SOLICITATION NOTICE
66 -- RFQ-FDA-75F40121Q00107 - Feeder and Chiller for Thermo Fisher Scientific Pharma 11 Extruder
- Notice Date
- 7/27/2021 9:12:26 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- 75F40121Q00107
- Response Due
- 8/5/2021 2:00:00 PM
- Archive Date
- 08/20/2021
- Point of Contact
- Adam Powell, Phone: 2404023941
- E-Mail Address
-
adam.powell@fda.hhs.gov
(adam.powell@fda.hhs.gov)
- Description
- This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION. A SEPARATE SOLICITATION DOCUMENT (I.E. STANDARD FORM) WILL NOT BE ISSUED. The solicitation number for this acquisition is RFQ-FDA-75F40121Q00107 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation: 334516 Analytical Laboratory Instrument Manufacturing. The Small Business Size Standard is 1,000 employees. This is an unrestricted brand-name or equal full-and-open competition RFQ. Simplified acquisition procedures will be utilized. The U. S Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) requires one (1) Twin Screw Feeder MiniTwin Gravimetric assembly (Thermo Fisher Scientific Pharma 11) or equal.� Inquires Offerors must submit all questions concerning this solicitation in writing electronically to adam.powell@fda.hhs.gov. Questions must be received no later than August 2, 2021 4:00 p.m. Eastern Standard Time. Any responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation. Even if provided in other form, only the question responses included in the amendment to the solicitation will govern performance of the contract. � BACKGROUND INFORMATION The FDA Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Office of Testing & Research (OTR) operates as an integrated testing and research FDA laboratory to develop scientific methods and tools to assess pharmaceutical quality issues and support the following core functions: standard, guidance, and policy development, pharmaceutical quality surveillance, quality assessment of regulatory submissions, and rapid response to public health emergencies. To fulfill its mission, OTR�s Division of Product Quality Research (DPQR) requires a gravimetric feeder for a pre-existing Thermo Fisher Scientific Pharma 11 hot melt extruder. �The purpose of the required gravimetric feeder is to manufacture complex polymeric drug products and implants to provide FDA in-house samples for related regulatory research projects. The equipment will be used to support projects investigating the impact of manufacturing process on product�s pharmaceutical quality. Note: Reference attached PDF titled, ""FDA RFQ 75F40121Q00107"" for complete combined synopsis solicitation.�
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/d15862a870ff40af827d3e6aa434d1a5/view)
- Place of Performance
- Address: Silver Spring, MD 20993, USA
- Zip Code: 20993
- Country: USA
- Zip Code: 20993
- Record
- SN06075324-F 20210729/210728203733 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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