[Federal Register Volume 61, Number 92 (Friday, May 10, 1996)]
[Notices]
[Pages 21470-21473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11670]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 617]
National Institute for Occupational Safety and Health;
Occupational Radiation and Energy-Related Health Research Grants;
Notice of Availability of Funds for Fiscal Year 1996
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.
CDC is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2000,'' a national activity
to reduce morbidity and mortality and improve the quality of life. This
announcement is related to the priority area of Occupational Safety and
Health. (For ordering a copy of ``Healthy People 2000,'' see the
section ``Where to Obtain Additional Information.'')
Authority
This program is authorized under the Public Health Service Act, as
amended, Section 301(a) (42 U.S.C. 241(a)); the Occupational Safety and
Health Act of 1970, Section 20 (a) (29 U.S.C. 669(a)). The applicable
program regulations include 42 CFR Parts 52 and 74.
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
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and promote the nonuse 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) 1996 to
fund approximately 3 to 5 research project grants. 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, 1996. 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 hypothesis-testing research projects to identify
and
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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 emphasize field research in the
following topical areas: (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, and (6) 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 investigations of: 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, sampling
strategy design to yield a representative understanding of exposed
groups, decision logic to select and use the most appropriate exposure
metric for epidemiologic and risk assessment use, and, development
approaches of ``Homogeneous Exposed Groupings'' and the advantages and
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 both
internal and external radiation dose data in epidemiologic research.
Examples of such issues include how to use nondetectable values,
missing dose data in historical radiation exposure measurements, and
the accuracy of historical external dosimetry techniques (film and
pocket dosimeters). Additional issues of interest include the use,
utility and limitations of internal dosimetry data (historical bioassay
and radiochemistry techniques) in epidemiologic studies.
(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
are the possible effects of radiation on the reproductive, neurologic,
and immune systems. Chemical exposures highly prevalent in Department
of Energy facilities, such as exposures to 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 analyses for combining
data across studies, whether in summary form or as 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) 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. Hypothesis-testing research in the areas of
exposure assessment, epidemiologic and related studies are needed to
evaluate these new conditions and processes and the impact on worker
health.
Women and Minority Inclusion Policy
It is the policy of the CDC to ensure that women and racial and
ethnic groups will be included in CDC supported research projects
involving human subjects, whenever feasible and appropriate. Racial and
ethnic groups are those defined in OMB Directive No. 15 and include
American Indian, Alaskan Native, Asian, Pacific Islander, Black and
Hispanic. Applicants shall ensure that women and racial and ethnic
minority populations are appropriately represented in applications for
research involving human subjects. Where clear and compelling rationale
exist that inclusion is not feasible, this situation must be explained
as part of the application. In conducting the review of applications
for scientific merit, review groups will evaluate proposed plans for
inclusion of minorities and both sexes as part of the scientific
assessment and assigned score. This policy does not apply to research
studies when the investigator cannot control the race, ethnicity and/or
sex of subjects. Further guidance to this policy is contained in the
Federal Register, Vol. 60, No. 179, Friday, September 15, 1995, pages
47947-47951.
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 evaluated for scientific and technical merit by an appropriate
peer review group convened by CDC in accordance with the review
criteria stated below. As part of the initial merit review, a process
may be used by the initial review group
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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 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 are as follows:
--Scientific, technical, or medical significance and originality of
proposed research;
--Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
--Qualifications and research experience of the Principal Investigator
and staff, particularly but not exclusively in the area of the proposed
research;
--Availability of resources necessary to perform the research;
--Adequacy of plans to include both sexes and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
The 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 guidelines and
form provided in the application kit.
Confidentiality Agreement
To comply with the routine uses allowing access to Department of
Energy (DOE) Privacy Act systems of records, grantees who will be
accessing DOE records to conduct epidemiologic studies and/or other
public health activities on behalf of NIOSH will be asked to sign a
written statement that documents data security procedures to be
maintained by the grantee and an agreement to comply with the privacy
and confidentiality requirements of the Privacy Act routine uses and
the Memorandum of Understanding between the Department of Energy and
the Department of Health and Human Services.
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 June 10, 1996. The letter should identify the announcement
number, name of principal investigator, and specify the priority area
to be addressed by the proposed project. The letter of intent does not
influence review or funding decisions, but it will enable CDC to plan
the review more efficiently, and will ensure that each applicant
receives timely and relevant information prior to application
submission.
B. Applications
Applicants should use Form PHS-398 (OMB Number 0925-0001) and
adhere to the ERRATA Instruction Sheet for Form PHS-398 contained in
the Grant Application Kit. Please submit an original and five copies on
or before July 10, 1996 to: Ron Van Duyne, Grants Management Officer,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention, (CDC), 255 East Paces Ferry Road, NE.,
Room 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 (404) 332-4561. You
will be asked your name, address, and phone number and will need to
refer to Announcement 617. 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. You will receive a complete
program description, information on application procedures, and
application forms. If you have questions after reviewing the contents
of all the documents, business management technical assistance may be
obtained from Georgia Jang, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., MS-E13,
Atlanta, GA 30305, telephone (404) 842-6796; fax: 404-842-6513;
internet: glj2@opspgo1.em.cdc.gov. Programmatic technical assistance
may be obtained from Roy M. Fleming, Sc.D., Associate Director for
Grants, National Institute for Occupational Safety and Health, Centers
for Disease Control and Prevention (CDC), 1600 Clifton Road,
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NE., Building 1, Room 3053, MS-D30, Atlanta, GA 30333, telephone: 404-
639-3343; fax: 404-639-4616; internet: rmf2@niood1.em.cdc.gov.
Please Refer to Announcement Number 617 When Requesting Information and
Submitting an Application
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: May 2, 1996.
Donald L. Holderman,
Acting Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention (CDC).
[FR Doc. 96-11670 Filed 5-9-96; 8:45 am]
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