[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
phs3@cdc.gov.
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 mfm4@cdc.gov.
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
