FDA-14-TISSUE

The Food and Drug Administration intends to award sole source contracts to state agencies to conduct regulatory inspections of animal producers and associated firms to investigate drug residues in animal tissues and to determine compliance with 21 CFR 589.2000, "BSE RULE". This program meets the criteria set forth in 41 U.S.C. 253 (c) (5), Authorized or Required by Statute. The Federal Food, Drug and Cosmetic Act (21 U.S.C. 301), requires the services from state organizations possessing the authority necessary to conduct regulatory inspections. This requirements period of performance allows for a 12 month base year as well as three (3) option years. 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 animal drug and feed 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 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 and authority to perform this kind of activity. This proposed contract action is for services for which the Government intends to solicit and negotiate with state organizations under the authority of FAR 6.302-5. 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 is 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 purpose of determining whether to conduct a competitive procurement. The solicitation will be available on or April 30, 2014 on the FedBizOpps website at http://www.fedbizopps.gov. Prospective offerors are responsible for downloading the solicitation and amendments. It is the offerors responsibility to monitor the FedBizOpps 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 Allison.mlawsky@fda.hhs.gov. No phone calls will be accepted. Point of Contact Allison Mlawsky, Contract Specialist, Phone -240-402-7602 Fax 301-827-7101, Email Allison.mlawsky@fda.hhs.gov - Lisa O'Neill, Contracting Officer, Phone 240-402-7608, Fax 301-827-7101, Email Lisa.Oneill@fda.hhs.gov.