[Federal Register Volume 64, Number 246 (Thursday, December 23, 1999)]
[Notices]
[Pages 72084-72085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33386]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0969]
FDA Response to Comments on a Proposed Framework for Evaluating
and Assuring the Human Food 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 of availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``FDA Response to Comments on a
Proposed Framework for Evaluating and Assuring the Human Food Safety of
the Microbial Effects of Antimicrobial New Animal Drugs Intended for
Use in Food-Producing Animals.'' The comments were received in response
to a document entitled ``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' '' (the Framework Document) that FDA made public and discussed
at the Veterinary Medicine Advisory Committee (VMAC) meeting in January
1999. FDA intends to revise the Framework Document in response to the
comments. Specific aspects of the Framework Document are to be
discussed at two workshops scheduled for December 9 and 10, 1999, and
February 22 and 23, 2000, and at later workshops currently being
considered. For additional information, see the notice of availability
of the guidance document entitled ``Guidance for Industry:
Consideration of the Human Health Impact of the Microbial Effects of
Antimicrobial New Animal Drugs Intended for Use in Food-Producing
Animals'' (GFI #78) that appears elsewhere in this issue of the Federal
Register.
DATES: Submit comments at any time.
ADDRESSES: Submit written comments on the guidance document to the
Dockets Management Branch (HFA-305), Food and Drug Administration, rm.
1061, 5630 Fishers Lane, Rockville, MD 20852.
FDA will also accept electronic comments. Persons who wish to
submit electronic comments should go to the FDA home page at http://
www.fda.gov, select ``Dockets'', and follow the instructions for
submitting electronic comments.
Submit written requests for single copies of the guidance document
entitled ``FDA Response to Comments on a Proposed Framework for
Evaluating and Assuring the Human Food Safety of the Microbial Effects
of Antimicrobial New Animal Drugs Intended for Use in Food-Producing
Animals'' and other documents discussed in the SUPPLEMENTARY
INFORMATION section of this Federal Register notice to the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Enclose
one self-addressed adhesive label to assist that office in processing
your requests. See section III. Electronic Access of this document for
information on electronic access to the guidance document and its
related documents.
FOR FURTHER INFORMATION CONTACT: Marcia R. Larkins, Center for
Veterinary Medicine (HFV-230), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0137, e-mail:
mlarkins@cvm.fda.gov.
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 document
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'' (GFI #78). The publication of this
draft guidance for industry (GFI #78) was the first step in the
agency's consideration of the issues related to the use of
antimicrobial new animal drugs in food-producing animals. GFI #78 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. Elsewhere in
this issue of the Federal Register is a notice of availability of the
final revised guidance.
In the Federal Register of January 6, 1999 (64 FR 887), FDA
announced the availability of a discussion paper called the Framework
Document, which was the second step in the agency's consideration of
issues related to the use of antimicrobial new animal drugs in food-
producing animals. 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
[[Page 72085]]
concepts to be used to develop microbial safety policies protective of
the public health. The Framework Document is related to GFI #78 in that
it sets out a conceptual risk-based framework for evaluating the
microbial effects (related to human health impact) of antimicrobial new
animal drugs intended for use in food-producing animals.
The agency invited comment on both GFI #78 and the Framework
Document. FDA received more than 50 comments to these documents. These
comments originated from a number of sources including individual
members and committees of Congress (3); individual physicians,
microbiologists, and hospitals (6); individual citizens and
organizations representing consumers (16); animal drug and feed
industries (3); individual veterinarians and organizations representing
veterinarians (5); environmental organizations (3); individual
producers and organizations representing producers (14); and another
Federal agency (1).
In addition to requesting comment from the public, the agency also
consulted with the VMAC on this issue. In a meeting held on January 25
and 26, 1999, the VMAC provided input on the Framework Document and
addressed five specific questions from the agency regarding its
contents. The goal of the meeting was ``to find the balance that
protects human health and gives veterinarians the tools they need to
treat animals.'' A transcript of this meeting is available on the CVM
home page at the Internet address provided below in section III.
Electronic Access.
FDA stated it would review the transcript of the VMAC meeting and
any comments on GFI #78 and the Framework Document that were submitted
to the agency, publish the analysis, and then appropriately revise GFI
#78 and the Framework Document. This guidance document entitled ``FDA
Response to Comments on a Proposed Framework for Evaluating and
Assuring the Human Food Safety of the Microbial Effects of
Antimicrobial New Animal Drugs Intended for Use in Food-Producing
Animals'' contains the analysis of the transcript, the comments
received regarding GFI #78 and the Framework Document, and provides
responses to the comments.
In the Federal Register of September 27, 1999 (64 FR 52099), the
agency announced a general public meeting and two public workshops to
discuss issues related to antimicrobial resistance in food-producing
animals. The general public meeting was held on October 4, 1999. The
first workshop called the ``Risk Assessment and the Establishment of
Resistance Thresholds Workshop'' is scheduled for December 9 and 10,
1999. The second workshop called ``Preapproval Studies in Antimicrobial
Resistance'' is scheduled for February 22 and 23, 2000. The agency
intends for the document entitled ``FDA Response to Comments on a
Proposed Framework for Evaluating and Assuring the Human Food Safety of
the Microbial Effects of Antimicrobial New Animal Drugs Intended for
Use in Food-Producing Animals,'' along with the Framework Document, to
serve as a basis for discussion at the two workshops and at future
workshops.
II. Comments
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written or electronic comments
regarding this response to comments. Two copies of any written comments
are to be submitted, except that individuals may submit one copy. All
comments are to be identified with the docket number found in brackets
in the heading of this document. A copy of the response to comments and
all received electronic and written comments may be seen in the office
above between 9 a.m. and 5 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain copies of the
document entitled ``FDA Response to Comments on a Proposed Framework
for Evaluating and Assuring the Human Food Safety of the Microbial
Effects of Antimicrobial New Animal Drugs Intended for Use in Food-
Producing Animals,'' the Framework Document, GFI #78, and transcripts
from the VMAC meeting at http://www.fda.gov/cvm.
Dated: December 8, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-33386 Filed 12-22-99; 8:45 am]
BILLING CODE 4160-01-F
