non-human_primates_SOW.pdf

Housing and Maintenance of Non‐Human Primates for NIAID VRC

Statement of Work

Independently and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the work set forth below.

Scope of Work to be Performed Non‐Human Primates:

1. House, feed and care for an estimated 250 Non‐Human Primates (NHP) with possibilities of up to four separate increments of 50 animals (a total of 450 NHP’s may be housed if all increments are exercised). Contract includes but is not limited to the following species:

Macaca mulatta, Macaca fascicularis, Macaca nemestrina, and any other combination of Old World and New World species.

2. Conduct up to 20 procedures per week for experimental groups consisting of 4 to 12 nonhuman primates for immunogenicity and viral challenge studies. The nature of investigations being conducted by the Vaccine Research Center (VRC) scientists using infectious agents including simian immunodeficiency viruses require long‐term, overlapping, labor intensive studies which will necessitate that animals be maintained for longer than 12 months post‐inoculation. Procedures will be conducted according to individual working protocols issued under VRC or NIAID ACUC approved Animal Study Proposals. Viruses to be tested include, but shall not be limited to, the following:

a. Various Simian Immunodeficiency Virus (SIV) strains.

b. Various Simian‐Human Immunodeficiency Virus (SHIV) strains

c. Various HIV strains

d. Vaccinia wild type and recombinant viruses.

e. Attenuated and wild type adenoviruses, including recombinant adenoviruses.

f. Attenuated and wild type Influenza Viruses

g. Various alphavirus e.g. Chikungunya

3. Perform procedures on animals which shall include but not be limited to: inoculation (intravenous, intraperitoneal, subcutaneous, intradermal, intramuscular, intravaginal, intranasal, electroporation and intrarectal) of the animals with various biological agents or vaccine preparations, monitoring animals for signs of disease, evaluation of new therapies such as antiviral agents and immunotherapies for their effectiveness against viral infection and collection of specimens as described by protocols furnished by the Project Officer. The details of the specimen collection for electron microscopy and/or light microscopy and virus isolation shall be detailed in each protocol or by approved Standard Operating Procedures.

4. During the disease course and at termination of study, perform various clinical or pathological procedures as needed or as requested by the Project Officer including but not limited to:

a. Phlebotomy

b. Cerebrospinal Fluid Aspiration

c. Bone Marrow Aspiration

d. Peripheral Lymph Node Excisional Biopsy

e. Comprehensive Experimental Necropsy

f. Bronchoalveolar Lavage

g. Survival Surgery: Partial Splenic Resection, splenectomy, messenteric lymph node excisional biopsy, GALT excisional biopsy.

h. Apheresis

i. Endoscopic jejunal biopsy

j. Mucosal fluid collections to include lung, rectal, vaginal, nasal, oral.

k. Various methods of delivery immunogens

5. The Contractor shall perform final detailed, comprehensive necropsies as specified by the Project Officer. Any special procedure conducted by the Contractor shall be performed in accordance with the Project Officer's specifications. Clinical and pathological specimens designated by the Project Officer will be collected and delivered intact, within 2‐4 hours of being drawn from the animal but no later than 12:00 P.M. on the day obtained, to the Vaccine Research Center in order to achieve optimal and maximum virus isolation and recovery rates. Furthermore, they will deliver the specimens in accordance to reasonable methods requested by Project Officer or designee.

NOTE TO OFFEROR: The performance of some specialized tests on specimens collected by the Contractor shall be the responsibility of Government scientists; the government may ask for samples or specimens to be evaluated by various contractors.

Physical Plant, Animal Environment, Housing and Management Requirements:

1. Contract facility needs to be within 50 miles of NIH. This is necessary for the delivery and oversight of VRC immunogens (some which are freshly prepared or have to be delivered within an hour) into NHP’s and return of study samples back to VRC in a timely manner for processing.

2. Biosafety Level: ABSL‐2 and ABSL‐3 practices, containment equipment, and facilities are required for activities using animals experimentally infected with the above viruses and opportunistic infections associated with these viruses.

3. Animal rooms: Provide the Project Officer separate rooms dedicated to these experiments (no co‐mingling of animals from other non VRC projects)

4. Exhaust Air: Pass exhaust air through absolute HEPA filters. Describe biocontainment modules and building exhaust system.

5. Special Procedures Rooms: Provide suitable and separate rooms and equipment consistent with the Guide for animal examination, necropsy, surgery, surgical preparation and radiography. The necropsy room will contain work stations and a downdraft ventilation necropsy table which meets OSHA and ASHRAI standards for exposure limits to formalin.

6. Storage Areas: Provide adequate (~500 cubic feet) secure floor and shelf space for the storage of all equipment, supplies, and pharmaceutical products. All pharmaceutical products (i.e., for treatment of intercurrent infections, all tranquilizers, all analgesics), supplies and equipment (i.e., for specimen collection, inoculation, biopsy, surgery, necropsy, etc.), may be specified by the Project Officer, and supplied by the Contractor.

a. Alternative Power Supply: An emergency electric generator shall be available to this project and available for immediate use in the event of a loss of electric power.

b. Security: Provide a 24‐hour security system, including video monitoring and 24 hour security personnel on site to prevent unauthorized entry into facilities and animal areas. Restrict entrances into the animal areas by security locks. Animal rooms shall display signs marked boldly with the designation "Biohazard Area” on animal room doors.

c. Caging Specifications: The Contractor shall provide caging (e.g combination of 6.0

Mobile Home Over/Under Modules, 6.0 Mobile Home Over/Under Biocontainment Modules, and at least one 9.0 Mobile Home Over/Under Module + 9.0 Mobile Activity/Observation Module.) Describe how mobile modular cages are designed to permit and foster social housing of primates and ferrets in accordance with the Guide and USDA/APHIS regulations under the Animal Welfare Act and USPHS policy, promote psychological well‐being of the animals, and minimize exposure to infectious agents.

d. HVAC: The Contractor shall describe HVAC system and best efforts to maintain 74‐

76 degrees F. and 15 air changes/hour. The Project Officer will be notified within 24 hours if there is a wide variance in environmental conditions including but not limited to temperature and humidity.

e. Disinfection and Sanitization: Describe disinfection and sanitization methods for cages, animal equipment, animal rooms, biocontainment chambers and the chemical disinfectant/sterilant used. Also describe environmental monitoring and quality assurance for sanitization methods.

f. Medical Pathological Waste (MPW): Describe how disposition of potentially infected materials shall be accomplished, sequentially, in the following manner:

(1) Animal Room Waste (2) Animal Carcasses (3) Specimens (4) Disposable Items: (e.g. Needles and Syringes: sharps container, autoclave as solid waste, commercial biohazard waste disposal service. b. Other Disposables: sealed bag, burn box, incinerator; and (5) Nondisposable Clothing.

g. Environmental Enrichment: The Contractor shall provide plans for enriching the environment of nonhuman primates and ferrets in compliance with the AWA and NIH manual 3040.

h. Food: Describe the diets for nonhuman primates and ferrets and fresh fruit and or vegetables regimen provided.

i. Identification and Records: Describe how animals are identified and how individual records for each animal are maintained to include the following as species appropriate: (1) Clinical and Research Record form which includes the following information columns: a. Immunizations b. Parasite Control c. Tuberculosis Tests d.

Weights (Kg.) e. Clinical Procedures f. Final Disposition g. Necropsy; (2) Chronological Record of Medical Care; (3) Physical Examination Form; (4) Food Consumption Form;

(5) Hematology Results; (6) Serum Chemistry Results; (7) Weight Charts; (8) and Stool Condition Record.

j. Animal Observation: Animals will be observed at least every 2 hours, 24 hours/day, 7 days/week.

NOTE TO OFFEROR: Proper maintenance of the Government‐supplied equipment shall be the responsibility of the Contractor. Proper maintenance includes keeping an updated inventory of equipment, retaining equipment in working condition, and notifying government of any damage or repairs needed. Repair to Government owned equipment shall be provided by the Government.

The Contractor shall adhere to the following:

1. The Contractor’s Institutional Animal Care and Use Program must have the following credentials:

a. Office of Laboratory Animal Welfare, Animal Welfare Assurance numbers

b. USDA Registration

c. Association for Assessment and Accreditation of Laboratory Animal Care

International file number (AAALAC).

2. The Contractor’s standards for all animal care, biosafety, and personnel occupational health and safety will conform to all Federal, State and local regulations, in accordance with NIH policy when applicable (reference http://oacu.od.nih.gov) and including but not limited to the following:

a. The Animal Welfare Act (P.L. 89‐544, as amended) Rules and Regulations published in the Code of Federal Regulations (CFR), Title 9 (Animals and Animal Products), Chapter 1, Subchapter A (Animal Welfare), Parts 1, 2, and 3.

b. Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, updated 1996.

c. The Guide for the Care and Use of Laboratory Animals, revised 1996 or 2010 version

d. Biosafety in Microbiological and Biomedical Laboratories (CDC_NIH 2009).

e. Occupational Health and Safety in the Care and Use of Research Animals (NRC

1997)

3. Nonhuman primates housed under this contract will be provided by the government.

4. All Animal Study Protocols (ASP’s) for procedures that are to be performed on Vaccine Research

Center (VRC) owned animals will be prepared by the NIH, VRC scientists and submitted to the Contractor through the Project Officer or his/her designee. However, contractor is responsible for submission of ASP’s to their Institutional Animal Care and Use Committee and Institutional Biosafety

Committee for approval prior to study start.

5. At the conclusion, the disposition of the animals shall be the responsibility of the NIH, VRC.

Specifically, the Contractor shall:

Institutional Policies and Responsibilities:

1. Personnel Qualifications and Training: Personnel shall be specifically trained and experienced in the care and maintenance of animals infected with the pathogens identified in this Statement of Work. Describe personnel experience and qualifications for working with specific infectious agents.

2. Personal Protection: Describe personal protection required for the animal facility, and at each BSL and ABSL levels.

3. Cross‐Contamination: Describe procedures for preventing animal to animal transmission of infectious agents during collection of specimens by taking appropriate precautions in these studies.

4. Occupational Health and Safety of Personnel: Describe personnel medical‐surveillance program, Veterinary Medical Care:

1. Surveillance, Diagnosis, Treatment, and Control of Disease: Describe program for ensuring all nonhuman primates are negative for SIV, STLV and SRV by serology and/or virus isolation before introducing onto contract. Include quarantine procedures, tuberculosis test regimen, physical examinations, and other evaluations for assessing animal’s condition prior to being placed on scientific protocol.

2. Intercurrent Infections/Conditions: The treatment of intercurrent infections and other conditions will first be discussed with the Project Officer, and no medication, other than routine, shall be administered without prior approval.

3. Euthanasia: The Project Officer shall be notified of any untoward findings in animals under this contract and prior approval shall be obtained from the Project Officer before any animal is sacrificed.