[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Notices]
[Pages 6591-6593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1603]


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DEPARTMENT OF ENERGY


Notice of Availability of Funds and Request for Applications To 
Support Medical Surveillance for Former Department of Energy Workers at 
the Pantex Plant in Amarillo, Texas

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 funds to evaluate former 
workers whose employment at the Pantex Plant in Amarillo, Texas, 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 at the Pantex Plant does not affect 
cooperative agreements awarded pursuant to similar Federal Register 
announcements published on March 1, 1996, and March 25, 1997.

DATES: Applications submitted in response to this announcement must be 
received by March 30, 2001.

ADDRESSES: U.S. Department of Energy, Office of Health Studies, EH-6/
270CC, 19901 Germantown Road, Germantown, Maryland 20874-1290.

FOR FURTHER INFORMATION CONTACT: Requests for further information may 
be directed to Ms. Kathleen Taimi, Office of Health Studies (EH-6), 
telephone: (301) 903-0262. Applications may be submitted to Ms. Taimi 
at the address listed above. (For application forms, please contact Ms. 
Sue Anderson, Office of Health Studies, telephone: (301) 903-7030.)

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Purpose
II. Project Description
III. DOE's Policy on Protection of Human Subjects Reviews
IV. Applications
V. Application 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. Law 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, 
the DOE Former Workers Program was implemented with the award of six 
cooperative agreements to begin 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 has evaluated medical surveillance needs among 
all former workers.
    On March 25, 1997, the second Federal Register Notice (62 FR 14123) 
announced the availability of additional funds for several new 
projects. In particular, DOE was interested in funding medical 
surveillance for former workers at major DOE sites not included in the 
first six projects. In September and December 1997, four new 
cooperative agreements were awarded to begin one project each at the 
Los Alamos National Laboratory and the Idaho Engineering and 
Environmental Laboratory, and two projects at the Savannah River Site. 
Currently, all ten projects in the DOE Former Workers Program are 
screening groups of former workers who are potentially at significant 
risk for health problems due to work-related exposures.
    This third Notice announces the availability of funds for one new 
project to be funded through a cooperative agreement. DOE is interested 
in applications for a new project at the Pantex Plant in Amarillo, 
Texas. Former workers at this major DOE site are not included in any of 
the ongoing medical surveillance projects. DOE will accept applications 
only for a project at the Pantex Plant.
    Experience with all of these projects will help DOE to evaluate 
needs and options for a long term medical surveillance program for 
former workers and to determine how such a program may be implemented 
and effectively integrated with other ongoing DOE activities.

II. Project Description

    DOE intends to award one new cooperative agreement with specific 
goals identical to the goals of the ongoing projects. The goals of the 
DOE Former Workers Program projects are to:
    <bullet> Identify groups of workers at significant risk for 
occupational diseases;
    <bullet> Notify members of these risk groups; and
    <bullet> Offer these workers medical screening that can lead to 
medical interventions.
    The cooperative agreement will begin with a needs assessment, and 
continue with medical screening, if determined by DOE to be warranted. 
The needs assessment should provide the basis for identifying the group 
or groups of former Pantex workers who are potentially at significant 
risk for health problems due to work-related exposures. It is 
recommended that no group or groups of former workers be initially 
excluded from evaluation during the needs assessment. Applications that 
select only certain worker groups for evaluation, while excluding other 
former Pantex workers from the needs assessment process, must provide 
site-specific information that fully justifies such initial targeting.
    Pursuant to this Notice, DOE intends to award one cooperative 
agreement

[[Page 6592]]

awarded in the amount of approximately $400,000 to conduct a needs 
assessment and to prepare a detailed plan for medical screening. This 
is expected to take 8-10 months. The medical screening, if warranted, 
will be funded through annual continuation awards under the same 
cooperative agreement for up to 3 more years. The estimated annual 
funding expected to be available for medical screening is $790,000.

Needs Assessment

    The awardee shall conduct a needs assessment that will include a 
review of existing site-specific information and other means to 
identify the most significant radiation and non-radiation exposures to 
former Pantex workers. During the needs assessment, the awardee shall 
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 at the Pantex Plant;
    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 Former Worker Program projects.
    The awardee shall prepare a draft needs assessment report that will 
document the need for medical surveillance of former Pantex workers and 
describe the targeted cohort(s) for which further evaluation and 
medical screening is recommended. The draft report also will: (1) 
Define the size of the former workers target population; (2) document 
the specific chemical, physical and/or radiological hazards and the 
degree of potential exposure (duration and magnitude); and (3) 
characterize the nature and extent of the health impacts that are 
anticipated.
    In addition, based upon the findings of the needs assessment, the 
awardee shall develop a detailed proposed plan and budget for medical 
screening of the targeted worker cohort(s). The proposed medical 
screening plan should include the specific tasks described below.
    The awardee shall submit the draft needs assessment and the 
proposed plan and budget for medical screening to DOE within 10 months 
from the award date. DOE will evaluate the draft needs assessment 
report and proposed plan and budget for medical screening. The draft 
needs assessment report will be finalized following review and comment 
by DOE. If warranted, DOE will approve and support the medical 
screening plan and budget through annual continuation awards.

Medical Screening

    The awardee shall conduct the following specific tasks to implement 
the approved medical screening plan:
    1. Identify and locate those former workers who, based on the 
results of the 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 
follow-up treatment, including the coordination with state and federal 
workers' compensation programs 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 to share information 
with other Former Worker Program projects.

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 former worker medical surveillance projects fall under 
the broad definition of human subjects research, and, accordingly, each 
project requires Institutional Review Board (IRB) review and approval. 
The IRB review and approval process will ensure adequate protection of 
workers' privacy and confidentiality during project activities such as 
the review and collection of identifiable private information and the 
handling of personal medical records.
    It is the DOE's policy that any DOE-funded project involving DOE 
workers at a specific site must be reviewed and approved by that DOE 
site's IRB. The DOE site IRB review takes place following award of the 
new cooperative agreement, and annually thereafter. Since the Pantex 
Plant yet does not have an IRB established, the DOE Human Subjects 
Manager will designate another DOE site's IRB for the review and 
approval of this project. In addition, applicants may have to comply 
with their own institution's requirements regarding review of human 
subjects research. Documentation of all required IRB approvals must be 
submitted to DOE prior to implementation of any project activities that 
involve collection of personally identified data or contact with 
individual workers.

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 as noted 
above.

V. Application Format

    The application shall contain two sections, technical scope of work 
and budget proposal. The technical scope of work shall be no more than 
fifty (50) pages in length; resumes of proposed key personnel should be 
submitted as an appendix to the technical scope of work and will not be 
counted against the page limit. Budget proposals have no page limit. 
Because the scope of medical screening will be dependent on the results 
of the needs assessment, the technical description of the proposed 
medical screening may be less specific than that for the needs 
assessment, but must clearly demonstrate a capability to conduct the 
medical screening. It is left to the applicant to determine how best to 
structure the application. However, the following information shall be 
included:
    1. Applications shall include a detailed project description that 
discusses all of the specific tasks to be performed under the proposed 
project. At a minimum, the tasks listed above, in Section II, Project 
Description, must be described in detail for the needs assessment, and 
more generally for medical screening. The project description must 
include clear

[[Page 6593]]

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 project will be conducted. The 
project description must demonstrate that the applicant has the ability 
to integrate its work with the activities of any other organizations at 
the Pantex Plant, as appropriate.
    2. Applications must demonstrate the competency of project 
personnel and the adequacy of resources. Applications must demonstrate 
that the applicant is perceived as neutral and credible, and is capable 
of conducting scientifically valid and responsible medical surveillance 
projects. Applications must demonstrate that the applicant has the 
experience and capability to plan, organize, manage, and facilitate 
worker and union participation in planning and execution. Applications 
must also demonstrate that the applicant 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. 
Applications must demonstrate that the applicant presently has or is 
capable of obtaining staff with the training, expertise, and experience 
needed to conduct a scientifically complex needs assessment and medical 
screening program. Applications must identify the technical and 
scientific staff that will conduct the project and detail their 
professional experience, as well as their level of project involvement. 
Applications must demonstrate that the applicant has the capability for 
both financial and scientific management, and a demonstrated skill in 
planning and scheduling a project of comparable magnitude to that 
proposed under this Notice.
    3. The budget proposal for the needs assessment 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 the medical screening tasks may be more general 
estimates since the initial award will support the preparation of a 
more detailed plan for the medical screening. For planning purposes, as 
noted above in Section II, Project Description, it is expected that 
annual funding in the amount of $790,000 will be available for medical 
screening for up to 3 years. Any expectation concerning cost sharing 
must be clearly stated. Cost sharing is encouraged, but it will not be 
considered in the selection process.
    4. Budget proposals shall include an estimate of the costs for any 
project support work by DOE site contractors not routinely provided by 
DOE (see section VII, DOE's Role). Costs for DOE contractor work such 
as copying, filming, scanning, and/or abstracting site data, including 
charges associated with any needed computer programming of data, should 
be included in the proposed budgets for the needs assessment and the 
medical screening.

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 applicant. DOE is under no 
obligation to pay for any costs associated with preparation or 
submission of an application, whether or not an award is made.
    DOE reserves the right to fund, in whole or in part, one or none of 
the applications submitted in response to this solicitation.

VII. DOE's Role

    In order for DOE to utilize a cooperative agreement for this 
project, there must be substantial involvement between DOE and the 
awardee. DOE established the specific tasks for this project and will 
conduct the selection and award process, which will include evaluations 
by persons outside the Federal Government. DOE will provide 
programmatic direction, policy guidance and oversight through 
continuous consultation and interaction with project investigators. DOE 
will evaluate the results of the needs assessment and, if warranted, 
will fund medical screening at the Pantex Plant. As outlined in DOE's 
``Access Handbook, Conducting Health Studies at Department of Energy 
Sites,'' DOE will facilitate access to the Pantex Plant, as 
appropriate, 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 reporting. DOE will 
coordinate the semiannual Former Worker Program meetings. DOE may 
establish an independent advisory group that will provide advice to DOE 
and to project investigators. Finally, DOE will monitor and evaluate 
the results of the project, including the worker participants' level of 
satisfaction. In addition to helping former workers at the Pantex 
Plant, information gained from this project will contribute to DOE's 
ongoing efforts to improve health and safety programs for current 
workers.

VIII. Applicants

    Applicants for this cooperative agreement 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 strongly 
encouraged to apply. The awardees will work cooperatively with former 
workers, DOE site officials, DOE operating contractors, labor 
organizations, health officials, and designated community 
representatives.

    Issued in Washington, DC, on January 11, 2001.
Paul J. Seligman,
Deputy Assistant Secretary for Health Studies.
[FR Doc. 01-1603 Filed 1-19-01; 8:45 am]
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