Document ID: FDA-2014-N-0079-0002
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: 2014-04-23T04:00Z

[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22687-22688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09201]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0079]

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 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 0910-0632. 
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.

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 Drug User Fee Act Cover Sheet--21 U.S.C. 
379j-21 (OMB Control Number 0910-0632)--Revision

    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 provide 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 Animal Generic Drug User Fee Amendments of 2013, signed by the 
President on June 13, 2013 (AGDUFA II) (Title II of Pub. L. 113-14), 
amended the FD&C Act authorizing FDA to collect user fees for certain 
abbreviated applications for generic new animal drugs, for certain 
generic new animal drug products, and for certain sponsors of such 
abbreviated applications for generic new animal drugs and/or 
investigational submissions for generic new animal drugs. To implement 
changes under the reauthorization by their effective date of October 1, 
2013, FDA sought and received OMB approval to update its Form FDA 3728 
as described as follows:

[[Page 22688]]

    On page 1 of the electronic questions under ``Select an Application 
Type'' users must select ``Original'' and then choose either, 
``Abbreviated New Animal Drug Application (ANADA)--under provisions of 
512(b)(2) of FFDCA [the FD&C Act]'' (21 U.S.C. 360b(b)(2)); or 
``Abbreviated New Animal Drug Application (ANADA)--for certain 
combination pioneer products approved under provisions of 512(d)(4) of 
FD&C Act.'' If they select the first ANADA type, they will be charge 
100 percent of the application fee. If they select the second ANADA 
type, they will be charged at a rate of 50 percent of the original 
application fee. To facilitate the application process in this regard, 
on Form FDA 3728 we have added a line in section 3 that allows 
applicants to select the option, ``3.2 Original Abbreviated New Animal 
Drug Application (ANADA)--for certain combination pioneer products 
approved under provisions of section 512(d)(4) of the FD&C Act.''
    In the Federal Register of February 18, 2014 (79 FR 9224), 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
                  FDA form 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 (4.8 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 generic animal 
drug applicants. Based on data for the past 3 years, FDA estimates 
there are approximately 20 submissions annually and a total of 3.2 
burden hours.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09201 Filed 4-22-14; 8:45 am]
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