Attachment_1_-_NCTR_Animal_Care_PWS_with_Appendices.pdf

JEFFERSON LABS (NCTR)

ANIMAL CARE, TECHNICAL PROCEDURES,

FORMULATIONS

AND

VETERINARY CARE SERVICES

PERFORMANCE WORK STATEMENT (PWS)

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ATTACHMENT 1

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16-223-SOL-00036

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Suzanne.Martella Typewritten Text

16-223-SOL-00036 ATTACHMENT 1

PERFORMANCE WORK STATEMENT (PWS)

Animal Care, Technical Procedures, Formulations, and Veterinary Care Services

TABLE OF CONTENTS

1. SCOPE……… ………………… ……………………………………………………………………………………….…3

1.1. Background……………………………………………………….…………………………………………………….…3

1.2. Objectives……………………………………………………………………………………………………………….…3

1.3. List of Appendices……… . ………………………………… …….………………………………………………….…3

2. APPLICABLE DOCUMENTS …………… ………………………………………………………………………………3

3. DEFINITIONS ………………… …………………………………………………………………………………..………4

4. REQUIREMENTS ………………… ………………………… ……………………………………… ……………..……6

4.1. General Requirements……… …… ………………………… ……………………………………… …………………6

4.2. Specific Requirements……… …… ………………………… …………………………………… ………………..…21

5. DELIVERABLES………………… ………………….……… …………………………………… …………….…….…28

Performance Work Statement (PWS) Animal Care, Technical Procedures, Formulations, and Veterinary Care Services

1. SCOPE. 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 provide animal care, technical procedures, formulations, and veterinary care services equivalent to or exceeding the accepted standards and practices of the Laboratory Animal Care industry to NCTR, as described herein.

1.1. Background. The National Center for Toxicological Research (NCTR) is located at the Jefferson Laboratories of the U.S. Food and Drug Administration (FDA) in Jefferson, Arkansas, approximately 35 miles south of Little Rock and 28 miles north of Pine Bluff. NCTR is an internationally recognized FDA research center that conducts toxicological research studies and other research activities designed to support the FDA’s mission to protect the public’s health. NCTR investigators partner with researchers elsewhere in the FDA as well as other government agencies, industry, and academia. FDA/NCTR and the National Institute of Environmental Health Sciences (NIEHS) have had an interagency agreement (IAA) since 1992, through which the FDA collaborates with the National Toxicology Program (NTP) to design and conduct toxicological studies involving compounds of regulatory interest to the FDA. NCTR is comprised of six research divisions and has facilities including: 132 general or special purpose research laboratories; AAALAC-accredited animal facilities, including rodent facilities accommodating conventional housing, a specific pathogen-free rodent production colony, isolators for germ-free rodents, and quarantine; a nonhuman primate (NHP) research center; a zebrafish production facility; a phototoxicology research center; an imaging center including microPET, MRI, and CT scanner; a nanotechnology core facility; and an inhalation toxicology facility. On-site support services for animal studies performed at NCTR have been obtained through contracts since the Center’s inception in 1972.

1.2. Objectives. The purpose of this contract is to provide support services to NCTR’s animal research program, specifically the provision of quality care to all research animals, sanitation of all animal care and diet preparation/formulation facilities, provision of protocol-specified technical procedures, provision of veterinary care to the NHP colony, and provision of formulation services (receipt, storage, formulation, packaging, and distribution of animal diets and test articles). Ancillary tasks necessary to accomplish these services are included (e.g., quality control, occupational safety and health, inventory control, equipment maintenance, development and maintenance of standard operating procedures, as well as maintaining a comprehensive employee training program). The need for these services is paramount as the preponderance of NCTR’s research mission can only be accomplished through animal research. In addition, major funding sources for the Center’s research program, such as the National Toxicology Program, mandate animal-based research projects. Such projects are highly regulated and demand exemplary execution.

1.3. List of Appendices. The attached Appendices are included to assist in providing a complete record of the services that have been previously provided, as well as to outline the expected level of services required under this contract. Appendices are attached immediately following this PWS.

Appendix 1: Historical and Estimated Workload Appendix 2: Government Furnished Property Appendix 3: Facility Floor Plans Appendix 4: Quality Assurance Surveillance Plan (QASP)

2. APPLICABLE DOCUMENTS. To ensure the successful accomplishments of NCTR’s research mission, animal care services, at a minimum, shall comply with regulations and guidelines below, as well as any amendments or revisions thereto.

2.1. Federal Regulations, Policies and Procedures.

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

https://www.aphis.usda.gov/animal_welfare/downloads/awa/awa.pdf

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

https://www.bids.tswg.gov/TSWG/bids.nsf/D179FB382B180B5A852572B1005FA7EB/$file/Title9_CFR_C hpt1_SubChptA_1-4.pdf

c. 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.

http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf

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

http://grants.nih.gov/grants/olaw/references/phspol.htm

e. American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, 2013 https://www.avma.org/KB/Policies/Documents/euthanasia.pdf

f. 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).

http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10106

g. Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH, 2007).

http://www.cdc.gov/biosafety/publications/bmbl5/index.htm

h. Good Laboratory Practice Regulations (21 CFR 58).

http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html

i. Environmental Protection Agency (EPA) Resource Conservation and Recovery Act Regulations.

http://www.epa.gov/oecaagct/lrca.html

2.2. Availability of Federal Regulations, Policies and Procedures. Unless otherwise indicated, copies of the aforementioned documents are available for free distribution online.

2.3. Center-Specific Policies and Procedures.

a. NCTR Environment, Safety, and Health Manual.

b. NCTR Occupant Emergency Plan.

c. NCTR Animal Care Standard Operating Procedures.

d. NCTR Diet Preparation Standard Operating Procedures.

2.4. Availability of Center-Specific Policies and Procedures. Center-specific documents can be accessed at NCTR’s on-site library.

3. DEFINITIONS. As used throughout this Performance Work Statement (PWS), the following terms shall have the meaning set forth below and specified as applicable to this contract.

3.1. AAALAC Accreditation. AAALAC, International is a private, nonprofit organization that evaluates institutions that use animals in research, teaching, or testing and awards accreditation to those that meet or exceed the standards for humane treatment of animals outlined in the Guide for the Care and Use of Laboratory Animals (National Research Council, 2011), the Guide for the Care and Use of Agricultural Animals in Research and Teaching (Federation of Animal Science Societies, 2010), and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purpose (Council of Europe, ETS 123).

3.2. American Association for Laboratory Animal Science (AALAS). AALAS is an association of professionals that advances responsible laboratory animal care and use to benefit people and animals. The association provides educational materials to laboratory animal care professionals and researchers, administers certification programs for laboratory animal technicians and managers, publishes scholarly journals, supports laboratory animal science research, and serves as the premier forum for the exchange of information and expertise in the care and use of laboratory animals.

http://grants.nih.gov/grants/olaw/references/phspol.htm https://www.avma.org/KB/Policies/Documents/euthanasia.pdf http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10106 http://www.cdc.gov/biosafety/publications/bmbl5/index.htm http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html http://www.epa.gov/oecaagct/lrca.html

3.3. Center for Tobacco Products (CTP). CTP, a part of the FDA, oversees the implementation of the Family Smoking Prevention and Tobacco Control Act.

3.4. Contracting Officer (CO). A Government employee with the authority to enter into and administer contracts and make determinations and findings with respect thereto, or with part of such authority.

3.5. Contract Specialist (CS). A Government employee, acting as a representative of and operating under the authority of the CO, who performs contract-related administration activities.

3.6. Contracting Officer’s Representative (COR). A Government employee who provides technical clarification and guidance with respect to the PWS and serves as the technical liaison between the Contractor and the CO.

3.7. Contractor. Refers to both the Prime Contractor and all Subcontractors. The Prime Contractor shall be responsible for ensuring that its Subcontractors comply with the requirements of this PWS.

3.8. Cooperative Research and Development Agreement (CRADA). A CRADA is an agreement between one or more FDA laboratories and one or more non-Federal parties under which the FDA laboratory provides personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts. The CRADA partner contributes all of the above and funding to the project.

3.9. Environmental, Safety, and Health Committee (ESHC). The Jefferson Laboratories ESHC is organized and maintained to monitor and support the campus environmental, health, and safety programs. The ESHC meets quarterly to assist in maintaining an open channel of communication between employees and management concerning issues related to these programs on the campus.

3.10. Good Laboratory Practice (GLP). A set of regulations that applies to animal and non-animal research and safety studies funded or reviewed by the FDA. The regulations are a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of non-clinical safety tests. (21CFR, Part 58;

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=58&showFR=1).

3.11. Government Furnished Property (GFP). All Government facilities, property, and supplies provided to the Contractor to be used by the Contractor in carrying out responsibilities set forth in this PWS. Ownership of GFP remains that of the Government at all times (unless and until consumed or expended in the normal course of business) and all GFP shall be returned and/or accounted for upon completion of the contract.

3.12. Interagency Agreement (IAA). A document between government agencies and departments that defines cooperative work between the agencies. The IAA between FDA/NCTR and NIEHS/NTP has been in place since 1992. The IAA supports the design and execution of toxicological studies that are consistent with the goals and needs of both the FDA and NTP.

3.13. Multi-Generation Support System (MGSS). An in-house data management system similar to commercial animal data tracking systems, e.g. Provantis.

3.14. NCTR Experiment Activity Tracking (NEAT). A computerized system to track time spent on individual experiments and other activities. Each experiment or activity in the system is capable of being broken down into a number of milestones with individual tasks to accurately track how time was spent on the experiment or activity.

3.15. National Institute of Environmental Health Sciences (NIEHS). Located in Research Triangle Park, North Carolina, NIEHS is a part of the National Institutes of Health (NIH), and has a mission to discover how the environment affects people in order to promote healthier lives.

3.16. National Toxicology Program (NTP). The NTP is an interagency program whose mission is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology.

3.17. Occupational Safety and Health Administration (OSHA). As part of the U.S. Department of Labor, OSHA sets and enforces standards to assure safe and healthful working conditions for working men and women.

OSHA Standards, 29 CFR 1910 and 1925:

http://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p_toc_level=0 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=58&showFR=1 http://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p_toc_level=0

3.18. Office of Scientific Coordination (OSC). This office provides and coordinates support for the conduct of research at NCTR, and is the location of the Veterinary Services Staff, Microbiology Surveillance Staff, and experimental support staff. OSC manages the IAA with the NTP, and the COR is part of this organization.

3.19. Organization for Economic Cooperation and Development (OECD) Test Guidelines. A collection of the most relevant internationally agreed test methods used by government, industry, and independent laboratories to determine the safety of chemicals and chemical preparations (http://www.oecd.org/env/ehs/testing/oecdguidelinesforthetestingofchemicals.htm).

3.20. Principal Investigator (PI). The PI is the lead scientist with ultimate responsibility for a research protocol.

The terms “PI” and “study director” (GLP term) are used interchangeably.

3.21. Protocol. Protocols are experimental designs written by Principal Investigators, approved through NCTR management, and performed at NCTR. The terms “protocol” and “study” are used interchangeably.

3.22. Quality Assurance Surveillance Plan (QASP). The plan developed specifically for the PWS, to assure compliance with the requirements. This should not be confused with the Contractor’s internal Quality Assurance (QA) required by GLP guidelines.

3.23. Quality Assurance Unit (QAU). The NCTR QAU in the Regulatory Compliance and Risk Management office conducts audits, inspections, and reviews to assess compliance with approved study protocols, established Standard Operating Procedures (SOPs), and the FDA’s GLP for Nonclinical Laboratory Studies (21 CFR Part 58).

QAU observations are reported to the responsible laboratory personnel, study director, investigators, and management. Corrective action responses as a result of a QAU observation include: protocol amendments;

protocol/data/report/SOP clarifications and/or revisions; and protocol/SOP deviation documentation.

3.24. Quality Control Plan (QCP). A document that includes all measures the Contractor will take to ensure that the quality of an end item or service meets the contract requirements regarding timeliness, accuracy, appearance, completeness, consistency, and conformity to appropriate standards and/or specifications. It includes, but is not limited to a written set of self-inspection checklists developed by the Contractor that comprehensively detect variations from the contract requirements; recording of work data; trend analysis; feedback and control systems for correcting deficiencies; and the necessary documentation to record findings.

3.25. Regulatory Compliance and Risk Management (RCRM). RCRM is the office responsible for NCTR’s Safety, Security, Archives, and QAU. Federal employees in this office conduct laboratory safety training and inspections, as well as QA inspections.

3.26. Restricted Areas. Special clearance procedures are required for access to the Nonhuman Primate (NHP) facility. Access to the NHP facility may be obtained when the following criteria are met: 1) legitimate need to enter the facility; 2) completion of NCTR NHP safety training; 3) negative tuberculosis test, positive measles titer, and respirator fit test; 4) NHP Facility Supervisor briefing; and 5) approval from the Director of Veterinary Services. In addition, access to the rodent breeding colony (a Specified Pathogen Free [SPF] area) is restricted so that no one may enter after previously having been in a conventional rodent facility on the same day. (Exceptions may be granted but will require a shower (including cleaning all skin and hair) and clothing change into clean clothing.) While in these areas, Contractor personnel are subject to applicable NCTR SOPs, which will be made available to those who are permitted access.

3.27. Standard Operating Procedures (SOPs). A formally documented specific set of procedures to be followed in carrying out a given operation or in a given situation.

3.28. Study. Studies are experimental designs written by PIs, approved through NCTR management and performed at NCTR. The terms “protocol” and “study” are used interchangeably.

3.29. Study Director. The study director is the lead scientist with ultimate responsibility for a research protocol.

The terms “PI” and “study director” (GLP term) are used interchangeably.

4. REQUIREMENTS.

4.1. General Requirements. Services shall include collaboration with NCTR PIs and other NCTR Contractors during planning and development of research protocols, provision of Animal Care, Technical Procedures, Formulation http://www.oecd.org/env/ehs/testing/oecdguidelinesforthetestingofchemicals.htm and Veterinary Care support services to conduct Institutional Animal Care and Use Committee (IACUC)-approved research protocols, and provision of data for preparation of scientific manuscripts. As requested by the COR and approved by the CO, the Contractor shall serve on committees (e.g., IACUC, Safety, etc.) and participate in seminars, workshops, and training programs on topics appropriate to fulfill NCTR’s goals.

The primary services requested by this PWS are for the Contractor to: 1) provide animal husbandry services including, but not limited to feeding, watering, maintaining a clean environment, operating cage processing areas, making and recording observations, and breeding laboratory animals; 2) provide extensive technical research support procedures in support of animal research protocols including, but not limited to, dosing by gavage, intravenous (IV), intraperitoneal (IP), and topical routes; 3) conduct blood collection from all species on-site as defined in research protocols; 4) provide support for research on behavioral testing of rodents and NHP; 5) provide veterinary medical services and psychological well-being programs for the NHP colony primarily, and for other species secondarily; 6) provide diet preparation/formulation services including, but not limited to receiving, storing, processing, and distributing a) produce for NHP enrichment programs, b) animal diets, and c) diets, water, gavage solutions, topical mixtures and other formulations containing specific amounts of test articles. Other important aspects of this Contract requiring Contractor resources include Quality Assurance, Quality Control, Occupational Safety and Health, Employee Training, Inventory Control, Equipment Management, and Data Management. In addition, the Contractor shall provide management and administrative support to ensure effective and efficient utilization of staff, participate in NCTR’s time keeping system (NEAT), provide for planning and scheduling of work, ensure the highest quality of work, and effectively carry out the business aspects of this contract.

A Memorandum of Agreement (MOA) has been established between NCTR and the on-site Arkansas Regional Laboratory (ARL) to provide ARL with animal facility space and specified animal care services under this contract in support of Clostridium toxin bioassays. If other MOAs are established, the Contractor will be expected to assume additional animal care services as set forth in the MOAs.

Facilities, equipment, and expendable supplies required for performance of work under this contract are provided by the NCTR.

The NCTR is a part of the U.S. FDA; therefore, the immediate needs of the contract may change as other FDA Centers require research services. This may occur through a modification to this contract or, on a limited basis, under this contract through the request of the NCTR COR and following approval by the CO.

Mice, rats, NHPs (rhesus macaque [Macaca mulatta] and squirrel monkey [Saimiri]), and zebrafish constitute the current animal care population at NCTR. Additional animal species may be utilized during this contract period and the Contractor shall have or quickly develop the expertise necessary to provide Animal Care, Technical Procedures, and Formulation, and Veterinary Care Services required of these species

4.1.1. Hours of Operation. The Contractor will be responsible for providing 24/7/365 Animal Care, Technical Procedures, Formulation, and Veterinary Care Services Monday through Friday during the core hours of 6:00 a.m. to 6:00 p.m. Central Time. Continuous service shall be provided as required during the core hours by using staggered start times with the normal workday scheduled from 8:00 a.m. to 4:30 p.m. Occasionally, scheduled protocol-directed technical procedures will occur outside the core hours.

The Contractor shall also provide essential animal care, technical procedures, formulations, and veterinary care services including scheduled protocol-specific tasks on Saturdays, Sundays, Holidays, and during inclement weather.

Weekend/Holiday hours are typically, 7:00 a.m. to 3:30 p.m., but are dependent on study needs.

4.1.2. Observance of Federal Holidays & Other Government Closings. The Federal Holidays are as below unless otherwise identified by the Contracting Officer (CO):

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 Independence Day July 4th Labor Day First Monday in Sept.

Columbus Day Second Monday in Oct.

Veteran’s Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th

In the event there is a Holiday or administrative leave announced other than those recognized Federal Holidays, the Contractor shall provide sufficient staff to provide essential services including scheduled protocol-specific tasks as identified above. Occasionally, the Contractor may be required to provide Animal Care Support/Technical Procedures between the hours of 6:00 p.m. and 6:00 a.m.

The Contractor’s management and professional personnel shall be on-site Mon-Fri from 8:00 a.m. to 4:30 p.m. If not on-site, they or qualified designees shall be available by telephone within 30 minutes for any emergency which may arise in the animal or diet preparation/formulation facilities. In addition, the contractor shall provide their contract management staff with designated cell phones (or other communication devices) to permit telephone access during emergencies that arise during non-core hours. If there is an emergency, the COR will notify the Contractor Project Director verbally, and within 24 hours, will provide a written authorization to cover additional work requirements. As with all contracts, only the CO is authorized to issue change orders or any directive that creates a cost implication.

Appendix 1, Table 5 shows the Holidays worked under the previous contract. This table documents past overtime and Holidays worked, but does not necessarily reflect the overtime and Holidays that will be required in the future.

4.1.3. Place of Performance. The primary place of performance will be at NCTR in Jefferson, AR. Some administrative matters pertaining to the contract may be performed at the contractor’s facility; however, the day-to-day animal-related services will take place at NCTR, 3900 NCTR Road, Jefferson, AR 72079.

4.1.4. Physical Security. The Contractor shall be responsible for safeguarding all Government equipment, information and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

4.1.5. Key and Access Card Control. The Contractor shall insure that keys and/or electronic access cards issued to the Contractor are not lost or misplaced and are not used by unauthorized persons. Only designated Government personnel shall duplicate keys issued to the Contractor. 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 COR. Contract employees shall not grant access to any work areas to persons other than Contract employees engaged in the performance of assigned work in those areas.

4.1.6. Standard Operating Procedures (SOPs). All work associated with Animal Care, Technical Procedures, Formulations, and Veterinary Care services shall be performed in strict compliance with the reviewed SOPs. SOPs for areas, operations, and procedures directly within the Contractor's responsibility shall be written and maintained by the Contractor to reflect the current procedures used by their firm. The Contractor shall enforce SOPs to ensure that procedures are conducted as specified. All SOPs shall be delivered to the COR, the Director of Veterinary Services, NCTR’s QAU, and, if applicable, the Center’s IACUC Chairman for review before finalizing and placing into service.

Review of SOPs by the COR, NCTR’s QAU, the Director of Veterinary Services, or NCTR’s IACUC prior to finalizing and placing into service is not intended as, and shall not be construed as, approval or any assumption of responsibility or liability by the Government. SOPs should be reviewed and revised as needed, but not greater than every 2 years.

During periods of Contractor transition, the new Contractor shall perform services under guidelines of in-place SOPs at the time duties are assumed and until such time that the SOPs are revised, if necessary.

4.1.7. Quality Control (QC). The Contractor shall provide all quality control for services performed under this contract, ensuring that the results produced are complete and accurate. The Quality Control program shall be designed to ensure that the Contractor is providing animal care, technical procedures, formulations and veterinary care services in compliance with established SOPs, approved protocols, and applicable GLP requirements. The Contractor shall write, implement, and enforce a Quality Control Plan (QCP), which shall be reviewed and approved by the CO. Submission of the QCP is detailed in Section 5, DELIVERABLES. The QCP shall be designed to monitor all functions in animal care, technical procedures, formulations and veterinary care services to confirm that results are complete, accurate, and in compliance with established SOPs, approved protocols, and applicable GLP requirements. Quality control functions under this contract shall include but not be limited to:

A. Verifying that all study activity schedules are accurate and comply with the approved protocol and that all study activity schedules are provided to the Study Director, the COR, and the NCTR QAU. All study activity schedules should be retained in the study file and submitted to the NCTR archives at the close of a study.

B. Ensuring that all formulated products (e.g., dosed feed, dosed water, solutions, skin creams, etc.) are accurate and comply with established SOPs and the approved protocol. Ensure that all containers are labeled appropriately (21 CFR 58 Subpart F). Ensure that all accountability documentation is complete, accurate, and retained accordingly.

C. Providing GLP training and maintain a current summary of training and experience and job description for each staff member.

D. Conducting at least monthly inspections of all animal care and diet preparation/formulation facilities for compliance with the contract, established SOPs, and approved protocols. Items inspected shall include but not be limited to performance in compliance with SOPs; housekeeping and sanitation status of physical plant; animal housing conditions; appearance of animals; up-to-date calibration of equipment; adherence to preventive maintenance schedules; expiration dates of chemicals, feed, bedding, etc.; proper use of required PPE; correct recordkeeping (documents, reports, logbooks, etc.); adherence to safety rules; etc.

E. Maintaining an FTE (Full Time Equivalent) schedule of all ongoing animal studies using a project management and/or database software program such as Microsoft Projects or Microsoft Access. Upon release of a new protocol for review by the IACUC and support groups, develop an FTE schedule for that protocol listing the number of FTEs that will be assigned to the protocol throughout its in-life phase. Include technical and management personnel assigned to the study and depict the number of FTEs in intervals appropriate to the study (e.g., daily, weekly, monthly, quarterly) and adjust the figures as needed during the study to keep the information current. The FTE schedule shall be used as a tool in planning animal care, technical procedures, formulations, and veterinary care support for IACUC-approved animal experiments.

This schedule shall be maintained current on a shared computer drive accessible to select Contractor and Government personnel for input and/or review. The software program will be provided by the Government.

4.1.8. Internal Quality Assurance. The Contractor shall provide Internal Quality Assurance (IQA) for the portion of each protocol performed by the Contractor. This IQA shall ensure that the processes followed by the Contractor for GLP studies are performed correctly and documented properly. In addition to IQA auditing performed by the Contractor, the NCTR QAU shall periodically perform QA audits/inspections of the Contractor’s procedures and records pertaining to GLP studies. In-life data generated by animal care, technical procedures, formulations, and during provision of veterinary care for GLP studies are subject to audit by NCTR’s QAU as a part of the review of the study reports.

A. As required by 21 CFR Part 58 (GLPs), 40 CFR Parts 160 and 792 (http://www.ecfr.gov/cgi-bin/text-idx?SID=c896b5fc9237c2649f2c84d5222c8d6a&node=40:33.0.1.1.3&rgn=div5), and the OECD Principles of Good Laboratory Practice, the Contractor’s IQA shall:

1. Be independent of the personnel engaged in the conduct of the regulated study.

2. Monitor each regulated study to assure that the facilities, equipment, personnel, methods, practices, records, and controls used in completing their responsible functions for a regulated study are in conformance with the applicable regulations.

3. Maintain a copy of a master schedule sheet of all non-clinical laboratory studies conducted at the testing facility that require animal care, technical procedures, or formulation support indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.

4. Maintain copies of all protocols (including applicable amendments/changes) pertaining to all regulated non-clinical laboratory studies for which the Contractor is responsible.

5. Inspect each regulated non-clinical laboratory study at intervals adequate to assure the integrity of the study, including periodic area assessments, phase inspections, data and report audits, and maintain written and properly signed records of each periodic audit/inspection showing the date of the http://www.ecfr.gov/cgi-bin/text-idx?SID=c896b5fc9237c2649f2c84d5222c8d6a&node=40:33.0.1.1.3&rgn=div5 http://www.ecfr.gov/cgi-bin/text-idx?SID=c896b5fc9237c2649f2c84d5222c8d6a&node=40:33.0.1.1.3&rgn=div5 audit/inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for re-inspection. Audits/inspections shall include but not be limited to, periodic phase inspections, raw data (including support group worksheets), and report audits.

6. Provide results of IQA audits/inspections conducted in support of regulated studies to the study director, Contractor management, NCTR management, the COR, and the NCTR QAU. Any problems which are likely to affect study integrity shall be documented and brought to the attention of the study director and Contractor management immediately.

7. Ensure that no deviations from approved protocols or standard operating procedures are made without proper authorization and documentation.

8. Review the contributing study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the non-clinical laboratory study.

9. Prepare and sign a Quality Assurance Statement for all studies to be included with the contributing study report that shall specify the date(s) inspections were made and findings reported to NCTR management and to the study director.

10. Maintain the applicable responsibilities, procedures, records, and indexing method of the Contractor’s IQA in writing. These items, including, but not limited to, inspection dates, study and phase or segment thereof, and the name of the individual performing the inspection, shall be made available for inspection to any designated representative of the FDA (for regulatory purposes), the NCTR QAU, the COR, and the study director.

11. Provide access as requested by a designated representative of the FDA (for regulatory purposes), the study director, the COR, or the NCTR QAU to the written procedures established for the inspection and certification from the Contractor’s General Manager that inspections are being implemented, performed, documented, and followed-up.

12. The Contractor shall provide a response to each non-compliance within two (2) weeks of the date of issue of the inspection findings from either the Contractor’s IQA or NCTR QAU. This response shall indicate the corrective action taken and be distributed to the study director, Contractor management, NCTR management, the COR, and the NCTR QAU.

4.1.9. Personnel. The Contractor shall provide the necessary professional, technical, and administrative personnel with the required qualifications needed to provide NCTR with high-quality Animal Care, Technical Procedures, Formulations, and Veterinary Care support services. The management and technical positions presented below reflect the required organizational structure for project management, veterinary care, animal care, technical procedures, and diet preparation/formulation. 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. 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 Assistant Laboratory Animal Technician (ALAT) level or higher. At least 85% of the technical workforce is required to be AALAS certified at all times. 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 NCTR is of paramount importance.

Management personnel shall have appropriate education and degrees for the position occupied and should have experience in areas of animal toxicology research, diet preparation/formulations, 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, Animal Welfare Act Regulations, and National Toxicology Program Specifications. The Project Director, Clinical Veterinarian, Program Manager, Supervisors, Behaviorist, and Quality Assurance Specialist are designated as key personnel.

The qualifications required for personnel employed on the Animal Care, Technical Support, Formulations, and Veterinary Care services contract are described for each position level listed below. Except where specified, these position levels should not be considered as the absolute requirement, type, or number of positions required for the duration of the contract. The Contractor should constantly seek to provide an organizational structure/labor mix which will operate the most efficiently and effectively. While Contractors are allowed great latitude in their approach pertaining to personnel, please note the following: the cage processing areas in Buildings 5A and 53 must be managed by individuals whose primary responsibility is ensuring the efficient and accurate conduct of all area procedures including monitoring of machinery and other equipment for proper functioning. Also, a supervisor must be assigned to each of the four major animal facilities [Building 5A (conventional rodent), Building 53 (conventional rodent), Building 62 (NHPs), and Building 62A (rodent production colony)]. The future of the Building 62A rodent production colony is currently unknown and it may be removed during the life of this contract. However, until that decision is made a supervisor must be assigned to that area.

Qualifications of proposed staff (key personnel) are subject to review by NCTR’s Director of Veterinary Services and the COR and to approval by the CO.

4.1.9.1. Project Director. The Project Director shall have full authority to act for the Contractor in all matters relating to the daily operation of this contract and shall provide competent on-site supervision to ensure that all functions of the contract are carried out in an efficient, courteous, and professional manner. In addition, the Project Director shall ensure that NCTR policies and procedures are followed and that the contract remains in total compliance with federal, state, and local regulations/guidelines.

The Project Director shall be a Veterinarian that graduated from a veterinary school accredited by the AVMA’s Council on Education or has a certificate of equivalency – Educational Commission for Foreign Veterinary Graduates (ECFVG)/(AVMA) or Program for the Assessment of Veterinary Education Equivalence (PAVE)/American Association of Veterinary State Boards (AAVSB). The Project Director shall have at least three years of experience directing a large and diverse animal care and/or technical procedures and formulations service workforce in an AAALAC accredited facility and experience in managing Occupational Safety and Health and GLP-focused Quality Assurance programs. This Veterinarian shall also have the clinical skills in NHP to participate in the NHP procedural and clinical support if required. Certification by the American College of Laboratory Animal Medicine (ACLAM), a research degree (e.g., MS or PhD), and a license to practice veterinary medicine in Arkansas are preferred.

4.1.9.2. Clinical Veterinarian. The Clinical Veterinarian shall be a Doctor of Veterinary Medicine (DVM or equivalent) with at least two years of experience providing veterinary medical and surgical care to NHPs. Such experience must also include participation in and administration of environmental enrichment and preventive medicine programs for NHPs. The Clinical Veterinarian will work with the Behaviorist in implementation of the environmental enrichment program and to develop and maintain compatible socially housed NHPs within the research requirements. At least one Veterinarian on the Animal Care, Technical Procedures, Formulations, and Veterinary Care Services contract (Program Director or Clinical Veterinarian) must have graduated from a veterinary school accredited by the AVMA’s Council on Education or have a certificate of equivalency - ECFVG (AVMA) or PAVE (AAVSB). Experience and expertise with other laboratory animal species, especially rodents and zebrafish is desirable. Certification by ACLAM, a research degree (e.g., MS or PhD), and a license to practice veterinary medicine in Arkansas are preferred.

4.1.9.3. Program Manager. A program manager shall have a bachelor’s degree or higher in a discipline specifically related to this position. Direct oversight of the Animal Care/Technical Procedures and Formulations program shall, at a minimum, be at this level. The Program Manager shall have at least three years of experience in supervising a workforce, managing the operation in compliance with established guidelines stated within this document and managing all procedures and functions for the position employed. In addition, Program Manager must have knowledge of federal, state and local regulations governing the discipline. The Program Manager for the animal care operation shall be AALAS certified at the Laboratory Animal Technologist (LATG) level and, preferably, will be a Certified Manager of Animal Resources (CMAR).

4.1.9.4. Supervisor. A Supervisor oversees personnel assigned to a specific work area(s) or function(s) and the day-to-day activities in a specific area(s) or function(s). Employees at this level shall have at least a High School diploma or GED, LATG certification, and at least three years of experience in the discipline at the technical specialist or equivalent level. Supervisors must exhibit outstanding organizational and communication skills with proficiency in conflict management. Animal Care supervisors shall be skilled in the technical procedures relative to their assignments and shall have operational knowledge and execution skills in computerized data collection systems. A supervisor must be assigned to each of the four major animal facilities [Building 5A (conventional rodent), Building 53 (conventional rodent), Building 62 (NHPs), and Building 62A (rodent production colony)].

4.1.9.5. Behaviorist. A Behaviorist observes and documents behavior in the NHP colony and will train the NHP staff on normal and abnormal behaviors in rhesus and squirrel monkeys. The Behaviorist will work with the Clinical

Veterinarian to develop and maintain compatible socially housed NHPs within the project requirements. The Behaviorist will be responsible for a variety of tasks related to the implementation and refinement of the Environmental Enhancement Plan for NHPs and other species, such as recommending and distributing environmental enrichment to promote psychological well-being, and assisting with social housing, animal training, and evaluating individual behavioral intervention plans. This individual should be committed to service as a member of an animal care team that integrates behavioral well-being with effective biomedical science. The employee in this position shall have a B.S. (or higher degree) in ethology, biological psychology, biological anthropology, zoology, behavioral biology, or related field.

4.1.9.6. Technical Specialist. A Technical Specialist (TS) oversees and coordinates the successful planning and execution of specific animal experiments or specific tasks. Each TS shall have at least a High School diploma or GED with at least three years of experience in the discipline. An animal care TS must be at least LATG certified with a minimum of three years of experience and training as an animal care technician in a laboratory animal facility.

Superior communication, logistic, and organizational skills are essential. Proficiency in all technical procedures relevant to his/her assignments is mandatory and operational knowledge and execution skills in computerized data collection systems are essential.

4.1.9.7. Training Coordinator. A Training Coordinator (TC) will have the knowledge and skills to develop and standardize a training program for technical procedures. A TC will have the technical skills to demonstrate, provide training on, and assess proficiency in the protocol required technical procedures. The TC will work with the Behaviorist and Clinical Veterinarian to develop, train, and implement a positive reinforcement training program for the NHP. Training and/or experience as a veterinary technician is preferred.

4.1.9.8. Internal Quality Assurance. The Internal Quality Assurance (IQA) shall have Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP) certification. The IQA will ensure the activities supporting GLP protocols are compliant with 21 CFR Part 58 (GLPs), 40 CFR Parts 160 and 792. All activities in the facility should be held to the same level of compliance.

4.1.9.9. Animal Care Technician. An Animal Care Technician (ACT) has experience working in a laboratory animal facility and performing laboratory animal duties. An ACT must be certified by the Contractor to reliably and accurately perform all assigned duties relative to the animals in his/her charge including handling animals, recognizing normal and abnormal behavior of animals, performing routine husbandry procedures, performing facility sanitation procedures, performing recordkeeping duties associated with assigned tasks, and performing technical procedures. An ACT is certified by AALAS at the ALAT level or higher. The minimum educational achievement is a High School diploma or GED certificate.

4.1.9.10. Assistant Animal Care Technician. An Assistant Animal Care Technician (AACT) must be certified by the Contractor to reliably and accurately perform all assigned duties relative to the animals in his/her charge including handling animals, recognizing normal and abnormal behavior of animals, performing routine husbandry procedures, performing facility sanitation procedures, performing recordkeeping duties associated with assigned tasks, and performing technical procedures. An AACT is typically not certified by AALAS at the ALAT level or higher, and the AACT is the appropriate position for individuals earning the ALAT (requires 1 yr of experience or ½ yr experience with an undergraduate degree). The minimum educational achievement is a High School Diploma or GED certificate.

4.1.9.11. Formulations Supervisor. A Formulations Supervisor (FS) has experience working in a diet preparation/formulation facility and performing diet preparation/formulation tasks. An FS must be certified by the Contractor to reliably and accurately perform all assigned duties including receipt, handling, storage, and delivery of animal feed products (including NHP produce for environmental enrichment); perform facility sanitation tasks; and prepare dosed diets, water, solutions, creams, etc. containing test articles. An FS is certified by AALAS at the ALAT level or higher. The minimum educational achievement is an undergraduate degree (BA or BS) in a relevant field.

4.1.9.12. Formulation Technician. A Formulation Technician (FT) has experience working in a diet preparation/formulation facility and performing diet preparation/formulation tasks. An FT must be certified by the Contractor to reliably and accurately perform all assigned duties including receipt, handling, storage, and delivery of animal feed products; perform facility sanitation tasks; and prepare dosed diets, water, solutions, creams, etc.

containing test articles. An FT is certified by AALAS at the ALAT level or higher. The minimum educational achievement is a high school diploma or GED certificate.

4.1.9.13. Production Aide. Employees hired with no prior laboratory animal care or diet preparation/formulations experience will enter the work force at the Production Aide level. An entry level employee shall have at minimum a High School diploma or GED certificate. However, if an individual has the requisite AALAS certifications, education, and/or experience, he/she can be employed at the highest level qualified.

4.1.9.14. Equipment Support Specialist. An Equipment Support Specialist (ESS) shall have experience maintaining equipment inventory, ensuring supplies for each type of equipment are available, performing minor repair on equipment, and managing the storage of equipment required for the contract during periods of non-use. The ESS is responsible for informing the COR regarding any required extensive repairs to equipment.

4.1.10. Employee Training. The Contractor shall provide for all training to animal care and formulation personnel as appropriate to their assigned duties which may include training in biology, husbandry, sanitation, handling and restraint, nutrition, zoonoses, personal protective equipment, safety, hazardous materials, and any other situation for which the staff may need training.