INTRODUCTION

The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), announces that grant applications are being accepted for research projects relating to occupational safety and health concerns associated with occupational exposures to radiation and other hazardous agents at nuclear facilities and in other energy-related industries. Studies in the nuclear power industry and deliberate exposure of human subjects in radiation experiments are outside the scope of this announcement.

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 area of Occupational Safety and Health. (For ordering a copy of "Healthy People 2000," see the section "WHERE TO OBTAIN ADDITIONAL INFORMATION.")

AUTHORITY

This program is authorized under the Public Health Service Act, as amended, Section 301(a) (42 U.S.C. 241(a)) and the Occupational Safety and Health Act of 1970, Sections 20(a) and 22 (29 U.S.C. 669(a)and 671). The applicable program regulation is 42 CFR Part 52.

ELIGIBLE APPLICANTS

Eligible applicants include domestic and foreign non-profit and for-profit organizations, universities, colleges, research institutions, and other public and private organizations, including State and local governments and small, minority and/or woman-owned businesses.

NOTE: An organization described in section 501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying activities shall not be eligible to receive Federal funds constituting an award, grant, contract, loan, or any other form.

SMOKE-FREE WORKPLACE

CDC strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products, and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, and early childhood development services are provided to children.

AVAILABILITY OF FUNDS

Approximately $250,000 is available in fiscal year (FY) 1997 to fund approximately 3 to 5 research project grants (R01). The amount of funding available may vary and is subject to change. Awards will range from $50,000 to $100,000 in total costs (direct and indirect) per year. Awards are expected to begin on or about September 1, 1997. Awards will be made for a 12-month budget period within a project period not to exceed 3 years. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds.

USE OF FUNDS

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352 (which has been in effect since December 23, 1989), recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying Congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition, the FY 1997 HHS Appropriations Act, which became effective October 1, 1996, expressly prohibits the use of 1997 appropriated funds for indirect or "grass roots" lobbying efforts that are designed to support or defeat legislation pending before State legislatures. This new law, Section 503 of Pub. L. No. 104-208, provides as follows:

Sec. 503(a) No part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress, . . . except in presentation to the Congress or any State legislative body itself.

(b) No part of any appropriation contained in this Act shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1997, as enacted by the Omnibus Consolidated Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L. No. 104-208 (September 30, 1996).

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; other workers potentially exposed to radiation; and workers exposed to potential hazards resulting from non-nuclear energy production and use.

The Comprehensive Epidemiologic Data Resource (CEDR) was established by DOE to serve as a repository for data from epidemiologic studies they had sponsored prior to transferring this responsibility to CDC. These data are available to investigators who wish to conduct additional analyses on these completed studies in response to this program announcement. The CEDR is maintained by DOE and to access the data, an investigator must make an application to the DOE's Office of Environment, Safety and Health.

PURPOSE

NIOSH will support applied field research projects to identify and investigate the relationships between health outcomes and occupational exposure to radiation and other hazardous agents; epidemiologic methods research relevant to energy-related occupational health research; and research related to assessing occupational exposures.

PROGRAMMATIC INTEREST

The focus of grants should reflect the following topical areas, emphasizing field research: (1) occupational exposure assessment, (2) radiation measurement issues, (3) non-cancer morbidity and mortality outcomes, (4) meta-analysis and combined analysis methodologies, (5) uncertainty analysis, (6) effects of measurement error on risk estimates, and (7) studies of current workers.

(1) Retrospective Exposure Assessment

Epidemiologic studies of occupational cohorts frequently involve, and can generally benefit from, retrospective exposure assessment to provide estimates of exposure or categorize groups of workers by common exposure. Exposure assessment in energy-related occupational epidemiology requires evaluating exposures to various hazards including ionizing and non-ionizing radiation, metals, acids, and solvents. Grant opportunities encompass the fields of industrial hygiene and retrospective exposure assessment of health physics dosimetry. Research areas of general interest include: methods to use limited data to best advantage; how to treat censored data in retrospective exposure assessment; uncertainty analysis techniques for industrial hygiene exposure data and health physics dosimetry; insight to sampling strategy design yielding a representative understanding of exposed groups; decision logic to select/use the most appropriate exposure metric for epidemiologic and risk assessment use; and, development approaches of "Homogeneous Exposed Groupings" and the advantages/limitations for epidemiologic use. Research opportunities of specific interest include: reconstruction and dose adjustment of historic film badges; exposure assessment for acid mists, carcinogenic solvents, exotic metals, and leukemogens; assessment of electromagnetic field exposure; and evaluation of biomarkers of exposure.

(2) Radiation Measurement Issues

This topic will focus on the applicability and utility of radiation dose data in epidemiological research. Examples of such issues include how to use nondetectable values and missing dose data in historical radiation exposure measurements, the accuracy of historical external dosimetry techniques (film and pocket dosimeters), combining external and internal doses into a useful index, historical bioassay, and radiochemistry techniques.

(3) Non-cancer Morbidity and Mortality Outcomes

The majority of analytical epidemiologic research of health effects of energy-related occupational and environmental exposures has focused historically on the assessment of the association between cancer mortality and exposure to ionizing radiation. Although the importance of this research should not be underestimated, it is essential that other potential adverse health effects, as well as other possible energy-related exposures, be thoroughly evaluated as well. Among these would be the possible effects of radiation on the reproductive, neurologic, and immune systems. Chemical exposures highly prevalent in Department of Energy facilities, such as beryllium and mercury, have also been associated with a variety of disease outcomes, particularly respiratory and neurologic in nature.

(4) Meta-Analysis and Combined Analysis Methodologies

Many of the cohorts at nuclear facilities are not individually large enough to detect statistically significant increases in mortality or incidence for rare cancer types. Methods and/or analyses for combining data across studies, whether in summary form or individual data, are valuable to the NIOSH research effort involving energy-related health research.

(5) Uncertainty Analysis

Measures of occupational exposure are inherently uncertain. Even when measures of external radiation exposure are generally available, the models used to estimate organ dose, shallow versus deep dose, neutron dose, etc., are subject to error. Measures of dose derived from biological monitoring of urine, feces, blood, etc., are even less precise. Methods for assessing the degree of error in various estimates of exposure to both ionizing radiation as well as other toxic agents (chemicals, EMF, etc.) are desirable.

(6) Effects of Measurement Error on Risk Estimates

Estimation of both bias and imprecision introduced into risk analyses through exposure measurement error have recently received considerable attention. Many of the suggested approaches are very computer intensive. Practical solutions to this problem with regard to the spectrum of epidemiologic designs (cohort, case-control, cross-sectional, etc.) are needed, with particular attention to the nature of exposure measurement in radiation epidemiology.

(7) Studies of Current Workers

Much of the epidemiologic research on nuclear workers conducted at nuclear facilities and other sites has emphasized retrospective studies. More recently new activities involve environmental restoration, waste management and other work that is not related to the design and production of nuclear weapons. Workers are being exposed to radiation and other hazardous agents under conditions and in processes not previously encountered. Exposure assessment, epidemiologic and related studies are needed to evaluate these new conditions and processes and the impact on worker health.

REPORTING REQUIREMENTS

Progress reports are required annually as part of the continuation application (75 days prior to the start of the next budget period). The annual progress reports must contain information on accomplishments during the previous budget period and plans for each remaining year of the project. Financial status reports (FSR) are required no later than 90 days after the end of the budget period. The final performance and financial status reports are required 90 days after the end of the project period. The final performance report should include, at a minimum, a statement of original objectives, a summary of research methodology, a summary of positive and negative findings, and a list of publications resulting from the project. Research papers, project reports, or theses are acceptable items to include in the final report. The final report should stand alone rather than citing the original application. Three copies of reprints of publications prepared under the grant should accompany the report.

In addition, under 45 CFR 74.36(c), "The Federal Government has the right to: (1) obtain, reproduce, publish, or otherwise use the data first produced under an award; and (2) authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes." This regulation is consistent with an HHS, DOE, MOU requirement that any data collected on workers at DOE facilities must be sent to DOE with personal identifiers removed. These data are then included in the CEDR database for future reference by other researchers. On or before the expiration date of the grant, the applicant shall submit study data, with appropriate documentation, to the CEDR, maintained by the Department of Energy at the Lawrence Berkeley Laboratory. This shall include analysis files and separate analytic files for all relevant study data, including demographic variables, radiation dosimetry, industrial hygiene, work history, and/or medical records data. A written report describing each data set and a code book for each data set shall also be submitted. Information about preparation of CEDR files can be obtained from Barbara Brooks (DOE Headquarters, telephone 301-903-4674) or Mark Durst (Lawrence Berkeley Labs, telephone 510-486-4136).

EVALUATION CRITERIA

Upon receipt, applications will be reviewed by NIOSH for completeness and responsiveness. Applications determined to be incomplete or unresponsive to this announcement will be returned to the applicant without further consideration. If the proposed project involves organizations or persons other than those affiliated with the applicant organization, letters of support and/or cooperation must be included.

Applications that are complete and responsive to the announcement will be evaluated for scientific and technical merit by appropriate peer reviewers in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the peer reviewers in which applications will be determined to be competitive or non-competitive using the evaluation criteria below to determine their scientific merit relative to other applications received in response to this announcement. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified.

The review criteria are:

- Scientific, technical, or medical significance and originality of proposed research;

- Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research;

- Qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research;

- Availability of resources necessary to perform the research;

- Adequacy of plans to include both sexes and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated.

The peer reviewers will critically examine the submitted budget and will recommend an appropriate budget and period of support for each scored application.

Secondary review criteria for programmatic importance are as follows:

1. Results of the initial review.

2. Magnitude of the problem in terms of numbers of workers affected.

3. Severity of the disease or injury in the worker population.

4. Usefulness to applied technical knowledge in the identification, evaluation, and/or control of occupational safety and health hazards.

Applicants will compete for available funds with all other approved applications that were submitted in response to this program announcement. The following will be considered in making funding decisions:

1. Quality of the proposed project as determined by peer review.

2. Availability of funds.

3. Program balance among research areas of the announcement.

EXECUTIVE ORDER 12372 REVIEW

Applications are not subject to the review requirements of Executive Order 12372, entitled Intergovernmental Review of Federal Programs.

PUBLIC HEALTH SYSTEM REPORTING REQUIREMENT

This program is not subject to the Public Health System Reporting Requirements.

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER

The Catalog of Federal Domestic Assistance number is 93.262.

OTHER REQUIREMENTS

Human Subjects

If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services Regulations (45 CFR Part 46) regarding the protection of human subjects. Assurance must be provided to demonstrate that the project will be subject to initial and continuing review by an appropriate institutional review committee. The applicant will be responsible for providing assurance in accordance with the appropriate guidelines and form provided in the application kit. In addition, the applicant will be responsible for complying with a NIOSH-DOE agreement that assures the research protocol is reviewed by the institutional review committee(s) (if such a committee exists) at each DOE site where the research will be conducted. This process will be coordinated by NIOSH after the award of the grant.

Women and Racial and Ethnic Minorities

It is the policy of the CDC to ensure that women and racial and ethnic groups will be included in CDC supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian, Alaskan Native, Asian, Pacific Islander, Black and Hispanic. Applicants shall ensure that women and racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is not feasible, this situation must be explained as part of the application. In conducting the review of applications for scientific merit, review groups will evaluate proposed plans for inclusion of minorities and both sexes as part of the scientific assessment and assigned score. This policy does not apply to research studies when the investigator cannot control the race, ethnicity and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, Friday, September 15, 1995, pages 47947-47951.

Confidentiality Agreement

To comply with the routine uses allowing access to Department of Energy (DOE) Privacy Act systems of records, grantees who will be accessing DOE records to conduct epidemiologic studies and/or other public health activities on behalf of NIOSH will be asked to sign a written statement that documents data security procedures to be maintained by the grantee and an agreement to comply with the privacy and confidentiality requirements of the Privacy Act routine uses and the Memorandum of Understanding between the Department of Energy and the Department of Health and Human Services.

Travel

The applicant shall include in its proposal the costs of travel to NIOSH in Cincinnati, Ohio, for the annual meeting of energy-related research extramural partners.

APPLICATION SUBMISSION AND DEADLINES

A. Preapplication Letter of Intent

Although not a prerequisite of application, a non-binding letter of intent-to-apply is requested from potential applicants. The letter should be submitted to the Grants Management Officer (whose address is reflected in section B., "Applications"). It should be postmarked no later than

May 30, 1997. The letter should identify the announcement number, name of principal investigator, and specify the priority area to be addressed by the proposed project. The letter of intent does not influence review or funding decisions, but it will enable CDC to plan the review more efficiently, and will ensure that each applicant receives timely and relevant information prior to application submission.

B. Applications

Applicants should use Form PHS-398 (OMB Number 0925-0001) 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 July 15, 1997 to: Ron Van Duyne, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, (CDC), 255 East Paces Ferry Road, NE., Room 321, MS-E13, Atlanta, GA 30305.

C. Deadlines

1. Applications shall be considered as meeting a deadline if they are either:

A. Received at the above address on or before the deadline date, or

B. Sent on or before the deadline date to the above address, and received in time for the review process. 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 accepted as proof of timely mailings.

2. Applications which do not meet the criteria above are considered late applications and will be returned to the applicant.

WHERE TO OBTAIN ADDITIONAL INFORMATION

To receive a complete program description, information on application procedures, and application forms, call (404) 332-4561. You will be asked your name, address, and telephone number and will need to refer to Announcement 740. In addition, this announcement is also available through the CDC Home Page on the Internet. The address for the CDC Home Page is http://www.cdc.gov. If you have questions after reviewing the contents of all the documents, business management information may be obtained from Joanne Wojcik, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., MS-E13, Atlanta, GA 30305, telephone (404) 842-6535, fax: (404) 842-6513; internet: jcw6@cdc.gov. Programmatic technical assistance may be obtained from Roy M. Fleming, Sc.D., Associate Director for Grants, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Building 1, Room 3053, MS-D30, Atlanta, GA 30333, telephone (404) 639-3343, fax: (404) 639-4616; internet: rmf2@cdc.gov.