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

Performance Work Statement (PWS)

To conduct a comprehensive third-party review and assessment of the USDA's Center for Veterinary Biologics (CVB) statutory authorities, regulations, memorandums, notices, and other guidance documents. The goal is to assess current frameworks, identify efficiencies, ensure scientific and technical integrity, and identify/propose changes to address gaps and inconsistencies.

The contractor will perform the following key tasks:

• Project Initiation and Planning: Develop a Project Management Plan and an Information Gathering and Access Plan.
• Statutory Authority Review: Research, compile, and analyze federal statutes, agency regulations, and related documents. Develop a Statutory Authority Compendium.
• Agency Document Review & Benchmarking: Inventory and categorize agency documents, research and compare with similar international regulatory entities, and conduct an alignment assessment and gap analysis. Produce an Inventory of Agency Documents and a Regulatory Alignment Report.
• Stakeholder Engagement: Develop a Stakeholder Engagement Plan, design engagement tools, conduct engagements with industry representatives and veterinary groups, and analyze findings. Deliverables include Engagement Tools and Protocols, Stakeholder Engagement Summaries/Notes, and a Final Stakeholder Insights Report and Presentation.
• Recommendations and Reporting: Develop actionable recommendations, a Final Comprehensive Report, and provide briefings and presentations.

No specific period of performance is detailed in this section, but deliverables have specific due dates relative to contract award.

• Government Furnished Information: CVB will provide website links to statutes, regulations, policies, memos, notices, and stakeholder group information.

• Travel: No travel is expected. If travel becomes necessary, the contractor is responsible for all arrangements and costs.

• Contractor's Key Personnel: Requires Subject Matter Experts in Licensure, production, and regulation of veterinary biologics, and Regulatory/Policy with at least 10 years of experience.

• Security Requirements: Personnel must sign a Confidential Information Memorandum and protect non-public CVB information. Handling of sensitive stakeholder information is also required.

• Data Rights: The Government has unlimited rights to all documents/material produced under this contract.

• Section 508 Compliance: All contract deliverables must conform to applicable Section 508 standards for electronic and information technology.

• Analysis and Recommendations: Must be accurate and actionable, aligning with statutory/regulatory requirements, clear, concise, and actionable for decision-makers, addressing all discrepancies with prioritization and strategies, and submitted within the agreed timeframe.

• Accuracy: ≥ 95%

• Completeness: 100% of identified discrepancies addressed.

• Timeliness: 100% on or before due date.

• Correction Window: Contractor must correct deficiencies within 5 business days of notification.

Amendment / Modification

This amendment modifies the solicitation with the following changes:

• Performance Work Statement (PWS): Section 7.0, Contractor's Key Personnel, is revised to include Subject Matter Expert (SME) support requirements.
• Provision 52.212-1: Instructions to Offerors - Commercial Products and Commercial Services (Nov 2025) is revised to incorporate formatting and submission requirements.
• AGAR Clauses Removed: AGAR clauses 452.239-72 and 452.239-75 have been removed from the solicitation.
• New Attachment: Attachment 2 - PWS Attachment Veterinary Services Memorandum No. 800.2 has been added to the solicitation attachments.
• Submission Deadline Extended: The quotation submission due date has been extended to May 28th at 5:00 PM CT.

• PWS Section 7.0
• Provision 52.212-1
• AGAR Clauses 452.239-72 and 452.239-75
• Solicitation Attachments (Addition of Attachment 2)

The deadline for submitting quotations has been extended to May 28th at 5:00 PM CT. Formatting and submission requirements for Provision 52.212-1 have also been updated.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding Solicitation 12639526Q0102 for the Third-Party Review of the USDA's Center for Veterinary Biologics (CVB) Authorities, Regulations, and Guidance Documents.

• New Requirement: The solicitation represents a new requirement, not a continuation of a previous contract.
• Regulatory/Policy Expert Experience: Experience in other federal operational environments may be considered relevant if applicable to veterinary biologics regulations. Comprehensive experience can be met by a combination of internal team members, particularly those with strong biologics regulatory experience.
• Submission Instructions: Specific details regarding the submission of technical approach, resumes, past performance, and price are found in the amended provision 52.212-1 Instructions to Offerors (Solicitation Amendment 12639526Q0102-0001).
• Cover Letter: A cover letter is not required for quotation submission.
• VS Memo 800.2: This document is provided as "Attachment 2 - PWS Attachment Veterinary Services Memorandum No. 800.2" in the "Attachments/Links" section.
• AGAR Clauses: Solicitation amendment 12639526Q0102-0001 removed AGAR 452.239-72 and AGAR 452.239-75.
• Document Volume: It is anticipated that no more than 100 pages of additional relevant documents may be required beyond those already listed. Most documents are available digitally.
• Data Access: Access to necessary regulatory datasets and documentation will be provided in digital format or available on public sites. Non-USDA documents must be sourced by the contractor.

This Q&A document clarifies requirements and submission details, referencing specific amendments and attachments that bidders must consult for complete instructions. It confirms the nature of the requirement as new and provides guidance on evaluating experience and accessing necessary documentation.

Form / Attachment / Pricing Sheet

This document, Veterinary Services Memorandum No. 800.2, dated December 22, 1999, emphasizes the confidential nature of certain information concerning the Veterinary Biologics Program. It cancels a previous memorandum dated August 2, 1984.

• Background: Highlights that information concerning the development, preparation, and distribution of veterinary biological products is confidential and the property of licensees, permittees, or applicants. This includes submissions, statements made by establishment employees to VS employees, and observations during site visits.
• Legal Basis: Mentions that unauthorized disclosure may violate 18 U.S.C. 1905 (Public Officers and Employees) and is subject to penalties.
• Security Procedures: Outlines specific procedures for handling confidential information:
  • Limit Discussion: Do not discuss activities at an establishment with personnel from other establishments or within their earshot.
  • Protect Submissions: Safeguard all submissions from unauthorized persons.
  • Control Release of Information: Keep submitted materials secured. Release information only to authorized representatives of the establishment or VS employees with a need-to-know. Release to others requires written authorization from the licensee, permittee, applicant, Deputy Administrator, or as required by the Freedom of Information Act.
  • Inform Affected Personnel: Distribute this memorandum to all VS employees who will interact with Veterinary Biologics Program documents or establishments.

While this document is primarily an internal procedural memorandum regarding the handling of confidential information within the Veterinary Services program, bidders should be aware of the strict confidentiality requirements. This may impact how information is shared during the solicitation process, site visits, or contract performance, particularly concerning proprietary data related to veterinary biological products.

Solicitation / RFP / RFQ

This solicitation is for a firm-fixed-price commercial services contract for a comprehensive third-party review and assessment of the USDA's Center for Veterinary Biologics' (CVB) statutory authorities, regulations, memorandums, notices, and other guidance and supporting documents. The government intends to make one award.

The core requirement is a third-party review and assessment of CVB's regulatory framework. Specific deliverables include:

• Signed VS Memo 800.2 for all contractor employees.

• Project Management Plan.

• Project Schedule (biweekly).

• Project status meetings (weekly).

• Document Request List and Access Plan.

• Statutory Authority Compendium.

• Inventory of Agency Documents.

• Regulatory Alignment Report.

• Final Benchmarking Report.

• Stakeholder Engagement Plan.

• Engagement Tools and Protocols.

• Stakeholder Engagement Summary / Notes.

• Stakeholder Insights Report & Presentation.

• Recommendations Report.

• Final Project Report.

• Presentation and Report Materials.

• Contract Type: Firm-fixed-price commercial services.

• Period of Performance: Approximately June 22, 2026, to April 23, 2027.

• Offer Due Date: May 22, 2026, 12:00 PM CT.

• Questions Due: May 8, 2026, 5:00 PM CT (submit via email to stephen.tees@usda.gov).

• Evaluation Criteria: Award will be made to the offeror with the highest technically rated quotation with fair and reasonable pricing and acceptable or neutral past performance. Tradeoffs will not be conducted.

• Technical Approach Evaluation: Focuses on the offeror's ability to provide a sound and compliant approach, demonstrating understanding of requirements. Minimum information required includes:

  • Resumes for all key personnel, demonstrating required skills and experience.
  • Professional references for each individual.
  • Disclosure of any potential organizational or personal conflicts of interest.
  • Signed contingent letters for proposed personnel.
  • Detailed explanation of the offeror's experience and ability to perform services.
  • Up to three (3) references for similar work within the past three years, including project description, dollar value, period of performance, offeror's role, tasks performed, and contact information.

• Price Evaluation: Will be evaluated for fairness and reasonableness.

• Past Performance Evaluation: Will be assessed as acceptable or neutral, utilizing provided references, USDA contracts, and CPARS.

• The acquisition is unrestricted.

• NAICS Code: 541690 (Other Scientific and Technical Consulting Services).

• Size Standard: $19 Million.

• The solicitation incorporates FAR clauses and provisions by reference. Full text is available upon request or electronically.

• Offerors must provide pricing for all line items.

• Offerors must disclose any planned or potential use of Artificial Intelligence (AI) technologies and provide a Statement of Attestation.

• The offeror agrees to hold prices firm for 90 calendar days from the offer due date.

Statement of Work (SOW) / Performance Work Statement (PWS)

To conduct a comprehensive third-party review and assessment of the U.S. Department of Agriculture's (USDA) Center for Veterinary Biologics (CVB) statutory authorities, regulations, memorandums, notices, and other guidance documents. The review aims to assess current frameworks, identify efficiencies, ensure scientific and technical integrity, and address gaps that may hinder novel technologies.

• Project Initiation and Planning: Develop a Project Management Plan and an Information Gathering and Access Plan.

• Statutory Authority Review: Compile and analyze federal statutes, agency regulations, policies, and guidance documents related to CVB's authority.

• Agency Document Review & Benchmarking: Inventory and categorize CVB documents, research and compare CVB with similar international regulatory entities, and assess alignment and identify gaps.

• Stakeholder Engagement: Develop a plan and tools to engage industry representatives, manufacturers, farmers, ranchers, and veterinary groups to gather insights on policy effectiveness and alignment.

• Recommendations and Reporting: Develop actionable recommendations for discrepancies, create a final comprehensive report, and provide briefings and presentations.

• Deliverables must be approved by CVB.

• Accuracy of analysis and recommendations: ≥ 95%.

• Completeness: 100% of identified discrepancies addressed.

• Timeliness: 100% on or before due dates.

• Correction Window: Deficiencies must be corrected within 5 business days of notification.

No travel is expected. Performance is expected to be completed within 10 months of contract award, with specific deliverable deadlines outlined in the document.

• Contractor personnel must sign the Veterinary Services Memorandum No. 800.2 for Confidential Information.
• Protection of Government-Furnished Information is required.
• Sensitive stakeholder information must be handled appropriately.
• All contract deliverables must conform to applicable Section 508 standards for accessibility.
• The Government has unlimited rights to all documents and materials produced under this contract.
• Key personnel require specific expertise in licensure, production, and regulation of veterinary biologics, and/or regulatory policy, with at least 10 years of experience.