Unknown. Final amendment; final order

3,889 words·~18 min read·/register/2024/09/03/2024-19725·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2024-09-03.xml --- 89 170 Tuesday, September 3, 2024 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Forest Service Animal Animal and Plant Health Inspection Service NOTICES Environmental Assessments; Availability, etc.: Release of Bagous nodulosus for Biological Control of Flowering Rush in the Continental United States, 71250-71251 2024-19639 Hearings, Meetings, Proceedings, etc.:

National Wildlife Services Advisory Committee, 71250 2024-19632 Architectural Architectural and Transportation Barriers Compliance Board PROPOSED RULES Guidance: Americans with Disabilities Act and Architectural Barriers Act Accessibility Guidelines; EV Charging Stations, 71215-71229 2024-18820 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71273-71276, 71279-71283 2024-19611 2024-19612 2024-19613 2024-19614 2024-19615 Hearings, Meetings, Proceedings, etc.:

Advisory Board on Radiation and Worker Health, Subcommittee for Procedure Reviews, 71277 2024-19622 Advisory Committee to the Director, 71276-71277 2024-19623 World Trade Center Health Program Scientific/Technical Advisory Committee, 71277-71279 2024-19624 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71283-71284 2024-19733 Secretarial Review and Publication of the Consensus Based Entity Report of 2023 Activities, 71284-71371 2024-19479 Children Children and Families Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Office of Community Services Affordable Housing and Supportive Services Demonstration Data Collection, 71371-71372 2024-19695 Coast Guard Coast Guard RULES Drawbridge Operation: Okeechobee Waterway, Stuart, FL; Correction, 71184 2024-19697 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71379-71381 2024-19710 2024-19711 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Debt Cancellation Contracts and Debt Suspension Agreements, 71783-71784 2024-19637 Drug Drug Enforcement Administration NOTICES Decision and Order: Stephen McCarthy, PA, 71427-71431 2024-19730 Education Department Education Department NOTICES Federal Need Analysis Methodology for the 2025-26 Award Year: Federal Pell Grant, Federal Work-Study, Federal Supplemental Educational Opportunity Grant, William D. Ford Federal Direct Loan, and TEACH Grant Programs, 71261-71263 2024-19670 Energy Department Energy Department See Energy Information Administration See Federal Energy Regulatory Commission NOTICES Hearings, Meetings, Proceedings, etc.:

Basic Energy Sciences Advisory Committee, 71263-71264 2024-19700 Energy Information Energy Information Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71264-71265 2024-19703 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: New Jersey; NOx State Implementation Plan Call and Removal of Clean Air Interstate Rule, 71185-71188 2024-19699 PROPOSED RULES Air Quality State Implementation Plans;

Approvals and Promulgations: Texas; Control of Air Pollution from Visible Emissions and Particulate Matter, 71237-71249 2024-19600 Texas; Freestone-Anderson and Titus Counties; Determination of Attainment by the Attainment Date for the 2010 1-Hour Primary Sulfur Dioxide National Ambient Air Quality Standard, 71230-71237 2024-19599 NOTICES Application for Emergency Exemption: Ortho-phthalaldehyde, 71268-71269 2024-19601 Proposed Settlement Agreement, Stipulation, Order, and Judgment, etc.:

Consent for Removal Actions and Recovery of Past Response Costs at the Max Johnson No. 9, Manuel Denetsone No. 2, and Juan Horse No. 3 Abandoned Uranium Mine Sites, Navajo Nation, Coconino County, AZ, 71272 2024-19709 Payment of Past Basin-Wide Remedial Investigation Response Costs at the Glendale North and South Operable Units of the San Fernando Valley (Area 2) Superfund Site in Glendale, CA, 71269-71270 2024-19708 Risk Evaluations for Chemical Substances, 71270-71272 2024-19698 Farm Credit Farm Credit Administration NOTICES Meetings;

Sunshine Act, 71272 2024-19798 Federal Aviation Federal Aviation Administration PROPOSED RULES Airspace Designations and Reporting Points: Buckley Space Force Base, Aurora, CO, 71191-71193 2024-19589 Guernsey, WY, 71189-71190 2024-19588 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Assistance to Individuals and Households Program, 71382-71383 2024-19693 Federal Energy Federal Energy Regulatory Commission NOTICES Application:

Alabama Power Co., 71265-71266 2024-19690 Combined Filings, 71266-71268 2024-19688 2024-19692 Records Governing Off-the-Record Communications, 71265 2024-19689 Federal Maritime Federal Maritime Commission NOTICES Filing: International Lumber Imports, Inc., Complainant, v. CEVA Freight, LLC; ZIM Integrated Shipping Service Ltd.; and ZIM American Integrated Shipping Services Company Co. LLC, Respondents, 71273 2024-19672 Food and Drug Food and Drug Administration RULES Medical Devices:

Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea, 71153-71155 2024-19725 Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder, 71155-71156 2024-19720 Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device, 71157-71159 2024-19726 Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression, 71159-71160 2024-19722 NOTICES Emergency Use Authorization:

In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Revocation, 71372-71374 2024-19724 Request for Information: Identifying Priority Focus Areas for Future Guidance Development and Engagement with Interested Parties in Model-Informed Drug Development, 71374-71376 2024-19712 Forest Forest Service NOTICES Proposed Recreation Fee Site, 71251-71252 2024-19610 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration Health Resources Health Resources and Services Administration NOTICES Charter Amendments, Establishments, Renewals and Terminations:

Advisory Committee on Organ Transplantation, 71376-71377 2024-19618 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See Transportation Security Administration See U.S. Citizenship and Immigration Services See U.S. Customs and Border Protection Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 2023 American Housing Survey, 71384-71385 2024-19706 Interior Interior Department See National Park Service See Ocean Energy Management Bureau See Surface Mining Reclamation and Enforcement Office Internal Revenue Internal Revenue Service PROPOSED RULES Guidance:

Clean Electricity Low-Income Communities Bonus Credit Amount Program, 71193-71214 2024-19617 Rules Regarding Dual Consolidated Losses and the Treatment of Certain Disregarded Payments; Correction, 71214-71215 2024-19027 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Revenue Procedure Waiver of 60-Day Rollover Requirement, 71787-71788 2024-19598 Superfund Tax on Chemical Substances: Modification to List of Taxable Substances; Filing for Diethylene Glycol Monomethyl Ether, 71788-71789 2024-19602 Modification to List of Taxable Substances;

Filing for Ethylene Glycol Phenyl Ether, 71785-71786 2024-19603 Modification to List of Taxable Substances; Filing for Methoxytriglycol, 71789 2024-19604 Modification to List of Taxable Substances; Filing for Propylene Glycol Methyl Ether, 71784-71785 2024-19607 Modification to List of Taxable Substances; Filing for Propylene Glycol Methyl Ether Acetate, 71789-71790 2024-19608 Modification to List of Taxable Substances; Filing for Propylene Glycol n-Propyl Ether, 71791 2024-19606 Modification to List of Taxable Substances;

Filing for Propylene Glycol Phenyl Ether, 71786-71787 2024-19605 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Advance Notification of Sunset Review, 71252 2024-19715 Initiation of Five-Year Sunset Reviews, 71252-71253 2024-19716 Opportunity to Request Administrative Review and Join Annual Inquiry Service List, 71254-71257 2024-19714 International Trade Com International Trade Commission NOTICES Investigations;

Determinations, Modifications, and Rulings, etc.: Certain Welded Large Diameter Line Pipe from Japan, 71417-71419 2024-19665 Circular Welded Carbon Quality Steel Line Pipe from China, 71419-71422 2024-19666 Diffusion-Annealed, Nickel-Plated Flat-Rolled Steel Products from Japan, 71424-71427 2024-19640 Fine Denier Polyester Staple Fiber, 71422-71424 2024-19673 Refillable Stainless Steel Kegs from China and Mexico, 71411-71414 2024-19668 Uncovered Innerspring Units from China, South Africa, and Vietnam, 71414-71416 2024-19667 Justice Department Justice Department See Drug Enforcement Administration National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Examining the Effectiveness of Lane Departure Warning and Lane Keep Assist Advanced Driver Assistance Systems for Improving Driver Response, 71777-71783 2024-19625 National Institute National Institutes of Health NOTICES Hearings, Meetings, Proceedings, etc.: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 71377 2024-19647 2024-19651 National Cancer Institute, 71377 2024-19701 National Oceanic National Oceanic and Atmospheric Administration NOTICES Hearings, Meetings, Proceedings, etc.:

Western Pacific Fishery Management Council; Correction, 71257-71259 2024-19705 Permits; Applications, Issuances, etc.: Marine Mammals; File No. 23188, 71259 2024-19636 National Park National Park Service NOTICES Intended Disposition: U.S. Army Corps of Engineers, Walla Walla District, Walla Walla, WA, 71393 2024-19676 Inventory Completion: Eastern Washington University, Cheney, WA, 71397-71398 2024-19679 Field Museum, Chicago, IL, 71392 2024-19675 Hartwick College, Oneonta, NY, 71391-71392 2024-19678 Hood Museum of Art, Dartmouth College, Hanover, NH, 71390-71391 2024-19686 Museum of Texas Tech University, Lubbock, TX, 71394-71397 2024-19674 2024-19680 Science Museum of Minnesota, Saint Paul, MN, 71385-71387 2024-19684 U.S.

Army Corps of Engineers, Omaha District, and Hood Museum of Art, Dartmouth College, Hanover, NH, 71393-71394 2024-19685 University of Michigan, Ann Arbor, MI, 71388-71389 2024-19682 Repatriation of Cultural Items: Denver Museum of Nature & Science, Denver, CO, 71388 2024-19681 Indiana University, Bloomington, IN, 71389-71390 2024-19677 Wesleyan University, Middletown, CT, 71387-71388 2024-19683 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 71431-71432 2024-19780 2024-19782 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Facility Operating Licenses:

Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 71433-71447 2024-18833 2024-19687 Petition: Pacific Gas and Electric Co.; Diablo Canyon Power Plant, Unit Nos. 1 and 2, 71432-71433 2024-19630 Ocean Energy Management Ocean Energy Management Bureau RULES Protection of Marine Archaeological Resources, 71160-71184 2024-19188 NOTICES Wind Lease Sale: Outer Continental Shelf Offshore Oregon, 71398-71410 2024-19619 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Recording Assignments, 71259-71260 2024-19669 Hearings, Meetings, Proceedings, etc.: National Medal of Technology and Innovation Nomination Evaluation Committee, 71260-71261 2024-19664 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 71447-71448 2024-19621 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71673-71676 2024-19628 2024-19629 Application: 24X National Exchange LLC, 71471-71472 2024-19646 Meetings;

Sunshine Act, 71673 2024-19818 Self-Regulatory Organizations; Proposed Rule Changes: BOX Exchange LLC, 71448-71471 2024-19652 Cboe BYX Exchange, Inc., 71650-71673 2024-19659 Cboe BZX Exchange, Inc., 71724-71747 2024-19645 Cboe C2 Exchange, Inc., 71501-71524 2024-19662 Cboe EDGA Exchange, Inc., 71676-71699 2024-19649 Cboe EDGX Exchange, Inc., 71601-71624 2024-19653 Cboe Exchange, Inc., 71570-71593 2024-19642 Depository Trust Co., 71773 2024-19643 Fixed Income Clearing Corp., 71593-71597 2024-19657 Investors Exchange LLC, 71747-71770 2024-19655 MEMX LLC, 71547-71570 2024-19658 Miami International Securities Exchange, LLC, 71472-71495 2024-19654 MIAX Emerald, LLC, 71524-71547 2024-19644 MIAX Sapphire, LLC, 71496-71501, 71624-71646 2024-19641 2024-19660 Nasdaq BX, Inc., 71722-71724 2024-19661 Nasdaq ISE, LLC, 71770-71773 2024-19663 National Securities Clearing Corp., 71646-71650 2024-19656 New York Stock Exchange LLC, 71699-71722 2024-19648 The Depository Trust Co., 71597-71601 2024-19650 Small Business Small Business Administration NOTICES Disaster Declaration:

Kentucky; Public Assistance Only, 71773 2024-19691 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Affidavit of Relationship, 71774-71775 2024-19620 Statement of Registration, 71773-71774 2024-19634 Hearings, Meetings, Proceedings, etc.: U.S. Advisory Commission on Public Diplomacy, 71775 2024-19704 Substance Substance Abuse and Mental Health Services Administration NOTICES List of Certified Laboratories and Instrumented Initial Testing Facilities that Meet Minimum Standards to Engage in Urine Drug Testing, 71377-71379 2024-19671 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Maintenance of State Programs and Procedures for Substituting Federal Enforcement of State Programs and Withdrawing Approval of State Programs, 71410-71411 2024-19732 Trade Representative Trade Representative, Office of United States NOTICES Request for Comments: Significant Foreign Trade Barriers for the 2025 National Trade Estimate Report, 71775-71777 2024-19694 Transportation Department Transportation Department See Federal Aviation Administration See National Highway Traffic Safety Administration Security Transportation Security Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: TSA PreCheck Application Program; Correction, 71383-71384 2024-19626 Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Due Diligence Programs for Correspondent Accounts for Foreign Financial Institutions and for Private Banking Accounts, 71791-71792 2024-19635 U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Online Request to be a Supporter and Declaration of Financial Support, 71384 2024-19842 Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Global Interoperability Standard, 71381-71382 2024-19627 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Trainee Request for Leave (Chapter 31, Veteran Readiness and Employment), 71794 2024-19723 Hearings, Meetings, Proceedings, etc.:

Advisory Committee on Minority Veterans, 71793 2024-19728 National Academic Affiliations Council, 71792-71793 2024-19631 Veterans' Advisory Committee on Rehabilitation, 71792 2024-19707 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 89 170 Tuesday, September 3, 2024 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 872 [Docket No.

FDA-2024-N-3948] Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; final order. SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is classifying the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea's classification.

We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices. DATES: This order is effective September 3, 2024. The classification was applicable on February 5, 2021. FOR FURTHER INFORMATION CONTACT: Anita Belani, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.

G236, Silver Spring, MD 20993-0002, 301-796-3944, *Anita.Belani@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device.

Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure.

A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act).

As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the 510(k) process, when necessary, to market their device. II. De Novo Classification On March 24, 2020, FDA received Signifier Medical Technologies' request for De Novo classification of the eXciteOSA without remote control, eXciteOSA with remote control device.

FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)).

After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on February 5, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 872.5575. 1 We have named the generic type of device neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea, and it is identified as a device that consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea. 1 FDA notes that the “ACTION” caption for this final order is styled as “Final amendment; final order,” rather than “Final order.

” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's

(OFR)interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. Table 1—Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea Risks and Mitigation Measures Identified risks to health Mitigation measures Adverse tissue reaction Biocompatibility evaluation. Interference with other devices/electrical shock Electrical safety testing, Electromagnetic compatibility

(EMC)testing, Battery safety testing, Wireless coexistence testing, and Labeling. Use error leading to pain, discomfort, or injury Human factors assessment; Software verification, validation, and hazard analysis; Electrical safety testing; and Labeling. Mucosal or skin overheating or burn Software validation, verification, hazard analysis; Electrical safety testing; Electromagnetic compatibility

(EMC)testing; and Labeling. Infection Labeling. FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. III. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 872 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 872 is amended as follows: PART 872—DENTAL DEVICES 1. The authority citation for part 872 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 872.5575 to subpart F to read as follows: § 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.

(a)*Identification.* A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.

(b)*Classification.* Class II (special controls). The special controls for this device are:

(1)Performance testing must demonstrate the wireless compatibility, electrical safety, battery safety, and electromagnetic compatibility of the device in its intended use environment.

(2)Software verification, validation, and hazard analysis must be performed.

(3)The patient-contacting components of the device must be demonstrated to be biocompatible.

(4)Patient labeling must include:

(i)Information on device components, setup, and use of the device including placement of sensors and mouthpieces, and images or illustrations;

(ii)A summary of technical specifications;

(iii)Instructions on how to clean and maintain the device;

(iv)A statement that the patient should maintain regular follow up visits with dentist and sleep specialist; and

(v)A statement that patients should have a comprehensive dental examination prior to using this device.

(5)A human factors assessment must evaluate simulated use of the device to demonstrate that the user can correctly use device based on the labeling and instructions for use. Dated: August 28, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-19725 Filed 8-30-24; 8:45 am]

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