Draft_Sanctuary_SOW-_31717.doc

Statement of Work Operation and Maintenance of the Federal Chimpanzee Sanctuary System for Retired Chimpanzees

I. BACKGROUND INFORMATION

In 2000 Congress passed the Chimpanzee Health Improvement, Maintenance, and Protection (CHIMP) Act. In the Act Congress designated that the Secretary shall provide for the establishment and operation of a national sanctuary system for federally owned or supported chimpanzees no longer needed for research. Full text of the CHIMP Act can be found at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_cong_public_laws&docid=f:publ551.106 The Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), one component of the National Institutes of Health (NIH), is the office responsible for programmatic oversight of the Federally Supported Chimpanzee Sanctuary System (the Sanctuary).

The primary purpose of the Federally Supported Chimpanzee Sanctuary System (the Sanctuary) is to provide for the lifetime care of chimpanzees that have been used, or were bred or purchased for use, in research conducted or supported by the National Institutes of Health, the Food and Drug Administration, or other agencies of the Federal Government.

II. OBJECTIVE

DPCPSI has a requirement for a Contractor to operate and maintain the Sanctuary and to provide lifetime care for approximately 230 to 250 chimpanzees, retired from active federally-supported research, in accordance with the CHIMP Act. The NIH will retain title to the chimpanzees. Any transfer of title will be determined at the sole discretion of the NIH. Construction of facilities will not be supported under the resultant contract.

III. CONTRACTOR REQUIREMENTS AND TASKS

A. General Requirements The Contractor shall furnish all the necessary labor, materials, supplies, equipment, and services (except as otherwise specified herein) necessary to perform the work set forth in this SOW. The Contractor shall ensure:

· Compliance with Federal Laws, Regulations and Policies The Contractor shall operate the sanctuary site in compliance with:

· The Animal Welfare Act (P.L. 89-544, as amended) Rules and Regulations published in the Code of Federal Regulations (CFR), Title 9 (Animals and Animal Products), Chapter 1, Subchapter A (Animal Welfare), Parts 1, 2, and 3 (AWRs);

· Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy);

· Guide for the Care and Use of Laboratory Animals (NRC 2011; Guide);

· Biosafety in Microbiological and Biomedical Laboratories (5th Edition, CDC-NIH, 2009; BMBL);

· Occupational Health and Safety and Use of Nonhuman Primates (NRC 2003);

· Chimpanzees in Research, Strategies for their Ethical Care, Management, and Use (NRC 1997);

· AVMA Guidelines for the Euthanasia of Animals: 2013 Edition;

· The Psychological Well-Being of Nonhuman Primates, (NRC 1998);

· 29 CFR 1910.1030, Bloodborne Pathogen Standard; and

· 42 CFR part 9, Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System; Final Rule.

· Applicable NIH Guidelines for Transfer of Federally Owned and Supported Chimpanzees to the Federal Sanctuary

· Prior to using any Federally supported chimpanzees for noninvasive studies, as authorized in the CHIMP Act, the contractor, subcontractors and/or consultants shall obtain and maintain 1) an Animal Welfare Assurance from NIH's Office of Laboratory Animal Welfare (OLAW); and 2) United States Department of Agriculture (USDA) assurances for animal welfare. In addition, the Contractor shall ensure the sanctuary achieves and maintains accreditation by the internationally recognized animal program accrediting body, AAALAC International.

B. Specific Requirements The Contractor shall operate and maintain the National Sanctuary System for Federally Owned or Supported Chimpanzees No Longer Needed For Research. Contractor Requirements include:

· The Contractor shall operate the sanctuary system whose primary purpose is to provide for the lifetime care of chimpanzees that have been used, or were bred or purchased for use, in research conducted or supported by the National Institutes of Health, the Food and Drug Administration, or other agencies of the Federal Government.

· The Contractor shall provide adequate property and facilities necessary to operate the sanctuary, for 230-250 chimpanzees, in accordance with this SOW.

· Cost Sharing. In accordance with the CHIMP Act the Contractor shall provide non-Federal contributions toward the costs to be incurred by the Contractor in operating the sanctuary system, in cash in an amount not less than 25 percent of total expenses associated with operating the federal sanctuary, including direct and indirect costs.

· Acceptance of Federally Owned Chimpanzees Into the System. All retired Federally-owned or Federally-supported chimpanzees may be eligible for acceptance into the Federal Sanctuary system. Requests of acceptance of Federally owned or Federally supported chimpanzees from Federal agencies other than NIH shall be submitted and approved by NIH prior to acceptance. The Federal government will retain ownership of these chimpanzees.

· Request For Acceptance of Non-Federally Owned Chimpanzees Into the Federally Supported Chimpanzee Sanctuary System. The Contractor shall follow the procedures and protocols for accepting non- Federally owned or supported chimpanzees detailed in Attachment A with the exception that Federally-owned chimpanzees will be given priority over non-Federally owned chimpanzees and the Federal government will retain ownership of these chimpanzees.

· Restriction Regarding Research. As stipulated in the Federal Register Notice (81 FR 6873 (February 9, 2016) found at http://docs.regulations.justia.com/entries/2016-02-09/2016-02554.pdf ), no invasive research shall be conducted on any federal owned animals residing at the Sanctuary. Noninvasive research deemed to be permissible in accordance with the CHIMP Act and the implementing regulations at 42 CFR part 9, may be considered for approval by the NIH on a case by case basis. Such research shall be limited to noninvasive behavioral studies or medical studies based on information collected during the course of normal veterinary care that is provided for the benefit of the chimpanzee, provided that any such study involves minimal physical and mental harm, pain, distress, and disturbance to the chimpanzee and the social group in which the chimpanzee lives. Noninvasive research means the use of procedures that depend upon close observation of chimpanzee behavior or on medical information collected during the course of normal veterinary care. These procedures do not require removal of the chimpanzees from their social group or environment, or require a separate anesthetic or sedation event to collect data or record observations. Some examples of noninvasive studies are: (1) Visual observation; (2) Behavioral studies designed to improve the establishment and maintenance of social groups. These activities may cause stress as a result of novel interactions between chimpanzees and caregivers, but they are not considered invasive as long as they are intended to maximize the well-being of the chimpanzees; (3) Medical examinations as deemed necessary to oversee the health of the chimpanzees, in the least invasive manner possible. Collection of samples routinely obtained during a physical examination for processing during this time is also considered noninvasive since a separate event is not required; (4) Administration and evaluation of environmental enrichment used to promote the psychological well-being of the chimpanzees; and (5) Actions taken to provide essential medical treatment to an individual chimpanzee exhibiting symptoms of illness. This applies only to serious illness that cannot be treated while the chimpanzee remains within the colony.

The Contractor shall request and obtain NIH approval prior to the start of any such research. Requests shall be sent to the Contracting Officer Representative (COR) and shall include:

a. Project title, abstract and specific aims

b. Certification that the research is noninvasive

c. Details about the research to support the investigator’s assertion that the work is noninvasive

d. Attachments (as needed)

e. The Principal Investigator (PI) and institution’s authorized signing official are required to certify that the submitted information is correct.

Each request will be entered into the NIH’s Chimpanzee Research Use (CRU) Reporting System and reviewed by NIH. Additional requests for information or questions from NIH may be made. A decision will be made and communicated to the contractor once NIH has completed its review.

NIH’s decision to allow such noninvasive research, as described in the Federal Notice (81 FR 6873 (February 9, 2016)), does not affect requirements for investigators and/or their institutions to obtain applicable permits from the U.S. Fish and Wildlife Service , if applicable, nor does it affect the responsibility to meet all applicable veterinary, colony, and husbandry obligations.

If research or exhibition is approved by NIH to occur using Federal Sanctuary animals, the Contractor must obtain its own animal assurance from OLAW and must hold and maintain for the duration of the Contract a USDA registration.

A license from the Drug Enforcement Agency to one or more veterinary staff for the use of drugs in chimpanzees at the sanctuary site will be required.

· NonHuman Primate Management Experience and Stability. The Contractor shall possess and maintain fiscal-management expertise, long-term financial stability, and management expertise of large groups of chimpanzees (>100 animals).

· Required Training and Certifications. The Contractor shall ensure all applicable training and certifications are obtained and maintained. Requirements include:

· The Contractor shall provide an effective training program in occupational health and safety. Prior to commencing any work, employees shall be properly trained in safe practices and informed of potential hazards.

· The Contractor shall provide written certification to the CO and the COR that such training has occurred. The Contractor shall ensure all Sanctuary staff members are provided with, understand, and follow applicable safety instructions.

· The Contractor shall ensure and provide all applicable training for new hires. The Contractor shall also provide periodic training for all employees at all levels. Required training includes, but is not limited to: applicable OSHA training, biosafety procedures, specific animal care procedures, behavioral observations including standardized tests, environmental enrichment, record keeping practices, and other continuing education.

· OLAW, USDA, other. The Contractor shall comply with the Animal Welfare Act, PHS Policy, and USDA regulations regarding the use of animals in research. The USDA representatives will periodically inspect the sanctuary and issue reports to the Contractor. The Contractor shall provide copies of the USDA reports to the NIH COR. Any deficiency reported by the USDA shall be promptly corrected. In addition, the Sanctuary shall maintain AAALAC International accreditation. Copies of AAALAC International site visits and reports shall be provided to the NIH COR.

C. Contractor Tasks

The Contractor shall provide all services and equipment necessary to ensure the health and well-being of all Sanctuary chimpanzees and effectively operate and maintain the Sanctuary. Contractor tasks include but are not limited to:

· The Contractor shall comply with all applicable Federal and State laws and regulations pertaining to the acquisition, registration, care, disposition and transportation of nonhuman primates. The animal care and use programs shall maintain the requirements prescribed by the AWRs and PHS Policy.

· The Contractor shall provide space and living conditions consistent with NIH Policy: NOT-OD-14-051 "Notice of Agency Decision: The Density of the Primary Living Space of Captive Chimpanzees Owned or Supported by the NIH or Used in NIH-Supported Research "

· Provide veterinary care. The Contractor shall provide veterinary services that result in an adequate level of long-term health and care of chimpanzees. This shall include but is not limited to: Periodic physicals and TB testing for all chimpanzees, serum and DNA and possibly semen banking, blood sampling and shipping for off site HIV and HCV testing, standard vaccinations and other standard preventative health care for chimpanzees, veterinary care for unexpected health problems and wounding from cage-mates, and rare instances of euthanasia when ordered by a veterinarian considering the best interests of a particular chimpanzee.

· Provide daily animal care and husbandry. The Contractor shall provide all the animal care and husbandry services necessary to properly maintain the chimpanzees 24 hours a day, 7 days a week, every day of the year, including weekends and holidays. The Contractor shall provide and ensure minimal staff shall report for duty every day of the year, including periods of inclement/severe weather or other adverse working conditions.

· Maintain the chimpanzees in socially compatible groups unless contraindicated for medical or management reasons.

· Provide and ensure all chimpanzees are fed a standard commercially available chow supplemented with fresh fruits and vegetables

· Provide the administrative infrastructure necessary to adequately support the veterinary and technical services.

· Provide custodial services to ensure facilities are sanitary at all times. Facilities shall comply with applicable USDA and PHS standards

· Provide contemporary environmental enrichment for the chimpanzees. The behaviorist, in collaboration with the enrichment technicians and animal care staff, shall provide environmental enrichment to every chimpanzee. Whenever possible, chimpanzees shall be housed in groups of females and vasectomized males. The chimpanzees shall be allowed access to the outdoors and be provided indoor shelter when necessary. Social groups shall be monitored and maintained to the extent possible.

· Conduct regular behavioral observations of all chimpanzees

· Maintain secure and proper records. Animal records shall be maintained on all animals, to include both behavioral and clinical health records.

· Provide and ensure adequate security (for chimpanzees, sanctuary staff and sanctuary visitors).

· Provide biohazard waste removal.

· Transfer of Animals to the Sanctuary. The Contractor shall receive and review medical and behavioral records of animals proposed for transfer to the Sanctuary. The Attending Veterinarian shall provide input on acceptance of the proposed animals. In conjunction with the sending institution, the Contractor shall make arrangements for transport with an approved animal transport shipper (verified Commercial Driver’s License, appropriate vehicle for transport, and past experience shipping large animals, particularly nonhuman primates). The Contractor shall arrange for quarantine space needs, post-transfer serological testing, and draft plans for introducing each animal into social groups. A veterinarian shall accompany shipments in accordance with all regulations. The original behavioral and medical records will be transferred with the animals at the time of transport.

· Ensure biosafety. Some of the retired chimpanzees have been exposed to zoonotic agents. Hazardous materials or operations required by this contract include medical and minor surgical procedures performed with chimpanzees that have been exposed and may be carrying infectious agents such as hepatitis B virus (HBV), hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV), Simian-Human Immunodeficiency Virus (SHIV), and other recombinant and natural agents. The Contractor shall establish and implement adequate and effective quarantine procedures to be used upon receipt of new animals and/or sick animals that threaten the health of the rest of the colony.

· Employ and implement the services of an experienced environmental health and safety component that includes a safety specialist.

· Establish and employ a Sanctuary Chimpanzee Care Committee (SCCC) that is appointed by and reports to the CEO or President of the Contractor as described in 42 CFR Part 9.3 (https://www.govregs.com/regulations/title42_chapterI_part9). The SCCC shall for oversee the chimpanzee care program and operations to ensure the health and wellbeing of the chimpanzees and the occupational safety of the staff are being addressed. The Committee shall consist of no fewer than five people and shall include: A Chair knowledgeable in the needs of chimpanzees; a veterinarian with chimpanzee care experience; a behaviorist with experience in chimpanzee behavior; a member of the chimpanzee care staff; and a community member. The SCCC shall carry out the specific functions described in 42 CFR Part 9.3.

· Establish, implement and maintain animal care Standard Operating Procedures (SOPs) and associated documents (e.g., Behavioral Management Plan, Assessment of Chimpanzee Quality of Life, Emergency Action Plan, Occupational Health and Safety Plan). Plans shall be approved in advance by the SCCC.

· Establish and employ an institutional biosafety committee (IBC) or equivalent. In accordance with federal regulations and policies (NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules) the IBC membership shall consist of, at minimum, five members, who collectively have experience in general issues of laboratory biosafety, use of infectious materials, and expertise in recombinant or synthetic nucleic acid molecule technology and the capability to assess the safety of such research and identify any potential risk to public health or the environment.

· Establish and implement plans, policies and procedures to address measures that shall be undertaken in the event any visitor or employee of the Sanctuary is in danger. These biosafety plans and policies shall be reviewed annually by the IBC or equivalent. The health and safety policies and procedures shall comply with all requirements of the Guide, BMBL, and Occupational Health and Safety in the Care and Use of Nonhuman Primates.

· Ensure all personnel involved in the daily care of infected sanctuary chimpanzees wear work clothing and Personal Protective Equipment (PPE) as required by the BMBL.

· Ensure all personnel use work practices that adhere to Occupational Health and Safety in the Care and Use of Nonhuman Primates and 29 CFR 1910.1030, Bloodborne Pathogen Standard.

· Provide effective pest control which complies with Federal, State and local laws, regulations, and policies.

· Report all instances of animal death and provide necropsies. Any instances of animal death or injury shall be reported by email to the Contracting Officer (CO) and COR within 24 hours. Any such incidents deemed to be due to significant deficiencies according to PHS Policy shall be verbally reported to the COR and followed-up in writing upon completion of appropriate Institutional Animal Care and Use Committee (IACUC) investigations and implementation of corrective actions. In the case of a death from an unknown cause, a necropsy shall be done under ABSL2 containment, except for chimpanzees exposed to prions.

· Ensure the prevention of conception. All male chimpanzees to be accepted into the sanctuary shall be vasectomized according to the specific guidelines established by the Contractor and approved by NIH. Under special circumstances, the Veterinarian shall consider the addition of other proven methods of female birth control (oral contraceptives, implants, or long-term injectables) to insure pregnancies do not occur. These special circumstances, such as inclusion of adolescent males who are maturing and still too young for vasectomy, shall be discussed with the COR prior to implementation. No conceptions of chimpanzees at the sanctuary shall occur. Any chimpanzee that is born at the NIH-supported sanctuary shall be owned and supported financially exclusively by the Contractor.

D. Personnel The Contractor shall be responsible for the selection, certification, assessment, supervision, management, and control of employees in performance of this Statement of Work. When necessary to ensure continued satisfactory performance of the required services, the Government will request and the Contractor shall replace any person under this contract due to inappropriate behavior, poor performance, misconduct, endangering life, abuse of U.S. Government property, inhumane treatment of chimpanzees or any other conduct or behavior that the Government determines as inappropriate. In accordance with HHSAR 352.242-70, the Contractor shall not divert or otherwise replace any key personnel without the written consent of the CO.

· Required Labor Categories and Qualifications. In accordance with 42 CFR Part 9, the Contractor shall provide the following staff:

Professional Staff.

· Director The Director of the facility shall have at minimum: a Bachelor’s degree in a related field. A doctoral degree (DVM/VMD, PhD, or MD) is preferred. Experience in managing a nonhuman primate facility that maintains over 100 animals is required with expertise in large nonhuman primates, such as chimpanzees, preferred.

· Veterinarians. The Contractor shall maintain at least 1.5 full time veterinarians on staff including:

· Attending Veterinarian (AV) : The Attending Veterinarian shall have a DVM/VMD degree with medical license in the state in which the facility is located. The AV shall have experience in handling nonhuman primates (NHPs), preferably large NHPs, such as chimpanzees.

· Clinical Veterinarian : The Clinical Veterinarian shall have a DVM/VMD degree with medical license in the state in which the facility is located. The Clinical Veterinarian shall be able to assist the AV and provide unsupervised veterinary care for the chimpanzees.

· Behaviorist The Behaviorist shall have a minimum of a bachelor’s degree in a related science (psychology, social sciences, biology) with a master’s or doctoral degree preferred; the Behaviorist shall have experience in: working with large NHPs, particularly chimpanzees; behavioral observations, environmental enrichment, NHP socialization, positive reinforcement training, and behavioral recordkeeping.

Technical Staff. Includes but is not limited to:

· Program administrator

· Fund raising personnel

· Information technologist

· Colony Manager

· Veterinary technician(s), and other.

Animal Care Staff.

· Supervisory and other

· Enrichment or animal care technicians. Minimum of 1 technician per 15 chimpanzees.

Maintenance Staff.

· Supervisory and others.

Consultants.

· Consultant veterinarians. Consultant veterinarians shall be made available when the Attending and Clinical Veterinarians are unavailable. Pathology services and expertise shall be provided to necropsy animals and process and interpret tissues.

E. Institutional Animal Care and Use Committee (IACUC)

The Contractor shall appoint and manage the IACUC. Members from the Contractor staff and outside members with appropriate qualifications shall be appointed by the Contractor to serve on the IACUC. The IACUC shall be constituted as described in the PHS policy and the USDA regulations 9 CFR, 2.31 (a) (b). This includes a minimum of one veterinarian, one practicing scientist, one nonscientific member, one external member not affiliated with the institution, and one public member. The IACUC shall meet at the sanctuary and shall provide the functions required by OLAW and the USDA, including reviewing and approving protocols, and submitting reports from the IACUC to NIH, upon request.

F. Publications, Abstracts, Presentations, etc.

Any publication, abstract or oral presentation at a scientific conference or public meeting resulting from data generated from Federally owned or Federally-supported animals that includes authors who are employees of the sanctuary shall first approved by the NIH before its release or publication. Meeting abstracts shall also be approved by NIH prior to submission. Publications shall be provided to NIH upon submission or acceptance by the publisher.

G. Request for Tours and Congressional/Media Interest The Contractor shall notify and request approval from the NIH CO and COR, in advance, for any tours or interviews from congressional or media entities. NIH reserves the right to approve or disapprove these events or request rescheduling.

H. Governing Board of Directors In accordance with 42 CFR Part 9 the contractor shall establish a Governing Board of Directors. The Contractor shall ensure:

· The Board of Directors is composed and appointed in accordance with paragraph (3) of the Chimp Act and is satisfactory to NIH.

· The terms of service for members of such board are in accordance with paragraph (e) (3) of the Chimp Act.

· The members of the board shall serve without compensation. The members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out duties of the board.

· A member of the Board of Directors serves as the Chair of the Board of Directors. The Chair shall be elected or appointed by the Board from among the individual members.

· Acceptance, agreement and adherence to non-Federal contributions described in paragraphed (e) (4) of the Chimp Act.

· Compliance with standards under subsection (d) of the Chimp Act.

· The access to and availability of necropsy reports on chimpanzees in the sanctuary system on a reasonable basis to persons who conduct biomedical or behavioral research, with priority given to such persons who are Federal employees or who receive financial support from the Federal Government for research.

· Prohibition of any invasive research on the resident chimpanzees, but permit noninvasive studies as defined previously (http://docs.regulations.justia.com/entries/2016-02-09/2016-02554.pdf).

· Composition of the Board of Directors The governing Board of Directors shall be composed and appointed as follows:

· Not more than 13 voting members (an NIH official shall participate in board meetings as a non-voting party for discussions pertinent to the contract).

· Membership that includes individuals with expertise and experience in the science of managing captive chimpanzees (including primate veterinary care), appointed from among individuals endorsed by organizations that represent individuals in such field.

· Membership that includes individuals with expertise and experience in the field of animal protection, appointed from among individuals endorsed by organizations that represent individuals in such field.

· Membership that includes individuals with expertise and experience in the zoological field (including behavioral primatology), appointed from among individuals endorsed by organizations that represent individuals in such a field.

· Membership that includes individuals with expertise and experience in the field of the business and management of nonprofit organizations, appointed from among individuals endorsed by organizations that represent individuals in such a field.

· Membership that includes representatives from entities that provide accreditation in the field of laboratory animal medicine. Specifically, NIH’s current or past members of the AAALAC Council or staff.

· Membership that includes individuals with expertise and experience in the field of containing biohazards.

· Membership shall NOT include any individual that has been fined, or signed a consent decree for, any violation of the Animal Welfare Act.

· Terms of Service for Members of the Board of Directors.

The Contractor shall ensure:

· The term of the Chair of the Board shall be 3 years.

· The initial members of the board select, by a random method, one member from each of the six fields specified in the subparagraph (A) of the Chimp Act to serve a term of 2 years and (in addition to the Chair) one member from each of such fields to serve a term of 3 years.

· An individual whose term of service expires may be reappointed to the board.

· After the initial terms under 2 above expire, each member of the board (other than the Chair) is appointed/reappointed to serve a term for 2 years.

· A vacancy in the membership of the board is filled in the manner in which the original appointment was made.

· If a member of the board does not serve the full term applicable to the member, the individual appointed to fill the resulting vacancy is appointed for the remainder of the term of the predecessor member.

· Board of Directors shall periodically (at least annually) review the sanctuary site(s) operation and serve as an advisory body for programmatic issues. Plans for possible facility modernization and major repairs shall be presented to the Board of Directors.

· NIH Acceptance of Board Members

· The Contractor shall present to the NIH a list of potential members to serve on the Board of Directors of the Federal Chimpanzee Sanctuary. The list shall indicate the full name, credentials, expertise and organizational affiliations(s) for each person. The Contractor shall consult with the NIH before the appointment of any board member, and shall appoint board members that are acceptable both to the Contractor and to the NIH.

I. Deliverables/Reports:

The Contractor shall provide the following:

· Monthly census reports of the animals in the Federal Sanctuary including Name, identification number, age, general location and information on an acquisitions and dispositions.

· Quarterly reports summarizing activities completed during the quarter. Activities include abstract/article submissions, acceptances and publications; staffing updates; continuing education updates; veterinary care procedures; colony and behavioral management reports; regulatory updates; and public affairs and relation activities.

· Behavioral Management Plan prepared by the Behaviorist. The plan shall be submitted with the technical proposal.

· Occupational Health and Safety Plan. The plan shall be submitted with the technical proposal.