THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL BE ISSUED ON A LATER DATE.

Despite HPV vaccines, screening will remain central for decades to control cervical cancer. Recently, HPV testing alone or with cytology was introduced in the US as an alternative to cytology screening. However, most HPV infections are harmless and additional tests are required to identify women at highest cancer risk. With three (3) options for primary screening, and without clear strategies for triage of screen-positive women, there is great confusion about the best approach. Also, increasing HPV vaccination coverage will lead to lower disease prevalence, and force new screening approaches. Therefore, NCI plans to evaluate performance of several promising biomarkers head-to-head in a screening population. Integral to these studies are cervical specimens and clinical data among women screened.

To evaluate these biomarkers, the Division of Cancer Epidemiology and Genetics (DCEG) at the National Cancer Institute (NCI), is seeking to obtain and store "discard" HPV and cytology specimens as well as collect the risk factor and clinical outcome data for a population-based sample of women in a cohort. These specimens are termed "discard" because they are routinely discarded soon after processing in the laboratory that runs the cervical cancer screening tests. Instead of discarding the specimens, the NCI seeks to collect them before they are destroyed. After transferring the specimen into storage tubes, they shall be shipped to the NCI Biorepository and stored for later testing by NCI.

The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source, Kaiser Permanente Northern California (KPNC), under the authority of FAR 6.302-1(a)(2)(ii). Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is not a request for competitive proposals. However, all proposals received will be considered by the Government. A determination by the Government not to continue with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive acquisition.

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. Kaiser Permanente Northern California is the only responsible source and no other supplies or services will satisfy agency requirements. The contractor is uniquely qualified as the only source that can provide the services for the following reasons:

1. KPNC is already collaborating with the NCI on a previous study that had similar design and has collected discard specimens from 55,000 women and is in the process of collecting from 23,000 women. Conducting the proposed effort through KPNC allows continued follow-up of women enrolled in the previous study with KPNC and the utilization of existing infrastructure including the established IRB and data sharing agreements with KPNC. KPNC is the only entity that has IRB approval to follow the participants and cohort. Beyond that, the NCI has another established collaboration with KPNC to collect data on all 1.5 million women screened for cervical cancer at KPNC clinics. The proposed acquisition will generate a representative sample of women from the overall screening population with biospecimens. This will allow the NCI to weigh results from the biospecimen cohort back to the entire screening population.

2. This effort requires a vendor who can quickly and efficiently collect HPV and cytology specimens for 47,000 women undergoing routine cervical cancer screening and provide detailed clinical and risk factor history and follow-up. Importantly, KPNC screens over 1.5 million women and initiated HPV and cytology cotesting in 2003. Since only 5-10% of women are HPV-positive and screening intervals are 3 years, a population of this size is needed to enroll a large number of HPV-positive women. Therefore, KPNC is uniquely qualified to continue this project that will systematically sample the screening population. There is no other provider routinely offering HPV-cytology co-testing to over 1 million women for over 10 years and allowing medical record linkage in a population large enough to provide the required participants.

The proposed contract action is for services for which the Government intends to solicit on a sole-source basis under the authority pf FAR 6.302.

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