3220 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 

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

Inclusion criteria Exclusion criteria 

Setting ................... KQ 1—KQ 5. All clinical settings ................................................................................................. NA 

Study Design ........ KQs 1, 2. Randomized controlled trials ......................................................................................

KQs 3–5. Randomized controlled trials. Comparative cohort studies with concurrent control 

groups, conducted within the same clinical setting. Other observational studies with concurrent control groups, that control for confounders. 

Studies conducted in countries rated as very high on the Human Development Index.a

KQs 1, 2: Other designs. 

KQs 3–5: Uncontrolled cohort studies, case-control 

studies, case reports, 

case series, cost-effectiveness and other modeling studies. 

Studies using nonconcurrent comparators (e.g., 

historical controls). 

Studies comparing methods 

across different settings/ 

clinics. 

Observational studies that 

do not control for confounders. 

Abbreviations: CF = conventionally fractionated external beam radiation therapy; CT = computed tomography; CRT = conventional radiotherapy; EBRT = external beam radiation therapy; ED = erectile dysfunction; GI = gastrointestinal issues; GU = genitourinary issues; Gy = gray; 

IMPT = intensity modulated proton therapy; KQ = key question; MHF = moderately hypofractionated radiation therapy; MRI = magnetic resonance imaging; MR-linac = MRI-guided linear accelerator; NA = not applicable; OARs = organs at risk; PET = positron emission tomography; PICOTS = population, interventions, comparators, outcomes, timing, and setting; SABR = stereotactic ablative radiotherapy; SBPT = stereotactic 

body proton therapy; SBRT = stereotactic body radiation therapy; UHF = ultra-hypofractionated radiation therapy; VMAT = volumetric modulated 

arc therapy. a United Nations Development Programme. Human Development Index. Retrieved from https://hdr.undp.org/data-center/human-developmentindex#/indicies/HDI. 

Dated: January 7, 2025. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2025–00547 Filed 1–13–25; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10777, CMS– 

R–235 and CMS–10662] 

Agency Information Collection 

Activities: Proposed Collection; 

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 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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 must be received by 

March 17, 2025. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

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-and-Guidance/Legislation/

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10777 Conditions of Participation 

for Intermediate Care Facilities for 

Individuals with Intellectual 

Disabilities (ICFs-IID) 

CMS–R–235 Data Use Agreement 

(DUA) Limited Data Set (LDS) Forms 

Research Identifiable Files (FIF) 

Forms 

CMS–10662 Administrative 

Simplification HIPAA Compliance 

Review 

Under the 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 


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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 3221 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires Federal agencies to publish a 

60-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. 

Information Collections 

1. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Conditions of 

Participation for Intermediate Care 

Facilities for Individuals with 

Intellectual Disabilities (ICFs-IID); Use: 

This is a reinstatement of the 

information collection request that 

expired on September 30, 2024. The 

previous iteration of this OMB Control 

Number 0938–1402 (approved 

September 22, 2021) had an annual 

burden of 114,478 hours and annual 

costs of $7,375,654. For this requested 

reinstatement, with changes, the total 

annual burden hours for industry is 

75,721 hours and the annual burden 

costs are $5,470,418. 

During the COVID–19 Public Health 

Emergency (PHE), individuals residing 

in congregate settings, such as ICFs-IID 

and Long-Term Care (LTC) facilities 

were at greater risk of acquiring COVID– 

19 infections and once infected, were at 

greater risk of severe illness or death. As 

a result, the Centers for Medicare and 

Medicaid Services (CMS) revised the 

Conditions of Participation (CoPs) for 

many of CMS’ certified providers 

including hospitals and institutional 

care settings in order to reduce the risk 

of exposure to and the severity from 

contracting the COVID–19 virus for 

medical and non-medical staff and 

patients. In addition to the CoPs, health 

care facilities were obligated to establish 

an infection control program that would 

protect the health and safety of 

residents, personnel, and the general 

public under Sections 1819(d)(3)(B) and 

1919(d)(3) of the Act. 

Individuals housed at ICFs-IID 

facilities are mentally and intellectually 

impaired, receive Medicaid assistance, 

and live in congregate settings. ICF–IID 

clients may also have other underlying 

medical conditions such as visual or 

hearing impairments, or seizure 

disorder. Based on their living situation 

and underlying health conditions, these 

clients were at higher risk of exposure 

and severe consequences from COVID– 

19 and continue to be at higher risk due 

to new variants of COVID–19 and other 

similar acute respiratory illnesses. 

In the interim final rule, entitled 

‘‘Medicare and Medicaid Programs; 

COVID–19 Vaccine Requirements for 

Long-Term Care (LTC) Facilities and 

Intermediate Care Facilities for 

Individuals with Intellectual Disabilities 

(ICFs-IID) Residents, Clients, and Staff,’’ 

86 FR 26306 (CMS–3414–IFC), that was 

published on May 13, 2021 (hereinafter 

‘‘May 2021 Interim Final Rule’’), CMS 

added new CoPs which required ICF/ 

IIDs facilities to: (1) develop policies 

and procedures to educate clients, their 

representatives, and staff on the benefits 

and risks, and potential side effects of 

the COVID–19 vaccine; (2) educate and 

offer the COVID–19 vaccine per the 

policy and procedures developed; (3) 

document that staff and clients were 

educated and offered the vaccine; and 

(4) document whether or not a client or 

staff member received the vaccine and 

if not, if it was due to medical 

contraindications or refusal. The May 

2021 Interim Final rule included an 

estimate for the burden hours and costs 

to industry associated with these 

specific information collection requests 

and which was subsequently submitted 

to OMB as the initial PRA package for 

this information collection request in 

2021. 

In November 2021, CMS issued 

‘‘Medicare and Medicaid Programs; 

Omnibus COVID–19 Health Care Staff 

Vaccination,’’ 86 FR 61555 (CMS–3415– 

IFC)(hereinafter ‘‘November 2021 

Interim Final Rule’’), which mandated 

health care staff in all CMS certified 

facilities, including ICFs-IID, to be 

vaccinated. Most significantly, health 

care staff were no longer permitted to 

refuse being vaccinated and had to 

request an exemption if they did not 

want to receive the COVID–19 vaccine. 

As a result, ICFs-IID had to document 

that their staff were educated and 

offered the vaccine, and also document 

whether their staff received a 

vaccination or were approved for an 

exemption. Clients of ICFs-IID, however, 

were still allowed to refuse taking the 

vaccine which would be documented in 

their medical record. 

On June 5, 2023, CMS issued a final 

rule, ‘‘Medicare and Medicaid Programs; 

Policy and Regulatory Changes to the 

Omnibus COVID–19 Health Care Staff 

Vaccination Requirements; Additional 

Policy and Regulatory Changes to the 

Requirements for Long-Term Care (LTC) 

Facilities and Intermediate Care 

Facilities for Individuals With 

Intellectual Disabilities (ICFs–IID) To 

Provide COVID–19 Vaccine Education 

and Offer Vaccinations to Residents, 

Clients, and Staff; Policy and Regulatory 

Changes to the Long Term Care Facility 

COVID–19 Testing,’’ 88 FR 36485 

(CMS–3415–F, 3414–F, and 3401– 

F)(hereinafter ‘‘June 2023 Final Rule’’), 

which eliminated the vaccine mandate 

on health care staff and finalized the 

CoPs related to the ‘‘educate and offer’’ 

activity for COVID–19 vaccines in LTCs 

and ICF–IID. Currently, ICFs-IID must 

continue to educate on the risks and 

benefits of the COVID vaccine and offer 

the vaccine to clients and staff and must 

continue to document this activity for 

clients in their medical records. 

However, when the June 2023 Final 

Rule removed the staff vaccine mandate 

by eliminating the CoPs at 483.430(f) in 

its entirety, documentation of the 

educate and offer activity for staff was 

also eliminated. Thus, ICFs-IID must 

continue to ‘‘educate and offer’’ the 

COVID–19 vaccine to both staff and 

clients, but the current CoPs require 

facilities to document this task only for 

their clients. Although the COVID–19 

PHE ended in May 2023, the COVID–19 

related CoPs for ICF–IID as updated in 

the June 2023 Final Rule remain in 

effect post-PHE in order to protect 

clients and staff from the same risks as 

before that may be due to new COVID– 

19 variants. 

This reinstatement estimates the new 

burden hours for ICFs-IID based on the 

revised CoPs. The burden of the 

information collections for LTC 

facilities is included in OMB Control 

Number 0938–1363. Form Number: 

CMS–10777 (OMB control number 

0938–1402); Frequency: Annually; 

Affected Public: Private Sector— 

Business or other for-profits and not-forprofits institutions; Number of 

Respondents: 5,523; Total Annual 

Responses: 5,523; Total Annual Hours: 

75,721. (For policy questions regarding 

this collection contact Claudia Molinar 

at 410–786–8445.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Data Use 

Agreement (DUA) Limited Data Set 

(LDS) Forms Research Identifiable Files 

(FIF) Forms; Use: The Privacy Act of 

1974, § 552a requires the Centers for 

Medicare & Medicaid Services (CMS) to 

track all disclosures of the agency’s 

Personally Identifiable Information (PII). 

CMS is also required by the Health 

Insurance Portability and 

Accountability Act (HIPAA) of 1996 and 

the Federal Information Security 

Management Act (FISMA) of 2002 to 

properly protect all Protected Health 

Information (PHI) data maintained by 

the agency and account for the 

disclosure of PHI. When entities, such 

as academic, Federal or State agency 


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3222 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 

researchers or CMS contractors request 

CMS PII/PHI data, they enter into a Data 

Use Agreement (DUA) with CMS. The 

DUA stipulates that the recipient of 

CMS data must properly protect the data 

according to all applicable data security 

standards and provide for its 

appropriate destruction at the 

completion of the project/study or the 

expiration date of the DUA. 

CMS is permitted to disclose data files 

for approved research purposes in 

compliance with 45 CFR 164.512(I). 

Researchers requesting limited data set 

files (LDS) must, as part of the request 

process, complete a research request 

packet that provides CMS with 

information pertaining to the research 

study, including describing how the 

research results/findings will be 

disseminated, as well as the data files 

being requested. Should CMS approve 

the research request, the data requestor 

enters into a Data Use Agreement 

(DUA). This data collection is necessary 

to ensure that disclosures of data for 

research purposes comply with Federal 

laws and regulations as well as CMS 

policy. Form Number: CMS–R–235 

(OMB control number 0938–0734); 

Frequency: Occasionally; Affected 

Public: Private Sector—State, Local, or 

Tribal Governments; and Business or 

other for-profits, Not-for-profits 

institutions and Federal Government 

Number of Respondents: 7,805; Total 

Annual Responses: 7,805; Total Annual 

Hours: 4,234. (For policy questions 

regarding this collection contact 

Rebecca Dorman at 410–786–2095 or 

rebecca.dorman@cms.hhs.gov.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Administrative 

Simplification HIPAA Compliance 

Review; Use: The purpose of this 

collection is to retrieve information 

necessary to conduct a compliance 

review and carry out the authority 

delegated to CMS as described in CMS– 

0014–N (68 FR 60694). These forms will 

be submitted to the Centers for Medicare 

& Medicaid Services (CMS), National 

Standards Group, from entities covered 

by HIPAA Administrative 

Simplification regulations. This 

collection is not applicable to HIPAA 

Privacy and Security Rules. Form 

Number: CMS–10662 (OMB control 

number 0938–1390); Frequency: 

Annually; Affected Public: Private 

Sector—State, Local, or Tribal 

Governments; and Business or other forprofits, Not-for-profits institutions and 

Federal Government; Number of 

Respondents: 100; Total Annual 

Responses: 140; Total Annual Hours: 

3,040. (For policy questions regarding 

this collection contact Kevin Stewart at 

410–786–6149 or Kevin.stewart@

cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2025–00593 Filed 1–13–25; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10203] 

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 February 13, 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-and-Guidance/Legislation/

PaperworkReductionActof1995/PRAListing. 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare Health 

Outcomes Survey; Use: The HOS is a 

longitudinal patient-reported outcome 

measure (PROM) that assesses selfreported beneficiary quality of life and 

daily functioning. As a PROM, the HOS 

measures the impact of services 

provided by MAOs, whereas process 

and patient experience measures only 

provide a snapshot of activities or 

experiences at a specific point in time. 

PROM data collected by the HOS allows 

CMS to continue to assess the health of 

the Medicare Advantage population. 

This older population is at increased 

risk of adverse health outcomes, 

including chronic diseases and mobility 

impairments that may significantly 

hamper quality of life. The HOS 

supports CMS’s commitment to improve 

health outcomes for beneficiaries while 

reducing burden on providers. CMS 

accomplishes this by focusing on highpriority areas for quality measurement 

and improvement established in the 

agency’s Meaningful Measures 

Framework. The HOS uses quality 


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