b. Attachment 1 Non-Human Primates (NHP) Specifications.pdf

Non-Human Primates (NHP) Specifications

Scope

The USUHS Contract requirement is for the purchase, testing, quarantine, housing, and shipping of the Non-Human Primates (NHPs). The NHPs will support the USUHS mission and other Government agencies collaborating with USUHS, for use in their research programs. There is a bona fide need associated with this Contract.

Table 1 identifies the NHP species required by USUHS. All NHPs must be from a domestic, qualified, U.S. Department of Agriculture (USDA) licensed dealer or commercial breeder. The Government requires the Offeror to provide proof of certification of USDA license dealer or commercial breeder for the species identified in Table 1 upon delivery.

Table 1: NHP Species Species Origin Sex Weight Age (Years)

1. Cercopithecus Aethiops, SPF African Green Male or Female 3-6 kgs F: ≥ 2.8

M: ≥ 4.8

The Vendor must ensure all NHPs delivered test negative for standard host specific protozoa, viral, and bacterial agents specific for each species, reference the MECs. The NHPs must be monitored by the Contractor and if the results of the tests are positive, the Contractor shall notify the Contracting Officer and the Technical Representative within five (5) business days upon confirmation.

The Vendor prior to contract award shall have a facility that is certified by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) or Canadian Council on Animal Care (CCAC) in addition to U.S. Federal, State, and local regulations, laws and ordinances.

The Vendor shall maintain accreditation and compliance with regulations, laws, and ordinances throughout the period of performance of the Contract. The Vendor is to provide the Contracting Officer and the Technical Representative with a copy of the certification at the time of contract award and when recertification occurs thereafter. If AAALAC or CCAC accreditation becomes lapsed, suspended, or is terminated during the period of performance, the Contractor shall notify the Technical Representative in writing within three (3) business days of the event.

All NHPs shall be accompanied by an Animal and Plant Health Inspection Service (APHIS) Form 7020 (Record of Acquisition, Disposition or Transport of Animals) which shall include the animal’s individual ID number and a signed interstate health certificate which shall include the animals individual ID number, and certification of tuberculin tests to include date of last test, type of tuberculin used, and test results.

All NHPs must be from a domestic, qualified U.S. Department of Agriculture (USDA) licensed dealer or commercial breeder. The Government requires the Offeror to provide proof of certification of USDA licensed dealer or commercial breeder for the species at the time of contract award and annual thereafter.

Minimum Essential Characteristics (MECs)

1. Ten (10) species of NHPs (reference Table A-1 below).

2. Animals must be less than (<) eight (8) years of age, and must not have previously been used for any surgical or other research experimentation.

3. Animals must be permanently tattooed with an individual ID number so as to be clearly visible on the chest, abdomen, or inguinal area and easily readable.

4. Animals must not be pregnant or reproductively altered (e.g. castrated, vasectomized, spayed).

5. Rhesus and Cynos must test antibody negative for Herpes B Virus, Filovirus (Ebola or Marburg), Simian T- Cell Lymphotropic Virus (STLV-1), Simian Immunodeficiency Virus (SIV), and Simian Retrovirus (SRV) Types 1, 2, 3, and 5 within 30 days prior to delivery.

6. Rehesus and Cynos must test negative by means of virus isolation or Polymerase Chain Reaction (PCR) for SRV Type 2 within 30 calendar days prior to delivery.

7. African Green Monkeys must test antibody negative for STLV-1, Cercopithecine Herpesvirus 2 (SA8), SIV, Measles, and Simian Hemorrhagic Fever (SHF) 30 calendar days prior to delivery.

8. Cynomolgus Macaques must test negative for Herpes B by serology; Simian type D retrovirus (SRV) negative by PCR; have been tested by industry standards for Tuberculosis (TB), SIV, and STLV-1; and are identified by tattoo in accordance with MEC #3 above.

9. Animals must be of either sex, as close to 50:50 as possible.

10. Animals must be as close to sexually mature as possible as follows:

a. Cercopithecus Aethiops (African Greens) (greater or equal to (≥): Females – 2.8 years old and

Males – 5.0 years old)

11. Animals must be negative for Salmonella, Shigella on two (2) rectal cultures performed two (2) days in a row within 30 days prior to delivery.

12. Animals must be tested one (1) time and found negative for Klebsiella pneumoniae, subtypes rmpA and magA, 30 days prior to delivery. All animals shall remain negative for these bacteria during tests performed by the Government for a period of 45 calendar days after delivery.

13. Animals must have had a minimum of three (3) consecutive negative intradermal tuberculin tests, two (2) to three (3) weeks apart, the last of which shall not have been administered any sooner than ten (10) calendar days prior to shipping.

14. Animals must be negative for common pathogenic helminth and protozoal parasites on fecal exam performed within 30 days of delivery.

15. Animals must have no visible evidence of external parasites (e.g. lice, ticks, mites, ringworm).

16. Animals must be from a domestic, qualified, U.S. Department of Agriculture (USDA) licensed dealer or commercial breeder. The Government requires the Offeror to provide proof of certification of USDA licensed dealer or commercial breeder for the species referenced above upon delivery.

17. All animals must remain negative during tests performed by the Government for a period of 45 calendar days after delivery.

18. Animals must be in good health to include well-fleshed and in good physical condition and be free of physical malformations and clinical signs of disease (i.e., cardiovascular, respiratory, intestinal, internal/external parasitism).

19. Animals must have no obvious behavioral problems (the animal does not exhibit any stereotypic maladaptive behavior such as self-clasping, self-biting, or consistent circling and there is no physical evidence such as bite wounds or alopecia secondary to excessive self-grooming, that indicates that the animal is exhibiting these behaviors).

20. Animals must be accompanied by an Animal and Plant Health Inspection Service (APHIS) Form 7020 (Record of Acquisition, Disposition or Transport of Animals) which shall include the animal’s individual ID number and a signed interstate health certificate which shall include the animal’s individual ID number, and certification of tuberculin tests to include date of last test, type of tuberculin used, and test results.

21. Animals placed into quarantine require a facility to be certified by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) in addition to U.S.

Federal, State, and local regulations, laws and ordinances.

22. Animals must have had a minimum of three (3) consecutive negative intradermal tuberculin tests, two (2) to three (3) weeks apart, the last of which shall not have been administered any sooner than ten (10) calendar days prior to shipping.

23. Animals must be negative for common pathogenic helminth and protozoal parasites on fecal exam performed within 30 days of delivery.

24. Animals must have no visible evidence of external parasites (e.g. lice, ticks, mites, ringworm).

25. Animals must be from a domestic, qualified, U.S. Department of Agriculture (USDA) licensed dealer or commercial breeder. The Government requires the Offeror to provide proof of certification of USDA licensed dealer or commercial breeder for the species referenced above upon delivery.

26. All animals must remain negative during tests performed by the Government for a period of 45 calendar days after delivery.

27. Animals must be in good health to include well-fleshed and in good physical condition and be free of physical malformations and clinical signs of disease (i.e., cardiovascular, respiratory, intestinal, internal/external parasitism).

28. Animals must have no obvious behavioral problems (the animal does not exhibit any stereotypic maladaptive behavior such as self-clasping, self-biting, or consistent circling and there is no physical evidence such as bite wounds or alopecia secondary to excessive self-grooming, that indicates that the animal is exhibiting these behaviors).

29. Animals must be accompanied by an Animal and Plant Health Inspection Service (APHIS) Form 7020 (Record of Acquisition, Disposition or Transport of Animals) which shall include the animal’s individual ID number and a signed interstate health certificate which shall include the animal’s individual ID number, and certification of tuberculin tests to include date of last test, type of tuberculin used, and test results.

30. Animals placed into quarantine require a facility to be certified by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) in addition to U.S.

Federal, State, and local regulations, laws and ordinances.