[Federal Register Volume 59, Number 106 (Friday, June 3, 1994)]
[Unknown Section]
[Page 0]
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