A -- Asessment of Validites of Selected Analytical Protocols/Prototypes for Dietary Supplemnets and Other Areas of Interest

The Food and Drug Administration (FDA) intends to award a contract to the Association of Official Analytical Chemists (AOAC) on a sole source basis for published AOAC Official MethodsSM for selected dietary supplements and/or other areas of interest. This will be a joint FDA/NIH project and will result in a five year IDIQ type contract with task orders. The development and validation of appropriate methods is crucial to protect and inform stakeholders (the Government, consumers, etc.) as well as to promote trade. Three stages in the validation of analytical methods are (1) establishment of acceptable performance parameters for a potential method within a laboratory; (2) demonstration of acceptable performance for this potential method in additional laboratories (or by other analysts); and (3) confirmation of acceptable performance of the method in an interlaboratory collaborative study. According to the Code of Federal Regulations (CFR) for Food and Drugs (21 CFR 2.19): "Where the method of analysis is not prescribed in a regulation, it is the policy of the Food and Drug Administration in its enforcement programs to utilize the methods of analysis of the Association of Official Analytical Chemists (AOAC) as published in the latest edition ... of their publication 'Official Methods of Analysis of the Association of Official Analytical Chemists,' and supplements thereto ... when available and applicable. [emphasis added] In the absence of an AOAC method, the Commissioner will furnish a copy of the particular method, or a reference of the published method, that the Food and Drug Administration uses in its enforcement program. Other methods may be used for quality control, specifications, contracts, surveys, and similar nonregulatory functions, but it is expected that they will be calibrated in terms of the method which the Food and Drug Administration uses in its enforcement program. Use of an AOAC method does not relieve the practioner of the responsibility to demonstrate that he can perform the method properly through the use of positive and negative controls and recovery and reproducibility studies." The major objective of this contract is to provide the Government with accurate, reliable, practical, validated and published AOAC Official MethodsSM for analytes (either present by intention or by contamination) in a wide range of matrices. A second major objective is to obtain and disseminate scientifically reliable information concerning the validity and ruggedness of analytical methods that can be used to support Government activities, including those related to public health as well as regulatory activities. A third major objective is to foster AOAC's administrative and technical support of its general validation program. A fourth major objective is to generate, consolidate, and make scientifically validated (ascertainable) information more readily available to additional stakeholders (e.g., consumers, industries, trade associations, academia, and international organizations). A fifth major objective is to adapt (as a model) an evaluation mechanism functionally equivalent to the so-called - NIH expert peer review committee, to be used by AOAC to more efficiently evaluate pertinent data and documents that are critical to the validation efforts overall. A sixth major objective is to organize and offer appropriate training courses to current / future analysts and associated stakeholders, i.e., to enhance the probability that a given method can be in-house validated to the technical and practical standards necessary to fulfill the criteria established beforehand. A seventh major objective to ensure that analysts involved in the development and validation of methods under study (via task orders for this contract) are sufficiently qualified. The proposed contract action is for R&D services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. Interested parties may identify their interest and capability to respond to the requirements or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within forty five days after the date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Respondents will not be notified of the Government's determination. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Responses may be submitted via email, courier, or U.S. Postal service to the attention of Ed Arnold at the above stated address.