Document ID: FDA-2014-N-0078-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Cover Sheet
Posted Date: 2014-04-23T04:00Z

[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22689-22690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09202]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0078]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

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

ADDRESSES: 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 oira_submission@omb.eop.gov. 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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

[[Page 22690]]

SUPPLEMENTARY INFORMATION: 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\
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                                                                 Number of       Number of responses     Total annual    Average burden
  FD&C Act section amended by ADUFA        FDA Form No.         respondents        per respondent         responses       per response     Total hours
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740(a)(1)...........................  3546 (Cover Sheet)....              17   1 time for each                     17                1               17
                                                                                application.
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\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.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09202 Filed 4-22-14; 8:45 am]
BILLING CODE 4160-01-P