
[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14801-14802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05339]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1046]


Veterinary Oversight of Antimicrobial Use in Livestock: Impact on 
Stakeholders; Public Meetings; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meetings; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing plans for 
five meetings to provide an opportunity for public dialogue and 
feedback on challenges faced by the animal agriculture industry and 
practicing veterinarians as FDA implements its initiative for the 
judicious use of medically important antimicrobials in medicated feed 
or drinking water of food-producing animals. Particular emphasis will 
be placed on challenges faced by animal producers in areas that may 
lack access to adequate veterinary services. The meetings are jointly 
sponsored by FDA and the U.S. Department of Agriculture's (USDA's) 
Animal and Plant Health Inspection Service (APHIS).

DATES: See the SUPPLEMENTARY INFORMATION section for meeting dates.

FOR FURTHER INFORMATION CONTACT: Patricia Arnwine, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855; 240-276-9724; FAX: 240-276-9101, 
patricia.arnwine@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Dates, Times, and Locations

     April 9, 2013, from 8:30 a.m. to 12:30 p.m., Western 
Kentucky University-Carroll Knicely Conference Center (Auditorium rm. 
138), 2355 Nashville Rd., Bowling Green, KY 42101; 270-745-1908; FAX: 
270-745-1911; http://www.wku.edu/.
     April 23, 2013, from 8:30 a.m. to 12:30 p.m., Evergreen 
State College (Library 4300), 2700 Evergreen Pkwy. NW., Olympia WA 
98505; 360-867-6192 or 6000; http://www.evergreen.edu/home.htm.
     May 8, 2013, from 8:30 a.m. to 12:30 p.m., The Natural 
Resource Research Center, USDA Animal and Plant Health & Inspection 
Service, Veterinary Services, Centers for Epidemiology & Animal Health, 
2150 Centre Ave. (Building B, Gray's Peak Conference Rooms A & B), Fort 
Collins, CO 80526-8117; 970-494-7200; FAX: 970-472-2668; http://www.aphis.usda.gov/about_aphis/programs_offices/veterinary_services/ceah.shtml.
     May 21, 2013, from 8:30 a.m. to 12:30 p.m., Best Western 
Ramkota Hotel & Conference Center (Amphitheater II), 920 West Sioux 
Ave., Pierre, SD 57501; 605-224-6877; FAX: 605-224-1042; http://pierre.bwramkota.com/.
     June 4, 2013, from 8:30 a.m. to 12:30 p.m., Texas A&M 
University (Memorial Student Center, rm. 2406A), Joe Routt Boulevard 
and Houston Street, College Station, TX 77840; 979-845-8904; FAX: 979-
845-2519; http://www.tamu.edu/.
    Oral Presentations: Interested persons may make oral presentations 
on the topic of the discussion of the meeting. Oral presentations from 
the public during the open public comment period will be scheduled 
approximately:
     April 9, 2013, from 9:45 a.m. to 11 a.m. on the day of the 
meeting in Bowling Green, KY;
     April 23, 2013, from 9:45 a.m. to 11 a.m. on the day of 
the meeting in Olympia, WA;
     May 8, 2013, from 9:45 a.m. to 11 a.m. on the day of the 
meeting in Fort Collins, CO;
     May 21, 2013, from 9:45 a.m. to 11 a.m. on the day of the 
meeting in Pierre, SD; and
     June 4, 2013, from 9:45 a.m. to 11 a.m. on the day of the 
meeting in College Station, TX.
    Although prior notification is not required, it is recommended that 
those desiring to make oral presentations notify the contact person 
before the meeting. In an effort to accommodate all who desire to 
speak, time allotted for each presentation may be limited.
    Registration is not required for these meetings; however, early 
arrival is recommended because seating may be limited. If you need 
special accommodations due to a disability, please contact FDA (see FOR 
FURTHER INFORMATION CONTACT) at least 7 days in advance.
    Comments: Regardless of attendance at the public meetings, 
interested persons may submit either electronic or written comments 
regarding the topics to be discussed at these meetings. Submit 
electronic comments to http://www.regulations.gov. Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is 
only necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday. The docket will 
remain open for written or electronic comments for 60 days following 
the last of these five meetings.
    FDA is concerned about the risk that antimicrobial resistance poses 
to public health from the use of medically important antimicrobial 
drugs in food-producing animals. Over the past several years, FDA's 
Center for Veterinary Medicine has developed a policy framework for 
decreasing this public health risk through the application of concepts 
of judicious use. Among these concepts, FDA believes that it is 
important to include veterinary oversight in the use of medically 
important antimicrobial drugs in the feed or water of food-producing 
animals to assure the drugs' appropriate and judicious use.
    Until the early 1990s, most antimicrobial drugs were approved for 
over-the-counter (OTC) use in food-producing animals. However, since 
that time increasing concerns about antimicrobial resistance and 
evolving understanding of the science related to the issue have 
resulted in greater scrutiny of the conditions under which these drugs 
are approved. As a result, since the early 1990s all new approvals for 
antimicrobial drug products for use in food-producing animals have been

[[Page 14802]]

labeled with veterinary prescription (Rx) or veterinary feed directive 
(VFD) marketing status, with the exception of approvals of generic 
copies of existing OTC products and approvals of combination medicated 
feeds using existing OTC antimicrobial Type A medicated articles. This 
shift to a marketing status requiring veterinary oversight has been 
viewed as an important step to mitigate the microbial food safety risks 
of antimicrobial new animal drugs, particularly for those drugs 
considered to be medically important.
    FDA believes that the judicious use of medically important 
antimicrobial drugs intended for use in food-producing animals requires 
the scientific and clinical training of a licensed veterinarian. In the 
Federal Register of April 13, 2012 (77 FR 22328), FDA announced the 
availability of a Guidance for Industry (GFI) 209 entitled 
``The Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals'' that outlines several recommendations regarding the 
judicious use of medically important antimicrobials, including the need 
for veterinary oversight or consultation when these antimicrobials are 
used in medicated feed or medicated drinking water of food-producing 
animals (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf).
    Accordingly, in the same issue of the Federal Register (77 FR 
22327, April 13, 2012), FDA published a notice announcing the 
availability of a draft guidance for industry (GFI 213) 
entitled ``New Animal Drugs and New Animal Drug Combination Products 
Administered in or on Medicated Feed or Drinking Water of Food-
Producing Animals; Recommendations for Aligning Product Use Conditions 
With GFI 209.'' In draft GFI 213 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), FDA is recommending that affected 
drug sponsors revise the conditions of use of their medically important 
antimicrobial new animal drugs and combination new animal drug products 
from OTC to VFD status for medicated feed products and from OTC to Rx 
status for medicated drinking water products. Also, the draft guidance 
proposes timelines for stakeholders wishing to comply voluntarily with 
the guidance.
    The following antimicrobial drugs, in products administered in the 
feed or water of food-producing animals, are covered under draft GFI 
213: Chlortetracycline, erythromycin, lincomycin, neomycin, 
oxytetracycline, penicillin, spectinomycin, sulfamethazine, tylosin, 
and virginiamycin.\1\ Ionophore drugs are not included under draft GFI 
213. FDA is currently reviewing the comments it received on 
draft GFI 213.
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    \1\ For additional information related to animal drugs in the 
classes of medically important antimicrobials, see Appendix A of GFI 
152 entitled ``Evaluating the Safety of Antimicrobial New 
Animal Drugs with Regard to Their Microbiological Effects on 
Bacteria of Human Health Concern'' (http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm).
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    After the FDA has completed its review of comments, the Agency will 
draft and publish final GFI 213. FDA anticipates that sponsors 
of affected products should be able to complete implementation of the 
changes discussed in this draft guidance within 3 years from the date 
of publication of the final version of this guidance.
    Also in that same issue of the Federal Register (77 FR 22247, April 
13, 2012), FDA provided the draft text of a proposed regulation (http://www.gpo.gov/fdsys/pkg/FR-2012-04-13/pdf/2012-8844.pdf) to streamline 
and modernize the current VFD regulation (21 CFR 558.6) which governs 
veterinary oversight and authorization of the use of certain animal 
drugs in medicated feed. The public comment period for that document 
remained open until July 12, 2012. FDA is currently reviewing the 
comments it received on the draft proposed regulation. After completion 
of this review, the Agency will draft and publish the proposed VFD 
regulation.
    FDA acknowledges that changing the marketing status of certain 
antimicrobial drugs to require the involvement of a licensed 
veterinarian has practical implications for animal producers and 
practicing veterinarians. Once the status is changed from OTC to Rx or 
VFD, producers will no longer be able to purchase the animal drug or 
medicated feed product directly from suppliers, unless the producer has 
a valid prescription or order from a licensed veterinarian. The impact 
of this change on producers may vary depending on the extent to which a 
given producer already has access to and utilizes veterinary services. 
This change also has potential impact on practicing veterinarians 
depending on their practice (business) model.
    FDA is seeking additional input as it moves forward to further 
develop and implement its judicious-use policy, including the plan to 
phase in veterinary oversight or consultation in the use of medically 
important antimicrobial drugs. As part of this input gathering effort, 
FDA is partnering with APHIS to conduct a series of five meetings (see 
DATES and ADDRESSES) to provide the public with opportunities to 
discuss and provide critical feedback on the challenges faced by 
stakeholders generally, and livestock producers and practicing 
veterinarians in particular, as FDA phases in veterinary oversight of 
the therapeutic use of medically important antimicrobials. During these 
meetings, particular emphasis will be placed on discussing the 
potential challenges faced by producers in areas of the country that 
may lack access to adequate veterinary services and on exploring 
possible options for minimizing such impacts. FDA also will seek public 
input through other forums, for example, Webinars, as it works 
collaboratively with the USDA, along with veterinary and producer 
organizations, to help address this important issue. Comments also may 
be made to the FDA docket at any time (see Comments).
    Agenda: The meeting will allow for public comment and discussion 
regarding the judicious use of antimicrobial drugs in food-producing 
animals. The following specific questions will be discussed at the 
upcoming meetings:
    (1) What is the current availability of veterinary services for 
your facility and how do you utilize this care?;
    (2) How would the proposed changes in marketing status for 
medically important antimicrobials to VFD/Rx and proposed revisions to 
the VFD regulations affect your operation or practice?; and
    (3) What are some possible solutions or models for access of 
veterinary services that would benefit your operation in light of these 
changes?
    The agenda for the public meeting will be made available on the 
Agency's Web site at http://www.fda.gov/AnimalVeterinary/NewsEvents/WorkshopsConferencesMeetings/default.htm and will be posted to the 
docket at http://www.regulations.gov.

    Dated: March 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05339 Filed 3-6-13; 8:45 am]
BILLING CODE 4160-01-P


