[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
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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
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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
