Notice of Intent to Sole Source - Support and Maintenance of the Existing Product Accountability and Stability Tracking System - W81XWH-17-T-0268

Notice of Intent to Sole Source

The United States Army Medical Research Acquisitions 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 has a requirement for continued support and maintenance of the existing Product Accountability and Stability Tracking System (PAS). The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Firm Fixed-Price sole source contract under the authority of FAR 13.106-1(b)(1)(i), on or about 01 August 2017 to Foxspire, LLC on behalf of the United States Army Medical Materiel Development Activity (USAMMDA). Further information about the requirement is below.

A product accountability system was previously fully customized and is 21 CFR Part 11 compliant. The PAS system tracks inventory for all OTSG-DA Sponsored products. The current accountability system is unique because it was developed and fully customized to the needs of the U.S. Army. Without a sole source award to the current contractor, this system could become nonfunctional as soon as the next patch is developed and implemented.

If the sole source is not awarded to the current contractor, the Government would not be able to fulfill the Sponsor's requirement per the Code of Federal Regulations. If the FDA were to inspect USAMMDA and were to deem their product accountability records as deficient the FDA would issue a FORM 483. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. An observation, depending on its severity, can result in Sponsor Clinical Hold. Sponsor Clinical Hold could halt all drug and biologic development until the PAS system records were reconciled to show accurate inventories. This would result in delays in getting products approved to treat the Warfighter.

PAS currently also has the ability to track stability time points and reports in accordance with the manufacturer's stability testing schedule. The current system sends out reminders of upcoming stability time points to ensure the required testing is performed per the Investigational New Drug application. Without a sole source award to the current contractor the Government could potentially be putting healthy subjects or patients at risk in the event a time point is missed.

RFQ W81XWH-17-T-0268 will be issued on a sole source basis. The North American Industry Classification System (NAICS) code for this requirement is 541511 and the small business size standard is $27.5 Million. Any sources that believe they are eligible to provide these 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 purpose 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 seventeen (17) days after the publication of this notice, the purchase order 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 Monday, 19 June 2017.