[Federal Register Volume 62, Number 87 (Tuesday, May 6, 1997)]
[Notices]
[Pages 24657-24661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11688]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 740]
Occupational Radiation and Energy-Related Health Research Grants;
Notice of Availability of Funds for Fiscal Year 1997
Introduction
The Centers for Disease Control and Prevention (CDC), National
Institute for Occupational Safety and Health (NIOSH), announces that
grant 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)) and the Occupational Safety
and Health Act of 1970, sections 20(a) and 22 (29 U.S.C. 669(a) and
671). The applicable program regulation is 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: 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, 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
[[Page 24658]]
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 $250,000 is available in fiscal year (FY) 1997 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 $50,000 to $100,000 in total costs (direct and indirect) per year.
Awards are expected to begin on or about September 1, 1997. 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. 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 1997 HHS Appropriations Act, which became
effective October 1, 1996, expressly prohibits the use of 1997
appropriated funds for indirect or ``grass roots'' lobbying efforts
that are designed to support or defeat legislation pending before State
legislatures. This new law, section 503 of Public Law 104-208, provides
as follows:
Sec. 503(a) 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, * * *
except in presentation to the Congress or any State legislative body
itself.
(b) 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.
Department of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus
Consolidated Appropriations Act, 1997, Division A, Title I, section
101(e), Public Law 104-208 (September 30, 1996).
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
program 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) 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
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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 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.
Reporting Requirements
Progress reports are required annually as part of the continuation
application (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.
In addition, under 45 CFR 74.36(c), ``The Federal Government has
the right to: (1) Obtain, reproduce, publish, or otherwise use the data
first produced under an award; and (2) authorize others to receive,
reproduce, publish, or otherwise use such data for Federal purposes.''
This regulation is consistent with an HHS, DOE, MOU requirement that
any data collected on workers at DOE facilities must be sent to DOE
with personal identifiers removed. These data are then included in the
CEDR database for future reference by other researchers. On or before
the expiration date of the grant, the applicant shall submit study
data, with appropriate documentation, to the 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, telephone
301-903-4674) or Mark Durst (Lawrence Berkeley Labs, telephone 510-486-
4136).
Evaluation Criteria
Upon receipt, applications will be reviewed by NIOSH 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 appropriate
peer reviewers in accordance with the review criteria stated below. As
part of the initial merit review, a process (triage) may be used by the
peer reviewers in which applications will be determined to be
competitive or non-competitive using the evaluation criteria below to
determine 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.
The review criteria are:
--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 peer reviewers will critically examine the submitted budget and
will recommend an appropriate budget and period of support for each
scored application.
[[Page 24660]]
Secondary review criteria for programmatic importance are as
follows:
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.
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 that were submitted in response to this program
announcement. The following will be considered in making funding
decisions:
1. Quality of the proposed project as determined by peer review.
2. Availability of funds.
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. 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 NIOSH
after the award of the grant.
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, 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.
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.
Travel
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.
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 May 30, 1997. 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 15, 1997 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 321, 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 a complete program description, information on
application procedures, and application forms, call (404) 332-4561. You
will be asked your name, address, and telephone number and will need to
refer to Announcement 740. 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. 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-E13,
[[Page 24661]]
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., 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, fax:
(404) 639-4616; internet: rmf2@cdc.gov.
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: April 29, 1997.
Diane D. Porter,
Acting Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention (CDC).
[FR Doc. 97-11688 Filed 5-5-97; 8:45 am]
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