SPECIAL NOTICE
A -- Valproic Acid for the Treatment of Significant Hemorrhage
- Notice Date
- 5/28/2020 8:11:17 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH20VPA
- Response Due
- 6/12/2020 2:00:00 PM
- Archive Date
- 06/27/2020
- Point of Contact
- Jeanette Wolfe
- E-Mail Address
-
jeanette.m.wolfe.civ@mail.mil
(jeanette.m.wolfe.civ@mail.mil)
- Description
- The United States Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702, intends to award a sole source contract to Westat, Inc. to procure services of an investigation new drug (IND) sponsor for the performance of Good Clinical Practice (GCP) compliant clinical trials leading to a new indication for Valproic Acid (VPA) for the treatment of patients with significant hemorrhage in accordance with government requirements.� The contractor will manage the planning and execution of placebo controlled randomized multicenter phases 2 and 3 clinical trials in a variety of patients. The study will require subjects with high risk of significant hemorrhage using VPA as an adjunct to resuscitation to obtain indication approval from the U.S. Food and Drug Administration (FDA). The contractor will be required to be the regulatory sponsor for the product development effort including everything until New Drug Application (NDA) filing with the FDA. Accordingly the intended contractor will bear the legal responsibilities of sponsor under 21 CFR 312 Subpart D and retain control over the product development effort. The proposed contract action is for the research and development for which the government intends to solicit and negotiate with only one source under the statutory authority permitting other than full and open competition, 10 U.S.C. 2304(c)(1), FAR 6.302-1 when the supplies or services required by the agency are available from only one or a limited number of responsible sources and no other type of supplies or services will satisfy agency requirements. The requirement is in support of Department of Defense, the United States Army Medical Research and Development Command, Joint Program Committee-6, Combat Casualty Care Research Programs (CCCRP), Fort Detrick, MD. USAMRAA intends to award a sole source contract to Westat, Inc. in accordance with FAR 6.302-1 under NAICS 541715. Capability statements received by 5:00 PM Eastern Time on 12 June 2020 will be considered by the government. A determination by the government not to compete the proposed contract based upon responses to this notice 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.� Capability statements shall be submitted by email only as a Microsoft Word or Adobe PDF attachment to Jeanette.m.wolfe.civ@mail.mil.� This announcement services as a notice of intent and shall not be construed as a solicitation or as an obligation on the part of the United States Army Medical Research and Development Command, Combat Casualty Care Research Program, the United States Army or the United States Army Medical Research Acquisition Activity.� This is not a request for proposal (RFP) or a request for quote (RFQ); this is strictly a notice of intent.� Neither unsolicited proposals nor any other kinds of offers will be considered in response to this notice of intent.� No contract will be awarded pursuant to this announcement.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/6cd36f042cda4240acd2f6deafbabaf9/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN05672614-F 20200530/200528230156 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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