Clinical Genetics Branch Support Services

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE ACCEPTED. The Division of Cancer Epidemiology and Genetics/Clinical Genetics Branch at the National Cancer Institute (NCI), Office of Acquisitions intends to negotiate a sole source modification to increase the level of effort and the extend the current, ongoing contract with Westat of Rockville, Maryland for a period of five months. Statutory Authority: 41 U.S.C. 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1(a)(2). Only one responsible source and no other supplies or services will satisfy agency requirements. Westat is the only source that will satisfy agency requirements. The purpose of extending the contract is for the contractor to continue and complete the following activities required by the government: 1. To support NCI Institutional Review Board approved, family studies and intervention trials, including: (a) Development of study-specific Standard Operating Procedures which permit standardized, uniform, systematic patient recruitment, enrollment and study participation. (b) Provide specialized staff with the required experience and unique training (clinical cancer genetics) to coordinate patient enrollment, support clinical data acquisition from multiple sources and process/assemble analytic data sets in a timely manner. Their expertise includes extensive training in the regulatory aspects of human subjects' research, research methods and ongoing continuing education related to clinical cancer genetics in general, as well as subject matter knowledge regarding the specific clinical syndromes currently under study. (c) Develop custom software systems specifically related to CGB's research portfolio, in order to track individual study participants' progress through the course of their particular study over a period of many years and the scheduling, acquisition, shipping, receipt, storage and distribution of research biospecimens obtained from study participants both at the Clinical Center and in the field (home communities). The software system also maintains the Familial Cancer Registry data base. The contractor has ensured that all of these systems are integrated in a manner that permits efficient electronic transfer of data from one component of the overall management process to another. Substantial delays and redundancies in costs will occur if a new contractor were to assume responsibilities for the development of these specialized systems. 2. Develop trusting, effective working relationships with intramural and extramural collaborating investigators (national and international), hospitals, repositories and laboratories which are essential to the successful monitoring receipt, processing, and storage of biospecimens. These relationships include multiple departments (outpatient clinic, radiology, and clinical laboratory scheduling, patient travel) in the NIH Clinical Center which are involved in bringing research participants to Bethesda; laboratories of dozens of collaborating investigators which are performing translational research using study participant biospecimens; major multi-institutional consortia (e.g., the International Testicular Cancer Linkage Consortium; the Consortium of Investigators of Modifiers of BRCA1/2, the Li-Fraumeni syndrome Consortium, National Bone Marrow Transplant Registry, Children's Oncology Group); and, by far of greatest importance, the long-term trusting relationships with CGB study participants whose cooperation is absolutely essential to the successful conduct of our mission. It would take a year or more for a new contractor to begin to master these relationships. 3. Utilize extensive experience and knowledge relative to working with state, federal and NIH regulations regarding privacy/confidentiality issues, informed consent procedures, adverse event reporting, and return of results for clinical genetic mutation testing, performed either in a research or a clinical care context. Maintenance of mutation test results in an electronic format is a highly controversial issue at present, about which the contractor is knowledgeable. 4. Develop, translate, implement and successfully conduct protocols related to clinical cancer genetics family and intervention studies. An award to a new contractor would result in delays in recruitment of new patients into studies, data collection/management, and biospecimen acquisition/management. In addition, there would be substantial delays caused by new contractor start-up. A new contractor would have to develop a Standard Operating Procedure (SOP), hire and train a large staff, build community relationships, and re-consent study participants. The cost for a new contractor start up would result in a duplication of costs not expected to be recovered through competition. The proposed contract is for supplies or sercies for which the Government intends to continue with one source under the authority of FAR 6.302. However, interested sources may identify their interest and capability must be respond by submitting capability statement (5 page limit) with 15 days of publication of this synopsis. A determination by the Government not to compete the proposed requirement based upon responses to this notice is solely 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 sent to: Deborah Brock at the National Cancer Institute, Office of Acquisitions. 6120 Executive Blvd., Bethesda, MD 20852. No collect calls or facsimile transmissions will be accepted. Respondents may submit capability statements via e-mail to Deborah.brock@nih.gov.