2017 Medical Device State Inspection Program

The Food and Drug Administration intends to award sole source contracts to State Agencies for the inspection of medical devices. The State Agencies must have the authority and capability required to gain access to private commercial establishments in order to conduct regulatory inspections in accordance with the Federal Food, Drug and Cosmetic Act. It is anticipated that awards will be made for a 12 month base contract period and one option year. The proposed contract actions are for services for which the Government intends to solicit and negotiate with only state organizations under the authority of 10 U.S.C. 2304(c)(5), authorized by statute. This notice is issued for informational purposes and not a request for competitive proposals. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirement of this synopsis can be met no later than 15 calendar days from this announcement. A determination by the Government not to compete the proposed contracts based on responses from this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The solicitation will be available on or about February 6, 2017, on the FedBizOpps website at http://www.fbo.gov. Prospective offerors are responsible for downloading the solicitation and amendments. It is the offerors responsibility to monitor the FedBizOpps website for the release solicitations and amendments. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. Responses to this notice must be sent via email to: yared.girmai@fda.hhs.gov. No phone calls will be accepted.