SOLICITATION NOTICE
B -- Collect and Process Serial Oral Rinse Specimens
- Notice Date
- 8/17/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NCI-70131-NG
- Response Due
- 8/31/2007
- Archive Date
- 9/15/2007
- Description
- The National Cancer Institute (NCI) Division of Cancer Epidemiology and Genetics (DCEG), Hormonal and Reproductive Epidemiology Branch (HREB) plans to procure on a sole source basis in accordance with 13.106-(b)(1) with H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, MRC-CANCONT, Tampa, FL 33612-9416; services to collect and process serial oral rinse specimens from 4500 study visits and store the specimens at -80 for future HPV DNA testing. Human papillomavirus type 16 (HPV16) is strongly associated with the development of invasive cervical, vulvar, and anal cancers in women, and penile and anal cancers in men (Cogliano V, Baan R, Straif K, Grosse Y, Secretan B, El Ghissassi F. Carcinogenicity of human papillomaviruses. Lancet Oncol 2005;6:204.) HPV16 is also associated cancers of the oropharynx (Cogliano V, Baan R, Straif K, Grosse Y, Secretan B, El Ghissassi F. Carcinogenicity of human papillomaviruses. Lancet Oncol 2005;6:204.); recent data suggests that HPV16 is an etiologic factor for more than 50% of oropharyngeal cancers (D'Souza G, Kreimer AR, Viscidi R, Pawlita M, Fakhry C, Koch WM, Westra WH, Gillison ML. Case control study of human papillomavirus and oropharyngeal cancer. NEJM 2007 (19):1944-56.) The purpose of this procurement is to investigate whether HPV infections at different anatomic sites are linked. To do so, we plan to conduct a large study to determine the timing of incident HPV16 infection and subsequent clearance in the oral region and anogenital tract among cancer-free individuals participating in two on-going, international, clinic-based studies being conducted by Dr. Anna Giuliano at the Moffitt Cancer Center. By nesting this work in an on-going study, we can efficiently and effectively evaluate our hypotheses and determine if a larger study is warranted. This study will be nested in an international (US, Mexico, Brazil), prospective study of the natural history of anogenital HPV Infection in Men (the HIM study), which already has a nested component that aims to evaluate HPV heterosexual transmission (The HPV International Transmission [HIT] Study) by enrolling the partners of the men in the HIM study. These on-going studies offer the ideal infrastructure to investigate oral HPV infection; approximately 1500 men will be followed every 6 months for 4 years for a total of 10 study visits and approximately 750 female partners will be evaluated every 6 months for a total of 2 years for a total of 5 study visits. The period of performance shall be for one year from date of award. The H. Lee Moffit Cancer Center and Research Institute in the laboratory of Dr. Anna Giuliano commenced enrollment for the HIM study in 2005. To date, the research infrastructure is well-established; the parent study rigorously tracks, organizes, and monitors the collection, processing, and storage of each of the anogenital specimens and corresponding laboratory analyses. This will be expanded to include the oral rinse specimens. From this study, there will be access to the data on the anogenital HPV status of the study population, which in turn will enable us to test the most pertinent oral specimens, those which have HPV16 positivity in the anogenital region. Completing this project will provide data on the feasibility of specimen collection, adequacy of DNA in the specimens, and estimates of oral HPV infection in men and women with anogenital HPV16 infection. In turn, we can begin to evaluate the relative timing of HPV infection in the oral and anogenital region, and among concurrently infected individuals, to assess the timing of HPV clearance. We will use this information to determine if a larger study is feasible. The Moffitt Cancer Center and the laboratory of Dr. Anna Giuliano has the only on-going study in which to nest our prospective evaluation of oral HPV among anogenitally HPV infected men and women. The research infrastructure is already in place. To maintain continuity in an on-going research project and avoid introducing new variables into the project, it is of critical importance that the procedures be conducted in the same laboratory so that there is no intra-laboratory variation. Assuring no intra-laboratory variation is essential to allow comparability the results. The North American Industry Classification System code is 541380 and the business size standard is $11M. This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party has the unique capabilities, resources and personnel to perform the requirement. Capability statements must be received in the contracting office by 1:00 PM ET, on August 31, 2007. For further information please contact Malinda Holdcraft, Contract Specialist via electronic mail at holdcram@exchange.nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. No faxed or emailed capability statements will be accepted. In order to receive an award, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA) http://orca.bpn.gov Reference NCI-70131-NG on all correspondence.
- Record
- SN01376218-W 20070819/070817220640 (fbodaily.com)
- Source
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