[Federal Register Volume 63, Number 48 (Thursday, March 12, 1998)]
[Notices]
[Pages 12098-12102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6360]


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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]
BILLING CODE 4163-19-P