SPECIAL NOTICE
A -- Intent to Sole Source to Ology BioServices for FDA-required Post Marketing Requirements
- Notice Date
- 12/14/2018
- Notice Type
- Synopsis
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- 10 General Green Avenue Building 1 Natick MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-19-S-0005
- Response Due
- 12/29/2018
- Point of Contact
- Leo J. Fratis, Contract Specialist, Phone 2405861523
- E-Mail Address
-
leo.j.fratis.civ@mail.mil
- Small Business Set-Aside
- N/A
- Description
- The Army Contracting Command - Aberdeen Proving Ground on behalf of the Defense Biological Product Assurance Office (DBPAO) intends to award a sole source contract to Ology Bioservices Inc. (Ology Bio), Inc. for regulatory and clinical support for Food and Drug Administration (FDA)-required Post-Marketing Requirements (PMR) and Post-Marketing Commitments (PMC) for the 2018 FDA-approved Atropine Injection, 2 mg/0.7 mL, Single-Dose AutoInjector manufactured by Rafa Laboratories Inc. (Rafa) and its partner Shalon Chemical Industries Inc. Ology Bio is Rafa's U.S. agent, and no other commercial source can provide the required regulatory support and filings as required by the FDA. Ology Bio has been Rafa's U.S. agent providing regulatory support of the Rafa Atropine AutoInjector for many years. The statutory authority permitting acquisition of these items other than full and open competition is 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. This is not a request for competitive proposals. Parties purporting to have the means to provide this capability without unacceptable delays in fulfilling the agency's requirements must furnish in writing, factual information which clearly supports and demonstrates that they are able to fulfill the FDA-required PMR and PMC for the 2018 FDA-approved Atropine Injection, 2 mg/0.7 mL, Single-Dose AutoInjector manufactured by Rafa and its partner Shalon Chemical Industries Inc. This information shall be provided no later than December 29, 2018. Please direct any questions regarding this announcement to Mr. Leo Fratis, Contracting Office, (240) 586-1523, email: leo.j.fratis.civ@mail.mil. A determination not to compete this proposed action based on any responses to this notice is solely within the discretion of the Contracting Officer. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (14-DEC-2018); 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/notices/7b2a8d7c0498bcc4c0bb3acd5915f8bb)
- Record
- SN05175060-F 20181216/181214230017 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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