December 10, 2021 – Federal Register Recent Federal Regulation Documents

Qualification of Drivers; Exemption Applications; Vision
Document Number: 2021-26798
Type: Notice
Date: 2021-12-10
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for 102 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
Qualification of Drivers; Exemption Applications; Vision
Document Number: 2021-26797
Type: Notice
Date: 2021-12-10
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for 156 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
Qualification of Drivers; Exemption Applications; Vision
Document Number: 2021-26795
Type: Notice
Date: 2021-12-10
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for 109 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirements in one eye.
Qualification of Drivers; Exemption Applications; Vision
Document Number: 2021-26794
Type: Notice
Date: 2021-12-10
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces receipt of applications from 13 individuals for an exemption from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions will enable these individuals to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
Agency Information Collection Activities: Comment Request; Antarctic Emergency Response Plan and Environmental Protection Information
Document Number: 2021-26793
Type: Notice
Date: 2021-12-10
Agency: National Science Foundation, Agencies and Commissions
The National Science Foundation (NSF) is announcing plans to renew this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting Office of Management and Budget (OMB) clearance of this collection for no longer than 3 years.
Safety Zone; Sacramento New Year's Eve Fireworks, Sacramento River, Sacramento, CA
Document Number: 2021-26792
Type: Rule
Date: 2021-12-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard will enforce the three safety zones in the navigable waters of the Sacramento River near River Walk Park and the Tower Bridge in Sacramento, CA in support of the Sacramento New Year's Eve Fireworks in the Captain of the Port, San Francisco area of responsibility on December 31, 2021. This action is necessary to protect personnel, vessels, and the marine environment from the dangers associated with pyrotechnics. During the enforcement periods noted below, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM) or other federal, state, or local law enforcement agencies on scene to assist the Coast Guard in enforcing the regulated area.
Safety Zone; Frantic Inc Chase Center Fireworks, San Francisco Bay, San Francisco, CA
Document Number: 2021-26791
Type: Rule
Date: 2021-12-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone on the navigable waters of the San Francisco Bay near Chase Center in San Francisco, CA in support of a fireworks display on December 19, 2021. The safety zone is necessary to protect personnel, vessels, and the marine environment from potential hazards created by pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without the permission of the Captain of the Port San Francisco or a designated representative.
Safety Zone; Sausalito Lighted Boat Parade Fireworks Display; Richardson Bay, Sausalito, CA
Document Number: 2021-26790
Type: Rule
Date: 2021-12-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard will enforce the safety zone in the navigable waters of Richardson Bay, off Sausalito, CA, in support of the Sausalito Lighted Boat Parade Fireworks Display. This safety zone is necessary to protect personnel, vessels, and the marine environment from the dangers associated with pyrotechnics. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone, unless authorized by the designated Patrol Commander (PATCOM) or other federal, state, or local agencies on scene to assist the Coast Guard in enforcing the regulated area.
Proposed Agency Information Collection Activities; Comment Request
Document Number: 2021-26789
Type: Notice
Date: 2021-12-10
Agency: Federal Railroad Administration, Department of Transportation
Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, this notice announces that FRA is forwarding the Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collection and its expected burden. On August 23, 2021, FRA published a notice providing a 60-day period for public comment on the ICR.
Airworthiness Directives; Gulfstream Aerospace Corporation Airplanes
Document Number: 2021-26786
Type: Rule
Date: 2021-12-10
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for all Gulfstream Aerospace Corporation (Gulfstream) Model GV and GV-SP airplanes. This AD was prompted by the omission of a life limit in the airworthiness limitations section (ALS) of the maintenance manual for a certain main landing gear (MLG) trunnion pin. This AD requires revising the ALS of your existing instructions for continued airworthiness (ICA) or inspection program for the airplane to establish a life limit of 20,000 flight cycles for the affected MLG trunnion pin. The FAA is issuing this AD to address the unsafe condition on these products.
Amendment of Class E Airspace; Ashland, KY
Document Number: 2021-26785
Type: Rule
Date: 2021-12-10
Agency: Federal Aviation Administration, Department of Transportation
This action amends the Class E airspace extending upward from 700 feet above the surface at Ashland Regional Airport, Ashland, KY, by updating the geographic coordinates of the airport in the airspace legal description to coincide with the FAA's aeronautical database. This action does not change the airspace boundaries or operating requirements.
Notice of Intent To Repatriate Cultural Items: The Field Museum of Natural History, Chicago, IL
Document Number: 2021-26784
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, National Park Service
The Field Museum of Natural History (Field Museum), in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of unassociated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the Field Museum. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Intent To Repatriate Cultural Items: The Field Museum of Natural History, Chicago, IL
Document Number: 2021-26783
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, National Park Service
The Field Museum of Natural History (Field Museum), in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural item listed in this notice meets the definition of an unassociated funerary object. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request to the Field Museum. If no additional claimants come forward, transfer of control of the cultural item to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Intent To Repatriate Cultural Items: American Museum of Natural History, New York, NY
Document Number: 2021-26782
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, National Park Service
The American Museum of Natural History in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural item listed in this notice meets the definition of an unassociated funerary object. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request to the American Museum of Natural History. If no additional claimants come forward, transfer of control of the cultural item to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Sam Noble Oklahoma Museum of Natural History, University of Oklahoma, Norman, OK
Document Number: 2021-26781
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, National Park Service
The Sam Noble Oklahoma Museum of Natural History (Museum) at the University of Oklahoma has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Museum. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Arizona Museum of Natural History, Mesa, AZ
Document Number: 2021-26780
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, National Park Service
The Arizona Museum of Natural History has completed an inventory of human remains and an associated funerary object, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary object and present- day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary object should submit a written request to the Arizona Museum of Natural History. If no additional requestors come forward, transfer of control of the human remains and associated funerary object to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2021-26778
Type: Notice
Date: 2021-12-10
Agency: Federal Reserve System, Agencies and Commissions
Electronic Tax Administration Advisory Committee (ETAAC) Nominations
Document Number: 2021-26776
Type: Notice
Date: 2021-12-10
Agency: Internal Revenue Service, Department of Treasury
The Internal Revenue Service (IRS) is requesting applications from individuals with experience in such areas as state tax administration, cybersecurity and information security, tax software development, tax preparation, payroll and tax financial product processing, systems management and improvement, implementation of customer service initiatives, public administration, and consumer advocacy to be considered for selection as members of the Electronic Tax Administration Advisory Committee (ETAAC).
New Postal Product
Document Number: 2021-26775
Type: Notice
Date: 2021-12-10
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Certain Carbon and Alloy Steel Cut-To-Length Plate From Germany: Final Results of Antidumping Duty Administrative Review; 2019-2020
Document Number: 2021-26774
Type: Notice
Date: 2021-12-10
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) determines that AG der Dillinger H[uuml]ttenwerke (Dillinger) did not make sales of certain carbon and alloy steel cut-to-length plate from Germany at less than normal value during the period of review (POR), May 1, 2019, through April 30, 2020.
Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes From Turkey: Notice of Initiation and Preliminary Results of Changed Circumstances Review
Document Number: 2021-26773
Type: Notice
Date: 2021-12-10
Agency: Department of Commerce, International Trade Administration
In response to a request for a changed circumstances review (CCR), the Department of Commerce (Commerce) is initiating a CCR of the antidumping duty (AD) order on heavy walled rectangular welded carbon steel pipes and tubes (HWR pipes and tubes) from Turkey. We preliminarily determine that Ozdemir Boru Profil Sanayi ve Ticaret Sirketi (A.S.) (Ozdemir AS) is the successor-in-interest to Ozdemir Boru Profil Sanayi ve Ticaret Limited Sirketi (Ozdemir Ltd. Sti.). Interested parties are invited to comment on these preliminary results.
Certain Cold-Drawn Mechanical Tubing of Carbon and Alloy Steel From India: Final Results of Countervailing Duty Administrative Review; 2019
Document Number: 2021-26772
Type: Notice
Date: 2021-12-10
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) finds countervailable subsidies are being provided to Goodluck India Limited (Goodluck) and Tube Investments of India Ltd. (TII), producers/exporters of certain cold-drawn mechanical tubing of carbon and alloy steel (cold-drawn mechanical tubing) from India during the period of review, January 1, 2019, through December 31, 2019.
Certain Frozen Warmwater Shrimp From India: Final Results of Antidumping Duty Administrative Review; 2019-2020; Correction
Document Number: 2021-26771
Type: Notice
Date: 2021-12-10
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) published a notice in the Federal Register of November 26, 2021 in which Commerce issued the final results of the 2019-2020 administrative review of the antidumping order on certain frozen warmwater shrimp from India. This notice incorrectly spelled the name of one company listed in Appendix II.
Call for Nominations to the San Juan Islands National Monument Advisory Committee, Washington
Document Number: 2021-26770
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, Bureau of Land Management
The purpose of this notice is to request public nominations to the Bureau of Land Management's (BLM) San Juan Islands National Monument Advisory Committee (MAC). This citizen-based committee advises the Secretary of the Interior with respect to the preparation and implementation of the San Juan Islands National Monument Management Plan.
Notice of Inventory Completion: University of Colorado Museum, Boulder, CO
Document Number: 2021-26769
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, National Park Service
The University of Colorado Museum has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the University of Colorado Museum. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: U.S. Department of the Interior, Bureau of Land Management, Alaska State Office, Anchorage, AK
Document Number: 2021-26768
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, National Park Service
The U.S. Department of the Interior, Bureau of Land Management, Alaska State Office (BLM) has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the BLM. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Information Collection: NRC Form 7, Application for NRC Export/Import License Amendment, Renewal, or Consent Request(s)
Document Number: 2021-26767
Type: Notice
Date: 2021-12-10
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, NRC Form 7, ``Application for NRC Export/Import License Amendment, Renewal, or Consent Request(s).''
Notice of Public Meeting, San Rafael Swell Recreation Area Advisory Council, Utah
Document Number: 2021-26766
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act, the Federal Advisory Committee Act, and the Federal Lands Recreation Enhancement Act, the U.S. Department of the Interior, Bureau of Land Management's (BLM) San Rafael Swell Recreation Area Advisory Council (Council) will meet as follows.
Applications for New Awards; Research Networks Focused on Critical Problems of Education Policy and Practice, and Improving Pandemic Recovery Efforts in Education Agencies
Document Number: 2021-26765
Type: Notice
Date: 2021-12-10
Agency: Department of Education
The Department of Education (Department) is issuing a notice inviting applications for new awards for fiscal year (FY) 2022 for the Research Networks Focused on Critical Problems of Education Policy and Practice, and the Improving Pandemic Recovery Efforts in Education Agencies, Assistance Listing Numbers 84.305N and 84.305X. This notice relates to the approved information collection under OMB control number 4040-0001.
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organizations and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers
Document Number: 2021-26764
Type: Rule
Date: 2021-12-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notification is to inform the public that CMS is exercising its discretion in how it enforces the payer-to-payer data exchange provisions. As a matter of enforcement discretion, CMS does not expect to take action to enforce compliance with these specific provisions until we are able to address certain implementation challenges.
Notice To Establish a New Federal Lands Recreation Enhancement Act Site at Canyon Ferry Reservoir, Helena, Montana
Document Number: 2021-26763
Type: Notice
Date: 2021-12-10
Agency: Department of the Interior, Bureau of Reclamation
The Bureau of Reclamation is proposing to designate Canyon Ferry Reservoir as a new site under the Federal Lands Recreation Enhancement Act which will authorize retention of recreation user fees for overnight camping, group use shelters, and special use permits.
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to U.S. Navy 2022 Ice Exercise Activities in the Arctic Ocean
Document Number: 2021-26762
Type: Notice
Date: 2021-12-10
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS has received a request from the U.S. Navy (Navy) for authorization to take marine mammals incidental to Ice Exercise 2022 (ICEX22) north of Prudhoe Bay, Alaska. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision. The Navy's activities are considered military readiness activities pursuant to the MMPA, as amended by the National Defense Authorization Act for Fiscal Year 2004 (2004 NDAA).
Approval of Subzone Status, Getinge Group Logistics Americas LLC, Dayton, New Jersey
Document Number: 2021-26760
Type: Notice
Date: 2021-12-10
Agency: Department of Commerce, Foreign-Trade Zones Board
Submission for OMB Review; Comment Request
Document Number: 2021-26759
Type: Notice
Date: 2021-12-10
Agency: Department of Agriculture
Notice of OFAC Sanctions Actions
Document Number: 2021-26758
Type: Notice
Date: 2021-12-10
Agency: Department of the Treasury, Office of Foreign Assets Control
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
Multi-Family Housing Non-Profit Transfer Technical Assistance Grants
Document Number: 2021-26757
Type: Notice
Date: 2021-12-10
Agency: Department of Agriculture, Rural Housing Service
The Rural Housing Service (RHS), a Rural Development agency (Agency) of the United States Department of Agriculture (USDA), announces the availability of $3 million and the timeframe to submit applications for Multi-Family Housing Non-Profit Transfer Technical Assistance (MFHNPTA) Grants program from qualified nonprofits (NP) and public housing authorities (PHA) to provide technical assistance to RHS Multi-Family Housing (MFH) borrowers and applicants to facilitate the acquisition of Section 515 properties by NPs and PHAs.
Safety Zone; Pensacola Bay, Pensacola Beach, FL
Document Number: 2021-26755
Type: Rule
Date: 2021-12-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone for all navigable waters within 100 yards from the pilings, work equipment, and structures of the Pensacola Bay Bridge, Pensacola Beach, FL, including the channel at the center span. This temporary safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by repair work on the bridge. Entry of vessels or persons into this zone is prohibited unless specifically authorized the Captain of the Port Sector Mobile (COTP) or a designated representative.
Withdrawal of Proposed Revision to Department Homeland Security Acquisition Regulation (HSAR); Privacy Training (HSAR Case 2015-003)
Document Number: 2021-26754
Type: Proposed Rule
Date: 2021-12-10
Agency: Department of Homeland Security
DHS is withdrawing a proposed rule titled Privacy Training (HSAR Case 2015-003) and providing notice of its cancellation. The Notice of Proposed Rulemaking proposed to amend the HSAR to require contractor and subcontractor employees to complete Privacy training before accessing a Government system of records; handling Personally Identifiable Information (PII) and/or Sensitive Personally Identifiable Information; or designing, developing, maintaining, or operating a Government system of records. DHS is withdrawing this proposed rule because the content of this proposal was addressed in a final rule issued by the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council and resultant DHS FAR Class Deviation Number 17-03, Implementation of FAR 52.224-3 Privacy Training Alternate I. Thus, DHS will not take any further action on this proposal.
Modernizing Electricity Market Design; Notice Inviting Post-Technical Conference Comments
Document Number: 2021-26751
Type: Notice
Date: 2021-12-10
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2021-26748
Type: Notice
Date: 2021-12-10
Agency: Department of Energy, Federal Energy Regulatory Commission
Environmental Impact Statements; Notice of Availability
Document Number: 2021-26743
Type: Notice
Date: 2021-12-10
Agency: Environmental Protection Agency
Arts Advisory Panel Meetings
Document Number: 2021-26742
Type: Notice
Date: 2021-12-10
Agency: National Foundation on the Arts and the Humanities, Agencies and Commissions, National Endowment for the Arts
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 7 meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference or videoconference.
Medical Devices; General and Plastic Surgery Devices; Classification of the Negative Pressure Wound Therapy Device for Reduction of Wound Complications
Document Number: 2021-26741
Type: Rule
Date: 2021-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is classifying the negative pressure wound therapy device for reduction of wound complications 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 negative pressure wound therapy device for reduction of wound complications' 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.
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