[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