agreement funds, must perform a

substantive role in carrying out project activities and not merely

serve as a conduit for an award to another party or provide funds to an

ineligible party. If contractors are proposed, justification must be

provided along with the following: (1) Name of contractor, (2) method

of selection, (3) period of performance, (4) detailed budget, (5)

justification for use of contractor, and (6) assurance of non-conflict

of interest.

Equipment may be purchased with cooperative agreement funds.

However, the equipment proposed should be appropriate and reasonable

for the activity to be conducted. The applicant, as part of the

application process, should provide: (1) a justification for the need

to acquire the equipment, (2) the description of the equipment, (3) the

intended use of the equipment, and (4) the advantages/disadvantages of

purchase versus lease of the equipment (if applicable). Requests for

equipment

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purchases will be reviewed and approved only under the following

conditions: (1) ATSDR retains the right to request return of all

equipment purchased (in operable condition) with cooperative agreement

funds at the conclusion of the project period, and (2) equipment

purchased must be compatible with CDC/ATSDR hardware.

Background

CERCLA, as amended, and RCRA, as amended, authorize ATSDR to

conduct activities to assess and mitigate the adverse human health

effects of hazardous substances and to ensure the implementation of

applied research programs to more accurately and credibly assess human

health effects associated with hazardous substance exposure. One of the

activities includes conducting public health assessments. The ATSDR

public health assessment is an analysis and statement of the public

health implications posed by a release of a hazardous substance. It is

an evaluation of relevant environmental and health data and community

concerns associated with a site where hazardous substances have been

released, and identifies populations living or working on or near

hazardous waste sites for which more extensive public health actions or

studies are indicated.

A critical aspect of assessing human health effects associated with

hazardous waste sites is the evaluation of past, current, and future

human exposures to hazardous substances. In order to accurately and

meaningfully evaluate such exposures, more sensitive, media specific,

and integrated methods must be developed through a program of research

coordinated across multiple relevant, intra-related environmental,

geochemical, and biomedical disciplines.

Hazardous waste sites present a number of unique circumstances and

problems for ATSDR's public health assessment process. Chief among

these is the widespread occurrence of a number of hazardous chemicals

and mixed hazardous chemical compounds. In addition, some of the more

complex hazardous waste sites may contain multiple waste disposal areas

within a single site. Thus, the health assessor may be confronted with

the need to evaluate exposures to widely varying contaminant

concentrations, exposure frequencies, exposure durations, with widely

varying geochemical and toxicological characteristics. More novel,

reliable, and expedient exposure-dose assessment methods must be

developed in order to adequately address site-specific issues.

Purpose

The purpose of this project is to conduct research related to

exposure-dose reconstruction associated with hazardous waste sites.

This research will advance the development, evaluation, application,

and maintenance of computational tools and decision support systems for

estimating exposure-dose relations resulting from exposure to

contaminated environmental media and hazardous substances.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient shall be responsible for conducting activities under A.,

below, and ATSDR will be responsible for conducting activities under

B., below.

A. Recipient Activities

1. Identify, pursue, and enhance where appropriate, emerging

technical advances in exposure-dose reconstruction to encompass

reconstruction of exposure histories and determination of biologically

effective doses. These advances should include (but not be limited to)

assessment of methods such as: (a) environmental multi-media exposure

(including such pathways as groundwater, surface water, air, soil, and

biota), (b) assessment of exposure and dose through bioavailability,

accumulation, and transformation, (c) delivery of past, current, or

potential future exposure and related dose through water-distribution

systems, (d) kinetic networks, (e) genetic algorithms, (f) dose

reconstruction, and (g) spatial analysis techniques integrated with (a)

through (f) above, as a means to bridge the gap between the release of

hazardous substances into the environment, potential dose (exposure),

and resulting health effects.

2. Reconstruct exposure and potential dose histories and determine

potential for future exposure resulting from hazardous substances in

the environment for populations in the environs around hazardous waste

sites by use of methodology driven environmental assessment tools.

These tools must include at a minimum numerical simulators such as: (a)

Analytical Contaminant Transport System (ACTS); (b) Steady flow in

Layered Aquifer Media and spatial analysis interface (SLAM-GIS); (c)

Contaminant transport in Layered Aquifer Media and spatial analysis

interface (CLAM-GIS); and (d) Water Network and Distribution System

hydraulic and water-quality simulator and spatial analysis interface

(WANDSS-GIS). These tools must be compatible with the desktop computing

devices and operating systems currently in use by the agency and its

exposure-dose reconstruction computational laboratory. The generalized

description of the theory of these assessment tools can be found in the

public domain literature.

3. Integrate uncertainty analysis techniques such as Monte Carlo

simulation into environmental assessment simulator tools so that

environmental exposures and health-based risk assessment analyses can

be conducted. This combined deterministic-probabilistic computational

tool must be developed to include a ``user-friendly'' interface and

should not rely on third-party or proprietary software programs or

licensing to accomplish this task.

4. Develop a ``user friendly'' decision support system that

considers, but is not limited to, the following:

(a) Site characterization and exposure scenario data;

(b) Environmental-media fate and transport computations;

(c) Exposure-route analysis and computations;

(d) Chemical-compound intake and exposure-dose computations;

(e) Probability distributions and uncertainty analyses;

(f) Spatial analysis computations and a geographic information

systems interface; and

(g) Access to the decision support system by means of desktop

computational devices available throughout the agency and in its

exposure-dose reconstruction computational laboratory.

5. Submit, as progress warrants, manuscripts to peer-reviewed

scientific journals on the developments and methodology describing

aspects of the research on exposure-dose reconstruction.

6. Prepare and conduct two workshops for agency personnel to

transfer technology and methodology developed as part of the research

program on exposure-dose reconstruction.

7. When the project is completed, provide a final report to the

agency which includes the methodology describing the exposure-dose

reconstruction process as applied to the public health assessment

process.

B. ATSDR Activities

1. Assist in the development of plausible exposure-dose relations

and criteria for the selection and use of

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computational tools and define appropriate assumptions.

2. Provide recipient organization with a list of hazardous waste

sites and environmental data from which they can choose to test and

validate the acceptability of the environmental assessment simulator

tools developed as part of the exposure-dose reconstruction research

program.

3. Establish a dialogue with recipient organization to identify and

pursue emerging disciplines related to advances in assessment of

exposure to hazardous chemicals and/or mixed wastes typically

associated with hazardous waste sites.

4. Provide technical assistance to recipient organization to extend

the appropriate use of novel exposure characterization and dose

relations protocols to hazard characterization and communication

efforts.

5. Assist in communicating advances in the above areas to all

relevant communities including State and local governments and the

public.

Technical Reporting Requirements

1. Progress and Financial Reports

An original and two copies of an annual progress report and

financial status report are required no later than 90 days after the

end of the budget period. Final financial and performance reports are

required no later than 90 days after the end of the project period. All

reports should be submitted to Ron Van Duyne, Grants Management

Officer, Grants Management Branch, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry Road NE., Mailstop E-13,

Atlanta, GA 30305.

The progress report must include the following for the program,

function, or activity involved: (1) a comparison of actual

accomplishments to the goals established for the period; (2) the

reasons for slippage if established goals are not met; and (3) other

pertinent information.

2. Peer and Technical Reviews

A. CERCLA, as amended by SARA, Section 104(i)(13), and [42 U.S.C.

9604 (I)] requires all studies and results of research (other than

public health assessments) that ATSDR carries out or funds in whole or

in part will be peer reviewed by ATSDR. The ATSDR peer review process

for final reports requires that:

1. Studies must be reported or adopted only after appropriate peer

review.

2. Studies shall be peer reviewed within a period of 60 days to the

maximum extent practical.

3. Studies shall be reviewed by no fewer than three or more than

seven reviewers who (1) are selected by the Administrator, ATSDR; (2)

are disinterested Scientific experts; (3) have a reputation for

scientific objectivity; and (4) who lack institutional ties with any

person involved in the conduct of the study or research under review.

B. ATSDR encourages the rapid reporting and interpretation of

laboratory results and references back to individual participants.

However, if summary tables or distribution of laboratory results are

prepared using the study data, this is considered a preliminary finding

and will require ATSDR technical and peer review prior to release.

C. When, in the opinion of the investigator(s), a public health

concern exists requiring the release of summary study statistics prior

to the completion of the study, the investigator must obtain

concurrence from ATSDR prior to releasing the summary statistics. A

request for ATSDR concurrence for the release of information must be

documented in a letter to ATSDR and should outline the public health

concern, and recommended response, and the draft document proposed for

release by the investigator. ATSDR will provide a technical review and

peer review within ten (10) working days to the maximum extent

possible. Summary statistics may be released only after peer review.

The release of summary statistics does not preclude the requirement for

a final report.

D. By statute, the reporting of preliminary studies and preliminary

research results to the public is not acceptable without prior review

by ATSDR. This includes manuscripts prepared for publication,

presentations at scientific meetings, and reporting of preliminary

findings to the community or the media.

E. The final report for every study should include a detailed

description of the problem, hypothesis, methods, results, conclusions,

and recommendations that constitute a complete performance record of

the study.

F. ATSDR is responsible for the technical and peer review of draft

final reports of any study that it funds prior to the submission of the

final report. This will allow for the recipient to incorporate all

technical and peer review comments into the final report. Responses to

all ATSDR required technical and peer review comments should be

summarized in a letter to ATSDR. This letter should also include the

investigator's response to each comment and a rationale for those

responses. Based upon the comments of the technical and peer reviewers,

modifications in the study report may result. The modified study report

should accompany the letter to ATSDR.

G. ATSDR will make available assistance to investigators in

formatting and copy editing draft final reports, should the

investigator request this assistance. Editing will be conducted by

ATSDR staff and an edited copy of the draft final report will be

supplied to the investigator for review and concurrence. Editing will

occur DURING the conduct of the peer review. It is requested that the

report be furnished in WordPerfect 5.1 on a disk with the hard copy

double-spaced, with clearly numbered pages, unbound and unstapled, and

printed on one side only. All appendices, including maps and reproduced

forms used in this study, should be furnished to ATSDR by the

investigator.

H. Following the steps outlined above, a final report of all

studies and results of research carried out or supported by ATSDR must

be submitted to the Procurement and Grants Office with a copy furnished

to ATSDR.

I. If assistance in printing the final report is needed, the

Principal Investigator can submit a hard copy of the final report to

the Procurement and Grants Office with a copy furnished to ATSDR.

Application Content

In a narrative form, the application should include a discussion of

areas listed under ``Evaluation Criteria'' as they relate to the

proposed program. Because these criteria serve as the basis for

evaluating the application, omissions or incomplete information may

affect the rating of the application. Although this program may not

require in-kind or matching funds, the applicant should include any in-

kind support in the formal application. For example, if the in-kind

support includes personnel, the applicant should provide the qualifying

experience of the personnel and clearly State the type of activity to

be performed.

The application must include a 200 word or less abstract of the

proposal. The application pages must be clearly numbered, and a

complete index to the application and its appendices must be included.

The original and each copy of the application must be submitted

unstapled and unbound. All material must be typed single-spaced, with

un-reduced type on 8\1/2\'' by 11'' paper, with at least 1'' margins,

and printed on one side only.

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Evaluation Criteria

Applications will be reviewed and evaluated according to the

following criteria:

1. Scientific and Technical Review Criteria of Application

a. Proposed Program (45%)

The extent to which the applicant's proposal addresses: (1) The

development and implementation of methods designed to characterize

exposure-dose relations associated with hazardous waste sites (10%);

(2) experience in methods of reconstruction of exposure histories

through the identification and pursuit of technical advances such as

environmental multi-media exposure, kinetic networks, genetic

algorithms, uncertainty analysis, dose reconstruction, and spatial

analysis techniques (10%); (3) the methods for reconstructing exposure

and potential dose histories and determining future exposure resulting

from hazardous substances released into the environment for populations

around hazardous waste sites (20%); and (4) the proposed project

schedule, including clearly established and obtainable project

objectives for which progress toward attainment can and will be

measured (5%).

b. Experience and Technical Ability (30%)

The extent to which the proposal has described: (1) the

familiarity, qualifications, knowledge, and experience of the principal

investigator in his/her ability to utilize and apply methodology driven

environmental assessment tools to reconstruct exposure histories (10%);

(2) the ability of the principal investigator to modify these tools in

order to meet the program objective as described in the Purpose section

of this announcement (10%); and (3) the demonstrated ability of the

principal investigator to integrate the aforementioned computational

tools into existing computational tools and platforms so as to develop,

maintain, or enhance a decision support system in order to support

ATSDR's public health assessment process (10%).

c. Program Personnel (10%)

The extent to which the proposal has described: (1) the

qualifications, experience, and commitment of the principal

investigator, and his/her ability to devote adequate time and effort to

provide effective leadership (5%); and (2) the competence of associate

investigators to accomplish the proposed study, their commitment, and

the time they will devote to the project (5%).

d. Applicant Capability (15%)

Description of the adequacy and commitment of institutional

resources to administer the program and the adequacy of the facilities

as they impact on performance of the proposed project.

e. Program Budget (Not Scored)

The extent to which the budget is reasonable, clearly justified,

and consistent with the intended use of cooperative agreement funds.

2. Continuation Awards Within the Project Period Will Be Made on the

Basis of the Following Criteria

a. Satisfactory progress has been made in meeting project

objectives;

b. Objectives for the new budget period are realistic, specific,

and measurable;

c. Proposed changes in described long-term objectives, methods of

operation, need for cooperative agreement support, and/or evaluation

procedures will lead to achievement of project objectives; and

d. The budget request is clearly justified and consistent with the

intended use of cooperative agreement funds.

Executive Order 12372 Review

The applications submitted under this Announcement are not subject

to Intergovernmental Review of Federal Programs as governed by

Executive Order 12372.

Public Health System Reporting Requirements

This program is not subject to the Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance number is 93.161.

Other Requirements

A. Paperwork Reduction Act

Projects that involve the collection of information from 10 or more

individuals and funded by cooperative agreement will be subject to

review by the Office of Management and Budget under the Paperwork

Reduction Act.

B. Cost Recovery

The Comprehensive Environmental Response, Compensation, and

Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments

and Reauthorization Act of 1986 (SARA), provides for the recovery of

costs incurred for health-related activities at each Superfund site

from potentially responsible parties. The recipient would agree to

maintain an accounting system that will keep an accurate, complete, and

current accounting of all financial transactions on a site-specific

basis, i.e., individual time, travel, and associated costs including

indirect cost, as appropriate for the site. The recipient will retain

the documents and records to support these financial transactions, for

possible use in a cost recovery case, for a minimum of ten (10) years

after submission of a final financial status report, unless there is a

litigation, claim, negotiation, audit, or other action involving the

specific site; then the records will be maintained until resolution of

all issues on the specific site.

Note: Recipients of awards must maintain all records for 10

years following submission of the final Financial Status Report

unless otherwise directed by the Cost Recovery Activity, ATSDR, and

must obtain written approval from the Cost Recovery Activity

Official before destroying any records.

C. Third Party Agreements

Project activities which are approved for contracting pursuant to

the prior approval provisions shall be formalized in a written

agreement that clearly establishes the relationship between the grantee

and the third party. The written agreement shall at a minimum:

1. State or incorporate by reference all applicable requirements

imposed on the contractors under the grant by the terms of the grant,

including requirements concerning peer review (ATSDR selected peer

reviewers), ownership of data, and the arrangement for copyright when

publications, data, or other copyrightable works are developed under or

in the course of work under a PHS grant supported project or activity;

2. State that any copyrighted or copyrightable works shall be

subject to a royalty-fee, nonexclusive, and irrevocable license to the

Government to reproduce, publish, or otherwise use them, and to

authorize others to do so for Federal Government purposes;

3. State that whenever any work subject to this copyright policy

may be developed in the course of a grant by a contractor under grant,

the written agreement (contract) must require the contractor to comply

with these requirements and can in no way diminish the Government's

right in that work; and

4. State the activities to be performed, the time schedule for

those activities, the policies and procedures to be followed in

carrying out the agreement, and the maximum amount of money for

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which the grantee may become liable to the third party under the

agreement.

The written agreement shall not relieve the grantee of any part of

its responsibility or accountability to ATSDR under the cooperative

agreement. The agreement shall therefore retain sufficient rights and

control to the grantee to enable it to fulfill this responsibility and

accountability.

Application Submission and Deadline Dates

The original and two copies of application PHS Form 5161-1 (OMB

Number 0937-0189) must be submitted to Ron Van Duyne, Grants Management

Officer, Attn: Patrick A. Smith, Grants Management Branch, Procurement

and Grants Office, Centers for Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room 300, Mailstop E-13, Atlanta,

Georgia 30305, on or before July 31, 1998. (By formal agreement, the

CDC Procurement and Grants Office will act for and on behalf of ATSDR

on this matter.)

1. Deadline: Applications shall be considered as meeting the

deadline if they are either:

(a) Received on or before the deadline date, or

(b) Sent on or before the deadline date and received in time for

submission to the objective review group.

(Applicants must request a legibly dated U.S. Postal Service postmark

or obtain a legibly dated receipt from a commercial carrier or U.S.

Postal Service. Private metered postmarks shall not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications which do not meet the criteria

in 1.(a) or 1.(b) above are considered late applications. Late

applications will not be considered and will be returned to the

applicant.

Where To Obtain Additional Information

To receive additional written information, call 1-888-GRANTS4. You

will be asked to leave your name, address, and phone number and will

need to refer to ATSDR Announcement 98027. You will receive a complete

program description, information on application procedures, and

application forms. CDC will not send application kits by facsimile or

express mail.

If you have questions after reviewing the contents of all the

documents, business management technical assistance may be obtained

from Patrick A. Smith, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-

13, Atlanta, Georgia 30305, (404) 842-6803, or INTERNET address

[email protected].

Programmatic technical assistance may be obtained from Morris L.

Maslia, P.E., Project Officer, Division of Health Assessment and

Consultation, Agency for Toxic Substances and Disease Registry, 1600

Clifton Road, NE., Mailstop E-32, Atlanta, Georgia 30333, (404) 639-

0674, or INTERNET address [email protected].

PLEASE REFER TO ANNOUNCEMENT NUMBER 98027 WHEN REQUESTING

INFORMATION AND SUBMITTING AN APPLICATION.

Potential applicants may obtain a copy of Healthy People 2000 (Full

Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary

Report, Stock No. 017-001-00473-1) referenced in the Introduction

through the Superintendent of Documents, Government Printing Office,

Washington, DC 20402-9325, (telephone 202-783-3238).

This and other ATSDR and CDC announcements are available through

the CDC homepage on the Internet. The address for the CDC homepage is:

http://www.cdc.gov.

Dated: June 3, 1998.

Georgi Jones,

Director, Office of Policy and External Affairs, Agency for Toxic

Substances and Disease Registry.

[FR Doc. 98-15258 Filed 6-8-98; 8:45 am]

BILLING CODE 4163-70-P