[Federal Register Volume 63, Number 110 (Tuesday, June 9, 1998)]
[Notices]
[Pages 31487-31491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15258]


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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

[[Page 31489]]

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.

[[Page 31490]]

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