[Federal Register Volume 77, Number 145 (Friday, July 27, 2012)]
[Proposed Rules]
[Pages 44177-44179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18366]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2012-N-0447]


Antimicrobial Animal Drug Sales and Distribution Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is soliciting 
comments regarding potential changes to its regulations relating to 
records and reports for approved new animal drugs. FDA is considering 
revisions to this regulation to incorporate the requirements of section 
105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part 
of that process, FDA is reviewing other reporting requirements 
applicable to antimicrobial new animal drug sponsors to determine 
whether additional information should be reported. Collecting data on 
antimicrobial drugs used in food-producing animals will assist FDA in 
tracking antimicrobial use trends and examining how such trends may 
relate to antimicrobial resistance.

DATES: Submit electronic or written comments by September 25, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0447, by any of the following methods:

[[Page 44178]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2012-N-0447 for this rulemaking. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary 
Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9062, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360b(l)) requires sponsors of approved or 
conditionally approved new animal drug applications to establish and 
maintain records and make such reports of data relating to experience 
with uses and other data or information received or obtained by the 
sponsor with respect to such animal drugs as required by regulation or 
order. FDA's regulation relating to records and reports for approved 
new animal drugs is found at 21 CFR 514.80. This regulation requires an 
animal drug sponsor to submit a number of different reports, including 
periodic drug experience reports, which must contain, among other 
things, drug distribution data showing the amount of the drug 
distributed domestically and the amount exported.
    In 2008, ADUFA 105 directed the Agency to collect additional data 
and information about approved antimicrobial new animal drugs by 
amending section 512(l) of the FD&C Act to include new reporting 
requirements for sponsors of approved antimicrobial new animal drugs. 
Under section 512(l) of the FD&C Act, as amended by ADUFA 105, 
antimicrobial new animal drug sponsors must now also submit to FDA on 
an annual basis a report specifying the amount of each antimicrobial 
active ingredient in the sponsor's drug that is sold or distributed for 
use in food-producing animals. Specifically, sponsors are required to 
report the amount of each antimicrobial active ingredient as follows: 
(1) By container size, strength, and dosage form; (2) by quantities 
distributed domestically and quantities exported; and (3) for each 
dosage form, a listing of the target animals, indications, and 
production classes that are specified on the approved label of the 
product. Currently, sponsors of antimicrobial drugs that are approved 
and labeled for multiple animal species, including both food-producing 
and nonfood-producing animals, do not report sales and distribution 
information for each individual animal species. Only total product 
sales information is reported. The information must be reported for the 
preceding calendar year, and include separate information for each 
month of the calendar year, and be submitted to FDA each year by no 
later than March 31. ADUFA 105 also requires FDA to publish an annual 
summary report of the antimicrobial drug sales and distribution data it 
receives.
    The sales and distribution information that is currently being 
collected from antimicrobial new animal drug sponsors in accordance 
with ADUFA 105 is important in supporting efforts such as the National 
Antimicrobial Resistance Monitoring System (NARMS), a surveillance 
program that tracks trends related to antimicrobial resistance in food-
producing animals and humans.
    A recent Government Accountability Office (GAO) report addressing 
antibiotic resistance concluded that sales and distribution information 
as currently collected by FDA does not provide sufficient data needed 
to analyze trends in antimicrobial resistance, such as information on 
actual drug use in specific food-producing animal species (Ref. 1). 
Having improved data would enable the Agency to better correlate 
resistance data in NARMS with drug exposure, thereby providing improved 
information for science-based decisionmaking in the approval and 
monitoring of safe and effective antimicrobial drugs. In addition, such 
information would further enhance FDA's ongoing activities related to 
antimicrobial resistance and is consistent with the recommendations in 
guidance recently issued by this Agency addressing the judicious use of 
medically important antimicrobial drugs in food-producing animals (Ref. 
2).

II. Agency Request for Comments

A. Sales and Distribution Data by Species

    FDA is considering revisions to the requirements in this Agency's 
regulation at Sec.  514.80 to incorporate the requirements of ADUFA 105 
and, as part of that process, is reviewing other reporting requirements 
applicable to antimicrobial new animal drug sponsors to determine 
whether additional information should be reported. FDA is soliciting 
public comment on whether, consistent with its authority under section 
512(l) of the FD&C Act to collect information relating to approved new 
animal drugs, it should amend its regulations to require the submission 
of additional sales and distribution information including, for 
antimicrobial animal drug products that are approved and labeled for 
more than one food-producing animal species, an estimate of the amount 
of each active antimicrobial ingredient sold or distributed for use in 
each approved food-producing animal species. Specifically, comments 
should address how sponsors can both practically and accurately provide 
separate sales and distribution information for each species.

B. FDA's Annual Summary Report

    ADUFA 105 directs FDA to issue on an annual basis a summary report 
of the sales and distribution data collected from sponsors of 
antimicrobial new animal drugs and further provides that such data must 
be reported by antimicrobial class. ADUFA 105 also directs FDA to 
independently report only those antimicrobial drug classes with three 
or more distinct sponsors, so as to protect confidential business 
information. Within these statutory parameters, FDA is seeking public 
comment on how best to compile and present this summary information.

[[Page 44179]]

C. Alternative Methods for Obtaining Antimicrobial Use Data

    FDA is seeking public comment on alternative methods available to 
the Agency for obtaining additional data and information about the 
extent of antimicrobial drug use in food-producing animals. 
Specifically, the Agency is requesting public input on alternative 
methods for assessing antimicrobial use the Agency can employ within 
its existing authority that may further support the analysis of factors 
related to the development and spread of antimicrobial resistance in 
connection with the use of medically important antibiotics in food-
producing animals.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    This advanced notice of proposed rulemaking is issued under section 
512 of the FD&C Act (21 U.S.C. 360b) and under the authority of the 
Commissioner of Food and Drugs.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site address, but we are not responsible for 
any subsequent changes to the Web site after this document publishes in 
the Federal Register.)

    1. U.S. General Accounting Office, ``Antibiotic Resistance: 
Agencies Have Made Limited Progress Addressing Antibiotic Use in 
Animals,'' GAO-11-801, Washington, DC, General Accounting Office, 
2011 (http://www.gao.gov/new.items/d11801.pdf).
    2. Guidance for Industry 209, entitled ``The Judicious 
Use of Medically Important Antimicrobial Drugs in Food-Producing 
Animals'' (http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm).


    Dated: June 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18366 Filed 7-26-12; 8:45 am]
BILLING CODE 4160-01-P