Advisory Committee on Immunization Practices (ACIP), 73712-73713 [2020-25658]

Download as PDF 73712 Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued PICOTS Inclusion Timing .................................. Duration of follow up: Focus on persistence of effects evaluated short term (1 to <6 months), intermediate term (≥6 to <12 months) and long term (≥12 months) following intervention. Outpatient, inpatient, institutional residence. Setting .................................. Study design, publication type. Exclusion Inclusion will focus on RCTs. Prospective cohort studies that control for confounding will be considered if RCTs are not available. Comparative cohorts that do not control for confounding will be considered if cohorts controlling for confounding are not available. In the absence of comparative studies, single arm (e.g., case series, pre-post studies) will be considered if they are clearly relevant to the Medicare population. • Inpatient or outpatient settings exclusively providing treatment for SUD/OUD or tertiary care, hospice, or similar settings. • Case reports. • Case series (unless no comparative studies). • Case-control studies, cross-sectional studies. • Conference proceedings, editorials, letters, white papers, citations that have not been peer-reviewed. CBT = Cognitive Behavioral Therapy; ED = emergency department; ESDR = end stage renal disease; HRQOL = Health-related quality of life; OT = occupational therapy; OUD = opioid use disorder; PICOTS = population, intervention, comparator, outcomes, timing, study design; PT = physical therapy; RCT = randomized control trial; SUD = substance use disorder. a Complex acute or subacute pain: Patients with acute pain (<6 weeks duration) or subacute pain (6 weeks to 12 weeks duration) who are at risk of developing chronic pain). b Chronic, nonactive cancer pain (based on Mersky 1994): Pain that persists for at least three months and is not associated with [active] malignant disease’’; pain could, however, be resultant from a previous malignancy that is no longer active. c The term nociplasticity has been used to describe pain resulting from altered nociception without underlying tissue damage resulting in hypersensitivity (e.g., fibromyalgia). Many pain conditions may have a nociplastic component. Some additional terms used in the literature include centralized pain and amplified pain. Dated: November 13, 2020. Marquita Cullom, Associate Director. [FR Doc. 2020–25451 Filed 11–18–20; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2020–0117] 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. Time will be available for public comment. The meeting will be webcast live via the World Wide Web. DATES: The meeting will be held on November 23, 2020 from 12:00 p.m. to 5:00 p.m., EST (times subject to change). Written comments must be received on or before November 23, 2020. ADDRESSES: For more information on ACIP please visit the ACIP website: SUMMARY: VerDate Sep<11>2014 19:40 Nov 18, 2020 Jkt 253001 https://www.cdc.gov/vaccines/acip/ index.html. You may submit comments, identified by Docket No. CDC–2020–0117 by any of the following methods: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. • Mail: Docket No. CDC–2020–0117, c/o Attn: November 23, 2020 ACIP Meeting, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H24–8, Atlanta, GA 30329–4027. 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. Written public comments submitted by 24 hours prior to the ACIP meeting will be provided to ACIP members before the meeting. 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: ACIP@cdc.gov. SUPPLEMENTARY INFORMATION: Purpose: The committee is charged with advising the Director, CDC, on the use of immunizing agents. In addition, PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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. No recommendation vote is scheduled for COVID–19 vaccines. 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 E:\FR\FM\19NON1.SGM 19NON1 Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices public disclosure. 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. CDC does not accept comment by email. 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 November ACIP meeting must submit a request at https:// www.cdc.gov/vaccines/acip/meetings/ no later than 11:59 p.m., EST, November 19, 2020 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 November 20, 2020. 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: Written comments must be received on or before November 23, 2020. 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. A notice of this ACIP meeting has also been posted on the ACIP website at: https://www.cdc.gov/vaccines/acip/ index.html. In the interest of promoting openness and transparency, we are publishing a VerDate Sep<11>2014 19:40 Nov 18, 2020 Jkt 253001 late notice in the Federal Register to inform the public. 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. 2020–25658 Filed 11–17–20; 4:15 pm] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–21–0666] Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Healthcare Safety Network (NHSN) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on June 15, 2020 to obtain comments from the public and affected agencies. CDC received two comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 73713 (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/ do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project National Healthcare Safety Network (NHSN) (OMB Control No. 0920–0666, Exp. 12/31/2022)—Revision—National Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Division of Healthcare Quality Promotion (DHQP), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) collects data from healthcare facilities in the National Healthcare Safety Network (NHSN) under OMB Control Number 0920–0666. NHSN provides facilities, states, regions, and the nation with data necessary to identify problem areas, measure the progress of prevention efforts, and ultimately eliminate healthcare-associated infections (HAIs) nationwide. NHSN allows healthcare facilities to track blood safety errors and various healthcare-associated infection prevention practice methods such as healthcare personnel influenza vaccine status and corresponding infection control adherence rates. NHSN currently has six components: Patient Safety (PS), Healthcare Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient Procedure (OPC), and the Dialysis Component. NHSN’s planned E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73712-73713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2020-0117]


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. Time will be available for 
public comment. The meeting will be webcast live via the World Wide 
Web.

DATES: The meeting will be held on November 23, 2020 from 12:00 p.m. to 
5:00 p.m., EST (times subject to change).
    Written comments must be received on or before November 23, 2020.

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-2020-0117 by 
any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Docket No. CDC-2020-0117, c/o Attn: November 23, 
2020 ACIP Meeting, Centers for Disease Control and Prevention, 1600 
Clifton Road NE, MS H24-8, Atlanta, GA 30329-4027.
    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.
    Written public comments submitted by 24 hours prior to the ACIP 
meeting will be provided to ACIP members before the meeting.

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: 
    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. No recommendation vote is scheduled for COVID-19 
vaccines. 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

[[Page 73713]]

public disclosure. 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. CDC does not accept comment by 
email.
    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 November ACIP meeting must submit a 
request at https://www.cdc.gov/vaccines/acip/meetings/ no later than 
11:59 p.m., EST, November 19, 2020 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 November 20, 2020. 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: Written comments must be received on or 
before November 23, 2020.
    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. A notice of this ACIP 
meeting has also been posted on the ACIP website at: https://www.cdc.gov/vaccines/acip/.
    In the interest of promoting openness and transparency, we are 
publishing a late notice in the Federal Register to inform the public.
    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. 2020-25658 Filed 11-17-20; 4:15 pm]
BILLING CODE 4163-18-P

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