58584 Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Notices 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued 

Key Question 1 

(diagnosis of OCD) 

Key Question 2 

(treatment of OCD) 

Æ Diagnosis of PANS/PANDAS. Æ Diagnosis of PANS/PANDAS. 

Æ OCD in first degree relatives. Æ OCD in first degree relatives. 

Æ Level of family accommodation. Æ Level of family accommodation. 

Æ Co-occurring disorders (e.g., major depressive disorder, 

anxiety disorders, attention-deficit hyperactivity disorder, 

conduct disorders, autism spectrum disorder, and 

Tourette syndrome, other tic disorders). 

Æ Co-occurring disorders (e.g., major depressive disorder, 

anxiety disorders, attention-deficit hyperactivity disorder, 

conduct disorders, autism spectrum disorder, and 

Tourette syndrome, other tic disorders). 

Æ Diagnosis during COVID–19 pandemic (as defined by 

study authors). 

Æ Diagnosis during COVID–19 pandemic (as defined by 

study authors). 

Æ Primary versus specialist care. 

• Respondent type. 

Æ Duration of symptoms prior to treatment. 

Æ Symptom severity. 

Æ In-session exposure and response prevention. 

Exclude: Æ Medication dose. 

• Neuroimaging, e.g., functional MRI. Æ Care settings and care intensities. 

D Traditional outpatient. 

D Intensive outpatient. 

• Day programs (e.g., partial hospitalization). 

• Residential. 

D Inpatient. 

D Other care settings, including school-based settings. 

D Telehealth (vs. in-person). 

D Primary 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 interest. 

• comparing two or more diagnostic strategies. 

Comparative trials: 

• Randomized controlled trials. 

• Nonrandomized comparative studies. 

Æ prospective 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/subgroups 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• Unpublished studies, including conference abstracts (but include studies with reported results in the ClinicalTrials.gov 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 include studies with reported results in the ClinicalTrials.gov 

database). 

Timing ........................................ Any. Any. 

Setting ........................................ Any, including administration of test(s) in-person or via telehealth. 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/upcomingmeeting.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/upcomingmeeting.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: 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Notices 58585 

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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