[Federal Register Volume 62, Number 57 (Tuesday, March 25, 1997)]
[Notices]
[Pages 14122-14125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7470]
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DEPARTMENT OF ENERGY
Office of Environment, Safety and Health
Notice of Availability of Funds and Request for Applications To
Support Medical Surveillance for Former Department of Energy Workers
AGENCY: Office of Environment, Safety and Health, DOE.
ACTION: Notice of availability of funds and request for applications.
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SUMMARY: The Department of Energy (DOE) Office of Environment, Safety
and Health (EH) announces the availability of additional funds to
evaluate former workers whose employment at departmental facilities may
have placed their long-term health at significant risk. This Notice of
Availability of Funds and Request for Applications to Support Medical
Surveillance for Former DOE Workers does not affect cooperative
agreements awarded pursuant to a similar Federal Register announcement
published on March 1, 1996. This new Notice is issued subsequent to the
more general Continuation of Solicitation for Epidemiology and Other
Health Studies Financial Assistance Program published in the Federal
Register (61 FR 53903) on October 16, 1996.
DATES: Applications submitted in response to this announcement must be
received by June 3, 1997.
ADDRESSES: U.S. Department of Energy, 19901 Germantown Road,
Germantown, Maryland 20874-1290.
FOR FURTHER INFORMATION CONTACT: Requests for further information and
application forms may be directed to Dr. John Peeters, Office of
Occupational Medicine and Medical Surveillance (EH-61), Telephone:
(301) 903-5902; facsimile: (301) 903-5072. Applications may be
submitted to Dr. Peeters at the address listed above.
[[Page 14123]]
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Purpose
II. Project Description
III. DOE's Policy on Protection of Human Subjects Reviews
IV. Applications
V. Proposal Format
VI. Application Evaluation and Selection
VII. DOE's Role
VIII. Applicants
I. Purpose
Section 3162 of the National Defense Authorization Act for Fiscal
Year 1993 (Pub. L. 102-484) directs the Secretary of Energy, in
consultation with the Secretary of Health and Human Services, to
develop a program of medical evaluation for current and former DOE
workers at significant risk for health problems due to exposures to
hazardous or radioactive substances during employment.
On March 1, 1996, the first ``Notice of Availability of Funds and
Request for Applications to Support Medical Surveillance for Former DOE
Workers'' was published in the Federal Register (61 FR 8047). In
September 1996, six cooperative agreements were awarded to begin phase
I projects at the following DOE sites: Hanford Site, Nevada Test Site,
Rocky Flats Environmental Technology Site, Portsmouth Gaseous Diffusion
Plant, Paducah Gaseous Diffusion Plant, and the Oak Ridge Reservation.
At five of the sites, the project teams are focusing on a selected
group or groups of former workers (e.g., production workers or
construction workers). At the Rocky Flats Site, the project team is
initially assessing all former workers.
This second Notice announces the availability of funds for up to
three new projects to be funded through cooperative agreements. In
particular, DOE is interested in applications that will help determine
the potential need for medical surveillance for former workers at major
DOE sites not included in the six phase I projects listed above. The
new projects will identify, and, where appropriate, notify and
medically screen groups of former workers who are potentially at
significant risk for health problems due to work-related exposures.
Experience with all of these projects will help DOE to evaluate
options for a possibly more comprehensive medical surveillance program
for former workers and to determine how such a program may be
integrated effectively with other ongoing site activities.
II. Project Description
DOE intends to award up to three cooperative agreements with
specific goals identical to the goals of the six ongoing projects. The
goals of the projects are to:
Identify groups of workers at significant risk for
occupational diseases.
Notify members of these risk groups.
Offer these workers medical screening that can lead to
medical interventions.
Each cooperative agreement will begin with an award for the first
year for a phase I needs assessment. Under the same cooperative
agreement, the project potentially could continue into phase II medical
screening, if determined by DOE to be warranted.
Pursuant to this Notice, there will be up to three cooperative
agreements awarded, totalling about $1.5 million. The initial funding
for each new cooperative agreement will be for a phase I needs
assessment only. Phase I is expected to take approximately 12 months.
Phase II, if warranted, will be funded through continuation awards
under the same cooperative agreement. Phase II could continue up to 4
years, renewable annually. The award continuation for phase II, if
made, will be based on the results from phase I, the availability of
funds, and negotiation of the costs for phase II. Only those who
participate in phase I will be eligible to participate in phase II.
Phase I
During phase I, the awardees will conduct a comprehensive needs
assessment. The needs assessment will include a review of existing
site-specific information and other means to initially identify the
most significant radiation and nonradiation exposures. During phase I,
investigators will conduct the following tasks:
1. Identify existing information relevant to exposure and health
outcomes among former workers;
2. Utilize this information to identify or develop viable methods
for contacting these former workers;
3. Provide an initial determination of the most significant worker
hazards, problems and concerns for each site;
4. Identify approaches for conducting the project in partnership
with unions, site management, operating contractors, community
representatives, and State and local health officials; and
5. Attend semiannual DOE-coordinated meetings of investigators to
share information on ongoing needs assessments.
During phase I, investigators will develop a detailed plan and
proposed budget for phase II focusing on the groups of workers
determined to be at significant risk for adverse health effects during
the needs assessment. The plan for phase II, and a draft of the needs
assessment, is expected at least 60 days prior to the conclusion of
phase I. Phase I will conclude with delivery of the final needs
assessment to DOE.
Phase II
DOE will determine the need for phase II activities based upon the
phase I results and, if appropriate, will support these efforts through
continuation awards. Where phase II plans are approved by DOE, the
investigators will conduct the following tasks:
1. Identify and locate those former workers who based on the
results of the phase I needs assessment are at significant risk of
adverse health effects;
2. Ascertain the health concerns of former workers identified in
task 1 related to their past DOE employment;
3. Communicate risk information to former workers regarding the
nature of their health risk and discuss the actions that could be
taken;
4. Provide medical screening to targeted former worker populations
based on exposure history and the availability of acceptable screening
tests;
5. Assist in the coordination of referrals, diagnostic workup, and
followup treatment, including the coordination with workman's
compensation and other existing insurance and benefits programs;
6. Ensure dialogue with local parties concerned with the project;
7. Evaluate former workers satisfaction with the project; and
8. Attend semiannual DOE-coordinated meetings of investigators to
share information on ongoing screening programs.
Potential Sites
A program policy factor for DOE is the determination of potential
needs for medical surveillance for former workers at major DOE sites
not included in the cooperative agreements awarded in September 1996.
Applicants for the cooperative agreements will propose individual
(or alternative groups of) DOE sites for study and justify the
technical factors used in site(s) selection. Such technical factors
should include:
1. Presence of existing worker and community health programs;
2. Availability of information on former workers and their
exposures;
[[Page 14124]]
3. Levels and types of exposures;
4. Number of former workers and access to them;
5. Concerns of workers about specific past exposures;
6. Concerns of DOE site managers and operating contractors about
specific past exposures; and
7. Concerns of both national and local unions about past exposures.
III. DOE's Policy on Protection of Human Subjects Reviews
DOE has codified the Federal Policy for the Protection of Human
Subjects in 10 CFR part 745. As defined in this regulation, human
subjects research may include a broad range of studies. DOE has
determined that both phase I and phase II of the former worker medical
surveillance program fall under the broad definition of human subjects
research, and, accordingly, each phase requires Institutional Review
Board (IRB) review and approval. Phase I activities will involve the
review and possible collection of identifiable private information,
either through records review or personal interviews. Therefore, IRB
reviews are necessary to ensure adequate protection of privacy. Phase
II, involving medical surveillance of former workers, including the
handling of personal medical records, requires IRB review to ensure
that all necessary protections are implemented.
It is the DOE's policy that each study involving DOE workers must
be reviewed by the ``local'' DOE site institutional review board.
``Local'' IRB reviews will take place following award of the new
cooperative agreements, and annually thereafter. Applicants also may
have to comply with their own institution's requirements regarding
review of human subjects research. Documentation of all reviews must be
submitted to DOE prior to implementation of each phase.
IV. Applications
This Notice of Availability is issued pursuant to DOE regulations
contained in 10 CFR part 602: ``Epidemiology and Other Health Studies
Financial Assistance Program'', as published in the Federal Register on
January 31, 1995 (60 FR 5841). The Catalog of Federal Domestic
Assistance number for 10 CFR part 602 is 81.108, and its solicitation
control number is EOHSFAP 10 CFR part 602. 10 CFR part 602 contains the
specific requirements for applications, evaluation, and selection
criteria. Only those applications following these specific criteria and
forms will be considered. Application forms may be obtained at the
address cited above.
V. Proposal Format
The proposal shall contain two sections, technical and cost.
Technical proposals shall be no more than fifty (50) pages in length;
resumes of proposed key personnel should be submitted as an appendix to
the technical proposal and will not be counted against the page limit.
Cost proposals shall have no page limit. Because each project will be
conducted in two phases, and the scope of phase II is dependent on the
results of phase I, the technical description for phase II may be less
specific than that for phase I, but must clearly demonstrate a
capability to conduct phase II. It is left to the proposer to determine
how best to structure the proposal. However, the following information
shall be included:
a. Proposals shall include a detailed project description that
discusses the specific tasks to be performed under the proposed
project. At a minimum, the tasks listed under section II above (Project
Description) must be described (in detail for phase I tasks and more
generally for phase II tasks). The project description must include
clear statements of what is not known and what is uncertain, as well as
statements of what is known. The project description must describe how
independent, external peer review of the results of the project will be
conducted. The project description must demonstrate that the offeror
has the ability to integrate its work with the activities of other
organizations conducting medical surveillance activities.
b. Proposals must demonstrate the competency of research personnel
and the adequacy of resources. Proposals must demonstrate that the
offeror is perceived as neutral and credible, and is capable of
conducting scientifically valid and responsible medical surveillance
projects.
Proposals must demonstrate that the offeror has the experience and
capability to plan, organize, manage, and facilitate worker and union
participation in planning and execution. Proposals must also
demonstrate that the offeror has the experience and ability to
effectively communicate complicated scientific information on potential
risks and uncertainties to workers, local and national stakeholders,
concerned citizens, and decision makers at all levels. Proposals must
demonstrate that the offeror presently has or is capable of obtaining
staff with the training, expertise, and experience needed to conduct
scientifically complex needs assessments and medical surveillance
programs. Proposals must identify the technical and scientific staff
that will actually conduct the studies and detail their professional
experience, as well as their level of program involvement. Proposals
must demonstrate that the offeror has capability, for both financial
and scientific management, and a demonstrated skill in planning and
scheduling projects of comparable magnitude to those proposed under
this Notice.
c. The cost proposal for phase I must include a summary breakdown
of all costs, and provide a detailed breakdown of costs on a task-by-
task basis for each task contained in the project description. Costs
for phase II tasks may be more general estimates since the initial
award will be for phase I only. Any expectation concerning cost sharing
must be clearly stated. Cost sharing is encouraged, but it will not be
considered in the selection process.
d. The cost proposal for phase I shall include an estimate of the
costs of copying, filming, scanning, or abstracting data needed for the
project, charges associated with site computer programming, and any
additional support not routinely provided by DOE (see Section VII,
DOE's Role). This amount should be included in the proposed budget for
phase I.
VI. Application Evaluation and Selection
Applications will be subjected to formal merit review (peer review)
and will be evaluated against the following criteria listed in
descending order of importance and codified at 10 CFR 602.9(d):
1. Scientific and technical merit of the proposed research;
2. Appropriateness of the proposed method or approach;
3. Competency of research personnel and adequacy of proposed
resources; and
4. Reasonableness and appropriateness of the proposed budget.
Applications will be peer reviewed by evaluators apart from DOE
employees and contractors as described in the Office of Environment,
Safety and Health's Merit Review System (57 FR 55524, November 25,
1992) and at 10 CFR 602.9(c). Submission of an application constitutes
agreement that this is acceptable to the investigator(s) and the
submitting institution.
In accordance with 10 CFR 602.9(e), DOE shall also consider, as
part of its evaluation, program policy factors such as an appropriate
balance among sites for efforts to target former workers potentially in
need of medical surveillance. As noted above in section
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II (Project Description, Potential Sites), a program policy factor for
DOE is the determination of potential needs for medical surveillance
for former workers at major DOE sites not included in the cooperative
agreements awarded in September 1996.
VII. DOE's Role
In order for DOE to utilize cooperative agreements for these
medical surveillance projects, there must be substantial involvement
between DOE and any awardee(s). DOE established the core tasks for
these projects and prepared this Federal Register Notice of
Availability. DOE will conduct the selection and award process, which
will include evaluations by persons outside the Federal government. DOE
will evaluate the results of phase I and, where warranted, authorize
and fund phase II. DOE will facilitate awardee access to the target
sites and help familiarize investigators with the facility and
historical operations. DOE will facilitate access to exposure records,
including the identification and retrieval of records relating to DOE
activities, and declassification of records, as needed. DOE will
establish requirements for data collection and handling. DOE will
consult with project investigators and coordinate semiannual meetings.
DOE will interact with an independent advisory group that will provide
advice to DOE and to project investigators. Finally, DOE will monitor
and evaluate the results of the projects, including the participant's
level of satisfaction, to determine how these projects could be
expanded to other groups of former workers both at the project sites
and at other DOE sites. In addition to helping former workers,
information gained from these projects will contribute to DOE's ongoing
efforts to improve health and safety programs for current workers.
VIII. Applicants
Applicants for the cooperative agreements could include domestic
nonprofit and for profit organizations, universities, medical centers,
research institutions, other public and private organizations,
including State and local governments, labor unions and other employee
representative groups, and small, minority and/or women-owned
businesses. Consortiums of interested organizations are encouraged to
apply. Awardees for each project will work cooperatively with former
workers, DOE site officials, DOE operating contractors, labor
organizations, health officials, and designated community
representatives.
Issued in Washington, D.C., on March 14, 1997.
Paul J. Seligman,
Deputy Assistant Secretary for Health Studies.
[FR Doc. 97-7470 Filed 3-24-97; 8:45 am]
BILLING CODE 6450-01-P
