[Federal Register Volume 65, Number 115 (Wednesday, June 14, 2000)]
[Notices]
[Pages 37391-37393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 00126]


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

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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:[email protected].
    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: [email protected].


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    Dated: June 8, 2000.
Georgi Jones,
Director, Office of Policy and External Affairs, Agency for Toxic 
Substances and Disease Registry.
[FR Doc. 00-14941 Filed 6-13-00; 8:45 am]
BILLING CODE 4163-70-P