Document ID: FDA-2012-N-0102-0001
Agency: fda
Document Type: Notice
Title: Antiparasitic Drug Use and Resistance in Ruminants and Equines Public Meeting
Posted Date: 2012-02-13T05:00Z

[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Page 7588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3221]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0102]

Antiparasitic Drug Use and Resistance in Ruminants and Equines; 
Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Antiparasitic Drug Use and Resistance in Ruminants 
and Equines.'' The purpose of the meeting is to discuss the current 
state of anthelmintic resistance in the United States and worldwide, 
tools for the evaluation of antiparasitic resistance, evaluation of the 
effectiveness of drugs against resistant parasites, and the scientific 
rationale for the use of combinations of antiparasitic drugs in 
ruminants and equines.

DATES: Date and Time: The public meeting will be held on March 5 and 6, 
2012, from 8 a.m. to 5:30 p.m.
    Location: The meeting will be held at the Hilton Washington, DC/
Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, 
Rockville, MD 20852-1699; 1-800-774-1500; FAX 301-468-0163; http://rockvillehotel-px.rtrk.com/.
    Contact Person: Aleta Sindelar, Center for Veterinary Medicine 
(HFV-3), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 
20855, 240-276-9004, FAX: 240-276-9030, email: 
Aleta.Sindelar@fda.hhs.gov.
    Requests for Oral Presentations and Registration: Interested 
persons may present data, information, or views, orally or in writing, 
on the topic of the discussion of the meeting. Written submissions may 
be made to the contact person on or before February 27, 2012. Oral 
presentations from the public during the open public comment period 
will be scheduled between approximately 2 p.m. and 3 p.m. on March 5, 
2012, and 10:30 a.m. and 12 noon on March 6, 2012. Those desiring to 
make oral presentations should notify the contact person by February 
20, 2012, and submit a brief statement of the general nature of 
information they wish to present and an indication of the approximate 
time requested to make their presentation. Time allotted for each 
presentation may be limited. The contact person will inform each 
speaker of their schedule prior to the meeting.
    Registration is not required for this meeting; however, early 
arrival is recommended because seating may be limited. If you need 
special accommodations due to a disability, please contact Aleta 
Sindelar, (see Contact Person) at least 7 days in advance.
    Comments: Regardless of attendance at the public meeting, 
interested persons may submit either electronic or written comments 
regarding this document. 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 meeting.

SUPPLEMENTARY INFORMATION: The main purpose of the meeting is to 
explore and discuss ways in which antiparasitic drugs can be used, 
alone or in combination, to maximize antiparasitic drug efficacy and 
minimize parasitic resistance in ruminant and equine species. Other 
topics for discussion include:
    (1) The current state of anthelmintic resistance in the United 
States and in other parts of the world;
    (2) The factors that have contributed to the development of 
anthelmintic resistance;
    (3) The role of refugia in the management of anthelmintic 
resistance;
    (4) The use of mathematical modeling as a tool for evaluating 
resistance;
    (5) The use of the fecal egg count reduction test in the detection 
and management of anthelmintic resistance; and
    (6) Ways to maximize the effectiveness of anthelmintics for today 
and the future.
    Agenda: The meeting will allow for public comment and discussion on 
current challenges regarding the use of antiparasitic drugs in 
ruminants and equines. The agenda for the public meeting will be made 
available on the Agency's Web site at http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/default.htm.
    Transcripts: FDA will prepare a meeting transcript and make it 
available on the Agency's Web site (see Agenda) after the meeting. FDA 
anticipates that transcripts will be available approximately 30 
business days after the meeting. The transcript will be available for 
public examination at the Division of Dockets Management (see Comments 
section of this document), between 9 a.m. and 4 p.m., Monday through 
Friday. A transcript will also be available in either hardcopy or on 
CD-ROM, after submission of a Freedom of Information request. Written 
requests are to be sent to Division of Freedom of Information (ELEM-
1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857.

    Dated: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3221 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P