Unknown. Final order

3,406 words·~15 min read·/register/2015/11/23/2015-29632·

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--- schema: federal-register doc_type: fedreg source_file: FR-2015-11-23.xml --- 80 225 Monday, November 23, 2015 Contents Agriculture Agriculture Department See Food and Nutrition Service Army Army Department NOTICES Exclusive Patent Licenses: MalarVx, Inc., 72954 2015-29778 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72968-72969 2015-29725 Children Children and Families Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 72969-72970 2015-29749 Civil Rights Civil Rights Commission NOTICES Meetings: Washington State Advisory Committee, 72947 2015-29741 Commerce Commerce Department See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration NOTICES Privacy Act; Systems of Records, 72947-72948 2015-29830 2015-29831 2015-29834 Defense Department Defense Department See Army Department Employee Benefits Employee Benefits Security Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 72990-72995 2015-29746 Energy Department Energy Department See Federal Energy Regulatory Commission NOTICES Applications to Export Liquefied Natural Gas: Sabine Pass Liquefaction, LLC, 72955-72956 2015-29791 Environmental Protection Environmental Protection Agency RULES Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical Release Reporting, 72906-72913 2015-29799 Air Quality State Implementation Plans; Approvals and Promulgations:

Virginia; Prevention of Significant Deterioration; Plantwide Applicability Limits for Greenhouse Gases, 72903-72906 2015-29680 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Colorado, Montana, North Dakota, and South Dakota; 2008 Ozone NAAQS Interstate Transport, 72937-72940 2015-29681 Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities, 72941-72943 2015-29808 NOTICES CERCLA Administrative Settlement:

Bremerton Auto Wrecking/Gorst Creek Landfill Site, Port Orchard, WA, 72967-72968 2015-29798 Meetings: Association of American Pesticide Control Officials/State FIFRA Issues Research and Evaluation Group Full Committee, 72966 2015-29803 Senior Executive Service Performance Review Board; Membership, 72966-72967 2015-29801 Federal Aviation Federal Aviation Administration NOTICES Meetings: RTCA Program Management Committee, 73036-73037 2015-29828 Federal Communications Federal Communications Commission RULES Unlicensed Use of TV Band and 600 MHz Band Spectrum, 73044-73086 2015-29496 Federal Emergency Federal Emergency Management Agency NOTICES Meetings:

Technical Mapping Advisory Council, 72981-72982 2015-29807 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: GB Energy Park, LLC, 72961-72962 2015-29765 Certificate Amendments: Paiute Pipeline Co., 72956-72957 2015-29753 Combined Filings, 72956, 72959-72965 2015-29751 2015-29752 2015-29758 2015-29759 2015-29760 2015-29761 2015-29776 Filings: Indiana Municipal Power Agency, 72964-72965 2015-29763 The City of Independence, MO, 72961 2015-29757 Meetings: Collection of Connected Entity Data from Regional Transmission Organizations and Independent System Operators;

Technical Conference, 72962-72963 2015-29756 Petitions for Declaratory Orders: Medallion Pipeline Co., LLC, 72960 2015-29764 Records Governing Off-the-Record Communications, 72958-72959 2015-29755 Requests for Blanket Authorizations: Tennessee Gas Pipeline Co., LLC, 72957-72958 2015-29762 Texas Gas Transmission, LLC, 72964 2015-29754 Federal Highway Federal Highway Administration NOTICES Fish and Wildlife Service Long Range Transportation Plan for Service-Managed Lands, 73037 2015-29779 Federal Railroad Federal Railroad Administration NOTICES Petition for Waiver of Compliance, 73037-73038 2015-29686 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control:

Acquisitions of Shares of a Bank or Bank Holding Company, 72968 2015-29771 Fish Fish and Wildlife Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Wildlife Refuge Visitor Check-In Permit and Use Report, 72984-72985 2015-29769 Food and Drug Food and Drug Administration RULES Medical Devices: Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System, 72899-72901 2015-29632 NOTICES Guidance:

Over-the-Counter Sunscreens—Safety and Effectiveness Data, 72975-72976 2015-29636 Sunscreen Innovation Act; Nonprescription Sunscreen Drug Products—Content and Format of Data Submissions, 72973-72975 2015-29637 Sunscreen Innovation Act; Section 586C(c) Advisory Committee Process, 72972-72973 2015-29635 Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request, 72970-72971 2015-29634 Meetings: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, 72971-72972 2015-29768 Food and Nutrition Food and Nutrition Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Review of Supplemental Nutrition Assistance Program/ Medicaid Eligibility Technology Integration, 72946-72947 2015-29697 Uniform Grant Application Package for Discretionary Grant Programs, 72945-72946 2015-29695 Foreign Trade Foreign-Trade Zones Board NOTICES Proposed Production Activities: BMW Manufacturing Co., LLC; Spartanburg, SC, 72948 2015-29811 Geological Geological Survey NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72985-72986 2015-29770 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See National Institutes of Health NOTICES Meetings:

President's Advisory Council on Faith-based and Neighborhood Partnerships, 72976 2015-29826 Homeland Homeland Security Department See Federal Emergency Management Agency See Transportation Security Administration Housing Housing and Urban Development Department NOTICES Annual Factors for Determining Public Housing Agency Administrative Fees for the Section 8 Housing Choice Voucher, Mainstream, and Moderate Rehabilitation Programs, 72983-72984 2015-29812 Meetings: Manufactured Housing Consensus Committee, Structure and Design Subcommittee;

Teleconference, 72982-72983 2015-29813 Industry Industry and Security Bureau NOTICES Meetings: Emerging Technology and Research Advisory Committee, 72949 2015-29814 Regulations and Procedures Technical Advisory Committee, 72949 2015-29817 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Land Management Bureau See National Park Service See Reclamation Bureau Internal Revenue Internal Revenue Service NOTICES Publication of the Tier 2 Tax Rates, 73039 2015-29718 International Trade Adm International Trade Administration NOTICES Investigations;

Determinations, Modifications, and Rulings, etc.: Crystalline Silicon Photovoltaic Cells, Whether or not Assembled into Modules, from the People's Republic of China, 72950 2015-29804 International Trade Com International Trade Commission NOTICES Complaints: Certain Arrowheads with Deploying Blades and Components Thereof, 72990 2015-29742 Certain Woven Textile Fabrics and Products Containing Same, 72989 2015-29700 Labor Department Labor Department See Employee Benefits Security Administration Land Land Management Bureau PROPOSED RULES Onshore Oil and Gas Operations;

Federal and Indian Oil and Gas Leases; Site Security; Measurement of Oil; and Measurement of Gas, 72943-72944 2015-29820 NOTICES Realty Actions: Change of Use for Recreation and Public Purposes Act Lease N-63293-01, Clark County, NV, 72986-72987 2015-29829 NASA National Aeronautics and Space Administration NOTICES Meetings: NASA Aerospace Safety Advisory Panel, 72995 2015-29767 National Highway National Highway Traffic Safety Administration RULES Final Theft Data; Motor Vehicle Theft Prevention Standard, 72929-72936 2015-29701 National Institute National Institutes of Health NOTICES Meetings:

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Multistakeholder Process to Promote Collaboration on Vulnerability Research Disclosure; Location Change, 72954 2015-29810 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Guidance: Ultimate Heat Sink for Nuclear Power Plants, 72996-72997 2015-29691 Meetings: Advisory Committee on Reactor Safeguards Subcommittee on Planning and Procedures, 72996 2015-29774 Advisory Committee on Reactor Safeguards Subcommittee on Power Uprates, 72997-72998 2015-29775 Advisory Committee on Reactor Safeguards Subcommittee on Reliability and Probabilistic Risk Assessment, 72995-72996 2015-29773 Pipeline Pipeline and Hazardous Materials Safety Administration RULES Hazardous Materials:

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Availability, etc.: Coordinated Long-Term Operation of the Central Valley Project and State Water Project, 72987-72988 2015-29719 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 73015-73016 2015-29745 Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., 73024-73025 2015-29727 BATS Y-Exchange, Inc., 73026-73027 2015-29712 EDGA Exchange, Inc., 73009-73011 2015-29710 EDGX Exchange, Inc., 72999-73006, 73032-73033 2015-29708 2015-29711 International Securities Exchange, LLC, 73034-73035 2015-29706 NASDAQ OMX BX, Inc., 73006-73009 2015-29709 NASDAQ OMX PHLX LLC, 73019-73024 2015-29707 National Securities Clearing Corp., 73028-73031 2015-29726 2015-29728 The NASDAQ Stock Market LLC, 73011-73019 2015-29713 2015-29705 Trading Suspension Orders:

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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. 80 225 Monday, November 23, 2015 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA-2015-N-3720] Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System AGENCY:

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

(FDA)is classifying the prostate lesion documentation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the prostate lesion documentation system classification. 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 order is effective November 23, 2015. The classification was applicable on April 27, 2012. FOR FURTHER INFORMATION CONTACT: Robert J. De Luca, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G214, Silver Spring, MD, 20993-0002, 301-796-6551, *robert.deluca@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the 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 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on April 22, 2010, classifying the prostate mechanical imager into class III, because it was neither substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, nor a device which was subsequently reclassified into class I or class II. On May 21, 2010, Artann Laboratories, Inc., submitted a request for classification of the prostate mechanical imager 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 request for de novo classification 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 request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on April 27, 2012, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.2050. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a prostate lesion documentation system will need to comply with the special controls named in this final order. The device is assigned the generic name prostate lesion documentation system, and it is identified as a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks intable 1. Table 1—Prostate Lesion Documentation System Risks and Mitigation Measures Identified risks Mitigation measures Failure to consistently produce an accurate image Performance Testing (non-clinical and clinical) Software Verification, Validation, and Hazard Analysis Labeling Misinterpretation of displayed images Labeling User error Labeling Microbial contamination from reusable components Labeling Validation of Reprocessing Methods and Instructions Adverse tissue reaction Biocompatibility Testing Electromagnetic incompatibility Electromagnetic Compatibility Testing Electrical injury Electrical Safety Testing Thermal injury Thermal Safety Testing Mechanical injury Mechanical Safety Testing FDA believes that the measures set forth in the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness: • Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image. • Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety. • Appropriate software verification, validation, and hazard analysis must be performed. • All elements of the device that may contact the patient must be demonstrated to be biocompatible. • Methods and instructions for reprocessing of any reusable components must be properly validated. • The labeling must include specific information needed to ensure proper use of the device. Prostate lesion documentation systems are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 21 CFR 801.109 ( *Prescription devices* ). 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 necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the prostate lesion documentation system they intend to market. II. Environmental Impact We have 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. Paperwork Reduction Act of 1995 This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485. IV. Reference The following reference has 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 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.* 1. DEN100016: De novo request per section 513(f)(2) of the FD&C Act from Artann Laboratories, Inc., dated May 21, 2010. List of Subjects in 21 CFR Part 876 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 876 is amended as follows: PART 876—GASTROENTEROLOGY-UROLOGY DEVICES 1. The authority citation for 21 CFR part 876 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 876.2050 to subpart C to read as follows: § 876.2050 Prostate lesion documentation system.

(a)*Identification.* A prostate lesion documentation system is a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions.

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

(1)Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image.

(2)Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.

(3)Appropriate software verification, validation, and hazard analysis must be performed.

(4)All elements of the device that may contact the patient must be demonstrated to be biocompatible.

(5)Methods and instructions for reprocessing of any reusable components must be properly validated.

(6)The labeling must include specific information needed to ensure proper use of the device. Dated: *November 16, 2015.* Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29632 Filed 11-20-15; 8:45 am]

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