SOW - African Green.docx

ARRA

ARRA Influenza Project-Animal Models:

Description of Requirement:

172 (One hundred and Seventy-two) African Green, Chlorcebus aethiops - Specific Requirements listed below

Delivery schedule:

0. 52 (Fifty -two) animals – December 1, 2010

0. 30 (Thirty) animals – May 1, 2011

0. 28 (Twenty-eight) animals – November 1, 2011

0. 28 (Twenty-eight) animals – May 1, 2012

0. 34 (Thirty -four) animals- November 1, 2012

Animals procured shall be shipped to NIH Animal Center, 16710 Elmer School Rd, Dickerson MD, 20842 according to the shipping schedule provided above. This will be funded in whole by the American Recovery and Reinvestment Act of 2009.

Cost per animal shall be inclusive, consisting of animal cost, blood sampling to NIH, quarantine associated holding and testing, serology testing crates and shipping to the NIH Animal center.

Specific Requirements Specifically, the contractor shall provide and deliver the following nonhuman primates that meet the specifications further described herein.

1. Chlorcebus aethiops (African green), SPF, Male or Female, Any Date of Birth, Weight 3-6 kg

Weight, Age, and Sex Requirements:

Monkey, male or female alive in good health and with a weight range of 3 to 6 kilograms upon arrival at NIH or other designated contract facility.

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 Contracting officer’s technical representative (COTR). 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, treatments and results. 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 SIV, SA8, measles, STLV1/2, SHF by serology and (1) one negative fecal culture for klebsiella performed within 21 days of arrival.

In addition all animal must be prescreened for NIH specific targeted respiratory viruses as noted below under Blood Samples. All animal care, technical, transportation and veterinary staff coming in direct contact with the animals should protect the animals by wearing a N95 mask at all times.

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 COTR prior to performing the required testing. No animal that must be tested for filovirus 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 vaccination against the rubella virus is required by the vendor, the Attenuvax vaccine shall be used or alternate vaccines must be approved by the COTR prior to the animals being vaccinated.

Animal Selection:

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, serology and/or virus isolation/culture for SIV, SA8, measles, STLV1/2, SHF and NIH specific respiratory viruses between 30 and 35 days post arrival at NIH. If animals test positive by PCR, culture/isolation, or serology, then the animal is considered positive. All animals shall be delivered in 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 for payment. 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 animals 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 contractors 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 who’s colony(s) are experiencing reportable diseases as defined by the CDC (yellow fever, monkey pox, hemorrhagic fevers [filovirus or others]) or mortality or morbidity of greater than 5% for a cohort group of animals without the prior approval of the COTR. 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 COTR.

2. Blood Sample, 3 - 30 ml (from animals identified to purchase) Within 20 business days of award of this contract, obtain a 10 ml blood sample collected into EDTA. After the sample(s) are obtained arrange to have them shipped to NIH at the location indicated by the COTR. 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, Human influenza viruses and VZV).

3. Transportation Animal 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 COTR by phone the proposed shipment schedule and method of transport (airline or ground) no less than 10 days prior to shipment. Any changes or delays in that schedule shall be made immediately to the COTR or his representative. Monkeys shall be delivered in properly ventilated escape proof, disposable, nonreturnable crates (cages) furnished by the contractor. 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. Exterior shipping containers and material not shipped in containers shall be marked, labeled or tagged as applicable and shall include (a) contractor’s name and address; (b) delivery order number, name and address; and (c) total number of cartons in shipment.

All ground transportation of nonhuman primates in connection with this contract will require a USDA licensed transport and 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, minimum one year experience. The vehicle must have at a minimum a mobile/cellular phone, flashlight, emergency contact list, animal bite and scratch kit, potable waters, feed and fruit (provided by the pickup site), animal capture equipment (catch gloves and net).

4.

Animal Housing / Per Diem Provide for the housing and care of animals identified by the COTR that will enter into holding status 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 COTR. 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, serological screening (not testing cost), routine clinical diagnostic testing and shipment preparation shall be incorporated into the per diem cost. Animals may also be requested by the project officer to be housed for extended time frames. The animals will be housed in groups of same sex or mixed sex arrangements that will be determined by the COTR prior to the animals being placed into groups.

All animals placed in a holding status for thirty (30) days or longer will require a monthly report to be sent to the COTR electronically at the beginning of each month. This report should 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 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, description of any current problems with proposed corrective action.

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 is associated with this contract must maintain an OLAW assurance. Animals will not be placed into holding status at any facility that is not AAALAC accredited. The Project Officer 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 COTR will be contacted as soon as possible and the COTR will initiate NIH disaster recovery assistance procedures in conjunction with the contractor with all resources available to minimize the impact to the government to the greatest extent possible.

5. Special requirements

a. Liability Coverage All non-human primates transported in conjunction with this contract must be adequately insured for the complete replacement cost of the animal and have liability coverage. The responsibility to ensure that all parties are properly protected relies on the party that hires the transportation company. There will be some instances when the Government will hire the transporter and others when the Contractor will have this responsibility. All animal transports that are performed in conjunction with this contract must be insured for the full replacement cost ($5,000 per animal unless noted in writing from the government) for each animal and liability insurance in the amount of $1,000,000.00. The Project Officer shall be provided with certificates of insurance prior to the animal(s) departure. The animal vendor may select to self insure the animals and accept the liabilities of the transport but must provide this in writing to the Project Officer before the animals depart.

b. Animal Guarantee All animals that are provided to the NIH through this contract shall be guaranteed for thirty-five (35) days. Any animal that dies, or becomes critically ill during this time will be replaced by the vendor at no cost to the government. This guarantee does not apply to animals that die or become ill due to animal care, i.e., bloat, dehydration, or traumatic injuries. Animals shall be guaranteed to arrive alive and be TB negative for three (3) consecutive tuberculin tests (on or about day 6, 20 and 34) after arrival at the point of destination. All animals virus status will be confirmed by serology and PCR or virus isolation/culture for STLV-I, SIV, SHF and NIH specific respiratory viruses as applicable to the requirements between thirty (30) and thirty-five (35) days post arrival at NIH. Tests will be performed in accordance with the species and SPF criteria as listed above. If animal(s) test positive or indeterminate (IND) for any of the listed viruses within thirty-five (35) days post arrival at the NIH, the animals shall be returned to the vendor at the vendors expense or a mutual cost agreement will be decided between the contractor and the government to keep the animal at NIH that is acceptable to the COTR. If animals test either positive or indeterminate by PCR, culture/isolation, or serology, then the animal is considered positive. All animals shall be delivered in 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 for payment. Only animals judged healthy based on an examination by a veterinarian during the entry physical, performed within six (6) days after arrival, will be acceptable. This assessment will be based on a physical examination and observation of the animals 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 contractors 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 importers who are experiencing reportable diseases (yellow fever, monkey pox, hemorrhagic fevers, TB) or significant losses of animals.

c. Sanitation, Feed and Water All sanitation, feed and water shall be in accordance with the; USDA standards, the Association for Accreditation and Assessment of Laboratory Animal Care International (AAALAC) as outlined in the "Guide for the Care and Use of Laboratory Animals", and the Public Health Service Policy on "Humane Care and Use of Laboratory Animals", Public Law 99-158. The Contractor shall have fully approved Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare (OLAW), and shall comply with all provisions of the Animal Welfare Act and other Federal statues and regulations relating to animals.

d. Animal Welfare Assurance The contractor shall obtain, prior to the start of any work under this contract, an approved Animal Welfare Assurance from the Office of Laboratory Animal Welfare (OLAW), Office of the Director, NIH, as required by Section I-43-30 of the Public Health Service policy on Humane Care and Use of Laboratory Animals. The Contractor shall maintain such assurance for the duration of this contract.

e. Restriction From Use of Live Vertebrate Animals Under Governing Policy, Federal Funds Administered by the Public Health Service (PHS) Shall Not Be Expended for Research Involving Live Vertebrate Animals Without Prior Approval by the Office of Laboratory Welfare (OLAW) of an Assurance to Comply with the PHS Policy on Humane Care and Use of Laboratory Animals. This Restriction Applies to All Performance Sites Without OLAW-approved Assurances, Whether Domestic or Foreign.

f. Care of Laboratory Animals (PHS 352.280-2) Notice to offerors of Requirements for Adequate Assurance of Protection of Vertebrate Animal Subjects (SEPTEMBER 1985) The PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions established a number of requirements for research activities involving animals. Before a PHS award may be made to an applicant organization, the organization shall posses or shall file, with the Office for Laboratory Animal Welfare (OLAW), 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 prepared by the Institute of Laboratory Animal Resources. Accordance with PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions, applicant organizations must establish a committee, qualified through experience and expertise of its members, to oversee the institutions 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 OLAW. Prior to award, the Contracting Officer will notify the contractor selected for projects that involve live vertebrate animals that an Animal Welfare Assurance is required. The Contracting Officer will request that OLAW negotiate an acceptable Animal Welfare Assurance with the Contractor. For further information OLAW may be contacted at NIH, Bethesda, Maryland 20892 on telephone # (301) 496-7041.

g.

Care of Live Vertebrate Animals (OCTOBER 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. (c) 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. (d)If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Protection from Research Risks (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraph (a) through (c)above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects 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 Contracting Officers written notice of suspension, the Contracting Officer may in consultation with OLAW, NIH, terminate this contract in whole or in part, and the contractors name may be removed from the list of those Contractors with approved Public Health Service Animal Welfare Assurance.

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.

h. Government Responsibilities The animal holding report as described above will be reviewed by the COTR within ten (10) business days after receipt and questions or comments will be discussed with the contractor at that time.

A copy of all invoices will be faxed or sent electronically by the contractor to the COTR for review and approval prior to being submitted to account payable.

i.

Reporting Requirements All animals placed in holding for thirty (30) days or longer will require a monthly report to be sent to the Project Officer electronically at the beginning of each month.

This report should 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, numbers of animals added, number of animal deaths and reasons, number of serology tests performed, number of non-routine clinical cases including ID, date found, date resolved and general description of overall colony status, description of any current problems with proposed corrective action.

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

j. Packaging and Marking Packaging, Marking, and shipping instructions are provided above under Transportation.

k. Inspection and Acceptance COTR or his designee is responsible for inspection & acceptance of all supplies to be delivered under this contract. Inspection and acceptance will be performed at the National Institutes of Health Animal Center (NIHAC), Office of Research Services (ORS), Division of Veterinary Resources (DVR), Building 103, Room 1A02B, 16701 Elmer School Road, Poolesville, Maryland 20837, or at other contract facilities as designated by the COTR. Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within thirty (30) days from departure.