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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 15, 2015 FBO #4800
SPECIAL NOTICE

B -- Procurement of Precursors for the Production and Manufacture of PET Drugs

Notice Date
1/13/2015
 
Notice Type
Special Notice
 
NAICS
325412 — Pharmaceutical Preparation 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
NIH-CC-P15-005092
 
Archive Date
2/10/2015
 
Point of Contact
Lisa L. Schaupp, Phone: 3014020735
 
E-Mail Address
Lisa.Schaupp@nih.gov
(Lisa.Schaupp@nih.gov)
 
Small Business Set-Aside
N/A
 
Description
Notice of Intent to Sole Source The National Institute of Health (NIH), Clinical Center (CC); Office of Purchasing and Contracts (OPC), on behalf of the CC Nuclear Pharmacy Department intends to negotiate on a sole source basis and award a Fixed Price Order, to ABX Advanced Biochemical compounds to procure precursors for the production and manufacture of PET Drugs under the authority of FAR 6.302-1. The North American Industry Classification System (NAICS) code for this acquisition is 325412, and the size standard is 750 employees. This notice of intent to award is not a request for competitive quotations. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. No solicitation is available. Information received will be evaluated for the purpose of determining whether to conduct a competitive procurement. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. The following verbiage is directly from the Justification for Other Than Full and Open Competition (JOFOC). The acquisition is to procure precursors for the production and manufacture of the following PET Drugs under the following approved FDA INDs: [68Ga]DOTATATE (IND # 119,098), 6-[18F]FluoroDOPA (IND # 35,513) and 6-[18F]Fluorodopamine (IND # 33,866). These three PET Drugs are vital to the PET Department mission. Each precursor is a key ingredient to the manufacture and cannot be changed without amendment to the IND and approval of the FDA. ABX is the trusted source for these three precursors. The PET Drugs: [68Ga]DOTATATE (IND # 119,098), 6-[18F]FluoroDOPA (IND # 35,513) and 6-[18F]Fluorodopamine (IND # 33,866) are routinely prepared by the PET Department for the use in human imaging protocols. The three precursor compounds needed to prepare Ga-68 DOTATATE, F-18 DOPA, and F-18 DOPAMINE, are used under FDA investigational new drug (IND) applications, 119098, 35513, and 33866 respectively. The manufacturing of these radiopharmaceuticals under IND requires a trusted source starting material (e.g. precursor) as these compounds are necessary to guarantee the quality, strength, purity, and safety of the finished radiopharmaceutical. The INDs on file with the FDA list ABX as the supplier of the precursor compounds. Any changes to the supplier of these critical components of the PET drug production process would require validation of the integrity of the component (a costly and timely undertaking). Also, amendments to the FDA would need to be submitted upon completion of the validation process for any non-ABX precursor compound. Finally, all precursors from ABX are in stock and ready to ship. Current supply of precursors are projected to run out at the end of January so it is imperative to use the ABX vendor to guarantee an uninterrupted supply of PET drugs for clinical center imaging studies. Such imaging studies are an integral component of patient care and the research mission of the Clinical center. All responses are due to the Contract Specialist within 15 calendar days from the date of this synopsis. Government Official Designated for Receipt of Information Lisa Schaupp Contract Specialist Email: Lisa.Schaupp@nih.gov Phone: 301-402-0735
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/NIH-CC-P15-005092/listing.html)
 
Place of Performance
Address: National Institutes of Health, Clinical Center, PET Department, 9000 Rockville Pike, 10 Center Drive, Building 10, Bethesda, Maryland, 20892-1180, United States
Zip Code: 20892-1180
 
Record
SN03615003-W 20150115/150113234716-afc2e09c3f717105f31b83c6c771601e (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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