2023-08246. Advisory Committee on Immunization Practices (ACIP)

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice and request for comment.

SUMMARY:

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment.

DATES:

The meeting will be held on April 19, 2023, 11 a.m. to 3 p.m., EDT (date and times subject to change; see the ACIP website for updates: https://www.cdc.gov/​vaccines/​acip/​index.htm).

Written comments must be received on or before April 19, 2023.

ADDRESSES:

You may submit comments, identified by Docket No. CDC–2023–0028, by either of the methods listed below. CDC does not accept comments by email.

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.

• Mail: ACIP Meeting, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H24–8, Atlanta, Georgia 30329–4027. Attn: Docket No. CDC–2023–0028.

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.

The meeting will be webcast live via the World Wide Web. The webcast link can be found on the ACIP website at https://www.cdc.gov/​vaccines/​acip/​index.html.

FOR FURTHER INFORMATION CONTACT:

Stephanie Thomas, Committee Management Specialist, Advisory Committee on Immunization Practices, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H24–8, Atlanta, Georgia 30329–4027. Telephone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Fewer than 15 calendar days' notice is being given for this meeting in accordance with 41 CFR 102–3.150(b). Following a discussion between CDC and the Food and Drug Administration regarding anticipated regulatory changes to the COVID–19 vaccination program, a decision was made late Monday, April 10, 2023, that it is essential for ACIP to have a public committee meeting to discuss and get input from the Committee members. This meeting is critical in order for the rationale for these changes to be conveyed to the public in a timely and efficient manner. Further, given the continuing COVID–19 pandemic, it is essential that all decision-making regarding vaccines be done as urgently as possible. A notice of the meeting has also been posted on the ACIP website at https://www.cdc.gov/​vaccines/​acip/​index.html. In addition, CDC has sent notice of the meeting by email to those who subscribe to receive email updates about ACIP.

Purpose: The Advisory Committee on Immunization Practices (ACIP) is charged with advising the Director, Centers for Disease Control and Prevention (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 program, along with schedules regarding dosing interval, dosage, and contraindications to administration of vaccines. Further, under applicable provisions of the Affordable Care Act and section 2713 of the Public Health Service Act, immunization recommendations of ACIP that have been approved by the Director, CDC, and appear on CDC immunization schedules generally must be covered by applicable health plans.

Matters To Be Considered: The agenda will include discussions on COVID–19 vaccines. No recommendation 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/​index.html.

Meeting Information: The meeting will be webcast live via the World Wide Web. For more information on ACIP, please visit the ACIP website: https://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.

Written Public Comment: Written comments must be received on or before April 19, 2023.

Oral Public Comment: This meeting will include time for members of the public to make an oral comment. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below.

Procedure for Oral Public Comment: All persons interested in making an oral public comment at the April 19, 2023, ACIP meeting must submit a request at https://www.cdc.gov/​vaccines/​acip/​meetings/​index.html no later than 11:59 p.m., EDT, April 17, 2023, 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 on April 18, 2023. To accommodate the significant interest in participation in the oral public comment session of ACIP meetings, each speaker will be limited to three minutes, and each speaker may only speak once per meeting.

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.