Federal Register - August 26, 2021

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Source: Federal Register

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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting comments.
Mail: Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H248, Atlanta, Georgia 30329
4027, Attn: August 3031, 2021 ACIP
Meeting.
Instructions: All submissions received must include the Agency name and Docket Number. All relevant comments received in conformance with the https www.regulations.gov suitability policy will be posted without change to https www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Stephanie Thomas, ACIP Committee Management Specialist, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, 1600 Clifton Road NE, MSH248, Atlanta, GA 30329
4027; Telephone: 4046398367; Email:
ACIP@cdc.gov.
SUPPLEMENTARY INFORMATION: Notice is hereby given of a change in the meeting of the Advisory Committee on Immunization Practices ACIP; August 24, 2021, 10:00 a.m.5:00 p.m., EDT
times subject to change, in the original FRN.
The virtual meeting was published in the Federal Register on Wednesday, August 18, 2021, Volume 86, Number 157, pages 4625646257.
The virtual meeting is being amended to change the dates to August 30, 2021
and August 31, 2021, update meeting times and supplemental information.
In accordance with 41 CFR 102
3.150b, less than 15 calendar days notice is being given for this meeting due to the exceptional circumstances of the COVID19 pandemic and rapidly evolving COVID19 vaccine development and regulatory processes.
A notice of this ACIP meeting has also been posted on CDCs ACIP website at:
http www.cdc.gov/vaccines/acip/
index.html. In addition, CDC has sent notice of this ACIP meeting by email to those who subscribe to receive email updates about ACIP.
Purpose: The committee is charged with advising the Director, CDC, on the use of immunizing agents. In addition, under 42 U.S.C. 1396s, the committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children VFC program, along with schedules regarding dosing interval, dosage, and contraindications
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to administration of vaccines. Further, under provisions of the Affordable Care Act, section 2713 of the Public Health Service Act, immunization recommendations of the ACIP that have been approved by the Director of the Centers for Disease Control and Prevention and appear on CDC
immunization schedules must be covered by applicable health plans.
Matters To Be Considered: The agenda will include discussions on Pfizers COVID19 vaccine, and additional discussions on mRNA booster doses. A
recommendation vote on Pfizers COVID19 vaccine is planned. No Vaccines for Children VFC votes are scheduled. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda visit https www.cdc.gov/vaccines/acip/
meetings/meetings-info.html.
Meeting Information: The meeting will be webcast live via the World Wide Web; for more information on ACIP
please visit the ACIP website: http
www.cdc.gov/vaccines/acip/index.html.
Public Participation Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on https www.regulations.gov.
Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display.
CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/
near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted into the docket.
Oral Public Comment: This meeting will include time for members of the public to make an oral comment. Oral public comment will occur before any scheduled votes including all votes relevant to the ACIPs Affordable Care Act and Vaccines for Children Program roles. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below.

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Procedure for Oral Public Comment:
All persons interested in making an oral public comment at the August 30, 2021, ACIP meeting must submit a request at http www.cdc.gov/vaccines/acip/
meetings/ no later than 11:59 p.m., EDT, August 28, 2021, according to the instructions provided.
If the number of persons requesting to speak is greater than can be reasonably accommodated during the scheduled time, CDC will conduct a lottery to determine the speakers for the scheduled public comment session.
CDC staff will notify individuals regarding their request to speak by email by August 29, 2021. To accommodate the significant interest in participation in the oral public comment session of ACIP meetings, each speaker will be limited to 3 minutes, and each speaker may only speak once per meeting.
Written Public Comment: The docket is currently open to receive written comments. Written comments must be received on or before August 31, 2021.
The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention.
FR Doc. 202118453 Filed 82421; 11:15 am BILLING CODE 416318P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0008

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues.
The meeting will be open to the public.

SUMMARY:

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Federal Register - August 26, 2021

TitreFederal Register

PaysÉtats-Unis

Date26/08/2021

Page count481

Edition count7802

Première édition14/03/1936

Dernière édition25/06/2026

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