Advisory Committee on Immunization Practices, 71641-71642 [2022-25538]

Download as PDF Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Notices is obtained.11 Such information may be kept confidential under exemption 4 of the Freedom of Information Act (FOIA) if the submitter substantiates that it is confidential commercial or financial information that is both customarily and actually treated as private.12 In addition, items 1 through 4 of Schedule G, which contain sensitive information regarding the reporting entity’s liquidity position, may be accorded confidential treatment under exemption 4 until the first reporting date after the final liquidity coverage ratio disclosure standard has been implemented. Information collected on the FR Y–15 may also be considered confidential under FOIA exemption 8 if it is obtained as part of an examination or supervision of a financial institution.13 Current actions: On July 6, 2022, the Board published a notice in the Federal Register (87 FR 40235) requesting public comment for 60 days on the extension, without revision, of the FR Y–15. The comment period for this notice expired on September 6, 2022. The Board did not receive any comments. Board of Governors of the Federal Reserve System, November 17, 2022. Michele Taylor Fennell, Deputy Associate Secretary of the Board. [FR Doc. 2022–25494 Filed 11–22–22; 8:45 am] BILLING CODE 6210–01–P FEDERAL RESERVE SYSTEM Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities lotter on DSK11XQN23PROD with NOTICES1 The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. 11 Several data items in the FR Y–15 are retrieved from the FR Y–9C and other items may be retrieved from the FFIEC 101. Confidential treatment will also extend to any automatically calculated items on the FR Y–15 that have been derived from confidential data items and that, if released, would reveal the underlying confidential data. 12 5 U.S.C. 552(b)(4). 13 5 U.S.C. 552(b)(8). VerDate Sep<11>2014 16:45 Nov 22, 2022 Jkt 259001 The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551–0001, not later than December 8, 2022. A. Federal Reserve Bank of Atlanta (Erien O. Terry, Assistant Vice President) 1000 Peachtree Street NE, Atlanta, Georgia 30309; Comments can also be sent electronically to Applications.Comments@atl.frb.org: 1. Synovus Financial Corp., through its wholly-owned subsidiary, Synovus Bank, both of Columbus, Georgia; to acquire Qualpay, Inc., San Mateo, California, and thereby engage in data processing activities pursuant to section 225.28(b)(14) of the Board’s Regulation Y. Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. [FR Doc. 2022–25458 Filed 11–22–22; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2022–0136] Advisory Committee on Immunization Practices Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting and request for comment. AGENCY: In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), located within the SUMMARY: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 71641 Department of Health and Human Services (HHS), 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 December 9, 2022, from 10 a.m. to 5 p.m. EST (dates and times subject to change, see the ACIP website for updates at https://www.cdc.gov/ vaccines/acip/). The meeting will be webcast live via the World Wide Web. Written comments must be received on or before December 7, 2022. ADDRESSES: You may submit comments, identified by Docket No. CDC–2022– 0136, by either of the following methods: • 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 H24–8, Atlanta, GA 30329–4027, Attn: December 9, 2022 ACIP Meeting. Instructions: All submissions received must include the Agency name and Docket Number. All relevant comments received 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, MS H24–8, Atlanta, GA 30329– 4027; Telephone: 404–639–8836; Email: ACIP@cdc.gov. SUPPLEMENTARY INFORMATION: 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 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 CDC Director and appear on CDC immunization schedules must be covered by applicable health plans. E:\FR\FM\23NON1.SGM 23NON1 71642 Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Notices Matters To Be Considered: The agenda will include discussions on use of Monkeypox vaccines. A recommendation vote(s) is not 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. A notice of this ACIP meeting has also been posted on CDC’s ACIP website at: https:// www.cdc.gov/vaccines/acip/. In addition, CDC has sent notice of this ACIP meeting by email to those who subscribe to receive email updates about ACIP. lotter on DSK11XQN23PROD with NOTICES1 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 or 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 December 7, 2022. 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 ACIP’s 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. Procedure for Oral Public Comment: All persons interested in making an oral public comment during the December 9, 2022 ACIP meeting must submit a request at https://www.cdc.gov/ vaccines/acip/meetings/ no later than 11:59 p.m. EST, December 7, 2022, according to the instructions provided. VerDate Sep<11>2014 16:45 Nov 22, 2022 Jkt 259001 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 by email on December 8, 2022 regarding their request to speak. 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. [FR Doc. 2022–25538 Filed 11–22–22; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3240] List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies two bulk drug substances that FDA has considered and proposes to include on the 503B Bulks List to compound three categories of compounded drug products: arginine hydrochloride (HCl) for oral use, lysine HCl for oral use, and lysine HCl for intravenous use in SUMMARY: PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 combination with FDA-approved, single-ingredient arginine HCl for intravenous use. This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: etomidate, furosemide, and rocuronium bromide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices. DATES: Either electronic or written comments on the notice must be submitted by January 23, 2023. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 23, 2023. 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 else’s 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 (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Pages 71641-71642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2022-0136]


Advisory Committee on Immunization Practices

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

ACTION: Notice of meeting and request for comment.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Federal Advisory Committee Act, the 
Centers for Disease Control and Prevention (CDC), located within the 
Department of Health and Human Services (HHS), 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 December 9, 2022, from 10 a.m. to 5 
p.m. EST (dates and times subject to change, see the ACIP website for 
updates at https://www.cdc.gov/vaccines/acip/). The meeting 
will be webcast live via the World Wide Web. Written comments must be 
received on or before December 7, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0136, by either of the following methods:
     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 H24-8, Atlanta, GA 30329-4027, Attn: December 9, 
2022 ACIP Meeting.
    Instructions: All submissions received must include the Agency name 
and Docket Number. All relevant comments received 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, MS H24-8, Atlanta, GA 30329-4027; Telephone: 404-639-8836; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: 
    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 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 CDC Director and appear on CDC immunization 
schedules must be covered by applicable health plans.

[[Page 71642]]

    Matters To Be Considered: The agenda will include discussions on 
use of Monkeypox vaccines. A recommendation vote(s) is not 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. A notice of this ACIP meeting has 
also been posted on CDC's ACIP website at: https://www.cdc.gov/vaccines/acip/. In addition, CDC has sent notice of this ACIP meeting 
by email to those who subscribe to receive email updates about ACIP.

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 or 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 December 7, 2022.
    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 ACIP's 
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.
    Procedure for Oral Public Comment: All persons interested in making 
an oral public comment during the December 9, 2022 ACIP meeting must 
submit a request at https://www.cdc.gov/vaccines/acip/meetings/ no 
later than 11:59 p.m. EST, December 7, 2022, 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 by email on December 8, 2022 
regarding their request to speak. 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.
[FR Doc. 2022-25538 Filed 11-22-22; 8:45 am]
BILLING CODE 4163-18-P
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