RFP_75F40125R00109.docx

Section 1 – General Information A. Summary of Requirement

This is a Request for Quotation (RFQ) for commercial products and services prepared in accordance with the procedures outlined in Federal Acquisition Regulation (FAR) Part 13 - Simplified Acquisition Procedures and FAR 6.302-1 (Only One Responsible Source). THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED.

The Request for Quotation (RFQ) number is 75F40125R00109.

This requirement is being solicited as a total small business set-aside.

a. The NAICS for this requirement is: 813312

b. The small business size standard for NAICS 813312 - Environment, Conservation and Wildlife Organizations is $8.5 million in average annual receipts. The full table of size standards can be found at: https://www.sba.gov/document/support-table-size-standards Description of Requirement: The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) has a need for services for the retirement of three female baboons from the White Oak Animal Program (WOAP).

Base Period: 10/15/2025 - 10/14/2026

Pick up Location:

FDA/CBER

10903 New Hampshire Ave Bldg 52, Silver Spring, MD 20993

B. Points of Contact Contracting Officer:

Ian Weiss Ian.Weiss@fda.hhs.gov

Contract Specialist:

Ryan Alexander Ryan.Alexander@fda.hhs.gov

Contracting Officer's Representative:

TBD

Section 2 - Contract Clauses Clauses Incorporated by Reference

This is a sole source procurement conducted under FAR 6.302-1 (Only One Responsible Source). Standard commercial contract terms and conditions apply as specified below.

Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (JAN 2025)

Clauses by Full Text

52.252-2 Clauses Incorporated By Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (JAN 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Section 3 – Attachments

Statement of Work (SOW)

Nonhuman Primate Retirement

1. Background

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.

2. Objective

The purpose of this objective is to establish a commercial firm-fixed price type contract with an experienced nonhuman primate retirement facility to provide a permanent home—a lifetime of animal care and humane retirement for three adult female baboons, that have been retired from FDA research.

3. Scope of Work

At a minimum, offerors must hold the credentials and meet criteria elaborated below.

The retirement facility shall:

· be U.S. based and hold approval by the FDA Animal Welfare Council (AWC). To receive approval from the Animal Welfare Council, a request for review must be made by the program or vendor. The AWC will conduct a review of the program and must include detailed on environment, housing, management, and veterinary care, a tour of the facility either in-person or virtual, and at least one question and answer session have a long and verifiable, successful history, optimally 8-10 consecutive years or more, in successfully caring for nonhuman primates, specifically a successful track record caring for adult baboons

· have sufficient existing facilities or facilities that could be modified in short order (i.e., no later than 90 calendar days from contract award) to accommodate the three female baboons. The facilities must be appropriate for the species and meet all Animal Welfare Act requirements; https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act

· Enclosures must exceed the minimum size standards outlined by the AWA and Guide for the Care and Use of Laboratory Animals (greater than 15 sq feet floor space per NHP). Overall cage volume and linear perch space should be optimized to allow freedom of movement, climbing, standing, running, swinging, and other routine normal non-human primate behaviors. Enclosures must be sufficiently secure to prevent escape. Caging must allow for continued social housing of the three baboons together for as long as they remain socially compatible.

· have an active and verifiable veterinarian care program suitable to the species; preferably with oversight and/or consultation by a veterinary diplomate of the American College of Laboratory Animal Medicine (ACLAM);

· provide an environment that includes baboon-specific enrichment plans;

· provide housing that is not strictly limited to the indoors and allows for safe outdoor access with appropriate refuge from harsh weather as applicable.

· provide sufficient emotional and psychological support, including regular interactive inter-species socialization;

· provide a wholesome and well-balanced diet nutritionally appropriate for baboons with variety to promote species typical foraging and fresh potable drinking water; A well-balanced diet is preferably achieved using a commercially available primate chow with standardized formula and guaranteed analysis. Feed should also include the routine provision of fresh fruits, vegetables, and forage items such as seeds and grains. Expired food items should not be utilized. Feed should be maintained free from pests, mold, and other contaminants that would negatively impact animal health.

· ensure that these animals are not exposed/provided for public entertainment, limiting public access to invited professionals on matters concerning their welfare;

· provide the FDA, prior to payment, documentation concerning receipt of the animals and a report on the animals’ health and well-being upon delivery.

The retirement facility shall not:

· exploit the animals in their care;

· breed, sell or trade the animals in their care;

· allow contact with the public or other captive wildlife;

· remove animals from their enclosures or facility property for exhibition, education, research, or commercial purposes.

The FDA reserves the right, prior to an award decision, to inspect an Offeror’s facility and examine all records necessary to ensure the adequacy of the permanent retirement home.

The FDA expects the animals to be delivered by an approved animal transportation service funded by the government within 90 days of contract award. Upon receipt, the retirement facility assumes full ownership and responsibility for the welfare of the animals for the remainder of their natural lives. The recipient retirement facility will be responsible for all future medical care and all future medical expenses. In the event that euthanasia is necessary for the welfare of the animal, it will be the responsibility and determination of the recipient facility. It is expected that the recipient has the resources to adequately provide safe and appropriate care for the animals natural life of the animals and euthanasia will not be for convenience.

4. Tasks

5. 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.

6. Government-Furnished Property, Material, Equipment, or Information (GFP_ GFM, FEW, or GFI) The Government will provide the following information and documentation to the Contractor:

· Veterinary medical records for each of the three baboons, including vaccination history, preventative health treatments such as deworming, clinical case history,and ongoing health conditions.

• Behavioral assessment profiles, socialization records, and any behavioral interventions for each animal

• Research participation history and any relevant exposure or treatment information

• Current dietary requirements and feeding protocols Emergency contact information for FDA veterinary and animal welfare personnel.

Timing: All Government-furnished information will be provided within 30 days of contract award to ensure proper preparation for animal transport and care.

Condition: All medical and behavioral records will be current as of the date of animal transfer. The Government will ensure all documentation is complete and accurate to support proper animal care.

7. Security Facility Security Requirements: • The Contractor shall maintain appropriate physical security measures to prevent unauthorized access to animals and sanctuary facilities and implement access control procedures for all personnel and visitors. The Contractor shall conduct background checks on all personnel with direct animal access in accordance with facility security protocols.

Information Security: • The Contractor shall protect all Government-furnished information and maintain confidentiality of animal records. The Contractor shall secure all medical and research history documentation in accordance with applicable privacy requirements.

No Special Clearances Required: No federal security clearances are required for personnel performing under this contract.

8. Travel All services under this contract shall be performed at the Contractor's sanctuary facility. No travel by Contractor personnel is required or authorized under this contract.

9. Special Material Requirements The Contractor shall provide all specialized materials, equipment, and supplies necessary for proper baboon care, including but not limited to:

Housing and Facility Materials: • Species-appropriate enclosures meeting FDA Animal Welfare Council standards • Environmental enrichment materials suitable for baboons • Specialized fencing and security barriers • Climate control systems appropriate for baboon welfare Veterinary and Medical Supplies: • Emergency medical equipment and supplies • Specialized veterinary instruments for baboon care • Pharmaceutical supplies and medications as needed • Quarantine facility materials and equipment Nutritional Materials: • Species-appropriate food and dietary supplements • Specialized feeding equipment and enrichment feeding devices • Water systems for the provision of safe and clean water and quality monitoring procedures and equipment Safety and Emergency Materials: • Emergency response equipment and supplies • Personal protective equipment for staff • Specialized restraint and handling equipment • Communication systems for emergency situations All materials must meet applicable federal, state, and local safety and animal welfare standards.

10. Other Unique Requirements FDA Animal Welfare Council Compliance: The Contractor must provide a good faith effort to maintain current FDA Animal Welfare Council approval throughout the lifespan of the baboons.

Operational Philosophy: The Contractor shall maintain a non-activist operational philosophy compatible with FDA's research mission. The Contractor shall not engage in activities that could compromise FDA's reputation or mission. The Contractor shall maintain professional relationships with research institutions and government agencies.

Emergency Response Capability: The Contractor shall provide 24/7 emergency veterinary and animal care response The Contractor shall have contingency plans for natural disasters, facility emergencies, and animal health crises.

Insurance and Liability: The Contractor shall maintain appropriate insurance coverage for animal care operations. The Contractor shall carry liability insurance adequate to cover potential animal-related incidents.

Regulatory Compliance: • The Contractor shall comply with all applicable federal, state, and local animal welfare regulations. The Contractor shall maintain all required licenses and permits for sanctuary operations. The Contractor shall submit to inspections by regulatory authorities as required.

Long-term Commitment: • The Contractor must demonstrate financial stability and capability to provide care for the estimated 15-20 year lifespan of the animals. The Contractor shall have succession planning in place to ensure continuity of care. The Contractor shall maintain appropriate staffing levels and expertise throughout the lifespan of the baboons.

11. Place of Performance: All services shall be performed at the Contractor's sanctuary facility.

12. Period of Performance: Transfer of ownership must occur 90 days post award.

13. Contract Type: Firm Fixed Price.

14. Total Contract Ceiling: $225,000.00

15. Invoicing:

Payment Schedule: IPP Invoicing Procedures which shall be provided at the time the Contract is awarded.

16. Points of Contract:

The Contract Specialist for this task order is:

Ryan Alexander Email: Ryan.Alexander@fda.hhs.gov

The Contracting Officer for this order is:

Ian Weiss Email: Ian.Weiss@fda.hhs.gov

The Contracting Officer’s Representative (COR) for this order is: TBD upon award.

Contract Administration Representatives The following COR will represent the Government for this order: Kellie Moran

The COR is responsible for the following as required by this order: (1) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The CO is the only person with authority to act as an agent of the Government under this order. Only the CO has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

Solicitation Provisions FAR Provision 52.252-1 Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that shall be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Contract Clauses and Provisions:

FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at:

https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

CLAUSES

i. The FAR clause at 52.212-4, Contract Terms and Conditions—Commercial Items (Deviation 2017-02) (Nov 2023) applies with deviation to subparagraph (r) below:

“(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.”

ii. INSTRUCTIONS TO OFFERORS The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items (Sep 2023), applies to this acquisition and is incorporated by reference. The following Addenda has been added to this provision:

Evaluation Criteria Nonhuman Primate Retirement Services for Three Baboons

Evaluation Method This acquisition will be conducted as a sole source procurement under FAR 6.302-1 (Only One Responsible Source) to Peaceable Primate Sanctuary. However, the following evaluation criteria establish the standards that the proposed contractor must meet to demonstrate capability and acceptability for contract award.

Evaluation Factors The Government will evaluate the contractor's capability based on the following factors, listed in order of importance.

Factor 1: Technical Capability and Experience (Most Important) Subfactor 1.1: Baboon-Specific Experience-

· Demonstrated experience in the care and management of baboons specifically

· Evidence of successful long-term baboon care (minimum 5 years)

· Documentation of baboon behavioral management and social grouping expertise

· Proven track record of baboon health management and veterinary care

· Evidence of species-appropriate housing and facility design for baboons Subfactor 1.2: Research Animal Retirement Experience

· Experience in transitioning research animals to sanctuary environments

· Understanding of the unique needs of animals with research backgrounds

· Demonstrated capability in managing research animal medical records and histories

· Knowledge of research animal welfare standards and requirements

Subfactor 1.3: Facility Capabilities

· Adequate housing facilities meeting FDA Animal Welfare Council standards

· Appropriate quarantine facilities and procedures

· Veterinary facilities and emergency care capabilities

· Environmental enrichment and behavioral management programs

· Security and safety measures for animal and personnel protection

Factor 2: Regulatory Compliance and Approvals (Important) Subfactor 2.1: FDA Animal Welfare Council Approval

· Current and valid FDA Animal Welfare Council approval

· Demonstrated understanding of FDA animal welfare standards

· Capability to maintain ongoing compliance with FDA requirements

· Record of timely response to any regulatory concerns or corrective actions

Subfactor 2.2: Other Regulatory Compliance

· Current USDA Animal and Plant Health Inspection Service (APHIS) license Compliance with state and local animal welfare regulations

· Current facility permits and licenses

· Environmental compliance and waste management capabilities

Factor 3: Organizational Capability and Stability (Important) Subfactor 3.1: Financial Stability

· Demonstrated financial capability to provide long-term care (15-20 years)

· Adequate funding sources and financial management

· Insurance coverage appropriate for animal care operations\n- Financial transparency and accountability measures

· Contingency planning for financial sustainability

Subfactor 3.2: Staffing and Expertise

· Qualified veterinary staff with baboon experience

· Trained animal care personnel with appropriate certifications

· Management staff with sanctuary operations experience

· Staff retention rates and training programs

· 24/7 emergency response capability

Subfactor 3.3: Operational Philosophy

· Non-activist operational approach compatible with FDA mission

· Professional relationships with research institutions

· Commitment to scientific and ethical animal welfare standards

· Transparency in operations and reporting

· Collaborative approach with government agencies

Factor 4: Past Performance (Somewhat Important) Subfactor 4.1: Contract Performance History

· Previous contract performance with federal agencies (if applicable)

· Quality of service delivery and customer satisfaction

· Responsiveness to contract requirements and modifications

· Problem resolution and corrective action implementation

Subfactor 4.2: Animal Care Performance

· Animal welfare outcomes and mortality rates

· Veterinary care quality and emergency response

· Regulatory compliance history and inspection results

· Incident reporting and resolution

· Continuous improvement initiatives

Factor 5: Management Approach and Understanding (Somewhat Important) Subfactor 5.1: Technical Approach

· Understanding of baboon care requirements and challenges

· Comprehensive care plan for the three baboons

· Integration and socialization strategies

· Long-term care planning and lifecycle management Quality assurance and monitoring procedures

Subfactor 5.2: Project Management

· Transportation and intake planning

· Quarantine and health assessment procedures

· Record keeping and reporting systems

· Communication and coordination with FDA

· Risk management and contingency planning

Evaluation Standards Acceptable: The contractor demonstrates adequate capability to meet all contract requirements with minimal risk of unsuccessful performance.

Unacceptable: The contractor fails to demonstrate adequate capability to meet contract requirements, or there is significant risk of unsuccessful performance.

Evaluation Process

1. Technical Evaluation: A technical evaluation team will assess the contractor's capability against all evaluation factors

2. Site Visit: FDA may conduct a site visit to assess facility capabilities and verify submitted information

3. Reference Checks: The Government may contact previous customers and regulatory agencies to verify past performance

4. Final Determination: The Contracting Officer will make the final determination of contractor acceptability based on the evaluation team's assessment

Instructions for Offerors

1. Proposal Submission Submit one electronic copy via email to Ryan.alexander@fda.hhs.gov of your proposal in PDF format.

All proposals must be received by 12:00PM ET on September 10, 2025, to the email address specified in the solicitation. All proposal questions must be received by 12:00PM ET on August 27, 2025, to the email address specified in the solicitation. Late proposals will not be considered unless authorized by applicable Federal Acquisition Regulation (FAR) provisions.

2. Proposal Format

· Use standard 8.5" x 11" paper with 1-inch margins.

· Use 12-point Times New Roman font with single spacing

· Number all pages consecutively

· Include a table of contents for proposals exceeding 10 pages

· Proposals should not exceed 20 pages for Sections I through V.

3. Proposal Organization Organize your proposal in the following sections:

Section I: Technical Capability and Experience Section II: Regulatory Compliance and Approvals Section III: Organizational Capability and Stability - Section IV: Past Performance Section V: Management Approach and Understanding Section VI: Supporting Documentation Section 1.1 Executive Summary Provide a concise overview of your organization's qualifications and approach to providing baboon retirement services.

Section 1.2 Organizational Capability A. Baboon-Specific Experience Describe your organization's experience in baboon care and management. Provide details of current and previous baboon populations under your care. Explain your understanding of baboon behavioral, social, and physiological needs. Describe specialized protocols developed for baboon welfare.

B. Research Animal Experience- Detail your experience with research animal retirement and transition. Describe your understanding of research animal backgrounds and special needs. Explain your approach to managing animals with research histories. Provide examples of successful research animal retirements, if any.

C. Facility Description. Provide detailed descriptions of housing facilities for baboons. Include photographs or diagrams of enclosures and common areas if you feel they would be beneficial. Describe quarantine facilities and procedures. Detail veterinary facilities and emergency care capabilities. Explain environmental enrichment programs and behavioral management.

Section 1.3 Regulatory Compliance A. FDA Animal Welfare Council Approval- Provide documentation of current FDA Animal Welfare Council approval. Describe your compliance monitoring and quality assurance programs. Explain procedures for maintaining ongoing animal welfare compliance, B. Other Regulatory Approvals Provide copies of current USDA APHIS license. Include state and local permits and licenses. Document compliance with environmental regulations. Provide evidence of occupational safety and health compliance.

1.4 Staffing and Qualifications

A. Key Personnel- Provide a brief description and background of key personnel. Include education, certifications, and relevant experience. Describe staff training programs and continuing education.

B. Organizational Structure-Provide a summary or chart showing reporting relationships. Describe staffing levels and coverage schedules. Explain 24/7 emergency response capabilities.

Section 1.5 Technical Approach.

A. Transportation and Intake Plan Describe your approach to animal transportation from FDA facilities- Explain transportation vehicle specifications and safety measures. Provide timeline for transportation and intake activities B. Quarantine and Health Assessment Describe quarantine facilities and procedures. Describe health assessment protocols and diagnostic capabilities. Explain veterinary oversight during quarantine period. Provide timeline for quarantine completion and integration.

C. Long-term Care Plan Describe housing arrangements and social grouping strategies. Detail nutrition programs and dietary management. Explain behavioral enrichment and welfare monitoring. Describe veterinary care and health management programs.

D. Record Keeping and Reporting Describe record keeping systems and data management. Explain quality assurance and monitoring procedures.

Section1.6 Risk Management and Contingency Planning Identify potential risks and mitigation strategies. Describe emergency response procedures. Explain contingency plans for facility emergencies\n- Detail succession planning and continuity of operations.

Section II: Past Performance Information

2.1 Contract Performance History For each relevant contract performed within the last five years:\n- Contract number and title\n- Customer name and contact information\n- Contract value and period of performance\n- Description of services provided\n- Performance outcomes and customer satisfaction\n\n2.2 Animal Care Performance (3-page maximum)\n- Animal welfare outcomes and mortality statistics\n- Regulatory compliance history and inspection results\n- Incident reports and resolution actions\n- Continuous improvement initiatives and outcomes\n\n2.3 References (No page limit)\nProvide at least three (3) references from:\n- Previous customers (government or private)\n- Regulatory agencies (FDA, USDA, state agencies)\n- Professional organizations or veterinary institutions\n\nInclude:\n- Organization name and address\n- Contact person name, title, phone, and email\n- Relationship to your organization\n- Services provided and time period\n\n### Section III: Cost/Price Proposal\n\n3.1 Cost Summary\nProvide a detailed cost breakdown including:\n- Initial setup and transportation costs\n- Annual care costs by category:\n - Personnel costs\n - Veterinary care\n - Food and nutrition\n - Facility maintenance\n - Utilities and operations\n - Insurance and administrative costs\n- Total estimated lifetime cost (15-20 years)\n\n3.2 Cost Justification\n- Explain the basis for cost estimates\n- Provide supporting documentation for major cost elements\n- Include escalation factors for multi-year costs\n- Describe cost control measures and efficiency initiatives\n\n3.3 Payment Schedule\n- Propose payment schedule and milestones\n- Explain invoicing procedures and documentation requirements\n- Describe cost reporting and financial management procedures\n\n### Section IV: Supporting Documentation\n\n4.1 Required Certifications and Representations\n- Complete all required certifications per FAR 52.204-8\n- Provide System for Award Management (SAM) registration documentation\n- Include any required small business certifications\n\n4.2 Financial Information\n- Provide audited financial statements for the last three years\n- Include current insurance certificates\n- Provide bank references and credit information\n- Document financial capability for long-term performance\n\n4.3 Legal and Regulatory Documentation\n- Articles of incorporation and bylaws\n- Current business licenses and permits\n- Regulatory inspection reports and compliance documentation\n- Legal opinions on organizational status (if applicable)\n\n### Proposal Evaluation Notice\n\nYour proposal will be evaluated based on the criteria specified in the solicitation. The Government reserves the right to:\n- Request clarifications or additional information\n- Conduct site visits to verify facility capabilities\n- Contact references and previous customers\n- Request presentations or demonstrations\n\n### Questions and Clarifications\n\n- All questions must be submitted in writing to Ryan.alexander@fda.hhs.gov\n- Questions must be received by August 27, 2025 \n- Responses will be provided to all potential offerors\n- No oral clarifications or commitments will be binding\n\n### Proposal Validity Period\n\nProposals must remain valid for 60 days after the proposal submission deadline to allow for evaluation and award processing.\n\n### Proprietary Information\n\nClearly mark any proprietary or confidential information in your proposal. The Government will protect such information in accordance with applicable laws and regulations, but cannot guarantee absolute confidentiality.\n\n### Award Notification\n\nThe successful offeror will be notified of award via official contract documentation. Unsuccessful offerors will be notified in writing and may request a debriefing in accordance with FAR procedures.

(END OF SOLICITATION)