Recommendations on the Regulation of Combination Drug Medicated Feeds; Availability; Reopening of Comment Period; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability; reopening of comment period; request for comments.

SUMMARY:

The Food and Drug Administration (FDA or we) is reopening the comment period and requesting public input on possible modifications to the current review processes for new animal drug applications (NADAs) for the use of multiple new animal drugs in combination drug medicated feeds. We are also announcing the availability of a Center for Veterinary Medicine (CVM) recommendations document for the animal drug user fee negotiating committee.

DATES:

Submit either electronic or written comments by July 29, 2016.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2014-N-1050 for “Regulation of Combination Drug Medicated Feeds.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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.

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, linda.wilmot@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In the Federal Register of September 9, 2014 (79 FR 53431), FDA announced that it was beginning to explore possible modifications to the current review processes for NADAs for the use of multiple new animal drugs in combination drug medicated feeds. This effort is consistent with the stated performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter.

In the same notice, FDA announced the opening of a docket to receive public input. Originally, interested persons were given until September 9, 2015, to provide comment. In a February 13, 2015 (80 FR 8092), notice of a public meeting on this subject, FDA extended the comment period until March 31, 2016. At this time, FDA is reopening the comment period until July 29, 2016.

A summary of FDA recommendations, “Recommendations on the Regulation of Combination Drug Medicated Feeds,” has been placed in the FDA Docket. Persons with access to the Internet may obtain this document at the CVM FOIA Electronic Reading Room: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm.