SOURCES SOUGHT
R -- BSL4 NonHuman Primate Challenge Studies
- Notice Date
- 2/18/2010
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, Maryland, 20817
- ZIP Code
- 20817
- Solicitation Number
- HHS-NIH-NIAID(AO)-SS-10-020
- Point of Contact
- Terrie L Nestor, Phone: 301-402-6790
- E-Mail Address
-
tnestor@niaid.nih.gov
(tnestor@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) is seeking sources that can execute projects that require challenge of nonhuman primates with a lethal dose of Ebola or Marburg virus. These challenge studies require Biosafety Level 4 (BSL-4) facilities and specially trained staff. The BSL-4 facility will execute the challenge studies to evaluate vaccine efficacy, and thereby provide data to support licensure by the Animal Rule of the Food and Drug Administration (FDA). The contractor must have the following credentials: Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International file number; Office of Laboratory Animal Welfare (OLAW) Animal Welfare Assurance number; and United States Department of Agriculture (USDA) R Registration (Class "R" Research). The facility in which the animals are housed shall operate in compliance with: The Animal Welfare Act (PI,. 89-544, as amended) Rules and Regulations published in the Code of Federal Regulations (CFR), Title 9 (Animals and Animal Products), Chapter I, Subchapter A (Animal Welfare), Parts I, 2, and 3; Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, updated 2002; The Guide for the Care and Use of Laboratory Animals, revised 1996; Occupational Health and Safety in the Care and use of Research Animals (NRC 1997); and Guidelines for the Prevention and Treatment of B-Virus Infections in Exposed Persons (Clinical Infectious Diseases, 1995; 20: 421-439). Most nonhuman primates housed under this contract will be provided by the government; however, the government may request the contractor to obtain animals. All Animal Study Protocols for procedures that are to be performed on Vaccine Research Center (VRC) owned animals will be prepared by the NIH, and submitted to the Contractor through the COTR or his/her designee. At the conclusion, the disposition of the animals shall be the responsibility of the NIH, VRC. The contract may include, but is not limited to, the following species: Macaca mulatta, Macaca fasicularis, Macaca nemestrina, and any other combination of Old World and New World species. (Individual macaques must be less than 10Kg in size). The contractor shall conduct up to 20 procedures per month for experimental groups consisting of 4 to 12 nonhuman primates for immunogenicity and viral challenge studies (No more than 8 macaques can be housed in the BSL-4 at any one time). The nature of investigations being conducted by the NIH require immunization with genetic vaccines, infectious challenges, and regular blood draws for chemistry, viral load, and immune response measurements. Procedures will be conducted according to individual working protocols issued under VRC or NIAID ACUC approved Animal Study Proposals. Viruses to be tested include, but shall not be limited to, the following: various Ebola virus strains; various Marburg virus strains; and replication-defective recombinant adenoviruses (human and chimp.) The Contractor shall perform procedures on animals which shall include, but not be limited to: inoculation (intravenous, intraperitoneal, subcutaneous, intradermal, intramuscular, intravaginal, intranasal, and intrarectal) of the animals with various biological agents or vaccine preparations; monitoring animals for signs of disease; evaluation of new therapies such as antiviral agents and immunotherapies for their effectiveness against viral infection; and collection of specimens as described by protocols furnished by the Project Officer. The details of the specimen collection for electron microscopy and/or light microscopy and virus isolation shall be detailed in each protocol or by approved Standard Operating Procedures. During the disease course and at termination of study, the contractor shall perform various clinical or pathological procedures as needed or as requested by the Project Officer including, but not limited to: Phlebotomy; Cerebrospinal Fluid Aspiration (Macaque); Bone Marrow Aspiration (Macaque); Peripheral Lymph Node Excisional Biopsy; Comprehensive Experimental Necropsy; Bronchoalveolar Lavage; Mucosal fluid collections to include lung, rectal, vaginal, nasal, oral; Various methods of delivery immunogens (No Aerosol or portal vein injection.) The Contractor shall perform final detailed, comprehensive necropsies as specified by the Project Officer. Any special procedure conducted by the Contractor shall be performed in accordance with the Project Officer's specifications. When necessary, clinical and pathological specimens designated by the Project Officer will be collected and delivered intact to the Vaccine Research Center after appropriate treatment to render them safe for analysis. Furthermore, specimens will be delivered with safe and reasonable methods requested by Project Officer or designee. The performance of some specialized tests on specimens collected by the Contractor shall be the responsibility of Government scientists; the government may ask for samples or specimens to be evaluated by various contractors. Biosafety Level-4 practices, containment equipment, and facilities are required for activities using animals experimentally infected with viruses listed above and opportunistic infections associated with these viruses. Animals must be housed in ventilated hepa filter enclosures which are environmentally controlled with non-recirculating air which is exchanged 10-15 times per hour. Negative air pressure relative to non-containment areas shall be accomplished by an independent exhaust fan system. Exhaust air must pass through absolute HEPA filters. Back-up exhaust fans shall be used to insure operational integrity of this system at all times. Special Procedures Rooms are required to contain suitable equipment consistent with the Guide for animal examination, necropsy, surgery, surgical preparation and radiography. The necropsy room must contain work stations and a downdraft ventilation necropsy table which meets OSHA and ASHRAE standards for exposure limits to formalin. Storage Areas must contain approximately 500 cubic feet of secure floor and shelf space for the storage of all equipment, supplies, and pharmaceutical products. All pharmaceutical products (i.e., for treatment of intercurrent infections, all tranquilizers, all analgesics), supplies and equipment (i.e., for specimen collection, inoculation, biopsy, surgery, necropsy, etc.), shall be specified by the COTR, and supplied by the Contractor. An emergency electric generator shall be available to this project and available for immediate use in the event of a loss of electric power. Contractor must provide a 24-hour security system, including 24-hour security personnel on site to prevent unauthorized entry into facilities and animal areas. Contractor must restrict entrances into the animal areas by security locks. Animal rooms shall display signs marked boldly with the designation "Biohazard Area" on animal room doors. Signs shall list the precautions necessary when entering the area(s) and entry shall be limited to authorized personnel only. The Contractor shall provide cages designed in accordance with the USDA/APHIS regulations under the Animal Welfare Act and USPHS policy. The caging shall promote the psychological well-being of the animals while minimizing exposure to infectious agents. The Contractor shall use its' best efforts to maintain 74-76 degrees F. and 10-15 air changes/hour. The Project Officer will be notified within 24 hours if there is a wide variance in environmental conditions including, but not limited to, temperature and humidity. Cages and biocontainment chambers shall be disinfected using a chemical disinfectant/sterilant approved by the Project Officer. All animal equipment (caging, feeders, etc.) shall be washed in a commercial cage washer containing a suitable detergent at 180 degrees F. at least every two weeks or on an Institutional Animal Care and Use Committee (IACUC)-approved schedule. Animal room floors shall be cleaned and sanitized with chemical disinfectants daily. Microbiological monitoring will be performed quarterly using RODAC plates. The disposition of potentially infected materials shall be accomplished, sequentially, in the following manner: (1) Animal Room Waste: a. Liquids: sewage pipes, decontamination tanks at 210 degrees F. for 2 hours, public sewage system or by chemical decontamination. b. Solids: double sealed bag, sterilized, dumpster; (2) Animal Carcasses: sealed bag, refrigerated, necropsy, burn box, incinerator; (3) Specimens: sealed bag, in house processing within Class II biological safety cabinet or sealed centrifuge rotors; double bagged in plastic, labeled appropriately, sealed outside container; delivered as directed; (4) Disposable Items: a. Needles and Syringes: sharps container, autoclave as solid waste, commercial biohazard waste disposal service. b. Other Disposables: sealed bag, burn box, incinerator; (5) Nondisposable Clothing: sealed bag, autoclave sterilized, in house laundry service. The Contractor shall provide plans for enriching the environment of nonhuman primates in compliance with the AWA and NIH Guide and provide appropriate diets of monkey chow and fresh fruit and or vegetables to nonhuman primates. Fresh fruit/vegetables (apples, kale, oranges. bananas, etc.) shall be fed to animals daily. The protein content of Old World primate diet shall be 15% and that of the New World primate diet shall be 25%, Rations shall be fed at the rate of 1-3.5% of the animal's weight. All animals shall be tattooed across the chest with identification numbers furnished by the Project Officer. Contractor shall maintain individual records for each animal which include the following: (1) Outside cover shall hold a Clinical and Research Record form which includes the following information columns: a. Immunizations; b. Parasite Control; c.Tuberculosis Tests; d. Weights (Kg.); e. Clinical Procedures; f. Final Disposition; g. Necropsy; (2) Chronological Record of Medical Care; (3) Physical Examination Form; (4) Food Consumption Form; (5) Hematology Results; (6) Serum Chemistry Results; (7) Weight Charts; (8) and Stool Condition Record. Animals will be observed regularly per a schedule appropriate to the species as mutually agreed by the project officer and contractor. Personnel shall be specifically trained and experienced in the care and maintenance of animals infected with the pathogens identified in this Statement of Work. All personnel involved in the daily care of BSL-4 animals shall wear appropriate personal protective equipment defined by CDC regulations. Personnel in contact with the monkeys should be immunized, as available, for the viruses being studied. It is the responsibility of the contractor to ensure that the contract personnel conform to the PPE in concordance of the study requirements. The contractor shall prevent animal-to-animal transmission of infectious agents during collection of specimens by taking appropriate precautions in these studies. New pairs of disposable gloves and covers for workbenches shall be required for each animal every time a specimen is collected. Clean/new protective barrier clothing shall be required daily and on each different procedure. Separate sets of sterile instruments shall be required for collection of each specimen. Personnel must be enrolled in a medical-surveillance program, including banking of their sera, and maintain work practices consistent with the handling of bloodborne pathogens (CDC 1988) and PPE practices. The treatment of intercurrent infections and other conditions in the non-human primates will first be discussed with the Project Officer, and no medication, other than routine, shall be administered without prior approval. The Project Officer shall be notified of any untoward findings in animals under this contract. To the extent possible, prior approval shall be obtained from the Project Officer before any animal is sacrificed; however, the responsible veterinarian shall have the authority to euthanize animals to alleviate undue pain and/or distress upon the recommendation of the IACUC committee. Contractor will be responsible for the overall management of technical activities and personnel, as well as any subcontractors, and must provide an appropriate technical and administrative infrastructure. Monthly meetings, teleconferences, and an annual site visit may be required. Contractor must also plan for an initial and final transition. Technical progress reports will be required on a monthly, quarterly, semi-annual, and annual basis. Proposals may be evaluated based on an offeror's technical plan/approach; scientific and technical personnel; project management; facilities, equipment and other resources. A cost reimbursement type contract is anticipated. Capability statements (limit of 15 pages) should be submitted to Terrie Nestor at tnestor@niaid.nih.gov by March 10, 2010. This is a market survey, not a request for proposals. Please submit any questions in writing to the e-mail address above.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/HHS-NIH-NIAID(AO)-SS-10-020/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN02069006-W 20100220/100218235549-9d9836f4bb18b40ff323ba639ae5653f (fbodaily.com)
- Source
-
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