20170808_-_2017-09962_-_Statement_of_Work_(SOW).pdf

STATEMENT OF WORK

TITLE: Purchase of 20 Male Rhesus Macaques, Indian Origin 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 twenty (20) male Rhesus Macaques, Indian origin, for antiretroviral and lubrication safety and efficacy studies for 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) to provide and deliver safely and humanely twenty male Rhesus Macaques, Indian origin, to the 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). Contactor shall provide a copy of the USDA license and AAALAC accreditations to the Government Contracting Office’s Representative (COR) to be reviewed by Government veterinarians.

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 policies and guidance as applicable that provide national standards for the acquisition, transportation, housing, control, maintenance, handling, treatment, care, use and disposal of animals.

International suppliers shall also be in compliance with their national policies.

The Contractor transport company shall also 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 the Government.

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

IV. TASKS TO BE PERFORMED

The Contractor shall provide twenty male Rhesus Macaques, Indian Origin, meeting the following specifications.

1. All animals shall be between the ages of 4 and 10 years. The Contractor shall provide the dates of birth.

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

3. No animals shall have participated in or exposed to HIV, SIV, SHIV or other retrovirus studies prior to purchase by the Government.

4. All animals shall have a breeder’s statement and/or CITES export permits and declaration forms available.

5. All animals shall be maintained in complex social and physical environments for behavioral and medical health.

6. No prior surgical procedures shall have been performed on any of the animals.

Note: The Government 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 history.

The Contractor shall perform the tasks specified below.

Task 1. Animal Identification

This task shall be performed within five business days of the date of award. In order to provide twenty male Indian Rhesus Macaques to the Government, the Contractor shall identify more than twenty potential Macaques (ideally, thirty potential Macaques) meeting the specifications listed above and provide medical histories (see below for criteria) to the Government for review and selection.

1. medical history and behavioral records/records criteria

2. country, place and date of origin

3. animal ID number

4. date of birth and sex

5. most recent weights with dates obtained

6. dates and result of all TB tests (must be negative)

7. dates, results, and external laboratory that performed testing for SIV, SRV, STLV, internal and external parasites, microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia) (must be negative)

8. test for measles antibody titer and special select agents, if any specified/identified by the Government (defined by the Government)

9. dates and results of Herpes B tests

10. copies of all clinical records for each animal since birth including any noted behavioral evaluations

11. pair or group housing history

12. all animals shall have a breeder’s statement and/or CITES export permits and declaration forms

Task 1.2 The Government shall select twenty acceptable animals based on review of the provided medical history/records/test results and shall notify the Contractor one to two weeks after receiving complete physical exam records/results.

Note: The Government 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.

Task 2. Post–Selection Testing and Examination

Task 2.1. The Contractor shall perform the following testing and exam (“a” and “b” below), gather results and records (previous testing results and medical history/records should have been already sent to the Government as mentioned above) and send to the Government for further review and acceptability.

If the Government rejects an animal for any reason after post selection testing and examination, the Contractor shall identify substitute candidate NHP meeting the requirements at no additional cost and provide all documentation for the substituted animal (as specified in this SOW).

1. Week 1, testing: start within five business days of the Government’s notification (described in Task 1.2)

2. First TB Test (Note: Three tests required in all—two–week intervals, must be negative)

3. Week 3, testing and exam:

a. second TB Test, two weeks after the first test

b. SIV, SRV antibody, SRV PCR, STLV, internal and external parasites, microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia) to document that the animals are negative for these pathogens and any special select agents testing, if any requested and/or identified by the Government; send 2ml of serum in ice packs overnight to the Government, if requested

c. Herpes B testing provide documentation for status

d. Measles—provide antibody titer

e. 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 provide results to the Government.

Task 2.3 Within seven (7) business days of receiving the third TB testing records and results, the Government shall notify or further confirm to the Contractor of post selected/acceptability of the animals and provide confirmation of selected animals.

Note: If the Government rejects an animal for any reason after the third TB test, the Contractor shall identify substitute candidate NHP meeting the requirements and provide all documentation for the substituted animal (as specified in this SOW).

Task 3. Delivery Instructions

Within three days of the Government’s notification (described in Task 2.3), the Contractor shall coordinate with the Government delivery of final twenty selected/approved animals. Delivery date must be within two weeks of the initial Government notification (Task 2.3). 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, the Contractor shall provide a copy of their transport ‘contingency plan’ for review by the Government.

Task 3.1. Perform pre-delivery physical exams two to three days prior to delivery date to ensure safety and health of selected animals. Prepare the exam records and send to the Government COR by the delivery date of animals.

Note: If the Government rejects an animal for any reason after the third TB test, the Contractor shall identify substitute candidate NHP meeting the requirements and provide all documentation for the substituted animal (as specified in this SOW).

Task 3.2. The Contractor shall coordinate with the Government and provide professional transportation services to safely and humanely deliver all Macaques to the designated Government facility following the delivery requirement below.

1. Schedule an appointment for delivery not less than three days in advance of delivery by contacting the Government COR.

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

3. Delivery shall be during Government’s regular business hours: 9:00am to 3:00pm Eastern Time, Monday through Thursday, except on Federal holidays. (Special arrangements must be made prior to delivery if outside of regular business hours.)

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

V. SPECIAL CONSIDERATIONS

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

In the event of discovering existing conditions/illness, death or finding positive results to TB, SIV, SRV, STLV, parasites, etc. of any Macaques within sixty days after delivery and/or acceptance while animals are in quarantine, replacements that meet the requirements in this SOW shall be made promptly (within fifteen days of notification or upon completion of required testing) at no additional cost to the Government or the Contractor shall reimburse the Government for the cost associated with procurement of the animal(s).

VI. PERIOD OF PERFORMANCE

The anticipated Period of Performance is six months from the date of award. 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, not to exceed six months.

VII. DELIVERABLES

The Contractor shall deliver humanely and safely twenty male Indian Rhesus Macaques meeting all of the specifications listed above to the Government. The Contractor shall also deliver all testing and animal records as indicated above and below. Deliverables shall be sent to the Government COR and/or Contracting Officer. The specific recipients for deliverables will be stated in the award.

Date Task # Description Deliverables

Day 0-5 Pre-selection, potential animals

Task 1 Ensure requirements are met and gather medical records/history of potential animals.

All test results, research history, medical and behavioral records from Birth to present as described in SOW for review.

Prepare and send all records/medical and behavioral history to the Government.

Post selection testing-Week

Task 2.1a

Perform 1st of three consecutive TB tests at 2 week interval.

Prepare to send TB test results.

Week 3 Task 2.1b

Perform SIV, SRV, STLV, Measles, internal and external parasites, and microbiology (e.g.

Shigella, Campylobacter, Salmonella, Yersinia), send serum, if required by the Government, for any Government identified special select agent testing, Herpes B testing and 2nd TB test. Perform physical exams including blood work (CBC, Chemistry, etc.)

and weight determinations.

Prepare and send test results/status/records.

Week 5 Task 2.2

Perform 3rd TB test Prepare and send results.

Weeks 6-7 Task 3 Coordinate with the Government delivery of selected/approved animals; Transportation driver must be a US Citizen; Perform pre-delivery exams 2-3 days before delivery date to ensure safety and health of the selected animals.

Information on drivers for Government security clearance approval.

And prepare records of pre-delivery exams.

Day of delivery

Task 3 Transport animals safely and humanely to the Government.

All 20 male Rhesus Macaques meeting requirements and the recent medical records.

0-3 years Section

III

Maintain a copy of records of sent animals.

VIII. POINTS OF CONTACT

The Contracting Officer, COR, and Technical Monitor will be designated at the time of award.

IX. PAYMENT TERMS

Payment will be made in accordance with the line items established herein and in accordance with FAR 52.232-25, Prompt Payment, which states that the due date for making invoice payments shall be the 30th day after the designated billing office (see block 21 of the order) has received a proper invoice from the vendor or the 30th day after Government acceptance of the services performed by the vendor, whichever is later.

X. MINIMUM CONTRACTOR QUALIFICATIONS

The Contractor shall 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 Government security approval to access Government facilities. 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.

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.

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 and/or pregnant (if females) to the DHAP Laboratory Branch in the past ten years.

The Contractor’s Animal Technicians/Veterinarians shall have a minimum of four years of experience working with non-human primates.

The Contractor shall provide past performance history of selling Indian Rhesus Macaques. The past performance history shall include three most recent procurements, preferably since 2012.