12458 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 

Plans), Prescription Drug Plan sponsors 

(PDPs), and Programs of All-Inclusive 

Care for the Elderly (PACE) 

organizations report financial 

information demonstrating the 

organization has a fiscally sound 

operation. The FSRR is designed to 

capture financial data of these 

contracting entities. The Division of 

Finance and Benefits (DFB) within the 

Medicare Advantage Contract 

Administration Group (MCAG) of CMS 

is assigned the responsibility of 

reviewing ongoing financial 

performance of the contracting entities. 

All contracting organizations must 

submit audited annual financial 

statements one time per year. In 

addition to the audited annual 

submission, Health Plans with a 

negative net worth and/or a net loss and 

the amount of that loss is greater than 

one-half of the organization’s total net 

worth submit quarterly financial 

statements for fiscal soundness 

monitoring. Part D organizations are 

required to submit three (3) quarterly 

financial statements. Lastly, PACE 

organizations are required to file four (4) 

quarterly financial statements for the 

first three (3) years in the program. After 

the first three (3) years, PACE 

organizations with a negative net worth 

and/or a net loss and the amount of that 

loss is greater than one-half of the 

organization’s total net worth must 

submit quarterly financial statements for 

fiscal soundness monitoring. Form 

Number: CMS–906 (OMB control 

number: 0938–0496); Frequency: 

Quarterly and Yearly; Affected Public: 

Private Sector (Business or other forprofits, Not-for-Profit Institutions); 

Number of Respondents: 936; Total 

Annual Responses: 1,958; Total Annual 

Hours: 652. (For policy questions 

regarding this collection contact Christa 

M. Zalewski at (410) 786–1971.) 

Dated: March 1, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–04644 Filed 3–3–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10108] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

May 3, 2022. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10108 Medicaid Managed Care 

Regulations 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicaid 

Managed Care Regulations; Use: 

Information collected includes 

information about managed care 

programs, grievances and appeals, 

enrollment broker contracts, and 

managed care organizational capacity to 

provide health care services. Medicaid 

enrollees use the information collected 

and reported to make informed choices 

regarding health care, including how to 

access health care services and the 

grievance and appeal system. States use 

the information collected and reported 

as part of its contracting process with 

managed care entities, as well as its 

compliance oversight role. We use the 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 12459 

information collected and reported in an 

oversight role of state Medicaid 

managed care programs. 

Among the proposed changes, this 

iteration also accommodates the use of 

reporting templates for existing 

reporting requirements at 42 CFR 

438.207(d) for network adequacy and 

access and § 438.74 for medical loss 

ratio. The templates are intended to 

help states by articulating the specific 

data elements needed and by providing 

an easy to use format that facilitates 

CMS’ tracking and analysis. The data 

gathered from these reports will enable 

CMS to ensure state compliance with 

regulatory requirements. 

Form Number: CMS–10108 (OMB 

control number: 0938–0920); Frequency: 

Occasionally; Affected Public: 

Individuals or households, Private 

sector (business or other for-profit and 

not-for-profit institutions), and State, 

local or Tribal Government; Number of 

Respondents: 609; Total Annual 

Responses: 13,742,805; Total Annual 

Hours: 1,682,411. (For policy questions 

regarding this collection contact Amy 

Gentile at 410–786–3499.) 

Dated: March 1, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–04645 Filed 3–3–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0150] 

Revocation of Two Authorizations of 

Emergency Use of In Vitro Diagnostic 

Devices for Detection and/or Diagnosis 

of COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorizations (EUAs) (the 

Authorizations) issued to Bio-Rad 

Laboratories for the BioPlex 2200 

SARS–CoV–2 IgG, and Quotient Suisse 

SA for the MosaiQ COVID–19 Antibody 

Magazine. FDA revoked these 

Authorizations under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). 

The revocations, which include an 

explanation of the reasons for each 

revocation, are reprinted in this 

document. 

DATES: The Authorizations are revoked 

as of January 11, 2022. 

ADDRESSES: Submit written requests for 

a single copy of the revocations to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a Fax number to which the 

revocations may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocations. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

240–402–8155 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents. Among 

other things, section 564 of the FD&C 

Act allows FDA to authorize the use of 

an unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On July 1, 

2021, FDA issued an EUA to Bio-Rad 

Laboratories for the BioPlex 2200 

SARS–CoV–2 IgG, subject to the terms 

of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

October 28, 2021 (86 FR 59738), as 

required by section 564(h)(1) of the 

FD&C Act. On September 25, 2020, FDA 

issued an EUA to Quotient Suisse SA 

for the MosaiQ COVID–19 Antibody 

Magazine, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on April 23, 2021 (86 

FR 21749), as required by section 

564(h)(1) of the FD&C Act. Subsequent 

updates to the Authorizations were 

made available on FDA’s website. The 

authorization of a device for emergency 

use under section 564 of the FD&C Act 

may, pursuant to section 564(g)(2) of the 

FD&C Act, be revoked when the criteria 

under section 564(c) of the FD&C Act for 

issuance of such authorization are no 

longer met (section 564(g)(2)(B) of the 

FD&C Act), or other circumstances make 

such revocation appropriate to protect 

the public health or safety (section 

564(g)(2)(C) of the FD&C Act). 

II. EUA Revocation Requests 

In a request received by FDA on 

December 20, 2021, Bio-Rad 

Laboratories requested revocation of, 

and on January 11, 2022, FDA revoked, 

the Authorization for the BioPlex 2200 

SARS–CoV–2 IgG. Because Bio-Rad 

Laboratories notified FDA that Bio-Rad 

Laboratories has not commercialized the 

authorized product in the United States 

and requested FDA revoke the BioPlex 

2200 SARS–CoV–2 IgG, FDA has 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

In a request received by FDA on 

December 22, 2021, Quotient Suisse SA 

requested termination of, and on 

January 11, 2022, FDA revoked, the 

Authorization for the MosaiQ COVID– 

19 Antibody Magazine. Because 

Quotient Suisse SA notified FDA that 

Quotient Suisse SA has decided not to 

continue to commercially support the 

product and requested FDA terminate 

the MosaiQ COVID–19 Antibody 

Magazine, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocations are available on the internet 

at https://www.regulations.gov/. 

IV. The Revocations 

Having concluded that the criteria for 

revocation of the Authorizations under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUA of BioRad Laboratories for the BioPlex 2200 

SARS–CoV–2 IgG and of Quotient 

Suisse SA for the MosaiQ COVID–19 

Antibody Magazine. The revocations in 

their entirety follow and provide an 

explanation of the reasons for each 

revocation, as required by section 

564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 


lotter on DSK11XQN23PROD with NOTICES1