20160425_-_2016-94596_-_Statement_of_Work_(SOW).pdf

Statement of Work (SOW) TITLE: Purchase of twelve (12) nonhuman primates (NHPs, Pigtail Macaques, females) for Division of

HIV/AIDS Prevention (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

The purpose of this requirement is to purchase twelve (12) Female Pigtail Macaques for efficacy studies of antiretroviral prophylaxis by the Centers for Disease Control and Prevention (CDC), Office of Infectious Diseases (OID), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), DHAP, 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 twelve (12) Female Pigtail Macaques.

The Contractor’s facility shall 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 Contractor’s facility shall 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. International suppliers shall also be in compliance with their national policies.

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 the Government and veterinarians.

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, 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 (3) years beyond the time of delivery and/or acquisition.

IV. Tasks to be Performed

The Government requires twelve (12) Female Pigtail Macaques, meeting the following specifications.

1. All Pigtail Macaques shall be between the ages of four and twelve (4–12) years of age. The Contractor shall provide the date of birth for all Pigtail Macaques.

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

3. Pigtail Macaques shall not have participated in or been exposed to HIV, SIV, SHIV or other retrovirus studies prior to purchase by the Government.

4. Contractor shall provide a breeder’s statement and/or CITES export permits and declaration forms available for all Pigtail Macaques.

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

6. Pigtail Macaques shall not be hysterectomized.

7. Pigtail Macaques shall not be pregnant.

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 following specified tasks.

Task 1.1 Contractor shall identify at least thirty (30) potential Pigtail Macaques, which meet the specifications listed above and provide medical histories/records to the Government for review and selection of twelve (12) potential candidates and several alternates.

1. Medical History/Records Criteria

a. country, place, and date of origin

b. animal identification number

c. date of birth and sex (not pregnant)

d. most recent weights with dates obtained

e. dates and result of all TB tests (test results shall be negative)

f. dates, results, and external laboratory that performed testing for SIV, SRV, STLV, internal and external parasites, microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia), shall be negative, test for measles antibody titer and special select agents, if any specified/identified by the Government (as defined by the Government)

g. dates and results of Herpes B tests

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

2. pair and/or group housing history

3. breeder’s statement and/or CITES export permits and declaration forms

4. pregnancy and surgery history, if any

5. dates and results of pregnancy test(s)

Task 1.2 Contractor shall collect blood for serum separation from potential animals. Contractor shall send 2ml of serum in Sarstedt 2 ml micro tube with an O-ring in the lid (ref #72.694.006), using 4°C ice packs via FedEx overnight delivery to the Government for additional testing. Additionally, two (2) weeks from the first blood collection, Contractor shall collect blood and send refrigerated 2ml of serum as above.

Task 1.3 The Government will select twelve (12) potential animals and several alternate animals and will notify the Contractor within two to four (2–4) weeks after receiving the second batch of serum specimen (from Task 1.2).

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/tests.

Task 2 Contractor shall post potential selection Testing and Examination (potential twelve (12) and several alternates).

Task 2.1 The Contractor shall perform the following testing and exam (“1” and “2” below), gather results and records (previous testing results and medical history/records should have been already sent to the Government per Task 1) 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 and there are no more alternates for substitution, the Contractor shall identify a substitute candidate NHPs meeting the requirements and provide all documentation for the substituted animal (as specified in this SOW).

1. Week 1, testing: Contractor shall start testing within five (5) business days of Government’s notification (described in Task 1.3).

First TB Test and (Note: Three (3) tests required in all—two week interval, must be negative.)

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

2. Week 3, testing and exam:

a. Second TB Test, two (2) weeks after the first TB test

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

c. Herpes B testing—Contractor shall provide documentation for status.

d. 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 Pigtail Macaques. Medical exam records shall be gathered and sent. (Note: Contractor’s pre–delivery exam is also required two to three (2–3) days prior to delivery date. See Task 3.1 for additional information.)

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

Task 2.3 Within seven (7) business days of receiving the third TB and second microbiology by PCR (e.g.

Shigella, Campylobacter, Salmonella, Yersinia) testing, provide records and results, the Government will confirm selected/acceptability of the animals and provide confirmation of selected animals. *If the Government rejects any animals for any reason after the third TB and second microbiology tests and the number remaining is less than twelve (12), 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). The cost of the replacement effort to to screen additional animals to bring the total to twelve (12) shall be solely the Contractor’s responsibility.

Task 3 Delivery Instructions After the Government’s notification (as described in Task 2.3), the Contractor shall coordinate with the Government delivery of final twelve (12) selected/approved animals. Delivery date must be within two (2) weeks of the initial Government notification (Task 2.3). The Contractor’s transport company shall 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.

Task 3.1 Contractor shall perform pre-delivery physical exams two to three (2–3) days prior to delivery date to ensure safety and health of selected animals. Contractor shall prepare the exam records and send to the Government by the delivery date of animals. *If the Government 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 SOW).

Task 3.2 The Contractor shall coordinate with the Government and provide professional transportation services to safely and humanly deliver the twelve (12) Pigtail Macaques to the designated address following the delivery requirement below:

1. Contractor shall schedule an appointment for delivery not less than three (3) days in advance of delivery by contacting the Project Officer.

2. Contractor shall provide driver(s) in formation, who must be a US citizen(s), (name, contact information) needed for security clearance at CDC, at least three (3) days prior to delivery.

3. Delivery shall be during regular business hours: 9:00am EDT to 3:00pm EDT, Monday through Thursday, except on Federal holidays. (Special arrangements shall be made prior to delivery for delivery outside of regular business hours.)

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

V. Special Consideration

The Contractor shall ensure that Pigtail 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 CDC. 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, microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia) etc. of any Pigtail Macaques within sixty (60) days after delivery/acceptance while animals are in quarantine, replacements that meet the requirements in this SOW shall be made promptly (within two (2) months of notification or upon completion of required testing) at the expense of the Contractor (including transportation). The Government shall not incur any additional costs for efforts made to replace animals.

The Contractor shall maintain copies of all medical records for three (3) years after the delivery date.

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 twelve (12) months unless notified in advance to extend the performance timeline.

Depending on availability of Pigtail Macaques, multiple shipments, up to two (2), are allowed.

VII. Deliverables

The Contractor shall deliver humanely and safely twelve (12) female Pigtail 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.

Date Task # Description Deliverables

Day 0-10

Pre-selection, potential animals

Task 1

Ensure requirements are met and gather medical records/history of potential animals. All test results, research history, and medical records from Birth to present as described in SOW for review.

Prepare and send all records/medical history to the

Project Officer

Day 0-10 and in two (2) weeks

Task 1.2

Collect blood. Send 2ml of serum in Sarstedt 2 ml micro tube with an O-ring in the lid (ref

#72.694.006), using 4°C ice packs via FedEx overnight delivery to Project Officer. Repeat two (2) weeks after and send serum.

Send 2ml of refrigerated serum to the Project Officer.

Post selection of potential animals testing-Week 1

Task 2.1a Perform first of three consecutive TB tests at two– week intervals. Perform microbiology by PCR (e.g.

Shigella, Campylobacter, Salmonella, and Yersinia).

Prepare to send TB test and microbiology test results to the

Project Officer.

Week 3 Task 2.1b

Perform testing for SIV, SRV, STLV, Measles, internal and external parasites, 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 to the

Project Officer.

Week 5 Task 2.2 Perform third TB test and microbiology by PCR

(e.g. Shigella, Campylobacter, Salmonella, Yersinia) Prepare and send results to the

Project Officer.

Weeks 6-10 Task 3

Coordinate with CDC delivery of selected/approved animals; Transportation driver(s) must be a US citizen(s); Perform pre-delivery exams

2-3 days before delivery date to ensure safety and health of the selected animals

Send information on drivers for CDC security clearance approval to the Project Officer.

Prepare records of pre-delivery exams.

Day of Delivery Task 3 Transport animals safely and humanely to CDC.

Deliver twelve (12) female

Pigtail Macaques and recent medical records for all animals.

VIII. Project Officer

The Project Officer will be designated at the time of the award.

IX. Payment Terms

Invoice shall be submitted sixty (60) days after Government acceptance, which is after all quarantine periods.

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 thirtieth (30th) day after the Government has received a proper invoice from the Contractor or the thirtieth (30th) day after Government acceptance of the services performed by the Contractor, 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 CDC security approval to access the Government’s facility. In order to transport animals, the Contractor shall 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 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 Pigtail 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/Technicians/Veterinarians shall have a minimum of four (4) years of experience working with non-human primates.

The Contractor shall provide past performance history of selling Pigtail Macaques. The past performance history shall include no fewer than three (3) of the most recent contracts, preferably within the past five (5) years.