Inactive

Agency/Office: U.S. Army Medical Research Acquisition Activity Location: U.S. Army Medical Research Acquisition Activity Title: Office of Regulatory Activities (ORA) Regulatory Clinical and Tech Suppo... Agency/Office: U.S. Army Medical Research Acquisition Activity Location: U.S. Army Medical Research Acquisition Activity Title: Office of Regulatory Activities (ORA) Regulatory Clinical and Tech Support Description(s): DUE TO A POST AWARD PROTEST AND TO COMPLY WITH THE REQUIREMENTS AT DFARS PGI 206.302-1 USAMRAA IS POSTING THIS SOURCES SOUGHT NOTICE. The U.S. Government currently anticipates award of a four (4) month extension, plus three (3) one (1) month Option Periods to Contract Number W81XWH-18-C-0178 for a period from 1 May 2021 through 31 August 2021 (1 September 2021 – 30 November 2021 for the option periods). The Government requires continued performance of the services to provide administrative, financial, regulatory, clinical, nonclinical, manufacturing, product accountability and quality support for drugs, biologics, and devices to support the medical product development mission as is necessary to facilitate full program coordination, management, policy development, execution, and oversight across all of ORA. Accordingly, in order to extend this contract, the contract action must fall within the ambit of a proper sole-source contract action under FAR Part 6.3. The proposed extension of Contract W81XWH-18-C-0178 falls under the provisions of statutory authority 10 U.S.C. 2304(c)(1) as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The contract will be modified on a sole source basis to ICON Government and Public Health Solutions (ICON GPS) located at 1265 Ridge Road Suite A, Hinckley, OH 44233, for the ORA mission to provide regulatory, clinical, and technical services as necessary to facilitate full program coordination, management, policy development, execution, and oversight across all ORA clinical, technical, and regulatory areas. The proposed sole source extension under contract W81XWH-18-C-0178 is in support of the ORA mission to provide regulatory and clinical support for the life cycle development of FDA-regulated medical products sponsored by The Surgeon General, Department of the Army, as well as other studies of interest to the Department of Defense Sponsored by other organizations. In response to this sources sought, please provide the following information to the U.S. Army Medical Research Acquisition Activity (USAMRAA) Contract Specialist at Herbert Caj Keen, herbert.e.keen.civ@mail.mil no later than 10:00am EDT 19 April 2021. 1. Name of the firm, point of contact, phone number, email address, DUNS number, CAGE code, business size (large business or a small business), and if applicable, a statement regarding small business status (including small business type(s)/certifications(s) such as SDB, 8(a), HUBZone, SDVOSB, WOSB, etc.) and the corresponding NAICS code. 2. Detailed information supporting how the firm would be capable of performing services currently ongoing under the existing contract for these services during the proposed extension period while awaiting protest resolution with no disruption or mission degradation. This notice does not constitute a Request for Quote (RFQ)/Invitation for Bid (IFB)/Request for Proposal (RFP) or a promise to issue an RFQ, IFB or RFP in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, bids or proposals at this time and will not accept unsolicited proposals in response to this sources sought notice. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. Primary Point of Contact: Herbert Caj Keen, Contract Specialist herbert.e.keen.civ@mail.mil