[Federal Register Volume 60, Number 123 (Tuesday, June 27, 1995)]
[Notices]
[Pages 33214-33217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15658]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[Announcement 530]


The Great Lakes Human Health Effects Research Program

Introduction

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces that grant applications will be accepted to conduct research 
on the impact on human health of fish consumption from the Great Lakes. 
ATSDR's mission includes the prevention of adverse health effects 
resulting from human exposure to hazardous substances in the 
environment. The ATSDR Great Lakes Human Health Effects Research 
Program will focus on identified populations that have a potentially 
higher risk of long- [[Page 33215]] term adverse health effects from 
exposure to contaminants in Great Lakes fish, i.e., Native Americans, 
sport anglers, urban poor, the elderly, Asian Americans and other 
racial/ethnic minority populations, and fetuses and nursing infants of 
mothers who consume contaminated Great Lakes fish.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led national activity to reduce morbidity and mortality 
and improve the quality of life. This announcement is related to the 
priority area of Environmental Health. (For ordering a copy of 
``Healthy People 2000,'' see the Section Where to Obtain Additional 
Information.)

Authority

    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)].

Smoke-Free Workplace

    PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, day care, health care, and early childhood development 
services are provided to children.

Eligible Applicants

    Eligible applicants are the Great Lakes 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 Lakes 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.

Availability of Funds

    Approximately $4 million is available in fiscal year (FY) 1995 to 
fund approximately 9 re-competing and 1 to 2 new awards. It is expected 
that the average award will be $250,000 ranging from $200,000 to 
$300,000. It is expected that the awards will be made on or about 
September 30, 1995. It is anticipated that the new as well as the re-
competing awards will be for a 12-month budget period with a proposed 
project period of 3 years. Funding estimates may vary and are subject 
to change.
    The continuation awards within the project period will be made on 
the basis of satisfactory progress 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 PHS 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 
must 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.

Purpose

    The purpose of this announcement is to solicit scientific proposals 
designed to investigate and characterize the association between the 
consumption of contaminated Great Lakes fish and potential long-term 
adverse health effects. 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 basin; (2) develop information, databases and 
research methodology that will provide long-term benefit to human 
health effects research in the Great Lakes basin; (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; and (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 Public Health 
Service (PHS) research programs and activities, 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.

Program Requirements

    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 basin, 
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 from exposure to Great Lakes 
contaminants in fish, i.e., Native Americans, sport anglers, urban 
poor, the elderly, Asian Americans, racial/ethnic minority populations, 
and fetuses and nursing infants of mothers who consume contaminated 
Great Lakes fish. 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; 
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) 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 areas may 
include, but are not limited to:

[[Page 33216]] 1. Investigating the feasibility of, or establishing, 
registries and/or surveillance cohorts in the Great Lakes region; and
2. Establishing a chemical mixtures database with emphasis on tissue 
and blood levels to identify new cohorts, conduct surveillance and 
health effects studies, and establish registries and/or surveillance 
cohorts.

    In awarding grants pursuant to the ATSDR Great Lakes Human Health 
Effects Research Program, ATSDR shall consider proposed projects that 
will help fill information gaps and address research needs regarding 
the human health impact of consumption of contaminated fish from the 
Great Lakes. ATSDR encourages collaborative efforts among potential 
applicants in pursuing these research needs.

Evaluation Criteria

    New and re-competing applications will be reviewed and evaluated 
according to the following criteria:
1. Scientific and Technical Review Criteria of New and Re-competing 
Continuation Applications
    a. PROPOSED PROGRAM--60%
    The extent to which the applicant's proposal 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);
    (2) the technical merit of the methods and procedures for the 
proposed project (analytic procedures should be state of the art, 
including quality assurance and quality control methods for comparison 
with other research projects; additionally, the applicant is expected 
to participate in a tissue bank as part of the quality assurance 
quality control program) 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;
    (3) the proposed project schedule, including clearly established 
and obtainable project objectives for which progress toward attainment 
can and will be measured;
    (4) the proposed mechanism to be utilized to address community 
concerns and opinion, and create lines of communication; and
    (5) the proposed method to disseminate the study results to State 
and local public health officials, tribal governments, and the other 
Federal agencies, community residents, and other concerned individuals 
and organizations.
    b. PROGRAM PERSONNEL--30%
    The extent to which the proposal describes:
    (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.
    c. APPLICANT CAPABILITY--10%
    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.
    d. PROGRAM BUDGET--(NOT SCORED)
    The extent to which the budget is reasonable, clearly justified, 
and consistent with intended use of grant funds.
2. Review of Continuation Applications
    Continuation awards within the project period will be made on the 
basis of the following criteria:
    a. Satisfactory progress in meeting project objectives;
    b. Realistic, specific, and measurable objectives for the new 
budget period;
    c. Applicability and feasibility of proposed changes in meeting 
long-term objectives; methods of operation, need for grant support, 
and/or evaluation procedures to achieve project objectives; and
    d. Budget request is clearly justified and consistent with the 
intended use of grant funds.

Funding Preferences

    ATSDR will give funding preference to the nine competitive 
continuation grants funded during FY 1994 on the basis of satisfactory 
progress.

Executive Order 12372

    The applications submitted under this announcement are not subject 
to the Intergovernmental Review of Federal Programs as governed by 
Executive Order 12372.
Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.161, 
Health Programs for Toxic Substances and Disease Registry.

Other Requirements

1. Protection of Human Subjects
    If the proposed project involves research on human subjects, the 
applicants must comply with Department of Health and Human Services 
Regulations (45 CFR Part 46) regarding the protection of human 
subjects. Assurances must be provided that the project will be subject 
to initial and continuing review by the appropriate institutional 
review committees. In addition to other applicable committees, Indian 
Health Service (IHS) institutional review committees also must review 
the project if any component of IHS will be involved or will support 
the research. If any Native American community is involved, its tribal 
government must also approve that portion of the project applicable to 
it. The applicant will be responsible for providing assurance in 
accordance with the appropriate guidelines and forms provided in the 
application kit.
2. Cost Recovery
    The Comprehensive Environmental Response, Compensation, and 
Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments 
and Reauthorization Act of 1986 (SARA), provides for the recovery of 
costs incurred for health-related activities at each Superfund site 
from potentially responsible parties. The recipient will agree to 
maintain an accounting system that will keep an accurate, complete, and 
current accounting of all financial transactions on a site-specific 
basis, i.e., individual time, travel, and associated costs, including 
indirect cost, as appropriate for the site. The recipient will retain 
the documents and records to support these financial transactions for 
possible use in a cost recovery case for a minimum of ten (10) years 
after submission of a final financial status report, unless there is a 
litigation, claim, negotiation, audit, or other action involving the 
specific site. The records will then be maintained until resolution of 
all issues on the specific site. Note: Recipients of awards must 
maintain all records for 10 years following submission of the final 
Financial Status Report unless otherwise directed by the Cost Recovery 
Activity, OPOM, ATSDR, and must obtain written approval from the Cost 
Recovery Activity Official before destroying any records.
3. Third Party Agreements
    Project activities which are approved for contracting pursuant to 
the prior approval provisions shall be formalized in a written 
agreement that clearly [[Page 33217]] establishes the relationship 
between the grantee and the third party.
    The written agreement shall at a minimum:
    1. State or incorporate by reference all applicable requirements 
imposed on the contractors under the grant by the terms of the grant, 
including requirements concerning peer review (ATSDR selected peer 
reviewers), ownership of data, and the arrangement for copyright when 
publications, data, or other copyrightable works are developed under or 
in the course of work under a PHS grant-supported project or activity;
    2. State that any copyrighted or copyrightable works shall be 
subject to a royalty-fee, nonexclusive, and irrevocable license to the 
Government to reproduce, publish, or otherwise use them, and to 
authorize others to do so for Federal Government purposes;
    3. State that whenever any work subject to this copyright policy 
may be developed in the course of a grant by a contractor under grant, 
the written agreement (contract) must require the contractor to comply 
with these requirements and can in no way diminish the Government's 
right in that work; and
    4. State the activities to be performed, the time schedule for 
those activities, the policies and procedures to be followed in 
carrying out the agreement, and the maximum amount of money for which 
the grantee may become liable to the third party under the agreement.
    The written agreement required shall not relieve the grantee of any 
part of its responsibility or accountability to PHS under the grant. 
The agreement shall therefore retain sufficient rights and control to 
enable the grantee to fulfill this responsibility and accountability.

Application Submission and Deadline Dates

    The original and two copies of the application PHS Form 5161-1 
(Revised 7/92, OMB Control Number 0937-0189) must be submitted to Henry 
S. Cassell, III, Grants Management Officer, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-
13, Atlanta, Georgia 30305 by August 10, 1995. (By formal agreement, 
the CDC Procurement and Grants Office will act for and on behalf of 
ATSDR on this matter.)
    1. 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. (Applicants should 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.)
    2. Late Applications: Applications which do not meet the criteria 
in 1.a. or 1.b. above are considered late applications. Late 
applications will not be considered in the current competition and will 
be returned to the applicant.

Where To Obtain Additional Information

    To receive additional written information call (404) 332-4561. You 
will be asked your name, address, and phone number and will need to 
refer to Announcement Number 530. You will receive a complete program 
description, information on application procedures, and application 
forms.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from Georgia Jang, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mail Stop 
E-13, Atlanta, Georgia 30305 or by calling (404) 842-6814. Programmatic 
technical assistance may be obtained from Dr. Heraline Hicks, Research 
Implementation Branch, or Michael Youson, Office of the Director, 
Division of Toxicology, Agency for Toxic Substances and Disease 
Registry, 1600 Clifton Road, NE., Mail Stop E-29, Atlanta, Georgia 
30333 or by calling (404) 639-6306 or 6300.
    Please refer to announcement number 530 when requesting information 
and submitting an application.
    Potential applicants may obtain a copy of ``Healthy People 2000,'' 
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000,'' 
(Summary Report, Stock No. 017-001-00473-1) referenced in the 
Introduction through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: June 20, 1995.
Claire V. Broome,
Deputy Administrator, Agency for Toxic Substances and Disease Registry.
[FR Doc. 95-15658 Filed 6-26-95; 8:45 am]
BILLING CODE 4163-70-P