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Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices
24 to 48 hours before the event, registrants will receive an email with the meeting link and a formal calendar invitation.
Request to Provide Open Public Comment: During online registration, you may indicate if you wish to make open public comments during the public meeting and which topics you would like to address. All requests to make public comments must be received by October 8, 2021 at 11:59
p.m. Eastern Time. We will do our best to accommodate requests to make public comments. We are seeking to have a broad representation of ideas and issues presented at the meeting. Individuals and organizations with common interests are urged to consolidate or coordinate their comments. FDA will determine the amount of time allotted to each commenter, the meeting day, the approximate time open public comments are to be provided and notify all registrants who requested to make public comments.
Streaming Webcast of the Public Meeting: This public meeting will be broadcast via YouTube.
Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https www.regulations.gov. It may be viewed at the Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20850. A link to the transcript will also be available on the internet at: https www.fda.gov/
food/workshops-meetings-webinarsfood-and-dietary-supplements/new-erasmarter-food-safety-summit-ecommerce-ensuring-safety-foodsordered-online-and-delivered.
Dated: August 31, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119219 Filed 9321; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSKJLST7X2PROD with NOTICES

Docket No. FDA2013N1529

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reclassification Petitions for Medical Devices AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA, Agency, or we is
SUMMARY:

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00:30 Sep 04, 2021

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announcing an opportunity for public comment on the proposed collection of certain information by the Agency.
Under the Paperwork Reduction Act of 1995 PRA, Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with reclassification of medical devices.
DATES: Submit either electronic or written comments on the collection of information by November 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 November 8, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 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 elses 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:

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Mail/Hand delivery/Courier for written/paper submissions: Dockets Management Staff HFA305, 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
2013N1529 for Agency Information Collection Activities; Proposed Collection; Comment Request;
Reclassification Petitions for Medical Devices. 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, 2404027500.
Confidential SubmissionsTo 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 FDAs 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-201509-18/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
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