NIH-NHPPrimateSOW-2015.docx

Statement of Work

A. Background Information The National Institutes of Health (NIH), Office of Research Services (ORS), Division of Veterinary Resources (DVR), provides NIH Intramural programs with the service and facilities to acquire and house non-human primates (NHPs) needed for research that is 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. Institutes funding for research supported by this contract is an annual appropriation. Without this contract mechanism in place, considering the dollar value associated with most NHP requests and the lead time needed to acquire NHP, individual orders may not be obligated within the FY in which the institutes received the appropriation.

B. Objectives This requirement will facilitate the efficient procurement, testing 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

C. General Requirements Independently, and not as an agent of the Government, the Contractor shall furnish various species of Specific Pathogen Free (SPF) and non- SPF monkeys, as well as serological testing, transportation and holding as requested by individual order which meet the specifications further described herein.

All work under this contract shall be monitored by the COR, whose position is defined elsewhere in this document.

D. Specific Requirements Specifically, the contractor shall provide and deliver the following as requested by individual order which meet the specifications further described herein.

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

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

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

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

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

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

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

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

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

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

11. Blood Sample, 3-30 ml

12. Crates

13. Transportation

14. Housing and Per Diem

E. Technical requirements

1. Macaca Mulatta (Rhesus), Macaca Fascicularis (Cynomolgus),and Macaca Nemestrina (Pigtailed), SPF

A. Weight, Age, and Sex Requirements:

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

B. Disease Prevention and Health Status:

All animals provided under this contract shall be quarantined and screened in the USA for a minimum of thirty-one (31) days and be in overt good health upon arrival at the NIH or other designated facility. In addition the animals must be research naive, physically sound and healthy, free of wounds, external parasites, and clinical signs of disease prior to shipment. No animal shall be shipped to the NIH or other designated facility that has a history of illness without the prior approval of the COR. A record of each individual animal shall accompany shipment to include sire and dam, date of birth, sex, and all medical records of clinical tests and results, treatments, and physical exams including body conditioning score. A electronic copy of the medical record shall be submitted to the COR not later than 5 business days prior to shipment for review and approval. All animals shall be identified by individual tattoo numbers, placed on the chest of the animal.

Prior to arrival all animals shall have no record of a positive TB test and shall have been TB tested a minimum of three times, one within 10 days of shipment, test negative one (1) time for Herpes B virus, SRV1, SRV2, SRV5, SIV and STLV-I by serology and test negative one (1) time for SRV1, SRV2, and SRV5 by PCR. Animals shall be returned to the vendor and replaced at the vendors cost if animals convert to any of the above mentioned diseases within 35 days after receipt by the NIH. The diagnostic laboratories used shall be approved by the COR prior to performing the required testing. No animal that must 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. Once an animal has been designated for the NIH and vaccinations are required by the vendor, all vaccines must be approved by the COR to ensure there will be no impact to the intended research. Based on individual orders, it may be necessary to request animals selected as domestic bred and not wild caught.

C. Animal Acceptance:

Animals shall be guaranteed to arrive alive and be TB negative for three (3) consecutive tuberculin 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 B virus between 30 and 35 days post arrival at NIH. 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 will be rejected. Only animals judged healthy based on an examination by a veterinarian during the entry physical, which will be performed within seven (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, euthanized at the contractor’s discretion, 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 colony(s) 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.

2. Chlorcebus Aethiops (African Green) and Erythrocebus Patas (Patas, SPF

3. Squirrel and Owl Monkeys, SPF, Male or female, Any Date of Birth, Weight, greater than 750 g

Weight, Age, and Sex Requirements:

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

Disease Prevention and Health Status:

Animals shall meet the same specifications listed in the section II subsection C, technical requirement Macaca Mulatta (rhesus) and Macaca fascicularis (Cynomolgus) SPF entitled: Disease Prevention and Health Status and Animal Acceptance, except that 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 Saimir by serology. Based on individual orders, it may be necessary to request animals selected as domestic bred and not wild caught. All other specifications must be met. Animals may be requested with any known date of birth.

4. Callithrix Jacchus (Marmoset), SPF, Male or female, 2-6 yrs of age, any weight.

Disease Prevention and Health Status:

Animals shall meet the same specifications listed in the section II subsection C, technical requirement Macaca Mulatta (rhesus) and Macaca fascicularis (Cynomolgus) SPF entitled: Disease Prevention and Health Status and Animal Acceptance, except that 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 Herpes-virus tamarinus and Herpes-virus Saimir by serology. Based on individual orders, it may be necessary to request animals selected as domestic bred and not wild caught. All other specifications must be met. Animals may be requested with any known date of birth.

5. Blood Sample, 3 - 30 ml (from animals identified to purchase) Within ten (10) business days of receiving a request from the COR, a blood sample will be obtained from the animal identified to be purchased by the NIH. The sample will be shipped to the location 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).

6. Transportation Transportation shall be in compliance with CDC and Animal Welfare Act requirements Title 9, Subchapter A, Part 3, Transportation Standards. The contractor shall be responsible for meeting all requirements associated with shipment and delivery of animals. The contractor shall maintain close liaison with carrier personnel in order to assure the animals receive proper care, in accordance with USDA standards and AAALAC guidelines, during transit. The contractor shall submit to the COR by email the proposed shipment schedule and method of transport (airline or ground) no less than 72 hours prior to shipment. Any changes or delays in that schedule shall be communicated immediately to the COR or his representative. NHPs shall be delivered in properly ventilated, escape proof, disposable, nonreturnable crates (cages). Each crate (cage) shall have separate water and feed containers for each compartment. 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.

All ground transportation of nonhuman primates under this contract will require a USDA licensed transporter. Two drivers must be present in the vehicle if in transit for longer than 10 hours. At least one of the drivers must be an experienced animal care provider with a minimum of one year experience. The vehicle must have at a minimum a mobile/cellular phone, flashlight, emergency contact list, animal bite and scratch kit, potable water, feed and fruit (provided by the pickup site), animal capture equipment (catch gloves and net) and a written driver awareness fact sheet on the precautions of nonhuman primates and Herpes B-virus exposure.

7. Animal Housing / Per Diem Provide housing and care of animals identified by the COR that will enter into holding status. 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. 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 and shipping for serological screening (not testing cost), routine clinical diagnostic testing and shipment preparation shall be incorporated into the per diem cost. 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 that will be determined by the COR prior to the animals being placed into pairs or groups.

All animals placed in holding status for thirty (30) days or longer will require a monthly report to be sent to the COR electronically by the 10th of each month. This report shall contain the following information:

· report date;

· current census;

· number of socially housed animals;

· number of individually housed animals;

· number of births (current period and year to date, if applicable);

· number of animals shipped;

· number of animals added;

· number of animal deaths, and reasons;

· number and type of serology tests performed;

· number of non-routine clinical cases including animal(s) ID number, date condition first noted, date resolved and general description of overall colony status; and

· Description of any current problems with proposed corrective action.

One (1) copy of this report must be submitted to the CORs no later than the 10th of each month in electronic format (MS word, MS Excel, Word Perfect or other format approved by the COR).

Animals that are placed into breeding groups as requested by the COR will require continual behavior and demographic assessments to ensure the best possible production rates and to minimize inbreeding.

A seventy (70) percent production rate is considered acceptable. If production rates drop below 70 percent, recommendations based on production and behavior assessments, to improve production rate to greater than 70%shalll be provided to the COR in writing within 30 days. The 70 percent production shall be based on the adult, greater than 4.5 yrs of age, female population in the group(s). Animals that are in excess of the governments needs may be offered to the vendor in exchange for a credit at a cost in line with current market price and agreed upon by the vendor and the COR. The credit will be applied to the next monthly invoice as applicable.

The animals will be provided housing, care, and feeding in accordance with the Animal Welfare Act, Association for the Accreditation and Assessment of Laboratory Animal Care International (AAALAC) standards, the PHS policy (The Guide for the Care and Use of Laboratory Animals) and USDA regulations. Any facility that holds animals on or is associated with this contract must maintain an Office of Lab Animal Welfare OLAW assurance, AAALAC accreditation, and registered with the USDA .

The COR will be informed within three (3) business days of any animals that are considered in poor condition or have been found dead. The animals are considered as government property and the contractor is not considered responsible for animal deaths of less than ten percent (10%). If the holding facility is under Emergency and/or Disaster status, the COR will be contacted as soon as possible. All effort necessary shall be deployed to minimize the impact to the government to the greatest extent possible.

Special Clauses.

PHS 352.280-2 Care of laboratory animals. The policies and procedures to be used when contracts involve live vertebrate animals are provided in Subpart PHS 380.2, and in the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions and accompanying implementation instructions published in a special edition of the NIH Guide for Grants and Contracts, Vol. 14, No. 8, June 25, 1985.

(b) The following provision shall be included in solicitations expected to involve vertebrate animals:

NOTICE TO OFFERORS OF REQUIREMENT FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS (SEP 1985) THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS BY AWARDEE INSTITUTIONS ESTABLISHES A NUMBER OF REQUIREMENTS FOR RESEARCH ACTIVITIES INVOLVING ANIMALS. BEFORE A PHS AWARD MAY BE MADE TO AN APPLICANT ORGANIZATION, THE ORGANIZATION SHALL FILE, WITH THE OFFICE FOR PROTECTION FROM RESEARCH RISKS (OPRR), NATIONAL INSTITUTES OF HEALTH (NIH), PHS, A WRITTEN ANIMAL WELFARE ASSURANCE WHICH COMMITS THE ORGANIZATION TO COMPLY WITH THE PROVISIONS OF THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS BY AWARDEE INSTITUTIONS, THE ANIMAL WELFARE ACT, AND THE GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS PREPARED BY THE INSTITUTE OF LABORATORY ANIMAL RESOURCES. IN ACCORDANCE WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS BY AWARDEE INSTITUTIONS, APPLICANT ORGANIZATIONS MUST ESTABLISH A COMMITTEE, QUALIFIED THROUGH THE EXPERIENCE AND EXPRETISE OF ITS MEMBERS, TO OVERSEE THE INSTITUTION'S ANIMAL PROGRAM, FACILITIES AND PROCEDURES. NO PHS AWARD INVOLVING THE USE OF ANIMALS SHALL BE MADE UNLESS THE ANIMAL WELFARE ASSURANCE HAS BEEN APPROVED BY OPRR. PRIOR TO AWARD, THE CONTRACTING OFFICER WILL NOTIFY CONTRACTOR(S) SELECTED FOR PROJECTS THAT INVOLVE LIVE VERTEBRATE ANIMALS THAT AN ANIMAL WELFARE ASSURANCE IS REQUIRED. THE CONTRACTING OFFICER WILL REQUEST THAT OPRR NEGOTIATE AN ACCEPTABLE ANIMAL WELFARE ASSURANCE WITH THOSE CONTRACTOR(S). FOR FURTHER INFORMATION, OPRR MAY BE CONTACTED AT NIH, BETHESDA, MARYLAND 20892 (301-496-7041).(End of provision)

(C) The following clause shall be included in all contracts involving research on vertebrate animals: CARE OF LIVE VERTEBRATE ANIMALS (OCT 1986)(A) BEFORE UNDERTAKING PERFORMANCE OF ANY CONTRACT INVOLVING RESEARCH ON LIVE VERTEBRATE ANIMALS, THE CONTRACTOR SHALL REGISTER WITH THE SECRETARY OF AGRICULTURE OF THE UNITED STATES IN ACCORDANCE WITH 7 U.S.C. 2316 AND 9 CFR 2.25-2.28. THE CONTRACTOR SHALL FURNISH EVIDENCE OF SUCH REGISTRATION TO THE CONTRACTING OFFICER.(B) THE CONTRACTOR SHALL ACQUIRE VERTEBRATE ANIMALS USED IN RESEARCH FROM A DEALER LICENSED BY THE SECRETARY OF AGRICULTURE UNDER 7 U.S.C. 2133 AND 9 CFR 2.1-2.11, OR FROM A SOURCE THAT IS EXEMPT FROM LICENSING UNDER THOSE SECTIONS.

(D) THE CONTRACTOR AGREES THAT THE CARE AND USE OF ANY LIVE VERTEBRATE ANIMALS USED OR INTENDED FOR USE IN THE PERFORMANCE OF THIS CONTRACT WILL CONFORM WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS BY AWARDEE INSTITUTIONS, THE CURRENT ANIMAL WELFARE ASSURANCE, THE GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS PREPARED BY THE INSTITUTE OF LABORATORY ANIMAL RESOURCES AND THE PERTINENT LAWS AND REGULATIONS OF THE UNITED STATES DEPARTMENT OF AGRICULTURE (SEE 7 U.S.C. 2131 ET SEQ. AND 9 CFR SUBCHAPTER A, PARTS 1-4). IN CASE OF CONFLICT BETWEEN STANDARDS, THE MORE STRINGENT STANDARD SHALL BE USED.

(E) IF AT ANY TIME DURING PERFORMANCE OF THIS CONTRACT, THE CONTRACTING OFFICER DETERMINES, IN CONSULTATION WITH THE OFFICE FOR PROTECTION FROM RESEARCH RISKS (OPRR), NATIONAL INSTITUTES OF HEALTH (NIH), THAT THE CONTRACTOR IS NOT IN COMPLIANCE WITH ANY OF THE REQUIREMENTS AND/OR STANDARDS STATED IN PARAGRAPHS (A) AND (C), ABOVE, THE CONTRACTING OFFICER MAY IMMEDIATELY SUSPEND, IN WHOLE OR IN PART, WORK AND FURTHER PAYMENTS UNDER THIS CONTRACT UNTIL THE CONTRACTOR CORRECTS SUCH NONCOMPLIANCE. NOTICE OF THE SUSPENSION MAY BE COMMUNICATED BY TELEPHONE AND CONFIRMED IN WRITING. IF THE CONTRACTOR FAILS TO COMPLETE CORRECTIVE ACTION WITHIN THE PERIOD OF TIME DESIGNATED IN THE CONTRACING OFFICER'S WRITTEN NOTICE OF SUSPENSION, THE CONTRACTING OFFICER MAY, IN CONSULTATION WITH OPRR, NIH, TERMINATE THIS CONTRACT IN WHOLE OR IN PART, AND THE CONTRACTOR'S NAME MAY BE REMOVED FROM THE LIST OF THOSE CONTRACTORS WITH APPROVED PUBLIC HEALTH SERVICE ANIMAL WELFARE ASSURANCES.NOTE:THE CONTRACTOR MAY REQUEST REGISTRATION OF ITS FACILITY AND A CURRENT LISTING OF LICENSED DEALERS FROM THE REGIONAL OFFICE OF THE ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS), USDA, FOR THE REGION IN WHICH ITS RESEARCH FACILITY IS LOCATED. THE LOCATION OF THE APPROPRIATE APHIS REGIONAL OFFICE, AS WELL AS INFORMATION CONCERNING THIS PROGRAM MAY BE OBTAINED BY CONTACTING THE SENIOR STAFF OFFICER, ANIMAL CARE STAFF, USDA/APHIS, FEDERAL CENTER BUILDING, HYATTSVILLE, MARYLAND 20782.

(End of clause) [51 FR 20491, June 5, 1986, as amended at 52 FR 9300, Mar. 24, 1987]