[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