PWS-Nonhuman_Primate_Colony_Maintenance.pdf

PERFORMANCE WORK STATEMENT

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

9. TRANSITION SUPPORT

10. KEY PERSONNEL

11. TRAVEL/TEMPORY DUTY (TDY) – Not applicable

12. GOVERNMENT FURNISHED PROPERTY – Not applicable

13. CONTRACT MANAGEMENT

14. COMPLIANCE DOCUMENTS

15. REFERENCE DOCUMENTS – Not applicable

16. OTHER TERMS, CONDITIONS, AND PROVISIONS

PERFORMANCE WORK STATEMENT (PWS)

Title: Non-Human Primate (NHP) Breeding Colony Maintenance

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Veterinary Services Program (VSP)

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed

Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense.

Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host three Centers of Excellence for Military

Psychiatry and Neuroscience Research, Military Infectious Disease Research, and Enabling Capabilities Research;

each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

WRAIR is a leader in infectious disease research. A critical component to this research is the use of Specific Pathogen

Free Indian Origin (SPF IO) Rhesus Macaque nonhuman primates (NHP). It is difficult to obtain these NHPs in sufficient number and of sufficient age to meet WRAIR research objectives on the open market in a timely manner.

Due to this, WRAIR maintains a breeding and holding colony of approximately 320 SPF IO rhesus NHPs to meet the demand. VSP currently maintains oversight of this colony, but the daily operation of a primate colony of this size exceeds the capabilities of the WRAIR vivarium and its staff. The WRAIR requires a separate entity to house and maintain this colony year round to include 24-7 security, routine husbandry, routine and emergency veterinary care and breeding management to these NHPs.

The Contractor shall furnish all supplies, services and facilities necessary for animal husbandry and veterinary care, plus they shall be responsible for the routine care and breeding of the NHPs and general maintenance and sanitation of the facilities in such a manner as to maintain AAALAC, International accreditation. As such, the Contractor shall be accredited and maintain AAALAC accreditation throughout the performance of this contract.

3. SCOPE

The Contractor shall provide for the husbandry and health maintenance of a primate colony to hold and breed SPF IO rhesus macaques, NHP, owned by WRAIR and managed by the VSP. When required by the Government, the monkeys shall be quarantined, immunized, and transported as directed.

The base size of the colony is expected to be approximately 300 NHPs at the initiation of this contract, with a growth rate of at least 5% per year in base colony size. The colony size may expand or contract based on the needs of the

Government. The Contractor shall be able to accommodate a surge of up to 200 additional NHPs.

Based on current and projected research needs, the Contractor will be expected to provide a minimum of 40 research naïve (RN) 2.5-3 year old, >3.0 Kg SPF IO rhesus macaques per year. Breeding shall be conducted in multi-animal housing arrangements.

All NHPs housed under this contract will be provided by the Government and will remain the property of the

Government unless sold. At the conclusion of the contract performance, the Government will direct the disposition of the NHPs. Any approved costs incurred with regard to animal transportation and/or relocation (to include completion of diagnostics required for transport) following conclusion of the contract will be reimbursable by the

Government.

Work is to be performed at the Contractor’s facility. The Contractor bears the responsibility of scheduling personnel to satisfy the requirements set forth in the statement of work.

The Contractor will maintain a digital system of records to store, analyze and display data on all past and present

NHPs of the colony for the duration of the contract.

The Contractor shall provide services to purchase additional NHPs and services to sell Government-owned NHPs.

The Government anticipates the availability of $700,000 per year for the combined efforts of purchasing new NHPs and the services required to sell Government-owned NHPs. The contractor may propose a separate administrative fee for their services to sell Government-owned NHPs. Separate task orders shall be awarded for the purchase of new

NHPs and the sale of Government-owned NHPs. Any proceeds on the sale of Government-owned NHPs above costs to sell, transport NHPs, and contractor administrative fee, shall be credited back to the Government to cover costs (per diem, ODCs) on this contract.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period 1 September 2022 to 31 August 2023

Option period 1 1 September 2023 to 31 August 2024

Option period 2 1 September 2024 to 31 August 2025

Option period 3 1 September 2025 to 31 August 2026

Option period 4 1 September 2026 to 31 August 2027

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work location is the contractor’s facility. Presently, the incumbent contractor’s location is Alice, Texas.

The Contractor’s facility shall be located in the Continental United States (CONUS) in order to facilitate ease of transport and reduce importation requirements.

5.1.1. Telecommuting

Telecommuting is not feasible. The nature of these services requires in-person performance.

5.1.2. Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. When any disruption of normal, daily operations occur, the Contractor Task Manager shall promptly open an effective means of communication with the COR and verify:

Key points of contact (Government and Contractor)

Temporary work locations (alternate office spaces, telework, virtual offices, etc.), if applicable,

• Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

• Essential contract performance expected to continue production by priority.

The Contractor Task Manager, in coordination with the COR, shall make use of the resources and tools available to continue WRAIR contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

5.2. Federal Holidays

5.2.1. The contractor shall perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander.

5.2.2. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall be performed.

The following are Federal Holidays:

▪ New Year’s Day

▪ Birthday of Martin Luther King, Jr.

▪ Washington’s Birthday

▪ Memorial Day

▪ Independence Day

▪ Labor Day

▪ Columbus Day

▪ Veterans Day

▪ Thanksgiving Day

▪ Christmas Day

▪ Juneteenth

5.3. Work Schedule

The Contractor shall provide staffing necessary to provide support and care for NHPs 365 days/year, 24 hours/day, 7 days/week.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

The contractor shall provide, manage and operate a holding/housing and breeding colony of SPF IO rhesus macaques (NHPs) for duration of the contract. Purchasing and selling services shall be identified as an optional task as the Government requires. The base size of the colony is expected to be approximately 300 NHPs at the initiation of this contract.

6.2. Specific Tasks / Requirements

6.2.1. Contingency Operations (Deliverable 1)

The Contractor shall develop a Contingency Operations Plan. A draft Contingency Operations Plan shall be submitted with contract proposal. The plan shall document Contractor procedures to maintain WRAIR support during an emergency. This plan shall specifically address the risks inherent to the particular facility while also demonstrating the flexibility to address less likely scenarios. This plan should consider natural, national, and localized disaster related events requiring preplanning and execution; events concerning entities with intent to damage or disrupt colony operations; and at a minimum, description of how the

Contractor will account for their employees during an emergency; and planned temporary work locations or alternate facilities as applicable.

The Contingency Operations Plan shall include the following:

• A description of the Contractor’s emergency management procedures and policy.

• A description of how the Contractor will account for their employees during an emergency.

• Planned temporary work locations or alternate facilities.

• How the Contractor will communicate with WRAIR during emergencies

• A list of primary and alternate Contractor points of contact, each with primary and alternate:

- Telephone numbers, E-mail addresses

• Procedures for protecting Government furnished equipment (if any).

• Procedures for safeguarding sensitive and/or classified Government information (if applicable).

6.2.2. Task Management

The Contractor shall provide all services, including preparation for shipping animals as necessary, in accordance with DoD, federal, state, and local regulations and industry standards to include Public Health

Service policy, Animal Welfare Act and Regulations, and standards described in The Guide for the Care and

Use of Laboratory Animals, 8th edition. The Contractor will maintain AAALAC, International accreditation.

Additionally, the Contractor shall designate a single manager to oversee this task and supervise staff assigned to this task.

6.2.3. Transition and Shipping Services

Transition includes those services and the action that transfers responsibility of the animal colony and all associated administrative actions to include shipment of NHPs, diagnostics in preparation for transition, quarantine efforts and transfer of records. The incumbent Contractor shall coordinate shipment and transition with the gaining Contractor. Shipment will comply with all current federal, state and local requirements for the shipment of nonhuman primates.

Shipping includes those services and the action to ship a specified number of NHPs in support of research protocols or a movement of NHPs as required. Services shall include, but are not limited to, shipment of

NHPs, diagnostics in preparation for transition, quarantine efforts and transfer of all medical and breeding records.

6.2.3.1. Shipping Services

Cages shall be in accordance with the United States Department of Agriculture (USDA) and International

Air Transport Association (IATA) guidelines (if applicable). Each compartmentalized, properly ventilated, and escape-proof cage shall have separate water and feed containers for each compartment.

Each shipment of NHPs shall be held separately while under quarantine following local Standard

Operation Procedure (SOP). If possible, a representative for the Government will be available on site to inspect NHPs during receipt at final destination.

6.2.3.2. Animal Delivery

The Contractor shall provide biological samples for pre-screening of NHPs prior to shipment. Each shipment of NHPs shall be held separately while under quarantine for a minimum of 10 days before transportation unless waived by the Government. During quarantine, NHPs will be tuberculin tested twice, and receive a broad spectrum antihelminthic as agreed upon by COR and the Contractor. All

NHPs will have serology submitted for Herpes B virus, measles, Simian Retrovirus Type D (SRV), Simian T-cell Leukemia Virus (STLV), Simian Immunodeficiency Virus (SIV) within three (3) months of delivery. Only seronegative NHPs will be shipped to the Government, unless the COR otherwise approves.

6.2.3.3. Health Records(Deliverable 2)

All animal health records, current medical condition, diagnostic test results, breeding records, and colony history, to include digital and any paper records, will be transferred to the gaining Contractor prior to animal shipment. The COR will determine the time and site of delivery and coordinate the mechanisms of shipment with the Contractor. +

6.2.3.4. Animal Delivery Upon Transition

The Contractor shall establish procedures to ensure a smooth transition of all management and functional responsibilities identified in this PWS as coordinated with and approved by the COR. The gaining

Contractor shall ensure all responsibilities are transferred without any degradation in service. The

Contractor shall provide the expertise and the mechanisms of shipment in order to reduce losses of infant and pregnant animals.

6.2.4. Animal Husbandry and Veterinary Care Services

The Contractor shall provide qualified trained personnel to provide husbandry and veterinary care for the primates 7 days a week, 365 days a year. Personnel must have experience in the operation and management of a non-human primate breeding colony.

6.2.4.1. Animal Health Maintenance

The Contractor will provide on-site veterinary care to include, but not limited to, twice daily health observations, 24 hour emergency care, clinical pathology, diagnostic pathology, hospital care and surgical treatment of NHPs. The Contractor will make every effort to maintain a colony that is SPF for

Herpes B Virus, measles, Simian Retrovirus Type D (SRV), Simian Immunodeficiency Virus (SIV) and

Simian T-cell Leukemia Virus (STLV).

Contractor will provide NHPs with treatment against endoparasites and ectoparasites in accordance with current accepted standards of veterinary care and using a product approved by COR. All primates dying unexpectedly must receive an examination and necropsy to determine the cause of death. NHPs shall be vaccinated against measles, rabies, or tetanus at the discretion of the Government.

The contractor will test all NHPs for Herpes B virus, measles, Simian Retrovirus Type D (SRV), Simian

T-cell Leukemia Virus (STLV), and Simian Immunodeficiency Virus (SIV) by serology and/or polymerase chain reaction (PCR) as appropriate. These tests will be done annually on all NHPs greater than 12 months of age. NHP’s will be tuberculin tested every 6 months. The cost for these colony diagnostics will be included in the daily per diem charge for the NHPs and not billed separately. The

Government may change the testing frequency as necessary.

6.2.4.2. Animal Breeding (Deliverable 3)

The Contractor is expected to provide at least 40 research naïve (RN) 2.5-3 year old, >3.0 Kg SPF IO rhesus macaques per year, with a 5% growth rate in base colony size per year. The maximum size of the base colony will be 375 NHPs. Table 1 demonstrates the WRAIR’s recent colony production rates employing a breeding method of out-door, gang-caged harems consisting of one male and up to 8 females. Based on historical production rates, our current needs and current literature (see Table –1-4 below), the Contractor shall provide an initial Animal Breeding Plan Report with proposal submission detailing its plan to achieve the required numbers of NHPs and then subsequent Animal Breeding Plan reports detailing the status and discussing progress made and/or possible causes of the lack of progress along with recommended courses of action. The plan shall include ways to improve breeding efficiency to the following objectives: a production rate (defined as the # of young weaned/ # documented pregnancies) of ≥70%, an infant loss rate ≤8%, and an adult mortality rate ≤ 4%. A reasonable rate of progress towards improving breeding efficiency is an increase of 5-7% per year. If

Contractor does not make reasonable strides towards reaching a 70% production rate, or if infant loss rate/adult mortality rate rises or exceeds the contract standard, the Contractor shall promptly notify

COR. Any changes in husbandry and/or breeding practices must be approved by COR prior to implementation.

6.2.5. Data Management

Contractor will maintain a digital system of records to store, analyze and display data on all past and present NHPs of the colony for the duration of the contract. The Contractor shall file and maintain vendor animal health reports, keeping information available for all current research protocols. The animal record shall reflect at a minimum:

▪ Individual Identification number

▪ Sire’s and Dam’s Individual Identification Numbers if known

▪ Birthdate

▪ Gender

▪ Offspring, when applicable, to include stillbirths:

a. by Individual Identification Number;

b. gender;

c. date of birth;

d. birth weight;

e. hospitalizations and cause;

f. date of death;

g. sire’s Individual Identification Number

▪ Health Status (e.g. herpes +, SIV +, in hospital)

▪ Hospitalizations and cause

▪ Specific location within facility

▪ Disposition, when applicable, to include date and cause

▪ Behavior related incidents including self-injurious behavior (SIB), aggression, and alopecia

6.2.6. Personnel Training (Deliverable 4)

The Contractor shall provide personnel trained in a manner that is consistent with AAALACi standards.

The Contractor shall maintain a documented training program for its personnel. Evidence of training program and employee documentation of training shall be made available upon Government request. Some general categories of training shall include, but are not limited to, humane care and ethical use of NHPs, animal care and veterinary medicine, animal husbandry techniques, animal handling and restraint, operation of service equipment, and safety.

6.2.7. Facilities

The Contractor shall provide secure, licensed and accredited CONUS NHP facilities which are certified and maintained in accordance with DoD, federal, state, and local regulations and industry standards to include

AAALACi, USDA, PHS policy, Animal Welfare Act and standards described in The Guide for the Care and Use of Laboratory Animals, (currently the 8th edition). The facility must maintain its AALACi accreditation and USDA licensure status for the duration of the contract. The facilities and equipment shall be of sufficient size, strength, safety, durability and ability to be sanitized to house NHPs while providing a psychologically enriching environment to the NHPs. Facilities and equipment shall be maintained in accordance with industry standards. The Contractor shall verify the efficacy of the sanitation and disinfection activities, the feed, bedding, water quality and environmental monitoring, treatment regimes, breeding practices and any other procedure which is suspected to impact colony health in order to ensure that NHPs remain healthy and pathogen free and subclinical disease agents are identified.

6.2.8. Visitation Program Policy (Deliverable 5)

Contractor shall establish and maintain a written health certification program and policy concerning all

COR approved visitors, staff, and guest investigators working at or visiting the breeding colony, and maintain updated records on all such individuals. Visitors shall wear dedicated shoes and clothing, as provided by the Contractor, while on the premises. Contractor shall maintain a registry of all visitors to the colony. The registry shall contain the visitor’s name, dates and time of visit and business address. The

Contractor shall provide the register to the COR. This program shall be in effect for the duration of the contract. Enforcement and maintenance of the health certification policy for visitors and staff is the responsibility of the Contractor.

6.2.9. Security

The Contractor shall provide adequate and appropriate physical, cyber and informational security to protect the facility, its NHPs, its employees and its information from entities with intent to damage or disrupt colony operations.

6.2.10. Animal Acquisition (Purchase) and Disposition (Sale) -Optional Task

Upon Government request, the Contractor shall purchase additional NHPs of various species or facilitate the sale of NHPs from the Government-owned colony. An amount up to $700,000 per year may be provided for the purchase of new NHPs to the colony on a separately issued task order for purchase.

Additional costs due to specific research requirements would be included in the purchase price of the animal. The Contractor shall provide the Government an option to sell excess NHPs from both the

Contractor maintained colony and the WRAIR in-house colony. The COR will identify any excess NHPs eligible for sale following fulfillment of research and breeding needs. The Government must approve the purchaser following review of requested documentation described below. The Contractor will receive a portion of total receipts following the sale. The portion of sales provided to the Contractor will be based on current market purchasing fees and mutually agreed upon by both the Government and Contractor. The

Government will also have the option to apply/offset its portion of receipts toward the cost of the husbandry/maintenance contract.

6.2.11. Animal Source Information

The Contractor will provide supplier information to COR if requested prior to animal purchase. This information may include but is not limited to: copy of any licensing (USDA) and or accreditation status

(AAALACi) documentation, description of animal housing and husbandry to include veterinary care, animal health records.

6.2.12. Report of Interested Buyers

Once potential buyers are identified, Contractor shall provide COR with buyer information to include but not limited to: accreditation status, licensing (USDA), animal housing, and proposed use of animal.

Contractor shall also include a quote detailing a breakdown of all costs associated with the sale to include any shipping costs and diagnostics charges. The Government retains the right to have final authority for sale of any identified NHPs.

6.2.13. Transition Out Plan – Optional Task- Requirements described in 9.2 Transition Out.

6.3. Management Reports and Plans

6.3.1. Monthly Activities Report (Deliverable 6)

The Contractor shall provide a Monthly Activities Report describing the progress of the animal husbandry/maintenance program to date, noting all technical areas in which effort is being directed and indicating the status of work within these areas will be furnished to the COR for review and acceptance.

The COR shall review each monthly activities report to ensure the Contractor is making adequate forward movement toward achieving the stated objectives of the proposal.

6.3.2. Monthly Colony Census Report (Deliverable 7)

Contractor shall provide the colony census report on a monthly basis or upon Government’s request. The

Contractor shall conduct a Monthly Colony Census to obtain and verify basic demographic data. The system of records shall be updated monthly to reflect the results of the respective census.

6.3.3. Reproductive Cull Report (Deliverable 8)

Contractor shall provide a reproductive cull report identifying NHPs not suitable for breeding to the COR on an annual basis or upon Government’s request.

6.3.4. Miscellaneous Data Reports (Deliverable 9)

Miscellaneous reports covering colony maintenance, husbandry data, health status, protocol use, or contract administrative reports, not otherwise addressed, may be requested by the Government and must be provided within 20 days. It is expected that no more than 3 miscellaneous reports per quarter will be requested.

6.3.5. Market Value Report (Deliverable 10)

The Contractor shall provide a report detailing market value for IO rhesus macaques, Chinese origin rhesus macaques and cynomolgus macaques. The COR will review this report and utilize information provided in the event NHPs need to be purchased.

6.3.6. Sale Documentation (Deliverable 11)

Following approval of sale by COR, Contractor shall provide a copy of all final sale documentation, transfer of ownership documentation, and confirm final shipment and receipt of NHPs.

6.3.7. Monthly Financial Tracking Report (Deliverable 12).

The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN). The initial report is due 45 days after contract award and monthly thereafter.

6.3.8. Quality Control Plan (Deliverable 13).

The contractor shall provide a draft Quality Control Plan (QCP) no later than (NLT) 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

6.3.9. Service Contract Reporting Application (SCRA) (Deliverable 14).

See FAR 52.204-14 for instructions.

6.3.10. Contractor Performance Assessment Reporting System (CPARS). (Deliverable 15)

A CPAR assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Performance evaluations are transmitted into the Past Performance Information

Retrieval System (PPIRS) which is used by government agencies to assess contractor past performance for future acquisitions.

The contractor shall appoint a Contractor Representative (CR) and provide this information to the

Contracting Officer (KO) within 10 calendar days of award. The contractor POC shall have the authority to comment on the CPAR assessment on behalf of their company and within the timeframes established. A

CPARS assessment must be completed within 120 calendar days after the evaluation. Evaluations are sent to PPIRS within 14 calendar days after the government Assessing Official (AO) has submitted the rating. If the CR has not concurred/non- concurred with the rating, PPIRS will show the government evaluation as

"Contractor Comment Pending Review". The CR has a total of 60 calendar days to concur/non- concur with the assessment. After 60 days, the CR can either concur/non-concur. The CR has the authority to:

access the Government evaluation; review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the government's assessment. The CR has the right to request a meeting

(in writing) with the government within 7 calendar days of notification of an assessment. Once the government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for

Source Selection. If the CR fails to respond within 60 days, the assessment will be finalized. Training for

CPARS can be found on the CPARS website: https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS

Ref.

Number Title/Description Due

6.2.1. Deliverable 1

Contingency Operations

The Contractor shall develop a Contingency Operations Plan With Proposal

6.2.3.3 Deliverable 2

All animal health records, current medical condition, diagnostic test results, breeding records, and colony history, to include digital and any paper records, will be transferred to the gaining Contractor prior to animal shipment.

With all shipments of

NHPs to the government or a gaining contractor

6.2.4.2. Deliverable 3

Animal Breeding

The contractor shall provide Animal Breeding Plan reports

Initial: Draft With proposal;

Final due 30 days after contract award (DACA)

Updated monthly

6.2.6. Deliverable 4

Personnel Training

The contractor shall provide evidence of training program and employee documentation of training

Upon request

6.2.8. Deliverable 5

Visitation Program Policy

The Contractor shall provide the register of visitors to the

COR

Upon request

6.3.1. Deliverable 6

Monthly Activities Report

The Contractor shall provide a Monthly Activities Report describing the progress of the animal husbandry/maintenance

30 DACA and Monthly thereafter

6.3.2. Deliverable 7

Monthly Colony Census Report

Contractor shall provide the colony census report

30 DACA and Monthly thereafter

6.3.3. Deliverable 8

Reproductive Cull Report

Contractor shall provide a reproductive cull report identifying

NHPs not suitable for breeding to the COR

30 days prior to the end of each option period and upon Government request

6.3.4. Deliverable 9

Miscellaneous Data Reports

Miscellaneous reports covering colony maintenance, husbandry data, health status, protocol use, or contract administrative reports not otherwise addressed

At COR request and not to exceed 3 per month https://www.cpars.gov/index.htm

6.3.5. Deliverable 10

Market Value Report

The Contractor shall provide a report detailing market value for

IO rhesus macaques, Chinese origin rhesus macaques and cynomolgus macaques.

Annually upon request

6.3.6. Deliverable 11

Sale Documentation

Following approval of sale by COR, Contractor shall provide a copy of all final sale documentation transfer of ownership documentation, and confirm final shipment and receipt of

NHPs.

15 days post transfer of ownership

6.3.7. Deliverable 12

Monthly Financial Progress Report

The Contractor shall ensure that a MPR is submitted outlining the financial expenditures, billings, progress, status, and any problems/risks or issues encountered in the performance of this task.

45 days after contract award and monthly thereafter

6.3.8. Deliverable 13

Quality Control Plan

The Contractor shall develop a Quality Control Plan that shall document how the Contractor will meet and comply with the quality standards established in this Performance Work

Statement (PWS).

Final due 30 DACA and updated quarterly

6.3.9. Deliverable 14

Service Contract Reporting Application

The contractor shall complete and deliver the SCRA.

By October 31 or on the last day of contract performance – whichever is first.

6.3.10 Deliverable 15

Contractor Performance Assessment Reporting System

(CPARS)

60 calendar days after

Government evaluation

9.1 Deliverable 16

Transition-In Plan

The contractor shall provide a Transition-In Plan

90 days prior to contract start

9.2 Deliverable 17

Transition-Out Plan

The contractor shall provide a Transition-Out Plan

NLT 120 days prior to POP end

9.2.m Deliverable 18 Summarized Final Report To be submitted along with

Transition-Out Plan

7.1. Technical Reports and Documents

The Government shall own all recorded information and/or data, regardless of the form or method of the recording that is created, produced, or developed pursuant to the performance of this contract by the Contractor and/or its employees. The Contractor may not use or disclose Government owned information or data without the written permission of the Contracting Officer, except as otherwise authorized by the terms of this contract. All Government owned information and/or data shall be returned to the Government at the conclusion of the contract unless the

Contracting Officer grants specific exception. Notwithstanding the foregoing, and pursuant to DFARS 252.227-

7013 (b) (4), the Contractor agrees that any and all technical data (as defined in DFARS 252.227-7013 (a) (15)) created, produced, or developed under this contract), will be the property of the United States Government. Neither the Contractor nor its personnel shall have an ownership interest in the technical data herein described.

7.2. Inspection and Acceptance

7.2.1. Delivery Address

All deliverables shall be submitted to the COR designated in the COR appointment letter.

Reports shall be created using Microsoft Office suite of tools (i.e. MS WORD, MS EXCEL, MS

POWERPOINT, MS PROJECT, or MS ACCESS format), unless otherwise specified by the COR.

Electronic submission shall be made via email, unless otherwise agreed to by the COR.

7.2.2. Deliverables Shipping

The Contractor shall use the U.S. Postal Service standard delivery for delivery of materials, equipment, or required hardcopy documents. The COR must approve all exceptions to this requirement.

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

The COR will have ten (10) workdays to review deliverables and make comments. The Contractor shall have five (5) workdays to make corrections. Upon receipt of the final deliverables, the COR will have two

(2) workdays for final review prior to acceptance or providing documented reasons for non-acceptance.

Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) work days the Government notifies the

Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The

Contractor shall have five (5) workdays to correct the rejected deliverable and return it per delivery instructions.

7.3. COR Information- To be determined upon award.

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance

Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary Matrix

# PWS Ref. Performance Objective Performance Measurement

Acceptable

Quality

Level

Method of Surveillance Incentive

1 6.2.1.

The Contractor shall develop a

Contingency Operations Plan.

A draft Contingency Operations

Plan shall be submitted with contract proposal.

Proper adherence to animal husbandry rules, regulations, and laws

Meets: 97%

Direct observation and random sampling.

Frequency: Submitted with proposal and as determined by the COR

Annotation to contractor’s past performance.

2 6.2.4.2.

The Contractor is expected to provide at least 40 research naïve (RN) 2.5-3 year old, >3.0

Kg SPF IO rhesus macaques per year.

Animal Breeding Plan Report detailing its plan to achieve the required numbers of

NHPs and then subsequent

Animal Breeding Plan reports detailing the status

Direct observation

Frequency: Submitted with proposal and as determined by the COR

Annotation to contractor’s past performance.

3 6.2.6.

The Contractor shall provide personnel trained in a manner that is consistent with

AAALACi standards.

Maintain a documented training program for its personnel

Frequency: as need by COR

Past Performance

4 6.2.8.

Contractor shall establish and maintain a written health certification program and policy concerning all COR approved visitors, staff, and guest investigators working at or visiting the breeding colony, and maintain updated records on all such individuals.

Maintain a registry of all visitors to the colony. The registry shall contain the visitor’s name, dates and time of visit and business address.

The Contractor shall provide the register to the COR.

Frequency: Monthly or as need by COR

Past Performance

9. TRANSITION SUPPORT

9.1. Incoming Transition Plan

The gaining Contractor shall develop an incoming transition plan (Deliverable 16) for 60 days of incoming transition for transitioning work from active award to a follow-on contract/order or Government entity. The incoming transition plan shall be delivered no later than 90 days prior to contract start.

9.2. Outgoing Transition Plan

The Contractor shall develop and deliver an outgoing transition plan (Deliverable 17) for 90 days of outgoing transition for transitioning work from an active award to a follow-on contract/order or Government entity. The transition out plan shall be delivered no later than 120 days prior to contract completion. This transition may be to a Government entity, another Contractor or to the incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required documents, metrics and statistics. The transition out plan shall outline all aspects of successful transition to include animal quarantine, diagnostic testing, animal transportation and delivery, and necessary administrative tasks. A Cull Report identifying NHPs that may not be suitable for transport due to illness, age, etc., must be provided to the Contracting Officer Representative (COR) prior to final transport. This transition plan shall include, but is not limited to:

a. Coordination with Government representatives,

b. Review, evaluation and transition of current support services,

c. Transition of historic data to new Contractor system,

d. Government-approved training and certification process,

e. Transfer of hardware warranties and software licenses (if applicable),

f. Transfer of all necessary business and/or technical documentation,

g. Transfer of compiled and un-compiled source code, to include all versions, maintenance updates and patches (if applicable),

h. Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes,

i. Disposition of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.,

j. Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and

GFE inventory management assistance.

k. Applicable WRAIR debriefing and personnel out-processing procedures.

l. Turn-in of all government keys, ID/access cards, and security codes.

m. Summarized final report

10. KEY PERSONNEL

a. Solicitation Requirement:

(1) The Government has identified the following positions to be filled by Key Personnel. The offeror may propose alternate and/or additional positions as Key personnel.

Position Title: _ Veterinarian _________________________________________________

(Government Fill-In)

(2) For all Key Personnel positions, provide an attachment naming the individuals proposed to fill Key

Personnel positions along with a description of the portion of the solicitation’s Performance Work Statement that each individual is being proposed to perform.

(3) A resume is required for all individuals proposed to fill Key Personnel positions. Do not submit resumes for all labor proposed, only for those Key Personnel identified above. A signed a letter of intent is required for those individuals proposed as Key Personnel who are not current employees of the prime contractor responding to this requirement. This includes letters of intent for key personnel proposed by subcontractors, teaming partners and consultants. A letter of intent is not required for individuals proposed as key personnel who are current employees of the prime contractor.

(4) The resumes must provide thorough and detailed documentation of the experience, abilities, and background for proposed Key Personnel or equivalent statements of qualifications. Such documentation shall include but not be limited to: name, curriculum vitae, type and description of experience.

b. Contract Requirement:

(1) The following positions have been identified to be filled by Key Personnel proposed for this award.

Position Title: __ Veterinarian _______________________________

(2) The approved Personnel identified to fill the Key Personnel positions shall be utilized as necessary to fulfill the requirements of this contract.

(3) The contractor agrees that during the contract performance period substitution for Key Personnel shall not be permitted unless such substitution is necessitated by sudden illness, death, or change in employment conditions

(e.g. termination, change in position, etc.). In any of these events, the contractor shall promptly notify the KO in writing and provide the information required by paragraph 4 below.

(4) All requests for substitutions must provide a detailed explanation of the circumstances necessitating the proposed substitution(s), a complete resume for the proposed substitute(s), and any other information requested by the KO needed to approve or disapprove the proposed substitution(s). Any proposed substitute or replacement key personnel shall have qualifications comparable to the individual being replaced, taking into account the requirements of the PWS. The KO or his authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.

(5) If any of the listed Key Personnel are subcontractor personnel, the contractor shall flow down the substance of this instruction in any subcontract which is awarded in support of this contract.

(End of Requirement)

KEY PERSONNEL TABLE

Key Personnel Position Minimum Requirements

Veterinarian a) Education: DVM, or equivalent doctoral degree, obtained from a college accredited with AVMA.

b) Experience: Must have experience providing medical care and breeding management for nonhuman primates, specifically

Rhesus macaques.

c) Certifications: Licensed to practice veterinary medicine in at least one state of the USA.

d) Specialized Training: N/A

e) Regulation: 9 CFR Animal Welfare Regulations state the definition of an attending veterinarian is “person who has graduated from a veterinary school accredited by the

American Veterinary Medical Association’s Council on

Education, or has a certificate issued by the American

Veterinary Medical Association’s Education Commission for

Foreign Veterinary Graduates, or has received equivalent formal education as determined by the Administrator; has received training and/or experience in the care and management of the species being attended; and who has direct or delegated authority for activities involving animals at a facility subject to the jurisdiction of the Secretary.”

11. TRAVEL/TEMPORARY DUTY (TDY) – Not applicable

12. GOVERNMENT FURNISHED PROPERTY – Not applicable

13. CONTRACT MANAGEMENT

13.1. Government Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer

(KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

13.2. Contractor Management

The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact

(POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

13.3. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

13.4. Contractor Vacant Positions

The contractor shall fill vacant key personnel positions within thirty (30) business days. If key personnel are vacant for more than thirty (30) days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

13.5. Subcontract management

13.5.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

13.5.2. The contractor is responsible and accountable for subcontractor performance on this contract.

13.5.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations.

13.5.4. Contractor may add subcontractors to their team after notification and written approval from the

KO.

13.5.5. Privy of contract is with the contractor and the subcontractor.

13.6. Foreign Nationals

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. A background investigation must be completed in its entirety before unescorted access to a Government facility is granted. Government computer access will not be approved until a background check is done in accordance with para 18.9. Typically, a background check cannot be performed on a foreign national unless the individual has lived in the United States for three (3) of the last five (5) years.

13.7. Other Direct Cost

All ODCs exceeding $3,000 requires that the Contractor conduct appropriate competition. The Wide Area

Workflow – Receipt and Acceptance application is the required method of submission for payment request.

The ODCs shall be billed on a cost reimbursable basis. Costs are defined as the purchase price of materials or service plus general and Administrative charges (G&A) or material and handling charges (M&H). All ODCs shall be fully supported in compliance with all competition requirements of the FAR PART 19. All ODCs shall be reported as stated in the Monthly Financial Progress Report Section 2.1.1.

ODCs may be attributable to a surge requirement of additional NHPs. Estimated additional ODCs are as follows:

Crating material not to exceed $47,000 annually.

Shipping Mileage or flat rate – annual estimate - $43,000

14. COMPLIANCE DOCUMENTS

14.1. General Compliance

14.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Development Command

(USAMRDC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The

International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://MRDC.amedd.army.mil/rodorphrpo.asp.

14.1.1.1. Occupational Safety and Health Administration- Not applicable

14.1.1.2. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program.

http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

c) Title 21 CFR Part 54 Financial Disclosure by Clinical Investigators https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

d) Dangerous Goods Regulations of the International Air Transport Association.

http://www.iata.org/Pages/default.aspx

14.2. Human Research Protections – Not applicable

14.3. Research Involving Animals – Not applicable

14.4. Information Technology Compliance – Not applicable

14.5. Cybersecurity…