[Federal Register Volume 63, Number 110 (Tuesday, June 9, 1998)]
[Notices]
[Pages 31483-31487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15257]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry
[Program Announcement 98074]


The Great Lakes Human Health Effects Research Program Notice of 
Availability of Funds for Fiscal Year 1998

Introduction

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces the availability of fiscal year (FY) 1998 funds for the 
continuation of a grant program to conduct research on the impact on 
human health of fish consumption from the Great Lakes. Congressionally 
mandated funds are provided to the ATSDR to conduct studies of the 
human health impact of consuming contaminated fish from the Great 
Lakes, as amended and authorized by the Great Lakes Critical Programs 
Act of 1990. 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-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 non-English 
speaking populations, and fetuses and nursing infants of mothers who 
consume contaminated Great Lakes fish.
    ATSDR is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a 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

    ATSDR strongly encourages all grant recipients to provide a smoke-
free workplace and to 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 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 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.

Availability of Funds

    Approximately $2.4 million is available in FY 1998 to fund 
approximately 10 re-competing awards. It is expected that the average 
award will be $250,000, ranging from $200,000 to $300,000. It is 
expected that the re-competing awards will be made on or about 
September 30, 1998, for a 12-month budget period and a project period 
of up to 3 years. Funding estimates may vary and are subject to change. 
This program is available only to the ten currently funded grantees. 
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 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.

Background

    The Great Lakes basin comprises one-fifth of the total freshwater 
on the earth's surface and is the historical heartland for American 
industrial and agricultural activity. The physical nature of the basin 
and the long retention time of the chemicals in the Lakes combine to 
make this huge freshwater resource a repository for chemical byproducts 
of these production activities. Through the process of bioaccumulation, 
these pollutants are taken up by aquatic life and become especially 
concentrated in Great Lakes game fish, and other wildlife. The presence 
of toxic substances in the Great Lakes continues to be a significant 
concern in the 1990s. Eleven of the most persistent and widespread 
toxic substances were identified as ``critical Great Lakes pollutants'' 
by the International Joint Commission (IJC). The critical pollutants 
are polychlorinated biphenyls (PCBs), dichlorodiphenyl trichloroethane 
(DDT and its metabolites), dieldrin, toxaphene, mirex, methylmercury, 
benzo[a]pyrene, hexachlorobenzene, furans, dioxins, and alkylated lead. 
Associations between the consumption of contaminated Great Lakes fish 
and long-term adverse health effects have been demonstrated in certain 
susceptible populations.
    Research conducted as part of this program may also serve to fill 
priority data needs identified in ATSDR's Substance-Specific Applied 
Research Program. PCB's, DDT, dieldrin, mercury, PAHs and lead are 
members of the first set of 38 substances selected by ATSDR for 
initiation of this Superfund mandated program (56 FR 52178). This 
research may also provide information for the assessment of human risk 
from simultaneous exposure to chemical mixtures in the Great Lakes 
basin; and

[[Page 31484]]

extend the knowledge of the effects of Great Lakes contaminants on 
human reproductive/developmental, behavioral, neurologic, 
endocrinologic, and immunologic health effects. Finally, ATSDR 
anticipates that the findings generated from this research program can 
be utilized on a national level by providing a ``model'' for other 
ecosystem level studies intended to determine potential human health 
impacts of hazardous wastes.

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 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.

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 and other non-English speaking 
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 
(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.
    All applicants should also participate in the ATSDR Great Lakes 
research quality assurance and quality control (QA/QC) and tissue bank 
programs.
    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 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.
    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.

Technical Reporting Requirements

1. Progress and Financial Reports

    An original and two copies of an annual progress report and 
financial status report are required no later than 90 days after the 
end of the budget period. Final financial and performance reports are 
required no later than 90 days after the end of the project period. All 
reports are submitted to Ron Van Duyne, Grants Management Officer, 
Grants Management Branch, Centers for Disease Control and Prevention 
(CDC), 255 East Paces Ferry Road, Mailstop E-13, Atlanta, GA 30305.
    The progress report must include the following for the program, 
function, or activity involved: (1) a comparison of actual 
accomplishments to the goals established for the period; (2) the 
reasons for slippage if established goals are not met; and (3) other 
pertinent information.

2. Peer and Technical Reviews

    A. CERCLA, as amended by SARA, Section 104(i)(13), and [42 U.S.C. 
9604 (I)] requires all studies and results of research (other than 
public health assessments) that ATSDR carries out or funds in whole or 
in part will be peer reviewed by ATSDR. The ATSDR peer review process 
for final reports requires that:
    1. Studies must be reported or adopted only after appropriate peer 
review.
    2. Studies shall be peer reviewed within a period of 60 days to the 
maximum extent practical.
    3. Studies shall be reviewed by no fewer than three or more than 
seven reviewers who (1) are selected by the Administrator, ATSDR; (2) 
are disinterested Scientific experts; (3) have a reputation for 
scientific objectivity; and (4) who lack institutional ties with any 
person involved in the conduct of the study or research under review.
    B. ATSDR encourages the rapid reporting and interpretation of 
laboratory results and references back to individual participants. 
However, if summary tables or distribution of laboratory results are 
prepared using the study data, this is considered a preliminary finding 
and will require ATSDR technical and peer review prior to release.
    C. When, in the opinion of the investigator(s), a public health 
concern exists requiring the release of summary study statistics prior 
to the completion of the study, the investigator must obtain 
concurrence from ATSDR prior to releasing the summary statistics. A 
request for ATSDR concurrence for the release of information must be

[[Page 31485]]

documented in a letter to ATSDR and should outline the public health 
concern, and recommended response, and the draft document proposed for 
release by the investigator. ATSDR will provide a technical review and 
peer review within ten (10) working days to the maximum extent 
possible. Summary statistics may be released only after peer review. 
The release of summary statistics does not preclude the requirement for 
a final report.
    D. By statute, the reporting of preliminary studies and preliminary 
research results to the public is not acceptable without prior review 
by ATSDR. This includes manuscripts prepared for publication, 
presentations at scientific meetings, and reporting of preliminary 
findings to the community or the media.
    E. The final report for every study should include a detailed 
description of the problem, hypothesis, methods, results, conclusions, 
and recommendations that constitute a complete performance record of 
the study.
    F. ATSDR is responsible for the technical and peer review of draft 
final reports of any study that it funds prior to the submission of the 
final report. This will allow for the recipient to incorporate all 
technical and peer review comments into the final report. Responses to 
all ATSDR required technical and peer review comments should be 
summarized in a letter to ATSDR. This letter should also include the 
investigator's response to each comment and a rationale for those 
responses. Based upon the comments of the technical and peer reviewers, 
modifications in the study report may result. The modified study report 
should accompany the letter to ATSDR.
    G. ATSDR will make available assistance to investigators in 
formatting and copy editing draft final reports, should the 
investigator request this assistance. Editing will be conducted by 
ATSDR staff and an edited copy of the draft final report will be 
supplied to the investigator for review and concurrence. Editing will 
occur DURING the conduct of the peer review. It is requested that the 
report be furnished in WordPerfect 5.1 on a disk with the hard copy 
double-spaced, with clearly numbered pages, unbound and unstapled, and 
printed on one side only. All appendices, including maps and reproduced 
forms used in this study, should be furnished to ATSDR by the 
investigator.
    H. Following the steps outlined above, a final report of all 
studies and results of research carried out or supported by ATSDR must 
be submitted to the Procurement and Grants Office with a copy furnished 
to ATSDR.
    I. If assistance in printing the final report is needed, the 
Principal Investigator can submit a hard copy of the final report to 
the Procurement and Grants Office with a copy furnished to the Division 
of Toxicology, ATSDR.

Application Content

    The application must be developed in accordance with PHS Form 5161-
1 (OMB) Number 0937-0189) information. In a narrative form, the 
application should include a discussion of areas listed under the 
``Evaluation Criteria'' section of this announcement as they relate to 
the proposed program. Because these criteria serve as the basis for 
evaluating the application, omissions or incomplete information may 
affect the rating of the application. 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.
    An original application and two copies should be submitted. 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\0'' by 11'' paper, with at least 1'' margins, and printed on one side 
only.

Evaluation Criteria

    Re-Competing applications will be reviewed and evaluated according 
to the following criteria:

1. Scientific and Technical Review Criteria of New 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 (analytic 
procedures should be state of the art, including participation in a 
quality assurance and quality control program for comparison with other 
research projects) 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;
    (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 as a resource 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, Indian Health 
Service, community residents, and to other concerned individuals and 
organizations.
B. Program Personnel--30%
    The extent to which the proposal 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.
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. Budget should reflect 
funds for participation in the QA/QC program.
E. Human Subjects--(Not Scored)
    The extent to which the applicant complies with the Department of 
Health and Human Services Regulations (45 CFR Part 46) regarding the 
protection of human subjects.

2. Review of Continuation Applications

    Continuation awards within the project period will be made on the 
basis of the following criteria:
    A. Satisfactory progress has been made in meeting project 
objectives;
    B. Objectives for the new budget period are realistic, specific, 
and measurable;
    C. Proposed changes in described long-term objectives, methods of 
operation, need for grant support, and/

[[Page 31486]]

or evaluation procedures will lead to achievement of project 
objectives; and
    D. Budget request is clearly justified and consistent with the 
intended use of grant funds.

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.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by the cooperative agreement will be subject to 
review and approval by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.

Human Subjects

    The applicant must comply with the Department of Health and Human 
Services Regulations, 45 CFR Part 46, regarding the protection of human 
subjects. Assurances must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
forms provided in the application kit.

Women, Racial and Ethnic Minorities

    It is the policy of the CDC to ensure that individuals of both 
sexes and the various racial and ethnic groups will be included in CDC-
supported research projects involving human subjects, whenever feasible 
and appropriate. Racial and ethnic groups are those defined in OMB 
Directive No. 15 and include American Indian or Alaska Native, Asian, 
Black or African American, Hispanic or Latino, and Native Hawaiian or 
other Pacific Islander. Applicants shall ensure that women, racial and 
ethnic minority populations are appropriately represented in 
applications for research involving human subjects. Where clear and 
compelling rationale exists that inclusion is inappropriate or not 
reasonable, this situation must be explained as part of the 
application. This policy does not apply to research studies when the 
investigator cannot control the race, ethnicity and/or sex of subjects. 
Further guidance to this policy is contained in the Federal Register, 
Vol. 60, No. 179, Friday, September 15, 1995, pages 47947-47951 (a copy 
is included in the application kit).

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 would 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; then the records will 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.

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 establishes the relationship between the grantee 
and the third party.
    The written agreement shall at a minimum:
    (A) 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;
    (B) 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;
    (C) 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
    (D) 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 shall not relieve the grantee of any part of 
its responsibility or accountability to ATSDR under the grant. The 
agreement shall therefore retain sufficient rights and control to the 
grantee to enable it to fulfill this responsibility and accountability.

Application Submission and Deadline Dates

    The original and two copies of the application PHS Form 5161-1 (OMB 
Number 0937-0189) must be submitted to Ron Van Duyne, Grants Management 
Officer, Attn: Patrick A. Smith, 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 on or before July 31, 1998. (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.

[[Page 31487]]

Where To Obtain Additional Information

    To receive additional written information call 1-888-GRANTS4. You 
will be asked to leave your name, address, and phone number and will 
need to refer to ATSDR Announcement Number 98074. You will receive a 
complete program description, information on application procedures, 
and application forms. CDC will not send application kits by facsimile 
or express mail.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from Patrick A. Smith, 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, telephone (404) 842-6803, Internet: 
[email protected].
    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, 
Internet:[email protected].
    PLEASE REFER TO ANNOUNCEMENT NUMBER 98074 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, D.C. 20402-9325 (Telephone 202-512-1800).
    This and other CDC announcements are available through the CDC 
homepage on the Internet. The address for the CDC homepage is: http://
www.cdc.gov.

    Dated: June 3, 1998.
Georgi Jones,
Director, Office of Policy and External Affairs, Agency for Toxic 
Substances and Disease Registry.
[FR Doc. 98-15257 Filed 6-8-98; 8:45 am]
BILLING CODE 4163-70-P