SOW_122121.pdf

Statement of Work_75F40122R00007

1. Background: The Food and Drug Administration (FDA) is the United States Government regulatory agency responsible for the safety of foods, cosmetics, drugs, biological products, medical devices and radiological products.

The FDA Centers at White Oak protect and promote public health by the regulation and oversight of pharmaceutical products, supplements, biologic products, and medical devices, including devices that emit electromagnetic radiation. The Center for Biologics Evaluation and Research (CBER)’s mission includes the regulation of biological products for human use such as vaccines, blood-derived and tissue-derived products, including xenografts, allergenic extracts, and cellular/gene therapy products. CBER conducts animal studies to support regulatory review and understanding of these diverse and innovative products, their safety, effectiveness, and potency. A number of mandated safety and potency tests of biological products are performed on laboratory animals, if suitable validated alternatives are not available. The Center for Drug Evaluation and Research (CDER)’s mission includes helping ensure that human drugs are safe and effective for their intended use and that these products meet established quality standards. Animal studies in CDER are focused on improving scientific standards for the composition, quality, safety and effectiveness of human drugs and protein therapeutic products. The Center for Devices and Radiological Health (CDRH)’s mission includes providing the public with understandable science-based information about the products they oversee. CDRH animal studies often focus on the stability and reliability of implanted devices and product materials. Current use of laboratory animals and development of new animal models support regulatory review and understanding of diverse medical products, as well as provide guidance to the regulated industry. These Centers maintain a consolidated on-site animal research program in support of these regulatory activities.

Animal based research performed by CBER, CDER, and CDRH is managed by the CBER Division of Veterinary Services and is conducted at Building 10 (52/72) Vivarium of the Federal Research Center, 10903 off New Hampshire Avenue in Silver Spring MD 20993. CBER, CDER, and CDRH house laboratory animals, primarily mice, rats, hamsters, guinea pigs, rabbits, ferrets, voles, gerbils, swine non-human primates, and frogs in an environmentally controlled animal vivarium that utilizes a single corridor system. Entrance into the vivarium, support spaces and animal rooms are controlled by a government issued personal identity verification card (PIV) through an electronic monitoring system. . The Vivarium may have between 50-57 active animal rooms at one time, some requiring BSL2 practices. In addition, the animal program also manages eight laboratory animal biosafety level three (ABSL-3) room suites capable of housing primarily rodents and ferrets in a controlled environment on the fifth floor of Buildings 52/72. The FDA centers (CBER/CDER and CDRH) has a requirement for animal husbandry services and vivarium management for a base year with 4 (1-year Option periods).

2. Objective: The purpose of this contract is to provide animal husbandry services and vivarium management including but not limited to:

• Sanitizing and sterilization of animal cages and associated equipment, animal receiving, animal transport, providing feed, water, and bedding, animal cage transfers, maintaining a clean environment, observing animals for general health and well-being, record keeping, providing health checks and study animal monitoring, providing post approval monitoring of new and ongoing studies and Animal Care and Use Committee support, skilled highly technical support to include training, minor surgery, anesthesia, sample collection, imaging, and breeding management, and other technical support tasks, as well as carrying out macro/micro environmental parameter checks and quality assurance in all animal housing, support, and storage areas of the facilities.

• Management of on and off-site storage areas and inventory.

• Development, revision, and monitoring of Standard Operating Procedures (SOPs).

• Ancillary tasks necessary to accomplish these services are included (e.g., quality control, occupational safety and health, inventory control, equipment maintenance, and a comprehensive staff training program).

3.0 SCOPE OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, and otherwise do all things necessary for or incident to the performance of the work as described below. These services at a minimum shall comply with regulations and guidelines contained in the following documents to ensure the successful accomplishments of the FDA mission:

• Animal Welfare Act as Amended (7 USC, 2131-2159).

• Animal Welfare Act Regulations (Code of Federal Regulations, Title 9, Chapter 1, Subchapter A - Animal Welfare).

• Guide for the Care and Use of Laboratory Animals, Eighth Edition, Institute of Laboratory Animal Resources (ILAR), Division of Earth and Life Sciences, National Research Council, 2011.

• Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, National Institutes of Health, 2015.

• American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, 2020.

• Occupational Safety and Health Administration Regulations (Standards – 29 CFR) including the Hazard Communication Standard (OSHA Standards, 29 CFR 1910.1200) and the Occupational Exposure to Hazardous Chemicals in Laboratories (29

CFR 1910.1450).

• Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH, 2020)

• Biological Safety Level-2 (BSL-2) Manual and Biological Safety Level-3 (BSL-3) Manual. Available upon request.

3.1. GENERAL

The approximate number of animals under study at the CBER/CDER/CDRH White Oak Animal Program has an average weekly census of up to 60,000 mice and rats, 500 guinea pigs, 500 hamsters, 500 other rodents (gerbils, voles), 120 rabbits, 50 ferrets, 80 frogs, 100 nonhuman primates and up to 4 minipigs.

The Contractor shall also provide technical services in support of approved protocols for animal studies associated with, but not limited to the use of aquatics (frogs), non-human primates, swine, rats, mice, rabbits, ferrets, and other species of small laboratory animals. Experimental procedures include but are not limited to administration of substances by subcutaneous, intramuscular, intravenous, or intraperitoneal injections, gavage, genotyping, necropsy and collection of tissues, blood collection, urine/fecal sampling, nasal washes, anesthesia administration and monitoring, surgical preparation and recovery, and management of breeding rodents, immunodeficient, humanized and gnotobiotic mice. Specialized technical support includes animal husbandry, care, and observations of BSL2 and BSL3 animals. Contractor shall provide experienced technical assistant for various imaging equipment such as MRI. Digital X-Ray, IVIS optical imaging, micro-CT, sonogram, and dual viewing port surgical microscope with camera.

The FDA White Oak BSL-3 facility is constructed and maintained in a manner to protect the environment and the public at large. The BSL-3 containment laboratory is designed and provided for work with Risk Group 3 microorganisms and with Risk Group 2 microorganisms where work involves production quantities or high concentrations of cultures and for activities with a high potential for aerosol production. The policies and procedures for the BSL-3 lab are in accordance with those of the United States Department of Agriculture Animal and Plant Health Services (USDA APHIS), the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and outlined in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition.

Animals (mice, rats, ferrets, hamsters, and guinea pigs) are housed in up to eight (8) animal holding rooms within the set of Animal Biosafety Level 3 (ABSL-3) suites. The requirements for safe practices, procedures, training, and medical surveillance of personnel who access these areas, as described above, hold true for the ABSL-3 holding rooms. Appropriate security clearance for working with Select Agents (avian influenza) will be obtained and maintained.

3.1.1. Hours of Operation.

Working core hours for contractor operations at White Oak shall be 7:00 AM to 4:00 PM Monday through Friday, Eastern Time.

Continuous service shall be provided during the core hours that shall be based on a normal 9-hour workday for each contract employee, which includes 1.0 hours for lunch. A Supervisor will be on site for all core hours, including weekends and holiday hours, or as arranged with the Animal Program Manager (APM) and/or COR. The Government reserves the right to impose a penalty for excessive turnover of the Contractor’s workforce due to the cost and time necessary to train new Contractor staff.

During weekends and holidays, the contractor will provide essential animal husbandry services and non-interrupted animal protocol support (e.g., including but not limited to feeding, watering, veterinary treatments, environmental parameter checks, daily observations, scheduled cage changed, and cagewash operations.) The contractor should provide approx. 4-6 hours, between the hours 6:00a-2:00p, depending on the services required.

In addition, a sum of hours will be made available for non-workday provision of technical assistance for studies for the WOAP each contract year. Program will provide the contractor, at least 2 weeks prior notice, or as early as possible, if technical assistance is requested outside of core hours. Contractor staff shall be flexible in their core work hours to allow for emergency responses and increased surge capability as may be needed. Alternate work schedules may be proposed in special circumstances such as when pandemic rates may rise. All proposals must be approved by the COR.

The contractor shall propose the most cost-effective means for providing weekend and holiday support to include staggered or alternative work schedules, and occasional overtime. If the proposed plan requires overtime for non-exempt staff, the contractor shall propose a plan that includes the proposed hours and overtime pay for hours worked over 40 in a workweek at a rate not less than time and one-half their regular rates of pay. Any overtime need and use, shall be reviewed by the COR. If there is an occurrence for this, the overtime cannot take place without prior written approval by the COR and/or CO.

In the event Government employees are granted administrative leave due to an FDA or executive order, on-site Contractor personnel may also be dismissed depending on the immediate needs for services. However, if staff is dismissed for any given reason, the Contractor shall continue to provide sufficient personnel that would allow for them to perform essential animal husbandry services and/or complete critical efforts already in progress or scheduled. For instance, all animals must be observed daily for health problems by the contracting staff, 365 days a year. In such situations, the Contractor shall be guided by the instructions issued by the Contracting Officer or her/his duly appointed representative.

The Contractor’s management personnel shall be on-site and available during core hours. If not on site, they or a qualified designee shall be available by telephone within 30 minutes for any emergency, which may arise in the animal facility. In addition, the contractor shall provide contract management with designated cell phones to permit telephone access during emergencies that occur during non-core hours. If there is an emergency, the Contracting Officer’s Representative or Technical Point of Contract will notify the Project Manager verbally followed within 24 hours with a written authorization to cover additional work requirements.

OBSERVANCE OF FEDERAL HOLIDAYS & OTHER GOVERNMENT CLOSINGS:

The Contractor shall provide essential services on the on the Federal legal holidays as shown below unless specifically requested by the Contracting Officer.

New Year’s Day January 1st Martin Luther King Day Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Juneteenth National Independence June 18th Day Independence Day July 4th Labor Day First Monday in Sept.

Columbus Day Second Monday in Oct.

Veteran’s Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25 Presidential Inauguration Day (When applicable)

3.1.2. Key Control. The Contractor shall insure that keys and/or electronic access cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. Keys issued to the Contractor by the Government shall be duplicated only by designated Government personnel. The Government will provide identification badges and electronic access cards to be used by all Contractor personnel.

The Contractor shall immediately report the occurrence of a lost key or electronic access card to the Contracting Officer’s Representative(s). Contract employees shall not grant access to any work areas to persons other than Contract employees engaged in the performance of assigned work on this contract.

3.1.3. Standard Operating Procedures. Animal husbandry and technical support services shall be performed utilizing approved Standard Operating Procedures (SOPs). It is the expectation of the government that care procedures and provision of enrichment be standardized so that different individuals are delivering care in a standardized way. The Contractor will be responsible for establishing and maintaining SOPs specific to each Task Order under this contract are required. SOPs will be provided to the Contractor upon award of the contract and enforced by the contractor's project management and the Government to ensure that procedures are conducted to maintain the appropriate animal welfare and facility conditions. If requested the Contractor shall write new SOPs and shall revise existing SOPs on an as needed basis. The Contracting Officer’s Representative will communicate the need for new or modifications to SOPs to the Contractor. New or revised SOPs shall be delivered to the Contracting Officer’s Representative(s) within 15 calendar days of the Representative communication. All SOPs will be approved by the Program's Contracting Officer’s Representative and reviewed, when appropriate, by the Program's Institutional Animal Care and Use Committee (IACUC). All SOPs become property of the Government.

3.1.4. Occupational Health and Safety Plan. The Contractor shall be responsible for the health and safety program for their employees and assure of its enforcement and compliance to meet requirements of the FDA Safety offices. A Final Draft Animal Exposure Safety Plan shall be provided 15 calendar days after award of the contract. This final draft should be in accordance with OLS directives regarding contractor AEP requirements (See Appendix B). The FDA will review the Final Draft Safety Plan within 15 calendar days of receipt. The Contractor shall submit a revised Final Safety Plan to the Contracting Officer 15 days after receipt of the Government’s review.

After award the Contractor shall make any necessary changes and meet the Contracting Officer or his/her designated representatives to discuss and develop a mutual understanding relative to the administration of each facility’s overall safety program. The Contractor shall perform all services and/or work in accordance with Federal, state, and local regulations including Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA), and Maryland regulations as well as FDA/Center specific safety policies, procedures, and guidelines.

The Contractor shall conduct an initial investigation of each animal care facility/site and risk assessment for each position type prior to commencement of the work in order to determine what safety equipment, personal protective equipment, and/or other safety-related measures are required for the performance of each task order. Further, the Contractor shall re-assess such needs quarterly throughout the duration and performance of each task order and submit a quarterly inspection report. Oversight by the Government includes but is not limited to the imposition of minimal safety standards; requirements that personal protective equipment be worn; review of standard operating procedures; and/or such additional safety measures as the Contracting Officer’s Representative may determine to be reasonably necessary.

Review and approval of the contractor’s proposed safety program by the Contracting Officer and/or his/her designated representative is not intended as, and shall not be construed as, any assumption of responsibility or liability by the government for the health or safety of the contractor’s employees.

The Contractor is liable for death, bodily injury, or property damage caused by violation of applicable laws, regulation, SOP’s, or other rules or safety precautions caused in whole or in part by the Contractor or its employees’ negligent or willful acts or omissions committed in the performance of this contract.

The government reserves the right to conduct unannounced safety inspections at any time.

For safety reasons, all personnel shall be able to read, understand and communicate in English.

The government reserves the right to investigate accidents involving contractor personnel. The contractor shall immediately report and document to the Contracting Officer’s Representative(s) any bodily injury or death in the performance of official duties, damaged government property estimated to be in excess of $100, all incidents involving animals, or loss of government property resulting from the activities of the contractor, its agents, or its employees.

The Contractor shall identify and purchase the necessary safety items according to each Task order, unless it has been provided by the government (i.e., rubber boots, safety shoes, non-disposable respirators, non-disposable ear protection and safety glasses/goggles and PAPR’s) as the Contractor and WO Safety deems adequate and necessary to assure the safety of its employees performing a task considered a safety hazard. It is the sole responsibility of the Contractor to ensure all training for its employees as mandated in current Center Safety Offices, Federal, state, and local regulations. The Contractor shall assure that each employee assigned to a hazardous procedure or task has sufficient training and possesses the requisite knowledge and skills to perform the procedure or task safely.

Further, the Contractor shall re-assess such needs throughout the duration and performance of each task order. The Contractor shall identify specialized training for the contract staff that requires involvement of Government personnel to the Contracting Officer’s Representative(s).

The Contractor shall comply with all Federal, state, and local regulations and as identified by OSHA, EPA, and Maryland as well as FDA safety and health policies and procedures and safety guidelines. Contractor employees shall: (1) eat and drink only in designated locations in the building; (2) use only designated elevators to transport animal equipment and supplies; (3) not block emergency showers with carts or equipment; and (4) not bring children into the animal facility.

Some experimental animal studies may be conducted using chemicals that are known or suspected to be hazardous to humans. Strict biological, chemical, or radiological containment for safe work practices and proper waste disposal procedures shall be employed to minimize exposures to personnel and the work environment. Any new safety SOPs for activities with hazardous chemicals shall be developed by the Contractor based on researchers' approved protocols. If available, Safety Data Sheets (SDS) from chemical manufacturers shall be used to determine the hazards and appropriate work practices. SOPs shall be in compliance with OSHA regulations including the Hazard Communication Standard (29 CFR 1910.1200), the OSHA Occupational Exposure to Hazardous Chemicals in the Laboratory (29 CFR 1920.1450), the Occupational Health and Safety in the Care and Use of Research Animals, National Research Council, 1997, Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH, 1999), and the Food and Drug Administration Safety Staff Manual Guides, safety manuals and policies and procedures.

The contractor shall identify a Safety Manager and his/her name and qualifications shall be submitted to the Contracting Officer prior to commencement of work.

3.1.5. Medical Examinations. The Contractor shall not knowingly employ any person who is identified as a potential threat to the health, safety, security or general wellbeing or mission of the Agency, or endangers themselves or other persons. The Contractor shall verify in writing, to each Task order COR, that personnel assigned to their respective Task orders have received a baseline physical examination and are medically fit for work prior to reporting to work. The baseline evaluation shall include the following procedures:

1) Medical history review with emphasis on:

a) status of tetanus immunization,

b) status of allergies to fur, animals, and latex

2) Audiogram

3) Urine drug screen

4) Pulmonary function test, if deemed medically necessary (required annually if using a respirator), to include:

a) Forced Vital Capacity (FVC)

b) Forced Expiratory Volume @ I second (FEV-1)

c) Percentage of air expired per person (FEVI/FVC)

5) TB screen (PPD test)

6) Tetanus booster, HBV, Dtap, MMR, Vaccinia, Rabies, Polio, annual Flu vaccinations, COVID-19 vaccinations, and/or titers and/or other immunizations/booster, if required

7) Vision screen

8) Vital signs (blood pressure, temperature, and pulse)

9) Chest X-ray (if indicated from other tests)

10) Respirator fit test, as needed

11) Other tests as indicated from history of individual

The Contractor's employees shall have annual physical examinations for each task order. All task orders will require annual physicals and the Contractor shall verify in writing that personnel have received an annual physical examination and remain medically fit for work. The periodic physical exams, and annual medical evaluations, including pre-placement or pre-assignment evaluations, along with associated medical record-keeping annual physical examination shall include the following procedures:

1) Interval medical history review related to Occupational Health Hazards with emphasis on:

a) status of tetanus and other required immunizations,

b) allergies to fur, animals, and latex

2) Vital signs (blood pressure, temperature, and pulse)

3) Vision screen

4) TB screen (PPD test)

5) Respiratory Fitness Test

6) Respirator Fit Test, as needed, with verification of understanding how and when to wear respiratory protection imaging

3.1.6. Animal Care and Use Laws and Regulations. The services under this contract at a minimum shall comply with regulations and guidelines listed in Section 3.0 to ensure the successful accomplishments of the FDA mission.

3.1.7. Data Management. The Contractor's animal care staff shall be familiar with FDA’s data systems (automated and manual) associated with animal census, purchase requests, etc., and be able to accomplish all data entry procedures accurately as instructed by the Contracting Officer’s Representative(s). The Center will train the appropriate contract staff in all aspects of the data operating systems that they shall be required to use.

The Contractor's staff shall enter the required data into the computer or manual systems and maintain other required records. These records include, but are not limited to, approved protocols and amendments, SOPs approved by the Contracting Officer’s Representative(s) or Safety Officers, logs for each room with dates for changing and sanitizing cages, racks, pans, feeders, water bottles, environmental checks, health reports, inventory control, breeding reports, animal usage reports, animal observations and animal or supply delivery/packing receipts, as required by each Task order. All entries shall be initialed and dated by the staff person performing the procedures. All original paperwork shall be provided to the Principal Investigator/Study Director immediately after the study is complete, as applicable, or to the COR or designee for filing; if not originals, copies will be provided to the COR or designee. All data are considered privileged information and cannot be shared or distributed by the Contractor without the Government’s permission.

The contract staff shall recognize computer system malfunctions and report the malfunctions to the Contracting Officer’s Representative- in a timely manner and then proceed with manual record keeping. The animal care staff shall enter the manually collected data into the computer system when it becomes available. Contract employees will abide by security requirements established by the Government for access and use of computers in federal facilities at all times.

3.1.8. Inventory Control. The Contractor shall maintain an accurate inventory of supplies that are routinely used in the course of the animal husbandry functions. Supplies include cages (e.g., plastic, stainless steel, metabolism) and racks, water bottles (type, size, and shape), sipper tubes (length and shape) feeders (jars, feeders attached to cages), microisolator lids (size of lid), animal feed, bedding, chemicals, enrichment items and veterinary supplies. The Contractor shall conduct a monthly inventory of on and off-site storage locations for equipment and supplies and prepare a report that summarizes the quantitative status of the inventoried items. This report should also include the date that items were entered into inventory to track retention time. The report should also include recommendations for ordering so that items do not run out and recommendations for removal from the program’s inventory of any unnecessary items. The contractor must work with government purchases and submit ordering requests through a standard form via electronic submission system or by completing a Microsoft document. The contractor must monitor ordering efficiency to reduce the frequency of orders being placed. Scheduled intervals of ordering are preferred.

In consultation with the Contracting Officer’s Representative, before and during each study, the Contractor shall conduct a regularly scheduled survey of the cages, bottles, stoppers, and associated animal support equipment to ensure that adequate quantities are available. The Contractor shall discard worn out equipment that is no longer functional and request new replacement equipment and supplies in a timely fashion. The Contractor shall maintain an accurate inventory of equipment and supplies that are routinely used in the course of the animal husbandry functions. The Contractor shall conduct an annual inventory of equipment and supplies and prepare a report that summarizes the quantitative status of the inventoried items and recommendations for items that can be a surplus or discarded.

The Contractor, in consultation with the Contracting Officer’s Representative, shall be responsible for handling the storage of unused equipment.

3.1.9. Employee Training Plan. The Contractor shall provide for all training to animal care personnel as appropriate to their assigned duties which may include training in biology, husbandry, rodent breeding, sanitation, handling, and restraint, NHP capture, nutrition, zoonoses, personal protective equipment, safety, hazardous materials, technical and surgical procedures, special procedures, and any other situation for which the staff may need training.

The Contractor shall make sure employees completed mandatory FDA trainings, such as Records Management, Security Awareness and other FDA mandated trainings that may arise for contract staff. Technicians working in any area shall receive the necessary training needed to perform their duties effectively and efficiently in that area and with maximum safety protection. Training provided should be standardized of the procedures and training processes with a standardized system to ensure that a pool of a minimum of 70% of the technical procedure staff is proficient on each protocol requiring technical procedure support at any one time. The program shall include Occupational Health and Safety training to ensure maximum safety of the employee and instruction in Good Laboratory Practices to ensure compliance with these regulations. In addition, the Contractor shall encourage, foster, and support the attainment of AALAS (American Association for Laboratory Animal Science) certification of all eligible contract personnel. The Contractor shall determine successful completion criteria for each type of training and include in the quarterly training report the date of training, type of training, the number of employees attending training, and the number of employees successfully completing training. The Contractor shall maintain plans/records of training for each employee separate from other personnel records and shall certify the competency of each employee for each procedure performed by the employee. The Contractor should be able to provide all training plans and records when requested.

It is the sole responsibility of the Contractor to develop an Employee Training Plan which shall provide the contract staff with the knowledge and skills necessary to ensure quality performance of their duties or task assignments in compliance with applicable laws, regulations, and guidelines. Therefore, the Government will assume no liability or responsibility for death, bodily injury, property damage or any other adverse condition resulting from the violation of applicable laws or regulations or insufficient training of staff.

The Contractor shall provide a plan ensuring that all staff are proficient and fully trained in all tasks for their role. They must identify and describe the training methods, frequency, training instructor(s), and qualifications of trainer/instructors(s). The Contractor shall provide a finalized version of the Employee Training Plan within 15 days after contract award.

3.1.10. Quality Control Plan. The Quality Control Program shall be designed to ensure the Contractor is providing animal care and veterinary care support in compliance with established SOPs, approved protocols, and applicable requirements. A draft of the Quality Control Plan shall be included with the Contractor’s proposal for review during the source selection process. The final Quality Control Plan shall be submitted within 30 days after award of contract.

The Contractor shall also establish and maintain a Quality Control Plan for each Task Order to assure that requirements of each task order are met as specified (i.e., regarding timeliness, accuracy, appearance, completeness, consistency, and conformity to appropriate standards and/or specifications. It includes but is not limited to written checklists that detect variations from the contract requirements; recording of work data; feedback and control systems for correcting deficiencies; and the necessary documentation to record findings. The draft of this plan shall be provided with the Contractor’s proposal, followed by a revised plan 15 calendar days after award of each task order. The FDA Contracting Officer’s Representative(s) for each task order will review the final draft plan within 15 calendar days of receipt. A final Quality Control Plan shall be submitted to the Contracting Officer’s Representative(s) 15 days after receipt of the Government’s review.

3.1.11. Contractor Furnished Materials. Except for those items specifically stated to be Government-furnished, the Contractor shall furnish everything required to perform this Statement of Work. The Contractor shall supply adequate and dedicated work shoes, boots, non-disposable eye and hearing protection, and non-disposable respirators and uniforms; uniforms to be maintained and sanitized regularly. The government will provide PAPR’s and dedicated shoes for the BSL 3 Suite.

3.1.12. Contract Phase-In Services. In order to ensure continuity of services, the Government may require the successor contractor to provide transition services beginning on the earliest mutually agreeable date. It is anticipated that the phase-in period for transition will be 30 days. During this period, staff from the incumbent contract shall be on-site to familiarize and train the new contractor staff with the operations of the Animal Care and Use Programs. The contractor’s transition plan shall provide adequate coverage to ensure uninterrupted service, be effectively and efficiently administered, and be completed within the 30-day transition period.

The successor contractor shall cooperate fully with the incumbent contractor, as directed by the COR, to ensure that all services continue without interruption.

Contract Phase-Out Services. As prescribed in FAR 52.237-3 Continuity of Services, if deemed necessary by the Government, the contractor shall provide transition/phase-in/phase-out training and support to the successor contractor.

3.1.13 Personnel. The Contractor shall provide the necessary professional, technical, and administrative personnel with the required qualifications needed to provide FDA with high-quality Animal Care and Veterinary Care support services. The management and technical positions in Appendix A reflect the anticipated organizational structure for project management, veterinary care, husbandry, quality control, training, occupational safety and health, inventory, and equipment maintenance support tasks are currently positioned at or above the technical specialist level. However, the Contractor may propose alternative labor mixes that they believe to be more efficient. Unless otherwise stated, the difference between a Level I, Level II, and Level III contract employee is that Level II and Level III employees will have greater experience of the specific labor category and be AALAS certified at the appropriate level specified. At the discretion of the Contracting Officer’s Representative, certain requirements associated with this position may be waived.

Please be advised that the Government places a high priority on the technical workforce (foremen, technicians, assistant technicians, and production aides) being AALAS certified at the ALAT level or higher. At least 85% of the technical workforce is required to be AALAS certified at all times and within one and a half (1.5) years of employment. In addition, the importance of providing a sufficient number of technicians who are highly trained, skilled, competent, and consistent in performing the technical procedures required for research animal protocols at FDA is of paramount importance. All technicians and research assistants should be at least 90% proficient on all technical procedures and at least one technician and/or research assistants should be at least 95% proficient on all technical procedures. All technicians and research assistants are required to demonstrate a minimum of 90% proficiency on all technical procedures within 60 days of task order initially and within 90 days for new employees after their date of hire and then annually thereafter as described in technical proficiency plan according to task order #1. Management personnel shall have appropriate education and degrees for the position occupied and should have experience in areas of veterinary technology, laboratory animal science or related disciplines. Specifically, key personnel shall be knowledgeable of the Guide for the Care and Use of Laboratory Animals, Public Health Service Policy on Humane Care and Use of Laboratory Animals, and Animal Welfare Act Regulations.

Job descriptions listed in Appendix A include but are not limited to the positions that may be negotiated for each task order.

3.2 SPECIFIC REQUIREMENTS

The specific requirements for the WOAP will be described in each task order.

3.3 TECHNICAL SERVICES

The specific technical services for the WOAP will be described in each task order.

3.4 ESTIMATED WORKLOAD

All essential animal care, veterinary and husbandry, must be performed daily. Animal Care and Veterinary Care research support services requested by Principal Investigators will be provided by the Contractor on a first-come, first-served basis unless the work has been prioritized by the COR. The government will not hold the Contractor responsible for work that cannot be performed due to its priority in the queue.

The Animal Care Support for each protocol will be requested by email by the Principal Investigator or representative listed on the protocol. The Contractor should be involved in the planning and scheduling stages of all protocols that require Animal Care and Veterinary Care (small animals and nonhuman primates) support. The COR must be notified during the planning or review stages of any issues or concerns identified by the Contractor that would hinder or prevent provision of any support services for the protocol.

While not anticipated, if significant changes occur in the protocol such as addition of animals, change of dose concentration, change in the number of dose levels, work description changes, or any other significant/material change resulting in a significant increase in required contractor-provided support, these changes will be reviewed by the COR and Contracting Officer to determine effect if they have a significant effect on price. The COR and Contracting Officer will review the changes to the protocol to determine if support can be provided by the Contractor within the established Firm Fixed Price (FFP) contract amount. If the Government determines that significant additional effort is required by the Contractor, a modification to the contract will be performed to allow for the additional support provided by the Contractor.

Projections of FDA animal care support services required for the next five-year contract period are based on information available at the time the Performance Work Statement was prepared. Animal population during this five-year contract period may fluctuate depending on an increase or decrease in the number of studies initiated or FDA research requirements. The support requirements are presented for each work area under each Task Orders. The number of employees may need to be adjusted if animal numbers remain increased or decreased for a prolonged period of time.

4.0 DELIVERABLES

The contractor shall submit deliverables that are clear, concise, and complete, and that conform in format and structure to standards that shall be agreed to in advance between the Contractor and the COR. Certain types of deliverables shall be submitted in draft form initially, allowing the COR to review and provide additional information and/or clarification/comments for possible inclusion in the final document. In the event of the rejection of any deliverable, the Contractor shall be notified in writing by the COR, giving the specific reason(s) for rejection. The Contractor shall have two (2) working days to respond to the rejected deliverable and return it to the COR.

All deliverables shall be submitted electronically to the COR, veterinarians, and other Federal employee staff using the Microsoft Office tool suite. Final deliverables shall be submitted electronically to the COR and the Contracting Officer.

Post-Award Conference (Kick-off Meeting)

This meeting shall provide an introduction between the Contractor and Government personnel who will be involved with the contract.

The meeting shall provide the opportunity to discuss technical, management and security issues. The Post-Award Conference will aid both the Government and Contractor in achieving a clear and mutual understanding of all requirements and identify and resolve any potential issues. The Contractor shall be prepared to discuss any items requiring clarification and gather information as necessary to support each deliverable. The Contractor shall provide a written summary of the Post-Award Conference.

Daily Report – a summary of daily equipment function such as house medical equipment, wet cages, cage wash equipment operations, service requests submitted, previous service requests still pending, contract staffing, staff husbandry and care coverage, significant animal health and welfare findings, animal holding HVAC parameters, animal micro-environmental parameters such as frog tank water quality test results and BSL 3 care, observations, and equipment function. Deviations from SOP and routine animal care and husbandry shall be reported daily by email.

Monthly Report – a summary of the work accomplished during the previous month shall quantitatively address the work performed for all contract tasks including animal care services, technical procedures performed; veterinary care provided for nonhuman primates and other species if applicable; employee training program functions; quality control program functions; occupational health and safety program functions; and equipment maintenance support activities. Also include personnel actions, travel, and any issues or problems that occurred during the month and/or need attention/rectification. A list of current employees by position to include assigned duties and change schedules and a position vacancy report to include duration of vacancy and efforts to get position filled should also be included.

New or Revised SOPs – report of any Standard Operating Procedures newly created, revised, or deleted during the previous month and a certification that SOPs are in place for all procedures, tasks, and duties required of the Contactor. Also included in the Daily and Monthly Report shall be a description of any SOP deviations by employees, the effects of those deviations, personnel action taken, and corrective procedures to ensure prevention of future deviations.

Summary of Baseline Medical Exams – prior to commencement of work, the Contractor shall provide their employees’ baseline summary showing their employees have met all medical requirements and list any restrictions.

Summary of Annual Medical Exams – the Contractor shall provide a summary showing their employees have met all medical requirements, are fit to work in their position and list any restrictions.

Inventory Reports – the Contractor should conduct inventory of on and off-site storage schedules for equipment and supplies and prepare a report that summarizes the quantitative status of the inventoried items and date that items were entered into inventory to track retention time.

Employee Training Plan – As described in Section 3.1.9, it is the sole responsibility of the Contractor to develop an Employee Training Plan, which shall provide the contract staff with the knowledge and skills necessary to ensure quality performance of their duties or task assignments in compliance with applicable laws, regulations, and guidelines. Therefore, the Government will assume no liability or responsibility for death, bodily injury, property damage or any other adverse condition resulting from the violation of applicable laws or regulations or insufficient training of staff. The Contractor shall provide a finalized version of the Employee Training Plan within 15 days after contract award. In addition, the Contractor shall present an Employee Training Plan annually for each Task Order as well. A quarterly update of the training plan will be provided to the Task Order COR, which shall include list of employees with BSL-3 clearance and list of employees trained to react to CT events.

Veterinary Technician Proficiencies Plan – The Contractor shall provide a plan in the Technical Proposal and demonstrate within sixty (60) days to ensure the proficiency of technicians on the contract. An annual demonstration of veterinary technical proficiency shall be scheduled with Facility Veterinarians.

Quality Control Plan – In addition to the draft version of the Quality Control Plan (QCP) that is to be submitted as part of the Contractor’s technical proposal, no later than thirty (30) days after contract award, the Contractor shall also provide a comprehensive QCP for each Task Order depicting the Contractor’s methodology for ensuring compliance with contract requirements.

Report on Access to Government Property – summary of the Contractor’s program for the protection, preservation and maintenance of all Government property, procedures to educate the contract employees concerning individual responsibilities for Government property, and efforts to monitor and assess the contractor’s property control system.

Safety Inspections Report – Provide quarterly an assessment of the Safety status for personnel and equipment documenting the conditions noted

Occupational Health and Safety Plan - The Contractor shall submit a Draft Safety Plan for complying with all the safety and health provisions. A Final Draft Safety Plan shall be provided 15 calendar days after award of the contract. The FDA will review the Final Draft Safety Plan within 15 calendar days of receipt. The Contractor shall submit a revised Final Safety Plan to the Contracting Officer 15 days after receipt of the Government's review. Further, the Contractor shall re-assess such needs quarterly throughout the duration and performance of each task order and submit a quarterly inspection report.

Scheduled Items Number of Copies

Due Dates

Post-Award Conference

(Kick-Off Meeting)

Due no later than 1 week after award

Daily Report 1 Close of Business each day

Monthly Report 1 NLT 7 days after the end of the month

New or Revised SOPs (Section 3.1.3)

1 As required

Summary of Baseline Medical Exams (Section 3.1.5)

1 Prior to employee beginning work

Summary of Annual Medical Exams (Section.3. 1.5)

1 Annually, or as described in each task order

Inventory Reports (Section 3.1.8)

1 Monthly, Quarterly and Annually as indicated in each task order

Employee Training Plan (Section 3.1.9)

1 15 days after contract award. Subsequent Reports submitted Quarterly.

Veterinary Technician Proficiencies Plan

1 90 days after contract award. Subsequent Reports submitted annually.

Quality Control Plan (Section 3.1.10)

1 As shown in (Section 3.1.10) and in each task order

Report on Access to Government Property (Section 9.0)

1 Annually

Occupational Health and Safety Plan

1 Fifteen (15) days after award of each Task Order; reassess quarterly and submit a quarterly inspection report

Safety Incident Report

1 NLT 3 to 5 Business Days after incident

5.0 PERIOD OF PERFORMANCE

The period of performance for this IDIQ vehicle will have a five (5) year ordering period. Individual task orders awarded under this IDIQ contract shall be for periods of varying duration but are anticipated to range from 12 to 60 months.

6.0 PLACE OF PERFORMANCE

Animal based research performed by CBER, CDER, and CDRH is managed by the Consolidated White Oak Animal Program:

FDA Federal Research Center Building 10 (10/52/72) Vivarium 10903 New Hampshire Avenue Silver Spring, MD 20993

Off-site Storage Facilities:

Self Storage Plus 11105 New Hampshire Ave.

Silver Spring MD 20904

In addition, the animal program also manages eight (8) laboratory Animal Biosafety Level three (ABSL-3), animal room suites capable of housing primarily rodents, ferrets, and rabbits in a controlled environment on the fifth floor of Buildings 52/72.

7.0 CONTRACTING OFFICER REPRESENTATIVE

Name: To be identified at award CBER Animal Resources Operations Manager Building 52 Room G112 10903 New Hampshire Avenue Silver Spring, MD 20993 Email:

Phone:

8.0 Government Furnished Facilities, Materials, and Property

The Government reserves the right to furnish property to the Contractor for use under the contract, when it determines that it is in the Government’s best interest to do so. Notwithstanding the Government’s decision to furnish such property, the Contractor shall have the capability to furnish all materials and equipment necessary for the performance of the work required under this contract.

Facilities: The Government will furnish and/or make available facilities at the sites cited in Section B-1, Background. Facilities have been inspected for compliance with the Occupational Safety and Health Act (OSHA).

The fact that no hazardous conditions have been identified does not warrant or guarantee that no possible hazard exists, or that work around procedures will not be necessary, or that the facilities as furnished will be adequate to meet the responsibilities of the Contractor. Compliance with the US and Maryland Occupational Safety and Health Acts and other applicable laws and regulations for the protection of employees is exclusively the obligation of the Contractor, and the Government will assume no liability or responsibility for these responsibilities with the following exception. If OSHA hazards are found in the Government-furnished facility, the Government will correct such hazards in accordance with Government-developed and approved plans of abatement, taking into account safety and health priorities. A higher priority for correction will not be assigned to the facilities provided hereunder merely because of this contracting initiative. The Contractor shall return the facilities to the Government in the same condition as received, fair wear and tear excepted. These facilities shall be used for performance of this Contract only.

Equipment: The Government will provide to the Contractor the equipment necessary to perform animal husbandry services.

Government furnished equipment shall be managed in accordance with the Government Property clause.

Equipment Inventory: On the first day of a task order, the Contractor and a Government…