Occupational Radiation and Energy-Related Health Research Grants; Notice of Availability of Funds for Fiscal Year 1998

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

[Announcement Number 98030]

Occupational Radiation and Energy-Related Health Research Grants;

Notice of Availability of Funds for Fiscal Year 1998

Introduction

The Centers for Disease Control and Prevention (CDC), National

Institute for Occupational Safety and Health (NIOSH), announces the

availability of fiscal year (FY) 1998 funds for the acceptance of grant

applications 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.)

[[Page 12099]]

Authority

This program is authorized under the Public Health Service Act, as

amended, Section 301(a) [42 U.S.C. 241(a)]; the Occupational Safety and

Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)]. The applicable

program regulations are in 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: Effective January 1, 1996, Public Law 104-65 states that

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

(cooperative agreement), 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 $500,000 is available in fiscal year (FY) 1998 to

fund approximately 3 to 5 research project grants (R01). The amount of

funding available is subject to change. Awards will range from $50,000

to $200,000 in total costs (direct and indirect) per year. Awards are

expected to begin on or about July 1, 1998. 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 1998 Department of Labor, Health and Human

Services, and Education, and Related Agencies Appropriations Act

(Public Law 105-78) states in Section 503 (a) and (b) that 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 or any State legislature, except in presentation to

the Congress or any State legislature itself. 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.

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

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) Retrospective 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, (7) studies of current workers, and (8) risk communication

and worker outreach.

(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.

[[Page 12100]]

(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 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.

(8) Risk Communication and Worker Outreach

Upon completion of a study, the findings must be presented to the

workers at the site where the study was conducted and to people living

in the nearby community. The communication of study results must be

done in a manner that can be readily understood by all persons who want

to know the impact of a given study, and without the use of highly

technical terms and scientific jargon. To communicate effectively with

workers, educational outreach may be needed to help workers understand

the scientific principles and terminology used in the research. Various

types of communications may be required to reach out to all workers and

the effectiveness of these communication modes must be measured.

Methodologies for such evaluations may presently exist or may have to

be developed for this purpose. Evaluation studies of communication of

study findings and health risk communication attempts which indicate

ways to influence worker behavior, demonstrates impact of the research

conducted, or provides insight into better ways to communicate to

diverse audiences is needed. Attention should focus on a process to

work with researchers to ensure that the workers and the public can

understand the key research findings and that the effectiveness of the

communication can be measured objectively.

Reporting Requirements

Progress reports are required annually as part of the continuation

application which is due 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.

On or before the expiration date of the grant, the applicant shall

submit study data, with appropriate documentation, to the Comprehensive

Epidemiologic Data Resource (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, 301-903-4674) or Mark

Durst (Lawrence Berkeley Labs, 510-486-4136).

For studies that involve workers as subjects, the applicant shall

also be responsible for presenting the study findings to workers and to

DOE and DOE contractor staff at all sites where the study was

conducted. In addition, a similar presentation will be done in a public

meeting to inform workers and people living near the site(s). NIOSH

will be responsible for arranging the times and a facility for these

presentations. The presentation can be done in person or by a

videotape. In the latter case, the applicant will be

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available by telephone to respond to questions from those in

attendance.

Evaluation Criteria

Upon receipt, applications will be reviewed by CDC 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 reviewed by an initial review group and will be determined to

be competitive or non-competitive, based on the review criteria

identified below and relative to other applications received.

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. Applications judged to be competitive will be

reviewed for scientific merit and assigned a priority score. Following

initial review for scientific merit, the applications will receive a

secondary review for programmatic importance.

Review criteria for scientific merit are as follows:

1. Technical significance and originality of proposed project.

2. Appropriateness and adequacy of the study design and methodology

proposed to carry out the project.

3. Qualifications and research experience of the Principal

Investigator and staff, particularly but not exclusively in the area of

the proposed project.

4. Availability of resources necessary to perform the project.

5. Documentation of cooperation from collaborators in the project,

where applicable.

6. Adequacy of plans to include both sexes and minorities and their

subgroups as appropriate for the scientific goals of the project.

(Plans for the recruitment and retention of subjects will also be

evaluated.)

7. Appropriateness of budget and period of support.

8. Human Subjects--Procedures adequate for the protection of human

subjects must be documented. Recommendations on the adequacy of

protections include: (1) protections appear adequate and there are no

comments to make or concerns to raise, (2) protections appear adequate,

but there are comments regarding the protocol, (3) protections appear

inadequate and the Initial Review Group has concerns related to human

subjects, or (4) disapproval of the application is recommended because

the research risks are sufficiently serious and protection against the

risks are inadequate as to make the entire application unacceptable.

Review criteria for programmatic importance are as follows:

1. Magnitude of the problem in terms of numbers of workers

affected.

2. Severity of the injury or disease in the population.

3. Usefulness to applied technical knowledge in the identification,

evaluation, or control of occupational safety and health hazards on a

national or regional basis.

The following will be considered in making funding decisions:

1. Scientific merit of the proposed project as determined by the

initial peer review.

2. Programmatic importance of the project as determined by

secondary review.

3. Availability of funds.

4. Program balance among priority areas of this announcement.

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

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 the

NIOSH Human Subjects Review Board after the award of the grant.

Travel

In the application, the applicant should allow for appropriate

travel to DOE sites, as established under guidelines developed by NIOSH

and DOE. This includes travel for data collection, and worker/community

notification of study results, at each site included in the study

protocol. 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.

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 or Alaska Native, Asian, Black or African American,

Native Hawaiian or Other Pacific Islander, and Hispanic or Latino.

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 a 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.

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 April 24, 1998. The letter should identify the

[[Page 12102]]

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 June 11, 1998 to: Ron Van Duyne, Grants Management Officer,

ATTN: Joanne Wojcik, Procurement and Grants Office, Centers for Disease

Control and Prevention, (CDC), 255 East Paces Ferry Road, NE., Room

300, 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 additional written information call 1-888-GRANTS4. You

will be asked for your name and address and will need to refer to

Announcement 98030. You will receive a complete program description,

information on application procedures, and application forms. 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).

The following documents may provide useful information: NIOSH

Occupational Energy Research Program agenda booklet and/or The DOE

Access Handbook: Conducting Health Studies at Department of Energy

Sites may be obtained from the business management contact listed

below.

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 E-13, Atlanta, GA

30305, telephone 404-842-6535; fax: 404-842-6513; Internet:

[email protected].

Programmatic technical assistance may be obtained from Roy M.

Fleming, Sc.D., Director Research Grants Program, 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: [email protected].

PLEASE REFER TO ANNOUNCEMENT NUMBER 98030 WHEN REQUESTING

INFORMATION AND SUBMITTING AN APPLICATION.

This and other CDC Announcements can be found on the CDC homepage

(http://www.cdc.gov) under the ``Funding'' section, as well as on the

NIOSH homepage (http://www.cdc.gov/niosh/homepage.html) under ``Funding

Opportunities/Extramural Programs.'' For your convenience, you may be

able to retrieve a copy of the PHS Form 398 from (http://www.nih.gov/

grants/funding/phs398/phs398.html).

CDC will not send application kits by facsimile or express mail.

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, DC 20402-9325,

telephone (202) 512-1800.

Dated: March 6, 1998.

Diane D. Porter,

Acting Director, National Institute for Occupational Safety and Health

Centers for Disease Control and Prevention (CDC).

[FR Doc. 98-6360 Filed 3-11-98; 8:45 am]

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