SOLICITATION NOTICE
A -- HPV Type 16 Vaccine Trial in Costa Rica
- Notice Date
- 7/22/2011
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- RFP-N01-CP-11015-63
- Point of Contact
- Seena Ninan, Phone: 3014353814
- E-Mail Address
-
ninans@mail.nih.gov
(ninans@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL BE ISSUED ON A LATER DATE. The Division of Cancer Epidemiology and Genetics (DCEG) at the National Cancer Institute (NCI), Office of Acquisitions intends to negotiate a 5 year contract to 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 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 invested substantial time and resources in obtaining the necessary IRB approvals for this study. The current contractor is the only entity that has IRB approval to follow the participants. 2. The contractor has developed working relationships with important entities, such as the Ministry of Health, various regulatory boards, and various hospitals in order to review study participant charts. They have also built relationships with members of the community such that the contractor is recognized and trusted within the community. In combination, these factors make the contractor uniquely qualified to lead this study. 3. The contractor has already built trusting relationships of over six (6) years with the majority of participants who are enrolled in the study. Continuity of study staff is viewed as an important component for retention in the study. 4. The contractor has established the necessary infrastructure to recruit, enroll and conduct study visits with study participants. FUNIN is a large research center dedicated to HPV and cervical cancer research, the only research center of its kind in Costa Rica. The infrastructure includes 4 study clinics, a state of the art repository, and laboratories for cytology, histology, HPV testing and peripheral blood mononuclear cell (PBMC) cryopreservation. The existing staff has already completed training tailored to enable them to conduct this study in the areas of data collection and entry, administration of questionnaires, and collection and processing of biological specimens specific to this study. This contractor has completed preparatory work and is in the data collection phase of this study. 5. A change of contractor would invalidate the current approvals, invalidate the current consent with participants in the study, and would require re-contacting, re-consenting and re-enrollment of the group. 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 must respond by submitting a capability statement (5 page limit) within 15 days of publication of this synopsis. 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 Ninan 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 submit their capability statements via email.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/RFP-N01-CP-11015-63/listing.html)
- Place of Performance
- Address: Costa Rica, United States
- Record
- SN02507892-W 20110724/110723010950-70d24b7431e74ccaa4b40d348e85c8ee (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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