Neurodevelopmental Test Methods Research; Notice of Availability of Funds

A. Purpose

The Agency for Toxic Substances and Disease Registry (ATSDR) announces the availability of fiscal year (FY) 2000 funds for a grant program for Neurodevelopmental Test Methods Research. This program addresses the “Healthy People 2010” focus area of Environmental Health. For the conference copy of the “Healthy People 2010.” visit the internet site: http://www.health.gov/healthypeople.

The purpose of the program is to determine and validate a battery of neurodevelomental tests for use in assessing the effects of prenatal or postnatal exposure to developmental toxicants. The battery of tests should: (1) be applicable to a wide range of potential neurodevelopmental toxicants found at waste sites and in the environment including metals and solvents; (2) be applicable to a wide range of exposure levels found in the environment; and (3) cover a broad range of developmental domains including cognitive function, sensory function, motor function, and complex multi-tasking performance. These research methods will address an agency goal to develop methods and tools for evaluating human health consequences from exposure to toxic substances in the environment.

B. Eligible Applicants

Applications may be submitted by official public health agencies of the States, or their bona fide agents. 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 Island, the Republic of Palau, federally-recognized Indian tribal governments, public and private non-profit and for profit universities, colleges, and research institutions.

Note:

Public Law 104-65 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 $100,000 is available in Fiscal Year 2000 to fund one award. It is expected to begin on or about September 30, 2000, and will be made for a 12-month budget period within a project period of up to 3 years. Funding estimates may change.

Continuation awards within the 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.

D. Program Requirements

Applicant will conduct studies to develop and validate a battery of neurodevelopmental tests for use in assessing the effects of prenatal or postnatal exposure to developmental neurotoxicants. Investigations of adverse health effects in developing organisms that are attributable to neurotoxicant exposure require measures that are sensitive across a wide range of exposure levels.

The study should include children at risk for the kinds of performance deficits these tests endeavor to measure, e.g., low birth weight children (<1000 grams), and/or children diagnosed as learning-disabled. Such a study will determine the ability of these tests and procedures to identify analogous deficits hypothesized to arise from developmental exposure to methylmercury and other neurotoxicants. Those components of the test battery that demonstrate validity, i.e., prove successful at differentiating these children from a referent group of children, will then be incorporated into future studies of possible developmental neurotoxicants. Applicants should have primary access to data in children which can be used to facilitate the validation step.

The applicant will establish an ad hoc advisory group for the study. A major purpose of the group will be to provide advice on developing and distributing educational materials on the use and application of this test battery to a broad spectrum of health professionals.

E. 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 double-spaced pages, printed on one side, with one inch margin, and unreduced font.

F. Submission and Deadline

Submit the original and five copies of the application PHS Form 398 (OMB Number 0925-0001). Forms are available at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm or in the application kit. On or before July 15, 2000, 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:

(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. (Applicant 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 (a) or (b) above are considered late applications, will not be considered, and will be returned to the applicant.

G. Evaluation Criteria

The application will be evaluated against the following criteria by an independent review group appointed by ATSDR.

Proposed Program—60 Percent of Total

The extent to which the applicant's application addresses:

1. 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); (15 percent)

2. The technical merit of the methods and procedures for the proposed project, 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; and demonstrate that an advisory group can be established at the onset of the project; (25 percent)

3. The proposed project schedule, including clearly established and obtainable project objectives for which progress toward attainment can and will be measured and plans for publishing research results in peer reviewed journals; (15 percent) and

4. 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 (5 percent).

This includes:

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

b. The proposed justification when representation is limited or absent.

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

d. 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.

Program Personnel—30 Percent of Total

The extent to which the application 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; and

(2) The competence of associate investigators to accomplish the proposed study, their commitment, and time devoted to the study.

Institutional Resources and Commitment—10 Percent of Total

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.

Program Budget—(NOT SCORED)

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

Human Subjects—(NOT SCORED)

Does the application adequately address the requirements of 45 CFR part 46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus two copies of

1. An annual progress report

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

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

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

For description of the following Other Requirements, see Attachment I.

AR-1 Human Subjects Requirements

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

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying 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

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under Section 104(i)(5)and(14) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended, 42 U.S.C. 9604 by the Superfund Amendments and Reauthorization Act (SARA) of 1986. The Catalog of Federal Domestic Assistance number is 93.161.

J. Where to Obtain Additional Information

This and other CDC/ATSDR announcements can be found on the CDC home page, Internet Address-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 (00126).

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Nelda Godfrey, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, Room 3000, 2920 Brandywine Road, Atlanta, Georgia 30341-4146, Telephone number (770)488-2722, Email address:NAG9@CDC.GOV.

For program technical assistance, contact: Dr. Mildred Williams-Johnson, Project Officer, Division of Toxicology, Agency for Toxic Substances and Disease Registry, 1600 Clifton Road, NE, Mailstop E-29, Atlanta, Georgia 30333, Telephone number: (404) 639-6306, E-mail address: MMW1@CDC.GOV.