19956 Federal Register / Vol. 87, No. 66 / Wednesday, April 6, 2022 / Notices 

181See supra I.B.5. 

182 In line with CDC’s emphasis on the 

importance of vaccination, CDC has kept its 

requirement for noncitizens to provide proof of 

vaccination for air travel and also supports DHS’s 

Order requiring the same at the land borders (see 

supra notes 67 and 83). 

183 ‘‘Persons whom customs officers determine, 

with approval from a supervisor, should be 

excepted from this Order based on the totality of the 

circumstances, including consideration of 

significant law enforcement, officer and public 

safety, humanitarian, and public health interests. 

DHS will consult with CDC regarding the standards 

for such exceptions to help ensure consistency with 

current CDC guidance and public health 

recommendations.’’ 86 FR 42828, 42841 (Aug. 5, 

2021). 

184 42 U.S.C. 268; 42 CFR 71.40(d). 

185While this Termination is not a rule subject to 

notice and comment under the APA (5 U.S.C. 553), 

the Office of Information and Regulatory Affairs has 

determined that this is a major rule as defined by 

Subtitle E of the Small Business Regulatory 

Enforcement Fairness Act of 1996, also known as 

the Congressional Review Act (CRA). 5 U.S.C. 

804(2). The agency finds, for the reasons listed 

above, that good cause exists to make this rule 

effective on May 23, 2022, under 5 U.S.C. 808(2). 

186 5 U.S.C. 553(b)(3)(B). 

187 5 U.S.C. 553(a)(1). 188 5 U.S.C. 553(a)(1). 

authorities; this program will be scaled 

up over the next two months.181 As 

stated above, CDC recognizes 

vaccination as the single most important 

public health tool for fighting COVID– 

19 and recommends that all eligible 

persons, regardless of citizenship, be 

vaccinated and remain up to date with 

boosters.182 The implementation 

timeline of this Termination will 

provide DHS with time to scale its 

vaccination program, as well as ready its 

operational capacity, implement 

appropriate COVID–19 protocols, and 

prepare for resumption of regular 

migration under Title 8. 

CDC recognizes that the Termination 

of the August Order will lead to an 

increase in the number of noncitizens 

being processed in DHS facilities which 

could result in overcrowding in 

congregate settings. Moreover, DHS 

projects, based on available intelligence 

as well as seasonal migration patterns, 

an increase in encounters in the coming 

months, which could lead to further 

crowding in DHS facilities. DHS reports 

that it is taking steps to plan for such 

increases, including by readying 

decompression plans, deploying 

additional personnel and resources to 

support U.S. Border Patrol, and 

enhancing its ability to safely hold 

noncitizens it encounters. Putting such 

plans in place, ensuring that the 

workforce is adequately and appropriate 

trained for their shifting roles, and 

deploying critical resources require 

time. This Termination will be 

implemented on May 23, 2022, to 

provide DHS with additional time to 

ready such operational plans and 

prepare for full resumption of regular 

migration under Title 8. 

For the foregoing reasons, this 

Termination will be implemented on 

May 23, 2022. To the extent that any 

state or local government has a 

misplaced reliance interest on the 

August Order, the timeline for 

implementation of the Termination also 

allows time for such entities to adjust 

their planning in anticipation of the full 

resumption of Title 8 border processing. 

During this temporary period of 

continued application of the August 

Order, DHS will continue to exercise its 

discretion to issue case-by-case 

exceptions based on the totality of the 

circumstances as set forth in the August 

Order.183 DHS has represented that it 

will continue to make use of this 

exception where, for example, a 

noncitizen may suffer particular harms 

associated with expulsion (e.g., 

vulnerable and medically fragile 

persons) until the Termination is 

effective. 

B. APA Review 

This Termination shall be 

implemented on May 23, 2022. I 

consulted with DHS and other federal 

departments as required by the Final 

Rule before I issued this Order and 

requested that DHS aid in the 

implementation of this Termination.184

DHS is developing operational plans for 

implementing this Termination. CDC 

will review these plans and ensure that 

they are consistent with the language of 

this Termination and public health best 

practices. 

This Termination, like the preceding 

Orders issued under this authority, is 

not a rule subject to notice and 

comment under the Administrative 

Procedure Act (APA).185 Even if it were, 

notice and comment are not required 

because there is good cause to dispense 

with prior public notice and the 

opportunity to comment on this 

Termination.186 Given the extraordinary 

nature of an order under Section 265, 

the resultant restrictions on application 

for asylum and other immigration 

processes under Title 8, and the 

statutory and regulatory requirement 

that an CDC order under the authority 

last no longer than necessary to protect 

public health, it would be impracticable 

and contrary to the public interest and 

immigration laws that apply in the 

absence of an order under 42 U.S.C. 265 

to delay the effective date of this 

termination beyond May 23, 2022 for 

the reasons outlined herein.187 As 

explained, DHS requires time to 

institute operational plans to implement 

this order, including COVID–19 

mitigation measures, and begin regular 

immigration processing pursuant to 

Title 8. In light of the August Order’s 

significant disruption of ordinary 

immigration processing and DHS’s need 

for time to implement an orderly and 

safe termination of the order, there is 

good cause not to delay issuing this 

termination or to delay the termination 

of this order past May 23, 2022. In 

addition, this Order concerns ongoing 

discussions with Canada, Mexico, and 

other countries regarding immigration 

and how best to control COVID–19 

transmission over shared borders and 

therefore directly ‘‘involve[s] . . . a . . . 

foreign affairs function of the United 

States;’’ 188 thus, notice and comment 

are not required. 

With this Termination, I hereby 

determine that the danger of further 

introduction, transmission, or spread of 

COVID–19 into the United States from 

covered noncitizens, as defined in the 

August Order, has ceased to be a serious 

danger to the public health and 

therefore the continuation of the August 

Order, and all previous orders issued 

under the same authority, is no longer 

necessary to protect public health. 

Nothing in this Termination will 

prevent me from issuing a new Order 

under 42 U.S.C. 265, 268 and 42 CFR 

71.40 based on new findings, as dictated 

by public health needs. 

Sherri Berger, 

Chief of Staff, Centers for Disease Control 

and Prevention. 

[FR Doc. 2022–07306 Filed 4–4–22; 11:15 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Board on Radiation and 

Worker Health (ABRWH); Notice of 

Charter Renewal 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of charter renewal. 

SUMMARY: This gives notice under the 

Federal Advisory Committee Act of 

October 6, 1972, that the Advisory 

Board on Radiation and Worker Health 

(ABRWH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services, has been renewed 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 66 / Wednesday, April 6, 2022 / Notices 19957 

for a 2-year period through March 22, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Rashaun Roberts, Ph.D., Designated 

Federal Officer, National Institute for 

Occupational Safety and Health, CDC, 

1090 Tusculum Avenue, Mailstop C–24, 

Cincinnati, Ohio 45226, Telephone: 

(513) 533–6800, Email: ocas@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–07241 Filed 4–5–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10511 and CMS– 

10440] 

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 

June 6, 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–10511 Medicare Coverage of 

Items and Services in FDA 

Investigational Device Exemption 

Clinical Studies—Revision of 

Medicare Coverage 

CMS–10440 Data Collection to 

Support Eligibility Determinations for 

Insurance Affordability Programs and 

Enrollment through Health Insurance 

Marketplaces, Medicaid and 

Children’s Health Insurance Program 

Agencies 

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: Reinstatement without change; 

Title of Information Collection: 

Medicare Coverage of Items and 

Services in FDA Investigational Device 

Exemption Clinical Studies—Revision 

of Medicare Coverage; Use: Section 

1862(m) of the Social Security Act (and 

regulations at 42 CFR Subpart B 

(sections 405.201–405.215) allows for 

payment of the routine costs of care 

furnished to Medicare beneficiaries in a 

Category A investigational device 

exemption (IDE) study and authorizes 

the Secretary to establish criteria to 

ensure that Category A IDE trials 

conform to appropriate scientific and 

ethical standards. Medicare does not 

cover the Category A device itself 

because Category A (Experimental) 

devices do not satisfy the statutory 

requirement that Medicare pay for 

devices determined to be reasonable and 

necessary. Medicare may cover Category 

B (Non-experimental) devices, and 

associated routine costs of care, if they 

are considered reasonable and necessary 

and if all other applicable Medicare 

coverage requirements are met. 

Under the current centralized review 

process, interested parties (such as 

study sponsors) that wish to seek 

Medicare coverage related to Category A 

or B IDE studies have a centralized 

point of contact for submission, review 

and determination of Medicare coverage 

IDE study requests. In order for CMS (or 

its designated entity) to determine if the 

Medicare coverage criteria are met, as 

described in our regulations, CMS (or its 

designated entity) must review 

documents submitted by interested 

parties or study sponsors. Such 

information submitted will be a FDA 

IDE approval letter, IDE study protocol, 

IRB approval letter, National Clinical 

Trials (NCT) number, and Supporting 

materials as needed. Form Number: 

CMS–10511 (OMB control number: 


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