DRAFT SOW 20 Female Pigtail Macaques.docx

STATEMENT OF WORK

TITLE: Purchase of 20 nonhuman primates (NHPs, Pigtail Macaques, females) for DHAP Laboratory Branch’s HIV Prevention Studies

I. BACKGROUND

The Laboratory Branch supports DHAP’s goals in HIV prevention as they pertain to clinical studies, viral transmission, diagnosis and incidence, intervention research with microbicides, vaccines, and chemoprophylaxis as well as investigates other human and zoonotic retroviruses. The lab conducts and develops multiple preclinical HIV intervention studies using animal models (NHPs) for HIV detection, quantitation, isolation, evolution, and surveillance including drug resistance.

II. PURPOSE

To purchase 20 Female Pigtail macaques for pharmacokinetic and efficacy studies of antiretroviral prophylaxis by the Centers for Disease Control and Prevention (CDC), OID, NCHHSTP, Division of HIV/AIDS Prevention, Laboratory Branch.

III. SCOPE OF WORK

Independently, and not as an agent of the Government, the contractor shall provide all necessary trained personnel, transport cages, equipment, and materials (other than that provided by Government), and deliver safely and humanely 20 female Pigtailed macaques to the Centers for Disease Control and Prevention (CDC), OID, NCHHSTP, Division of HIV/AIDS Prevention, Laboratory Branch.

The contracting facility must be licensed by the United States Department of Agriculture and accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC).

The contracting facility must be in compliance with the Animal Welfare Act and Regulations (Title 9 Code of Federal Regulations part 1), The Guide for the Care and Use of Laboratory Animals, and other federal and state policies and guidances as applicable that provide national standards for the acquisition, transportation, housing, control, maintenance, handling, treatment, care, use and disposal of animals.

The contractor transport company also must be USDA licensed as either a carrier or intermediate handler or in the event that a secondary subcontractor is used; a contract carrier. Per 2013 USDA regulations, contractor shall provide a copy of their transport ‘contingency plan’ for review by CDC Contracting Officer’s Representative (COR) and veterinarians.

The Contractor shall maintain its primates in complex social and physical environments (other than during diagnostic testing or as clinically necessary for treatment) in order to provide behaviorally and medically healthy animals.

The contractor shall provide detailed information on the veterinary care, medical history, and a description of any procedures that have been performed on the animals. The Contractor shall send records of animals to CDC COR and veterinarians, and also maintain a copy for at least 3 years beyond the time of delivery/acquisition.

IV. TASKS TO BE PERFORMED

The Government needs 20 female Pigtailed macaques, meeting the following specifications.

1. Between the ages of 4 and 11 years, the Contractor shall provide the date of birth.

2. All macaques shall have been tested negative for tuberculosis (TB), tested for the presence of a measles antibody titer, tested negative to simian retroviruses (SRV) by PCR, tested negative for antibodies to SRV, simian T-lymphotropic viruses (STLV), and simian immunodeficiency virus (SIV), been tested for the presence of internal and external parasites, and tested negative by PCR for microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia) and special select agents, if any identified by CDC.

3. No macaques shall have participated in prior studies with, or have been exposed to, HIV, SIV, SHIV or other retrovirus studies prior to purchase by CDC.

4. All macaques must have either a breeder’s statement or CITES export permits and declaration forms available. This must be provided to the Government for each animal.

5.All macaques will have been maintained in complex social and physical environments for behavioral and medical health.

6. All macaques shall have had no invasive surgical procedures except caesarian. No hysterectomies.

7. All macaques shall have been confirmed to NOT be pregnant at time of selection or shipment.

Note: CDC reserves the right to request further information based on history of pathogens noted in animals’ medical records and reserves the right to deny the selection of any animal based on the medical history and/or diagnostic testing.

The Contractor shall perform the tasks specified below:

Task 1. This task should be performed within 10 business days of the date of award. In order to provide healthy 20 Female Pigtail macaques to CDC, the Contractor shall identify ~30 potential macaques meeting the specifications listed above and provide medical histories/records (see below for criteria) to the CDC for review and selection of 20 potential candidates and several alternates.

Task 1.1 Medical History/records criteria

a. Country, place and date of origin

b. Animal ID number

c. Date of birth and Sex

d. Most recent weights with dates obtained

e. Dates and results of all TB tests (must be negative)

f. Dates, results, and external laboratory that performed testing for SIV, SRV, STLV, internal and external parasites, PCR for microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia), test for measles antibody titer and special select agents, if any specified/identified by CDC.

g. Dates and results of Macacine alphaherpesvirus 1 (McHV-1) tests (formerly known as Macacine herpesvirus 1, Herpesvirus simiae, or Herpes virus B)

h. Copies of all clinical records for each animal since birth including any noted behavioral evaluations

i. Pair or group housing history preferred when available

j. All animals should have a breeder’s statement and/or CITES export permits and declaration forms

k. Pregnancy and surgery history, if any

l. Dates and results of pregnancy test (must not be pregnant)

Task 1.2. This task should be performed within 10 business days of identification of candidates. Collect blood for serum separation from potential animals. Send 2ml of serum in Sarstedt 2 ml micro tube with an O-ring in the lid (ref #72.694.006 or similar), ship using 4°C ice packs via FedEx overnight delivery to CDC COR for additional testing. In addition, two weeks prior to shipment, collect blood and send 2ml of serum as above.

Task 1.3. CDC shall select 20 potential animals and several alternate animals that meet the specifications listed above and shall notify the Contractor 2-4 weeks after receiving the complete medical records (from Task 1.1). Note: CDC reserves the right to request further information based on history of pathogens noted in animal’s medical records and reserves the right to deny the selection of animals based on the medical records/tests.

Task 2. Post potential selection Testing and Examination (potential 20 and several alternates) Task 2.1. The Contractor shall perform the following testing and exams (“a” and “b” below), gather results and records (previous testing results and medical history/records should have been already sent to CDC as mentioned above) and send to CDC for further review and acceptability. *If CDC’s COR or veterinarian rejects an animal for any reason after post selection testing and examination and there are no more alternates for substitution, the contractor shall identify substitute candidate NHPs meeting the requirements and provide all documentation for the substituted animal (as specified in this statement of work). Contractor shall provide to the Government the actual paperwork of all results received from outside diagnostic laboratory testing.

a. Week 1, testing: start within 5 business days of CDC’s notification (described in Task 1.3)

i. First TB Test and (Note: Three (3) tests required in all at two-week intervals, must be negative)

ii. Microbiology testing by PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia)

b. Week 3, testing and exam:

i. Second TB Test, two weeks after the first

ii. SIV, SRV antibody, SRV PCR, STLV, internal and external parasites to document that the macaques are negative for these pathogens, test for measles antibody titer and any special select agents testing, if any requested/identified by CDC

iii. McHV-1 testing--provide documentation for status

iv. Physical exam requirement-- The Contractor’s veterinarian(s) shall perform physical exams (including collection of blood for CBC, Chemistry, etc) and weight determination on the macaques. Medical exam records shall be gathered and sent. (Note: Contractor’s Pre-delivery exam is also required 2-3 days prior to delivery date. See task 3.1)

Task 2.2 The Contractor shall perform the third TB testing (two weeks after the 2nd) and microbiology by PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia) and provide results to CDC.

Task 2.3 Within 7 business days of receiving the 3rd TB and 2nd microbiology by PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia) testing, provide records and results. CDC shall notify or further confirm to the Contractor of post selected/acceptability of the animals and provide confirmation of selected animals. *If CDC’s COR or veterinarian rejects any animals for any reason after the third TB and second microbiology tests and the number remaining is less than 20, the contractor shall identify additional substitute/alternate candidate NHPs meeting the requirements and provide all documentation and testing for the alternate/substitution animals (as specified in this statement of work). This replacement effort to screen additional animals to bring the total to 20 shall not incur added cost to CDC.

Task 3. Delivery instruction for 20 Pigtail macaques After CDC’s notification (described in Task 2.3), the Contractor shall coordinate with CDC delivery of final 20 selected/approved animals. Delivery date must be within two weeks of the initial CDC notification (task 2.3). Also, in order to transport these animals, the Contractor’s transport company must be USDA licensed as either a carrier or intermediate handler or in the event that a secondary subcontractor is used; a contract carrier. Per 2013 USDA regulations, Contractor shall provide a copy of their transport ‘contingency plan’ for review by CDC COR and veterinarians.

Task 3.1. Perform pre-delivery physical exams 2-3 days prior to delivery date to ensure safety and health of selected animals. Prepare the exam records and send to CDC COR and veterinarian by the delivery date of animals. *If CDC’s COR or veterinarian rejects an animal for any reason after delivery, the contractor shall identify substitute candidate NHP meeting the requirements and provide all documentation for the substituted animal (as specified in this statement of work).

Task 3.2. The Contractor shall coordinate with the CDC COR or designee/veterinarian and provide professional transportation services to safely and humanly deliver the 20 Pigtail macaques to the designated CDC Atlanta facility following the delivery requirements below:

a. Schedule an appointment for delivery not less than 5 days in advance of delivery by contacting the CDC COR.

b. Provide drivers information (name, contact information), who must be a US citizen(s), needed for security clearance at CDC, at least three days prior to delivery.

c. Delivery should be during CDC’s regular business hours: 9:00AM to 3:00PM, ideally Tuesday through Thursday, except on Federal holidays. (Special arrangements must be made prior to delivery if outside of regular business hours or if a delivery day might include a Monday or Friday.)

d. Delivery Location: CDC, Roybal Campus, 1600 Clifton Road, NE, Building 23, Atlanta, GA 30329 (loading dock).

Special consideration: The contractor shall ensure that macaques are negative to TB, SIV, SRV, STLV antigens and SRV PCR, internal and external parasites, negative PCR microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia), and any special select agents, if any required/identified by CDC. The Government reserves the right to reject/deny animals prior to delivery and the Contract shall find replacement animals upon request.

In addition, in the event of discovering existing conditions/illness, death or finding positive results to TB, SIV, SRV, STLV, parasites, microbiology via PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia) etc. of any macaques within 60 days after delivery/acceptance while animals are in quarantine, replacements that meet the requirements in this SOW shall be made promptly (within 2 months of notification or upon completion of required testing) at the expense of the contractor (including transportation) or the contractor shall reimburse the government for the cost associated with procurement of the animal.

V. GOVERNMENT FURNISHED MATERIALS

NONE

VI. PERIOD OF PERFORMANCE

The contractor shall start the process of identifying potential candidates of animals, testing, gathering history, records and results to deliver the NHPs as soon as possible after the date of award. Delivery of the animals shall occur within 12 months unless notified in advance to extend the performance/delivery timeline.

VII. DELIVERABLES

The contractor shall deliver humanely and safely 20 Female Pigtail macaques meeting all of the specifications listed above to CDC, Atlanta GA. The contractor shall also deliver all testing and animal records as indicated above and below.

Day 0-10 Pre-selection, potential animals

And prepare records of pre-delivery exams

VIII. MINIMUM CONTRACTOR QUALIFICATIONS

The contractor should have the capacity, license, insurance to provide and transport safely and treat humanely nonhuman primates and cages. Also, the contractor shall have or provide transportation company drivers that are US citizens for CDC security approval to access CDC campus. In order to transport animals, the contractor must be USDA licensed as either a carrier or intermediate handler or in the event that a secondary subcontractor is used; a contract carrier. Per 2013 USDA regulations, contractor shall provide a copy of their transport ‘contingency plan’ for review by CDC COR and veterinarians.

The Contractor shall have animal facilities fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

The Contractor shall maintain its primates in complex social and physical environments in order to provide behaviorally and medically healthy animals other than during diagnostic testing or as clinically necessary for treatment.

The contractor shall have no history of providing macaques that had been exposed to TB or tested positive to TB, SIV, SRV, and/or STLV, Shigella, Campylobacter, Salmonella, Yersinia, and/or pregnant (if females) to the DHAP Laboratory Branch in the past 15 years.

PIs and Veterinarians shall have a minimum of 4 years of experience working with Non-human Primates.