FDA Seeks Input on Changes to Food and Color Additive Petition Submissions

The Food and Drug Administration (FDA) has called for comment on “the information collection provisions of FDA’s regulations for submission of petitions, including food and color additive petitions (including labeling) and generally recognized as safe (GRAS) affirmations.” As required by the Office of Management and Budget, the agency has invited comments on the following: (i) “Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility”; (ii) “the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used”; (iii) “ways to enhance the quality, utility, and clarity of the information to be collected”; and (iv) “ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.”

FDA has also requested feedback on revisions to Form FDA 3503 for food additive petitions (FAPs) and Form FDA 3504 for color additive petitions (CAPs). To facilitate electronic and multi-use submissions, the agency has altered Form FDA 3503 “to accept submissions for both FAP and CAP, thus making Form FDA 3504 redundant . . . Therefore, FDA is eliminating Form FDA 3504.” Comments will be accepted until August 13, 2010.