[Federal Register Volume 64, Number 3 (Wednesday, January 6, 1999)]
[Notices]
[Pages 887-888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34842]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-1146]
Discussion Paper: ``A Proposed Framework for Evaluating and
Assuring the Human Safety of the Microbial Effects of Antimicrobial New
Animal Drugs Intended for Use 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 ``A Proposed Framework for
Evaluating and Assuring the Human Safety of the Microbial Effects of
Antimicrobial New Animal Drugs Intended for Use in Food-Producing
Animals'' (discussion paper). This discussion paper is the second step
in the agency's consideration of issues related to the use of
antimicrobial new animal drugs in food-producing animals. FDA is making
the discussion paper 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 microbial safety policies protective of the public health.
DATES: Written comments on the discussion paper should be submitted by
April 6, 1999.
ADDRESSES: Submit written requests for single copies of the discussion
paper to the Communications Staff (HFV-12), Center for Veterinary
Medicine (CVM), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
the office in processing your requests.
Submit written comments on the discussion paper to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with
the full title of the discussion paper and the docket number found in
brackets in the heading of this document.
See the SUPPLEMENTARY INFORMATION section of this document for
electronic access to the discussion paper.
FOR FURTHER INFORMATION CONTACT:
Sharon R. Thompson, Office of the Director (HFV-1), Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1798.
Margaret A. Miller, Office of New Animal Drug Evaluation (HFV-100),
Center for Veterinary Medicine, Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1620.
Linda R. Tollefson, Office of Surveillance and Compliance (HFV-
200), Center for Veterinary Medicine, Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855, 301-827-6644.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 18, 1998 (63 FR 64094), FDA
published a notice of availability of a draft guidance entitled
``Guidance for Industry: Evaluation of the Human Health Impact of the
Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in
Food-Producing Animals.'' The release of this draft guidance was the
first step in the agency's consideration of issues related to the use
of antimicrobial new animal drugs in food-producing animals. The draft
guidance lays out the agency's rationale for its current thinking about
its authority under the Federal Food, Drug, and Cosmetic Act to
consider the human health impact of the microbial effects associated
with the use of antimicrobial new animal drugs in food-producing
animals. Since the 1970's, and until scientific evidence indicated that
a change was necessary, the agency had evaluated the human health
impact of the microbial effects of only certain uses of antimicrobial
new animal drugs in animal feeds. The draft guidance provides that the
agency now believes that sponsors of all antimicrobial new animal drugs
intended for use in food-producing animals need to provide information
that will allow the agency to evaluate the human health impact of the
microbial effects of the intended uses. In assessing the human health
impact of such uses, the draft guidance states that two separate but
related factors should be evaluated: (1) The quantity of antimicrobial
drug-resistant enteric bacteria formed in the animal's
[[Page 888]]
intestinal tract following exposure to the antimicrobial new animal
drug (resistance), and (2) changes in the number of enteric bacteria in
the animal's intestinal tract that cause human illness (pathogen load).
The discussion paper that is the subject of this notice is the
second step of the agency's consideration of these issues. It augments
the draft guidance made available in November 1998 by setting out a
conceptual risk-based framework for evaluating the microbial safety
(relating to human health impact) of antimicrobial new animal drugs
intended for use in food-producing animals. FDA is making the
discussion paper available to the public in order 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 policies that are protective of the public health. The
agency is seeking comment from the public in two areas. The first is
whether the concepts set out in this document, if implemented, will
accomplish the goal of protecting the public health by ensuring that
significant human antimicrobial therapies are not lost as a result of
use of antimicrobial new animal drugs in food-producing animals, while
providing for the safe use of antimicrobials in food-producing animals.
The second is to obtain input on important areas of scientific
complexity outlined in the discussion paper.
This will not be the only opportunity for public comment on these
issues. The agency intends to solicit further public comments at the
next meeting of FDA's Veterinary Medicine Advisory Committee in
Rockville, MD, which is scheduled to be held on January 25 and 26,
1999. Also, comments regarding the draft guidance entitled ``Guidance
for Industry: Evaluation of the Human Health Impact of the Microbial
Effects of Antimicrobial New Animal Drugs Intended for Use in Food-
Producing Animals'' may be submitted at any time.
II. Comments
Interested persons may, on or before April 6, 1999, submit to the
Dockets Management Branch (address above) written comments regarding
this discussion paper. Two copies of any comments are to be submitted,
except that individuals 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 discussion paper and received comments may
be seen in the office above between 9 a.m. and 4 p.m., Monday through
Friday.
III. Electronic Access
Persons with access to the Internet may obtain the discussion paper
using the World Wide Web (WWW). For WWW access, connect to CVM at
``http://www.fda.gov/cvm''.
Dated: December 30, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-34842 Filed 12-31-98; 12:04 pm]
BILLING CODE 4160-01-F