2020-24806. Request for Information and Comments on Consumption of Certain Uncommon Produce Commodities in the United States; Extension of Comment Period

AGENCY:

Food and Drug Administration, Health and Human Services (HHS).

ACTION:

Notification; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA or we) is extending the comment period for the notification entitled “Request for Information and Comments on Consumption of Certain Uncommon Produce Commodities in the United States” that appeared in the Federal Register of August 10, 2020. We are taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested persons to develop and submit data, information, and/or comments for this Request for Information.

DATES:

FDA is extending the comment period on the Request for Information published August 10, 2020 (85 FR 48124). Submit either electronic or written comments by January 8, 2021.

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 8, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 8, 2021. 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-2020-N-1119 for “Request for Information and Comments on Consumption of Certain Uncommon Produce Commodities in the United States.” 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, 240-402-7500.

• 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.govinfo.gov/​content/​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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:

Samir Assar, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of August 10, 2020 (85 FR 48124), we published a notification entitled “Request for Information and Comments on Consumption of Certain Uncommon Produce Commodities in the United States.” This action opened a docket with a 90-day comment period to receive information and comments related to certain produce commodities with no or low reported consumption in the database relied on to create the list of rarely consumed raw commodities that are exempt from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112) (produce safety regulation).

FDA has received a request for a 60-day extension for this comment period in order to allow additional time for interested persons to develop and submit data, information, and/or comments for this Request for Information. We have concluded that it is reasonable to extend for 60 days the comment period for this Request for Information. The Agency believes that this extension allows adequate time for any interested persons to submit data, information, and/or comments for this Request for Information.

Dated: November 3, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.