Grants and cooperative agreements; availability, etc.: Radiation studies and research program,

[Federal Register: December 15, 1998 (Volume 63, Number 240)]

[Notices]

[Page 69076-69079]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr15de98-76]

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]

1. 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.

2. 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.

3. 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

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   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.

4. 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:

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 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.

5. 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.

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   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.

6. 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.

7. 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?

8. 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

   1. 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.

10. 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.

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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. 98-33162Filed12-14-98; 8:45 am]

    BILLING CODE 4163-18-P