[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.
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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]
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