Human West Nile Virus Vaccine Meeting and Request for Information, 15993-15994 [2024-04745]
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
conference login information and the
agenda to registrants from the CPSTF@
cdc.gov mailbox approximately two
weeks before the meeting start date.
To register for the meeting,
individuals should send an email to
CPSTF@cdc.gov and include the
following information: name, title,
organization name, organization
address, phone, and email.
Public Comment: Individuals who
would like to make public comments
during the April meeting must state
their desire to do so in an email to the
CPSTF@cdc.gov mailbox no later than
April 10, 2024. The request should
include name, organizational affiliation,
and topic to be addressed. Public
comment must be relevant to one of the
topics proposed for the meeting. The
requestor will receive instructions
related to the public comment process
for this meeting after the request is
received. A public comment period
follows the CPSTF’s discussion of each
systematic review and will be limited to
no more than three minutes per person.
Public comments may be used to inform
task force discussions and will be
included in the meeting summary.
Background on the CPSTF: The
CPSTF is an independent, nonfederal
panel whose members are appointed by
the CDC Director. CPSTF members
represent a broad range of research,
practice, and policy expertise in
prevention, wellness, health promotion,
and public health. The CPSTF was
convened in 1996 by HHS to identify
community preventive programs,
services, and policies that increase
health and longevity, save lives and
dollars, and improve Americans’ quality
of life. CDC is mandated to provide
ongoing administrative, research, and
technical support for the operations of
the CPSTF. During its meetings, the
CPSTF considers the findings of
systematic reviews of existing research
and practice-based evidence, and issues
recommendations. CPSTF
recommendations are not mandates for
compliance or spending. Instead, they
provide information about evidencebased options that decision makers and
affected community members can
consider when they are determining
what best meets the specific needs,
preferences, available resources, and
constraints of their jurisdictions and
constituents. The CPSTF’s
recommendations, along with the
systematic reviews of the evidence on
which they are based, are compiled on
the Community Guide website
(www.thecommunityguide.org).
Matters proposed for discussion: The
agenda will consist of deliberation on
systematic reviews of literature. Topics
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proposed for the April 2024 meeting
include substance use, public health
emergency preparedness and response,
oral health, and social determinants of
health. Changes regarding the start and
end times for each day, and any updates
to agenda topics, will be available on
the Community Guide website
(www.thecommunityguide.org) closer to
the date of the meeting.
The meeting agenda is subject to
change without notice.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2024–04779 Filed 3–5–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2024–0017]
Human West Nile Virus Vaccine
Meeting and Request for Information
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of public teleconference
and request for information.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), is announcing a
meeting and opportunity to comment on
a human West Nile virus (WNV)
vaccine. The primary purpose of the
meeting is to inform critical next steps
toward the deployment of a human
WNV vaccine.
DATES: The meeting will be held on
April 5, 2024, from 8 a.m. to 5 p.m.,
eastern time.
Written comments must be received
on or before April 4, 2024.
ADDRESSES: You may submit written
comments, identified by docket number
CDC–2024–0017, by either of the
following two methods listed below.
CDC does not accept comments by
email.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Randall Nett, MD, MPH,
Centers for Disease Control and
Prevention, 3156 Rampart Road, MS
P02, Fort Collins, CO 80521.
Instructions: All information received
in response to this notice must include
the agency name and docket number
[CDC–2024–0017]. All relevant
comments received will be posted
SUMMARY:
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15993
without change to https://
www.regulations.gov, including any
personal information provided. This
will be an in-person and virtual meeting
with a limited number of available
Zoom lines. The in-person gathering
will be by invitation only and held at
Constitution Center, 400 7th St. SW,
Washington, DC.
Accessibility: For information on
access or services for individuals with
disabilities, or to request
accommodations for a disability, please
contact Shawna Zuck by email at
wnv.vaccine@cdc.gov, or by phone at
(970) 221–6400, preferably at least 10
days before the meeting to allow as
much time as possible to process your
request.
FOR FURTHER INFORMATION CONTACT:
Randall J. Nett, MD MPH, Chief,
Arboviral Diseases Branch, 3156
Rampart Road, MS P02, Fort Collins, CO
80521; telephone number: (970) 221–
6400; email address wnv.vaccine@
cdc.gov.
SUPPLEMENTARY INFORMATION:
Background: WNV is a disease spread
by mosquitoes that continues to cause
illness and deaths each year in the
United States and other areas of the
world. Current mosquito control
measures have been unsuccessful at
decreasing the number of WNV disease
cases. An approved human WNV
vaccine could reduce the public health
impact of WNV disease.
Purpose: The primary purpose of the
meeting and public comment period is
to inform critical next steps toward the
development of a human WNV vaccine
that is approved for use.
Attending the meeting: The meeting
will be open to the general public. The
meeting agenda and information on how
to register for and attend the meeting
online will be provided on request. If
interested in attending the meeting
online, please email wnv.vaccine@
cdc.gov. This meeting is open to the
public, limited only by the number of
Zoom lines. The Zoom line will
accommodate up to 500 participants
and be available on a first come-first
serve basis.
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
E:\FR\FM\06MRN1.SGM
06MRN1
15994
Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
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.
Oral Statements: CDC will allocate 15
minutes for the public to present oral
comments during the meeting. Oral
statements will be limited to three
minutes per person during the public
comment period. It is preferred that
only one person present a statement on
behalf of a group or organization.
Persons interested in presenting an oral
statement should send an email to
wnv.vaccine@cdc.gov by 12 p.m.,
eastern time, on March 29, 2024. A
limited number of time slots are
available and will be assigned on a first
come-first served basis.
Written Public Comment: Written
comments will also be accepted per the
instructions provided in the addresses
section above. Comments should be
submitted on or before April 4, 2024.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2024–04745 Filed 3–5–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3448–N]
Medicare Program; Announcement of
the Re-Approval of COLA Under the
Clinical Laboratory Improvement
Amendments of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
This notice announces the
application of COLA for re-approval as
an accreditation organization for clinical
laboratories under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) program for the
following specialty and subspecialty
areas under CLIA: Microbiology,
including Bacteriology,
SUMMARY:
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16:57 Mar 05, 2024
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Mycobacteriology, Mycology,
Parasitology, and Virology; Diagnostic
Immunology, including Syphilis
Serology, and General Immunology;
Chemistry, including Routine
Chemistry, Toxicology, and
Endocrinology; Hematology, including
routine hematology and coagulation;
Immunohematology, including ABO
Group, D (Rho) typing, Unexpected
Antibody Detection, Compatibility
Testing, and Antibody Identification;
Pathology, including Histopathology,
Oral Pathology, and Cytology. We have
determined that COLA meets or exceeds
the applicable CLIA requirements. We
are announcing the re-approval and
grant COLA deeming authority for a
period of 6 years.
DATES: Effective Date: This notice is
effective from March 6, 2024 to March
6, 2030.
FOR FURTHER INFORMATION CONTACT:
Jelani Sanaa, (410) 786–1139.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(Pub. L. 100–578) (CLIA). CLIA
amended section 353 of the Public
Health Service Act. We issued a final
rule implementing the accreditation
provisions of CLIA on July 31, 1992 (57
FR 33992). Under those provisions, we
may grant deeming authority to an
accreditation organization if its
requirements for laboratories accredited
under its program are equal to or more
stringent than the applicable CLIA
program requirements in 42 CFR part
493 (Laboratory Requirements). Subpart
E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption Under an Approved State
Laboratory Program) specifies the
requirements an accreditation
organization must meet to be approved
by CMS as an accreditation organization
under CLIA.
II. Notice of Re-Approval of COLA as
an Accreditation Organization
In this notice, we approve COLA as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements for the following specialty
and subspecialty areas under CLIA:
• Microbiology, including
Bacteriology, Mycobacteriology,
Mycology, Parasitology, and Virology.
• Diagnostic Immunology, including
Syphilis Serology, and General
Immunology.
PO 00000
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Fmt 4703
Sfmt 4703
• Chemistry, including Routine
Chemistry, Toxicology, and
Endocrinology.
• Hematology, including routine
hematology and coagulation.
• Immunohematology, including
ABO Group, D (Rho) typing,
Unexpected Antibody Detection,
Compatibility Testing, and Antibody
Identification.
• Pathology, including
Histopathology, Oral Pathology, and
Cytology.
We have examined the initial COLA
application and all subsequent
submissions to determine its
accreditation program’s equivalency
with the requirements for re-approval of
an accreditation organization under
subpart E of part 493. We have
determined that COLA meets or exceeds
the applicable CLIA requirements. We
have also determined that COLA will
ensure that its accredited laboratories
will meet or exceed the applicable
requirements in subparts H, I, J, K, M,
Q, and the applicable sections of R.
Therefore, we grant COLA re-approval
as an accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for the submitted specialty and
subspecialty areas under CLIA. As a
result of this determination, any
laboratory that is accredited by COLA
during the time period stated in the
DATES section of this notice will be
deemed to meet the CLIA requirements
for the listed subspecialties and
specialties, and therefore, will generally
not be subject to routine inspections by
a State survey agency to determine its
compliance with CLIA requirements.
The accredited laboratory, however, is
subject to validation and complaint
investigation surveys performed by
CMS, or its agent(s).
III. Evaluation of COLA’s Request for
Re-Approval as an Accreditation
Organization Under CLIA
The following describes the process
we used to determine that COLA’s
accreditation program meets the
necessary requirements to be approved
by CMS and that, as such, CMS may
approve COLA as an accreditation
program with deeming authority under
the CLIA program. COLA formally
applied to CMS for re-approval as an
accreditation organization under CLIA
for the following specialties and
subspecialties:
• Microbiology, including
Bacteriology, Mycobacteriology,
Mycology, Parasitology, and Virology.
• Diagnostic Immunology, including
Syphilis Serology, and General
Immunology.
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 15993-15994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04745]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2024-0017]
Human West Nile Virus Vaccine Meeting and Request for Information
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of public teleconference and request for information.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), within
the Department of Health and Human Services (HHS), is announcing a
meeting and opportunity to comment on a human West Nile virus (WNV)
vaccine. The primary purpose of the meeting is to inform critical next
steps toward the deployment of a human WNV vaccine.
DATES: The meeting will be held on April 5, 2024, from 8 a.m. to 5
p.m., eastern time.
Written comments must be received on or before April 4, 2024.
ADDRESSES: You may submit written comments, identified by docket number
CDC-2024-0017, by either of the following two methods listed below. CDC
does not accept comments by email.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Randall Nett, MD, MPH, Centers for Disease Control
and Prevention, 3156 Rampart Road, MS P02, Fort Collins, CO 80521.
Instructions: All information received in response to this notice
must include the agency name and docket number [CDC-2024-0017]. All
relevant comments received will be posted without change to https://www.regulations.gov, including any personal information provided. This
will be an in-person and virtual meeting with a limited number of
available Zoom lines. The in-person gathering will be by invitation
only and held at Constitution Center, 400 7th St. SW, Washington, DC.
Accessibility: For information on access or services for
individuals with disabilities, or to request accommodations for a
disability, please contact Shawna Zuck by email at [email protected],
or by phone at (970) 221-6400, preferably at least 10 days before the
meeting to allow as much time as possible to process your request.
FOR FURTHER INFORMATION CONTACT: Randall J. Nett, MD MPH, Chief,
Arboviral Diseases Branch, 3156 Rampart Road, MS P02, Fort Collins, CO
80521; telephone number: (970) 221-6400; email address
[email protected].
SUPPLEMENTARY INFORMATION:
Background: WNV is a disease spread by mosquitoes that continues to
cause illness and deaths each year in the United States and other areas
of the world. Current mosquito control measures have been unsuccessful
at decreasing the number of WNV disease cases. An approved human WNV
vaccine could reduce the public health impact of WNV disease.
Purpose: The primary purpose of the meeting and public comment
period is to inform critical next steps toward the development of a
human WNV vaccine that is approved for use.
Attending the meeting: The meeting will be open to the general
public. The meeting agenda and information on how to register for and
attend the meeting online will be provided on request. If interested in
attending the meeting online, please email [email protected]. This
meeting is open to the public, limited only by the number of Zoom
lines. The Zoom line will accommodate up to 500 participants and be
available on a first come-first serve basis.
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
[[Page 15994]]
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.
Oral Statements: CDC will allocate 15 minutes for the public to
present oral comments during the meeting. Oral statements will be
limited to three minutes per person during the public comment period.
It is preferred that only one person present a statement on behalf of a
group or organization. Persons interested in presenting an oral
statement should send an email to [email protected] by 12 p.m.,
eastern time, on March 29, 2024. A limited number of time slots are
available and will be assigned on a first come-first served basis.
Written Public Comment: Written comments will also be accepted per
the instructions provided in the addresses section above. Comments
should be submitted on or before April 4, 2024.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease Control and Prevention.
[FR Doc. 2024-04745 Filed 3-5-24; 8:45 am]
BILLING CODE 4163-18-P
