Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability, 37450-37451 [2010-15289]
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Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
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response
(hours)
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II: College Student Survey .................................................................
II: Late Adolescent Survey .................................................................
II: Early Adolescent Survey ................................................................
III: Follow-up Focus Group of Prevention Educators .........................
III: Follow-up Focus Group of College Students ................................
III: Follow-up Focus Group of Late Adolescents ................................
III: Follow-up Focus Group of Early Adolescents ..............................
IV: Confirmatory Survey of College Students ....................................
IV: Confirmatory Survey of Late Adolescents ....................................
IV: Confirmatory Survey of Early Adolescents ...................................
200
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10
10
10
500
200
200
1
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1
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2410
Dated: June 23, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–15780 Filed 6–28–10; 8:45 am]
BILLING CODE 4163–18–P
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Draft Guidance: The Judicious Use of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.
emcdonald on DSK2BSOYB1PROD with NOTICES4
ACTION:
Notice.
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availability of a draft guidance (#209)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 FoodProducing 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 This draft
guidance is intended to inform the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considers your comment on this draft
guidance before it begins work on the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-
VerDate Mar<15>2010
19:55 Jun 28, 2010
Jkt 220001
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 https://
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, email: 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
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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 foodproducing 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 foodproducing 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
E:\FR\FM\29JNN1.SGM
29JNN1
Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Notices
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.
emcdonald on DSK2BSOYB1PROD with NOTICES4
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
https://www.fda.gov/AnimalVeterinary/
default.htm or https://
www.regulations.gov.
VerDate Mar<15>2010
19:55 Jun 28, 2010
Jkt 220001
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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Closed Meetings
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Date: July 13, 2010.
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Agenda: To review and evaluate grant
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Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Dana Jeffrey Plude, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3176,
MSC 7848, Bethesda, MD 20892, 301–435–
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This notice is being published less than 15
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limitations imposed by the review and
funding cycle.
PO 00000
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37451
Name of Committee: Center for Scientific
Review Special Emphasis Panel; ARRA:
Member Conflict in Cognition and Perception
Competitive Revisions.
Date: July 14, 2010.
Time: 12 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Dana Jeffrey Plude, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3176,
MSC 7848, Bethesda, MD 20892, 301–435–
2309, pluded@csr.nih.gov.
This notice is being published less than 15
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Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
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Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Hungyi Shau, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6186,
MSC 7804, Bethesda, MD 20892, 301–357–
9099, Hungyi.Shau@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 23, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–15784 Filed 6–28–10; 8:45 am]
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E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Notices]
[Pages 37450-37451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15289]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/AnimalVeterinary/default.htm or https://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
