95-15658. The Great Lakes Human Health Effects Research Program  

  • [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
    
    

Document Information

Published:
06/27/1995
Department:
Agency for Toxic Substances and Disease Registry
Entry Type:
Notice
Document Number:
95-15658
Pages:
33214-33217 (4 pages)
Docket Numbers:
Announcement 530
PDF File:
95-15658.pdf