[Federal Register Volume 60, Number 16 (Wednesday, January 25, 1995)]
[Notices]
[Pages 4916-4918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1807]
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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 521]
Occupational Radiation and Energy-Related Health Research Grants;
Notice of Availability of Funds for Fiscal Year 1995
Introduction
The Centers for Disease Control and Prevention (CDC), National
Institute for Occupational Safety and Health (NIOSH), announces that
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.
The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of ``Healthy People
2000,'' a PHS-led 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, 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.
Smoke-Free Workplace
The Public Health Service strongly encourages all grant recipients
to provide a smoke-free workplace and promote the non-use of all
tobacco products. This is consistent with the PHS mission of promoting
the protection and advancement of an individual's physical and mental
health.
Availability of Funds
Approximately $500,000 is available in FY 1995 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 $25,000 to $200,000 in total costs (direct and indirect) per year.
Awards are expected to begin on or about September 1, 1995. 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.
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. [[Page 4917]]
(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.
Inclusion of Minorities and Women in Study Populations
Applicants are required to give added attention (where feasible and
appropriate) to the inclusion of minorities and/or women study
populations for research into the etiology of diseases, research in
behavioral and social sciences, clinical studies of treatment and
treatment outcomes, research on the dynamics of health care and its
impact on disease, and appropriate interventions for disease prevention
and health promotion. Exceptions would be studies of diseases which
exclusively affect males or where involvement of pregnant women may
expose the fetus to undue risks. If minorities and/or women are not
included in a given study, a clear rationale for their exclusion must
be provided.
Evaluation Criteria
Upon receipt, applications will be reviewed for completeness and
responsiveness by NIOSH. Incomplete applications will be returned to
the applicant without further consideration. If NIOSH staff finds that
the application is not responsive to this announcement, it will be
returned without further consideration. If the proposed project
involves organizations or persons other than those affiliated with the
applicant organization, letters of suport and/or cooperation must be
included.
Applications that are complete and responsive to this announcement
will be evaluated for scientific and technical merit by an appropriate
peer review group convened by the CDC in accordance with the review
criteria stated below. As part of the initial merit review, a process
(triage) may be used by the initial review group in which applications
will be determined to be competitive or non-competitive based on 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.
Review criteria for this announcement is the same as those for
unsolicited research grant applications:
--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 exclusively in the area of the proposed
research;
--Availability of resources necessary to perform the research;
--Adequacy of plans to include both genders 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 review group will critically examine the submitted budget and
will recommend an appropriate budget and period of support for each
scored application.
In the secondary (programmatic importance) review, the following
factors will be considered:
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; and
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. The following will be considered in making funding
decisions:
1. Quality of the proposed project as determined by peer review;
2. Availability of funds; and
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
[[Page 4918]] guidelines and form provided in the application kit.
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 March 15, 1995. 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 April 19, 1995 to: Henry S. Cassell, III, Grants Management
Officer, 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
All application procedures and guidelines are contained within the
present announcement. Business management information may be obained
from Lisa G. Tamaroff, Grants Management Specialist, Procurement and
Grants Office, Centers for Disease Control and Prevention (CDC), 255
East Paces Ferry Road, NE., MS-E13, Atlanta, GA 30305, telephone (404)
842-6796. 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.
When requesting information, please refer to announcement number
521.
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) 783-3238.
Dated: January 18, 1995.
Linda Rosenstock,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention (CDC).
[FR Doc. 95-1807 Filed 1-24-95; 8:45 am]
BILLING CODE 4163-19-P
