B -- Services to Assist LACF Team in Process Review

Services to Assist LACF Team in Process Review This is A NOTICE OF INTENT TO AWARD to a sole source for commercial service prepared in accordance with the format in FAR 5.207 AND FAR 12.603 as supplemented with additional information included in this notice. . This reference number is FDA-1018788, and is issued as a NOTICE TO THE PUBLIC The contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2001-27. The North American Industry Classification (NAICS) Code is 611430 with a small business size standard of $6.5M. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The government intends to award the requirement to a small business set aside (FAR 13 and FAR 19). The award will be made to : Michael Ellison 412 Main Street Fruitland, MD 21826 Background: The Food and Drug Administration's requirements for registration, manufacturing, and process filing of low-acid canned foods (LACF) and acidified foods (AF) in hermetically sealed containers are codified in Title 21, Code of Federal Regulations, Parts 108, 113, and 114. Process filing is required for all processing establishments in the United States and those located in other countries which process acidified or low-acid canned foods for export to the United States. Low-acid canned food processors are required to provide the Food and Drug Administration information as to the scheduled processes including, but not limited to: processing method, type of retort or other thermal processing equipment employed, minimum initial temperature, times and temperatures of processing, sterilizing value (F0, -or other equivalent scientific evidence of process adequacy), critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such LACF and acidified food in each container size; not later than 60 days after registration, and prior to the packing of a new product. Acidified food processors are required to provide to the FDA information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels; and source and date of the establishment of the process for each acidified food in each container size. FDA does not approve, license, or issue permits for finished food products shipped in interstate commerce. However, all commercial processors of LACF and AF, are required to register their establishments and file processing information for all products with the FDA using appropriate forms The LACF Team conducts technical reviews of process filings submitted by industry world wide for process adequacy to ensure that hermetically sealed containers containing shelf stable foods are safe. These process filings can be submitted either in hard copy or electronically online. The technical review requires knowledge of various processing systems, the critical factors associated with each and an understanding of the principles of food processing to apply to new technology. Total forms reviewed the past three years are: 2003 11,991 2004 12,984 2005 14,074 The workload has increased over the years while the staff has decreased. Scope of Work: Independently and not as an agent of the Government, the contractor shall furnish the necessary services and otherwise do all things necessary for, or incident to, the performance of the work as described below. The work shall be divided into separate tasks: Technical Assistance in Reviewing Process Filings Online and Paper: The Contractor must be fully competent and knowledgeable in the application of the current Good Manufacturing Practice Regulations (GMP’s) for low-acid canned foods (21 CFR 113) and the GMP’s for acidified foods (21 CFR 114). The Contractor must be completely familiar with at least the following: • Nomenclature for studies in thermal processing; • Protocol for carrying out heat penetration studies; • Temperature distribution protocol for processing in all types of retorts; • Protocol for conducting temperature distribution; • Application of HACCP to LACF and AF processing; • FDA import procedures. Tasks involve conducting technical reviews of online and papers submissions and responding appropriately by either accepting the filing into the master file or returning the submission to the filer with concerns or questions to be answered. If necessary, the contractor will generate a letter to the Project Officer detailing process adequacy concerns for a specific submission. The Project Officer will review and accept the letter prior to its being sent. The Contractor will also provide expert technical opinions on thermal processing issues on an as needed basis, as determined by the Project Officer. Period of Performance: Anticipated date of award (expected within 5 days after this posting expires to June 30, 2007) Qualifications: This sole source award is based on the vendor’s prior experience and participation on Michael Ellison was a field investigator with FDA for 32 years. He has over 20 years involvement in international inspection of Low-Acid Canned Food (LACF) manufacturers . In 1989 Mr. Ellison was selected to attend a one-year FDA training program in LACF. Following that program he was promoted to Regional LACF Specialist. In 1993 Mr. Ellison accepted the position of National Food Expert with FDA’s Division of Field Investigations. He is recognized by government and industry for his expertise in LACF and HACCP. Mr. Ellison was responsible for training FDA, State and Foreign government investigators regarding the newest and most complex LACF processing equipment. Mr. Ellison was the primary author of the FDA’s Investigators guides to inspections of LACF. As a LACF training consultant since leaving FDA, he has remained current with LACF food issues. Therefore, he has extensive experience and knowledge of the existing LACF regulations and demonstrates a unique capability to perform the required services with no learning curve, and is capable beyond any other candidate to undertake this contract and produce high quality products efficiently within the federal system. Additionally, to obtain these services from another vendor with similar knowledge and experience or to train a vendor with less experience and knowledge would take significantly more effort and would be more costly on the part of the government. Evaluation Criteria was based on the qualifications and requirements as stated above. This is a notice of intent and not a request for competitive proposals. However, interested vendors capable of furnishing the government with the service specified in this notice may identify their interest and respond to the requirements by submitting their response to the below address. All responses will be due fifteen (15) calendar days from the publication date of this synopsis. The quotation must reference the Solicitation number FDA-1018788. The government reserves the right to issue an award without further notice.