Daily Rules, Proposed Rules, and Notices of the Federal Government
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This draft guidance provides information on the implementation of section 901 of the Food and Drug Administration Amendments Act of 2007, which authorizes FDA to require certain drug and biological product application holders to make safety related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or the Public Health Service Act. FDA plans to request safety labeling changes by sending a notification letter to the application holder. Under section 505(o)(4)(B) of the FD&C Act (21 U.S.C. 355(o)(4)(B)), the application holder must respond to FDA's notification by submitting a labeling supplement or notifying FDA that the applicant does not believe the labeling change is warranted and submitting a statement detailing the reasons why the application holder does not believe a change is warranted (a rebuttal statement).
The submission of rebuttal statements may result in the collection of information that is not already approved by OMB. Based on FDA's experience thus far with safety labeling changes requirements under section 505(o)(4) of the FD&C Act, FDA estimates that approximately six application holders will elect to submit approximately one rebuttal statement each year and that each rebuttal statement will take approximately 6 hours to prepare.
In addition, in the draft guidance, the Agency states that new labeling prepared in response to a safety labeling change notification should be available on the application holder's Web site within 10 calendar days of approval, which may result in the collection of information that is not already approved by OMB. FDA estimates that approximately 197 application holders will post new labeling one time each year in response to a safety labeling change notification and that the posting of the labeling will take approximately 4 hours to prepare.
FDA estimates the burden of the collections of information that have not already been approved by OMB is as follows:
This draft guidance also refers to previously approved collections of information. Specifically, the draft guidance describes: Labeling supplements for new drug applications, abbreviated new drug applications, and biologics license applications submitted under 21 CFR 314.70, 314.71, 314.97, and 601.12, and the content and format of prescription drug labeling submitted under 21 CFR 201.56 and 201.57. These collections of information are subject to review by OMB under the PRA and are approved under OMB control numbers 0910-0001, 0910-0338, and 0910-0572. Section V of the draft guidance refers to the guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level,” which describes collections of information approved under OMB control number 0910-0430.