[Federal Register Volume 63, Number 118 (Friday, June 19, 1998)]
[Notices]
[Pages 33677-33680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16327]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
[Announcement Number 98068]
Notice of Availability of Funds for Fiscal Year 1998; Grants for
Radiation Studies and Research
Introduction
The Centers for Disease Control and Prevention (CDC), announces
that applications are being accepted for Grants for Radiation Studies
and Research. The efforts funded by these grants will result in models
and procedures that will improve systems to track environmental
exposures and diseases.
CDC 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 priority areas 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 Section 301(a) of the Public
Health Service Act [42 U.S.C. Section 241(a)] as amended, and under the
Occupational Safety and Health Act [29 U.S.C. Section 669(a)].
Eligible Applicants
Eligible applicants include all non-profit organizations. Thus
State and local health departments and other State and local
governmental agencies, universities, colleges, research institutions,
laboratories, and other public and private organizations, including
small, minority and/or woman-owned businesses are eligible for these
research grants.
Availability of Funds
Approximately $350,000 is expected to be available in Fiscal Year
1998 to fund approximately two to four awards. It is expected that the
average award will be $100,000-$150,000, the range being $60,000 to
$200,000 (including both direct and indirect costs). It is expected
that the awards will begin on or about September 30, 1998, and are
usually made for a 12-month budget period within a project period of up
to three years. Funding estimates may vary and are subject to change.
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Continuation awards within the project period will be made on the
basis of satisfactory progress and the availability of funds.
Use of Funds: Grant funds may not be used to support direct care
services.
Background
The Secretary, Department of Health and Human Services (HHS) and
the Secretary, Department of Energy (DOE) signed a Memorandum of
Understanding (MOU) transferring the authority and resources to manage
and conduct energy-related analytic epidemiologic research from DOE to
HHS. This includes the authority, resources, and responsibility for the
design, implementation, analysis, and scientific interpretation of
analytic epidemiologic studies of the following populations: workers at
DOE facilities; residents of communities in the vicinity of DOE
facilities; other persons potentially exposed to radiation; and persons
exposed to potential hazards resulting from non-nuclear energy
production and use.
The Secretary, HHS, delegated the responsibility for implementation
of the MOU to the Centers for Disease Control and Prevention (CDC). The
Director, CDC, designated the National Center for Environmental Health
(NCEH) as lead for CDC and for the conduct of environmental studies.
The National Institute for Occupational Safety and Health has the
responsibility for the conduct of occupational studies.
Purpose
The purposes of this program are:
A. To support radiation research on priority issues in the
following categories:
1. A broad-based need for participation in International Validation
Studies for Environmental Transport Models.
2. Development of methodologies for using current sampling data as
an indicator of past contaminant releases to the environment.
3. Development of Usage Factors for Environmental Dose
Calculations.
4. Uncertainty Analysis of Dose Conversion Factors for Radio
nuclides.
5. Risk Factors for Thyroid Disease.
6. Development of Ultra sensitive Measurement Techniques for
Individual Environmental Radiation Dosimetry.
B. To encourage professionals from a wide spectrum of disciplines
such as engineering, medicine, health care, public health, physical
sciences, and others, to undertake radiation research programs.
C. To evaluate current and new scientific methodologies and
strategies in the areas of radiation research.
Program Requirements
The following are applicant requirements:
A. A director who has specific authority and the responsibility to
carry out the project.
B. Demonstrated experience in conducting, evaluating, and
publishing radiation, epidemiology, and or dose assessment research.
C. Effective and well-defined working relationships within the
performing organization and with outside entities which will ensure
implementation of the proposed activities.
D. The ability to disseminate and implement the research findings
through organizations (such as public health agencies) or systems, both
public and private.
E. An overall match between the applicant's proposed theme and
research objectives, and the program priorities as described in the
PURPOSE, A. Radiation research.
Eligible applicants may enter into contracts, including consortia
agreements (as set forth in the PHS Grants Policy Statement) as
necessary to meet the requirements of the program and strengthen the
overall application.
Programmatic Interest
The focus of each grant application should reflect priority issues
in one or more of the following areas; (1) a broad-based need for
participation in International Validation Studies for Environmental
Transport Models; (2) development of methodologies for using current
sampling data as an indicator of past contaminant releases to the
environment; (3) development of Usage Factors for Environmental Dose
Calculations; (4) Uncertainty Analysis of Dose Conversion Factors for
Radio nuclides; (5) Risk Factors for Thyroid Disease; and (6)
Development of Ultra sensitive Measurement Techniques for Individual
Environmental Radiation Dosimetry.
International Validation Studies for Environmental Transport Models
The best way to determine the accuracy of any environmental
transport model is to compare predictions made by the model with
measurements of the same quantity in the environment, a process known
as model validation. The environmental transport models potentially
useful in dose reconstruction projects must be validated to the extent
possible if the results produced by the models are to be scientifically
and publicly defensible. A series of recent international projects
coordinated by the International Atomic Energy Agency have been
attempting to address this issue using environmental radio nuclide data
gathered from around the world, especially from nations formerly part
of the Soviet Union.
Environmental Indicators of Past Releases
All environmental dose reconstructions will require the extensive
use of mathematical models of source term development and environmental
transport and dosimetry. These models will be validated against past
and present environmental monitoring results. Early environmental
monitoring was not as comprehensive or sensitive as today's methods.
Therefore, the use of monitoring data for model validation for early
years of site operations potentially will be less certain than later
years. A number of methods are available for defining long-term trends
of environmental contamination. For example, tree ring analyses have
been performed to reconstruct historical concentrations of tritium and
mercury. Methods developed must provide information on the temporal and
geographic patterns of contamination in the environment.
Usage Factors for Environmental Dose Calculations
There are four major factors that determine the dose and risk to
people from the inhalation and ingestion of radio nuclides and
chemicals released to the environment:
1. the source term (the type and amount of contaminant released to
the environment);
2. environmental transport to people (via the atmosphere,
hydrosphere, and/or food chains);
3. usage factors (time spent outdoors, rate of inhalation, amount
of a particular food product consumed, etc.); and
4. metabolism or the particular radio nuclide or chemical in the
body resulting in a particular dose or risk.
What is required for modern dose and risk estimation is a
probability distribution for each usage factor.
Uncertainty Analysis of Dose Conversion Factors for Radio Nuclides
All environmental dose reconstructions require the extensive use of
Dose Conversion Factors (DCF) that relate intake or exposure to
radioactive materials to the endpoint dose. The DCFs in use today have
been developed mainly for radiation protection purposes. In as much,
these DCFs were derived by the use of conservative values and
assumptions, non-stochastic values of DCFs are listed singularly (i.e.,
with no estimates of
[[Page 33679]]
uncertainty). Modern dose and risk estimates require that (1)
probability distributions be defined for each of the parameters used to
derive the DCF's; (2) each of these distributed parameters be
propagated through the model which defines the specific DCF; and (3)
the final DCF be presented as a distribution with uncertainties.
Risk Factors for Thyroid Disease
Historical releases of iodine from activities at DOE facilities and
during weapons testing have raised questions concerning the risk of
thyroid disease associated with radiation exposure. Not only have
questions been raised about the risk of thyroid neoplasia, but also
about other thyroid diseases that may or may not be related to
radiation exposure. Medical monitoring for all thyroid diseases has
been proposed for the population around the Hanford nuclear weapons
facility potentially exposed to historical releases of radio iodine. A
large number of studies have been completed in the last ten years that
shed light on the risk factors for thyroid disease and on the
association between thyroid disease and radiation.
Development of Ultra Sensitive Measurement Techniques for
Individual Environmental Radiation Dosimetry
Much work on environmental dose reconstruction deals with computer
modeling using limited environmental monitoring data to ascertain
radiation doses to individuals for the purpose of risk assessment and
epidemiologic study. This is often due to the fact that the radio
nuclides of concern have short effective half lives with respect to the
elapsed time from exposure to assessment. In many cases the
environmental levels of contamination are significantly below
conventional levels of detection for in vivo radiation detection. The
purpose of this grant is to develop Ultra sensitive techniques that
could be used for assessing environmental exposures to people who are
now alive and who may have been exposed to historical releases from DOE
weapons facilities. Development of novel techniques or significant
improvements on current techniques will be considered.
Application Content
Applications for radiation research should include:
A. The project's focus that justifies the research need and
describes the scientific basis for the research, the expected outcome,
and the relevance of the findings. The focus should be based on one or
more of the priority topic issues.
B. Specific, measurable, and time-framed objectives.
C. A detailed plan describing the methods by which the objectives
will be achieved, including their sequence. A comprehensive evaluation
plan is an essential component of the application.
D. A description of the grant's principal investigator's role and
responsibilities.
E. A description of all project staff regardless of their funding
source. It should include their title, qualifications, experience,
percentage of time each will devote to the project, as well as that
portion of their salary to be paid by the grant.
F. A description of those activities related to, but not supported
by the grant.
G. A description of the involvement of other entities that will
relate to the proposed project, if applicable. It should include
commitments of support and a clear statement of their roles.
H. A detailed first year budget for the grant with future annual
projections, if relevant.
I. Applicants must identify the principal priority topic areas upon
which their project focuses.
An applicant organization has the option of having specific salary
and fringe benefit amounts for individuals omitted from the copies of
the application which are made available to outside reviewing groups.
To exercise this option, on the original and six copies of the
application, the applicant must use asterisks to indicate those
individuals for whom salaries and fringe benefits are not shown; the
subtotals must still be shown. In addition, the applicant must submit
an additional copy of page four of Form PHS-398, completed in full,
with the deleted amounts shown. This budget page will be reserved for
internal staff use only.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria:
1. The specific aims of the research project, i.e., the broad long
term objectives, the intended accomplishment of the specific research
proposal, and the hypothesis to be tested; (15 points)
2. The background of the proposal, i.e., the basis for the present
proposal, the critical evaluation of existing knowledge, and specific
identification of the knowledge gaps which the proposal is intended to
fill; (10 points)
3. The significance and originality from a scientific or technical
standpoint of the specific aims of the proposed research, including the
adequacy of the theoretical and conceptual framework for the research;
(20 points)
4. The progress of preliminary studies pertinent to the
application; (5 points)
5. The adequacy of the proposed research design, approaches, and
methodology to carry out the research, including quality assurance
procedures, plan for data management, and a statistical analysis plan;
(15 points)
6. The extent to which the evaluation plan will allow for the
measurement of progress toward the achievement of the stated
objectives; (15 points)
7. Qualifications, adequacy, and appropriateness of personnel to
accomplish the proposed activities; (10 points)
8. The degree of commitment and cooperation of other interested
parties (as evidenced by letters detailing the nature and extent of the
involvement); (5 points)
9. The budget request is clearly explained, adequately justified,
reasonable and consistent with the intended use of grant funds; (Not
scored) and
10. Adequacy of existing and proposed facilities and resources. (5
points)
Executive Order 12372 Review
Applications are not subject to the review requirements of
Executive Order 12372.
Public Health System Reporting Requirement
This program is not subject to the Public Health System Reporting
Requirement.
Catalog of Federal Domestic Assistance Number (CFDA)
The Catalog of Federal Domestic Assistance number is 93.283.
Application Submission and Deadlines
Applicants should use Form PHS-398 and adhere to the ERRATA
Instruction Sheet for Form PHS-398 contained in the Grant Application
Kit. Please submit an original and six copies, on or before August
7,1998 to: David Elswick, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, N.E., Room
300, Atlanta, GA 30305.
Deadlines: Applications shall be considered as meeting a 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
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the review committee. Applicants should 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 mailings.
Applications which do not meet the criteria in 1. or 2. above are
considered late applications and will be returned to the applicant.
Where To Obtain Additional Information
All application procedures and guidelines are contained within the
present announcement. Business management technical information may be
obtained from David Elswick, Grants Management Specialist, Procurement
and Grants Office, Centers for Disease Control and Prevention (CDC),
255 East Paces Ferry Road, N.E., Mailstop E-13, Atlanta, GA 30305,
telephone (404) 842-6521.
Programmatic technical assistance may be obtained from Steven
Adams, Project Officer, Radiation Studies Branch, Division of
Environmental Hazards and Health Effects, National Center for
Environmental Health, Centers for Disease Control and Prevention (CDC),
4770 Buford Hwy, N.E., Mailstop F-35, Atlanta, GA 30341-3724, telephone
(770) 488-7040.
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, D.C. 20402-9325
(Telephone (202) 513-1800).
Dated: June 15, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 98-16327 Filed 6-18-98; 8:45 am]
BILLING CODE 4163-18-P
