SPECIAL NOTICE
A -- Artesunate for Injection Post-marketing Safety Studies and Clinical Trials
- Notice Date
- 3/19/2021 3:34:44 PM
- 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
- W81XWH21R0043-NOI
- Response Due
- 4/5/2021 7:00:00 AM
- Archive Date
- 04/20/2021
- Point of Contact
- Matthew Teel
- E-Mail Address
-
matthew.d.teel.civ@mail.mil
(matthew.d.teel.civ@mail.mil)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- THIS IS A NOTICE OF INTENT TO AWARD A SOLE-SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate a cost type�/ fixed-price level of effort (LOE)�contract, on a sole source basis, under the authority of 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 to Amivas (US) LLC 100 Tuscanny Dr. Unit B2, Frederick, MD, 21702-5958 in direct support of the U.S. Army Medical Materiel Development Activity (USAMMDA) product development effort. The Government is seeking to conduct post-marketing safety studies and clinical trials to assess possible serious risks associated with Artesunate for Injection.� Post-marketing requirement and commitment studies occur after a drug or biological product has been approved by Food and Drug Administration (FDA).� Under various statutory and regulatory authorities, FDA can require manufacturers of certain drug products to conduct post-marketing studies and clinical trials. Amivas is uniquely positioned to execute the post-marketing safety and clinical studies necessary to meet the requirements under 505(o) of Federal Food, Drug, and Cosmetic Act (the Act).� Amivas LLC is the regulatory sponsor of the New Drug Application (NDA). Their drug was FDA approved in May 2020 and they will continue to manufacture, market, and distribute the Artesunate for Injection; therefore they are the only contractor who has the necessary knowledge and expertise to conduct the studies. The intended procurement will be classified under North American Industry Classification System (NAICS) 541715 with a small business size standard of 1,000 employees. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement.� Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work.� Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point.� All capability statements received by the due date of this notice will be considered by the Government.� A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response.� A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract. Capability statements are due by 10:00 AM EST, April 05, 2021.�� Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF to Matthew Teel at, matthew.d.teel.civ@mail.mil.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/b1ecfbbfac3c49f1ad2ad2e775cb4fa2/view)
- Place of Performance
- Address: Frederick, MD 21704, USA
- Zip Code: 21704
- Country: USA
- Zip Code: 21704
- Record
- SN05947913-F 20210321/210319230110 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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