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Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Notices
• June 4, 2013, from 9:45 a.m. to 11 Officer. All requests should be Patricia Arnwine, Center for Veterinary a.m. on the day of the meeting in identified by the title of the information Medicine (HFV–6), Food and Drug College Station, TX. collection. Email address: Administration, 7519 Standish Pl., Although prior notification is not Rockville, MD 20855; 240–276–9724; required, it is recommended that those OMB Comment: OMB is required to FAX: 240–276–9101, desiring to make oral presentations make a decision concerning the notify the contact person before the collection of information between 30 meeting. In an effort to accommodate all SUPPLEMENTARY INFORMATION:
and 60 days after publication of this who desire to speak, time allotted for document in the Federal Register.
Dates, Times, and Locations
each presentation may be limited. Therefore, a comment is best assured of Registration is not required for these • April 9, 2013, from 8:30 a.m. to having its full effect if OMB receives it meetings; however, early arrival is 12:30 p.m., Western Kentucky within 30 days of publication. Written recommended because seating may be University–Carroll Knicely Conference comments and recommendations for the limited. If you need special Center (Auditorium rm. 138), 2355 proposed information collection should accommodations due to a disability, Nashville Rd., Bowling Green, KY be sent directly to the following: Office please contact FDA (see FOR FURTHER
42101; 270–745–1908; FAX: 270–745– of Management and Budget, Paperwork INFORMATION CONTACT) at least 7 days in
Reduction Project, Fax: 202–395–7285, April 23, 2013, from 8:30 a.m. to Comments: Regardless of attendance 12:30 p.m., Evergreen State College at the public meetings, interested Attn: Desk Officer for the (Library 4300), 2700 Evergreen Pkwy. persons may submit either electronic or Administration for Children and NW., Olympia WA 98505; 360–867– written comments regarding the topics to be discussed at these meetings. Submit electronic comments to Robert Sargis,
• May 8, 2013, from 8:30 a.m. to Reports Clearance Officer. 12:30 p.m., The Natural Resource comments to the Division of Dockets [FR Doc. 2013–05331 Filed 3–6–13; 8:45 am] Research Center, USDA Animal and Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. BILLING CODE 4184–01–P
Plant Health & Inspection Service, Veterinary Services, Centers for 1061, Rockville, MD 20852. It is only Epidemiology & Animal Health, 2150 necessary to send one set of comments. DEPARTMENT OF HEALTH AND
Centre Ave. (Building B, Gray's Peak Identify comments with the docket HUMAN SERVICES
Conference Rooms A & B), Fort Collins, number found in brackets in the CO 80526–8117; 970–494–7200; FAX: heading of this document. Received Food and Drug Administration
970–472–2668; comments may be seen in the Division of Dockets Management between 9 a.m. [Docket No. FDA–2012–N–1046]
and 4 p.m., Monday through Friday. The docket will remain open for written Veterinary Oversight of Antimicrobial
• May 21, 2013, from 8:30 a.m. to or electronic comments for 60 days Use in Livestock: Impact on
12:30 p.m., Best Western Ramkota Hotel following the last of these five meetings. Stakeholders; Public Meetings;
& Conference Center (Amphitheater II), FDA is concerned about the risk that Request for Comments
920 West Sioux Ave., Pierre, SD 57501; antimicrobial resistance poses to public health from the use of medically AGENCY: Food and Drug Administration,
605–224–6877; FAX: 605–224–1042; important antimicrobial drugs in food- producing animals. Over the past ACTION: Notice of public meetings;
June 4, 2013, from 8:30 a.m. to several years, FDA's Center for request for comments. 12:30 p.m., Texas A&M University Veterinary Medicine has developed a (Memorial Student Center, rm. 2406A), policy framework for decreasing this SUMMARY: The Food and Drug
Joe Routt Boulevard and Houston Street, public health risk through the Administration (FDA) is announcing College Station, TX 77840; 979–845– application of concepts of judicious use. plans for five meetings to provide an 8904; FAX: 979–845–2519; Among these concepts, FDA believes opportunity for public dialogue and that it is important to include veterinary feedback on challenges faced by the Oral Presentations: Interested persons oversight in the use of medically animal agriculture industry and may make oral presentations on the important antimicrobial drugs in the practicing veterinarians as FDA topic of the discussion of the meeting. feed or water of food-producing animals implements its initiative for the Oral presentations from the public to assure the drugs' appropriate and judicious use of medically important during the open public comment period antimicrobials in medicated feed or will be scheduled approximately: Until the early 1990s, most drinking water of food-producing • April 9, 2013, from 9:45 a.m. to 11 antimicrobial drugs were approved for animals. Particular emphasis will be a.m. on the day of the meeting in over-the-counter (OTC) use in food- placed on challenges faced by animal Bowling Green, KY; producing animals. However, since that producers in areas that may lack access • April 23, 2013, from 9:45 a.m. to 11 time increasing concerns about to adequate veterinary services. The a.m. on the day of the meeting in antimicrobial resistance and evolving meetings are jointly sponsored by FDA understanding of the science related to and the U.S. Department of • May 8, 2013, from 9:45 a.m. to 11 the issue have resulted in greater Agriculture's (USDA's) Animal and a.m. on the day of the meeting in Fort scrutiny of the conditions under which Plant Health Inspection Service these drugs are approved. As a result, • May 21, 2013, from 9:45 a.m. to 11 since the early 1990s all new approvals DATES: See the SUPPLEMENTARY
a.m. on the day of the meeting in Pierre, for antimicrobial drug products for use INFORMATION section for meeting dates.
in food-producing animals have been VerDate Mar<15>2010 14:43 Mar 06, 2013 E: FR FM 07MRN1.SGM emcdonald on DSK67QTVN1PROD with NOTICES Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Notices
labeled with veterinary prescription Chlortetracycline, erythromycin, the use of medically important (Rx) or veterinary feed directive (VFD) lincomycin, neomycin, oxytetracycline, antimicrobial drugs. As part of this marketing status, with the exception of penicillin, spectinomycin, input gathering effort, FDA is partnering approvals of generic copies of existing sulfamethazine, tylosin, and with APHIS to conduct a series of five OTC products and approvals of virginiamycin.1 Ionophore drugs are not meetings (see DATES and ADDRESSES) to
combination medicated feeds using included under draft GFI #213. FDA is provide the public with opportunities to existing OTC antimicrobial Type A currently reviewing the comments it discuss and provide critical feedback on medicated articles. This shift to a received on draft GFI #213. the challenges faced by stakeholders marketing status requiring veterinary After the FDA has completed its generally, and livestock producers and oversight has been viewed as an review of comments, the Agency will practicing veterinarians in particular, as important step to mitigate the microbial draft and publish final GFI #213. FDA FDA phases in veterinary oversight of food safety risks of antimicrobial new anticipates that sponsors of affected animal drugs, particularly for those the therapeutic use of medically products should be able to complete drugs considered to be medically important antimicrobials. During these implementation of the changes discussed in this draft guidance within meetings, particular emphasis will be FDA believes that the judicious use of 3 years from the date of publication of placed on discussing the potential medically important antimicrobial drugs the final version of this guidance. challenges faced by producers in areas intended for use in food-producing Also in that same issue of the Federal
of the country that may lack access to animals requires the scientific and Register (77 FR 22247, April 13, 2012),
adequate veterinary services and on clinical training of a licensed FDA provided the draft text of a exploring possible options for veterinarian. In the Federal Register of
proposed regulation ( minimizing such impacts. FDA also will April 13, 2012 (77 FR 22328), FDA seek public input through other forums, announced the availability of a for example, Webinars, as it works Guidance for Industry (GFI) #209 and modernize the current VFD collaboratively with the USDA, along entitled ‘‘The Judicious Use of regulation (21 CFR 558.6) which with veterinary and producer Medically Important Antimicrobial governs veterinary oversight and organizations, to help address this Drugs in Food-Producing Animals'' that authorization of the use of certain important issue. Comments also may be outlines several recommendations animal drugs in medicated feed. The made to the FDA docket at any time (see regarding the judicious use of medically public comment period for that Comments). important antimicrobials, including the document remained open until July 12, need for veterinary oversight or Agenda: The meeting will allow for 2012. FDA is currently reviewing the consultation when these antimicrobials public comment and discussion comments it received on the draft are used in medicated feed or medicated proposed regulation. After completion regarding the judicious use of drinking water of food-producing of this review, the Agency will draft and antimicrobial drugs in food-producing publish the proposed VFD regulation. animals. The following specific FDA acknowledges that changing the questions will be discussed at the marketing status of certain antimicrobial upcoming meetings: drugs to require the involvement of a (1) What is the current availability of Accordingly, in the same issue of the licensed veterinarian has practical veterinary services for your facility and Federal Register (77 FR 22327, April 13, implications for animal producers and
2012), FDA published a notice how do you utilize this care?; practicing veterinarians. Once the status announcing the availability of a draft (2) How would the proposed changes is changed from OTC to Rx or VFD, guidance for industry (GFI #213) in marketing status for medically producers will no longer be able to entitled ‘‘New Animal Drugs and New purchase the animal drug or medicated important antimicrobials to VFD/Rx and Animal Drug Combination Products feed product directly from suppliers, proposed revisions to the VFD Administered in or on Medicated Feed unless the producer has a valid regulations affect your operation or or Drinking Water of Food-Producing prescription or order from a licensed Animals; Recommendations for veterinarian. The impact of this change (3) What are some possible solutions Aligning Product Use Conditions With on producers may vary depending on or models for access of veterinary the extent to which a given producer services that would benefit your already has access to and utilizes operation in light of these changes? veterinary services. This change also has The agenda for the public meeting potential impact on practicing will be made available on the Agency's FDA is recommending that affected drug veterinarians depending on their sponsors revise the conditions of use of practice (business) model. FDA is seeking additional input as it their medically important antimicrobial new animal drugs and combination new moves forward to further develop and and will be posted to the animal drug products from OTC to VFD implement its judicious-use policy, status for medicated feed products and including the plan to phase in from OTC to Rx status for medicated veterinary oversight or consultation in Dated: March 4, 2013. drinking water products. Also, the draft Leslie Kux,
1 For additional information related to animal guidance proposes timelines for drugs in the classes of medically important Assistant Commissioner for Policy. stakeholders wishing to comply antimicrobials, see Appendix A of GFI #152 entitled [FR Doc. 2013–05339 Filed 3–6–13; 8:45 am] voluntarily with the guidance. ‘‘Evaluating the Safety of Antimicrobial New BILLING CODE 4160–01–P
Animal Drugs with Regard to Their Microbiological The following antimicrobial drugs, in Effects on Bacteria of Human Health Concern'' products administered in the feed or water of food-producing animals, are covered under draft GFI #213: VerDate Mar<15>2010 14:43 Mar 06, 2013 E: FR FM 07MRN1.SGM emcdonald on DSK67QTVN1PROD with NOTICES



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