[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: 
[email protected].

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