Simian Vaccine Evaluation Units (SVEUs)

Introduction: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background: 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 NIAID, Division of AIDS (DAIDS), has a requirement for the provision of support services for the NIAID/DAIDS preclinical research portfolio. 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. Purpose and Objectives 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). 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. Project Requirements: 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, 3 and 4, 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. 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 to 3 separate contractors as cost reimbursement, 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. The performance requirement will be the delivery of 1.00 full time equivalents (FTEs) per year. In addition, Options for Increased Level of Effort to add 0.30 FTE/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/level of effort form task orders including a performance requirement for delivery of 0.27 FTE 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 .01 FTE for maintenance of an additional five (5) nonhuman primates per year in an ABSL2/3 facility will be included in this Task Order. Options 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/level of effort form task order including a performance requirement for delivery of 0.05 FTE. 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 .01 FTE for the maintenance of 10 additional nonhuman primates per year in an ABSL2 facility will be included in this Task Order. This Option may be exercised up to three (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 0.22 FTE. 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 an additional 0.0075 FTE for the maintenance of 50 additional nonhuman primates per year may be exercised 1 time per year. Anticipated Period of Performance: The anticipated period of performance is for seven years beginning February 1, 2020 through January 31, 2027. Other Important Considerations: Offerors should be capable of maintaining full and continuous accreditation of animal facilities by AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) [http://www.aaalac.org/accreditation/index.cfm], Office of Laboratory Animal Welfare (OLAW) Assurance [http://grants.nih.gov/grants/olaw/olaw.htm], and compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, including environmental enrichment [http://grants.nih.gov/grants/olaw/references/phspol.htm]. 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. Capability Statement/Information Sought: Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement (eight page limitation, excluding resumes) describing their company's experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 8 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: - DUNS. - Company Name. - Company Address. - Company Point of Contact, Phone and Email address - Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. - Do you have a Government approved accounting system? If so, please identify the agency that approved the system. - Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Ashley Virts, Contracting Officer, at virtsa@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF). One electronic copy must of your response must be provided. The e-mail subject line must specify HHS-NIH-NIAID-SBSS-18-011. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:30 PM Eastern Prevailing Time on 08/23/2018. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes: This notice does not obligate the Government to award an IDIQ contract or Task Order or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).