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

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

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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

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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/

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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.

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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