DRAFT_APF_SOW_and_Evaluation_Factors_5-25-2018.pdf

Statement of Work

Title: Operation and Maintenance of the Alamogordo Primate Facility (APF)

Program: National Institutes of Health (NIH) / Office of the Director (OD) / Office of Research Infrastructure Programs (ORIP)

NAICS CODE: 541940 --Professional, Scientific, and Technical Services-- Veterinary Services

BACKGROUND INFORMATION

The National Institutes of Health (NIH) and the U.S. Air Force (USAF) have an agreement to house and care for chimpanzees at the facility named Alamogordo Primate Facility located on the Holloman Air Force Base (HAFB) in Alamogordo, New Mexico. The National Institutes of Health (NIH) requires a Contractor to operate and maintain the APF and its animal care and use program. MAINTENANCE OF CHIMPANZEES IS REQUIRED; NO RESEARCH IS ALLOWED. The Contractor’s personnel must clear background checks performed by HAFB and the Contractor must be approved by HAFB to enter the facilities as the APF occupies a series of closely located buildings on the HAFB. Each of Buildings 1301, 1302, 1303, and 1304 can house approximately 72 animals, in 12 dens holding approximately 6 animals each. Thus, the theoretical capacity is approximately 288 chimpanzees.

The current primate population at APF is expected to be between 40 to 50 aged chimpanzees housed in single sex groups. Most of the chimpanzees have been exposed to viruses such as hepatitis C virus (HCV) and human immunodeficiency virus (HIV), or both. The animals have disease complications associated with aging, including cardiovascular disease, renal disease, diabetes, hepatitis, arthritis, obesity, and uterine masses. Most have comorbidities. These chimpanzees need to be routinely monitored and medically managed with an emphasis on the animal’s quality of life. Few of the chimpanzees are vasectomized or implanted with Norplant. NO MORE ANIMALS CAN BE BROUGHT ON BASE. Any NIH-owned animals taken off the base cannot be returned to the base. The number of chimpanzees is expected to decrease over time as they die due to natural causes or are humanely euthanized in accordance with quality of life guidelines.

OWNERSHIP ISSUES

The NIH will retain title to the chimpanzees. There is no requirement or expectation for the Contractor to take title to the chimpanzees. However, any chimpanzee that is born at APF shall be owned and supported financially by the Contractor.

DESCRIPTION OF EXISTING FACILITIES AND RESOURCES

The APF occupies a series of closely located buildings on the HAFB. Each of Buildings 1301, 1302, 1303, and 1304 can house approximately 72 animals, in 12 dens holding approximately 6 animals each. Building 1305 is a smaller animal housing area. Thus, the theoretical caging capacity is approximately 288 chimpanzees. Mechanical support for buildings 1301-1305 is provided by equipment in Building 1300. Buildings 1300-1305 were built and first occupied in the 1990s and are reasonably well preserved and functional. Building 1301 houses a clinic and nearby Building 1320 contains a necropsy area. Building 1269, near the primary facilities houses a welding and repair shop.

Various site and building schematics of the above buildings are available from the Contracting Officer.

The housing in 1301-1305 meets or exceeds required size minimums and is a valuable facility that is worth repairing as necessary. If repairs are required to a specific area housing up to 24 animals, there is sufficient capacity within Buildings 1301-1305 to move animals to allow repairs to be completed.

At a time agreeable to the Contracting Officer's Representative (COR), but not later than 30 calendar days after contract implementation, the Contractor shall conduct an inventory of major equipment already on-site at the APF. The Contractor and the Government will determine the working order, condition and value of all major pieces of equipment, and the Contractor shall request permission to charge the contract for the repair of any necessary items not in working order. Title to all equipment purchased with contract funds shall vest in the Government, so that this equipment is available for use in any follow-on contract. The Contractor shall be responsible for the routine operation and maintenance of all equipment used in the contract.

REQUIREMENTS

All Contractor vehicle drivers shall possess a valid driver's license and must have a safe driving record with no evidence of DWI or DUI. The Contractor shall maintain a certificate of vehicle liability insurance for all Contractor vehicles operated at the APF for the duration of this contract. Animals may only be transported in Contractor vehicles specifically designated for this use. Personal vehicles are not to be used. Contractor personnel must comply with all HAFB policy and procedures regarding use of vehicles on the base.

PERSONNEL - The following description is the present estimate of the staff that is required:

Professional Staff - Director, Clinical Veterinarian, and Nurse/Occupational Safety and Health (OSH) Officer;

Technical Staff - Colony Manager;

Animal Care Staff - 1 supervisory and 3 other, including technicians to address enrichment and psychological wellbeing; and

Maintenance Staff - 1 supervisory and 1 other.

The Contractor shall possess and maintain fiscal-management expertise, long-term financial stability, and management expertise to care for groups of aged chimpanzees (<50 animals). The Contractor shall demonstrate capabilities of medical management of chimpanzees with various illnesses associated with aging. This includes, but is not limited to, medical management of cardiovascular and renal disease, diabetes, hepatitis; pain management associated with arthritis and uterine masses; and management of obesity. All personnel must clear background checks performed by HAFB. The Director and Clinical Veterinarian are considered key personnel.

CONSULTANTS AND NECROPSY SERVICE- The perceived advantage of having consultants is that they would not have to be retained as full-time employees, and some would not necessarily have to be located in New Mexico. An off-site veterinary pathologist and related services (such as those available from other locations of the Contractor) may be needed to necropsy animals, and process and interpret necropsy tissues. In addition, the Contractor should develop a formal agreement with an Alamogordo or Las Cruces physician who will provide scheduled and emergency consultations and care, related to potential zoonoses acquired from chimpanzees.

ON-SITE TRAINING - New hire training and periodic refresher training for all employees will be needed for employees at all levels. Guidance regarding these issues can be obtained from the Office of Laboratory Animal Welfare (OLAW), the Guide for the Care and Use of Laboratory Animals (most current version; Guide), American Association for Laboratory Animal Science (AALAS), American

College of Laboratory Animal Medicine (ACLAM), and Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).

ANIMAL CARE - In accordance with the current NIH-held Animal Welfare, APF contractor staff shall receive training comparable to that provided by the Associate Director for Training, Education, and Program-Liaison which will be approved by the Director, Office of Animal Care and Use (OACU), and presented by Contractor personnel at the APF.

MAJOR CHALLENGES - The major challenges at the APF are related to medical management of the aged chimpanzee population. Many of the animals have comorbidities and these must be managed to assure a high quality of life for individual chimpanzees. The Contractor must submit a Chimpanzee Quality of Life Plan with their proposal. This plan shall outline the steps undertaken to assess the quality of life of individual chimpanzees and provide guidelines for consideration of euthanasia.

Additional challenges are associated with the desert climate with its rapidly fluctuating temperatures, and the biosafety considerations for these chimpanzees. A walk-through every 4 to 6 hours for temperature monitoring, security reasons, and gross observation of the animals is required. Protective clothing, appropriate showering, proper waste disposal, and other BL2/BL3 biosafety practices are necessary. Most of the animals have been exposed to viruses such as hepatitis C virus (HCV) and human immunodeficiency virus (HIV), or both. Not all animals exhibit signs of active infection, but all animals should be routinely monitored for infection. Care, diet, housing, and sanitization must comply with The Chimpanzee Health Improvement, Maintenance, and Protection Act (CHIMP Act); The Animal Welfare Act (P.L. 89-544, as amended) Rules and Regulations published in the Code of Federal Regulations (CFR), Title 9 (Animals and Animal Products), Chapter 1, Subchapter A (Animal Welfare), Parts 1, 2, and 3 (AWRs); Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy); and Guide for the Care and Use of Laboratory Animals.

DIET - Standard commercially available chow supplemented with fresh fruits and vegetables.

SANITATION - Hosing of floors 2 times/day, periodic pressure washing of den surfaces in accordance with The Guide for the Care and Use of Laboratory Animals (NRC 2011).

HEALTH CARE - Periodic physicals (at least annual) and TB testing for all chimpanzees, blood sampling and shipping for off-site HIV and HCV testing, standard vaccinations and other standard preventative health care for chimpanzees, veterinary care for existing medical conditions as well as unexpected health problems and wounding from den-mates, and instances of euthanasia when ordered by a veterinarian considering the best interests of an individual chimpanzee. The Contractor must submit a Chimpanzee Quality of Life Plan with their proposal. This plan shall outline the steps undertaken to assess the quality of life of individual chimpanzees and provide guidelines for consideration of euthanasia.

PREVENTION OF BREEDING/GROUPING OF CHIMPANZEES - The animals have already been divided into dens containing animals of the same sex, and this shall continue to be the primary method used to prevent breeding. In this case, some shields may need to be placed to prevent inter-den copulation. However, since non-single housing is a primary need for environmental enrichment, and not all adult male chimpanzees can be cohoused with other male chimpanzees, other allowable methods to prevent breeding can include vasectomy, tubal ligation, Norplant implants, and pregnancy terminations. NIH expects that no conceptions of chimpanzees at the APF will occur, and for surgical terminations to be performed if they do occur. Any chimpanzee that is born at APF shall be owned and supported financially by the Contractor. The Air Force will require that any chimpanzee that is born at the APF be removed to the Federal Sanctuary at the earliest time possible. The Contractor will follow the procedures outlined for acceptance of Non-Federal chimpanzees to the Federal Sanctuary as described in the CHIMP Act.

ENVIRONMENTAL ENRICHMENT - Environmental enrichment will be provided to all animals. A primary need of chimpanzees is to be housed with other conspecifics whenever possible. The chimpanzees shall be allowed access to the outdoors when climatically advisable and be provided indoor shelter when necessary. Buildings 1301, 1302, 1303, and 1304 each include 12 dens with indoor and outdoor sections that together hold approximately 6 animals per den.

INFORMATION TECHNOLOGY – Computerized records shall be maintained on all animals, to include both behavioral and clinical health records. Security procedures such as the use of passwords and backup copies, and LAN system implementation and maintenance shall be performed.

CLINICAL LAB ACCESS - Access to on-site or off-site clinical lab capabilities is necessary to maintain the health of the chimpanzees.

NECROPSY - The APF chimpanzee population is aged and the existing animals will likely die over the course of this contract. As specified in the Memorandum of Understanding between the Director, ORIP and the Deputy Director of Intramural Research, any instances of animal death or injury must be reported by phone or email to the Contracting Officer's Representative (COR) and the Director, NIH OACU, within 24 hours. Any such incidents deemed to be significant deficiencies according to PHS Policy will be verbally reported to OLAW and followed-up in writing upon completion of appropriate Animal Care and Use Committee (ACUC) investigations and implementation of corrective actions. In the case of a death from an unknown cause, a necropsy must be done under BSL2 containment.

ADMINISTRATIVE - NIH staff believe that a variety of logistical methods mixing on-site and off-site capabilities can be used to satisfy administrative requirements. Various types of umbrella liability, employee injury, renter's insurance for damage to the buildings and theft of contents, vehicle insurance, etc. will be obtained as needed by the Contractor. One definite need is that all costs for operating and maintaining the APF must receive separate accounting from other costs to the Contractor for other sites and tasks. Inspections by the COR and/or Contracting Officer are to be expected, but it is not likely that a NIH representative will usually be located on-site.

USDA, OLAW, AAALAC - Intramural NIH's Animal Welfare Assurance includes the APF and expects the APF to hold a United States Department of Agriculture (USDA) R Registration for the APF and continue to be subject to courtesy inspections. It is expected that both USDA and AAALAC, International representatives will periodically visit the APF and issue reports to the Contractor and NIH.

Major Alterations and Renovations may be needed to the APF to correct deficiencies that the USDA may categorize as "must be replaced or repaired." The Contractor will be responsible for obtaining estimates for these repairs, and the work scope of the contract and funds for its completion will be modified through the contract as necessary. After discussion with NIH staff members, deficiencies identified during AAALAC, International site visits will be addressed. The APF will continue to maintain accreditation by AAALAC, International. In addition, as noted in NIH POLICY MANUAL 3040-2 ANIMAL CARE AND USE IN THE INTRAMURAL PROGRAM, please see (http://oacu.od.nih.gov/NIHpolicy/3040-2.pdf), the NIH Director of OACU will review and approve all animal facility renovation plans.

A license from the Drug Enforcement Agency to one or more veterinary staff of the APF for the use of drugs in chimpanzees at the APF will be required.

http://oacu.od.nih.gov/NIHpolicy/3040-2.pdf

ACUC - Since Intramural NIH holds the Animal Welfare Assurance, the designees of this subdivision of NIH will manage the ACUC in accordance with the Memorandum of Understanding between the Director of ORIP and the Deputy Director of Intramural Research. The ACUC will be constituted and meet in New Mexico, and will provide the functions required by OLAW, USDA, and NIH Policy Manual 3040-2. Standard reports from the ACUC are required to be filed with the COR and Director, NIH OACU (The Animal Welfare Act (P.L. 89-544, as amended) Rules and Regulations published in the Code of Federal Regulations (CFR), Title 9 (Animals and Animal Products), Chapter 1, Subchapter A (Animal Welfare), Parts 1, 2, and 3 (AWRs); Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy); and Guide for the Care and Use of Laboratory Animals (NRC 2011;

Guide). Members from the Contractor's staff and outside members with appropriate qualifications will be appointed by the Director of the Office of Research Infrastructure Programs, to serve on the ACUC.

As specified in the Memorandum of Understanding between the Director, ORIP and the Deputy Director of Intramural Research, any instances of animal death or injury must be reported by phone or email to both the COR and the Director, NIH OACU, within 24 hours. Any such incidents deemed to be significant deficiencies according to PHS Policy will be verbally reported to OLAW and followed-up in writing upon completion of appropriate ACUC investigations and implementation of corrective actions.

PAYROLL/TAXES/HIRING+TERMINATION/BILLING/PURCHASING - The offeror's proposal shall describe an acceptable plan of on-and off-site sources that shall accomplish these tasks. The plan will be discussed during negotiations and will be incorporated into the contract upon award.

Minimal Staffing Plan - The plan must be provided with the proposal for evaluation by the technical evaluation panel and will be incorporated into the contract upon award.

The Contractor shall be responsible for the selection, professional certifications, maintenance of valid and appropriate licensures, assessment, supervision, management, and control of employees in performance of the Statement of Work. When necessary to ensure continued satisfactory performance of the required services, the Government will request, and the Contractor shall replace any person under this contract due to inappropriate behavior, poor performance, misconduct, endangering life, abuse of U.S. Government property or inhumane treatment of animals.

The Contractor shall provide veterinary care and husbandry service necessary to properly maintain chimpanzees 24 hours a day, 7 days a week, every day of the year, including weekends and Government holidays. Contractor staff shall be designated essential employees, and at least a minimal staff shall report for duty every day of the year, including periods of inclement/severe weather or other adverse working conditions. The Contractor shall observe the same holidays as the Federal Government.

The Contractor shall document actual employee hours worked by use of a time sheet, time clock, or other time keeping method, and shall only bill for actual hours worked. Overtime and holiday pay is expected but shall be justified. The Contractor shall maintain a flexible work schedule and shall use a cost-effective method of providing essential coverage after normal working hours, on weekends, Government holidays, and other periods of Government closure, and may include staggered or alternative schedules. The Contractor shall organize the workforce in a way that critical functions are performed even when unforeseen absences of personnel occur.

SECURITY - The Contractor shall ensure that an effective security system and procedures are in place at the AFP and procure and establish these if necessary. The Government is not liable for the loss of personal possessions of the Contractor or its staff. The HAFB has a manned guard booth that restricts vehicular access to the large HAFB. During non-regular business hours, a walk-through of the various APF buildings every 4-6 hours for temperature monitoring, security reasons, and gross observation of the animals is required. Plans for replacing all or some of the walk-throughs by use of video and other electronic surveillance methods shall be approved in advance by the APF ACUC and the COR, and be submitted to the Director, NIH OACU. It is expected that the person performing the walk-through shall carry a cell phone.

WRITTEN STANDARD OPERATING PROCEDURES (SOPS) - SOPs shall be written that cover most aspects of animal care and health, occupational safety and health for the staff, and for reporting and administrative requirements. SOPs relevant to OSH shall be approved by the Nurse/OSH Director, and SOPs relevant to Animal Care shall be approved by the ACUC. These must be submitted for approval within 30 days of award.

ADVISORY COMMITTEE - The Contractor shall set up an advisory committee of 5-6 members that shall periodically (at least annually) review the APF's operation and serve as an advisory body for programmatic issues. These individuals should have expertise in animal facility maintenance or oversight of large nonhuman primates, chimpanzee expertise preferred. Appointment individuals shall not have a perceived financial or other conflict of interest. Plans for possible facility repairs, major or minor, should be presented to the advisory committee. The COR has the right to refuse the appointment of any named member that the COR believes would be disruptive to the functioning of the committee or be detrimental to NIH's interests.

OCCUPATIONAL SAFETY AND HEALTH (OSH)/ ANIMAL EXPOSURE SURVEILLANCE PLAN

(AESP) - This plan shall be submitted with the proposal for evaluation by the technical evaluation panel.

The Contractor shall provide an effective training program in occupational safety and health. Prior to commencing any work, employees shall be properly trained in safe practices and informed of potential hazards by Contract managers and supervisors. The Contractor shall be responsible for insuring their staff are provided with, understand, and follow those safety instructions.

Specific areas to be covered shall include, but not be limited to: i) Safety procedures when working with chimpanzees, ii) Emergency response and first aid training, iii) Safe handling of biohazardous material,

iv) Waste management procedures, v) Hazard containment and spill clean-up procedures, vi) Fire safety and extinguisher use training, vii) Respirator use (when appropriate), viii) Use of Material Safety Data Sheets (MSDS), ix) Use of biosafety cabinets and fume hoods, when appropriate, x) Safe operation of powered equipment, xi) Proper lifting techniques, xii) Hazards of drug and alcohol abuse in the workplace.

The Contractor shall provide continuing training to address safety and health issues specific to the Statement of Work.

The Contractor shall provide the COR a detailed Safety and Health Training Plan for ongoing training for Contractor personnel thirty (30) calendar days after contract implementation.

Other training may be identified by the Government or Contractor as needed. The Contractor shall submit all requests for additional training and associated costs to the COR for approval.

The Contractor shall establish and implement safety and health controls to protect the life and health of all persons on the Contract job site. The Contractor shall implement a Safety and Health Plan in accordance with the Contractor's corporate personnel policies, with Federal laws, and with Air Force policies and procedures. The plan shall detail possible dangers that may be encountered while performing the job, proper protective equipment and procedures to be used, and an emergency plan in case of an accident. The Contractor shall be responsible for and shall comply with the following requirements:

• Establish proper safety and health precautions to protect the work site, employees, other personnel frequenting the work site, animals, and the property of others;

• Instruct all employees in appropriate safety practices and inform them of all hazards associated with their work before the work commences;

• Provide all necessary insurance for the nature of the work employees shall be required to perform under this Contract;

• Provide employees with appropriate occupational medical care;

• Provide employees with the appropriate protective clothing and equipment;

• Document and immediately report all safety hazards to the COR;

• Document and immediately report all incidents or accidents to the COR;

• Take any additional safety measures that the COR or Contracting Officer may direct by written order.

The Contractor shall establish an Occupational Medical Program and provide employees with appropriate medical care to include pre-employment evaluations, occupational medical surveillance, and job-related emergency treatment.

The Contractor shall conduct a pre-placement medical evaluation to determine if the applicant is currently medically and physically able to fulfill the requirements of the position without risk of injury or illness to themselves, other individuals or the animals; provide the applicant with position-related health and safety information; and provide the applicant with appropriate immunizations to reduce the risk of a work-related infection. The pre-placement medical evaluation shall include: i) Occupational medical history, ii) Safety and health counseling, iii) Pre-employment drug screen, iv) Tetanus screening (immunization within last 10 years), v) Baseline audiogram for employees exposed to elevated noise levels, vi) Pulmonary function for employees required to wear full face respirators, vii) Other appropriate immunizations and screenings determined by the species (chimpanzees) and potential hazards (HIV, HCV, Hepatitis B virus [HBV]and possibly Hepatitis A virus [HAV]) that the contract employee will be exposed.

The Contractor shall establish an Occupational Medical Surveillance Program. Employees shall be required to participate in this program if they are involved in the direct care of animals or their living quarters, or have direct contact with live or dead animals, their viable tissues, body fluids or waste. The Contractor's Occupational Medical Surveillance Program shall be organized so that the level of surveillance is appropriate for the species and potential hazard that the contract employee will be exposed to, e.g., i) Chimpanzees, ii) Chimpanzee tissues.

Routine collection and storage of serum for Contractor employees is not required after a baseline collection. However, the Contractor shall collect and store serum if a contractor employee sustains an injury involving percutaneous or mucous membrane exposure to blood or body fluids of chimpanzees and shall provide off-site storage of serum that is consistent with Federal Policy for the Protection of Human Subjects.

PREEMPLOYMENT PHYSICAL EXAMS, HEALTH SCREENING, and VACCINATIONS for hepatitis B, measles, vaccinia, mumps, and rubella are needed, as appropriate for each individual employee.

Contractor personnel entering the HAFB shall comply with all relevant HAFB Health and Safety requirements. Persons having active tuberculosis shall be excluded from work with contract chimpanzees. All appropriate personnel shall be immunized against hepatitis A and C viruses, HIV, and other relevant diseases as safe and effective vaccines become available.

CONTINUED HEALTH SURVEILLANCE - A schedule for periodic TB testing and revaccination of employees with chimpanzee contact shall be followed.

EMERGENCY CARE plans on a 24/7 basis shall be maintained and provided to all employees.

PREEMPLOYMENT AND CONTINUED TRAINING REGARDING OSH for microbiological biosafety and prevention of chimpanzee-related injuries is necessary.

WASTES - At present, urine and feces from the chimpanzees are treated at the same sewage treatment plant that receives potentially HIV and HCV contaminated-human sewage. Sharps such as hypodermic needles, soiled personnel protective equipment, and animal tissues that are potentially biohazardous must be appropriately treated and disposed, probably through an appropriate commercial company such as Stericycle of El Paso, Texas.

REPORTS – Monthly and Annual Progress Reports shall be submitted to the COR, Contracting Officer, and the Director, NIH OACU. Monthly reports shall cover a summary of activities related to:

Administration, Veterinary Care, Animal Husbandry, Facility Maintenance, and Colony Census. The annual report shall include these same topics with more in-depth reporting to include colony details and ACUC meeting minutes.

FACILITIES OPERATION, MAINTENANCE AND MODERNIZATION

MAINTENANCE - Maintenance and minor repairs to the interior and exterior, and for general maintenance of the APF shall be performed. The Contractor shall develop a proactive method by which necessary major repairs are identified, evaluated, and implemented in a timely manner. The ACUC shall be involved in oversight of repairs. The methods for this are expected to vary depending on the scope and severity and expense of the repair. Repairs requiring extensive cost shall be reviewed and approved by the COR/CO prior to initiating work.

USDA INSPECTIONS - The Contractor shall be responsible for ensuring the APF complies with standards established by the U.S. Department of Agriculture (USDA) and the Public Health Service (PHS). However, major Alterations and Renovations may be needed to the APF to correct deficiencies that the USDA may categorize as "must be replaced or repaired." The Contractor shall be responsible for obtaining estimates for these repairs, and the work scope of the contract and funds for its completion will be modified as necessary. After discussion with NIH staff members, deficiencies identified during AAALAC, International site visits will be addressed. The APF shall maintain accreditation by AAALAC, International. As noted in the NIH Policy Manual 3040-2, the NIH Director OACU will review and approve all animal facility renovation plans.

RENT - The lease of the APF buildings to NIH and sublease to the contractor is expected to cost no more than $1/yr.

UTILITIES - As discussed in the Use Permit, the Air Force will provide electricity, gas, water, and disposal of wastewater up to a designated cost per month. Any costs above this designated cost per month will be paid by NIH via the contract, unless the Contractor has been negligent in the use of utilities.

REQUESTS FOR TOURS AND CONGRESSIONAL/MEDIA INTEREST - As discussed in NIH Policy Manual 3040-2, NIH animal facilities have controlled access and shall not be opened to the public, for a variety of reasons. Requests by outside individuals or groups to visit NIH animal facilities shall be coordinated through the OACU, Office of Intramural Research, the Division of Police, Office of Research Services, and the COR. The COR and the NIH Office of Communications and Public Liaison shall be notified, in writing, of all such requests.

Requests for information or inquiries/allegations regarding activities at the APF to the Contractor shall be forwarded to the Director, ORIP, or designee, who will promptly notify the NIH OACU of any inquiries that lead to or that have public, media, or congressional interest. All information and data related to this contract that the contractor gathers or obtains shall be both protected from unauthorized release and considered the property of the government.

OPTION FOR ADDITIONAL SERVICES

Options for additional services may be exercised solely at the Government’s discretions and can only be implemented via express written authorization from the Contracting Officer.

SHIPPING OF ANIMALS TO OTHER LOCATIONS - If and when the NIH directs the Contractor to relocate chimpanzees from APF to the Federal Sanctuary, the Contractor shall cooperate with the shipping effort, including the performance of pre-shipment physical examinations and required blood tests. Shipping of chimpanzees must comply with the Animal Welfare Act, Title 9, Subchapter A, Part 3, Transportation Standards, and Current CDC General Guidelines for Handling Nonhuman Primates During Transit and Quarantine. If the APF animals are transferred to the Federal Sanctuary, all medical records shall be transferred to the Federal Sanctuary and remain with the animals. It is anticipated that all animals currently residing at the APF facility will die of natural causes or be transferred to the Federal Sanctuary System before contract expiration. CDC and USDA regulations and considerations for shipping of chimpanzees must be followed.

OTHER COSTS

COSTS - No invasive biomedical research shall be required or allowed under this contract and no direct or indirect costs for any independent research and development project can be charged to this contract.

UNPREDICTABLE COSTS TO THE CONTRACTOR - If the Contractor notes, or the USDA identifies, deficiencies that require major repairs or corrections to the buildings, then the costs of such repairs and/or corrections will be additive to the planned cost of the contract.

PREDICTABLE COSTS TO THE CONTRACTOR - NIH will pay for maintenance of essential professional, technical, and administrative infrastructure, plus equipment, supplies, travel, etc. The use of "per diem" charges for daily care of the chimpanzees does not appear to be a preferable method for computing costs to the contract.

TRAVEL

Upon the Contracting Officer’s approval, the professional staff described above may attend 1 professional meeting per year at the Contract's expense. The veterinary staff must stagger this attendance to allow 24/7 coverage of the APF. Only travel related to continuing education conferences for appropriate personnel will be considered for approval on incoming invoices.

MANDATORY CRITERIA

Chimpanzees require significant attention to psychological and social environments. In addition, nonhuman primates can carry a variety of zoonotic agents that can be transmitted to humans and other non-infected animals. For example, some of these infectious agents, such as hepatitis B and C viral agents, may have been acquired through previous exposure and may persist in the animal for a significant period of its lifetime. These potential risks increase the importance of identifying infectious hazards for humans working with nonhuman primates. Therefore, the offeror must demonstrate the following:

1) The ability to comply with the federal laws, regulations and policies governing the care of chimpanzees, including: The Chimpanzee Health Improvement, Maintenance, and Protection Act; The Animal Welfare Act (P.L. 89-544, as amended) Rules and Regulations published in the Code of Federal Regulations (CFR), Title 9 (Animals and Animal Products), Chapter 1, Subchapter A (Animal Welfare), Parts 1, 2, and 3 (AWRs); Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy); Guide for the Care and Use of Laboratory Animals (most current version; Guide); Biosafety in Microbiological and Biomedical Laboratories (5th Edition, CDC-NIH, 2009; BMBL); Occupational Health and Safety and Use of Nonhuman Primates (NRC 2003); Chimpanzees in Research, Strategies for their Ethical Care, Management, and Use (NRC 1997); AVMA Guidelines for the Euthanasia of Animals: 2013 Edition; The Psychological Well-Being of Nonhuman Primates, (NRC 1998); and 29 CFR 1910.1030, Bloodborne Pathogen Standard.

2) Proper experience in the identification, handling, and maintenance of infected chimpanzees.

3) Proper experience and knowledge of nonhuman primate infectious agents, including hepatitis

B and C viral agents.

No proposals will be considered without demonstrating these specifications.

PLACE OF PERFORMANCE

Alamogordo Primate Facility, Holloman Air Force Base in Alamogordo, NM 88330.

EVALUATION FACTORS FOR AWARD

The major factors for this solicitation include technical (which encompasses experience), past performance and cost/price. Offerors are advised that the award will be made to that offeror whose proposal provides the best overall value to the Government.

The evaluation will be based on the demonstrated capabilities of the prospective Contractor in relation to the needs of the project set forth in the solicitation. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of this solicitation. Offerors must submit information sufficient to evaluate proposals based on the detailed criteria listed below

Evaluation Factor 1: Competence in the operation and maintenance of a chimpanzee facility conforming to all Federal laws, Federal policies, National Resource Council (NRC) and Institute for Laboratory Animal research (ILAR) recommendations.

Weight: 40

• Adequacy of proposed procedures for veterinary care and animal husbandry of approximately 40 to 50 aged chimpanzees, many with comorbidities; dealing with biohazards; obtaining IACUC approvals; preventing the APF chimpanzees from breeding; and adequacy of the Chimpanzee Quality of Life Plan.

• Ability to comply with all applicable Federal and State laws and regulations pertaining to the acquisition, registration, care disposition, and transportation of nonhuman primates.

• Adequacy of the proposed administration infrastructure, either on-site at the APF or at the Contractor’s main facility, that will adequately support the veterinary and technical services.

• Adequacy of plans to maintain the facilities within appropriate regulations and guidelines for the care of chimpanzees.

• Experience in and technical approach for fulfilling the following requirements:

a. Routine care, housing, nutrition, hygiene of chimpanzees.

b. Sanitation and cleaning of the equipment and facilities.

c. Environmental monitoring of facilities, including vermin control and security.

d. Animal health surveillance, observations, identification, written and computerized record keeping.

e. Animal handling (including animals infected with human pathogens), restraint, clinical procedures, and euthanasia.

f. Veterinary medical assistance, treatments/medications, diagnose of diseases, medical management of multiple diseases, including treatment with multiple medications (consideration of drug-drug interactions and contraindications), induction of anesthesia and surgical assistance.

g. Clinical laboratory technical support.

h. Animal transportation within APF.

i. Environmental enrichment for chimpanzees.

j. Maintenance of equipment and supplies or other logistical support.

k. Clerical and data entry support.

l. Appropriate management oversight.

Evaluation Factor 2: Expertise and experience of proposed professional and support personnel.

Weight: 30

Personnel must possess extensive experience in nonhuman primate medicine, specifically chimpanzees, and infectious diseases. The Principal Investigator/Director and clinical veterinarian are considered key personnel and will be evaluated, as appropriate, with respect to specialty board certification by the American College of Laboratory Animal Medicine, advanced degrees, state veterinary licenses, residency training in laboratory animal medicine, and experience in medical management of aged chimpanzees with comorbidities as well as experience managing a contract of this nature (past performance).

The technical staff (e.g., Colony Manager, Laboratory Supervisor and laboratory animal caretakers) will be evaluated with respect to the American Association for Laboratory Animal Science technician certification and work experience related to aged chimpanzees with serious medical conditions and infected with human pathogens.

This criterion also includes the adequacy of the Contractor’s proposed staffing plan, proposed Quality of Life Plan, and proposed OSH training program.

Evaluation Factor 3: Reports and Records

Weight: 10

• Demonstrated ability to maintain computerized and detailed animal records at the site.

• Adequacy of plans to contact the Contracting Officer Representative (COR), Contracting Officer

(CO) as NIH representatives to report incidents, accidents, injuries or deaths of chimpanzees.

• Demonstrated ability to timely complete monthly and annual reports.

Evaluation Factor 4: Organizational Commitment

Weight: 20

• Experience of organization in managing a contract of this nature.

• Evidence of commitment of the organization to provide the management oversight, support, staffing, quality control, assistance, and resources needed to perform the work at the APF.

• Evidence of the organization’s willingness to work with the HAFB and submit to background checks and follow all applicable rules and regulations associated with the Air Force Base.