SPECIAL NOTICE
B -- Study on the Investigation of the Sensitivity of Pharmacokinetics in Detecting Differences in Physicochemical Properties of the Active in Suspension Nasal Products for Local Action
- Notice Date
- 6/26/2017
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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-1185715
- Archive Date
- 7/14/2017
- Point of Contact
- Heather Kinsey, Phone: 2404027591
- E-Mail Address
-
heather.kinsey@fda.hhs.gov
(heather.kinsey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Subject: Notice of Intent to Sole Source FDA-1185715 Date: June 26, 2017 The U.S. Food & Drug Administration intends to issue a sole-source purchase order to the University of Florida for additional work to continue the study on the investigation of the sensitivity of pharmacokinetics in detecting differences in physicochemical properties of the active in suspension nasal products for local action. The additional work is to develop and validate the Morphologically- Directed Raman Spectroscopy (MDRS) method. The LC-MS/MS bioanalysis is critical to achieve the sensitivity limit of 0.5 pg/mL (or better) required. This limit was not included in the original contract. Award will be made in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements using Simplified Acquisition Procedures per FAR Part 13. University of Florida is the sole-supplier and only company that is able to provide all of the above requirements. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within five (5) days after the publication of this synopsis which shall be considered by the agency. Responses received after 5 days or without the required information may not be considered. A determination by the Government not to compete as a result of information received is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. For information concerning this acquisition, contact Heather Kinsey, Contract Specialist at Heather.Kinsey@fda.hhs.gov or call (240) 402 - 7591.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-1185715/listing.html)
- Record
- SN04558051-W 20170628/170626235228-e7365d2653cb0530e86fb7d5a780dc49 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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