Simian Vaccine Evaluation Units (SVEUs)

Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The development of HIV vaccines and other prevention strategies relies on the use of nonhuman primates in preclinical studies to advance the development of effective AIDS vaccine candidates and to advance development of effective topical microbicides and other prevention modalities or immune-based therapies. For this reason, he NIAID, Division of AIDS, has a requirement for Simian Vaccine Evaluation Units. Description The NIAID Simian Vaccine Evaluation Unit (SVEU) contracts shall provide nonhuman primate resources that primarily support preclinical evaluation of AIDS vaccines and prevention strategies. The SVEUs conduct studies in support of vaccines being developed by a wide range of investigators. These studies complement NIAID-supported basic vaccine research and vaccine evaluation studies funded through R01 (investigator-initiated research) grants, HIVRAD (HIV Vaccine Research and Design Program) grants, IPCAVD (Integrated Preclinical-Clinical AIDS Vaccine Development) grants, and NHP Consortium awards. The SVEUs also perform studies of candidate vaccines offered by companies or other researchers. The SVEUs will use state-of-the-art techniques and technologies in evaluating promising AIDS prevention strategies in nonhuman primate models and will incorporate new and improved techniques and technologies into the studies conducted throughout the contract period. This is a recompetition of existing contracts entitled "Simian Vaccine Evaluation Units (SVEUs)" (contract number HHSN272201300002I with Advanced BioScience Laboratory, Inc., Rockville, Maryland, contract number HHSN272201300003I with BioQual, Inc., Rockville, Maryland, and contract number HHAN272201300004I with Tulane University, New Orleans, Louisiana). Anticipated Period of Performance NIAID anticipates awarding two to three Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts to the organizations that best meet the overall qualifications needed to fulfill the technical requirements outlined in the Statement of Work. The base contracts will be awarded on or about February 1, 2020 for a period of 7 years, through January 31, 2027. The requirement includes four Task Areas as follows: Task Area 1: Administrative, Management, and Technical Support Core Activities, Task Area 2: Maintenance of Nonhuman Primates, Task Area 3: Conduct of Studies in Nonhuman Primates, and Task Area 4: Operation of a Nonhuman Primate Breeding Colony. Offerors must demonstrate capabilities to perform all of the work in Task Areas 1, 2, and 3, or the work in Task Area 4 alone. Offerors may submit capabilities to perform all work in Task Areas 1, 2, 3, and 4. If an offeror chooses to submit a capability statement for all Task Areas, the capabilities for Task Area 4 should be included in a separate section. Facilities requirements include: 1) Animal Biosafety Level (ABSL) 2/3 facilities (ABSL2 with ABSL3 practices) capable of housing from 200 to 300 nonhuman primates on Study Plans; and 2) ABSL2/3 facilities capable of housing approximately 15-30 nonhuman primates not assigned to a Study Plan. As appropriate for the task order, other facilities requirements may include: 1) ABSL2 facilities capable of housing approximately 30-60 nonhuman primates not assigned to a Study Plan; and 2) facilities for housing a breeding colony of approximately 500-550 SPF Indian-origin Rhesus macaques. Below is a general description of the Task Areas: Task Area 1 - Core Activities: Administrative and Technical Support: Under this Task Area the Contractor shall support work that will be performed on a regular, on-going basis including (i) general administration and financial management; (ii) project planning (iii) coordination of activities across all nonhuman primate activities awarded to an SVEU unit under Task Areas 2 and 3; (iv) receipt, storage and shipment of vaccines, virus stocks, study samples including cells, tissues, mucosal secretions, blood, sera, and plasma; (v) reporting and maintenance of data; and (vi) transition activities. Task Area 2 - Maintenance of Nonhuman Primates: Under this Task Area the Contractor shall provide support to obtain, transport, quarantine, house, care and maintain nonhuman primates that are not yet on study under Task Area 3. Task Area 3 - Conduct of Studies in Nonhuman Primates: Under this Task Area the Contractor shall (i) initiate Contracting Officer Representative (COR)-approved studies; (ii) obtain, transport, and provide for quarantine of nonhuman primates for specific studies, as needed; (iii) provide housing, care and maintenance of nonhuman primates; and (iv) conduct studies as described in the scope of the Task Orders. Studies under this Task Area may include: - immunogenicity and/or efficacy of candidate vaccines such as larger-scale studies of vaccines that have already demonstrated promise in nonhuman primates and immunogenicity testing of candidate HIV vaccines (or immunogenicity and efficacy of SIV vaccines which parallel HIV vaccines in approach) in anticipation of Phase I human clinical trials; - in vivo titrations of virus stocks and infection of nonhuman primates to generate or evaluate virus stocks; - route of immunization or route of infection, or other preliminary studies needed for subsequent vaccine study; - efficacy of passively administered antibodies, microbicides, and other anti-viral substances; - pilot studies of antiviral drugs and/or immunotherapy regimens; - pilot studies of new vaccines; - comparative studies of vaccines and/or adjuvants from multiple sources; and - studies with topically administered microbicides or other antiviral substances to block infection of non-human primates with virus administered vaginally or by other mucosal routes. Task Area 4 - Operation of a Nonhuman Primate Breeding Colony: Under this Task Area, the Contractor shall provide support for the operation and maintenance of a Specific Pathogen, Free (SPF) Indian-origin Rhesus macaque (Macaca mulatta) breeding colony dedicated to the support of NIAID research studies primarily conducted under the SVEU. Immediately upon award of the contract, the Government intends to award Task Orders in Task Area 1, Core Activities: Administrative Management, and Technical Support, Task Area 2, Maintenance of Nonhuman Primates, and Task Area 4, Operation of a Nonhuman Primate Breeding Colony. Task Area 1, Core Activities: Administrative and Technical Support: Up to three Task Orders will be awarded as term/level of effort type contracts for a period of 1 year with Options to extend the contracts on an annual basis for a maximum period of performance of 7 years. It is anticipated that up to 3 Task Orders will be issued to up to 3 separate contractors. The performance requirement will be the delivery of 1.00 full time equivalent (FTE) per year. In addition, Options for Increased Level of Effort to add 0.30 FTEs/year may be exercised one time per year. Task Area 2, Maintenance of Nonhuman Primates: - Up to three (3) Task Orders will be awarded to 3 separate contractors for maintenance of an average of 15 nonhuman primates per year in ABSL2/3 facilities. These Task Orders will be awarded as cost reimbursement, term form/level of effort task orders including a performance requirement for delivery of 0.27 FTEs per Task Order per year. The Task Orders will be awarded for a 1 year period with Options to extend the period of the Task Orders annually for a maximum performance period of 7 years. In addition, Options for Increased Level of Effort for delivery of an additional 0.09 FTEs for maintenance of an additional five (5) nonhuman primates in an ABSL2/3 facility will be included in this Task Order. Options for Increased Level of Effort may be exercised up to 3 times per year. - One (1) Task Order will be awarded to 1 contractor for maintenance of 30 nonhuman primates in an ABSL2 facility. This Task Order will be awarded as cost reimbursement, term form/level of effort task order including a performance requirement for delivery of 0.06 FTEs. The Task Order will be awarded for a 1 year period with Options to extend the period of the Task Order annually for a maximum performance period of 7 years. In addition, Options for Increased Level of Effort for delivery of an additional 0.02 FTEs for the maintenance of 10 additional nonhuman primates in an ABSL2 facility will be included in this Task Order. Options for Increased Level of Effort may be exercised up to 3 times per year. Future Task Orders will be issued as the need for maintenance of additional nonhuman primates arises. Task Area 3, Conduct of Studies in Nonhuman Primates: Although the Government does not plan to award Task Orders for Task Area 3 immediately upon award of the base contracts, it is anticipated that four (4) to eight (8) Task Orders will be issued per year for Task Area 3, Conduct of Studies in Nonhuman Primates, as nonseverable completion form contracts with a performance requirement for the completion of studies and submission of a final study report. Task Area 4, Operation of a Nonhuman Primate Breeding Colony: One (1) Task Order will be awarded to 1 contractor to provide support for appropriate housing, care and maintenance of 550 SPF non-human primates per year including breeding harems to achieve a production rate of 60-100 live births per year. This Task Order will be awarded as a cost reimbursement, term/level of effort form contract including a performance requirement for delivery of 0.50 FTEs. The Task Order will be awarded for a 1 year period with Options to extend the contract annually for a maximum performance period of 7 years. In addition, Options for Increased Level of Effort for delivery of 0.05 FTEs for maintenance of 50 additional SPF non-human primates per year will be included in this Task Order. Options for Increased Level of Effort may be exercised one time per year. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about October 24, 2018, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract or Task Order. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."