Follow on to Human Papillomarvirus Type 16 Vaccine Trial in Costa Rica

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Division of Cancer Epidemiology and Genetics (DCEG) at the National Cancer Institute (NCI) intends to negotiate a 5 year extension to the contract with Fundacion Inciensa to continue follow-up of women enrolled in studies regarding HPV infection and cervical neoplasia among vaccinated and unvaccinated women. The planned extension will provide invaluable data that will allow for the continued investigation into the risks and benefits of the prophylactic HPV vaccine. The requirements of this extension will permit DCEG/NCI to evaluate the long-term vaccine effects and will enable evaluation of numerous questions regarding HPV vaccine immunology and the epidemiology of HPV and associated disease that cannot adequately be addressed in the first 4 years of follow-up or that can be addressed with increased power by increasing follow-up time. Follow-up will allow for the evaluation of the HPV-16/18 vaccine among women through their early to mid-30s, therefore extending follow-up through the peak years of pre-cancer diagnosis among well-screened women. A more comprehensive evaluation of vaccine impact will therefore be possible, and larger numbers of pre-cancer outcomes (particularly pre-cancers caused by HPV types other than HPV-16/18) will be accrued for the various analyses envisioned. Fundacion Inciensa will follow vaccinated and unvaccinated women enrolled in the NCI sponsored HPV-16/18 vaccine trial and associated studies (totaling close to 10,000 women) with state-of-the-art screening during the extended follow-up period. Fundacion Inciensa will continue to perform the above requirements to complete these studies with no disruption in service. Statutory authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(a)(2)(ii), only one responsible source and no other supplies or services will satisfy agency requirements. Fundacion Inciensa is the only responsible source and no other supplies or services will satisfy agency requirements. The contractor is uniquely qualified by virtue of its continued performance over this period of time and is the only source that can provide the services for the following reasons: 1) The contractor has unique access to this population. This procurement is designed to follow a group of women previously enrolled in the CVT study. The Contractor has been following this group since 2004. The population has been cooperative and willing to participate in long-term follow-up studies. 2) The contractor is a large research center dedicated to HPV and cervical cancer research. It has specialized staff and personnel; including epidemiologists, clinicians, nurses, pharmacists, microbiologists, molecular biologists and statisticians; with ample experience in conducting complex epidemiologic studies and clinical trials under Good Clinical Practice (GCP) and with extensive quality assurance. With a new contractor, new staff would need to be hired and trained with unavoidable learning curve inefficiencies as well as training costs. 3) Fundacion Inciensa has been heavily involved in the planning of several ongoing studies and is crucial to the performance of the tasks. The time required to gain this experience by a new contractor would lead to extensive time delays and lost opportunities. The support by Funadcion Inceinsa is important and should produce results of benefit to people in both the United States and Costa Rica. By understanding the efficacy of vaccines designed to protect against HPV, strategies aimed at the prevention of the infection and its serious cancer outcomes can be based on solid scientific evidence. The proposed contract action is for supplies or services for which the Government intends to continue with one source under authority FAR 6.302. However, interested sources may identify their interest and capability by submitting a capability statement (5 page limit) before or on the response date. 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. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement. Overnight deliveries should be mailed to Seena Mathews at the National Cancer Institute, Office of Acquisitions, 6120 Executive Boulevard, Suite 600, MSC 7192 Bethesda, Maryland 20852. No collect calls or facsimile transmissions will be accepted. Respondents may also submit their capability statements via email.