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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices person will notify interested persons regarding their request to speak by October 14, 2021.
Closed Committee Deliberations: On October 28, 2021, from 12:20 p.m.to 1:20 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy 5 U.S.C.
552bc6. The recommendations of the advisory committee regarding the progress of the individual investigators research programs, along with other information, will be discussed during this session. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy.
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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/
public-conduct-during-fda-advisorycommittee-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: September 2, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119436 Filed 9821; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0951

lotter on DSK11XQN23PROD with NOTICES1

Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis; Public Workshop; Request for Comments AGENCY:

Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.

ACTION:

The Food and Drug Administration FDA, the Agency, or
SUMMARY:

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we is announcing the following public workshop entitled Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy REMS in an Evolving Opioid Crisis. Convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and DukeMargolis, the purpose of the public workshop is to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS. We expect interested stakeholders to include healthcare providers, healthcare professional associations, pharmacists, pharmacy benefit managers, public and private insurers, patient organizations, Federal and State Agencies, providers of continuing education for healthcare professionals, and the public. A second public workshop is being planned to solicit input on additional issues associated with a move to mandatory prescriber education under a REMS, such as operational and technical issues related to such a system and what should be included in potential mandatory prescriber education.
DATES: The public workshop will be held on October 13, 2021, from 1 p.m.
to 5 p.m. Eastern Time and October 14, 2021, from 1 p.m. to 4:05 p.m. Eastern Time. Submit either electronic or written comments on this public workshop by December 3, 2021. See the SUPPLEMENTARY INFORMATION section for registration date and information.
ADDRESSES: Due to the impact of the COVID19 pandemic, these meetings will be held virtually to help protect the public and limit the spread of the virus.
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 December 3, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 3, 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,
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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
2021N0951 for Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy REMS in an Evolving Opioid Crisis. Comments filed and received 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
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