Department of Health and Human Services June 14, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments 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, submission of information to a Master File in support of petitions, and electronic submission using FDA Form 3503. This notice also notifies the public of and solicits comments on FDA's proposed changes to Form FDA 3503 and elimination of Form FDA 3504.