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Occupational Radiation and Energy-Related Health Research Grants; Notice of Availability of Funds for Fiscal Year 1998
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: March 12, 1998 (Volume 63, Number 48)]
[Notices]
[Page 12098-12102]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr98-70]
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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
[[Page 12101]]
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:
jcw6@cdc.gov.
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: rmf2@cdc.gov.
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