Inactive

On 12/19/2022 the U.S. Small Business Administration updated the size standards. Therefore, the size standard for NAICS code 541380 Testing Laboratories and Services has been updated below. The due da... On 12/19/2022 the U.S. Small Business Administration updated the size standards. Therefore, the size standard for NAICS code 541380 Testing Laboratories and Services has been updated below. The due date and time for responses remains unchanged. The Statement of Work (SOW) attachment remains unchanged. Amendment 1 - Dated 12/21/2022 Small Business Sources Sought Notice Title: NCI Genomic Characterization Centers Notice Number: HHS-NIH-NCI-SBSS-TSB-75N91023R00007 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. A determination by the Government not to compete this requirement as a set-aside based upon responses to this Notice is solely within the discretion of the Government. Interested parties are expected to review this notice and the DRAFT Statement of Work (SOW) to familiarize themselves with the requirements of this project; failure to do so will be at your firm's own risk. Background: Cancer is a complex and heterogeneous disease in which mutations and other genomic and epigenomic abnormalities play a role in both its initiation and progression. Accumulated research data implicate numerous somatic mutations and a more limited number of inherited mutations in carcinogenesis. Understanding cancer-specific somatic mutations can provide important clues regarding the molecular processes underlying the development and progression of certain tumors. Given cancer’s complexity, it is generally believed that only a fraction of alterations that may be useful as characteristic markers of specific tumor types and/or potential molecular targets have been identified to date. Therefore, to be successful, comprehensive genomic analyses of cancer must overcome a broad range of challenges stemming from the biological complexity and heterogeneity of human tumors and subtypes. An important role in tumor heterogeneity is played by the genomic instability, which is inherent to the progression of cancer. The dynamic changes in tumor genomes are influenced by the cellular and biological context, genetic characteristics of individual persons, and environmental factors. Certain similarities exist across tumor types, however any effort to characterize the genomes of tumors in a comprehensive, systematic manner must address the heterogeneity across distinct cancer types and subtypes. The Center for Cancer Genomics (CCG) conducts and collaborates on genomic studies on biospecimens from cancer patients for whom clinical characteristics and treatment outcome data are also available using many of the components in the existing CCG infrastructure. CCG has decided that all of its in-process genomic characterization projects will proceed using the same operational model through a coordinated pipeline to receive tissues accrued to the different projects, process analytes, generate and analyze data and present the results to the community. Components of this pipeline are: Biospecimen Processing Center (BPC) provides biospecimen receipt, processing to molecular analyte, and distribution services for all CCG supported projects. BCP provides the biomolecules for GCCs. Genome Characterization Centers (GCCs) (current acquisition): As a part of any CCG project, the GCCs will perform high quality genomic, transcriptomic, and epigenomic characterizations with validated technologies (e.g., DNA and RNA sequencing, methylation arrays, etc.) to reveal the spectrum of alterations in human tumors. Genome Data Analysis Centers (GDACs): The Genome Data Analysis Centers (GDACs) work hand-in-hand with the Genome Characterization Centers (GCCs) to perform “higher level” analyses of the data produced by the GCC and to develop state-of-the-art tools that assist researchers with processing and integrating data analyses across the entire genome. Data Management, Bioinformatics, and Computational Analysis: Data generated by CCG projects will be deposited into the NCI Genomic Data Commons (GDC) for use by the cancer research community. The end goal of CCG’s programs is to make cancer genomic data available to the research community via the GDC. Contractors shall submit tailored capability statements for at least one pool as listed below in this section. Offerors are permitted but not required to respond with tailored capability statements for multiple pools. Pool 1: High Throughput DNA Sequencing Pool 2: High Throughput RNA Sequencing Pool 3: Epigenetic Characterization with Sequencing-based Assays or Array-based Assays Pool 4: Single-Cell/Single-Nuclei Sequencing Purpose and Objectives: The purpose of this Small Business Sources Sought Notice is to identify qualified small business concerns including HUBZone small businesses; service disabled, veteran-owned small businesses; 8(a) small businesses; women-owned small businesses; or small disadvantaged businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received. As a result of this SBSS notice, the NCI may issue a Request for Proposal (RFP) and a single RFP maybe used to solicit for all four pools described above. THERE IS NO SOLICTATION AVAILABLE AT THIS TIME. However, should such a requirement materialize no basis for claim against the NCI shall arise as a result of a response to this Small Business Sources Sought Notice or the NCI’s use of such information as either part of our evaluation process or in developing specification for any subsequent requirement. Project Requirements: The overarching goal for the GCCs is to perform high-resolution, systematic and comprehensive characterization of cancer-related genomic alterations in multiple types of cancers for an expanding list of National Cancer Institute (NCI)-supported genomics projects. These genome-wide characterizations should be conducted with validated methods using high-throughput and quality-controlled pipelines. The GCCs will receive cancer biomaterials (DNA, RNA, protein or other types of molecular analyte) and associated data from a centralized Biospecimen Processing Center (funded by NCI separately). The aim is to have all molecular characterizations conducted on biomolecules from the same biospecimens for optimal analytical integration and for data comparability. The specific or mandatory requirements for characterization platforms will be identified in a separate Task Order Statement of Work. All Contractors shall perform the following tasks in general: 1. Receive molecular analytes from BCR 2. Operate genome characterization pipelines 3. Perform Quality Control 4. Improve performance of characterizations 5. Informatics and Data Delivery 6. Conduct Transition Activities Anticipated Period of Performance: It is anticipated that any awards that may result from this solicitation will be Indefinite Delivery/Indefinite Quantity (IDIQ) contract(s). Task orders issued under the IDIQ contract(s) are anticipated to be either be firm fixed price or cost reimbursement. The duration of the IDIQ contract(s) is anticipated to be for a five (5) year period of performance. The anticipated start date is on or about August 2024. The anticipated number of IDIQ awards is up to sixteen (16). If a RFP is issued, the NCI anticipates that the following number of awards may result from the issuance of the RFP (per pool): Pool 1: High Throughput DNA sequencing – up to four (4) IDIQ awards estimated Pool 2: High Throughput RNA sequencing – up to four (4) IDIQ awards estimated Pool 3: Epigenetic Characterization with Sequencing-based Assays or Array-based Assays – up to four (4) IDIQ awards estimated Pool 4: Single-Cell/Single-Nuclei Sequencing – up to four (4) IDIQ awards estimated NAICS Code and Size Standard/Product Support Code: In an event an RFP is issued, the NAICS code for this acquisition is 541380, Testing Laboratories and Services, which has a size standard of $19 million. The Product Service Code (PSC) for this requirement is B529 – Special Studies/Analysis-Scientific Data. Delivery: Public availability of data/information generated by GCCs will be critical to facilitate disease-relevant discoveries of clinical significance. Data generated by GCCs shall be transmitted into NCI Genomic Data Commons (GDC) as soon as they are validated, in general within four weeks of generation. GCCs will submit primary data and metadata to GDC by adapting their submission process to meet the submission requirements of GDC. Contractors are required to submit a Data Sharing Plan documenting how data will be released and shared. The Data Sharing Plan must be consistent with the goals of CCG and NCI genomic programs, with adherence to NIH data sharing policies for the protection of human subjects. Other Important Considerations: A copy of the Draft Statement of Work (SOW), which is subject to revisions, is attached. Capability Statement/Information Sought: Sources are expected to furnish the necessary services, qualified personnel, materials, facilities, equipment and experience to meet the requirements in the attached, DRAFT SOW. Respondents must be qualified and prepare a tailored capability statement that demonstrated a clear understanding of all Task Areas in the attached, DRAFT SOW. 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 outlined in the Task Area(s) I the attached, DRAFT Statement of Work; 2. Provide appropriate Personnel for the project; 3. Access appropriate resources (e.g., Facilities & Equipment); and 4. Implement appropriate Quality Management programs. Information Submission Instructions: 1. Format: Interested, qualified small business organizations should submit a SEPARATE TAILORED CAPABILITY STATEMENT for each pool in which they are interest. Small businesses may submit between 1-4 Capability Statements (one per pool). 2. Page Limitations: Interested, qualified small business organizations should submit a tailored capability statement for this requirement not to exceed ten (10) single-sided pages excluding all attachments, resumes, charts, and other relevant supporting documentation etc. (single spaced, 12 point font minimum) that clearly details the firm’s ability to perform the aspects of the notice described above and in the DRAFT SOW. Tailored capability 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 concerns name and address) as well as the eligible small business concern’s name, point of contact, address and DUNS number. All pages must be numbered including attachments, resumes, charts etc. 3. Delivery Point: All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Alexis Hudak, Contracting Officer at alexis.hudak@nih.gov and Lindsay Nelson, Contract Specialist at Lindsay.tonon@nih.gov in Microsoft Word or Adobe Portable Document Format (PDF). The subject line must specify HHS-NIH-NCI-SBSS-TSB-75N91023R0007 and clearly indicate which pool(s) the Capability Statement is addressing. 4. Common Cut-Off Date: Electronically submitted tailored capability statement are due no later than 3:00 PM (EST) on Wednesday, January 4, 2023. 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 this 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 SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation(s). 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). Contracting Office Address: 8490 Progress Drive, Suite 400 Riverside Five Frederick, MD 21701 Primary Point of Contact: Alexis Hudak Contracting Officer alexis.hudak@nih.gov Secondary Point of Contact: Lindsay Nelson Contract Specialist lindsay.tonon@nih.gov