SOURCES SOUGHT
B -- Procurement of IND PET Drug Precursors
- Notice Date
- 3/27/2015
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument 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-P15-008235
- Archive Date
- 4/23/2015
- 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
- The National Institutes of Health, Clinical Center is conducting a market survey/sources sought to help determine the availability and technical capability of qualified small businesses, veteran-owned small businesses, service disabled veteran-owned small businesses, HUBZONE small businesses, small businesses under the 8(a) program, and/or businesses under GSA Schedule, capable of serving the needs mentioned below. This market survey/sources sought announcement is not a request for proposals and the Government is not committed to award a contract pursuant to this announcement. The information from this market research is for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning this market research. The Government will not pay for any costs incurred in the preparation of information for responding to this market survey. The Positron Emission Tomography (PET) Department, National Institutes of Health (NIH), Clinical Center in Bethesda, Maryland has a need to order from the precursors listed below for PET Drug preparation for use in human imaging protocols. Each of the precursor compounds needed to manufacture the listed PET Drug Products must be approved for use by the FDA as either Investigational New Drugs (INDs) or in one case prepared under the authority of NIH's Radioactive Drug Research Committee (RDRC). The manufacture of these radiopharmaceuticals in accordance with 21 CFR 212 - CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS or USP General Chapter <823> - Radiopharmaceuticals for Positron Emission Tomography - Compounding requires that any key ingredient that has the potential to effect either the quality, strength, purity, and/or safety of the finished radiopharmaceutical or Active Pharmaceutical Ingredient (API) be obtained from a trusted and validated source. Continuous supply of these key ingredients is critical to the success of the NIH PET Department imaging studies. These imaging studies are an integral component of patient care and the research mission of the Clinical center. All precursors must be ready to ship within 24 hours of ordering. Included with each delivery must be the proper documentation as to the identity and purity of the product. Table 1 - Compound Name and PET Drug Product 1a N-Formyl-3,4-di-tert-butoxycarbonyloxy-6-(trimethylstannyl)-L-phenylalanine ethyl ester; L-Tyrosine, 5-[[(1,1-dimethylethoxy)carbonyl]oxy]-N-formyl-2-(trimethylstannyl)-, ethyl ester, 1,1-dimethylethyl carbonate PET Drug Product - Stannylated precursor for 6-[18F]Fluoro-L-DOPA 1b 6-Fluoro-L-DOPA hydrochloride PET Drug Product - Reference standard for 6-[18F]Fluoro-L-DOPA 2a N-Trifluoroacetyl-3,4-di-tert-butoxycarbonyloxy-6-trimethylstannyl-phenethylamine; Carbonic acid, 4-[2-[(trifluoroacetyl)amino]ethyl]-5-(trimethylstannyl)-1,2-phenylene bis(1,1-dimethylethyl) ester PET Drug Product - Precursor for 6-[18F]Fluorodopamine 2b 6-Fluorodopamine PET Drug Product - Reference standard for 6-[18F]Fluorodopamine 3 DOTATATE PET Drug Product - Precursor for [68Ga]DOTATATE 4a Tosyl-Fallypride; (S)-2,3-dimethoxy-5-[3-[[(4-methylphenyl)sulfonyl]oxy]propyl]-N-[[1-(2-propenyl)-2-pyrrolidinyl]methyl] benzamide; (S)-2,3-dimethoxy-5-[3-[[(4-methylphenyl)-sulfonyl]oxy]-propyl]-N-[[1-(2-propenyl)-2-pyrrolidinyl]methyl]-benzamide PET Drug Product - Precursor for [18F]Fallypride 4b Fallypride PET Drug Product - Reference standard for [18F]Fallypride 5a (2S,3S)-N-Boc-norethylreboxetine; 1,1-Dimethylethyl-2-[(S)-(2-hydroxyphenoxy)-phenylmethyl]-(2S)-4-Morpholinecarboxylate PET Drug Product - Precursor for [11C]MeNER 5b (2S,3S)-Methylreboxetine PET drug Product - Reference standard for [11C]MeNER 6a N-[(2-hydroxyphenyl)methyl]-N-(4-phenoxy-3-pyridinyl)acetamide PET Drug Product - Precursor for [11C]-PBR28 6b PBR28; N-(2-Methoxybenzyl)-N-(4-phenoxypyridin-3-yl)acetamide PET Drug Product - Reference standard for [11C]-PBR28 7 Trifluoromethanesulfonate salt of Pentamethylbenzyl-(4-trimethylammonium) benzoate PET Drug Product - Precursor for the FPAC labeling agent, 4-[18F]Fluorobenzoic acid The NIH-PET Department seeks a contractor who can provide proof of a successful FDA audit for GMP compliance for APIs in the last 4 years. A Certificate of Analysis sample must be provided for each pre-cursor listed in Table 1. A pre-approval Facility Inspection Certificate, facility and product flow diagrams, and documentation of the proposed manufacturing facility's current possession of and procession of a U.S. FDA facility registration must also be provided. The vendor responses must demonstrate their capability of providing each precursor with the characteristics described above. Please note that failure to specifically demonstrate capability to provide the precursors listed, required certifications, certificates and other listed proofs in your response to this market survey may affect the Government's review of industry's ability to perform these services. The vendor's response shall be in sufficient detail to allow the Government to assess the capability of your firm. The vendor response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the company to perform the specialized requirements described in this synopsis. Interested organizations must demonstrate and document in any response submitted to this market survey extensive experience with and the ability to perform all of the specialized requirements elsewhere described. This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. THIS IS NOT A REQUEST FOR PROPOSALS. The Government will not award a Purchase Order or Contract based upon Vendor responses to this announcement. The Government shall not assume any costs for preparing or submitting any information in response to the market survey or the Government's use of the information. Any proprietary information should be clearly identified as "proprietary information". Vendors must send written capability responses by April 8, 10:00 a.m. Eastern Time to Lisa Schaupp, the Contract Specialist at the e-mail address Lisa.Schaupp@nih.gov. For any questions regarding the response submission process, please respond in writing to the email address provided.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/NIH-CC-P15-008235/listing.html)
- Place of Performance
- Address: National Institutes of Health, Clinical Center, PET Department, 10 Center Drive], Building 10, Room 1C-498, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03681204-W 20150329/150327234556-534a046ab8af01f260e56c06b2bc8823 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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