Notice of Intent to Sole Source Medical Device State Inspection Program

The Food and Drug Administration intends to award sole source contracts to state agencies to conduct Medical Device Inspections. In accordance with the Food, Drug, and Cosmetic Act, services can only be obtained from state organizations possessing the authority necessary to conduct regulatory inspections. It is anticipated that awards will be made for one base year (12 months) and four options. Contractors must meet the following special requirements: (1) possess legal authority under state law necessary to gain access to any regulated private commercial establishment for the unique purpose of conducting regulatory inspections and investigations to determine compliance with the provisions of the Federal Food, Drug, and Cosmetic Act at any geographical location within the state; (2) have trained personnel experienced with the inspectional procedures and evidence of development techniques necessary to assess the performance of an establishment with the federal law and regulations or comparable state requirements; and (3) demonstrate experience with state regulatory or voluntary procedures for correcting violative practices. This proposed contract action is for services for which the Government intends to solicit and negotiate with state organizations under the authority of 10 U.S.C. 2304(c)(5). This notice is issued for informational purposes and is not a request for competitive proposals. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met, no later than 15 days from the date of 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 purposes to determine whether to conduct a competitive procurement. The solicitation will be available on or about the Second Quarter of the Government Fiscal Year in the Sam.Gov website at http://www.sam.gov. Prospective offerors are responsible for downloading the solicitation and amendments. It is the offerors responsibility to monitor the SAM.Gov website for the release of the solicitation and amendments. Hard copies will be provided to individuals eligible under the American with Disabilities Act and Rehabilitation Act upon request. Responses to this notice must be sent via email to: [email protected] No phone calls will be accepted