[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7272-7274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3029]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

-----------------------------------------------------------------------

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 March 
22, 2010.

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 e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910--NEW 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: Denver Presley Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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-
NEW)--Extension

    Section 105 of the Animal Drug User Fee Amendments of 2008 (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 Sec.  
514.80(b)(4) (21 CFR Sec.  514.80(b)(4) (OMB Control No. 0910-0284).
    In the Federal Register of October 26, 2009 (74FR 55046), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received comments from two 
organizations. Both commenters supported the information collection and 
stated that the data to be collected would be useful in addressing

[[Page 7273]]

the problem of antimicrobial resistance. However, both comments 
suggested that more extensive measures are necessary to address this 
problem. For example, one of the comments stated that the practical 
utility of the data would be broadened in conjunction with a larger 
federal monitoring effort requiring manufacturers to report uses of 
their products in all food animal products, which would involve 
collecting data from end users such as veterinarians and animal owners. 
The other comment stated that the information collection would not be 
sufficient to show how much of each class of antimicrobial is sold for 
use in different types of food animals, and recommended that FDA 
collect distribution data on medicated feeds for this purpose because 
feeds are specific to animal species and class. The comment also 
recommended that FDA require all data to be submitted through a Web-
based application directly into a form created by FDA, and that FDA 
create a publically accessible database that allows searches by drug 
class, dose form, and marketing status. FDA has considered the 
comments, but at this time we have decided to only require the 
submission of information that is expressly required to be submitted by 
section 512(l)(3) of the act. We are pursuing notice and comment 
rulemaking to codify these requirements, during which time we will 
assess any additional data requirements.
    FDA estimates the burden of this collection of information as 
follows:

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


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
   FD&C Act
    Section           No. of        Annual Frequency of     Total Annual    Hours per  Record     Total Hours
   512(l)(3)       Respondents         Recordkeeping          Records
----------------------------------------------------------------------------------------------------------------
All Applicants                 34                     1                 34                  2                 68
----------------------------------------------------------------------------------------------------------------
Total                                                                                                         68
----------------------------------------------------------------------------------------------------------------
\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 
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 Web site, however, use of the 
form would be entirely voluntary. The form contains various fields for 
information, including the drug manufacturer's name, NADA 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 either the FDA-
provided form or one of their own design 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 x 80 hours x $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

[[Page 7274]]

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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) (OMB Control No. 0910-0284). 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 an additional hourly burden required by section 512(l)(3) of 
the act as shown in table 2 of this document.

    Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3029 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S