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, 


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