Skip to Content


Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Cover Sheet

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.


Fax written comments on the collection of information by May 23, 2014.


To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to All comments should be identified with the OMB control number 0910-0539. Also include the FDA docket number found in brackets in the heading of this document.

Start Further Info


FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,

End Further Info End Preamble Start Supplemental Information Start Printed Page 22690


In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Animal Drug User Fee Cover Sheet; Form FDA 3546 (OMB Control Number 0910-0539)—Extension

Under Section 740 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-12), as amended by Animal Drug User Fee Act (ADUFA) (Pub. L. 108-130), FDA has the authority to assess and collect for certain animal drug user fees. Because concurrent submission of user fees with applications and supplements is required, review of an application cannot begin until the fee is submitted. The types of fees that require a cover sheet are certain animal drug application fees and certain supplemental animal drug application fees. The ADUFA cover sheet (Form FDA 3546) is designed to provide the minimum necessary information to determine whether a fee is required for the review of an application or supplement, to determine the amount of the fee required, and to assure that each animal drug user fee payment and each animal drug application for which payment is made is appropriately linked to the payment that is made. The form, when completed electronically, will result in the generation of a unique payment identification number used in tracking the payment. FDA will use the information collected to initiate administrative screening of new animal drug applications and supplements to determine if payment has been received.

In the Federal Register of February 3, 2014 (79 FR 6199), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden 1

FD&C Act section amended by ADUFAFDA Form No.Number of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
740(a)(1)3546 (Cover Sheet)171 time for each application17117
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Respondents to this collection of information are new animal drug applicants or manufacturers. Based on FDA's database system, there are an estimated 173 manufacturers of products or sponsors of new animal drugs potentially subject to ADUFA. However, not all manufacturers or sponsors will have any submissions in a given year and some may have multiple submissions. The total number of annual responses is based on the average number of submissions received by FDA in fiscal years 2011-2013. The estimated hours per response are based on past FDA experience with the various submissions. The hours per response are based on the average of these estimates.

Start Signature

Dated: April 17, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2014-09202 Filed 4-22-14; 8:45 am]