This section is provided for "ease of viewing" of the original document and WAS NOT part of the original Federal Register notice.
The Agency for Toxic Substances and Disease Registry (ATSDR) announces the availability of fiscal year (FY) 1993 funds for a cooperative agreement program to develop a 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.
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led 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.)
This program is authorized under sections 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 RCRA, as amended (Hazardous and Solid Waste Amendments of 1984) [42 U.S.C. 6939a(b) and (c)].
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.
Approximately $165,000 is available in FY 1993 to fund one award. It is expected that the award will begin on or about September 30, 1993, for a 12-month budget period with a proposed project period of up to 4 years. Funding estimates may vary and are subject to change.
Continuation awards within the project period will be made on the basis of satisfactory progress and the availability of funds.
The purpose of this project is to assist in research related to exposure-dose reconstruction associated with hazardous waste sites. This research will develop, evaluate, and apply computational tools and a decision support system for estimating exposure-dose relations resulting from exposure to contaminated environmental media and hazardous substances commonly found at sites.
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:
2. Identify and pursue emerging technical advances in the exposure-dose reconstruction area to encompass reconstruction of exposure histories and determination of biologically effective doses. These advances should include assessment of methods such as environmental multi-media exposure, kinetic networks, and dose reconstruction as a means to bridge the gap between the release of hazardous substances into the environment, potential dose (exposure), and resulting health effects.
3. 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 may include numerical simulators that can be run on 486-type personal computers such as: (a) Steady flow in Layered Aquifer Media (SLAM486); (b) Unsteady flow in Layered Aquifer Media (ULAM486); and (c) Contaminant transport in Layered Aquifer Media (CLAM486). The generalized description of the theory of these assessment tools can be found in the public domain literature.
4. Integrate the environmental assessment simulator tools (described in 3 above) to meet multi-environmental media customization requirements.
5. Develop a "user friendly" decision support system that may consider the following, but is not limited to: (a) site characterization and exposure scenario data; (b) environmental fate and transport computations; (c) chemical-compound intake and exposure-dose computations; (d) probability distributions and uncertainty analyses; and (e) access to the decision support system by means of desktop computational devices.
6. When the project is terminated, provide a report 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 computational tools and define appropriate assumptions.
2. Provide recipient organization with a list of hazardous waste sites 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. Collaborate 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. Collaborate with 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.
Applications will be reviewed and evaluated according to the following criteria:
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 at selected sites (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 kinetic networks so as to develop a decision support system in order to support and enhance the preparation of public health assessments (10%).
c. Program Personnel (20%)
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 (10%); and (2) the competence of associate investigators to accomplish the proposed study, their commitment, and the time they will devote to the project (10%).
d. Applicant Capability (10%)
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:
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.
Applications are not subject to Intergovernmental Review of Federal Programs as governed by Executive Order 12372.
This program is not subject to the Public Health System Reporting Requirements.
The Catalog of Federal Domestic Assistance number is 93.161.
B. Technical Review
All protocols, studies, and results of research that ATSDR carries out or funds in whole or in part will be reviewed to meet the requirements of CERCLA, section 104(i)(13) [42 U.S.C. 9604(i)(13)].
C. Protection of Human Subjects
If the proposed project involves research on human subjects, the applicant must comply with Department of Health and Human Services Regulations (45 CFR Part 46) regarding the protection of human subjects. Assurances must be provided to demonstrate that the project will be subject to initial and continuing review by an appropriate institutional review committee. The applicant will be responsible for providing assurance in accordance with the appropriate guidelines and form provided in the application kit.
D. Animal Welfare
If the proposed project involves research on animal subjects, the applicant must comply with the "PHS Policy Statement on Humane Care and Use of Laboratory Animals by Awardee Institutions." An applicant organization proposing to use vertebrate animals in PHS-supported activities must file an Animal Welfare Assurance with the Office for the Protection from Research Risks at the National Institutes of Health.
E. Cost Recovery
CERCLA, as amended, 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.
F. Disclosure
Recipient is required to provide proof by way of citation to state code or regulation or other state pronouncement given the authority of law, that medical information obtained pursuant to the agreement, pertaining to an individual, and therefore considered confidential, will be protected from disclosure when the consent of the individual to release identifying information is not obtained.
G. 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:
(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.
(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 which the grantee may become liable to the third party under the agreement.
The written agreement required shall not relieve the grantee of any part of its responsibility or accountability to PHS under the grant. The agreement shall therefore retain sufficient rights and control to the grantee to enable it to fulfill this responsibility and accountability.
The original and two copies of application PHS Form 5161-1 must be submitted to Henry S. Cassell, III, Grants Management Officer, 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 August 13, 1993. (By formal agreement, the CDC Procurement and Grants Office will act for and on behalf of ATSDR on this matter.)
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 in the current competition and will be returned to the applicant.
A complete program description, information on application procedures, an application package, and business management technical assistance may be obtained from Maggie Slay, 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) 842-6797. Programmatic technical assistance may be obtained from Allan Susten, Ph.D., Division of Health Assessment and Consultation, Agency for Toxic Substances and Disease Registry, 1600 Clifton Road, NE., Mailstop E-32, Atlanta, Georgia 30333, (404) 639-0610.
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).
Dated: July 2, 1993