Document ID: FDA-2011-D-0889-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209
Posted Date: 2012-04-13T04:00Z

[Federal Register Volume 77, Number 72 (Friday, April 13, 2012)]
[Notices]
[Pages 22327-22328]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8845]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0889]

Draft Guidance for Industry on New Animal Drugs and New Animal 
Drug Combination Products Administered in or on Medicated Feed or 
Drinking Water of Food-Producing Animals: Recommendations for Drug 
Sponsors for Voluntarily Aligning Product Use Conditions With GFI 
209; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (draft GFI 213) 
entitled ``New Animal Drugs and New Animal Drug Combination Products 
Administered in or on Medicated Feed or Drinking Water of Food-
Producing Animals: Recommendations for Drug Sponsors for Voluntarily 
Aligning Product Use Conditions With GFI 209.'' The purpose of 
this document is to provide information to sponsors of certain new 
animal drug products who are interested in developing revised 
conditions of use for those products consistent with FDA's GFI 
209, ``The Judicious Use of Medically Important Antimicrobial 
Drugs in Food-Producing Animals'' and to set timelines for stakeholders 
wishing to comply voluntarily with this guidance.

[[Page 22328]]

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 12, 2012.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HVF-1), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9084, 
william.flynn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    This document is related to two documents published elsewhere in 
this issue of the Federal Register, wherein FDA is announcing: (1) The 
availability of a final guidance entitled ``The Judicious Use of 
Medically Important Antimicrobial Drugs in Food-Producing Animals'' 
(GFI 209) and (2) the availability of a draft proposed 
regulation for veterinary feed directives.
    FDA is announcing the availability of a draft guidance for industry 
entitled ``New Animal Drugs and New Animal Drug Combination Products 
Administered in or on Medicated Feed or Drinking Water of Food-
Producing Animals: Recommendations for Drug Sponsors for Voluntarily 
Aligning Product Use Conditions With GFI 209'' (draft GFI 
213). The audience for this draft guidance is sponsors of 
approved applications for new animal drug products containing medically 
important antimicrobial new animal drugs for use in or on medicated 
feed or in drinking water of food-producing animals. The purpose of 
this draft guidance is to provide sponsors of the affected new animal 
drug products with more specific information on how to supplement their 
approved new animal drug applications to align with FDA's 
recommendations in GFI 209.
    Final GFI 209, published elsewhere in this edition of the 
Federal Register, discusses FDA's concerns regarding the development of 
antimicrobial resistance in human and animal bacterial pathogens when 
medically important antimicrobial drugs are used in food-producing 
animals in an injudicious manner. GFI 209 recommends that the 
use of medically important antimicrobial drugs be limited to uses in 
animals that are considered necessary for assuring animal health and 
include veterinary oversight or consultation (namely through the use of 
prescription or veterinary feed directive products).
    FDA encourages all sponsors of new animal drug products covered by 
draft GFI 213 to participate in the voluntary program outlined 
in the draft guidance. FDA believes a voluntary approach, conducted in 
a cooperative and timely manner, will be a far faster and less 
burdensome route to achieving the common goal of more judicious use of 
medically important antimicrobials in animal agriculture. However, FDA 
also believes it is critical to see meaningful progress toward reaching 
this goal. Therefore, in order to ensure an orderly, equitable, and 
timely transition, draft GFI 213 also includes clear timelines 
for sponsors of affected products wishing to revise their approved 
applications.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the Agency's current thinking on this 
topic. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 514 have been approved under 
OMB control numbers 0910-0032 and 0910-0669.

IV. 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.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: April 5, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-8845 Filed 4-11-12; 11:15 am]
BILLING CODE 4160-01-P