Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 34887 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS AND SAFETY AND PROBABLE BENEFIT

SUMMARIES FOR APPROVED HDES MADE AVAILABLE FROM JANUARY 1, 2021, THROUGH FEBRUARY 14, 2022— 

Continued 

PMA No., docket No. Applicant Trade name Approval 

date 

P190012, FDA–2021–M–1119 .... Spatz FGIA Inc ........................... Spatz3 Adjustable Balloon System ...................................... 10/15/2021 

P160046/S010, FDA–2021–M– 

0532.

Ventana Medical Systems, Inc ... VENTANA PD–L1 (SP263) Assay ....................................... 10/15/2021 

P150031/S040, FDA–2021–M– 

1176.

Boston Scientific Corporation ..... Vercise PC, Vercise Gevia and Vercise Genus DBS Systems.10/20/2021 

P150038/S014, FDA–2021–M– 

1182.

INSIGHTEC, Inc ......................... Exablate Model 4000 Type 1.0 and 1.1 System (‘‘Exablate 

Neuro’’).

10/29/21 

P130026/S070, FDA–2021–M– 

1207.

Abbott Medical ............................ TactiCath Contact Force Ablation Catheter, Sensor Enabled (Uni-Directional); TactiCath Contact Force Ablation 

Catheter, Sensor Enabled (Bi-Directional); TactiSys 

Quartz Equipment; Ampere RF Generator and Cool 

Point Irrigation Pump.

11/4/21 

P210020, FDA–2021–M–1284 .... Urotronic, Inc .............................. Optilume® Urethral Drug Coated Balloon ............................ 12/3/21 

P190022, FDA–2021–M–1271 .... OPKO Health, Inc ....................... 4Kscore® Test ...................................................................... 12/7/21 

P200035, FDA–2021–M–1317 .... OrganOx Limited ........................ OrganOx metra® System ...................................................... 12/9/21 

P210014, FDA–2021–M–1321 .... Svelte Medical Systems, Inc ...... SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary 

Stent Rapid Exchange Delivery System.

12/13/21 

P200041, FDA–2021–M–1316 .... OrbusNeich Medical (Shenzhen) 

Co., Ltd.

Scoreflex NC Scoring PTCA Catheter ................................. 12/21/21 

P200015/S011, FDA–2021–M– 

1325.

Edwards Lifesciences LLC ......... Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent.12/16/21 

P200040, FDA–2021–M–1352 .... Delphinus Medical Technologies, 

Inc.

SoftVue Automated Whole Breast Ultrasound System with 

Sequr Breast Interface Assembly.

10/6/21 

P170002/S012, FDA–2022–M– 

0029.

TEOXANE S.A ........................... RHA® RedensityTM ............................................................... 12/22/21 

P970051/S205, FDA–2022–M– 

0071.

Cochlear Americas ..................... Nucleus 24 Cochlear Implant System .................................. 1/10/22 

P130022/S042, FDA–2022–M– 

0087.

Nevro Corporation ...................... Senza® Spinal Cord Stimulation (SCS) System .................. 1/18/22 

P840001/S469, FDA–2022–M– 

089.

Medtronic Neuromodulation ....... Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord 

Stimulation Systems, Pisces, Specify and Vectris Spinal 

Cord Stimulation Leads.

1/21/22 

P080012/S068, FDA–2022–M– 

0090.

Flowonix Medical, Inc ................. Prometra® Programmable Infusion Pump System ............... 1/12/22 

P160048/S016, FDA–2022–M– 

0171.

Senseonics, Incorporated ........... Eversense® E3 Continuous Glucose Monitoring System .... 2/10/22 

II. Electronic Access 

Persons with access to the internet 

may obtain the documents at https://

www.fda.gov/MedicalDevices/ 

ProductsandMedicalProcedures/Device

ApprovalsandClearances/ 

PMAApprovals/default.htm. 

Dated: June 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12371 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Information 

Collection Request Title: HRSA Ryan 

White HIV/AIDS Program HIV Quality 

Measures Module, OMB No. 0906– 

0022—Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than August 8, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Samantha Miller, the acting 

HRSA Information Collection Clearance 

Officer at (301) 443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information collection request title for 

reference. 


khammond on DSKJM1Z7X2PROD with NOTICES
34888 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 

1HRSA. Ryan White HIV/AIDS Program Data 

Report, 2020. 

Information Collection Request Title: 

HIV Quality Measures (HIVQM) Module 

OMB No. 0906–0022—Extension. 

Abstract: The HRSA Ryan White HIV/ 

AIDS Program (RWHAP) funds and 

coordinates with cities, states, and local 

clinics/community-based organizations 

to deliver efficient and effective HIV 

care, treatment, and support to lowincome people with HIV. Since 1990, 

the RWHAP has developed a 

comprehensive system of safety net 

providers who deliver high quality 

direct health care and support services 

to over half a million people with HIV— 

more than 50 percent of all people 

diagnosed with HIV in the United 

States. Nearly two-thirds of clients live 

at or below 100 percent of the federal 

poverty level and approximately threequarters of RWHAP clients are racial/ 

ethnic minorities.1

RWHAP Parts A, B, C, and D 

recipients and sub recipients must 

follow legislative requirements for the 

establishment of clinical quality 

management programs to assess the 

extent to which their HIV services are 

consistent with the most recent 

Department of Health and Human 

Services Clinical Treatment guidelines. 

In support of these requirements, HRSA 

created the HIV Quality Measures 

(HIVQM) Module as an online tool to 

assist recipients in meeting the clinical 

quality management program 

requirement by allowing recipients to 

input data for the HRSA performance 

measures. HRSA maintains over 40 

performance measures across the 

following categories: (1) core, (2) all 

ages, (3) adolescent/adult, (4) HIVinfected children, (5) HIV-exposed 

children, (6) medical case management, 

(7) oral health, (8) AIDS Drug Assistance 

Program, and (9) systems. The HIVQM 

Module also supports the requirement 

imposed by the Uniform Administrative 

Requirements, Cost Principles, and 

Audit Requirements for Health and 

Human Service Award (45 CFR 75.301) 

that recipients relate financial data to 

performance accomplishments of their 

federal awards. The HIVQM Module 

helps recipients set goals and monitor 

performance measures and quality 

improvement projects. The use of the 

HIVQM Module is voluntary for 

RWHAP recipients but strongly 

encouraged. 

Need and Proposed Use of the 

Information: The HIVQM Module 

supports recipients and sub-recipients 

in their clinical quality management 

programs, performance measurement, 

service delivery, and monitoring of 

client health outcomes and quality HIV 

services. The HIVQM Module is 

accessible via the RWHAP Services 

Report, an existing online portal that 

RWHAP recipients use for required data 

collection of their services. Recipients 

may enter performance measures data 

into the HIVQM Module four times a 

year and then generate reports to assess 

their performance. Recipients have the 

option to enter data for specific 

populations for a subset of performance 

measures based on age, gender, race/ 

ethnicity, and risk factor. Recipients 

may also compare their performance 

against other recipients in their state, 

region, and nationally. Additionally, 

recipients can choose the performance 

measures they want to monitor and 

enter data accordingly. For recipients 

and sub-recipients participating in the 

Centers for Medicare & Medicaid 

Incentive Programs, such as the 

Medicare Promoting Interoperability 

Program and the Merit-based Incentive 

Payment System, the HIVQM Module 

may be used to monitor the HRSA 

measures that qualify and comply with 

the requirements to receive incentives 

from these programs. 

Likely Respondents: RWHAP Part A, 

Part B, Part C, and Part D recipients and 

their sub-recipients. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

HIVQM Report ..................................................................... 2,063 4 8,252 1 8,252 

2,063 ........................ 8,252 ........................ 8,252 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2022–12287 Filed 6–7–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Post-Award Reporting 

Requirements Including Research 

Performance Progress Report 

Collection (OD) 

AGENCY: National Institutes of Health. 

ACTION: Notice. 


khammond on DSKJM1Z7X2PROD with NOTICES