[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Notices]
[Pages 37450-37451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance: The Judicious Use of Medically Important 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availability of a draft guidance (209) entitled ``The 
Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals.'' This draft guidance is intended to inform the 
public of FDA's current thinking on the use of medically important 
antimicrobial drugs in food-producing animals.

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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 30, 2010.

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. Additional copies of this guidance are 
available from the Office of Communication, Outreach and Development 
(OCOD) (HFM-40), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 
301-827-1800, or e-mail: [email protected]. 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INFORMATION section for electronic access to the draft guidance 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    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 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 (HFV-1), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9084, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance 
(209) entitled ``The Judicious Use of Medically Important 
Antimicrobial Drugs in Food-Producing Animals.'' Antimicrobial drugs 
have been widely used in human and veterinary medicine for more than 50 
years, with tremendous benefits to both human and animal health. The 
development of resistance to this important class of drugs, and the 
resulting loss of their effectiveness as antimicrobial therapies, poses 
a serious public health threat. Misuse and overuse of antimicrobial 
drugs creates selective evolutionary pressure that enables 
antimicrobial resistant bacteria to increase in numbers more rapidly 
than antimicrobial susceptible bacteria and thus increases the 
opportunity for individuals to become infected by resistant bacteria. 
Because antimicrobial drug use contributes to the emergence of drug 
resistant organisms, these important drugs must be used judiciously in 
both animal and human medicine to slow the development of resistance. 
Using these drugs judiciously means that unnecessary or inappropriate 
use should be avoided. Although efforts to assure judicious use should 
be directed at all uses of antimicrobial drugs, the focus of this 
document is on the use of medically important antimicrobial drugs in 
food-producing animals.
    In regard to the use of antimicrobial drugs in animals, concerns 
have been raised by the public and components of the scientific and 
public health communities that a significant contributing factor to 
antimicrobial resistance is the use of medically important 
antimicrobial drugs in food-producing animals for production or growth-
enhancing purposes. This document summarizes some of the key scientific 
reports on the use of antimicrobial drugs in animal agriculture and 
outlines FDA's current thinking on strategies for assuring that 
medically important antimicrobial drugs are used judiciously in food-
producing animals in order to help minimize antimicrobial resistance 
development.
    Based on a consideration of the available scientific information, 
FDA is making a number of recommendations regarding the appropriate or 
judicious use of medically important antimicrobial drugs in food-
producing animals. These recommendations include phasing in such 
measures as follows: (1) Limiting medically important antimicrobial 
drugs to uses in food-producing animals that are considered necessary 
for assuring

[[Page 37451]]

animal health and (2) limiting such drugs to uses in food-producing 
animals that include veterinary oversight or consultation. Developing 
strategies for reducing antimicrobial resistance is critically 
important for protecting both public and animal health. Collaboration 
involving both the public and animal health communities on the 
development and implementation of such strategies is needed to assure 
that the public health is protected while also assuring that the health 
needs of animals are addressed.
    This draft guidance discusses FDA's general public health concerns 
regarding the potential impact of certain uses of medically important 
antimicrobial drugs in food-producing animals on the development of 
antimicrobial resistance, and provides two broad recommendations 
regarding such use. The agency intends to issue further guidance in the 
near future to provide more specific information on approaches for 
implementing the recommendations outlined in this draft guidance.

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

    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. It is no 
longer necessary to send two copies of mailed 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.

IV. Electronic Access

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

    Dated: June 10, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15289 Filed 6-28-10; 8:45 am]
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