98-34842. 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  

  • [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
    
    
    

Document Information

Published:
01/06/1999
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
98-34842
Dates:
Written comments on the discussion paper should be submitted by April 6, 1999.
Pages:
887-888 (2 pages)
Docket Numbers:
Docket No. 98D-1146
PDF File:
98-34842.Pdf