[Federal Register Volume 65, Number 251 (Friday, December 29, 2000)]
[Notices]
[Pages 83070-83071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33215]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1677]
Discussion Paper: An Approach for Establishing Thresholds in
Association With the Use of 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 discussion paper entitled ``An Approach for
Establishing Thresholds in Association With the Use of Antimicrobial
Drugs in Food-Producing Animals (discussion paper).'' This discussion
paper reflects the Center for Veterinary Medicine's (CVM's) current
thinking on one concept for establishing resistance thresholds for
antimicrobial drugs used in food-producing animals. The concept will be
presented for discussion at a public meeting on January 22 to 24, 2001.
CVM wants to receive comment on scientific and policy issues regarding
this concept, as well as suggestions for alternative approaches.
DATES: Submit written comments on this discussion paper by April 9,
2001.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
See the SUPPLEMENTARY INFORMATION section for electronic access to
the discussion paper. Persons without Internet access may submit
written requests for single copies of this discussion paper to the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: For general inquiries: Sharon R.
Thompson, Center for Veterinary Medicine (HFV-3), Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4514,
e-mail at [email protected].
For technical inquiries: William T. Flynn, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-7570, e-mail at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 6, 1999 (64 FR 887), FDA
announced the availability of a discussion paper entitled ``A Proposed
Framework for Evaluating and Assuring the Human Safety of the Microbial
Effects of Antimicrobial Drugs Intended for Use in Food-Producing
Animals'' (the Framework Document). FDA made the Framework Document
available to the public to initiate discussions with the scientific
community and other interested parties on the agency's thinking about
appropriate underlying concepts to be used to develop new policy for
evaluating and ensuring that antimicrobial drug use in food-producing
animals is safe for the public health. The Framework Document discussed
several strategies for addressing concerns regarding the development of
antimicrobial drug resistance associated with the use of antimicrobial
drugs in food-producing animals. These strategies covered both
preapproval and postapproval approaches and included: (1) Revision of
the preapproval safety assessment for antimicrobial resistance for new
animal drug applications to consider all uses of antimicrobial drugs in
food-producing animals, (2) categorization of antimicrobial drugs based
upon the importance of the drug for human medicine and upon which
preapproval and postapproval requirements would be based, (3)
postapproval monitoring of the development of antimicrobial drug
resistance, and (4) elaboration of resistance and monitoring
thresholds.
The Framework Document discussed the concept of two thresholds, the
resistance threshold and the monitoring threshold, that would be
established prior to the approval of an antimicrobial new animal drug
for use in food-producing animals to ensure that food products derived
from the animal species treated with the drug are safe for consumers.
The resistance threshold would be established in humans to represent
the upper limit of resistant bacteria that can be transferred from
animals to consumers. The Framework Document discussed the possibility
of establishing resistance thresholds based on human data, animal data,
or both.
The Framework Document noted that monitoring thresholds also would
be established to guide the postapproval monitoring of resistance
development in animals. According to the Framework Document, a
monitoring threshold would need to be determined for each antimicrobial
drug prior to approval, and the threshold could vary depending on the
human or animal pathogen of concern. Monitoring thresholds would be
established in animals so that they would serve as an early warning
system, signaling when loss of susceptibility or resistance prevalence
is approaching the resistance threshold.
If a monitoring threshold were reached, the drug sponsor could
implement mitigation actions to address the loss of susceptibility or
the increasing resistance trend. According to the concepts described in
the Framework Document, if mitigation actions were found to be
unsuccessful, and resistance levels exceeded the resistance threshold,
withdrawal of the approval of the drug for the use(s) of concern would
be warranted.
The discussion paper, which is the subject of this notice of
availability, further describes an approach for establishing thresholds
intended to limit the emergence and spread of antimicrobial resistance
in human pathogens attributed to antimicrobial drug use in food-
producing animals. The discussion paper attempts to describe the
possible complexities of this approach to establishing thresholds in
order to encourage discussion before, during, and after the January
public meeting mentioned above. A notice of the public meeting was
announced in the Federal Register of September 26, 2000 (65 FR 57820).
The discussion paper discusses the use of two types of thresholds,
a human health threshold and a resistance-in-animals threshold. The
human health threshold represents the level at which there is no longer
a reasonable certainty of no harm to human health associated
[[Page 83071]]
with antimicrobial resistance development as a consequence of
antimicrobial drug use in food-producing animals. The resistance-in-
animals threshold represents the upper limit of acceptable levels of
antimicrobial resistance in a food-producing animal species. This
resistance threshold is derived through a risk assessment model that
builds a link between the human health threshold and the resistance
levels in animals. Therefore, exceeding the resistance threshold would
be considered an unacceptable human health risk.
II. Comments
This discussion paper is being distributed at this time for
consideration by the public in anticipation of the January 22 to 24,
2001, public meeting. Interested persons may submit to the Dockets
Management Branch (address above) written comments regarding this
discussion paper by April 9, 2001. Two copies of any comments are to be
submitted, except that an individual may submit one copy. Comments are
to be identified with the docket number found in brackets in the
heading of this document. A copy of the docket including transcript and
comments may be seen in the Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Copies of the discussion paper may be obtained on the Internet from
the CVM home page at
http://www.fda.gov/cvm/.
Dated: December 21, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-33215 Filed 12-26-00; 11:47 am]
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