99-33386. 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  

  • [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
    
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    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
    
    
    

Document Information

Published:
12/23/1999
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of availability.
Document Number:
99-33386
Dates:
Submit comments at any time.
Pages:
72084-72085 (2 pages)
Docket Numbers:
Docket No. 98D-0969
PDF File:
99-33386.pdf