In the preamble of these proposed rules, FDA requested comments by February 15, 2013, on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FDA is taking the action of extending the deadline for the comment period in response to requests for that extension, in order to allow interested persons additional time to submit comments. May 16, 2013 is also the deadline for submitting comments to the proposed rules.