3214 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 

11The maximum penalty amount for an 

institution is the lesser of this amount or 1 percent 

of total assets. 

12The maximum penalty amount for an 

institution is the lesser of this amount or 1 percent 

of total assets. 

13These amounts also apply to CMPs in statutes 

that cross-reference 12 U.S.C. 1818, such as 12 

U.S.C. 2601, 2804(b), 3108(b), 3349(b), 4009(a), 

4309(a), 4717(b); 15 U.S.C. 1607(a), 1681s(b), 

1691(b), 1691c(a), 1693o(a); and 42 U.S.C. 3601. 

14The maximum penalty amount for an 

institution is the lesser of this amount or 1 percent 

of total assets. 

15The $157-per-day maximum CMP under 12 

U.S.C. 1828(h) for failure or refusal to pay any 

assessment applies only when the assessment is 

less than $10,000. When the amount of the 

assessment is $10,000 or more, the maximum CMP 

under section 1828(h) is 1 percent of the amount 

of the assessment for each day that the failure or 

refusal continues. 

16The maximum penalty amount for an 

institution is the lesser of this amount or 1 percent 

of total assets. 

17The maximum penalty amount for an 

institution is the greater of this amount or 1/ 

100,000th of the institution’s total assets. 

18The maximum penalty amount for an 

institution is the greater of this amount or 1/ 

50,000th of the institution’s total assets. 

19The maximum penalty amount for an 

institution is the lesser of this amount or 1 percent 

of total assets. 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

standards enumerated in the BHC Act 

(12 U.S.C. 1842(c)). 

Comments received are subject to 

public disclosure. In general, comments 

received will be made available without 

change and will not be modified to 

remove personal or business 

information including confidential, 

contact, or other identifying 

information. Comments should not 

include any information such as 

confidential information that would not 

be appropriate for public disclosure. 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington DC 20551–0001, not later 

than February 13, 2025. 

A. Federal Reserve Bank of Chicago 

(Colette A. Fried, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414. 

Comments can also be sent 

electronically to 

Comments.applications@chi.frb.org: 

1. UIR Acceptance Corporation, 

Lemont, Illinois; to become a bank 

holding company by acquiring Easton 

Bancshares, Inc., and thereby indirectly 

acquiring Community Bank of Easton, 

both of Easton, Illinois. 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Associate Secretary of the Board. 

[FR Doc. 2025–00599 Filed 1–13–25; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on The Performance of Fusion 

Procedures for Degenerative Disease 

of the Lumbar Spine 

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 

The Performance of Fusion Procedures 

for Degenerative Disease of the Lumbar 

Spine, 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 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 The Performance of Fusion 

Procedures for Degenerative Disease of 

the Lumbar Spine. 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 The Performance of 

Fusion Procedures for Degenerative 

Disease of the Lumbar Spine. The entire 

research protocol is available online at: 

https://effectivehealthcare.ahrq.gov/ 

products/lumbar-spinal-fusion/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on The Performance of 

Fusion Procedures for Degenerative 

Disease of the Lumbar Spine 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 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 3215 

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) 

Questions on Surgery (KQ 1–4) 

In adults with symptomatic, stable 

degenerative lumbar spondylolisthesis 

(DLS) with or without radiculopathy or 

neurogenic claudication 

• Key Question 1. What are the 

benefits and harms of surgery with 

instrumentation in addition to 

decompression compared with 

decompression alone? 

In symptomatic adults with unstable 

or stable DLS with or without 

radiculopathy or neurogenic 

claudication undergoing instrumented 

fusion: 

• Key Question 2. What are the 

benefits and harms of the addition of an 

interbody cage to instrumentation (e.g., 

pedicle screws) compared to use of 

instrumentation alone (i.e., 

posterolateral fusion)? 

• Key Question 3. What are the 

benefits and harms of the use of bone 

graft extenders and biologic substitutes 

compared to the use of autografts? 

In adults with symptomatic, 

degenerative lumbar spine disease 

undergoing instrumented fusion: 

• Key Question 4. Does the use of 

intraoperative monitoring (IONM) 

decrease perioperative neurological 

injuries compared with not using 

IONM? 

PICOTS (Populations, Interventions, 

Comparators, Outcomes, Timing, and 

Setting) 

TABLE 1—EPC PROPOSED PICOTS AND CORRESPONDING INCLUSION AND EXCLUSION CRITERIA KEY QUESTIONS 1,2,3 

AND 4 ON SURGERY

Inclusion Exclusion 

Population ..................................................................... Key Questions (1–3) 

• Symptomatic adult patients with a radiographic 

diagnosis (based on dynamic (flexion and extension radiographs) of degenerative lumbar 

spondylolisthesis (any grade) who remain 

symptomatic following conservative treatment 

• Patients with or without evidence of nerve 

compression (radiculopathy, neurogenic 

claudication) 

KQ 1 

• Stable (non-mobile, static) DLS (<3 mm slip 

on extension/flexion radiographs) 

KQ 2, 3 

• Patients with unstable or stable DLS on 

radiographs 

KQ 4 

• Patients with symptomatic degenerative lumbar spine disease undergoing fusion of 5 or 

fewer levels (stratify by presence of DLS) 

ALL Key Questions 

• Patients <18 years old. 

• Asymptomatic patients. 

• Other forms of spondylolisthesis are excluded (i.e., 

excluding dysplastic, isthmic, traumatic, and 

pathologic causes/forms). 

• Patients with osteoporosis, vertebral compression fractures. 

• Exclude pts undergoing revisions or repeat 

procedures. 

• Patients having reoperation/repeat procedures. 

KQs 1–3 

• Patients without degenerative 

spondylolisthesis. 

• Studies with <80% of patients have 

spondylolisthesis. 

KQ 1 

• Patients with unstable (dynamic) DLS: (exclude study if stable is not specified, is unclear). 

Interventions ................................................................. ALL Key Questions 

• FDA approved devices or materials (or in 

Phase III trials) as applicable to the KQ 

• Open and minimally invasive (e.g., 

endoscopic) procedures 

KQ 1 

• Decompression (discectomy, indirect and direct methods) with instrumented spinal fusion 

(e.g., with pedicle screws, interbody cages, or 

other hardware) 

KQ 2 

• Surgical decompression and instrumented 

posterolateral fusion (e.g., using pedicle 

screws) with addition of interbody cage (expandable or static, ALIF, TLIF, LLIF) 

KQ 3 

• Decompression and spinal fusion using bone 

graft extenders or biologic substitutes 

(demineralized bone matrix, cadaveric 

allograft, cortical fibers, bone morphogenic 

protein, cellular allografts 

KQ 4 

• IONM (Motor Evoked Potentials (MEP), 

Somatosensory Evoked Potentials (SSEP), 

Free Running EMG (electromyography) Direct 

Stimulation 

ALL Key Questions 

• Devices or materials that are not FDA approved or in Phase III trials (as applicable to 

the question) or not available in the U.S. 

• Mesenchymal stem cells (MSCs) 

• Procedures that don’t include decompression 

• Non-instrumented fusions 

• Coflex, interspinous fixation 

• Minimally invasive lumbar decompression 

(MILD) procedure 

• Surgical procedures not listed 

KQ 4 

• Other monitoring formats (e.g., imaging, computer assisted navigation systems, etc.) 

• Combinations of graft materials (other than 

with autograft) 

• Comparison of graft materials with each other 


khammond on DSK9W7S144PROD with NOTICES
3216 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 

TABLE 1—EPC PROPOSED PICOTS AND CORRESPONDING INCLUSION AND EXCLUSION CRITERIA KEY QUESTIONS 1,2,3 

AND 4 ON SURGERY—Continued 

Inclusion Exclusion 

Comparators ................................................................. ALL Key Questions 

• FDA approved devices or materials (or in 

Phase III trials) as applicable to the KQ 

• Open and minimally invasive (e.g., 

endoscopic) procedures 

KQ 1 

• Decompression alone 

KQ 2 

• Decompression and instrumented 

posterolateral spinal fusion (e.g., using pedicle 

screws alone) 

KQ 3 

• Decompression and instrumented spinal fusion 

using autograft 

KQ 4 

• No use of IONM 

ALL Key Questions 

• Conservative care, non-operative care, usual 

care 

• Devices or materials that are not FDA approved or in Phase III trials (as applicable to 

the question) or not available in the U.S. 

• Mesenchymal stem cells (MSCs) 

KQ 1 

• Other surgical procedures 

KQ 2, 3 

• Non-instrumented fusion, 

• Instrumentation prior to 2000 

• Coflex, interspinous fixation 

KQ 3 

• Combinations of graft materials with autograft 

Outcomes ..................................................................... ALL Key Questions 

• Validated measures for pain and symptoms 

Æ Pain (e.g., VAS) 

Æ Function (e.g., ODI) 

Æ Quality of Life (e.g., SF–36, SF–12) 

• Peri- and post-operative harms (including serious AEs/harms, persistent pain, sacro-iliac 

joint pain, instrument failure) 

Additional outcomes by KQ 

KQ 1: Reoperation rates 

KQ 2: Fusion (arthrodesis) rates 

KQ 3: Fusion (arthrodesis) rates 

KQ 4: Persistent neurological damage based on clinical exam (e.g., foot drop) 

ALL Key Questions 

• Measures of pain, function that are not validated 

• Measures/outcomes not listed 

• Radiographic parameters (e.g., evidence of 

global spinal alignment) 

Timing ........................................................................... Key Questions 1–3 

• Pain, function, reoperation: 3, 6 and ≥12 

months (up to 60 months) 

• Reoperation-any time (KQ 2): 

• Harms: any time 

KQ 4 

• Any time during post-operative followup 

KQ 1 

• Re-operation beyond 12 months 

KQs 1–3 

• Outcomes measured less than 3 months (except harms) 

KQ 4 

• Alerts and responses to alerts during surgery 

Settings ......................................................................... ALL Key Questions 

• Inpatient care followed by care in specialty 

and primary care clinics 

• Outpatient ambulatory surgery centers 

Study designs ............................................................... ALL Key Questions 

• RCTs for effectiveness/efficacy outcomes 

• FDA SSED if there is inadequate information 

from published studies 

• Studies published in 2000 or later 

KQ 1–3: NRSIs will be considered for harms only 

and must be specifically designed to evaluate/report on AE/harms and control for confounding and 

focused on rare or long-term harms. 

KQ 4: NRSIs on effectiveness and harms 

ALL Key Questions 

• NRSI that do not control for confounding 

• NRSI that include historical controls 

• NRSI of treatment 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 published prior to 2000 

• Studies not in English 

KQ 1–3 

• Trials with fewer than 15 patients per treatment arm 

Serious adverse events are defined as events that are life-threatening or require additional medical attention. AE = adverse event; ALIF = anterior lumbar interbody 

fusion; DLS = degenerative lumbar spondylolisthesis; EQ–5D = EuroQol 5D scale; FDA = Food and Drug Administration; IONM = intraoperative neurological monitoring; KQ = Key Question; LLIF = lateral lumbar interbody fusion; MCID = minimum clinically important difference; NRSI = nonrandomized studies of intervention; 

ODI = Oswestry Disability Index; RCT = randomized controlled trial; RMD = Roland-Morris Disability Questionnaire; SSED = Summary of Safety and Effectiveness 

Data; SF–36/12 = Short Form 36 or 12 questionnaire; TLIF = transforaminal lumbar interbody fusion; U.S. = United States; VAS = visual analog scale. 

KQ 5 and 6: Questions on Non-Surgical 

Procedures for Chronic Low Back Pain 

Due To Degenerative Spine Disease 

Key Question 5. In adult patients with 

chronic low-back pain (≥3 months) 

resulting from degenerative disease 

what are the benefits and harms of 

lumbar epidural steroid injections, 

intra-articular (facet) injection, medial 

branch blocks, or radio frequency 

ablation? 

Key Question 6. In adult patients with 

chronic low-back pain (≥3 months) 

resulting from degenerative disease of 

the lumbar spine, does symptomatic 

improvement to therapeutic challenge 

with lumbar epidural steroid injections, 

intra-articular (facet) injection, medial 

branch blocks or radio frequency 

ablation predict positive outcomes after 

lumbar fusion surgery? 

Special populations and factors for 

Key Questions 5 and 6: Age, sex, BMI, 

presence of psychological 

comorbidities, presence of medical 

comorbidities, baseline pain severity, 

presence and type of concomitant 

degenerative lumbar spine disease, 

presence and severity of DLS. 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 3217 

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

Inclusion Exclusion 

Population ..................................................................... KQ 5, 6 

• Adult patients with chronic low-back pain (≥3 

months duration) resulting from degenerative 

disease 

KQ 5, 6 

• Patients with acute or subacute LBP 

• Patients with disc herniation 

• Patients with failed back surgery syndrome 

• Sacroiliac pain 

• Patients having reoperation 

Interventions ................................................................. KQ 5, 6 

• Epidural steroid injections (ESI) 

• Intra-articular (facet) injections 

• Radiofrequency Ablation (RFA) 

• Medial branch blocks 

KQ 5, 6 

• Discoblock, provocative discography 

• Neuromodulation (e.g., spinal cord, dorsal column, dorsal root stimulation, peripheral nerve 

stimulation) 

• Injections: exclude other biologics (e.g., PRP), 

intradiscal injections 

• Minimally invasive lumbar decompression 

(MILD), percutaneous decompression 

• Selective nerve root blocks 

• Intraosseous basivertebral nerve ablation 

• Combinations of procedures; Studies evaluating additive benefits of one procedure with 

another 

Comparators ................................................................. KQ 5 

• Other nonoperative treatment, no treatment, 

sham 

KQ 6 

• No therapeutic challenge; (prognostic/predictive modeling study) 

KQ 5, 6 

• Combinations of procedures; Studies evaluating additive benefits of one procedure to another 

KQ 5 

• For ESI, exclude comparison with disc procedures (e.g., discography); comparisons of 

medications 

• For RFA exclude comparisons of different 

types of neurotomy (conventional vs. pulsed 

[cooled] RF; RF vs. alcohol ablation) 

Outcomes ..................................................................... KQ 5 and 6: Harms (e.g., serious peri-procedural and 

post-procedural harms) 

KQ 5 

• Validated measures for pain and symptoms 

Æ Pain (e.g., VAS, NRS) 

Æ Function (e.g., ODI) 

Æ Quality of Life (e.g., SF–36, SF12) 

KQ 6 

• Response to challenge: Improvement in symptoms vs. non-improvement; [stratify other outcomes by response] 

• Validated measures for pain and symptoms 

following fusion surgery 

Æ Pain (e.g., VAS, NRS) 

Æ Function (e.g., ODI) 

Æ Quality of Life (e.g., SF–36, SF–12) 

Æ Symptoms associated with neural compression 

• Successful arthrodesis [as radiographically determined via x-ray/computed tomography or by 

proxy (e.g., lack of revision, pedicle screw 

loosening)] 

KQ 5, 6 

• Measures of pain, function that are not validated 

• Measures/outcomes not listed 

Timing ........................................................................... KQ 5 and 6 

• Serious harms—periprocedural 

KQ 5 

• 3-month and 6-month periods following the 

procedure 

KQ 6 

• Outcomes measured at 3, 6 and ≥12 months 

after surgical procedure (up to 24 months) 

Settings ......................................................................... KQ 5 

• Outpatient 

KQ 6 

• Outpatient care for therapeutic challenge. Inpatient care followed by care in specialty and 

primary care clinics for surgical procedure 

• Outpatient ambulatory surgery centers for surgery 


khammond on DSK9W7S144PROD with NOTICES
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