Document ID: FDA-2012-N-0032-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008
Posted Date: 2012-01-17T05:00Z

[Federal Register Volume 77, Number 10 (Tuesday, January 17, 2012)]
[Notices]
[Pages 2302-2303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-639]

[[Page 2302]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0032]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Antimicrobial Animal Drug Distribution Reports Under 
Section 105 of the Animal Drug User Fee Amendments of 2008

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 paperwork requirements for an 
electronic form (e-form), to collect distribution reports for 
antimicrobials in food producing animals.

DATES: Submit either electronic or written comments on the collection 
of information by March 19, 2012.

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:  Denver Presley II, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-3793.

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 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.

Antimicrobial Animal Drug Distribution Reports Under Section 105 of the 
Animal Drug User Fee Amendments of 2008--Federal Food, Drug, and 
Cosmetic Act, Section 512(l)(3) (OMB Control Number 0910-0659)--
Revision

    Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 
II) (Public Law 316) amended section 512 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360b) by, among other things, 
creating section 512(l)(3) to require that the sponsor of each new 
animal drug that contains an antimicrobial agent submit an annual 
report to FDA on the amount of each antimicrobial active ingredient in 
the drug that is sold or distributed for use in food-producing animals, 
including information on any distributor-labeled product. The 
legislation was enacted to address the problem of antimicrobial 
resistance and to help ensure that FDA has the necessary information to 
examine safety concerns related to the use of antibiotics in food-
producing animals (154 Congressional Record H7534).
    Each report must specify: (1) The amount of each antimicrobial 
active ingredient by container size, strength, and dosage form; (2) 
quantities distributed domestically and quantities exported; and (3) a 
listing of the target animals, indications, and production classes that 
are specified on the approved label of the product. The first report 
under the statute was to be submitted not later than March 31, 2010. 
The report covered the period of the preceding calendar year and 
included separate information for each month of the calendar year.
    We are now seeking to further implement the statutory requirements 
of ADUFA II and enhance its public health and safety mission as 
envisioned by Congress by introducing an electronic form for the 
submission of the required annual reports under ADUFA II. The e-form 
FDA 3744a will enable sponsors to submit electronically and capture all 
information as mandated by Section 105 of ADUFA II. Form FDA 3744 will 
continue to be designated for paper submissions.
    List of information required on form FDA 3744 and e-form FDA 3744a:

 Application Type
 Application Number
 Firm Name
 Dosage Form(s)
 Production Class(es)
 Animal Species--Food Animal or Food and Non-Food Animal
 Indications
 Active Ingredient(s)
 Domestic Quantities
    [cir] Unit of Measure for All Active Ingredients
    [cir] Calendar Year
    [cir] Quantity Sold by Month for All Active Ingredients
    [cir] Annual Total Sold for All Active Ingredients
 Export Quantities
    [cir] Unit of Measure for All Active Ingredients
    [cir] Calendar Year
    [cir] Quantity Sold by Month for All Active Ingredients
    [cir] Annual Total Sold for All Active Ingredients
 Individual Product Information for All Active Ingredients
    [cir] Dosage Form
    [cir] Container Size
    [cir] Container Units
    [cir] Active Ingredient Strength
 Quantities of Individual Products Sold or Distributed 
(Domestic and Export)
    [cir] Unit of Measure for All Active Ingredients
    [cir] Quantity Sold by Month for All Active Ingredients
    [cir] Annual Total Sold for All Active Ingredients

    FDA estimates the burden of this collection of information as 
follows:

[[Page 2303]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                             Number of
   FD&C Act section 512(l)(3)          Form FDA No.          Number of     responses per   Total annual   Average burden    Total hours    Capital costs
                                                            respondents     respondent       responses     per response
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Annual Reports for Sponsors      3744...................              14             5.9              83              60           4,980          $6,975
 With Active Applications--
 Paper Submission.
Annual Reports for Sponsors      e-Form 3744a...........              12             6.7              80              50           4,000  ..............
 With Active Applications--
 Electronic Submission.
Annual Reports for Sponsors      3744...................              13             6.2              81               2             162  ..............
 With Inactive Applications--
 Paper Submission.
Annual Reports for Sponsors      e-Form 3744a...........              11             7.3              80               2             160  ..............
 With Inactive Applications--
 Electronic Submission.
                                ------------------------------------------------------------------------------------------------------------------------
    Total......................  .......................  ..............  ..............  ..............  ..............           9,302  ..............
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\1\ There are no operating and maintenance costs associated with this collection of information.

    The total annual responses were calculated by multiplying the 
number of respondents times the number of responses per respondent. 
Total burden hours were calculated by multiplying total annual 
responses times the average burden per response.
    As explained in the supporting statement for the subject collection 
of information (OMB control number 0910-0659), the initial one-time 
capital costs are for the design of the report. Here, e-form FDA 3744a 
and reporting via the Electronic Submission Gateway are provided by 
FDA. Thus, the remaining cost, as described in approved OMB control 
number 0910-0659 is $6,975 per year (3 hours x $46.50 wage rate x 50 
sponsors) = $6,975. FDA believes that the sponsors already possess the 
computer equipment needed to prepare the report so that additional 
capital expenditures will not be necessary.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                    Revised 21 CFR 514.80(b)(5)                         Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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All Applicants.....................................................              34                1               34                2               68
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Total annual records were calculated by multiplying the number of 
recordkeepers times the number of records per recordkeeper. Total hours 
were calculated by multiplying total annual records times the average 
burden per recordkeeping.

    Dated: January 10, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-639 Filed 1-13-12; 8:45 am]
BILLING CODE 4160-01-P