Validation and Optimization of ONE-STEP Tagging in Human induced Pluripotent Stem Cells

. The National Institute on Aging (NIA), National Institutes of Health (NIH), Department of Health and Human Services (HHS), intends to negotiate and award a sole source contract to: The Jackson Laboratory 600 Main Street Bar Harbor, ME 04609-1500 UEI: XR6LMXNKDJJ1 for the acquisition titled: Validation and Optimization of ONE-STEP Tagging in Human induced Pluripotent Stem Cells The Government anticipates awarding this requirement under the authority of FAR 13.501(a) and FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This Is Not a Request for Quotes This notice is not a Request for Quotations (RFQ), Request for Proposals (RFP), or Invitation for Bids (IFB). The Government does not intend to solicit competitive quotes or proposals in response to this notice. No solicitation package is available. This notice shall not be construed as a commitment by the Government to issue a solicitation, award a contract, or pay for any information submitted in response to this notice. However, any responsible source that believes it is capable of satisfying the Government�s requirement may submit a capability statement for consideration. Capability statements must be submitted by the response deadline identified in this notice. The Government will review all timely responses solely for the purpose of determining whether adequate competition exists to support a competitive procurement. Background The National Institute on Aging requires highly specialized human induced pluripotent stem cell (iPSC) engineering services to support the iPSC Neurodegenerative Disease Initiative (iNDI) and the Center of Alzheimer�s Disease and Related Dementias (CARD). The purpose of this acquisition is to validate and optimize the ONE-STEP tagging system and generate functionally engineered iPSC lines for Alzheimer�s disease and related dementias (ADRD) research. This work is part of an ongoing NIA/CARD effort to create rigorously characterized, genetically defined cellular models and distribute them to the research community as standardized resources. The requirement builds upon prior iNDI engineering efforts and requires continuity of methods, quality control, and repository-compatible deliverables. Required Services The contractor shall provide all personnel, materials, equipment, facilities, and technical expertise necessary to perform the required work, including but not limited to: identification of high-activity guides for monoallelic and biallelic attP insertion at safe harbor loci; optimization of Bxb1 mRNA and cargo plasmid delivery; testing of novel landing pad designs and alternative reagents; validation of monoallelic and biallelic ONE-STEP tagging across multiple loci; validation of cargo design for ONE-STEP tagging; generation of functionalized iPSC lines, including ADRD variant lines, MAPT 4R lines, wild-type process-control clones, and Discovery background CRISPR machinery lines; advanced quality control and sequencing validation; and repository-ready delivery of engineered cell lines. Sole Source Rationale The Jackson Laboratory is the only known source capable of meeting the Government�s requirement due to its unique combination of: direct continuity with the existing iNDI engineering program; demonstrated success in large-scale CRISPR/Cas9 engineering of human iPSCs; established workflows for KOLF2.1J, FA13.1J, and Discovery background lines; validated quality control pipelines, including long-read sequencing and repository deposition; and prior successful performance on related NIA iNDI and iNDI+ efforts. Award to another source would result in unacceptable duplication of cost, schedule delay, and scientific risk due to the need to re-establish workflows and demonstrate comparability with the existing iNDI collection. Period of Performance Base Year: September 1, 2026 � August 31, 2027 Option Year 1: September 1, 2027 � August 31, 2028 Submission Instructions Interested organizations may submit a capability statement demonstrating their ability to satisfy the Government�s requirement. Capability statements must clearly address the organization�s ability to provide: specialized iPSC engineering services at the required scale; validated workflows compatible with the existing iNDI program; experience with KOLF2.1J, FA13.1J, and related Discovery background lines; advanced sequencing-based quality control and validation; and repository-ready delivery of engineered cell lines. Capability statements shall be limited to a reasonable length and must include sufficient technical detail to allow the Government to evaluate the respondent�s capability. Responses must be received no later than: August 21, 2026, 11:00 AM EST Responses shall be submitted via email to both of the points of contact listed below. Primary Point of Contact Linda Smith Email: linda.smith2@nih.gov Secondary Point of Contact Danielle Tines Email: danielle.tines@nih.gov Contracting Office Address Office of Acquisitions National Institutes of Health Department of Health and Human Services Bethesda, MD 20892