[Federal Register Volume 59, Number 106 (Friday, June 3, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13505]
[[Page Unknown]]
[Federal Register: June 3, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[Program Announcement Number 444]
Health Studies Related to the National Exposure Registry
Introduction
The Agency for Toxic Substances and Disease Registry (ATSDR)
announces the availability of fiscal year (FY) 1994 funds for a
cooperative agreement/grant program to conduct health studies of
trichloroethylene (TCE)-exposed subpopulations that comprise the TCE
Subregistry of the National Exposure Registry. The studies will address
health conditions identified by ATSDR as potential health conditions
associated with environmental exposure to TCE, with emphasis on
neurotoxic disorders. The recipient will utilize the National Exposure
Registry Trichloroethylene (TCE) Subregistry database in designing and
executing these studies.
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 under sections
104(i)(1)(E),(7), and (15) of the Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA) of 1980 as
amended by the Superfund Amendments and Reauthorization Act (SARA)
of 1986, (42 U.S.C. 9604 (i)(1)(E),(7), and (15)).
Smoke-Free Workplace
The PHS strongly encourages all grant recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.
This is consistent with the PHS mission to protect and advance the
physical and mental health of the American People.
Eligible Applicants
Eligible applicants are the official public health agencies of
States or their bona fide agents. This includes the District of
Columbia, American Samoa, the Commonwealth of Puerto Rico, the Virgin
Islands, the Federated States of Micronesia, Guam, the Northern Mariana
Islands, the Republic of the Marshall Islands, the Republic of Palau,
and federally-recognized Indian tribal governments. State
organizations, including State universities, State colleges, and State
research institutions, must establish that they meet their respective
State's legislature definition of a State entity or political
subdivision to be considered an eligible applicant.
Availability of Funds
Approximately $1,000,000 is available in FY 1994 to fund 3-5 new
and competing awards. It is expected that the average award will be
$200,000, ranging from $100,000 to $300,000. It is expected that the
awards will begin on or about September 30, 1994, and will be made for
a 12-month budget period within a project period of up to 3 years.
Continuation awards within the project period will be made on the
basis of satisfactory progress and the availability of funds.
Purpose
The purpose of this announcement is to solicit scientific proposals
designed to study the occurrence of/and risk factors for specified
health outcomes for persons who have had documented environmental
exposure to TCE through drinking or using contaminated water. The study
population will include all, or a subset, of the TCE Subregistry
registrants. These studies will increase the knowledge base, and hence
improve the ability of public health programs to address potential
public health problems related to exposure to hazardous substances.
Several research topics were suggested based on the analysis of the
TCE Subregistry baseline data. The topics are to be considered
suggestions and not limitations. These topics are:
--Hearing, speech impairment in subpopulation exposed at 10
years of age (neurological disorders)
--Cardiac problems (possibly congenital) in subpopulation exposed at
10 years of age
--Diabetes
--Hypertension/stroke/heart problems in adult subpopulation
Program Requirements
The TCE baseline data and documentation are available on CD-ROM
(4.75 inch disc) which is accessed using the Statistical Export and
Tabulation System (SETS), data format ISO 9660. This can be run on a
fully IBM-compatible microcomputer 286/386/486 with 640K of memory,
three megabytes of free space on a hard drive, an operating system of
MS-DOS 3.1 or higher and a fully installed CD-Rom reader.
Applicants must propose studies which will address one or more of
the following areas of investigation:
A. Evaluate the occurrence of adverse health effects in the
identified population. This will include the evaluation of the
incidence or prevalence of a disease, disease symptoms, self-reported
health concerns, or biological markers of disease, susceptibility, or
exposure (see Purpose section for the specific disease outcomes
specified).
B. Identify risk factors for adverse health effects in the
identified populations. This will include hypothesis generating cohort
or case-control studies on potentially impacted populations to identify
linkages between exposure and adverse health effects and those risk
factors which may be impacted by prevention actions. (See Purpose
section for a listing of the adverse health effects of concern.)
C. Develop methods to diagnose adverse health effects (see Purpose
section for the adverse health effects of concern) in populations. This
will include medical research to evaluate currently available
biological tests (biomarkers) and disease occurrence in potentially
impacted populations.
ATSDR will provide financial assistance to applicants in designing
and executing analytic epidemiologic studies to explore the
relationship between exposure to hazardous substances and the
occurrence of, and risk factors for, environmental exposure to TCE
through drinking and using contaminated water, using all or a subset of
the TCE Subregistry registrants.
Applicants must specify the type of award for which they are
applying, either grant or cooperative agreement. These two types of
Federal assistance are explained below.
A. Grants
In a grant, the applicant will be required to conduct the proposed
study without substantial programmatic involvement by ATSDR. Grantees
must meet the following requirements: The application should be
presented in a manner that demonstrates the applicant's ability to
address the environmental health problems.
The applicant's protocol should contain consent forms and
questionnaires, baseline morbidity and mortality information,
procedures for collecting biologic and environmental specimens and for
conducting laboratory analysis and evaluation of the test results of
biologic specimens, statistical and epidemiologic analysis of the study
information, and a description of the safeguards for protecting the
confidentiality of individuals on whom data are collected.
By comparison, the activities of the recipient and the ATSDR for a
cooperative agreement are described in paragraph B.
B. Cooperative Agreements
In a cooperative agreement, ATSDR will assist the collaborator in
conducting the study. The application should be presented in a manner
that demonstrates the applicant's ability to address the health problem
in a collaborative manner with the funding agency. In conducting
activities to achieve the purpose of this program, the recipient shall
be responsible for the activities under 1., below and ATSDR shall be
responsible for conducting activities under 2., below:
1. Recipient Activities
a. Recipient will design, develop, and implement a protocol to
conduct the necessary study of exposed individuals.
b. Recipient is required to provide proof, by citation of State
code or regulation or other State pronouncement given the authority of
law, that medical information obtained pursuant to the agreement, which
pertains to an individual and is therefore considered confidential,
will be protected from disclosure when the consent of the individual to
release identifying information is not obtained.
c. If study requires knowledge of registrant personal identifiers,
recipient will develop a mechanism, working through ATSDR, for
interaction with the affected community to obtain necessary permission
for the release of this information to the recipient.
2. ATSDR Activities
a. ATSDR will assist in developing the study.
b. ATSDR will provide epidemiologic and other technical assistance
in both the planning and implementation phases of the field work called
for under the study protocol.
c. ATSDR will provide consultation and assist in monitoring the
collection and handling of information and the sampling and testing
activities.
d. ATSDR will participate in the statistical and epidemiologic
analysis.
e. ATSDR will collaborate in interpreting the study findings.
f. ATSDR will assist (act as the intermediary) in obtaining
registrant permission for the release to the recipient of personal
information.
g. ATSDR will conduct technical and peer review.
Evaluation Criteria
Applications will be reviewed and evaluated for scientific and
technical merit according to the following criteria:
A. Scientific and Technical Review Criteria of New Applications
1. Appropriateness and Knowledge of Study Design--25%
The extent to which the applicant's proposal addresses: (a)
Rationale for the proposed study design; (b) the identification of a
target (exposed/diseased) population; (c) the identification of an
appropriate comparison group; (d) a consideration of sample size; (e) a
plan for exposure assessment and/or a plan for evaluating adverse
health outcomes; and (f) a detailed plan for analysis of the data.
2. Proposed Study--25%
The adequacy of the proposal relevant to: (a) The study purpose,
objectives, and rationale; (b) the quality of program objectives in
terms of specificity, measurability, and feasibility; (c) the
specificity and feasibility of the applicant's timetable for
implementing program activities and timely completion of the study; and
(d) the likelihood of the applicant agency completing proposed program
activities and attaining proposed objectives based on the thoroughness
and clarity of the overall program.
3. Relationship to Initiative--15%
The extent to which the application addresses the areas of
investigation outlined by ATSDR.
4. Quality of Data Collection--15%
The extent to which: (a) The study ascertains the information
necessary to meet the objectives, including (but not limited to)
information on pathways of exposure, confounding factors, and
biomedical testing; (b) the quality control and quality assurance of
questionnaire data are provided, including (but not limited to)
interviewer training and consistency checks of data; (c) the laboratory
tests (if applicable) are sensitive and specific for the analyte or
disease outcome of interest; and d) the quality control, quality
assurance, precision and accuracy of information for the proposed tests
are provided and acceptable.
5. Applicant Capability and Coordination Efforts--10%
The extent to which the proposal has described: (a) The capability
of the applicant's administrative structure to foster successful
scientific and administrative management of a study; (b) the capability
of the applicant to demonstrate an appropriate plan for interaction
with the community; and (c) the suitability of facilities and equipment
available or to be purchased for the project.
6. Program Personnel--10%
The extent to which the proposed program staff is qualified and
appropriate, and the time allocated for them to accomplish program
activities is adequate.
7. Program Budget--(Not Scored)
The extent to which the budget is reasonable, clearly justified,
and consistent with intended use of cooperative agreement/grant funds.
B. Review of Continuation Applications
Continuation awards within the project period will be made on the
basis of the following criteria:
1. Satisfactory progress has been made in meeting project
objectives;
2. Objectives for the new budget period are realistic, specific,
and measurable;
3. Proposed changes in described long-term objectives, methods of
operation, need for grant support, and/or evaluation procedures will
lead to achievement of project objectives; and
4. The budget request is clearly justified and consistent with the
intended use of grant funds.
Executive Order 12372
Applications are subject to the Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets
up a system for State and local government review of proposed Federal
assistance applications. Applicants (other than federally-recognized
Indian tribal governments) should contact their State Single Point of
Contact (SPOC) as early as possible to alert them to the prospective
applications and receive any necessary instructions on the State
process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each affected State. A
current list of SPOCs is included in the application kit. If SPOCs have
any State process recommendations on applications submitted to CDC,
they should forward them 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, GA 30305, no later than 60
days after the application deadline. (By formal agreement, the CDC
Procurement and Grants Office will act on behalf of and for ATSDR on
this matter.) The granting agency does not guarantee to ``accommodate
or explain'' for State process recommendations it receives after that
date.
Indian tribes are strongly encouraged to request tribal government
review of the proposed application. If tribal governments have any
tribal process recommendations on applications submitted to CDC, they
should forward them 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., Mailstop E-13, Atlanta, GA 30305. This should be done no
later than 60 days after the application deadline date. The granting
agency does not guarantee to ``accommodate or explain'' for tribal
process recommendations it receives after that date.
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
A. Protection of Human Subjects
If the proposed project involves research on human subjects, the
applicant must comply with the Department of Health and Human Services
Regulation, 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. 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
form provided in the application kit.
B. Cost Recovery
The Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA) of 1980, as amended by the Superfund Amendments
and Reauthorization Act (SARA) of 1986, provides for the recovery of
costs incurred for health assessments and health effects studies 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 cost including indirect cost, as appropriate for the
site. The recipient would also maintain documentation that describes
the site-specific actions taken with respect to the site, e.g.,
contracts, work assignments, progress reports, and other documents that
describe the work performed at a 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 (FSR), 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.
C. Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and that are funded by the cooperative agreement mechanism
will be subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act.
D. Disclosure
Recipient is required to provide proof by way of citation to State
code or regulation or other State pronouncement given the authority of
law, that medical information obtained pursuant to the agreement,
pertaining to an individual, and therefore considered confidential,
will be protected from disclosure when the consent of the individual to
release identifying information is not obtained.
E. 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:
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 technical review (ATSDR selected
reviewers), release of data, 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-free, 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 a
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.
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.
5. 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 the grantee to enable it to fulfill this responsibility and
accountability.
Application Submission and Deadline
The original and two copies of the application PHS Form 5161-1 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, GA 30305, on or before July 21, 1994.
(By formal agreement, the CDC Procurement and Grants Office will act on
behalf of and for 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 must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or the 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
Additional information on application procedures, copies of
application forms, other material, and business management assistance
may be obtained from Maggie Slay, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop
E-13, Atlanta, GA 30305, telephone (404) 842-6797. Programmatic
assistance may be obtained from Dr. Jeffrey A. Lybarger, Director,
Division of Health Studies, Agency for Toxic Substances and Disease
Registry, 1600 Clifton Road, NE., Mailstop E-31, Atlanta, GA 30333,
telephone (404) 639-6200.
The complete technical report ``National Exposure Registry
Trichloroethylene (TCE) Subregistry Baseline Technical Report'' is
available through NTIS (# PB93-209187), May 1993. A summary of the
technical report, the ``Registrants Report'', and a copy of the
questionnaire used to collect the data is available through ATSDR
(request by calling Dr. JeAnne Burg, telephone (404) 639-6202.
Please refer to Announcement Number 444 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) through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325,
telephone (202) 783-3238.
Dated: May 27, 1994.
Claire V. Broome,
Acting Deputy Administrator, Agency for Toxic Substances and Disease
Registry.
[FR Doc. 94-13505 Filed 6-2-94; 8:45 am]
BILLING CODE 4163-70-P