Clinical Laboratory Improvement Advisory Committee
| Court | Centers For Disease Control And Prevention |
| Citation | 88 FR 58584 |
| Published date | 28 August 2023 |
| Record Number | 2023-18448 |
| Section | Notices |
58584
Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Notices
PICOTS (P
OPULATIONS
, I
NTERVENTIONS
, C
OMPARATORS
, O
UTCOMES
, T
IMING
,
AND
S
ETTING
)—Continued
Key Question 1
(diagnosis of OCD) Key Question 2
(treatment of OCD)
ÆDiagnosis of PANS/PANDAS. ÆDiagnosis of PANS/PANDAS.
ÆOCD in first degree relatives. ÆOCD in first degree relatives.
ÆLevel of family accommodation. ÆLevel of family accommodation.
ÆCo-occurring disorders (e.g., major depressive disorder,
anxiety disorders, attention-deficit hyperactivity disorder,
conduct disorders, autism spectrum disorder, and
Tourette syndrome, other tic disorders).
ÆCo-occurring disorders (e.g., major depressive disorder,
anxiety disorders, attention-deficit hyperactivity disorder,
conduct disorders, autism spectrum disorder, and
Tourette syndrome, other tic disorders).
ÆDiagnosis during COVID–19 pandemic (as defined by
study authors).
ÆDiagnosis during COVID–19 pandemic (as defined by
study authors).
ÆPrimary versus specialist care.
•Respondent type.
ÆDuration of symptoms prior to treatment.
ÆSymptom severity.
ÆIn-session exposure and response prevention.
Exclude: ÆMedication dose.
•Neuroimaging, e.g., functional MRI. ÆCare settings and care intensities.
DTraditional outpatient.
DIntensive outpatient.
•Day programs (e.g., partial hospitalization).
•Residential.
DInpatient.
DOther care settings, including school-based settings.
DTelehealth (vs. in-person).
DPrimary versus specialist care.
Design ........................................ Cohort or cross-sectional studies:
•comparing an index test(s) to a reference standard.
•comparing an index test(s) in two or more subgroups of inter-
est.
•comparing two or more diagnostic strategies.
Comparative trials:
•Randomized controlled trials.
•Nonrandomized comparative studies.
Æprospective or retrospective with appropriate adjustment
for confounding.
Randomized controlled trials.
Nonrandomized comparative studies:
•prospective or retrospective with appropriate adjustment for
confounding.
Single arm studies, N ≥ 50:
•with multivariable analyses of potential effect modifiers/sub-
groups of interest.
Systematic reviews (for reference lists only). Systematic reviews (for reference lists only).
Exclude:
•Prevalence studies.
•Qualitative studies.
•Case reports and case series.
•Unpublished studies, including conference abstracts (but in-
clude studies with reported results in the ClinicalTrials.gov
database).
Exclude:
•Cross-sectional studies (no longitudinal follow-up).
•Qualitative studies.
•Case reports and case series.
•Unpublished studies, including conference abstracts (but in-
clude studies with reported results in the ClinicalTrials.gov
database).
Timing ........................................ Any. Any.
Setting ........................................ Any, including administration of test(s) in-person or via tele-
health. Any.
*Prioritized outcome.
Dated: August 21, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–18415 Filed 8–25–23; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee
AGENCY
: Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION
: Notice of meeting.
SUMMARY
: In accordance with regulatory
provisions, the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
Clinical Laboratory Improvement
Advisory Committee (CLIAC). This is a
hybrid meeting, accessible both in
person and virtually. It is open to the
public, limited only by the in-person
space available. The public is also
welcome to view the meeting by joining
the audio conference (information
below). Time will be available for public
comment, and the public is also
welcome to submit written comments in
advance of the meeting (see the public
participation section below).
DATES
: The meeting will be held on
November 8, 2023, from 8:30 a.m. to
5:30 p.m., EST, and November 9, 2023,
from 8:30 a.m. to 12 p.m., EST.
ADDRESSES
: Centers for Disease Control
and Prevention, 2400 Century Parkway
NE, Room 1020/1023, Atlanta, Georgia
30345. The conference room will have
seating for approximately 60 people.
Meeting Information: All people
attending the CLIAC meeting in person
are required to register online for the
meeting at least five business days in
advance for U.S. citizens and at least 20
business days in advance for
international registrants. Register at:
https://www.cdc.gov/cliac/upcoming-
meeting.html. Register by scrolling
down and clicking the ‘‘Register for this
Meeting’’ button and completing all
forms according to the instructions
given. Please complete all the required
fields before submitting your
registration and submit no later than
November 1, 2023, for U.S. registrants
and October 11, 2023, for international
registrants. The confirmed meeting
times, agenda items, and meeting
materials, including instructions for
accessing the live meeting broadcast,
will be available on the CLIAC website
at https://www.cdc.gov/cliac/upcoming-
meeting.html.
FOR FURTHER INFORMATION CONTACT
:
Heather Stang, MS, Senior Advisor for
Clinical Laboratories, Division of
Laboratory Systems, Office of
Laboratory Science and Safety, Centers
for Disease Control and Prevention,
1600 Clifton Road NE, Mailstop V24–3,
Atlanta, Georgia 30329–4027.
Telephone: (404) 498–2769; Email:
HStang@cdc.gov.
SUPPLEMENTARY INFORMATION
:
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58585
Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Notices
Purpose: The Clinical Laboratory
Improvement Advisory Committee
(CLIAC) is charged with providing
scientific and technical advice and
guidance to the Secretary, Department
of Health and Human Services; the
Assistant Secretary for Health; the
Director, Centers for Disease Control
and Prevention (CDC); the
Commissioner, Food and Drug
Administration (FDA); and the
Administrator, Centers for Medicare &
Medicaid Services (CMS). The advice
and guidance pertain to general issues
related to improvement in clinical
laboratory quality and laboratory
medicine and specific questions related
to possible revision of the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) standards. Examples
include providing guidance on studies
designed to improve quality, safety,
effectiveness, efficiency, timeliness,
equity, and patient-centeredness of
laboratory services; revisions to the
standards under which clinical
laboratories are regulated; the impact of
proposed revisions to the standards on
medical and laboratory practice; and the
modification of the standards and
provision of non-regulatory guidelines
to accommodate technological
advances, such as new test methods, the
electronic transmission of laboratory
information, and mechanisms to
improve the integration of public health
and clinical laboratory practices.
Matters To Be Considered: The agenda
will include agency updates from CDC,
CMS, and FDA. Presentations and
CLIAC discussions will focus on the
final report from the CLIA Regulations
Assessment Workgroup, efforts to
address the CLIA top 10 laboratory
deficiencies, standardization of test
result communication, and the role of
the laboratory in antibiotic stewardship.
Agenda items are subject to change as
priorities dictate.
Public Participation
It is the policy of CLIAC to accept
written public comments and provide a
brief period for oral public comments
pertinent to agenda items.
Oral Public Comment: Public
comment periods for each agenda item
are scheduled immediately prior to the
Committee discussion period for that
item. In general, each individual or
group requesting to present an oral
comment will be limited to a total time
of five minutes (unless otherwise
indicated). Speakers should email
CLIAC@cdc.gov or notify the contact
person above (see
FOR FURTHER
INFORMATION CONTACT
) at least five
business days prior to the meeting date.
Written Public Comment: CLIAC
accepts written comments until the date
of the meeting (unless otherwise stated).
However, it is requested that comments
be submitted at least five business days
prior to the meeting date so that the
comments may be made available to the
Committee for their consideration and
public distribution. Written comments
should be submitted by email to
CLIAC@cdc.gov or to the contact person
above. All written comments will be
included in the meeting minutes posted
on the CLIAC website.
The Director, Office of Strategic
Business Initiatives, 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, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2023–18448 Filed 8–25–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Solicitation of Nominations for
Appointment to the Lead Exposure and
Prevention Advisory Committee
AGENCY
: Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION
: Notice.
SUMMARY
: The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), is soliciting
nominations for membership on the
Lead Exposure and Prevention Advisory
Committee (LEPAC). The LEPAC is
composed of 15 members that are
Federal and non-Federal experts in
fields associated with lead screening,
the prevention of lead exposure, and
services for individuals and
communities affected by lead exposure.
DATES
: Nominations for membership on
the LEPAC must be received no later
than September 30, 2023. Packages
received after this time will not be
considered for the current membership
cycle.
ADDRESSES
: All nominations should be
emailed to LEPAC@cdc.gov.
FOR FURTHER INFORMATION CONTACT
: Paul
Allwood, Ph.D., M.P.H., Designated
Federal Officer, National Center for
Environmental Health, Centers for
Disease Control and Prevention, 4770
Buford Highway, Atlanta, Georgia
30341. Telephone: 770–488–6774;
Email: PAllwood@cdc.gov.
SUPPLEMENTARY INFORMATION
:
Nominations are being sought for
individuals with expertise in the fields
of epidemiology, toxicology, mental
health, pediatrics, early childhood
education, special education, diet and
nutrition, and environmental health.
Members may be invited to serve for
three-year terms. Selection of members
is based on candidates’ qualifications to
contribute to the accomplishment of
Lead Exposure and Prevention Advisory
Committee (LEPAC) objectives.
The members of this Committee are
selected by the Secretary of the
Department of Health and Human
Services (HHS). The committee’s
objective is to advise the Secretary, HHS
and the Director, Centers for Disease
Control and Prevention (CDC)/
Administrator, Agency for Toxic
Substances and Disease Registry on a
range of activities to include: (1) review
of Federal programs and services
available to individuals and
communities exposed to lead; (2) review
of the current research on lead exposure
to identify additional research needs; (3)
review of and identification of best
practices, or the need for best practices
regarding lead screening and the
prevention of lead exposure; (4)
identification of effective services,
including services relating to healthcare,
education, and nutrition for individuals
and communities affected by lead
exposure and lead poisoning, including
in consultation with, as appropriate, the
lead exposure registry as established in
Public Law 114–322 section 2203(b) (42
U.S.C. 300j–27); and (5) undertaking of
any other review or activities that the
Secretary determines to be appropriate.
Annually as determined necessary by
the Secretary or as required by Congress,
the committee shall submit a report to
include: (1) an evaluation of the
effectiveness of the Federal programs
and services available to individuals
and communities exposed to lead; (2) an
evaluation of additional lead exposure
research needs; (3) an assessment of any
effective screening methods or best
practices used or developed to prevent
or screen for lead exposure; (4) input
and recommendations for improved
access to effective services relating to
health care, education, or nutrition for
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