SPECIAL NOTICE
65 -- Keyhole Limpet Hemocyanin
- Notice Date
- 1/13/2010
- Notice Type
- Special Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- NIHCL2010053v2
- Point of Contact
- Brian J. Lind, Phone: 301-402-0735
- E-Mail Address
-
LindBJ@cc.nih.gov
(LindBJ@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICIATATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Clinical Center at the National Institutes of Health, Department of Pharmacy intends to negotiate on a sole source basis, under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1 a contract for Stellar Biotechnologies, Inc- 415 High Molecular Weight Keyhole Limpet Hemocyanin. This material is required to support ongoing clinical trials with multiple previously submitted Investigational New Drug (IND) applications with the Food and Drug Administration (FDA). Any change in the source of the material would require new analytical assays to be developed, new formulations to be produced, new IND's to be filed with the FDA, and would have a negative impact on the evaluation of data already generated from the ongoing trials. The North American Industry Classification System (NAICS) Code is 325414 and the threshold is 500 employees. There are 3 ongoing NIH protocols using this substance, each with a separate IND describing the use and character of this sterile product. The Keyhole Limpet is a type of sea urchin and the Hemocyanin is a constituent of the sea urchin's blood which has been extracted in a certain way. There are differences in the activity of different colonies of Limpets and so, it is important for the integrity of the studies to get the KLH from the same source. The FDA is aware of the importance of this control factor in the ongoing protocols. It is critical to the integrity of the protocols and the ongoing research that the KLH be from the current supply source previously used in the ongoing trials. Stellar Biotechnologies currently is the only provider that can supply the current source being used in the ongoing protocols. A Market survey was conducted in December 2009. This notice is not a request for competitive proposals; however all responses received within 5 days from the date of the publication of this synopsis will be considered by the Government. Interested parties may identify their interest and capability in writing to Mr. Brian Lind at the address stated below. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purposes of determining whether to conduct a competitive procurement. There is no solicitation package available. For any questions regarding this announcement please contact Mr. Brian Lind at LindBJ@cc.nih.gov. Mailing Address: Mr. Brian Lind Contract Specialist Office of Purchasing and Contracts 6707 Democracy Boulevard Suite 106 Room F Bethesda, MD 20892
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/NIHCL2010053v2/listing.html)
- Place of Performance
- Address: National Institutes of Health, 10 Center Drive, Building 10, Room 1N249, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02041004-W 20100115/100113234503-d98b2ea9a208fa396e956e5153fdde39 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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