Unknown. Final rule

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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-2011-06-15.xml --- 76 115 Wednesday, June 15, 2011 Contents Agriculture Agriculture Department See Federal Crop Insurance Corporation See Forest Service See Rural Housing Service Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Investigator Integrity Questionnaire, 35016-35017 2011-14726 Antitrust Division Antitrust Division NOTICES Proposed Final Judgments:

U.S. et al. v. United Regional Health Care System, 35017-35022 2011-14628 Army Army Department NOTICES Grant of an Exclusive License of U.S. Government-Owned Inventions, 34968 2011-14802 Licensing of Inventions Concerning Intrepid Dynamic Exoskeletal Orthosis, 34968 2011-14803 Licensing of Inventions: Methods and Compositions for Treating Status Epilepticus and Seizures Causing Status Epilepticus, 34968-34969 2011-14801 Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 34995-34998 2011-14788 2011-14791 2011-14792 Children Children and Families Administration See Refugee Resettlement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 34998-34999 2011-14627 2011-14626 Coast Guard Coast Guard RULES Drawbridge Operation Regulations: Atlantic Intracoastal Waterway, Elizabeth River, Southern Branch, Chesapeake, VA, 34848-34852 2011-14824 Safety Zones: Annual Fireworks Events in the Captain of the Port Detroit Zone, 34867-34868 2011-14776 Augusta Southern Nationals Drag Boat Race, Savannah River, Augusta, GA, 34859-34862 2011-14826 Chicago Harbor, Navy Pier Southeast, Chicago, IL, 34854-34855 2011-14829 Fireworks Displays in the Captain of the Port Columbia River Zone, 34862 2011-14832 Fireworks Displays in the Sector Columbia River Area of Responsibility, 34852-34854 2011-14781 M/V DAVY CROCKETT, Columbia River, 34862-34864 2011-14775 Marine Events in Captain of the Port Long Island Sound Zone, 34855-34859 2011-14828 Rochester Harbor Festival, Genesee River, Rochester, NY, 34865-34867 2011-14780 Seafair Blue Angels Air Show Performance, Seattle, WA, 34867 2011-14779 Truman-Hobbs Alteration of the Elgin Joliet & Eastern Railroad Drawbridge;

Illinois River, Morris, IL, 34869-34871 2011-14773 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration NOTICES Cybersecurity, Innovation, and the Internet Economy, 34965-34967 2011-14710 Comptroller Comptroller of the Currency NOTICES Stress Testing for Banking Organizations with more than $10 Billion in Total Consolidated Assets, 35072-35084 2011-14777 Defense Department Defense Department See Army Department Education Education Department NOTICES Meetings:

Pre-applications for Investing in Innovation Fund, 34969 2011-14861 Employment and Training Employment and Training Administration NOTICES Amended Certifications Regarding Eligibility to Apply for Worker Adjustment Assistance: Hutchinson Technology, Inc., et al., Hutchinson and Plymouth, MN, 35026 2011-14816 Nokia, Inc., Fort Worth, TX, 35025 2011-14821 Precision Dynamics Corp., San Fernando and Valencia, CA, 35024-35025 2011-14820 Travelers Indemnity Co., Knoxville, TN, 35024 2011-14815 XPEDX, Livonia and Grand Rapids, MI, 35025-35026 2011-14819 Amended Negative Determinations:

Weather Shield Manufacturing, Inc., Corporate Office, Medford, WI, 35026-35030 2011-14818 Amended Revised Determinations on Reconsideration: Severstal North America, Inc., Martins Ferry, Yorksville, Mingo Junction and Steubenville, OH, 35030-35031 2011-14817 Energy Department Energy Department See Federal Energy Regulatory Commission PROPOSED RULES Energy Conservation Program for Consumer Products and Certain Commercial and Industrial Equipment: Proposed Determination of Set-top Boxes and Network Equipment as a Covered Consumer Product, 34914-34918 2011-14825 NOTICES Environmental Impact Statements;

Availability, etc.: Northern Pass Transmission Line Project, 34969-34970 2011-14823 Environmental Protection Environmental Protection Agency RULES Approvals and Promulgations of Implementation Plans: California; Regional Haze and Interstate Transport, 34872-34876 2011-14480 Pesticide Tolerances: Difenoconazole, 34877-34883 2011-14770 Pesticide Tolerances; Technical Amendments, 34883-34886 2011-14569 PROPOSED RULES Approvals and Promulgations of Implementation Plans and Designations of Areas for Air Quality Planning Purposes:

Kentucky and Indiana; Louisville; Determination of Attainment by Applicable Attainment Date for 1997 Annual Fine Particulate Standards, 34935-34937 2011-14812 Proposed Tolerance Actions: Amitraz, Bentazon, Bifenthrin, Chlorfenapyr, Cyfluthrin, Deltamethrin, et al., 34937-34945 2011-14827 NOTICES Meetings: Science Advisory Board Panel for the Review of Great Lakes Restoration Initiative Action Plan, 34977-34978 2011-14810 Petition Supplement Requesting Cancellation of Propoxur Pet Collar Uses;

Availability, 34978-34979 2011-14763 Product Cancellation Order for Certain Pesticide Registrations, 34979-34982 2011-14765 Proposed Consent Decrees, Clean Air Act Citizen Suit, 34982-34984 2011-14830 2011-14833 Registration Review Final Decision: Propetamphos, 34984-34985 2011-14568 Equal Equal Employment Opportunity Commission NOTICES Meetings; Sunshine Act, 34985 2011-14980 Executive Office of the President See Presidential Documents See Science and Technology Policy Office Farm Credit System Insurance Farm Credit System Insurance Corporation NOTICES Meetings:

Farm Credit System Insurance Corporation Board, 34985 2011-14856 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Boeing Co. Model 767 Airplanes, 34918-34920 2011-14698 Federal Bureau Federal Bureau of Investigation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Applicant Information Form, 35022 2011-14727 Federal Crop Federal Crop Insurance Corporation NOTICES Funding Opportunities: Risk Management Education in Targeted States, 34953-34961 2011-14838 Federal Deposit Federal Deposit Insurance Corporation NOTICES Stress Testing for Banking Organizations with more than $10 Billion in Total Consolidated Assets, 35072-35084 2011-14777 Federal Election Federal Election Commission NOTICES Agency Procedure for Disclosure of Documents and Information in the Enforcement Process, 34986-34992 2011-14096 Federal Emergency Federal Emergency Management Agency NOTICES Demolition of Private Structures Recovery Policy;

Availability, 35006 2011-14871 Research-related Equipment and Furnishings Recovery Policy; Availability, 35006-35007 2011-14867 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: ANR Pipeline Co., 34971-34972 2011-14748 Avista Corp., 34970-34971 2011-14754 City of Dover, NH, 34971 2011-14750 Union Electric Co., dba AmerenUE, 34973 2011-14751 USG Pipeline Co., 34972-34973 2011-14749 Authorizations for Continued Project Operation: Public Utility District No. 1 of Snohomish County, 34974 2011-14753 Filings:

Cranberry Pipeline Corp., 34974 2011-14758 Regency Intrastate Gas LP, 34974-34975 2011-14759 Petitions for Rate Approval: Atmos Pipeline-Texas, 34975 2011-14757 Kinder Morgan Texas Pipeline, LLC, 34975 2011-14756 Preliminary Permit Applications: U.S. Farmers, LLC, 34975-34976 2011-14755 Records Governing Off-the-Record Communications, 34976-34977 2011-14747 Federal Maritime Federal Maritime Commission PROPOSED RULES Request from People's Republic of China for Adjustment of Optional Bond Rider, 34945-34947 2011-14860 NOTICES Agreements Filed, 34992 2011-14836 Ocean Transportation Intermediary Licenses;

Applicants, 34992-34993 2011-14837 Ocean Transportation Intermediary Licenses; Reissuances, 34993 2011-14813 Ocean Transportation Intermediary Licenses; Revocations, 34993-34994 2011-14814 Federal Railroad Federal Railroad Administration RULES Track Safety Standards; Concrete Crossties, 34890 2011-14835 Federal Reserve Federal Reserve System NOTICES Stress Testing for Banking Organizations with more than $10 Billion in Total Consolidated Assets, 35072-35084 2011-14777 Food and Drug Food and Drug Administration RULES Medical Devices:

Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid, 34845-34847 2011-14790 NOTICES Draft Guidances for Industry and Staff; Availability: Performance Characteristics of In Vitro Diagnostic Devices for Detection of Methicillin-Resistant Staphylococcus Aureus, etc., 34999-35000 2011-14789 Foreign Trade Foreign-Trade Zones Board NOTICES Applications for Reissuance of Grant of Authority: Foreign-Trade Zone 41; Milwaukee, WI, 34964 2011-14851 Forest Forest Service NOTICES Meetings:

Eastern Washington Cascades Provincial Advisory Committee and the Yakima Provincial Advisory Committee, 34962 2011-14735 Sabine Resource Advisory Committee, 34962 2011-14638 General Services General Services Administration RULES Acquisition Regulations: Implementation of Information Technology Security Provision, 34886-34890 2011-14728 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Children and Families Administration See Food and Drug Administration See Refugee Resettlement Office See Substance Abuse and Mental Health Services Administration NOTICES Meetings:

Vaccine to Protect Children from Anthrax Public Engagement Workshop, 34994-34995 2011-14722 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S. Customs and Border Protection Interior Interior Department See National Park Service NOTICES Meetings: Tribal Consultation on Implementation of Indian Land Consolidation Program under Cobell Settlement, 35009 2011-14923 International Trade Adm International Trade Administration NOTICES Cybersecurity, Innovation, and the Internet Economy, 34965-34967 2011-14710 Partial Rescission of Antidumping Duty Administrative Reviews:

Stainless Steel Bar from India, 34964 2011-14858 International Trade Com International Trade Commission NOTICES Commission Determinations: Certain Ground Fault Circuit Interrupters and Products Containing Same, 35014 2011-14701 Complaints, 35014-35015 2011-14700 Investigations: Certain Lighting Control Devices Including Dimmer Switches and Parts Thereof, 35015-35016 2011-14778 Justice Department Justice Department See Alcohol, Tobacco, Firearms, and Explosives Bureau See Antitrust Division See Federal Bureau of Investigation See Justice Programs Office Justice Programs Justice Programs Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals:, 35023 2011-14725 National Institute of Justice Protective Helmet Standards Workshop, 35023-35024 2011-14798 National Institute of Justice Stab-Resistant Body Armor Standard Workshop, 35024 2011-14799 Labor Department Labor Department See Employment and Training Administration Millenium Millennium Challenge Corporation NOTICES Quarterly Reports: January 1, 2011 - March 31, 2011, 35031-35048 2011-14603 National Archives National Archives and Records Administration NOTICES Records Schedules, 35048-35049 2011-14932 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings:

Arts Advisory Panel National Endowment for the Arts, 35049 2011-14707 National Endowment for the Arts Advisory Committee on International Exhibitions, 35049-35050 2011-14708 National Institute National Institute of Standards and Technology NOTICES Cybersecurity, Innovation, and the Internet Economy, 34965-34967 2011-14710 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of Caribbean, Gulf of Mexico, and South Atlantic: Snapper-Grouper Fishery of South Atlantic, Management Measures, 34892-34903 2011-14850 Magnuson-Stevens Act Provisions;

Fisheries off West Coast States: Pacific Coast Groundfish Fishery; Biennial Specifications and Management Measures, 34910-34913 2011-14846 Pacific Halibut Fisheries: Limited Access for Guided Sport Charter Vessels in Alaska, 34890-34892 2011-14854 Revisions to the Northeast Multispecies Fishery Management Plan and Sector Annual Catch Entitlements: Updated Annual Catch Limits for Sectors and the Common Pool for Fishing Year 2011, 34903-34910 2011-14853 PROPOSED RULES Fisheries of Northeastern United States:

Atlantic Herring Fishery, 34947-34952 2011-14874 NOTICES Meetings: Marine Fisheries Advisory Committee, 34967 2011-14845 Permit Modification Applications: Endangered Species; File No. 10027, 34967-34968 2011-14857 National Park National Park Service NOTICES Environmental Impact Statements; Availability, etc.: Big South Fork National River and Recreation Area and Obed Wild and Scenic River, 35009-35010 2011-14752 Inventory Completions: Colorado Historical Society (History Colorado), Denver, CO, 35010-35012 2011-14764 Fort Vancouver National Historic Site, Vancouver, WA;

Correction, 35013 2011-14772 Minor boundary revision of Boston National Historical Park, 35013-35014 2011-14761 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 35050 2011-15018 National Telecommunications National Telecommunications and Information Administration NOTICES Cybersecurity, Innovation, and the Internet Economy, 34965-34967 2011-14710 Pension Benefit Pension Benefit Guaranty Corporation RULES Allocation of Assets in Single-Employer Plans;

Benefits Payable in Terminated Single-Employer Plans, etc., 34847-34848 2011-14852 Personnel Personnel Management Office NOTICES Privacy Act; Systems of Records, 35050-35054 2011-14839 2011-14840 Postal Service Postal Service RULES Mobile Barcode Promotion, 34871-34872 2011-14251 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Flag Day and National Flag Week (Proc. 8689), 35087-35090 2011-15046 ADMINISTRATIVE ORDERS Belarus; Continuation of National Emergency (Notice of June 14, 2011), 35091-35094 2011-15054 Refugee Refugee Resettlement Office NOTICES Award of Urgent Single-Source Grant to Heartland Alliance, Chicago, IL., 35000 2011-14841 Rural Housing Service Rural Housing Service NOTICES Project Waiver of Buy American Requirements of the American Recovery and Reinvestment Act:

Haywood County, NC, Social Services Adaptive Renovation Project, 34962-34963 2011-14738 Science Technology Science and Technology Policy Office NOTICES Meetings: President's Council of Advisors on Science and Technology, 35054-35055 2011-14879 Securities Securities and Exchange Commission PROPOSED RULES Exemptions For Security-Based Swaps Issued By Certain Clearing Agencies, 34920-34935 2011-14717 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35055 2011-14782 Applications:

Precidian ETFs Trust, et al., 35055-35062 2011-14843 Orders of Suspension of Trading: Apparel America, Inc., et al., 35062 2011-14986 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 35066-35067 2011-14848 NYSE Arca, Inc., 35062-35066 2011-14849 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35067-35068 2011-14741 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition Determinations:

Monet/Lichtenstein; Rouen Cathedrals, 35068 2011-14822 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35000-35006 2011-14795 2011-14796 2011-14797 Surface Transportation Surface Transportation Board NOTICES Abandonment Exemptions: Duluth, Missabe and Iron Range Railway Co., St. Louis County, MN, 35068-35069 2011-14639 Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Qualitative Feedback on Agency Service Delivery, 35069-35070 2011-14784 Canexus Chemicals Canada L.P. v. BNSF Railway Co.; Oral Arguments, 35070 2011-14844 Release of Waybill Data, 35070 2011-14739 Thrift Supervision Thrift Supervision Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Mutual to Stock Conversion Application, 35084-35085 2011-14804 Savings and Loan Holding Company Application, 35085-35086 2011-14805 Appointments of Receivers:

Atlantic Bank & Trust, Charleston, SC, 35086 2011-14806 Transportation Department Transportation Department See Federal Aviation Administration See Federal Railroad Administration See Surface Transportation Board Treasury Treasury Department See Comptroller of the Currency See Thrift Supervision Office NOTICES Privacy Act; Systems of Records, 35071-35072 2011-14834 Customs U.S. Customs and Border Protection NOTICES Final Determinations: Country of Origin of Certain Office Chairs, 35007-35009 2011-14842 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Fully Developed Claims; Applications for Compensation, Pension, DIC, Death Pension, and/or Accrued Benefits, 35086 2011-14760 Separate Parts In This Issue Part II Presidential Documents, 35087-35090 2011-15046 Part III Presidential Documents, 35091-35094 2011-15054 Reader Aids Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 76 115 Wednesday, June 15, 2011 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 874 [Docket No.

FDA-2011-N-0361] Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This rule is effective July 15, 2011. The classification was effective on March 31, 2011. FOR FURTHER INFORMATION CONTACT: Vasant Dasika, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2443, Silver Spring MD 20993-0002, 301-796-5365. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807). Section 513(f)(2) of the FD&C Act provides that any person who submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device into class III under section 513(f)(1), request FDA to classify the device under the criteria set forth in section 513(a)(1). FDA will, within 60 days of receiving this request, classify the device by written order. This classification will be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the **Federal Register** announcing this classification. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on September 13, 2010, classifying the CLEAR 440 Series of hearing aids into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device that was subsequently reclassified into class I or class II. On October 13, 2010, Widex Hearing Aid Co. submitted a petition requesting classification of the CLEAR 440 Series of hearing aids under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies 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 to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition and information submitted during interactive review, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device. The device is assigned the generic name wireless air-conduction hearing aid, and it is identified as a wearable sound-amplifying device, intended to compensate for impaired hearing, that incorporates wireless technology in its programming or use. FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks: Identified risk Required measures Degradations in device function due to electromagnetic interference

(EMI)Electromagnetic compatibility

(EMC)testing; labeling. Degradations in device function due to wireless technology disruption such as slow-down, lost or corrupted information, security issues including potential cross-talk or control by other users with a similar medical device Wireless technology design, description, and testing; performance testing; labeling. Exposure to non-ionizing radiation emitted by wireless technology can potentially induce tissue heating Wireless technology design, description, analysis, and testing; labeling. FDA believes that the following special controls, in addition to general controls, address the risks to health and provide reasonable assurance of the safety and effectiveness of the device:

(1)Appropriate analysis/testing should validate EMC and safety of exposure to non-ionizing radiation;

(2)Design, description, and performance data should validate wireless technology functions; and

(3)Labeling should specify appropriate instructions, warnings, and information relating to EMC and wireless technology and human exposure to non-ionizing radiation. Therefore, on March 31, 2011, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying the classification of the device by adding § 874.3305. Following the effective date of this final classification rule, any firm introducing a wireless air-conduction hearing aid into interstate commerce in the United States will need to comply with the special controls named in the regulation. However, the firm need only show that its device meets the recommendations of the special controls or in some other way provides equivalent assurance of safety and effectiveness. Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is exempt from premarket notification requirements. II. 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. III. Analysis of Impacts FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action under Executive Order 12866. The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because reclassification of this device from class III to class II will relieve manufacturers of the device of the cost of complying with the premarket approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $136 million, using the most current

(2010)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. IV. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain Federal requirements applicable to devices. (See section 521 of the FD&C Act (21 U.S.C. 360k); See *Medtronic* v. *Lohr,* 518 U.S. 470 (1996); *Riegel* v. *Medtronic, Inc.,* 552 U.S. 312 (2008). The special controls established by this final rule create “requirements” for specific medical devices under 21 U.S.C. 360k, even though product sponsors have some flexibility in how they meet those requirements. (See *Papike* v. *Tambrands, Inc.,* 107., 107 F.3d 737, 740-42 (9th Cir. 1997).) V. Paperwork Reduction Act of 1995 FDA concludes that this final rule contains no new collections of information. Therefore, clearance by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995

(PRA)(44 U.S.C. 3501-3520) is not required. VI. References The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Petition from Widex Hearing Aid Co., dated October 13, 2010. List of Subjects in 21 CFR Part 874 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 874 is amended as follows: PART 874—EAR, NOSE, AND THROAT DEVICES 1. The authority citation for 21 CFR part 874 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Section § 874.3305 is added to subpart D to read as follows: § 874.3305 Wireless Air-Conduction Hearing Aid.

(a)*Identification.* A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use.

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

(1)Appropriate analysis/testing should validate electro magnetic compatibility

(EMC)and safety of exposure to non-ionizing radiation;

(2)Design, description, and performance data should validate wireless technology functions; and

(3)Labeling should specify appropriate instructions, warnings, and information relating to EMC and wireless technology and human exposure to non-ionizing radiation.

(c)*Premarket notification.* The wireless air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9. Dated: June 9, 2011 *.* Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2011-14790 Filed 6-14-11; 8:45 am]

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