[Federal Register Volume 74, Number 205 (Monday, October 26, 2009)]
[Notices]
[Pages 55046-55048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0512]


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 and 
including each proposed extension of a collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on reporting and recordkeeping requirements for 
antimicrobial animal drug distribution as required by Section 105 of 
the Animal Drug User Fee Amendments of 2008 (ADUFA).

DATES: Submit written or electronic comments on the collection of 
information by December 28, 2009.

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, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 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

[[Page 55047]]

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(1)(3) (OMB Control Number 0910-NEW)

    Section 105 of ADUFA amended section 512 of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 360b) 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 must be submitted not later than March 31, 2010. 
The report must cover the period of the preceding calendar year and 
include separate information for each month of the calendar year. The 
reports required under section 105 of ADUFA are required to be separate 
from periodic drug experience reports that are required under 21 CFR 
514.80(b)(4) (OMB Control No. 0910-0284).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                 No. of         Annual Frequency       Total Annual        Hours per
       FD&C Act  Section 512(1)(3)            Respondents         per Response          Responses           Response       Total  Hours    Capital  Cost
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Annual Reports for Sponsors with Active                   29                   6.7                194                 80          15,520        $107,880
 Applications
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Annual Reports for Sponsors with Inactive                 23                   4.0                 92                  1              92  ..............
 Applications
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Total                                                                                                                             15,612        $107,880
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\1\ There are no operating and maintenance costs associated with this collection of information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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   FD&C Act
    Section           No. of        Annual Frequency of     Total Annual    Hours per  Record     Total Hours
   512(1)(3)       Respondents         Recordkeeping          Records
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All Applicants                 34                     1                 34                  2                 68
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Total                                                                                                         68
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The reporting burden estimates, including the total number of 
annual responses, are based on the number of sponsors and approved 
applications for antimicrobial drug products in food-producing animals. 
The annual frequency of responses was calculated as the total annual 
responses divided by the number of respondents.
    The agency arrived at the estimates for reporting as follows: There 
are 34 sponsors with approved applications for antimicrobial drugs for 
food-producing animals. There are 29 animal drug manufacturers with 194 
approved applications for antimicrobial drugs for food-producing 
animals for which the drugs are being actively marketed (active 
applications). Additionally, there are 93 approved applications for 
antimicrobial drugs for food-producing animals for which the drugs are 
not being marketed (inactive applications), owned by 23 animal drug 
manufacturers.
    Regarding the reporting burden associated with the collection of 
information, FDA believes that the large majority of the burden will be 
incurred by industry in the first year in which reporting is required 
to design a report that meets the requirements of section 512(l)(3) of 
the act. The agency has estimated this burden at 80 hours per applicant 
with active applications. The agency has factored into this estimate 
the time it will take industry to identify and locate the necessary 
information within existing records, and to develop a report that 
complies with section 512(l)(3) of the act. Once this has been 
accomplished, FDA believes that the process for producing reports in 
subsequent years will essentially be automated, and that it will take

[[Page 55048]]

approximately 3 hours to run a report that satisfies the act's 
requirements. For sponsors of approved applications that are inactive 
(i.e., the approved drug is not being marketed), the sponsor would only 
have to submit a report stating that the drug is not being marketed, 
which FDA estimates will take approximately 1 hour.
    FDA has developed a form to report the information required by 
section 512(l)(3) of the act. FDA plans to make the form available to 
animal drug manufacturers through FDA's website however, use of the 
form would be entirely voluntary. The form contains various fields for 
information, including the drug manufacturer's name, new animal drug 
approval number, active ingredient name, National Drug Code number, 
container size, potency, and the number of units sold by month.
    The animal drug manufacturers can meet the statutory requirements 
by submitting their information in paper format using the FDA-provided 
form, one of their own designs, or by designing their own electronic 
form whose results could be submitted to the agency on a compact disc 
or on paper. The cost to animal drug sponsors for gathering the 
necessary information for report design and preparation or for 
completing FDA's form in the first year of reporting is $107,880 (29 
active sponsors times 80 hours times $46.50 per hour = $107,880). This 
is a one-time cost for a computer or mathematic employees to design and 
prepare a report that satisfies the statutory requirements of section 
512(l)(3) of the act.\1\ For subsequent years, the preparation of the 
report should take approximately 3 hours. Thus, the total cost in 
subsequent years would be $139.50.
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    \1\ BLS Occupation Employment and Wages, May 2006, by 
occupation, for all industries (http://www.bls.gov). Wage ($46.50) 
includes mean hourly wage of $33.22 for Standard Occupational 
Classification 15-0000, computer and mathematics occupations, all 
industries; we add 40 percent to account for benefits.
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    Regarding the recordkeeping burden associated with this collection 
of information, FDA believes that most of the necessary information for 
the annual report required to be submitted under section 512(l)(3) of 
the act is already collected and maintained by animal drug 
manufacturers under existing requirements.
    Animal drug manufacturers are already required to maintain 
distribution records for their drug products to comply with FDA's 
current good manufacturing practice regulations under Sec.  211.196 (21 
CFR Sec.  211.96) (OMB Control No. 0910-0139), and to comply with 
regulations for periodic drug experience reports under Sec.  
514.80(b)(4)(i) (21 CFR Sec.  514.80(b)(4)(i)) (OMB Control No. 0910-
0284) of FDA regulations. Therefore, FDA believes that manufacturers of 
animal drugs already possess the computers, software, and additional 
equipment necessary to collect and maintain the necessary records, and 
to make reports.
    Section 512(l)(3) of the act differs from Sec.  514.80(b)(4)(i) in 
that it requires that records include separate information for each 
month of the calendar year. Under Sec.  211.196 (OMB Control No. 0910-
0139), manufacturers currently are required to maintain distribution 
records that include the dosage form and date the drug is distributed. 
Additionally, FDA believes that manufacturers already keep detailed 
records of the dates when antimicrobial drugs are distributed for 
marketing and recall purposes from which monthly reports can be 
prepared as part of their usual and customary practice. However, FDA 
estimates additional hourly burden required by section 512(l)(3) of the 
Act as shown in table 2 of this document.

    Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25671 Filed 10-23-09; 8:45 am]
BILLING CODE 4160-01-S