Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Rules and Regulations 34779 

performance characteristics must be 

tested: 

(i) Tensile testing of joints and 

materials; 

(ii) Mechanical integrity testing; 

(iii) Friction testing; 

(iv) Flush testing; 

(v) Air leakage and liquid leakage 

testing; 

(vi) Latching and unlatching testing; 

(vii) Kink and bend testing; 

(viii) Insertion force testing; 

(ix) Torque testing; 

(x) Corrosion testing; and 

(xi) Dimensional tolerance testing. 

(3) Performance data must support the 

sterility and pyrogenicity of the device 

components intended to be provided 

sterile. 

(4) Performance data must support the 

shelf life of the device by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

identified shelf life. 

(5) The patient contacting 

components of the device must be 

demonstrated to be biocompatible. 

(6) Software verification, validation, 

and hazard analysis must be performed. 

(7) Performance data must 

demonstrate electromagnetic 

compatibility (EMC), electrical safety, 

thermal safety, and mechanical safety. 

(8) Human factors performance 

evaluation must demonstrate that the 

user can correctly use the device, based 

solely on reading the directions for use. 

(9) Labeling must include: 

(i) Instructions for use; 

(ii) A shelf life and storage conditions; 

(iii) Compatible procedures; 

(iv) A sizing table; and 

(v) Quantification of blood detected. 

Dated: June 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12364 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[Docket ID: DoD–2020–HA–0040; and DoD– 

2020–HA–0050] 

RIN 0720–AB81; 0720–AB82; and 0720– 

AB83 

TRICARE Coverage and 

Reimbursement of Certain Services 

Resulting From Temporary Program 

Changes in Response to the COVID–19 

Pandemic; Correction 

AGENCY: Office of the Assistant 

Secretary of Defense for Health Affairs, 

Department of Defense (DoD). 

ACTION: Final rule; correction. 

SUMMARY: The DoD is correcting a final 

rule that appeared in the Federal 

Register on June 1, 2022. The Assistant 

Secretary of Defense for Health Affairs 

issued this final rule related to certain 

provisions of three TRICARE interim 

final rules (IFRs) with request for 

comments issued in 2020 in response to 

the novel coronavirus disease 2019 

(COVID–19) public health emergency 

(PHE). Subsequent to publication of the 

final rule, DoD discovered an error in 

the preamble. This document corrects 

that error. 

DATES: This final rule correction is 

effective on July 1, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Erica Ferron, Defense Health Agency, 

Medical Benefits and Reimbursement 

Section, 303–676–3626 or 

erica.c.ferron.civ@mail.mil. Sharon 

Seelmeyer, Defense Health Agency, 

Medical Benefits and Reimbursement 

Section, 303–676–3690 or 

Sharon.l.seelmeyer.civ@mail.mil, 

Diagnosis Related Groups, Hospital 

Value Based Purchasing, Long Term 

Care Hospitals, and New Technology 

Add-On Payments. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2022–10545 appearing at 87 FR 33001– 

33015 in the Federal Register of 

Wednesday, June 1, 2022, the following 

corrections are made: On page 33007, in 

the third column, in section III.B.a.1, 

correct the first paragraph to read: ‘‘The 

IFR temporarily waived the regulatory 

requirement that an individual be an 

inpatient of a hospital for not less than 

three consecutive calendar days before 

discharge from the hospital (three-day 

prior hospital stay) for coverage of a 

SNF admission for the duration of the 

COVID–19 national emergency, 

consistent with a similar waiver under 

Medicare and TRICARE’s statutory 

requirement to have a SNF benefit like 

Medicare’s. The waiver will terminate 

when the President’s national 

emergency for COVID–19 is 

terminated.’’ 

Dated: June 2, 2022. 

Aaron T. Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2022–12263 Filed 6–7–22; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket Number USCG–2022–0444] 

RIN 1625–AA08 

Special Local Regulation; Lake of the 

Ozarks MM 1–6, Lake Ozark, MO 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a special local regulation 

for the navigable waters of the Lake of 

the Ozarks within a 50-yard radius of all 

vessels participating in a boat parade 

starting at the foremost vessel in the 

World’s Largest Parade marine event 

and extending to the last vessel in the 

parade. This special local regulation 

will follow the vessels until the parade’s 

conclusion. The special local regulation 

is needed to protect personnel, vessels, 

and the marine environment from 

potential hazards created by the 

gathering of participant vessels during 

the Parade. Entry of vessels or persons 

into this zone is prohibited unless 

specifically authorized by the Captain of 

the Port Upper Mississippi River. 

DATES: This rule is effective from 10:30 

a.m. through 1 p.m. June 10, 2022. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2022– 

0444 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Lieutenant Commander Stephanie 

Moore, Sector Upper Mississippi River 

Waterways Management Division, U.S. 

Coast Guard; telephone 314–269–2560, 

email Stephanie.R.Moore@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of The Port Sector Upper 

Mississippi River 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 


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