[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83244-83245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27942]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1050]
Report of the Center for Veterinary Medicine Working Group on the
Regulation of Animal Drug Availability Act Combination Drug Medicated
Feeds; 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 report of a Center for Veterinary Medicine (CVM)
working group proposing possible changes to the current review
processes for new animal drug applications (NADAs) providing for the
use of multiple new animal drugs in combination drug medicated feeds.
This report was developed for the use of the CVM committee that will be
participating in discussions concerning the reauthorization of the
animal drug user fee program for 5 additional years through fiscal year
2023 (per the Animal Drug User Fee Amendments (ADUFA) IV).
ADDRESSES: For access to the docket to read background documents or the
electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
[[Page 83245]]
Submit written requests for single copies of the report to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the document.
FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary
Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0829, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2014
(79 FR 53431), CVM announced that it was beginning to explore possible
changes to the current review processes for NADAs for the use of
multiple new animal drugs in combination drug medicated feeds. In the
same Federal Register notice, FDA announced the opening of a docket to
receive input from the public on this issue. This effort is consistent
with the stated performance goal in the Animal Drug User Fee Amendments
of 2013 (ADUFA III) goals letter.
In the Federal Register of April 29, 2016 (81 FR 25677), FDA
published a notice of availability of a draft CVM report, giving
interested persons until July 29, 2016, to comment. Those comments were
considered as the CVM working group report was finalized without
substantive changes. This report was developed for the discussions with
the regulated industry for reauthorization of ADUFA.
Persons with access to the Internet may obtain this document on the
CVM ADUFA Meetings Web page: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm.
Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27942 Filed 11-18-16; 8:45 am]
BILLING CODE 4164-01-P