FDA enterprise access to CMMI Model and Systems as well as MDDAP Training, linking the CMMI model to FDA's regulatory processes.

The Food and Drug Administration (FDA) hereby issues a notice of intent in accordance with FAR 5.201. Pursuant to FAR 8.405-6 (a)(2)(A), the FDA will sole source with formation Systems Audit and Control Association, INC (ISACA), 1700 E. Golf Rd. #400, Schaumburg, IL 60173 for enterprise access to CMMI Model and Systems as well as MDDAP Training, linking the CMMI model to FDA's regulatory processes. ISACA is the only Contractor able to meet the requirement of this procurement. The FDA intends to award a purchase order against the GSA contract holder ISACA for one, 12 month base period and one, 12 month option period. ISACA is the sole proprietor and owns the copy rights to the CMMI Model. ISACA is the only contractor who is able to provide licensed access, maintenance and support, as well as the associated training. The NAICS code is 511210, Software Publishers. This notice is not a request for competitive quotes or proposal. No solicitation document is available and telephone requests will not be accepted. Respondents may submit information pertaining to their capabilities to perform the services required above within a timely manner to Laurel Woest at laurel.woest@fda.hhs.gov , which may be considered by the agency. A determination to compete this procurement from the responses received shall be based upon the discretion of the Government. It is anticipated that an award will be issued to ISACA, INC. in approximately fifteen (15) days after the date of this notice unless, the Government determines another vendor has the capabilities of meeting this requirement and is more advantageous to the Government. All responses to this notice of intent shall be received no later than 12:00 PM Eastern Time (ET) on September 15th, 2020 via email to Laurel Woest at laurel.woest@fda.hhs.gov.