Document ID: FDA-2010-N-0600-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Animal Drug User
Fee Cover Sheet
Posted Date: 2017-07-18T04:00Z

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32826-32827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14997]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0600]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Drug User Fee 
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 August 
17, 2017.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 11601 Landsdown 
St., North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov.

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 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), FDA has the authority to assess and 
collect application fees from each person who submits certain new 
animal drug applications or certain supplemental animal drug 
applications. The Animal Drug User Fee cover sheet (Form FDA 3546) is 
designed to collect the minimum necessary information to determine 
whether a fee is required for the review of an application or 
supplement or whether an application fee waiver was granted, to 
determine the amount of the fee required, and to assure that each 
animal drug user fee payment is appropriately linked to the

[[Page 32827]]

animal drug application for which payment is made. The form, when 
completed electronically, will result in the generation of a unique 
payment identification number used by FDA to track the payment. FDA's 
Center for Veterinary Medicine and FDA's Office of Management will use 
the information collected to initiate the administrative screening of 
new animal drug applications and supplements to determine whether the 
payment has been received.
    Description of Respondents: Respondents to this collection of 
information are new animal drug applicants.
    In the Federal Register of October 21, 2016 (81 FR 72810), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments. FDA estimates the 
burden of this collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
       FD&C act section/ description                FDA form No.             Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
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740(a)(1); Animal Drug User Fee cover       FDA 3546....................              21               1              21               1              21
 sheet.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimates in table 1 are based on our experience with new 
animal drug applications and supplemental animal drug applications and 
the average number of Animal Drug User Fee cover sheets submitted 
during fiscal years 2013-2015. We estimate 21 respondents will each 
submit a cover sheet (Form FDA 3546) for a total of 21 responses. We 
calculate a reporting burden of 1 hour per response, for a total of 21 
hours. The burden hours are increased. The overall increase in burden 
hours (by 4 hours) is due to the normal variation in the number of 
Animal Drug User Fee cover sheets submitted to FDA.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14997 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P