NIH_NHP SOW_ActualApr162021v.2Rev.docx

Non-human Primate Acquisition, Testing, Transportation and Housing Contract Statement of Work

1. Background and Introduction:

The National Institutes of Health (NIH), Office of Research Services (ORS), Division of Veterinary Resources (DVR), provides NIH Intramural programs with acquisition services acquire and facilities to house non-human primates (NHPs) needed for research conducted at the NIH. DVR is a service organization that provides the acquisition, quarantine and conditioning facility for most of the NHPs used at the NIH.

There is a bona fide need associated with this contract. Institute’s research relies on this contract mechanism to provide the animals needed to support their ongoing biomedical research. NHPs are indispensable models for evaluating medical diseases and are considered the most appropriate animal model for various human diseases. The lack of suitable substitutes for NHP models for predicting response in humans, illustrates the critical and bona fide need for this contract and these critical research models.

Considering the dollar value associated with NHP requests and the lead time needed to acquire NHP, without this contract mechanism in place, NHPs would not be able to be obtained in a timely manner for their research needs, significantly delaying research.

Due to the urgent need of animals and the quantity and quality of animals required, it is essential that a contract is in place to facilitate the necessary procurement in an efficient and timely fashion The Contractor shall be required to carry out, directly or through subcontractors and/or consultants, the activities defined below for the acquisition, testing, transportation and holding/ maintenance of a nonhuman primates. The Government intends to award multiple IDIQ contracts to acquire and maintain NHPs.

2. Scope:

The overall scope to be performed by the Contractor shall encompass all necessary functions and activities needed for the acquisition and maintenance of nonhuman primates. This shall include but not limited to acquiring various species of NHPs, testing, transporting and providing the necessary infrastructure, level of staffing and expertise to operate and maintain Government-owned NHP colonies of various species. It shall be noted that all progeny resulting from the government owned breeding colonies will be assigned to the government upon birth. This scope includes the delivery of research-aged animals to the NIH researchers and other investigators or institutions as directed by the government.

Note: This contract will NOT provide funds to support facility construction/building costs.

3. Objective:

This requirement will facilitate the efficient procurement, testing, transporting and housing of nonhuman primates as detailed by individual orders which meet the specifications as described.

The period of performance for this contract shall be for one twelve (12) month period, with options to renew for four (4) successive twelve (12) month periods.

4. Technical requirements:

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment, and facilities to provide for the acquisition of various species of both Specific Pathogen Free (SPF) and non-SPF NHPS and the daily maintenance colonies owned by the Government.

The Contractor shall ensure that all animal care and procedures are conducted in a humane manner, in appropriate holding spaces, and with the level of experienced personnel necessary to conduct and maintain all animal husbandry and breeding (if applicable) activities, environmental enrichment including the psychological well-being of the primates, continuous medical care and veterinary support, and all appropriate record keeping.

5. Regulations:

The Contractor’s standards for animal care, biosafety, and occupational health and safety, and transportation will conform to but not limited to, the most recent versions of the following regulations and all applicable amendments:

· 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 1-3;

· PHS Policy on Humane Care and Use of Laboratory Animals, updated 2015

· The Guide for the Care and Use of Laboratory Animals revised 2010 version;

· Biosafety in Microbiological and Biomedical Laboratories [Centers for Disease Control and Prevention (CDC)_ NIH 2020];

· Occupational Health and Safety in the Care and Use of Research Animals National Research Council.

· Any additional state or federal regulations that govern the use of NHPs as laboratory animals.

5.1. All Contractor must have and maintain the following credentials and requirements:

5.1.1. NIH Office of Laboratory Animal Welfare (OLAW), Animal Welfare Assurance number.

5.1.2. United States Department of Agriculture (USDA) Registration (Class “A, B, or R”).

5.1.3. Association for Assessment and Accreditation of Laboratory Animal Care International file number.

5.1.4. Institutional Animal Care and Use Program (IACUC)

IACUC roles and responsibilities regarding animals owned by National Institutes of Health but housed and handled at Contractors site (Contractor; herein after referred to as “Vendor”).

5.1.4.1. Considering that both the National Institutes of Health (NIH) and the Vendor have responsibilities regarding animals held at the Vendors site, but owned by NIH, the roles and responsibilities of each institute and its respective Animal Care and Use Committee (IACUC) are outlined below.

5.1.4.2. As there is no requirement for dual review of the animal study proposal (protocol) by both NIH and Vendor, NIH agrees to delegate review of proposed animal activities to the Vendor IACUC. Vendor agrees to comply with all relevant federal regulations regarding the composition and duties of a properly constituted IACUC and to review the relevant protocol(s) covering all NIH-owned animals while they are held at premises owned, leased, managed, or operated by Vendor. Vendor further agrees to notify NIH whenever the relevant protocol(s) is reviewed, and anytime significant changes are made to the protocol or if the protocol is suspended/expires/approval is withheld or disapproved for any reason. Vendor’s approved protocol will be available for review by NIH site visit teams or upon request.

5.1.4.3. Vendor acknowledges that it receives funding from NIH pertaining to the care and housing of NIH-owned animals and as such it must comply with federal regulations including PHS Policy on Humane Care and Use of Laboratory Animals, the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and adhere to the standards outlined in the Guide for the Care and Use of Laboratory Animals. Vendor agrees to maintain its assurance with OLAW and further agrees that its OLAW assurance will cover NIH-owned animals while they are held at premises owned, leased, managed, or operated by Vendor. Vendor further agrees to include NIH-owned animals in their annual report to OLAW and to promptly notify the NIH Contracting Officers Representative (COR) and Contract Officer (CO) of any OLAW-reportable incident and any final outcome.

5.1.4.4. NIH acknowledges that Vendor is accredited by AAALAC International and as such is evaluated by AAALAC independent of the NIH program’s AAALAC accreditation. Vendor agrees that their AAALAC program description will cover NIH-owned animals held by Vendor. Vendor further agrees to promptly notify NIH of any changes to its AAALAC accreditation status.

5.1.4.5. Vendor agrees to comply with all applicable provisions of the Animal Welfare Act and Regulations and to allow USDA APHIS to inspect their premises and animals, including those owned by NIH. Vendor agrees to promptly notify NIH COR of any deviations from the provisions of the Animal Welfare Act and Regulations and of any violations of the act as they may pertain to NIH-owned animals.

5.1.4.6. NIH-owned animals will remain under the total control and responsibility of NIH with delegated authority to Vendor for day-to-day care and management of said animals.

5.1.4.7. NIH agrees and Vendor acknowledges that, for the purposes of compliance with the Animal Welfare act and regulations, Vendor’s premises, where NIH-owned animals are held, will be a recognized site under the Vendors USDA facility registration.

5.1.4.8. NIH agrees to delegate the responsibility for semi-annual facility inspections and program review pertaining to NIH-owned animals held at premises owned, leased, managed or operated by Vendor to the Vendor IACUC. Vendor agrees to report to NIH that such inspection and program review were completed, including any major deficiencies, as such findings apply to NIH-owned animals. The complete Vendor IACUC semi-annual facility inspection and program review shall be available upon request to NIH site-visit teams. NIH retains the right to revoke this delegated responsibility and to conduct its own semi-annual facility inspection or site visits at any time and for any reason, with or without cause. Vendor agrees to permit access to its premises and facilities to the NIH facility inspection team for the purposes of evaluating how NIH-owned animals are being held and cared for and to assure compliance with federal regulations.

5.1.4.9. Vendor agrees that animals owned by NIH, but held at premises owned, leased, managed, or operated by Vendor, will be reported on Vendor’s annual report to the USDA under Vendor’s Dealer’s license. To avoid duplication, NIH will not include these animals on its annual report to USDA.

6. Acquisition of various species of NHP as noted below.

6.1. Disease Prevention and Health Status:

All animals provided under this contract shall be in overt good health. Domestic bred and purpose-bred animals are always preferred over wild caught, however, based on individual study needs, it may be necessary to utilize wild caught animals. Animals may be requested by the government with a specific age range and or a known date of birth.

In addition, the animals must be research naive, physically sound and healthy, free of wounds, external parasites, and clinical signs of disease prior to acceptance. No animals shall be accepted by the NIH that have a history of illness without the prior approval of the COR. A record of each individual animal shall be provided to include sire and dam, date of birth, sex, behavioral assessments and all medical records of clinical tests and results, treatments, and physical exams including body conditioning score. An electronic copy of the medical record shall be submitted to the COR, a minimum of 5 business days, preferably 10 business days, for review and approval prior to shipment.

Animals shall also have no documented and/or observed behavioral abnormalities, animal shall not exhibit any stereotypic maladaptive behavior such as self-clasping, self-biting, floating limb, saluting and or consistent circling. There shall be no physical evidence such as bite wounds or alopecia secondary to excessive self-grooming, that indicates that the animal is exhibiting these abnormal behaviors. Any behavioral observations and assessments shall be documented with in the animal’s medical record and will be provided with medical histories for evaluation.

Serological testing:

Prior to acceptance and or arrival, all animals shall be identified by individual tattoo number located on the chest, have no record of a positive TB test and shall have been TB tested a minimum of three times one within 30 days of shipment, test negative one (1) time for Macacine herpesvirus -1 (B virus), SRV1, SRV2, SRV5, SIV and STLV-I by serology, test negative one (1) time for SRV1, SRV2, and SRV5 by PCR. The diagnostic laboratories used shall be approved by the COR prior to performing the required testing. No animal required to be tested for filo-virus shall be accepted under this contract, unless the contractor pays for testing required to comply with Center for Disease Control (CDC) guidelines, and the animal’s cohort group test results are seronegative.

Animals shall be rejected by the NIH if they convert to any of the above-mentioned diseases within 35 days after receipt.

Once an animal is identified as a candidate for a NIH request and/or accepted by the NIH, all vaccinations proposed by the vendor, must be reviewed and approved by the COR. This is to ensure there will be no impact to the intended research.

Macaca Fascicularis (Cynomolgus) In addition to the requirement listed above, all animals shall test negative using Intuitive Bioscience’s (Madison, WI) serological CSA Simian TB test for TB complex antibodies, one time within 45 days of shipment. This requirement may be waived by the COR and/or supplemental testing requested, based on the availability of new and improved TB testing methods.

Chlorcebus Aethiops (African Green) and Erythrocebus Patas (Patas).

There will be no Herpes B SRV1, SRV2, SRV5, SIV and STLV-I seronegative test required or SRV1, SRV2, and SRV5 by PCR negative test requirements. In lieu of the testing requirements listed above the following tests are required test negative (1) one-time for SIV, SA8, measles, STLV1/2, SVV and SHF by serology. (1) one-time negative fecal culture for klebsiella performed within 30 days of arrival.

Squirrel and Owl Monkeys There will be no Herpes B SRV1, SRV2, SRV5, SIV and STLV-I seronegative test required or SRV1, SRV2, and SRV5 by PCR negative test requirements. In lieu of the testing requirements listed above the following tests are required test negative (1) one time for Herpesvirus tamarinus and Herpesvirus saimiri by serology.

Callithrix Jacchus (Marmoset), There will be no Herpes B SRV1, SRV2, SRV5, SIV and STLV-I seronegative test required or SRV1, SRV2, and SRV5 by PCR negative test requirements. In lieu of the testing requirements listed above the following tests are required test negative (1) one time for Herpesvirus tamarinus and Herpes-virus saimiri by serology. Additionally, the animals shall also test negative for Klebsiella pneumoniae HMV on two (2) cultures (one each, oral and rectal) when animals have not been on antimicrobial treatment for 7 (seven) days prior to sampling, 30-60 days prior to shipment.

Additional Testing:

Animals shall be negative for Salmonella, Shigella and Campylobacter via one (1) rectal culture performed within 30-45 days prior to shipment, animals shall not be on antimicrobial treatment for a minimum of 7 (seven) days prior to sample collection. Animals testing Campylobacter positive, that are asymptomatic, may be approved by the COR on a case by case basis, based on the intended research.

Animals shall be negative for common pathogenic helminth and protozoal parasites on fecal exam performed within 30 days of delivery. Also, animals must have no visible evidence of external parasites or dermatological conditions (e.g. lice, ticks, mites, etc.).

Additional order specific testing and or screening requirements may be requested by the COR on a case by case bases.

6.2. Animal Acceptance:

Animals shall be guaranteed to be TB negative for three (3) consecutive tuberculin skin tests after arrival at the point of destination. All animals’ disease status will be confirmed by PCR and serology for SRV-1, SRV-2, SRV-3, SRV-4, SRV-5, SIV, STLV-1, and Macacine herpesvirus -1 (B virus) within 35 days of arrival. If animals test positive by PCR or serology, then the animal is considered positive. All animals shall be delivered in a physically sound and healthy condition and shall be free of wounds, external parasites and clinical signs of disease. Animals with clinical signs of disease or obvious behavioral abnormalities will be rejected. Only animals judged healthy based on an examination by a veterinarian, which will be perform within 7 days after arrival, will be acceptable. This judgment will be based on a physical examination and observation of the animal’s general appearance and state of nutrition. Animals judged as unacceptable will be returned to the contractor at no expense to the Government, or the contractor may allow appropriate treatment by the Government to render the delivered animals acceptable, with all such cost to be borne by the contractor as a credit to the Government.

Animals will not be accepted from the vendor whose colonies are experiencing reportable diseases as defined by the CDC (yellow fever, monkey pox, hemorrhagic fevers [filo-virus or others]) or mortality or morbidity of greater than 5% for a cohort group of animals without the prior approval of the COR. In addition, animals will not be accepted from vendors that are experiencing positive or suspicious Tuberculosis results from Tuberculin skin tests, necropsy findings or lab results without the prior approval of the COR.

6.3. Requested Species of NHP.

Specifically, the contractor shall provide and deliver the following as requested by individual order which meet the specifications further described herein. Animals may be requested with any known date of birth.

Weight, Age, and Sex Requirements:

NHP, male or female alive in good health, and at the weight and/or Date of Birth as specified by individual order upon arrival at the NIH or other designated contract facility.

6.3.1. Macaca mulatta (rhesus), Specific Pathogen Free (SPF), Chinese/Asian Origin, Male or Female, Any Date of Birth, Weight 2-8 kg

6.3.2. Macaca mulatta (rhesus), SPF Indian Origin, Male or Female, Any Date of Birth, Weight 2- 8 kg

6.3.3. Macaca fascicularis (cynomolgus), SPF, Mauritius origin, Male or Female, Any Date of Birth, Weight 2-8 kg

6.3.4. Macaca fascicularis (cynomolgus), SPF, Other than Mauritius origin, Male or Female, Any Date of Birth, Weight 2-8 kg

6.3.5. Macaca nemestrina (Pigtailed), SPF, Male or Female, Any Date of Birth, Weight 2-6 kg

6.3.6. Chlorcebus aethiops (African green), SPF, Male or Female, Any Date of Birth, Weight 2-8 kg

6.3.7. Erythrocebus patas (patas), SPF, Males or Female, any Date of Birth, weight 2-8 kgs.

6.3.8. Saimiri sciureus (common squirrel monkey) or Saimiri boliviensis (Bolivian Squirrel Monkey), SPF, Male or Female, Any Date of Birth, Weight greater than 750 grams

6.3.9. Aotus nancymae or Aotus vociferans ( Owl monkeys), SPF, Male or Female, Any Date of Birth, Weight greater than 750 grams

6.3.10. Callithrix Jacchus Marmoset, SPF, either sex, 2-6 yrs of age.

6.4. Blood Sample, 3-30 ml.

Within ten (10) business days of receiving a request from the COR, a blood sample will be obtained from the animal(s) identified to be acquired by the NIH. The sample will be shipped to the location/testing laboratory indicated by the COR. These samples are normally used for NIH specific testing requirements that are not commercially available, i.e. blood typing or non-routine virus screening (PIV, RSV and VZV). Cost shall be based on a per animal bases for the requested sample(s).

6.5. Shipping Crates

All shipping containers/crates must confirm to the following requirements:

All NHPs shall be placed into and delivered in properly ventilated, escape-proof, disposable, non-returnable containers furnished by a USDA licensed transporter, unless specifically requested to be provided by the Contractor by COR. Any shipping container requested by the COR will be reimbursed by the government.

Containers must be in accordance with or exceed the regulatory requirements below

Each cage or compartmentalized container shall have separate water and feed containers for each compartment.

NHPs shall be delivered in properly ventilated, escape proof, disposable, nonreturnable crates (cages). Crates shall be in accordance with the country of origin regulations, USDA, CDC and IATA guidelines. Standard commercial marking shall be used and shall be in compliance with USDA, and IATA guidelines. Shipping crates shall be marked, labeled or tagged as applicable and shall include (a) contractors name and address; (b) delivery order number, name and address; and (c) total number of cartons in shipment.

6.6. Transportation

The Contractor shall perform all necessary tasks to complete animal shipping requested by the COR as noted below.

Upon request from the COR, the Contractor shall prepare primates for shipping by the age and/or quantity specified. The COR, in conjunction with the Contractor, shall determine the time and mechanisms of shipment. The COR shall make the necessary shipping arrangements with the USDA registered transporter unless specifically requested by the COR to the Contractor. Any transportation arrangements requested by the COR and paid for by the Contractor, will be reimbursed by the government.

Upon receipt of appropriate verbal or email instructions from the COR, the Contractor shall begin pre-shipment testing as follows. All animals scheduled for shipping shall receive a TB test, physical exam and rectal culture to be performed within 45 days of shipment. Rectal culture shall be taken when the animals have not been on medical treatment for a minimum of 7 days and shall be negative for Shigella, Campylobacter, Salmonella, and Yersinia. After initial cultures are received, preshipment treatment and reculture for enteric pathogens may be initiated at the request of the COR depending on colony health and intended research requirements. All culture results and complete medical records shall be provided to the COR no less than 14 days prior to shipping.

6.6.1. Transportation Regulations:

When NHPs are requested for shipment, the Contractor shall meet all the following required regulations for shipping:

· Animal Welfare Act, Title 9, Subchapter A, Part 3, “Transportation Standards”.

· Current CDC requirements. CDC General Guidelines for Handling Nonhuman Primates During Transit and Quarantine, MMWR 1990: 39: 29-30.

· Contractor and COR will maintain contact with carrier personnel to ensure their compliance with proper care of macaques during transit.

· Contractor shall coordinate with the COR by telephone or email, the actual shipment schedule no less than 30 days prior to shipment. The COR shall be immediately informed of any changes or delays in this schedule.

6.6.1.1. Ground Transportation Requirements: All transport shall be in accordance with the following:

· USDA-Licensed Transporters.

· Federal Highway Administration/Interstate Commerce Commission (FHWA/ICC) authority.

· Fully insured for the value of the cargo.

· The vehicle must have at a minimum a mobile/cellular phone, emergency contact list, animal bite and scratch kit in accordance with CDC recommendations, flashlight, potable water, feed and fruit (provided by the pick-up site), animal capture equipment (catch gloves and net) and a written driver awareness fact sheet on the precautions of nonhuman primates and B virus exposure.

7. NHP Housing / Colony Maintenance and Care, Per Diem:

The contractor shall provide housing and care of animals identified by the COR that will enter into “holding” status. Holding status is defined as NHPs that will not be immediately shipped to NIH or designated facilities and the animal will be cared for and maintained at the vendor site until requested to be shipped by the COR. The animals that will enter into the holding status will be identified by the COR or approved by the COR after the necessary pre-screening, testing, and other requirements have been completed in conjunction with the purchase of the animals. The animals will enter into the holding status when the animals would normally be ready for shipment but are not shipped as per the request of the COR. Animals may be requested by the COR to be housed for extended time frames. The animals will be housed in groups or pairs of same sex or mixed sex arrangements, this will be determined by the COR prior to the animals being placed into holding. Each cohort of animals will be designated a unique identifying description/number that distinguishes the cohort/colony from other NIH owned NHP held at the vendors site.

The cost of the “holding” shall be based on a per diem, per day, per animal basis.

All costs associated with animal manipulation normally associated with the holding and shipping of NHP such as but not limited to feeding, watering, twice daily health observations, sedation, physical exams, TB testing, pregnancy checks, sample collection, annual behavioral assessments, testing cost and shipping for annual serological screening, routine clinical diagnostic testing and shipment preparation including crating, shall be incorporated into the per diem cost.

7.1. Infrastructure / Facilities:

The contractor shall provide all (indoor/outdoor) facilities, equipment, and other resources necessary to adequately house, feed, care for, and maintain colonies of NHPs. This could range from as little as a few NHPs up 1,500 NHPs

NIH owned colonies must be physically separated, and not housed with NHPs owned by other sources. Exceptions to this housing arrangement must be discussed and approved by the COR in writing.

The Contractor may also be required to provide separate facilities to provide clinical care and support, as well as segregate, prescreen and prepare animals for shipment to research facilities as requested by the COR.

The Contractor shall perform upgrades, modifications, and expansion of facilities as necessary and/or as recommended by AAALAC or USDA inspections to maintain their regulatory compliance and accreditation. This contract does not support facility construction costs.

The Contractor shall provide facility schematics that includes details of current and planned housing and clinic facilities including physical or geographical barriers that will be used to isolate NIH colony(s) from the other animals that the Contractor may have on site. The documentation should indicate any proposed future changes and timelines of proposed changes or facility improvements.

Any proposed future plans and changes to housing arrangements for the NIH owned colonies, including moving groups to new areas or facilities, shall be provided to the COR at least 30 calendar days prior to changes. Provide drawings, schematics and descriptions should be included if not previously provided.

The Contractor shall have a detailed integrated pest management (IPM) program. This program shall be overseen by a certified entomologist. The plan shall outline the frequency of monitoring, trapping and baiting and mitigation of identified pests. The plan shall also include the detailed approaches and practices that will be employed to minimize or eliminate any known pest that may transmit diseases to the NHP population.

The Contractor shall have and make available, if requested, detailed sanitation and maintenance protocols/SOPs for housing, clinical care, and related areas upon request by the COR.

The Contractor shall have and make available, if requested, detailed transportation procedures and related equipment upon request from the COR.

The Contractor shall have and make available, if requested, detailed descriptions and procedures for all environmental monitoring, security, back-up power and alarm systems for all locations upon request from the COR.

The Contractor shall have and make available, if requested, a detailed description of all Information Technology systems support resources, including but not limited to system backups, quality assurance of data and off site storage ) of systems or data which will be required to effectively complete the Statement of Work.

7.2. Reproduction

There may be occasions, based on a request from the COR, to establish breeding colonies of NIH owned animals in holding status. The following requirements will apply to all NHPs requested to be place into breeding arrangements by the COR.

7.2.1. The contractor shall establish a breeding program to produce healthy SPF progeny. All animals and future progeny within the colony shall be owned by the government and identified within the animal medical records system as either breeders (animal in active breeding arrangements), boarders (animals in holding status), and future breeders (minimum number of young animals needed to maintain the integrity and reproductive goals of the breeding colony over the next 3-5 years). The goals of the breeding program shall be to maintain:

· Annual colony production rates of greater than or equal to 75% pregnancy rate of breeder age females (4 years of age and older).

· Annual colony production rates of greater than or equal to 70% live births from all females in breeding and of breeding age.

· Annual colony mortality rates of less than or equal to 8% of total colony population.

· Annual colony infant (less than 1 year of age) mortality rates of less than or equal to 10% of all live births.

7.2.2. If production and or pregnancy rates drop below the desired rates noted above, a detailed plan shall be developed, based on production and behavior assessments to improve production and pregnancy rate(s). The plan shall be provided to the COR in writing within 30 days of the noted decrease.

An annual review of the reproductive rates of all breeder groups shall be conducted with the COR annually, in the July/August time frame of each year, if not otherwise agreed upon by the COR, this will allow adjustments to be made, if needed, prior to the seasonal breeding season.

The contractor shall provide plans and details of the established breeding groups or harems. The establishment of harems or breeding groups recommended by the vendor post award, may only proceed with the COR’s approval. The contractor shall provide plans, justifications, and details of any non-routine or major changes to the make-up of established breeding groups.

7.2.3. The contractor shall, unless waived by the COR, provide a Genetic Diversity and Integrity Program Plan, as part of their response to the RFP, including microsatellite testing, for the pedigree analysis, evaluation, monitoring, and maintaining of appropriate genetic diversity and integrity for the breeding colony. Include methods and details for monitoring the kinship coefficients for all breeding groups and the inbreeding coefficient of all progeny

Unless waived by the COR, annually submit for COR review and approval a revised Program for Genetic Diversity and Integrity Plan. The Revise the Draft Program for Genetic Diversity and Integrity Plan in accordance with the COR comments and submit the final plan within 15 calendar days of receipt of COR comments.

The contractor shall, unless waived by the COR, submit a list of animals for which pedigree analysis microsatellite typing were initiated or completed each month with the Monthly Report or requested by the COR.

Provide physical exams every six (6) months, including monitoring of each breeding-age female for pregnancy.

Inform the COR and provide a written report within fourteen (14) calendar days regarding increased morbidity within the colony (e.g. viral or bacterial outbreaks, high levels of infestation), how these events were addressed clinically, and the resolution.

Inform the COR within two (2) calendar days of any potential or significant threatening infectious disease outbreaks affecting the colony or other colonies or animals at the facility.

7.3. Colony Health: Routine health surveillance and environmental enrichment for nonhuman primates:

The Contractor shall provide daily maintenance of any government owned colony. The maintenance shall consist of but not limited to the following, daily feeding, free access to water at all times, all routine animal husbandry tasks, daily monitoring of all animals, ongoing assessment of social compatibility and the establishment of breeding and social groups conducted by a trained, skilled and experienced NHP breeding colony behaviorist, at least daily observations of the health status of each nonhuman primate, daily veterinary care including weekends and holidays including on-call veterinary coverage of the nonhuman primate facility 24 hours a day, seven days a week. Contractor shall implement a behavioral program to include environmental enrichment, social housing and annual behavioral assessments

· The Contractor shall provide physical exams every six (6) months, including monitoring of each breeding-age female for pregnancy.

· The Contractor shall inform the COR and provide a written report within fourteen (14) calendar days regarding increased morbidity within the colony (e.g. viral or bacterial outbreaks, high levels of infestation), how these events were addressed clinically, and the resolution.

· The Contractor shall inform the COR within two (2) calendar days of any potential or significant threatening infectious disease outbreaks affecting the colony or other colonies or animals at the facility.

7.3.1. SPF Surveillance:

7.3.1.1. The term SPF in the context of this requirement is defined as animals free (serologically and/or by polymerase chain reaction (PCR) and tested annually for the presence of Macacine herpesvirus -1 (B virus), Simian Immunodeficiency Virus (SIV), Type D Simian Retroviruses 1,2,3,4,5 (SRV-D) and Simian T-Lymphotrophic Virus (STLV-1), or as noted for species specific testing as noted in section 6.1, all animal shall be tested annually for the targeted viruses.

The presence of any of the retroviral infections listed above makes the infected animals unsuitable for most NIH research projects. Thus, investigators must have animals free of viruses that might confound research findings. Although Macacine herpesvirus -1 (B virus) infection does not appear to compromise NIH-related research, the potential health risk for personnel dictates that any breeding colony must be free of this virus as well.

7.3.1.2. In addition to the testing noted above all animals shall receive a physical exam by a veterinarian semiannually to ensure animals are healthy, free of disease, are of proper body condition, and free of pathogenic ecto- and endoparasites. A minimum of 10% of the resident NHP population, from all housing locations, shall have a rectal/fecal culture taken annually to determine the presents of bacterial enteric pathogens of Salmonella, Shigella, campylobacter and Yersinia within the colony.

7.3.1.3. The Contractor shall provide a health surveillance plan as part of the response to the solicitation. The plan should detail methods of surveilling and segregating SPF-targeted viruses as well as operational procedures when positive results are received. The Contractor is responsible for updating the surveillance plan as necessary. All changes to the surveillance plan must be approved by the COR prior to implementation. The diagnostic laboratories used shall be approved by the COR prior to performing the required testing.

7.4. Quarantine:

7.4.1.1. Provide quarantine for all NHPs newly imported to the Contractor’s facilities, the quarantine facilities shall be in a physically separated location, with a physical or geographical barrier.

7.4.1.2. Any animal added to the NIH colony location shall undergo the following requirements before being introduced into the colony:

· An individual identification (ID) of animals; blood draw for CBC and chemistries with results reviewed by a veterinarian for abnormalities; and serological testing to identify and segregate for all SPF-targeted viruses.

· Any animal exhibiting enteritis shall have a rectal culture and fecal sample tested for enteric pathogens and treated as necessary.

· All animals shall receive vaccination(s) as proposed by the vendor and approved by the COR.

· Prophylactic deworming.

· Tuberculin tests negative three times (3) using standard accepted procedures.

· Quarantining and conditioning period shall be a minimum of 30 days

· Receive a comprehensive physical examination by a veterinarian and a behavioral assessment by a trained and skilled NHP behaviorist to determine if the overall health of the animal is acceptable to be placed within an existing colony.

· All animals must successfully complete all quarantine procedures before being incorporated into an existing NIH colony. If alternative quarantine procedures are proposed, a detailed plan must be submitted for review and approval by the COR prior to implementation.

7.5. Recording of deaths and euthanasia:

The Contractor shall notify the COR within two (2) business days when a nonhuman primate is sufficiently ill for the veterinarian to recommend euthanasia. Euthanasia, when necessary, shall be conducted according to procedures consistent with AVMA Guidelines and approved by the Contractor’s Institutional Animal Care and Use Committee (IACUC). The decision to euthanize shall be properly documented in the animal’s medical records and shall be at the discretion of the Attending Veterinarian. All deaths of undetermined cause shall receive an examination, necropsy and pathology as required to determine cause of death within 48 hours or the next business day. Necropsies must be performed by a licensed veterinarian, and a report of the findings incorporated into each animal’s medical record.

7.6. TB testing of nonhuman primates;

All nonhuman primates acquired or placed in holding status maintained in a TB-free facility. The contractor must have all NHPs entering their facilities, tested for Mycobacterium Tuberculosis (TB) and on a minimum of an annual basis. All NIH owned NHP shall be TB tested on a semiannual bases or as requested by the COR. The NIH will only accept NHP that are confirmed TB-negative. Any NIH owned NHP that has a suspicious TB test shall require the contractor to notify the COR immediately to determine a plan of action.

7.7. Vaccines:

All proposed vaccinations recommended by the vendor, shall be reviewed and approved by the COR prior to being administered to any animal. Information on vaccines provided to the COR shall include the product name, manufacturer’s name, and any accompanying literature. Vaccine information shall be submitted to the COR for review and approval a minimum of 30 days prior to scheduled use.

7.8. Support Services:

The Contractor shall provide all necessary clinical laboratory and diagnostic testing and pathology support facilities and services.

7.9. Animal Identification:

The Contractor shall individually identify all animals by unique number via chest tattoo. The Contractor shall conduct a monthly census and monitor the population to obtain basic demographic data. The contractor shall maintain electronic records of genealogy to ensure proper tracking of parental linage and offspring so as to allow tracking back to the original founding colony animals.

7.10. Medical records:

The Contractor shall maintain all animal medical records electronically which the following requirements:

The Contractors animal medical records database must be able to store, analyze, and display all medical data - past and present; and shall include, at minimum, animal ID, date of birth (DOB), current and past weight(s), housing locations, sire & dam, receipt date, serology results, medical treatments, behavioral assessments, disposition, TB test results, and all vaccinations. The databased must be able to provide reports on all data points. Individual electronic medical records must be provided to the COR electronically upon request, as well as for review a minimum of 14 days prior to any scheduled shipment.

The contractors veterinary and technical support staff are required to document the cause of any animal injury or death in the animals’ electronic medical record within 24 hours.

The Contractor shall provide, at a minimum, weekly backup security for long-term electronic storage of colony, social group, and individual animal records. Changes to the method, location and frequency of backup and technologies, including encryption, may be modified only upon consultation with and written approval with the COR.

The Contractor shall provide security against unauthorized access and use of the computer system and data.

7.11. Actions Relating to Colony-Threatening Circumstances:

The Contractor shall provide all necessary care in handling colony-threatening circumstances throughout the life of the contract. The Contractor will be required to provide an outline of how they will respond to emergency situations, this includes but is not limited to all natural and/or man-made disasters, disease outbreaks, and animal rights group protests, vandalism and infiltration. The Contractor shall advise the COR of specific plans for the facilities and animals no later than 24 hours prior to any predicted, potentially impactful event. The COR shall be contacted within 24 hours of any colony threatening or impactful event and notified within three (3) business days of any animals considered to be in poor condition or found dead post event. The Contractor is required to make every effort to contact and update the COR on the status of its facilities each 24-hour period until risks to its facilities and any animals have been mitigated.

7.11.1. All primates are considered Government property. The Contractor shall not be responsible for animal deaths of less than ten percent (10%) unless the loss is due to negligence by Contractor or subcontractor staff. The Contractor shall insure the colony for losses greater than 10%. The Contractor will be required to document how insurance coverage will be met.

7.11.2. If the Contractor’s facilities are under “Emergency” and/or “Disaster” status, the COR shall be notified as soon as possible. In extreme circumstances, the Contractor may request assistance from the COR. At such time, the COR may request NIH disaster recovery assistance procedures in conjunction with the Contractor’s efforts. The COR may request all resources available to minimize the impact to the Government. The Contractor shall not rely on NIH for recovery but consider them as a resource above and beyond the Contractor’s established plans and available resources.

7.12. Notifications and Media inquiries:

In the event of any media inquiries the Contractor shall:

7.12.1. Notify the COR immediately of any publicity of an adverse nature. All press releases or statements to the press regarding the NIH colonies shall be provided by the NIH public information office and shall be reviewed and approved by the COR prior to release.

7.12.2. Notify the COR within two (2) calendar days of any potential change in Contractor ownership, changes in Department of Health and Human Services Contractor status and or legal actions against the Contractor.

7.13. Reporting and deliverables

7.13.1. Monthly report:

A technical report shall be sent to the COR electronically by the 10th of each month.

This report must be submitted to the COR in electronic format (MS Word or Excel, or another format approved by the COR). This report should contain the following information: report date, current census, previous month census, number of socially housed animals, number of individually housed animals, justification for single housing, general description of overall colony status, and description of any current problems with proposed corrective action.

The monthly report shall also capture both monthly and year to date totals for number of births, number of animals shipped, number of animals added, and number of animal deaths, YTD total shall correspond with the calendar year.

7.13.2. Monthly Teleconferences with the COR:

The Contractor shall plan and conduct monthly teleconferences with the COR(s) to review overall progress; pending approvals or action items; identify technical problems and develop approaches for their resolution; and discuss any current and or future issues or plan relevant to the technical or financial management of Contractor activities. The monthly meetings/teleconferences shall be attended the COR and depending on the agenda, NIH investigator designated staff and the Contracting Officer may also participate in the monthly meetings / teleconferences as needed. Additional Government staff shall attend as required. The schedule for monthly teleconferences will be established by the Contractor, in consultation with the COR

7.13.3. Annual Breeding Report:

The Contractor shall provide annual breeding data outlining an annual breeding colony review and shall be provided to the COR(s) by July 1st of each year. The annual breeding report data shall include at a minimum:

· Overall reproductive statistics and activities on the effectiveness of SPF breeder population

· Breeder Population Pregnancy, live birth and mortality rates based on demographics (age class).

· Review the reproductive history of all individual breeding groups and make recommendations to the COR for reproductive improvement, culling and selective replacement of breeders based upon the reproductive history of each group.

· Effective breeder population pregnancy rate(s) based on demographics and by group

· Fetal (premature) death rate

· Live Birth Rate

· Infant (less than 1 year of age) death rate

· Pregnancy and live birth production rates based on females of 4 yrs. of age or older

· Mortality based on age class

· Demographics age of the rhesus macaque colony:

· Effective breeder population-prime (5 yrs. and greater)

· Subadult (4 yrs.)

· Juvenile (3 yrs.)

· Juvenile (2 yrs.)

· Yearling (1 yr.)

· Infant (<1 yr.)

· Total males and total females

· Pre-weanlings (unknown sex)

· Total (includes pre-weanlings)

7.13.4. SUPPLEMENTAL REPORTS

A supplemental report may be requested from the COR to include a complete census of all animals. The report may include animal ID, location, sire & dam, DOB, gender, most recent weight, weight date, status (breeder, boarder or future breeder), serological tests and dates, cause of any deaths including necropsy reports; and number of non-routine clinical cases to include animal ID number; date condition first noted, and date resolved.

All reports required herein shall be submitted in electronic format.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

7.14. Staffing:

The Contractor shall provide qualified on-site veterinary, management, supervisory, technical, husbandry and administrative support staff necessary to meet the requirements of the contract. On-site staffing shall be provided at levels that promote appropriate colony health and care, record keeping, breeding colony efficiencies oversight as well as clinical treatment of all animal conditions and accommodate staff absenteeism and all other contract requirements.

· The administrative and/or managerial staff shall be on site and be able to respond to inquiries, accept shipment request requirements and details, coordinate shipments, provide data requests and/or overall colony status information on a daily basis.

· The Contractor shall have colony dedicated staff. If any colony staff are required to work in other areas/colonies, a plan outlining management practices shall be submitted and approved by the COR, prior to implementing.

· The contractors staffing levels shall be included in the contractor’s response to the RFP and shall include role descriptions and level of effort of veterinary managerial and technical personnel.

· Clearly identify what staff are to be considered as Key Personnel.

7.15. Occupational Medical Health:

The contractor shall develop a written Health Certification Policy concerning all visitors, staff, and guest investigators working at or visiting the colony and maintain up to date records on all such individuals. The Contractor’s Health Certification Policy must be strictly enforced. In addition to the Health Certification Policy, the Contractor must maintain a registry of all visitors to the colony. The registry shall contain, at a minimum, the visitor’s name and title, dates of visit, complete business address, and purpose of visit.

Due to the high risk of susceptibility to transmissible disease(s) within the colony, the Health Certification Policy shall require written proof of the following for all staff and visitors: Negative tuberculin test and/or chest x-ray within six months of exposure to colony (staff must be retested every 6 months).

Proof of prior measles infection or vaccination (vaccination must be at least three months old before time of proposed exposure to the colony).

Valid tetanus vaccination (for pre-exposure protection against monkey bites or injuries).

No exposure to the following illnesses three weeks prior to exposure to colony: Coronavirus, Chicken Pox, Measles, Mumps, Rubella, Yellow Fever or other Arbovirus infections.

Visitors and staff exposed to the colony must be in overt good health with no signs of respiratory disease, gastrointestinal dysfunction, or cold sores.

8. Access:

The contractor shall provide authorized Government officials access to rhesus macaques during business hours, and with notice (minimum 24-hour notice) during off-hour access. It shall be expected that a site visit will be conducted by the government to the Contractor’s facility within 6 months of award and at least annually thereafter. The government reserves the right to conduct unannounced site visits during normal business hours, M-F, 8am-4pm, if in the government’s opinion they are warranted. There will no cost reimbursement by the government for man hours or resources that the Contractor will need to provide to facilitate or responded to questions from any site visits.

9. Key Personnel

As prescribed in HHSAR 337.103(f), 352.237-75, Key Personnel (December 18, 2015), the key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual.