Attachment 1 - Performance Work Statement (PWS).pdf

US Department of Agriculture (USDA)

Performance Work Statement

Contents Project Title

General Information

1.0 Background and Purpose

2.0 Definitions

Contractor Requirements

3.0 Technical Requirements / Tasks

4.0 Deliverable / Schedule

5.0 Government Furnished

6.0 Travel

7.0 Contractor’s Key Personnel

8.0 Security Requirements

9.0 Data Rights

10.0 Section 508 - Electronic and Information Technology Standards

11.0 Performance Requirement Measures

Attachment

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

General Information

1.0 Background and Purpose

Objective: The objective of this effort is to conduct a comprehensive third-party review and assessment of the USDA's Center for Veterinary Biologics (CVB). This review and assessment will cover CVB’s statutory authorities, regulations, memorandums, notices and other guidance and supporting documents. The review and assessment will:

Assess current frameworks and provide recommendations and options to improve consistency and identify efficiencies.

Ensure scientific and technical integrity by maintaining requirements necessary for oversight of veterinary biologic products that are pure, safe, potent, and effective.

Identify and define gaps and inconsistencies in guidance documents that may create barriers to novel technologies and innovative products, as defined by CVB using the initiatives outlined by the Animal Health Industry’s Innovation Task Force.

Identify and propose changes to address identified gaps in the Virus-Serum-Toxin Act (VSTA), Title 9 of the Code of Federal Regulations (9 CFR), Parts 101–118, and any CVB documents, as needed.

Overview of CVB: The CVB regulates the licensure, manufacturing, and post-licensure quality control of veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin), in the U.S. Operating under the VSTA, the CVB ensures veterinary biologics are pure, safe, potent, effective, and available for the diagnosis, prevention, and treatment of animal diseases. The VSTA mandates and authorizes the CVB to use sound science and technology to ensure that the veterinary biologics are free from disease-producing agents, especially foreign animal diseases; develop standards and procedures for product release; issue licenses and permits; monitor and inspect products and facilities; and control use of unlicensed product in field tests. The organization maintains transparency by publishing policies and practices. Additionally, the CVB is committed to be a global partner of the steering committee members of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) – a trilateral (European Union, Japan, U.S.) program aimed at harmonizing technical requirements for veterinary product regulations. CVB harmonizes processes and test methods in alignment with VICH to facilitate product availability for the global market.

The CVB is structured into 3 functional areas: Product Evaluation and Licensing (PEL), Product Testing via the CVB Laboratory (CVB-L), and Inspection & Compliance (IC). These 3 functional areas are linked by and interact through Quality Management and information management systems to assure the quality and consistency of product and the satisfaction of the customer.

CVB Product Licensing To sell and distribute either a domestically produced or imported veterinary biological product in the U.S., a biologics manufacturer must apply for, be granted, and maintain licenses or permits. These licenses or permits include a Veterinary Biologics Establishment License for a U.S. manufacturing facility, a Veterinary Biological Product License for a domestically produced product and/or a Veterinary Biological Product Permit for biological products imported into the U.S.

The PEL Licensing staff is responsible for reviewing license and permit applications and assuring that the manufacturer has supplied all of the supporting documentation, and that the data provided is scientifically sound and in compliance with Federal laws and regulations. The Licensing staff may seek additional input to review study protocols, as well as test or study results, from other subject matter experts at the CVB. With certain agents or products, a Reviewer may determine that a Risk Analysis is warranted to assess the risks associated with use of the product to animals, humans, and the environment.

Additionally, the USDA has the authority to formulate and issue regulations to prevent the preparation and marketing of worthless, contaminated, dangerous, or harmful veterinary biologics. The Licensing staff is responsible for the process of developing and implementing licensing and permit requirements, and for the process of developing and publishing program policy and procedures in regulations, standard requirements, memoranda, and notices.

CVB Product Testing The CVB-L staff provides technical expertise to the CVB program by conducting a variety of tests on master seeds, master cells, pre-license product, and post-license product. These tests are requested by the Licensing staff or by the IC staff or conducted for biologics that are part of a USDA control program. The results of these tests are used to assist in the determination of the fitness of a product for licensure, for sale, and also for investigative purposes.

The basic test systems/methodologies for the majority of tests performed on conventional biological products at the CVB are specified in the Standard Requirements (SRs) found in the 9 CFR part 113, as described in published Supplemental Assay Methods (SAMs) developed by the CVB-L, in firm's Outlines of Production or Special Outlines, or in CVB test protocols. Non-standard tests are developed and performed as necessary on novel products or in unique situations for which there are no SR tests available. In addition, the CVB-L staff produces and tests specific references and reagents, both for in-house testing, and to supply to manufacturers for use in required tests.

CVB Inspection and Compliance The IC staff are responsible for ensuring that licensed and permitted veterinary biological products are prepared, maintained, and distributed in compliance with the VSTA and associated Federal regulations. The IC staff review a summary of required test results that licensees and permittees perform on each serial or subserial of completed product in order to obtain CVB permission to sell and further distribute (i.e. “release”) that product. Under certain circumstances, IC staff may review additional product considerations from licensees and permittees, such as extensions of dating or reprocessing. Also, IC staff issue Export Certificates and Certificates of Licensing and Inspection to licensees and distributors, upon request. These specialized documents assist firms with the export and sale of U.S. licensed veterinary biological products in foreign countries. Further, IC staff perform inspections (in-depth, follow-up, and special) at manufacturing facilities and distribution sites to determine if the products have been produced and tested by competent people using acceptable facilities, equipment, and methods. There are 100 US and 22 foreign inspection facilities and sites. The IC staff monitors product performance in the field via mandatory reporting of adverse events related to the use of veterinary biological products. Finally, the IC staff are responsible for conducting Veterinary Biological Investigations (VBI) to prove or disprove violations of the VSTA when a credible complaint or concern is raised regarding a licensed or an unlicensed firm or product.

Quality Management The CVB is committed to maintaining scientific excellence by continual evaluation and improvement of the processes involved in evaluating, licensing, inspecting, and/or evaluating veterinary biological products. Development and maintenance of a formally registered Quality Management System (QMS) confirms to the public and industry, both on a national and on an international basis, that the CVB is committed to a robust quality program. The CVB was initially certified to the ISO 9001 standards September 4, 2007, and is currently registered to these standards through March 7, 2029.

Overview of documents To achieve its mission, CVB utilizes various types of documentation and resources. At the top are laws such as the VSTA and National Environmental Policy Act (NEPA), followed by the Code of Federal Regulations (CFR). Further interpretation and guidance for the laws and regulations are found in Veterinary Services Memoranda and CVB Notices. Additional forms of public guidance include SAMs, procedure manuals, protocols, user guides, and templates. Internally, there are additional work process protocols, decision memos, external input, and electronic systems to support tracking precedent and consistency. All these sources of information are considered for CVB decision making.

2.0 Definitions

Artificial Intelligence (AI) – use of computers systems to perform tasks typically associated with human intelligence including reasoning and decision-making.

CFR (Code of Federal Regulations) – codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government.

COR (Contracting Officer Representative) – authorized representative of the Contracting Officer to monitor the technical or administrative aspects of contractor performance during the life-cycle of the contract.

CVB (Center for Veterinary Biologics) – federal regulatory entity responsible for ensuring veterinary biologics are safe, pure, potent, and effective.

CVB-IC (CVB Inspection & Compliance) – responsible for ensuring that licensed and permitted veterinary biological products are prepared, maintained, and distributed in compliance with the VSTA and associated Federal regulations.

CVB-L (CVB Laboratory) – provides technical expertise to the CVB program by conducting a variety of tests on master seeds, master cells, pre-license product, and post-license product.

CVB-PEL (CVB Product Evaluation and Licensing) – responsible for reviewing license and permit applications and assuring that the manufacturer has supplied all of the supporting documentation, and that the data provided is scientifically sound and in compliance with Federal laws and regulations.

NEPA (National Environmental Policy Act) PMI (Project Management Institute) SAM (Supplemental Assay Method) – Standardized instructions on the performance of product testing prescribed in Title 9, Code of Federal Regulations.

USDA (United States Department of Agriculture) VS (Veterinary Services) VSTA (Virus-Serum-Toxin-Act) of 1913 – Federal legislation enacted to ensure veterinary biologics products aren’t “worthless, contaminated, dangerous, or harmful”.

Contractor Requirements

3.0 Technical Requirements / Tasks

Each task below shall have a specified completion date agreed upon by the contractor and CVB, provided that all dates are consistent with the Deliverables Schedule in section 4.0.

I. Project Initiation and Planning Deliverables/Tasks

1. Project Initiation & Plan Development:

Task 1.1: Contractor must provide project initiation and planning documentation to CVB to coordinate and outline scope, objectives, key personnel, communication protocols, and timelines.

Deliverable 1.1: Project Management Plan outlining the contractor's approach, methodology, detailed work breakdown structure, resource allocation, communication plan, risk management strategy, and proposed schedule.

2. Information Gathering and Access Plan:

Task 1.2: Contractor must work with CVB to identify and gain access to all necessary statutes, agency regulations, policies, memos, notices, publicly available documents, and as requested from CVB any relevant documents.

Deliverable 1.2: Document Request List and Access Plan detailing all documents required, their location, and the proposed method of access (e.g., electronic access, physical copies, interviews with agency staff).

II. Statutory Authority Review Deliverables/Tasks

1. Comprehensive Statutory Authority Research and Documentation:

Task 2.1: Contractor must conduct thorough legal research to identify, compile, and analyze all federal statutes granting authority to the agency, including amendments, legislative history (publicly available), and relevant judicial and administrative interpretations (publicly available).

Deliverable 2.1: Statutory Authority Compendium which includes:

A consolidated list of all relevant statutes.

Summaries of key provisions and their legislative intent.

Analysis of the scope and limitations of the agency's statutory authority.

Identification of any ambiguities or areas requiring further interpretation.

III. Agency Document Review & Benchmarking / Comparative Analysis

1. Agency Document Inventory and Categorization:

Task 3.1: Contractor must review the provided agency statutes and regulations to include:

The Virus-Serum-Toxin Act 21 USC 151-159 et. seq., Title 9 Code of Federal Regulations, Title 9, Subchapter E (Parts 101–118, and 124) Veterinary Services Memoranda listed on the CVB website (approx. 90 documents) o https://www.aphis.usda.gov/veterinary-biologics/memoranda Center for Veterinary Biologics Public Notices (approx. 170 documents) o https://www.aphis.usda.gov/veterinary-biologics/regulations-guidance/notices Single Tier Label Claim Industry Guidance o https://www.aphis.usda.gov/veterinary-biologics/regulations-guidance/stlc-industry-guidance

Risk Analysis and Summary Information Formats for Veterinary Biologics o https://www.aphis.usda.gov/veterinary-biologics/regulations-guidance/summary-info-format Other relevant publicly available documents and/or policy instruments (as provided by CVB)

Deliverable 3.1: Inventory of Agency Documents categorized by type, date, subject matter, and the specific statutory authority they purport to implement.

2. Conduct Comparative Research:

Task 3.2: The contractor shall research and identify regulatory entities similar to CVB including at a minimum the following listed below:

Regulatory entities o Australian Pesticides and Veterinary Medicines Authority o Canada Food Inspection Agency o European Medicines Agency o Japan Ministry of Agriculture, Forestry and Fisheries o New Zealand Agriculture Compounds and Veterinary Medicines o United Kingdom Veterinary Medicines Directorate o USHHS-FDA Center for Veterinary Medicine o SENASICA - Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria

For each identified regulatory entity, the contractor shall gather and analyze their guidance, regulatory requirements, and implementation practices. For CVB and each identified similar regulatory entity, the contractor shall:

o Identify and document the regulatory assumptions underpinning their systems.

o Articulate the underlying goals and paradigms driving their regulatory approaches.

o Evaluate the alignment of the collected guidance, requirements, and implementation practices with CVB’s established program goals and objectives, with particular focus on different regulatory and/or policy methods to achieve similar goals (i.e. different quality assurance processes to ensure product safety).

o Identify similarities, differences, and implications in guidance types, regulatory requirements, and implementation approaches.

3. Alignment Assessment and Gap Analysis:

Task 3.3: Contractor must systematically compare each agency document against the identified statutory authority and against comparable regulatory entities identified in Task 3.2 to determine:

Whether the document falls within the scope of the agency's delegated authority.

Whether the document is consistent with the language and intent of the governing statutes.

Whether there are any provisions in agency documents that exceed, contradict, or are not supported by statutory authority.

Whether there are areas where the agency has statutory authority but has not yet promulgated regulations or guidance.

Deliverable 3.2: Regulatory Alignment Report providing:

A detailed analysis of each reviewed document, cross-referenced to specific statutory provisions.

Clear identification of any instances of misalignment, overreach, or underutilization of authority.

An assessment of the legal risks associated with identified discrepancies with a focus on any discrepancy that creates liability for the CVB and/or product quality issues in the field.

4. Deliverable 3.3: Final Benchmarking Report

The contractor must provide a comprehensive benchmarking report that includes:

An executive summary outlining key findings and recommendations.

A detailed comparative analysis of CVB's guidance, requirements, and implementation practices against similar regulatory entities identified in Task 3.2.

Documentation of the regulatory assumptions, underlying goals, and paradigms for each system analyzed.

IV. Stakeholder Engagement

Goal / Objective: Contractor must gather insights from industry representatives, manufacturers, farmers, ranchers, and veterinary groups to evaluate gaps, risks, scientific merit, policy effectiveness, and alignment with similar regulatory entities defined in Task 3.2.

1. Develop Stakeholder Engagement Plan

Task 4.1:

Identify and categorize key stakeholders within industry representatives, manufacturers, farmer and rancher communities, and veterinary groups.

Propose a methodology for engagement (e.g., individual interviews, focus groups, surveys, workshops), including a rationale for each approach.

Develop a detailed list of target stakeholders, including contact information (if available or to be provided by the agency).

Draft a communication strategy for inviting and engaging stakeholders.

Deliverable 4.1: Stakeholder Engagement Plan A formal document outlining the identified stakeholder groups, proposed engagement methodologies, target list of participants, and communication strategy.

2. Design Engagement Tools and Protocols:

Task 4.2:

Develop structured interview guides, feedback forms, and discussion prompts tailored to each stakeholder group.

Ensure questions are designed to elicit insights on scientific merit, effectiveness, and consistency of specified policies.

Establish clear protocols for data collection, including consent, confidentiality, and recording methods.

Deliverable 4.2: Engagement Tools and Protocols

A set of approved interview guides, feedback forms, and discussion prompts for each stakeholder group.

A document detailing data collection protocols (e.g., consent forms, recording procedures).

3. Conduct Stakeholder Engagements:

Task 4.3:

Schedule and coordinate meetings, interviews, or other engagement activities with identified stakeholders including the Animal Health Institute; Association of Veterinary Biologics Companies; Major Cattle, Swine, Poultry Commodity Groups (e.g. National Cattlemen’s Beef Association, National Pork Board, National Chicken Council, National Turkey Federation, American Association of Bovine Practitioners, American Association of Equine Practitioners, American Association of Swine Veterinarians, Association of Avian Veterinarians, American Association of Avian Pathologists, American Association of Small Ruminant Practitioners, American Animal Hospital Association, American Sheep Industry Association); American Veterinary Medical Association; National Association of State Animal Health Officials (NASAHO); and National Association of State Departments of Agriculture (NASDA).

Execute the approved engagement methodology (e.g., conduct individual interviews, facilitate focus groups).

Accurately capture all insights, feedback, and data as per the established protocols.

Deliverable 4.3: Stakeholder Engagement Summaries/Notes

Detailed summaries or anonymized transcripts/notes from all conducted interviews, focus groups, or other engagement activities.

A log of all conducted engagements, including dates, participants (anonymized if required), and duration.

4. Analyze and Synthesize Findings:

Task 4.4:

Transcribe, organize, and synthesize all collected data from stakeholder engagements.

Conduct a thorough analysis to identify common themes, divergent perspectives, key insights, and actionable recommendations related to policy scientific merit, effectiveness, and consistency.

Identify any gaps in information or areas requiring further investigation.

Develop a comprehensive report detailing the methodology, findings, analysis, and recommendations.

Structure the report to clearly address insights regarding scientific merit, effectiveness, and consistency of policies, broken down by stakeholder group or key themes.

Prepare and deliver a presentation summarizing the key findings and recommendations to relevant agency staff.

Deliverable 4.4: Final Stakeholder Insights Report and Presentation:

A revised and finalized comprehensive report incorporating feedback from CVB on the draft.

A professional presentation deck summarizing the key findings, analysis, and recommendations for agency leadership and relevant teams.

V. Recommendations and Reporting Deliverables/Tasks

1. Recommendations:

Task 5.1: Based on the alignment assessment, the contractor must develop actionable recommendations for the agency to address identified discrepancies.

Deliverable 5.1: Recommendations Report detailing:

Specific actions needed to bring agency documents into compliance with statutory authority (e.g., revision, rescission, new rulemaking).

Prioritization of recommendations based on legal risk and impact.

Potential strategies for implementation, considering legal, operational, and resource implications.

2. Final Comprehensive Report:

Task 5.2: Contractor must consolidate all findings, analyses, and recommendations into a comprehensive final report.

Deliverable 5.2: Final Project Report summarizing the entire project, including executive summary, methodology, key findings, and all previous deliverables approved by CVB as appendices.

3. Briefings and Presentations:

Task 5.3: Contractor must provide oral briefings and presentations to agency leadership and relevant stakeholders to discuss findings, answer questions, and present recommendations.

Deliverable 5.3: Presentation Materials (e.g., PowerPoint slides) and participation in scheduled briefings.

Disclosure of the use of Artificial Intelligence (AI) – the contractor shall disclose use of AI to complete work outlined in this PWS. If AI is used, the contractor must identify where it was used and for what purposes. Additionally, any AI generated content is reviewed by human personnel for accuracy. Disclosure shall be made with the following statement (as applicable):

During the preparation of this work, [NAME TOOL / SERVICE] was used in order to [REASON]. After using this tool/service, the contractor reviewed and edited the content (including images and data tables) as needed and take(s) full responsibility for the text’s factual and citation accuracy; as well as data, mathematical, logical, and common-sense reasoning.

OR

[Contractor] declares that generative artificial intelligence was not used in the creation or processing of content, including the creation of data files, images, graphics, tables, or their corresponding captions.

4.0 Deliverable / Schedule

Deliverables shall be considered complete only when approved by CVB that the stated performance standards are met.

Key Deliverables Deliverable

Deliverable / Item

Title Description Frequency Delivery

Format Due By

1.1 Signed VS Memo

800.2 for all Contactor employees

Agreement that all employed providing the services for this contract are fully aware of and comply with the Confidential Business Information requirement.

Once Signed VS Memo 800.2 PDF via email to COR and CVB liaison(s).

No later than ten

(10) days after contract award.

1.1 Project

Management Plan

Documentation outlining contractor’s approach, methodology, communication plan, and risk management strategy.

Once Via email to COR and CVB liaison(s).

No later than ten

(10) days after contract award.

1.1 Project Schedule Schedule with detailed

methodology, tasks, timeline, milestones, assigned resources, deliverables, target dates, completion dates, and percent complete.

Performance baseline is identified.

Changes to baseline, target dates, and completion dates are highlighted for review by COR and

CVB.

Every two weeks Via email to COR and CVB liaison(s).

No later than thirty (30) days after contract award, every two weeks thereafter.

1.1 Project status

meetings

Regular project status meetings to review the overall project status, milestones, successes, risks, and roadblocks.

At a minimum every week at the beginning of the project.

Frequency can change as needed as agreed upon by contractor and

CVB.

Via teleconference with COR and CVB liaisons.

No later than ten

(10) days after contract award.

1.2 Document Request

List and Access Plan

Outline of all documents required for the assessment, their location, and proposed method of access.

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than thirty (30) days after contract award.

2.1 Statutory

Authority Compendium

A report which includes:

- Consolidated list of all relevant statutes

- Summaries of key provisions and their legislative intent

- Analysis of the scope and limitations of the agency’s regulatory authority

- Identification of any ambiguities or areas needing further interpretation.

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than 3 months after contract award.

3.1 Inventory of

Agency Documents

Inventory that includes documents categorized by type, date, subject matter, and the specific statutory authority they purport to implement.

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than 4 months after contract award.

3.2 Regulatory

Alignment Report

Report that includes:

- A detailed analysis of each reviewed document, cross-referenced to specific statutory provisions.

- Clear identification of any instances of misalignment, overreach, or underutilization of Authority

- An assessment of the legal risks associated with identified discrepancies.

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than 5 months after contract award.

3.3 Final

Benchmarking Report

Report that includes:

- An executive summary outlining key findings and recommendations.

- A detailed comparative analysis of CVB's guidance, requirements, and implementation practices against those of similar regulatory entities.

- Documentation of the regulatory assumptions, underlying goals, and paradigms for each system analyzed.

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than 6 months after contract award.

4.1 Stakeholder

Engagement Plan

Document outlining:

- Identified stakeholder groups

- Proposed engagement methodologies

- Target list of participants

- Communication strategy

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than 6

4.2 Engagement Tools

and Protocols

- A set of approved interview guides, questionnaires, or discussion prompts for each stakeholder group.

- A document detailing data collection protocols (e.g., consent forms, recording procedures).

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than 6 months after contract award.

4.3 Stakeholder

Engagement Summary / Notes

- Detailed summaries or anonymized transcripts/notes from all conducted interviews, focus groups, or other engagement activities.

- A log of all conducted engagements, including dates, participants (anonymized if required), and duration.

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than 7 months after contract award.

4.4 Stakeholder

Insights Report & Presentation

- A revised and finalized comprehensive report incorporating feedback from the agency on the draft.

- A professional presentation deck summarizing the key findings, analysis, and recommendations for agency leadership and relevant teams.

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than 8 months after contract award.

5.1 Recommendations

Report

Report that includes:

- Specific actions needed to bring agency documents into compliance with statutory authority (e.g., revision, rescission, new rulemaking).

- Prioritization of recommendations based on legal risk and impact.

- Potential strategies for implementation, considering legal, operational, and resource

- implications.

Once, updated as necessary.

Via email to COR and CVB liaison(s).

No later than 9

5.2 Final Project

Report

Report that summarizes the entire project, including executive summary, methodology, key findings, and all previous deliverables as appendices.

Once Via email to COR and CVB Liaison(s).

No later than 10 months after contract award.

5.3 Presentation and

Report Materials

Briefings, presentations, and furnishing all presentation materials.

Once Via teleconference , email to COR and CVB liaison(s).

No later than 10

5.0 Government Furnished

CVB will provide the contractor the following data:

- Website links to pages where all necessary statutes, agency regulations, policies, memos, notices, and publicly available documents relevant to completing Deliverable 1.2.

- Stakeholder group information necessary to complete Deliverables 4.1 and 4.2

CVB will be closed during the following federal holidays: New Year’s Day, Birthday of Martin Luther King, Jr., Washington’s Birthday, Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

If a holiday falls on a Saturday, the preceding Friday will be treated as a holiday. If a holiday falls on a Sunday, the following Monday will be treated as a holiday.

6.0 Travel

No travel is expected in performance of the tasks described in this Performance Work Statement. In the event that travel becomes necessary, the contractor shall be fully responsible for all travel arrangements and all associated costs.

The Government will not reimburse travel expenses under this contract. Any contractor-initiated travel shall not proceed without prior written notification to the Contracting Officer.

7.0 Contractor’s Key Personnel

Performance of the contract requires the following skills & experience from contractor key personnel:

Subject Matter Expert(s) in:

o Licensure, production, and regulation of veterinary biologics – A resume detailing preferably 10 or more years’ experience demonstrated by previous position(s) held, relevant skills and responsibilities, and accomplishments (using quantifiable data) is required. References with direct knowledge of this experience must be included. Conflicts of interest must be fully disclosed and addressed.

o Regulatory/Policy – A resume describing preferably 10 or more years’ experience with the initiation, authoring, or publication of statutes, regulations, and/or regulatory guidance, and the regulatory approval process is required. Include if any of the experience relates to veterinary biologics. References with direct knowledge of this experience must be included.

* These functions may be covered by one or more positions and may not be subcontracted.

8.0 Security Requirements

Confidentiality and Non‑Disclosure Prior to performing any work under this contract, Contractor personnel must sign the Veterinary Services Memorandum No. 800.2 for Confidential Information Concerning the Veterinary Biologics Program. This requirement applies to all personnel who will access non‑public CVB documents, internal analyses, or stakeholder input generated or provided during contract performance.

Protection of Government‑Furnished Information The Contractor must protect all non-public information provided by CVB or collected during contract performance, including Government-furnished documents, internal analyses, draft materials, and stakeholder input. Access shall be limited to authorized Contractor personnel.

Handling of Sensitive Stakeholder Information Information collected during stakeholder engagements, including interview notes, contact information, responses, and any stakeholder comments, shall be treated as sensitive and shall not be disclosed outside the Contractor’s project team or the Government without CVB approval.

Controlled Unclassified Information (CUI)

If CVB identifies any Government‑furnished material as Controlled Unclassified Information (CUI), the Contractor shall handle and safeguard such information in accordance with Government instructions provided with the material. No classified information is required or authorized under this contract.

Information Safeguards The Contractor shall implement reasonable administrative, physical, and electronic safeguards to prevent unauthorized disclosure of sensitive and non‑public information obtained under this contract, including secure storage and secure transmission of such information.

Access Credentials Performance of this contract does not require routine, unescorted access to federally controlled facilities or routine access to Government information systems. Accordingly, Personal Identity Verification (PIV) credentials are not required for this effort.

Return or Disposal of Information Upon completion or termination of the contract, the Contractor shall return or securely dispose of all non‑public Government‑provided information and stakeholder data in accordance with CVB direction.

9.0 Data Rights

The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

10.0 Section 508 - Electronic and Information Technology Standards All contract deliverables are subject to these 508 standards as applicable. Regardless of format, all web content or communications materials produced, including text, audio, or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards document above. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the PWS, shall be the responsibility of the contractor or consultant.

The following Section 508 provisions apply to the content or communications material identified in this PWS 36 CFR Part 1194.21 a - l 36 CFR Part 1194.22 a - p 36 CFR Part 1194.31 a - f 36 CFR Part 1194.41 a – c

11.0 Performance Requirement Measures

Performance Objective

Required Task or Deliverable

Performance Standard Method of Surveillance

Positive/Negative Incentive % for NOT meeting the Task

Analysis and Recommendations are accurate and actionable

All Deliverables specified in this

PWS:

Deliverables 1.1 through 5.3

- Accuracy:

Recommendations align with statutory/regulatory requirements and documented analysis

- Clarity: Report is clear, concise, and actionable for decision-makers

- Completeness: All discrepancies addressed with prioritization and strategies

- Timeliness: Submitted within agreed timeframe

COR and CVB Liaisons will review the report for completeness, accuracy, and adherence to standards.

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.

Attachment Veterinary Services Memorandum No. 800.2

December 22, 1999

VETERINARY SERVICES MEMORANDUM NO. 800.2

Subject: Confidential Information Concerning the Veterinary Biologics Program

To: Veterinary Services Management Team Directors, Center for Veterinary Biologics Area Veterinarians in Charge, VS

I. PURPOSE

This memorandum emphasizes the confidential nature of certain information concerning the Veterinary Biologics Program.

II. CANCELLATION

This memorandum cancels Veterinary Services Memorandum No. 800.2 dated August 2, 1984.

III. BACKGROUND

Much of the information concerning the development, preparation, and distribution of veterinary biological products obtained from licensees, permittees, or applicants is confidential and is the property of such licensees, permittees, or applicants. Confidential information may include anything Veterinary Services receives as a submission from a veterinary biologics establishment, anything told by a veterinary biologics establishment’s employee to a Veterinary Services employee, and anything seen during a visit to a veterinary biologics establishment. Unauthorized disclosure of confidential information may be in violation of l8 U.S.C. 1905, Public Officers and Employees, and subject to penalties specified therein.

IV. SECURITY PROCEDURES

A. Limit Discussion

Do not discuss the activities at an establishment with anyone from another establishment or within earshot of such a person. The mere mention of a procedure may be enough to provide a trained person with confidential information regarding a competitor’s establishment.

Veterinary Services Memorandum No. 800.2 2

B. Protect Submissions

Protect all submissions from unauthorized persons. A glance may be enough to provide an unauthorized person with confidential information.

C. Control Release of Information

Keep all submitted materials under lock. Release information only to an authorized representative of the establishment involved or to Veterinary Services employees who have need for the information. Release information to other persons only on written authorization from the licensee, permittee, applicant, or the Deputy Administrator or as required by the Freedom of Information Act.

D. Inform Affected Personnel

Provide a copy of this memorandum to each Veterinary Services employee who will be dealing with Veterinary Biologics Program documents or establishments.

/s/ Thomas E. Walton for

Alfonso Torres Deputy Administrator Veterinary Services

Trainee Signature:

Trainer Signature:

Justification:

Justification: