03-11975. Cooperative Agreement for a Research Program on Exposure-Dose Reconstruction Notice of Availability of Funds

Application Deadline: June 30, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

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 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)). The Catalog of Federal Domestic Assistance number is 93.161.

B. Purpose

The Agency for Toxic Substances and Disease Registry (ATSDR) announces the availability of fiscal year (FY) 2003 funds for a cooperative agreement research program for exposure-dose reconstruction. This program addresses the “Healthy People 2010” focus area of Environmental Health.

The purpose of the program is to develop and evaluate methods 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 program will advance the development, evaluation, application, and maintenance of computational methodologies and decision support systems for estimating exposure-dose relations from contaminated environmental media and hazardous substances.

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. No human subjects are involved.

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, and 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.

Measurable outcomes of the program will be in alignment with the following performance goal for ATSDR: evaluate the human health risk from toxic sites and releases.

C. Eligible Applicants

Applications may be submitted by:

• State and local governments or their bona fide agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau).
• Political subdivisions of states (in consultation with states), which may include state universities, state colleges, and state research institutions.

Note:

Title 2 of the United States Code section 1611 states that an organization described in section 501c(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant or loan.

D. Funding

Availability of Funds

Approximately $300,000 is available in FY 2003 to fund one award. It is expected that the award will begin on or about September 15, 2003, and will be made for a 12-month budget period within a project period of up to 5 years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports 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 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.

Recipient Financial Participation

Matching funds are not required for this program.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. Recipient Activities, and ATSDR will be responsible for the activities listed under 2. ATSDR Activities.

1. Recipient Activities

a. 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 are not limited to, assessment of methods such as: (1) Environmental multi-media exposure (including such pathways as groundwater, surface water, air, soil, and biota); (2) assessment of exposure and dose through bioavailability, accumulation, and transformation; (3) delivery of past, current, or potential future exposure and related dose through water-distribution systems; (4) kinetic networks; (5) genetic algorithms; (6) dose reconstruction; and (7) spatial analysis techniques integrated with (1) through (6) above, as a means to bridge the gap between the release of hazardous substances into the environment, potential dose (exposure), and resulting health effects.

b. 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, simulators such as: (a) Analytical contaminant transport analysis 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 distribution system network hydraulic and water-quality simulators integrated with spatial analysis interface and progressive optimality genetic algorithm (POGA) optimization. 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.

c. Identify, characterize, and 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 methodology must include a user-friendly interface and should not rely on third-party or proprietary software programs or licensing to accomplish this task.

d. Serve as a leading technical resource that provides information and assists in developing methodologies and setting the standard for use of methods for incorporating fuzzy system mathematics and modeling in the area of exposure assessment and exposure-dose reconstruction.

e. Provide technical consultation and assistance in the development of a user friendly decision support system that considers, but is not limited to, the following:

(1) Site characterization and exposure scenario data.

(2) Environmental-media fate and transport computations.

(3) Exposure-route analysis and computations.

(4) Chemical-compound intake and exposure-dose computations.

(5) Probability distributions and uncertainty analyses.

(6) Spatial analysis computations and a geographic information systems interface.

(7) Access to the decision support system by means of desktop computational devices available throughout the agency and in its exposure-dose reconstruction computational laboratory.

f. Provide technical consultation and assistance in applying innovative and emerging exposure-dose reconstruction methodologies and computational analyses, described above, to areas characterized by contaminated environmental media that may pose potential health risks to the public.

g. Provide information on development of methodologies related to exposure-dose reconstruction by submitting, as progress warrants, manuscripts to symposia, conferences, and peer-reviewed scientific journals on the developments and methodology describing aspects of the research on exposure-dose reconstruction.

h. Organize and conduct workshops, conferences, or symposia to publicize and promote benefits of methodologies developed and to transfer technology as part of the research program on exposure-dose reconstruction.

i. When the project is completed, recipient will summarize activities in a written report that includes the methodology describing the exposure-dose reconstruction process as applied to the public health assessment process.

2. ATSDR Activities

a. Collaborate with and assist in the development of plausible exposure-dose methodologies, relations, and criteria for the selection and application of computational tools, and define appropriate assumptions.

b. Serve as a direct conduit for accessing environmental and exposure data and hazardous waste site information that would be of value to recipient organization to test and validate the acceptability of the environmental assessment simulator tools developed as part of the exposure-dose reconstruction research program.

c. Collaborate with and assist recipient organization with benchmarking, testing, and evaluation of methodology driven exposure-dose reconstruction assessment computational tools by providing recipient organization with results derived from application of methodology driven exposure-dose reconstruction assessment computational tools when applied to hazardous waste sites.

d. Collaborate with and assist recipient with identifying and pursuing emerging disciplines related to advances in assessment of exposure to hazardous chemicals and mixed wastes typically associated with hazardous waste sites.

e. 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.

f. Assist recipient organization in communicating information on development of methodologies related to exposure-dose reconstruction by submitting, as progress warrants, manuscripts to symposia, conferences, and peer-reviewed scientific journals on the developments and methodology describing aspects of the research on exposure-dose reconstruction.

g. Assist in the development and dissemination of advances in the areas of exposure-dose reconstruction methodologies to all relevant scientific and technical groups and communities including state and local governments and the public.

h. Assist in the planning, organization, and conduct of workshops, conferences, or symposia to publicize and promote benefits of methodologies developed; and assist with the transfer of technology, as part of the research program on exposure-dose reconstruction.

i. Collaborate with recipient to summarize program activities in a written report that includes the methodology describing the exposure-dose reconstruction process as applied to the public health assessment process.

F. Content

Applications

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than 50 pages, single spaced, printed on one side, with one inch margins, and unreduced 12-point font.

The narrative should consist of, at a minimum, a Plan, Objectives, Methods, Evaluation and Budget. The objectives must include a project schedule for the entire five-year project. (See evaluation criteria 1.d.) 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.

G. Submission and Deadline

Application Forms

Submit the signed original and two copies of PHS 398 (OMB number 0925-0001). Adhere to the instructions on the Errata Instruction Sheet (posted on the CDC web site) for PHS 398. Forms are available at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received by 4 p.m. Eastern Time on June 30, 2003. Submit the application to: Technical Information Management-PA #03059, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Deadline

Applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will, upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the purpose section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

An independent review group appointed by ATSDR will evaluate each application against the following criteria:

1. Scientific and Technical Review Criteria of Application

a. Methods (45 percent total). The extent to which the applicant's proposal fully and adequately addresses: (1) Experience in methods of reconstruction of exposure histories through the identification and pursuit of technical advances such as environmental multi-media exposure, kinetic networks, progressive optimality genetic algorithm (POGA) optimization and water-distribution system operations, uncertainty analysis, fuzzy mathematics, dose reconstruction, and spatial analysis techniques (20 percent); (2) 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 percent); (3) 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 (5 percent); and (4) 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 percent).

b. Evaluation (25 percent total). The extent to which the applicant has fully and adequately described how it will demonstrate its effectiveness in meeting all objectives in the evaluation of its work plan, including: (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 percent); (2) the competence of associate investigators to accomplish the proposed study, their commitment, and the time they will devote to the project (5 percent); and (3) the adequacy and commitment of institutional resources to administer the program and the adequacy of facilities, such as the availability of a multimedia environmental simulations laboratory, as they impact on performance of the proposed project (10 percent).

c. Proposed Plan (20 percent total). The extent to which the applicant's proposal fully and adequately addresses: (1) the development and implementation of methods designed to characterize exposure-dose relations associated with hazardous waste sites (10 percent); and (2) the applicant's experience and past performance in assisting ATSDR in methods development, conducting exposure assessments, and exposure-dose reconstruction analyses (10 percent).

d. Objectives (10 percent total). The extent to which the applicant's proposal fully and adequately addresses: (1) the proposed project schedule, including clearly established and obtainable project objectives for which progress toward attainment can and will be measured: (5 percent); and (2) experience and past performance in meeting project objectives (5 percent).

e. Program Budget (Reviewed, but not scored). The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of cooperative agreement funds. If applicant's proposed budget exceeds the availability of funds, their application will be funded at the level of availability of funds.

f. Performance goals (Reviewed, but not scored). The extent to which the applicant's proposal adequately addresses the following performance goal for ATSDR: evaluate the human health risk from toxic sites and releases.

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.

d. The budget request is clearly justified and consistent with the intended use of cooperative agreement funds.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Interim progress report, no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity Objectives.

d. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement, as posted on the CDC website.

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-19 Third Party Agreements—ATSDR

AR-22 Research Integrity

Executive Order 12372 does not apply to this program.

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC web site, Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements”.

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone].

For business management and budget assistance, contact: Edna Green, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone], E-mail address: [e-mail].

For business management and budget assistance in the territories, contact: Julie Grace, Contract Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone], E-mail: [e-mail].

For program technical assistance, contact: Morris L. Maslia, P.E., Project Officer, Agency for Toxic Substances and Disease Registry, 1825 Century Boulevard, Room 3094, Mail Stop E-32, Atlanta, Georgia 30345, Telephone number: [phone], E-mail address: [e-mail].

Dated: May 8, 2003.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.