Transit Times to Slaughter Facilities, Milking Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times Assigned to New Animal Drugs; Request for Comments; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments, extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for the request for comments that appeared in the Federal Register of August 9, 2019. In that document, we requested comments on transit times to slaughter, milking frequency, and how end users interpret zero-day withdrawal period, or zero-day milk discard times statements found on new animal drug labeling. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

DATES:

FDA is extending the comment period on the request for comments published August 9, 2019 (84 FR 39340). Submit either electronic or written comments by January 6, 2020.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 6, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, 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-2019-N-3019 for “Transit Times to Slaughter Facilities, Milking Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times Assigned to New Animal Drugs.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Charli M. Long-Medrano, Center for Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 Standish Pl., Rm. E340, Rockville, MD 20855, 240-402-0850, Charli.Long-Medrano@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In the Federal Register of August 9, 2019, FDA published a request for comments with a 60-day comment period to request comments on transit times to slaughter, milking frequency, and how end users interpret zero-day withdrawal period, or zero-day milk discard time statements found on new animal drug labeling. Comments on interpretation of these labeling statements will help to evaluate if our current approach to assigning zero-day withdrawal periods and zero-day milk discard times to new animal drugs is appropriate.

The Agency has received requests for a 90-day extension of the comment period for the request for comments. The requests convey concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the request for comments.

FDA has considered the requests and is extending the comment period for the request for comments for 90 days, until January 6, 2020. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.