Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Energy

# AGENCY:

Office of Environment, Safety and Health, DOE. 

# ACTION:

Notice of availability of funds and request for applications.

# 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: 
    - Identify groups of workers at significant risk for occupational diseases;
    - Notify members of these risk groups; and
    - 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                           ( print 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                           ( print 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]

BILLING CODE 6450-01-P