[Federal Register Volume 64, Number 3 (Wednesday, January 6, 1999)]
[Notices]
[Pages 887-888]
From the Federal Register Online via the Government Printing 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