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Notice of Intent to Sole Source - Whole Blood Pathogen Reduction Device

General Information

Document Type:SNOTE
Posted Date:Aug 23, 2017
Category: Research and Development
Set Aside:N/A

Contracting Office Address

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

Description

Notice of Intent to Sole Source The United States Army Medical Research Acquisition Activity (USAMRAA), on behalf of the U.S. Army Medical Research and Materiel Command (USAMRMC), is issuing this notice of Intent to Award Sole Source. 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 Terumo Biotechnologies BCT, LLC. This modification is initiated due to extensive delays to the Whole Blood Pathogen Reduction Device (WBPRD) Program. The major cause of the delays resulted from the Food and Drug Administration (FDA) revising their previously agreed upon guidance for the Phase 3 pivotal clinical trial, requiring timely negotiation of the study design which will now take longer to execute. This requirement is for the direct support of ongoing US Army product development efforts to obtain a Food and Drug Administration (FDA) licensed pathogen reduction technology for use with whole blood. The purpose of this contract modification is the continuation of development of Terumos Whole Blood Pathogen Reduction Device (Mirasol® System for Whole Blood) through FDA licensure. Specifically, this modification will: a. Increase the number of subjects required in the ongoing Phase 3 Pivotal Clinical Trial to achieve the required statistical power of the study. b. Include the addition of up to four non-US clinical trial sites in order to satisfy the required patient sample size of the study. Inclusion of non-US sites requires the addition of an international clinical trial organization, hospitals, and blood centers. c. Provide additional regulatory support to maintain the Mirasol® Pathogen Reduction System Investigational Device Exemption, support PreMarket Approval (PMA) meeting with the FDA, complete a gap assessment of development and design control documentation to support PMA approval, and support of an expected panel review meeting with the FDA after PMA submission. d. Test the operation of the Mirasol® System for Whole blood across a range of specifications for key parameters for cell quality, pathogen kill, WBC inactivation, and neoantigenicity to satisfy FDA expectations for system robustness in terms of efficacy and safety. e. Investigate the Mirasol® System for Whole Blood pathogen reduction performance with respect to recent guidance received from the FDA. Terumo has already completed a subset of pathogens, however some do not have the sample size that is now expected by the FDA and will require additional testing. 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 541711 and the small business size standard is 1,000 employees. Any sources that believe they are eligible and capable of providing these R&D services 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 Wednesday, 07 September 2017.

Original Point of Contact

POC Douglas A. Medcalf,

Place of Performance

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