NCI Cervical Cancer - Last Mile Initiative

Description: 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 541715 (Medical research and development laboratories or services, with a size standard of 1000 employees) 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 National Cancer Institute (NCI) does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Background: Following substantial reductions in cervical cancer incidence rates in the United States in the last half of the twentieth century, rates have plateaued. For the past two decades, despite the availability of highly sensitive screening methods such as human papillomavirus (HPV) testing, over 13,000 women continue to be diagnosed with and over 4,000 women continue to die of cervical cancer annually. Over half of the new cervical cancer cases in the US are among women who have been never screened or who are infrequently screened, reflecting barriers presented by socioeconomic disparities, geographic inaccessibility, among other factors. An alternative screening approach that has been widely evaluated to overcome these barriers is self-collection of samples (self-sampling) by women themselves and sending the sample for HPV testing This approach offers several benefits including ease of collection at a time/place of women's choice without a need for a clinic appointment or speculum examination. This intervention has significant potential to expand cervical cancer screening to never screened or under-screened women and address a pressing public health concern of lack of access to screening as a health disparity. The National Cancer Institute (NCI) Division of Cancer Prevention (DCP) has developed the - Last Mile Initiative (LMI) as a public private partnership between several stakeholders (including federal agencies, industry partners, and professional societies/clinical practice guidelines organizations) to validate self-sampling-based HPV testing as a comparable (non-inferior) alternative to provider-collected cervical specimen for HPV testing in cervical cancer screening. Towards this goal, the NCI will support a nationwide, multicentric screening trial, the - Last Mile Initiative (LMI) - Self-sampling for HPV testing to Improve Cervical Cancer Prevention (SHIP) Trial (or the - LMI-SHIP Trial) in diverse delivery settings. Approximately 9,000 women in the screening age range approved for standalone HPV testing (25-64 years) will be enrolled in the study with a balanced representation of three groups: Approximately 3000 women who are referred for abnormal cytology or positive HPV test results to colposcopy clinics, or the - Colposcopy Population (Accrual Group A: Colposcopy Population) Approximately 3000 women who are under-screened (i.e., not been screened within the 4 years of the last cytology, or within 6 years of the last co-test or primary HPV test). Women in this - Intended-Use Population will be identified through diverse efforts for community outreach to attend a clinical visit to participate in the study (Accrual Group B: Intended-Use Population) Approximately 3000 women undergoing routine screening per current recommendations, i.e., these will be the - Average-Risk Population who will be recruited during their routine screening visit (Accrual Group C: Average-Risk Population) Enrolled participants will provide informed consent and undergo a provider-collected cervical sampling at the initial visit. HPV self-sampling kits will be handed (or mailed) to participants immediately after their clinic visits. Clear written instructions for self-sampling will be provided and participants will be instructed on how and where to return the self-collected specimen and in what time frame. Aliquots of self-collected samples and provider-collected samples will be sent for HPV testing to evaluate (in a masked fashion) paired results of self vs. provider-collected specimens for HPV testing assays. The HPV result on the provider-collected sample will be considered the reference standard (predicate test) for comparison with the HPV result on the self-sample. The provider-collected specimen will inform clinical management, and women will be managed as per local clinical guidelines. Project Requirements: A copy of the draft Statement of Work (SOW) pertaining to this requirement, is attached to this notice. Capability Statement/Information Sought: Respondents must be qualified small businesses under NAICS code 541715 and must present a capability statement that is responsive to the requirements set forth in the Statement of Work. The Capability Statement will be evaluated based on the information provided in relation to the following: 1) potential to perform the work described in the attached draft Statement of Work. 2) provide evidence of prior completed projects and Government contracts of a similar nature. 3) demonstrated capability in conducting one or more components of the work remotely/virtually (with descriptions if any portion of the process is proprietary). Instructions for Submission of Capability Statements: Information Submission Instructions: Interested qualified small business organizations should submit a tailored capability statement, not to exceed 10 total single-spaced pages, including all attachments, using a 12-point font size at a minimum, that clearly details the firms ability to perform and that addresses the specific requirements described above and in the draft Statement of Work (SOW). Please provide your DUNS number, organization name, address, point of contact, including names, titles, addresses, telephone, fax numbers, email addresses, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code (541715). Number of Copies/Delivery Point: All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Noor Shakeel, Contracting Officer at noor.shakeel@nih.gov either in MS Word, or Adobe Portable Document Format (PDF). The email subject line must specify HHS-NIH-NCI-SS-PCPSB-HPV-0002. Facsimile and telephone responses will not be accepted. Electronically submitted tailored capability statements are due no later than Friday, March 19, 2021, 4:00 PM EST. Capability statements received after that date and time will not be considered for purposes of this market research. 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 respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).