[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] ----------------------------------------------------------------------- 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 [[Page 31488]] 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 [[Page 31491]] 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