Inactive

The Food and Drug Administration intends to award sole source contracts to State Agencies for Egg Inspections. The State Agencies must have the authority and capability' necessary to gain access to pr... The Food and Drug Administration intends to award sole source contracts to State Agencies for Egg Inspections. The State Agencies must have the authority and capability' necessary to gain access to private commercial establishments in order to conduct regulatory inspections in accordance with the Federal, Food, Drug and Cosmetic Act. On July 9, 2009, FDA published a final rule requiring shell egg producers to implement certain measures to prevent salmonella enteritidis (SE) from contaminating eggs on the farm from further growth during storage and transportation. The final rule, which is codified in 21 CFR 118, will be implemented in a staggered fashion with larger producers (greater than 50,000 layers) required to be in compliance by July 9, 2010 and smaller producers (3,000-49,999 layers) being in compliance by July 9, 2012. It is anticipated that awards will be made for a 12-month contract period and one (1) 12 month option periods to all the producers. 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 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 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 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©The solicitation will be available on or about May 20, 2021 on the Beta Sam website at http://beta sam.gov. (4)Prospective offers are responsible for downloading the solicitation and amendment s. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act upon request. (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 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; Julia.Savage@fda.hhs.go v. No phone calls will be accepted.