3218 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 

TABLE 2—EPC PROPOSED PICOTS AND CORRESPONDING INCLUSION AND EXCLUSION CRITERIA: KEY QUESTIONS 5 AND

6 ON SPECIFIC PROCEDURES IN PATIENTS WITH CHRONIC LOW BACK PAIN DUE TO DEGENERATIVE SPINE DISEASE— 

Continued 

Inclusion Exclusion 

Study designs ............................................................... KQ 5 

• RCTS for effectiveness/efficacy outcomes 

• Prospective NRSIs that control for confounding 

will be considered for effectiveness in the absence of RCTs 

• NRSIs for harms must be specifically designed 

to evaluate/report on serious AE/harms and 

that control for confounding OR focused on 

rare or long-term harms 

KQ 6 

• Predictive/prognostic modeling studies evaluating the association of procedure response 

impact on outcomes that control for confounding 

KQ 5, 6 

• NRSI that do not control for confounding 

• NRSI that include historical controls 

• NRSI with fewer than 50 patients per treatment arm 

• Case reports, case-series, single-arm and prepost studies 

• Publication types: Conference abstracts or 

proceedings, editorials, letters, white papers, 

citations that have not been peer-reviewed, 

single site reports of multi-site studies 

• Studies not in English 

Serious adverse events are defined as events that are life-threatening or anything needing additional medical attention. AE = adverse event; DLS = degenerative 

lumbar spondylolisthesis; EQ–5D = EuroQol 5D scale; ESI = epidural steroid injection; FDA = Food and Drug Administration; IONM = intraoperative neuro monitoring; 

KQ = Key Question; LBP = low back pain; MCID = minimum clinically important difference; NRSI = nonrandomized studies of intervention; ODI = Oswestry Disability 

Index; RCT = randomized controlled trial; RF = radiofrequency ablation; RMD = Rolland-Morris Disability Questionnaire; SSED = Summary of Safety and Effectiveness Data; SF–36/12 = Short Form 36 or 12 questionnaire; VAS = visual analog scale. 

Dated: January 7, 2025. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2025–00548 Filed 1–13–25; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Primary Hypofractionated 

Radiation Therapy for Localized 

Prostate Cancer: A Systematic Review 

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 

Primary Hypofractionated Radiation 

Therapy for Localized Prostate Cancer: 

A Systematic Review, 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 February 13, 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 Primary Hypofractionated 

Radiation Therapy for Localized 

Prostate Cancer: A Systematic Review. 

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 Primary Hypofractionated 

Radiation Therapy for Localized 

Prostate Cancer: A Systematic Review. 

The entire research protocol is available 

online at: https://effectivehealthcare.

ahrq.gov/products/hypofractionatedradiation-therapy/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Primary 

Hypofractionated Radiation Therapy for 

Localized Prostate Cancer: A Systematic 

Review 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 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 3219 

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) 

KQ 1: For patients with localized 

prostate cancer receiving external beam 

radiation therapy (EBRT) with curative 

intent, what are the benefits and harms 

of moderate hypofractionation 

compared to conventional fractionation? 

KQ 1a: Do findings vary with respect 

to patient characteristics (e.g., age, race 

and ethnicity), pretreatment 

characteristics (e.g., risk group, prostate 

gland volume, lower urinary tract 

symptoms, prior prostate procedures), 

treatment targets (i.e., prostate with or 

without treatment of pelvic lymph 

nodes), and use of adjunctive therapies 

(e.g., with or without neoadjuvant or 

adjuvant androgen deprivation 

therapy)? 

KQ 2: For patients with localized 

prostate cancer receiving EBRT with 

curative intent, what are the benefits 

and harms of ultra-hypofractionation 

compared to moderate 

hypofractionation or conventional 

fractionation? 

KQ 2a: Do findings vary with respect 

to patient characteristics (e.g., age, race, 

and ethnicity), pretreatment 

characteristics (e.g., risk group, prostate 

gland volume, lower urinary tract 

symptoms, prior prostate procedures), 

treatment targets (i.e., prostate with or 

without treatment of pelvic lymph 

nodes), and use of adjunctive therapies 

(i.e., with or without neoadjuvant or 

adjuvant androgen deprivation 

therapy)? 

KQ 3: For patients with localized 

prostate cancer receiving moderate or 

ultra-hypofractionated EBRT with 

curative intent, what are the benefits 

and harms of different dosefractionation regimens? 

KQ 3a: Do findings vary with respect 

to pretreatment characteristics (i.e., 

tumor stage, disease risk, urinary tract 

symptoms, prior prostate procedures)? 

KQ 4: For patients with localized 

prostate cancer receiving moderate or 

ultra-hypofractionated EBRT with 

curative intent, what are the benefits 

and harms associated with different 

target volumes (i.e., prostate alone, 

prostate with seminal vesicles, prostate 

with seminal vesicles and pelvic lymph 

nodes; with or without focal 

intraprostatic boosts)? 

KQ 4a: Do findings vary with respect 

to pretreatment characteristics (i.e., 

imaging)? 

KQ 5: For patients with localized 

prostate cancer receiving moderate 

or ultra-hypofractionated EBRT 

with curative intent, what are the 

benefits and harms of different 

treatment planning and delivery 

techniques? 

Contextual Question 

Does the utilization of fractionation 

schedule (i.e., conventional 

fractionation, moderate 

hypofractionation, and ultrahypofractionation) differ by factors such 

as age, race, ethnicity, socioeconomic 

status, or geography? 

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

Inclusion criteria Exclusion criteria 

Preliminary PICOTS criteria 

Population ............. KQs 1–5. Adult aged ≥18 years with localized prostate cancer (stages T1 to T4N0M0) who 

have elected to receive EBRT as their primary treatment regardless of pretreatment characteristics.

KQs 1a, 2a: Consider patient characteristics (e.g., age, race and ethnicity), pretreatment 

characteristics (e.g., prostate cancer risk group, prostate gland volume, presence of lower 

urinary tract symptoms), use of adjunctive therapies (e.g., androgen deprivation therapy).

Individuals aged <18 years, 

those with non-localized 

stage of prostate cancer 

at enrollment. 

Interventions ......... All KQs. Radiation therapy administered as a primary treatment ..............................................

KQ 1. MHF (2.4 to 3.4 Gy per fraction). 

KQ 2. UHF (≥5.0 Gy per fraction). 

KQ 3. Various dose-fractionation regimens (MHF, UHF). 

KQ 4. Various target volumes (MHF, UHF) (e.g., prostate, seminal, vesicles, pelvic lymph 

nodes, focal intraprostatic boosts). 

KQ 5. Various treatment planning and delivery techniques. 

• Advanced imaging for target delineation (any pretreatment imaging, i.e., CT, MRI, MRlinac, PET, urethral contrast). 

• Dose-volume criteria for OARs (urethra). 

• Image-guidance techniques (i.e., cone-beam CT, intraprostatic fiducial markers, MRI, electromagnetic tracking). 

• Delivery techniques (i.e., IMRT, VMAT [term ARCS] protons [IMPT, passive scatter], 

SBPT, SBRT/SABR, 3D CRT). 

• Rectal-sparing technologies (e.g., rectal spacers). 

• Online adaptive radiotherapy (treatment planning software). 

• Patient preparation for treatment planning and daily treatment (e.g., daily enemas, full 

bladder, empty rectum). 

Other treatments and techniques. Salvage radiation 

therapy; adjuvant or 

neoadjuvant radiation 

therapy. 

Comparators ......... KQ 1. CF (1.8 to 2.0 Gy per fraction) .........................................................................................

KQ 2. CF, MHF. 

KQ 3. Dose-fractionation regimens compared to each other. 

KQ 4. Target volumes compared to each other [all grouped by type of hypofractionation 

(MHF and UHF). 

KQ 5. Treatment planning and delivery techniques compared to each other 

Other comparators. 

Outcomes ............. KQ 1—KQ 5. Overall and prostate cancer-specific survival, local recurrence, metastases, 

biochemical recurrence-free survival, acute and late gastrointestinal toxicity, acute and late 

genitourinary toxicity, patient reported outcomes (i.e., GI, GU, ED) and quality of life.

Other outcomes. 

Timing ................... Any followup duration .................................................................................................................. NA 


khammond on DSK9W7S144PROD with NOTICES
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 


khammond on DSK9W7S144PROD with NOTICES