Advisory Committee on Immunization Practices (ACIP), 24866-24867 [2021-09893]

Download as PDF 24866 Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Notices for cruise ship operators to test the efficacy of their health and safety protocols in U.S. waters. In lieu of conducting a simulated voyage, a cruise ship operator’s responsible officials, at their discretion, may sign and submit to CDC an attestation under 18 U.S.C. 1001 that 98 percent of crew are fully vaccinated and submit to CDC a clear and specific vaccination plan and timeline to limit cruise ship sailings to 95 percent of passengers who have been verified by the cruise ship operator as fully vaccinated prior to sailing. CDC’s oversight and inspection of cruise ships during simulated and restricted passenger voyages will be based on the Operations Manual. The findings and/or observations of these inspections will be shared with the cruise ship operator. Cruise ship operators are expected to align their health and safety protocols with any CDC findings and observations. Such findings and observations must also be incorporated into the cruise ship operator’s simulated voyage after-action report or as a condition of applying for and retaining permission to conduct restricted passenger voyages. Based on these inspections, CDC may also issue additional recommendations to the cruise ship operator that the operator should consider for adoption into their health and safety protocols as best practices. The Technical Instructions document for Cruise Ship Operator’s Agreement with Port and Local Health Authorities under CDC’s Framework for Conditional Sailing Order is found at https:// www.cdc.gov/quarantine/cruise/ instructions-local-agreements.html. The Technical Instructions document for Simulated Voyages by Cruise Ship Operators under CDC’s Framework for Conditional Sailing Order is found at https://www.cdc.gov/quarantine/cruise/ ti-simulated-voyages-cso.html. The COVID–19 Operations Manual for Simulated and Restricted Voyages under the Framework for Conditional Sailing Order is found at https://www.cdc.gov/ quarantine/cruise/covid19-operationsmanual-cso.html. khammond on DSKJM1Z7X2PROD with NOTICES Authority The Technical Instructions and Operations Manual are issued pursuant to the Framework for Conditional Sailing which was issued under the authority of Sections 361 and 365 of the Public Health Service Act (42 U.S.C. 264, 268) and 42 CFR 70.2, 71.31(b), 71.32(b). VerDate Sep<11>2014 19:05 May 07, 2021 Jkt 253001 Dated: May 5, 2021. Sherri Berger, Acting Chief of Staff, Centers for Disease Control and Prevention. [FR Doc. 2021–09895 Filed 5–6–21; 4:15 pm] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2021–0049] Advisory Committee on Immunization Practices (ACIP) 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), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. The meeting will be webcast live via the World Wide Web. DATES: The meeting will be held on May 12, 2021, from 11:00 a.m. to 5:00 p.m., EDT (dates and times subject to change, see the ACIP website for updates: https:// www.cdc.gov/vaccines/acip/ index.html). The public may submit comments from May 10, 2021 through May 12, 2021. ADDRESSES: For more information on ACIP please visit the ACIP website: https://www.cdc.gov/vaccines/acip/ index.html. You may submit comments, identified by Docket No. CDC–2021–0049 by any 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: May 12, 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 SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 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: 404–639–8367; Email: ACIP@cdc.gov. SUPPLEMENTARY INFORMATION: In accordance with 41 CFR 102–3.150(b), less than 15 calendar days’ notice is being given for this meeting due to the exceptional circumstances of the COVID–19 pandemic and rapidly evolving COVID–19 vaccine development and regulatory processes. The Secretary of Health and Human Services has determined that COVID–19 is a Public Health Emergency. 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. 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 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 COVID–19 vaccines, including use of the PfizerBioNTech COVID–19 vaccine under the Food and Drug Administration’s (FDA) expanded Emergency Use Authorization (EUA) for adolescents 12–15 years of age. A recommendation vote(s) is 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: https:// www.cdc.gov/vaccines/acip/. Public Participation Interested persons or organizations are invited to participate by submitting written views, recommendations, and E:\FR\FM\10MYN1.SGM 10MYN1 24867 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Notices 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 May 12, 2021. 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 at the May 12, 2021 ACIP meeting must submit a request at https://www.cdc.gov/vaccines/acip/ meetings/ no later than 11:59 p.m., EDT, May 10, 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 12:00 p.m., EDT, May 11, 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. 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 VerDate Sep<11>2014 19:05 May 07, 2021 Jkt 253001 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. 2021–09893 Filed 5–6–21; 11:15 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA Number: 93.676] Announcement of Intent To Issue Multiple Single-Source Awards To Provide Residential (Shelter) and Transitional Foster Care Services, and for Finger Print Services for Unaccompanied Children Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services (HHS). ACTION: Notice of issuance of multiple single-source awards to seven recipients. AGENCY: ACF, ORR announces the issuance of multiple Single-Source Awards to seven recipients in the amount of $65,366,800. ORR has been identifying additional permanent capacity to provide shelter for recent increases in apprehensions of Unaccompanied Children (UC) at the Southwest Border. The addition of permanent capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter and appropriate services for UC referred to its care by the Department of Homeland Security. DATES: The proposed period of performance is May 1, 2021 to May 1, 2022. FOR FURTHER INFORMATION CONTACT: Stephen Antkowiak, Office of Refugee Resettlement, Division of Unaccompanied Alien Children Operations, 330 Street SW, Washington, DC 20447. Phone: 202–260–6165. Email: stephen.antkowiak@acf.hhs.gov. SUPPLEMENTARY INFORMATION: ORR is continuously monitoring its capacity to shelter the UC referred to HHS, as well as the information received from interagency partners, to inform any future decisions or actions. ORR has specific requirements for the provision of services. Award recipients must have the infrastructure, licensing, SUMMARY: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 experience, and appropriate level of trained staff to meet those requirements. ORR announces the intent to award the following single-source awards: Recipient Award amount Child Crisis, Mesa, AZ ................ Catholic Guardian Services, New York, NY .................................. Center for Family Services, Camden, NJ ............................ LIRS—Shelter/TFC, Multiple Locations ..................................... Baptiste Group, Memphis, TN .... Bethany Christian Service, Multiple Locations ......................... LIRS—Safe Release Expansion, Multiple Locations ................... $5,780,118 5,183,433 1,665,980 27,767,725 14,135,642 7,018,576 3,815,326 Statutory Authority: This program is authorized by— (A) Section 462 of the Homeland Security Act of 2002, which in March 2003, transferred responsibility for the care and custody of UAC from the Commissioner of the former Immigration and Naturalization Service to the Director of ORR within HHS. (B) The Flores Settlement Agreement, Case No. CV85–4544RJK (C.D. Cal. 1996), as well as the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (Pub. L. 110–457), which authorizes post release services under certain conditions to eligible children. All programs must comply with the Flores Settlement Agreement, Case No. CV85– 4544–RJK (C.D. Cal. 1996); pertinent regulations; and ORR policies and procedures. Elizabeth Leo, Senior Grants Policy Specialist, Office of Grants Policy, Office of Administration. [FR Doc. 2021–09758 Filed 5–4–21; 4:15 pm] BILLING CODE 4184–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2020–N–2030; FDA– 2017–N–4951; FDA–2017–N–5569; FDA– 2020–N–1652; FDA–2017–N–7012; and FDA–2019–N–4763] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have SUMMARY: E:\FR\FM\10MYN1.SGM 10MYN1

Agencies

[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24866-24867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2021-0049]


Advisory Committee on Immunization Practices (ACIP)

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), announces the 
following meeting of the Advisory Committee on Immunization Practices 
(ACIP). This meeting is open to the public. The meeting will be webcast 
live via the World Wide Web.

DATES: The meeting will be held on May 12, 2021, from 11:00 a.m. to 
5:00 p.m., EDT (dates and times subject to change, see the ACIP website 
for updates: https://www.cdc.gov/vaccines/acip/). The public 
may submit comments from May 10, 2021 through May 12, 2021.

ADDRESSES: For more information on ACIP please visit the ACIP website: 
https://www.cdc.gov/vaccines/acip/.
    You may submit comments, identified by Docket No. CDC-2021-0049 by 
any 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: May 12, 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, MS-H24-8, Atlanta, GA 30329-4027; Telephone: 404-639-8367; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: In accordance with 41 CFR 102-3.150(b), less 
than 15 calendar days' notice is being given for this meeting due to 
the exceptional circumstances of the COVID-19 pandemic and rapidly 
evolving COVID-19 vaccine development and regulatory processes. The 
Secretary of Health and Human Services has determined that COVID-19 is 
a Public Health Emergency. 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.
    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 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 
COVID-19 vaccines, including use of the Pfizer-BioNTech COVID-19 
vaccine under the Food and Drug Administration's (FDA) expanded 
Emergency Use Authorization (EUA) for adolescents 12-15 years of age. A 
recommendation vote(s) is 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: 
https://www.cdc.gov/vaccines/acip/.

Public Participation

    Interested persons or organizations are invited to participate by 
submitting written views, recommendations, and

[[Page 24867]]

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 May 12, 2021.
    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 at the May 12, 2021 ACIP meeting must submit a 
request at https://www.cdc.gov/vaccines/acip/meetings/ no later than 
11:59 p.m., EDT, May 10, 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 12:00 p.m., EDT, May 11, 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.
    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. 2021-09893 Filed 5-6-21; 11:15 am]
BILLING CODE 4163-18-P

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