[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Pages 5463-5465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 
February 25, 2013.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0659 and 
title, ``Antimicrobial Animal Drug Distribution Reports Under Section 
105 of the Animal Drug User Fee Amendments of 2008.'' Also include the 
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, [email protected].

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. Antimicrobial Animal Drug Distribution Reports 
Under Section 105 of the Animal Drug User

Fee Amendments of 2008--(OMB Control Number 0910-0659)--Extension

    Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 
II) (Pub. L. 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,

[[Page 5464]]

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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                             Number of                        Average
    FD&C Act section 512(1)(3)          Form FDA No.         Number of     responses per   Total annual     burden per      Total hours    Capital costs
                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Reports for Sponsors With    3744................              14             5.9              83              60           4,980          $6,975
 Active Applications--Paper
 Submission.
Annual Reports for Sponsors With    e-Form 3744a........              12             6.7              80              50           4,000               0
 Active Applications--Electronic
 Submission.
Annual Reports for Sponsors With    3744................              13             6.2              81               2             162               0
 Inactive Applications--Paper
 Submission.
Annual Reports for Sponsors With    e-Form 3744a........              11             7.3              80               2             160               0
 Inactive Applications--Electronic
 Submission.
                                                         -----------------------------------------------------------------------------------------------
    Total.........................  ....................  ..............  ..............  ..............  ..............           9,302          $6,975
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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.

[[Page 5465]]



                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                           Number of       Number of records     Total annual     Average burden per
                 21 CFR 514.80(b)(5)                     recordkeepers     per recordkeeper         records          recordkeeping        Total hours
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Records and reports concerning experience with                       34                   1                  34                   2                  68
 approved new animal drugs--special drug experience
 report.............................................
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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.
    In the Federal Register of January 17, 2012 (77 FR 2302), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information to which three comments were received: two 
from organizations and one from a member of Congress. The commenters 
generally supported the collection of sales data, and stated that this 
information would be useful in assessing antimicrobial drugs used in 
food-producing animals to better address the problem of antimicrobial 
resistance. One commenter stated that the information supplied by drug 
companies should be submitted in a format that would allow it to be 
easily merged with data from other FDA databases.
    Beyond the scope of this Federal Register notice, all commenters 
recommended collection of antimicrobial use information in addition to 
the current requirements of ADUFA II sales reporting. All commenters 
also recommended revisions to the public reporting of the data being 
collected. The commenters requested FDA report sales of antimicrobial 
drug classes by month, by route of administration, by indication, by 
over-the-counter or prescription status, or grouped by their importance 
in human medicine. It was recommended that FDA collect and publicly 
report distribution information down to the state or regional level. 
ADUFA II requires that no class with fewer than three distinct sponsors 
of approved applications shall be independently reported; it was 
recommended that FDA seek additional authority from Congress to report 
sales figures for all antimicrobial classes regardless of the number of 
distinct drug sponsors. There was also a recommendation that all of the 
information collected be made publicly available in a searchable 
database.
    FDA has considered the comments, but at this time we can only 
require the submission of information on the new e-form FDA 3744a that 
is expressly required to be submitted by section 512(l)(3) of the FD&C 
Act. We are pursuing notice and comment rulemaking to codify these 
requirements, and are currently assessing any additional data 
requirements. In this regard, FDA published an Advance Notice of 
Proposed Rulemaking on July 27, 2012, in which FDA solicited comment on 
the following: (1) Whether FDA should require submission of an estimate 
of the amount of antimicrobial ingredient sold or distributed for use 
in each approved food animal species, (2) how FDA can best compile and 
present required summary information, and (3) alternative methods there 
may be for obtaining additional data and information about the extent 
of antimicrobial drug use in food-producing animals and are there 
alternative methods the Agency can employ within its existing 
authority.

    Dated: January 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01446 Filed 1-24-13; 8:45 am]
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