[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]


-----------------------------------------------------------------------

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.

[[Page 33678]]

    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

[[Page 33680]]

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