[Federal Register Volume 63, Number 240 (Tuesday, December 15, 1998)]
[Notices]
[Pages 69076-69079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33162]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
[Announcement Number 99020]
Grants for Radiation Studies and Research Notice of Availability
of Funds
Announcement 99020 supersedes Announcement 98068 which was
published in the Federal Register on June 19, 1998, [Vol. 63, FR No.
118] [Page 33677-33680]
A. Purpose
The Centers for Disease Control and Prevention (CDC), announces the
availability of fiscal year (FY) 1999 funds for the Grants for
Radiation Studies and Research program. The purpose of the program will
result in models and procedures that will improve systems to track
environmental exposures and diseases. These grants are: (1) To support
radiation research on priority issues in the following categories: (a)
A broad-based need for participation in International Validation
Studies for Environmental Transport Models. (b) Development of
methodologies for using current sampling data as an indicator of past
contaminant releases to the environment. (c) Development of Usage
Factors for Environmental Dose Calculations. (d) Uncertainty Analysis
of Dose Conversion Factors for Radionuclides. (e) Risk Factors for
Thyroid Disease. (f) Development of Ultra sensitive Measurement
Techniques for Individual Environmental Radiation Dosimetry. (2) 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. (3) to evaluate
current and new scientific methodologies and strategies in the areas of
radiation research. This program addresses the ``Healthy People 2000''
priority area of Preventive Services.
B. Eligible Applicants
Eligible applicants include all non-profit and for-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.
Note: Public Law 104-65 states that an organization described in
section 501(c)(4) of the Internal Revenue Code of 1986 that engages
in lobbying activities is not eligible to receive Federal funds
constituting an award, grant, cooperative agreement, contract, loan,
or any other form.
C. Availability of Funds
Approximately $350,000 is expected to be available in Fiscal Year
1999 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
[[Page 69077]]
expected that the awards will begin on or about May 1, 1999, and are
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.
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.
D. Programmatic Interest
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 radionuclide 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 radionuclides and chemicals
released to the environment:
A. The source term (the type and amount of contaminant released to
the environment);
B. Environmental transport to people (via the atmosphere,
hydrosphere, and/or food chains);
C. Usage factors (time spent outdoors, rate of inhalation, amount
of a particular food product consumed, etc.); and,
D. Metabolism or the particular radionuclide 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 Radionuclides
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, and non-stochastic values of DCFs are listed singularly
(i.e., with no estimates of 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
radionuclides 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. There
is a need for development of 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.
E. Application Content
Use the information below to develop the applicant content. The
application will be evaluated on the criteria listed, so it is
important to follow them in laying out the program plan. The narrative
addressing the scored criteria should be no more that 40 single-spaced
pages, printed on one side, with one inch margin, and unreduced font.
Applications for radiation research should include:
1. 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.
2. Specific, measurable, and time-framed objectives.
3. 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.
4. The proposed plan for the inclusion of both sexes and racial and
ethnic minority populations for appropriate representation.
5. A description of the grant's principal investigator's role and
responsibilities.
6. 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.
7. A description of those activities related to, but not supported
by the grant.
8. 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.
9. A detailed first year budget for the grant with future annual
projections, if relevant.
[[Page 69078]]
10. Human Subjects--If human subjects will be involved, how will
they be protected, i.e., describe the review process which will govern
their participation. The applicant must demonstrate that they have met
the CDC Policy requirements regarding the inclusion of women, ethnic,
and racial groups in the proposed research.
F. 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 five copies, on or before February
16, 1999 to: Victoria Sepe, 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. Please list the Announcement number 99020 on
the covering address label. If your application does not arrive in time
for submission to the independent Special Emphasis Panel, it will not
be considered in the current competition unless you can provide proof
that you mailed it on or before the deadline (i.e., receipt from U.S.
Postal Service or a commercial carrier; private metered postmarks are
not acceptable.
G. Evaluation Criteria
Applications which are complete and responsive will be reviewed and
evaluated by an independent Special Emphasis Panel in accordance with
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. (a) 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;
(b) The proposed plan for the inclusion of both sexes and racial
and ethnic minority populations for appropriate representation. (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. 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, the applicant must use asterisks to indicate
those individuals for whom salaries and fringe benefits are not shown;
the subtotals must still be shown and the applicant must complete 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. (Not scored) and
10. Adequacy of existing and proposed facilities and resources. (5
points)
11. Human Subjects--Not Scored
This includes the extent to which the application adequately
addresses the requirements of Title 45 CFR Part 46 for the protection
of human subjects. If the project involves research on human
participants, assurance and evidence must be provided to demonstrate
that the project will be subject to initial and continuing reviews by
an appropriate institutional review board. Does the project adequately
address the requirements of 45 CFR 46 for the protection of human
subjects?
H. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. Annual progress reports; due no more than 30 days after the end
of each budget period;
2. Financial status report, due no more than 90 days after the end
of each budget period; and
3. Final financial and performance reports, due no more than 90
days after the end of the project period.
The following additional requirements are applicable to this
program. For a complete description of each, see Addendum I in the
application kit.
AR98-1 Human Subjects Requirements
AR98-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR98-9 Paperwork Reduction Act Requirements
AR98-10 Smoke-Free Workplace Requirements
AR98-11 Healthy People 2000
AR98-12 Lobbying Restrictions
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under Section 301(a) of the Public
Health Services Act, as amended [42 U.S.C. Section 241(a)] and under
the Occupational Safety and Health Act [29 U.S.C. Section 669(a)]
Sections 301 and 391 of the Public Health Service Act [42 U.S.C. 241
and 280(b)]. The Catalog of Federal Domestic Assistance number is
93.283.
J. Where To Obtain Additional Information
To receive additional written information and to request an
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked
to leave your name and address and will be instructed to identify the
Announcement number of interest. Also, the CDC Home Page on the
Internet: http://www.cdc.gov is available for copies of this
Announcement, application forms, and funding information.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Victoria Sepe, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Announcement 99020 Centers for
Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry
Road, NE, Mailstop E-13, Atlanta, GA, 30305-2209, telephone (404) 842-
6804. E-mail address: vxw1@cdc.gov.
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. E-mail address: saa1@cdc.gov.
[[Page 69079]]
Dated: December 9, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 98-33162 Filed 12-14-98; 8:45 am]
BILLING CODE 4163-18-P
