[Federal Register Volume 66, Number 71 (Thursday, April 12, 2001)]
[Notices]
[Pages 18943-18946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9070]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 01037]


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

[[Page 18944]]

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 8\1/2\" by 11" paper, with at least 1" margins, and printed 
on one side only.

[[Page 18945]]

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

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number 770-488-2722. Email address: [email protected].
    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, (404) 639-5097. 
Email address: [email protected].

    Dated: April 6, 2001.
Donna Garland,
Acting Director, Office of Policy and External Affairs, Agency for 
Toxic Substances and Disease Registry.
[FR Doc. 01-9070 Filed 4-11-01; 8:45 am]
BILLING CODE 4163-70-P