iNDI FA13.1J Cell Lines Expansion and Distribution for the iPSC Neurodegenerative Disease Initiative (iNDI) Project

Notice of Intent to Award a Sole Source Contract

This notice announces the Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute on Aging (NIA)'s intent to award a sole source contract for the expansion, quality control, curation, biobanking, and distribution of iPSC cell lines for the iPSC Neurodegenerative Disease Initiative (iNDI) Project. This is not a request for competitive proposals.

• Expansion and distribution of up to 936 isogenic Alzheimer's disease and related dementias (ADRD) induced pluripotent stem cell (iPSC) lines.

• Specific requirements include:

  • FA13.1J female SNV lines (486 lines)
  • 25 high-priority SNV trios across six additional iPSC lines (450 lines)
  • Expansion and quality control per current iNDI protocols
  • Product and web content creation for each iPSC line
  • Public distribution via a contractor-hosted website/platform

• Contract Type: Firm-fixed-price

• Period of Performance:

  • Base Year: September 1, 2026 – August 31, 2027
  • Option Year 1: September 1, 2027 – August 31, 2028
  • Option Year 2: September 1, 2028 – August 31, 2029
  • Option Year 3: September 1, 2029 – August 31, 2030

• Place of Performance: Contractor's facility

• This is not a solicitation. However, responsible sources may submit a capability statement demonstrating their ability to meet the requirements.

• Capability statements must address:

  • Provision of specific iNDI FA13.1J cell lines and associated iNDI lines.
  • Expansion and quality control per iNDI protocols.
  • Product and web content creation.
  • Public distribution via an established platform.
  • Continuity with existing iNDI resources.

• Responses must include company name, UEI/CAGE code, business size, socioeconomic status, technical point of contact, and narrative capability statement.

• Submission Deadline: June 23, 2026, 11:00 am EST.

• Sole source award to The Jackson Laboratory.

• The statutory authority cited is 41 U.S.C. 1901, FAR 13.501(a)(1)(ii), and FAR 6.302-1, due to only one responsible source satisfying agency requirements.

• Market research indicates The Jackson Laboratory is the only known source capable of providing the required services and possesses the necessary infrastructure and prior experience.

• Responses are for determining whether to conduct a competitive procurement; a decision not to compete is at the Government's discretion.

• The Government is not responsible for costs incurred in preparing responses.

• Primary Point of Contact: Linda Smith, linda.smith2@nih.gov

• Secondary Point of Contact: Danielle Tines, danielle.tines@nih.gov

Statement of Work (SOW)

To generate a collection of up to 936 isogenic Alzheimer's disease and related dementias (ADRD) induced pluripotent stem cell (iPSC) lines for the iPSC Neurodegenerative Disease Initiative (iNDI) project.

• Expand and quality control gene-edited iPSC lines using CRISPR-Cas12a technology according to current iNDI cell line protocols.
• Generate FA13.1J female SNV lines (162 trios totaling 486 iPSC lines) and 25 of the most relevant SNVs across six additional iPSC lines (totaling 450 iPSC lines).
• Offer the option to engineer and expand iPSC lines via manual or automated processes.
• Make distribution lots available for purchase by the scientific community through a contractor-created website.

Detailed quality control procedures are outlined for both manual and automated expansion, including criteria for:

• Post-thaw viability (>80% for manual, >50% confluency within 10 days for automated).

• Non-viral and viral agent testing (qPCR).

• Yeast and fungal testing.

• Bacterial testing (Gram-negative and Gram-positive).

• Gene-edited variant sequence confirmation (PCR and Sanger sequencing).

• SNP-Based Digital Karyotyping (Illumina Infinium Global Diversity Array).

• Pluripotency Expression Profile (RNA sequencing).

• Reprogramming Vector Clearance (RNA sequencing).

• Sterility and Mycoplasma testing.

• Base Year: September 1, 2026 - August 31, 2027

• Option Year 1: September 1, 2027 - August 31, 2028

• Option Year 2: September 1, 2028 - August 31, 2029

• Option Year 3: September 1, 2029 - August 31, 2030

• Principal place of performance is the contractor's work site; no travel is necessary.

• Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities.

• Provide a report for each cell line documenting quality control testing.

• A dedicated senior PhD accredited project manager is required.