[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Draft Guidance: The Judicious Use of Medically Important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availability of a draft guidance (209) entitled ``The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 This draft guidance is intended to inform the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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 30, 2010.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INFORMATION section for electronic access to the draft guidance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Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to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FDA is announcing the availability of a draft guidance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
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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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