Small Business Sources Sought: Protocol Information Office Support Services

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 this requirement is 541611, Administrative Management and General Management Consulting Services, and the size standard is $21,500,000. Background: The National Cancer Institute (NCI), Division of Cancer Prevention (DCP) supports science that seeks to identify those at increased risk for developing cancer, as well as to identify and develop chemopreventive and other interventions to delay, arrest or reverse carcinogenesis at its earliest stages. The Division of Cancer Prevention manages a diverse portfolio of scientific and clinical initiatives in order to identify and prioritize potential cancer prevention agents, and to move these promising agents from pre-clinical testing to Phase 0, Phase I and Phase II clinical trials, and ultimately into large Phase III cancer prevention clinical trials. These clinical trials are conducted by extramural investigators at national and international clinical sites and are supported through a variety of federal funding mechanisms including grants, cooperative agreements, and contracts. The Protocol Information Office (PIO) (1) supports the mission of the Division by using quality processes, collaborative relationships and clinical information technology to facilitate the movement of prevention science from concept to practice; (2) using a centralized and standardized method, provides systematic review, tracking and reporting on all Division of Cancer Prevention (DCP) Phase I, II and III clinical trials; and (3) works directly with members of all the clinically-focused DCP Research Groups to forge and foster interaction within the matrix structure thus optimizing opportunities for improving the quality of scientific peer review of clinical research sponsored by the Division. The PIO has a requirement for administrative support services for the processing of clinical trial protocol documents and tracking the implementation and completion of human clinical research studies. The contract will relieve the administrative burden from the scientific staff by processing documents, abstracting key data elements into the DCP database; arranging study reviews; tracking review response; coordinating with clinical trial sites; tracking study timelines and manuscript completion, and coordinating trial information with other NCI projects. Purpose and Objectives: The National Cancer Institute, Division of Cancer Prevention (DCP) is seeking administrative support to provide the services required to perform the following tasks: Project Area 1: Abstraction of key elements from protocol-related documents. Project Area 2: File management of electronic files for all DCP clinical trials. Project Area 3: Clinical trial review support, including support of clinical trial review meetings. Project Area 4: Manage and perform quality control of data relating to people (persons such as investigators, coordinators, reviewers. etc.), organizations, and the relationships of people to organizations in the PIO Clinical Trials System (CTS). Project Area 5: Operational support to PIO, to include efforts to streamline or augment protocol processes, submission of DCP protocols, Standard Operating Procedures, educational programs, contingency plans, reporting, and other operational and administrative support. Project Requirements: A copy of the draft Statement of Work (SOW) pertaining to this requirement, which is subject to revisions, is attached to this notice. Anticipated Period of Performance: The period of performance for this contract is anticipated to be 5 years (a base year, plus four option years). The anticipated start date is September 24, 2023. A single award is anticipated. Capability Statement/Information Sought: Respondents must be qualified and prepare a capability statement that speaks to all sections in the Statement of Work. The Capability Statement will be evaluated based on the information provided in relation to the Project Areas and the following specifics: 1) current capability and capacity to perform the work in the Project Area (s) in the attached Draft Statement of Work; 2) staff with the appropriate education, training, experience, expertise and knowledge; 3) experience with prior completed projects and Government contracts of similar nature; 4) corporate experience and management capability. Instructions for Submission of Capability Statements: Information Submission Instructions: Interested qualified small business organizations should submit a capability statement, not to exceed 15 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 UEI 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 (541611). Delivery Point: All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Paula Wilkison, Contracting Officer, at paula.wilkison@nih.gov either in MS Word, or Adobe Portable Document Format (PDF). The email subject line must specify the notice number, HHS-NIH-NCI-SBSS-PCPSB-00009-39. Facsimile and telephone responses will not be accepted. Due Date/Time for Submission: Electronically submitted tailored capability statements are due no later than Friday, July 22, 2022, 4:00PM 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 response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).