BROAD_NonComp Posting_NHGRI_AM.doc
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- IDENTIFY Study Participants – 5-Base Sample Preparation and Whole Genome Multiomic Profiling
- Solicitation number
- 75N98026Q01158
About this file
This is a Non-Competitive Synopsis and Notice of Intent to Award on a Sole-Source Basis issued by the National Institutes of Health, National Human Genome Research Institute (NHGRI), Center for Precision Health Research, Prenatal Genomics and Therapy Section. The Government intends to award a purchase order to The Broad Institute, Inc. on a sole-source basis for 5-base sample preparation and whole genome multiomic profiling services supporting the IDENTIFY study, with an anticipated award date of September 25, 2026. The acquisition is not expected to exceed the Simplified Acquisition Threshold and is being conducted under the Revolutionary FAR Overhaul (RFO) framework, specifically RFO FAR Part 13 for simplified procedures for noncommercial acquisitions.
The contractor shall perform 5-base sample preparation on Government-furnished plasma-derived cell-free DNA samples, conduct whole genome multiomic profiling and sequencing, generate genomic and epigenomic data, perform quality-control activities, and provide resulting data in mutually agreed electronic formats along with associated technical documentation. The period of performance is 12 months from award, with services performed at the contractor's facility and electronic deliverables submitted to NHGRI at the specified Bethesda, Maryland address. The associated NAICS code is 541380 with a small business size standard of $19.5 million, and the requirement has no set-aside restrictions. The Government determined that The Broad Institute is the only reasonably available source due to the ongoing nature of the research and the requirement to maintain scientific continuity with previously generated data; introducing another source could introduce unknown variables and compromise study validity. Capability statements from other sources will be accepted until September 15, 2026 at 12:00 PM EST and must be submitted electronically to ty.main@nih.gov, addressing experience with 5-base whole genome sequencing of cell-free DNA, technical capability, quality-control processes, and the ability to maintain scientific continuity without introducing material technical or methodological variables.
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Exhibit 11
NON-COMPETITIVE SYNOPSIS
NOTICE OF INTENT TO AWARD ON A SOLE-SOURCE BASIS
Title: IDENTIFY Study Participants – 5-Base Sample Preparation and Whole Genome Multiomic Profiling
(i) This announcement constitutes a non-competitive synopsis and Notice of Intent to award on a sole-source basis and is not a solicitation for competitive quotations or proposals. A separate written solicitation will not be issued.
The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI), Center for Precision Health Research, Prenatal Genomics and Therapy Section, intends to award a purchase order on a sole-source basis to The Broad Institute, Inc. for 5-base sample preparation and whole genome multiomic profiling services in support of the IDENTIFY study.
The anticipated award date is 09/25/2026.
This acquisition is not expected to exceed the Simplified Acquisition Threshold (SAT) and is being conducted under the Revolutionary FAR Overhaul (RFO) framework, including RFO FAR Part 13 – Simplified Procedures for Noncommercial Acquisitions, as applicable. HHSAR Class Deviation 2026-04 aligns HHSAR Part 313 with the RFO FAR Part 13 framework.
The Government intends to solicit from a single source pursuant to RFO FAR 13.101(b), Competition. Under that authority, a contracting officer may solicit from a single source based on a determination and findings that only one source is reasonably available.
The Government has determined that The Broad Institute, Inc. is the only source reasonably available to satisfy the Government's current requirement.
The basis for this determination is that the requirement supports an ongoing research study and The Broad Institute has previously provided the applicable services supporting the research. Maintaining scientific continuity with previously generated research data is essential. Use of a different service provider could introduce unknown or uncontrolled variables into sample preparation, sequencing, data generation, or related technical processes. Such variables could affect comparability with previously generated research data and could compromise or invalidate the scientific interpretation of the ongoing study results.
Accordingly, the Government has determined that only The Broad Institute, Inc. is reasonably available to meet the current requirement while maintaining the scientific continuity necessary for the ongoing research.
(ii) Notice/Solicitation Number: 75N98026Q01158 This notice is issued in connection with the Government's proposed sole-source acquisition described herein.
(iii) The associated NAICS code 541380 and the small business size standard is $19.5M. This requirement has no set-aside restrictions.
(iv) Background and Purpose:
A central objective of the IDENTIFY study is to determine whether circulating cell-free DNA analyses can identify the tissue of origin of incidentally detected maternal malignancies.
To support this objective, the National Human Genome Research Institute requires 5-base whole genome sequencing services on stored plasma-derived cell-free DNA samples collected under the IDENTIFY protocol.
The resulting genomic and epigenomic data will be integrated into ongoing bioinformatic analyses to refine tissue-of-origin classification models and improve interpretation of atypical prenatal cell-free DNA sequencing findings.
This work supports NIH's mission to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability.
(v) Project Requirements The Contractor shall provide 5-base sample preparation and whole genome multiomic profiling services for stored plasma-derived cell-free DNA samples collected under the IDENTIFY study protocol.
The Contractor shall:
1. Perform 5-base sample preparation on Government-furnished plasma-derived cell-free DNA samples;
2. Conduct whole genome multiomic profiling/sequencing;
3. Generate genomic and epigenomic data from the processed samples;
4. Perform appropriate sequencing and data quality-control activities;
5. Provide the resulting data to the Government in mutually agreed electronic formats; and
6. Provide associated technical and quality-control documentation necessary for the Government to incorporate the resulting data into ongoing bioinformatic analyses.
The services must support scientific continuity with data previously generated for the ongoing study. Consistency in sample preparation, sequencing methodology, data generation, and associated technical processes is necessary to minimize the introduction of unknown variables that could affect comparability with existing research data.
Period of Performance: Upon award for 12 months.
(vi) PLACE OF PERFORMANCE / DELIVERYThe provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services, applies to this acquisition.
Services will be performed at the Contractor's facility, as applicable.
Government-furnished samples will be transferred in accordance with instructions coordinated between the Government and Contractor.
Electronic data and other deliverables shall be provided to:
National Institutes of Health National Human Genome Research Institute Center for Precision Health Research Prenatal Genomics and Therapy Section 10 Center Drive, MSC 1960 Bethesda, MD 20892-1960
(vii)
SOLE-SOURCE AUTHORITY AND DETERMINATION
This acquisition is being conducted under RFO FAR 13.101(b), Competition.
Under RFO FAR 13.101(b), a contracting officer may solicit from a single source based on a determination and findings that only one source is reasonably available.
The Government's determination that only one source is reasonably available is based on the ongoing nature of the research and the requirement to maintain scientific continuity with previously generated data.
The Broad Institute has previously provided the applicable services supporting the ongoing research. Introducing another source could introduce unknown variables into the study and affect the comparability, consistency, or validity of previously generated and newly generated research data.
The Government therefore intends to award this requirement on a sole-source basis to:
The Broad Institute, Inc.
The Government's Sole-Single Source Justification / Determination and Findings provides the supporting findings for this determination.
(viii)
CAPABILITY STATEMENTS
This Notice of Intent is not a request for competitive quotations or proposals.
However, any responsible source that believes it is capable of satisfying the Government's requirement may submit a written capability statement within the response period identified below.
A capability statement must provide clear and convincing evidence demonstrating the respondent's ability to satisfy the requirement, including information addressing:
1. Experience performing 5-base whole genome sequencing and multiomic profiling of plasma-derived cell-free DNA;
2. Capability to perform the required sample preparation and sequencing services;
3. Ability to generate genomic and epigenomic data suitable for integration with existing IDENTIFY study datasets;
4. Relevant quality-control processes;
5. Ability to perform the services within the required period of performance; and
6. Technical information demonstrating the ability to perform the requirement without introducing material technical or methodological variables that would adversely affect scientific continuity or comparability with previously generated study data.
The response should also include:
· Legal business name;
· Unique Entity Identifier (UEI);
· Business size;
· SAM.gov registration status;
· Point of contact information; and
· Sufficient supporting technical information for the Government to evaluate the respondent's capability.
Pricing information is not required unless specifically requested by the Contracting Officer.
Information received in response to this notice will be considered solely for the purpose of determining whether conducting a competitive acquisition is appropriate.
A determination by the Government not to compete the proposed acquisition based upon responses to this notice is solely within the discretion of the Government.
The Government will not reimburse respondents for any costs incurred in preparing or submitting a response to this notice.
(ix)
RESPONSE DEADLINE AND SUBMISSION
Capability statements must be received no later than: 09/15/2026. 12:00PM EST Reference: IDENTIFY Study Participants – 5-Base Sample Preparation and Whole Genome Multiomic Profiling Notice/Solicitation No. 75N98026Q01158 Responses shall be submitted electronically to:
Ty Main Hospital and Laboratory Support Division
Office of Logistics and Operations (OLAO)
Office of Acquisition and Logistics Management (OALM)
Office of the Director (OD)
National Institutes of Health (NIH)
Email: ty.main@nih.gov Telephone and fax responses will not be accepted.
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