[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Notices]
[Pages 6199-6200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02190]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Animal Drug User Fee Act Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the paperwork burden of animal 
drug sponsors to fill out the Animal Drug User Fee Act (ADUFA) cover 
sheet.

DATES: Submit either electronic or written comments on the collection 
of information by April 4, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Animal Drug User Fee Cover Sheet--(OMB Control Number 0910-0539)--
Extension

    Under section 740 of the FD&C Act (21 U.S.C. 379j-12), as amended 
by ADUFA (Pub. L. 108-130), FDA has the authority to assess and collect 
for certain animal drug user fees. Because the submission of user fees 
concurrently 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of    Number of responses per   Total annual   Average burden
  FD&C Act section amended by ADUFA          FDA Form No.          respondents          respondent           responses     per response     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(a)(1)............................  3546 (Cover Sheet)......              17  1 time for each                      17               1              17
                                                                                  application.
--------------------------------------------------------------------------------------------------------------------------------------------------------
 \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-
13. The estimated hours per response are based on past FDA experience 
with the various submissions. The hours per

[[Page 6200]]

response are based on the average of these estimates.

    Dated: January 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02190 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P