Unknown. Final guidance; issuance
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/register/2018/07/16/2018-14853·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-2018-07-16.xml --- 83 136 Monday, July 16, 2018 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 32872-32874 2018-15104 Meetings: National Advisory Council for Healthcare Research and Quality, 32871-32872 2018-15105 Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Annual Capital Expenditures Survey, 32832-32833 2018-15070 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 32874-32875 2018-15146 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 32875-32877 2018-15149 Commerce Commerce Department See Census Bureau See Foreign-Trade Zones Board See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration NOTICES Hearings:
National Security Investigation of Imports of Automobiles, including Cars, SUVs, Vans and Light Trucks, and Automotive Parts; Change of Date, 32833 2018-15193 Defense Department Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 32846-32847 2018-15132 Meetings: National Security Education Board, 32847 2018-15136 Drug Drug Enforcement Administration RULES Controlled Substances Quotas, 32784-32790 2018-15141 NOTICES Bulk Manufacturers of Controlled Substances;
Applications: Siegfried USA, LLC, 32905-32906 2018-15138 Importers of Controlled Substances; Applications: Cerilliant Corp., 32906-32908 2018-15139 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Magnet Schools Assistance Program—Government Performance and Results Act Table Form, 32847-32848 2018-15150 Energy Department Energy Department See Federal Energy Regulatory Commission Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans;
Approvals and Promulgations: Maryland; Emissions Statement Requirement for 2008 Ozone Standard, 32796-32798 2018-15048 Virginia; Interstate Transport Requirements for 2012 Fine Particulate Matter Standard, 32794-32796 2018-15049 National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Partial Deletion of Beloit Corp. Superfund Site, 32798-32804 2018-15144 PROPOSED RULES National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List:
Partial Deletion of Beloit Corp. Superfund Site, 32825-32826 2018-15145 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cross-Media Electronic Reporting Rule, 32855 2018-15134 Cross-Media Electronic Reporting: Authorized Program Revision Approval, Commonwealth of Massachusetts, 32854-32855 2018-15135 Federal Aviation Federal Aviation Administration RULES Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Series Airplanes;
Flight Envelope Protection—High Incidence Protection System, 32759-32764 2018-15071 Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures, 32766-32768 2018-15059 Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures, 32764-32766 2018-15058 PROPOSED RULES Yaw Maneuver Conditions—Rudder Reversals, 32807-32815 2018-15154 Federal Deposit Federal Deposit Insurance Corporation NOTICES Guidance: Resolution Planning for Eight Large, Complex U.S.
Banking Organizations, 32856-32871 2018-15066 Federal Emergency Federal Emergency Management Agency PROPOSED RULES National Flood Insurance Program: Conforming Changes to Reflect Biggert-Waters Flood Insurance Reform Act, Homeowners Flood Insurance Affordability Act, and Additional Clarifications for Plain Language, 32956-33015 2018-13292 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: California Department of Water Resources, 32849 2018-15122 Dakota Natural Gas, LLC, 32853-32854 2018-15128 Combined Filings, 32848-32851 2018-15117 2018-15118 2018-15124 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations:
Big Level Wind, LLC, 32850 2018-15121 Brantley Farm Solar, LLC, 32853 2018-15119 Pratt Wind, LLC, 32849-32850 2018-15120 Meetings: Jordan Cove Energy Project, LP; Pacific Connector Gas Pipeline, LP, 32850, 32852 2018-15125 2018-15126 2018-15127 Records Governing Off-the-Record Communications, 32851-32852 2018-15123 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.: Lake, Cook and McHenry Counties, IL, 32947-32948 2018-15097 Memoranda of Understanding:
Certain Federal Environmental Responsibilities to State of Nebraska, Including National Environmental Policy Act Authority for Certain Categorical Exclusions, 32948-32949 2018-15099 Federal Motor Federal Motor Carrier Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Truck and Bus Maintenance Requirements and Their Impact on Safety, 32950-32952 2018-15151 Withdrawal of Proposed Enhancements to Safety Measurement System, 32949-32950 2018-15109 Federal Railroad Federal Railroad Administration PROPOSED RULES Railroad Noise Emission Compliance Regulations, 32826-32829 2018-14961 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 32855-32856 2018-15108 Guidance:
Resolution Planning for Eight Large, Complex U.S. Banking Organizations, 32856-32871 2018-15066 Federal Trade Federal Trade Commission RULES Premerger Notification; Reporting and Waiting Period Requirements, 32768-32784 2018-14378 Federal Transit Federal Transit Administration NOTICES Fiscal Year 2018 Apportionments, Allocations, Program Information and Guidance, 33018-33043 2018-14989 Fish Fish and Wildlife Service RULES Migratory Bird Permits: Removal of Depredation Orders for Double-crested Cormorants to Protect Aquaculture Facilities and Public Resources, 32805-32806 2018-15103 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Guidance for Industry and FDA Staff—Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, 32883-32884 2018-15089 Guidance for Industry on Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities, 32882-32883 2018-15095 New Animal Drugs for Investigational Use, 32877-32878 2018-15087 Petition to Request Exemption from 100 Percent Identity Testing of Dietary Ingredients:
Current Good Manufacturing Practice in Manufacturing, Packaging, 32880-32881 2018-15088 Guidance: Hypertension: Conducting Studies of Drugs to Treat Patients on Background of Multiple Antihypertensive Drugs, 32878-32880 2018-15092 Meetings: Opioid and Nicotine Use, Dependence, and Recovery—Influences of Sex and Gender; Scientific Conference, 32881-32882 2018-15096 Foreign Trade Foreign-Trade Zones Board NOTICES Subzone Status; Approvals: VF Outdoor, LLC Ontario, Santa Fe Springs and Corona, CA, 32833 2018-15113 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration NOTICES Emergency Use of Treatment for Uncontrolled Hemorrhage Due to Agents of Military Combat, 32884-32885 2018-15152 Homeland Homeland Security Department See Federal Emergency Management Agency See U.S.
Customs and Border Protection Housing Housing and Urban Development Department RULES Adjustment of Civil Monetary Penalty Amounts for 2018, 32790-32794 2018-15116 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Congregate Housing Services Program, 32887-32888 2018-15129 Human Trafficking Housing Partnership, 32886-32887 2018-15131 Pre-Purchase Homeownership Counseling Demonstration and Impact Evaluation, 32888-32889 2018-15130 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Ocean Energy Management Bureau See Office of Natural Resources Revenue International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
Certain Cut-to-Length Carbon-Quality Steel Plate from Republic of Korea, 32840-32842 2018-15137 Certain Frozen Warmwater Shrimp from India, 32835-32840 2018-15115 Small Diameter Graphite Electrodes from the People's Republic of China, 32833-32835 2018-15114 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Citric Acid and Certain Citrate Salts from Belgium, Colombia, and Thailand, 32905 2018-15067 Justice Department Justice Department See Drug Enforcement Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: National Survey of Victim Service Providers, 32908-32909 2018-15056 Land Land Management Bureau NOTICES Plats of Surveys: Arizona, 32891-32892 2018-15098 Realty Actions: Classification for Lease and/or Conveyance for Recreation and Public Purposes of Public Lands for Park in Northwest Portion of Las Vegas Valley, Clark County, NV, 32892-32893 2018-15062 Direct Sale of Public Land in Garfield County, CO, 32893-32894 2018-15060 Non-Competitive (Direct) Sale of Public Land in Park County, Wyoming, 32890-32891 2018-15061 Proposed Direct Sale of Public Land, Utah, 32894-32895 2018-15065 Proposed Modified Competitive Sale of Public Land, Utah, 32889-32890 2018-15063 Legal Legal Services Corporation NOTICES Meetings;
Sunshine Act, 32909-32911 2018-15175 National Institute National Institute of Standards and Technology NOTICES Requests for Information: Current and Future Workforce Needs to Support Strong Domestic Semiconductor Industry, 32842-32843 2018-15077 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Regional Observer Program Insurance Requirements, 32829-32831 2018-15057 NOTICES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Reef Fish Fishery of Puerto Rico and U.S.
Virgin Islands; Exempted Fishing Permit, 32843-32845 2018-15074 Requests for Nominations: Marine Mammal Scientific Review Groups, 32845-32846 2018-15064 National Park National Park Service NOTICES Minor Boundary Revisions: Indiana Dunes National Lakeshore, 32895 2018-15072 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 32911-32912 2018-15229 Nuclear Regulatory Nuclear Regulatory Commission RULES Medical Use of Byproduct Material: Medical Event Definitions and Training and Experience, 32759 2018-14853 Medical Event Definitions, Training and Experience, and Clarifying Amendments, 33046-33112 2018-14852 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Criteria and Procedures for Emergency Access to Non-Federal and Regional Low-Level Waste Disposal Facilities, 32915-32916 2018-15081 Financial Protection Requirements and Indemnity Agreements, 32918-32919 2018-15080 Environmental Assessments; Availability, etc.: Energy Northwest Columbia Generating Station, 32916-32918 2018-15091 License Amendments: Watts Bar Nuclear Plant, Unit 1, 32912-32915 2018-15100 License Applications: Holtec International's HI-STORE Consolidated Interim Storage Facility for Interim Storage of Spent Nuclear Fuel, 32919-32925 2018-15079 Occupational Safety Health Rev Occupational Safety and Health Review Commission NOTICES Privacy Act;
Systems of Records, 32925 2018-15069 Ocean Energy Management Ocean Energy Management Bureau NOTICES Gulf of Mexico Outer Continental Shelf Region-Wide Oil and Gas Lease Sale 251, 32897-32903 2018-15180 Gulf of Mexico, Outer Continental Shelf, Oil and Gas Lease Sale 251, 32903-32905 2018-15181 Requests for Information and Nominations: Commercial Leasing for Wind Power on the Outer Continental Shelf in the New York Bight, 32896-32897 2018-15133 Natural Resources Office of Natural Resources Revenue NOTICES Indian Gas Production in Designated Areas Not Associated with Index Zones:
Major Portion Prices and Due Date for Additional Royalty Payments, 32895-32896 2018-15111 Withdrawal of Temporary Physical Address Change for General Ledger Team, 32896 2018-15112 Pension Benefit Pension Benefit Guaranty Corporation PROPOSED RULES Terminated and Insolvent Multiemployer Plans and Duties of Plan Sponsors, 32815-32825 2018-15076 Presidential Documents Presidential Documents EXECUTIVE ORDERS Committees; Establishment, Renewal, Termination, etc.: Market Integrity and Consumer Fraud, Task Force on;
Establishment (EO 13844), 33113-33117 2018-15299 Securities Securities and Exchange Commission NOTICES Applications: Charles Schwab and Co., Inc. and Charles Schwab Investment Management, Inc., 32926-32929 2018-15078 DMS ETF Trust I, et al., 32925-32926 2018-15068 Meetings; Sunshine Act, 32932 2018-15233 Self-Regulatory Organizations; Proposed Rule Changes: Miami International Securities Exchange, LLC, 32932-32944 2018-15178 NYSE American, LLC, 32930-32932 2018-15083 NYSE Arca, Inc., 32929-32930 2018-15082 Surface Transportation Surface Transportation Board NOTICES Discontinuances of Service Exemptions:
Tennessee, Alabama and Georgia Railway Co.; Walker County, GA, 32945 2018-15142 Tennessee Tennessee Valley Authority NOTICES Environmental Impact Statements; Availability, etc.: Natural Resource Plan, 32945-32947 2018-15161 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration See Federal Transit Administration Customs U.S. Customs and Border Protection NOTICES Meetings:
Commercial Customs Operations Advisory Committee, 32885-32886 2018-15107 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Notice of Lapse, Notice of Past Due Payment, 32954 2018-15084 Survey of Veteran Enrollees' Health and Use of Health Care, 32953-32954 2018-15085 Environmental Impact Statements; Availability, etc.: Housing Loan Program, 32952-32953 2018-15073 Separate Parts In This Issue Part II Homeland Security Department, Federal Emergency Management Agency, 32956-33015 2018-13292 Part III Transportation Department, Federal Transit Administration, 33018-33043 2018-14989 Part IV Nuclear Regulatory Commission, 33046-33112 2018-14852 Part V Presidential Documents, 33113-33117 2018-15299 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. 83 136 Monday, July 16, 2018 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 32, and 35 [NRC-2014-0030] RIN 3150-AI63 Medical Use of Byproduct Material—Medical Event; Definitions and Training and Experience AGENCY:
Nuclear Regulatory Commission. ACTION: Final guidance; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission
(NRC)is issuing a final guidance document entitled, “Final Guidance for the Rule `Medical Use of Byproduct Material—Medical Events Definitions, Training and Experience, and Clarifying Amendments.' ” This guidance document addresses implementation of the NRC's final rule amending its medical use of byproduct material regulations which is being published concurrently in Separate Part IV of this issue of the **Federal Register** . DATES: The guidance document is available on July 16, 2018. ADDRESSES: Please refer to Docket ID NRC-2014-0030 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods: • *Federal Rulemaking Website:* Go to *http://www.regulations.gov* and search for Docket ID NRC-2014-0030. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: *Carol.Gallagher@nrc.gov.* For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document. • *NRC's Agencywide Documents Access and Management System (ADAMS):* You may obtain publicly-available documents online in the ADAMS Public Documents collection at *http://www.nrc.gov/reading-rm/adams.html.* To begin the search, select *“ADAMS Public Documents”* and then select *“Begin Web-based ADAMS Search.”* For problems with ADAMS, please contact the NRC's Public Document Room
(PDR)reference staff at 1-800-397-4209, 301-415-4737, or by email to *pdr.resource@nrc.gov.* The final guidance document is available in ADAMS under Accession No. ML18176A377. • *NRC's PDR:* You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. FOR FURTHER INFORMATION CONTACT: Donna-Beth Howe, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5441; email: *Donna-Beth.Howe@nrc.gov.* SUPPLEMENTARY INFORMATION: The NRC published the draft guidance document in the **Federal Register** on July 21, 2014 (79 FR 42224). The NRC received seven comments on the draft guidance. The NRC's response to the public comments received can be found in the fourth section of the final guidance. The guidance document is for use by applicants, licensees, Agreement States, and the NRC staff. This guidance document (ADAMS Accession No. ML18176A377) has four parts: the first two are revisions to existing information in the NUREG-1556, “Consolidated Guidance About Materials Licenses,” series of volumes for medical uses (Volume 9) and commercial nuclear pharmacies (Volume 13); the third part is a series of questions and answers to assist applicants and licensees in understanding and implementing the new regulatory changes; and the fourth is the comments received on the proposed guidance during the public comment period, and the NRC's responses. The current NUREG-1556 documents provide guidance to applicants for the completion and submission of materials license applications to the NRC. The documents also include model procedures that an applicant may consider when developing its radiation safety program. The guidance document can be found on the NRC's Medical Uses Licensee Toolkit website ( *http://www.nrc.gov/materials/miau/med-use-toolkit.html* ). The NRC is publishing concurrently with this guidance document the final rule, “Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments” (RIN 3150-AI63, NRC-2008-0175) in Separate Part IV of this issue of the **Federal Register** . In conjunction with the final rule, the NRC developed this final guidance document which provides guidance to licensees and applicants for implementing the revisions in the final rule. Dated at Rockville, Maryland, this 3rd day of July 2018. For the Nuclear Regulatory Commission. Daniel S. Collins, Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards. [FR Doc. 2018-14853 Filed 7-13-18; 8:45 am]