97618 Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 

1. Principal Deputy, Chief Operating 

Officer; 

2. Deputy Director, Field Operations; 

3. Deputy Director for Labor Policy 

and Communications; 

4. Director, Procurement and 

Operational Support; 

5. General Counsel; 

6. Associate Deputy Director for Field 

Operations, National; 

7. Associate Deputy Director for Field 

Operations, Regional; 

8. Director, Human Resources; and 

9. Director, Budget. 

No individual who is serving in an 

office listed in this order in an acting 

capacity, by virtue of so serving, shall be 

delegated the functions and duties of 

the Director. 

Dated: December 4, 2024. 

Gregory Goldstein, 

Chief Operating Officer Performing the Duties 

of the Director. 

[FR Doc. 2024–28847 Filed 12–6–24; 8:45 am] 

BILLING CODE 6732–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Medical Care for Adults 

With Down Syndrome 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for supplemental 

evidence and data submission. 

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 

Medical Care for Adults with Down 

Syndrome, which is currently being 

conducted by the AHRQ’s Evidencebased 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Access to published and unpublished 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 January 8, 2025. 

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 Medical Care for Adults 

with Down Syndrome. 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 Medical Care for Adults 

with Down Syndrome. The entire 

research protocol is available online at: 

https://effectivehealthcare.ahrq.gov/ 

products/care-adults-down-syndrome/ 

protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Medical Care for Adults 

with Down Syndrome 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 

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 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

https://effectivehealthcare.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) 

1. What are the benefits, harms, and 

considerations of screening and 

diagnostic interventions, for cooccurring medical and behavioral health 

conditions in adults with Down 

syndrome? 

2. What are the benefits and harms, 

and considerations of interventions to 

treat co-occurring medical and 

behavioral health conditions 

specifically in adults with Down 

syndrome? 

Contextual Questions (CQ) 

1. What conditions occur at an 

increased or decreased prevalence in 

adults with Down syndrome compared 

to the general adult population. How 

does prevalence vary by age/decade of 

age, gender, setting (rural), and race/ 

ethnicity? 

2. How do clinical symptoms and the 

presentation of common co-occurring 

behavioral/mental health conditions 

(e.g., anxiety and depression) differ 

among adults with Down syndrome 

compared to their presentation in the 

general adult population? 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 97619 

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

PICOTS KQ1 KQ2 

Population ............................ Adults 18+ years of age with Down syndrome. 

Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic 

status. 

Adults 18+ years of age with Down syndrome 

Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic 

status. 

Intervention .......................... Screening/diagnostic tests for co-occurring medical 

conditions in adults with Down syndrome. 

Treatment interventions for co-occurring medical conditions in adults with Down syndrome. 

Comparator .......................... Alternative test for screening/diagnosis or no screening. For all conditions, compared with usual care or alternative intervention for treatment. 

Outcome ............................... Benefits: accurate diagnosis, time to diagnosis or intervention/treatment. 

Health and quality of life outcomes. 

Harms: adverse events related to screening/diagnosis 

(mortality, medical trauma, unnecessary testing, etc.). 

Intermediate outcomes: 

Treatment adherence. 

Lab values. 

Healthcare utilization. 

Final outcomes: 

Change in standardized symptom measures. 

Morbidity/mortality. 

Quality of life. 

Functional outcomes (e.g., activities of daily living, assisted living/nursing home status). 

Caregiver or family outcomes (including caregiver 

health and quality of life). 

Harm outcomes: 

Adverse treatment effects. 

Timing .................................. All duration and follow up. All duration and follow up. 

Setting .................................. US and non-US settings. 

All healthcare settings (e.g., primary care, specialty 

care, specialized clinics, etc.) 

US and non-US settings. 

All healthcare settings (e.g., primary care, specialty 

care, specialized clinics, etc.). 

Abbreviations: KQ = key question. 

Dated: December 3, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–28830 Filed 12–6–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–319, CMS–2088– 

17, CMS–224–14 and CMS–R–297/CMS– 

L564] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by January 8, 2025. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. To obtain copies of a 

supporting statement and any related 

forms for the proposed collection(s) 

summarized in this notice, please access 

the CMS PRA website by copying and 

pasting the following web address into 

your web browser: https://

www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Use: Title XIX and title XXI State 

agencies are required to submit the 

MEQC pilot planning document in 

accordance with § 431.814(b), and the 

MEQC case level and CAP reports based 

on pilot findings in accordance with 

§§ 431.816 and 431.820, respectively. 


ddrumheller on DSK120RN23PROD with NOTICES1