G
MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for Bordetella-Free Weanling Baboons.
This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the required supply item/services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.
The appropriate NAICS code for the acquisition is 112990 - All Other Animal Production; Small Business Size standards $.75 million.
Background:
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 Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (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 pertussis pathogenesis, evaluate host responses to pertussis infection and vaccination, and evaluate candidate vaccines and therapeutics require large numbers of weanling baboons be delivered to the CBER primate facility over the study period.
Statement of Need:
The purpose of this solicitation is to obtain weanling baboons for studies to be conducted at FDA/CBER Facility in Silver Spring, Maryland.
Minimum Requirements:
Delivery acceptance criteria:
The animals shall be of the age specified. The animals shall be free of exposure to Bordetella. The animals shall arrive in good health. Acceptance of the animals will be made by the supervising veterinarian at the quarantine facility upon completion of a quarantine entry.
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 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:
1. 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.
2. 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.
3. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing.
4. 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 parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 2:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on November 3, 2016 to [email protected], Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Jennifer L. Johnson, 3900 NCTR Road, Building 50, Room 429, Jefferson, AR 72079-9502 and Reference: FDA1176223.
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).