Document ID: FDA-2011-D-0889-0156
Agency: fda
Document Type: Notice
Title: 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 Guidance for Industry #209; Availability
Posted Date: 2013-12-12T05:00Z

[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Notices]
[Pages 75570-75571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29697]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 Guidance for Industry 
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 guidance for industry 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 Guidance for Industry 209.'' The purpose of 
this document is to provide information to sponsors of certain 
antimicrobial new animal drug products who are interested in revising 
conditions of use for those products consistent with FDA's Guidance for 
Industry (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.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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-

[[Page 75571]]

addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the 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, email: 
william.flynn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of April 13, 2012 (77 FR 22327), FDA 
published the notice of availability for a draft guidance 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,'' giving 
interested persons until July 12, 2012, to comment on the draft 
guidance. FDA received numerous comments on the draft guidance and 
those comments were considered as the guidance was finalized. In 
addition, editorial changes were made to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated April 13, 
2012.
    The purpose of this guidance document is to provide information to 
sponsors of certain antimicrobial new animal drug products who are 
interested in revising conditions of use for those products consistent 
with FDA's Guidance for Industry (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. FDA intends to work with affected drug 
sponsors to help them to voluntarily implement the principles described 
above through modifications to the approved conditions of use of their 
new animal drug products. FDA believes a voluntary approach, conducted 
in a cooperative and timely manner, is the most effective approach to 
achieve the common goal of more judicious use of medically important 
antimicrobials in animal agriculture.
    FDA recognizes that it is important to identify ways to assess the 
effect of GFI 209 and GFI 213 over time. FDA 
currently collects data on the sale and distribution of antimicrobial 
drugs intended for use in food-producing animals, as well as data on 
antimicrobial resistance among foodborne pathogens as part of the 
National Antimicrobial Resistance Monitoring System. FDA is currently 
working in collaboration with other agencies, including United States 
Department of Agriculture and the Centers for Disease Control, to 
explore approaches for enhancing current data collection efforts in 
order to measure the effectiveness of the strategy. FDA anticipates 
seeking additional public input as it develops these enhancements.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the Agency's current thinking on the 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 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

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

    Dated: December 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29697 Filed 12-11-13; 8:45 am]
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