Document ID: FDA-2011-N-0655-0017
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Animal Generic
Drug User Fee Act Cover Sheet
Posted Date: 2017-06-15T04:00Z

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27512-27513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12432]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Generic 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 July 
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 0910-0632. 
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, 10A63, 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.

Form FDA 3728, Animal Generic User Fee Act Cover Sheet--21 U.S.C. 379j-
21--OMB Control Number 0910-0632--Extension

    Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 379j-21) establishes three different kinds of user 
fees: (1) Fees for certain types of abbreviated applications for 
generic new animal drugs; (2) annual fees for certain generic new 
animal drug products; and (3) annual fees for certain sponsors of 
abbreviated applications for generic new animal drugs and/or 
investigational submissions for generic new animal drugs (21 U.S.C. 
379j-21(a)). Because concurrent submission of user fees with 
applications is required, the review of an application cannot begin 
until the fee is submitted. Form FDA 3728 is the Animal Generic Drug 
User Fee Act (AGDUFA) Cover Sheet, which is designed to collect the 
minimum necessary information to determine whether a fee is required 
for review of an application, to determine the amount of the fee 
required, and to account for and track user fees. The form, when 
completed electronically, will result in the generation of a unique 
payment identification number used by FDA to track the payment. It will 
be used by FDA's Center for Veterinary Medicine and FDA's Office of 
Financial Management to initiate the administrative screening of new 
generic animal drug applications to determine if payment has been 
received.
    In the Federal Register of September 2, 2016 (81 FR 60707), 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:

[[Page 27513]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                Form FDA No.                    Number of      responses per     Total annual         Average burden per response          Total hours
                                               respondents       respondent       responses
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3728.......................................              20                2               40   .08 (5 minutes)........................             3.2
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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 generic 
animal drug applicants. Based on Agency data for the past 3 years, FDA 
estimates there are approximately 40 submissions annually and a total 
of 3.2 burden hours. The burden for this information collection has not 
changed since the last OMB approval.

    Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12432 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P