Advisory Committee on Immunization Practices (ACIP), 52781-52782 [2022-18734]
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Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
work product) regarding the quality and
safety of health care delivery.
The Patient Safety Act requires PSOs,
to the extent practical and appropriate,
to collect patient safety work product
from providers in a standardized
manner that permits valid comparisons
of similar cases among similar
providers. (42 U.S.C. 299b–24(b)(1)(F)).
The Patient Safety Act also authorizes
the development of data standards,
known as the Common Formats, to
facilitate the aggregation and analysis of
non-identifiable patient safety data
collected by PSOs and reported to the
network of patient safety databases
(NPSD). (42 U.S.C. 299b–23(b)). The
Patient Safety Act and Patient Safety
Rule can be accessed at: https://
www.pso.ahrq.gov/legislation/.
AHRQ has issued Common Formats
for Event Reporting (CFER) for three
settings of care—hospitals, nursing
homes, and community pharmacies.
AHRQ has also issued Common Formats
for Event Reporting—Diagnostic Safety
(CFER–DS) designed for use in all
healthcare settings.
Federally listed PSOs can meet the
requirement to collect patient safety
work product in a standardized manner
to the extent practical and appropriate
by using AHRQ’s Common Formats. The
Common Formats are also available in
the public domain to encourage their
widespread adoption. An entity does
not need to be listed as a PSO or
working with one to use the Common
Formats. However, the Federal privilege
and confidentiality protections only
apply to information developed as
patient safety work product by
providers and PSOs working under the
Patient Safety Act.
khammond on DSKJM1Z7X2PROD with NOTICES
Agenda, Registration, and Other
Information About the Meeting
The Agency for Healthcare Research
and Quality (AHRQ) will be hosting this
fully virtual meeting to discuss
implementation of the Common Formats
with members of the public, including
software developers and other interested
parties. The agenda will include
discussion on ways to improve the
portion of the PSO Privacy Protection
Center’s website for Software
Developers and Vendors: https://
www.psoppc.org/psoppc_web/
publicpages/forDevelopersAndVendors.
Active participation and discussion by
meeting participants is encouraged.
AHRQ requests that interested
persons send an email to SDMeetings@
infinityconferences.com for registration
information. Before the meeting, an
agenda and logistical information will
be provided to registrants.
VerDate Sep<11>2014
17:01 Aug 26, 2022
Jkt 256001
Dated: August 23, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022–18486 Filed 8–26–22; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2022–0103]
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), 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
September 1, 2022, from 10:00 a.m. to
5:00 p.m., EDT and September 2, 2022,
from 10:00 a.m. to 12:00 p.m., EDT
(dates and times subject to change, see
the ACIP website for updates https://
www.cdc.gov/vaccines/acip/
index.html). The meeting will be
webcast live via the World Wide Web.
Written comments must be received on
or before September 2, 2022.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0103, 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: September 1–2, 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
SUMMARY:
PO 00000
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52781
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 Advisory Committee on
Immunization Practices (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 CDC Director and
appear on CDC immunization schedules
must be covered by applicable health
plans.
Matters To Be Considered: The agenda
will include discussions on use of
COVID–19 vaccines booster doses. 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/
index.html.
The meeting will be webcast live via
the World Wide Web; for more
information on ACIP, 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\29AUN1.SGM
29AUN1
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52782
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
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
September 2, 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 September
1–2, 2022, ACIP meeting must submit a
request at https://www.cdc.gov/
vaccines/acip/meetings/ no later than
11:59 p.m. EDT, August 30, 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 August 31, 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
VerDate Sep<11>2014
17:01 Aug 26, 2022
Jkt 256001
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. 2022–18734 Filed 8–25–22; 4:15 pm]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
[FR Doc. 2022–18519 Filed 8–26–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that ZYNTEGLO
(betibeglogene autotemcel),
manufactured by bluebird bio, Inc.,
meets the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that ZYNTEGLO (betibeglogene
autotemcel), manufactured by bluebird
bio, Inc., meets the criteria for a priority
review voucher. ZYNTEGLO is
indicated for the treatment of adult and
pediatric patients with +-thalassemia
who require regular red blood cell
transfusions.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
SUMMARY:
PO 00000
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration,
HHS.
ACTION:
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/industry/
developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For
further information about ZYNTEGLO,
go to the Center for Biologics Evaluation
and Research’s Approved Cellular and
Gene Therapy Products website at
https://www.fda.gov/vaccines-bloodbiologics/cellular-gene-therapyproducts/approved-cellular-and-genetherapy-products.
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Food and Drug Administration
[Docket No. FDA–2013–N–0093]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Review
Transparency and Communication for
New Molecular Entity New Drug
Applications and Original Biologics
License Applications in Prescription
Drug User Fee Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by September
28, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0746. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
SUMMARY:
E:\FR\FM\29AUN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52781-52782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18734]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2022-0103]
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), 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 September 1, 2022, from 10:00 a.m.
to 5:00 p.m., EDT and September 2, 2022, from 10:00 a.m. to 12:00 p.m.,
EDT (dates and times subject to change, see the ACIP website for
updates 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 September 2, 2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0103, 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: September 1-2,
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: 404-639-8367;
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 Advisory Committee on
Immunization Practices (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 CDC Director and appear on CDC immunization
schedules must be covered by applicable health plans.
Matters To Be Considered: The agenda will include discussions on
use of COVID-19 vaccines booster doses. 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/.
The meeting will be webcast live via the World Wide Web; for more
information on ACIP, 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 52782]]
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 September 2, 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 September 1-2, 2022, ACIP meeting
must submit a request at https://www.cdc.gov/vaccines/acip/meetings/ no
later than 11:59 p.m. EDT, August 30, 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 August 31, 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. 2022-18734 Filed 8-25-22; 4:15 pm]
BILLING CODE 4163-18-P
