Unknown. Final order

4,501 words·~20 min read·/register/2016/10/04/2016-23899·

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-2016-10-04.xml --- 81 192 Tuesday, October 4, 2016 Contents Agriculture Agriculture Department See Economic Research Service See Food and Nutrition Service See National Institute of Food and Agriculture See Rural Business-Cooperative Service See Rural Utilities Service Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68407 2016-23860 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 68417-68419 2016-23925 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare and Medicaid Programs: Reform of Requirements for Long-Term Care Facilities, 68688-68872 2016-23503 NOTICES Privacy Act; Computer Matching Program, 68419-68420 2016-23866 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68421-68422 2016-23865 Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Interstate Administrative Subpoena and Notice of Interstate Lien, 68421 2016-23950 Unaccompanied Children Case Summary Form, 68420-68421 2016-23951 Single-Source Grants: National Child Welfare Capacity Building Center for Tribes, 68420 2016-23909 Coast Guard Coast Guard RULES Special Local Regulations: Ouachita River, Monroe, LA, 68318-68319 2016-23973 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Oceanic and Atmospheric Administration Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 68407-68408 2016-23963 Defense Department Defense Department See Navy Department RULES Department of Defense (DoD)'s Defense Industrial Base Cybersecurity Activities, 68312-68317 2016-23968 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Commercial Item Acquisitions, 68416-68417 2016-23868 Drug Drug Enforcement Administration NOTICES Importers of Controlled Substances; Applications: Fisher Clinical Services, Inc., 68455-68456 2016-23887 Economic Research Economic Research Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 68398 2016-23869 Energy Department Energy Department See Federal Energy Regulatory Commission Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arkansas; Regional Haze and Interstate Visibility Transport Federal Implementation Plan, 68319 C1--2016--22508 California; Sacramento Metropolitan Air Quality Management District and San Diego County Air Pollution Control District, 68320-68322 2016-23837 Louisiana;

Infrastructure State Implementation Plan Requirements for the National Ambient Air Quality Standards, 68322-68335 2016-24036 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Sacramento Metropolitan Air Quality Management District and San Diego County Air Pollution Control District, 68379 2016-23838 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68412-68413 2016-23982 Denial of Petitions for Reconsideration:

Oil and Natural Gas Sector—New Source Performance Standards; Final Action, 68411-68412 2016-23972 Meetings: Clean Air Scientific Advisory Committee Oxides of Nitrogen Primary National Ambient Air Quality Standards Review Panel, 68414 2016-23974 Human Studies Review Board, 68414-68415 2016-23987 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: The Boeing Company Airplanes, 68371-68378 2016-23936 2016-23938 2016-23939 NOTICES Meetings: Fifteenth RTCA Tactical Operations Committee, 68498 2016-23896 Petitions for Exemption;

Summaries: Airbus SAS, 68498 2016-23960 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68415-68416 2016-23916 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 68416 2016-24040 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68443-68444 2016-23946 Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Application for Surplus Federal Real Property Public Benefit Conveyance and BRAC Program for Emergency Management Use, 68444-68445 2016-23947 Residential Basement Floodproofing Certification, 68442-68444 2016-23888 2016-23889 Individuals and Households Program Unified Guidance, 68442 2016-23948 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 68409-68411 2016-23921 2016-23922 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations:

AltaGas Pomona Energy Storage Inc., 68409 2016-23923 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.: Route 82/85/11 Corridor, New London County, CT; Rescission, 68499 2016-23934 Federal Motor Federal Motor Carrier Safety Administration RULES General Technical, Organizational, Conforming, and Correcting Amendments, 68336-68359 2016-22996 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 68416 2016-23959 Federal Transit Federal Transit Administration NOTICES Transfers of Federally Assisted Facilities, 68499-68500 2016-23940 Fish Fish and Wildlife Service RULES 2016-2017 Refuge-Specific Hunting and Sport Fishing Regulations, 68874-68921 2016-23190 PROPOSED RULES Endangered and Threatened Wildlife and Plants:

Western Glacier Stonefly and Meltwater Lednian Stonefly and Western Glacier Stonefly; 12-Month Finding on Petition to List and Status, 68379-68397 2016-23710 Food and Drug Food and Drug Administration RULES Medical Devices: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format, 68293-68295 2016-23899 Medical Devices; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format, 68295-68297 2016-23901 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals, 68426 2016-23898 Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway, 68434 2016-23897 United States Firms and Processors that Export to European Union, 68424-68426 2016-23930 Guidance: Dietary Supplements; New Dietary Ingredient Notifications and Related Issues, 68434-68435 2016-23931 Meetings:

Center for Devices and Radiological Health Veteran Amputee Devices; Public Workshop, 68422-68424 2016-23924 Microbiology Devices Panel of Medical Devices Advisory Committee, 68432-68434 2016-23895 Workshop on Promoting Semantic Interoperability of Laboratory Data, 68435-68437 2016-23894 New Drug Applications: Hospira, Inc. et al.; Withdrawal, 68427-68432 2016-23893 Food and Nutrition Food and Nutrition Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Child Nutrition Program Operations Study II, 68398-68400 2016-23859 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 68500-68501 2016-23942 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: MTD Consumer Group, Inc. (Lawn and Garden Equipment), Verona, MS, Foreign-Trade Zone 158, Vicksburg and Jackson, MS, 68404 2016-23965 General Services General Services Administration RULES General Services Administration Acquisition Regulations:

Inflation of Acquisition-Related Thresholds, 68335-68336 2016-24015 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Commercial Item Acquisitions, 68416-68417 2016-23868 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 National Institutes of Health Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S.

Citizenship and Immigration Services See U.S. Customs and Border Protection Housing Housing and Urban Development Department RULES Section 108 Loan Guarantee Program: Announcement of Fee to Cover Credit Subsidy Costs, 68297-68299 2016-23986 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Energy Benchmarking, 68446-68450 2016-23979 Energy Benchmarking of Public Housing, 68450-68453 2016-23978 Information Information Security Oversight Office NOTICES Meetings:

National Industrial Security Program Policy Advisory Committee, 68459 2016-23958 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau Internal Revenue Internal Revenue Service RULES Credit for Increasing Research Activities, 68299-68312 2016-23174 PROPOSED RULES Estate, Gift, and Generation-Skipping Transfer Taxes: Restrictions on Liquidation of an Interest; Correction, 68378-68379 2016-23957 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68501-68502 2016-23944 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Corrosion-Resistant Steel Products from Republic of Korea, 68404-68405 2016-23967 International Trade Com International Trade Commission NOTICES Enforcement Proceedings: Certain Network Devices, Related Software and Components Thereof, 68455 2016-23863 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Recombinant Factor VIII Products; Termination of Investigation, 68454 2016-23864 Justice Department Justice Department See Drug Enforcement Administration NOTICES Proposed Consent Decrees under CERCLA, 68456 2016-23926 Labor Department Labor Department See Occupational Safety and Health Administration Land Land Management Bureau NOTICES Meetings:

Grand Staircase-Escalante National Monument Advisory Committee, 68453-68454 2016-23937 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Commercial Item Acquisitions, 68416-68417 2016-23868 Meetings: NASA Advisory Council; Science Committee, 68459 2016-23872 National Archives National Archives and Records Administration See Information Security Oversight Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 68459-68460 2016-23935 National Highway National Highway Traffic Safety Administration RULES List of Nonconforming Vehicles Decided to be Eligible for Importation, 68359-68369 2016-23941 National Institute Food National Institute of Food and Agriculture NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery, 68401-68402 2016-23956 National Institute National Institutes of Health NOTICES Meetings:

Center for Scientific Review, 68440 2016-23876 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 68439 2016-23875 National Center for Complementary and Integrative Health, 68438-68439 2016-23877 2016-23878 National Heart, Lung, and Blood Institute, 68437-68439 2016-23879 2016-23880 2016-23881 National Institute of Allergy and Infectious Diseases, 68438-68441 2016-23873 2016-23874 2016-23882 2016-23883 National Institute of Mental Health, 68439-68440 2016-23885 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska:

Several Groundfish Species in Bering Sea and Aleutian Islands Management Area, 68369-68370 2016-23969 NOTICES Endangered and Threatened Species: Recovery Planning Workshop, 68405-68406 2016-23857 Permits: Marine Mammals; File No. 20452, 68406-68407 2016-23933 National Science National Science Foundation NOTICES Antarctic Conservation Act Permits, 68460 2016-23900 National Transportation National Transportation Safety Board NOTICES Meetings; Sunshine Act, 68460-68461 2016-24090 Senior Executive Service Performance Review Board, 68461 2016-23867 Navy Navy Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 68408-68409 2016-23861 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Facility Operating and Combined Licenses: Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 68467-68474 2016-23210 License Transfer Applications: Susquehanna Nuclear, LLC, Susquehanna Steam Electric Station, Units 1 and 2, 68462-68466 2016-23955 Meetings: Advisory Committee on Reactor Safeguards Subcommittee on Fukushima, 68461-68462 2016-23952 2016-23953 Advisory Committee on Reactor Safeguards Subcommittee on Metallurgy and Reactor Fuels, 68461 2016-23949 Advisory Committee on Reactor Safeguards Subcommittee on Radiation Protection and Nuclear Materials, 68474 2016-23954 Occupational Safety Health Adm Occupational Safety and Health Administration PROPOSED RULES Standards Improvement Project—Phase IV, 68504-68685 2016-19454 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Cranes and Derricks in Construction, 68456-68457 2016-23985 Occupational Exposure to Noise Standard, 68457-68459 2016-23984 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 68474-68475 2016-23912 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Child Health Day (Proc. 9506), 68929-68932 2016-24171 EXECUTIVE ORDERS Defense and National Security: National Background Investigations Bureau, Establishing Rules and Responsibilities of the;

Amendment to Executive Order 13467 (EO 13741), 68289-68292 2016-24066 ADMINISTRATIVE ORDERS Foreign Assistance Act of 1961; Delegation of Authority (Memorandum of April 12, 2016), 68927-68928 2016-24168 Unexpected Urgent Refugee and Migration Needs (Presidential Determination No. 2016-05 of January 13, 2016), 68923-68925 2016-24165 Railroad Retirement Railroad Retirement Board NOTICES Meetings; Sunshine Act, 68475 2016-24029 Rural Business Rural Business-Cooperative Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 68402-68403 2016-23914 2016-23915 Rural Utilities Rural Utilities Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68403-68404 2016-23932 Securities Securities and Exchange Commission NOTICES Applications: Virtus Alternative Solutions Trust, et al., 68495-68496 2016-23911 Meetings; Sunshine Act, 68480-68481 2016-24091 Self-Regulatory Organizations: NYSE MKT, LLC, 68481-68491 2016-23902 Self-Regulatory Organizations;

Proposed Rule Changes: Bats BZX Exchange, Inc., 68493-68495 2016-23904 Financial Industry Regulatory Authority, Inc., 68492 2016-23905 National Stock Exchange, Inc., 68476-68479 2016-23929 New York Stock Exchange, LLC, 68475-68476 2016-23906 NYSE Arca, Inc., 68480 2016-23907 NYSE MKT, LLC, 68493 2016-23908 Suspension of Trading Orders: Infinex Ventures, Inc., 68480 2016-24061 Rainbow International, Corp., a/k/a Raintree Brands Inc., 68492-68493 2016-24062 Sierra Resource Group, Inc., 68492 2016-23996 Small Business Small Business Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 68496-68498 2016-23732 2016-23764 2016-23765 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Federal Transit Administration See National Highway Traffic Safety Administration Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Petition by Entrepreneur to Remove Conditions on Permanent Resident Status, 68445-68446 2016-23981 Customs U.S. Customs and Border Protection NOTICES Expansion of Global Entry to Nine Additional Airports, 68441-68442 2016-23966 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Inquiry Routing and Information System, 68502 2016-23964 Meetings: Voluntary Service National Advisory Committee, 68502 2016-23920 Separate Parts In This Issue Part II Labor Department, Occupational Safety and Health Administration, 68504-68685 2016-19454 Part III Health and Human Services Department, Centers for Medicare & Medicaid Services, 68688-68872 2016-23503 Part IV Interior Department, Fish and Wildlife Service, 68874-68921 2016-23190 Part V Presidential Documents, 68923-68925, 68927-68928 2016-24168 2016-24165 Part VI Presidential Documents, 68929-68932 2016-24171 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. 81 192 Tuesday, October 4, 2016 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2016-P-1026] Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format AGENCY:

Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration

(FDA)is publishing an order denying a petition requesting exemption from the premarket notification requirements for “method, metallic reduction, glucose (urinary, nonquantitative)” devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as “copper reduction tablet test”). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). DATES: This order is effective October 4, 2016. FOR FURTHER INFORMATION CONTACT: Sheila Connors, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4620, Silver Spring, MD 20993-0002, 301-796-6181, *Sheila.Connors@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Statutory Background Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of the safety and effectiveness of the device. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), as amended by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls) 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 such assurance; and into class III (premarket approval) if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device, or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury. Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations (21 CFR part 807) require persons who intend to market a device intended for human use to submit a premarket notification (510(k)) to FDA containing information that allows FDA to determine whether the device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval (PMA). On November 21, 1997, the President signed into law FDAMA (Pub. L. 105-115). Section 206 of FDAMA, in part, added a new section, 510(m), to the FD&C. Section 510(m)(1) of the FD&C Act requires FDA, within 60 days after enactment of FDAMA, to publish in the **Federal Register** a list of each type of class II device that does not require a report under section 510(k) to provide reasonable assurance of safety and effectiveness. Section 510(m) of the FD&C Act further provides that a 510(k) will no longer be required for these devices upon the date of publication of the list in the **Federal Register** . FDA published that list in the **Federal Register** of January 21, 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that 1 day after the date of publication of the list under section 510(m)(1), FDA may exempt a class II device on its own initiative or upon petition of an interested person if FDA determines that a 510(k) is not necessary to provide a reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the **Federal Register** a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. Within 120 days of publication of this document, FDA must publish in the **Federal Register** its final determination regarding the exemption of the device that was the subject of the notice. If FDA fails to respond to a petition under this section within 180 days of receiving it, the petition shall be deemed granted. FDA classified the urinary glucose (nonquantitative) test system into class II effective July 30, 1987 (52 FR 16102 at 16122, May 1, 1987). The classification for urinary glucose (nonquantitative) test system is at § 862.1340 (21 CFR 862.1340). The urinary glucose (nonquantitative) test system is identified as a device that is intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. Devices under this classification regulation require premarket notification under section 510(k) of the FD&C Act. II. Criteria for Exemption There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (Ref. 1). Accordingly, FDA generally considers the following factors to determine whether premarket notification is necessary:

(1)The device does not have a significant history of false or misleading claims or risks associated with inherent characteristics of the device;

(2)characteristics of the device necessary for its safe and effective performance are well established;

(3)changes in the device that could affect safety and effectiveness will either

(a)be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or

(b)not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and

(4)any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices, these devices would still be subject to the limitations on exemptions. III. Petition On March 18, 2016, FDA received a petition requesting an exemption from premarket notification requirements for copper reduction tablet tests that are classified as class II devices under § 862.1340, urinary glucose (nonquantitative) test system, from Martin O'Connor, Germaine Laboratories, Inc. (See Docket No. FDA-2016-P-1026). On May 4, 2016 (81 FR 26802), FDA published a notice in the **Federal Register** announcing that this petition had been received in accordance with section 510(m)(2) of the FD&C Act. On June 20, 2016 (81 FR 39929), FDA republished a notice of the petition due to an inadvertent error in the docket number and provided an opportunity for interested persons to submit comments on the petition by July 20, 2016. FDA received no comments regarding this petition. FDA has completed review of the referenced petition and assessed the need for 510(k) clearance for copper reduction tablet test against the criteria laid out in section II. For the reasons described in this document, FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of the copper reduction tablet tests classified under § 862.1340 and assigned the classification product code JIM. Accordingly, FDA responded to the petition by letter dated September 6, 2016, denying the petition within the 180-day timeframe under section 510(m)(2) of the FD&C Act. (See Docket No. FDA-2016-P-1026). IV. Order After reviewing the petition, FDA has determined that the petition failed to provide information to demonstrate that premarket notification is not necessary to provide a reasonable assurance of the safety and effectiveness of the device. Accordingly, FDA is denying the referenced petition for exemption from the premarket notification requirements. With regard to the first factor (see section II, Criteria for Exemption), although there have been no medical device reports reported to the Agency in recent years, there have been numerous reports to the Agency 1 and in medical literature of risks associated with the inherent characteristics of this device, including possible device-associated deaths, serious injuries, and malfunctions such as burns, explosions of the product bottle due to heat, and consumption of the device. For instance, there have been reports in the medical literature of patients consuming the tablets because of their similarity to pills, which has led to poisoning and one report of a death. Therefore, FDA does not agree with the petitioner that the device does not have a significant history of risks associated with inherent characteristics of the device. 1 For more information, see Medical Device Reporting

(MDR)database at *http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.* Additionally, failure to observe the reaction at all times after the tablet has been added to the sample is another risk associated with the inherent characteristics of the device. This can lead to a false-negative result and result in improper patient management, which can lead to serious injury or possibly death. The petition does not address how the device's inherent risks can be mitigated or controlled without premarket notification to provide a reasonable assurance of the safety and effectiveness of the device. With regard to the second factor, the petition stated that healthcare and laboratory professionals understand the appropriate use of a copper reduction tablet test and that a definitive diagnostic or therapeutic decision should not be based on the result of this method. However, a copper reduction tablet test can be used to evaluate pediatric patients for possible hereditary metabolic disorders through detection of reducing substances. For example, although all States require mandatory newborn screening for genetic metabolic defects, clinical laboratories may still use this device as a screening test on pediatric urine samples if there are any suspicions of metabolic disease prior to receiving newborn screening results or if the newborn screening results do not match the clinical state of the newborn. Although further diagnostic testing may be performed to confirm the result(s), physicians may immediately treat the newborn relying solely on the result of this test while awaiting the results for any followup diagnostic tests. False negative results also present a safety and effectiveness concern because followup diagnostic testing may not be performed, leading to the failure to start needed treatment for the newborn. The petition failed to demonstrate that a premarket submission is not necessary to provide a reasonable assurance of the safety and effectiveness of the device for such uses, and FDA does not agree that the characteristics of the device necessary for its safe and effective use are well established. With regard to the third factor, FDA also does not agree that changes in the device that could affect safety and effectiveness will either be readily detectable or not materially increase risks. The petition claimed that users could employ positive or negative controls to validate the reagents performance. However, while available quality control materials may contain glucose, they do not contain other reducing sugars ( *e.g.,* galactose, lactose). Therefore, such materials might not readily detect an issue with the device's safety or effectiveness in detecting other reducing sugars before causing harm. The petition argued that well-established protocols and methods could ensure there is no material increase in risk. The petition provided insufficient information to support this argument that changes in the device that could affect safety and effectiveness will either be readily detectable or not materially increase risks. Moreover, changes in the device that could affect safety and effectiveness might materially increase the risk of injury, incorrect diagnosis or ineffective treatment given the device type's intended uses. The petition also did not provide information to the contrary. The petition did not provide any relevant information regarding the fourth factor. In addition to these four factors, FDA considers the “limitations on exemption.” Manufacturers of any commercially distributed device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA prior to marketing the device when any of the limitations of exemption are exceeded. The general limitations of exemption from premarket notification contained in § 862.9 (21 CFR 862.9) are broadly applicable to in vitro diagnostic

(IVD)devices classified under part 862 (21 CFR part 862). Under § 862.9, the exemption from the premarket notification requirements applies, in the case of IVD devices, only to those devices under part 862 for which misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. FDA has previously assessed that this limitation is exceeded, and a premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of an IVD device, when such device is intended for use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism (§ 862.9(c)(2)) or intended for use in diabetes management (§ 862.9(c)(5)). The petition argued that the copper reduction tablet test is not intended for use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism, or for use in diabetes management. However, as explained previously, FDA disagrees and believes that the copper reduction tablet test described in the petition is intended for such uses and would likely exceed the limitations previously mentioned. Accordingly, for all of the foregoing reasons, the petition failed to demonstrate that a premarket submission is not necessary to provide a reasonable assurance of the safety and effectiveness of the device intended for such uses. Therefore, FDA is issuing this order denying the petition requesting exemption for a method, metallic reduction, glucose (urinary, nonquantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine) from the premarket notification requirements. Manufacturers of this device type must continue to submit and receive FDA clearance of a 510(k) before marketing their device, as well as comply with all other applicable requirements under the FD&C Act. V. Reference The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at *http://www.regulations.gov.* FDA has verified the Web site address, as of the date this document publishes in the **Federal Register** , but Web sites are subject to change over time. 1. “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 1998, available at *http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.* Dated: September 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-23899 Filed 10-3-16; 8:45 am]

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