[Federal Register Volume 59, Number 156 (Monday, August 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20000]


[[Page Unknown]]

[Federal Register: August 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[Announcement 498]

 

A Research Program on the Public Health Assessment of Toxic 
Interactions for Chemical Mixtures

Introduction

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces the availability of fiscal year (FY) 1994 funds for a 
cooperative agreement to initiate a research program to develop methods 
to determine the health effects of hazardous substances in combination 
with other substances with which they are commonly found at 
Comprehensive Environmental Response, Compensation, and Liability Act 
(CERCLA) hazardous substance releases and facilities. Such combinations 
will be referred to as ``chemical mixtures.'' The objective of this 
program is to develop methods of toxicity assessment for populations 
that live in the vicinity of hazardous substance releases and 
facilities who are exposed to chemical mixtures.
    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 areas of Environmental Health, Surveillance and Data Systems, 
and Occupational Safety and 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) 5(A) and (15) of 
the Comprehensive Environmental Response, Compensation, and Liability 
Act (CERCLA) as amended by the Superfund Amendments and Reauthorization 
Act (SARA) of 1986 (42 U.S.C. 9604(i) 5(A) and (15)).

Smoke-Free Workplace

    The Public Health Service 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 Applicant

    Eligible applicants are the official public health agencies of the 
States or their bona fide agents or instrumentalities. 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 affirmatively establish that they 
meet their respective State's legislative definition of a State entity 
or political subdivision to be considered an eligible applicant.

Availability of Funds

    Approximately $150,000 will be available in FY 1994 to fund this 
program. The award is expected to begin on or about September 30, 1994, 
for a 12-month budget period within a project period of 3 years. 
Continuation awards within the project period will be made on the basis 
of satisfactory progress and availability of funds. The funding 
estimate above may vary and is subject to change.

Purpose

    The purpose of this program to develop methods for the assessment 
of health effects of chemical mixtures found at hazardous substance 
releases and facilities to: (1) Identify environmental chemical 
mixtures that impact public health, (2) evaluate the potential for 
exposure of human populations to chemical mixtures, (3) study the 
pharmacokinetic behavior of chemical mixtures, (4) study the various 
endpoints that would be affected and the target organs that would be 
impacted, (5) study the mechanisms of action, progression and repair of 
the injury caused by chemical mixtures, (6) identify biomarkers 
(specific and generic) that would allow the determination of the health 
of an organism, (7) develop qualitative and quantitative health 
assessment methods for chemical mixtures, and (8) develop methods for 
assessments of multiple health effects.

Program Requirements

    ATSDR will provide financial assistance for developing assessment 
methods and/or conduct of experimental animal research. The objective 
of the assessment component is to solve the immediate problems posed to 
the Agency while the research component allows the development of 
generic guidance for chemical mixtures through a long term plan. Both 
of these activities are necessary and complementary for the successful 
development of a viable research program. This research program for 
chemical mixtures would improve the knowledge base on the linkage 
between the uptake of hazardous substances and their health 
consequences, and reduce the uncertainties in the public health 
assessments performed at hazardous substance releases and facilities.
    In conducting activities to achieve the objectives of this program, 
the recipient will be responsible for the activities listed under A., 
below, and ATSDR will be responsible for conducting activities listed 
under B., below:

A. Recipient Activities

    1. Develop a detailed program of research to investigate toxic 
interactions of chemical mixtures found at hazardous substance releases 
and facilities based on the specific areas listed in the purpose of 
this announcement.
    2. Establish and maintain a research plan and system for collecting 
information.
    3. Periodically hold workshops or symposia to exchange current 
information, opinions and research findings on mixtures.

B. ATSDR Activities

    1. Provide consultative, administrative and technical assistance, 
as needed, in the development of the program of research activities for 
the enhancement of identified disciplinary areas.
    2. Collaborate with the recipient in the establishment of a 
research plan and system for collecting data and developing periodic 
reports on activity.
    3. Collaborate on the preparation of reports and briefing materials 
on a timely basis to assist recipient in presenting and writing 
publications including abstracts, and journal articles.
    4. Participate and collaborate with the applicant in planning 
workshops or symposia to exchange current information, opinions, and 
research findings on mixtures.

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) a plan for exposure 
assessment and/or a plan for evaluating adverse health outcomes; and 
(c) 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 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 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 chemical 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.
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, Georgia 30305, no later 
than 30 days after the application deadline. (A waiver for the 60-day 
requirement has been requested.) Since the funding for this program was 
received late in the fiscal year, time will not permit a 60-day State 
recommendation process. The granting agency does not guarantee to 
``accommodate or explain'' 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., Room 300, Mailstop E-13, Atlanta, Georgia 30305, no later 
than 30 days after the application deadline. The granting agency does 
not guarantee to ``accommodate or explain'' for tribal process 
recommendations it receives after that date. (By formal agreement, the 
CDC Procurement and Grants Office will act on behalf of and for ATSDR 
on this matter.)

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. 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.

B. Animal Subjects

    If the proposed project involves research on animal subjects, the 
applicant must comply with the ``PHS Policy on Humane Care and Use of 
Laboratory Animals by Awardee Institutions.'' An applicant organization 
proposing to use vertebrate animals in PHS-supported activities must 
file an Animal Welfare Assurance with the Office for Protection from 
Research Risks at the National Institutes of Health.

Application Submission Deadline

    The original and two copies of the application Form PHS 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, Mail Stop E-13, Atlanta, Georgia 30305, on or before 
September 15, 1994. (By formal agreement, the CDC Procurement and 
Grants Office will act on behalf of and for ATSDR on this matter.)

A. Deadline

    Applications shall be considered as meeting the deadline if they 
are either:
    1. Received on or before the deadline date, or
    2. 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 U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing).

B. Late Applications

    Applications which do not meet the criteria in A.1. or A.2. 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 Georgia Jang, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Mail Stop 
E-13, Atlanta, Georgia 30305, telephone (404) 842-6630. Programmatic 
assistance may be obtained from Dr. Moiz Mumtaz, Project Officer, 
Division of Toxicology, Agency for Toxic Substances and Disease 
Registry, 1600 Clifton Road, NE., Mail Stop E-29, Atlanta, Georgia 
30333, telephone (404) 639-6306.
    Please refer to Announcement 498 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: August 10, 1994.
Claire V. Broome,
Deputy Administrator, Agency for Toxic Substances and Disease Registry.
[FR Doc. 94-20000 Filed 8-12-94; 8:45 am]
BILLING CODE 4163-70-P