81 FR 83244 - Report of the Center for Veterinary Medicine Working Group on the Regulation of Animal Drug Availability Act Combination Drug Medicated Feeds; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 224 (November 21, 2016)

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).

[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83244-83245]
From the Federal Register Online  [www.thefederalregister.org]
[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