SPECIAL NOTICE
A -- Sole Source Notice - Freeze Dried Plasma
- Notice Date
- 3/20/2019
- Notice Type
- Synopsis
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Attn: MCMR-AAA 820 Chandler Street Frederick, MD 21702-5014 MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-19-FDP-Sole-Source
- Response Due
- 4/4/2019
- Point of Contact
- Douglas A. Medcalf, Contract Specialist
- E-Mail Address
-
douglas.a.medcalf.civ@mail.mil
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent to Sole Source The United States Army Medical Research Acquisition Activity (USAMRAA), on behalf of the U.S. Army Medical Materiel Development Activity (USAMMDA), is issuing this notice of intent to award an out of scope contracting modification on a sole source basis. This is not a request for proposals. This notice does not represent a commitment by the Government to pay for costs incurred from the preparation and/or submission of data in response to this notice. The Government intends to award a sole source out of scope contract modification to Westat, Inc. This requirement is to support a Phase 2 clinical trial for commercial sustainability of Freeze Dried Plasma (FDP). One of the Food and Drug Administration (FDA) requirements for Biologic License Application (BLA) approval is to start enrollment for a Phase 2 warfarin reversal clinical trial at or immediately following BLA approval (summer 2019). This modification is initiated due to changes in the regulatory strategy based on discussions with the FDA. The Phase 2 study required by the FDA is now a multi-site pivotal study in warfarin reversal healthy normal subjects (rather than liver disease patients). The purpose of this contract modification is to continue the performance of Good Clinical Practices (GCP) compliant clinical trials of a Freeze Dried Plasma product to obtain FDA Licensure under Contract # W81XWH-15-C-0048. Specifically, this modification will: a. Change patient population from liver disease to warfarin reversal. The study remains a Phase 2 multi-site trial. b. Increase the required number of screened subjects in the Phase 2 Pivotal Clinical Trial to achieve the required statistical power of the study (due to projected subject dropout rate for this type of study). c. Conduct additional required testing per the FDA and submit Clinical Data Interchange Standards Consortium (CDISC) delivery of all data components to USAMMDA for the submission of data to the FDA in the required format. This modification will enable the Freeze Dried Plasma program to continue development without the Government incurring a significant schedule lapse or duplicative costs. The product Sponsor is seeking FDA approval utilizing the accelerated approval pathway. As such, the FDA is requiring that the Phase 2 study protocol be FDA approved and the study to be initiated at the time of Biologic License Application (BLA) submission (currently scheduled for June 2019). Westat, Inc. is the only responsible source that can initiate the study in the required timeframe. Award to any other contractor will incur additional/duplicative costs and a delay in the program achievement of FDA approval. This out of scope modification will be issued on a sole source basis. The North American Industry Classification System (NAICS) code for this requirement is 541715 and the small business size standard is 1,000 employees. Any sources that believe they are eligible and capable of providing these services without duplicating the time and cost already invested must respond in writing. Responses must be supported with clear and convincing evidence articulating the ability to provide the items outlined above. A request for documentation will not be considered an affirmative response. Information received will be considered solely for the purposes of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects fifteen (15) days after the publication of this notice, the modification will be awarded without further remark. This notice is provided solely as information to the marketplace. CONTACT INFORMATION: Questions may be submitted to Mr. Doug Medcalf at douglas.a.medcalf.civ@mail.mil no later than 4:00PM EST on Thursday, 04 April, 2019. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (20-MAR-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-19-FDP-Sole-Source/listing.html)
- Record
- SN05255232-F 20190322/190320230025 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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