Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 60681 

service providers to adopt a robocall 

mitigation program and file a 

description of that program in the 

Robocall Mitigation Database as well as 

requiring all classes of providers to file 

additional information in the Robocall 

Mitigation Database. On May 18, 2023, 

the Commission adopted an Order 

modifying some of these requirements. 

See Call Authentication Trist Anchor, et 

al., WC Docket No. 17–97 et al., Seventh 

Report and Order et al., FCC 23–37 

(adopted May 18, 2023). 

Federal Communications Commission. 

Marlene Dortch, 

Secretary, Office of the Secretary. 

[FR Doc. 2023–19073 Filed 9–1–23; 8:45 am] 

BILLING CODE 6712–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Treatment of Stage I–III 

Squamous Cell Anal Cancer 

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 

Treatment of Stage I–III Squamous Cell 

Anal Cancer, 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Access to published and unpublished 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 October 5, 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 Treatment of Stage I–III 

Squamous Cell Anal Cancer. 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 Treatment of Stage I–III 

Squamous Cell Anal Cancer. The entire 

research protocol is available online at: 

https://effectivehealthcare.ahrq.gov/ 

products/anal-cancer-treatment/ 

protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Treatment of Stage I–III 

Squamous Cell Anal Cancer 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://

www.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. What are the effectiveness and 

harms of different modalities of initial 

treatment for stages I–III squamous cell 

anal cancer? 

KQ 2. What are the effectiveness and 

harms of different modalities of 

radiation therapy for initial treatment of 

stages I–III squamous cell anal cancer? 

KQ 3. What are the effectiveness and 

harms of different radiation therapy 

doses, volumes, and fractionation 

schema for initial treatment of stage I– 

III squamous cell anal cancer? 

KQ 4. What are the effectiveness and 

harms of different combinations of 

chemotherapy and radiation therapy, 

and dose de-escalation or dose 

escalation for initial treatment of stages 

I–III squamous cell anal cancer? 

KQ 5. What are the effectiveness and 

harms of immunotherapy for initial 

treatment of stages I–III squamous cell 

anal cancer? 

KQ 6. What are the effectiveness and 

harms of different frequencies and 

modalities for post-treatment 

surveillance strategies after initial 

treatment of stages I–III squamous cell 

anal cancer? 

For all KQs, do the outcomes differ by 

patient characteristics such as age, sex, 

immunocompromised status, or other 

characteristics associated with health 

inequities (such as race/ethnicity)? 


ddrumheller on DSK120RN23PROD with NOTICES1
60682 Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 

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

Inclusion Exclusion 

Population: 

All KQ .............. Adults with stages I–III squamous cell anal cancer (anal canal and anal 

margin).

Adults with: 

• Stage IV anal cancer. 

• Lower rectal cancer that has spread to the 

anal canal. 

• Non-squamous cell anal cancer (e.g., 

adenocarcinomas, undifferentiated cancer). 

Patient characteristics such as age, sex, immunocompromised status, 

or other characteristics associated with health inequities (such as 

race/ethnicity).

.................................................................................................................... Studies including mixed populations with 

Stages I–IV squamous cell anal cancer which 

contain 20% or greater proportion of stage IV 

squamous cell anal cancer. 

Interventions: 

KQ1 ................. Alone or in combination as neoadjuvant/adjuvant or as induction/maintenance:.

• Surgery, radiation therapy, or chemotherapy ........................................

• Reconstructive surgery. 

• Palliative therapy (includes chemotherapy 

with palliative intent). 

• Treatment for premalignant lesions. 

KQ2 ................. Different modalities of radiation therapy such as, but not limited to, 

IMRT, proton radiation therapy, and Brachytherapy boost.

• Palliative therapy. 

KQ3 ................. Radiation therapy; varying: ....................................................................... • Palliative therapy. 

• Doses .....................................................................................................

• Target (primary and nodal) volumes .....................................................

• Fractionation schema.

KQ4 ................. • Chemotherapy and radiation therapy combinations (e.g., 5- 

Fluorouracil, Mitomycin-C, Cisplatin).

• Palliative therapy. 

• Variations in dose of: .............................................................................

Æ Radiation therapy ...................................................................................

Æ Chemotherapy.

KQ5 ................. Immunotherapy (e.g., pembrolizumab, nivolumab).

KQ6 ................. Post-treatment surveillance strategies: ..................................................... • Screening for primary prevention. 

• Frequency.

• Modalities (e.g., MRI, PET scans, biopsy, DRE, anoscopy, flexible 

sigmoidoscopy).

• Initial staging. 

• Strategies for surveillance post non-initial treatment.

Comparison: 

KQ1 ................. Alone or in combination as neoadjuvant/adjuvant or as induction/maintenance:.• Reconstructive surgery. 

• Palliative therapy (includes chemotherapy 

with palliative intent). 

• Surgery, radiation therapy, or chemotherapy ........................................ • Treatment for premalignant lesions. 

KQ2 ................. Comparators for different modalities of radiation therapy such as, but 

not limited to, 3–D CRT, photon or electron radiation therapy, and external beam radiation therapy boost.

• Palliative therapy. 

KQ3 ................. Radiation therapy; varying: ....................................................................... • Palliative therapy. 

• Doses .....................................................................................................

• Target (primary and nodal) volumes .....................................................

• Fractionation schema.

KQ4 ................. • Chemotherapy and radiation therapy combinations (e.g., 5- 

Fluorouracil, Mitomycin-C, Cisplatin).

• Palliative therapy. 

• Variations in dose ..................................................................................

Æ Radiation therapy ...................................................................................

Æ Chemotherapy.

KQ5: ................ Other treatment (e.g., chemotherapy, radiation therapy, chemotherapy + 

radiation therapy).

KQ6 ................. Post-treatment surveillance strategies: ..................................................... • Screening for primary prevention. 

• Initial staging. 

• Strategies for surveillance post non-initial 

treatment. 

• Frequency ..............................................................................................

• Modalities (e.g., MRI, PET scans, biopsy, DRE, anoscopy, flexible 

sigmoidoscopy).

Outcomes: 

All KQ .............. • Overall survival.

• Disease specific survival.

• Disease-free survival (including persistence, recurrence, or relapse).

• Colostomy-free survival.

• Local control.

• Complete clinical response.

• Salvage rate.

• Sphincter preservation.

• Health-related quality of life.


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 60683 

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

Inclusion Exclusion 

• Treatment breaks (frequency or duration), treatment discontinuation, 

interruptions, or median treatment days.

• Bleeding per rectum.

• Functional outcomes (e.g., fecal or urinary incontinence, erectile dysfunction, sexual dysfunction, use of vaginal dilators).

• Harms of treatment including acute and late toxicity (e.g., 

myelosuppression, gastrointestinal toxicity, such as diarrhea, vomiting, and bowel obstruction, secondary malignancy, radiation dermatitis, radiation proctitis, radiation cystitis, pelvic insufficiency fractures, 

vaginal stenosis).

Timing: 

All KQ .............. No restrictions on duration of treatments or follow-up.

Setting: 

All KQ .............. Cancer care settings.

Study design: 

All KQ .............. Randomized controlled trials, non-randomized controlled trials, observational cohort with concurrent comparator, interrupted time-series, and 

other quasi-experimental designs using appropriate analytic techniques.

Case reports, case series, commentaries, 

cross-sectional studies, reviews, qualitative 

studies, studies with sample size less than 30 

patients (or less than 15 per treatment group/ 

arm), non-randomized studies with unspecified or poorly defined intervention/treatment 

protocol (e.g., lack of names of chemotherapy agents used), non-randomized studies with analytic techniques that don’t allow 

drawing causal inferences. 

Abbreviations: 3–D CRT= three-dimensional conformal radiation therapy; DRE= digital rectal exam; IMRT=intensity-modulated radiation therapy; KQ=key question; MRI= magnetic resonance imaging; PET= positron emission tomography; RCT=randomized controlled trial; VMAT= Volumetric modulated arc therapy. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2023–19031 Filed 9–1–23; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project ‘‘Use of 

Open-Ended Responses to Explore 

Disparities in Patient Experience.’’ This 

proposed information collection was 

previously published in the Federal 

Register on June 27th, 2023, and 

allowed 60 days for public comment. 

AHRQ received no substantive 

comments from members of the public. 

The purpose of this notice is to allow an 

additional 30 days for public comment. 

DATES: Comments on this notice must be 

received by October 5, 2023. 

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. Copies of the proposed 

collection plans, data collection 

instruments, and specific details on the 

estimated burden can be obtained from 

the AHRQ Reports Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Use of Open-Ended Responses To 

Explore Disparities in Patient 

Experience 

The Consumer Assessment of 

Healthcare Providers and Systems 

(CAHPS) program, which is sponsored 

by AHRQ, has the purpose of advancing 

the scientific understanding of the 

patient experience of care, including the 

development and testing of new surveys 

and/or approaches to data collection to 

promote or improve the collection of 

consumer reports and evaluations of 

their experiences with health care. 

This Project has the following goals: 

(1) Use open-ended (narrative) 

responses to provide context, detail, and 

understanding regarding observed 

differences in patient experience based 

on race, ethnicity, gender, and preferred 

language. 

(2) Use Clinician and Group-CAHPS 

Narrative Item Set (NIS)-generated 

narrative data to examine potential 

algorithmic bias in natural language 

programs (NLP) that could potentially 

be used to code large quantities of 

narrative data. 

(3) Where algorithmic bias is 

uncovered, use this analysis to identify 

adjustments that can be applied to both 

the input for these programs or the 

outputs. 

This project is being conducted by 

AHRQ through its contractor, the RAND 

Corporation, pursuant to AHRQ’s 

statutory authority to conduct and 

support research on health care and on 

systems for the delivery of such care, 

including activities with respect to the 

quality, effectiveness, efficiency, 

appropriateness, and value of healthcare 

services and with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(1) and (2). 

Method of Collection 

To achieve the goals of this project the 

following data collections will be 

implemented: 

Online survey: Data will be collected 

from a sample of 4,998 survey 


ddrumheller on DSK120RN23PROD with NOTICES1