Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet, FDA Form 3546, 33231-33232 [E7-11527]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 115 (Friday, June 15, 2007)]
[Notices]
[Pages 33231-33232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0220]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Animal Drug User Fee Cover Sheet, FDA Form 3546

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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 hourly burden necessary to 
complete FDA Form 3546, ``Animal Drug User Fee Cover Sheet.''

DATES:  Submit written or electronic comments on the collection of 
information by August 14, 2007.

ADDRESSES:  Submit electronic comments on the collection of information 
to: https://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets

[[Page 33232]]

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:  Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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; FDA Form 3546; 21 U.S.C. 379j-12 (OMB 
Control Number 0910-0539)--Extension

    Under Section 740 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j-12), as amended by the Animal Drug User Fee Act of 2003 
(ADUFA), 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 cover sheet, FDA Form 
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 that payment. The 
form, when completed electronically, will result in the generation of a 
unique payment identification number used for 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.
    Respondents to this collection of information are new animal drug 
sponsors, applicants, or manufacturers.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                           Number of       Annual Frequency      Total Annual      Hours per
   21 U.S.C. 379j-12      Respondents        per Response         Responses         Response       Total Hours
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740(a)(1)                           69   1 time for each                   69                1              69
FDA Form 3546 (Cover                      application.
 Sheet)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information

    Based on FDA's database system, there are an estimated 140 
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 number of 
submissions received by FDA in fiscal year 2003. The Center for 
Veterinary Medicine estimates 69 annual responses that include the 
following: 28 new animal drug premarket approval applications and 41 
supplements. The estimated hours per response are based on past FDA 
experience with the various submissions, and range from 30 minutes to 1 
hour. The hours per response are based on the average of these 
estimates.

    Dated: June 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11527 Filed 6-14-07; 8:45 am]
BILLING CODE 4160-01-S