Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33317 

CFR 46, followed by an expert panel 

discussion on the impact of artificial 

intelligence algorithms on Institutional 

Review Board considerations for human 

subjects protections. The day will 

conclude with discussion of a new 

SACHRP charge addressing the current 

system of engagement and the 

interpretation of HHS support in 45 CFR 

46. The second day, July 22, will 

include discussion of consideration of 

risks to third parties in research, and 

continue discussion of topics from the 

first day’s agenda. Other topics may be 

added; for the full and updated meeting 

agenda, see https://www.dhhs.gov/ohrp/ 

sachrp-committee/meetings/index.html. 

The meeting will adjourn by 4:30 p.m. 

July 22. 

The public will have an opportunity 

to send comment to SACHRP during the 

meeting’s public comment session or to 

submit written public comment in 

advance. Persons who wish to provide 

public comment should review 

instructions at https://www.hhs.gov/ 

ohrp/sachrp-committee/meetings/ 

index.html and respond by midnight 

July 16th, 2021, ET. Individuals 

submitting written statements as public 

comment should submit their comments 

to SACHRP at SACHRP@hhs.gov. 

Comments are limited to three minutes 

each. 

Time will be allotted for public 

comment on both days. Note that public 

comment must be relevant to topics 

currently being addressed by SACHRP. 

Dated: June 14, 2021. 

Julia G. Gorey, 

Executive Director, Secretary’s Advisory 

Committee on Human Research Protections, 

Office for Human Research Protections. 

[FR Doc. 2021–13362 Filed 6–23–21; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Appointment of Administrative Dispute 

Resolution Board Members 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: On December 14, 2020, the 

Department of Health and Human 

Services published in the Federal 

Register a final rule (‘‘Rule’’) 

establishing the 340B Drug Pricing 

Program (340B Program) Administrative 

Dispute Resolution (ADR) Board 

(hereafter, ‘‘the Board’’). See 85 FR 

80632 (Dec. 14, 2020). According to the 

Rule, the purpose of the 340B Program’s 

ADR process is to resolve (1) claims by 

covered entities that they have been 

overcharged for covered outpatient 

drugs by manufacturers and (2) claims 

by manufacturers, after a manufacturer 

has conducted an audit as authorized by 

section 340B(a)(5)(C) of the Public 

Health Service Act, that a covered entity 

has violated the prohibitions on 

diversion or duplicate discounts. The 

Rule states that Board members from the 

Centers for Medicare & Medicaid 

Services (CMS) and the Health 

Resources and Services Administration 

(HRSA) must have relevant expertise 

and experience in drug pricing or drug 

distribution. The Rule also states that 

Board members from the Office of the 

General Counsel (OGC) must have 

expertise and experience in handling 

complex litigation. From the 340B ADR 

Board, the HRSA Administrator will 

select three voting members, one from 

each of the three HHS operating/staff 

divisions involved (i.e., CMS, HRSA, 

OGC) to form 340B ADR Panels that will 

review claims and, pursuant to 

delegated authority from the Secretary, 

make certain final agency decisions. 

All previous appointments to the 

Board are revoked. Based on 

recommendations from OGC, CMS, and 

HRSA, I hereby appoint the following 

Board members, who shall serve a term 

of two years, to be extended for 

additional terms upon agreement by the 

member and the head of his or her 

operating/staff division. 

Sean R. Keveney, Deputy General 

Counsel, the Office of the General 

Counsel, Department of Health and 

Human Services; 

Andy J. Miller, National Complex 

Litigation and Investigations Division 

Attorney, the Office of the General 

Counsel, Department of Health and 

Human Services; 

Glenn Clark, Public Health Advisor, 

HIV/AIDS Bureau, Health Resources 

and Services Administration, 

Department of Health and Human 

Services; 

CAPT Christina Meade, Area Regional 

Pharmacy Consultant, Office of Regional 

Operations, Health Resources and 

Services Administration, Department of 

Health and Human Services; 

CDR Timothy Lape, Division of 

Medicare Health Plans Operations, 

Medicare Branch, Centers for Medicare 

& Medicaid Services, Department of 

Health and Human Services; 

Adele Pietrantoni, Office of Program 

Operations and Local Engagement, 

Division of Drug and Health Plan 

Operations, Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services; 

Chantelle Britton, Senior Advisor, 

Office of Pharmacy Affairs, Health 

Resources and Services Administration, 

Department of Health and Human 

Services, as ex-officio, non-voting 

member; and 

Julie Zadecky, Pharmacist, Office of 

Pharmacy Affairs, Health Resources and 

Services Administration, Department of 

Health and Human Services, as exofficio, non-voting member. 

Dated: June 21, 2021. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–13461 Filed 6–23–21; 8:45 am] 

BILLING CODE 4150–26–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0955–0003] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before July 26, 2021. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0955–0003–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (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 


khammond on DSKJM1Z7X2PROD with NOTICES
33318 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 

1Public Law 104–191, 110 Stat. 1936 (Aug 21, 

1996), available at https://www.congress.gov/104/ 

plaws/publ191/PLAW-104publ191.pdf. 

2Centers for Medicare and Medicaid Services, 

Final Rule: Medicare and Medicaid Programs; 

Patient Protection and Affordable Care Act; 

Interoperability and Patient Access for Medicare 

Advantage Organization and Medicaid Managed 

Care Plans, State Medicaid Agencies, CHIP 

Agencies and CHIP Managed Care Entities, Issuers 

of Qualified Health Plans on the FederallyFacilitated Exchanges, and Health Care Providers,’’ 

85 FR 25510, May 1, 2020, available at https://

www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/ 

2020-05050.pdf. 

3Public Law 114–255, 130 STAT. 1033 (Dec. 13, 

2016), available at https://www.congress.gov/114/ 

plaws/publ255/PLAW-114publ255.pdf. 

4Public Law 111–148, 124 Stat. 119 (Mar 13. 

2010), available at https://www.congress.gov/111/ 

plaws/publ148/PLAW-111publ148.pdf. 

5Public Law 111–5, Title XIII, 123 Stat. 115, 226 

(Feb. 17, 2009), available at https://

www.govinfo.gov/content/pkg/PLAW-111publ5/pdf/ 

PLAW-111publ5.pdf. 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Generic 

Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery. 

Type of Collection: Father Generic ICR 

revision. 

OMB No. 0955–0003—Office of the 

National Coordinator for Health 

Information Technology. 

Abstract: The Office of the National 

Coordinator for Health Information 

Technology is seeking a three-year 

revision of OMB control number 0955– 

0003 to continue collecting routine 

customer feedback on agency service 

delivery. The proposed information 

collection activity provides a means to 

garner qualitative customer and 

stakeholder feedback in an efficient, 

timely manner, in accordance with the 

Administration’s commitment to 

improving service delivery. Qualitative 

feedback means information that 

provides useful insights on perceptions 

and opinions, and is not statistical 

surveys that yield quantitative results 

that can be generalized to the 

population of study. This feedback will 

provide insights into customer or 

stakeholder perceptions, experiences, 

and expectations; provide an early 

warning of issues with the service; or 

focus attention on areas where 

communication, training, or changes in 

operations might improve delivery of 

products or services. These collections 

will allow for ongoing, collaborative, 

and actionable communications 

between the Agency and its customers 

and stakeholders. It will also allow 

feedback to contribute directly to the 

improvement of program management. 

The solicitation of feedback will target 

areas such as timeliness, 

appropriateness, accuracy of 

information, courtesy, efficiency of 

service delivery, and resolution of 

issues with service delivery. Responses 

will be assessed to plan and inform 

efforts to improve or maintain the 

quality of service offered to the public. 

If this information is not collected, vital 

feedback from customers and 

stakeholders on the Agency’s services 

will be unavailable. 

Affected Public: Individuals, 

households, professionals, and/or the 

public/private sector. 

Average estimates for the next three 

years: 

Estimated Total Number of 

Respondents: 10,000. 

Expected Annual Number of 

Activities: 6. 

Average Number of Respondents per 

Activity: 1667. 

Frequency of Response: Once per 

activity. 

Average Minutes per Response: 7. 

Total Burden Hours: 1167. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Individuals, households, professionals, and/or the public/private sector ........ 10,000 1 7/60 1167 

Total .......................................................................................................... 10,000 1 7/60 1167 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2021–13224 Filed 6–23–21; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Notice of Meeting and 

Request for Public Comment 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting and request for 

public comment. 

Name: National Committee on Vital 

and Health Statistics (NCVHS), 

Listening Session to be held by the 

Subcommittee on Standards. 

Dates and Times: Wednesday, August 

25, 2021: 10:00 a.m.–5:30 p.m. EST. 

Place: Virtual. 

Status: Open. 

Purpose: The purpose of this listening 

session is to obtain input from 

representatives of standards 

development organizations, invited 

industry stakeholders, and 

representatives from federal agencies on 

a variety of topics pertaining to data 

standards, harmonization of standards 

and code sets, new Fast Healthcare 

Interoperability Resources (FHIR) 

application programming interfaces 

(APIs) to enhance the exchange of 

clinical and administrative data, the 

state of readiness for certain 

administrative and clinical standards to 

be considered for adoption or use as 

standards under the Health Insurance 

Portability and Accountability Act 

(HIPAA),1 for interoperability, and other 

subjects beyond HIPAA transactions. 

This Notice also includes a Request 

for Public Comment to solicit input 

from interested individuals and 

stakeholders who would like to provide 

input to the Subcommittee in advance 

of the August 25, 2021, listening 

session. 

The Subcommittee seeks to 

understand the extent to which current 

and emerging standards for exchanging 

electronic health-related data under 

HIPAA and other applicable federal 

legislation and regulatory processes are 

meeting the business needs of the health 

care system. Applicable legislation and 

regulation include, but are not limited 

to HIPAA, the final Interoperability and 

Patient Access Rule promulgated by the 

Centers for Medicare and Medicaid 

Services (CMS),2 the 21st Century Cures 

Act,3 the Affordable Care Act of 2010,4

the Health Information Technology for 

Economic and Clinical Health Act 

(HITECH),5 and Medicare Access and 


khammond on DSKJM1Z7X2PROD with NOTICES