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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
than 2 business days before the meeting.
If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDAs website after the meeting. Background material is available at https www.fda.gov/
advisory-committees/advisorycommittee-calendar. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions made to the Docket see ADDRESSES on or before February 24, 2021, will be provided to the committee.
Comments received after February 24, 2021, and by March 4, 2021, will be taken into consideration by FDA. Oral presentations from the public will be scheduled between approximately 1:30
p.m. Eastern Time and 2:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 18, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 19, 2021.
For press inquiries, please contact the Office of Media Affairs at fdaoma@
fda.hhs.gov or 3017964540.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities.
If you require accommodations due to a disability, please contact Kathleen Hayes, CBERVRBPAC@fda.hhs.gov, at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https www.fda.gov/advisorycommittees/about-advisory-committees/
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committee-meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act 5
U.S.C. app. 2.
Dated: February 8, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202103014 Filed 21221; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2019D5364

Submission of Plans for Cigarette Packages and Cigarette Advertisements Revised; Guidance for Industry; Availability AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice of availability.

The Food and Drug Administration FDA or Agency is announcing the availability of a revised guidance for industry entitled Submission of Plans for Cigarette Packages and Cigarette Advertisements Revised. This is a revision to the second edition of this final guidance, which issued in May 2020, and is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. FDA is revising this guidance to reflect the December 2, 2020, court order that postponed the effective date of the final rule entitled Tobacco Products; Required Warnings for Cigarette Packages and Advertisements to January 14, 2022.
Pursuant to the court order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by March 16, 2021.

SUMMARY:

The announcement of the revised guidance is published in the Federal Register on February 16, 2021.
ADDRESSES: You may submit electronic or written comments on Agency guidances at any time as follows:
DATES:

Electronic Submissions Submit electronic comments in the following way:
Federal eRulemaking Portal:
https www.regulations.gov. Follow the
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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:
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
2019D5364 for Submission of Plans for Cigarette Packages and Cigarette Advertisements Revised. Received comments 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 office 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
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