STEMvision Instrument

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 issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER), in order to determine if there are existing small business sources capable of providing a STEMvision Instrument.

The appropriate NAICS code for the acquisition is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size standards - 1000 employees.

Background:
The U.S. Food and Drug Administration (FDA); Center for Biologics Evaluation and Research (CBER), Division of Cellular and Gene Therapies of the Office of Tissues and Advanced Therapies has a critical need for a computer-operated bench-top instrument that images and quantitates hematopoietic colonies in colony forming units (CFU) assays of human bone marrow, peripheral blood and cord blood. Currently CFU assay is the most established assay for measuring potency of CD34+ hematopoietic stem and progenitor cells. Subjectivity associated with the traditional manual colony counting, however, has been an issue affecting the assay accuracy and reproducibility. Development of computer-operated instrument such as STEMvision could potentially address the assay accuracy issue and the need for central standards, issues important in manufacturing gene and cell therapies from human CD34+ cells. Acquisition of this instrument will facilitate our understanding of its performance and limitations, which is essential for our ability to develop and regulate advanced manufacturing of stem cell products. The STEMVsion Instrument in accordance with the below minimum technical requirements and configured as followed with all required consumables and accessories:

1. Stemcell Technologies, STEMVsion Instrument, item #22000 or equal.

Minimum Technical Requirements:
1. Shall be a computer-operated bench-top instrument that images and counts hematopoietic colonies in CFU assays of human bone marrow, peripheral blood and cord blood.
2. Shall have the capability to produce a high-resolution image of all colonies in a CFU assay.
3. Shall create a permanent electronic record of each assay performed.
4. Shall be equipped with software with image analysis algorithms to count hematopoietic colonies produced by CFU-E, BFU-E, CFU--G/M/GM and CFU-GEMM progenitor cells.
5. Shall include installation and onsite training.
6. Shall include a 1-year warranty.

Delivery/Period of Performance: 60 days after receipt of order.

Place of Performance/Ship to Address (FOB Destination):
U. S. FDA - CBER
ATTN: To be provided at contract award
10903 New Hampshire Ave.
Bldg. 52 Loading Dock,
Bldg. 52/72, Room 1238
Silver Spring, MD 20993

Responses to this source sought shall unequivocally demonstrate the respondent is regularly manufacturing and/or selling STEMvision Instrument. Though the target audience is small business vendors or small businesses capable of supplying a U.S. supply item of a small business vendor or producer, 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 the equipment/supply item/services the responding firm is regularly engaged in manufacturing and/or selling.

4. The offeror shall furnish sufficient technical information necessary for the Government to
conclusively determine that the offered item meet the technical requirements identified above.

5. 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 4:00 pm (Central Time - Local Prevailing Time in Jefferson, Arkansas) on July 2, 2019 to jennifer.johnson3@fda.hhs.gov, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Jennifer L. Johnson, 3900 NCTR Rd., Bldg. 50, Rm. 429, Jefferson, AR 72079-9502 and Reference: FDA-SSN-1213951.

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).

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 supply item would be helpful.

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