2614 Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Notices 

organizations include Health 

Maintenance Organizations (HMOs) and 

Competitive Medical Plans (CMPs) 

under Section 1876, in addition to, 

Health Care Prepayment Plans (HCPPs) 

under Section 1833. These entities may 

be collectively referred to as Managed 

Care Organizations (MCOs). The cost 

and statistical data is submitted to CMS 

within the cost report, Form CMS 276 

(OMB No.0938–0165). CMS is 

responsible for the receipt and 

processing of Form CMS 276. Form 

CMS 276, provided by CMS as excel 

worksheets, covers the prescribed 

format for the cost reports. 

The cost report worksheets are 

designed to be of sufficient flexibility to 

take into account the diversity of 

operations, yet provide the necessary 

cost and statistical information to enable 

CMS to determine the proper amount of 

payment to the Plan. Cost-based MCOs 

must submit through HPMS an annual 

Budget Forecast, semi-annual interim, 

and final cost report to CMS, all of 

which are included in this collection. 

Additionally, HMOs/CMPs are required 

to submit fourth quarter interim reports 

annually to CMS; however, the required 

submission of 4th quarter interim 

reports is waived until further notice by 

CMS. Please note that HCPPs are not 

required to submit fourth quarter 

interim reports. Form Number: CMS– 

276 (OMB control number: 0938–0165); 

Frequency: Quarterly; Affected Public: 

Private Sector Number of Respondents: 

17; Number of Responses: 51; Total 

Annual Hours: 1,612. (For questions 

regarding this collection contact Frank 

Cisar at 410–786–7553). 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: The PACE 

Organization Application Process in 42 

CFR part 460; Use: The Programs of AllInclusive Care for the Elderly (PACE) 

consist of pre-paid, capitated plans that 

provide comprehensive health care 

services to frail, older adults in the 

community who are eligible for nursing 

home care according to State standards. 

PACE organizations (PO) must provide 

all Medicare and Medicaid covered 

services; financing of this model is 

accomplished through prospective 

capitation of both Medicare and 

Medicaid payments. Upon approval of a 

PACE application, CMS executes a 

3-way program agreement with the 

applicant entity and the applicable State 

Administering Agency (SAA). CMS 

regulations at 42 CFR 460.98(b)(2) 

require a PO to provide PACE services 

in at least the PACE center, the home, 

and inpatient facilities. The PACE 

center is the focal point for the delivery 

of PACE services; the center is where 

the interdisciplinary team (IDT) is 

located, services are provided, and 

socialization occurs with staff that is 

consistent and familiar to participants. 

Collection of this information is 

mandated by statute under sections 

1894(f) and 1934(f) of the Act and at 42 

CFR part 460, subpart B, which 

addresses the PO application and 

waiver process. In general, PACE 

services are provided through a PO. An 

entity wishing to become a PO must 

submit an application to CMS that 

describes how the entity meets all the 

requirements in the PACE program. An 

entity’s application must be 

accompanied by an assurance from the 

SAA of the State in which the PO 

wishes to operate its PACE program. 

CMS accepts applications on a 

designated date four times per year (i.e., 

on a quarterly basis, generally the last 

Friday of March, June, September and 

December). Form Number: CMS–10631 

(OMB control number: 0938–1326); 

Frequency: Occasionally; Affected 

Public: Private Sector, State, Local or 

Tribal governments, Business or other 

for-profits; Number of Respondents: 72; 

Total Annual Responses: 130; Total 

Annual Hours: 7,271. For policy 

questions regarding this collection 

contact Debbie Vanhoven at 410–786– 

6625. 

Dated: January 11, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–00735 Filed 1–14–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7065–N] 

Announcement of the Advisory Panel 

on Outreach and Education (APOE) 

February 3, 2022 Virtual Meeting 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces the 

next meeting of the APOE (the Panel) in 

accordance with the Federal Advisory 

Committee Act. The Panel advises and 

makes recommendations to the 

Secretary of the U.S. Department of 

Health and Human Services (HHS) (the 

Secretary) and the Administrator of the 

Centers for Medicare & Medicaid 

Services (CMS) on opportunities to 

enhance the effectiveness of consumer 

education strategies concerning the 

Health Insurance Marketplace®, 

Medicare, Medicaid, and the Children’s 

Health Insurance Program (CHIP). This 

meeting is open to the public. 

DATES: 

Meeting Date: Thursday, February 3, 

2022 from 12:00 p.m. to 5:00 p.m. 

eastern standard time (e.s.t). 

Deadline for Meeting Registration, 

Presentations, Special 

Accommodations, and Comments: 

Thursday, January 27, 2022 5:00 p.m. 

(e.s.t). 

ADDRESSES: 

Meeting Location: Virtual. All those 

who RSVP will receive the link to 

attend. 

Presentations and Written Comments: 

Presentations and written comments 

should be submitted to: Lisa Carr, 

Designated Federal Official (DFO), 

Office of Communications, Centers for 

Medicare & Medicaid Services, 200 

Independence Avenue SW, Mailstop 

325G HHH, Washington, DC 20201, 

202–690–5742, or via email at APOE@

cms.hhs.gov. 

Registration: Persons wishing to 

attend this meeting must register at the 

website https://www.eventbrite.com/e/ 

apoe-february-3-2022-virtual-meetingtickets-212590763697 or by contacting 

the DFO listed in the FOR FURTHER

INFORMATION CONTACT section of this 

notice, by the date listed in the DATES

section of this notice. Individuals 

requiring sign language interpretation or 

other special accommodations should 

contact the DFO at the address listed in 

the ADDRESSES section of this notice by 

the date listed in the DATES section of 

this notice. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Carr, Designated Federal Official, Office 

of Communications, 200 Independence 

Avenue SW, Mailstop 325G HHH, 

Washington, DC 20201, 202–690–5742, 

or via email at APOE@cms.hhs.gov. 

Additional information about the APOE 

is available at: https://www.cms.gov/ 

Regulations-and-Guidance/Guidance/ 

FACA/APOE. Press inquiries are 

handled through the CMS Press Office 

at (202) 690–6145. 

SUPPLEMENTARY INFORMATION: 

I. Background and Charter Renewal 

Information 

A. Background 

The Advisory Panel for Outreach and 

Education (APOE) (the Panel) is 

governed by the provisions of the 

Federal Advisory Committee Act 

(FACA) (Pub. L. 92–463), as amended (5 


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Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Notices 2615 

1We note that the Citizen’s Advisory Panel on 

Medicare Education is also referred to as the 

Advisory Panel on Medicare Education (65 FR 

4617). The name was updated in the Second 

Amended Charter approved on July 24, 2000. 

2Health Insurance Marketplace® and 

Marketplace® are service marks of the U.S. 

Department of Health and Human Services. 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

federal advisory committees. The Panel 

is authorized by section 1114(f) of the 

Social Security Act (the Act) (42 U.S.C. 

1314(f)) and section 222 of the Public 

Health Service Act (42 U.S.C. 217a). 

The Secretary of the U.S. Department 

of Health and Human Services (HHS) 

(the Secretary) signed the charter 

establishing the Citizen’s Advisory 

Panel on Medicare Education 1 (the 

predecessor to the APOE) on January 21, 

1999 (64 FR 7899) to advise and make 

recommendations to the Secretary and 

the Administrator of the Centers for 

Medicare & Medicaid Services (CMS) on 

the effective implementation of national 

Medicare education programs, including 

with respect to the Medicare+Choice 

(M+C) program added by the Balanced 

Budget Act of 1997 (Pub. L. 105–33). 

The Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Pub. L. 108–173) 

expanded the existing health plan 

options and benefits available under the 

M+C program and renamed it the 

Medicare Advantage (MA) program. 

CMS has had substantial responsibilities 

to provide information to Medicare 

beneficiaries about the range of health 

plan options available and better tools 

to evaluate these options. The 

successful MA program implementation 

required CMS to consider the views and 

policy input from a variety of private 

sector constituents and to develop a 

broad range of public-private 

partnerships. 

In addition, Title I of the MMA 

authorized the Secretary and the 

Administrator of CMS (by delegation) to 

establish the Medicare prescription drug 

benefit. The drug benefit allows 

beneficiaries to obtain qualified 

prescription drug coverage. In order to 

effectively administer the MA program 

and the Medicare prescription drug 

benefit, we have substantial 

responsibilities to provide information 

to Medicare beneficiaries about the 

range of health plan options and 

benefits available, and to develop better 

tools to evaluate these plans and 

benefits. 

The Patient Protection and Affordable 

Care Act (Pub. L. 111–148) and Health 

Care and Education Reconciliation Act 

of 2010 (Pub. L. 111–152) (collectively 

referred to as the Affordable Care Act) 

expanded the availability of other 

options for health care coverage and 

enacted a number of changes to 

Medicare as well as to Medicaid and 

CHIP. Qualified individuals and 

qualified employers are now able to 

purchase private health insurance 

coverage through a competitive 

marketplace, called an Affordable 

Insurance Exchange (also called Health 

Insurance Marketplace®, or 

Marketplace® 2). In order to effectively 

implement and administer these 

changes, we must provide information 

to consumers, providers, and other 

stakeholders through education and 

outreach programs regarding how 

existing programs will change and the 

expanded range of health coverage 

options available, including private 

health insurance coverage through the 

Marketplace®. The APOE (the Panel) 

allows us to consider a broad range of 

views and information from interested 

audiences in connection with this effort 

and to identify opportunities to enhance 

the effectiveness of education strategies 

concerning the Affordable Care Act. 

The scope of this Panel also includes 

advising on issues pertaining to the 

education of providers and stakeholders 

with respect to the Affordable Care Act 

and certain provisions of the Health 

Information Technology for Economic 

and Clinical Health (HITECH) Act 

enacted as part of the American 

Recovery and Reinvestment Act of 2009 

(ARRA) (Pub. L. 111–5). 

On January 21, 2011, the Panel’s 

charter was renewed and the Panel was 

renamed the Advisory Panel for 

Outreach and Education. The Panel’s 

charter was most recently renewed on 

January 19, 2021, and will terminate on 

January 19, 2023 unless renewed by 

appropriate action. 

B. Charter Renewal 

In accordance with the January 19, 

2021, charter, the APOE will advise the 

HHS and CMS on developing and 

implementing education programs that 

support individuals who are enrolled in 

or eligible for Medicare, Medicaid, 

CHIP, or coverage available through the 

Health Insurance Marketplace® and 

other CMS programs. The scope of this 

FACA group also includes advising on 

education of providers and stakeholders 

with respect to health care reform and 

certain provisions of the HITECH Act 

enacted as part of the ARRA. 

The charter will terminate on January 

19, 2023, unless renewed by appropriate 

action. The APOE was chartered under 

42 U.S.C. 217a, section 222 of the Public 

Health Service Act, as amended. The 

APOE is governed by provisions of 

Public Law 92–463, as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

advisory committees. 

In accordance with the renewed 

charter, the APOE will advise the 

Secretary and the CMS Administrator 

concerning optimal strategies for the 

following: 

• Developing and implementing 

education and outreach programs for 

individuals enrolled in, or eligible for, 

Medicare, Medicaid, the CHIP, and 

coverage available through the Health 

Insurance Marketplace® and other CMS 

programs. 

• Enhancing the federal government’s 

effectiveness in informing Medicare, 

Medicaid, CHIP, or the Health Insurance 

Marketplace® consumers, issuers, 

providers, and stakeholders, pursuant to 

education and outreach programs of 

issues regarding these programs, 

including the appropriate use of publicprivate partnerships to leverage the 

resources of the private sector in 

educating beneficiaries, providers, 

partners and stakeholders. 

• Expanding outreach to minority and 

underserved communities, including 

racial and ethnic minorities, in the 

context of Medicare, Medicaid, the CHIP 

and the Health Insurance Marketplace®

education programs, and other CMS 

programs as designated. 

• Assembling and sharing an 

information base of ‘‘best practices’’ for 

helping consumers evaluate health 

coverage options. 

• Building and leveraging existing 

community infrastructures for 

information, counseling, and assistance. 

• Drawing the program link between 

outreach and education, promoting 

consumer understanding of health care 

coverage choices, and facilitating 

consumer selection/enrollment, which 

in turn support the overarching goal of 

improved access to quality care, 

including prevention services, 

envisioned under the Affordable Care 

Act. 

The current members of the Panel as 

of September 15, 2021, are as follows: 

• Julie Carter, Senior Federal Policy 

Associate, Medicare Rights Center. 

• Scott Ferguson, Director of Care 

Transitions and Population Health, 

Mount Sinai St. Luke’s Hospital. 

• Jean-Venable Robertson Goode, 

Professor, Department of 

Pharmacotherapy and Outcomes 

Science, School of Pharmacy, Virginia 

Commonwealth University. 

• Ted Henson, Director of Health 

Center Performance and Innovation, 

National Association of Community 

Health Centers. 


khammond on DSKJM1Z7X2PROD with NOTICES
2616 Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Notices 

• Joan Ilardo, Director of Research 

Initiatives, Michigan State University, 

College of Human Medicine. 

• Cheri Lattimer, Executive Director, 

National Transitions of Care Coalition. 

• Cori McMahon, Vice President, 

Tridiuum. 

• Alan Meade, Director of 

Rehabilitation Services, Holston 

Medical Group. 

• Michael Minor, National Director, 

H.O.P.E. HHS Partnership, National 

Baptist Convention USA, Incorporated. 

• Jina Ragland, Associate State 

Director of Advocacy and Outreach, 

AARP Nebraska. 

• Morgan Reed, Executive Director, 

Association for Competitive 

Technology. 

• Margot Savoy, Senior Vice 

President, American Academy of Family 

Physicians. 

• Congresswoman Allyson Schwartz, 

Senior Advisor, FTI Consulting. 

• Tia Whitaker, Statewide Director, 

Outreach and Enrollment, Pennsylvania 

Association of Community Health 

Centers. 

II. Provisions of This Notice 

In accordance with section 10(a) of 

the FACA, this notice announces a 

meeting of the APOE. The agenda for 

the February 3, 2022 meeting will 

include the following: 

• Welcome and listening session with 

CMS leadership 

• Recap of the previous (September 15, 

2021) meeting 

• CMS programs, initiatives, and 

priorities 

• An opportunity for public comment 

• Meeting summary, review of 

recommendations, and next steps 

Individuals or organizations that wish 

to make a 5-minute oral presentation on 

an agenda topic should submit a written 

copy of the oral presentation to the DFO 

at the address listed in the ADDRESSES

section of this notice by the date listed 

in the DATES section of this notice. The 

number of oral presentations may be 

limited by the time available. 

Individuals not wishing to make an oral 

presentation may submit written 

comments to the DFO at the address 

listed in the ADDRESSES section of this 

notice by the date listed in the DATES

section of this notice. 

III. Meeting Participation 

The meeting is open to the public, but 

attendance is limited to registered 

participants. Persons wishing to attend 

this meeting must register at the website 

https://www.eventbrite.com/e/apoefebruary-3-2022-virtual-meeting-tickets212590763697 or contact the DFO at the 

address or number listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice by the date specified in the 

DATES section of this notice. This 

meeting will be held virtually. 

Individuals who are not registered in 

advance will be unable to attend the 

meeting. 

IV. Collection of Information 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: January 11, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–00745 Filed 1–14–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1037] 

Fresenius USA, Inc., et al.; Withdrawal 

of Approval of 216 Abbreviated New 

Drug Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of October 22, 2021. The 

document announced the withdrawal of 

approval of 216 abbreviated new drug 

applications (ANDAs) from multiple 

applicants, as of November 22, 2021. 

The document was published with an 

incorrect date. In addition, the 

document indicated that FDA was 

withdrawing approval of ANDA 075941, 

Strontium Chloride SR–89 Injection, 1 

millicurie/milliliter, held by BioNucleonics, Inc., 1600 Market St., Suite 

13200, Philadelphia, PA 19103, for 

repeated failure to submit annual 

reports. Before FDA withdrew the 

approval of this ANDA, the application 

holder informed FDA that it submitted 

annual reports for ANDA 075941. 

Therefore, FDA rescinds its withdrawal 

of approval of ANDA 075941. The 

approval of ANDA 075941 is still in 

effect. 

FOR FURTHER INFORMATION CONTACT: 

James Hanratty, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1671, 

Silver Spring, MD 20993–0002, 240– 

402–4718, James.Hanratty@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Corrections 

In the Federal Register of Friday, 

October 22, 2021 (86 FR 58675), in FR 

Doc. 2021–23075, the following 

corrections are made: 

1. On page 58675, in the second 

column, correct the DATES section to 

read: DATES: Approval is withdrawn as 

of October 22, 2021.’’ 

2. On page 58679, in the table, remove 

the entry for ANDA 075941. 

Dated: January 12, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00831 Filed 1–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0885] 

Determination That PEPCID 

(Famotidine) Tablet, 20 Milligrams and 

40 Milligrams, Was Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that PEPCID (famotidine) 

tablet, 20 milligrams (mg) and 40 mg, 

was not withdrawn from sale for reasons 

of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 


khammond on DSKJM1Z7X2PROD with NOTICES