SOLICITATION NOTICE
66 -- Notice of Intent to Sole Source – EMD Millipore (MilliporeSigma)
- Notice Date
- 8/17/2016
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-NOI-1163232
- Archive Date
- 9/6/2016
- Point of Contact
- Marty F. Nemec, Phone: 2404027663
- E-Mail Address
-
marty.nemec@fda.hhs.gov
(marty.nemec@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent to Sole Source - EMD Millipore (MilliporeSigma) The Food and Drug Administration intends to award a Sole Source firm-fixed price contract to EMD Millipore (MilliporeSigma) at 290 Concord Road, Billlerica, MA 01821 in accordance with FAR part 13.106-1(b)(1)(i). This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Parts 12 and 13. The NAICS code is 334516 - Analytical Laboratory Instrument Manufacturing. This procurement is for two Instruments for Sterility Testing of Drug Products. The laboratory is one of the laboratories in FDA selected for the analysis of drug products under the Lab Optimization Initiative. This new instrumentation is state-of-the-art technology. This particular EMD Millipore instrument will enable the laboratory to achieve analytical results in a five (5) day timeframe. This is an essential requirement since drug products analyzed as either "for cause" or surveillance has a short timeframe. In addition to having results in a more timely manner, during illness/injury outbreaks related to drug products, the FDA would have a more rapid response. The current USP method requires a fourteen (14) day incubation period, this instrument would significantly decrease the time it takes to recover harmful microbial pathogens. The analysts in the laboratory are familiar with the USP methods used for the analysis of many of the products normally analyzed by the laboratory. Having the instrument software and the hardware will allow the FDA's work flow to continue without any interruption. The FDA laboratories currently utilize many filtration products from this specific manufacturer and analysts are knowledgeable with various products related to filtration techniques and methods employed to recover pathogens. For these reasons, an award to EMD Millipore (MilliporeSigma) is intended. This notice is not a request for competitive quotes. However, any party that believes it is capable of meeting the requirements as stated herein may submit a written response, i.e. capability statement, which clearly supports and demonstrates its ability to perform the requirements. Any response shall be received by the response date and time of this notice. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed contract based upon a response to this notice is solely within the discretion of the Government. Response Date: 4:00 p.m. ET on August 22, 2016. Please email responses to Marty Nemec at marty.nemec@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-NOI-1163232/listing.html)
- Record
- SN04227825-W 20160819/160817234808-7661a04d589ff724004502a5bc735c6c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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