01-9070. The Great Lakes Human Health Effects Research Program; Notice of Availability of Funds

A. Purpose

The Agency for Toxic Substances and Disease Registry (ATSDR) announces the availability of fiscal year (FY) 2001 funds for a grant program for The Great Lakes Human Health Effects Research Program. This program addresses the “Healthy People 2010” focus area(s) which include Educational and Community-Based Programs, Environmental Health, and Maternal, Infant, and Child Health. The purpose of the program is to assess the adverse effects of water pollutants via the diet, i.e., consumption of contaminated fish in the Great Lakes on the health of persons in the Great Lakes states.

B. Eligible Applicants

Eligible applicants are the Great Lake States and political subdivisions thereof, including 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. The Great Lake States include Illinois, Indiana, Michigan, Minnesota, Ohio, Pennsylvania, New York, and Wisconsin, consistent with section 106, subsection 118(e) of the Great Lakes Critical Programs Act of 1990 (33 U.S.C. 1268(e)). ATSDR encourages collaborative efforts among these potential applicants.

Note:

Title 2 of the United States Code, chapter 26, section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

C. Availability of Funds

Approximately $1,000,000 is available in FY 2001 to fund approximately 10 awards. It is expected that the average award will be $120,000, ranging from $100,000 to $140,000. It is expected that the awards will begin on or about September 30, 2001, and will be made for a 12-month budget period within a project period of up to three 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 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. Property may be acquired only when authorized in the grant. The grantee, as part of the application process, should provide a justification of need to acquire property, the description, and the cost of purchase versus lease. At the completion of the project, the equipment must be returned to ATSDR.

Funding Preferences

Although applications for new Great Lakes research are encouraged, funding preference will be given to competing continuation applications over applications for programs not already receiving support under the ATSDR Great Lakes Human Health Effects Research Program.

D. Program Priority Areas of Research

Priority areas of research for this program include:

1. Characterizing exposure and determining the profiles and levels of Great Lakes contaminants in biological tissues and fluids in high risk populations;

2. Identifying sensitive and specific human health endpoints, i.e., reproductive/developmental, behavioral, endocrinologic, and immunologic effects and correlating them to exposure to Great Lakes contaminants (several of these contaminants have been identified as endocrine disruptors); and

3. Determining the short- and long-term risk(s) of adverse health effects in children which result from parental exposure to Great Lakes contaminants.

Proposed projects covering these priority areas should include strategies (risk communication and health intervention) to inform susceptible populations about the potential human health impact of consuming contaminated fish from the Great Lakes.

Based upon research findings, longer term priority research areas may include, but are not limited to:

1. Establishing the chemical etiology between exposure, body burden levels, and adverse health effects;

2. Investigating the feasibility of, or establishing registries and/or surveillance cohorts in the Great Lakes region; and

3. Establishing a chemical mixtures database with emphasis on tissue and blood levels in order to identify new cohorts, conduct surveillance and health effects studies, and establish registries and/or surveillance cohorts.

E. Program Requirements

The research objectives of this program are to: (1) Build upon and amplify the results from past and on-going research in the Great Lakes; (2) develop information, databases, and research methodology that will provide long-term benefit to human health effects research in the Great Lakes; (3) provide direction for future health effects research; (4) provide health information to state and local health officials, the concerned public and their medical health care professionals; (5) in concert with State and local health officials, increase the public awareness regarding the potential health implications of toxic pollution in the Great Lakes basin; and (6) coordinate as necessary with relevant research programs and activities of other agencies, including those of the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and the Indian Health Service (IHS), as well as the Environmental Protection Agency (EPA), and State and local health departments, to ameliorate adverse public health impacts of persistent toxic substances in the Great Lakes basin.

ATSDR will provide financial assistance to applicants in conducting studies on potential human health effects which result from human consumption of contaminated fish from the Great Lakes, particularly in the 31 areas of concern within the U.S. boundaries identified by the International Joint Commission. ATSDR encourages the submission of applications that emphasize research that will extend existing studies. ATSDR is also interested in funding applicant programs that identify populations which have a higher risk of short- and long-term adverse health effects, i.e., Native Americans, sport anglers, urban poor, the elderly, Asian Americans, and other non-English speaking populations, and fetuses and nursing infants of mothers who consume contaminated Great Lakes fish.

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 single-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. All material must be typed single-spaced, with un-reduced type on a 81/2″ by 11″ paper, with at least 1″ margins, and printed on one side only.

G. Submission and Deadline

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-0189) on or before June 15, 2001. Submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Deadline: Applications shall be considered as meeting the deadline if they are either:

1. Received on or before the deadline date; or

2. Sent on or before the deadline date and received in time for submission to the independent 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.)

Late Applications: Applications which do not meet the criteria in 1. or 2. above are considered late applications, will not be considered, and will be returned to the applicant.

H. Evaluation Criteria

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

1. Proposed Research—60 percent

The extent to which the applicant's project addresses:

(a) The scientific merit of the hypothesis of the proposed project, including the originality of the approach and the feasibility, adequacy, and rationale of the design (the design of the study should ensure statistical validity for comparison with other research projects);

(b) The technical merit of the methods and procedures (analytic procedures should be state of the art), including the degree to which the project can be expected to yield results that meet the program objective as described in the Purpose section of this announcement;

(c) The proposed project schedule, including clearly established and obtainable project objectives for which progress toward attainment can and will be measured;

(d) The proposed mechanism to be utilized as a resource to address community concerns and opinion, and create lines of communication; and

(e) The proposed method to disseminate the study results to state and local public health officials, tribal governments, Indian Health Service, community residents, and to other concerned individuals and organizations.

(f) The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

(1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

(2) The proposed justification when representation is limited or absent.

(3) A statement as to whether the design of the study is adequate to measure differences when warranted.

(4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

2. Program Personnel—30 percent

The extent to which the proposal has described:

(a) The qualifications, experience, and commitment of the Principal Investigator, and his/her ability to devote adequate time and effort to provide effective leadership; and

(b) The competence of Associate Investigators to accomplish the proposed study, their commitment, and time devoted to the study.

3. Applicant Capability—10 percent

Description of the adequacy and commitment of the institutional resources to administer the program and the adequacy of the facilities as they impact on performance of the proposed study.

4. Program Budget—(Not Scored)

The extent to which the budget is reasonable, clearly justified, and consistent with intended use of grant funds.

5. Human Subjects—(Not Scored)

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. Annual progress reports;

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

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.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I in the application kit.

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-9 Paperwork Reduction Act Requirements

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

AR-22 Research Integrity

J. 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 93.208.

K. Where to Obtain Additional Information

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

To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked to leave your name and address and will be instructed to identify the Announcement number of interest.

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Ms. Nelda Godfrey, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, Room 3000, 2920 Brandywine Road, Atlanta, GA 30341-4146. Telephone number 770-488-2722. Email address: [e-mail].

For program technical assistance, contact: Dr. Heraline E. Hicks, Research Implementation Branch, Division of Toxicology, 1600 Clifton Road, N.E., Mail Stop E-29, Atlanta, Georgia 30333, [phone]. Email address: [e-mail].

Dated: April 6, 2001.

Donna Garland,

Acting Director, Office of Policy and External Affairs, Agency for Toxic Substances and Disease Registry.