Centralized Follow-up for the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial

This is a Small Business Sources Sought Notice. This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for the project is 541990. The small business size standard is $7M. Background: The Division of Cancer Prevention and Control, NCI approved the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial in January 1991. Contracts were awarded in September 1992. Ten Screening Centers (SCs), a Coordinating Center (CC), and a Laboratory (Lab) were competitively selected. In July 2009, the NCI approved the continuation of centralized follow-up of PLCO participants beyond the originally planned 13-year follow-up period. Currently the 10 Screening Centers are conducting the follow-up activities and the intent is to administer follow-up through a single contractor. The National Cancer Institute (NCI), Divisions of Cancer Epidemiology and Genetics (DCEG) and Cancer Prevention (DCP) is proposing to contract for services to support centralized follow-up of Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial participants who have agreed to continued PLCO participation to obtain cancer diagnosis-, death- and risk factor-related data on these participants to determine if screening for the named cancers reduces deaths from these cancers. Approximately 155,000 men and women were enrolled in PLCO between 1993 and 2001. An anticipated 80,000 to 90,000 participants will be included in centralized follow-up. Purpose and Objectives: The purpose of this proposed acquisition is to identify qualified organizations that can provide support to the NCI for centralized follow-up of participants from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial with minimal delay while maintaining the highest quality standards for the project. PLCO is designed to determine if screening for prostate, lung, colorectal and ovarian cancer can reduce mortality from these cancers. In addition, PLCO has a collection of pre- and post-diagnostic biological samples stored in the PLCO Biorepostory, and epidemiological data from questionnaires. These data are a valuable resource for cutting-edge molecular epidemiologic research. The value of the resource can be increased 1) by continuing the active follow-up of PLCO participants for at least a 5-year period (2010-2015); 2) by updating key exposure data and collecting additional data, including medication use and medical conditions that are common among older adults; and 3) collecting additional clinical data and tumor tissue of selected cancers, such as that of the colon and ovaries. The centralization of the PLCO will enhance the value of the PLCO resources through the substantial increase in the number of incident cancers accrued within the Trial, strengthen the Trial's ability to clarify further the long-term effects of screening on cancer mortality, and provide a final opportunity to collect additional exposure data and expand the existing tumor pathological resource within the PLCO. Given the rich collection of biological specimens across multiple time points and the extensive questionnaire data, the continuation of the PLCO Trial is essential and will enable the PLCO to remain as one of the premier resources with a unique and comprehensive database for future molecular epidemiologic research. Project Requirements: The proposed acquisition will involve the following type of activities: 1) Establish a Central Data Collection Center (CDCC) for the continued, centralized follow up of PLCO participants for approximately five years, 2) Develop a mechanism to transfer data from the central data collection server to the existing PLCO Coordinating Center, 3) Prepare IRB Submissions as required, 4) Conduct Annual Study Update Administration to determine participants current health and identify newly diagnosed cancers, 5) Conduct Risk Factor Questionnaire Administration to enhance key exposure data, 6) Conduct Health Screening Questionnaire (HSQ) Administration to assess current screening behavior in the cohort, 7) Conduct Retention Activities to keep participants engaged in the study, 8) Conduct Tracing Procedures for participants lost to follow up, 9) Conduct Medical Record Collection and Abstraction for identified cancers,10) Conduct Pathology Tissue Collection from identified cancers, 11) Collect Death Certificates from next of kin of deceased participants or from state agencies to ascertain the cause of death, 12) Provide coordination with the PLCO Sites to establish scientific and administrative liaisons with personnel from the ten original PLCO Screening Centers to facilitate clinical data collection, if needed, 13) Identify Sites that will need to submit to State Tumor Registries, 14) Establish a toll-free Call Number for PLCO Participants and 15) Establish a PLCO Website for PLCO Participants. Anticipated Period of Performance: The anticipated period of performance for the proposed acquisition will be from November 2010 to October 2015; for a period of five years. Capability Statement/Information Sought: Respondents must provide, as part of their responses, information concerning (a) staff experience, including their availability, experience, and training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capabilities; and (e) examples of prior completed Government contracts, references, and other related information. Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 20 total single-spaced pages (including all attachments, resumes, charts, etc) presented in single-space using a 12 point font size at a minimum that clearly details the ability to perform the aspects of the notice and addresses the specific requirements described above. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name, address and DUNS number). All proprietary information should be marked as such. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Information Submission Instructions: All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via e-mail) to Charles H. Jackson, Jr., Contracting Officer at: cj14k@nih.gov either in MS Word, Wordperfect or Adobe Portable Document Format (PDF) not later than March 5, 2010, 2:30 PM EST. All responses must be received by the specified due date and time in order to be considered. ANY RESPONSES RECEIVED AFTER THAT DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondent s with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in the Federal Business Opportunities in accordance with FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentially: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).