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Notice of Intent to Sole Source
FDA- 75F40125R00109
NHP Retirement
Synopsis – Notice of Intent to Sole Source This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This synopsis is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13 for the following, under simplified acquisition procedures. The Government intends to negotiate and solicit with only one source:
Peaceable Primate Sanctuary Inc.
6415 N 800 W Winamac, Indiana 46996-8280, United States
The NAICS code is 812910– Animal Shelters
An important mission of the Food and Drug Administration (FDA) centers at White Oak is to protect and promote public health by the regulation and oversight of pharmaceutical products, supplements, biologic products, and medical devices, including devices that emit electromagnetic radiation. CBER’s mission includes the regulation of biological products for human use such as viral and bacterial vaccines, blood-derived and tissue-derived products, including xenografts, allergenic extracts, and cellular/gene therapy products. CBER conducts animal studies to support regulatory review and understanding of these diverse and innovative products, their safety, effectiveness, and potency. Current use of laboratory animals and development of new animal models support regulatory review and understanding of diverse medical products, as well as provide science-based guidance to the regulated industry. The CBER Division of Veterinary Services (DVS) manages and oversees the care and welfare of all species of laboratory animals on the White Oak campus.
Adoption or retirement of research animals is valued by the public, laboratory animal professionals, and the entire research community. The FDA, Office of the Chief Scientist, Animal Welfare Council (AWC) developed a policy and detailed the procedures necessary for the transfer, adoption, retirement, or other handling of FDA-owned research animals. In February 2020, FDA spokeswoman commented to multiple public media news outlets:
“The FDA has supported and continues to support the transfer, adoption, or retirement of FDA-owned research study animals that have completed their assigned studies and meet applicable eligibility criteria,” she said. “The November 2019 guideline expressly states the eligibility criteria for adoption, retirement, and transfer. This is not a procedural change, but a newly approved internal standard guideline developed to provide overarching support to enhance and promote harmonization of FDA animal research activities.”
Nonhuman primates are not eligible for private adoption under any circumstances. Nonhuman primates owned by FDA can only be transferred to another approved research protocol, government agency, or retired to an approved retirement facility with expertise and resources to safely provide lifelong care of the animal(s). Nonhuman primates retired from FDA subsequently may not be sold, bred, released into the wild, or used for food.
This is a proposal for the retirement of three young adult female baboons from the FDA White Oak Animal Program (WOAP). The baboons originate from a domestic specific pathogen free breeding colony of purpose bred research baboons at the Southwest National Primate Research Center. The baboons are approximately seven years old and healthy after completing FDA IACUC approved research. The animals are socially housed in a trio together in the same enclosure. They are excellent behavioral disposition and excellent general health.
All deliverables submitted under this contract shall be complete, clear, concise, technically accurate, well organized, and properly referenced. The Contractor shall deliver data in a mutually agreed upon format. Deliverables are to be transmitted via email with a description of the content, including which deliverables are included.
1. Deliverables include:
| # |
| Task Title |
| Subtask |
| Description |
| Deliverable |
| Due Date |
| 1 |
| Pre-Arrival Preparation and Coordination |
| 1.1 |
| Facility Preparation |
| 1.1.1 |
| Prepare designated housing areas for three baboons in accordance with FDA Animal Welfare Council standards |
| 1.1.2 |
| Conduct facility safety inspection and address any deficiencies identified |
| 1.1.3 |
| Prepare quarantine facilities with appropriate isolation capabilities and veterinary access |
| 1.1.4 |
| Install or verify environmental controls including temperature, humidity, and ventilation systems |
| 1.1.5 |
| Set up monitoring equipment for continuous welfare observation during transition period |
| 1.2 |
| Transportation Planning |
| 1.2.1 |
| Develop detailed transportation plan including vehicle specifications, route planning, and emergency procedures |
| 1.2.2 |
| Coordinate with FDA personnel to schedule animal transfer and establish communication protocols |
| 1.2.3 |
| Arrange veterinary oversight for transportation including sedation protocols if necessary |
| 1.2.4 |
| Prepare transport containers meeting USDA and IATA standards for baboon transport |
| 1.2.5 |
| Establish emergency response procedures for transport-related incidents |
| 1.3 |
| Staff Preparation |
| 1.3.1 |
| Brief all staff on incoming animals including medical histories, behavioral profiles, and special needs |
| 1.3.2 |
| Conduct training refreshers on baboon handling, emergency procedures |
| 1.3.3 |
| Assign primary care teams for each animal with backup coverage arrangements |
| 1.3.4 |
| Review and update protocols for intake, quarantine, and integration procedures |
| Transportation and Facility Preparation Plan |
| 30 days after contract award |
| 2 |
| Animal Transportation and Intake |
| 2.1 |
| Transportation Execution |
| 2.1.1 |
| Execute safe transportation of three baboons from FDA facilities to sanctuary |
| 2.1.2 |
| Provide veterinary supervision during transport with continuous monitoring |
| 2.1.3 |
| Maintain detailed transport logs documenting animal condition, environmental conditions, and any incidents |
| 2.1.4 |
| Coordinate with FDA personnel for animal transfer and documentation handover |
| 2.1.5 |
| Implement emergency procedures if required during transport |
| 2.2 |
| Initial Intake and Assessment |
| 2.2.1 |
| Conduct immediate health assessment upon arrival including physical examination and vital signs |
| 2.2.2 |
| Document animal conditions |
| 2.2.3 |
| Initiate quarantine procedures in designated isolation facilities |
| 2.2.4 |
| Begin behavioral assessment to evaluate stress levels and adaptation needs |
| 2.2.5 |
| Establish individual care plans based on medical histories and initial observations |
| Transportation Completion Report and Initial Health Assessment |
| Within 5 days of animal arrival |
| 3 |
| Quarantine and Health Management |
| 3.1 |
| Quarantine Period Management |
| 3.1.1 |
| Maintain quarantine isolation for minimum 30 days or as determined by veterinary assessment |
| 3.1.2 |
| Conduct daily health monitoring including appetite, behavior, and physical condition observations |
| 3.1.3 |
| Perform diagnostic testing as recommended by veterinary staff including blood work and parasite screening |
| 3.1.4 |
| Implement stress reduction measures including environmental enrichment appropriate for quarantine setting |
| 3.1.5 |
| Document all observations |
| 3.2 |
| Comprehensive Health Evaluation |
| 3.2.1 |
| Conduct complete veterinary examination |
| 3.2.2 |
| Perform diagnostic imaging if indicated by physical examination findings |
| 3.2.3 |
| Update vaccination protocols according to sanctuary standards and veterinary recommendations |
| 3.2.4 |
| Develop long-term health management plans for each animal based on assessment findings |
| 3.2.5 |
| Coordinate with FDA veterinary staff for consultation on any significant findings |
| Quarantine Completion Report and Health Assessment Summary |
| When quarantine period is complete |
| 4 |
| Integration and Socialization |
| 4.1 |
| Gradual Integration Process |
| 4.1.1 |
| Develop individualized integration plans based on behavioral assessments and social compatibility |
| 4.1.2 |
| Implement gradual introduction protocols allowing visual and olfactory contact before physical interaction |
| 4.1.3 |
| Monitor social dynamics and adjust integration timeline based on animal responses |
| 4.1.4 |
| Provide appropriate environmental enrichment to facilitate natural behaviors and reduce stress |
| 4.1.5 |
| Document integration progress with behavioral observations and interaction assessments |
| 4.2 |
| Permanent Housing Establishment |
| 4.2.1 |
| Transition animals to permanent housing once integration is successful and quarantine is complete |
| 4.2.2 |
| Establish social groupings based on compatibility assessments and behavioral observations |
| 4.2.3 |
| Implement permanent enrichment programs including foraging opportunities, climbing structures, and cognitive challenges |
| 4.2.4 |
| Finalize daily care routines with assigned staff and established protocols |
| 4.2.5 |
| Conduct final integration assessment to ensure successful adaptation to sanctuary environment |
| Integration Completion Report |
| Upon completion |
| 5.1 |
| Daily Care and Monitoring |
| 5.1.1 |
| Provide daily animal care including feeding, cleaning, health monitoring, and behavioral observation |
| 5.1.2 |
| Implement enrichment programs with rotating activities and environmental modifications |
| 5.1.3 |
| Maintain detailed daily logs documenting animal behavior, appetite, social interactions, and any concerns |
| 5.1.4 |
| Conduct weekly behavioral assessments to monitor welfare and identify any changes requiring intervention |
| 5.1.5 |
| Provide 24/7 emergency response capability for health or welfare emergencies |
| 5.2 |
| Veterinary Care Program |
| 5.2.1 |
| Conduct annual comprehensive examinations including full physical assessment and diagnostic testing |
| 5.2.2 |
| Provide preventive care including vaccinations, parasite prevention, and dental care |
| 5.2.3 |
| Implement geriatric care protocols as animals age, including modified diets and environmental accommodations |
| 5.2.4 |
| Respond to health emergencies with immediate veterinary intervention and appropriate treatment |
| 5.2.5 |
| Coordinate specialized care with external veterinary specialists when required |
| 5.3 |
| Facility Maintenance and Improvement |
| 5.3.1 |
| Maintain housing facilities in excellent condition with regular cleaning, repairs, and upgrades |
| 5.3.2 |
| Implement facility improvements to enhance animal welfare and operational efficiency |
| 5.3.3 |
| Conduct regular safety inspections and address any hazards or deficiencies immediately |
| 5.3.4 |
| Maintain environmental controls ensuring appropriate temperature, humidity, and air quality |
| 5.3.5 |
| Update enrichment equipment regularly to provide novel experiences and prevent habituation |
| Ongoing lifetime care |
| 6 |
| Record Keeping and Reporting |
| 6.1 |
| Documentation Management |
| 6.1.1 |
| Maintain comprehensive medical records for each animal including all veterinary care, treatments, and health assessments |
| 6.1.2 |
| Document observations in standardized formats with behavioral, health, and welfare information |
| 6.1.3 |
| Maintain records documenting animal condition, facility status, and significant events |
| 6.1.4 |
| Ensure data security and backup for all electronic records with appropriate access controls |
| 6.1.5 |
| Provide record access to FDA personnel for inspections and oversight activities (if needed) |
| 6.2 |
| Regular Reporting |
| 6.2.1 |
| Coordinate with FDA personnel for regular communication and consultation on animal welfare matters |
| 6.2.2 |
| Maintain regulatory compliance documentation for all applicable federal, state, and local requirements |
| 7 |
| Quality Assurance and Compliance |
| 7.1 |
| Regulatory Compliance |
| 7.1.1 |
| Maintain FDA Animal Welfare Council approval through ongoing compliance with all standards and requirements |
| 7.1.2 |
| Submit to regulatory inspections by FDA, USDA, and other applicable agencies |
| As needed |
| 7.1.3 |
| Implement corrective actions promptly for any deficiencies identified during inspections |
| 7.1.4 |
| Maintain current licenses and permits for all facility operations and animal care activities |
| 7.1.5 |
| Ensure staff training compliance with all applicable regulations and sanctuary standards |
| 7.2 |
| Continuous Improvement |
| 7.2.1 |
| Conduct internal quality assessments to identify opportunities for improvement in animal care and facility operations |
| 7.2.2 |
| Implement best practices from current research and industry standards for baboon welfare |
| 7.2.3 |
| Participate in professional development activities to maintain current knowledge and expertise |
| 7.2.4 |
| Evaluate and update protocols regularly based on experience and evolving standards |
| 7.2.5 |
| Maintain emergency preparedness with regular drills and equipment testing |
2. Delivery The FDA will coordinate the delivery of animals via an approved experienced animal transportation service within 90 days of contract award. The delivery will be covered at the expense of the FDA. If the facility has experience with primate transportation either themselves or with an approved vendor, they may recommend the company and provide a quote to be included in the price of the contract. Upon receipt, the retirement facility assumes ownership and responsibility for the welfare of the animals for the remainder of their natural lives.
THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. However, a determination by the Government not to compete this proposed action based upon responses to this draft agreement is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.
All responses are due by 12:00pm ET on Monday, August 28, 2025, due via email to the Primary Point of Contact: Ryan Alexander by email at: ryan.alexander@fda.hhs.gov.
Attachments:
Attachment A: Statement of Work
