The U.S. Food and Drug Administration (FDA) intends to award, using Simplified Acquisition Procedures, in accordance with FAR Part 13, a sole source award to Attagene Inc., under authority of FAR 6.302-1 41 U.SC. 253 (C)( 1 ) which states that only one responsible source and no other supplies or services will satisfy agency requirements. The Government anticipates the issuance of Award within (5) days after the response date of this notice. It is anticipated that the period of performance will be conducted over a period of 60 days from date of award.
The FACTORIAL® test was developed by Attagene Inc. for uniform quantification of the activity of 51 transcription factors controlling all major biochemical and immunological processes in mammalian cells. It produces a unique amount of information necessary to predict both efficacy and safety of vaccine adjuvants. The test is patented by Attagene Inc., and is not performed by any other commercial company. It uses a number of proprietary plasmids carrying transcription control elements. The plasmids are not available to independent investigators, and thus the tests cannot be performed at FDA. Therefore the only way to use FACTORIAL® method is to contract Attagene to perform the analyses. (U.S. Patent: 200601601408) Because this service was determined to be available only from Attagene, Inc in FY2009 through OAGS competitive process, and this data must be consistent with data received from that initial study.
All responsible sources may submit a response by the due date of this posting to
[email protected] and all questions regarding the post should be sent to the same e-mail address. Responses must be received within five days from the published date of this notice. All responses must be sent electronically, no faxes will be accepted.
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