SOURCES SOUGHT
B -- Radiopharmaceutical F-18 FDG in single dose radiation shields for daily delivery
- Notice Date
- 5/13/2015
- Notice Type
- Sources Sought
- 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-15-011387
- Archive Date
- 6/6/2015
- 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 NIH Nuclear Medicine Clinic, National Institutes of Health (NIH), Clinical Center in Bethesda, Maryland has a need to order the radiopharmaceutical F-18 FDG for human use. This radiopharmaceutical must be properly compounded, dispensed, calibrated and delivered in single dose radiation shield delivery systems for a specific patient at a specific time on a specific date and must be obtained from a trusted Food and Drug Administration (FDA) and US Nuclear Regulatory Commission (US NRC) validated source. Continuous supply of F-18 FDG is critical to the success of the NIH Nuclear Medicine Clinic imaging and therapeutic studies. These imaging and therapeutic studies are an integral component of patient care and the research mission of the Clinical center. Since the radioactivity of this radiopharmaceutical decay away in 110 minutes, F-18 FDG cannot be purchased in advance for storage. Each radioactive dose must be ordered on the day before the imaging study is scheduled. A specific patient dose (unit dose) of F-18 FDG is then delivered on the same day. Any delay in the ordering or shipping will jeopardize the life of the patient because the life-saving imaging/therapeutic study cannot be performed. The NIH-PET Department seeks a contractor who can provide proof of a successful FDA audit for GMP compliance for radiopharmaceuticals in the last 4 years. A signed Certificate of Analysis sample must be provided for F-18 FDG. A pre-approval Facility Inspection, 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. Certification from the US NRC must also be provided proving the manufacturer meets the US Nuclear Regulatory Commission requirements for safe handling of these radioactive drugs. The vendor responses must demonstrate their capability of providing the radiopharmaceutical F-18 FDG with the characteristics and delivery system described above. Please note that failure to specifically demonstrate capability to provide the required certifications for F-18 FDG 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 May 22, 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-15-011387/listing.html)
- Place of Performance
- Address: National Institutes of Health, Clinical Center, Building 21, 21 Wilson Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03729355-W 20150515/150513234554-59c674c38cf9741870a2cd4034f9516e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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