Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Notices 58581 

GSA Bulletin FTR 23–07 can be 

viewed in its entirety at https://

www.gsa.gov/ftrbulletins. 

Krystal J. Brumfield, 

Associate Administrator, Office of 

Government-wide Policy. 

[FR Doc. 2023–18398 Filed 8–25–23; 8:45 am] 

BILLING CODE 6820–14–P 

OFFICE OF GOVERNMENT ETHICS 

Agency Information Collection 

Activities; Notice of Approval of 

Information Collection Requirements 

AGENCY: Office of Government Ethics 

(OGE). 

ACTION: Notice of approval of 

information collection requirements. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995 

(PRA), the U.S. Office of Government 

Ethics (OGE) is announcing Office of 

Management and Budget (OMB) 

approval of new information collection 

requirements contained in a final rule 

published in the Federal Register on 

May 25, 2023, ‘‘Legal Expense Fund 

Regulation.’’ 

FOR FURTHER INFORMATION CONTACT: 

McEvan Baum at the U.S. Office of 

Government Ethics; telephone: 202– 

482–9287; TTY: 800–877–8339; Email: 

usoge@oge.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501 et seq.), an agency 

may not conduct or sponsor a collection 

of information, and the public is not 

obligated to respond to a collection of 

information, unless the collection of 

information displays a currently valid 

OMB control number. 

On May 25, 2023, OGE published a 

final rule establishing a framework to 

govern an executive branch employee’s 

acceptance of payments for legal 

expenses through a Legal Expense Fund 

(LEF) for matters arising in connection 

with the employee’s official position, 

the employee’s prior position on a 

campaign of a candidate for President or 

Vice President, or the employee’s prior 

position on a Presidential Transition 

Team. The requirements for establishing 

and maintaining a LEF are found in 5 

CFR part 2635, subpart J (LEF 

regulation). 

The LEF regulation requires that 

employees who wish to establish a legal 

expense fund do so through a trust with 

a single, named employee beneficiary 

and a trustee. It also requires an 

employee beneficiary to file quarterly 

reports that include information (1) 

regarding members of the public who 

make financial donations to help pay for 

the employee beneficiary’s legal 

expenses (donors) and (2) members of 

the public who receive payments from 

a legal expense fund (payees). The 

employee beneficiary must also file a 

termination report upon the termination 

of the trust and/or executive branch 

employment. The trust documents, 

quarterly reports, and termination 

reports will be posted directly on OGE’s 

website in accordance with 5 CFR 

2635.1007(g). Together, this information 

collection (IC) is titled ‘‘OGE Legal 

Expense Fund Information Collection.’’ 

OGE submitted a request for approval 

of this information collection on May 

25, 2023, and OMB approved it on July 

21, 2023. It was assigned OMB Control 

Number 3209–0012. Therefore, in 

accordance with the PRA, OGE hereby 

announces OMB approval of the 

information collection requirements as 

contained in the final rule, which will 

be effective November 21, 2023. 

Approved: August 23, 2023. 

Shelley K. Finlayson, 

Acting Director, U.S. Office of Government 

Ethics. 

[FR Doc. 2023–18526 Filed 8–25–23; 8:45 am] 

BILLING CODE 6345–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Diagnosis and 

Management of Obsessive Compulsive 

Disorders in Children 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for supplemental 

evidence and data submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review on 

Diagnosis and Management of Obsessive 

Compulsive Disorders in Children, 

which is currently being conducted by 

the AHRQ’s Evidence-based Practice 

Centers (EPC) Program. Access to 

published and unpublished pertinent 

scientific information will improve the 

quality of this review. 

DATES: Submission Deadline on or 

before September 27, 2023. 

ADDRESSES: 

Email submissions: epc@

ahrq.hhs.gov. 

Print submissions: 

Mailing Address: Center for Evidence 

and Practice Improvement, Agency for 

Healthcare Research and Quality, 

ATTN: EPC SEADs Coordinator, 5600 

Fishers Lane, Mail Stop 06E53A, 

Rockville, MD 20857. 

Shipping Address (FedEx, UPS, etc.): 

Center for Evidence and Practice 

Improvement, Agency for Healthcare 

Research and Quality, ATTN: EPC 

SEADs Coordinator, 5600 Fishers Lane, 

Mail Stop 06E77D, Rockville, MD 

20857. 

FOR FURTHER INFORMATION CONTACT: 

Kelly Carper, Telephone: 301–427–1656 

or Email: epc@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the 

Evidence-based Practice Centers (EPC) 

Program to complete a review of the 

evidence for Diagnosis and Management 

of Obsessive Compulsive Disorders in 

Children. AHRQ is conducting this 

review pursuant to Section 902 of the 

Public Health Service Act, 42 U.S.C. 

299a. 

The EPC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Diagnosis and 

Management of Obsessive Compulsive 

Disorders in Children. The entire 

research protocol is available online at: 

https://effectivehealthcare.ahrq.gov/ 

products/obsessive-compulsivedisorder/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Diagnosis and 

Management of Obsessive Compulsive 

Disorders in Children helpful: 

D A list of completed studies that 

your organization has sponsored for this 

topic. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

D For completed studies that do not 

have results on ClinicalTrials.gov, a 

summary, including the following 

elements, if relevant: study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/ 

enrolled/lost to follow-up/withdrawn/ 

analyzed, effectiveness/efficacy, and 

safety results. 

D A list of ongoing studies that your 

organization has sponsored for this 

topic. In the list, please provide the 


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58582 Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Notices 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including, if relevant, a study 

number, the study period, design, 

methodology, indication and diagnosis, 

proper use instructions, inclusion and 

exclusion criteria, and primary and 

secondary outcomes. 

D Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

organization for this topic and an index 

outlining the relevant information in 

each submitted file. 

Your contribution is very beneficial to 

the Program. Materials submitted must 

be publicly available or able to be made 

public. Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on topics not included in 

the review cannot be used by the EPC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EPC Program website and 

available for public comment for a 

period of 45 days. 

If you would like to be notified when 

the draft is posted, please sign up for the 

email list at: https://www.effective

healthcare.ahrq.gov/email-updates. 

The review will answer the following 

questions. This information is provided 

as background. AHRQ is not requesting 

that the public provide answers to these 

questions. 

Key Questions (KQ) 

KQ 1: How accurate are assessment 

tools compared to reference standard 

methods to identify OCD in 

symptomatic children and adolescents? 

KQ 1a: How does diagnostic accuracy 

of assessment tools vary by patient, 

family, social, or other characteristics, 

or by respondent type? 

KQ 2: What are the comparative 

effects and harms of treatment 

interventions, used alone or in 

combination, for OCD in children and 

adolescents? 

KQ 2a: How do the effectiveness and 

harms vary with patient, family, social, 

or other characteristics? 

Study Eligibility Criteria 

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

Key Question 1 

(diagnosis of OCD) 

Key Question 2 

(treatment of OCD) 

Population .................................. Children and adolescents (<21 years): 

• in whom there is clinical consideration of OCD. 

• diagnosed with OCD and/or other conditions which may be either be comorbid with OCD or may present with similar symptoms. 

Children and adolescents (<21 years) with diagnosed OCD, including those with: 

• possible PANS/PANDAS (with OCD). 

• other comorbid conditions (e.g., autism). 

Include: Exclude: 

• Studies evaluating only children and adolescents with OCD 

(to estimate test sensitivity alone). 

• Children and adolescents diagnosed with other OCD-spectrum conditions (e.g., body dysmorphic disorder, body focused 

repetitive behaviors) without an OCD diagnosis. 

Exclude: 

• Studies that include both adults and children that do not explicitly report a pediatric or adolescent subgroup in the abstract. 

• Studies that perform population-based screening (among individuals without a clinical concern for OCD). 

• Subclinical OCD or obsessive or compulsive symptoms without an OCD diagnosis. 

• Studies that include both adults and children that do not explicitly report a subgroup by age in the abstract. 

Interventions .............................. Index Test(s): 

• Tools to diagnose OCD in symptomatic patients. For example, 

Psychological interventions for OCD, alone or in combination 

with pharmacological and/or other interventions, including: 

Æ Obsessive Compulsive Inventory-Child Version (OCI– 

CV–R). 

Æ Toronto Obsessive-Compulsive Scale (TOCS). 

Æ Short Obsessive-Compulsive Screener (SOCS). 

• Diagnostic prediction models. 

• Must report use of specific cut-point(s) to classify an individual as having OCD or a prediction algorithm or model to 

predict the probability of OCD. 

• Alternative administration (e.g., child versus parent versus 

teacher report, in-person versus telehealth). 

• Cognitive behavioral therapy (CBT). 

Æ Exposure and response prevention (ERP). 

Æ Psychoeducation. 

Æ Coping skills. 

Æ Cognitive therapy. 

• Acceptance and commitment therapy (ACT). 

• Targeted family interventions. 

• Other psychological interventions. 

• Delivery method. 

Æ Therapist led, e.g., scheduled, in-person, or via telephone, video conference. 

Æ Self-guided, e.g., asynchronous, therapist serves as supportive coach. 

Exclude: 

• Specific individual symptoms, behaviors, or characteristics. 

• Genetic studies. 

• Biomarker studies. 

Pharmacological interventions, alone or in combination with psychological interventions: 

• Selective serotonin reuptake inhibitors (SSRIs). 

• Tricyclic antidepressants (TCA), including clomipramine. 

• Serotonin and norepinephrine reuptake inhibitors (SNRIs). 

• Medication augmentation strategies: 

Æ SSRI augmentation with clomipramine, and other medications, including neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs). 

Æ Glutamate modulating agents (e.g., D-cycloserine, 

riluzole). 

• Other pharmacologic interventions, alone or in combination 

with psychological and/or other interventions, including dose 

escalation, longer treatment duration. 

Neuromodulation interventions: 

• Transcranial magnetic stimulation (TMS), 

• Transcranial direct current stimulation (tDCS), 

• Transcranial alternating current stimulation (tACS), 

• Deep brain stimulation (DBS). 

Complementary/integrative therapies: 

• Naturopathic interventions. 

• Mind-body practices (e.g., mindfulness, meditation, yoga). 

• Sensory integration (e.g., deep pressure). 


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

Key Question 1 

(diagnosis of OCD) 

Key Question 2 

(treatment of OCD) 

Exclude: 

• Specific treatments for PANS/PANDAS (e.g., antibiotics, 

immunomodulation, intravenous immunoglobulin). 

Comparators .............................. Reference standard(s): • No treatment (e.g., waitlist control). 

• Clinical interview. • Pill placebo or sham control. 

• Validated diagnostic assessment instruments (others may be 

included). 

• Another active intervention or co-intervention (e.g., relaxation 

therapy). 

Æ Anxiety Disorders Interview Schedule for DSM–5 child 

version. 

• Alternative delivery methods. 

Æ (ADIS–C). 

Æ Kiddie Schedule for Affective Disorders and Schizophrenia, Present and Lifetime version (K–SADS–PL) for 

DSM–5. 

Æ Mini-International Neuropsychiatric Interview for Children 

and Adolescents (MINI–KID). 

Æ Children’s Yale-Brown Obsessive-Compulsive Scale 

(CY–BOCS). 

Æ Children’s Yale-Brown Obsessive-Compulsive Scale Second Edition (CY–BOCS–II). 

• Different index tests (if also compared with reference standard). 

• Different reference standards (i.e., comparison of reference 

standards). 

• Different respondents (e.g., clinician, self, parent, educator). 

• Different methods to give test (e.g., in person vs. via telehealth). 

• Different populations (see effect modifiers below). 

Outcomes (prioritized outcomes 

have an asterisk and are in 

bold font).

OCD diagnosis: 

• Sensitivity/Specificity.* 

• Positive and negative likelihood ratios. 

• Accuracy. 

• Area under the Receiver Operator Characteristic Curve (AUC 

ROC). 

• Predicted probability of OCD (model calibration/discrimination). 

• Time to initiation of treatment (cohort studies). 

OCD symptom severity: 

• Children’s Yale-Brown Obsessive Compulsive Scale Total 

(CY–BOCS).* 

• Clinical Global Impression–Severity (CGI–S).* 

Treatment response and remission: 

• Clinical remission (posttreatment CY–BOCS total score ≤12 

as defined by Farhat et. al.23, or as reported).* 

• Clinical Global Impression–Improvement (CGI–I).* 

Exclude: 

• Studies not reporting predictive validity that report other psychometric properties of scales: for example, reliability or validity (content, construct, convergent, discriminant, divergent, 

face). 

Functional impairment in school, social, and home/family domains: 

• The Child Obsessive Compulsive Impact Scale—Revised 

(COIS–R).* 

Æ Raters: child (COIS–C), parent (COIS–P). 

Family accommodation: 

• Family Accommodation Scale (FAS).* 

Family functioning: 

• OCD Family Functioning Scale. 

• Family Environment Scale (FES). 

• Parental Attitudes and Behaviors Scale (PABS). 

Patient/parent reported experience measures (PREMs). 

Patient reported outcome measure (PROMs): 

• Top Problems assessment (TPA). 

Quality of Life (QoL) General and Health Related (HRQoL) (validated scales only): * 

• Quality of Life Enjoyment and Satisfaction QuestionnaireShort Form (QLESQ). 

Acceptability of treatment: * 

• Parental satisfaction with services. 

• Withdrawals/discontinuation. 

Sleep-related problems. 

Suicidal thoughts and behavior: 

• Columbia Suicide Severity Rating Scale Recent Self-Report 

Screener (C–SSRS). 

Anxiety and depression. 

Adverse events related to treatment.* 

Exclude: 

• Neuroimaging (e.g., functional MRI). 

Potential Effect Modifiers/Subgroups of interest.• Patient, family, social, and other characteristics, including: 

Æ Race/Ethnicity (racial and ethnic discrimination is the effect modifier of interest but many/most studies will not 

contain that so we will use race/ethnicity as a marker for 

likelihood of experience with discrimination and would explicitly discuss this in the review). 

• Patient, family, social, and other characteristics, including: 

Æ Race/Ethnicity (racial and ethnic discrimination is the effect modifier of interest but many/most studies will not 

contain that so we will use race/ethnicity as a marker for 

likelihood of experience with discrimination and would explicitly discuss this in the review). 

Æ Identity and Culture (e.g., spiritual and religious beliefs 

and practices, native language, gender identity, sexual 

orientation, physical/mental disability status) 

Æ Identity and Culture (e.g., spiritual and religious beliefs 

and practices, native language, gender identity, sexual 

orientation, physical/mental disability status). 

Æ Age. Æ Age. 

Æ Age at symptom onset. Æ Age at symptom onset. 

Æ Social determinants of health, including education level, 

socioeconomic status, immigration status, refugee status, 

and geography (e.g., urban vs. rural). 

Æ Social determinants of health, including education level, 

socioeconomic status, immigration status, refugee status, 

and geography (e.g., urban vs. rural). 


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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: 


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