Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF MAY 27, 2021 SAM #7117
SOURCES SOUGHT

66 -- Notice of Intent to Sole Source for RoboSep

Notice Date

5/25/2021 3:16:17 PM
 

Notice Type

Sources Sought
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

FDA Office of Acquisitions and Grants Services Rockville MD 20857 USA
 

ZIP Code

20857
 

Solicitation Number

FDA-NOI-SS-1241447
 

Response Due

6/1/2021 8:00:00 AM
 

Archive Date

06/01/2021
 

Point of Contact

Sarah Hussain
 

E-Mail Address

Sarah.Hussain@fda.hhs.gov
(Sarah.Hussain@fda.hhs.gov)
 

Small Business Set-Aside

SBA Total Small Business Set-Aside (FAR 19.5)
 

Description

The U.S. Food & Drug Administration (FDA), intends to issue a Sole Source award to STEMCELL Technologies Inc. (STEMCELL) for procurement of one (1) each Automated Cell Separation Instrument RoboSep�.� The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other will satisfy the agency requirements for the above stated equipment. FDA currently owns and operates a RoboSep� cell separator instrument to support research of Antibody-dependent functions of innate cells such as Natural Killer Cells and Monocytes. The current cell separator is obsolete, and maintenance is no longer supported by the manufacturer, STEMCELL. Therefore, FDA requires an upgraded automated cell separation instrument that needs to be compatible with existing qualified SOPs and assays developed using the original RoboSep� to continue the FDA mission in research and expand capability with advanced technology.� The instrument shall be fully automated where the protocol steps need to be done inside the instrument. It shall also be able to use the same customized and qualified protocols, proprietary reagents, accessories and consumables that were used and developed using the existing FDA instrument to maintain the consistency of procedures in place. RoboSep� is unique in its operation and many of the features and benefits of the technology are not available in other commercially available instruments that may perform similar functions. It is the only known source to be capable of providing seamless transfer of parameters and support FDA program office requirement. STEMCELL is the sole source manufacturer and supplier of the RoboSep� instrument, software and ancillary products. � Previous award to STEMCELL has been made for the old model of the Automated Cell Separation Instrument, RoboSep�, this award will be to procure the upgraded model. This will be a firm fixed price award.� The NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing STEMCELL Technologies Inc. 6425 S 216TH ST, KENT, WA 98032 This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement to Sarah Hussain, sarah.hussain@fda.hhs.gov in writing and must be within seven (7) days after date of publication of this notice which may be considered by the agency.�� A determination by the Government not to compete as a result of information received is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No phone calls will be accepted.
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/2a3de62ec30e47d889799477e2b50d98/view)
 

Place of Performance

Address: Silver Spring, MD 20903, USA

Zip Code: 20903

Country: USA
 

Record

SN06012876-F 20210527/210525230106 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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