SOLICITATION NOTICE
R -- Performance of Routine Experiments and Tests
- Notice Date
- 6/25/2012
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- HHSN261200577001C
- Archive Date
- 7/28/2012
- Point of Contact
- Scott P. Keasey, Phone: 3014968606, Lisa A. Hill, Phone: 3014353796
- E-Mail Address
-
scott.keasey@nih.gov, hilll1@mail.nih.gov
(scott.keasey@nih.gov, hilll1@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Department of Health and Human Services, National Institutes of Health, at the National Cancer Institute, the Vaccine Branch, and Office of Acquisitions intends to negotiate a sole source modification for a twelve (12) month extension to the contract with Advanced Bioscience Laboratories, Inc. in Rockville, MD to continue to provide animal facilities and perform routine experiments and tests. The contractual history of the current contracts began in the 1970's, first with the former Laboratory of Tumor Cell Biology, then the Basic Research Laboratory, and now the Vaccine Branch (VB), all in the National Cancer Institute. Historically, previous contracts provided immunological and virological support services for experiments carried out using animal under the contract. These included in vitro immunological assays in appropriate BL2/BL3 laboratories to characterize humoral or cellular immune responses following inoculation with viral antigens or virus infection and in vitro culture and detection of virus from peripheral blood and/or tissues of retrovirus-infected animals. The immunological and virological testing phases of the prior contracts have been substantially removed and moved to a separate contract. This allowed a greater pool of contractors with either testing and/or animal facilities to compete for the work. A breeding colony of patas monkeys was maintained along with appropriate support for hand-rearing newborns until mid-2009, when this work was removed. The colony was moved to an NIH facility in order to obtain cost savings. The contracts have screened non-human primates for various retroviruses and for a small panel of MHC haplotypes prior to acquisition, and have conducted CD4/CD8 and complete blood counts. Otherwise, the current contracts have been solely for the purpose of provision and maintenance of non-human primates, and experimentation in animal models. Statutory authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(a)(2)(ii), only one responsible source and no other supplies or services will satisfy agency requirements. Advanced Bioscience Laboratories, Inc. is the only responsible source and no other supplies or services will satisfy agency requirements. ABL is the only source that will satisfy agency requirements because long-term pre-clinical vaccine studies have been initiated at this facility in non-human primates and must be completed in the same environment, using the same procedures and technical approaches to ensure continuity of the experiments. Differences in immunization procedures, which include administration of vaccines by different parenteral and mucosal routes may result in changes in the induced immune responses. Differences in techniques used to challenge the animals with infectious virus could drastically affect the outcome of the study and levels of protective efficacy obtained. Differences in technical procedures used in obtaining various tissue biopsies for analysis of immune responses could influence the quantity and quality of samples available for study, affecting in vitro evaluation of vaccine-induced immune responses. Moving the animals to a new environment would cause stress, impacting the outcome of studies and subjecting the study animals to different environmental exposures which could affect their health and well-being, thus adversely affecting the overall experiment. The purpose of extending this contract is to complete the following active studies: 1) The contractor shall provide a well-equipped and maintained animal facility with containment capability of biosafety level two (BL-2) with biosafety level three (BL-3) practices for the maintenance of non-human primates and standard laboratory animals. 2) The Contractor shall maintain separate records of current inventory of all animals and under study, grouped according to the NCI investigator supported by the contract and performing the study. 3) The contractor shall provide housing, care, and routine health surveillance of all animals maintained under the contract 7 days a week. The Contractor shall provide veterinary care for the animals in accordance with (1) the "Guide for the Care and Use of Laboratory Animals", revised August 16, 1996 (http://grants.nih.gov/grants/olaw/); (2) the NIH Manual "Responsibility for Care and Use of Animals", Issuance 4206 and 6000-3-4-58 (http://www3.od.nih.gov/oma/manualchapters/contracts/6380-2/); and (3) the Public Health Services Policy on Humane Care and Use of Laboratory Animals, Revised August, 2002 (http://grants.nih.gov/grants/olaw/). 4) The contractor shall provide standard technical assistance and professional veterinary assistance as necessary for inoculation and bleeding of mice. Murine experiments may include harvesting of ascites fluid, spleens, or other tissues. 5) The contractor shall provide health monitoring of the non-human primates under study, including sedations and bleedings, physicals, vet screens, and quarterly TB tests. The contractor shall conduct clinical laboratory testing for analysis of animal materials (such as complete blood counts, parasite evaluations, and bacterial culture and serum chemistry tests) as required for appropriately monitoring the animals' health and treating any occurrences of disease. 6) The contractor shall provide accurate CD4, CD8, B cell, and total lymphocyte counts of blood samples obtained from study subjects as required by research protocols 7) The contractor shall provide standard technical assistance and veterinary assistance as needed for performance of all routine procedures such as inoculation and bleeding of the animals. The contractor shall perform inoculations of viral and cellular antigens, proteins, nucleic acids, cells or drugs, and perform immunizations with candidate vaccine vectors provided by the government. Viruses under study may include but are not limited to SIV, SHIV, and HTLV-I. Vectors may include but are not limited to DNA, adenovirus vectors, poxvirus vectors, and pseudovirions. A variety of routes may be utilized such as intravenous, intramuscular, subcutaneous, intradermal, intranasal, sublingual, oral, intrarectal, intravaginal, and intraperitoneal. Specialized delivery devices or techniques may include but are not limited to gene gun, biojector, electroporator, and nasal spray device. Viral challenges with SIV and/or SHIV may be single high-dose or repeated low-dose, administered by routes including but not limited to intravenous, rectal, vaginal, oral, or penile. 8) The contractor shall provide standard technical assistance and professional veterinary assistance as necessary for collection of mucosal samples and secretions, including rectal, vaginal, and nasal secretions; saliva, and bronchial alveolar lavage. 9) The contractor shall provide technical assistance and professional veterinary assistance as necessary for performance of minimally invasive surgical procedures such as genital/rectal pinch biopsies, peripheral lymph node biopsies, and collection of bone marrow. 10) The contractor shall provide professional veterinary assistance for performance of all survival surgical procedures (such as intestinal resections, mesenteric lymph node biopsies, endoscopic surgery and laparotomy) and necropsies. Necropsies shall include euthanasia, and tissue collection including but not limited to blood, LN, GI and genital tissues, and a pathology report. 11) The contractor shall provide histological and microscopic pathological examination of tissues obtained from test animals or at necropsy. The contractor shall provide for fixation or cryopreservation of tissues for further study as directed by the COTR. 12) The contractor shall provide standard technical assistance and professional veterinary assistance as needed for administration of daily therapy to non-human primates infected with SIV or SHIV. Animals receiving ART therapy shall be monitored twice daily by the caretaker staff for inappetance, abnormal stools, emesis, and signs of pain or distress. An animal technician shall observe these animals daily for any abnormal clinical or behavioral signs. A chem screen including amylase and lipase shall be performed on any animal with signs consistent with pancreatitis. Any signs of hyperglycemia such as polyuria, polydipsia, or significant weight loss, will require analysis of serial blood and urine glucose. Because these animals are anesthetized and handled frequently and are receiving potent therapy, they shall be given additional nutritional supplementation daily. 13) The contractor shall deliver blood and tissues from animals under sterile and viable conditions to the appropriate NCI investigator on the Bethesda campus or at NCI-Frederick within one hour after processing as specified by the COTR. 14) Because some biologic substances are labile, should remain sterile, and may be biohazardous, the contractor shall provide an appropriate BL2/BL3 laboratory space for preparation of inocula; filling of injection devices, and aliquoting of samples. 15) The contractor shall provide refrigerator and freezer space for temporary storage of samples transported to and from the facility. 16) The contractor shall have the capability to store biologic materials at -20° and -80° C and in liquid nitrogen, and shall maintain a back-up system capable of maintaining stored materials at the specified temperature. 17) The contractor shall maintain an electronic inventory of all stored samples by NCI investigator, and a record of the amounts of refrigeration and freezer space used by each NCI Investigator. 18) The contractor shall maintain phone and email contact with the COTR at all times and shall meet with the COTR and/or the NCI scientists involved in the studies upon request to discuss planned and on-going experiments. 19) The contractor shall provide a Final Transition Plan to ensure the orderly, efficient, and smooth transition of all contract activities and materials. As part of the work under this potential contract semi-annual and final technical report are expected. The proposed contract action is for supplies or services for which the Government intends to continue with one source under authority FAR 6.302. However, interested sources may identify their interest and capability must respond by submitting a capability statement (5 page limit) within 15 days of publication of this synopsis. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement. Overnight deliveries should be mailed to Scott Keasey at the National Cancer Institute, Office of Acquisitions, 6120 Executive Boulevard, Room 6039, Bethesda, Maryland 20852. No collect calls or facsimile transmissions will be accepted. Respondents may submit their capability statements via email at scott.keasey@ nih.gov.
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