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The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER), who requires Bordetella-Free Weanling Baboons.
If your firm is considered a small business source under North American Industry Classification System (NAICS) 112990 - All Other Animal Production; with a Small Business Size standards $.75 million, and believe your firm would be able to provide the FDA with Bordetella-Free Weanling Baboons, please submit an email to [email protected]. The vendor shall include information about the company which demonstrates they can meet all of the minimum requirements.
Background/ Statement of Need:
Pertussis is an acute, highly contagious, potentially life threatening respiratory disease, caused by the Gram-negative bacterium Bordetella pertussis. The underlying factors leading to the failure of public health measures to control pertussis disease using currently licensed vaccines are poorly understood. A more complete understanding of this disease and of the mechanisms of vaccine-mediated protection is a critical public health need. Currently, the baboon model of pertussis, developed in the laboratories of the FDA/CBER, is the only animal model of pertussis that recapitulates the disease as observed in human patients. The use of this animal model to study to study the relative effectiveness of mucosal vaccination with acellular pertussis vaccine and acellular pertussis vaccine containing the iron-regulated antigens requires the delivery of vaccinated, weanling baboons to the CBER primate facility.
Minimum Requirements:
- Bordetella-Free Weanling Baboons (quantity of 31)
- Vaccinated as directed with FDA provided vaccines at 2 and 4 months of age before delivery to CBER
- The contractor shall draw blood prior to each vaccination and ship sera to CBER laboratories
- The contractor shall be able to provide all age-matched baboons in a single delivery (between 5-7 months of age at time of delivery)
- All baboons shall be examined by a licensed veterinarian, Doctor of Veterinary Medicine (DVM) as defined by the Animal Welfare Act Regulations (9 CFR, Subchapter A, Part 1 - Definition of Terms), experienced in Non-Human Primates (NHP) medicine and surgery, and found to be in good health prior to shipping accompanied by a certificate of health for each baboon
- Baboons shall be shipped by USDA-licensed carriers and the Contractor shall be responsible for meeting all requirements associated with shipment and delivery of animals
- Shippers shall comply with Animal Welfare Act Regulations regarding the transportation standards for NHP, Title 9, Subchapter A - Part 3 -- Transportation Standards.
- Contractor shall maintain liaison with carrier personnel in order to assure the animals receive proper care in accordance with USDA standards and guidelines during transit
FOB Destination:
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
Silver Spring, MD 20993
Responses to this sources sought shall unequivocally demonstrate that the respondent is regularly engaged in providing research baboons. Though the target audience is small business or small businesses capable of providing baboons from another small business, all interested parties may respond. At a minimum, responses shall include the following:
- Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.
- Past Performance information shall include date of services, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent.
- Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing.
- If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.
Interested Contractors must respond with capability statements in person, by e-mail, fax, mail or other delivery method before 1:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on June 16, 2016 to [email protected], Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Howard Nesmith, 3900 NCTR Road, Building 50, Room 424, Jefferson, AR 72079-9502 and Reference: FDA_16-223-SOL-1168212-629.
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 FedBizOpps. 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).
Additional Notes:
If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.