SPECIAL NOTICE
A -- Triazine Drug Manufacturing
- Notice Date
- 3/16/2017
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- 11000279
- Archive Date
- 5/15/2017
- Point of Contact
- Sharew Hailu,
- E-Mail Address
-
sharew.hailu.civ@mail.mil
(sharew.hailu.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis, IAW FAR 6.302-1(a), with the Ricerca Bioisciences, LLC located at 7528 Auburn Road, Concord, Ohio 44077 as the only responsible source that can provide Walter Reed Army Institute of Research to successfully manufacture, label, package, and test a triazine compound in accordance with the manufacturing process, product specification, and analytical test methods specified under each of the following tasks: Task 1 - Final Quality Agreement/Plan with WRAIR and USAMMDA Task 2 - Analytical Test Methods Task 3 - Phase 1 & 2a Manufacture BDS, formulated into capsules for oral dosing Manufacture a placebo BDS, formulated into capsules for oral dosing Shipping & Storage Task 4 - (Optional) Phase 2b Manufacture BDS, formulated into capsules for oral dosing Manufacture a placebo BDS, formulated into capsules for oral dosing Shipping & Storage Task 5 - (Optional) Phase 3 Manufacture BDS, formulated into capsules for oral dosing Manufacture a placebo BDS, formulated into capsules for oral dosing Shipping & Storage Task 6 - (Optional) Formulation of triazine and placebo BDS into an alternate solid oral dosage form. Shipping & Storage Task 7 - Technical Data Package (TDP) Task 8 - eCTD-compliant Module 2 summaries and Module 3 Quality sections
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/11000279/listing.html)
- Record
- SN04437535-W 20170318/170316234749-b2ebede8b8c8048fad2473b233cb0b58 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |