Biospecimen Core Resource (BCR)

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 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: A Biospecimen Core Resource (BCR) serves various functions in support of research, encompassing biospecimen collection, processing, storage and distribution of biospecimens for research. The National Cancer Institute (NCI) supports projects that require the use of a BCR both now and in future years. The purpose of this acquisition is to obtain services for research biospecimen acquisition and management through establishment of one or more NCI contract(s) with a biorepository(ies) that will serve as BCR. NCI projects that will facilitate the Beau Biden Cancer Moonshot and additional NCI research through biospecimen collections need a central BCR to perform biobanking and pathology quality control, and to make the biospecimens and associated data available to researchers. The BCR(s) will accelerate research through high quality management of biospecimens and associated data and provision of biospecimens to qualified researchers. Some of NCI's biorepository work will require handling of biospecimens in Clinical Laboratory Improvement Amendment (CLIA)-accredited laboratories, while some work will not require CLIA. The BCR(s) will work closely with NCI and NCI-designated medical institutions to manage biospecimen protocols from collection kits to receipt, processing, storage, and distribution for research, per NCI protocols. The services will be provided to manage the biospecimen resource so that biospecimens are appropriately collected, tracked, prioritized, analyzed, stored and distributed. Purpose and Objectives: The National Cancer Institute, through a Biospecimen Core Resource (BCR), is seeking a wide range of sponsor and regulatory resources and services to fulfill this requirement, including: Project Management and Communications Quality Assurance and Quality Control (QA/QCP) Laboratory Information Management System (LIMS) Transmission and Integration of Biospecimen and Processing Data Biospecimen Identification Standard Operating Procedures (SOPs) and Laboratory Manual Development and Written Specification of Biospecimen Collection Kits Plan for Tracking of Kits and Biospecimen Shipments including CLIA Biospecimen Shipping Biospecimen Accession Biospecimen Processing upon Receipt Special CLIA Biospecimen Accessioning, Processing, and Shipping Histology and Pathology Review Plan for Hosting and Remote Viewing Access of Histology Images Capability Plan for Biospecimen Processing into Molecular Analytes Quality Control of Biospecimen Processing Biospecimen Distribution to Research Laboratories (Other than CLIA Laboratories) Plan for Storage of Biospecimens and Molecular Derivatives Project Requirements: A copy of the draft Statement of Work (SOW) pertaining to this requirement, is attached to this notice. Anticipated Period of Performance: The estimated period of performance for this contract is five (5) years (a base year, plus four option years). The anticipated start date is March 2022. A single award is anticipated. Capability Statement/ Information Sought: Respondents must be qualified small businesses under NAICS code 541380 and must present a capability statement that addresses all requirements set forth in the Statement of Work. The Capability Statement will be evaluated based on the information provided in relation to the project requirements and the current capability and capacity to: 1) perform the work described in the attached draft Statement of Work; 2) demonstrate staff education, training, experience, expertise and knowledge; 3) provide evidence of prior completed projects and Government contracts of a similar nature; 4) demonstrate corporate experience, and 5) demonstrate management capability. Instructions for Submission of Capability Statements: Information Submission Instructions: Interested qualified small business organizations should submit a tailored 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 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 (541380). 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 and Apisit - Ide Viriya, Contracting Officer at apisit.viriya@nih.gov either in MS Word, or Adobe Portable Document Format (PDF). The email subject line must specify HHS-NIH-NCI-SS-PCPSB-BCR-0002. Facsimile and telephone responses will not be accepted. 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).