Federal Bid

Last Updated on 27 Sep 2013 at 8 AM
Solicitation
Center Kentucky

GMP percursor

Solicitation ID CC-P13-015395
Posted Date 06 Sep 2013 at 5 PM
Archive Date 27 Sep 2013 at 5 AM
NAICS Category
Product Service Code
Set Aside 8(a) Set-Aside (FAR 19.8)
Contracting Office Clinical Center/Office Of Purchasing & Contracts
Agency Department Of Health And Human Services
Location Center Kentucky United states
This is a notice of intent to award a sole source purchase order and is not a request for competitive proposals under the authority of 41.U.S.C. 253 (c)(1) as set forth in Federal Acquisition Regulation FAR 6.302-2-2(b)(2). The government has entered into a firm fixed price award with ABX GmbH, Attention Frank Gersten, ABX, Heinrich-Glaeser-Strasse 10-14, D-01454 Radeberg, Germany, DUNS Number 499166874.


The Positron Emission Tomography Department (PET), resides within the Mark O. Hatfield Clinical Research Center, a state of the art, 250-bed biomedical research hospital located on the campus of the National Institutes of Health in Bethesda, MD.

Currently The PET Department requires the procurement of Ga-68 DOTA-TATE GMP precursor (9772) from ABX advanced biochemical compounds GmbH for the preparation of an IND PET Drug (IND Number 119098). The precursor and the source are specified within the Food and Drug Administration IND Application and as such cannot be changed without amendment of the IND as per 21CFR 212 - CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS.

The purpose of this award was to procure Ga-68 DOTA-TATE. Ga-68 DOTA-(Tyr3,Thr8)-Octreotide is a Ga-68 labeled analog of the peptide, somatostatin, and primarily used for the PET imaging of neuroendocrine tumors. Here at the NIH, Ga-68 DOTATATE will be used in the following Institute directed human use protocols:

Small businesses are encouraged to respond to this notice if they are capable to meet the needs of this requirement. Written responses to this notice shall contain sufficient documentation to establish a bonafide capability and compatibility to fulfill the requirement. A complete statement of work is attached for reference.

The intended procurement will be classified under North American Industry Classification System Code 424210 Pharmacy and Drug Stores with a size standard of 100 employees.

The Government shall consider all responses received prior to the close date of this announcement. All responses must be received no later than September 12, 2013 at 1:00PM, Eastern Standard Time. Please email Brian Lind, Contract Specialist, at [email protected] with technical questions or written responses pertaining to this notice. No phone calls will be accepted.

Bid Protests Not Available

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