Loren Data's SAM Daily™

FBO DAILY ISSUE OF MAY 22, 2004 FBO #0908
SOLICITATION NOTICE

B -- Evaluation of Chronic Lymphocytic Leukemia among North American Nuclear Workers

Notice Date

5/20/2004
 

Notice Type

Solicitation Notice
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, Center for Disease Control and Prevention, Acquisition and Assistance Field Branch (Cincinnati), 4676 Columbia Parkway M/S C-4, Cincinnati, OH, 45226
 

ZIP Code

45226
 

Solicitation Number

Reference-Number-000HCC56-2004-10010
 

Response Due

6/4/2004
 

Archive Date

6/19/2004
 

Point of Contact

Jennifer Bayer, Purchasing Agent, Phone (513)533-8586, Fax (513)533-8283, - Dwight Favors, Supervisory Contract Specialist, Phone (513)533-8137, Fax (513)533-8283,
 

E-Mail Address

jmh8@cdc.gov, dyf3@cdc.gov
 

Description

Negotiations are being conducted on a sole source basis with the International Agency for Research on Cancer (IARC), Unit of Radiation and Cancer for a technical report of the scientific link between radiation exposure and occurrence of chronic lymphocytic leukemia (CLL). BACKGROUND INFORMATION/PROJECT OVERVIEW: The National Institute for Occupational Safety and Health (NIOSH) received a mandate from the U.S. Congress in fiscal year 2004 appropriations legislation to ?conduct epidemiological research and other activities to establish the scientific link between radiation exposure and the occurrence of chronic lymphocytic leukemia.? Studies of workers exposed to ionizing radiation are a highly relevant potential source of information regarding the radiation-associated risk for chronic lymphocytic leukemia (CLL). The Multi-National Nuclear Worker Epidemiologic Study, recently completed by the International Agency for Research on Cancer (IARC), includes analysis of leukemia radiogenicity that, with further work, could provide risk estimates for CLL relation to external radiation exposures. This requirement requests that the contractor complete this analysis and provide results to NIOSH in a technical report by October 31, 2004. CLL is strongly associated with attained age and has a number of sub-types. There is some evidence that its etiology is similar to non-Hodgkin?s lymphoma, and that it may be associated with herbicide exposure (Institute of Medicine 2003, pp 372-375). To date, epidemiologic studies that evaluated the relation between ionizing radiation and CLL have not shown a positive association, as summarized below. As a result several formal committees have concluded that CLL is not radiogenic, or have declined to estimate radiation-related risk for CLL (NRPB 2002, UNSCEAR 2000, NAS/NRC 1990). CLL risk as a result of external radiation exposures has not been observed in the Life Span Study of Japanese atomic bomb survivors (Preston et al 1994). However, the incidence of this disease is much lower in many Asian populations than in North America and Europe. Several important studies have been conducted among Western populations, including those exposed to relatively high doses during medical procedures. No association of radiation exposure with CLL was observed among 14,000 U.K. ankylosing spondylitis patients treated with x-rays, although only a very small number of CLL deaths occurred in this population (a total of 2 CLL deaths; Darby et al. 1987). No elevation of CLL risk has been observed among U.S., Canadian and European women exposed to radiation during treatment for uterine cancer (a total of 57 CLL deaths; Curtis et al. 1994). The acute exposure profiles for the atomic bomb survivors and medically exposed cohorts are quite different, however, from that seen in occupational environments, and the reliability of extrapolation from one to the other is uncertain. Among nuclear workers, no significant relationship between occupational exposure to radiation and CLL has been observed in a U.K. study of over 124,000 workers (a total of 26 deaths, Muirhead et al. 1999). No relationship was observed between external radiation dose and CLL in the first combined international nuclear workers study (a total of 27 CLL deaths; Cardis et al 1995). Few published studies of U.S. Department of Energy workers have explicitly evaluated the association between internal radiation and CLL. A study of over 14,000 plutonium workers at Sellafield in the UK identified just three fatal cases of CLL, only one of which occurred among workers with quantitative dose estimates, and risks were not explicitly estimated (Omar et al. 1999). At least one study was conducted among medically-exposed populations. No increased risk was found for CLL among patients in Denmark exposed to Thorotrast, a 232Th-containing contrast medium (Andersson et al. 1993, IARC 2001). Still, there remains a need to better estimate risk of CLL associated with radiation exposure. CLL is currently considered a non-radiogenic cancer under DHHS regulations (42 CFR part 81.30) for determining the probability of causation under the Energy Employees Occupational Illness Compensation Program Act of 2000. CLL is the only cancer for which the Department of Labor assigns a probability of causation of zero. This has raised concerns among some workers and their representatives about the treatment of this cancer compared to others not shown to be radiogenic (e.g., prostate, non-Hodgkin?s lymphoma, malignant melanoma). These others have risk estimates in the NIOSH Interactive RadioEpidemiological Program (IREP), which is used for calculating probabilities of causation under EEOICPA. Few studies have quantitatively estimated risk for CLL and it currently is not possible to develop a quantitative model that might provide the basis for modifications to the NIOSH-IREP. As CLL is not rapidly fatal like many other leukemia subtypes, it is important to including non-underlying causes of death when evaluating CLL risk. STATEMENT OF WORK: Using the work history, demographic and exposure data previously compiled for the Combined International Nuclear Worker Study, estimate the relative risk (RR) and excess relative risks (ERR) per unit dose for (1) all leukemia; (2) all leukemia except CLL; and (3) CLL alone, using Poisson regression with the cohorts in the Combined International Nuclear Worker Study, evaluating risk for all cohorts together and the U.S. cohorts separately. The U.S. cohorts should include Hanford, Idaho National Engineering and Environmental Laboratory, and Oak Ridge National Laboratory. All analyses will utilize both underlying and non-underlying causes of death. The analysis method should follow the general methods outlined in the Procedures Documents guiding the work of the Combined International Nuclear Worker Study. The emphasis of the analyses will be to estimate the RR and ERR for these groups and outcomes, with profile likelihood-based 90%, 95%, and 99% confidence intervals reported where possible. To the extent that the data will allow, risk estimates should also incorporate dose estimate uncertainties. DELIVERABLES: Technical report that summarizes the methods used, gives results of the analyses and provides an interpretation of results is due on October 31, 2004. Progress reports will be due on the first Monday of each month between award of contract and submission of the technical report (e.g., August 1, September 1, October 1). Report will be e-mailed to the NIOSH Project Officer. CAPABILITIES REQUIREMENTS: Through this announcement, alternate sources are being offered the opportunity to demonstrate their capabilities to provide the services specifically identified above. To be considered qualified, sources must submit a capabilities statement which demonstrates in writing that they have a high level of experience in cancer epidemiology relating to low level radiation exposure. They must also have the capability to obtain the data which is controlled by the 15 countries. This data is known as ?15 Country Combined International Nuclear Study Cohort?. Qualified organizations are encouraged to submit a capabilities statement which addresses the requirements and contains material in sufficient detail to allow NIOSH to determine if the organization can perform this requirement. Capabilities are to be received in the NIOSH contracting office no later than fifteen (15) days from the date of this announcement. Submit written information to: Jennifer Bayer, CDC/PGO/AAFB, 4676 Columbia Parkway, Cincinnati, Ohio 45226, Mail Stop C-4. Reference #000HCC56-2004-10010. The intent of this synopsis is to determine whether alternative sources exist. Information received will be used solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to complete this proposed requirement base upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a response, which shall be considered by the Agency.
 

Place of Performance

Address: 150, cours Albert Thomas, 69008 Lyon

Zip Code: 69008

Country: France
 

Record

SN00589347-W 20040522/040520211724 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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