[Federal Register Volume 77, Number 72 (Friday, April 13, 2012)]
[Notices]
[Pages 22328-22329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0094]


Guidance for Industry on the Judicious Use of Medically Important 
Antimicrobial Drugs in Food-Producing Animals; 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 (GFI 209) entitled 
``The Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals.'' This guidance is intended to inform the public of 
FDA's current thinking on the use of medically important antimicrobial 
drugs in animal agriculture.

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-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:[sol][sol]www.regulations.gov. Submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration,

[[Page 22329]]

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 protected].

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availability of a draft guidance entitled ``New Animal Drugs and New 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'' (draft GFI 213); and (2) the availability of a 
draft proposed regulation for veterinary feed directives.
    In the Federal Register of June 29, 2010 (75 FR 37450), FDA 
published the notice of availability for a draft guidance entitled 
``The Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals,'' giving interested persons until August 30, 2010, 
to comment on the draft guidance. FDA received numerous comments on the 
draft guidance, and those comments were considered as the guidance was 
finalized. Minor editorial changes were made to improve clarity.
    The Agency was pleased to receive a number of comments that were 
generally supportive of the concepts outlined in draft GFI 
209. However, other comments were more critical, based largely 
on the guidance's lack of specificity related to implementation issues. 
FDA decided not to make any substantive changes to GFI 209 but 
rather to address specific issues related to implementation through 
issuance of a separate draft guidance document, draft GFI 213, 
that would afford additional opportunity for public comment. As noted 
earlier, a notice of availability for draft GFI 213 is 
published elsewhere in this issue of the Federal Register.
    The guidance announced in this notice finalizes the draft guidance 
dated June 28, 2010.

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

    FDA concludes that there are no collections of information under 
the Paperwork Reduction Act of 1995.

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 guidance at 
either http:[sol][sol]www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
http:[sol][sol]www.regulations.gov.

    Dated: April 5, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-8846 Filed 4-11-12; 11:15 am]
BILLING CODE 4160-01-P