SPECIAL NOTICE — INTENT TO SOLE SOURCE Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS)
\n\nAcquisition Title: FY26–FY30 precisionFDA Platform Indefinite Delivery Indefinite Quantity (IDIQ)
\n\nAcquisition Identification Number: ODT-2026-132021
\n\nNAICS Code: 541714
\n\nPSC Code: D319 (Cloud Computing)
\n\nSet-Aside: Small Business (DNAnexus confirmed SB under NAICS 541714)
\n\nContract Type: Firm-Fixed-Price IDIQ
\n\nPeriod of Performance: 08/10/2026 – 08/09/2030
\n\nEstimated Value: $33,000,000
\n\nNotice:
\n\nThe Food and Drug Administration (FDA), Office of Digital Transformation (ODT), Office of Data Analytics and Research (ODAR), Health Informatics Staff (HIS), intends to award a sole-source Indefinite Delivery Indefinite Quantity (IDIQ) contract to:
\n\nDNAnexus, Inc. 1975 West El Camino Real, Suite 204 Mountain View, CA 94040
\n\nThis action is being conducted under the authority of FAR 6.302-1 (Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements), pursuant to 41 U.S.C. 3304(a)(1).
\n\nDescription of Requirement:
\n\nThe FDA requires continued operations, sustainment, modernization, and cloud support for the precisionFDA platform — a FISMA-authorized, secure, cloud-based collaborative research environment for next-generation sequencing (NGS) assay evaluation, genomics and multi-omics research, and regulatory science applications. The platform supports collaboration between FDA researchers and reviewers, as well as external collaborators and sponsors across multiple FDA centers, including CDER, CBER, CDRH, CVM, and CFSAN.
\n\nServices to be acquired include:
\n\nPlace of Performance: Contractor facility and FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993
\n\nBasis for Sole Source Determination:
\n\nComprehensive market research was conducted in accordance with FAR Part 10, evaluating 20 vendors with a detailed assessment of 8 shortlisted vendors against 33 critical capability requirements. The research conclusively determined that DNAnexus is the only vendor capable of meeting FDA's requirements for Day-1 continuity of the precisionFDA mission on the date of contract award, for the following reasons:
\n\nOnly vendor with zero capability gaps: DNAnexus is the only vendor that scored fully across all 33 assessed capabilities. No alternative vendor can replicate on Day 1 the precisionFDA capabilities of immutable files with chain of provenance, file locking, Government-only spaces, Protected spaces, Review spaces, FHIR Stations, the Scientific Challenge Framework, or custom data portal development capability.
\n\tUnique secure external collaboration capability: DNAnexus is the only platform provider able to facilitate secure FDA-sponsored scientific challenges and controlled communication with industry sponsors, vendors, academic researchers, and international regulatory partners while maintaining regulatory-grade confidentiality controls, data segregation, audit trails, and compliance features.
\n\tInstitutional knowledge and validated workflows: FDA has invested over seven years in developing, validating, and documenting bioinformatics workflows on the precisionFDA platform. Over 300 FDA scientific reviewers, bioinformaticians, and research scientists have been trained on the platform. The application library includes 100+ versioned apps. Migration to an alternative platform would require complete revalidation and an estimated $14.7M full rebuild.
\n\tFedRAMP and FISMA compliance: DNAnexus holds FedRAMP Class C (Moderate) authorization (Cert ID FR1814557199, confirmed June 18, 2026) and FISMA Moderate ATO (FDA-sponsored). DNAnexus is actively enrolled in the PRISM High-Impact Platform Pilot (March 2026) providing a structured pathway to FedRAMP High authorization, with a parallel FISMA High ATO track to support the precisionFDA High platform.
\n\tSmall Business: DNAnexus is confirmed as a Small Business under NAICS 541714 (~277 employees; 1,000-employee size standard).
\n\tResponse Instructions:
\n\nThis notice is not a solicitation and does not commit the Government to award a contract. No award will be made solely on the basis of responses to this notice.
\n\nInterested parties who believe they are capable of meeting the Government's requirements in their entirety may submit a written capability statement to the Contracting Officer no later than 15 calendar days from the date of this notice. Capability statements will be evaluated to determine whether full and open competition should be conducted in lieu of a sole-source award.
\n\nCapability statements must address, at a minimum, the vendor's ability to provide Day-1 continuity of all current precisionFDA capabilities, FedRAMP Class C (Moderate) authorization status, and a demonstrated pathway to FISMA High authorization.
\n\nResponses must be submitted electronically to:
\n\nSteven Gagnon, Contracting Officer Email: Steven.Gagnon@fda.hhs.gov
\n\nAllison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov
\n\nSubject Line: Capability Statement — precisionFDA IDIQ Sole Source Notice, ODT-2026-132021
\n\nTelephone responses will not be accepted. The Government is not responsible for any costs incurred in preparing a response to this notice.
\n\nPoint of Contact:
\n\nSteven Gagnon, Contracting Officer Food and Drug Administration, Office of Acquisitions and Grants Services Email: Steven.Gagnon@fda.hhs.gov
\n\nAllison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov
","text":"SPECIAL NOTICE — INTENT TO SOLE SOURCE Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS)\n\nAcquisition Title: FY26–FY30 precisionFDA Platform Indefinite Delivery Indefinite Quantity (IDIQ)\n\nAcquisition Identification Number: ODT-2026-132021\n\nNAICS Code: 541714\n\nPSC Code: D319 (Cloud Computing)\n\nSet-Aside: Small Business (DNAnexus confirmed SB under NAICS 541714)\n\nContract Type: Firm-Fixed-Price IDIQ\n\nPeriod of Performance: 08/10/2026 – 08/09/2030\n\nEstimated Value: $33,000,000\n\nNotice:\n\nThe Food and Drug Administration (FDA), Office of Digital Transformation (ODT), Office of Data Analytics and Research (ODAR), Health Informatics Staff (HIS), intends to award a sole-source Indefinite Delivery Indefinite Quantity (IDIQ) contract to:\n\nDNAnexus, Inc. 1975 West El Camino Real, Suite 204 Mountain View, CA 94040\n\nThis action is being conducted under the authority of FAR 6.302-1 (Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements), pursuant to 41 U.S.C. 3304(a)(1).\n\nDescription of Requirement:\n\nThe FDA requires continued operations, sustainment, modernization, and cloud support for the precisionFDA platform — a FISMA-authorized, secure, cloud-based collaborative research environment for next-generation sequencing (NGS) assay evaluation, genomics and multi-omics research, and regulatory science applications. The platform supports collaboration between FDA researchers and reviewers, as well as external collaborators and sponsors across multiple FDA centers, including CDER, CBER, CDRH, CVM, and CFSAN.\n\nServices to be acquired include:\n\n• Platform access licenses, cloud computing resources (compute, storage, data transfer on AWS), operations and maintenance, security patching, and technical support\n\n• Continuation of all current precisionFDA capabilities, including immutable files with chain of provenance, file locking, Government-only spaces, Protected spaces, Review spaces, FHIR Stations, Scientific Challenge Framework, and custom data portal development capability\n\n• Development and maintenance of the precisionFDA High (FISMA High) platform on FDA GovCloud\n\n• FedRAMP Class C (Moderate) and FISMA High compliance maintenance per NIST SP 800-53 Rev5\n\n• Integration support for FDA enterprise systems including the Global Substance Registration System (GSRS)\n\n• Training, user support, disaster recovery, and business continuity services\n\nPlace of Performance: Contractor facility and FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993\n\nBasis for Sole Source Determination:\n\nComprehensive market research was conducted in accordance with FAR Part 10, evaluating 20 vendors with a detailed assessment of 8 shortlisted vendors against 33 critical capability requirements. The research conclusively determined that DNAnexus is the only vendor capable of meeting FDA's requirements for Day-1 continuity of the precisionFDA mission on the date of contract award, for the following reasons:\n\n•\nOnly vendor with zero capability gaps: DNAnexus is the only vendor that scored fully across all 33 assessed capabilities. No alternative vendor can replicate on Day 1 the precisionFDA capabilities of immutable files with chain of provenance, file locking, Government-only spaces, Protected spaces, Review spaces, FHIR Stations, the Scientific Challenge Framework, or custom data portal development capability.\n\n•\nUnique secure external collaboration capability: DNAnexus is the only platform provider able to facilitate secure FDA-sponsored scientific challenges and controlled communication with industry sponsors, vendors, academic researchers, and international regulatory partners while maintaining regulatory-grade confidentiality controls, data segregation, audit trails, and compliance features.\n\n•\nInstitutional knowledge and validated workflows: FDA has invested over seven years in developing, validating, and documenting bioinformatics workflows on the precisionFDA platform. Over 300 FDA scientific reviewers, bioinformaticians, and research scientists have been trained on the platform. The application library includes 100+ versioned apps. Migration to an alternative platform would require complete revalidation and an estimated $14.7M full rebuild.\n\n•\nFedRAMP and FISMA compliance: DNAnexus holds FedRAMP Class C (Moderate) authorization (Cert ID FR1814557199, confirmed June 18, 2026) and FISMA Moderate ATO (FDA-sponsored). DNAnexus is actively enrolled in the PRISM High-Impact Platform Pilot (March 2026) providing a structured pathway to FedRAMP High authorization, with a parallel FISMA High ATO track to support the precisionFDA High platform.\n\n•\nSmall Business: DNAnexus is confirmed as a Small Business under NAICS 541714 (~277 employees; 1,000-employee size standard).\n\nResponse Instructions:\n\nThis notice is not a solicitation and does not commit the Government to award a contract. No award will be made solely on the basis of responses to this notice.\n\nInterested parties who believe they are capable of meeting the Government's requirements in their entirety may submit a written capability statement to the Contracting Officer no later than 15 calendar days from the date of this notice. Capability statements will be evaluated to determine whether full and open competition should be conducted in lieu of a sole-source award.\n\nCapability statements must address, at a minimum, the vendor's ability to provide Day-1 continuity of all current precisionFDA capabilities, FedRAMP Class C (Moderate) authorization status, and a demonstrated pathway to FISMA High authorization.\n\nResponses must be submitted electronically to:\n\nSteven Gagnon, Contracting Officer Email: Steven.Gagnon@fda.hhs.gov\n\nAllison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov\n\nSubject Line: Capability Statement — precisionFDA IDIQ Sole Source Notice, ODT-2026-132021\n\nTelephone responses will not be accepted. The Government is not responsible for any costs incurred in preparing a response to this notice.\n\nPoint of Contact:\n\nSteven Gagnon, Contracting Officer Food and Drug Administration, Office of Acquisitions and Grants Services Email: Steven.Gagnon@fda.hhs.gov\n\nAllison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov","origin":"detail"},"notice_type":{"code":"s","label":"Special Notice"},"schema_version":1,"place_of_performance":{"zip":"20993","state":{"code":"MD","name":"Maryland"},"country":{"code":"USA","name":"UNITED STATES"}}}],"due_at":"2026-10-09T13:00:00Z","due_date":"2026-10-09","closes_at":"2026-10-09T13:00:00Z","awardable":false,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7524","sub_name":"FOOD AND DRUG ADMINISTRATION","office_key":"o-n-FOODANDDRUGADMINISTRATION","office_name":"FOOD AND DRUG ADMINISTRATION","state":"MD","county":null,"county_name":null,"city":null,"city_name":null,"country":"USA","winner_key":null,"amount":null,"linked_awards":0,"cancelled":false,"archived":false,"updated_at":"2026-09-24T04:24:26.592861Z","principal_notice_id":"3d45a38609ec4064be998059aaa00851","description":{"text":"SPECIAL NOTICE — INTENT TO SOLE SOURCE Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS)\n\nAcquisition Title: FY26–FY30 precisionFDA Platform Indefinite Delivery Indefinite Quantity (IDIQ)\n\nAcquisition Identification Number: ODT-2026-132021\n\nNAICS Code: 541714\n\nPSC Code: D319 (Cloud Computing)\n\nSet-Aside: Small Business (DNAnexus confirmed SB under NAICS 541714)\n\nContract Type: Firm-Fixed-Price IDIQ\n\nPeriod of Performance: 08/10/2026 – 08/09/2030\n\nEstimated Value: $33,000,000\n\nNotice:\n\nThe Food and Drug Administration (FDA), Office of Digital Transformation (ODT), Office of Data Analytics and Research (ODAR), Health Informatics Staff (HIS), intends to award a sole-source Indefinite Delivery Indefinite Quantity (IDIQ) contract to:\n\nDNAnexus, Inc. 1975 West El Camino Real, Suite 204 Mountain View, CA 94040\n\nThis action is being conducted under the authority of FAR 6.302-1 (Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements), pursuant to 41 U.S.C. 3304(a)(1).\n\nDescription of Requirement:\n\nThe FDA requires continued operations, sustainment, modernization, and cloud support for the precisionFDA platform — a FISMA-authorized, secure, cloud-based collaborative research environment for next-generation sequencing (NGS) assay evaluation, genomics and multi-omics research, and regulatory science applications. The platform supports collaboration between FDA researchers and reviewers, as well as external collaborators and sponsors across multiple FDA centers, including CDER, CBER, CDRH, CVM, and CFSAN.\n\nServices to be acquired include:\n\n• Platform access licenses, cloud computing resources (compute, storage, data transfer on AWS), operations and maintenance, security patching, and technical support\n\n• Continuation of all current precisionFDA capabilities, including immutable files with chain of provenance, file locking, Government-only spaces, Protected spaces, Review spaces, FHIR Stations, Scientific Challenge Framework, and custom data portal development capability\n\n• Development and maintenance of the precisionFDA High (FISMA High) platform on FDA GovCloud\n\n• FedRAMP Class C (Moderate) and FISMA High compliance maintenance per NIST SP 800-53 Rev5\n\n• Integration support for FDA enterprise systems including the Global Substance Registration System (GSRS)\n\n• Training, user support, disaster recovery, and business continuity services\n\nPlace of Performance: Contractor facility and FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993\n\nBasis for Sole Source Determination:\n\nComprehensive market research was conducted in accordance with FAR Part 10, evaluating 20 vendors with a detailed assessment of 8 shortlisted vendors against 33 critical capability requirements. The research conclusively determined that DNAnexus is the only vendor capable of meeting FDA's requirements for Day-1 continuity of the precisionFDA mission on the date of contract award, for the following reasons:\n\n•\nOnly vendor with zero capability gaps: DNAnexus is the only vendor that scored fully across all 33 assessed capabilities. No alternative vendor can replicate on Day 1 the precisionFDA capabilities of immutable files with chain of provenance, file locking, Government-only spaces, Protected spaces, Review spaces, FHIR Stations, the Scientific Challenge Framework, or custom data portal development capability.\n\n•\nUnique secure external collaboration capability: DNAnexus is the only platform provider able to facilitate secure FDA-sponsored scientific challenges and controlled communication with industry sponsors, vendors, academic researchers, and international regulatory partners while maintaining regulatory-grade confidentiality controls, data segregation, audit trails, and compliance features.\n\n•\nInstitutional knowledge and validated workflows: FDA has invested over seven years in developing, validating, and documenting bioinformatics workflows on the precisionFDA platform. Over 300 FDA scientific reviewers, bioinformaticians, and research scientists have been trained on the platform. The application library includes 100+ versioned apps. Migration to an alternative platform would require complete revalidation and an estimated $14.7M full rebuild.\n\n•\nFedRAMP and FISMA compliance: DNAnexus holds FedRAMP Class C (Moderate) authorization (Cert ID FR1814557199, confirmed June 18, 2026) and FISMA Moderate ATO (FDA-sponsored). DNAnexus is actively enrolled in the PRISM High-Impact Platform Pilot (March 2026) providing a structured pathway to FedRAMP High authorization, with a parallel FISMA High ATO track to support the precisionFDA High platform.\n\n•\nSmall Business: DNAnexus is confirmed as a Small Business under NAICS 541714 (~277 employees; 1,000-employee size standard).\n\nResponse Instructions:\n\nThis notice is not a solicitation and does not commit the Government to award a contract. No award will be made solely on the basis of responses to this notice.\n\nInterested parties who believe they are capable of meeting the Government's requirements in their entirety may submit a written capability statement to the Contracting Officer no later than 15 calendar days from the date of this notice. Capability statements will be evaluated to determine whether full and open competition should be conducted in lieu of a sole-source award.\n\nCapability statements must address, at a minimum, the vendor's ability to provide Day-1 continuity of all current precisionFDA capabilities, FedRAMP Class C (Moderate) authorization status, and a demonstrated pathway to FISMA High authorization.\n\nResponses must be submitted electronically to:\n\nSteven Gagnon, Contracting Officer Email: Steven.Gagnon@fda.hhs.gov\n\nAllison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov\n\nSubject Line: Capability Statement — precisionFDA IDIQ Sole Source Notice, ODT-2026-132021\n\nTelephone responses will not be accepted. The Government is not responsible for any costs incurred in preparing a response to this notice.\n\nPoint of Contact:\n\nSteven Gagnon, Contracting Officer Food and Drug Administration, Office of Acquisitions and Grants Services Email: Steven.Gagnon@fda.hhs.gov\n\nAllison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov","html":"SPECIAL NOTICE — INTENT TO SOLE SOURCE Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS)
\n\nAcquisition Title: FY26–FY30 precisionFDA Platform Indefinite Delivery Indefinite Quantity (IDIQ)
\n\nAcquisition Identification Number: ODT-2026-132021
\n\nNAICS Code: 541714
\n\nPSC Code: D319 (Cloud Computing)
\n\nSet-Aside: Small Business (DNAnexus confirmed SB under NAICS 541714)
\n\nContract Type: Firm-Fixed-Price IDIQ
\n\nPeriod of Performance: 08/10/2026 – 08/09/2030
\n\nEstimated Value: $33,000,000
\n\nNotice:
\n\nThe Food and Drug Administration (FDA), Office of Digital Transformation (ODT), Office of Data Analytics and Research (ODAR), Health Informatics Staff (HIS), intends to award a sole-source Indefinite Delivery Indefinite Quantity (IDIQ) contract to:
\n\nDNAnexus, Inc. 1975 West El Camino Real, Suite 204 Mountain View, CA 94040
\n\nThis action is being conducted under the authority of FAR 6.302-1 (Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements), pursuant to 41 U.S.C. 3304(a)(1).
\n\nDescription of Requirement:
\n\nThe FDA requires continued operations, sustainment, modernization, and cloud support for the precisionFDA platform — a FISMA-authorized, secure, cloud-based collaborative research environment for next-generation sequencing (NGS) assay evaluation, genomics and multi-omics research, and regulatory science applications. The platform supports collaboration between FDA researchers and reviewers, as well as external collaborators and sponsors across multiple FDA centers, including CDER, CBER, CDRH, CVM, and CFSAN.
\n\nServices to be acquired include:
\n\nPlace of Performance: Contractor facility and FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993
\n\nBasis for Sole Source Determination:
\n\nComprehensive market research was conducted in accordance with FAR Part 10, evaluating 20 vendors with a detailed assessment of 8 shortlisted vendors against 33 critical capability requirements. The research conclusively determined that DNAnexus is the only vendor capable of meeting FDA's requirements for Day-1 continuity of the precisionFDA mission on the date of contract award, for the following reasons:
\n\nOnly vendor with zero capability gaps: DNAnexus is the only vendor that scored fully across all 33 assessed capabilities. No alternative vendor can replicate on Day 1 the precisionFDA capabilities of immutable files with chain of provenance, file locking, Government-only spaces, Protected spaces, Review spaces, FHIR Stations, the Scientific Challenge Framework, or custom data portal development capability.
\n\tUnique secure external collaboration capability: DNAnexus is the only platform provider able to facilitate secure FDA-sponsored scientific challenges and controlled communication with industry sponsors, vendors, academic researchers, and international regulatory partners while maintaining regulatory-grade confidentiality controls, data segregation, audit trails, and compliance features.
\n\tInstitutional knowledge and validated workflows: FDA has invested over seven years in developing, validating, and documenting bioinformatics workflows on the precisionFDA platform. Over 300 FDA scientific reviewers, bioinformaticians, and research scientists have been trained on the platform. The application library includes 100+ versioned apps. Migration to an alternative platform would require complete revalidation and an estimated $14.7M full rebuild.
\n\tFedRAMP and FISMA compliance: DNAnexus holds FedRAMP Class C (Moderate) authorization (Cert ID FR1814557199, confirmed June 18, 2026) and FISMA Moderate ATO (FDA-sponsored). DNAnexus is actively enrolled in the PRISM High-Impact Platform Pilot (March 2026) providing a structured pathway to FedRAMP High authorization, with a parallel FISMA High ATO track to support the precisionFDA High platform.
\n\tSmall Business: DNAnexus is confirmed as a Small Business under NAICS 541714 (~277 employees; 1,000-employee size standard).
\n\tResponse Instructions:
\n\nThis notice is not a solicitation and does not commit the Government to award a contract. No award will be made solely on the basis of responses to this notice.
\n\nInterested parties who believe they are capable of meeting the Government's requirements in their entirety may submit a written capability statement to the Contracting Officer no later than 15 calendar days from the date of this notice. Capability statements will be evaluated to determine whether full and open competition should be conducted in lieu of a sole-source award.
\n\nCapability statements must address, at a minimum, the vendor's ability to provide Day-1 continuity of all current precisionFDA capabilities, FedRAMP Class C (Moderate) authorization status, and a demonstrated pathway to FISMA High authorization.
\n\nResponses must be submitted electronically to:
\n\nSteven Gagnon, Contracting Officer Email: Steven.Gagnon@fda.hhs.gov
\n\nAllison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov
\n\nSubject Line: Capability Statement — precisionFDA IDIQ Sole Source Notice, ODT-2026-132021
\n\nTelephone responses will not be accepted. The Government is not responsible for any costs incurred in preparing a response to this notice.
\n\nPoint of Contact:
\n\nSteven Gagnon, Contracting Officer Food and Drug Administration, Office of Acquisitions and Grants Services Email: Steven.Gagnon@fda.hhs.gov
\n\nAllison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov
","origin":"detail"},"contacts":[{"name":"Steven Gagnon","role":"primary","email":"Steven.gagnon@fda.hhs.gov"}],"place_of_performance":{"zip":"20993","state":{"code":"MD","name":"Maryland"},"country":{"code":"USA","name":"UNITED STATES"}},"office_address":{"zip":"20841","city":"Rockville","state":"MD","country":"US"},"naics_codes":["541714"],"award":null,"attachments":[],"awards":[],"related":[]}