The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), intends to negotiate with CWC Group, LLC. on a sole source basis in accordance with FAR 19.1506 Economically Disadvantaged Woman-Owned Small Business Program (EDWOSB) sole source awards, to provide MasterControl Quality Management Information System (QMiS) operations and maintenance, and development, modernization, and enhancement. CWC Group, LLC., 16701 Melford Blvd., Ste 400, Bowie, MD  20715-4411, is eligible to receive awards under the EDWOSB Program. The NAICS for this acquisition is 541519, Other Computer Related Services. The authority for this acquisition is set forth in the Federal Acquisition Regulation (FAR) 6.302-5 (b)(7) “Sole source awards under the EDWOSB Program-15 U.S.C. 637(m).” Written responses to this notice shall contain sufficient documentation to establish a bona fide capability to fulfill this requirement. This is not a request for quotation, and the Government does not intend to pay for information received. A determination by the Government not to compete the requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purposes of determining whether to conduct a competitive procurement. All questions and submissions in response to this notice must be submitted electronically via email to [email protected] by 10:00AM ET, Friday, July 31, 2020. Telephone calls regarding this matter may be not be accepted or returned.