Advisory Committee on Immunization Practices (ACIP), 40058-40059 [2021-15799]
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40058
Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices
password protected platforms.
Respondents will include educational
developers requesting accreditation for
their trainings and public health and
healthcare professionals who seek
training. No statistical methods will be
used to analyze the information
TCEO and CDC TRAIN will be used to
improve educational activities and
assess learning outcomes.
CDC requests approval for an
estimated 412,600 annual burden hours.
There are no costs to respondents other
than their time.
collected. CDC will use identifiable
information in TCEO to track
participant completion of educational
activities to facilitate required reporting
to earn continuing education credits,
hours, or units. Aggregate and nonaggregate data from the evaluations in
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Educational Developers (Health Educators).
Public Health and Health Care Professionals (Learners).
Public Health and Health Care Professionals (Learners).
Public Health and Health Care Professionals (Learners).
TCEO Proposal ................................
Number of
responses per
respondent
Average
burden time
per response
(in hours)
Total
Response
Burden
(in hours)
120
1
5
600
TCEO New Participant Registration
300,000
1
5/60
25,000
TCEO Post-Course Evaluation ........
300,000
3
10/60
150,000
TCEO Follow-Up Evaluation ............
30,000
3
3/60
4,500
TCEO Sub-Total ........................
Public Health and Health Care Professionals (Learners).
Public Health and Health Care Professionals (Learners).
...........................................................
CDC TRAIN Immediate Post-Course
Evaluation Tool.
CDC TRAIN Delayed Follow-Up
Evaluation Tool.
........................
300,000
........................
3
........................
15/60
180,100
225,000
30,000
3
5/60
7,500
0.33TRAIN Sub-Total ................
...........................................................
........................
........................
........................
232,500
Total ....................................
...........................................................
........................
........................
........................
412,600
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–15794 Filed 7–23–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. CDC–2021–0075]
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. For more
information on ACIP please visit the
ACIP website: https://www.cdc.gov/
vaccines/acip/.
SUMMARY:
VerDate Sep<11>2014
17:10 Jul 23, 2021
Jkt 253001
The meeting will be held on
September 29, 2021, from 10:00 a.m. to
5:05 p.m., EDT, and September 30,
2021, from 10:00 a.m. to 1:10 p.m., EDT
(times subject to change), see the ACIP
website for updates: https://
www.cdc.gov/vaccines/acip/.
The public may submit written
comments from July 26, 2021 through
September 30, 2021.
DATES:
FOR FURTHER INFORMATION CONTACT:
You may submit comments,
identified by Docket No. CDC–2021–
0075 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, Georgia 30329–
4027, Attn: 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. Written
public comments submitted 72 hours
prior to the ACIP meeting will be
provided to ACIP members before the
meeting.
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, Georgia 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,
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 cholera
vaccine, hepatitis vaccines, herpes
zoster vaccines, orthopoxvirus vaccine,
pneumococcal vaccine, and tickborne
ADDRESSES:
Centers for Disease Control and
Prevention
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Number of
respondents
Type of respondents
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Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
encephalitis vaccine. 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/
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: The docket
will be opened to receive written
comments on September 1, 2021.
Written comments must be received on
or before September 30, 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 September 29–
30, 2021, ACIP meeting must submit a
request at https://www.cdc.gov/vaccines/
acip/meetings/ no later than 11:59 p.m.,
EDT, September 24, 2021, according to
the instructions provided.
If the number of persons requesting to
speak is greater than can be reasonably
accommodated during the scheduled
VerDate Sep<11>2014
17:10 Jul 23, 2021
Jkt 253001
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
September 28, 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. 2021–15799 Filed 7–23–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0651]
Cellular, Tissue and Gene Therapies
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of public
docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Cellular, Tissue and Gene Therapies
Advisory Committee (CTGTAC). The
general function of the committee is to
provide advice and recommendations to
FDA on regulatory issues. Matters
considered at the meeting will include
discussion of the toxicity risks of adenoassociated virus (AAV) vector-based
gene therapy products. The discussion
topics include oncogenicity risks due to
vector genome integration and safety
issues identified during preclinical and/
or clinical evaluation. The meeting will
be open to the public on both days. FDA
is establishing a docket for public
comment on this document.
DATES: The meeting will be held on
September 2 and 3, 2021, from 10 a.m.
to 6 p.m. Eastern Time.
SUMMARY:
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Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/advisory-committees/
about-advisory-committees/commonquestions-and-answers-about-fdaadvisory-committee-meetings. The
online web conference meeting will be
available at the following links on the
day of the meeting: Day 1 https://
youtu.be/58KjL9_p9Tw and Day 2
https://youtu.be/yLggQF0XUUY.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0651.
The docket will close on September 1,
2021. Submit either electronic or
written comments on this public
meeting on or before September 1, 2021.
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 September 1, 2021. 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.
Comments received on or before
August 26, 2021, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
ADDRESSES:
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
E:\FR\FM\26JYN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40058-40059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15799]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2021-0075]
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. For more information on ACIP please visit the ACIP website: https://www.cdc.gov/vaccines/acip/.
DATES: The meeting will be held on September 29, 2021, from 10:00 a.m.
to 5:05 p.m., EDT, and September 30, 2021, from 10:00 a.m. to 1:10
p.m., EDT (times subject to change), see the ACIP website for updates:
https://www.cdc.gov/vaccines/acip/. The public may submit
written comments from July 26, 2021 through September 30, 2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0075 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, Georgia 30329-4027, Attn: 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.
Written public comments submitted 72 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, Georgia 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
cholera vaccine, hepatitis vaccines, herpes zoster vaccines,
orthopoxvirus vaccine, pneumococcal vaccine, and tickborne
[[Page 40059]]
encephalitis vaccine. 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/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: The docket will be opened to receive
written comments on September 1, 2021. Written comments must be
received on or before September 30, 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 September 29-30, 2021, ACIP meeting must
submit a request at https://www.cdc.gov/vaccines/acip/meetings/ no later
than 11:59 p.m., EDT, September 24, 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 September 28, 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. 2021-15799 Filed 7-23-21; 8:45 am]
BILLING CODE 4163-18-P
