SOLICITATION NOTICE
A -- Notice of Intent to Sole Source Phase 3 Development of Sufentanil NanoTab
- Notice Date
- 12/3/2014
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- 0010622458
- Response Due
- 12/18/2014
- Archive Date
- 2/1/2015
- Point of Contact
- TOLORIA DUVALL, 3016192836
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(toloria.s.duvall.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD intends to issue a sole source award to AcelRx Pharmaceuticals, Inc., in Redwood City, CA. The Government is seeking to develop a fast-acting, easily dispensed, sufentanil-based, sublingual battlefield pain management product designed to relieve acute pain with minimal side-effects usually associated with the use of common analgesics currently in use. The current lead candidate for an alternative Battlefield Pain Management product that is safe, fast-acting, and administered without the necessity of starting an intravenous or intraosseous infusion is the Sufentanil Nanotab under development by AcelRx Pharmaceuticals. The US Army and the US Army Medical Materiel Development Activity (USAMMDA) Pharmaceutical Systems Project Management Office (PSPMO) have selected the Sufentanil Nanotab program for clinical development to satisfy the capability for an alternative pain management product on the battlefield. The Sufentanil Nanotab Program is scheduled to begin a Phase 3 clinical trial to assess the safety, tolerability and efficacy of single and repeat dosing of the sufentanil microtablet. AcelRx Pharmaceuticals, Inc. is the only source capable of rendering services required to initiate the Phase 3 clinical trial. The Army has no knowledge of any additional efforts for development of a sufentanil-based battlefield pain management product, thus this procurement shall be under other than full and open competition procedures in accordance with FAR 6.302. This notice of intent is for information purposes only, therefore, no solicitation will result from this announcement. All sources eligible to provide this service must respond in writing. Responses must be supported with clear and convincing evidence to clearly be able to provide services outlined above. A request for documentation will not be considered as an affirmative response. If no responses are received, within fifteen (15) days, 18 December 2014, after publication of this notice, to the effect that comparable supplies and services are available, and that it is more advantageous to the Government than obtaining these services through a sole-source contract, then a sole source acquisition award will be made. Response to this notice should be sent to toloria.s.duvall.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/0010622458/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03585643-W 20141205/141203234220-5658a1be186bf770a08729d024077523 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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