Advisory Committee on Immunization Practices (ACIP), 20497-20498 [2021-08275]

Download as PDF Federal Register / Vol. 86, No. 74 / Tuesday, April 20, 2021 / Notices errors or inconsistencies are identified during these stages, clinics are contacted and data are immediately corrected. In addition, CDC conducts annual site visits by selecting 7–10% of all reporting clinics and about 70–80 cycles per clinic for data validation. This data validation process involves comparing information of key variables from patient’s medical record with the data submitted to the National ART Surveillance System (NASS), the CDC data reporting system for ART procedures, to calculate discrepancy rates for these variables. Data validation helps ensure that clinics submit accurate data and to identify any systematic problems that could cause data collection to be inconsistent or incomplete. Data Validation CDC is currently conducting data validation using stratified random sampling of reporting clinics to assess discrepancy rates for key variables that are generalizable for all reporting clinics as described in ‘‘Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs’’ (80 FR 51811). Effective for calendar year 2022, CDC also will conduct targeted validation of clinics to better capture systematic reporting errors by assessing certain reporting characteristics that may predict erroneously inflated ART success rates (e.g. number of cancelled cycles, inability to confirm reported live births, etc.). Information gained from targeted validation will be used to identify and address systematic reporting errors, but will not be used in calculating discrepancy rates since it cannot be generalized to all reporting clinics. If a clinic is selected to participate in the NASS data validation process (either through stratified random sampling or through targeted selection), participates in validation, and major data discrepancies are identified (e.g., lack of supporting information for a significant proportion of reported pregnancy outcomes, inability to confirm a significant proportion of reported live births, underreporting a significant proportion of cycles, etc.), a message will be displayed in the ART Fertility Clinic Success Rates Report for the clinic as: CDC conducts data validation of a sample of reporting clinics to assess discrepancy rates for key variables, to identify any systematic problems, and to help ensure clinics submit accurate data. This clinic was visited for validation of (insert: Reporting year) data and major data discrepancies were identified. This clinic’s reported success rates data are therefore not published in this VerDate Sep<11>2014 17:10 Apr 19, 2021 Jkt 253001 report and not included in aggregate national data reports. CDC may re-select this ART program during the following reporting year(s) to assess corrections of identified data errors. In addition, CDC will publish a statement in the annual ART Fertility Clinic Success Rates Report to identify clinics that are selected by CDC to participate in the NASS data validation but decline to participate.(See 80 FR 51811 for further information concerning external validation of clinic data). If a clinic is selected to participate in the NASS data validation process and declines to participate, the following message will be displayed in the ART Fertility Clinic Success Rates Report for the clinic as: CDC conducts data validation of a sample of reporting clinics to assess discrepancy rates for key variables, to identify any systematic problems, and to help ensure clinics submit accurate data. This clinic was selected for validation of (insert: Reporting year) data, but declined to participate. This clinic’s reported data are therefore not published in this report and not included in aggregate national data reports. CDC may re-select this ART program during the following reporting year(s). Participation in data validation is integral to helping ensure the accuracy of the required pregnancy success rates reported to have been achieved by clinics. Therefore, displaying this message, as well as the other messages outlined herein, is important in providing the public with the most accurate information. For consistency, for all other clinics that are selected to participate in the NASS data validation and do participate, the following footnote will be added: CDC conducts data validation of a sample of reporting clinics to assess discrepancy rates for key variables, to identify any systematic problems, and to help ensure clinics submit accurate data. This clinic was visited for validation of (insert: Reporting year) data and no systematic problems were identified. Any messages added to a clinic’s success rates page in the ART Fertility Clinic Success Rates Report will appear only for the reporting year that the clinic was selected for validation. These enhanced processes and messages in the annual ART Fertility Clinic Success Rates Report will help to inform the public if there are issues with data quality, thereby increasing the transparency and help ensure the accuracy of the NASS data reporting. PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 20497 Dated: April 15, 2021. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2021–08117 Filed 4–19–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2021–0044] 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 April 23, 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 April 20, 2021 through April 23, 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–2021–0044 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: April 23, 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: E:\FR\FM\20APN1.SGM 20APN1 20498 Federal Register / Vol. 86, No. 74 / Tuesday, April 20, 2021 / Notices 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 Janssen (Johnson & Johnson) COVID–19 Vaccine Safety. 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 data. Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to VerDate Sep<11>2014 17:10 Apr 19, 2021 Jkt 253001 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 23, 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 April 23, 2021 ACIP meeting must submit a request at https://www.cdc.gov/vaccines/acip/ meetings/ no later than 11:59 p.m., EDT, April 21, 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, April 22, 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 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 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. 2021–08275 Filed 4–16–21; 4:15 pm] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Data Collection for the Engaging Fathers and Paternal Relatives: A Continuous Quality Improvement Approach in the Child Welfare System Project (New Collection) Office of Planning, Research, and Evaluation, Administration for Children and Families, HHS. ACTION: Request for public comment. AGENCY: The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing to conduct data collection activities for the Engaging Fathers and Paternal Relatives: A Continuous Quality Improvement Approach in the Child Welfare System (Fathers and Continuous Learning in Child Welfare [FCL]) Project. This evaluation is a descriptive study of child welfare agencies’ use of a continuous quality improvement process called the Breakthrough Series Collaborative (BSC) to implement strategies to improve father and paternal relative engagement in the child welfare system. The project is designed to examine the use of the BSC methodology to strengthen fathers’ and paternal relatives’ engagement with children involved in child welfare and to add to the evidence base on engagement strategies for fathers and paternal relatives in child welfare. DATES: Comments due within 60 days of publication. In compliance with the requirements of the Paperwork Reduction Act of 1995, ACF is soliciting public comment on the specific aspects of the information collection described above. ADDRESSES: Copies of the proposed collection of information can be obtained and comments may be forwarded by emailing OPREinfocollection@acf.hhs.gov. Alternatively, copies can also be obtained by writing to the Administration for Children and SUMMARY: E:\FR\FM\20APN1.SGM 20APN1

Agencies

[Federal Register Volume 86, Number 74 (Tuesday, April 20, 2021)]
[Notices]
[Pages 20497-20498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08275]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2021-0044]


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 April 23, 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 April 20, 2021 through April 23, 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-2021-0044 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: April 23, 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

[[Page 20498]]

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 
Janssen (Johnson & Johnson) COVID-19 Vaccine Safety. 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 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 23, 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 April 23, 2021 ACIP meeting must submit a 
request at https://www.cdc.gov/vaccines/acip/meetings/ no later than 
11:59 p.m., EDT, April 21, 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, April 22, 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. 2021-08275 Filed 4-16-21; 4:15 pm]
BILLING CODE 4163-18-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.