[Federal Register Volume 62, Number 108 (Thursday, June 5, 1997)]
[Notices]
[Pages 30865-30868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry
[Announcement Number 747]


Research Programs for the Development of Methods for the Toxicity 
Assessment of Environmental Chemical Mixtures

Introduction

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces the availability of fiscal year (FY) 1997 funds for a 
cooperative agreement based 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 National 
Priorities List (NPL) sites and facilities. Such combinations are 
referred to as ``chemical mixtures.'' The objective of this program is 
to develop methods of toxicity assessment of chemical mixtures so as to 
promote public health practices based on current scientific 
understanding and to evaluate exposure to environmental chemicals of 
populations living in the vicinity of hazardous waste sites.
    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 Healthy People 2000 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) of 1980 as amended by the Superfund Amendments and 
Reauthorization Act (SARA) of 1986 ((42 U.S.C. 9604(i)5(A) and (15)).

Eligible Applicants

    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.
    Funding preference will be given to the three applicants that are 
currently funded under this cooperative agreement program.

Smoke-Free Workplace

    ATSDR strongly encourages all cooperative agreement recipients to 
provide a smoke-free workplace and promote the non-use of all tobacco 
products. 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.

Availability of Funds

    Approximately $400,000 will be available in FY 1997 to fund up to 3 
cooperative agreement awards. It is expected that the average award 
will be approximately $125,000, ranging from $50,000 to $250,000. The 
awards are expected to begin on or about September 30, 1997, for a 12-
month budget period within a project period of 5 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 waste sites. 
Specific areas of funded research may include to: (1) Identify hazards 
associated with chemical mixtures found in the environment that impact 
public health; (2) evaluate potential toxicity to human populations 
from exposure 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

[[Page 30866]]

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 toxicity 
of chemical mixtures found at hazardous waste sites and facilities 
based on the specific objectives listed in the Purpose section of this 
announcement.
    2. Establish and maintain a research plan and system for collecting 
information.
    3. Provide technical and research updates to ATSDR on a quarterly 
basis. Also, provide a formal annual report of research and financial 
status of the project.
    4. Conduct workshops or symposia (periodically) to exchange current 
information, opinions and research findings on mixtures.
    5. Develop and implement mechanisms to assure the publication of 
research supported through this cooperative agreement.
    6. Demonstrate the potential application of research findings to 
public health assessment at hazardous waste sites.

B. ATSDR Activities

    1. Provide consultative, administrative and technical assistance, 
as needed, in the development of the program of research activities.
    2. Conduct technical peer review of protocols, studies and results 
according to ATSDR established policies.
    3. Collaborate with the recipient in the establishment of a 
research plan and system for collecting/monitoring data and developing 
periodic reports on activity.
    4. 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.
    5. Participate and collaborate with the applicant in planning 
workshops or symposia to exchange current information, opinions, and 
research findings on mixtures.

Application Content

    In a narrative form, the applicant shall submit sufficient 
supporting evidence to satisfy all items in the EVALUATION CRITERIA 
section of this announcement. The applications submitted under this 
cooperative agreement will contain a testing program to distinguish 
health effects posed by exposure to mixtures of hazardous chemicals. It 
is anticipated that the application received will contain technical 
proposal(s) that may cover up to a five-year period.

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; (d) 
the likelihood of the applicant completing proposed program activities 
and attaining proposed objectives based on the thoroughness and clarity 
of the overall program; and (e) the degree to which the applicant has 
met the CDC Policy requirements regarding the inclusion of women, 
ethnic, and racial groups in the proposed project. This includes, (1) 
the proposed plan for the inclusion of both sexes and racial and ethnic 
minority populations for appropriate representation; (2) the proposed 
justification when representation is limited or absent; (3) a statement 
as to whether the design of the study is adequate to measure the 
differences when warranted; and (4) a statement as to whether the plans 
for recruitment and outreach for study participants include the process 
of establishing partnerships with community(ies) and recognition of 
mutual benefits.
3. Relationship to Initiative--15%
    The extent to which the application addresses the areas of 
investigation outlined by ATSDR. (See examples under PURPOSE section of 
this announcement).
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 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

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consistent with intended use of cooperative agreement/grant funds.
8. 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.

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.

Technical Reporting Requirements

    Quarterly progress reports are required. An annual progress report 
is due with submission of the application for continuation. Annual 
Financial Status Reports (FSRs) are due 90 days after the end of each 
budget period. The final financial status and performance reports are 
required 90 days after the end of the project period.

Executive Order 12372

    Applications are subject to the Intergovernmental Review of Federal 
Programs as governed by Executive Order 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 Ron Van Duyne, Grants Management Officer, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., 
Room 321, Mailstop E-13, Atlanta, Georgia 30305, no later than 45 days 
after the application deadline. 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 Ron Van Duyne, Grants Management Officer, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 321, 
Mailstop E-13, Atlanta, Georgia 30305, no later than 45 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. Technical Review

    All protocols, studies, and results of research that ATSDR carries 
out or funds in whole or in part will be reviewed to meet the 
requirements of CERCLA section 104(i)(13). ATSDR funded or conducted 
studies must be:
    1. Reported or adopted only after appropriate review;
    2. Technically reviewed within a period of 60 days to the maximum 
extent practical; and
    3. Reviewed by no fewer than three nor more than seven reviewers 
who are selected by the Administrator, ATSDR, are disinterested 
scientific experts, have a reputation for scientific objectivity, and 
lack institutional ties with any persons involved in the conduct of the 
study or research under review.

B. Paperwork Reduction Act

    Projects that involve collection of information from 10 or more 
individuals and funded by cooperative agreements will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act. OMB clearance will be requested, if required.

C. Protection of Human Subjects

    If the proposal involves research on human subjects, the applicant 
must comply with 45 CFR part 46, regarding the protection of human 
subjects. Assurances must be provided that the project or activity will 
be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing evidence of this assurance in accordance with the appropriate 
guidelines and forms provided in the application kit.
    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 American Indian community is involved, its tribal government must 
also approve that portion of the project applicable to it.
D. Women, Racial and Ethnic Minorities
    It is the policy of CDC and ATSDR to ensure that individuals of 
both sexes and the various racial and ethnic groups will be included in 
CDC/ATSDR-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, Alaskan 
Native, Asian, Pacific Islander, Black and Hispanic. 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 exist that inclusion is 
inappropriate or not feasible, this situation must be explained as part 
of the application. In conducting review for scientific merit, review 
groups will evaluate proposed plans for inclusion of minorities and 
both sexes as part of the scientific assessment and scoring. 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, 
pages 47947-47951, Friday, September 15, 1995.
E. Cost Recovery
    CERCLA, as amended by SARA, 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

[[Page 30868]]

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 will retain the documents and records to support 
these financial transactions, for possible use in a cost recovery case, 
for a minimum of 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.
F. 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 DHHS under the 
grant. The agreement shall, therefore, retain sufficient rights and 
control to the grantee to enable it to fulfill this responsibility and 
accountability.
G. 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 DHHS-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 
(Revised 7/92, OMB Number 0937-0189) must be submitted to Ron Van 
Duyne, Grants Management Officer, Grants Management Branch, Procurement 
and Grants Office, Centers for Disease Control and Prevention (CDC), 
255 East Paces Ferry Road, NE., Room 321, Mail Stop E-13, Atlanta, 
Georgia 30305, on or before July 15, 1997. (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

    To receive an application kit, call (404) 332-4561. You will be 
asked your name, address, and telephone number and will need to refer 
to Announcement 747. In addition, this announcement is also available 
through the CDC Home Page on the Internet. The address for the CDC Home 
Page is http://www.cdc.gov. If you have questions after reviewing the 
contents of all the documents, business management assistance may be 
obtained from Kathy Raible, 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) 842-6803. 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 747 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) 512-1800.

    Dated: May 29, 1997.
Georgi Jones,
Director, Office of Policy and External Affairs, Agency for Toxic 
Substances and Disease Registry.
[FR Doc. 97-14525 Filed 6-4-97; 8:45 am]
BILLING CODE 4163-70-P