Third-Party Review of the USDA's Center for Veterinary Biologics (CVB) Authorities, Regulations, and Guidance Documents

The USDA Animal and Plant Health Inspection Service seeks a comprehensive third-party review and assessment of the Center for Veterinary Biologics' statutory authorities, regulations, and guidance documents, with quotations due May 28, 2026. This is an unrestricted commercial item procurement under FAR Part 12 with no small-business set-aside; all responsible sources may compete.

Place of performance is Ames, Iowa 50010, with contracting administration by USDA APHIS in Minneapolis, Minnesota. The period of performance runs June 22, 2026 through April 23, 2027. The NAICS code is 541690 (Other Scientific and Technical Consulting Services) with a small-business size standard of $19.0 million.

The contractor must possess a minimum of 10 years' demonstrated experience in veterinary biologics regulation and regulatory policy development, with subject matter expertise that cannot be subcontracted. The engagement spans five major task categories: Project Initiation and Planning; Statutory Authority Review producing a compendium of relevant federal statutes and legislative history; Agency Document Review and Benchmarking involving inventory of approximately 260 CVB documents and comparative analysis against eight international regulatory entities (Australia, Canada, European Union, Japan, New Zealand, United Kingdom, FDA, and Mexico); Stakeholder Engagement with industry representatives, manufacturers, and veterinary groups; and Recommendations and Final Reporting. The contract calls for 16 deliverables including regulatory alignment reports, benchmarking analyses, stakeholder insights, and a comprehensive final project report with prioritized recommendations. All contractor personnel must sign Veterinary Services Memorandum 800.2 addressing confidential information handling and protection of government-furnished materials. All deliverables are government-owned with unlimited intellectual property rights, and Section 508 accessibility standards apply.

Award will be made to the highest technically rated offeror with fair and reasonable pricing and acceptable or neutral past performance. Technical evaluation emphasizes proposed key personnel resumes, detailed explanation of experience and capability addressing the PWS, up to three comparable project references from the past three years, and disclosure of planned AI technology use with required Statement of Attestation. Questions must be submitted by May 8, 2026 at 5:00 PM Central Time to stephen.tees@usda.gov. Quotations must not exceed 25 pages in PDF format with minimum 12-point font.