Medicated Feed Manufacturing Compliance Program
The Food and Drug Administration intends to award sole source contracts to state agencies to conduct animal food manufacturing inspections to determine compliance with 21CFR part 225 (medicated feed GMP inspections), 21 CFR part 507 subpart B and related requirements of subparts A and F and/or PCAF PC requirements subparts C and E and related requirements of subparts A, D, and F (FSMA PCAF inspections), 21 CFR 589.2000, "BSE RULE" and 21 CFR 589.2001, 21 CFR 558.6 (VFD drug 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 year (12 months). 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 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(c)(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 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 purpose of determining whether to conduct a competitive procurement. The solicitation will be available on or about April 4, 2017 on the FBO website at http://www.fbo.gov. Prospective offerors are responsible for downloading the solicitation and amendments. It is the offerors responsibility to monitor the FBO 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: Cynthia.Martin@fda.hhs.gov. No phone calls will be accepted.
Cynthia D. Martin, Phone 240-402-7597, Email cynthia.martin@fda.hhs.gov
