[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: [email protected].
    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: [email protected].


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    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