FDA Seeking Public Input on Animal Generic Drug User Fee Act Information Collection
February 18, 2014
Inquiries: AskCVM@fda.hhs.gov, 210-276-9300
The U.S. Food and Drug Administration announced today an opportunity for public comment on FDA’s proposed collection of information from sponsors of generic animal drugs. FDA collects information from the sponsors of generic animal drugs via the Animal Generic Drug User Fee Act cover sheet, which is required for submission of a New Animal Drug Application for a generic animal drug. This cover sheet helps FDA assess fees associated with applications, and also assists with tracking the fee payment. This notice publishes in the Federal Register on February 18, 2014, and the public can submit comment on this notice for 60 days following publication.
FDA is interested in comments on the following topics regarding the cover sheet: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) 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.
To electronically submit comments on this notice, go to www.regulations.gov and insert docket no. FDA-2014-N-0079. Send written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please include the docket number at the top of each page of your comment.