Sources Sought Notice: Hypoxia Workstation
Sources Sought Notice: Hypoxia Workstation
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 Drug Evaluation and Research’s (CDER). CDER’s Office of Biotechnology Products regulates therapeutic mAbs developed to treat virus infections, cancer and autoimmune disease. The mechanisms of action of many mAbs include antibody dependent cellular cytotoxicity (ADCC) mediated via NK cells as a mode or action. Upon exposure to cytokines, NK cell activation/function is controlled by various metabolites in the micro-environment and NK cells deprived of nutrients in the tumor micro-environment perform regulatory functions. Our experiments study the metabolism of NK cells and macrophages under hypoxic conditions. Currently, the FDA uses chemicals to induce hypoxia, but using hypoxic conditions that are controlled by oxygen levels within the system is more physiologically relevant.
To assist this mission, the FDA seeks to purchase a hypoxia work station possessing the ability to culture cells in a chamber that accurately maintains and controls temperature, humidity, oxygen and carbon dioxide. Through this hypoxia workstation one can study even the most complex cell interactions under perfect hypoxic or anoxic conditions
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 will 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.
Capabilities Required:
The FDA is seeking sources of a hypoxia workstation, to be determined capable of proving this source interested vendors shall be able to provide a workstation meeting or exceeding the following salient characteristics:
Should be a Closed Cell Culture “Lab in a Box” delivering very stable O2, CO2, temperature and humidity control for continuous physiological oxygen cell culture experiments.
The Workstation Working Volume/Capacity should be at least 210L, and should accommodate up to 400 x 96 well plates. The Interlock is 41L and should accommodate 42 x 96 well plates.
The O2 sensor should be digital and needs a minimal replacement for once a year.
Front cover should be removable and operated electronically.
The instrument should include a minimum of 1-year warranty on all parts.
The instrument should have a user friendly Intelligent interlock, that automatically equates O2 level inside interlock to that of main chamber.
Because we have a limited space, the workstation should have a compact foot print and should not exceed 14”x13”x16” (inches WxDxH).
The work station should possess automatic hypoxic Cycling that allows user to set up to 4 different O2 and 4 different CO2 levels.
The workstation should possess an Internal HEPA filtration equivalent to ISO class 4/Class 100
Potential sources shall have the capability to provide technical support with a 24-hour response time for the entire warranty period.
Intuitive, user-friendly software; minimal training needed to run the instrument and perform necessary data analysis
In addition, the respondent vendors shall be required to have the capability to furnish the following accessories/services:
i) One (1) Invivo O2 500
ii) One (1) 262-450 External Hepa Containment
iii) One (1) Annual End-User Service Kit
iv) One (1) Biennial Preventative Maintenance Service Kit
v) One (1) 263-482 Manual Adjustable Stand
vi) Shipping costs should be included
vii) Set-up and Installation and
viii) Initial User training for 3-5 users.
Capability Statements:
Responses to this sources sought shall unequivocally demonstrate the respondent’s capabilities to provide the instrument, accessories, and services described above. Though the target audience is 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,
3. 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.
4. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing.
5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and Schedule Item Numbers (SIN)s that are applicable to this potential requirement are also requested. If a large business, clarify if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.
Response Instructions:
Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 3:00 PM Eastern Time on March 22nd, 2018 to Christopher.mcgucken@fda.hhs.gov.
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).
Christopher R. McGucken, Contracting Officer, Phone (240) 402-7566, Email christopher.mcgucken@fda.hhs.gov
