MISOW.pdf

Statement of Work

Breed and Maintain Free-Ranging Macaca Mulatta (Rhesus) Monkeys

Independently and not as an agent of the Government, the Contractor shall provide the necessary personnel, materials, services, facilities, and otherwise perform all actions necessary for and/or incidental to the performance of the work as described below.

I. Background

Morgan Island is a free-ranging rhesus colony that has been in place for over 30 years. The colony consists of approximately 2800 Indian-origin rhesus monkeys and has been a closed colony with no additional animals being added for over 25 years. The colony is used to provide animals for the critical research within the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and with its collaborators. The Contractor must work closely with the Government to oversee and manage the colony. This team approach is essential to preserving this critical resource as well as maintaining due diligence in being good stewards of the island, the surrounding wet lands and water ways. The intention of the Government is to maintain this colony in its existing location near Beaufort, South Carolina (SC) for the foreseeable future. The island colony poses specific logistical challenges and requires personnel commitments on behalf of the Contractor.

II. Introduction

The objectives of this contract are the operation and daily care of a year-round outdoor breeding colony of free-ranging Indian-origin Macaca mulatta (rhesus monkeys). The actual base size of the colony is expected to be approximately 2800-3000 animals at the initiation of this contract. The Contractor shall be responsible for accepting the colony at the designated site with existing facilities and arranging for the lease of Morgan Island from the South Carolina Department of Natural Resources. The colony is currently located on Morgan Island, near Beaufort, SC. Morgan Island will be utilized solely for Government-owned animals provided hereunder or progeny from facilities and resources related to this contract on Morgan Island.

The Contractor will be required to maintain Morgan Island as well as the mainland dock that is utilized for access to the island. Morgan Island nor the dock sites will be utilized to support any other animals that may be located at the Contractor's facilities; these are stand-alone facilities and shall not be used to support other activities.

III. Specific Requirements

A. Colony Maintenance

The Contractor shall provide for the year-round daily maintenance of a non-human primate (NHP) breeding colony. Optimum reproduction will be considered as equal to or greater than 70 percent live births per year from the female animals at risk to pregnancy. (Note: It is anticipated that the number of animals provided by the Government should produce a minimum of 500 animals per year for the Government's use). If reproduction is not achieved at optimum levels the Contractor shall work with the COR to identify the issue and make resolution. Breeding shall be a natural selection process conducted outdoors in a free-ranging environment. As the adolescent monkeys become available, and when required by the Government, the monkeys shall be trapped, quarantined, immunized as instructed by the Contracting Officer’s Representative (COR) and transported to a designated holding facility as instructed by the COR. The holding facility could be NIH-owned and operated, contracted, or leased animal facilities located in Poolesville, Maryland; Bethesda, Maryland; Frederick, Maryland; or other facilities conducting or collaborating with NIAID research. All NHPs housed under this contract are currently on site at Morgan Island or will be provided by the Government. At the conclusion of the contract performance, the disposition of the animals shall be the responsibility of the Government.

B. Animal Welfare Assurance

The Contractor shall:

1. Provide qualified experienced veterinary services for clinical care of NHPs in a free-ranging colony, as well as veterinary review of animals during trapping/processing. All unexpected deaths must receive an examination to determine the cause of death. Examinations as well as review of trapping/processing require and on-site certified Doctor of Veterinary Medicine.

2. Maintain a tuberculosis-free colony of monkeys. Each shipment of animals shall be held separately while under quarantine before being transported from the island. The duration of holding prior to shipment will be determined after consultation with the COR and the project manager, after a veterinary assessment. During that time, animals will be tuberculin-tested at least once and receive an initial dose of an anthelmintic. Access to the animals shall be limited to the necessary clinicians and caretakers. Detection of a tuberculosis infected animal could be detrimental to the colony and have varying level of impact on the operation. As such, the Contractor must consult with the COR immediately to develop and implement an action plan to regain integrity of the colony.

3. Provide the necessary care in handling any colony-threatening circumstances.

The Contractor shall inform and consult with the COR immediately, providing an initial assessment and proposing a plan to handle the situation. This shall be in addition to providing maximum veterinary, and colony management expertise, and obtaining outside consultants as deemed necessary to minimize the impact to the colony. Any non-routine clinical drug treatment therapies shall be approved by the Government before being administered. All treatment plans administered to the animals must be by standards acceptable with good veterinary practice.

4. Ensure that all Animal Study Proposals for procedures to be performed on NIAID-owned animals were prepared by the NIAID scientists and submitted to the Contractor through the COR or his/her designee for review and approval by the Institutional Animal Care and Use Committee (IACUC). Procedures could vary according to the needs of the NIAID and will likely include, but are not limited to, holding and breeding of animals and obtaining blood samples. There must be a minimum of two NIAID/Government members on the IACUC.

5. 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.

6. As noted in III.B.3. above, contact the COR as soon as possible in an emergency and/or disaster situation so it can be determined if NIH disaster recovery assistance procedures should be initiated in conjunction with the Contractor, to minimize the impact to the Government to the greatest extent possible.

C. Animal Status and Shipments

1. All animals will remain the property of the Government.

2. Prior to one (1) year of age, each animal shall be individually marked by tattoo or other means as approved by the COR. Animals of (1) year of age that are not able to be captured for identification purposes shall be reported to the COR.

3. Animals found not suitable for breeding shall be identified and the COR notified;

a determination will be made on the disposition of the animals in consultation with the COR.

4. Transportation shall be in compliance with all applicable Animal Welfare Act requirements, the Guide for the Care and Use of Laboratory Animals, United States Department of Agriculture (USDA) regulations and Centers for Disease Control and Prevention (CDC) guidelines as required.

5. Shipments shall be conducted with a USDA-approved transporter and all arrangements, including the final destination, will be coordinated with the COR a minimum of two weeks prior to departure.

6. Animals shall be delivered in properly ventilated, escape proof, disposable cages furnished by the Contractor and approved by the COR, or the Government may decide to provide them at the Government’s discretion. Each compartmentalized cage shall have separate water and feed containers for each compartment. Cages shall be in accordance with the USDA and International Air Transport Association (IATA) guidelines.

7. All costs of shipping approximately 100-150 monkeys from the island to the holding facilities, either contract or NIH-owned or leased, four times per year shall be included in the contract, or the Government may decide to provide this service with subcontractors at the Government’s discretion.

8. Serological testing of animals will be completed as part of this contract during the yearly processing (please see Section D2 of this SOW for details regarding processing.). All animals shall be tested for B-virus, simian T-lymphotropic virus, simian retrovirus, simian immunodeficiency virus and measles virus prior to being transported from the island. The diagnostic laboratory to be used must be approved by the COR in advance of each scheduled processing. Testing results shall be communicated with the COR. Positive results will require consultation with the COR to develop and action plan.

9. The Government shall determine when animal shipments will be required and inform the Contractor about the numbers of animals, time frames and destinations where the animals will be shipped. The COR will work closely with the Contractor’s project manager to establish timing and methods of transport, make the necessary arrangements with contract carriers as needed, communicate all necessary information prior to ensure shipments are carried out properly.

10. The Contractor will assist the COR in identifying and facilitating the placement of surplus animals from the island. The responsibilities of the Contractor could include identifying a buyer for surplus animals, identifying temporary housing facilities for animals cropped from the island and arranging for the delivery of surplus animals to the buyer in accordance with all applicable rules and regulations. The number of animals that are surplused will be provided and approved by the COR after the needs of the Government are fulfilled. No animals shall be shipped from the island without prior approval by the COR.

Proceeds from the sale of excess animals shall be directed to the institute which will manage returning funds to the treasury.

D. Personnel Requirements

The Contractor shall:

1. Provide and maintain the expertise and experience in personnel for the year-round maintenance of an outdoor rhesus (monkeys) breeding colony on a remote island operation. Based on the uniqueness and critical nature of the project, as well as the relatively small number of full-time staff, all full-time staff and all veterinary staff will be considered Key Personnel. Due to the uniqueness and remoteness of the island operation, as well as the vast number of critical and potentially life-threatening situations and decisions that arise from the remote operation, the Contractor must ensure that all staff are cross-trained in the various positions to the most extend practicable.

2. Provide qualified and experienced personnel 7 days per week, 365 days per year to provide animal care and program oversight. In addition, provide increased staffing as needed for the basis of capturing, performing health assessments and culling of NHPs as required by the Government. This is referred to as “processing” and is normally conducted 4 times per year. Management personnel shall have experience in the care and monitoring of a breeding colony of NHPs, the management of a large free-ranging NHP colony and the necessary skill sets to manage the execution of an island-based operation.

3. ACUC: The Government maintains the Association for Assessment and

Accreditation of Laboratory Animal Care (AAALAC) accreditation and maintains an OLAW assurance for Morgan Island. However, the Contractor shall support the preparation for Institutional Animal Care and Use Committee (IACUC) meetings and provide off-site meeting facilities as needed. It is expected that individuals of the contract staff (project manager and veterinarian) will participate and be active members of the IACUC. The Government requires the contract management personnel to meet at least two times per year on site with Government representatives to review the animal program as a committee.

Additionally, the Government requires that the Contractor’s Key Personnel meet periodically throughout the year, during processing or whenever possible, to ensure overall quality assurance and conduct reviews of the progress of the program. These meetings may not include Government representatives;

however, outcomes from these meetings will be discussed with the COR as soon as possible and based on the nature of the findings, additional discussions may be necessary at the ACUC committee meetings with Government representatives.

E. Facilities and Equipment

The Contractor shall:

1. Obtain land lease(s), provide facilities upkeep and recommend equipment replacement as needed to maintain a free-ranging environment for the NHP colony. The Contractor must have adequate and appropriate resources for containing and housing the animals in a free-range environment. The Contractor must maintain a detailed facilities and equipment replacement schedule. The Contractor must also plan for the projected life expectancy of all significant and critical equipment as well as facility structures and other items that require routine maintenance and/or replacement. At the time of contract award, the Government will provide the Contractor with a current property inventory list that includes a recommended replacement schedule; the Contractor will be required to maintain and update this listing throughout the life of the contract.

2. Provide clinical laboratory and diagnostic pathology support facilities and services.

3. Provide accessibility to animals for authorized Government officials during business hours and with reasonable advance notice to the Contractor during off hours. The Contractor should be prepared for unannounced visits from authorized Government officials as well, and be prepared to provide accessibility with very little notice. The COR will make the determination of who is authorized to enter the facility and will communicate this determination to the Contractor.

4. Provide facility oversight including security measures. The facility security plan should address staff awareness and understanding of the sensitive nature of the work, staff schedules, and training. The Contractor shall be prepared to initiate legal action against individuals that trespass or that have been found to have trespassed on the island or harass the animals. The Contractor must maintain agreements and/or understandings with local law enforcement officials to provide for the security of the colony. The Government encourages prosecution of any individuals or groups to the greatest extent of the law to ensure the health and welfare of the colony.

5. Ensure that visitors to the colony are minimized. Any non-routine contract staff or visitors to the colony must be authorized by the COR in advance. The Contractor shall maintain a registry of all visitors to the colony. The registry shall contain, as a minimum, the visitor's name and title, dates of visit, complete business address including phone number, and purpose of visit.

F. Operational Compliance

The Contractor shall adhere to the following and the facility in which the animals are housed shall be operated in compliance with:

1. 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.

2. Public Health Service (PHS) Policy on Humane Care and Use of Laboratory

Animals, updated 2015.

3. The Guide for the Care and Use of Laboratory Animals, revised 2011.

4. NIH Manual 3040-3 Intramural Contracts Involving Animals.

5. Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH 2009).

6. Occupational Health and Safety in the Care and use of Research Animals (NRC 1997).

7. Recommendations for prevention of and therapy for exposure to B virus

(Cercopithecine herpesvirus 1).Cohen JI, Davenport DS, Stewart JA, Deitchman S, Hilliard JK, Chapman LE; B Virus Working Group. Clin Infect Dis. 2002 Nov 15;35(10):1191-203. Epub 2002 Oct 17.

8. Conduct all animal care and related activities in a manner that ensures the continued full accreditation by AAALAC international.

IV. Record Keeping

A. All animals shall be individually marked with identification by tattoo number, or by other means approved by the COR. A quarterly census shall be provided by the Contractor and the population shall be monitored so that basic demographic data is obtained and updated on a continuous basis throughout the period of performance.

B. The Contractor, in collaboration with the COR, shall maintain an existing database, currently utilizing a Microsoft Excel spreadsheet, to store, analyze and display data on all animals of the colony, regardless of status, during the period of performance.

Minimal data shall include the following for each animal:

• Identification (tattoo) number, or other means as requested by the COR

• Year of birth

• Gender

• Offspring, by gender, year of birth and identification number

• Status, e.g., alive or dead, (date and cause of death)

• Health status

• Location (e.g., free-ranging, corralled, clinic, quarantine, placement)

• Disposition (when applicable) http://www.ncbi.nlm.nih.gov/pubmed/12410479 http://www.ncbi.nlm.nih.gov/pubmed/12410479

Additional colony census data must also reflect, at minimum:

• Number of live male adults (14 years and older)

• Number of live male adults (4 years to 14 years)

• Number of live male adolescents (between 2 and 4 years of age)

• Number of live males (1-2 years of age)

• Total number of live male infants less than 1 year

• Number of live female adults (14 years and older)

• Number of live female adults (4 years to 14 years)

• Number of live female adolescents (between 2 and 4 years of age)

• Number of live females (1-2 years of age)

• Total number of live female infants less than 1 year

• Number of pregnant females

• Number of dead animals by gender

• Number of still-births by gender

• Number of newborns by gender (6 months of age or less)

Data contained in the database shall be updated at a minimum of monthly, or more frequently if deemed necessary by the COR, following the consolidation of census data collected from the field.

C. Morgan Island has a “No Visitors” policy and entrance onto the island must have prior approval from the COR. The Contractor will establish and maintain a written health certification policy concerning all approved visitors, staff, and approved subcontractors working at or visiting the breeding colony, and will maintain all records on all individuals. Due to the high risk and susceptibility of the primates in the breeding colony to transmissible disease, the certification policy will require, as a minimum, written proof of the following health requirements prior to visiting the island:

1. Negative tuberculin test and/or chest x-ray within six months of exposure to colony (staff must be retested every six months). NIAID contracting and technical staff must maintain a current NIH occupation medical services (OMS) clearance on file with the Contractor on site to work with NHPs.

2. Proof of prior measles infection or vaccination (vaccination must have been administered three months before time of proposed exposure to colony).

3. Valid tetanus inoculation (for pre-exposure protection against monkey bites or injuries).

4. No exposure to the following illnesses during the three weeks prior to contact with the colony: Chicken Pox, Measles, Mumps, Rubella, Yellow Fever or other Arbovirus infection.

5. Visitors and staff exposed to the colony must be in visually overt good health with no signs or declarations of respiratory disease, gastrointestinal dysfunction, or cold sores.

V. Reporting Requirements

The following reports are necessary for the successful performance of this contract and shall be provided by the Contractor in the content and timeframes specified:

A. Technical Progress Report

The Contractor shall submit to the Contracting Officer and COR each 90-day period (quarterly, except at each year-end when an annual summary report will be required in lieu of), a technical report describing progress of the program to date, noting all technical areas in which effort is being directed and indicating the status or work within these areas. These reports will include:

1. A description of overall progress.

2. An indication of any current problems that may impede performance and proposed corrective action.

3. List of all visitors including their purpose.

4. An outline of the work to be performed during the next reporting period.

5. Copy of the latest census data and discussion of:

(a) Presence of any infectious disease

(b) Conception rate

(c) Still-births

(d) Congenital defects

(e) Number and dates of healthy newborns

(f) Addition of new mature males and females, (as provided by the

Government or natural maturation)

(g) Total adolescents (male and female)

(h) Number of deaths and cause of death of each animal

(i) Disposition of all animals leaving the colony

B. Annual Summary Report, Annual report based on calendar year not contract year.

The Contractor shall submit to the Contracting Officer, in electronic format, an Annual Summary Report documenting and summarizing each consecutive 12-month period of contract performance, including any subsequent extension(s) thereof. The Annual Summary Report shall be submitted not later than thirty (30) days after completion of the corresponding 12-month period of performance (provided that options are exercised) and shall include tables, graphs, diagrams, curves, sketches, photographs, and drawings as necessary, and in sufficient detail, to explain the results achieved during this period.

The Annual Summary Report shall contain all the data required on the fourth quarter rather than preparing a separate fourth quarter progress report.

C. Annual USDA Report, Annual report provided by the 15th of October.

The Contractor shall submit to the COR, in electronic format, an Annual USDA Report documenting and summarizing the previous consecutive 12-month period from October 1st to September 30th. The Annual USDA Report shall be submitted no later than October 15th of each year and shall include tables and narratives as necessary, and in sufficient detail, to explain quantitative adjustments to the census. The report shall capture all animal deaths, births, deletions, animals not observed and any other adjustment to reflect a detailed and correct census of the island population throughout the reporting period.

D. Final Report

The Contractor shall submit electronically, the Final Report to the Contracting Officer and COR. This report shall function as a summary of the entire contract period of performance and as a detail of the last ninety (90) days. It shall contain complete, up-to-date census information for the entire 5 years, and shall be submitted on, or prior to, the expiration date of the contract. The Final Report shall include tables, graphs, diagrams, curves, sketches, photographs, and drawings as necessary and in sufficient detail to comprehensively explain the results achieved under this contract along with three (3) copies of the up-to-date animal inventory.

E. Miscellaneous Reports

In addition to the aforementioned reports, the Contractor may periodically be requested by the COR to furnish written data relative to contract performance and shall be prepared to discuss orally any phase of contract performance or progress.