Antimicrobial Drugs in Food-Producing Animals

The Food and Drug Administration (FDA) of the U. S. Department of Health and Human Services (HHS) has published a draft guidance (#209) entitled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals and is seeking public comment on the guidance. The solicitation appeared in the Federal Register (75 FR 37450, June 29, 2010).

 

The text of the FDA notice follows this memorandum.  I also have attached the FDA press release on the guidance.

 

The deadline for submitting input is August 30, 2010. All questions about the announcement should be directed to the point of contact listed in the FDA solicitation.

 

Please do not hesitate to contact me whenever I can be of any assistance.

 

 

Federal Register: June 29, 2010 (Volume 75, Number 124)

[Notices]               

[Page 37450-37451]

From the Federal Register Online via GPO Access 

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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Draft Guidance: The Judicious Use of Medically Important 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availability of a draft guidance (209) entitled ``The 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 This draft guidance is intended to inform the 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this draft guidance before it begins work on the final version of the 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: ocod@fda.hhs.gov. 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: 

william.flynn@fda.hhs.gov.

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]

BILLING CODE 4160-01-S

 

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Eddie G. Gouge

Associate Director, Federal Relations -- Food and Agricultural Sciences/CARET

 

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E-Mail:  egouge@aplu.org

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