Animal Care and Laboratory Support Services to the Vaccine Research Center

Predicted recompete opportunity based on federal award data.
Current Contract: 75N93019C00069 Incumbent: BIOQUAL, INC. Contract Value: $60,706,866.13 Potential End Date: 2026-09-27T00:00:00.000Z Competition: FULL AND OPEN COMPETITION Pricing: COST PLUS FIXED FEE Classification: full-recompete (Confidence: high - 90/100)
Sources Sought Reference Number: NIHAO201800005 Type of Requirement: Follow-on (Contract No.: HHSN272201400012I) Place of Performance: Place of performance is known. Address or general location: Contract facility shall be in close enough proximity of NIH, located in Bethesda, MD to enable research-related deliveries within an hour. Recompetition (if applicable): Bioqual, Inc. 9600 Medical Center Drive Rockville, MD 20850 Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821 Sources Sought Notice Information 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. The applicable NAICS code for this notice is 541715. Background, Purpose, and Objectives The mission of the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC) is to conduct research to facilitate the development of effective vaccines to elicit humoral and/or cellular immune responses to prevent human diseases. Specific Pathogen Free (SPF) non-human primates (NHPs) such as rhesus macaques, are required by the VRC for infectious disease and AIDS vaccine and pathogenesis research and development. Support services include the acquisition of approved NHP species, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, necessary to perform the work. The required work includes purchasing, acquiring, transporting, and housing of NHPs for VRC Animal Care and Use Committee (ACUC)-approved experimental protocols. The investigations conducted by VRC scientists involve the use of BSL2, and BSL3 agents. Procedures will be conducted in accordance with individual protocols issued under VRC or NIAID ACUC-approved Animal Study Proposals (ASPs). Support services provided will allow the VRC Translational Research Program (TRP) to conduct basic and translational research via in vivo research protocols that involve the testing of novel vaccine candidates and immunotherapeutics in NHPs using new and/or proven vaccine/therapeutic strategies. The Contractor shall adhere to the following: 1. The Contractor shall have an Institutional Animal Care and Use Program with the following credentials: a) Office of Laboratory Animal Welfare, Animal Welfare Assurance numbers b) United States Department of Agriculture USDA Registration c) Association for Assessment and Accreditation of Laboratory Animal Care International file number (AAALAC). 2. The Contractor's standards for all animal care, biosafety, and personnel occupational health and safety will conform to all Federal, State and local regulations, in accordance with NIH policy when applicable (reference http://oacu.od.nih.gov) and including but not limited to the following: a) 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 b) Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, updated 1996. c) The Guide for the Care and Use of Laboratory Animals, revised 2010 version (The Guide) d) Biosafety in Microbiological and Biomedical Laboratories (CDC_NIH 2009). e) Occupational Health and Safety in the Care and Use of Research Animals (NRC 1997) 3. NHPs housed under this contract will be owned by the Government; however, the Contractor shall provide the following: House, feed, and provide veterinary care and technical service support for up to 700 NHPs of various Old World and New World species. 4. ASPs will be submitted to the Contractor through the Contracting Officer's Representative (COR) or his/her designee. However, the Contractor is responsible for submission of ASPs to their Institutional Animal Care and Use Committee, and Institutional Biosafety Committee, for approval prior to study start. 5. Physical Plant Requirements: a) Biosafety Level: ABSL-3 practices, containment equipment, and facilities. b) Animal rooms: Separate rooms dedicated to VRC experiments. c) Exhaust Air: Exhaust air must be passed through absolute HEPA filters. d) Special Procedures Rooms: Suitable and separate rooms and equipment consistent with the Guide for animal examination, necropsy, surgery, surgical preparation and radiography. The necropsy room shall contain work stations and a downdraft ventilation necropsy table that meets Occupational Safety and Health Administration (OSHA) and American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) standards for exposure limits to formalin. e) Storage Areas: Adequate (~500 cubic feet) secure floor and shelf space for the storage of all equipment, supplies, and pharmaceutical products. f) Alternative Power Supply: An emergency electric generator shall be available to this project and available for immediate use in the event of a loss of electric power. g) Security: Provide a 24-hour security system, including video monitoring and 24-hour security personnel on site to prevent unauthorized entry into facilities and animal areas. h) Proximity: samples (blood, serum, tissues) need to be delivered to the NIH Bethesda campus before noon on the day it is collected. 6. Animal Environment, Housing, and Management Requirements: a) Caging Specifications: mobile modular cages designed to permit and foster social housing of primates in accordance with The Guide and USDA/Animal and Plant Health Inspection Service (APHIS) regulations under the Animal Welfare Act (AWA) and PHS policy, that promote psychological well-being of the animals, and minimize exposure to infectious agents. b) HVAC: HVAC system and best efforts to maintain 74-76 degrees F. and 15 air changes/hour. c) Disinfection and Sanitization: disinfection and sanitization methods for cages, animal equipment, animal rooms, and biocontainment chambers. d) Medical Pathological Waste (MPW): methods to dispose of medical pathological waste resulting from these support services. e) Environmental Enrichment: plans for enriching the environment of NHPs in compliance with the AWA and NIH manual 3040. g) Identification and Records: comprehensive information and records management system. h) Animal Observation: at least every 2 hours, 24 hours/day, 7 days/week. 7. Veterinary Medical Care Requirements: a) Surveillance, Diagnosis, Treatment, and Control of Disease: program for ensuring all nonhuman primates are negative for Simian immunodeficiency virus (SIV), simian T-lymphotropic virus (STLV) and simian retrovirus (SRV) by serology and/or virus isolation before introducing onto contract. 8. Technical Procedure Requirements: a) Technical procedures to support immunogenicity and viral challenge studies. The nature of investigations being conducted by the VRC scientists using infectious agents including SIVs require long-term, overlapping, labor intensive studies which will necessitate that animals be maintained for longer than 12 months post-inoculation. Viruses to be tested include, but shall not be limited to, the following: i. Various Simian Immunodeficiency Virus (SIV) strains. ii. Various Simian-Human Immunodeficiency Virus (SHIV) strains iii. Various HIV strains iv. Vaccinia wild type and recombinant viruses. v. Attenuated and wild type adenoviruses, including recombinant adenoviruses. vi. Attenuated and wild type Influenza Viruses vii. Various alphaviruses e.g., Chikungunya b) Procedures on animals shall include but not be limited to: inoculation (intravenous, intraperitoneal, subcutaneous, intradermal, intramuscular, intravaginal, intranasal, electroporation and intrarectal) of the animals with various biological agents or vaccine preparations, sample collection (e.g., blood, tissues, biopsies, BAL, mucosal collections) 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 COR. 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. c) During the disease course and at termination of study, various clinical or pathological procedures will be performed, including but not limited to: i. Phlebotomy ii. Cerebrospinal Fluid Aspiration iii. Bone Marrow Aspiration iv. Peripheral Lymph Node Excisional Biopsy v. Comprehensive Experimental Necropsy vi. Bronchoalveolar Lavage vii. Survival Surgery: Partial Splenic Resection, splenectomy, mesenteric lymph node excisional biopsy, GALT excisional biopsy. viii. Apheresis ix. Endoscopic jejunal biopsy x. Mucosal fluid collections to include lung, rectal, vaginal, nasal, oral. xi. Various methods of immunogen delivery Anticipated period of performance It is anticipated that an award will be made on or about August 27, 2019 for the period of September 1, 2019 through August 31, 2020 with six option years as indicated below: Option Year 1 - September 1, 2020 through August 31, 2021 Option Year 2 - September 1, 2021 through August 31, 2022 Option Year 3 - September 1, 2022 through August 31, 2023 Option Year 4 - September 1, 2023 through August 31, 2024 Option Year 5 - September 1, 2024 through August 31, 2025 Option Year 6 - September 1, 2025 through August 31, 2026 Capability statement / information sought In 10 pages or less, respondents should submit a capability statement of their organization which demonstrates their ability to supply the above requirements (see paragraph C. Requirements). Responses must reference the sources sought number and include the following: 1. Name and Address of the Company, DUNS number. 2. Size and type of business, pursuant to the applicable NAICS code 541715. 3. Point of contact with name, title, address, phone, fax and email. 4. Capability to provide the specifics of this requirement, with appropriate documentation supporting claims of organizational and staff capability. 5. Examples of prior completed Government contracts, references, the dollar value of that work, and other related information; 6. List of organizations to whom similar types of services have been previously provided and the dollar value of that work. Please respond by e-mail with a capability statement by April 25, 2018 at 3:00 PM EST. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. 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: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Patrick Wilson, Contract Specialist, at contact@example.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSSNIHAO201800005. Facsimile responses will not be accepted. Disclaimer and Important Notes This notice does not obligate the Government to award a contract 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).