H -- OSIT Medical Device Inspections

The Food and Drug Administration intends to award a sole source contract to the Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas, 78756, for the Quality System Inspection Technique (OSIT) medical device inspection program. This program meets the criteria set forth in41 U.S.C 253(c)(1). The services can be obtained only from state organizations possessing the authority necessary to conduct regulatory inspections. The contracts are renewed annually, but adjustments in the length of the contracts may be made for management purpose or at the request of the state with individual performance periods ranging from 12 to 24 months. Contractors must meet the following requirements: (1) The contractor must 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 medical device provision of the Federal Food, Drug, and Cosmetic Act at any geographical location within the state; (2) have trained personnel experienced with the inspection procedures and evidence development techniques necessary to assess the conformance of an establishment with the federal law and regulations or comparable state requirements; and (3) demonstrate experience with state regulatory or voluntary procedures for corrective violative practices. Only governmental organizations have the unique qualifications to perform this kind of activity. This proposed contract action is for services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. 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 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 this requirement 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. Responses to this notice must be sent via e-mail to [email protected]. No phone calls will be accepted.