02-15152. Program for Research and Development of Methods for the Joint Toxicity Assessment of Environmental Mixtures; Notice of Availability of Funds

A. Purpose

The Agency for Toxic Substances and Disease Registry (ATSDR) announces the availability of fiscal year (FY) 2002 funds for a cooperative agreement program for Research and Development of Methods for the Joint Toxicity Assessment of Mixtures. This program addresses the “Healthy People 2010” Environmental Health focus area.

The purpose of the program is to conduct research and develop methods for the assessment of health effects of environmental chemical mixtures that can impact human health.

Measurable outcomes of the program will be in alignment with the following performance goal for ATSDR: Evaluate relationships between hazardous substances in the environment and adverse human health outcomes.

B. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized in Sections 104(i)(5)(A) and (15) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)(5)(A) and (15)]; and section 106, subsection 118(e) of the Great Lakes Critical Programs Act of 1990 [33 U.S.C. 1268(e)]. The Catalog of Federal Domestic Assistance number is 93.161.

C. Eligible Applicants

Assistance will be provided only to the health departments of states or their bona fide agents, and additionally the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of Northern Mariana Islands, American Samoa, Guam, the Federal States of Micronesia, 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 definitions of State entity or political subdivision to be considered as an eligible applicant.

Note:

Title 2 of the United States Code section 1611 states that an organization described in section 501(c)(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. Availability of Funds

Approximately $350,000 is available in FY 2002 to fund three to four awards. It is expected that the average award will be $100,000, ranging from $75,000 to $200,000. It is expected that the awards will begin on September 1, 2002, and will be made for a 12-month budget period within a project period of five years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by the required reports and 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 grantee, as the direct and primary recipient of ATSDR grant 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. Equipment may be purchased with grant funds. However, the equipment proposed should be appropriate and reasonable for the research activity to be conducted. Equipment may be acquired only when authorized, and the application should provide a justification of need to acquire equipment, the description, and the cost of purchase versus lease. To the greatest extent practicable, all equipment and products purchased with CDC/ATSDR funds should be American made. ATSDR retains the right to request return of all equipment purchased (in operable condition) with grant funds at the conclusion of the project period.

E. Program Requirements

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

1. Recipient Activities

a. To conduct research to investigate the toxicity of chemical mixtures found in the environment through one or more of the following activities: evaluate the potential toxicity of chemical mixtures to human populations; identify relevant endpoints of toxicity common to chemical mixtures; evaluate pharmacokinetic interactions of chemical mixtures in biological systems; explore the role of toxicogenomics in deciphering interaction mechanisms; combine the knowledge gained through experimental work into the development of biologically based models; apply biologically based models to estimate and predict low-level interaction threshold effects; and develop methods for assessments of multiple health effects.

b. Establish and maintain a research plan and system for collecting information.

c. Share current information, and communicate opinions and research findings through reports and other means.

d. Participate in planning workshops or symposia to exchange current information, opinions, and research finding on mixtures.

2. ATSDR Activities

a. Provide consultative, administrative and technical assistance, as needed, in the development of the program of research activities for the enhancement of identified disciplinary areas.

b. Collaborate with the recipient in the establishment of a research plan and system for collecting data and developing periodic reports on activity.

c. Collaborate in analysis of data, assistance in interpretation of results, and further synthesis of conclusions so as to effectively communicate with partners and other interested parties.

d. Assist the recipient in writing and presenting publications including abstracts and journal articles.

e. Develop briefing materials for agency officials involved in public hearings.

f. Participate and collaborate with the applicant in planning workshops or symposia to exchange current information, opinions, and research findings on mixtures.

F. Application Content

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 25 double-spaced pages, printed on one side, with one inch margins, and unreduced font.

Although this program does not require in-kind support or matching funds, the applicant should describe any in-kind support in the 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 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.

G. Submission and Deadline

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-0189). Forms are available at the following Internet address: www.cdc.gov/​od/​pgo/​forminfo.htm.

The application must be received on or before 5:00 P.M. Eastern Time on July 22, 2002. Submit the application to: Technical Information Management—PA 02133, Acquisition and Assistance Branch B, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146.

Deadline: Applications shall be considered as meeting the deadline if they are received before 5:00 P.M. Eastern Time on the deadline date. Applicants sending applications by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of application by the closing date and time. If an application is received after the closing date due to (1) carrier error, when the carrier accepted the package with a guarantee of 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. Applications which do not meet the above criteria will not be eligible for competition and will be discarded. Applicants will be notified of their failure to meet submission requirements.

H. Evaluation Criteria

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

Each applicant will be evaluated individually against the following criteria by an independent review group appointed by ATSDR:

1. Appropriateness and Knowledge of Study Design (25 points)

The extent to which the applicant's proposal addresses: (a) rationale for the proposed study design; (b) a plan for exposure assessment and/or a plan for evaluating adverse health outcomes; and (c) a detailed plan for analysis of the data.

2. Proposed Study (25 points)

The adequacy of the proposal relevant to: (a) The study purpose, objectives, and rationale; (b) the quality of program objectives in terms of specificity, measurability, and feasibility; (c) the specificity and feasibility of the applicant's timetable for implementing program activities and timely completion of the study; and (d) the likelihood of the applicant completing proposed program activities and attaining proposed objectives based on the thoroughness and clarity of the overall program.

3. Relationship to Initiative (15 points)

The extent to which the application addresses the areas of investigation outlined by ATSDR.

4. Quality of Data Collection (15 points)

The extent to which: (a) the laboratory tests (if applicable) are sensitive and specific for the chemical or disease outcome of interest and (b) the quality control, quality assurance, precision and accuracy of information for the proposed tests are provided and acceptable.

5. Applicant Capability and Coordination Efforts (10 points)

The extent to which the proposal has described: (a) the capability of the applicant's administrative structure to foster successful scientific and administrative management of a study and (b) the suitability of facilities and equipment available.

6. Program Personnel (10 points)

The extent to which the proposed program staff is qualified and appropriate, and the time allocated for them to accomplish program activities is adequate.

7. Program Budget (Not Scored)

The extent to which the budget relates directly to project activities, is clearly justified, and is consistent with intended use of funds. The budget should include funds for one health assessor, one health educator, and one epidemiologist, health scientist or principal investigator to attend annual training meetings in Atlanta (five days).

8. Human Subjects (Not Scored)

Whether or not exempt from the DHHS regulations, are procedures adequate for the protection of human subjects? Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects?

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Semi-annual progress report which should include:

a. A brief program description.

b. A listing of program goals and objectives accompanied by a comparison of actual accomplishments related to the goals and objectives for the period.

c. If established goals and objectives to be accomplished were delayed, describe both the reason for the deviation and anticipated corrective action or deletion of the activity from the project.

d. Other pertinent information, including the status of the program.

e. Measures of effectiveness data requirement to be submitted with, or incorporated into the semi-annual progress reports.

f. Financial recap of obligated dollars to date as a percentage of total available funds.

2. Financial Status Report (FSR), no more than 90 days after the end of the budget period.

3. Final FSR 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.

The following additional requirements are applicable to this program:

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-3 Animal Subjects Requirements

AR-7 Executive Order 12372 Review

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobby Restrictions

AR-17 Peer and Technical Reviews of Final Reports of Health Studies—ATSDR

AR-18 Cost Recovery—ATSDR

AR-19 Third Party Agreements—ATSDR

J. Where To Obtain Additional Information

This and other ATSDR announcements can be found on the CDC home page Internet address—http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Edna Green, Grants Management Specialist, Acquisition and Assistance Branch B, Procurement and Grants Office, Centers for Disease Control and Prevention, Announcement 02133, Room 3000, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone [phone], E-mail address: [e-mail].

For program technical assistance, contact(s): Dr. Moiz Mumtaz, Division of Toxicology, 1600 Clifton Road, N.E., Mail Stop E-29, Atlanta, Georgia 30333, Telephone [phone], E-mail address: [e-mail].

Dated: June 11, 2002.

Sandra Manning,

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