Biospecimen Core Resource

SMALL BUSINESS SOURCES SOUGHT NOTICE Notice Number: HHS-NIH-NCI-SBSS-PCPSB-65002-45 Title: BioSpecimen Central Repository (BCR) and Biospecimen Processing Center (BPC). 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 NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Task Area A is assigned NAICS code 541380 - Testing Laboratories which has a size standard of $15,000,000. Task Area B is assigned NAICS code 493120 - Refrigerated Warehouse and Storage which has a size standard of $27,500,000. 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. Background: The Center for Cancer Genomics (CCG) conducts genomics studies on biospecimens from patients in clinical trials and from other source sites using many of the components in The Cancer Genome Atlas (TCGA) infrastructure. These components include one or more Tissue Source Site (TSS), Biospecimen Processing Center (BPC), Clinical Data Center (CDC), CCG Biorepository and Archive (CBA), Genome Characterization Center (GCC), Genomic Data Analysis Center (GDAC), and Genomic Data Commons (GDC). The CCG Biospecimen Processing Center (BPC) will support an expanding list of genomics studies. CCG Biospecimen Core Resource A major prerequisite of the genomics studies supported by CCG is the acquisition of high quality biospecimens. To meet this need, NCI maintains relations with clinical sites and projects providing high quality, clinically annotated biospecimens to a centralized quality control and processing facility. The term "high quality" refers to the histological and molecular properties of the tissue, the existence of appropriate informed consent provisions for the intended use of the biomolecules and data, collection and subsequent distribution under an Institutional Review Board (IRB) reviewed protocol, as well as unencumbered access for research use (e.g., intellectual property restrictions). For these genomics studies, the BPC contractor will be the primary biospecimen interface between CCG and the sites that provide samples. The CCG BCR will serve as the centralized tissue processing center for genomics studies. In addition, the BCR will provide analytes for one or more designated characterization center(s) and collect and standardize clinical annotations. Standard Operating Protocols (SOP) will govern sample collection, pathological examination, analytes (e.g., DNA and RNA) extractions, quality control, laboratory data collection, and analyte distribution to designated characterization center(s). The BCR will ensure that samples and sample data are received and managed under Material Transfer Agreements that represent the policies of the National Institutes of Health (NIH) for each genomics study. Project Requirements: TASK AREA A - Biospecimen Processing Center (BPC) Services 1) Biospecimen and Associated Data Procurement 2) Biospecimen Management and Biorepository Operations 3) Biospecimen Quality Control 4) Biospecimen Processing into Molecular Analytes 5) Biospecimen and Analyte Distribution 6) Data Export 7) Other BPC-related Services 8) Pilot Studies 9) Transition Activities TASK AREA B - Biospecimen Processing Center 1) Biospecimen and Associated Data Receipt and Storage 2) Biospecimen Management and Biorepository Operations 3) Biospecimen and Analyte Distribution 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 ID/IQ contract would be 5 years. The anticipated start date is December 15, 2016. One or more awards are anticipated for each Task Area. Capability Statement/Information Sought: Respondents are expected to have the expertise, personnel, and systems to meet requirements of the draft Statement of Work (SOW). Tailored Capability Statements shall demonstrate a clear understanding of the tasks specified in the attached draft SOW. Respondents must be qualified and prepare a capability statement for Task Area A, Task Area B, or both Task Areas of the Statement of Work. Respondents must clearly state on the face page the Task Area(s) to which they are responding. The Capability Statements will be evaluated based on the information provided in relation to the project requirements and the current capability to: 1) perform the work in the Task Area(s) in the attached Draft Statement of Work; 2) staff education, training, experience, expertise and knowledge; 3) prior completed projects and Government contracts of a similar nature; 4) corporate experience and management; and 5) computing infrastructure. Information Submission Instructions: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed fifteen (15) total single-spaced pages including all attachments, resumes, charts, etc. ( 12 point font size at a minimum), that clearly details the firm's ability to perform and that addresses the specific requirements described above and the draft Statement of Work (SOW). Tailored capability statements should also include an indication of current certified small business status. 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 on the first page of your capability statement. Additionally include the Task Area(s) to which you are responding to on the first page. Responses can be for one or both Task Areas. 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 Miguel Diaz, Contracting Officer, at miguel.diaz@nih.gov either in MS Word, or searchable Adobe Portable Document Format (PDF). The email subject line must specify HHS-NIH-NCI-SBSS-PCPSB-65002-45. Facsimile and telephone responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 4:00PM EST on March 28, 2016. CAPABILITY STATEMENTS RECEIVED AFTER THIS 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 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).