DRAFT_SOW.pdf

Statement of Work

October 3, 2019

Title: Operation and Maintenance of the Chimpanzee Care Center (CCC)

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

For over 40 years, the National Institutes of Health (NIH) has supported a facility at the Chimpanzee Care Center (CCC), MD Anderson Cancer Center, University of Texas, in Bastrop, TX to care for NIH-owned chimpanzees. The program previously supported biomedical research on chimpanzees but ceased biomedical/invasive research in 2012. Since NIH’s announcement on November 18, 2015 eliminating biomedical research on NIH-owned and-supported chimpanzees, the CCC has continued to provide care for the chimpanzees residing at their facility until those animals that could be transferred to the Federal Sanctuary were retired. Chimpanzees that were deemed unable to relocate to the Federal Sanctuary due to a high probability that “relocation would severely and irreversibly accelerate deterioration of the chimpanzee’s physical and behavioral health” (Announcement_of_Agency_Decision-Relocation_of_At-Risk_Chimpanzees) remain at the CCC. The NIH requires a Contractor to operate and maintain the facility at the CCC and care for the NIH-owned chimpanzees. MAINTENANCE OF CHIMPANZEES IS REQUIRED; NO RESEARCH IS ALLOWED AS

PART OF THE CONTRACT.

The current chimpanzee population at the CCC is expected to be between 45 to 55 aged chimpanzees housed in social groups. Chimpanzees may have been exposed to viruses such as hepatitis B or C virus (HBV, HCV) or both HBV and HCV, or other pathogens. 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. 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 the CCC shall be owned and supported financially by the Contractor.

DESCRIPTION OF EXISTING FACILITIES AND RESOURCES

The CCC was established in 1975 on 381 acres of central Texas ranchland near Bastrop, TX about 35 miles east of Austin, TX. The Chimpanzee Housing Complex includes a total of 103,114 sq. ft. of indoor/outdoor sheltered housing and support space divided among four facilities: the Main Chimpanzee Housing Facility (Building 302), the Chimpanzee Housing Expansion Facility (Building 302A), the Chimpanzee Socialization and Rehabilitation Facility (Building 301), and the Chimpanzee Quarantine Facilities (Q Buildings). Following the NIH recommended space requirement of 250 sq. ft. per chimpanzee, the holding capacity is 180 to 216 animals. This does not include 10 runs in the Chimpanzee Socialization and Rehabilitation Facility that are designated for recovering or convalescent chimpanzees.

https://dpcpsi.nih.gov/sites/default/files/Announcement_of_Agency_Decision-Relocation_of_At-Risk_Chimpanzees_508.pdf https://dpcpsi.nih.gov/sites/default/files/Announcement_of_Agency_Decision-Relocation_of_At-Risk_Chimpanzees_508.pdf

All the buildings within the Chimpanzee Housing Complex have common design features. Water is provided in the animal facilities by automatic animal-operated devices. There are inside and outside water faucets for cleaning procedures. Fluorescent electric lights, inaccessible to the animals, provide a minimum of 75-ft. candles of light in the dens and 125-ft. candles in the work areas. Primary and secondary heating units can maintain minimum temperatures of 600F in the animal dens. Heated air is not recirculated in animal housing areas. During winter months, the doors from the animal dens to outside quarters are covered by swinging doors of nylon-reinforced rubber to block cold air, while still allowing animal access to the outside. Forced ventilation provides 10 to 15 air changes per hour in indoor animal quarters. Treatment, procedure, and isolation rooms are air conditioned with non-recirculated air.

During warm weather, the inside areas of the Chimpanzee Socialization and Rehabilitation, and the Chimpanzee Quarantine Facilities are largely open, and these buildings are oriented to catch the prevailing southerly breeze. Wind-powered turbines provide additional ventilation in the Chimpanzee Socialization and Rehabilitation Facility. Emergency power for the Chimpanzee Housing Complex is provided by an 810 KW generator that is activated within 3-6 seconds following power failure. All animal quarters and work areas have flooring that is sealed concrete or has an epoxy flooring material applied. Solid walls in the animal dens are either sealed concrete or masonry covered with a pigmented impervious surface. Guillotine doors and sliding doors that separate indoor from outdoor cages, or adjoining cages from one another are eight-gauge plated steel. Guillotine doors are operated from the service area using a counterweight mechanism and both guillotine and sliding doors can be locked. Strategically placed aluminum bed boards with polyethylene tops, in all indoor dens and in the runs of the Chimpanzee Isolation and Socialization and Chimpanzee Quarantine Facilities, provide elevated perching and resting areas.

A perimeter fence constructed of heavy gauge perforated galvanized steel surrounds the entire Chimpanzee Housing Complex and extends 16 feet above the ground to contain chimpanzees within the Complex in the rare case of an escape event. The fence is supported with galvanized steel posts mounted in a concrete foundation. Secondary security fencing encloses all the entrances to outside runs. The Main Chimpanzee Housing Facility and the Chimpanzee Socialization and Rehabilitation Facility clinics are equipped with door sensors. Escape barriers are placed at intervals inside the Main Chimpanzee Housing Facility, the Chimpanzee Housing Expansion Facility, and the Chimpanzee Socialization and Rehabilitation Facility to confine escaped animals until they can be immobilized or coaxed into a secure area.

The Main Chimpanzee Housing Facility (Building 302) is a 178’ x 312’ masonry building with eight octagonal outdoor habitats, 75 feet in diameter (4,416 sq. ft. each), each attached to a pair of indoor dens. The habitats are grouped four to a side along a central service corridor. The habitats and indoor dens provide housing for social groups of up to 12 chimpanzees. Habitat walls are tilt-wall construction with reinforced concrete, 16 feet high, and contain barred windows close to the ground for ventilation and viewing. The earthen habitat floors are sloped away from the building toward the vehicle access doors (8' wide x 9' high) for drainage and are sodded with common and coastal Bermuda grasses.

Enrichment structures for chimpanzee use include utility poles anchored in the ground, 3" diameter marine tow ropes, steel chains, 55-gallon plastic drums, concrete culverts, cargo nets, uprooted trees, and a two-tiered 8' x 8' x 12' climbing structure. No elevated structures are located within 16’ of a habitat wall. Habitats 1 and 3, 2 and 4, 5 and 7, and 6 and 8 are paired and interconnect via a sliding door. Animal access to each habitat from the dens is via guillotine doors. The dens, two for each habitat, each measure 6' wide x 15' long x 11' high. Attached to one den for each habitat is a metabolism cage that measures 4' x 8'. All dens and metabolism cages interconnect via sliding doors.

The Chimpanzee Housing Expansion Facility (Building 302A) is composed of a 66’ x 366’ masonry building with indoor dens, indoor/outdoor dens, two rooms for single cages, and eight geodesic dome-shaped exercise yards (Primadome®). The Primadomes® are connected to the indoor dens of the building and to the outdoor runs. These outdoor runs connect to indoor dens. Each Primadome® is 34’ in diameter (907 sq. ft.) and 21' in height and has a cupola from which the animals may view the surrounding countryside and the habitats. The Primadomes® are outfitted with a variety of climbing and swinging structures and animals have full use of the vertical space and volume in these geodesic domes. Structural additions to the Primadomes® to accommodate geriatric animals include ramps, hand-holds, lower perching, etc. Additionally, there are two octagonal outdoor habitats on one end of the building (one on either side of the building). The habitats are 90 feet in diameter (6,358 sq. ft. each) with two indoor dens each and provide housing for social groups of up to 16 animals. Habitat walls are tilt-wall construction with reinforced concrete walls 16 feet high with barred windows near the ground for ventilation and viewing. The earthen habitat floors are sloped away from the building toward the vehicle access doors (8' wide x 9' high) for drainage and are sodded with common and coastal Bermuda grasses. Enrichment structures for chimpanzee use include utility poles anchored in the ground, 3" diameter marine tow ropes, steel chains, 55-gallon plastic drums, concrete culverts, cargo nets, uprooted trees, and a multi-tiered 8' x 8' x 12' climbing structure. No elevated structures are located within 16’ of a habitat wall. Animal access to each habitat from the dens is via guillotine doors.

The Chimpanzee Socialization and Rehabilitation Facility (Building 301) is a 32’ x 180’, L-shaped masonry building with two connected domes. This facility is composed of 20 housing units with indoor dens and outdoor runs. The housing units are divided into two 10-unit sections by a central clinic.

Individual units are 8' wide x 8' long x 6' high for the den portion and 8' wide x 12' long x 8' high for the outdoor run. Each unit typically supports two adult animals; groups of >2 animals are provided with access to multiple units via sliding doors between the runs. The building has an additional irregularly shaped outdoor run of 420 sq. ft. and a central procedure room (20' x 22'). This building serves two functions: the first is to introduce animals and subgroups prior to the establishment of larger social groups, and the second is to provide animals in need of treatment/rehabilitation with a safe physical environment to recover.

The Chimpanzee Quarantine Facility (Q Buildings) consists of five separate masonry buildings, each comprising of four indoor den units with an attached Primadome®. The buildings are a minimum of 50’ from one another and from any other chimpanzee housing. Each building is 29½' x 17½' with two front dens measuring 7'9" wide x 6' high x 7'9¾" long and two rear dens measuring 7'9" wide x 8' high x 12'4" long. These buildings are "open air" during warm weather and the human work/indoor den areas are enclosed with corrugated translucent fiberglass windbreak panels during the cold weather season.

Each has attached Primadome®. The Q Buildings provide housing for social groups that need to be separated from the rest of the colony or for introduction or reintroduction of animals into a new social group.

REQUIREMENTS

The Contractor shall be responsible for the selection, certification, assessment, supervision, management, and control of employees in performance of this 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, inhumane treatment of chimpanzees or any other conduct or behavior that the Government determines as inappropriate. In accordance with HHSAR 352.242-70, the Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer (CO).

In accordance with 42 CFR Part 9.9, the Contractor shall provide the following staff:

Professional Staff – Director/Attending Veterinarian, Behavior Management Leader;

Technical Staff - Clinical Veterinarian, Colony Manager, , Veterinary or Behavioral Technicians;

Animal Care/Enrichment Staff – Minimum of 1 technician per 15 chimpanzees.

The Contractor shall possess and maintain fiscal-management expertise, long-term financial stability, and management expertise of groups of chimpanzees (<55 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 diseases, diabetes, hepatitis, pain management associated with arthritis and uterine masses, and management of obesity.

The Director/Attending Veterinarian 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 in Bastrop, TX. An off-site veterinary pathologist and related services may be needed to necropsy animals, and process and interpret necropsy tissues.

ON-SITE TRAINING - New hire training and periodic refresher training for all employees will be needed for employees at all levels. Required training includes but is not limited to: applicable Occupational Safety and Health Administration (OSHA) training, biosafety procedures, specific animal care procedures, behavioral observations including standardized tests, environmental enrichment, record keeping practices, and other continuing education. 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, 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) International.

MAJOR CHALLENGES - The major challenges at the CCC are related to medical management of an 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 biosafety considerations for these chimpanzees. A walk-through every 4 to 6 hours during the daytime hours for temperature monitoring, security reasons, and gross observation of the animals is required. Protective clothing, appropriate showering, proper waste disposal, and other Biosafety Level (BSL) 2/BSL3 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.

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 (National Research Council [NRC] 2011).

HEALTH CARE - Periodic physicals (at least annual) and TB testing for all chimpanzees, blood sampling and shipping for offsite 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.

PREVENTION OF BREEDING/GROUPING OF CHIMPANZEES - The animals will be maintained in social groups. In cases of mixed sex groups, preventative contraception must be practiced. Allowable methods to prevent breeding can include vasectomy, tubal ligation, Norplant implants, and pregnancy terminations. NIH expects that no conceptions of chimpanzees at the CCC will occur. Any chimpanzee that is born at CCC shall be owned and supported financially exclusively by the Contractor.

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.

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. NIH retains ownership of the chimpanzees and as such has rights to copies of the records, which are the property of the facility.

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

NECROPSY - The CCC chimpanzee population is aged and the existing animals will likely die over the course of this contract. Any instances of animal death or injury must be reported by phone or email to the Contracting Officer's Representative (COR) and CO within 24 hours. Any such incidents deemed to be significant deficiencies according to the Public Health Service (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 Biological Safety Level 2(BSL2) containment.

Necropsy of animals found dead or euthanized for poor quality of life in which case the cause of death is known is at the discretion of the attending or clinical veterinarians.

ADMINISTRATIVE - NIH staff believes 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, insurance for damage to the buildings and theft of contents, vehicle insurance, etc.

will be obtained as needed by the Contractor. All costs for operating and maintaining the CCC must receive separate accounting from other costs to the Contractor for any other sites or tasks. Inspections by the COR and/or CO are to be expected, but it is not likely that a NIH representative will usually be located on-site.

U.S. Department of Agriculture (USDA), OLAW, AAALAC International – NIH expects the CCC to hold an USDA Registration and be subjected to inspections as well as maintain AAALAC International accreditation. It is expected that both USDA and AAALAC International representatives will periodically visit the CCC and issue reports to the Contractor and NIH. Major Alterations and Renovations may be needed to the CCC 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 as necessary. After discussion with NIH staff members, deficiencies identified during AAALAC International site visits will be addressed.

The CCC will continue to maintain accreditation by AAALAC International.

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

ACUC - The CCC will constitute a local ACUC that will provide the functions required by OLAW, USDA, and the NIH Policy Manual 3040-2. Required reports from the ACUC will be described in the Contract document upon award. Members from the Contractor's staff and outside members with appropriate qualifications will be appointed to serve on the ACUC. Any instances of animal death or injury must be reported by phone or email to both the COR and CO 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 Contractor'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 Contractor shall provide written procedures for maintaining adequate coverage during inclement weather or periods of other closure. Plans to reduce staff as animal number decline should be included. This Minimal Staffing Plan will be considered a draft. The plan will be discussed during negotiations and will be incorporated into the contract upon award.

The Contractor shall provide veterinary care and husbandry service necessary to properly maintain chimpanzees 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 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 CCC and procure and establish these if necessary. The Government is not liable for the loss of personal possessions of the Contractor or its staff. During regular business hours, a walk-through of the various Chimpanzee facility 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 CCC ACUC and the COR. It is expected that the person performing the walk-through shall carry a cell phone.

WRITTEN STANDARD OPERATING PROCEDURES (SOPs) – SOPs, if not already in existence, 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 Occupational Safety and Health (OSH) shall be approved by the Nurse/OSH Director, and SOPs relevant to Animal Care shall be approved by the ACUC. SOPs should be reviewed on an on-going basis to address any potential required updates.

ADVISORY COMMITTEE - The Contractor shall set up an advisory committee of 5-6 members that shall periodically (at least annually) review the CCC's operation and serve as an advisory body for programmatic issues. 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.

OSH/ ANIMAL EXPOSURE SURVEILLANCE PLAN (AESP) – The Contractor shall provide a draft OSH/Animal Exposure Surveillance Plan (AESP) with the proposal. The plan will be discussed during negotiations and will be incorporated into the contract upon award. This plan should be reviewed and updated annually as needed. Updates will be included in the annual report.

The Contractor shall provide an effective training program in OSH. 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 ensuring 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 continuous 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 University of Texas/MD Anderson 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 CO 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, Hepatitis B virus [HBV], HCV, 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 analysis of serum for Contractor employees is not required after the baseline screening performed during the pre-placement medical evaluation as described above. However, the Contractor shall collect and analyze serum if a contractor employee sustains an injury involving percutaneous or mucous membrane exposure to blood or body fluids of chimpanzees. Additionally, as part of the routine Occupational Medical Surveillance Program, the Contractor may perform an annual screening for potential hazards as described above (e.g., HIV, HCV, HBV and possibly HAV)

PRE-EMPLOYMENT 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 CCC shall comply with all relevant CCC Health and Safety requirements. Persons having active tuberculosis shall be excluded from work with contract chimpanzees. All appropriate personnel shall be immunized against HAV, HCV, 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 shall be maintained and provided to all employees.

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

WASTES - Urine and feces from the chimpanzees should be considered as potentially HIV and HCV contaminated 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.

REPORTS – Monthly and Annual Progress Reports shall be submitted to the COR and CO. 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 as well as any updates to Minimal Staffing Plan, .

Item Description Quantity Due Date

(1) Monthly Progress Report

Electronic copy Due within ten (10) calendar days following the end of the reporting period

(2) Annual Progress Report

Electronic copy Due before the end of the Base period and each exercise option period

(3) Minimal Staffing Plan Electronic copy Due with the proposal; Updates due with the Annual Progress Report

(4) OSH/ ANIMAL

EXPOSURE

SURVEILLANCE

PLAN (AESP)

Electronic copy Due with the proposal; Updates due with the Annual Progress Report

(5) Occupational Safety and Health Training

Electronic copy Due within sixty (60) calendar days of contract award

(6) Initial Occupational Safety and Health Training Assurance Statement

Electronic copy Due within sixty (60) calendar days of the hire date for new personnel

(7) Incident and Accident Reports

Electronic copy Due within ten (10) calendar days of the incident/accident occurrence

(8) Equipment Inventory Electronic copy Due within thirty (30) calendar days of contract award

(9) Animal Death or Injury Report

Electronic copy Due within 24 hours of the incident’s occurrence

(10) Congressional/Media Interest Reports

Electronic copy Due within three (3) working days of the inquiry

(11) Information Security Reporting Requirements

Electronic copy As specified

The above items shall be addressed and delivered to:

Addressee Deliverable Item No. Quantity

Sheri Hild, Office of Research Infrastructure Programs (ORIP) Sheri.hild@nih.gov

1-10 1

Em’Ria Briscoe, Office of Acquisitions, NLM biscoee@mail.nlm.nih.gov

1-10 1

COPY: April Merriwether, Office of Acquisitions, NLM merriwetheran@mail.nlm.nih.gov

1-10 1

COPY: Patty Newman, Office of Research Infrastructure Programs (ORIP) Pv8m@nih.gov

1-10 1

FACILITIES OPERATION, MAINTENANCE AND MODERNIZATION

MAINTENANCE - Maintenance and minor repairs to the interior and exterior, and for general maintenance of the CCC 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 methods for this are expected to vary depending on the scope, severity and expense of the repair.

Maintenance of space required to house chimpanzees will be the responsibility of the Contractor. As the colony decreases, it is anticipated that buildings will be emptied, and either be re-purposed for other uses or left dormant.

USDA AND AAALAC INTERNATIONAL INSPECTIONS - The Contractor shall be responsible for ensuring the CCC complies with standards established by the USDA and the PHS. However, major Alterations and Renovations may be needed to the CCC 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 site visits will be addressed. The CCC shall maintain accreditation by AAALAC International.

SHIPPING OF ANIMALS TO OTHER LOCATIONS - When the NIH directs the contractor to relocate chimpanzees from CCC to the Federal Sanctuary, the Contractor shall cooperate with the shipping effort. If the CCC animals are transferred to the Federal Sanctuary, copies of all medical records shall be transferred to the Federal Sanctuary and remain with the animals. It is anticipated that animals currently residing at the CCC facility will die of natural causes or be transferred to the Federal Sanctuary System before contract expiration. A list of relevant regulations and considerations for shipping of chimpanzees is available from the CO.

UTILITIES - MD Anderson 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 the 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 mailto:Sheri.hild@nih.gov mailto:Sheri.hild@nih.gov mailto:biscoee@mail.nlm.nih.gov mailto:biscoee@mail.nlm.nih.gov mailto:merriwetheran@mail.nlm.nih.gov mailto:merriwetheran@mail.nlm.nih.gov mailto:Pv8m@nih.gov mailto:Pv8m@nih.gov shall be coordinated through the COR and the Office of Extramural Research, . 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 CCC to the Contractor shall be forwarded to the COR and CO, who will promptly notify the NIH Office of Communications and Public Liaison of any inquiries that lead to or that have public, media, or congressional interest.

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 projects 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 may be additive to the planned cost of the contract pending discussion of options between the contractor and NIH (COR and CO).

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 CO’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 coverage of the CCC. All travel requests must be submitted to the CO in advance of any travel.

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 agents, 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:

• Applicable portions of The Chimpanzee Health Improvement, Maintenance, and Protection Act (CHIMP Act) 42CFR Part 9, specifically:

9.4 Physical facility policies and design.

9.6 Animal care, well-being, husbandry, veterinary care, and euthanasia.

9.8 Animal records.

9.9 Facility staffing.

9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements.

9.11 Animal transport.

9.12 Compliance with the Standards of Care, USDA and PHS policies and regulations.

9.13 Other federal laws, regulations, and statutes that apply to this part;

• 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 (NRC 2011; 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 agents.

No proposals will be considered without demonstrating these specifications.

PLACE OF PERFORMANCE

Keeling Center for Comparative Medicine and Research, MD Anderson Cancer Center, University of Texas, Bastrop, TX.

PERIOD OF PERFORMANCE

The period of performance of this contract shall be a base period of one year from date of award, plus the Government has 4 option years.

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, NRC and Institute for Laboratory Animal Research recommendations.

Weight: 40

• Adequacy of proposed procedures for veterinary care and animal husbandry of approximately 45 to 55 aged chimpanzees, many with comorbidities; dealing with biohazards; obtaining ACUC approvals; preventing the CCC 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 administrative infrastructure, either on-site at the CCC 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 animal care, housing, nutrition, hygiene.

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 CCC.

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 Director/Attending Veterinarian 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). Likewise, the Behavior Management Leader (minimum BS in related field) is expected to have extensive experience in understanding chimpanzee behavior and appropriate environments and enrichment designed for chimpanzees.

The technical staff (e.g., Colony Manager, Veterinary or Behavioral Technicians, Animal Care/Enrichment Staff) 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 CCC.