Inactive

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIH-NINDS-NOI- 21-007422 TITLE: Genetic Testing Services for Patients with Rare and Unknown Neuromuscular CLASSIFICATION CODE: Q301 Medical- Labora... NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIH-NINDS-NOI- 21-007422 TITLE: Genetic Testing Services for Patients with Rare and Unknown Neuromuscular CLASSIFICATION CODE: Q301 Medical- Laboratory Testing NAICS CODE: 621511 - Medical Laboratories RESPONSE DATE: September 6, 2021 PRIMARY POINT OF CONTACT: Shayna Simpson, Contract Specialist NINDS Contracts Management Branch, NIDA Shayna.Simpson@nih.gov DESCRIPTION: THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO AWARD ON A SOLE SOURCE BASIS. THIS IS NOT A REQUEST FOR QUOTE/PROPOSALS. On behalf of the National Institute of Neurological Disorders and Stroke (NINDS), the Office of Acquisitions Contracts Management Branch Red, NINDS Section of the National Institute on Drug Abuse (NIDA), intends to solicit on a sole-source basis by a request for quotation to The Broad Institute (Broad) to provide next generation-based sequencing services including: whole exome sequencing, whole genome sequencing, access to data on or around September 10, 2021, with an award issued on or around September 30, 2021. The purpose of this acquisition is to acquire: (1) whole exome sequencing, (2) whole genome sequencing, (3) RNA sequencing to provide and (4) access to data through an analysis platform Seqr to obtain genetic diagnosis and identify novel genetic causes for muscle disease. NINDS requires application of the proprietary processes for a specific outcome for the NINDS protocol 12-N-0095 (“Protocol”). Broad shall provide the next generation-based sequencing processing services for the NINDS Neuromuscular and Neurogenetic Disorders of Childhood Section. These services shall be provided by Broad, the owner of the proprietary processes. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 621511 with a Size Standard of $35M. This acquisition is NOT set aside for small businesses, but rather is a sole-source acquisition to The Broad Institute. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source. BACKGROUND, PURPOSE AND OBJECTIVES OF REQUIREMENT The National Institute of Neurological Disorders and Strokes (NINDS) supports research into the causes, treatment, and prevention of neurological disorders and stroke. This request originates from the NINDS Neuromuscular and Neurogenetic Disorders of Childhood Section. The NINDS Neuromuscular and Neurogenetic Disorders of Childhood Section has samples collected under NIH protocol 12-N-0095. These sample can only be processed by utilizing the propriety process developed by Broad. Broad shall pursue sequencing. Government will provide summarized deidentified data through ‘Phenotips’ which is integrated in seqr. The seqr platform contains a wealth of data that the NINDS will build on for its research to identify genetic causes of neuromuscular disease. Government will be responsible to enroll patients in protocol 12-N-0095, obtain and process samples and facilitate transfer to Broad following the agreed upon submission pipeline. This process is critical to the NIH scientific community in order to continue to support cutting-edge research conducted by the Neuromuscular and Neurogenetic Disorders of Childhood Section. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The Broad Institute established the proprietary sequencing processes. They are the only contractor authorized and capable of providing the processes to analyze samples and has developed Seqr, an open source software platform for rare disease genomics. This proprietary processes and data platform shall be utilized across a variety of studies for various disorders. The Seqr platform contains a wealth of data that the NINDS will build on for its research to identify genetic causes of neuromuscular disease. Specifically, NINDS requires application of this proprietary processes for a specific outcome for the NINDS protocol 12-N-0095 (“Protocol”). NINDS Protocol objective is to better understand nerve and muscle disorders that start early in life and run in families. The seqr platform contains a wealth of data that the NINDS will build on for its research to identify genetic causes of neuromuscular disease. Board is the only source with this proprietary sequencing processes. In accordance with FAR part 10, extensive market research was conducted to reach this determination. Specifically, contact with knowledgeable individuals both in industry and Government, as well as reviews of available product literature, revealed no other sources. A review of previous Government acquisitions returned no results that meet all requirements. Therefore, only The Broad Institute, is found to be capable of meeting the needs of this unique requirement. The intended source is: The Broad Institute 415 Main Street Cambridge, MA 02142 Salient characteristics: Contractor shall deposit all sequencing data in seqr for analysis. Seqr is being developed by the contractor as an open-source web interface to make research productive, accessible, and user-friendly while leveraging resources and infrastructure at the Broad Institute. Generated sequencing data is owned by the Government. Appropriate transfer agreements have been put in place (MTA 2015-0012). Genomics Platform activities shall fall under the Broad’s Specialized Service Facility (SSF), which covers all high-throughput production activities. The SSF designation provides for costs to be separately allocated for the purpose of determining a total charge for a specific activity. The SSF determines and charges funding source per-unit-prices for various activities (e.g., WGS) based on the accumulated direct costs for the activity (personnel, materials, equipment amortization, equipment maintenance, and other charges) together with an indirect cost rate based on the allocation of the actual departmental administration, central administration, and facilities operations, including rent, utilities, and maintenance actually attributable to the SSF. Contractor shall deposit all sequencing data in Seqr for analysis. Seqr is being developed by the Contractor as an open-source web interface to make research productive, accessible, and user-friendly while leveraging resources and infrastructure at the Broad Institute. The EIT may be used by federal employees with disabilities. Estimated Period of Performance: Base year: 09/30/2021 - 09/29/2022 Option year 1: 09/30/2022 - 09/29/2023 Option year 2: 09/30/2023 - 09/29/2024 Option year 3: 09/30/2024 - 09/29/2025 Option year 4: 09/30/2025 - 09/29/2026 Place of Performance: Porter Neuroscience Research Center 35 Convent Drive, Bldg 35, Room GF-125 Bethesda, MD 20892-3705 Contract Type: An indefinite delivery, indefinite quantity, fixed price type contract with option quantities and option periods is planned for this acquisition. CLOSING STATEMENT THIS NOTICE OF INTENT TO AWARD ON A SOLE-SOURCE BASIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must provide evidence that they can provide equipment that meets all of the requirements in this announcement. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIH-NINDS-NOI-21-007422. Responses must be submitted electronically to Shayna Simpson, Contract Specialist, Contracts Management Branch – Red, NINDS Section, NIDA, at Shayna.Simpson@nih.gov. U.S. Mail and Fax responses will not be accepted.