Vol. 80 Tuesday, No. 96 May 19, 2015

Pages 28537–28806

OFFICE OF THE FEDERAL REGISTER

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The FEDERAL REGISTER (ISSN 0097–6326) is published daily, SUBSCRIPTIONS AND COPIES Monday through Friday, except official holidays, by the Office PUBLIC of the Federal Register, National Archives and Records Administration, Washington, DC 20408, under the Federal Register Subscriptions: Act (44 U.S.C. Ch. 15) and the regulations of the Administrative Paper or fiche 202–512–1800 Committee of the Federal Register (1 CFR Ch. I). The Assistance with public subscriptions 202–512–1806 Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402 is the exclusive distributor of the official General online information 202–512–1530; 1–888–293–6498 edition. Periodicals postage is paid at Washington, DC. Single copies/back copies: The FEDERAL REGISTER provides a uniform system for making Paper or fiche 202–512–1800 available to the public regulations and legal notices issued by Assistance with public single copies 1–866–512–1800 Federal agencies. These include Presidential proclamations and (Toll-Free) Executive Orders, Federal agency documents having general FEDERAL AGENCIES applicability and legal effect, documents required to be published Subscriptions: by act of Congress, and other Federal agency documents of public interest. Assistance with Federal agency subscriptions: Documents are on file for public inspection in the Office of the Email [email protected] Federal Register the day before they are published, unless the Phone 202–741–6000 issuing agency requests earlier filing. For a list of documents currently on file for public inspection, see www.ofr.gov. The seal of the National Archives and Records Administration authenticates the Federal Register as the official serial publication established under the Federal Register Act. Under 44 U.S.C. 1507, the contents of the Federal Register shall be judicially noticed. The Federal Register is published in paper and on 24x microfiche. It is also available online at no charge at www.fdsys.gov, a service of the U.S. Government Publishing Office. The online edition of the Federal Register is issued under the authority of the Administrative Committee of the Federal Register as the official legal equivalent of the paper and microfiche editions (44 U.S.C. 4101 and 1 CFR 5.10). It is updated by 6:00 a.m. each day the Federal Register is published and includes both text and graphics from Volume 59, 1 (January 2, 1994) forward. For more information, contact the GPO Customer Contact Center, U.S. Government Publishing Office. Phone 202-512-1800 or 866-512- 1800 (toll free). E-mail, gpocusthelp.com. The annual subscription price for the Federal Register paper edition is $749 plus postage, or $808, plus postage, for a combined Federal Register, Federal Register Index and List of CFR Sections Affected (LSA) subscription; the microfiche edition of the Federal Register including the Federal Register Index and LSA is $165, plus postage. Six month subscriptions are available for one-half the annual rate. The prevailing postal rates will be applied to orders according to the delivery method requested. The price of a single copy of the daily Federal Register, including postage, is based on the number of pages: $11 for an issue containing less than 200 pages; $22 for an issue containing 200 to 400 pages; and $33 for an issue containing more than 400 pages. Single issues of the microfiche edition may be purchased for $3 per copy, including postage. Remit check or money order, made payable to the Superintendent of Documents, or charge to your GPO Deposit Account, VISA, MasterCard, American Express, or Discover. Mail to: U.S. Government Publishing Office—New Orders, P.O. Box 979050, St. Louis, MO 63197-9000; or call toll free 1-866-512-1800, DC area 202-512-1800; or go to the U.S. Government Online Bookstore site, see bookstore.gpo.gov. There are no restrictions on the republication of material appearing in the Federal Register. How To Cite This Publication: Use the volume number and the page number. Example: 80 FR 12345. Postmaster: Send address changes to the Superintendent of Documents, Federal Register, U.S. Government Publishing Office, Washington, DC 20402, along with the entire mailing label from the last issue received.

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Contents Federal Register Vol. 80, No. 96

Tuesday, May 19, 2015

Agriculture Department NOTICES See Animal and Plant Health Inspection Service Agency Information Collection Activities; Proposals, Submissions, and Approvals, 28580–28581 Animal and Plant Health Inspection Service NOTICES Defense Department Agency Information Collection Activities; Proposals, See Army Department Submissions, and Approvals: See Navy Department Importation of Christmas Cactus and Easter Cactus in NOTICES Agency Information Collection Activities; Proposals, Growing Media from the Netherlands and Denmark, Submissions, and Approvals, 28609 28579 Meetings: Army Department Strategic Environmental Research and Development RULES Program, Scientific Advisory Board, 28609–28610 Law Enforcement Reporting, 28545–28555 Delaware River Basin Commission PROPOSED RULES Centers for Disease Control and Prevention Meetings: NOTICES Amendments to the Rules of Practice and Procedure, Agency Information Collection Activities; Proposals, 28567–28568 Submissions, and Approvals, 28615–28619 NOTICES Charter Renewals: Meetings: World Trade Center Health Program Scientific/Technical Delaware River Basin Commission, 28610–28611 Advisory Committee, 28617 Meetings: Drug Enforcement Administration Advisory Board on Radiation and Worker Health, NOTICES National Institute for Occupational Safety and Decisions and Orders: Health, 28617 Annicol Marrocco, 28695–28706 Disease, Disability, and Injury Prevention and Control Bobby D. Reynolds, et al., 28643–28667 Special Emphasis Panel, 28615, 28618, 28620 JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Safety and Occupational Health Study Section, National Pharma Corp., 28667–28689 Institute for Occupational Safety and Health, 28619– Karen S. Dunning, 28640–28643 28620 Maryanne Phillips-Elias, M.D., 28689–28693 Sharad C. Patel, M.D., 28693–28695 Children and Families Administration NOTICES Education Department Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals, 28620 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Civil Rights Commission 2015–16 National Postsecondary Student Aid Study; Full NOTICES Scale Institution Contacting and Enrollment List Meetings: Collection, 28611–28612 Idaho Advisory Committee; Teleconference, 28580 Graduate Assistance in Areas of National Need Performance Report, 28612 Coast Guard RULES Employment and Training Administration Drawbridge Operation Regulations: NOTICES Long Island, New York Inland Waterway from East Worker Adjustment Assistance Eligibility; Amended Rockaway Inlet to Shinnecock Canal, NY, 28558 Certifications: Safety Zones and Special Local Regulations Eaton Corp., Cooper Power Systems, Olean, NY, 28709 Recurring Marine Events in Captain of the Port Long Worker Adjustment Assistance; Amended Certifications: Island Sound Zone, 28556–28558 Hewlett Packard Co., HP Enterprise Services, Omaha, NE, Safety Zones: et al., 28711–28712 Agat Marina, Agat, Guam, 28559–28561 Kelly Services; Kraft Foods Group Global, Woburn, MA, PROPOSED RULES 28710 Special Local Regulations: Southern California Edison, a subsidiary of Edison 86th Major League Baseball All-Star Week/Game, Ohio International, Irwindale, CA, et al., 28709–28710 River Mile 469.5 to 471.2; Cincinnati, OH, 28569– Worker and Alternative Trade Adjustment Assistance; 28571 Revised Determinations: San Bernardino Sun, a Subsidiary of California Commerce Department Newspapers Partnership, San Bernardino, CA, and See International Trade Administration Inland Valley Daily Bulletin, a Subsidiary of See National Oceanic and Atmospheric Administration California Newspapers Partnership, Ontario, CA, See Patent and Trademark Office 28710–28711

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Energy Department Food and Drug Administration See Federal Energy Regulatory Commission NOTICES NOTICES Agency Information Collection Activities; Proposals, Meetings: Submissions, and Approvals: Environmental Management Site-Specific Advisory Regulations for In Vivo Radiopharmaceuticals Used for Board, 28612–28613 Diagnosis and Monitoring, 28621 Guidance for Industry and Staff: Environmental Protection Agency Compounding Animal Drugs From Bulk Drug Substances; PROPOSED RULES Withdrawal of Compliance Policy Guide on Electronic Reporting and Recordkeeping Requirements for Compounding of Drugs for Use in Animals, 28624– New Source Performance Standards, 28571–28572 28629 NOTICES List of Bulk Drug Substances That May be Used by an Fiscal Year 2014 Service Contract Inventory, 28613 Outsourcing Facility to Compound Drugs for Use in Animals; Request for Nominations, 28622–28624 Federal Aviation Administration Meetings: RULES Exploring Naloxone Uptake and Use, 28621–28622 Modification of Class D and Class E Airspace: Pasco, WA, 28537–28538 Health and Human Services Department Prohibition of Fixed-Wing Special Visual Flight Rules See Centers for Disease Control and Prevention Operations at Washington–Dulles International Airport; See Children and Families Administration Withdrawal, 28538–28539 See Food and Drug Administration NOTICES See National Institutes of Health Petitions for Exemptions; Summaries: NOTICES Gus Christopher Toulatos, 28760 Meetings: Advisory Group on Prevention, Health Promotion, and Federal Deposit Insurance Corporation Integrative and Public Health, 28629–28630 NOTICES National Committee on Vital and Health Statistics, 28629 Updated Listing of Financial Institutions in Liquidation, 28613–28614 Homeland Security Department See Coast Guard Federal Election Commission See U.S. Customs and Border Protection NOTICES Meetings; Sunshine Act, 28614 Interior Department See Fish and Wildlife Service Federal Energy Regulatory Commission See National Park Service NOTICES Petitions for Declaratory Orders: Internal Revenue Service Southline Transmission, LLC; SU FERC, LLC, 28613 NOTICES Agency Information Collection Activities; Proposals, Federal Highway Administration Submissions, and Approvals, 28764–28765 NOTICES Agency Information Collection Activities; Proposals, Manual for Assessing Safety Hardware Transition, 28761– Submissions, and Approvals: 28762 Form 3949–A, 28763–28764

Federal Motor Carrier Safety Administration International Trade Administration NOTICES NOTICES Meetings; Sunshine Act, 28762 Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Federal Reserve System Wooden Bedroom Furniture from the People’s Republic NOTICES of China, 28581–28582 Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Justice Department Company, 28614–28615 See Drug Enforcement Administration Changes in Bank Control: NOTICES Acquisitions of Shares of a Bank or Bank Holding Agency Information Collection Activities; Proposals, Company, 28614 Submissions, and Approvals, 28708–28709 Agency Information Collection Activities; Proposals, Fish and Wildlife Service Submissions, and Approvals: NOTICES Semi-Annual Progress Report for Grantees from the Agency Information Collection Activities; Proposals, Enhanced Training and Services to End Violence Submissions, and Approvals: Against and Abuse of Women Later in Life Program, Horseshoe Crab Tagging Program, 28637–28638 28707–28708 National Initiative to Understand and Connect Americans September 11th Victim Compensation Fund Claimant and Nature, 28638–28639 Eligibility and Compensation Form, 28707 Meetings: Trinity River Adaptive Management Working Group, Labor Department 28639 See Employment and Training Administration

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RULES Navy Department Rules of Practice and Procedure for Administrative RULES Hearings Before the Office of Administrative Law Certifications and Exemptions under the International Judges, 28768–28802 Regulations for Preventing Collisions at Sea, 1972, NOTICES 28555 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Nuclear Regulatory Commission General Inquiries to State Agency Contacts, 28712–28713 NOTICES Agency Information Collection Activities; Proposals, National Highway Traffic Safety Administration Submissions, and Approvals: NOTICES Destinations of Released Patients Following Treatment Petitions for Exemptions: with Iodine–131 and Estimation of Doses to Members Jaguar Land Rover North America, LLC; Vehicle Theft of the Public at Locations Other than Conventional Prevention Standard, 28762–28763 Residences Receiving Such Patients, 28715–28716 Disposal of High-Level Radioactive Wastes in Geologic Repositories, 28714–28715 National Institutes of Health NOTICES Patent and Trademark Office Exclusive Licenses: RULES Biomarkers for Acute Ischemic Stroke, 28633–28634 Amendments to the Rules of Practice for Trials Before the Meetings: Patent Trial and Appeal Board, 28561–28566 Center for Scientific Review, 28630–28632, 28634–28636 National Institute of Allergy and Infectious Diseases, Personnel Management Office 28633 NOTICES National Institute of Mental Health, 28632, 28635–28636 Meetings: National Institute on Aging, 28633 Presidents Commission on White House Fellowships National Institute on Alcohol Abuse and Alcoholism, Advisory Committee, 28716 28632–28633 National Institute on Drug Abuse, 28636 Postal Regulatory Commission NOTICES National Oceanic and Atmospheric Administration New Postal Products, 28716–28717 RULES Fisheries of the Exclusive Economic Zone off Alaska: Presidential Documents Bering Sea and Aleutian Islands Crab Rationalization ADMINISTRATIVE ORDERS Program; Amendment 45; Pacific Cod Sideboard Burma; Continuation of National Emergency (Notice of May Allocations in the Gulf of Alaska, 28539–28545 15, 2015), 28803–28805 PROPOSED RULES Fisheries of the Northeastern United States: Securities and Exchange Commission Atlantic Mackerel, Squid, and Butterfish Fisheries; NOTICES Framework Adjustment 9, 28575–28578 Meetings; Sunshine Act, 28737 International Fisheries: Self-Regulatory Organizations; Proposed Rule Changes: Pacific Tuna Fisheries; Establishment of Tuna Vessel BOX Options Exchange, LLC, 28738–28739 Monitoring System in the Eastern Pacific Ocean, EDGA Exchange, Inc., 28719–28721 28572–28575 EDGX Exchange, Inc., 28742–28757 NOTICES Financial Industry Regulatory Authority, Inc., 28740– Fee Rate Adjustments: 28742 Fishing Capacity Reduction Program; Southeast Alaska ICE Clear Europe, Ltd., 28733–28735 Purse Seine Salmon Fishery, 28608–28609 NASDAQ OMX PHLX, LLC, 28739–28740 Takes of Marine Mammals Incidental to Specified NASDAQ Stock Market, LLC, 28757–28759 Activities: NYSE Arca, Inc., 28721–28733, 28735–28737 Anacortes Tie-up Slips Dolphin and Wingwall NYSE MKT, LLC, 28717–28719 Replacement, 28582–28588 Construction Activities at the Children’s Pool Lifeguard Small Business Administration Station at La Jolla, CA, 28588–28608 NOTICES Meetings: Advisory Committee On Veterans Business Affairs, National Park Service 28759–28760 NOTICES Interagency Task Force on Veterans Small Business National Register of Historic Places: Development, 28759 Pending Nominations and Related Actions, 28639–28640 Transportation Department National Science Foundation See Federal Aviation Administration NOTICES See Federal Highway Administration Agency Information Collection Activities; Proposals, See Federal Motor Carrier Safety Administration Submissions, and Approvals: See National Highway Traffic Safety Administration Foundation Proposal/Award Information –– NSF Proposal and Award Policies and Procedures Guide, Treasury Department 28713 See Internal Revenue Service

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U.S. Customs and Border Protection Part III NOTICES Presidential Documents, 28803–28805 Meetings: U.S. Customs and Border Protection Airport and Seaport Inspections User Fee Advisory Committee; Reader Aids Correction, 28636–28637 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. Separate Parts In This Issue 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 Part II archives, FEDREGTOC-L, Join or leave the list (or change Labor Department, 28768–28802 settings); then follow the instructions.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

3 CFR Administrative Orders: Notice of May 15, 2015 ...... 28805 14 CFR 71...... 28537 91...... 28538 15 CFR 902...... 28539 18 CFR Proposed Rules: 410...... 28567 29 CFR 18...... 28768 32 CFR 635...... 28545 706...... 28555 33 CFR 100...... 28556 117...... 28558 165 (2 documents) ...... 28556, 28559 Proposed Rules: 100...... 28569 37 CFR 42...... 28561 40 CFR Proposed Rules: 60...... 28571 50 CFR 680...... 28539 Proposed Rules: 300...... 28572 648...... 28575

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Rules and Regulations Federal Register Vol. 80, No. 96

Tuesday, May 19, 2015

This section of the FEDERAL REGISTER September 15. For further information, the airspace necessary for the safety and contains regulatory documents having general you can contact the Airspace Policy and management of aircraft departing and applicability and legal effect, most of which ATC Regulations Group, Federal arriving under IFR operations at the are keyed to and codified in the Code of Aviation Administration, 800 airport. The Class D airspace area is Federal Regulations, which is published under Independence Avenue SW., expanded from the existing 4.3 miles to 50 titles pursuant to 44 U.S.C. 1510. Washington, DC 29591; telephone: 202– 4.8 miles, west of the airport, from the The Code of Federal Regulations is sold by 267–8783. 255° radial to the 12° radial, and two the Superintendent of Documents. Prices of FOR FURTHER INFORMATION CONTACT: segments extending 5.8 miles southwest new books are listed in the first FEDERAL Richard Roberts, Federal Aviation and northeast of the airport is added. REGISTER issue of each week. Administration, Operations Support The cutout of the Class D airspace area Group, Western Service Center, 1601 for Vista Airport is eliminated, as Vista Lind Avenue SW., Renton, WA 98057; Airport is closed. The Class E surface DEPARTMENT OF TRANSPORTATION telephone (425) 203–4517. airspace is adjusted to coincide with the SUPPLEMENTARY INFORMATION: dimensions of the Class D airspace area. Federal Aviation Administration Class E airspace designated as an History extension to the Class D and Class E 14 CFR Part 71 On July 3, 2014, the FAA published surface area is removed as it is no longer [Docket No. FAA–2014–0279; Airspace in the Federal Register a notice of needed for IFR operations. The Class E Docket No. 14–ANM–3] proposed rulemaking (NPRM) to modify airspace extending 700 feet above the controlled airspace at Tri-Cities Airport, surface is decreased to an 11-mile radius Modification of Class D and Class E Pasco, WA (79 FR 37967). Interested of the airport with segments extending Airspace; Pasco, WA parties were invited to participate in from the 11-mile radius to 13 miles northeast and southeast of the airport, AGENCY: Federal Aviation this rulemaking effort by submitting written comments on the proposal to the and a segment 4 miles south and 9 miles Administration (FAA), DOT. ° FAA. No comments were received. north of a 226 bearing from the airport ACTION: Final rule. Class D airspace and Class E airspace extending to 15 miles southwest of the SUMMARY: This action modifies the Class designations are published in airport. These actions are necessary to D and Class E airspace at Tri-Cities paragraphs 5000, 6004 and 6005, accommodate RNAV (GPS) standard Airport, Pasco, WA. Controlled airspace respectively, of FAA Order 7400.9Y, instrument approach procedures at the is necessary to accommodate the new dated August 6, 2014, and effective airport. Area Navigation (RNAV) Global September 15, 2014, which is The FAA has determined that this Positioning System (GPS) standard incorporated by reference in 14 CFR regulation only involves an established instrument approach procedures at the 71.1. The Class D and E airspace body of technical regulations for which airport. This action, initiated by the designations listed in this document frequent and routine amendments are biennial review of the Pasco, WA, will be published subsequently in that necessary to keep them operationally enhances the safety and management of Order. Except for editorial corrections current, is non-controversial and IFR operations at the airport. this rule is the same as published in the unlikely to result in adverse or negative NPRM. comments. It, therefore, (1) is not a DATES: Effective 0901 UTC, August 20, ‘‘significant regulatory action’’ under 2015. The Director of the Federal Availability and Summary of Executive Order 12866; (2) is not a Register approves this incorporation by Documents for Incorporation by ‘‘significant rule’’ under DOT reference action under title 1, Code of Reference Regulatory Policies and Procedures (44 Federal Regulations, part 51, subject to This document amends FAA Order FR 11034; February 26, 1979); and (3) the annual revision of FAA Order 7400.9Y, airspace Designations and does not warrant preparation of a 7400.9 and publication of conforming Reporting Points, dated August 6, 2014, Regulatory Evaluation as the anticipated amendments. and effective September 15, 2014. FAA impact is so minimal. Since this is a ADDRESSES: FAA Order 7400.9Y, Order 7400.9Y is publicly available as routine matter that only affects air traffic Airspace Designations and Reporting listed in the ADDRESSES section of this procedures and air navigation, it is Points, and subsequent amendments can final rule. FAA Order 7400.9Y lists certified that this rule, when be viewed on line at http:// Class A, B, C, D, and E airspace areas, promulgated, does not have a significant www.faa.gov/airtraffic/publications/. air traffic service routes, and reporting economic impact on a substantial The Order is also available for points. number of small entities under the inspection at the National Archives and criteria of the Regulatory Flexibility Act. Records Administration (NARA). For The Rule The FAA’s authority to issue rules information on the availability of this This amendment to Title 14, Code of regarding aviation safety is found in material at NARA, call 202–741–6030, Federal Regulations (14 CFR) part 71 Title 49 of the United States Code. or go to http://www.archives.gov/ modifies Class D airspace, Class E Subtitle I, Section 106 describes the federal_register/code_of_federal- surface airspace, and Class E airspace authority of the FAA Administrator. regulations/ibr_locations.html. extending upward from 700 feet above Subtitle VII, Aviation Programs, FAA Order 7400.9, Airspace the surface at Tri-Cities Airport, Pasco, describes in more detail the scope of the Designations and Reporting Points, is WA. After a biennial review of the agency’s authority. This rulemaking is published yearly and effective on airspace, the FAA found modification of promulgated under the authority

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described in Subtitle VII, Part A, Class D airspace area is effective during the Issued in Seattle, Washington, on May 8, Subpart I, Section 40103. Under that specific dates and times established in 2015. section, the FAA is charged with advance by a Notice to Airmen. The effective Christopher Ramirez, prescribing regulations to assign the use date and time will thereafter be continuously Acting Manager, Operations Support Group, of airspace necessary to ensure the published in the Airport/Facility Directory. Western Service Center. safety of aircraft and the efficient use of Paragraph 6002 Class E airspace designated [FR Doc. 2015–12019 Filed 5–18–15; 8:45 am] airspace. This regulation is within the as surface areas. BILLING CODE 4910–13–P scope of that authority as it amends * * * * * controlled airspace at Tri-Cities Airport, Pasco, WA. ANM WA E2 Pasco, WA [Modified] DEPARTMENT OF TRANSPORTATION Environmental Review Pasco, Tri-Cities Airport, WA Federal Aviation Administration (Lat. 46°15′53″ N., long. 119°07′09″ W.) The FAA has determined that this action qualifies for categorical exclusion That airspace extending upward from the 14 CFR Part 91 under the National Environmental surface within a 4.3-mile radius of Tri-Cities Airport and that airspace within 4.8-mile [Docket No. FAA–2015–0190; Amdt. No. 91– Policy Act in accordance with FAA 337] radius of the airport from the 256° bearing Order 1050.1E, ‘‘Environmental from the airport clockwise to the 11° bearing RIN 2120–AK69 Impacts: Policies and Procedures,’’ from the airport and that airspace within a paragraph 311a. This airspace action is 5.8-mile radius of the airport from the 11° Prohibition of Fixed-Wing Special not expected to cause any potentially bearing from the airport clockwise to the 83° Visual Flight Rules Operations at significant environmental impacts, and bearing from the airport and within 5.8-mile Washington-Dulles International no extraordinary circumstances exist radius of the airport from 213° bearing Airport; Withdrawal that warrant preparation of an clockwise to the 256° bearing from the environmental assessment AGENCY: Federal Aviation airport. This Class D airspace area is effective Administration (FAA), DOT. during the specific dates and times Lists of Subjects in 14 CFR Part 71 ACTION: Direct final rule; withdrawal. established in advance by a Notice to Airspace, Incorporation by reference, Airmen. The effective date and time will Navigation (air). SUMMARY: The FAA is withdrawing a thereafter be continuously published in the previously published direct final rule Adoption of the Amendment: Airport/Facility Directory. that would have prohibited fixed-wing In consideration of the foregoing, the Paragraph 6004 Class E airspace areas special visual flight rules operations at Federal Aviation Administration designated as an extension to Class D or Washington-Dulles International amends 14 CFR part 71 as follows: Class E surface area. Airport. The FAA is withdrawing this * * * * * action because it has received an PART 71—DESIGNATION OF CLASS A, adverse comment. B, C, D, AND E AIRSPACE AREAS; AIR ANM WA E4 Pasco, WA [Removed] DATES: The direct final rule published TRAFFIC SERVICE ROUTES; AND Paragraph 6005 Class E airspace areas on March 26, 2015, at 80 FR 15887, is REPORTING POINTS extending upward from 700 feet or more withdrawn, effective May 19, 2015. above the surface of the earth. FOR FURTHER INFORMATION CONTACT: For ■ 1. The authority citation for Part 71 technical questions concerning this continues to read as follows: * * * * * action, contact David Maddox, Airspace Authority: 49 U.S.C. 106(f), 106(g) 40103, ANM WA E5 Pasco, WA [Modified] Policy and Regulation Group, AJV–113, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Pasco, Tri-Cities Airport, WA Federal Aviation Administration, 800 1959–1963 Comp., p. 389. (Lat. 46°15′53″ N., long. 119°07′09″ W.) Independence Avenue SW., § 71.1 [Amended] That airspace extending upward from 700 Washington, DC 20591; telephone (202) 267–8783; email david.maddox@ ■ 2. The incorporation by reference in feet above the surface within 7.8-mile radius faa.gov. 14 CFR 71.1 of FAA Order 7400.9Y, of the Tri-Cities Airport, and that airspace within an 11-mile radius of the airport from For legal questions concerning this Airspace Designations and Reporting the 265° bearing from the airport clockwise action, contact Robert Frenzel, Office of Points, dated August 6, 2014, and to 16° bearing from the airport, and that the Chief Counsel, AGC–200, Federal effective September 15, 2014, is airspace from the 54° bearing from the airport Aviation Administration, 800 amended as follows: clockwise to the 112° from the airport, and Independence Avenue SW., Paragraph 5000 Class D Airspace. that airspace 3.5 miles either side of the 35° Washington, DC 20591; telephone (202) * * * * * bearing of the airport extending from the 11- 267–3073; email [email protected]. mile radius to 13 mile northeast of the SUPPLEMENTARY INFORMATION: ANM WA D Pasco, WA [Modified] airport, and that airspace and that airspace Pasco, Tri-Cities Airport, WA 4.0 miles either side of the 133° bearing Background ° ′ ″ ° ′ ″ (Lat. 46 15 53 N., long. 119 07 09 W.) extending from the airport to 13 miles On March 26, 2015 (80 FR 15887), the That airspace extending upward from the southeast of the airport, and that airspace 4 FAA published in the Federal Register surface to and including 2,900 feet MSL miles southeast and 9 miles northwest of the a direct final rule prohibiting fixed-wing within a 4.3-mile radius of Tri-Cities Airport, 226° bearing from the airport extending from special visual flight rules (SVFR) and that airspace within a 4.8-mile radius of the airport 15 miles southwest; that airspace operations at Washington-Dulles the airport from the 256° bearing from the extending upward from 1,200 feet above the airport clockwise to the 11° bearing from the International Airport (IAD). The direct surface bounded by a line beginning at lat. final rule was to become effective on airport, and that airspace within a 5.8-mile ° ′ ″ ° ′ ″ radius of the airport from the 11° bearing 45 49 00 N., long. 118 00 00 W.; to lat. May 26, 2015. ° 45°49′00″ N., long. 119°45′00″ W.; to lat. from the airport clockwise to the 83 bearing Reason for Withdrawal from the airport, and within a 5.8-mile radius 47°00′00″ N., long. 119°45′00″ W.; to lat. of the airport from the 213° bearing clockwise 47°00′00″ N., long. 118°00′00″ W.; thence to The FAA is withdrawing the direct to the 256° bearing from the airport. This the point of origin. final rule because the agency received

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an adverse comment to the rule and is DEPARTMENT OF COMMERCE • The Regulatory Impact Review/ required by 14 CFR 11.31(c) to Initial Regulatory Flexibility Analysis withdraw a direct final rule if the National Oceanic and Atmospheric (RIR/IRFA), and the Categorical agency receives any adverse comment or Administration Exclusion prepared for this action notice of intent to file any adverse (collectively referred to as the comment. We received a comment from 15 CFR Part 902 ‘‘Analysis’’); • an individual pilot who objected to the The Harvest Specifications prohibition of fixed-wing SVFR 50 CFR Part 680 Supplemental Information Report (SIR) operations at IAD. The commenter [Docket No. 130820737–5408–02] prepared for the final 2015 and 2016 stated that the blanket prohibition of harvest specifications; RIN 0648–BD61 • The Final Environmental SVFR was inappropriate and Assessment/Final RIR/IRFA for unnecessary. The commenter further Fisheries of the Exclusive Economic Amendment 83 to the Fishery stated that he had personally used SVFR Zone Off Alaska; Bering Sea and Management Plan for Groundfish of the twice in the last few years to land at IAD Aleutian Islands Crab Rationalization Gulf of Alaska (GOA FMP) Allocation of to participate in an event at the Program; Amendment 45; Pacific Cod Pacific Cod Among Sectors in the Smithsonian National Air and Space Sideboard Allocations in the Gulf of Western and Central GOA; and Museum’s Steven F. Udvar-Hazy Center, Alaska • The Alaska Groundfish Harvest which is located adjacent to IAD. The AGENCY: National Marine Fisheries Specifications Final Environmental commenter further suggested that the Service (NMFS), National Oceanic and Impact Statement (Harvest IAD control tower should approve or Atmospheric Administration (NOAA), Specifications EIS). disapprove SVFR operations on a case- Commerce. Written comments regarding the by-case basis. ACTION: Final rule. burden-hour estimates or other aspects The FAA has determined that the of the collection of information comment meets the requirements for SUMMARY: NMFS publishes regulations requirements contained in this final rule consideration as an adverse comment to implement Amendment 45 to the may be submitted by mail to NMFS, per § 11.31(a). In accordance with the Fishery Management Plan for Bering Alaska Region, P.O. Box 21668, Juneau, AK 99802–1668, Attn: Ellen Sebastian, provisions of § 11.31(c), the FAA Sea/Aleutian Islands King and Tanner Crabs (Crab FMP). Amendment 45 Records Officer; in person at NMFS, withdraws the direct final rule. establishes, for a limited period of time, Alaska Region, 709 West 9th Street, Conclusion a process for NMFS to permanently Room 420A, Juneau, AK; or by email to remove Pacific cod catch limits, known [email protected] or fax Withdrawal of Amendment No. 91– as sideboard limits, which are to 202–395–5806. 337 does not preclude the FAA from applicable to certain hook-and-line FOR FURTHER INFORMATION CONTACT: issuing rulemaking on the subject in the catcher/processors in the Central and Rachel Baker, 907–586–7228 future, nor does it commit the agency to Western Gulf of Alaska (GOA) SUPPLEMENTARY INFORMATION: This final any future course of action. The agency Regulatory Areas. This action authorizes rule implements Amendment 45 to the may also make any future necessary NMFS to remove these Pacific cod Crab FMP. The king and Tanner crab changes to the Code of Federal sideboard limits in the Central and/or fisheries in the exclusive economic zone Regulations through a notice of Western GOA if each eligible participant (EEZ) of the Bering Sea and Aleutian proposed rulemaking with opportunity in the hook-and-line catcher/processor Islands are managed under the Crab for public comment. Therefore, the FAA sector in a regulatory area signs and FMP. While the groundfish fisheries in withdraws Amendment No. 91–337 submits a request that NMFS remove the the EEZ of the Gulf of Alaska are published at 80 FR 15887, March 26, sideboard limit. Each eligible managed primarily under the Fishery 2015. participant will be required to submit Management Plan for Groundfish of the the request to NMFS within 1 year of Issued under authority provided by 49 Gulf of Alaska (GOA FMP), some the date of publication of this final rule. aspects of groundfish fishing in the Gulf U.S.C. 106(f), 44701(a), and 44703 in This action is necessary to provide Washington, DC, on May 13, 2015. of Alaska are managed under the Crab participants in the Central and Western FMP. Jodi S. McCarthy, GOA hook-and-line catcher/processor NMFS published the Notice of Director, Airspace Services. sectors with an opportunity to Availability for Amendment 45 in the [FR Doc. 2015–12047 Filed 5–18–15; 8:45 am] cooperatively coordinate harvests of Federal Register on February 2, 2015 BILLING CODE 4910–13–P Pacific cod through private arrangement (80 FR 5499), with a 60-day comment to the participants’ mutual benefit, period that ended April 3, 2015. The which would remove the need for Secretary approved Amendment 45 on sideboard limits in these regulatory April 29, 2015, after accounting for areas. This action is intended to information from the public, and promote the goals and objectives of the determining that Amendment 45 is Crab FMP, the Magnuson-Stevens consistent with the Crab FMP, the Fishery Conservation and Management Magnuson-Stevens Act, and other Act (Magnuson-Stevens Act), and other applicable law. NMFS published a applicable law. proposed rule for Amendment 45 on DATES: Effective June 18, 2015. February 12, 2015 (80 FR 7817). The 30- ADDRESSES: Electronic copies of the day comment period on the proposed following documents may be obtained rule ended March 16, 2015. NMFS from http://www.regulations.gov or from received one comment letter during the the NMFS Alaska Region Web site at comment periods on Amendment 45 http://alaskafisheries.noaa.gov: and the proposed rule. A summary of

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the comment and NMFS’ response is specifications process. Sideboard limits other than crab. The Council and NMFS provided in the Comment and Response constrain harvests by specific vessels recognized that the benefits of the CR section of this preamble. based on regulatory requirements Program could create incentives for established under various management recipients of snow crab QS to increase Background programs. Sideboard limits are their level of participation in groundfish A detailed review of the provisions of calculated as a portion of the TACs for fisheries, especially Pacific cod fisheries Amendment 45, the implementing some groundfish species and in the Central and Western GOA. regulations, and the rationale for these established in the annual harvest Therefore, Federal regulations regulations is provided in the preamble specifications. The resulting sideboard implementing the CR Program to the proposed rule (79 FR 36702, June limits for Pacific cod, expressed in established CR Program GOA sideboards 30, 2014) and is not repeated here. The metric tons, are published in the annual to limit the potential adverse effects of proposed rule is available from the GOA groundfish harvest specification the CR Program on GOA groundfish NMFS Alaska Region Web site (see notices (for the most recent example, see fisheries. These sideboards prevent CR ADDRESSES). 80 FR 10250, February 25, 2015). Program participants from preempting This final rule establishes, for a Under this final rule, the GOA Pacific fishermen in the GOA that did not limited period of time, a regulatory cod OFL, ABC, TACs, and sector receive benefits from the CR Program. process for NMFS to permanently allocations will continue to be During a fishing year, NMFS manages remove Pacific cod catch limits, known established through the annual GOA CR Program GOA Pacific cod sideboard as sideboard limits, that are applicable harvest specifications process. NMFS limits by tracking all catch of vessels to some participants in the Central GOA will continue to manage Pacific cod in subject to a sideboard limit to make sure Regulatory Area (Central GOA) and the GOA by limiting harvests to the the sideboard limits are not exceeded. Western GOA Regulatory Area (Western established TACs and sector allocations. NMFS will prohibit directed fishing for GOA) hook-and-line catcher/processor Therefore, this final rule does not GOA Pacific cod in a specific regulatory sectors. This final rule preamble increase the likelihood that an OFL, area by vessels subject to the CR provides a brief description of Pacific ABC, TAC, or sector catch limit will be Program GOA Pacific cod sideboard cod fishery management for the Central exceeded. See the preamble to the limit through the annual harvest and Western GOA hook-and-line proposed rule and sections 1.5.2 and 3.2 specifications if NMFS determines at catcher/processor sectors and the of the Analysis for additional details. the start of the fishing year that the CR management provisions that apply to NMFS also manages Pacific cod Program GOA Pacific cod sideboard Amendment 45 and this final rule. fisheries through the License Limitation limit is insufficient to support a directed Management of Pacific Cod in the Program (LLP). A vessel is required to fishery by those vessels (see regulations Central and Western GOA be named on an LLP license before it at § 680.22(e)(2) and (3)). can be deployed to directed fish (i.e., The preamble to the proposed rule NMFS implements conservation and specifically target) for Pacific cod in and section 1.6 of the Analysis describe management measures, such as catch Federal waters of the GOA. NMFS has that some of the vessels and LLP limits, to prevent overfishing while issued a specific number of LLP licenses active in the hook-and-line achieving the optimum yield in licenses, which establish an upper limit catcher/processor sector are subject to federally managed fisheries. Catch on the total number of potential CR Program GOA Pacific cod sideboard limits for GOA Pacific cod are participants in GOA Pacific cod limits. The hook-and-line catcher/ established as part of the annual harvest fisheries. LLP licenses must have the processor sector operating in the EEZ off specifications process for GOA necessary endorsements to directed fish Alaska currently consists of 36 vessels. groundfish. The North Pacific Fishery for Pacific cod in the GOA. Specific to NMFS has determined that eight of Management Council (Council) annually this final rule, participants in the these 36 vessels are subject to the CR recommends, and NMFS specifies, an Central GOA and Western GOA hook- Program GOA Pacific cod sideboard amount of catch at which overfishing is and-line catcher/processor sectors must limits. The Federal Fisheries Permit occurring (i.e., overfishing limit or have an LLP license with endorsements (FFP) issued by NMFS to each of these OFL), an acceptable biological catch assigned for (1) Central GOA or Western eight vessels includes a designation (ABC), and a total allowable catch (TAC) GOA, (2) hook-and-line gear, (3) indicating that the vessel is subject to for each stock or stock complex (i.e., catcher/processor, and (4) Pacific cod. the CR Program GOA Pacific cod species or species group). Separate sideboard limits. Of the LLP licenses GOA Pacific Cod Sideboard Limits TACs are calculated using the that authorize a vessel to participate in Established Under the BSAI Crab apportionment of TAC for specific the Central and/or Western GOA Pacific Rationalization Program regulatory areas to limit catch and cod hook-and-line catcher/processor ensure that fisheries can be effectively The Bering Sea and Aleutian Islands sector, NMFS has determined that five managed. Specific to this final rule, the (BSAI) Crab Rationalization Program LLP licenses are subject to the CR Council recommends, and NMFS (CR Program) was implemented in 2005 Program GOA Pacific cod sideboard implements an OFL and ABC for Pacific and established a catch share program limits. These five LLP licenses include cod in the GOA, and separate TACs for that allocates BSAI crab resources a designation indicating that the license the Eastern, Central, and Western GOA among harvesters, processors, and is subject to the CR Program GOA Pacific cod fisheries. NMFS apportions coastal communities. As part of the CR Pacific cod sideboard limits. each TAC among various gear types Program, eligible vessel owners and (e.g., pot or trawl gear), operation types vessel captains were allocated quota Allocations of Pacific Cod in the GOA (e.g., catcher vessels and catcher/ share (QS) in several valuable crab CR Program GOA Pacific cod processors), and sectors (e.g., hook-and- fisheries, including the Bering Sea snow sideboard limits constrain the harvest of line catcher/processors) as required by crab (Chionoecetes opilio) fishery. The GOA Pacific cod by vessels and holders regulation (see regulations at CR Program provides increased of license limitation program (LLP) § 680.20(a)). Similarly, the Council flexibility for crab fishermen to choose licenses that were used to harvest recommends and NMFS establishes when and where to fish or whether to specific amounts of Pacific cod in the sideboard limits as part of the harvest lease their crab QS and fish for species GOA and snow crab in the Bering Sea

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and Aleutian Islands Management Area. relative to the sideboard limits. The complete and submit to NMFS the form Originally, the CR Program GOA Pacific proposed rule preamble and sections 1.5 requesting removal of the CR Program cod sideboard limits for the Eastern, and 1.6 of the Analysis provide GOA Pacific cod sideboard limit in the Central, and Western GOA were additional detail on the impacts of Central GOA. Similarly, each holder of calculated using the Pacific cod TACs Amendment 83 on participants in the an LLP license with Western GOA for each area. With the implementation Central and Western GOA hook-and-line endorsements listed in Table 10 to Part of Amendment 83 to the Fishery catcher/processor sectors who are 680 will be required to complete and Management Plan for Gulf of Alaska subject to CR Program GOA Pacific cod submit to NMFS the form requesting Groundfish in 2012, the CR Program sideboard limits. removal of the CR Program GOA GOA Pacific cod sideboard limits in the sideboard limit in the Western GOA. Implementation of This Action Central and Western GOA are calculated This final rule modifies regulations at using the apportionment of Pacific cod This final rule is necessary to provide 50 CFR 680.22(e) that require NMFS to TAC established for specific gear types participants in the Central and Western establish Pacific cod sideboard limits for (e.g., hook-and-line gear, pot gear) and GOA hook-and-line catcher/processor hook-and-line catcher/processors during by operation type (i.e., catcher/ sectors with an opportunity to the annual harvest specification process. processor vessels, catcher vessels). CR cooperatively coordinate harvests of Under this final rule, NMFS will not Program GOA Pacific cod sideboard Pacific cod through private arrangement establish these sideboard limits for the limits in the Central and Western GOA to the participants’ mutual benefit, Central or Western GOA if all for vessels using hook-and-line gear and which would remove the need for participants eligible to use a hook-and- operating as catcher/processors (the current regulations that impose line catcher/processor to fish for Pacific hook-and-line catcher/processor sector) sideboard harvest restrictions on some cod in the regulatory area sign and are now much smaller than they were participants in the sectors. This final submit to NMFS a request that NMFS prior to Amendment 83. As a result, rule establishes regulatory conditions remove the sideboard limit for that NMFS prohibits directed fishing for that must be met prior to the removal of regulatory area. Pacific cod in the Central and Western CR Program GOA Pacific cod sideboard Each eligible participant will be GOA by participants in the hook-and- limits for the hook-and-line catcher/ required to submit that request to NMFS line catcher/processor sector who are processor sectors in the Central and/or on or before May 18, 2016. Each eligible subject to CR Program GOA Pacific cod Western GOA. NMFS will remove the participant in the Central and/or sideboard limits so that these small sideboard limits if each person holding Western GOA must sign an affidavit, sideboard limits are not exceeded. The an LLP license or LLP licenses with included on a form, to request that proposed rule preamble describes that endorsements that authorize directed NMFS no longer establish Pacific cod Amendment 83 did not change Pacific fishing for Pacific cod as a hook-and- sideboard limits for the hook-and-line cod management in the Eastern GOA line catcher/processor in the Central or catcher/processor sector in the Central because the same level of competition, Western GOA (i.e., eligible participants) and/or Western GOA. If NMFS receives or race for fish, did not exist in the provides NMFS with a signed form the required affidavits during the 1-year Eastern GOA compared to the Central requesting that NMFS remove the period, NMFS will announce the and Western GOA. As a result, the CR Pacific cod sideboard limit for that permanent removal of the Central and/ Program GOA Pacific cod sideboard regulatory area. or Western GOA sideboard limits during limits in the Eastern GOA were not Under this final rule, NMFS will not the annual GOA groundfish recalculated for gear and operation type. remove the Pacific cod sideboard limit specification process and will no longer for the Central or Western GOA unless establish Pacific cod sideboard limits for The Effect of Pacific Cod Sideboard each eligible participant in the Central the hook-and-line catcher/processor Limits on Hook-and-Line Catcher/ or Western GOA submits to NMFS a sector in the Central and/or Western Processors in the Central and Western completed Request to Extinguish Pacific GOA. If NMFS does not receive the GOA Cod Sideboard Limit in the Central or required affidavits on or before May 18, The CR Program GOA Pacific cod Western GOA. As described in the 2016, NMFS will continue to establish sideboard limits affected the eight preamble to the proposed rule, the GOA Pacific cod sideboard limits for the vessels and the five LLP licenses subject holders of LLP licenses with the hook-and-line catcher/processor sectors to the sideboard limits differently necessary endorsements, rather than through the annual GOA groundfish starting in 2012 under Amendment 83 vessels owners, represent the universe specification process and the than under management provisions of eligible fishery participants in the opportunity to remove them will expire. when the CR Program was first Central and Western GOA hook-and-line Although this final rule is intended to implemented in 2006 through 2011. catcher/processor sectors. This final rule provide an opportunity for coordination Since the implementation of adds Table 10 to Part 680 to identify the and cooperation among all eligible Amendment 83, NMFS has prohibited 23 LLP licenses with endorsements that participants in both the Central and directed fishing by participants subject authorize a vessel to catch and process Western GOA, this final rule allows the to CR Program GOA Pacific cod Pacific cod at-sea using hook-and-line eligible participants to submit requests sideboard limits in the hook-and-line gear in the Central GOA, and the 18 LLP for each regulatory area separately. catcher/processor sector in the Central licenses with endorsements that Therefore, a CR Program GOA Pacific and Western GOA. NMFS has made this authorize a vessel to catch and process cod sideboard limit could be removed determination each year based on the Pacific cod at-sea using hook-and-line for one regulatory area without small amount of the sideboard limits, gear in the Western GOA. The holders requiring all eligible participants in both the need to account for incidental catch of the LLP licenses listed in Table 10 to areas to agree. of Pacific cod by sideboarded hook-and- Part 680 comprise the universe of This final rule adds regulations at line catcher/processors in other participants eligible to request removal § 680.22(e)(1)(ii) to clarify that NMFS groundfish fisheries in the Central and of a GOA Pacific cod sideboard limit. will not establish CR Program GOA Western GOA, and the potential catch Each holder of an LLP license with Pacific cod sideboard limits for the rates of Pacific cod by sideboarded Central GOA endorsements listed in hook-and-line catcher/processor sector hook-and-line catcher/processors Table 10 to Part 680 will be required to in a regulatory area through the annual

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harvest specification process if NMFS Changes From the Proposed Rule as the level above which overfishing is receives completed request forms from NMFS made no changes from the occurring for a species or species group. all eligible participants in a regulatory proposed to final rule. NMFS manages fisheries in an effort to area by the deadline. CR Program GOA ensure that no OFLs are exceeded in any Pacific cod sideboard limits are OMB Revisions to Paperwork year. Section 3.2.4.3 of the GOA FMP currently implemented through the Reduction Act References in 15 CFR clarifies that if catch is approaching an annual harvest specification process; 902.1(b) OFL, NMFS will prevent overfishing by therefore, CR program GOA Pacific cod Section 3507(c)(B)(i) of the PRA closing specific fisheries identified by sideboard limits could not be removed requires that agencies inventory and gear and area that incur the greatest immediately upon receipt by NMFS of display a current control number catch. Closures expand to other fisheries the required forms. NMFS will remove assigned by the Director, OMB, for each if the rate of take is not sufficiently a CR Program GOA Pacific cod agency information collection. Section slowed. Regulations at § 679.20(d)(1), (d)(2), and (d)(3) define the process sideboard limit for the hook-and-line 902.1(b) identifies the location of NOAA NMFS uses to limit or prohibit fishing catcher/processor sector during the next regulations for which OMB approval numbers have been issued. Because this to prevent overfishing and maintain annual harvest specification cycle for total catch at or below the OFL. final rule revises and adds data GOA groundfish. Amendment 45 and this final rule elements within a collection-of- This final rule does not require establish a process for NMFS to remove information for recordkeeping and eligible participants to enter into a GOA Pacific cod sideboard limits. The reporting requirements, 15 CFR 902.1(b) private contractual agreement to GOA Pacific cod sideboard limits are an is revised to reference correctly the additional level of harvest limits within coordinate fishing practices within that sections resulting from this final rule. regulatory area prior to submitting to the GOA Pacific cod sector allocations. NMFS the required forms requesting Comment and Response Removal of sideboard limits does not mean the GOA Pacific cod fisheries will removal of a CR Program GOA Pacific During the public comment periods not have a harvest limit. The proposed cod sideboard limit. If the holders of the for the Notice of Availability for rule preamble and sections 1.5.2 and 3.2 LLP licenses listed in Table 10 to Part Amendment 45 and the proposed rule to of the Analysis describe that Pacific cod 680 are unable, or unwilling, to agree to implement Amendment 45, NMFS request that NMFS remove a CR OFLs, ABCs, TACs, and sector received one comment letter that did allocations will continue to be Program GOA Pacific cod sideboard not support Amendment 45 and the established through the annual GOA limit in a regulatory area within the proposed rule. A summary of the harvest specifications process. time provided, the sideboard limit for comment received and NMFS’ response Amendment 45 and this final rule do that regulatory area will continue to follows. not change or otherwise supersede that apply. Maintaining the CR Program Comment: Amendment 45 is not process. NMFS will continue to manage GOA Pacific cod sideboard limits—if consistent with National Standard 1 of Pacific cod in the GOA by limiting unanimous agreement for their removal the Magnuson-Stevens Act because it harvests to the established TACs and is not reached by the eligible does not prevent overfishing while sector allocations as specified in participants—is consistent with the achieving the optimum yield of fish regulations at § 679.20. Therefore, this objectives of sideboard management as stocks. Under Amendment 45, industry final rule does not increase the established by the CR Program and the participants would utilize self- likelihood that an OFL, ABC, TAC, or sideboard limit calculation method regulation and private contractual sector catch limit will be exceeded. A established under regulations agreements to limit GOA Pacific cod detailed description of the annual implementing Amendment 83. harvests if all operations consent to harvest specification process is Removing sideboard limits without eliminating GOA Pacific cod sideboard provided in the Harvest Specifications unanimous agreement of all of the limits. This self-regulation would lead SIR prepared for the final 2015 and 2016 eligible participants could indicate that to overfishing because industry harvest specifications and the Alaska eligible participants have not agreed to participants do not have sufficient Groundfish Harvest Specifications EIS coordinate harvests. This could increase biological information to establish (see ADDRESSES). the likelihood of a race for fish and sustainable catch limits. Furthermore, The Council determined, and NMFS could allow those who received QS individual fishing operations have a agrees, that Amendment 45 and this under the CR Program to expand their significant economic incentive to agree final rule are necessary to provide efforts in the GOA Pacific cod fisheries. to eliminate the Pacific cod sideboard participants in the Central and Western Such a result would not be consistent catch limits and then engage in GOA hook-and-line catcher/processor with the goals of the CR Program or the overfishing in order to increase fishing sectors with an opportunity to Council’s objectives for this action. revenue. cooperatively coordinate harvests of Response: NMFS has determined that Pacific cod through private arrangement This final rule does not modify the CR Amendment 45 and this final rule are to the participants’ mutual benefit, Program GOA Pacific cod sideboard consistent with the Magnuson-Stevens which would remove the need for limits for hook-and-line catcher/ Act, the Crab FMP, and other applicable sideboard limits in these regulatory processors in the Eastern GOA. As law. Under Amendment 45 and this areas. The preamble to the proposed explained in the preamble to the final rule, the Council and NMFS will rule (79 FR 36702, June 30, 2014) and proposed rule, this action does not continue to manage the Pacific cod section 1.4 of the Analysis describe that remove the sideboard designations on fisheries in the GOA to prevent Amendment 45 and this final rule are the FFPs for the eight sideboarded overfishing while achieving, on a intended to balance the Council’s vessels or the five sideboarded LLP continuing basis, the optimum yield competing objectives: (1) To relieve the licenses, and these vessels and LLP from each fishery, consistent with CR Program GOA Pacific cod sideboard licenses will still be subject to a CR National Standard 1 of the Magnuson- limits for some vessels and LLP licenses Program Pacific cod sideboard limit if Stevens Act and the GOA FMP. Section that benefitted from allocations under they are used in the Eastern GOA. 3.2.1 of the GOA FMP defines the OFL the CR program, and (2) to protect the

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GOA-only participants from adverse of any change made to the proposed rule small business if it is independently impacts that may result from removal of in the final rule as a result of the owned and operated, is not dominant in those sideboard limits. comments; (4) a description of and an its field of operation (including its estimate of the number of small entities affiliates), and has combined annual Classification to which the rule will apply or an employment, counting all individuals The Administrator, Alaska Region, explanation of why no such estimate is employed on a full-time, part-time, or NMFS, determined that Amendment 45 available; (5) a description of the other basis, not in excess of 500 to the Crab FMP is necessary for the projected reporting, recordkeeping and employees for all its affiliated conservation and management of the other compliance requirements of the operations worldwide. For seafood GOA groundfish fishery and that it is rule, including an estimate of the classes dealers/wholesalers, the same qualifiers consistent with the Crab FMP, GOA of small entities which will be subject apply, except the employment threshold FMP, the Magnuson-Stevens Act, and to the requirement and the type of is 100 employees. In determining a other applicable laws. professional skills necessary for concern’s number of employees, SBA preparation of the report or record; and counts all individuals employed on a Small Entity Compliance Guide (6) a description of the steps the agency full-time, part-time, or other basis. This Section 212 of the Small Business has taken to minimize the significant includes employees obtained from a Regulatory Enforcement Fairness Act of economic impact on small entities temporary employee agency, 1996 states that, for each rule or group consistent with the stated objectives of professional employee organization or of related rules for which an agency is applicable statutes, including a leasing concern. SBA will consider the required to prepare a final regulatory statement of the factual, policy, and totality of the circumstances, including flexibility analysis (FRFA), the agency legal reasons for selecting the alternative criteria used by the Internal Revenue shall publish one or more guides to adopted in the final rule and why each Service (IRS) for Federal income tax assist small entities in complying with one of the other significant alternatives purposes, in determining whether the rule, and shall designate such to the rule considered by the agency individuals are employees of a concern. publications as ‘‘small entity which affect the impact on small Volunteers (i.e., individuals who receive compliance guides.’’ The agency shall entities was rejected. no compensation, including no in-kind explain the actions a small entity is The ‘‘universe’’ of entities to be compensation, for work performed) are required to take to comply with a rule considered in a FRFA generally not considered employees. Where the or group of rules. The preamble to the includes only those small entities that size standard is number of employees, proposed rule and this final rule serve can reasonably be expected to be the method for determining a concern’s as the small entity compliance guide. directly regulated by the final rule. If the size includes the following principles: This action does not require any effects of the rule fall primarily on a (1) The average number of employees of additional compliance from small distinct segment of the industry, or the concern used (including the entities that is not described in the portion thereof (e.g., user group, gear employees of its domestic and foreign preambles. Copies of this final rule are type, geographic area), that segment affiliates) based upon numbers of available from NMFS at the following would be considered the universe for employees for each of the pay periods Web site: http:// purposes of this analysis. for the preceding completed 12 calendar alaskafisheries.noaa.gov. The Small Business Administration months; (2) part-time and temporary (SBA) has established size standards for Executive Order 12866 employees are counted the same as full- all major industry sectors in the U.S., time employees. This rule has been determined to be including commercial finfish harvesters not significant for purposes of Executive (NAICS code 114111), commercial Need for and Objectives of This Action Order 12866. shellfish harvesters (NAICS code A statement of the need for, and 114112), other commercial marine Final Regulatory Flexibility Analysis objectives of, the rule is contained in the harvesters (NAICS code 114119), for- preamble to this final rule and is not Section 604 of the Regulatory hire businesses (NAICS code 487210), repeated here. Flexibility Act (RFA) requires that, marinas (NAICS code 713930), seafood when an agency promulgates a final rule dealers/wholesalers (NAICS code Summary of Significant Issues Raised under section 553 of Title 5 of the U.S. 424460), and seafood processors (NAICS During Public Comment Code, after being required by that code 311710). A business primarily NMFS published a proposed rule on section, or any other law, to publish a involved in finfish harvesting is February 12, 2015 (80 FR 7817). An general notice of proposed rulemaking, classified as a small business if it is initial regulatory flexibility analysis the agency shall prepare a final independently owned and operated, is (IRFA) was prepared and summarized in regulatory flexibility analysis. not dominant in its field of operation the ‘‘Classification’’ section of the Section 604 describes the contents of (including its affiliates), and has preamble to the proposed rule. The a FRFA: (1) A statement of the need for, combined annual gross receipts not in comment period closed on March 16, and objectives of, the rule; (2) a excess of $20.5 million, for all its 2015. NMFS received one letter of statement of the significant issues raised affiliated operations worldwide. For public comment on the proposed rule. by the public comments in response to commercial shellfish harvesters, the This comment letter did not address the the initial regulatory flexibility analysis, same qualifiers apply, except the IRFA or the economic impacts of the a statement of the assessment of the combined annual gross receipts rule generally. The Chief Counsel for agency of such issues, and a statement threshold is $5.5 million. For other Advocacy of the SBA did not file any of any changes made in the proposed commercial marine harvesters, for-hire comments on the proposed rule. rule as a result of such comments; (3) fishing businesses, and marinas, the the response of the agency to any same qualifiers apply, except the Number and Description of Small comments filed by the Chief Counsel for combined annual gross receipts Entities Regulated by This Action Advocacy of the Small Business threshold is $7.5 million. This action would directly regulate Administration in response to the A business primarily involved in eight entities. These eight entities proposed rule, and a detailed statement seafood processing is classified as a include the owners of the eight vessels,

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and the holders of the five LLP licenses NMFS requesting removal of the CR the sub-option, if the annual form is not currently subject to CR Program GOA Program GOA sideboard limits. received by NFMS, the sideboard limits Pacific cod sideboard limits in the Description of Significant Alternatives would not be removed for the following Central and Western GOA hook-and-line That Minimize Adverse Impacts on fishing year (i.e., January 1 through catcher/processor sectors. The owners of Small Entities December 31). the eight vessels and holders of the five This action implements Alternative 2 LLP licenses directly regulated by this A FRFA also requires a description of with the option to permanently remove action are affiliated through their the steps the agency has taken to membership in the Freezer Longline minimize the significant impact on the CR Program GOA sideboard limits if Conservation Cooperative (FLCC). The small entities consistent with the stated each eligible participant in a regulatory FLCC represents LLP holders and the objectives of applicable statutes, area submits to NMFS a form requesting owners and operators of vessels that including a statement of the factual, removal and provides that form to participate in the Pacific cod hook-and- policy, and legal reasons for selecting NMFS within the required timeline. The line catcher/processor sector in the the alternative (Alternative 2 as Council rejected the sub-option because Federal waters of the BSAI. The FLCC modified by Option 1, described below) the annual suspension of sideboards is comprised of businesses that are adopted in the final rule and why each could create uncertainty for engaged in the harvesting and of the other significant alternatives to participants, result in additional processing of finfish. The annual the rule considered by the agency that administrative burden and costs, and revenue of members of the FLCC has affect the economic impact on small potentially create management exceeded $130 million per year since its entities was rejected. The suite of instability. Although this action does formation, and $172 million in 2012, the potential actions includes two not directly regulate small entities, the alternatives, one associated option, and most recent year of available revenue preferred alternative is the only one associated suboption. A detailed data (see Table 1–14 in Section 1.6 of alternative in the suite of options and the Analysis for additional detail). description of these alternatives and options is provided in section 1.6 of the alternatives considered that reduces the Members of the FLCC are not burden on directly regulated entities considered small entities because the Analysis prepared for this action. The Council considered two and best meets the purpose and need for annual revenue of the cooperative alternatives for this action. Alternative 1 this action. exceeds the size standards for small is the status quo, which does not meet entities. Collection-of-Information Requirements the objectives of the action. Alternative Three entities hold LLP licenses and 2 would remove the CR Program GOA This rule contains a collection-of- own vessels that operate only in the Pacific cod sideboard limits in either the information requirement subject to the GOA as hook-and-line catcher/ Central GOA, Western GOA, or both Paperwork Reduction Act (PRA) and processors. These three entities are not regulatory areas. As part of Alternative directly regulated by the CR Program which has been approved by Office of 2, the Council and NMFS also Management and Budget (OMB) under GOA Pacific cod sideboard limits, and considered an option and a suboption are not members of the FLCC. One control number 0648–0334. Public for removing the CR Program GOA reporting burden for the Request to entity owns a vessel named on an LLP Pacific cod sideboard limits. The option Extinguish Pacific Cod Sideboard Limits license with Central GOA Pacific cod (i.e., this action) removes the CR for Hook-and-Line Catcher/Processors in hook-and-line catcher/processor Program GOA Pacific cod sideboard endorsements; the other two entities limits for the hook-and-line catcher/ the Western or Central GOA is estimated each own a vessel named on LLP processor sector permanently if certain to average 30 minutes per individual licenses with Western GOA Pacific cod conditions are met by a specified date. response, including the time for hook-and-line catcher/processor The sub-option would have suspended reviewing instructions, searching endorsements. These three entities are the CR Program GOA Pacific cod existing data sources, gathering and not directly regulated by this action sideboard limits for the hook-and-line maintaining the data needed, and because this action would not impose catcher/processor sector on an annual completing and reviewing the collection regulations on these vessels or the basis if certain conditions are met of information. associated LLP licenses, or relieve them annually. Send comments on this burden from regulation. These three entities The option requires all hook-and-line estimate or any other aspect of this data may voluntarily choose to submit a catcher/processor LLP license holders collection, including suggestions for request for removal of the sideboard that are authorized to target Pacific cod reducing the burden, to NMFS (see limits under this action, but are not in the Central or Western GOA (i.e., ADDRESSES), and by email to OIRA_ required to do so. eligible participants) to submit a form to [email protected], or fax to NMFS requesting the permanent Reporting, Recordkeeping, and Other 202–395–5806. Compliance Requirements removal of the GOA Pacific cod sideboard limit in that regulatory area Notwithstanding any other provision The reporting, recordkeeping, and on a one-time basis. The option also of the law, no person is required to other compliance requirements will requires the request to be submitted respond to, nor shall any person be increase slightly under the action if within one year of the date of subject to a penalty for failure to comply eligible participants in the Central or publication in the Federal Register of with, a collection of information subject Western GOA agree to submit an the final rule implementing Amendment to the requirements of the PRA, unless affidavit to NMFS requesting removal of 45, if approved by the Secretary. that collection of information displays a the CR Program GOA sideboard limits. The sub-option would have required currently valid OMB control number. The reporting, recordkeeping, and other all eligible participants to annually All currently approved NOAA compliance requirements will not submit a form to NMFS requesting collections of information may be change under the action if eligible removal of the GOA Pacific cod viewed at: http://www.cio.noaa.gov/ participants in the Central or Western sideboard limit in that regulatory area services_programs/prasubs.html. GOA do not submit an affidavit to for the upcoming fishing year. Under

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List of Subjects (e) Conversion of sideboard ratios into for Hook-and-Line Catcher/Processors in annual sideboard harvest limits. NMFS the Western or Central GOA, and the 15 CFR Part 902 will convert sideboard ratios into request must be received by NMFS on Reporting and recordkeeping annual sideboard harvest limits or before May 18, 2016. requirements. according to the following procedures. * * * * * (1) Annual sideboard harvest limits. 50 CFR Part 680 ■ 5. Add Table 10 to part 680 to read as (i) Except as provided in paragraph follows: Alaska, Fisheries, Reporting and (e)(1)(ii) of this section, annual recordkeeping requirements. sideboard harvest limits for each TABLE 10 TO PART 680—LICENSE LIM- Dated: May 11, 2015. groundfish species, except fixed-gear ITATION PROGRAM LICENSE NUM- Samuel D. Rauch III, sablefish, will be established by BERS THAT AUTHORIZE THE OWN- Deputy Assistant Administrator for multiplying the sideboard ratios Regulatory Programs, National Marine calculated under paragraph (d) of this ERS AND OPERATORS OF CATCHER/ Fisheries Service. section by the proposed and final TACs PROCESSORS TO DIRECTED FISH For the reasons set out in the in each area for which a TAC is FOR PACIFIC COD WITH HOOK-AND- preamble, NMFS amends 15 CFR part specified. If a TAC is further LINE GEAR IN THE CENTRAL GULF 902 and 50 CFR part 680 as follows: apportioned by season, the sideboard OF ALASKA REGULATORY AREA harvest limit also will be apportioned by (COLUMN A) AND IN THE WESTERN Title 15—Commerce and Foreign Trade season in the same ratio as the overall GULF OF ALASKA REGULATORY TAC. The resulting harvest limits PART 902—NOAA INFORMATION AREA (COLUMN B) COLLECTION REQUIREMENTS UNDER expressed in metric tons will be published in the annual GOA THE PAPERWORK REDUCTION ACT: Column A: Column B: OMB CONTROL NUMBERS groundfish harvest specification notices. (ii) NMFS will not establish an annual LLG1125 ...... LLG1400. ■ 1. The authority citation for part 902 sideboard harvest limit for Pacific cod LLG1128 ...... LLG1401. continues to read as follows: for vessels that catch and process Pacific LLG1400 ...... LLG1576. cod using hook-and-line gear in the LLG1576 ...... LLG1578. Authority: 44 U.S.C. 3501 et seq. Central GOA Regulatory Area if all LLG1713 ...... LLG1785. ■ 2. In § 902.1, in the table in paragraph eligible participants request that the LLG1785 ...... LLG1916. (b), under the entry ‘‘50 CFR’’,add an sideboard harvest limit be removed in LLG1916 ...... LLG1917. entry in alphanumeric order for accordance with the requirements of LLG1917 ...... LLG2026. ‘‘680.22’’ to read as follows: paragraph (e)(1)(ii)(A) of this section. LLG1989 ...... LLG2081. NMFS will not establish an annual LLG2081 ...... LLG2112. § 902.1 OMB control numbers assigned LLG2112 ...... LLG2892. pursuant to the Paperwork Reduction Act. sideboard harvest limit for Pacific cod LLG2238 ...... LLG2935. for vessels that catch and process Pacific LLG2705 ...... LLG3090. * * * * * cod using hook-and-line gear in the (b) * * * LLG2783 ...... LLG3602. Western GOA Regulatory Area if all LLG2892 ...... LLG3617. eligible participants request that the LLG2958 ...... LLG3676. sideboard harvest limit be removed in LLG3609 ...... LLG4004. accordance with the requirements of LLG3616 ...... LLG4823. CFR part or section Current OMB LLG3617. where the information Control No. paragraph (e)(1)(ii)(B) of this section. collection requirement is (all numbers begin NMFS will publish notification of the LLG3676. located with 0648–) removal of the sideboard harvest limit LLG3681. LLG3973. for Pacific cod for vessels that catch and LLG4823. ***** process Pacific cod using hook-and-line 50 CFR: gear in the Central GOA Regulatory Area [FR Doc. 2015–12066 Filed 5–18–15; 8:45 am] or the Western GOA Regulatory Area BILLING CODE 3510–22–P ***** through the annual GOA groundfish 680.22 ...... –0334 harvest specifications (see § 679.20(c)(1)(iii) and (c)(3)(ii)). ***** (A) Central GOA. For the Central GOA DEPARTMENT OF DEFENSE Regulatory Area (Statistical Areas 620 Department of the Army Title 50—Wildlife and Fisheries and 630; see Figure 3 to 50 CFR part 679), the holders of all LLP licenses 32 CFR Part 635 PART 680—SHELLFISH FISHERIES OF listed in Column A of Table 10 to this THE EXCLUSIVE ECONOMIC ZONE part must submit to NMFS a completed RIN 0702–AA62 OFF ALASKA Request to Extinguish Pacific Cod [Docket No. USA–2010–0020] Sideboard Limits for Hook-and-Line ■ 3. The authority citation for part 680 Catcher/Processors in the Western or continues to read as follows: Law Enforcement Reporting Central GOA, and the request must be Authority: 16 U.S.C. 1862; Pub. L. 109– received by NMFS on or before May 18, AGENCY: Department of the Army, DoD. 241; Pub. L. 109–479. 2016. ACTION: Interim rule; request for ■ 4. In § 680.22, revise paragraph (e) (B) Western GOA. For the Western comments. heading and introductory text, and GOA Regulatory Area (Statistical Area paragraph (e)(1) to read as follows: 610; see Figure 3 to 50 CFR part 679), SUMMARY: The Department of the Army the holders of all LLP licenses listed in amends its regulation concerning law § 680.22 Sideboard protections for GOA Column B of Table 10 to this part must enforcement reporting for a number of groundfish fisheries. submit to NMFS a completed Request to statutory requirements to better * * * * * Extinguish Pacific Cod Sideboard Limits coordinate law enforcement work and

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personnel both within the Department against the DOD. While DOD and the Army Form 3975 which feeds into the of the Army, across DoD, and with other Army have implemented many of these Army’s law enforcement records Federal, State, and local law requirements through official messages management system, Centralized enforcement officials. It meets law and memorandum, they are not yet Operations Police Suite (COPS). This enforcement reporting requirements for published in the internal Army provides the Army an ability to query selected criminal and national security Regulation until this rule becomes final. the number of victim witness incidents and provides law enforcement For example, until this rule is notifications for congressional inquiries. agencies, such as the Department of published: The rule adds the requirement to Homeland Security and Transportation • Army law enforcement does not input Army crime data into the Defense Security Administration, with the most have a regulation directing them to Incident-Based Reporting System current information available. It also report Suspicious activity to the FBI’s (DIBRS) to comply with the Uniform provides the Army chain of command threat reporting system, eGuardian. Federal Crime Reporting Act, Section • with timely criminal information to Sexual assaults are not properly 534 note of title 28, U.S.C. respond to queries from the Department reported using the 2012 National The rule adds registration of sex of Defense, the news media, and others. Defense Authorization Act Sexual offenders on Army installation to Assault definition. effectuate federal and state registration The rule establishes policies and • procedures for offense and serious- Offense codes used by Army law requirements including the Sex incident reporting with the Army; for enforcement to describe the complaint Offender Registration and Notification reporting to the Department of Defense or offense as used in reports to congress Act (SORNA), 42 U.S.C. 16901 et seq,. and the Department of Justice, as are not adequately updated. This ensures all registered sex offenders • Changes to the restricted sexual appropriate; and for participating in the who reside or are employed on an Army assault evidence kits retention schedule Federal Bureau of Investigation’s installation register with the installation from one year to 5 years per the most National Crime Information Center, the PMO or DES. This allows the Army to recent version of the NDAA is causing Department of Justice’s Criminal Justice track or monitor sex offender confusion regarding proper procedures Information System, the National Law registration compliance on Army which could result in inconsistency in Enforcement Telecommunications installations which impacts the safety of retaining sexual assault evidence. all personnel residing on Army System, and State criminal justice In addition, the rule adds the systems. It also updates various installations. requirement to report positive drug The rule ensures compliance with the reporting requirements described in urinalysis tests to the National Instant various Federal statutes. requirement from the Protecting the Checks System (NICS) under the Force: Lessons from Ft. Hood, report of DATES: Effective May 22, 2015. authority of the Brady Handgun the DoD Independent Review, January Consideration will be given to all Violence Prevention Act of 1993 as comments received by: July 20, 2015. 2010, which requires reporting of amended (18 U.S.C. 922). While the Suspicious Activity to the FBI’s ADDRESSES: You may submit comments, United States Army Criminal Records eGuardian. identified by 32 CFR part 635, Docket Center is currently providing these No. USA–2010–0020 and or RIN 0702– reports to NICS, it may be happening I. Purpose of the Regulatory Action AA62, by any of the following methods: inconsistently. a. The publication of this rule will • Federal eRulemaking Portal: http:// The Lautenberg Amendment to the ensure the Army is in compliance with www.regulations.gov. Follow the Gun Control Act of 1968, requires multiple Department of Defense and instructions for submitting comments. commanders and family advocacy • Federal requirements. Mail: Department of Defense, Office programs report all domestic violence This regulatory action will add policy of the Deputy Chief Management incidents to the local Installation pertaining to the collection of Officer, Directorate of Oversight and Provost Marshal Office/Directorate of fingerprints and DNA from individuals Compliance, Regulatory and Audit Emergency Services (PMO/DES). This suspected of certain offenses through Matters Office, 9010 Defense Pentagon, rule provides guidance to Army the Department of the Defense Washington, DC 20301–9010. Commanders on reporting domestic Instruction 5505.14, Deoxyribonucleic Instructions: All submissions received violence to the PMO/DES in accordance Acid (DNA) collection requirements for must include the agency name and with the Lautenberg Amendment. criminal investigations, found at: http:// docket number or Regulatory Without this rule in place, it is possible www.dtic.mil/whs/directives/corres/pdf/ Information Number (RIN) for this for a soldier who is prohibited from 550514p.pdf and Department of Defense Federal Register document. The general carrying a weapon due to a qualifying Instruction 5505.11, Fingerprint Card policy for comments and other conviction not being properly identified and Final Disposition Report submissions from members of the public and continuing in assignments and Submission Requirements, found at: is to make these submissions available missions which are prohibited. http://www.dtic.mil/whs/directives/ for public viewing on the Internet at The rule ensures crime victims and corres/pdf/550511p.pdf. http://www.regulations.gov as they are witness are notified about their rights This rule adds policy on sex offenders received without change, including any according to the Victim Rights and on Army Installations and thus ensures personal identifiers or contact Restitution Act (42 U.S.C. 10601) and the safety of our Soldiers, family information. Victim and Witness Protection Act members, and civilians that live and FOR FURTHER INFORMATION CONTACT: Ms. (Sections 1512–1514 of Title 18, U.S.C.). work on Army installation through Katherine Brennan, (703) 692–6721. The Army currently must advise the identifying, monitoring and tracking sex SUPPLEMENTARY INFORMATION: victim or witness of their rights using offenders on Army installations. the Department of Defense Form 2701 This rule includes policy pertaining Justification for Interim Final Rule (Initial Information for Victims and to the release of Military Police (MP) Publication of this rule as interim is Witnesses of Crime) in accordance with records by adding reporting requirement necessary to maintain national security, Army Regulation (AR) 190–45. This rule of domestic incidents to the Army ensure the safety and wellbeing of the requires victim witness notifications to Family Advocacy Program. This rule Soldiers, and/or to avoid legal action be reported on the Department of the authorizes the limited use of the Federal

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Bureau of Investigations (FBI), National dtic.mil/whs/directives/corres/pdf/ II. Summary of the Major Provisions of Crime Information Center (NCIC) 132507p.pdf. the Regulatory Action in Question pursuant to FBI regulations and policy The rule implements the victim/ The major provisions of this to conduct checks of visitors to an witness requirements contained in regulatory action include: Records DODI 1030.2, Victim and Witness installation. administration, release of information, Assistance Procedures, found at http:// The rule implements the reporting offense reporting, victim and witness dtic.mil/whs/directives/corres/pdf/ requirements of DODD 7730.47, Defense assistance procedures, and the National 103002p.pdf, which implements Incident-Based Reporting System Crime Information Center policy. (DIBRS), found at http://www.dtic.mil/ Sections 1512–1514 of Title 18, United The records administration section States Code and Sections 113 (note), whs/directives/corres/pdf/773047p.pdf, includes procedures for safeguarding 1058, 1059 and 1408 of Title 10, United by mandating the use of the Centralized official information, special States Code by providing guidance on Operations Police Suite (COPS) Military requirements of the Privacy Act of 1974 assisting victims and witnesses of crime Police Reporting System. This to protect personal information, purpose from initial contact through implements reporting requirements of of gathering police intelligence/criminal investigation, prosecution, and Section 534 of Title 28, United States information, name checks for criminal confinement. Code (also known as ‘‘The Uniform background check purposes using the Federal Crime Reporting Act of 1988’’), The Army will use eGuardian to report, share and analyze unclassified Army’s law enforcement databases, the victim and witness assistance registration of sex offenders on Army notifications of Sections 10607 10608 of suspicious activity information regarding potential threats or suspicious Installations in the Continental United Title 42 (also known as ‘‘The Victims’ States and Outside the Continental Rights and Restitution Act of 1990’’), activities affecting DOD personnel, facilities, or forces in transit in both United States (CONUS and OCONUS), Section 922 of Title 18, United States CONUS and OCONUS. eGuardian is the and collection by law enforcement Code (also known as ‘‘The Brady Federal Bureau of Investigation’s (FBI) officials of deoxyribonucleic acid (DNA) Handgun Violence Prevention Act and sensitive-but-unclassified web-based from subjects of certain offenses. The The Lautenberg Amendment to the Gun platform for reporting, and in some System of Records Notice, SORN Control Act’’), Sections 16901 through instances, sharing, suspicious activity A0190–45, Military Police Reporting 16928 of Title 42, United States Code and threat related information with Program Records (MRRP) describes the (Sex Offender Registration and other federal, state, tribal, and territorial policies and practices for storing, Notification Act (SORNA)), Section law enforcement and force protection retrieving, accessing, retaining, and 1701, NDAA FY 14, DoDD 1030.01, entities. Information entered into disposing of records in the system, it DoDI 1030.2. and Public Law 107–188, eGuardian by the Army may be either can be found at: http:// ‘‘Public Health Security and shared with all eGuardian participants dpcld.defense.gov/Privacy/ Bioterrorism Preparedness and or reported directly to the FBI. All SORNsIndex/ Response Act of 2002,’’ June 12, 2002. information entered into eGuardian by DODwideSORNArticleView/tabid/6797/ The rule implements the sex offender the Army will comply with the policy Article/569993/a0190-45-opmg.aspx registration requirements of DODI framework for the system and any The Privacy Impact Assessment can be 1325.07, Administration of Military existing agency agreements, which found at: http://ciog6.army.mil/Portals/ Correctional Facilities and Clemency incorporate privacy protections. 1/PIA/2014/CIMS-CID.pdf. and Parole Authority, found at http:// Analysis of Suspicious Activity The release of information section dtic.mil/whs/directives/corres/pdf/ Reporting (SARs) will assist Criminal discusses release of information from 132507p.pdf. The rule’s registration Intelligence analysts and commanders Army records, under the Freedom of requirements allow the Provost Marshal in mitigating potential threats and Information Act (FOIA) and Privacy Act or Director of Emergency Services to vulnerabilities, and developing annual of 1974, and release of law enforcement provide all military sex offenders with threat assessments. information furnished by foreign the ‘‘State registration’’ document(s) and b. The Department is issuing this governments or international direct Soldiers to the local or State law interim final rule pursuant to its organizations. The section also contains enforcement agency, which will register authority under 28 U.S.C. 534, procedures for requesting amendment of them based on their physical residence Acquisition, preservation, and exchange records and accounting for military address. If a MOU/MOA exists with the of identification records and police record disclosure. local or State law enforcement agency, information, 42 U.S.C. 10607, Services The section on offense reporting they will notify the installation. to Victims, 18 U.S.C. 922, Unlawful provides information on completing the Installation PMs and DESs in the United Act,, 10 U.S.C. 1562, Database on DA Form 4833 (Commander’s Report of States will provide written notice of the domestic violence incidents, 10 U.S.C. Disciplinary or Administrative Action), conviction or transfer to the offender’s Chap. 47, Uniform Code of Military found at: http://www.apd.army.mil/pub/ gaining unit commander, the State’s Justice, Section 1701, National Defense eforms/pdf/a4833.pdf, for civilian chief LE officer, the chief LE officer of Authorization Act for Fiscal Year 2014, subjects, requirements for submitting the local jurisdiction in which the Sexual Assault Prevention and fingerprint card and final disposition accused will reside, the State or local Response and Related Reforms, DoDD reports, releasing of domestic incidents agency responsible for the receipt or 1030.01, Victim and Witness Assistance, reports to the Army Family Advocacy maintenance of a sex offender and DoDI 1030.2, Victim and Witness Program (FAP). This section also registration where the person will Assistance Procedures. Implements includes reporting of domestic violence reside, and upon request, governmental crime reporting requirements of the incidents to law enforcement, issuing of officials of foreign countries. Installation Uniform Federal Crime Reporting Act protective orders, procedures for PM and DES notifications to State and (Title 10, United States Code, Section establishing Memoranda of local officials are described in DODI 534), the Brady Handgun Violence Understanding with civilian law 1325.07, Administration of Military Prevention Act (18 U.S.C. 922), and the enforcement agencies, and reporting of Correctional Facilities and Clemency Victim Rights and Restitution Act (42 Suspicious Activity to the FBI’s and Parole Authority, found at http:// U.S.C. 10607). eGuardian.

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The victim and witness assistance Comments are invited on: (a) Whether number and title for this Federal procedures ensure Army personnel the proposed collection of information Register document. The general policy involved in the detection, investigation, is necessary for the proper performance for comments and other submissions and prosecution of crimes protect of the functions of DoD, including from members of the public is to make victims and witnesses rights. The whether the information will have these submissions available for public National Crime Information Center practical utility; (b) the accuracy of the viewing on the Internet at http:// (NCIC) policy section authorizes NCIC estimate of the burden of the proposed www.regulations.gov as they are checks, pursuant to FBI regulations and information collection; (c) ways to received without change, including any policy, of visitors to a military enhance the quality, utility, and clarity personal identifiers or contact installation. of the information to be collected; and information. (d) ways to minimize the burden of the III. Cost and Benefits information collection on respondents, To request more information on this This rule will not have a monetary including the use of automated proposed information collection or to effect upon the public. This rule collection techniques or other forms of obtain a copy of the proposal and facilitates information sharing between information technology. associated collection instruments, authorized agencies to enhance Title: Army Sex Offender Information. please write to the Department of protection of personnel and resources Type of Request: New. Defense, Office of the Deputy Chief critical to DoD mission assurance. Number of Respondents: 550. Management Officer, Directorate of Responses per Respondent: 1. IV. Retrospective Review Oversight and Compliance, Regulatory Annual Responses: 550. and Audit Matters Office, 9010 Defense The revisions to this rule will be Average Burden per Response: 20 Pentagon, Washington, DC 20301–9010. reported in future status updates as part minutes. of DoD’s retrospective plan under Annual Burden Hours: 183 hours. E. Executive Order 12630 (Government Executive Order 13563 completed in Needs and Uses: The Army requires Actions and Interference With August 2011. DoD’s full plan can be tracking and management of sex Constitutionally Protected Property accessed at: http://www.regulations.gov/ offenders that reside or are employed on Rights) #!docketDetail;D=DOD-2011-OS-0036. an Army installation due to the transient nature of the Army The Department of the Army has V. Regulatory Procedures community. Without such a determined that Executive Order 12630 A. Regulatory Flexibility Act requirement, the Army would have does not apply because the rule does not The Department of the Army has difficulty tracking sex offenders once impair private property rights. determined that the Regulatory they transfer to other states or overseas without anyone’s knowledge. All F. Executive Order 12866 (Regulatory Flexibility Act does not apply because Planning and Review) and Executive the rule does not have a significant registered sex offenders who reside or are employed on an Army installation Order 13563 (Improving Regulation and economic impact on a substantial Regulatory Review) number of small entities within the will submit their registration meaning of the Regulatory Flexibility information with the installation The Department of the Army has Act, 5 U.S.C. 601–612. Provost Marshal Office (PMO). determined that according to the criteria Affected Public: Individuals or defined in Executive Order 12866 and B. Unfunded Mandates Reform Act households. Executive Order 13563 this rule is a The Department of the Army has Frequency: On occasion. significant regulatory action and has determined that the Unfunded Respondent’s Obligation: Voluntary. been reviewed by OMB. Mandates Reform Act does not apply OMB Desk Officer: because the rule does not include a Written comments and G. Executive Order 13045 (Protection of recommendations on the proposed mandate that may result in estimated Children From Environmental Health information collection should be sent to costs to State, local or tribal Risk and Safety Risks) governments in the aggregate, or the Ms. Jasmeet Seehra at the Office of private sector, of $100 million or more. Management and Budget, DoD Desk The Department of the Army has Officer, Room 10102, New Executive determined that the criteria of Executive C. National Environmental Policy Act Office Building, Washington, DC 20503, Order 13045 do not apply because this The Department of the Army has with a copy to the Department of rule does not implement or require determined that the National Defense, Office of the Deputy Chief actions impacting environmental health Environmental Policy Act does not Management Officer, Directorate of and safety risks on children. apply because the rule does not have an Oversight and Compliance, Regulatory adverse impact on the environment. and Audit Matters Office, 9010 Defense H. Executive Order 13132 (Federalism) Pentagon, Washington, DC 20301–9010.. D. Paperwork Reduction Act Comments can be received from 30 to 60 The Department of the Army has The Department of the Army has days after the date of this notice, but determined that the criteria of Executive determined that the Paperwork comments to OMB will be most useful Order 13132 do not apply because this Reduction Act (PRA) does apply to this if received by OMB within 30 days after rule will not have a substantial effect on rule’s sex offender registration the date of this notice. the States, on the relationship between requirement; all other requirements are You may also submit comments, the national government and the States, exempted since it is information identified by docket number and title, or on the distribution of power and collected during a criminal by the following method: responsibilities among the various investigation. * Federal eRulemaking Portal: http:// levels of government. DoD has submitted the sex offender www.regulations.gov. Follow the registration requirement to OMB under instructions for submitting comments. the provisions of the Paperwork Instructions: All submissions received Reduction Act (44 U.S.C. Chapter 35). must include the agency name, docket

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List of Subjects in 32 CFR Part 635 Subpart A—Records Administration addition to Executive Order 9397, as amended by Executive Order 13478, the § 635.1 General. Crime, Law, Law enforcement, Law solicitation of the SSN is authorized by enforcement officers, Military law. The proponent of this part is the paragraph 2.c.(2) of DoD Instruction Provost Marshal General. The proponent Thomas Blair 1000.30, ‘‘Reduction of Social Security has the authority to approve exceptions Number (SSN) Use Within DoD’’ Chief, Law Enforcement Branch, Operations or waivers to this Part that are (available at http://www.dtic.mil/whs/ Division, Office of the Provost Marshal consistent with controlling law and General, DA. directives/corres/pdf/100030p.pdf). The regulations. In distributing information purpose is to provide commanders and For reasons stated in the preamble the on juvenile victims or subjects, the law enforcement officials with means by Department of the Army revises 32 CFR installation Freedom of Information Act which information may accurately be part 635 to read as follows: (FOIA) Office will ensure that only identified. The SSN is used as an individuals with a need to know of the additional/alternate means of PART 635—LAW ENFORCEMENT personally identifiable information (PII) identification to facilitate filing and REPORTING of a juvenile are provided the retrieval. The following procedures will identifying information on the juvenile. Subpart A—Records Administration be used for identification: For example, a community commander (1) Retired military personnel are Sec. is authorized to receive pertinent required to produce their Common 635.1 General. information on juveniles under their Access Card or DD Form 2 (Ret) (U.S. 635.2 Safeguarding official information. jurisdiction. When a MPR identifying Armed Forces of the United States 635.3 Special requirements of the Privacy juvenile offenders must be provided to General Convention Identification Act of 1974. multiple commanders or supervisors, Card), or other government issued 635.4 Police Intelligence/Criminal the FOIA Office must sanitize each Information. identification, as appropriate. 635.5 Name checks. report to withhold juvenile information (2) Family members of sponsors will 635.6 Registration of Sex Offenders on not pertaining to that commander’s area be requested to produce their DD Form Army Installations (inside and outside of responsibility. 1173 (Uniformed Services Identification and Privilege Card). Information the Continental United States). § 635.2 Safeguarding official information. 635.7 Collection of deoxyribonucleic acid. contained thereon (for example, the (a) Military police records are sponsor’s SSN) will be used to verify Subpart B—Release of Information unclassified except when they contain and complete applicable sections of 635.8 General. national security information as defined MPRs and related forms. 635.9 Release of information. in AR 380–5 (Available at http:// (3) Non-Department of Defense (DoD) 635.10 Release of information under the www.apd.army.mil/pdffiles/r380_5.pdf), civilians, including military family Freedom of Information Act (FOIA). Department of the Army Information members and those whose status is 635.11 Release of information under the Security Program. unknown, will be advised of the Privacy Act of 1974. (b) Military police records will also be 635.12 Amendment of records. provisions of the Privacy Act Statement released to Federal, state, local or 635.13 Accounting for military police when requested to disclose their PII, record disclosure. foreign law enforcement agencies as including SSN, as required. 635.14 Release of law enforcement prescribed by 32 CFR part 505, The (d) Notwithstanding the requirement information furnished by foreign Army Privacy Program. Expanded to furnish an individual with a PAS governments or international markings will be applied to these when his or her PII will be maintained organizations. records. in a system of records, AR 340–21, The Army Privacy Program, http:// Subpart C—Offense Reporting § 635.3 Special requirements of the _ Privacy Act of 1974. www.apd.army.mil/pdffiles/r340 635.15 DA Form 4833 (Commander’s 21.pdf, provides that records contained Report of Disciplinary or Administrative (a) Certain PII is protected in Action) for Civilian Subjects. in SORN A0190–45, Military Police accordance with the provisions of the Reporting Program Records (MRRP), 635.16 Fingerprint Card and Final Privacy Act of 1974, 5 U.S.C. 552a, as Disposition Report Submission http://dpcld.defense.gov/Privacy/ implemented by 32 CFR part 310, DoD SORNsIndex/tabid/5915/Article/6066/ Requirements. Privacy Program, 32 CFR part 505, The 635.17 Release of domestic incidents a0190-45-opmg.aspx, that fall within 5 reports to the Army Family Advocacy Army Privacy Program, and OMB U.S.C. 552a(j)(2) are exempt from the Program (FAP). guidance defining PII. requirement in 5 U.S.C. 552a(e)(3) to 635.18 Domestic violence. (b) Pursuant to 5 U.S.C. 552a(e)(3), provide a PAS. 635.19 Protection Orders. when an Army activity asks an 635.20 Establishing Memoranda of individual for his or her PII that will be § 635.4 Police Intelligence/Criminal Understanding. maintained in a system of records, the Information. 635.21 Suspicious Activity Reporting activity must provide the individual (a) The purpose of gathering police (SAR). with a Privacy Act Statement (PAS). A intelligence is to identify individuals or Subpart D—Victim and Witness Assistance PAS notifies individuals of the groups of individuals in an effort to Procedures authority, purpose, and use of the anticipate, prevent, or monitor possible 635.22 Procedures. collection, whether the information is criminal activity. Police intelligence mandatory or voluntary, and the effects aids criminal investigators in Subpart E—National Crime Information of not providing all or any part of the developing and investigating criminal Center Policy requested information. cases. 32 CFR part 633 designates the 635.23 Standards. (c) Army law enforcement personnel U.S. Army Criminal Investigation Authority: 28 U.S.C. 534, 42 U.S.C. 10601, performing official duties often require Command (USACIDC) as having the 18 U.S.C. 922, 10 U.S.C. 1562, 10 U.S.C. an individual’s PII, including SSN, for primary responsibility to operate a Chap. 47, 42 U.S.C. 16901 et seq., 10 U.S.C. identification purposes. This PII can be criminal intelligence program. Criminal 1565, 42 U.S.C. 14135a. used to complete MPRs and records. In Intelligence will be reported through the

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Army Criminal Investigation and 520027p.pd), AR 380–13, Acquisition will conform to the provisions of this Criminal Intelligence (ACI2) System and and Storage of Information Concerning part. Any exceptions to this policy must other criminal intelligence products. Non-Affiliated Persons and be coordinated with Headquarters The crimes listed in paragraphs (a)(1)– Organizations (available at http:// Department of the Army (HQDA), Office (9) of this section, as well as the www.apd.army.mil/pdffiles/r380_ of the Provost Marshal General (OPMG) reportable incidents, behavioral threat 13.pdf) and AR 25–400–2, The Army before any name checks are conducted. indicators, and other matters of Records Information Management The following are examples of counterintelligence interest specified by System (ARIMS) (available at http:// appropriate uses of the name check AR 381–12, Threat Awareness and www.apd.army.mil/pdffiles/r25_400_ feature of COPS MPRS: Reporting Program, (available at http:// 2.pdf). (1) Individuals named as the subjects www.apd.army.mil/pdffiles/r381_ (d) Local police intelligence files may of serious incident reports. 12.pdf) will be reported to the nearest be exempt from 32 CFR part 518 and the (2) Individuals named as subjects of Army counterintelligence office. FOIA’s disclosure requirements. investigations who must be reported to (1) Sedition; the USACRC. (2) Aiding the enemy by providing § 635.5 Name checks. (3) Individuals seeking employment intelligence to the enemy; (a) Information contained in military as child care/youth program providers. (3) Spying; police records will be released under (4) Local checks of the COPS MPRS as (4) Espionage; the provisions of 32 CFR part 505, The part of placing an individual in the (5) Subversion; Army Privacy Program, to authorized COPS MPRS system. (6) Treason; personnel for valid background check (5) Name checks for individuals (7) International terrorist activities or purposes. Examples include child care/ seeking employment in law enforcement material support to terrorism (MST); youth program providers, sexual assault positions. (8) Unreported contacts with response coordinator, unit victim foreigners involved in intelligence advocate, access control, unique or § 635.6 Registration of Sex Offenders on activities; Army Installations (inside and outside the special duty assignments, security Continental United States). (9) Unauthorized or intentional clearance procedures and suitability and disclosure of classified info. credentialing purposes. Any (a) Sex Offenders on US Army (b) Information on persons and information released must be restricted Installations. Garrison Commander’s organizations not affiliated with DoD to that necessary and relevant to the responsibilities: Garrison Commanders may not normally be acquired, reported, requester’s official purpose. Provost will ensure that sex offenders, as processed or stored. Situations Marshals/Directors of Emergency defined in paragraph (b) of this section justifying acquisition of this information Services (PM/DES) will establish that reside or are employed on an Army include, but are not limited to— written procedures to ensure that Installation register with the installation (1) Theft, destruction, or sabotage of release is accomplished in accordance PM/DES. This includes service weapons, ammunition, equipment with 32 CFR part 505. members, civilian employees, facilities, or records belonging to DoD (b) Checks will be accomplished by a accompanying dependent family units or installations. review of the COPS Military Police members, and contractors. (2) Protection of Army installations Reporting System (MPRS). Information (b) Sex offender is defined as: and activities from potential threat. will be disseminated according to (1) Any person, including but not (3) Information received from the FBI, Subpart B of this part. limited to a Service member, Service state, local, or international law (c) In response to a request for local member’s family member, Civilian enforcement agencies which directly files or name checks, PM/DES will employee, Civilian employee’s family pertains to the law enforcement mission release only founded offenses with final member, or contractor, who either is and activity of the installation Provost disposition. Offenses determined to be registered or required to register as a sex Marshal Office/Directorate of unfounded will not be released. These offender by any law, regulation or Emergency Services (PMO/DES), Army limitations do not apply to requests policy of the United States, the Command (ACOM), Army Service submitted by law enforcement agencies Department of Defense, the Army, a Component Command (ASCC) or Direct for law enforcement purposes, and State, the District of Columbia, the Reporting Unit (DRU) PMO/DES, or that counterintelligence investigative Commonwealth of Puerto Rico, Guam, has a clearly identifiable military agencies for counterintelligence America Samoa, The Northern Mariana purpose and connection. A purposes. Islands, the United States Virgin determination that specific information (d) A successful query of COPS MPRS Islands, or a Federally recognized may not be collected, retained or would return the following information: Indian tribe. This definition is not disseminated by intelligence activities (1) Military Police Report Number; limited to persons convicted for felony does not indicate that the information is (2) Report Date; sex offenses but includes all persons automatically eligible for collection, (3) Social Security Number; who are registered or required to register retention, or dissemination under the (4) Last Name; as a sex offender regardless of the provisions of this part. The policies in (5) First Name; classification of their offenses, including this section are not intended and will (6) Protected Identity (Y/N); felonies, misdemeanors, and offenses not be used to circumvent any federal (7) A link to view the military police not classified as a felony or law that restricts gathering, retaining or report; and misdemeanor. dissemination of information on private (8) Whether the individual is a (2) The persons who are sex offenders individuals or organizations. subject, victim, or a person related to as defined in paragraph (b)(1) include (c) Retention and disposition of the report disposition. those convicted by a foreign government information on non-DoD affiliated (e) Name checks will include the of an offense equivalent or closely individuals and organizations are information derived from COPS MPRS analogous to a covered offense under subject to the provisions of DoD and the United States Army Crime the Uniform Code of Military Justice as Directive 5200.27 (available at http:// Records Center (USACRC). All of the provided in AR 27–10, Military Justice www.dtic.mil/whs/directives/corres/pdf/ policies and procedures for such checks (available at http://www.apd.army.mil/

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pdffiles/r27_10.pdf), Chapter 24.’’ See all other sex offenders required to (2) Army LE personnel will use the 42 U.S.C. 16911(5)(B) and U.S. register on the installation— U.S. Army Criminal Investigation Department of Justice, Office of the (1) Complete a DA Form 3975 as an Laboratory (USACIL) DNA kit which Attorney General, The National information entry into COPS. includes a DNA sample card and the Guidelines for Sex Offender Registration (2) Complete ‘‘Section III—Subject USACIL DNA database collection eform. and Notification, Final Guidelines, 73 (1a–7)’’ on the DA Form 3975 to identify Army LE personnel will forward FR 38030, 38050–1 (July 2, 2008) for the sex offender. Ensure the sex offender civilian DNA samples to the USACIL. guidelines and standards. Contact the produces either evidence of the Army LE personnel will document, in servicing Office of the Staff Judge qualifying conviction or the sex offender the appropriate case file, when civilian Advocate for assistance in interpreting registration paperwork in order to LE agencies handle any aspect of the or applying this provision. complete ‘‘Section VII—Narrative’’ with DNA processing and whether the (c) Sex Offender Registration the state in which the sex offender was civilian LE agency forwarded the DNA Requirements. Sex offenders, as defined convicted, date of conviction, and sample to the FBI laboratory. in paragraph (b)(1) of this section must results of conviction, to include length (c) DoD Instruction 5505.14 (available register with the installation PMO/DES of time required to register and any at http://www.dtic.mil/whs/directives/ within three working days of first specific court ordered restrictions. corres/pdf/550514p.pdf) details the arriving on an installation. Sex (f) DoD civilians, contractors, and procedures former Soldiers and offenders must provide the installation family members that fail to register at civilians must follow to request PMO/DES with evidence of the the installation PMO/DES are subject to expungement of their DNA records. qualifying conviction. The PMO/DES a range of administrative sanctions, Former Soldiers and civilians from will enter the registering sex offender’s including but not limited to a complete whom DNA samples have been taken, conviction information on a Department or limited bar to the installation and but who were not convicted of any of the Army Form 3975 as an removal from military housing. offense giving rise to the collection of information entry into the Army’s DNA, do not submit requests to have Centralized Operations Police Suite § 635.7 Collection of deoxyribonucleic their DNA record expunged through (COPS) with the state the sex offender acid. installation PMO/DES channels. To was convicted, date of conviction, and (a) Army Law Enforcement (LE) request expungement of DNA records results of conviction, to include length personnel will collect deoxyribonucleic for civilians pursuant to Sections 14132 of time required to register and any acid (DNA) pursuant to DoDI 5505.14 of title 42, United States Code, the specific court ordered restrictions. (available at http://www.dtic.mil/whs/ requestor or legal representative must Registration with the PMO/DES does directives/corres/pdf/550514p.pdf), submit a written request to: FBI, not relieve sex offenders of their legal DNA Collection Requirements for Laboratory Division, 2501 Investigation obligation to comply with applicable Criminal Investigations. Per this Parkway, Quantico, VA 22135, state and local registration requirements subpart, a sample of an individual’s Attention: Federal Convicted Offender for the state in which they reside, work, DNA is to allow for positive Program Manager. or attend school (see, AR 190–47 identification and to provide or generate Subpart B—Release of Information (available at http://www.apd.army.mil/ evidence to solve crimes through pdffiles/r190_47.pdf), chapter 14 and database searches of potentially § 635.8 General. AR 27–10 (available at http:// matching samples. DNA samples will (a) The policy of HQDA is to conduct www.apd.army.mil/pdffiles/r27_10.pdf), not be collected from juveniles. activities in an open manner and chapter 24). Registration with the state (b) Army LE personnel will obtain a provide the public accurate and timely is also required under the Sex Offender DNA sample from a civilian in their information. Accordingly, law Registration and Notification Act control at the point it is determined enforcement information will be (SORNA), 42 U.S.C. 16901 et seq., and there is probable cause to believe the released to the degree permitted by law implemented by AR 27–10 (Available at detained person violated a Federal and Army regulations. http://www.apd.army.mil/pdffiles/r27_ statute equivalent to the offenses (b) Any release of military police 10.pdf), Military Justice, and DoDI identified in DoDI 5505.11 (available at records or information compiled for law 1325.7 (Available at http:// http://www.dtic.mil/whs/directives/ enforcement purposes, whether to www.dtic.mil/whs/directives/corres/pdf/ corres/pdf/550511p.pdf), Fingerprint persons within or outside the Army, 132507p.pdf). In addition, upon Card and Final Disposition Report must be in accordance with the FOIA assignment, reassignment, or change of Submission Requirements, and 32 CFR and the Privacy Act. address, sex offenders will inform the part 310, Department of Defense Privacy (c) Requests by individuals for access installation PM/DES within three Program, except for the listed violations to military police records about working days. Failure to comply with that are exclusively military offenses. themselves will be processed in registration requirements is punishable For the purposes of this rule, DNA shall compliance with FOIA and the Privacy under Federal or State law and/or under be taken from all civilian drug Act. the UCMJ. ‘‘State’’ in this paragraph offenders, except those who are arrested (d) Military police records in the includes any jurisdiction listed in or detained for the offenses of simple temporary possession of another paragraph (b)(1) of this section in which possession and personal use. organization remain the property of the a sex offender is required to register. (1) When Army LE personnel make a originating law enforcement agency. (d) Installation PMOs and DESs will probable cause determination The following procedures apply to any maintain and update a monthly roster of concerning a civilian not in their organization authorized temporary use current sex offenders names and control, Army LE personnel are not of military police records: provide it to the Sexual Assault Review required to collect DNA samples. (1) Any request from an individual Board; the Army Command PM and DES Likewise, Army LE personnel are not seeking access to military police records and the garrison commander. required to obtain DNA samples when will be immediately referred to the (e) Installation PMs and DESs will another LE agency has, or will, obtain originating law enforcement agency for complete the following procedures for the DNA. processing. The temporary custodian of

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military police records does not have part 518 and 32 CFR part 505, and this There is no requirement to coordinate the authority to release those records. part. such referrals at the installation level. (2) When the temporary purpose of (c) Authority to deny access to The request will simply be forwarded to the using organization has been criminal records information rests with the Director, United States Army Crime satisfied, the military police records will the initial denial authority (IDA) for the Records Center (USACRC) for action. be returned to the originating law FOIA and the denial authority for (6) Requests for military police enforcement agency or the copies will Privacy Acts cases, as addressed in 32 records that have been forwarded to be destroyed. CFR part 518 and 32 CFR part 505. USACRC and are no longer on file at the (3) A using organization may maintain § 635.10 Release of information under the installation PMO/DES will be forwarded information from military police records to the Director, USACRC for processing. in their system of records, if approval is Freedom of Information Act (FOIA). (a) The release and denial authorities (7) Requests concerning USACIDC obtained from the originating law reports of investigation or USACIDC enforcement agency. This information for all FOIA requests concerning files will be referred to the Director, may include reference to a military military police records include PM/DES USACRC. In each instance, the police record (for example, MPR and the Commander, USACIDC. requestor will be informed of the number or date of offense), a summary Authority to act on behalf of the referral and provided the Director, of information contained in the record, Commander, USACIDC is delegated to USACRC address. or the entire military police record. the Director, USACRC. When a user includes a military police (b) FOIA requests from members of (8) Requests concerning records that record in its system of records, the the press will be coordinated with the are under the supervision of an Army originating law enforcement agency will installation public affairs officer prior to activity, or other DoD agency, will be delete portions from that record to release of records under the control of referred to the appropriate agency for protect special investigative techniques, the installation PM/DES. When the response. maintain confidentiality, preclude record is on file at the USACRC the § 635.11 Release of information under the compromise of an investigation, and request must be forwarded to the Privacy Act of 1974. protect other law enforcement interests. Director, USACRC. (c) Requests will be processed as (a) Military police records may be § 635.9 Release of information. prescribed in 32 CFR part 518 and as released according to provisions of the (a) Release of information from Army follows: Privacy Act of 1974, 5 U.S.C. 552a, as records to agencies outside DoD will be (1) The installation FOIA Office will implemented by 32 CFR part 310, DoD governed by 32 CFR part 518, 32 CFR review requested reports to determine if Privacy Program, 32 CFR part 505, The part 505, AR 600–37, Unfavorable any portion is exempt from release. Army Privacy Program, and this part. Information (Available at http:// (2) Statutory and policy questions will (b) The release and denial authorities www.apd.army.mil/pdffiles/r600_ be coordinated with the local staff judge for all Privacy Act cases concerning 37.pdf), and this part. Procedures for advocate (SJA). military police records are provided in release of certain other records and (3) Coordination will be completed § 635.9. information is contained in AR 20–1, with the local USACIDC activity to (c) Privacy Act requests for access to Inspector General Activities and ensure that the release will not interfere a record, when the requester is the Procedures (available at http:// with a criminal investigation in progress subject of that record, will be processed www.apd.army.mil/pdffiles/r20_1.pdf), or affect final disposition of an as prescribed in 32 CFR part 505. AR 27–20, Claims (available at http:// investigation. www.apd.army.mil/pdffiles/r27_20.pdf), (4) If it is determined that a portion § 635.12 Amendment of records. AR 27–40, Litigation (available at of the report, or the report in its entirety (a) Policy. An amendment of records http://www.apd.army.mil/pdffiles/r27_ will not be released, the request to is appropriate when such records are 40.pdf), AR 40–66, Medical Record include a copy of the Military Police established as being inaccurate, Administration and Healthcare Report or other military police records irrelevant, untimely, or incomplete. Documentation (available at http:// will be forwarded to the Director, Amendment procedures are not www.apd.army.mil/pdffiles/r40_66.pdf), USACRC, ATTN: CICR–FP, 27130 intended to permit challenging an event AR 195–2, Criminal Investigation Telegraph Road, Quantico, VA 22134. that actually occurred. Requests to Activities (available at http:// The requestor will be informed that amend reports will be granted only if www.apd.army.mil/pdffiles/r195_2.pdf), their request has been sent to the the individual submits new, relevant AR 360–1, The Army Public Affairs Director, USACRC, and provided the and material facts that are determined to Program (available at http:// mailing address for the USACRC. When warrant their inclusion in or revision of www.apd.army.mil/pdffiles/r360_1.pdf), forwarding FOIA requests, the outside the police report. The burden of proof and AR 600–85, The Army Substance of the envelope will be clearly marked is on the individual to substantiate the Abuse Program (available at http:// ‘‘FOIA REQUEST.’’ request. Requests to delete a person’s www.apd.army.mil/pdffiles/r600_ (5) A partial release of information by name from the title block will be 85.pdf). Installation drug and alcohol an installation FOIA Office is granted only if it is determined that offices may be provided an extract of permissible when it is acceptable to the there is not probable cause to believe DA Form 3997 (Military Police Desk requester. (An example would be the that the individual committed the Blotter) for offenses involving the use of redaction of a third party’s social offense for which he or she is listed as alcohol or drugs (for example, drunk security number, home address, and a subject. It is emphasized that the driving, drunk and disorderly conduct, telephone number, as permitted by law). decision to list a person’s name in the or positive urinalysis). If the requester agrees to the redaction title block of a police report is an (b) Installation PM/DES are the of exempt information, such cases do investigative determination that is release authorities for military police not constitute a denial. If the requester independent of whether or not records under their control. They may insists on the entire report, a copy of the subsequent judicial, non-judicial or release criminal record information to report and the request for release will be administrative action is taken against other activities as prescribed in 32 CFR forwarded to the Director, USACRC. the individual.

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(b) In compliance with DoD policy, an subjects titled by military LE are installation PM/DES will notify the individual will still remain entered in available in CJIS to support NCIC Family Advocacy Program Manager the Defense Clearance Investigations background checks for firearms (FAPM) and Social Work Services Index (DCII) to track all reports of purchases, employment, security (SWS) of all incidents in which a investigation. clearances etc. preponderance of indicators reveal a potential risk of reoccurrence and § 635.13 Accounting for military police § 635.16 Fingerprint Card and Final increasing severity of maltreatment record disclosure. Disposition Report Submission Requirements. which could lead to domestic violence (a) 32 CFR part 505 prescribes or child abuse. Installation PM/DES will accounting policies and procedures (a) General. This paragraph ensure these notifications are recorded concerning the disclosure of military implements DoDI 5505.11, Fingerprint in the official military police journal in police records. Card and Final Disposition Report COPS. This is to: (b) PM/DES will develop local Submission Requirements, which (1) Establish a history of incidents procedures to ensure that disclosure of prescribes procedures for Army LE to that indicate an emerging pattern of risk military police records as described in report offender criminal history data, by of maltreatment/victimization to 32 CFR part 505 are available on submitting FBI Form FD 249 (Suspect Soldiers and or Family members. See request. Fingerprint Card) to USACRC. USACRC AR 608–18 for incidents that define (c) In every instance where records forwards this data to the Criminal maltreatment. are disclosed; individuals, agencies or Justice Information Services (CJIS) (2) Develop a trend history of components are reminded that use or division of the FBI for inclusion in the unsubstantiated–unresolved incidents further disclosure of any military police Next Generation Identification Database. in order to prevent possible violence or reports, Military Police Investigator This paragraph does not eliminate other maltreatment from occurring. (MPI) reports, or other information requirements to provide criminal received must be in compliance with history data, including those concerning § 635.18 Domestic violence. DoDI 5505.7 (available at http:// the DIBRS. (a) Responding to incidents of www.dtic.mil/whs/directives/corres/pdf/ (b) Installation PM/DES will submit domestic violence requires a 550507p.pdf), paragraph 6.5.2. which offender criminal history data to coordinated effort by LE, medical, and states that ‘‘judicial or adverse USACRC, based on a probable cause social work personnel, to include administrative actions shall not be taken standard determined in conjunction sharing information and records as against individuals or entities based with the servicing SJA or legal advisor permitted by law and regulation. AR solely on the fact that they have been for all civilians investigated for offenses 608–18, Chapter 3, contains additional titled or indexed due to a criminal equivalent to those listed in DoDI information about domestic violence investigation.’’ 5505.11. This includes foreign and protective orders. AR 608–18, nationals, persons serving with or Glossary, Section II refers to domestic § 635.14 Release of law enforcement accompanying an armed force in the violence as including the use, attempted information furnished by foreign governments or international organizations. field in time of declared war or use, or threatened use of force or contingency operations, and persons violence against a person or a violation (a) Information furnished by foreign subject to Public Law 106–523 in of a lawful order issued for the governments or international accordance with DoDI 5525.11 protection of a person, who is: organizations is subject to disclosure, (Available at http://www.dtic.mil/whs/ (1) A current or former spouse; unless exempted by 32 CFR part 518 directives/corres/pdf/552511p.pdf), (2) A person with whom the abuser and 32 CFR part 505, federal statutes or Criminal Jurisdiction Over Civilians shares a child in common; or executive orders. Employed By or Accompanying the (3) A current or former intimate (b) Release of U.S. information Armed Forces Outside the United partner with whom the abuser shares or (classified military information or States, Certain Service Members, and has shared a common domicile. controlled unclassified information) to Former Service Members. (b) All domestic violence incidents foreign governments is accomplished (c) For purposes of this paragraph will be reported to the local installation per AR 380–10 (available at http:// PMO/DES. _ commanders will notify their www.apd.army.mil/pdffiles/r380 installation PMO/DES when they § 635.19 Protection Orders. 10.pdf). become aware that a non-DoD and/or Subpart C—Offense Reporting foreign LE organization has initiated an (a) A DD Form 2873, Military investigation against a Soldier, military Protective Order (MPO) is a written § 635.15 DA Form 4833 (Commander’s dependent, or DoD civilian employee or lawful order issued by a commander Report of Disciplinary or Administrative that orders a Soldier to avoid contact Action) for Civilian Subjects. contractor, for the equivalent of an offense listed in DoDI 5525.11 (available with those persons identified in the Civilian Subjects titled by Army Law at http://www.dtic.mil/whs/directives/ order. MPOs may be used to facilitate a Enforcement. PM/DES and USACIDC corres/pdf/552511p.pdf), Enclosure 2, or ‘‘cooling-off’’ period following domestic will complete and submit disposition punishable pursuant to the U.S.C. violence and sexual assault incidents, to reports to USACRC for civilian subjects, include incidents involving children. not subject to the UCMJ, who are titled § 635.17 Release of domestic incidents The commander should provide a by Army law enforcement. PM/DES and reports to the Army Family Advocacy written copy of the order within 24 USACIDC will complete the DA Form Program (FAP). hours of its issuance to the person with 4833 and submit the form to USACRC (a) Installation PM/DES will comply whom the member is ordered not to for these subjects. PM/DES and with the reporting requirements set have contact and to the installation LE USACIDC will not include these forth in AR 608–18 (available at activity. completed DA Form 4833 for civilian http://www.apd.army.mil/pdffiles/r608_ (b) Initial notification. In the event a personnel in reporting compliance 18.pdf). MPO is issued against a Soldier and any statistics for commanders. This ensures (b) In addition to substantiated individual involved in the order does records of dispositions of civilian incidents of domestic violence, not reside on a Army installation at any

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time during the duration of the MPO, law enforcement services at water Privacy Act of 1974 (see 5 U.S.C. the installation PMO/DES will notify resource development projects under 552a(b)(7)). the appropriate civilian authorities the jurisdiction of the Secretary of the (13) Regular meetings between the (local magistrate courts, family courts, Army to meet needs during peak local civilian law enforcement agency and local police) of: visitation periods. and the installation law enforcement (1) The issuance of the protective (c) MOUs will address the following office to review cases and MOU order; issues at a minimum: procedures. (2) The individuals involved in the (1) A general statement of the purpose order; § 635.21 Suspicious Activity Reporting of the MOU. (SAR). (3) Any change made in a protective (2) An explanation of jurisdictional (a) The Army will use eGuardian to order; issues that affect respective report, share and analyze unclassified (4) The termination of the protective responsibilities to and investigating suspicious activity information order. incidents occurring on and off the regarding potential threats or suspicious (c) A Civilian Protective Order (CPO) installation. This section should also activities affecting DoD personnel, is an order issued by a judge, magistrate address jurisdictional issues when a facilities, or forces in transit in both or other authorized civilian official, civilian order of protection is violated CONUS and OCONUS. USACIDC is the ordering an individual to avoid contact on military property (see 10 U.S.C. with his or her spouse or children. Army’s eGuardian program manager. 1561a). (b) eGuardian is the Federal Bureau of Pursuant to the Armed Forces Domestic (3) Procedures for responding to Security Act, 10 U.S.C. 1561a, a CPO Investigation’s (FBI) sensitive-but- incidents that occur on the installation unclassified web-based platform for has the same force and effect on a involving a civilian alleged offender. military installation as such order has reporting, and in some instances, (4) Procedures for local law within the jurisdiction of the court that sharing, suspicious activity and threat enforcement to immediately (within 4 issued the order. related information with other federal, hours) notify the installation law state, tribal, and territorial law § 635.20 Establishing Memoranda of enforcement office of incidents/ enforcement and force protection Understanding. investigations involving service entities. Information entered into (a) Coordination between military law members. eGuardian by the Army may be either enforcement personnel and local (5) Procedures for transmitting shared with all eGuardian participants civilian law enforcement personnel is incident/investigation reports and other or reported directly to the FBI. All essential to improve information law enforcement information involving information entered into eGuardian by sharing, especially concerning active duty service members from local the Army will comply with the policy investigations, arrests, and prosecutions civilian law enforcement agencies to the framework for the system and any involving military personnel. PM/DES installation law enforcement office. existing agency agreements, which or other law enforcement officials shall (6) Notification that a Solider is incorporate privacy protections. seek to establish formal Memoranda of required to register as a sex offender Analysis of SARs will assist Understanding (MOU) with their either as the result of military judicial CRIMINTEL analysts and commanders civilian counterparts to establish or proceedings or civilian judicial in mitigating potential threats and improve the flow of information proceedings. vulnerabilities, and developing annual between their agencies, especially in (7) Procedures for transmitting threat assessments. instances involving military personnel. civilian protection orders (CPOs) issued (c) Any concerned soldier or citizen MOUs can be used to clarify by civilian courts or magistrates can submit a SAR to the nearest jurisdictional issues for the involving active duty service members installation PMO/DES, CI or CID office. investigation of incidents, to define the from local law enforcement agencies to The receiving office will then be mechanism whereby local law the installation law enforcement office. responsible for reviewing the enforcement reports involving active (8) Designation of the title of the information and determining whether it duty service members will be forwarded installation law enforcement recipient is appropriate for submission into to the appropriate installation law of such information from the local law eGuardian. enforcement office, to encourage the enforcement agency. (9) Procedures for transmitting Subpart D—Victim and Witness Assistance local law enforcement agency to refer Procedures victims of domestic violence to the military protection orders (MPOs) from installation Family Advocacy office or the installation law enforcement office § 635.22 Procedures. victim advocate, and to foster to the local civilian law enforcement (a) As required by DoDD 1030.01 cooperation and collaboration between agency with jurisdiction over the area in (Available at http://www.dtic.mil/whs/ the installation law enforcement agency which any person named in the order directives/corres/pdf/103001p.pdf), and local civilian agencies. resides. Army personnel involved in the (b) Installation commanders are (10) Designation of the title of the detection, investigation, and authorized to contract for local, state, or local law enforcement agency recipient prosecution of crimes must ensure that federal law enforcement services of domestic violence and CPO victims and witnesses rights are (enforcement of civil and criminal laws information from the installation law protected. Victim’s rights include- of the state) from civilian police enforcement agency. (1) The right to be treated with departments. (Section 120 of the Water (11) Respective responsibilities for fairness, dignity, and a respect for Resources Development Act of 1976). providing information to victims privacy. Section 120(a) of the Water Resources regarding installation resources when (2) The right to be reasonably Development Act of 1976 authorizes the either the victim or the alleged offender protected from the accused offender. Secretary of the Army, acting through is an active duty service member. (3) The right to be notified of court the Chief of Engineers, to contract with (12) Sharing of information and proceedings. States and their political subdivisions facilities during the course of an (4) The right to be present at all public for the purpose of obtaining increased investigation in accordance with the court proceedings related to the offense,

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unless the court determines that ACTION: Final rule. direction. The DAJAG (Admiralty and testimony by the victim would be Maritime Law) has also certified that the materially affected if the victim heard SUMMARY: The Department of the Navy lights involved are located in closest other testimony at trial, or for other (DoN) is amending its certifications and possible compliance with the applicable good cause. exemptions under the International 72 COLREGS requirements. (5) The right to confer with the Regulations for Preventing Collisions at Moreover, it has been determined, in attorney for the Government in the case. Sea, 1972, as amended (72 COLREGS), accordance with 32 CFR parts 296 and (6) The right to restitution, if to reflect that the Deputy Assistant 701, that publication of this amendment appropriate. Judge Advocate General for public comment prior to adoption is (7) The right to information regarding (DAJAG)(Admiralty and Maritime Law) impracticable, unnecessary, and conviction, sentencing, imprisonment, has determined that USS JACKSON contrary to public interest since it is and release of the offender from (LCS 6) is a vessel of the Navy which, based on technical findings that the custody. due to its special construction and placement of lights on this vessel in a (b) [Reserved] purpose, cannot fully comply with manner differently from that prescribed Subpart E—National Crime Information certain provisions of the 72 COLREGS herein will adversely affect the vessel’s Center Policy without interfering with its special ability to perform its military functions. function as a naval ship. The intended § 635.23 Standards. effect of this rule is to warn mariners in List of Subjects in 32 CFR Part 706 The use of NCIC is limited to waters where 72 COLREGS apply. Marine safety, Navigation (water), authorized criminal justice purposes DATES: This rule is effective May 19, Vessels. such as, stolen vehicle checks or wants 2015 and is applicable beginning May 7, For the reasons set forth in the and warrants. Subject to FBI regulations 2015. and policy, NCIC checks of visitors to a preamble, the DoN amends part 706 of military installation may be authorized FOR FURTHER INFORMATION CONTACT: title 32 of the Code of Federal by the Installation/Garrison Commander Commander Theron R. Korsak, Regulations as follows: (Admiralty and Maritime Law), Office of as set forth in DoD 5200.08–R (Available PART 706—CERTIFICATIONS AND at http://www.dtic.mil/whs/directives/ the Judge Advocate General, Department of the Navy, 1322 Patterson Ave. SE., EXEMPTIONS UNDER THE corres/pdf/520008r.pdf) and DoDI INTERNATIONAL REGULATIONS FOR 5200.08 (Available at http:// Suite 3000, Washington Navy Yard, DC 20374–5066, telephone 202–685–5040. PREVENTING COLLISIONS AT SEA, www.dtic.mil/whs/directives/corres/pdf/ 1972 520008p.pdf). Visitors to Army SUPPLEMENTARY INFORMATION: Pursuant to the authority granted in 33 U.S.C. installations are non-DoD affiliated ■ 1. The authority citation for part 706 1605, the DoN amends 32 CFR part 706. personnel. continues to read as follows: [FR Doc. 2015–11943 Filed 5–18–15; 8:45 am] This amendment provides notice that BILLING CODE 3710–08–P the DAJAG (Admiralty and Maritime Authority: 33 U.S.C. 1605. Law), under authority delegated by the ■ 2. Section 706.2 is amended in Table Secretary of the Navy, has certified that Four, paragraph 15, by revising the DEPARTMENT OF DEFENSE USS JACKSON (LCS 6) is a vessel of the entry for USS JACKSON (LCS 6) to read Navy which, due to its special as follows: Department of the Navy construction and purpose, cannot fully comply with the following specific § 706.2 Certifications of the Secretary of 32 CFR Part 706 provisions of 72 COLREGS without the Navy under Executive Order 11964 and 33 U.S.C. 1605. Certifications and Exemptions Under interfering with its special function as a naval ship: Annex I, paragraph 3(c), * * * * * the International Regulations for Table Four Preventing Collisions at Sea, 1972 pertaining to the task light’s horizontal distance from the fore and aft centerline * * * * * AGENCY: Department of the Navy, DoD. of the vessel in the athwartship ■ 15. * * *

Vessel Number Horizontal distance from the fore and aft centerline of the vessel in the athwartship direction

******* USS JACKSON ...... LCS 6 ...... Upper—0.10 meters Middle—1.31 meters Lower—1.31 meters

* * * * * Approved: May 7, 2015. A.B. Fischer, Captain, JAGC, U.S. Navy, Deputy Assistant Judge Advocate, General (Admiralty and Maritime Law). Dated: May 11, 2015 N.A. Hagerty-Ford Commander, Judge Advocate General’s Corps, U.S. Navy, Federal Register Liaison Officer. [FR Doc. 2015–11908 Filed 5–18–15; 8:45 am] BILLING CODE 3810–FF–P

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DEPARTMENT OF HOMELAND SUMMARY: The Coast Guard will enforce enforced during the dates and times as SECURITY one special local regulation for a boat listed in the SUPPLEMENTARY race, 16 safety zones for fireworks INFORMATION section of this document. Coast Guard displays and one safety zone for a swim event in the Sector Long Island Sound FOR FURTHER INFORMATION CONTACT: If 33 CFR Parts 100 and 165 area of responsibility on the dates and you have questions on this notice, call times listed in the tables below. This or email Petty Officer Ian Fallon, Waterways Management Division, U.S. [Docket No. USCG–2012–1036] action is necessary to provide for the safety of life on navigable waterways Coast Guard Sector Long Island Sound; Safety Zones and Special Local during the events. During the telephone 203–468–4565, email Regulations; Recurring Marine Events enforcement periods, no person or [email protected]. vessel may enter the regulated area or in Captain of the Port Long Island SUPPLEMENTARY INFORMATION: The Coast safety zones without permission of the Sound Zone Guard will enforce the special local Captain of the Port (COTP) Sector Long regulation listed in 33 CFR 100.100 and AGENCY: Coast Guard, DHS. Island Sound or designated representative. the safety zones listed in 33 CFR ACTION: Notice of enforcement of 165.151 on the specified dates and times DATES: regulation. The regulations in 33 CFR as indicated in the following Tables. 100.100 and 33 CFR 165.151 will be

TABLE TO § 100.100

August

1.1 Harvard-Yale Regatta, Thames River, New London, CT ...... • Event type: Boat Race. • Date: June 7, 2015. • Time: 8:30 a.m. to 12:30 p.m. • Location: All waters of the Thames River at New London, Con- necticut, between the Penn Central Draw Bridge 41°21′46.94″ N., 072°5′14.46″ W. to Bartlett Cove 41°25′ 35.9″ N., 072°5′42.89″ W. (NAD 83). • Additional stipulations: Spectator vessels must be at anchor within a designated spectator area or moored to a waterfront facility within the regulated area in such a way that they shall not interfere with the progress of the event at least 30 minutes prior to the start of the races. They must remain moored or at anchor until the men’s varsity have passed their positions. At that time, spectator vessels located south of the Harvard Boathouse may proceed downriver at a reason- able speed. Vessels situated between the Harvard Boathouse and the finish line must remain stationary until both crews return safely to their boathouses. If for any reason the men’s varsity crew race is postponed, spectator vessels will remain in position until notified by Coast Guard or regatta patrol personnel. The last 1000 feet of the race course near the finish line will be delineated by four temporary white buoys provided by the sponsor. All spectator craft shall remain behind these buoys during the event. Spectator craft shall not an- chor: to the west of the race course, between Scotch Cap and Bart- lett Point Light, or within the race course boundaries or in such a manner that would allow their vessel to drift or swing into the race course. During the effective period all vessels shall proceed at a speed not to exceed six knots in the regulated area. Spectator ves- sels shall not follow the crews during the races. Swimming is prohib- ited in the vicinity of the race course during the races. A vessel oper- ating in the vicinity of the Submarine Base may not cause waves which result in damage to submarines or other vessels in the floating dry-docks.

TABLE 1 TO § 165.151

6.2 Town of Branford Fireworks ...... • Date: June 27, 2015. • Rain Date: June 28, 2015. • Time: 9:00 p.m. to 10:30 p.m. • Location: Waters of Branford Harbor, Branford, CT in approximate position, 41°15′30″ N., 072°49′22″ W. (NAD 83). 6.3 Vietnam Veterans/Town of East Haven Fireworks ...... • Date: June 27, 2015. • Rain Date: June 29, 2015. • Time: 9:00 p.m. to 11:00 p.m. • Location: Waters off Cosey Beach, East Haven, CT in approximate position, 41°14′19″ N., 072°52′9.8″ W. (NAD 83). 7.1 Point O’Woods Fire Company Summer Fireworks ...... • Date: July 3, 2015. • Rain Date: July 5, 2015. • Time: 9:00 p.m. to 10:00 p.m.

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TABLE 1 TO § 165.151—Continued • Location: Waters of the Great South Bay, Point O’Woods, NY in ap- proximate position 40°39′18.57″ N., 073°08′5.73″ W. (NAD 83). 7.4 Norwalk Fireworks ...... • Date: July 3, 2015. • Rain Date: July 5, 2015. • Time: 8:30 p.m. to 10:30 p.m. • Location: Waters off Calf Pasture Beach, Norwalk, CT in approxi- mate position, 41°04′50″ N., 073°23′22″ W. (NAD 83). 7.5 Lawrence Beach Club Fireworks ...... • Date: July 3, 2015. • Rain Date: July 5, 2015. • Time: 9:00 p.m. to 10:30 p.m. • Location: Waters of the Atlantic Ocean off Lawrence Beach Club, At- lantic Beach, NY in approximate position 40°34′42.65″ N., 073°42′56.02″ W. (NAD 83). 7.6 Sag Harbor Fireworks ...... • Date: July 4, 2015. • Rain Date: July 5, 2015. • Time: 9:00 p.m. to 10:30 p.m. • Location: Waters of Sag Harbor Bay off Havens Beach, Sag Harbor, NY in approximate position 41°00′26″ N., 072°17′9″ W. (NAD 83). 7.7 South Hampton Fresh Air Home Fireworks ...... • Date: July 3, 2015. • Rain Date: July 5, 2015. • Time: 8:45 p.m. to 10:00 p.m. • Location: Waters of Shinnecock Bay, Southampton, NY in approxi- mate positions, 40°51′48″ N., 072°26′30″ W. (NAD 83). 7.18 Independence Day Celebration Fireworks ...... • Date: July 4, 2015. • Rain Date: July 5, 2015. • Time: 8:30 p.m. to 10:00 p.m. • Location: Waters off of Umbrella Beach, Montauk, NY in approximate position 41°01′44″ N., 071°57′13″ W. (NAD 83). 7.27 City of Long Beach Fireworks ...... • Date: July 10, 2015. • Rain Date: July 11, 2015. • Time: 8:30 p.m. to 10:00 p.m. • Location: Waters off Riverside Blvd, City of Long Beach, NY in ap- proximate position 40°34′38.77″ N., 073°39′41.32″ W. (NAD 83). 7.33 Groton Long Point Yacht Club Fireworks ...... • Date: July 18, 2015. • Rain Date: July 19, 2015. • Time: 9:00 p.m. to 10:30 p.m. • Location: Waters of Long Island Sound, Groton, CT in approximate position 40°59′41.40″ N., 072°06′08.70″ W. (NAD 83). 7.34 Devon Yacht Club Fireworks ...... • Date: July 4, 2015. • Rain Date: July 5, 2015. • Time: 8:45 p.m. to 10:00 p.m. • Location: Waters of Napeague Bay, in Block Island Sound off Amagansett, NY in approximate position 40°59′41.40″ N., 072°06′08.70″ W. (NAD 83). 7.40 Rowayton Fireworks ...... • Date: July 4, 2015. • Rain Date: July 5, 2015. • Time: 9:00 p.m. to 11:00 p.m. • Location: Waters of Long Island Sound south of Bayley Beach Park in Rowayton, CT in approximate position 41°03′11″ N., 073°26′41″ W. (NAD 83). 7.42 Connetquot River Summer Fireworks ...... • Date: July 2, 2015. • Rain Date: July 3, 2015. • Time: 8:45 p.m. to 9:55 p.m. • Location: Waters of the Connetquot River off Snapper Inn Res- taurant, Oakdale, NY in approximate position 40°43′32.38″ N., 073°9′02.64″ W. (NAD 83). 8.4 Town of Babylon Fireworks ...... • Date: August 22, 2015. • Rain Date: August 23, 2015. • Time: 8:30 p.m. to 10:00 p.m. • Location: Waters off of Cedar Beach Town Park, Babylon, NY in ap- proximate position 40°37′53″ N., 073°20′12″ W. (NAD 83). 9.1 East Hampton Fire Department Fireworks ...... • Date: August 29, 2015. • Rain Date: August 30, 2015. • Time: 8:45 p.m. to 10:15 p.m. • Location: Waters off Main Beach, East Hampton, NY in approximate position 40°56′40.28″ N., 072°11′21.26″ W. (NAD 83). 9.4 The Creek Fireworks ...... • Date: September 5, 2015. • Rain Date: September 6, 2015. • Time: 7:45 p.m. to 9:15 p.m. • Location: Waters of Long Island Sound off the Creek Golf Course, Lattingtown, NY in approximate position 40°54′13″ N., 073°35′58″ W. W. (NAD 83).

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TABLE 2 TO § 165.151

1.6 Swim Across America Greenwich ...... • Date: June 27, 2015. • Time: 5:30 a.m. to 10:30 a.m. • Location: All navigable waters of Stamford Harbor within a half mile long and 1,000 foot wide polygon shaped box stretching from Dol- phin Cove to Rocky Point between Stamford and Greenwich, CT. Formed by connecting the following points. Beginning at point (A) 41°01′32.03″ N., 073°33′8.93″ W., then south east to point (B) 41°01′ 15.01″ N., 073°32′55.58″ W.; then south west to point (C) 41°00′49.25 N., 073°33′ 20.36″ W.; then north west to point (D) 41°00′58.00″ N., 073°33′27.00″ W., then north east to point (E) 41°01′15.80″ N., 073°33′09.85″ W., then heading north and ending at point (A) (NAD 83).

Under the provisions of 33 CFR ACTION: Notice of deviation from The Meadowbrook State Parkway 100.100 and 33 CFR 165.151, the drawbridge regulation. Bridge, mile 12.8, across Sloop Channel regatta, fireworks displays and swim has a vertical clearance in the closed SUMMARY: The Coast Guard has issued a event listed above are established as a position of 22 feet at mean high water special local regulation or safety zone. temporary deviation from the operating schedule that governs the operation of and 25 feet at mean low water. The Under the provisions of 33 CFR 100.100 existing bridge operating regulations are and 165.151, vessels may not enter the the Loop Parkway Bridge, mile 0.7, across Long Creek, and the found at 33 CFR 117.799(h). Long Creek regulated area unless given permission and Sloop Channel are transited by from the COTP or a designated Meadowbrook State Parkway Bridge, mile 12.8, across Sloop Channel, both at commercial fishing and recreational representative. Spectator vessels may vessel traffic. transit outside the safety zones but may Hempstead, New York. This temporary deviation is necessary to facilitate the not anchor, block, loiter in, or impede Long Island Cares, Inc. requested and 2015 Dee Snider’s Ride to Fight Hunger the transit of other vessels. The Coast the bridge owner for both bridges, the on Long Island. This temporary Guard may be assisted by other Federal, State of New York Department of deviation allows two bridges to remain State, or local law enforcement agencies Transportation, concurred with this in the closed position during this public in enforcing this regulation. temporary deviation from the normal event. This notice is issued under authority operating schedule to facilitate a public DATES: of 33 CFR 100, 33 CFR 165 and 5 U.S.C. This deviation is effective from event, the 2015 Dee Snider’s Ride. 552 (a). In addition to this notice in the 11 a.m. to 1 p.m. on September 20, 2015. Under this temporary deviation, the Federal Register, the Coast Guard will Loop Parkway and the Meadowbrook ADDRESSES: provide the maritime community with The docket for this State Parkway Bridges may remain in deviation, [USCG–2015–0314] is advance notification of this enforcement the closed position between 11 a.m. and available at http://www.regulations.gov. period via the Local Notice to Mariners 1 p.m. on September 20, 2015. or marine information broadcasts. If the Type the docket number in the COTP determines that the regulated area ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ There are no alternate routes for need not be enforced for the full Click on Open Docket Folder on the line vessel traffic; however, vessels that can duration stated in this notice, a associated with this deviation. You may pass under the closed draws during this Broadcast Notice to Mariners may be also visit the Docket Management closure may do so at any time. The used to grant general permission to Facility in Room W12–140, on the bridges may be opened in the event of enter the regulated area. ground floor of the Department of an emergency. Transportation West Building, 1200 The Coast Guard will inform the users Dated: May 7, 2015. New Jersey Avenue SE., Washington, of the waterways through our Local and E.J. Cubanski, III, DC, 20590, between 9 a.m. and 5 p.m., Captain, U.S. Coast Guard, Captain of the Monday through Friday, except Federal Broadcast Notice to Mariners of the Port Sector Long Island Sound. holidays. change in operating schedule for the bridges so that vessels can arrange their [FR Doc. 2015–12103 Filed 5–18–15; 8:45 am] FOR FURTHER INFORMATION CONTACT: If BILLING CODE 9110–04–P you have questions on this temporary transits to minimize any impact caused deviation, contact Ms. Judy K. Leung- by the temporary deviation. Yee, Project Officer, First Coast Guard In accordance with 33 CFR 117.35(e), DEPARTMENT OF HOMELAND District, telephone (212) 514–4330, the drawbridges must return to its SECURITY [email protected]. If you have regular operating schedule immediately Coast Guard questions on viewing the docket, call at the end of the effective period of this Ms. Cheryl Collins, Program Manager, temporary deviation. This deviation 33 CFR Part 117 Docket Operations, telephone (202) from the operating regulations is 366–9826. authorized under 33 CFR 117.35. SUPPLEMENTARY INFORMATION: The Loop Dated: May 8, 2015. [Docket No. USCG–2015–0314] Parkway Bridge, mile 0.7, across Long C.J. Bisignano, Drawbridge Operation Regulation; Creek has a vertical clearance in the Supervisory Bridge Management Specialist, Long Island, New York Inland closed position of 21 feet at mean high First Coast Guard District. Waterway From East Rockaway Inlet to water and 25 feet at mean low water. Shinnecock Canal, NY The existing bridge operating [FR Doc. 2015–12112 Filed 5–18–15; 8:45 am] regulations are found at 33 CFR BILLING CODE 9110–04–P AGENCY: Coast Guard, DHS. 117.799(f).

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DEPARTMENT OF HOMELAND Regulatory Information Enforcement dates may need to be SECURITY The Coast Guard is issuing this changed or adjusted in the event that temporary final rule without prior sea or weather conditions are not Coast Guard notice and opportunity to comment conducive to safe operations. In the pursuant to authority under section 4(a) event of a change in dates the new dates 33 CFR Part 165 and times will be broadcast in a of the Administrative Procedure Act Broadcast Notice to Mariners and [Docket No. USCG–2015–0300] (APA) (5 U.S.C. 553(b)). This provision transmited via email to all port partners. authorizes an agency to issue a rule RIN 1625–AA00 The safety zone is located within the without prior notice and opportunity to Guam COTP Zone (See 33 CFR 3.70–15), comment when the agency for good Safety Zone; Agat Marina, Agat, Guam and will cover all waters of the Agat cause finds that those procedures are Marina Channel located at 13 degrees 28 AGENCY: Coast Guard, DHS. ‘‘impracticable, unnecessary, or contrary minutes 54 seconds North and 144 ACTION: Temporary final rule. to the public interest.’’ Under 5 U.S.C. degrees 47 minutes 30 seconds East 553(b)(B), the Coast Guard finds that (NAD 1983), from the surface of the SUMMARY: The Coast Guard will good cause exists for not publishing a water to the ocean floor within 25 yards establish a safety zone in the waters of notice of proposed rulemaking (NPRM) of the construction barge KIWI 1. There Agat Marina, Guam, to be enforced daily with respect to this rule because the will be a no wake zone while transiting during the repairs to the Agat marina official notification of Agat Marina the entire channel. The general channel markers from 7:30 a.m. through Channel repairs, and the need for this regulations governing safety zones 6:00 p.m. from May 25, 2015 through safety zone, was not finalized 60 days contained in 33 CFR 165.23 apply. Any June 8, 2015 while the construction prior to the start of the repairs. Coast Guard commissioned, warrant or barge is in the channel. The safety zone Publishing an NPRM and delaying the petty officer, and any COTP will encompass all waters within 25 effective date would be contrary to the representative permitted by law, may yards of the construction barge in the public interest since the event would enforce the zone. The COTP may waive Agat Marina Channel. This safety zone occur before the rulemaking process was any of the requirements of this rule for is necessary to protect the crew working complete, thereby jeopardizing the any person, vessel, or class of vessel the channel markers, and the mariners safety of the people and property upon finding that application of the from the hazards of the repairs taking unknowingly transiting or remaining in safety zone is unnecessary or place at the Agat Marina. the area. impractical for the purpose of maritime DATES: This rule is effective from 7:30 Under 5 U.S.C. 553(d)(3), the Coast safety. Vessels or persons violating this a.m. May 25, 2015 through 6:00 p.m., Guard finds that good cause exists for rule are subject to the penalties set forth (local Kilo time) on August 8, 2015. This not publishing an NPRM prior to in 33 U.S.C. 1232. rule is enforced daily Monday through making this rule effective 30 days after Saturday from 7:30 a.m. to 6:00 p.m. publication in the Federal Register. The Regulatory Analyses May 25, 2015 through June 8, 2015 COTP finds this good cause to be the We developed this rule after (local Kilo time). immediate need for a safety zone to considering numerous statutes and ADDRESSES: Documents indicated in this allay the aforementioned safety executive orders related to rulemaking. preamble as being available in the concerns surrounding the construction Below we summarize our analyses docket are part of docket USCG–2015– work to be undertaken at Agat Marina. based on 13 of these statutes or 0300 and are available online by going Basis and Purpose executive orders. to http://www.regulations.gov, inserting USCG–2015–0300 in the ‘‘Keyword’’ The legal basis for this rule is the Regulatory Planning and Review box, and then clicking ‘‘Search.’’ They Coast Guard’s authority to establish This rule is not a significant are also available for inspection or limited access areas: 33 U.S.C. 1231; 46 regulatory action under section 3(f) of copying at the Docket Management U.S.C. Chapter 701, 3306, 3703; 50 Executive Order 12866, Regulatory Facility (M–30), U.S. Department of U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–6, Planning and Review, and does not Transportation, West Building Ground 160.5; Public Law 107–295, 116 Stat. require an assessment of potential costs Floor, Room W12–140, 1200 New Jersey 2064; and Department of Homeland and benefits under section 6(a)(3) of that Avenue SE., Washington, DC 20590, Security Delegation No. 0170.1. Order. The Office of Management and between 9 a.m. and 5 p.m., Monday A safety zone is a water area, shore Budget has not reviewed it under that through Friday, except Federal holidays. area, or water and shore area, for which Order. FOR FURTHER INFORMATION CONTACT: access is limited to authorized person, If Small Entities you have questions on this temporary vehicles, or vessels for safety or rule, call Chief Kristina Gauthier, U.S. environmental purposes. The purpose of Under the Regulatory Flexibility Act Coast Guard Sector Guam at (671) 355– this rulemaking is to protect mariners (5 U.S.C. 601–612), we have considered 4866. from the potential hazards associated whether this rule would have a If you have questions on viewing the with the construction barge operating in significant economic impact on a docket, call Cheryl Collins, Program a narrow channel. substantial number of small entities. The term ‘‘small entities’’ comprises Manager, Docket Operations; telephone Discussion of Rule 202–366–9826, or 1–800–647–5527. small businesses, not-for-profit In order to protect the public from the SUPPLEMENTARY INFORMATION: organizations that are independently hazards of the construction associated owned and operated and are not Table of Acronyms with the channel marker replacement, dominant in their fields, and DHS Department of Homeland Security the Coast Guard is establishing a governmental jurisdictions with FR Federal Register temporary safety zone, enforced daily populations of less than 50,000. NPRM Notice of Proposed Rulemaking Monday through Saturday, from 7:30 The Coast Guard certifies under 5 COTP Captain of the Port a.m. to 6:00 p.m. May 25, 2015 through U.S.C. 605(b) that this rule will not have PAG Port Authority Guam June 8, 2015 (Kilo, Local Time). a significant economic impact on a

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substantial number of small entities. impose a substantial direct cost of consider the use of voluntary consensus This rule would affect the following compliance on them. We have analyzed standards. entities, some which might be small this rule under that Order and have Environment entities: The owners or operators of determined that it does not have vessels intending to transit the Agat implications for federalism. We have analyzed this rule under Marina Channel daily from 07:30 a.m. Department of Homeland Security May 25, 2015 through 6 p.m. June 8, Unfunded Mandates Reform Act Management Directive 023–01 and 2015. Due to the nature of the work to The Unfunded Mandates Reform Act Commandant Instruction M16475.lD, be undertaken to ensure the proper of 1995 (2 U.S.C. 1531–1538) requires which guide the Coast Guard in demarkation of the Agat Marina Federal agencies to assess the effects of complying with the National Channel, the channel will be adversely their discretionary regulatory actions. In Environmental Policy Act of 1969 affected during the anticipated 14 days particular, the Act addresses actions (NEPA)(42 U.S.C. 4321–4370f), and of construction. The narrowing of the that may result in the expenditure by a have concluded this action is one of a channel in the area around the State, local, or tribal government, in the category of actions which do not construction barge will require aggregate, or by the private sector of individually or cumulatively have a additional safety precautions be taken $100,000,000 or more in any one year. significant effect on the human by local mariners. The safety zone will Though this rule will not result in such environment. This rule is categorically not have significant economic impact on an expenditure, we do discuss the excluded, under figure 2–1, paragraph a substantial number small entities for effects of this rule elsewhere in this (34)(g), of the Instruction. This rule the following reasons. The nature of the preamble. involves is categorically excluded from work and location of the barge may further environmental documentation Taking of Private Property cause some delays in the entering and because it is a regulation establishing a exiting of the channel by small boat This rule will not affect a taking of safety zone. An environmental analysis operators berthed in the Agat Marina, private property or otherwise have checklist and a categorical exclusion however traffic will still be allowed to taking implications under Executive determination are available in the transit around the construction barge Order 12630, Governmental Actions and docket where indicated under with no wake. Before the activation of Interference with Constitutionally ADDRESSES. the zone, maritime advisories will be Protected Property Rights. List of Subjects in 33 CFR Part 165 widely available to users of the channel. Civil Justice Reform Harbors, Marine safety, Navigation Assistance for Small Entities This rule meets applicable standards (water), Reporting and record-keeping Under section 213(a) of the Small in sections 3(a) and 3(b)(2) of Executive requirements, Security measures, Business Regulatory Enforcement Order 12988, Civil Justice Reform, to Waterways. Fairness Act of 1996 (Pub. L. 104–121), minimize litigation, eliminate For the reasons discussed in the we offer to assist small entities in ambiguity, and reduce burden. preamble, the Coast Guard amends 33 understanding the rule so that they can Protection of Children CFR part 165 as follows: better evaluate its effects on them and participate in the rulemaking process. We have analyzed this rule under PART 165—REGULATED NAVIGATION Small businesses may send comments Executive Order 13045, Protection of AREAS AND LIMITED ACCESS AREAS on the actions of Federal employees Children from Environmental Health who enforce, or otherwise determine Risks and Safety Risks. This rule is not ■ 1. The authority citation for part 165 compliance with, Federal regulations to an economically significant rule and continues to read as follows: the Small Business and Agriculture does not create an environmental risk to Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Regulatory Enforcement Ombudsman health or risk to safety that may Chapter 701; 50 U.S.C. 191, 195; 33 CFR and the Regional Small Business disproportionately affect children. 1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, 116 Stat. 2064; Department of Regulatory Fairness Boards. The Indian Tribal Governments Ombudsman evaluates these actions Homeland Security Delegation No. 0170.1. annually and rates each agency’s This rule does not have tribal ■ 2. Add § 165.T14–300 to read as responsiveness to small business. If you implications under Executive Order follows: wish to comment on actions by 13175, Consultation and Coordination employees of the Coast Guard, call 1– with Indian Tribal Governments, § 165.T14–300 Safety Zone; Agat Marina, Agat, Guam. 888–REG–FAIR (1–888–734–3247). The because it does not have a substantial Coast Guard will not retaliate against direct effect on one or more Indian (a) Location. The following area, small entities that question or complain tribes, on the relationship between the within the Guam COTP Zone (See 33 about this rule or any policy or action Federal Government and Indian tribes, CFR 3.70–15), from the surface of the of the Coast Guard. or on the distribution of power and water to the ocean floor, is a safety zone: responsibilities between the Federal 25 yards around the construction barge Collection of Information Government and Indian tribes. KIWI 1 in the waters of Agat Marina, This rule calls for no new collection Guam located at 13 degrees 28 minutes Energy Effects of information under the Paperwork 54 seconds North and 144 degrees 47 Reduction Act of 1995 (44 U.S.C. 3501– We have analyzed this rule under minutes 30 seconds East (NAD 1983). 3520). Executive Order 13211, Actions There is a no wake zone established for Concerning Regulations That the entire length of the Agat Channel. Federalism Significantly Affect Energy Supply, (b) Effective Dates. This rule is A rule has implications for federalism Distribution, or Use. effective from 7:30 a.m. May 25, 2015 under Executive Order 13132, through 6:00 p.m. on August 8, 2015 Federalism, if it has a substantial direct Technical Standards (Kilo, Local Time) while the effect on State or local governments and This rule does not use technical construction barge KIWI 1 is in the would either preempt State law or standards. Therefore, we did not channel.

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(c) Regulations. The general FOR FURTHER INFORMATION CONTACT: reviews, the final rules clarify, regulations governing safety zones Susan L. C. Mitchell, Lead consistent with the AIA, that such contained in 33 CFR 165.23 apply. Entry Administrative Patent Judge by reviews may be extended in the case of into, transit through or anchoring within telephone at (571) 272–9797. joinder and that no petition for a this zone is prohibited unless SUPPLEMENTARY INFORMATION: Executive covered business method patent review authorized by the COTP or a designated Summary: Purpose: This final rule may be filed if the petitioner or real representative thereof. Authorization increases the page limitations for party-in-interest filed a civil action can be requested from PAG Harbor briefing for Patent Owner’s motion to challenging the validity of a claim of the Master via phone at (671) 477–5931 ext amend and for Petitioner’s reply brief in covered business method patent. 533. response to comments from the public. Costs and Benefits: This rulemaking is (d) Enforcement. This rule is enforced This final rule also addresses clarifying not economically significant, and is not daily Monday through Saturday from changes to the rules so that they significant, under Executive Order 7:30 a.m. to 6:00 p.m. May 25, 2015 conform to Office practice in conducting 12866 (Sept. 30, 1993), as amended by through June 8, 2015 (Kilo, Local Time) AIA proceedings. Executive Order 13258 (Feb. 26, 2002) while the construction barge KIWI 1 is Summary of Major Provisions: In an and Executive Order 13422 (Jan. 18, in the channel. Any Coast Guard effort to gauge the effectiveness of the 2007). commissioned, warrant, or petty officer, rules governing AIA trials, the Office Background and any other COTP representative conducted a nationwide listening tour permitted by law, may enforce this in April and May of 2014, and in June Development of the Final Rule temporary safety zone. 2014, published a Federal Register On September 16, 2011, the AIA was (e) Waiver. The COTP may waive any Notice asking for public feedback about enacted into law (Pub. L. 112–29, 125 of the requirements of this rule for any the AIA trial proceedings. The Office Stat. 284 (2011)), and shortly thereafter person, vessel, or class of vessel upon has carefully reviewed the comments in 2012, the Office implemented rules to finding that application of the safety and, in response to public input, will govern Office trial practice for AIA zone is unnecessary or impractical for issue two rules packages; a first, final proceedings, including inter partes the purpose of maritime security. rule package with more ministerial review, post-grant review, the (f) Penalties. Vessels or persons changes to the rules, and a second, transitional program for covered violating this rule are subject to the proposed rule package that will issue business method patents, and derivation penalties set forth in 33 U.S.C. 1232. later to address more involved changes proceedings pursuant to 35 U.S.C. 135, Dated: April 30, 2015. to the rules and the Office Patent Trial 316 and 326 and AIA 18(d)(2). See Rules James B. Pruett, Practice Guide. The Office presents the of Practice for Trials Before the Patent Captain, U.S. Coast Guard, Captain of the following final rules to address issues Trial and Appeal Board and Judicial Port Guam. concerning Patent Owner’s motion to Review of Patent Trial and Appeal [FR Doc. 2015–12121 Filed 5–18–15; 8:45 am] amend and Petitioner’s reply brief that Board Decisions, 77 FR 48,612 (Aug. 14, involve ministerial changes, and will BILLING CODE P 2012); Changes to Implement Inter address public comments relating to Partes Review Proceedings, Post-Grant those specific issues only, in this first, Review Proceedings, and Transitional final rule package. For instance, the Program for Covered Business Method DEPARTMENT OF COMMERCE following final rules provide ten Patents, 77 FR 48,680 (Aug. 14, 2012); Patent and Trademark Office additional pages for a Patent Owner Transitional Program for Covered motion to amend, allow a claims Business Method Patents—Definitions 37 CFR Part 42 appendix for a motion to amend, and of Covered Business Method Patent and provide ten additional pages for Technological Invention, 77 FR 48,734 [Docket No. PTO–P–2015–0032] Petitioner’s reply brief. (Aug. 14, 2014). Additionally, the Office These final rules also provide changes RIN 0651–AD00 published a Patent Trial Practice Guide to conform the rules to the Office’s for the rules to advise the public on the Amendments to the Rules of Practice established practices in handling AIA general framework of the regulations, for Trials Before the Patent Trial and proceedings. For instance, the final including the structure and times for Appeal Board rules require a specific font to ensure taking action in each of the new readability of briefs, clarify that more proceedings. See Office Patent Trial AGENCY: Patent Trial and Appeal Board, than one back-up counsel can be named, Practice Guide, 77 FR 48,756 (Aug. 14, United States Patent and Trademark and clarify how to count challenged 2012). Office, U.S. Department of Commerce. claims to calculate fees. The final rules In an effort to gauge the effectiveness ACTION: Final rule. also clarify that providing a statement of of the rules governing AIA trials, the material fact by a party is optional and Office conducted a nationwide listening SUMMARY: This final rule amends the that routine discovery contemplates tour in April and May of 2014. During existing consolidated set of rules only cross-examination of affidavit the listening tour, the Office focused relating to the United States Patent and testimony prepared for the proceeding. particularly on transparency and public Trademark Office (Office or USPTO) The final rules further provide that involvement in making trial proceedings trial practice for inter partes review, uncompelled direct testimony must be more effective going forward by post-grant review, the transitional in the form of an affidavit, not a adjusting the rules and guidance where program for covered business method deposition; that motions in limine are necessary. As a result, in June of 2014, patents, and derivation proceedings that not used in AIA practice; that objections the Office published a Request for implemented provisions of the Leahy- to evidence should be made part of the Comments in the Federal Register and, Smith America Invents Act (‘‘AIA’’) record by filing them; and that only a at stakeholder request, extended the providing for trials before the Office. single request for rehearing may be filed period for receiving comments to DATES: Effective Date: This rule is as of right. Finally, with regard to October 16, 2014. See Request for effective May 19, 2015. covered business method patent Comments on Trial Proceedings Under

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the America Invents Act Before the replies to oppositions to Motions to accord with the specific request that the Patent Trial and Appeal Board, 79 FR Amend): 5 pages’’; and add (3) to read Board more freely grant requests for 36,474 (June 27, 2014). ‘‘Replies to oppositions to Motions to additional pages, however, the Board The Request for Comments asked Amend: 12 pages.’’ will continue to consider requests for seventeen questions on ten broad topics, • Amend 37 CFR 42.121(b) to read additional pages on a case-by-case basis. including a general catchall question, to ‘‘Content. A motion to amend claims The specific request that a patent elicit any proposed changes to the AIA must include a claim listing, which owner be able to allocate pages from the post-grant program that stakeholders claim listing may be contained in an patent owner’s response to a motion to suggest would be beneficial. See appendix to the motion, show the amend is not adopted. This procedure is Request for Comments, 79 FR at 36,476– changes clearly, and set forth . . . .’’ not warranted in light of the above • 77. The Office received thirty-seven Amend 37 CFR 42.221(b) to read amendments relaxing the page comments from bar associations, ‘‘Content. A motion to amend claims limitation on Patent Owner’s motion to corporations, law firms, and must include a claim listing, which amend. In addition, this procedure individuals, encompassing a wide range claim listing may be contained in an would be difficult to administer in light of issues. The Office expresses its appendix to the motion, show the of the above amendments, placing an gratitude for the thoughtful and changes clearly, and set forth . . . .’’ undue administrative burden on the comprehensive comments provided by b. Response to Comments Office to determine and monitor the the public, which are available on the total number of pages allocated to the Comments: Although some comments USPTO Web site: http://www.uspto.gov/ patent owner, to the petitioner’s advocated no change to the Office’s page/comments-trial-proceedings- opposition to the motion to amend, and motion to amend practice in AIA under-america-invents-act-patent-trial- to any reply. and-appeal-board. proceedings, numerous comments Several commenters expressed suggested relaxing the page limitation Petitioner’s Reply satisfaction with the current AIA post- on Patent Owner’s motion to amend. a. Amendments to the Rules grant programs, and several commenters Several comments proposed a specific offered suggestions on how to number of additional pages, and/or In response to comments received strengthen the AIA post-grant programs. permitting the listing of claims in an from the public, the Office is increasing For example, some suggestions appendix not counted toward the page the page limitation for Petitioner’s reply concerned the claim construction limit. One comment suggested a flexible brief to Patent Owner’s response to standard used by the PTAB, motions to page limit based on the number of petition by 10 pages. To implement this amend, discovery procedures, and substitute claims proposed, and one increase in the page limitation for handling of multiple proceedings. The comment suggested that the Board more Petitioner’s reply brief from fifteen to Office will address all public comments freely grant requests for additional twenty-five pages, the Office amends 37 that do not involve changes to the page pages. Another comment suggested CFR 42.24(c)(1) to read: ‘‘Replies to limitations for Patent Owner’s motion to permitting the patent owner to allocate patent owner responses to petitions: 25 amend or Petitioner’s reply brief in the unutilized pages from the patent pages.’’ second, proposed rule package. owner’s response to the motion to b. Response to Comments amend. Discussion of Specific Final Rules Response: The overall request to relax Comments: Although at least one Subpart A—Trial Practice and the page limitation on Patent Owner’s commenter wanted no change, several Procedure motion to amend is adopted. As set commenters suggested that the fifteen forth above, the Office amends 37 CFR pages afforded for a Petitioner’s reply Patent Owner’s Motion To Amend 42.24(a) to increase the page limit for brief is not commensurate with the a. Amendments to the Rules motions to amend from 15 pages to 25 number of pages afforded to Patent In response to comments received pages. Applying the provision of 37 CFR Owner, especially if Patent Owner raises from the public concerning amendment 42.24(b)(3) mandating an equal page new issues. Commenters suggested that practice in AIA proceedings, the Office limitation for oppositions, the page limit increasing the page limitation for is increasing the page limitation for for oppositions to motions to amend Petitioner’s reply brief would allow a Patent Owner’s motion to amend by ten also increases from 15 pages to 25 pages. more complete record before the Office. pages and allowing a claims appendix The Office also amends 37 CFR 42.24(c) One comment suggested that to provide that is not included in the page to increase the page limit for replies to Petitioner with a fair opportunity to limitation. To implement this increase oppositions to motions to amend from 5 respond, the number of pages afforded in the page limitation for a motion to pages to 12 pages. Also, the Office for Petitioner’s reply brief may amend from fifteen to twenty-five pages, amends 37 CFR 42.121(b) and 37 CFR correspond to the number of pages in exclusive of any claims appendix, with 42.221(b) to permit an appendix for the Patent Owner’s post-institution a commensurate increase in the number claim listing accompanying a motion to response that is devoted to new issues. of pages for an opposition to a motion amend that is not counted toward the Response: The overall request to relax to amend, the Office amends 37 CFR 25-page limitation. page limitations on Petitioner’s reply 42.24(a) and (c), 42.121(b), and The specific request for a flexible page brief to Patent Owner’s response is 42.221(b) as follows: limit based on the number of substitute adopted. As set forth above, the Office • Amend 37 CFR 42.24(a)(1) to add claims is not adopted. This procedure is amends 37 CFR 42.24(c)(1) to increase the phrase ‘‘or claim listing’’ after ‘‘or not warranted in light of the above the page limit for Petitioner’s reply brief appendix of exhibits.’’ amendments relaxing the page from 15 to 25 pages. • Amend 37 CFR 42.24(a)(1)(v) to limitation on Patent Owner’s motion to The specific request for a flexible page read ‘‘Motions (excluding Motions to amend. In addition, this approach may limit based on new issues raised in Amend): 15 pages’’; and add (vi) to read encourage parties to increase Patent Owner’s response is not adopted. ‘‘Motions to Amend: 25 pages.’’ unnecessarily the number of substitute This procedure is not warranted in light • Amend 37 CFR 42.24(c)(2) to read claims presented solely to procure of the above amendment relaxing the ‘‘Replies to oppositions (excluding additional pages for the motion. In page limitation on Petitioner’s reply

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brief. In addition, this procedure would • Delete the first instance of the evidence. Therefore, the Office Patent be difficult to administer, placing an phrase ‘‘request fee’’ in the following Trial Practice Guide states that a motion undue administrative burden on the phrase ‘‘Post-Grant or Covered Business to exclude evidence requires a party to Office to determine the total number of Method Patent Review request fee Post- identify where in the record the pages allocated by Patent Owner to new Institution request fee’’ in 42.15(b)(4). objection originally was made, but 37 issues. • Add the content ‘‘, including CFR 42.64(b)(1) merely requires service unchallenged claims from which a of objections to evidence, which does Required Font challenged claim depends’’ after the text not make such objections part of the In AIA post-grant proceeding filings, ‘‘each claim in excess of 15’’ in 37 CFR record. Therefore, the Office amends the the Office has required either a 42.15(a)(4) and 42.15(b)(4). first and second sentences of 37 CFR proportional or monospaced font that is 42.64(b)(1) to replace ‘‘served’’ with Oppositions and Replies and Page 14-point or larger, with an additional ‘‘filed’’ so as to require filing of Limits for Petitions, Motions, requirement that any monospaced font objections, which also requires service Oppositions, and Replies must not contain more than four under 37 CFR 42.6(e)(2). To clarify that supplying a statement characters per centimeter or ten Decision on Petition or Motions characters per inch. See 37 CFR of material fact by a party is optional, 42.6(a)(2)(ii). The Office has received the Office amends 37 CFR 42.23 and To clarify that a party may file only briefs from parties that utilize narrow 42.24 as follows: a single request for rehearing as of right, fonts that may be compliant with these • Replace the phrase ‘‘and must the Office amends 37 CFR 42.71(d) to requirements, but nevertheless, have include a statement identifying material add ‘‘single’’ before ‘‘request for proved difficult to read. To address this facts in dispute’’ from the first sentence rehearing’’ in the first sentence. concern, the Office is amending 37 CFR of 37 CFR 42.23(a) with ‘‘and, if the Subpart D—Transitional Program for 42.6(a)(2) to require 14-point, Times paper to which the opposition or reply Covered Business Method Patents New Roman proportional font, with is responding contains a statement of normal spacing, to ensure readability of material fact, must include a listing of Procedure and Pendency all briefs. facts that are admitted, denied, or To clarify that the pendency of a cannot be admitted or denied.’’ covered business method patent review Counsel • Replace the phrase ‘‘the required’’ proceeding can be extended in the case To clarify the rule regarding with ‘‘any’’ in the first sentence of 37 of joinder and to harmonize the rule designation of counsel for an AIA CFR 42.24(c). with similar rules in other post grant proceeding that more than one back-up Discovery proceedings, the Office amends 37 CFR counsel may be designated, the Office 42.300(c) to add ‘‘, or adjusted by the amends 37 CFR 42.10 as follows: To clarify that routine discovery Board in the case of joinder’’ at the end • Replace the article ‘‘a’’ before includes only the cross-examination of of the second sentence after ‘‘Chief ‘‘back-up counsel’’ with ‘‘at least one’’ affidavit testimony prepared for the Administrative Patent Judge.’’ in 37 CFR 42.10(a). proceeding, the Office amends 37 CFR 42.51(b)(1)(ii) to add the phrase Who May Petition for a Covered Fees ‘‘prepared for the proceeding’’ after Business Method Patent Review The Office has explained in the Office ‘‘affidavit testimony.’’ The Office may not institute a covered business method patent review of a Patent Trial Practice Guide that to Taking Testimony challenged patent when the petitioner understand the scope of a dependent Because uncompelled direct filed a civil action challenging the claim, the claim(s) from which the testimony must be submitted in the validity of a claim of the patent before dependent claim depends must be form of an affidavit, the Office is filing the petition. See AIA section construed along with the dependent amending 37 CFR 42.53(c)(2) as follows: 18(a)(1); 35 U.S.C. 325(a)(1); SecureBuy, claim. Therefore, to calculate any fee • Delete the word ‘‘deposition’’ from LLC v. CardinalCommerce Corp., Case due under 37 CFR 42.15 that is based on the phrase ‘‘uncompelled direct CBM2014–00035 (PTAB Apr. 25, 2014) the number of claims, each claim deposition testimony.’’ (Paper 12) (precedential). To state this challenged will be counted as well as To clarify that either party is prohibition explicitly, the Office any claim from which a challenged permitted to file testimony as an exhibit, amends 37 CFR 42.302 to add a section claim depends, unless the parent claim the Office amends 37 CFR 42.53(f)(7) to (c) as set forth in the regulatory text of is also separately challenged. See Rules delete the phrase ‘‘by proponent’’ in the this rule. of Practice for Trials Before the Patent second sentence. Trial and Appeal Board and Judicial Rulemaking Considerations Review of Patent Trial and Appeal Motion in Limine A. Administrative Procedure Act Board Decisions; Final Rule, 77 FR The term motion in limine is included (APA): This final rule revises the 48,612, 48,619 (Aug. 14, 2012). in the title for 37 CFR 42.64, but the rule consolidated set of rules relating to To clarify the fees rule to reflect does not provide for a motion in limine. Office trial practice for inter partes explicitly this requirement to include To clarify the rule, the Office amends 37 review, post-grant review, the unchallenged claims from which a CFR 42.64 to delete ‘‘motion in limine’’ transitional program for covered challenged claim depends in the claim from the title of the rule. business method patents, and derivation count for fee calculating purposes, the proceedings. The changes being adopted Office is amending 37 CFR 42.15 as Objection in this rule do not change the follows: The Office amends 37 CFR 42.64(b)(1) substantive criteria of patentability. • Add the content ‘‘, including for consistency with the Office Patent These changes involve rules of agency unchallenged claims from which a Trial Practice Guide. The Office Patent practice. See, e.g., 35 U.S.C. 316(a)(5), as challenged claim depends’’ after the text Trial Practice Guide requires that a amended. http:// ‘‘each claim in excess of 20’’ in 37 CFR party wishing to challenge admissibility www.cruiseamerica.com/rent/our_ 42.15(a)(3) and 42.15(b)(3). of evidence must object timely to the vehicles/ These rules are procedural

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and/or interpretive rules. See Bachow an open exchange of information and submit a report containing the rule and Commc’ns Inc. v. F.C.C., 237 F.3d 683, perspectives among experts in relevant other required information to the United 690 (D.C. Cir. 2001) (rules governing an disciplines, affected stakeholders in the States Senate, the United States House application process are procedural private sector and the public as a whole, of Representatives, and the Comptroller under the Administrative Procedure and provided on-line access to the General of the Government Act); Inova Alexandria Hosp. v. Shalala, rulemaking docket; (7) attempted to Accountability Office. The changes in 244 F.3d 342, 350 (4th Cir. 2001) (rules promote coordination, simplification, this final rule are not expected to result for handling appeals were procedural and harmonization across government in an annual effect on the economy of where they did not change the agencies and identified goals designed 100 million dollars or more, a major substantive requirements for reviewing to promote innovation; (8) considered increase in costs or prices, or significant claims); Nat’l Org. of Veterans’ approaches that reduce burdens and adverse effects on competition, Advocates v. Sec’y of Veterans Affairs, maintain flexibility and freedom of employment, investment, productivity, 260 F.3d 1365, 1375 (Fed. Cir. 2001) choice for the public; and (9) ensured innovation, or the ability of United (rule that clarifies interpretation of a the objectivity of scientific and States-based enterprises to compete statute is interpretive); JEM Broad. Co. technological information and with foreign-based enterprises in v. F.C.C., 22 F.3d 320, 328 (D.C. Cir. processes. domestic and export markets. Therefore, 1994) (rules are not legislative because E. Executive Order 13132 this final rule is not a ‘‘major rule’’ as they do not ‘‘foreclose effective (Federalism): This rulemaking does not defined in 5 U.S.C. 804(2). opportunity to make one’s case on the contain policies with federalism L. Unfunded Mandates Reform Act of merits’’). implications sufficient to warrant 1995: The changes set forth in this Accordingly, prior notice and preparation of a Federalism Assessment rulemaking do not involve a Federal opportunity for public comment are not under Executive Order 13132 (Aug. 4, intergovernmental mandate that will required pursuant to 5 U.S.C. 553(b) or 1999). result in the expenditure by State, local, (c) (or any other law), and thirty-day F. Executive Order 13175 (Tribal and tribal governments, in the aggregate, advance publication is not required Consultation): This rulemaking will not: of 100 million dollars (as adjusted) or pursuant to 5 U.S.C. 553(d) (or any other (1) Have substantial direct effects on one more in any one year, or a Federal law). See Cooper Techs. Co. v. Dudas, or more Indian tribes; (2) impose private sector mandate that will result 536 F.3d 1330, 1336–37 (Fed. Cir. 2008) substantial direct compliance costs on in the expenditure by the private sector (stating that 5 U.S.C. 553, and thus 35 Indian tribal governments; or (3) of 100 million dollars (as adjusted) or U.S.C. 2(b)(2)(B), do not require notice preempt tribal law. Therefore, a tribal more in any one year, and will not and comment rulemaking for summary impact statement is not significantly or uniquely affect small ‘‘interpretative rules, general statements required under Executive Order 13175 governments. Therefore, no actions are of policy, or rules of agency (Nov. 6, 2000). necessary under the provisions of the organization, procedure, or practice’’) G. Executive Order 13211 (Energy Unfunded Mandates Reform Act of (quoting 5 U.S.C. 553(b)(A)); U.S. v. Effects): This rulemaking is not a 1995. See 2 U.S.C. 1501 et seq. Gould, 568 F.3d 459, 476 (4th Cir. 2009) significant energy action under M. National Environmental Policy (‘‘The APA also requires publication of Executive Order 13211 because this Act: This rulemaking will not have any any substantive rule at least 30 days rulemaking is not likely to have a effect on the quality of the environment before its effective date, 5 U.S.C. 553(d), significant adverse effect on the supply, and is thus categorically excluded from except where the rule is interpretive distribution, or use of energy. Therefore, review under the National . . . .’’). a Statement of Energy Effects is not Environmental Policy Act of 1969. See B. Regulatory Flexibility Act: As prior required under Executive Order 13211 42 U.S.C. 4321 et seq. notice and an opportunity for public (May 18, 2001). N. National Technology Transfer and comment are not required pursuant to 5 H. Executive Order 12988 (Civil Advancement Act: The requirements of U.S.C. 553 or any other law, neither a Justice Reform): This rulemaking meets section 12(d) of the National regulatory flexibility analysis nor a applicable standards to minimize Technology Transfer and Advancement certification under the Regulatory litigation, eliminate ambiguity, and Act of 1995 (15 U.S.C. 272 note) are not Flexibility Act (5 U.S.C. 601–612) is reduce burden as set forth in sections applicable because this rulemaking does required. See 5 U.S.C. 603. 3(a) and 3(b)(2) of Executive Order not contain provisions which involve C. Executive Order 12866 (Regulatory 12988 (Feb. 5, 1996). the use of technical standards. Planning and Review): This rulemaking I. Executive Order 13045 (Protection O. Paperwork Reduction Act: The has been determined to be not of Children): This rulemaking does not Paperwork Reduction Act of 1995 (44 significant for purposes of Executive concern an environmental risk to health U.S.C. 3501–3549) requires that the Order 12866 (Sept. 30, 1993). or safety that may disproportionately Office consider the impact of paperwork D. Executive Order 13563 (Improving affect children under Executive Order and other information collection Regulation and Regulatory Review): The 13045 (Apr. 21, 1997). burdens imposed on the public. This Office has complied with Executive J. Executive Order 12630 (Taking of final rule involves information Order 13563. Specifically, the Office Private Property): This rulemaking will collection requirements which are has, to the extent feasible and not affect a taking of private property or subject to review by the Office of applicable: (1) Made a reasoned otherwise have taking implications Management and Budget (OMB) under determination that the benefits justify under Executive Order 12630 (Mar. 15, the Paperwork Reduction Act of 1995 the costs of the rule; (2) tailored the rule 1988). (44 U.S.C. 3501–3549). This rulemaking to impose the least burden on society K. Congressional Review Act: Under does not add any additional information consistent with obtaining the regulatory the Congressional Review Act requirements or fees for parties before objectives; (3) selected a regulatory provisions of the Small Business the Board. Therefore, the Office is not approach that maximizes net benefits; Regulatory Enforcement Fairness Act of resubmitting information collection (4) specified performance objectives; (5) 1996 (5 U.S.C. 801 et seq.), prior to packages to OMB for its review and identified and assessed available issuing any final rule, the United States approval because the revisions in this alternatives; (6) involved the public in Patent and Trademark Office will rulemaking do not materially change the

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information collections approved under which a challenged claim depends: ■ 7. Section 42.51 is amended by OMB control number 0651–0069. $400.00. revising paragraph (b)(1)(ii) to read as Notwithstanding any other provision (b) * * * follows. of law, no person is required to respond (3) In addition to the Post-Grant or to, nor shall any person be subject to, a Covered Business Method Patent § 42.51 Discovery. penalty for failure to comply with a Review request fee, for requesting * * * * * collection of information subject to the review of each claim in excess of 20, (b) * * * requirements of the Paperwork including unchallenged claims from (1) * * * Reduction Act unless that collection of which a challenged claim depends: (ii) Cross examination of affidavit information displays a currently valid $250.00. testimony prepared for the proceeding is OMB control number. (4) In addition to the Post-Grant or authorized within such time period as Covered Business Method Patent the Board may set. List of Subjects in 37 CFR Part 42 Review Post-Institution request fee, for * * * * * Administrative practice and requesting review of each claim in ■ 8. Section 42.53 is amended by procedure, inventions and patents. excess of 15, including unchallenged revising paragraphs (c)(2) and (f)(7) to claims from which a challenged claim For the reasons set forth in the read as follows: preamble, 37 CFR part 42 is amended as depends: $550.00. follows. * * * * * § 42.53 Taking testimony. ■ 5. Section 42.23 is amended by * * * * * PART 42—TRIAL PRACTICE BEFORE revising the first sentence of paragraph (c) * * * THE PATENT TRIAL AND APPEAL (a) to read as follows: (2) Unless stipulated by the parties or BOARD ordered by the Board, cross- § 42.23 Oppositions and replies. ■ 1. The authority citation for 37 CFR examination, redirect examination, and (a) Oppositions and replies must part 42 continues to read as follows: re-cross examination for uncompelled comply with the content requirements direct testimony shall be subject to the Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41, for motions and, if the paper to which follow time limits: Seven hours for 135, 311, 312, 316, 321–326 and Public Law the opposition or reply is responding 112–29. cross-examination, four hours for contains a statement of material fact, redirect examination, and two hours for must include a listing of facts that are re-cross examination. Subpart A—Trial Practice and admitted, denied, or cannot be admitted Procedure * * * * * or denied. * * * (f) * * * ■ 2. Section 42.6 is amended by revising * * * * * (7) Except where the parties agree paragraph (a)(2)(ii) to read as follows: ■ 6. Section 42.24 is amended by otherwise, the proponent of the revising paragraphs (a)(1) introductory testimony must arrange for providing a § 42.6 Filing of documents, including text and (a)(1)(v), the first sentence of copy of the transcript to all other exhibits; service. paragraph (c) introductory text, and parties. The testimony must be filed as (a) * * * paragraphs (c)(1) and (c)(2), and adding an exhibit. (2) * * * paragraphs (a)(1)(vi) and (c)(3) to read as * * * * * (ii) 14-point, Times New Roman follows: proportional font, with normal spacing, ■ 9. Section 42.64 is amended by must be used; § 42.24 Page limits for petitions, motions, revising the section heading and the oppositions, and replies. * * * * * first two sentences of paragraph (b)(1) to read as follows. ■ 3. Section 42.10 is amended by (a) Petitions and motions. (1) The following page limits for revising paragraph (a) to read as follows: § 42.64 Objection; motion to exclude. petitions and motions apply and § 42.10 Counsel. include any statement of material facts * * * * * (b) * * * (a) If a party is represented by to be admitted or denied in support of (1) Objection. Any objection to counsel, the party must designate a lead the petition or motion. The page limit evidence submitted during a counsel and at least one back-up does not include a table of contents, a preliminary proceeding must be filed counsel who can conduct business on table of authorities, a certificate of within ten business days of the behalf of the lead counsel. service, or appendix of exhibits or claim listing. institution of the trial. Once a trial has * * * * * been instituted, any objection must be ■ 4. Section 42.15 is amended by * * * * * (v) Motions (excluding Motions to filed within five business days of revising paragraphs (a)(3), (a)(4), (b)(3), service of evidence to which the and (b)(4) to read as follows: Amend): 15 pages. (vi) Motions to Amend: 25 pages. objection is directed. * * * § 42.15 Fees. * * * * * * * * * * (a) * * * (c) Replies. The following page limits ■ 10. Section 42.71 is amended by (3) In addition to the Inter Partes for replies apply and include any revising the first sentence of paragraph Review request fee, for requesting statement of facts in support of the (d) to read as follows: review of each claim in excess of 20, reply. * * * § 42.71 Decisions on petitions or motions. including unchallenged claims from (1) Replies to patent owner responses which a challenged claim depends: to petitions: 25 pages. * * * * * $200.00. (2) Replies to oppositions (excluding (d) Rehearing. A party dissatisfied (4) In addition to the Inter Partes Post- replies to oppositions to Motions to with a decision may file a single request Institution request fee, for requesting Amend): 5 pages. for rehearing without prior review of each claim in excess of 15, (3) Replies to oppositions to Motions authorization from the Board. * * * including unchallenged claims from to Amend: 12 pages. * * * * *

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Subpart B—Inter Partes Review (b) Content. A motion to amend or adjusted by the Board in the case of claims must include a claim listing, joinder. ■ 11. Section 42.121 is amended by which claim listing may be contained in * * * * * revising paragraph (b) introductory text an appendix to the motion, show the ■ 14. Section 42.302 is amended by to read as follows: changes clearly, and set forth: adding paragraph (c) to read as follows: * * * * * § 42.121 Amendment of the patent. § 42.302 Who may petition for a covered * * * * * Subpart D—Transitional Program for business method patent review. (b) Content. A motion to amend Covered Business Method Patents * * * * * claims must include a claim listing, (c) A petitioner may not file a petition which claim listing may be contained in ■ 13. Section 42.300 is amended by to institute a covered business method an appendix to the motion, show the revising paragraph (c) to read as follows: patent review of the patent where, changes clearly, and set forth: before the date on which the petition is § 42.300 Procedure; pendency. filed, the petitioner or real party-in- * * * * * * * * * * interest filed a civil action challenging the validity of a claim of the patent. Subpart C—Post-Grant Review (c) A covered business method patent review proceeding shall be administered Dated: May 14, 2015. ■ 12. Section 42.221 is amended by such that pendency before the Board Michelle K. Lee, revising paragraph (b) introductory text after institution is normally no more Under Secretary of Commerce for Intellectual to read as follows: than one year. The time can be extended Property and Director of the United States Patent and Trademark Office. § 42.221 Amendment of the patent. by up to six months for good cause by the Chief Administrative Patent Judge, [FR Doc. 2015–12117 Filed 5–18–15; 8:45 am] * * * * * BILLING CODE 3510–16–P

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Proposed Rules Federal Register Vol. 80, No. 96

Tuesday, May 19, 2015

This section of the FEDERAL REGISTER may impose time limits on speakers. meetings and ‘‘Public Dialogue’’ are contains notices to the public of the proposed Written comments will be accepted by available on the web at: http:// issuance of rules and regulations. The any of the means described below and www.state.nj.us/drbc/library/ purpose of these notices is to give interested must be received by 5:00 p.m. on documents/procedures120414.pdf. For persons an opportunity to participate in the Wednesday, July 1, 2015. More further information, please contact rule making prior to the adoption of the final rules. information regarding the procedures Commission Secretary Pamela M. Bush, for the hearing and comments is set 609–477–7203. forth in the section ‘‘Oral Testimony SUPPLEMENTARY INFORMATION: DELAWARE RIVER BASIN and Written Comments.’’ Background COMMISSION ADDRESSES: The public hearing will be held at the Washington Crossing Because DRBC and its Signatory 18 CFR Part 410 Historic Park Visitor’s Center at 1112 Parties share common water resource River Road in Washington Crossing, management objectives, sponsors of Proposed Amendments to the Rules of Pennsylvania. Please check many water resource-related projects in Practice and Procedure To Allow Each washingtoncrossingpark.org/contact/ for the Delaware River Basin are currently Signatory Party and the DRBC To directions, as Internet mapping services required to apply to both the DRBC and Administer a Single Process for the provide unreliable directions to this a state agency, among others, for Review and Adjudication of Projects location. approvals. The proposed rule provides AGENCY: Delaware River Basin Oral Testimony and Written for DRBC and the administrative Commission. Comments: Persons wishing to testify at agencies of the Signatory Parties to the hearing are asked to register in ACTION: Proposed rule; notice of public identify regulatory programs that by advance by contacting Paula Schmitt at hearing. mutual agreement will be managed 609–883–9500, ext. 224 or through a single process resulting in one SUMMARY: The Commission will hold a [email protected]. Written decision or approval. Agreements public hearing to receive comments on comments may be submitted as follows: between DRBC and federal agencies are proposed amendments to its If by email (preferred), to possible under the rule, but none are Administrative Manual Part III—Rules [email protected]; by fax, currently contemplated. of Practice and Procedure (18 CFR part to Commission Secretary at 609–883– One Process/One Permit is intended 401) to provide for DRBC and each of 9522; by U.S. Mail, to Commission to promote interagency cooperation and the parties to the Delaware River Basin Secretary, DRBC, P.O. Box 7360, West collaboration on shared mission Compact (United States Public Law 87– Trenton, NJ 08628–0360; or by objectives, achieve regulatory program 328, Approved September 27, 1961, 75 overnight mail, to Commission efficiencies, avoid unnecessary Statutes at Large 688; 53 Delaware Laws, Secretary, DRBC, 25 State Police Drive, duplication of effort, and reduce the Chapter 71, Approved May 26, 1961; West Trenton, NJ 08628–0360. potential for confusion on the part of New Jersey Laws of 1961, Chapter 13, Comments also may be delivered by regulated entities and the public. The Approved May 1, 1961; New York Laws hand at any time during DRBC’s regular regulatory standards and authorities of of 1961, Chapter 148, Approved March office hours (Monday through Friday, the DRBC and each of its Signatory 17, 1961; and Pennsylvania Acts of 8:30 a.m. through 5:00 p.m. except on Parties are expressly preserved by the 1961, Act No. 268, Approved July 7, national holidays) until the close of the Program, including in the proposed 1961 (‘‘the Compact’’)—Delaware, New comment period. In all cases, please rule. The more protective of the Jersey, New York, Pennsylvania and the include the commenter’s name, address applicable DRBC or Signatory Party federal government (‘‘Signatory and affiliation, if any, in the comment agency’s requirements will be included Parties’’)—to coordinate and collaborate document and ‘‘One Process/One in each permit or approval issued under in the administration of a single process Permit’’ or ‘‘OPOP’’ in the subject line. the Program. for the review and adjudication of FOR FURTHER INFORMATION CONTACT: The The proposed rule provides for DRBC projects. The program, called ‘‘One rule text is available on the DRBC Web and each Signatory Party agency Process/One Permit,’’ (also herein, ‘‘the site, DRBC.net. Also posted to the Web choosing to implement One Process/ Program’’) will allow DRBC and site are an extensive FAQ document; One Permit to enter into an administrative agencies of the Signatory DRBC Resolution No. 2015–4, administrative agreement that identifies Parties participating in the Program to authorizing the Executive Director to the types of projects and approvals to be incorporate the requirements and initiate rulemaking and enter into an covered. Initially, the Program is determinations of both DRBC and the administrative agreement with the New expected to be implemented for (a) Signatory Party agency into a single Jersey Department of Environmental withdrawals of basin waters subject to permit or other approval instrument. Protection (NJDEP) for demonstration of both DRBC review and state allocation DATES: The public hearing will start on the Program; and the administrative programs; and (b) wastewater discharges or around 2 p.m. on Tuesday, June 9, agreement between DRBC and the subject to DRBC review and the state- 2015, during the Commission’s regularly NJDEP to provide for the demonstration administered National Pollutant scheduled public hearing. The hearing program, which includes provisions for Discharge Elimination System (NPDES) will continue until all those wishing to fully implementing One Process/One program. For water withdrawals, the testify have had an opportunity to do so. Permit once a final rule has been lead agency under One Process/One Depending upon the number of people adopted. Detailed procedures of the Permit may be the state or the DRBC, wishing to speak, the hearing officer DRBC for public hearings, public depending upon current state programs.

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The delegated state environmental to calculate an alternative mixing zone New Jersey Demonstration Program agencies will be lead agencies for the for a discharge of treated industrial review of wastewater discharges. Other wastewater to the Delaware Estuary. For By Resolution No. 2015–4 approved regulatory programs, such as programs certain projects, DRBC staff also will by the Commission on March 11, 2015, relating to floodplain management, continue to identify conditions of DRBC and NJDEP have agreed to could be included in the future. All approval to ensure that projects subject ‘‘practice’’ using new collaborative administrative agreements between to review under the Compact and processes between the two agencies for DRBC and agencies of the Signatory implementing regulations do not impair the review of wastewater discharge Parties for implementing One Process/ or conflict with the Commission’s applications, pending the adoption of a One Permit will be subject to comprehensive plan. The purpose of new rule such as the one proposed Commission approval following a One Process/One Permit is to eliminate today. The agreement between DRBC public hearing. unnecessary effort, not to eliminate and NJDEP provides for the effort needed to fully review a project Authority demonstration program and sets forth under all applicable standards and provisions needed to fully implement Sections 1.5 and 3.9 of the Compact rules. Under the Program, each party One Process/One Permit once a final and existing DRBC rules allow and continues to recognize the authority of encourage the Commission to use the rule has been adopted. In the event that the other to promulgate rules, a project reviewed under the New Jersey agencies of the Signatory Parties regulations and standards. The rule does Demonstration Program reaches the wherever feasible and advantageous not change that authority. consistent with the Compact. Notably, a separate DRBC review and stage where it is ready for final approval Accordingly, under the proposed rule, decision for water withdrawal and before DRBC has adopted a final rule, permits issued by Signatory Party discharge activities will still be required the application will be acted upon by agencies may include a finding required in certain cases, such as when a new DRBC and the NJDEP independently. As by Section 3.8 of the Compact. project must be incorporated into the explained above, additional information Specifically, after the rule and amended Commission’s comprehensive plan. about the New Jersey Demonstration agreements are in place, based on the Both parties also will retain the right to Program is available on the appropriate level of review and a act separately, such as in the instances, Commission’s Web site. recommendation by the DRBC staff, anticipated to be rare, where the parties approvals issued under the Program cannot agree on the terms and Preservation of the 1954 Supreme Court may include the finding that when conditions of approval. Certain Decree operated in accordance with the terms categories of projects that are subject to In accordance with Sections 3.3(a) and conditions of the approval, the DRBC review will not be covered by the and 3.5 of the Compact, the proposed activities regulated by the approval will Program, and the Executive Director and rule expressly provides that it does not not substantially impair or conflict with Commissioners will have the ability to grant authority to any Signatory Party DRBC’s comprehensive plan. remove a project from the Program. agency to impair, diminish or otherwise Operation of the Program However, the objective of One Process/ One Permit is to encompass most, if not adversely affect the diversions, Under the proposed rule, an all, elements of the review and approval compensating releases, rights, application for initial approval, renewal for covered projects. conditions, obligations and provisions or revision of project activities subject to The proposed rule does not modify for administration thereof provided in the One Process/One Permit program the existing project review fee schedule the United States Supreme Court decree will be filed only with the lead agency. of the DRBC or that of any Signatory in New Jersey v. New York, 347 U.S. 995 This does not mean that the DRBC or Party agency. Although One Process/ (1954) (‘‘Decree’’). The rule further others will not be involved in the One Permit is expected to improve reiterates that any such action may be review of applications for new and process efficiency, in many instances as taken only by the Commission with the renewal water withdrawal and described above, the DRBC will devote unanimous consent of the parties to the discharge projects. Rather, DRBC and significant resources and work effort to Decree or upon unanimous consent of the Signatory Party agency will follow a review projects and support its the members of the Commission single process, and reviews will be regulatory programs. Accordingly, the following a declaration of a state of performed more efficiently and more DRBC regulatory program will continue emergency in accordance with Section collaboratively. for the present to be supported by its 3.3(a) of the Compact. Consistent with the proposed rule, the existing regulatory program fees. The agreements between DRBC and Commission’s fee schedule set forth in No Effect on Section 401 State Water Signatory Party agencies will provide Resolution No. 2009–2 will remain in Quality Certification Programs for a level of DRBC review appropriate effect unless and until the Commission to the circumstances. Some reviews, amends it through rulemaking or a The proposed rule also does not affect such as those for simple and standard comparable public process. Under One the authority of Signatory Party states to renewals of existing permits, may be Process/One Permit, all DRBC fees issue water quality certifications under significantly streamlined or subject to applicable under current practices will Section 401 of the Clean Water Act. inter-agency notifications only. Others, continue to be paid directly to the Dated: May 13, 2015. including to implement standards for Commission. which the DRBC staff have special The proposed rule provides that Pamela M. Bush, expertise, will involve substantial DRBC persons aggrieved by the final action of Commission Secretary. staff effort. For example, under the a state agency on behalf of the [FR Doc. 2015–12076 Filed 5–18–15; 8:45 am] wastewater discharge program, DRBC Commission under One Process/One BILLING CODE 6360–01–P staff will continue to perform modeling Permit must exhaust their to determine ‘‘No Measurable Change’’ administrative remedies under the law requirements for the Commission’s of the Signatory Party agency that issued Special Protection Waters program and the decision.

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DEPARTMENT OF HOMELAND [email protected] or Petty postcard or envelope. We will consider SECURITY Officer Caloeb Gandy, Sector Ohio all comments and material received Valley, U.S. Coast Guard; telephone during the comment period and may Coast Guard (502) 779–5346, email Caloeb.L.Gandy@ change the rule based on your uscg.mil If you have questions on comments. 33 CFR Part 100 viewing or submitting material to the 2. Viewing Comments and Documents [Docket Number USCG–2015–0219] docket, call Cheryl Collins, Program Manager, Docket Operations, telephone To view comments, as well as RIN 1625–AA08 (202) 366–9826. documents mentioned in this preamble SUPPLEMENTARY INFORMATION: as being available in the docket, go to Special Local Regulations: 86th Major http://www.regulations.gov, type the League Baseball (MLB) All-Star Week/ Table of Acronyms docket number (USCG–2015–0219) in Game, Ohio River Mile 469.5 to 471.2; COTP Captain of the Port the ‘‘SEARCH’’ box and click Cincinnati, OH DHS Department of Homeland Security ‘‘SEARCH.’’ Click on Open Docket AGENCY: Coast Guard, DHS. FR Federal Register Folder on the line associated with this NPRM Notice of Proposed Rulemaking rulemaking. You may also visit the ACTION: Notice of proposed rulemaking. A. Public Participation and Request for Docket Management Facility in Room SUMMARY: The Coast Guard proposes to Comments W12–140 on the ground floor of the establish a special local regulation for Department of Transportation West all waters of the Ohio River, surface to We encourage you to participate in Building, 1200 New Jersey Avenue SE., bottom, extending from Ohio River mile this rulemaking by submitting Washington, DC 20590, between 9 a.m. 469.5 to 471.2 at Cincinnati, OH July 10, comments and related materials. All and 5 p.m., Monday through Friday, 2015 through July 14, 2015. This special comments received will be posted except Federal holidays. without change to http:// local regulation is necessary to protect 3. Privacy Act persons and property from potential www.regulations.gov and will include damage and safety hazards during the any personal information you have Anyone can search the electronic ‘‘86th Major League Baseball (MLB) All- provided. form of comments received into any of Star Week/Game’’, an event which will 1. Submitting Comments our dockets by the name of the individual submitting the comment (or likely involve a high density of boater If you submit a comment, please traffic in the river miles specified. This signing the comment, if submitted on include the docket number for this behalf of an association, business, labor proposed special local regulation is rulemaking, indicate the specific section intended to temporarily restrict vessel union, etc.). You may review a Privacy of this document to which each Act notice regarding our public dockets traffic in a portion of the Ohio River comment applies, and provide a reason during this event and implement a in the January 17, 2008, issue of the for each suggestion or recommendation. Federal Register (73 FR 3316). moving security zone for certain vessel You may submit your comments and traffic within the special local regulated material online at http:// 4. Public Meeting zone. www.regulations.gov, or by fax, mail, or We do not now plan to hold a public DATES: Comments and related material hand delivery, but please use only one meeting. But you may submit a request must be received by the Coast Guard on of these means. If you submit a for one, using one of the methods or before June 1, 2015. comment online, it will be considered specified under ADDRESSES. Please ADDRESSES: You may submit comments received by the Coast Guard when you explain why you believe a public identified by docket number using any successfully transmit the comment. If meeting would be beneficial. If we one of the following methods: you fax, hand deliver, or mail your determine that one would aid this (1) Federal eRulemaking Portal: comment, it will be considered as rulemaking, we will hold one at a time http://www.regulations.gov. having been received by the Coast and place announced by a later notice (2) Fax: 202–493–2251. Guard when it is received at the Docket in the Federal Register. (3) Mail or Delivery: Docket Management Facility. We recommend B. Regulatory History and Information Management Facility (M–30), U.S. that you include your name and a Department of Transportation, West mailing address, an email address, or a The Captain of the Port (COTP) Ohio Building Ground Floor, Room W12–140, telephone number in the body of your Valley is proposing to establish a special 1200 New Jersey Avenue SE., document so that we can contact you if local regulation for all waters of the Washington, DC 20590–0001. Deliveries we have questions regarding your Ohio River, surface to bottom, extending accepted between 9 a.m. and 5 p.m., submission. from Ohio River mile 469.5 to 471.2 at Monday through Friday, except federal To submit your comment online, go to Cincinnati, OH July 10, 2015 through holidays. The telephone number is 202– http://www.regulations.gov, type the July 14, 2015. This special local 366–9329. docket number [USCG–2015–0219] in regulation is necessary to protect See the ‘‘Public Participation and the ‘‘SEARCH’’ box and click persons and property from potential Request for Comments’’ portion of the ‘‘SEARCH.’’ Click on ‘‘Submit a damage and safety hazards during the SUPPLEMENTARY INFORMATION section Comment’’ on the line associated with ‘‘86th MLB All-Star Week/Game’’, below for further instructions on this rulemaking. which may involve high density of submitting comments. To avoid If you submit your comments by mail boater traffic in the river miles duplication, please use only one of or hand delivery, submit them in an specified. This proposed special local these three methods. unbound format, no larger than 81⁄2 by regulation is intended to temporarily FOR FURTHER INFORMATION CONTACT: If 11 inches, suitable for copying and restrict vessel traffic in a portion of the you have questions on this rule, call or electronic filing. If you submit Ohio River during this event and email Petty Officer James Robinson, comments by mail and would like to implement a moving security zone for Sector Ohio Valley, U.S. Coast Guard; know that they reached the Facility, certain vessel traffic within the special telephone (502) 779–5432, email please enclose a stamped, self-addressed local regulated zone. There is no

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regulatory history related to this Below we summarize our analyses accordingly for temporary restrictions proposed special local regulation or the based on a number of these statutes or on transit. event triggering a need for the proposed executive orders. If you think that your business, special local regulation. organization, or governmental 1. Regulatory Planning and Review jurisdiction qualifies as a small entity C. Basis and Purpose This proposed rule is not a significant and that this rule would have a The Coast Guard’s authority for regulatory action under section 3(f) of significant economic impact on it, establishing a special local regulation Executive Order 12866, Regulatory please submit a comment (see for marine events is contained at 33 Planning and Review, as supplemented ADDRESSES) explaining why you think it U.S.C. 1233. by Executive Order 13563, Improving qualifies and how and to what degree Major League Baseball is holding the Regulation and Regulatory Review, and this rule would economically affect it. ‘‘86th All-Star Week/Game’’ July 10, does not require an assessment of 2015 through July 14, 2015. This event potential costs and benefits under 3. Assistance for Small Entities is planned to take place at the Great section 6(a)(3) of Executive Order 12866 Under section 213(a) of the Small American Ballpark in the vicinity of the or under section 1 of Executive Order Business Regulatory Enforcement waters of the Ohio River, at Cincinnati, 13563. The Office of Management and Fairness Act of 1996 (Pub. L. 104–121), OH. Based on the need for additional Budget has not reviewed it under those we want to assist small entities in safety measures to protect persons and Orders. This proposed special local understanding this proposed rule. If the property during this event on the regulation restricts transit on the Ohio rule would affect your small business, waterway, the Coast Guard proposes to River from mile 469.5 to 471.2, for a organization, or governmental establish a special local regulation on short duration of four days; Broadcast jurisdiction and you have questions specified waters of the Ohio River. The Notices to Mariners and Local Notices to concerning its provisions or options for proposed special local regulation would Mariners will also inform the compliance, please contact the person be in effect from July 10, 2015 through community of this special local listed in the FOR FURTHER INFORMATION July 14, 2015 and would encompass all regulation so that they may plan CONTACT, above. The Coast Guard will waters of the Ohio River, mile 469.5– accordingly for this short restriction on not retaliate against small entities that 471.2. transit. Vessel traffic may request question or complain about this permission from the COTP Ohio Valley D. Discussion of Proposed Rule proposed rule or any policy or action of or a designated representative to enter the Coast Guard. The Captain of the Port (COTP) Ohio the restricted area. Valley is proposing to establish a special 4. Collection of Information 2. Impact on Small Entities local regulation for all waters of the This proposed rule will not call for a Ohio River, surface to bottom, extending The Regulatory Flexibility Act of 1980 new collection of information under the from Ohio River mile 469.5 to 471.2 at (RFA), 5 U.S.C. 601–612, as amended, Paperwork Reduction Act of 1995 (44 Cincinnati, OH July 10, 2015 through requires federal agencies to consider the U.S.C. 3501–3520). July 14, 2015. This special local potential impact of regulations on small regulation is necessary to protect entities during rulemaking. The term 5. Federalism persons and property from potential ‘‘small entities’’ comprises small A rule has implications for federalism damage and safety hazards during the businesses, not-for-profit organizations under Executive Order 13132, ‘‘86th MLB All-Star Week/Game’’, an that are independently owned and Federalism, if it has a substantial direct event which will likely involve a high operated and are not dominant in their effect on the States, on the relationship density of boater traffic in the river fields, and governmental jurisdictions between the national government and miles specified. This proposed special with populations of less than 50,000. the States, or on the distribution of local regulation is intended to The Coast Guard certifies under 5 U.S.C. power and responsibilities among the temporarily restrict vessel traffic in a 605(b) that this proposed rule will not various levels of government. We have portion of the Ohio River and have a significant economic impact on analyzed this proposed rule under that implement a moving security zone for a substantial number of small entities. Order and determined that this rule certain vessel traffic within the special This proposed rule will affect the does not have implications for local regulated zone during this event in following entities, some of which may federalism. order to promote the safety of life and be small entities: The owners or 6. Protest Activities property on the navigable waterway. operators of vessels intending to transit There is no regulatory history related to mile marker 469.5 to 471.2 on the Ohio The Coast Guard respects the First this proposed special local regulation or River, from July 10, 2015 through July Amendment rights of protesters. the event triggering a need for the 14, 2015. The special local regulation Protesters are asked to contact the proposed special local regulation. will not have a significant economic person listed in the FOR FURTHER The effect of this proposed rule will impact on a substantial number of small INFORMATION CONTACT section to be to restrict general navigation during entities for the following reasons. This coordinate protest activities so that your the event. Vessels intending to transit special local regulation will be in effect message can be received without the Ohio River through the designated for a limited duration for a period of jeopardizing the safety or security of mile markers will only be allowed to four days. Although, the regulation people, places or vessels. transit the area when the COTP Ohio would apply to the entire width of the 7. Unfunded Mandates Reform Act Valley, or a designated representative, river, traffic would be allowed to pass has deemed it safe to do so or at the through the regulated area with the The Unfunded Mandates Reform Act completion of the event each day. permission of the COTP Ohio Valley or of 1995 (2 U.S.C. 1531–1538) requires a designated representative or at the Federal agencies to assess the effects of E. Regulatory Analyses completion of the event each day. their discretionary regulatory actions. In We developed this proposed rule after Broadcast Notices to Mariners will also particular, the Act addresses actions considering numerous statutes and inform the community of this special that may result in the expenditure by a executive orders related to rulemaking. local regulation so that they may plan State, local, or tribal government, in the

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aggregate, or by the private sector of M16475.lD, which guide the Coast ENVIRONMENTAL PROTECTION $100,000,000 (adjusted for inflation) or Guard in complying with the National AGENCY more in any one year. Though this Environmental Policy Act of 1969 proposed rule would not result in such (NEPA) (42 U.S.C. 4321–4370f), and 40 CFR Part 60 an expenditure, we do discuss the have made a preliminary determination effects of this rule elsewhere in this [EPA–HQ–OAR–2009–0174; FRL–9927–80– that this action is one of a category of OAR] preamble. actions that do not individually or 8. Taking of Private Property cumulatively have a significant effect on RIN 2060–AP63 the human environment. This proposed This proposed rule would not cause a rule involves a special local regulation Electronic Reporting and taking of private property or otherwise involving a high media event and the Recordkeeping Requirements for New have taking implications under potential for high boating traffic. This Source Performance Standards; Executive Order 12630, Governmental Extension of Comment Period Actions and Interference with rule is categorically excluded from Constitutionally Protected Property further review under paragraph 34(h) of AGENCY: Environmental Protection Rights. Figure 2–1 of the Commandant Agency (EPA). Instruction. A preliminary ACTION: Proposed rule; extension of 9. Civil Justice Reform environmental analysis checklist public comment period. This proposed rule meets applicable supporting this determination and a standards in sections 3(a) and 3(b)(2) of Categorical Exclusion Determination are SUMMARY: The Environmental Protection Executive Order 12988, Civil Justice available in the docket where indicated Agency (EPA) is announcing that the Reform, to minimize litigation, under ADDRESSES. We seek any period for providing public comments eliminate ambiguity, and reduce comments or information that may lead on the March 20, 2015, proposed burden. to the discovery of a significant ‘‘Electronic Reporting and Recordkeeping Requirements for New 10. Protection of Children From environmental impact from this proposed rule. Source Performance Standards’’ is being Environmental Health Risks extended by 30 days. We have analyzed this proposed rule List of Subjects in 33 CFR Part 100 DATES: Comments. The public comment under Executive Order 13045, period for the proposed rule published Marine safety, Navigation (water), Protection of Children from March 20, 2015 (80 FR 15100), is being Reporting and recordkeeping Environmental Health Risks and Safety extended by 30 days to June 18, 2015, requirements, and Waterways. Risks. This rule is not an economically in order to provide the public additional significant rule and would not create an For the reasons discussed in the time to submit comments and environmental risk to health or risk to preamble, the U.S. Coast Guard supporting information. safety that might disproportionately proposes to amend 33 CFR part 100 as ADDRESSES: Comments. Written affect children. follows: comments on the proposed rule may be 11. Indian Tribal Governments submitted to the EPA electronically, by PART 100—SAFETY OF LIFE ON mail, by facsimile or through hand This proposed rule does not have NAVIGABLE WATERWAYS delivery/courier. Please refer to the tribal implications under Executive proposal (80 FR 15100) for the addresses Order 13175, Consultation and ■ and detailed instructions. Coordination with Indian Tribal 1. The authority citation for part 100 Docket. Publicly available documents Governments, because it would not have continues to read as follows: relevant to this action are available for a substantial direct effect on one or Authority: 33 U.S.C. 1233. public inspection either electronically at more Indian tribes, on the relationship http://www.regulations.gov or in hard between the Federal Government and ■ 2. Section 100.35T08–0219 is added copy at the EPA Docket Center, EPA Indian tribes, or on the distribution of to read as follows: WJC West Building, Room 3334, 1301 power and responsibilities between the § 100.35T08–0219 Special Local Constitution Ave. NW., Washington, DC Federal Government and Indian tribes. Regulation; Ohio River, Miles 469.5 to 471.2, 20004. The Public Reading Room is 12. Energy Effects Cincinnati, OH. open from 8:30 a.m. to 4:30 p.m., This proposed rule is not a (a) Location. The following area is a Monday through Friday, excluding legal ‘‘significant energy action’’ under special local regulation: All waters of holidays. A reasonable fee may be charged for copying. The EPA has Executive Order 13211, Actions the Ohio River, beginning at mile established the official public docket for Concerning Regulations That marker 469.5 to mile 471.2 at this rulemaking under Docket ID No. Significantly Affect Energy Supply, Cincinnati, OH. Distribution, or Use. EPA–HQ–OAR–2009–0174. (b) Enforcement date. This section is World Wide Web. The EPA Web site 13. Technical Standards enforceable from: July 10, 2015 through containing information for this This proposed rule does not use July 14, 2015. rulemaking is at http://www.epa.gov/ technical standards. Therefore, we did Dated: April 22, 2015. ttn/atw/eparules.html. not consider the use of voluntary R.V. Timme, FOR FURTHER INFORMATION CONTACT: Ms. Gerri Garwood, Measurement Policy consensus standards. Captain, U.S. Coast Guard, Captain of the Port Ohio Valley. Group (MPG), Sector Policies and 14. Environment Programs Division (D243–05), Office of We have analyzed this proposed rule [FR Doc. 2015–12122 Filed 5–18–15; 8:45 am] Air Quality Planning and Standards, under Department of Homeland BILLING CODE 9110–04–P U.S. Environmental Protection Agency, Security Management Directive 023–01 Research Triangle Park, North Carolina and Commandant Instruction 27711, telephone number: (919) 541–

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2406; fax number: (919) 541–1039; and authorize a vessel owner or operator to Stelle, Jr., NMFS West Coast Region, email address: [email protected]. shut down a VMS unit, and in a few 7600 Sand Point Way NE., Bldg 1, SUPPLEMENTARY INFORMATION: non-substantive ways as described Seattle, WA 98115–0070 or by email to below. This rule is intended to ensure RegionalAdministrator.WCRHMS@ Comment Period full U.S. compliance with its noaa.gov. After considering a request submitted international obligations under the FOR FURTHER INFORMATION CONTACT: by the Air Permitting Forum to extend IATTC Convention. Rachael Wadsworth, NMFS West Coast the public comment period, the EPA has DATES: Written comments on this Region, 562–980–4036. decided to extend the public comment supplemental proposed rule must be SUPPLEMENTARY INFORMATION: NMFS period for an additional 30 days. received on or before June 18, 2015. published a proposed rule in the Therefore, the public comment period ADDRESSES: You may submit comments Federal Register (79 FR 7152) on will end on June 18, 2015, rather than on this document, identified by NOAA– February 6, 2014, to broaden the May 19, 2015. This extension will NMFS–2013–0117, by any of the existing Vessel Monitoring System ensure that the public has sufficient following methods: (VMS) requirements in the Pacific time to review and comment on all of • Electronic Submission: Submit all Ocean and to clarify the applicability of the information available, including the electronic public comments via the VMS requirements to U.S. commercial proposed rule and other materials in the Federal e-Rulemaking Portal. Go to fishing vessels, 24 meters (78.74 feet) or docket. www.regulations.gov/ more in overall length, used to target Dated: May 8, 2015. #!docketDetail;D=NOAA-NMFS-2013- tuna (i.e., any fish of the genus Thunnus Stephen D. Page, 0117, click the ‘‘Comment Now!’’ icon, or of the species Euthynnus Director. complete the required fields, and enter (Katsuwonus) pelamis (skipjack tuna)) [FR Doc. 2015–12100 Filed 5–18–15; 8:45 am] or attach your comments. in the waters of the Convention Area. • Mail: Submit written comments to BILLING CODE 6560–50–P The Convention Area is bounded by the Rachael Wadsworth, NMFS West Coast west coast of the Americas and on the Region, 501 W. Ocean Blvd., Suite 4200, north, south, and west respectively, by Long Beach, CA 90802. Include the the 50° N. and 50° S. parallels, and the DEPARTMENT OF COMMERCE identifier ‘‘NOAA–NMFS–2013–0117’’ 150° W. meridian. The original in the comments. National Oceanic and Atmospheric proposed rule was intended to ensure • Public Hearing: The public is Administration full U.S. implementation of Resolution welcome to attend a public hearing and C–04–06, adopted by the Inter-American offer comments on this supplemental 50 CFR Part 300 Tropical Tuna Commission (IATTC) at proposed rule from 1 p.m. to 4 p.m. its 72nd Meeting in June 2004. [Docket No. 130722646–5430–02] PST, June 9, 2015, at 501 W. Ocean After publication of the original Boulevard, Suite 4200, Long Beach, CA RIN 0648–BD54 proposed rule, the IATTC adopted 90802. The public may also participate Resolution C–14–02 at its 87th Meeting International Fisheries; Pacific Tuna in the public hearing via conference in July 2014, which amends and Fisheries; Establishment of Tuna line: 888–790–6181; participant replaces Resolution C–04–06. This Vessel Monitoring System in the passcode: 64120. supplemental proposed rule revises the Eastern Pacific Ocean Instructions: Comments must be applicability of the VMS requirements submitted by one of the above methods to reflect Resolution C–14–02 and AGENCY: National Marine Fisheries to ensure they are received, updates other sections of the regulatory Service (NMFS), National Oceanic and documented, and considered by NMFS. text that was published in the original Atmospheric Administration (NOAA), Comments sent by any other method, to proposed rule. The regulatory text of the Commerce. any other address or individual, or original proposed rule is republished in ACTION: Supplemental proposed rule; received after the end of the comment this supplemental proposed rule with request for comments. period, may not be considered. All the changes described above and in comments received are a part of the more detail below. SUMMARY: NMFS revises a proposed rule public record and will generally be published on February 6, 2014, to posted for public viewing on Background and Need for Action implement Inter-American Tropical www.regulations.gov without change. A detailed description of the original Tuna Commission (IATTC) Resolution All personal identifying information proposed rule was published in the C–04–06. Under the original proposed (e.g., name, address, etc.) submitted preamble to that rule, which is available rule Vessel Monitoring Systems (VMS) voluntarily by the sender will be online (https://federalregister.gov/a/ would be required for any U.S. publicly accessible. Do not submit 2014-02598) and from NMFS (see commercial fishing vessels that are 24 confidential business information, or ADDRESSES). The VMS requirements meters (78.74 feet) or more in overall otherwise sensitive or protected from the original proposed rule are length and used to target tuna in the information. NMFS will accept briefly summarized here. eastern Pacific Ocean. After publication anonymous comments (enter ‘‘N/A’’ in Commercial fishing vessels that are 24 of the proposed rule on February 6, the required fields if you wish to remain meters or more in overall length are 2014, the IATTC adopted Resolution C– anonymous). required to install, activate, carry and 14–02, which expands the applicability Copies of the draft Regulatory Impact operate VMS units (also known as of the VMS requirements to vessels Review (RIR) and other supporting ‘‘mobile transmitting units’’). The VMS engaged in fishing activities for either documents prepared for the original units and mobile communications tuna or tuna-like species; this action proposed rule are available via the service providers must be type- would implement that expanded Federal eRulemaking Portal: http:// approved by NOAA for fisheries in the application. This action would also www.regulations.gov, docket NOAA– IATTC Convention Area. Information revise the original proposed rule by NMFS–2013–0117 or by contacting the for current NOAA type-approved VMS allowing additional conditions to Regional Administrator, William W. units can be obtained from: NOAA,

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Office of Law Enforcement (OLE), 1315 commercial fishing vessel of the United procedures and requirements for the East-West Hwy, Suite 3301, Silver States that is 24 meters or more in Regional Vessel Register for the IATTC Spring, MD 20910–3282; telephone at overall length and engaging in fishing (74 FR 1607, January 13, 2009), NMFS (888) 210–9288; fax at (301) 427–0049. activities for tuna or tuna-like species in uses permits rather than fishing area as Or, by contacting NOAA OLE VMS the Convention Area, and for which any a basis for providing the IATTC a list of Helpdesk: telephone: (888) 219–9228; of the following permits is required: U.S. vessels to be placed on the email: [email protected]; or online Pacific highly migratory species permit Regional Vessel Register. Specifically, by going to http://www.nmfs.noaa.gov/ under 50 CFR 660.707, or high seas NMFS considers vessels that are ole/about/our_programs/vessel_ fishing permit under 50 CFR 300.13. authorized to fish for highly migratory monitoring.html, and click ‘‘approved Second, the supplemental proposed species in the Convention Area under VMS units.’’ The business hours of the rule would allow additional conditions the following fishing permits: Pacific VMS Helpdesk are: Monday through for the SAC to authorize a vessel owner highly migratory species permit under Friday, except Federal holidays, 7 a.m. or operator to shut down a VMS unit. 50 CFR 660.707, and high seas fishing to 11 p.m., Eastern Time. Vessel owners or operators must submit permit under 50 CFR 300.13. Therefore, Compliance with the existing VMS requests to shut down their VMS unit to the proposed update to the regulatory requirements at 50 CFR 300.219, 50 CFR the SAC. See the regulatory text for definition of the Convention Area 660.712, 50 CFR 660.14, or 50 CFR more details on the specific conditions would not affect the current process 665.19 would satisfy these new and procedures for obtaining SAC NMFS uses to provide the IATTC a list requirements relating to the installation, authorization for shutting down VMS of U.S. vessels to place on the Regional carrying, and operation of VMS units, units. Vessel Register. provided that the VMS unit and mobile Third, the supplemental proposed Lastly, the supplemental proposed communications service provider are rule would update the address for the rule would update the purpose and type-approved by NOAA for fisheries in SAC of the Pacific Islands Division, scope of Title 50, part 300, subpart C, the Convention Area, and the VMS unit reflecting an address change that section 300.20 of the CFR for is operated continuously at all times occurred after the publication of the consistency with the updated definition while the vessel is at sea unless the original proposed rule. for the Convention Area. Special-Agent-In-Charge, NOAA Office Fourth, this supplemental proposed of Law Enforcement, Pacific Islands rule would also update the regulatory Classification Division (or designee) (SAC) authorizes definition of the Convention Area, The NMFS Assistant Administrator a VMS unit to be shut down and the which is currently defined as the waters has determined that this supplemental same requirements proposed for the within the area bounded by the proposed rule is consistent with the case of VMS unit failure are followed. mainland of the Americas, lines Tuna Conventions Act of 1950 and other This supplemental proposed rule extending westward from the mainland applicable laws, subject to further ° would revise the proposed rule in the of the Americas along the 40 N. latitude consideration after public comment. following ways: (1) Expand the and 40° S. latitude, and 150° W. applicability of the VMS requirements longitude. The current regulatory National Environmental Policy Act to include fishing activities for tuna-like definition would be updated to be This action is categorically excluded species in the Convention Area; (2) consistent with the definition described from the requirement to prepare an additional conditions to allow the SAC in the preamble of the original proposed environmental assessment in to authorize a vessel owner or operator rule, and the Convention for the accordance with NAO 216–6. A to shut down a VMS unit; (3) update the Strengthening of the Inter-American memorandum for the file has been address for the SAC; (4) update the Tropical Tuna Commission (Antigua prepared that sets forth the decision to definition of ‘‘Convention Area;’’ (5) Convention). The Antigua Convention use a categorical exclusion. revise the description of the purpose entered into force in 2010 and all IATTC and scope of part 300, subpart C, section resolutions adopted subsequent to 2010, Executive Order 12866 300.20 of Title 50 of the Code of Federal such as Resolution C–14–02, are This supplemental proposed rule has Regulations (CFR); and (6) make minor premised on the definition of been determined to be not significant for revisions to the regulatory text for ‘‘Convention Area’’ in the Antigua purposes of Executive Order 12866. punctuation and clarify circumstances Convention. Accordingly, this Regulatory Flexibility Act when a vessel owner or operator is supplemental proposed rule would responsible for an action. These changes define the Convention Area as all waters An Initial Regulatory Flexibility are described in greater detail below. of the eastern Pacific Ocean within the Analysis (IRFA) was prepared for the First, IATTC Resolution C–14–02 area bounded by the west coast of the original proposed rule (79 FR 7152), expanded the scope of the initial IATTC Americas and by the following lines: published on February 6, 2014, as Resolution. The original proposed rule The 50° N. parallel from the coast of required by section 604 of the would have applied only to commercial North America to its intersection with Regulatory Flexibility Act (RFA) and is fishing vessels that are 24 meters or the 150° W. meridian; the 150° W. not repeated here. As described above, more in overall length and used to target meridian to its intersection with the 50° this supplemental proposed rule would tuna in the Convention Area. This S. parallel; and the 50° S. parallel to its not result in different impacts than supplemental proposed rule would intersection with the coast of South those described in the IRFA for the apply to commercial fishing vessels America. original proposed rule. engaging in fishing activities for tuna or If the proposed update to the As discussed in the preamble, this tuna-like species, including those regulatory definition of the Convention supplemental proposed rule would managed under the Fishery Area becomes effective, there would be expand the applicability of the VMS Management Plan for U.S. West Coast no additional impacts to vessels. requirements to commercial fishing Fisheries for Highly Migratory Species, Although NMFS relied on the current vessels that are 24 meters or more in in conformance with Resolution C–14– definition (40° N. latitude and 40° S. overall length and engaging in fishing 02. Therefore, this supplemental latitude, and 150° W. longitude) of the activities for tuna or tuna-like species in proposed rule would apply to any Convention Area to modify the the Convention Area. To estimate the

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number of affected entities for the § 300.20 Purpose and scope. (aa) Disable, destroy, damage or original proposed rule, the number of The regulations in this subpart are operate improperly a VMS unit installed vessels authorized to fish for highly issued under the authority of the Tuna under § 300.26, or attempt to do any of migratory species in the Convention Conventions Act of 1950 (Act) and the same, or fail to ensure that its Area through fishing permits was apply to persons and vessels subject to operation is not impeded or interfered considered a reasonable proxy. The the jurisdiction of the United States. with, as provided in § 300.26(e). permits used to estimate affected The regulations implement resolutions (bb) Fail to make a VMS unit installed entities were those issued under the of the Inter-American Tropical Tuna under § 300.26 or the position data authority of the Magnuson-Stevens Commission (IATTC) for the obtained from it available for Fishery Conservation and Management conservation and management of stocks inspection, as provided in § 300.26(f) Act (16 U.S.C. 1801 et seq.) through of highly migratory fish resources in the and (g). regulations codified at 50 CFR 660.707 Convention Area. ■ 5. Section 300.26 is added to read as or under the authority of the High Seas ■ 3. In § 300.21, the definition for follows: Fishing Compliance Act of 1995 (16 ‘‘Convention Area’’ is revised and the § 300.26 Vessel monitoring system (VMS). U.S.C. 5501 et seq.) through regulations definitions for ‘‘Commercial’’, ‘‘Vessel codified at 50 CFR 300.13. NMFS also monitoring system (VMS)’’, and ‘‘VMS (a) Special-Agent-In-Charge (SAC), considers these fishing permits a unit’’ are added, in alphabetical order, NOAA Office of Law Enforcement, reasonable proxy for estimating the to read as follows: Pacific Islands Division (or designee) number of vessels used to fish for tuna and VMS Helpdesk contact information or tuna-like species in the Convention § 300.21 Definitions. and business hours: Area. Copies of the IRFA, prepared for * * * * * (1) The contact information for the the original proposed rule, are available Commercial with respect to SAC for the purpose of this section: from NMFS (see ADDRESSES). commercial fishing, means fishing in 1845 Wasp Blvd., Building 176, which the fish harvested, either in Honolulu, HI 96818; telephone: (808) Paperwork Reduction Act Collections of whole or in part, are intended to enter 725–6100; facsimile: 808–725–6199; Information commerce through sale, barter or trade. email: [email protected]; business This supplemental proposed rule * * * * * hours: Monday through Friday, except contains a collection-of-information Convention Area or IATTC Federal holidays, 8 a.m. to 4:30 p.m., requirement subject to the Paperwork Convention Area, means all waters of Hawaii Standard Time. Reduction Act (PRA) and approved by the eastern Pacific Ocean within the (2) The contact information for the OMB under control number (0648– area bounded by the west coast of the NOAA Office of Law Enforcement’s 0690) for the original proposed rule (79 Americas and by the following lines: VMS Helpdesk is telephone: (888) 219– FR 7152), published on February 6, The 50° N. parallel from the coast of 9228; email: [email protected]. 2014. This supplemental proposed rule North America to its intersection with The business hours of the VMS does not result in changes to the burden the 150° W. meridian; the 150° W. Helpdesk are Monday through Friday, hour estimates prepared for the original meridian to its intersection with the 50° except Federal holidays, 7 a.m. to 11 proposed rule. Public comment S. parallel; and the 50° S. parallel to its p.m., Eastern Time. regarding the burden-hour estimates or intersection with the coast of South (b) Applicability. This section applies other aspects of the collection-of- America. to any U.S. commercial fishing vessel information requirements was requested that is 24 meters or more in overall * * * * * length and engaging in fishing activities in the original proposed rule. Vessel monitoring system (VMS) for tuna or tuna-like species in the means an automated, remote system that List of Subjects in 50 CFR Part 300 Convention Area, and for which either provides information about a vessel’s of the following permits is required: Administrative practice and identity, location and activity, for the Pacific highly migratory species permit procedure, Fish, Fisheries, Fishing, purposes of routine monitoring, control, under § 660.707, or high seas fishing Marine resources, Reporting and surveillance and enforcement of area recordkeeping requirements, Treaties. permit under § 300.13 of this part. and time restrictions and other fishery (c) Provisions for Installation, Dated: May 11, 2015. management measures. Activation and Operation—(1) VMS Samuel D. Rauch III, VMS unit, sometimes known as a Unit Installation. The vessel owner or ‘‘mobile transmitting unit,’’ means a Deputy Assistant Administrator for operator must obtain and have installed Regulatory Programs, National Marine transceiver or communications device, on the fishing vessel, in accordance Fisheries Service. including all hardware and software with instructions provided by the SAC that is carried and operated on a vessel For the reasons set out in the and the VMS unit manufacturer, a VMS as part of a VMS. preamble, 50 CFR part 300 is proposed unit that is type-approved by NOAA for to be amended as follows: ■ 4. In § 300.24, paragraphs (y) through (bb) are added to read as follows: fisheries in the IATTC Convention Area. The vessel owner or operator shall PART 300—INTERNATIONAL § 300.24 Prohibitions. arrange for a NOAA-approved mobile FISHERIES REGULATIONS * * * * * communications service provider to Subpart C—Eastern Pacific Tuna (y) Fail to install, activate, or operate receive and relay transmissions from the Fisheries a VMS unit as required in § 300.26(c). VMS unit to NOAA. The vessel owner (z) In the event of VMS unit failure or or operator shall authorize NOAA OLE, ■ 1. The authority citation for 50 CFR interruption; fail to repair or replace a the U.S. Coast Guard (USCG) and other part 300, subpart C continues to read as VMS unit; fail to notify the Special- authorized entities to receive and relay follows: Agent-In-Charge, NOAA Office of Law position reports. The owner or operator Enforcement, Pacific Islands Division must authorize NOAA to set up the Authority: 16 U.S.C. 951–961 et seq. (or designee); and follow the reporting interval of the VMS unit as ■ 2. Section 300.20 is revised to read as instructions provided; or otherwise fail once per hour. The NOAA OLE VMS follows: to act as provided in § 300.26(c)(4). Helpdesk is available to provide

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instructions for VMS installation and a SAC that proper transmissions are being the mobile communications service list of the current type-approved VMS received from the VMS unit. provider as necessary to ensure the units and mobile communication (4) Failure of VMS unit. If the VMS transmission of automatic position service providers. unit has become inoperable or reports to NOAA as required in (2) VMS Unit Activation. If the VMS transmission of automatic position paragraph (c) of this section. However, unit has not yet been activated as reports from the VMS unit has been if NOAA is paying for the VMS- described in this paragraph, or if the interrupted, or if notified by NOAA or associated costs because the VMS unit VMS unit has been newly installed or the USCG that automatic position is carried and operated under a reinstalled, or if the mobile reports are not being received from the requirement of 50 CFR 300.219, 50 CFR communications service provider has VMS unit or that an inspection of the 660.712, or 50 CFR 665.19, the vessel changed since the previous activation, VMS unit has revealed a problem with owner and operator shall not be or if directed by the SAC, the vessel the performance of the VMS unit, the responsible to pay the costs. owner or operator must, prior to leaving vessel owner or operator shall comply (e) Tampering. The vessel owner and port: with the following requirements: operator must ensure that the VMS unit (i) Turn on the VMS unit to make it (i) If the vessel is at port: The vessel is not tampered with, disabled, operational; owner or operator shall repair or replace destroyed, damaged or maintained (ii) Submit a written activation report the VMS unit and ensure it is operable improperly, and that its operation is not to the SAC, via mail, facsimile or email, before the vessel leaves port. impeded or interfered with. that includes the vessel’s name; the (ii) If the vessel is at sea: The vessel (f) Inspection. The vessel owner and vessel’s official number; the VMS unit owner, operator, or designee shall operator must make the VMS unit, manufacturer and identification contact the SAC by telephone, facsimile, including its antenna, connectors and number; and telephone, facsimile or or email at the earliest opportunity antenna cable, available for inspection email contact information for the vessel during the SAC’s business hours and by authorized officers. owner or operator; and identify the caller and vessel. The vessel (g) Access to data. The vessel owner (iii) Receive verbal or written operator shall follow the instructions and operator must make the vessel’s confirmation from the SAC that the provided by the SAC which could position data obtained from the VMS proper VMS unit transmissions are include, but are not limited to, ceasing unit or other means immediately and being received from the VMS unit. fishing, stowing fishing gear, returning always available for inspection by (3) VMS Unit Operation. The vessel to port, and/or submitting periodic NOAA personnel, USCG personnel, and owner and operator shall continuously position reports at specified intervals by authorized officers. operate the VMS unit at all times, other means; and repair or replace the except that the VMS unit may be shut VMS unit and ensure it is operable [FR Doc. 2015–11991 Filed 5–18–15; 8:45 am] down while the vessel is in port or before starting the next trip. BILLING CODE 3510–22–P otherwise not at sea, or if, after the end (5) Related VMS Requirements. of the fishing season, the vessel will no Installing, carrying and operating a VMS longer be engaging in fishing activities unit in compliance with the DEPARTMENT OF COMMERCE in the Convention Area for which either requirements in 50 CFR 300.219, 50 CFR National Oceanic and Atmospheric a Pacific highly migratory species 660.712, 50 CFR 660.14, or 50 CFR Administration permit or a high seas fishing permit is 665.19 relating to the installation, required, provided that the owner or carrying, and operation of VMS units 50 CFR Part 648 operator: shall be deemed to satisfy the (i) Prior to shutting down the VMS requirements of paragraph (c) of this [Docket No. 150401329–5437–01] unit, reports to the SAC or the NOAA section, provided that the VMS unit is RIN 0648–BF00 Office of Law Enforcement’s VMS operated continuously and at all times Helpdesk via facsimile, email, or web- while the vessel is at sea, unless the Fisheries of the Northeastern United form the following information: The SAC authorizes a VMS unit to be shut States; Atlantic Mackerel, Squid, and intent to shut down the VMS unit; the down as described in paragraph (c)(3), Butterfish Fisheries; Framework vessel’s name; the vessel’s official the VMS unit and mobile Adjustment 9 number; an estimate for when the communications service providers are vessel’s VMS may be turned back on; type-approved by NOAA for fisheries in AGENCY: National Marine Fisheries and telephone, facsimile or email IATTC Convention Area, the owner or Service (NMFS), National Oceanic and contact information for the vessel owner operator has authorized NOAA to Atmospheric Administration (NOAA), or operator. In addition, the vessel receive and relay transmissions from the Commerce. owner or operator shall receive verbal or VMS unit, and the specific requirements ACTION: Proposed rule, request for written confirmation from the SAC of paragraph (c)(4) of this section are comments. before shutting down the VMS unit after followed. If the VMS unit is owned by the end of the fishing season; and NOAA, the requirement under SUMMARY: Framework Adjustment 9 (ii) When turning the VMS unit back paragraph (c)(4) of this section to repair proposes management measures to on, report to the SAC or the NOAA or replace the VMS unit will be the further enhance catch monitoring and Office of Law Enforcement’s VMS responsibility of NOAA, but the vessel address discarding catch before it has Helpdesk, via mail, facsimile or email, owner and operator shall be responsible been sampled by observers (known as the following information: That the for ensuring that the VMS unit is slippage), in the Atlantic mackerel VMS unit has been turned on; the operable before leaving port or starting fishery. Framework 9 would implement vessel’s name; the vessel’s official the next trip. slippage consequence measures, and a number; and telephone, facsimile or (d) Costs. The vessel owner and requirement that slippage events be email contact information for the vessel operator shall be responsible for all reported via the vessel monitoring owner or operator; and costs associated with the purchase, system. For allowable slippage events, (iii) Prior to leaving port, receive installation and maintenance of the due to safety, mechanical failure, or verbal or written confirmation from the VMS unit and for all charges levied by excess catch of spiny dogfish, vessels

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must move 15 nm from the location of mackerel, squid, and butterfish fisheries Corrections the slippage event. For non-allowable through Amendment 14 to the Atlantic This proposed rule also contains an slippage events, due to reasons other Mackerel, Squid, and Butterfish Fishery additional regulation change that was than those listed previously, vessels Management Plan (FMP) (79 FR 10029, mistakenly omitted in the 2015–2017 must terminate their fishing trip. February 24, 2014). The focus of Atlantic mackerel, squid, and butterfish Slippage events have the potential to Amendment 14 was to improve specifications final rule (80 FR 14870, substantially affect analysis or evaluation of the incidental catch of March 20, 2015). This regulation change extrapolations of incidental catch, river herring (alewife and blueback would prohibit all vessels with a valid including river herring and shad, these herring) and shad (American shad and mackerel permit from fishing for, proposed measures are designed to hickory shad), and to address incidental possessing, transferring, receiving, or address this issue. catch of river herring and shad. NMFS selling more than 20,000 lb (9.07 mt) of DATES: Public comments must be disapproved three measures that were mackerel per trip or per day after 95 received by June 18, 2015. initially included in Amendment 14 percent of the river herring and shad ADDRESSES: Copies of supporting including: A dealer reporting catch cap has been harvested. This documents used by the Mid-Atlantic requirement; a cap that, if achieved, change in the regulations was identified, Fishery Management Council, including would require vessels discarding catch described, and made available for public the Environmental Assessment (EA) and before it had been sampled by observers comment in the proposed rule for the Regulatory Impact Review (RIR)/Initial (known as slippage) to return to port; 2015–2017 Atlantic mackerel, squid, Regulatory Flexibility Analysis (IRFA), and a recommendation of 100-percent and butterfish specifications (79 FR are available from: Dr. Christopher M. observer coverage on midwater trawl 68202, November 14, 2014). Moore, Executive Director, Mid-Atlantic vessels and 100-, 50-, and 25-percent Fishery Management Council, 800 North observer coverage on bottom trawl Classification State Street, Suite 201, Dover, DE 19901, mackerel vessels, with the industry Pursuant to section 304(b)(1)(A) of the telephone (302) 674–2331. The EA/RIR/ contributing $325 per day toward Magnuson-Stevens Fishery IRFA is also accessible via the Internet observer costs. Conservation and Management Act at http:// Currently, slippage events are (Magnuson-Stevens Act), the NMFS www.greateratlantic.fisheries.noaa.gov. prohibited for vessels issued a limited Assistant Administrator has determined You may submit comments, identified access mackerel permit or a longfin that this proposed rule is consistent by NOAA–NMFS–2015–0049, by any squid/butterfish moratorium permit and with the Atlantic Mackerel, Squid, and one of the following methods: carrying a NMFS-approved observer Butterfish FMP, other provisions of the • Electronic Submission: Submit all except in circumstances which allow Magnuson-Stevens Act, and other electronic public comments via the slippage events including: Safety; applicable law, subject to further Federal e-Rulemaking Portal. Go to mechanical failure; and excess catch of consideration after public comment. www.regulations.gov/ spiny dogfish. Additionally, following a This proposed rule has been #!docketDetail;D=NOAA-NMFS-2015- slippage event, vessels are currently determined to be not significant for 0049, click the ‘‘Comment Now!’’ icon, required to submit a Released Catch purposes of Executive Order 12866. complete the required fields, and enter Affidavit within 48 hours of the end of An IRFA was prepared, as required by or attach your comments. the fishing trip. In response to the section 603 of the Regulatory Flexibility • Mail: Submit written comments to disapproval of the slippage measures in Act (RFA). The IRFA describes the NMFS, Northeast Regional Office, 55 Amendment 14, the Mid-Atlantic economic impact this proposed rule, if Great Republic Drive, Gloucester, MA Fishery Management Council developed adopted, would have on small entities. 01930. Mark the outside of the envelope Framework Adjustment 9 to the Atlantic A summary of the analysis follows. ‘‘Comments on Framework 9.’’ Mackerel, Squid, and Butterfish FMP to Instructions: Comments sent by any further enhance catch monitoring and to Description of the Reasons Why Action other method, to any other address or address slippage in the Atlantic by the Agency Is Being Considered individual, or received after the end of mackerel fishery. Framework 9 would This action proposes management the comment period, may not be add slippage consequence measures and measures for the slippage consequences considered by NMFS. All comments slippage reporting requirements to build to better monitor catch of river herring received are a part of the public record upon the current measures and to and shad in the Atlantic mackerel and will generally be posted for public address monitoring the catch of river fishery. The preamble to this proposed viewing on www.regulations.gov herring and shad. rule includes a complete description of without change. All personal identifying Framework 9 would require Tier 1, 2, the reasons why the Council and NMFS information (e.g., name, address, etc.), and 3 mackerel vessels on observed are considering this action and these are confidential business information, or trips to move 15 nm following an not repeated here. otherwise sensitive information excepted slippage event, which includes submitted voluntarily by the sender will safety, mechanical failure, or excess Statement of the Objectives of, and be publicly accessible. NMFS will catch of spiny dogfish. These vessels Legal Basis for, This Proposed Rule accept anonymous comments (enter ‘‘N/ would also be required to terminate a The purpose of this proposed action A’’ in the required fields if you wish to fishing trip and immediately return to is to minimize slippage, which will remain anonymous). port following a non-excepted slippage improve observer data, and should in FOR FURTHER INFORMATION CONTACT: event, which would be due to any turn improve decision-making that uses Carly Bari, Fishery Policy Analyst, (978) reason other than those listed above. In observer data. Failure to implement the 281–9224, fax (978) 281–9135. addition to submitting a Released Catch measures described in this proposed SUPPLEMENTARY INFORMATION: Affidavit, vessels carrying an observer rule could result in biased observer would also be required to report all data. The preamble to this proposed rule Background slippage events through the vessel includes a complete description of the NMFS implemented measures to monitoring system daily catch report for objectives of and legal basis for this improve catch monitoring of the mackerel and longfin squid. action and these are not repeated here.

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Description and Estimate of the Number on these or any other aspects of the possible that prohibiting slippages of Small Entities to Which This collection of information to the Regional could lead to the mackerel fishery Proposed Rule Would Apply Administrator (see ADDRESSES), and closing earlier (because of the river _ The proposed alternative applies to email to OIRA Submission@ herring and shad cap) than it otherwise mackerel limited access permits. Based omb.eop.gov, or fax to (202) 395–5806. would if more slippages were occurring. Notwithstanding any other provisions on permit data for 2013, 150 separate However, given the very low mackerel of the law, no person is required to, nor vessels hold mackerel limited access catches in recent years (less than 20 shall any person be subject to a penalty permits, 114 entities own those vessels, percent of the quota), it is more likely for failure to comply with, a collection and, based on current Small Business that catch increases might be limited of information subject to the Administration (SBA) definitions, 107 rather than actually having decreased requirements of the PRA, unless that of these are small entities. Of the 107 catches, so small entities should not be collection of information displays a more than minimally impacted small entities, 4 had no revenue in 2013 currently valid OMB Control Number. and those entities with no revenue are compared to recent fishery operations. All currently approved NOAA In addition, if vessels are prohibited considered small entities for the collections of information may be purpose of this analysis. All of the from targeting mackerel due to the cap, viewed at: http://www.cio.noaa.gov/ they will likely partially mitigate any entities that had revenue fell into the services_programs/prasubs.html. finfish or shellfish categories, and the foregone revenue by fishing for other SBA definitions for those categories for Federal Rules Which May Duplicate, species (e.g. squid, butterfish, herring, 2014 are $20.5 million for finfish fishing Overlap, or Conflict With This Proposed etc.). and $5.5 million for shellfish fishing. Of Rule List of Subjects in 50 CFR Part 648 the entities with revenues, their average This action contains no other Fisheries, Fishing, Recordkeeping and revenues in 2013 were $1,201,419. 70 compliance costs. It does not duplicate, reporting requirements. had primary revenues from finfish overlap, or conflict with any other fishing and 33 had their primary Federal law. Dated: May 13, 2015. revenues from shellfish fishing. Samuel D. Rauch III, Description of Significant Alternatives Deputy Assistant Administrator for Description of the Projected Reporting, to the Proposed Action Which Regulatory Programs, National Marine Record-Keeping, and Other Compliance Accomplish the Stated Objectives of Fisheries Service. Requirements of This Proposed Rule Applicable Statues and Which Minimize For the reasons set out in the Any Significant Economic Impact on The proposed action contains preamble, 50 CFR part 648 is proposed Small Entities collection-of-information requirements to be amended as follows: subject to review and approval by the The proposed alternative should not Office of Management and Budget have more than minimal impact on the PART 648—FISHERIES OF THE (OMB) under the Paperwork Reduction affected small entities compared to NORTHEASTERN UNITED STATES Act (PRA). This requirement has been recent operation of the fishery (2011– submitted to OMB for approval under 2013, and 2014 landings to date appear ■ 1. The authority citation for part 648 Control Number 0648–0679. similar to 2013). First, the primary continues to read as follows: Under the proposed action, all limited impact should only be that vessels will Authority: 16 U.S.C. 1801 et seq. access mackerel vessels carrying an not slip catches before observers have a ■ 2. In § 648.11, paragraph (n)(3)(ii) is observer would be required to report all chance to observe/sample them, which revised and paragraph (n)(3)(iii) is slippage events on the VMS mackerel should have almost no economic impact added to read as follows: and longfin squid daily catch report. on vessels. Slippage for reasons besides This information collection is intended safety, mechanical issues, and spiny § 648.11 At-sea sea sampler/observer to improve monitoring the catch of river dogfish are already prohibited, and this coverage. herring and shad in the Atlantic proposed action would require vessels * * * * * mackerel fishery. The burden estimates to move 15 nm before fishing again if a (n) * * * for these new requirements apply to all slippage for those excepted reasons (3) * * * limited access mackerel vessels. In a occurs (vessels could not fish within 15 (ii) If fish are released prior to being given fishing year, NMFS estimates that nm of the slippage event for the brought on board the vessel due to any these additionally reporting remainder of the trip). Total small entity of the exceptions in paragraphs requirements will not cause any mackerel revenues over 2011–2013 (n)(3)(i)(A)–(C) of this section, the vessel additional time or cost burden from that averaged $2.0 million, for an average of operator must move at least 15 nm from which was previously approved under approximately $19,000 per affected the location of release before fishing OMB Control Number 0648–0679. small entity (107), compared to their again, and must stay at least 15 nm from Public comment is sought regarding: average revenues of $1,201,419 in 2013 the slippage event location for the Whether this proposed collection of as described above. Given the small remainder of the fishing trip. The vessel information is necessary for the proper relative value of mackerel for most operator must also complete and sign a performance of the functions of the affected entities, the infrequency of Released Catch Affidavit detailing the agency, including whether the slippage, and given the consequence of vessel name and permit number; the information shall have practical utility; excepted slippages is only to move 15 VTR serial number; where, when, and the accuracy of the burden estimate; nm, it seems likely that the economic for what reason the catch was released; ways to enhance the quality, utility, and impacts should be minimal for affected the estimated weight of each species clarity of the information to be small entities. This is especially true brought on board (if only part of the tow collected; and ways to minimize the since only a small portion of trips are was released) or released on that tow. A burden of the collection of information, observed, and the measures only apply completed affidavit must be submitted including through the use of automated to observed trips. to NMFS within 48 hr of the end of the collection techniques or other forms of If slippages have been masking higher trip. The vessel operator must also information technology. Send comments river herring and shad landings, it is report a slippage event on the VMS

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mackerel and longfin squid daily catch mackerel and longfin squid daily catch is not carrying a NMFS-approved report. report. observer, or otherwise discard fish at sea (iii) If fish are released prior to being * * * * * before bringing the fish aboard and brought on board the vessel due to any ■ 3. In § 648.14, paragraph (g)(2)(ii)(G) is making it available to the observer for reason other than the exceptions in added, paragraphs (g)(2)(vi) and (vii) are sampling, unless subject to one of the exceptions defined at § 648.11(n)(3) if paragraphs (n)(3)(i)(A)–(C) of this revised and paragraphs (g)(2)(viii), (ix), and (x) are added to read as follows: issued a Limited Access Atlantic section, the vessel operator must mackerel permit, or a longfin squid/ immediately terminate the trip and § 648.14 Prohibitions. butterfish moratorium permit. return to port. No fishing activity may * * * * * occur during the return to port. The (g) * * * (vii) Fail to move 15 nm, as specified vessel operator must also complete and (2) * * * at § 648.11(n)(3)(ii). sign a Released Catch Affidavit detailing (ii) * * * (viii) Fail to immediately return to the vessel name and permit number; the (G) Fish for, possess, transfer, receive, port as specified at § 648.11(n)(3)(iii). or sell; or attempt to fish for, possess, VTR serial number; where, when, and (ix) Fail to complete, sign, and submit transfer, receive, or sell; more than for what reason the catch was released; a Released Catch Affidavit if fish are 20,000 lb (9.07 mt) of mackerel per trip; the estimated weight of each species released pursuant to the requirements at or land, or attempt to land more than brought on board (if only part of the tow § 648.11(n)(3). 20,000 lb (9.07 mt) of mackerel per day was released) or released on that tow. A after 95 percent of the river herring and (x) Fail to report a slippage event on completed affidavit must be submitted shad cap has been harvested, if the the VMS mackerel and longfin squid to NMFS within 48 hr of the end of the vessel holds a valid mackerel permit. daily catch report. trip. The vessel operator must also * * * * * report the slippage event on the VMS * * * * * (vi) Release fish from codend of the [FR Doc. 2015–12060 Filed 5–18–15; 8:45 am] net, transfer fish to another vessel that BILLING CODE 3510–22–P

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Notices Federal Register Vol. 80, No. 96

Tuesday, May 19, 2015

This section of the FEDERAL REGISTER room hours are 8 a.m. to 4:30 p.m., the foreign plant protection service and contains documents other than rules or Monday through Friday, except the grower. proposed rules that are applicable to the holidays. To be sure someone is there to We are asking the Office of public. Notices of hearings and investigations, help you, please call (202) 799–7039 Management and Budget (OMB) to committee meetings, agency decisions and before coming. approve our use of these information rulings, delegations of authority, filing of petitions and applications and agency FOR FURTHER INFORMATION CONTACT: For collection activities for an additional 3 statements of organization and functions are information on the importation of years. examples of documents appearing in this Christmas cactus and Easter cactus in The purpose of this notice is to solicit section. growing media from the Netherlands comments from the public (as well as and Denmark, contact Mr. William Aley, affected agencies) concerning our Senior Regulatory Specialist, PPP, RPM, information collection. These comments DEPARTMENT OF AGRICULTURE PPQ, APHIS, 4700 River Road Unit 133, will help us: Riverdale, MD 20737; (301) 851–2130. (1) Evaluate whether the collection of Animal and Plant Health Inspection For copies of more detailed information information is necessary for the proper Service on the information collection, contact performance of the functions of the [Docket No. APHIS–2015–0032] Ms. Kimberly Hardy, APHIS’ Agency, including whether the Information Collection Coordinator, at information will have practical utility; Notice of Request for Extension of (301) 851–2727. (2) Evaluate the accuracy of our Approval of an Information Collection; SUPPLEMENTARY INFORMATION: estimate of the burden of the collection Importation of Christmas Cactus and of information, including the validity of Title: Importation of Christmas Cactus Easter Cactus in Growing Media From the methodology and assumptions used; the Netherlands and Denmark and Easter Cactus in Growing Media From the Netherlands and Denmark. (3) Enhance the quality, utility, and clarity of the information to be AGENCY: Animal and Plant Health OMB Control Number: 0579–0266. Inspection Service, USDA. collected; and Type of Request: Extension of (4) Minimize the burden of the ACTION: Extension of approval of an approval of an information collection. collection of information on those who information collection; comment Abstract: Under the Plant Protection are to respond, through use, as request. Act (7 U.S.C. 7701 et seq.), the Secretary appropriate, of automated, electronic, of Agriculture is authorized to restrict mechanical, and other collection SUMMARY: In accordance with the the importation, entry, or interstate Paperwork Reduction Act of 1995, this technologies; e.g., permitting electronic movement of plants, plant products, and submission of responses. notice announces the Animal and Plant other articles to prevent the Health Inspection Service’s intention to Estimate of burden: The public introduction of plant pests into the reporting burden for this collection of request an extension of approval of an United States or their dissemination information collection associated with information is estimated to average 0.57 within the United States. The Secretary hours per response. regulations for the importation of has delegated this authority to the Respondents: Foreign plant protection Christmas cactus and Easter cactus in Animal and Plant Health Inspection service officials and growers in the growing media from the Netherlands Service (APHIS). Netherlands and Denmark. and Denmark. The regulations contained in DATES: We will consider all comments Estimated annual number of ‘‘Subpart—Plants for Planting’’ (7 CFR respondents: 20. that we receive on or before July 20, 319.37 through 319.37–14) prohibit or Estimated annual number of 2015. restrict, among other things, the responses per respondent: 10.5. importation of living plants, plant parts, ADDRESSES: You may submit comments Estimated annual number of and seeds for propagation. These by either of the following methods: responses: 210. • regulations are intended to ensure that Federal eRulemaking Portal: Go to Estimated total annual burden on imported plants for planting do not http://www.regulations.gov/ respondents: 120 hours. (Due to serve as a host for plant pests, such as #!docketDetail;D=APHIS-2015-0032. averaging, the total annual burden hours • insects or pathogens, that can cause Postal Mail/Commercial Delivery: may not equal the product of the annual damage to U.S. agricultural and Send your comment to Docket No. number of responses multiplied by the environmental resources. APHIS–2015–0032, Regulatory Analysis reporting burden per response.) and Development, PPD, APHIS, Station Under these regulations, Christmas All responses to this notice will be 3A–03.8, 4700 River Road Unit 118, cactus and Easter cactus in approved summarized and included in the request Riverdale, MD 20737–1238. growing media may be imported into for OMB approval. All comments will Supporting documents and any the United States from the Netherlands also become a matter of public record. comments we receive on this docket and Denmark under certain conditions, may be viewed at http:// which require the use of a phytosanitary Done in Washington, DC, this 13th day of www.regulations.gov/ certificate and declaration stating the May 2015. #!docketDetail;D=APHIS-2015-0032 or plants were grown in accordance with Kevin Shea, in our reading room, which is located in specific conditions, an agreement Administrator, Animal and Plant Health room 1141 of the USDA South Building, between APHIS and the plant protection Inspection Service. 14th Street and Independence Avenue service of the country where the plants [FR Doc. 2015–12073 Filed 5–18–15; 8:45 am] SW., Washington, DC. Normal reading are grown, and an agreement between BILLING CODE 3410–34–P

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COMMISSION ON CIVIL RIGHTS them to Angelica Trevino, Civil Rights Average Hours Per Response: 0.0273. Analyst, Western Regional Office, at Burden Hours: 19,347. Notice of Public Meeting of the Idaho [email protected]. Persons who desire Needs and Uses: The Census Bureau Advisory Committee for Members of additional information should contact plans to request clearance from the the Committee To Receive Member the Western Regional Office, at (213) Office of Management and Budget Orientation and Discuss Civil Rights 894–3437, (or for hearing impaired TDD (OMB) for the collection of same sex Issues in the State 913–551–1414), or by email to atrevino@ marriage data as part of the basic demographic information on the Current AGENCY: usccr.gov. Hearing-impaired persons U.S. Commission on Civil Population Survey (CPS) beginning in Rights. who will attend the meeting and require the services of a sign language June 2015. The current clearance ACTION: Announcement of meeting. interpreter should contact the Regional expires July 31, 2017. The CPS has been SUMMARY: Notice is hereby given, Office at least ten (10) working days the source of official government pursuant to the provisions of the rules before the scheduled date of the statistics on employment and and regulations of the U.S. Commission meeting. unemployment for over 50 years. The on Civil Rights (Commission) and the Records and documents discussed Bureau of Labor Statistics (BLS) and the Federal Advisory Committee Act during the meeting will be available for Census Bureau jointly sponsor the basic (FACA) that a meeting of the Idaho public viewing prior to and after the monthly survey. The Census Bureau Advisory Committee (Committee) to the meeting at http://facadatabase.gov/ also prepares and conducts all the field Commission will be held on Friday, committee/meetings.aspx?cid=245 and work. At the OMB’s request, the Census June 5, 2015, for the purpose of clicking on the ‘‘Meeting Details’’ and Bureau and the BLS divide the discussing project proposals on equity ‘‘Documents’’ links. Records generated clearance request in order to reflect the in school spending and state from this meeting may also be inspected joint sponsorship and funding of the compliance with the Supreme Court and reproduced at the Western Regional CPS program. The BLS submits a Olmsted decision. The meeting will be Office, as they become available, both separate clearance request for the held by teleconference. before and after the meeting. Persons portion of the CPS that collects labor DATES: Friday, June 5, 2015 from 3:30 interested in the work of this Committee force information for the civilian p.m. to 4:30 p.m. MST. are directed to the Commission’s Web noninstitutional population. Some of the information within that portion FOR FURTHER INFORMATION CONTACT: site, http://www.usccr.gov, or may Peter Minarik, DFO, at (213) 894–3437 contact the Western Regional Office at includes employment status, number of or [email protected]. the above email or street address. hours worked, job search activities, earnings, duration of unemployment, SUPPLEMENTARY INFORMATION: This Agenda: and the industry and occupation meeting is available to the public Election of vice-chair classification of the job held the through the following toll-free call-in Discussion of proposal on equity in school district spending previous week. number: 888–437–9455 conference ID: The justification that follows is in 6159656. Any interested member of the Discussion of proposal on state compliance with Olmsted decision support of the demographic data. The public may call this number and listen demographic information collected in to the meeting. An open comment Adjournment Public Call Information: the CPS provides a unique set of data on period will be provided to allow selected characteristics for the civilian members of the public to make a Dial: 888–437–9445 noninstitutional population. Some of statement as time allows. The Conference ID: 6159656 the demographic information we collect conference call operator will ask callers Dated: May 13, 2015. are age, marital status, gender, Armed to identify themselves, the organization David Mussatt, Forces status, education, race, origin, they are affiliated with (if any), and an Chief, Regional Programs Coordination Unit. and family income. We use these data email address prior to placing callers in conjunction with other data, into the conference room. Callers can [FR Doc. 2015–12041 Filed 5–18–15; 8:45 am] BILLING CODE 6335–01–P particularly the monthly labor force expect to incur charges for calls they data, as well as periodic supplement initiate over wireless lines, and the data. We also use these data Commission will not refund any DEPARTMENT OF COMMERCE independently for internal analytic incurred charges. Callers will incur no research and for evaluation of other charge for calls they initiate over land- Submission for OMB Review; surveys. In addition, we use these data line connections to the toll-free Comment Request as a control to produce accurate telephone number. Persons with hearing estimates of other personal impairments may also follow the The Department of Commerce will characteristics. proceedings by first calling the Federal submit to the Office of Management and Affected Public: Individuals or Relay Service at 1–800–977–8339 and Budget (OMB) for clearance the Households. providing the Service with the following proposal for collection of Frequency: Monthly. conference call number and conference information under the provisions of the Respondent’s Obligation: Voluntary. ID number. Paperwork Reduction Act (44 U.S.C. Legal Authority: Title 13, United Members of the public are also chapter 35). States Code, Section 182; and Title 29, entitled to submit written comments. Agency: U.S. Census Bureau. United States Code, Sections 1–9. The comments must be received in the Title: Current Population Survey, This information collection request Western Regional Office of the Basic Demographic Items. may be viewed at www.reginfo.gov. Commission by July 6, 2015. The OMB Control Number: 0607–0049. Follow the instructions to view address is Western Regional Office, U.S. Form Number(s): There are no forms. Department of Commerce collections Commission on Civil Rights, 300 N. Los We conduct all interviews on currently under review by OMB. Angeles Street, Suite 2010, Los Angeles, computers. Written comments and CA 90012. Persons wishing to email Type of Request: Regular. recommendations for the proposed their comments may do so by sending Number of Respondents: 708,000. information collection should be sent

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within 30 days of publication of this Woodwork Co. Ltd. (‘‘Nanhai’’) and reinstated the wood valuation from the notice to OIRA_Submission@ Dongguan Liaobushangdun Huada first redetermination. Pursuant to the omb.eop.gov or fax to (202)395–5806. Furniture Factory and Great Rich (HK) CIT’s order, the Department filed the Dated: May 13, 2015. Enterprise Co., Ltd. (‘‘Dongguan’’). final results of its third redetermination Glenna Mickelson, DATES: Effective Date: May 1, 2015. with the CIT on March 27, 2015 in which it valued Huafeng’s wood inputs Management Analyst, Office of the Chief FOR FURTHER INFORMATION CONTACT: using surrogate values and continued to Information Officer. Patrick O’Connor, AD/CVD Operations, exclude Insular Rattan’s financial [FR Doc. 2015–11979 Filed 5–18–15; 8:45 am] Office IV, Enforcement and statements from its calculations.7 On BILLING CODE 3510–07–P Compliance—International Trade April 21, 2015, the CIT sustained the Administration, U.S. Department of Department’s Remand Redetermination Commerce, 14th Street and Constitution III.8 DEPARTMENT OF COMMERCE Avenue NW., Washington, DC, 20230; telephone (202) 482–0989. Timken Notice International Trade Administration SUPPLEMENTARY INFORMATION: In its decision in Timken, 893 F.2d at [A–570–890] Background 341, as clarified by Diamond Sawblades, the CAFC held that, pursuant to section Wooden Bedroom Furniture From the In the Final Results, the Department 516A(e) of the Tariff Act of 1930, as People’s Republic of China: Notice of valued certain wood inputs used by the amended (‘‘the Act’’), the Department Court Decision Not in Harmony With respondent, Huafeng, with surrogate must publish a notice of a court Final Results of Administrative Review values and used Insular Rattan and decision that is not ‘‘in harmony’’ with and Notice of Second Amended Final Native Products Corporation’s (‘‘Insular a Department determination and must Results of Administrative Review Rattan’’) 2009 financial statements, suspend liquidation of entries pending Pursuant to Court Decision among others, to calculate surrogate a ‘‘conclusive’’ court decision. The CIT’s 4 AGENCY: Enforcement and Compliance, financial ratios. The CIT twice April 21, 2015, judgment sustaining the International Trade Administration, remanded issues involving the Final Department’s Remand Redetermination Department of Commerce. Results to the Department, and, in its III in which it valued certain wood SUMMARY: On April 21, 2015, the United second redetermination, the Department inputs using surrogate values, rather States Court of International Trade valued certain wood inputs used by than market economy purchase prices, (‘‘CIT’’) issued its final judgment in Huafeng with market economy purchase constitutes a final decision of that court Home Meridian Int’l, Inc. v. United prices and revised the calculation of the that is not in harmony with the States, Consol. Court No. 11–00325,1 surrogate financial ratios by excluding Department’s Amended Final Results. and sustained the Department of Insular Rattan’s financial statements This notice is published in fulfillment 5 Commerce’s (‘‘the Department’’) third from the calculation. On November 14, of the publication requirements of remand redetermination.2 Consistent 2013, the CIT sustained the final results Timken. Accordingly, the Department with the decision of the United States of the Department’s second will continue the suspension of Court of Appeals for the Federal Circuit redetermination and, in accordance liquidation of the subject merchandise (‘‘CAFC’’) in Timken Co. v. United with Timken, the Department published pending the expiration of the period of 6 States, 893 F.2d 337 (Fed. Cir. 1990) a notice of Amended Final Results. The appeal, or if appealed, pending a final (‘‘Timken’’), as clarified by Diamond American Furniture Manufacturers and conclusive court decision. Sawblades Mfrs. Coalition v. United Committee for Legal Trade and Amended Final Results Vaughan-Bassett Furniture Company, States, 626 F.3d 1374 (Fed. Cir. 2010) Because there is now a final court (‘‘Diamond Sawblades’’), the Inc. appealed the valuation of wood inputs, but not the issue of excluding decision with respect to this case, the Department is notifying the public that Department is amending its Amended the final judgment in this case is not in Insular Rattan’s financial statements, to the CAFC. On December 1, 2014, the Final Results with respect to Huafeng’s harmony with the Department’s weighted-average dumping margin for 3 CAFC reversed the CIT’s decision and Amended Final Results. The the period January 1, 2009 through Department is amending its Amended vacated the Department’s redetermination results in which it used December 31, 2009. In addition, the Final Results with regard to the Department has amended the Amended calculation of the weighted average market economy purchase prices, rather than surrogate values, to value certain of Final Results for Nanhai and Dongguan, dumping margin applied to the the separate rate respondents included mandatory respondent, Dalian Huafeng Huafeng’s wood inputs. The CAFC directed the CIT to reinstate the in this final court decision. The Furniture Group Co., Ltd. (‘‘Huafeng’’), remaining weighted-average dumping and the two separate rate respondents Department’s wood valuation in the first redetermination (using surrogate values margins from the Final Results, as included in this decision: Nanhai Baiyi 9 for Huafeng’s wood inputs). On January subsequently amended, remain unchanged. 1 See Home Meridian Int’l, Inc. v. United States, 28, 2015, the CIT ordered the Department to file a redetermination Consol. Court No. 11–00325, Slip Op. 15–34 (April Weighted-average 21, 2015) (‘‘Home Meridian III’’). with the Court in which it continued to Manufacturer/exporter dumping margin 2 See Final Results of Third Redetermination exclude Insular Rattan’s financial (percent) Pursuant to Court Order,’’ Court No. 14–1251, statements from its calculations and (March 27, 2015) (‘‘Remand Redetermination III’’) Dalian Huafeng Furniture available at http://enforcement.trade.gov/remands/ cafc-1415-1251.pdf. 4 See Wooden Bedroom Furniture from the Group Co., Ltd ...... 45.83 3 See Wooden Bedroom Furniture From the People’s Republic of China: Final Results and Final People’s Republic of China: Notice of Court Rescission in Part, 76 FR 49729 (Aug. 11, 2011) 7 See Remand Redetermination III. Decision Not in Harmony With Final Results of (‘‘Final Results’’). 8 See Home Meridian III. Administrative Review and Notice of Amended 5 See Second Redetermination Pursuant to Court 9 See Wooden Bedroom Furniture From the Final Results of Administrative Review Pursuant to Order, Court No. 11–00325, dated August 26, 2013 People’s Republic of China: Amended Final Results Court Decision, 78 FR 72862 (December 4, 2013) (‘‘Remand Redetermination II’’). of Antidumping Duty Administrative Review, 76 FR (‘‘Amended Final Results’’). 6 See Amended Final Results. 57713 (September 16, 2011).

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Weighted-average Office of Protected Resources, National harassment of marine mammals. Within Manufacturer/exporter dumping margin Marine Fisheries Service, 1315 East- 45 days of the close of the comment (percent) West Highway, Silver Spring, MD period, NMFS must either issue or deny 20910. A copy of the application the authorization. Nanhai Baiyi Woodwork containing a list of the references used Co. Ltd ...... 45.83 Summary of Request Dongguan in this document, NMFS’ Liaobushangdun Environmental Assessment (EA), On April 1, 2014, WSDOT submitted Huada Furniture Fac- Finding of No Significant Impact a request to NOAA requesting an IHA tory ...... 45.83 (FONSI), and the IHA may be obtained for the possible harassment of small Great Rich (HK) Enter- by writing to the address specified numbers of 11 marine mammal species prise Co., Ltd. above or visiting the Internet at: incidental to construction associated http://www.nmfs.noaa.gov/pr/permits/ with the Anacortes Tie-up Slips In the event the CIT’s ruling is not incidental/. Documents cited in this Dolphin and Wingwall Replacement in appealed or, if appealed, upheld by the notice may be viewed, by appointment, the city of Anacortes, on Fidalgo Island, CAFC, the Department will instruct CBP during regular business hours, at the adjacent to Guemes Channel, Skagit to liquidate entries of subject aforementioned address. County, Washington, between merchandise based on the revised FOR FURTHER INFORMATION CONTACT: September 1, 2015, and February 15, assessment rates calculated by the Shane Guan, Office of Protected 2016. NMFS determined that the IHA Department. Resources, NMFS, (301) 427–8401. application was complete on July 1, This notice is issued and published in 2014. accordance with sections 516A(e)(1), SUPPLEMENTARY INFORMATION: 751(a)(1), and 777(i)(1) of the Act. Background Description of the Specified Activity Dated: May 11, 2015. Sections 101(a)(5)(A) and (D) of the A detailed description of the Paul Piquado, MMPA (16 U.S.C. 1361 et seq.) direct WSDOT’s Anacortes tie-up slips Assistant Secretary for Enforcement and the Secretary of Commerce to allow, dolphin and wingwall project is Compliance. upon request, the incidental, but not provided in the Federal Register notice [FR Doc. 2015–12084 Filed 5–18–15; 8:45 am] intentional, taking of small numbers of for the proposed IHA (80 FR 11648; BILLING CODE 3510–DS–P marine mammals by U.S. citizens who March 4, 2015). Since that time, no engage in a specified activity (other than changes have been made to the commercial fishing) within a specified proposed construction activities. DEPARTMENT OF COMMERCE geographical region if certain findings Therefore, a detailed description is not are made and either regulations are provided here. Please refer to that National Oceanic and Atmospheric issued or, if the taking is limited to Federal Register notice for the Administration harassment, a notice of a proposed description of the specific activity. RIN 0648–XD741 authorization is provided to the public Comments and Responses for review. Taking of Marine Mammals Incidental An authorization for incidental A notice of NMFS’ proposal to issue to Specified Activities; Anacortes Tie- takings shall be granted if NMFS finds an IHA to WSDOT was published in the Up Slips Dolphin and Wingwall that the taking will have a negligible Federal Register on March 4, 2015. That Replacement impact on the species or stock(s), will notice described, in detail, WSDOT’s not have an unmitigable adverse impact activity, the marine mammal species AGENCY: National Marine Fisheries on the availability of the species or that may be affected by the activity, and Service (NMFS), National Oceanic and stock(s) for subsistence uses (where the anticipated effects on marine Atmospheric Administration (NOAA), relevant), and if the permissible mammals. During the 30-day public Commerce. methods of taking and requirements comment period, NMFS received ACTION: Notice; issuance of an incidental pertaining to the mitigation, monitoring comments from the Marine Mammal take authorization. and reporting of such takings are set Commission (Commission). Specific forth. NMFS has defined ‘‘negligible comments and responses are provided SUMMARY: In accordance with the impact’’ in 50 CFR 216.103 as ‘‘. . . an below. Marine Mammal Protection Act impact resulting from the specified Comment 1: The Commission notes (MMPA) regulations, notification is activity that cannot be reasonably that the construction would be hereby given that NMFS has issued an expected to, and is not reasonably likely conducted in December and January, Incidental Harassment Authorization to, adversely affect the species or stock however, WSDOT’s ambient noise (IHA) to the Washington State through effects on annual rates of measurements were conducted in March Department of Transportation (WSDOT) recruitment or survival.’’ and showed that median ambient noise to take, by harassment, small numbers Section 101(a)(5)(D) of the MMPA level at the proposed construction area of 11 species of marine mammals established an expedited process by is 123 dB re 1 mPa. The Commission incidental to construction activities for which citizens of the U.S. can apply for states that the ambient noise levels a tie-up slips dolphin and wingwall a one-year authorization to incidentally would be lower in winter (December replacement project in Anacortes, take small numbers of marine mammals and January) than those were collected Washington State, between September by harassment, provided that there is no in March when vessel traffic is greater. 1, 2015, and August 31, 2016. potential for serious injury or mortality Therefore, the Commission recommends DATES: Effective September 1, 2015, to result from the activity. Section that NMFS either (1) require WSDOT to through August 31, 2016. 101(a)(5)(D) establishes a 45-day time measure ambient sound levels during ADDRESSES: Requests for information on limit for NMFS review of an application winter and adjust the Level B the incidental take authorization should followed by a 30-day public notice and harassment zones accordingly or (2) be addressed to Jolie Harrison, Chief, comment period on any proposed base the Level B harassment zones on Permits and Conservation Division, authorizations for the incidental the 120-dB re 1 mPa threshold and adjust

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the zones to ensure adequate protection Nevertheless, WSDOT agreed that Description of Marine Mammals in the for southern resident killer whales. modeled 120 dB isopleths to be used as Area of the Specified Activity Response: NMFS worked with the threshold for Level B takes for WSDOT and its acoustic consultant vibratory pile driving and pile removal The marine mammal species under regarding the ambient noise levels in the activities and submitted a updated NMFS jurisdiction most likely to occur vicinity of the construction area. In monitoring plan to encompass this in the proposed construction area general, doubling the number of boats larger zone of influence (ZOI). The include Pacific harbor seal (Phoca would only increase the background updated monitoring measures are vitulina richardsi), northern elephant sound levels by about 3 decibels so discussed in details below in the seal (Mirounga angustirostris), adding or subtracting one boat will not ‘‘Mitigation Measure’’ and ‘‘Monitoring California sea lion (Zalophus have a substantial effect on the overall and Reporting’’ sections. californianus), Steller sea lion background sound levels. The ferry In addition, WSDOT is considering (Eumetopias jubatus), killer whale vessels dominate the sound levels in the getting new winter background data (Orcinus orca) (transient and Southern areas around the terminals where prior to the start of the project. If the Resident stocks), gray whale WSDOT’s measurement was collected. It measurement shows smaller ZOI, (Eschrichtius robustus), humpback is only expected a slight increase in WSDOT will inform NMFS with another whale (Megaptera novaeangliae), minke sound levels in the summer months due revised monitoring plan that reflects the whale (Balaenoptera acutorostrata), to more recreational boats in the area. updated ZOI based on onsite harbor porpoise (Phocoena phocoena), Both NMFS and WSDOT’s acoustic measurements. consultant considers that sound levels The revised ZOI does not change the Dall’s porpoise (P. dali), and Pacific between about September to May number of marine mammals takes, white-sided dolphin (Lagenorhynchus should be consistent from month to because all animals within the general obliquidens). A list of the species and month and representative of the work vicinity of the project are being their status are provided in Table 1. period. considered for potential takes.

TABLE 1—MARINE MAMMAL SPECIES POTENTIALLY PRESENT IN REGION OF ACTIVITY

Species ESA status MMPA status Occurrence

Harbor Seal ...... Not listed ...... Non-depleted Frequent. California Sea Lion ...... Not listed ...... Non-depleted Frequent. Northern Elephant Seal ...... Not listed ...... Non-depleted Occasional. Steller Sea Lion (eastern DPS) ...... Not listed ...... Under review Rare. Harbor Porpoise ...... Not listed ...... Non-depleted Frequent. Dall’s Porpoise ...... Not listed ...... Non-depleted Occasional. Pacific White-sided dolphin ...... Not listed ...... Non-depleted Occasional. Killer Whale ...... Endangered (S. Resident) ...... Depleted ...... Occasional. Gray Whale ...... Delisted ...... Unclassified Occasional. Humpback Whale ...... Endangered ...... Depleted ...... Rare. Minke Whale ...... Not listed ...... Non-depleted Rare.

General information on the marine the effects of anthropogenic noise on of the MMPA, NMFS must set forth the mammal species found in Washington marine mammals, which is not repeated permissible methods of taking pursuant coastal waters can be found in Caretta here. No instances of hearing threshold to such activity, and other means of et al. (2014), which is available at the shifts, injury, serious injury, or effecting the least practicable adverse following URL: http:// mortality are expected as a result of impact on such species or stock and its www.nmfs.noaa.gov/pr/sars/pdf/ WSDOT’s activities given the strong habitat, paying particular attention to po2013.pdf. Refer to that document for likelihood that marine mammals would rookeries, mating grounds, and areas of information on these species. A list of avoid the immediate vicinity of the pile similar significance, and on the marine mammals in the vicinity of the driving area. availability of such species or stock for action and their status are provided in taking for certain subsistence uses. Potential Effects on Marine Mammal Table 3. Specific information For WSDOT’s proposed Anacortes tie- Habitat concerning these species in the vicinity up slips dolphin and wingwall of the proposed action area is provided The primary potential impacts to replacement project, NMFS is requiring in detail in the WSDOT’s IHA marine mammals and other marine WSDOT to implement the following application. species are associated with elevated mitigation measures to minimize the sound levels, but the project may also Potential Effects of the Specified potential impacts to marine mammals in result in additional effects to marine Activity on Marine Mammals the project vicinity as a result of the in- mammal prey species and short-term water construction activities. The effects of underwater noise from local water turbidity caused by in-water in-water pile removal and pile driving construction due to pile removal and No Impact Pile Driving associated with the construction pile driving. These potential effects are To avoid potential injury to marine activities for a tie-up slips dolphin and discussed in detail in the Federal mammals, only vibratory pile hammer wingwall replacement project in Register notice for the proposed IHA will be used for pile removal and pile Anacortes has the potential to result in and are not repeated here. driving. behavioral harassment of marine mammal species and stocks in the Mitigation Measures Time Restriction vicinity of the action area. The Notice of In order to issue an incidental take Work would occur only during Proposed IHA included a discussion of authorization under section 101(a)(5)(D) daylight hours, when visual monitoring

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of marine mammals can be conducted. currently uses received level of 120 dB construction and adjust the Level B In addition, all in-water construction as the onset of Level B harassment from behavioral harassment zone based on will be limited to the period between non-impulse sources such as vibratory measurements. September 1, 2015, and February 15, pile driving and pile removal. Although The 120-dB Level B harassment ZOIs 2016. ambient measurement during March at from in-water vibratory pile removal the vicinity of Anacortes Ferry Terminal and pile driving are modeled based on Establishment of Level B Harassment showed that the median ambient noise in-water measurements at the WSDOT Zones of Influence level is at 123 dB re 1 mPa, WSDOT will Port Townsend Ferry Terminal Because WSDOT will not use impact use 120 dB re 1 mPa as the isopleths for (Laughlin 2011) and Friday Harbor pile driving for the proposed modeling its Level B harassment zone. Ferry Terminal (Laughlin 2010) construction work, no Level A exclusion WSDOT is considering collecting constructions. These modeled results zone exists for marine mammals. NMFS ambient noise data before in-water are presented in Table 2 below.

TABLE 2—MODELED ZOI DISTANCES TO LEVEL B BEHAVIORAL HARASSMENT FROM THE PILE DRIVING AND PILE REMOVAL AT WSDOT’S ANACORTES PROJECT AREA

In-water ZOI In-air ZOI Vibratory pile type/method Threshold (km) (m)

12-inch timber removal ...... 120 dBRMS re 1 μPa 2.3 ...... 24-inch steel removal/driving ...... 120 dBRMS re 1 μPa 6.3 ...... 30-inch steel driving ...... 120 dBRMS re 1 μPa 39.8 ...... 36-inch steel driving ...... 120 dBRMS re 1 μPa 63.1 ...... All piles/in-air (harbor seals) ...... 90 dBRMS re 20 μPa ...... 30 All piles/in-air (other pinnipeds) ...... 100 dBRMS re 20 ...... 10 μPa

Soft Start issued), if such marine mammals are the region. This acoustic network, WSDOT will implement ‘‘soft start’’ sighted within the vicinity of the project combined with the volunteer (or ramp up) to reduce potential area and are approaching the Level B (incidental) visual sighting network startling behavioral responses from harassment zone during in-water allows researchers to document marine mammals. Soft start requires construction activities. presence and location of various marine contractors to initiate noise from the mammal species. Coordination With Local Marine With this level of coordination in the vibratory hammer for 15 seconds at Mammal Research Network region of activity, WSDOT will be able reduced energy followed by a 1-minute to get real-time information on the waiting period. The procedure will be Prior to the start of pile driving, the presence or absence of whales before repeated two additional times. Each Orca Network and/or Center for Whale starting any pile driving. day, WSDOT will use the soft-start Research will be contacted to find out technique at the beginning of pile the location of the nearest marine Mitigation Conclusions mammal sightings. The Orca Sightings driving, or if pile driving has ceased for NMFS has carefully evaluated the more than one hour. Network consists of a list of over 600 (and growing) residents, scientists, and mitigation measures and considered a Shutdown Measures government agency personnel in the range of other measures in the context U.S. and Canada. Sightings are called or of ensuring that NMFS prescribes the WSDOT shall implement shutdown means of effecting the least practicable emailed into the Orca Network and measures if southern resident killer impact on the affected marine mammal immediately distributed to other whales are sighted within the vicinity of species and stocks and their habitat. Our sighting networks including: the the project area and are approaching the evaluation of potential measures Northwest Fisheries Science Center of Level B harassment zone (zone of included consideration of the following NOAA Fisheries, the Center for Whale influence, or ZOI) during in-water factors in relation to one another: Research, Cascadia Research, the Whale construction activities. • The manner in which, and the Museum Hotline and the British If a killer whale approaches the ZOI degree to which, the successful Columbia Sightings Network. during pile driving or removal, and it is implementation of the measure is unknown whether it is a Southern ‘Sightings’ information collected by expected to minimize adverse impacts Resident killer whale or a transient the Orca Network includes detection by to marine mammals killer whale, it shall be assumed to be hydrophone. The SeaSound Remote • The proven or likely efficacy of the a Southern Resident killer whale and Sensing Network is a system of specific measure to minimize adverse WSDOT shall implement the shutdown interconnected hydrophones installed impacts as planned measure. in the marine environment of Haro • The practicability of the measure If a Southern Resident killer whale or Strait (west side of San Juan Island) to for applicant implementation. an unidentified killer whale enters the study orca communication, in-water Any mitigation measure(s) prescribed ZOI undetected, in-water pile driving or noise, bottom fish ecology and local by NMFS should be able to accomplish, pile removal shall be suspended until climatic conditions. A hydrophone at have a reasonable likelihood of the whale exits the ZOI to avoid further the Port Townsend Marine Science accomplishing (based on current level B harassment. Center measures average in-water sound science), or contribute to the Further, WSDOT shall implement levels and automatically detects accomplishment of one or more of the shutdown measures if the number of unusual sounds. These passive acoustic general goals listed below: any allotted marine mammal takes devices allow researchers to hear when (1) Avoidance or minimization of reaches the limit under the IHA (if different marine mammals come into injury or death of marine mammals

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wherever possible (goals 2, 3, and 4 may populations of marine mammals that are collect data on marine mammals in and contribute to this goal). expected to be present in the proposed around the project area for 30 minutes (2) A reduction in the numbers of action area. WSDOT submitted a marine before, during, and for 30 minutes after marine mammals (total number or mammal monitoring plan as part of the all pile removal and pile installation number at biologically important time IHA application, and updated the plan work. If a PSO observes a marine or location) exposed to received levels based on comments received from the mammal within a ZOI that appears to be of pile driving and pile removal or other Commission. The updated monitoring disturbed by the work activity, the PSO activities expected to result in the take plan can be found at http:// will notify the work crew to initiate of marine mammals (this goal may www.nmfs.noaa.gov/pr/permits/ shutdown measures. contribute to 1, above, or to reducing incidental.htm. The plan may be Monitoring of marine mammals harassment takes only). modified or supplemented based on around the construction site shall be (3) A reduction in the number of comments or new information received conducted using high-quality binoculars times (total number or number at from the public during the public (e.g., Zeiss, 10 × 42 power). Due to the biologically important time or location) comment period. different sizes of ZOIs from different individuals would be exposed to Monitoring measures prescribed by pile sizes, two different ZOIs and received levels of pile driving and pile NMFS should accomplish one or more monitoring protocols corresponding to a removal, or other activities expected to of the following general goals: specific pile size will be established. result in the take of marine mammals (1) An increase in the probability of Specifically, during vibratory timber (this goal may contribute to 1, above, or detecting marine mammals, both within removal, and 24″ steel vibratory pile to reducing harassment takes only). the mitigation zone (thus allowing for driving and removal, one land-based (4) A reduction in the intensity of more effective implementation of the PSO will monitor the area from the exposures (either total number or mitigation) and in general to generate terminal work site, and one boat with a number at biologically important time more data to contribute to the analyses driver and a PSO will travel through the or location) to received levels of pile mentioned below; monitoring area. During 30/36″ driving, or other activities expected to (2) An increase in our understanding vibratory pile driving, one land-based result in the take of marine mammals of how many marine mammals are PSO will monitor the area from the (this goal may contribute to a, above, or likely to be exposed to levels of pile terminal work site, and two boats with to reducing the severity of harassment driving that we associate with specific two drivers and two PSOs will travel takes only). adverse effects, such as behavioral through the monitoring area (see Figures (5) Avoidance or minimization of harassment, TTS, or PTS; 2 and 3 in WSDOT’s updated Marine adverse effects to marine mammal (3) An increase in our understanding Mammal Monitoring Plan). habitat, paying special attention to the of how marine mammals respond to Data collection during marine food base, activities that block or limit stimuli expected to result in take and mammal monitoring will consist of a passage to or from biologically how anticipated adverse effects on count of all marine mammals by important areas, permanent destruction individuals (in different ways and to species, a description of behavior (if of habitat, or temporary destruction/ varying degrees) may impact the possible), location, direction of disturbance of habitat during a population, species, or stock movement, type of construction that is biologically important time. (specifically through effects on annual occurring, time that pile replacement (6) For monitoring directly related to rates of recruitment or survival) through work begins and ends, any acoustic or mitigation—an increase in the any of the following methods: visual disturbance, and time of the probability of detecting marine D Behavioral observations in the observation. Environmental conditions mammals, thus allowing for more presence of stimuli compared to such as weather, visibility, temperature, effective implementation of the observations in the absence of stimuli tide level, current, and sea state would mitigation. (need to be able to accurately predict also be recorded. Based on our evaluation of the received level, distance from source, Reporting Measures prescribed mitigation measures, NMFS and other pertinent information); has determined the measures provide D Physiological measurements in the WSDOT is required to submit a final the means of effecting the least presence of stimuli compared to monitoring report within 90 days after practicable impact on marine mammal observations in the absence of stimuli completion of the construction work or species or stocks and their habitat, (need to be able to accurately predict the expiration of the IHA (if issued), paying particular attention to rookeries, received level, distance from source, whichever comes earlier. This report mating grounds, and areas of similar and other pertinent information); shall detail the monitoring protocol, significance. D Distribution and/or abundance summarize the data recorded during monitoring, and estimate the number of Monitoring and Reporting comparisons in times or areas with concentrated stimuli versus times or marine mammals that may have been In order to issue an incidental take areas without stimuli; harassed. NMFS shall have an authorization (ITA) for an activity, (4) An increased knowledge of the opportunity to provide comments on the section 101(a)(5)(D) of the MMPA states affected species; and report, and if NMFS has comments, that NMFS must set forth, (5) An increase in our understanding WSDOT shall address the comments ‘‘requirements pertaining to the of the effectiveness of certain mitigation and submit a final report to NMFS monitoring and reporting of such and monitoring measures. within 30 days. taking.’’ The MMPA implementing In addition, NMFS requires WSDOT regulations at 50 CFR 216.104(a)(13) Monitoring Measures to notify NMFS’ Office of Protected indicate that requests for ITAs must WSDOT shall employ NMFS- Resources and NMFS’ Stranding include the suggested means of approved protected species observers Network within 48 hours of sighting an accomplishing the necessary monitoring (PSOs) to conduct marine mammal injured or dead marine mammal in the and reporting that will result in monitoring for its Anacortes tie-up vicinity of the construction site. increased knowledge of the species and dolphins and wingwall replacement WSDOT shall provide NMFS with the of the level of taking or impacts on project. The PSOs will observe and species or description of the animal(s),

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the condition of the animal(s) (including defines ‘‘harassment’’ as: Any act of potentially harass marine mammals in carcass condition, if the animal is dead), pursuit, torment, or annoyance which (i) the vicinity of WSDOT’s proposed location, time of first discovery, has the potential to injure a marine Anacortes Ferry Terminal tie-up slip observed behaviors (if alive), and photo mammal or marine mammal stock in the dolphin and wingwall replacement or video (if available). wild [Level A harassment]; or (ii) has project. In the event that WSDOT finds an the potential to disturb a marine injured or dead marine mammal that is As mentioned earlier in this mammal or marine mammal stock in the document, currently NMFS uses 120 dB not in the vicinity of the construction wild by causing disruption of behavioral area, WSDOT would report the same re 1 mPa and 160 dB re 1 mPa at the patterns, including, but not limited to, received levels for the onset of Level B information as listed above to NMFS as migration, breathing, nursing, breeding, soon as operationally feasible. harassment from non-impulse (vibratory feeding, or sheltering [Level B pile driving and removal) and impulse Estimated Take by Incidental harassment]. sources (impact pile driving) Harassment As discussed above, in-water pile underwater, respectively. Table 3 Except with respect to certain removal and pile driving (vibratory and summarizes the current NMFS marine activities not pertinent here, the MMPA impact) generate loud noises that could mammal take criteria.

TABLE 3—CURRENT ACOUSTIC EXPOSURE CRITERIA FOR NON-EXPLOSIVE SOUND UNDERWATER

Criterion Criterion definition Threshold

Level A Harassment (Injury) ...... Permanent Threshold Shift (PTS) (Any level 180 dB re 1 μPa (cetaceans). above that which is known to cause TTS). 190 dB re 1 μPa (pinnipeds) root mean square (rms). Level B Harassment ...... Behavioral Disruption (for impulse noises) ...... 160 dB re 1 μPa (rms). Level B Harassment ...... Behavioral Disruption (for non-impulse noise) 120 dB re 1 μPa (rms).

As explained above, ZOIs will be modeled based on in-water data sets, and information from state established that encompass the areas measurements at the WSDOT Port and federal agencies. All haulout and where received underwater sound Townsend Ferry Terminal (Laughlin observation data available are pressure levels (SPLs) exceed the 2011) and Friday Harbor Ferry Terminal summarized in Section 3 of WSDOT’s applicable thresholds for Level B (Laughlin 2010) constructions (Table 2). IHA application. Project duration is harassment. In the case of WSDOT’s Incidental take is calculated for each presented in Section 2 of WSDOT’s IHA proposed Anacortes construction species by estimating the likelihood of application. project, the Level B harassment ZOI for a marine mammal being present within The calculation for marine mammal non-impulse noise sources will be at the a ZOI during active pile removal/ exposures is estimated by: received level at 120 dB. This level may driving. Expected marine mammal be revised and the Level B ZOI presence is determined by past Exposure estimate = N (number of reestablished if WSDOT conduct an observations and general abundance animals in the area) * Number of days ambient noise measurement during the near the Anacortes ferry terminal during of pile removal/driving activity. time of construction. There will not be the construction window. Ideally, Estimates include Level B acoustical a zone for Level A harassment in this potential take is estimated by harassment during vibratory pile case, because source levels from multiplying the area of the ZOI by the removal and driving. All estimates are vibratory hammer do not exceed the local animal density. This provides an threshold for Level A harassment, and conservative, as pile removal/driving estimate of the number of animals that will not be continuous during the work no impact hammer will be used in the might occupy the ZOI at any given proposed project. day. Using this approach, a summary of moment. However, there are no density estimated takes of marine mammals Sound Levels From Proposed estimates for any Puget Sound incidental to WSDOT’s Anacortes Ferry Construction Activity population of marine mammal. Terminal tip-up dolphins and wingwall As mentioned earlier, the revised 120- As a result, the take requests were replacement work are provided in Table dB Level B harassment ZOIs are estimated using local marine mammal 4.

TABLE 4—ESTIMATED NUMBERS OF MARINE MAMMALS THAT MAY BE EXPOSED TO RECEIVED PILE REMOVAL LEVELS ABOVE 120 DB RE 1 μPA (RMS)

Estimated marine Species mammal takes Abundance Percentage

Pacific harbor seal ...... 900 14,612 6.0 California sea lion ...... 180 296,750 0.06 Steller sea lion ...... 360 52,847 0.7 Northern elephant seal ...... 72 124,000 0.06 Harbor porpoise ...... 612 10,682 5.7 Dall’s porpoise ...... 108 42,000 0.3 Killer whale, transient ...... 70 354 20 Killer whale, Southern Resident ...... 4 81 5.0 Pacific white-sided dolphin ...... 360 25,233 1.4 Gray whale ...... 36 18,017 0.2 Humpback whale ...... 30 2,043 1.5

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TABLE 4—ESTIMATED NUMBERS OF MARINE MAMMALS THAT MAY BE EXPOSED TO RECEIVED PILE REMOVAL LEVELS ABOVE 120 DB RE 1 μPA (RMS)—Continued

Estimated marine Species mammal takes Abundance Percentage

Minke whale ...... 10 202–600 1.7–5

Analysis and Determinations surrounding landmasses; therefore, the The activities may cause some fish to noise generated is not expected to leave the area of disturbance, thus Negligible Impact contribute to increased ocean ambient temporarily impacting marine Negligible impact is ‘‘an impact noise. In addition, due to shallow water mammals’ foraging opportunities in a resulting from the specified activity that depths in the project area, underwater limited portion of the foraging range; cannot be reasonably expected to, and is sound propagation of low-frequency but, because of the short duration of the not reasonably likely to, adversely affect sound (which is the major noise source activities and the relatively small area of the species or stock through effects on from pile driving) is expected to be the habitat that may be affected, the annual rates of recruitment or survival’’ poor. impacts to marine mammal habitat are (50 CFR 216.103). A negligible impact In addition, WSDOT’s proposed not expected to cause significant or finding is based on the lack of likely activities are localized and of short long-term negative consequences. adverse effects on annual rates of duration. The entire project area is Based on the analysis contained recruitment or survival (i.e., population- limited to WSDOT’s Anacortes Ferry herein of the likely effects of the level effects). An estimate of the number Terminal construction work. The entire specified activity on marine mammals of Level B harassment takes, alone, is project would involve the removal of and their habitat, and taking into not enough information on which to 272 existing piles and installation of 81 consideration the implementation of the base an impact determination. In piles. The duration for the construction proposed monitoring and mitigation addition to considering estimates of the would involve 68 hours in 9 days for measures, NMFS finds that the total number of marine mammals that might pile removal and 27 hours in 27 days for marine mammal take from WSDOT’s be ‘‘taken’’ through behavioral pile installation. These low-intensity, Anacortes Ferry Terminal tie-up harassment, NMFS must consider other localized, and short-term noise dolphins and wingwall replacement factors, such as the likely nature of any exposures may cause brief startle project will have a negligible impact on responses (their intensity, duration, reactions or short-term behavioral the affected marine mammal species or etc.), the context of any responses modification by the animals. These stocks. (critical reproductive time or location, reactions and behavioral changes are Small Number migration, etc.), as well as the number expected to subside quickly when the and nature of estimated Level A exposures cease. Moreover, the Based on analyses provided above, it harassment takes, the number of proposed mitigation and monitoring is estimated that approximately 900 estimated mortalities, and effects on measures are expected to reduce harbor seals, 180 California sea lions, habitat. potential exposures and behavioral 360 Steller sea lions, 72 northern WSDOT’s Anacortes Ferry Terminal modifications even further. elephant seals, 612 harbor porpoises, tie-up dolphins and wingwall Additionally, no important feeding and/ 108 Dall’s porpoises, 70 transient killer replacement project would involve or reproductive areas for marine whales, 4 Southern Resident killer vibratory pile removal and pile driving mammals are known to be near the whales, 360 Pacific white-sided activities. Elevated underwater noises proposed action area. Therefore, the dolphins, 36 gray whales, 30 humpback are expected to be generated as a result take resulting from the proposed whales, and 10 minke whales could be of these activities; however, these noises Anacortes Ferry Terminal tie-up exposed to received noise levels that are expected to result in no mortality or dolphins and wingwall replacement could cause Level B behavioral Level A harassment and limited Level B work is not reasonably expected to, and harassment from the proposed harassment of marine mammals. is not reasonably likely to, adversely construction work at the Anacortes WSDOT will not use impact hammer for affect the marine mammal species or Ferry Terminal in Washington State. pile driving, thus eliminating the stocks through effects on annual rates of These numbers represent approximately potential for injury (including PTS) and recruitment or survival. 0.06% to 20% of the populations of TTS from noise impact. For vibratory The project area is not a prime habitat these species that could be affected by pile removal and pile driving, noise for marine mammals, nor is it Level B behavioral harassment, levels are not expected to reach the level considered an area frequented by respectively (see Table 5 above), which that may cause TTS, injury (including marine mammals. Therefore, behavioral are small percentages relative to the PTS), or mortality to marine mammals. disturbances that could result from total populations of the affected species Therefore, NMFS does not expect that anthropogenic noise associated with or stocks. any animals would experience Level A WSDOT’s construction activities are Based on the analysis contained harassment (including injury or PTS) or expected to affect only a small number herein of the likely effects of the Level B harassment in the form of TTS of marine mammals on an infrequent specified activity on marine mammals from being exposed to in-water pile and limited basis. and their habitat, and taking into removal and pile driving associated The project also is not expected to consideration the implementation of the with WSDOT’s construction project. have significant adverse effects on mitigation and monitoring measures, Additionally, the sum of noise from affected marine mammals’ habitat, as which are expected to reduce the WSDOT’s proposed Anacortes Ferry analyzed in detail in the ‘‘Anticipated number of marine mammals potentially Terminal tie-up dolphins and wingwall Effects on Marine Mammal Habitat’’ affected by the proposed action, NMFS replacement construction activities is section. The project activities would not finds that small numbers of marine confined to a limited area by modify existing marine mammal habitat. mammals will be taken relative to the

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populations of the affected species or 2015. A copy of the EA and FONSI is mailbox address for providing email stocks. available upon request (see ADDRESSES). comments is [email protected]. Please include 0648–XD807 in the Impact on Availability of Affected Authorization subject line. NMFS is not responsible Species for Taking for Subsistence Uses NMFS has issued an IHA to WSDOT for email comments sent to addresses There are no subsistence uses of for the potential harassment of small other than the one provided here. marine mammals in the proposed numbers of 11 marine mammal species Comments sent via email, including all project area; and, thus, no subsistence incidental to the Anacortes Ferry attachments, must not exceed a 25- uses impacted by this action. Therefore, Terminal tie-up slip dolphins and megabyte size. NMFS has determined that the total wingwall replacement construction in All comments received are a part of taking of affected species or stocks Washington State, provided the the public record and will generally be would not have an unmitigable adverse previously mentioned mitigation, posted to http://www.nmfs.noaa.gov/pr/ impact on the availability of such monitoring, and reporting requirements permits/incidental/ without change. All species or stocks for taking for are incorporated. Personal Identifying Information (for subsistence purposes. Dated: May 12, 2015. example, name, address, etc.) Endangered Species Act (ESA) Donna S. Wieting, voluntarily submitted by the commenter may be publicly accessible. Do not The humpback whale and the Director, Office of Protected Resources, submit Confidential Business Southern Resident stock of killer whale National Marine Fisheries Service. Information or otherwise sensitive or are the only marine mammal species [FR Doc. 2015–12097 Filed 5–18–15; 8:45 am] protected information. currently listed under the ESA that BILLING CODE 3510–22–P An electronic copy of the IHA could occur in the vicinity of WSDOT’s application containing a list of the proposed construction projects. Under references used in this document may section 7 of the ESA, the Federal DEPARTMENT OF COMMERCE be obtained by writing to the address Highway Administration (FHWA) and specified above, telephoning the contact WSDOT have consulted with NMFS National Oceanic and Atmospheric listed below (see FOR FURTHER West Coast Regional Office (WCRO) on Administration INFORMATION CONTACT), or visiting the the proposed WSDOT Anacortes Ferry RIN 0648–XD807 Internet at: http://www.nmfs.noaa.gov/ Terminal tie-up slip dolphins and pr/permits/incidental/. Documents cited wingwall replacement project. WCRO Takes of Marine Mammals Incidental to in this notice, including the IHA issued a Biological Opinion on July 15, Specified Activities; Construction application, may also be viewed, by 2014, which concludes that the Activities at the Children’s Pool appointment, during regular business proposed Anacortes Ferry Terminal tie- Lifeguard Station at La Jolla, California hours, at the aforementioned address. up slip dolphins and wingwall AGENCY: National Marine Fisheries FOR FURTHER INFORMATION CONTACT: replacement project may affect, but is Service (NMFS), National Oceanic and not likely to adversely affect the listed Howard Goldstein or Jolie Harrison, Atmospheric Administration (NOAA), Office of Protected Resources, NMFS, marine mammal species and stocks. Commerce. The issuance of an IHA to WSDOT 301–427–8401. constitutes an agency action that ACTION: Notice; proposed Incidental SUPPLEMENTARY INFORMATION: Harassment Authorization (IHA); authorizes an activity that may affect Background ESA-listed species and, therefore, is request for comments. Sections 101(a)(5)(A) and (D) of the subject to section 7 of the ESA. As the SUMMARY: NMFS has received an MMPA (16 U.S.C. 1361 et seq.), directs effects of the activities on listed marine application from the City of San Diego the Secretary of Commerce (Secretary) mammals were analyzed during a for an IHA to take small numbers of to allow, upon request, the incidental, formal consultation between the FHWA marine mammals, by Level B but not intentional, taking of small and NMFS, and as the underlying action harassment, incidental to construction numbers of marine mammals, by United has not changed from that considered in activities at the Children’s Pool States citizens who engage in a specified the consultation, the discussion of Lifeguard Station in La Jolla, California. activity (other than commercial fishing) effects that are contained in the NMFS has reviewed the IHA within a specified geographical region if Biological Opinion and accompanying application, including all supporting certain findings are made and either memo issued to the FHWA on July 15, documents, and determined that it is regulations are issued or, if the taking is 2014, pertains also to this action. adequate and complete. Pursuant to the limited to harassment, a notice of a Therefore, NMFS has determined that Marine Mammal Protection Act proposed authorization is provided to issuance of an IHA for this activity (MMPA), NMFS is requesting comments the public for review. would not lead to any effects to listed on its proposal to issue an IHA to the Authorization for the incidental marine mammal species apart from City of San Diego to take, by Level B takings shall be granted if NMFS finds those that were considered in the harassment only, three species of that the taking will have a negligible consultation on FHWA’s action. marine mammals during the specified impact on the species or stock(s), will activities. National Environmental Policy Act not have an unmitigable adverse impact (NEPA) DATES: Comments and information must on the availability of the species or NMFS prepared an Environmental be received no later than June 18, 2015. stock(s) for subsistence uses (where Assessment (EA) and analyzed the ADDRESSES: Comments on the IHA relevant), and if the permissible potential impacts to marine mammals application should be addressed to Jolie methods of taking and requirements that would result from WSDOT’s Harrison, Chief, Permits and pertaining to the mitigation, monitoring, Anacortes Ferry Terminal tie-up slip Conservation Division, Office of and reporting of such takings are set dolphins and wingwall replacement Protected Resources, National Marine forth. NMFS has defined ‘‘negligible project. A Finding of No Significant Fisheries Service, 1315 East-West impact’’ in 50 CFR 216.103 as ‘‘. . . an Impact (FONSI) was signed in May Highway, Silver Spring, MD 20910. The impact resulting from the specified

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activity that cannot be reasonably IHA for an additional year. The application) with completion of the new expected to, and is not reasonably likely construction activities are planned to lifeguard station to be completed by to, adversely affect the species or stock take place during June 2015 to June December 15, 2015. The City of San through effects on annual rates of 2016 in La Jolla, CA. Regarding the Diego and NMFS are requiring a recruitment or survival.’’ previous IHA, NMFS published a notice moratorium on all construction Section 101(a)(5)(D) of the MMPA in the Federal Register (79 FR 8160) on activities during harbor seal pupping established an expedited process by February 11, 2014, making preliminary and weaning (i.e., December 15th to which citizens of the United States can determinations and proposing to issue May 30th; see page 5 of the Mitigated apply for an authorization to an IHA. The notice initiated a 30-day Negative Declaration in the IHA incidentally take small numbers of public comment period. On June 6, application). Therefore, work on this marine mammals by harassment. 2014, NMFS published a notice in the project can only be performed between Section 101(a)(5)(D) of the MMPA Federal Register (79 FR 32699) June 1st and December 14th of any year. establishes a 45-day time limit for announcing the issuance of an IHA. Proposed construction activities NMFS’s review of an application Additional information on the would generally occur Monday through followed by a 30-day public notice and construction activities at the Children’s Friday (no work will occur on holidays) comment period on any proposed Pool Lifeguard Station is contained in during daylight hours only, as authorizations for the incidental the IHA application, which is available stipulated in the ‘‘Mitigated Negative harassment of small numbers of marine upon request (see ADDRESSES). Declaration’’ included in the IHA mammals. Within 45 days of the close Also, NMFS issued the City of San application and local ordinances. As a of the public comment period, NMFS Diego an IHA in 2013 (78 FR 40705, July modification to the original IHA, the must either issue or deny the 8, 2013) for demolition and construction City of San Diego has requested that authorization. activities at the Children’s Pool planned construction activities be Except with respect to certain Lifeguard Station that were scheduled to allowed on weekends (i.e., Saturday and activities not pertinent here, the MMPA be completed in 2013. Because the Sunday to ensure completion of the defines ‘‘harassment’’ as: any act of construction activities were subject to project during 2015. The exact dates of pursuit, torment, or annoyance which (i) delays (e.g., nesting migratory birds, the proposed activities depend on has the potential to injure a marine unexpected drainage pipes, unexpected logistics and scheduling. The IHA is mammal or marine mammal stock in the demolition and construction planning, wild [Level A harassment]; or (ii) has valid through June 2016 to allow for etc.) and could not be completed by construction delays. the potential to disturb a marine December 15, 2013, the City of San mammal or marine mammal stock in the Diego requested a renewal of the 2013 Proposed Specific Geographic Region wild by causing disruption of behavioral IHA for an additional year. Additional patterns, including, but not limited to, The La Jolla Children’s Pool Lifeguard information on the construction 1 migration, breathing, nursing, breeding, Station is located at 827 ⁄2 Coast activities at the Children’s Pool Boulevard, La Jolla, CA 92037 (32° 50′ feeding, or sheltering [Level B Lifeguard Station is contained in the ″ ° ′ ″ harassment]. 50.02 North, 117 16 42.8 West). The IHA application, which is available locations and distances (in ft) from the Summary of Request upon request (see ADDRESSES). construction site to the Children’s Pool On February 25, 2015, NMFS received Description of the Proposed Specified haul-out area, breakwater ledge/rocks an application from the City of San Activity haul-out area, reef haul-out area, and Diego, Engineering and Capital Projects Casa Beach haul-out area can be found Department, requesting an IHA for the Overview in the City of San Diego’s IHA taking of marine mammals incidental to The City of San Diego plans to application. construction activities. NMFS conduct construction activities at the Detailed Description of the Proposed determined that the IHA application Children’s Pool Lifeguard Station in La Specified Activities was adequate and complete on April 9, Jolla, CA in order to meet the needs of 2015. the lifeguards at Children’s Pool and the The Children’s Pool was created in The City of San Diego would demand for lifeguard services. The 1931 by building a breakwater wall undertake the proposed construction overall project includes the demolition which created a protected pool for activities between June 2015 and June of the existing lifeguard station and swimming. Although partially filled 2016 at the Children’s Pool Lifeguard construction of a new, three-story, with sand, the Children’s Pool still has Station in La Jolla, California. In-air lifeguard station on the same site. open water for swimming and a beach noise generated from equipment used Demolition of the existing lifeguard for sunbathing and beachcombing. The during the construction activities is station was completed in 2013 to 2014 Children’s Pool and nearby shore areas likely to result in the take of marine and construction of the new lifeguard (i.e., shoreline, beaches, and reefs of La mammals. The requested IHA would station is expected to be completed in Jolla) are used by swimmers, authorize the take, by Level B 2015 to 2016. Because the previously sunbathers, SCUBA divers and (behavioral) harassment, of small existing lifeguard station was snorkelers, shore/surf fishermen, school numbers of Pacific harbor seals (Phoca demolished and closed to entry, a classes, tide pool explorers, kayakers, vitulina richardii), California sea lions temporary lifeguard tower was moved surfers, boogie and skim boarders, seal, (Zalophus californianus), and northern onto the bluff near the previous sea lion, bird and nature watchers, and elephant seals (Mirounga angustirostris) lifeguard station. for other activities by the general public. incidental to construction activities of Over the last three years (2010 through the Children’s Pool Lifeguard Station at Proposed Dates and Duration 2012), an average of 1,556,184 people La Jolla, CA. Because the proposed The City of San Diego is planning to have visited the Children’s Pool construction activities were subject to begin/resume the project at the annually, and lifeguards have taken an delays and cannot be completed by June Children’s Pool in La Jolla, CA on June average of 8,147 preventive actions and 27, 2015, the City of San Diego has 1, 2015, (see page 30 to 31 of the 86 water rescues annually (CASA, 2010; requested a renewal of the 2014 to 2015 Negative Declaration in the IHA 2011; 2012).

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The previous lifeguard facility at community. Enhanced paving, seating This phase will be completed in 2015 Children’s Pool, built in 1967, was old, and viewing space, drinking fountains, and has a maximum source level of 100 deteriorating from saltwater intrusion, adapted landscaping, and water efficient dB. and no longer served the needs of the irrigation will also be included. (6.) Building exterior: lifeguard staff or the beach-going public. The City of San Diego has divided the Doors and windows, siding paint, The structure was condemned on demolition and construction activities light fixtures, and plumbing fixtures. February 22, 2008 due to its deteriorated are divided into phases: Equipment—truck, hand/power tools, condition and lack of structural (1.) Mobilization and temporary and chop saw. integrity. Because the existing building facilities; Timeframe—Approximately 4 weeks. was no longer viable, a temporary (2.) Demolition and site clearing; This phase will be completed in 2015 lifeguard tower was moved in. However, (3.) Site preparation and utilities; and has a maximum source level of 100 a new lifeguard station is required to (4.) Building foundation; dB. meet the needs of the lifeguards and the (5.) Building shell; (7.) Building interiors: demand for lifeguard services. (6.) Building exterior; Walls, sewage lift station, rough and finish mechanical electrical plumbing The overall project includes the (7.) Building interior; structural (MEPS), wall board, door demolition of the existing lifeguard (8.) Site improvements; and frames, doors and paint. station and construction of a new, three- (9.) Final inspection and Equipment—truck, hand/power tools, story, lifeguard station on the same site. demobilization. and chop saw. Demolition and construction of the Demolition and removal of the existing Timeframe—Approximately 37 days. lifeguard station was completed in 2013 new lifeguard station was initially This phase will be completed in 2015 to 2014 and construction of the new estimated to take approximately 7 and has a maximum source level of 100 lifeguard station is expected to be months (148 actual demolition and dB. completed in 2015 to 2016. The construction days) and be completed by (8.) Site improvements: building contractor utilized excavators, December 15, 2013; however, Modify storm drain, concrete seat backhoes, concrete saws, and demolition and construction did not walls, curbs, and planters, fine grade, jackhammers for demolishing the start until later than previously planned irrigation, hardscape, landscape, hand previous structure and has hauled the in June 2013 and June 2014 due to the rails, plaques, and benches. waste materials to an offsite landfill presence of nesting migratory birds (i.e., Equipment—backhoe, truck, hand/ where it was separated into recycled Western seagulls [Larus occidentalis] power tools, concrete pump/truck, and content and waste. During the second and eggs/chicks). There were additional fork lift. year of construction (2014 to 2015) and unexpected delays in the demolition Timeframe—Approximately 37 days. in the same footprint as the old due to unforeseen underground This phase will be completed in 2015 lifeguard station, the new lifeguard structures at the site making it and has a maximum source level of 110 station is being constructed within and impossible to finish the project by dB. adjacent to the previous facility. Rough December 15, 2013 or 2014. The City of (9.) Final inspection and plumbing and electrical have been laid; San Diego completed phases 1 to 4 demobilization: the foundation has been poured and during 2013 and 2014. During the 2013 System testing, remove construction some of the steel structure has been to 2014 construction window, the equipment, inspection, and corrections. erected. The new lifeguard facility is in temporary on-site tower was removed Equipment—truck, and hand/power an optimal location to provide lifeguard and two temporary towers were tools. service to the community. The new, installed nearby (one about 500 m Timeframe—Approximately 41 days. three-story, building will contain a [1,640.4 ft] south of the construction site This phase will be completed in 2015 lower level with beach access level and another about 1,000 m [3,280.8 ft] and has a maximum source level of 100 public restrooms and showers, lifeguard east of the construction site to serve dB. lockers, and sewage pump room; a citizens utilizing the beaches and ocean The exact dates of the planned second level with two work stations, waters nearby. Construction of phases 5 activities depend on logistics and ready/observation room, kitchenette, to 9 would commence in June 2015, scheduling. restroom, and first aid station; and a thereby necessitating a renewal of the Sound levels during all phases of the third ‘‘observation’’ level (with a 270° previous IHA. project would not exceed 110 dB re 20 view of the beach and nearby reef areas) The notice of the final IHA for the mPa at five feet from the sound sources. with a single occupancy observation City of San Diego’s demolition and The 110 dB estimate is based on space, radio storage closet, and exterior construction activities that was equipment manufacturers’ estimates catwalk. Interior stairs will link the published in the Federal Register on obtained by the construction contractor. floors. The existing below grade July 8, 2013 (78 FR 40705) provides a The City of San Diego utilized retaining walls will remain in place and detailed summary on phases 1 to 4 (i.e., published or manufacturers’ new retaining walls will be constructed mobilization and temporary facilities, measurement data based on the for a ramp from street level to the lower demolition and site clearing, site proposed equipment (i.e., a backhoe, level for emergency vehicle beach preparation and utilities, and building dump truck, cement pump, air access and pedestrian access to the foundation). Phases 5 to 9 include compressor, electric screw guns, lower level restrooms and showers. A (phases overlap in time): jackhammers, concrete saw, chop saw, 5.6 m (18. 5 ft) wall will be located (5.) Building shell: and hand tools) to be utilized on the along the north end of the lower level. Pre-cast concrete panel walls, panel project site. Operation of the equipment The walls will be designed for a walls, rough carpentry and roof framing, is the primary activity within the range minimum design life of 50 years and wall board, cable railing, metal flashing, of construction activities that is likely to will not be undermined from ongoing and roofing. affect marine mammals by potentially coastal erosion. The walls will not be Equipment—crane, truck, fork lift, exposing them to in-air (i.e., airborne or readily viewed from Coast Boulevard, and hand/power tools. sub-aerial) noise. During the working the public sidewalks or the surrounding Timeframe—Approximately 35 days. day, the City of San Diego estimates

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there would be sound source levels and mean distance from sound sources species of marine mammals that occur above 90 dB re 20 mPa, including 65 by the type of equipment and and are likely to be found within the days of 100 to 110 dB re 20 mPa at the monitoring location. The City of San immediate vicinity of the activity area. construction site. Diego intends to continue to measure in- Therefore, these three species are likely On average, pinnipeds will be about air background noise levels in the days to be exposed to effects of the proposed 30.5 meters (m) (100 feet [ft]) or more immediately prior to, during, and after specified activities. A variety of other from the construction site with a the construction activities. marine mammals have on occasion been Additional details regarding the potential minimum of about 15.2 m (50 reported in the coastal waters off proposed construction activities of the southern California. These include gray ft). During 2013 and 2014, measured Children’s Pool Lifeguard Station can be sound levels from the demolition whales, killer whales, bottlenose found in the City of San Diego’s IHA dolphins, Steller sea lions, northern fur equipment reaching the pinnipeds did application. The IHA application can seals, and Guadalupe fur seals. not exceed approximately 90 dB re 20 also be found online at: http:// However, none of these species have mPa at the haul-out area closest to the www.nmfs.noaa.gov/pr/permits/ been reported to occur in the immediate demolition and construction and a peak incidental/construction.htm. of about 83 dB re 20 mPa at the mean proposed action area of the Children’s hauling-out distance (30.5 m). The City Description of Marine Mammals in the Pool beach. Therefore, NMFS does not of San Diego used the formula and Specified Geographic Area of the expect, and is not authorizing, online calculator on the Web site: Proposed Specified Activity incidental take of other marine mammal http://sengpielaudio.com/calculator- Three species of pinnipeds are known species from the proposed specified distance.htm and measured distances to or could occur in the Children’s Pool activities. Table 1 below identifies the from the sound source to determine the proposed action area and off the Pacific cetacean and pinnipeds species, their area of potential impacts from in-air coastline (see Table 1 below). Pacific habitat, and conservation status in the sound. Table 1 of the City of San Diego’s harbor seals, California sea lions, and nearshore area of the general region of monitoring report provides mean sound northern elephant seals are the three the proposed project area.

TABLE 1—THE HABITAT, ABUNDANCE, AND CONSERVATION STATUS OF MARINE MAMMALS INHABITING THE GENERAL REGION OF THE ACTION AREA IN THE PACIFIC OCEAN OFF THE SOUTHERN COAST OF CALIFORNIA

Best population 2 3 Species Habitat Occurrence Range estimate ESA MMPA (minimum) 1

Mysticetes

Gray whale (Eschrichtius Coastal and Transient dur- North Pacific Ocean, 20,990 DL—Eastern NC—Eastern robustus). shelf. ing season Gulf of California to (20,125). Pacific stock. North Pacific migrations. Arctic—Eastern North EN—Western stock Pacific stock. Pacific stock. D—Western North Pacific stock.

Odontocetes

Killer whale (Orcinus Widely distrib- Varies on inter- Cosmopolitan ...... 354 (354)— NL ...... NC orca). uted. annual basis. West Coast EN—Southern D—Southern Resi- Transient resident pop- dent and AT1 stock. ulation. Transient popu- lations. Bottlenose dolphin Offshore, Limited, small Tropical and temperate 323 (290)— NL ...... NC. (Tursiops truncatus). inshore, population waters between 45° California coastal, estu- within 1 km North and South. Coastal aries. of shore. stock. Long-beaked common Inshore ...... Common, more Nearshore and tropical 107,016 NL ...... NC. dolphin (Delphinus inshore dis- waters. (76,224)— capensis). tribution, California year-round stock. presence.

Pinnipeds

Pacific harbor seal Coastal ...... Common ...... Coastal temperate to 30,968 NL ...... NC. (Phoca vitulina polar regions in North- (27,348)— richardii). ern Hemisphere. California stock. Northern elephant seal Coastal, pe- Common ...... Eastern and Central 179,000 NL ...... NC. (Mirounga lagic when North Pacific—Alaska (81,368)— angustirostris). not migrating. to Mexico. California breeding stock. California sea lion Coastal, shelf .. Common ...... Eastern North Pacific 296,750 NL ...... NC. (Zalophus californianus). Ocean—Alaska to (153,337)— Mexico. U.S. stock.

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TABLE 1—THE HABITAT, ABUNDANCE, AND CONSERVATION STATUS OF MARINE MAMMALS INHABITING THE GENERAL REGION OF THE ACTION AREA IN THE PACIFIC OCEAN OFF THE SOUTHERN COAST OF CALIFORNIA—Continued

Best population 2 3 Species Habitat Occurrence Range estimate ESA MMPA (minimum) 1

Steller sea lion Coastal, shelf .. Rare ...... North Pacific Ocean— 72,223 DL—Eastern D. (Eumetopias jubatus). Central California to (52,847)— U.S. stock. Korea. Eastern EN—Western U.S. stock. U.S. stock. Northern fur seal Pelagic, off- Rare ...... North Pacific Ocean— 12,844 NL ...... NC—California (Callorhinus ursinus). shore. Mexico to Japan. (6,722)— stock. California stock. Guadalupe fur seal Coastal, shelf .. Rare ...... California to Baja Cali- 7,408 T ...... D. (Arctocephalus fornia, Mexico. (3,028)— townsendi). Mexico to California. NA = Not available or not assessed. 1 NMFS Marine Mammal Stock Assessment Reports 2 U.S. Endangered Species Act: EN = Endangered, T = Threatened, DL = Delisted, and NL = Not listed. 3 U.S. Marine Mammal Protection Act: D = Depleted, S = Strategic, and NC = Not classified.

The rocks and beaches at or near the make extensive pelagic migrations, but for foraging (Perrin et al., 2008). Of the Children’s Pool in La Jolla, CA, are do travel 300 to 500 kilometers (km) known haul-out sites, 14 locations are almost exclusively Pacific harbor seal (162 to 270 nautical miles [nmi]) on rookeries (2 locations have multiple hauling-out sites. On infrequent occasion to find food or suitable sites, for a total of 17 sites) on or near occasions, one or two California sea breeding areas (Herder, 1986; Harvey the mainland of California. The lions or a single juvenile northern and Goley, 2011). Previous assessments population of harbor seals has grown off elephant seal have been observed on the of the status of harbor seals have the U.S. west coast and has led to new sand or rocks at or near the Children’s recognized three stocks along the west haul-out sites being used in California Pool (i.e., breakwater ledge/rocks haul- coast of the continental U.S.: (1) (Hanan, 1996). Harbor seals are one of out area, reef haul-out area, and Casa California, (2) Oregon and Washington the most common and frequently Beach haul-out area). These sites are not outer coast waters, and (3) inland waters observed marine mammals along the usual haul-out locations for California of Washington. An unknown number of coastal environment. sea lions and/or northern elephant seals. harbor seals also occur along the west The City of San Diego commissioned Harbor seals have been observed coast of Baja California, at least as far hauling-out and documented giving two studies of harbor seal abundance south as Isla Asuncion, which is about trends at the Children’s Pool. Both birth at the Children’s Pool since the 100 miles south of Punta Eugenia. 1990’s (Yochem and Stewart, 1998; studies reported that appearances of Animals along Baja California are not California sea lions and northern Hanan & Associates, 2004). Pacific considered to be a part of the California harbor seals haul-out year-round on elephant seals are infrequent, but not stock because it is not known if there is rare at Children’s Pool (Yochem and beaches and rocks (i.e., breakwater any demographically significant ledge/rocks haul-out area, reef haul-out Stewart, 1998; Hanan, 2004; Hanan & movement of harbor seals between Associates, 2011). During 2013, the City area, and Casa Beach haul-out area) California and Mexico and there is no below the lifeguard tower at Children’s of San Diego observed one juvenile and international agreement for joint three adult California sea lions and two Pool. According to Yochem (2005), the management of harbor seals. Harbor seal Children’s Pool beach site is used by juvenile northern elephant seals at the presence at haul-out sites is seasonal Children’s Pool. During 2014, the City of harbor seals at all hours of the day and with peaks in abundance during their at all tides with the exception of San Diego observed 22 California sea pupping and molting periods. Pupping lions (during 19 days) and 30 juvenile occasional high tide/high swell events and molting periods are first observed to in which the entire beach is awash. It is elephant seals (during 29 days) at the the south and progress northward up Children’s Pool. Adult sea lions were one of the three known haul-out sites for the coast with time (e.g., January to May this species in San Diego County. These also observed hauling out on rocks and near San Diego, April to June in Oregon cliffs near the Children’s Pool. animals have been observed in this area and Washington) (Jeffries, 1984; Jeffries, moving to/from the Children’s Pool, Pacific Harbor Seal 1985; Huber et al., 2001; Hanan, 2004; exchanging with the rocky reef directly Harbor seals are widely distributed in Hanan & Associates, 2011). west of and adjacent to the breakwater the North Atlantic and North Pacific. In California, approximately 400 to and with Seal Rock, which is about 150 Two subspecies exist in the Pacific 600 harbor seal haul-out sites are m (492 ft) west of the Children’s Pool. Ocean: P. v. stejnegeri in the western distributed along the mainland coast Harbor seals have also been reported on North Pacific near Japan, and P. v. and on offshore islands, including the sandy beach just southwest of the richardii in the eastern North Pacific. intertidal sandbars and ledges, rocky Children’s Pool. At low tide, additional The subspecies in the eastern North shores and islets, and beaches (Harvey space for hauling-out is available on the Pacific Ocean inhabits near-shore et al., 1995; Hanan, 1996; Lowry et al., rocky reef areas outside the retaining coastal and estuarine areas from Baja 2008). Preferred haul-out sites are those wall and on beaches immediately California, Mexico, to the Pribilof that are protected from the wind and southward. Haul-out times vary by time Islands in Alaska. These seals do not waves, and allow access to deep water of year, from less than an hour to many

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hours. There have been no foraging average number of harbor seals on the would expect similar numbers in 2015 studies at this site, but harbor seals have beach varied from 83 to 120 animals to 2016. been observed in nearshore waters and before people entered the beach or when A complete count of all harbor seals kelp beds nearby, including La Jolla people were behind the rope. During in California is impossible because some Cove. this same period, when people were on are always away from the haul-out sites. The Children’s Pool area is the only the beach and/or across the rope, the A complete pup count (as is done for rookery in San Diego County and the average number of harbor seals varied other pinnipeds in California) is also not only mainland rookery on the U.S. west from 7 to 27. The City of San Diego possible because harbor seals are coast between the border of Mexico and observed 12 counts totaling more than precocial, with pups entering the water Point Mugu in Ventura County, CA 200 and a maximum of 238 animals almost immediately after birth. (321.9 km [200 miles]). The number of during the 2014 to 2015 construction Population size is estimated by counting harbor seals in this area has increased window. The weather (i.e., wind and/or the number of seals ashore during the since 1979, and seals are documented to rain) and the proximity of humans to peak haul-out period (May to July) and give birth on these beaches during the beach likely affect the presence of by multiplying this count by a December through May (Hanan, 2004; harbor seals on the beach. correction factor equal to the inverse of Hanan & Associates, 2011). The official Radio-tagging and photographic the estimated fraction of seals on land. start to pupping season is December 15. studies have revealed that only a Based on the most recent harbor seal Females in an advanced stage of portion of seals utilizing a hauling-out counts (2009) and including a revised pregnancy begin to show up on the site are present at any specific moment correction factor, the estimated Children’s Pool beach by late October to or day (Hanan, 1996, 2005; Gilbert et al., population of harbor seals in California early November. Several studies have 2005; Harvey and Goley, 2011; and is 30,196 individuals (NMFS, 2011), identified harbor seal behavior and Linder, 2011). These radio-tagging with an estimated minimum population estimated harbor seal numbers studies indicate that harbor seals in of 26,667 for the California stock of including patterns of daily and seasonal Santa Barbara County haul-out about 70 harbor seals. Counts of harbor seals in area use (Yochem and Stewart, 1998; to 90% of the days annually (Hanan, California increased from 1981 to 2004. Hanan & Associates, 2011; Linder, 1996). The City of San Diego expects The harbor seal is not listed under the 2011). Males, females, and pups (in harbor seals to behave similarly at the ESA and the California stock is not season) of all ages and stages of Children’s Pool. Tagged and branded considered depleted or strategic under development are observed at the harbor seals from other haul-out sites the MMPA (Carretta et al., 2010). Children’s Pool and adjacent areas. have been observed by Dr. Hanan at the California Sea Lion In southern California, a considerable Children’s Pool. For example, harbor amount of information is known about seals with red-stained heads and coats, The California sea lion is a full the movements and ecology of harbor which are typical of some harbor seals species, separate from the Galapagos sea seals, but population structure in the in San Francisco Bay have been lion (Zalophus wollebaeki) and the region is not as well known (Stewart observed at Children’s Pool, indicating extinct Japanese sea lion (Zalophus and Yochem, 1994, 2000; Keper et al., that seals tagged at other locations and japonicus) (Brunner, 2003; Wolf et al., 2005; Hanan & Associates, 2011). Linder haul-out sites visit the site. A few seals 2007; Schramm et al., 2009). This (2011) suggests that this population have been tagged at the Children’s Pool species of sea lion is found from moves along the California coast and the and there are no reports of these tagged southern Mexico to southwestern beach at Children’s Pool is part of a animals at other sites (probably because Canada. The breeding areas of the ‘‘regional network of interconnected’’ of very low re-sighting efforts and a California sea lion are on islands located haul-out and pupping sites. Harbor seals small sample size [10 individuals radio- in southern California, western Baja often haul-out in protected bays, inlets, tagged]), which may indicate a degree of California, and the Gulf of California. A and beaches (Reeves et al., 1992). At and site-fidelity (Yochem and Stewart, genetic analysis of California sea lions near the Children’s Pool, harbor seals 1998). These studies further indicate identified five genetically distinct haul-out on the sand, rocks, and that seals are constantly moving along geographic populations: (1) Pacific breakwater base in numbers of 0 to 15 the coast including to/from the offshore Temperate, (2) Pacific Subtropical, (3) harbor seals to a maximum of about 150 islands and that there may be as many Southern Gulf of California, (4) Central to 250 harbor seals depending on the as 600 individual harbor seals using Gulf of California, and (5) Northern Gulf time of day, season, and weather Children’s Pool during a year, but of California (Schramm et al., 2009). In conditions (Hanan, 2004, Hanan & certainly not all at one time. that study, the Pacific Temperate Associates, 2011; Linder, 2011). Because The City of San Diego has fitted a population included rookeries within space is limited behind the breakwater polynomial curve to the number of U.S. waters and the Coronados Islands at the Children’s Pool, Linder (2011) expected harbor seals hauling-out at the just south of U.S./Mexico border. predicted that it is unlikely that Children’s Pool by month (see Figure 1 Animals from the Pacific Temperate numbers will exceed 250 harbor seals. of the IHA application and Figure 2 population range north into Canadian Based on monitoring from a camera, below) based on counts at the Children’s waters, and movement of animals Western Alliance for Nature (WAN) Pool by Hanan (2004), Hanan & between U.S. waters and Baja California reported that during the month of May Associates (2011), Yochem and Stewart waters has been documented, though 2013 up to 302 harbor seals were (1998), and the Children’s Pool docents the distance between the major U.S. and documented resting on the Children’s (Hanan, 2004). A three percent annual Baja California rookeries is at least 740.8 Pool beach at any given time, with growth rate of the population was km (400 nmi). Males from western Baja additional harbor seals on the rocks and applied to Yochem and Stewart (1998) California rookeries may spend most of in the water (Wan, personal counts to normalize them to Hanan & the year in the United States. communication). Almost every day, Associates and docent counts in 2003 to The entire California sea lion except for weekends, over 250 2004. Based on monitoring during 2013 population cannot be counted because individual harbor seals were present on to 2014, Dr. Hanan estimates that all age and sex classes are never ashore the beach. During the months of similar numbers of harbor seals hauling- at the same time. In lieu of counting all September 2012 to January 2013, the out at Children’s Pool during 2011 and sea lions, pups are counted during the

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breeding season (because this is the only counting the number of pups produced later in this document will include a age class that is ashore in its entirety), and multiplying by the inverse of the quantitative analysis of the number of and the numbers of births is estimated expected ratio of pups to total animals individuals that are expected to be taken from the pup count. The size of the (McCann, 1985). Based on counts of by this activity. The ‘‘Negligible Impact population is then estimated from the elephant seals at U.S. rookeries in 2010, Analysis’’ section will include the number of births and the proportion of Lowry et al. (2014) reported that 40,684 analysis of how this specific activity pups in the population. Censuses are pups were born. Lowry et al. (2014) will impact marine mammals and will conducted in July after all pups have applied a multiplier of 4.4 to extrapolate consider the content of this section, the been born. There are no rookeries at or from total pup counts to a population ‘‘Estimated Take by Incidental near the Children’s Pool, although in the estimate of approximately 179,000 Harassment’’ section, the ‘‘Proposed past two years births have been reported elephant seals. This multiplier is Mitigation’’ section, and the at La Jolla Cove (about 0.75 km [0.47 derived from life tables based on ‘‘Anticipated Effects on Marine Mammal miles] east of Children’s Pool). published elephant seal fecundity and Habitat’’ section to draw conclusions Population estimates for the U.S. stock survival rates, and reflects a population regarding the likely impacts of this of California sea lions range from a with approximately 23% pups (Cooper activity on the reproductive success or minimum of 153,337 to an average and Stewart, 1983; Le Boeuf and Reiter, survivorship of individuals and from estimate of 296,750 animals. They are 1988; Hindell 1991; Huber et al., 1991; that on the affected marine mammal considered to be at carrying capacity of Reiter and Le Boeuf, 1991; Clinton and populations or stocks. the environment. The California sea lion Le Boeuf, 1993; Le Boeuf et al., 1994; When considering the influence of is not listed under the ESA and the U.S. Pistorius and Bester, 2002; McMahon et various kinds of sound on the marine stock is not considered depleted or al., 2003; Pistorius et al., 2004; Condit environment, it is necessary to strategic under the MMPA. et al., 2014). The minimum population understand that different kinds of size for northern elephant seals in 2010 marine life are sensitive to different Northern Elephant Seal can be estimated very conservatively as frequencies of sound. Based on available Northern elephant seals breed and 81,368, which is equal to twice the behavioral data, audiograms have been give birth in California (U.S.) and Baja observed pup count (to account for the derived using auditory evoked California (Mexico), primarily on pups and their mothers). The potentials, anatomical modeling, and offshore islands (Stewart et al., 1994) population is reported to have grown at other data, Southall et al. (2007) from December to March (Stewart and 3.8% annually since 1988 (Lowry et al., designate ‘‘functional hearing groups’’ Huber, 1993). Spatial segregation in 2014). Northern elephant seals are not for marine mammals and estimate the foraging areas between males and listed under the ESA and are not lower and upper frequencies of females is evident from satellite tag data considered as depleted or a strategic functional hearing of the groups. The (Le Beouf et al., 2000). Males migrate to stock under the MMPA. functional groups and the associated the Gulf of Alaska and western Aleutian Further information on the biology frequencies are indicated below (though Islands along the continental shelf to and local distribution of these marine animals are less sensitive to sounds at feed on benthic prey, while females mammal species and others in the the outer edge of their functional range migrate to pelagic areas in the Gulf of region can be found in the City of San and most sensitive to sounds of Alaska and the central North Pacific to Diego’s IHA application, which is frequencies within a smaller range feed on pelagic prey (Le Beouf et al., available upon request (see ADDRESSES), somewhere in the middle of their 2000). Adults return to land between and the NMFS Marine Mammal Stock functional hearing range): March and August to molt, with males Assessment Reports, which are available • Low-frequency cetaceans (13 returning later than females. Adults online at: http://www.nmfs.noaa.gov/pr/ species of mysticetes): functional return to their feeding areas again sars/. hearing is estimated to occur between between their spring/summer molting Potential Effects of the Proposed approximately 7 Hz and 30 kHz; and their winter breeding seasons. • Mid-frequency cetaceans (32 Specified Activity on Marine Mammals Populations of northern elephant species of dolphins, six species of larger seals in the U.S. and Mexico have This section includes a summary and toothed whales, and 19 species of recovered after being nearly hunted to discussion of the ways that the types of beaked and bottlenose whales): extinction (Stewart et al., 1994). stressors associated with the proposed functional hearing is estimated to occur Northern elephant seals underwent a specified activity (e.g., construction between approximately 150 Hz and 160 severe population bottleneck and loss of equipment and activities) have been kHz; genetic diversity when the population observed to impact marine mammals. • High-frequency cetaceans (eight was reduced to an estimated 10 to 30 This discussion may also include species of true porpoises, six species of individuals (Hoelzel et al., 2002). reactions that we consider to rise to the river dolphins, Kogia spp., the However, movement and genetic level of a take and those that we do not franciscana (Pontoporia blainvillei), and exchange continues between rookeries consider to rise to the level of take (for four species of cephalorhynchids): when they start breeding (Huber et al., example, with acoustics), we may functional hearing is estimated to occur 1991). The California breeding include a discussion of studies that between approximately 200 Hz and 180 population is now demographically showed animals not reacting at all to kHz; and isolated from the Baja California sound or exhibiting barely measureable • Phocid pinnipeds in water: population. The California breeding avoidance). This section is intended as functional hearing is estimated to occur population is considered in NMFS’s a background of potential effects and between approximately 75 Hz and 100 stock assessment report to be a separate does not consider either the specific kHz; stock. manner in which this activity will be • Otariid pinnipeds in water: A complete population count of carried out or the mitigation that will be functional hearing is estimated to occur elephant seals is not possible because implemented, or how either of those between approximately 100 Hz and 40 all age classes are not ashore will shape the anticipated impacts from kHz. simultaneously. Elephant seal this specific activity. The ‘‘Estimated As mentioned previously in this population size is typically estimated by Take by Incidental Harassment’’ section document, 3 marine mammal species (0

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cetacean and 3 pinniped species) are The primary anticipated adverse around the Children’s Pool less likely to occur in the proposed action impacts upon habitat consist of desirable during construction activities. area. Of the 3 pinniped species likely to temporary changes to the in-air acoustic Proposed Mitigation occur in the City of San Diego’s environment, as detailed in the notice of proposed action area, 2 are classified as the proposed IHA (79 FR 8160, February In order to issue an Incidental Take phocid pinnipeds (i.e., Pacific harbor 11, 2014). These changes are minor, Authorization (ITA) under section seal and northern elephant seal) and, 1 temporary, and limited in duration to 101(a)(5)(D) of the MMPA, NMFS must is classified as an otariid pinniped (i.e., the period of the construction activities. prescribe, where applicable, the California sea lion) (Southall et al., The temporary impacts on the acoustic permissible methods of taking pursuant 2007). The City of San Diego requests environment are not expected to have to such activity, and other means of authorization for Level B harassment of any permanent effects on the species or effecting the least practicable impact on these 3 species of marine mammals (i.e., stock populations of marine mammals such species or stock and its habitat, Pacific harbor seals, California sea lions, occurring at the Children’s Pool. paying particular attention to rookeries, and northern elephant seals) incidental All proposed construction activities mating grounds, and areas of similar to the use of equipment and its are beyond or outside the habitat areas significance, and on the availability of propagation of in-air noise from various where harbor seals and other pinnipeds such species or stock for taking for acoustic mechanisms associated with are found. Visual barriers would be certain subsistence uses (where the construction activities of the erected to shield construction activities relevant). Children’s Pool Lifeguard Station at La from the visual perception and The City of San Diego has established Jolla, CA discussed above. NMFS potentially dampen acoustic effects on the Children’s Pool as a shared beach for considers a species’ functional hearing pinnipeds. Because the public pinnipeds and people (except during group when we analyze the effects of occasionally harasses the harbor seals pupping season when the beach has exposure to sound on marine mammals. with various activities, the NMFS- been closed to the public). In the past, The notice of the proposed IHA (79 qualified PSO monitoring the site would during the pupping season, a rope was FR 8160, February 11, 2014) included a make observations and attempt to placed along the upper part of the beach discussion of the effects of in-air sounds distinguish and attribute any observed with signage to inform and designate from construction activities on harassment to the public or to the how close people can come to the haul- pinnipeds, which included tolerance, proposed construction activities and out area and the pinnipeds. The behavioral disturbance, and hearing give all details in the observation report. timeframe for the rope has been impairment. NMFS refers readers to the If any short-term, temporary impacts to extended so that it is now present year- City of San Diego’s IHA application and habitat due to sounds or visual presence round. The construction activities are NMFS’s EA for additional information of equipment and workers did occur, planned to occur outside the harbor seal on the behavioral reactions (or lack the City of San Diego would expect pupping and weaning periods. thereof) by all types of marine mammals pinniped behavior to return to pre- The City of San Diego would to high levels of in-air sounds. implement the following proposed The potential effects to marine construction conditions soon after the activities are completed, which is mitigation measures to help ensure the mammals described in this section of least practicable impact on marine the document generally do not take into anticipated to occur before the next pupping season (Hanan & Associates, mammals: consideration the monitoring and (1) Prohibition of construction during 2011). mitigation measures described later in pupping season; this document (see the ‘‘Proposed The area of habitat affected is small (2) Daily construction timing; Mitigation’’ and ‘‘Proposed Monitoring and the effects are localized and (3) Construction of visual and and Reporting’’ sections), which are temporary; thus there is no reason to acoustic barriers; designed to effect the least practicable expect any significant reduction in (4) Use of Protected Species impact on affected marine mammal habitat available for foraging and other Observers; species or stocks. habitat uses. No aspect of the project is (5) Establishment of buffer zones; and anticipated to have any permanent (6) Potential abandonment survey. Anticipated Effects on Marine Mammal effect on the location or use of pinniped Visual and acoustic barriers were Habitat haul-outs or related habitat features in constructed in 2013 to mitigate the The rocks and beaches at or near the the area (Hanan & Associates, 2011). effects of the construction activities. The Children’s Pool in La Jolla, CA, are Further, the site is already very visual and acoustic barriers were almost exclusively Pacific harbor seal disturbed by member of the public who constructed of plywood, 1.2 to 2.4 m (4 hauling-out sites. Harbor seals have come to the area during the day and to 8 ft) tall stood on end and held up been observed hauling-out and night to view the pinnipeds. The City of by wood posts. The sheets of plywood documented giving birth at the San Diego and NMFS do not project any were stood upright and held up with Children’s Pool since the 1990’s loss or modification of physical habitat two wooden two by fours hinged to the (Yochem and Stewart, 1998; Hanan & for these species. Any potential top of the frame, so they could be Associates, 2004). It is one of the three temporary loss or modification of collapsed and moved depending on the known haul-out sites for this species in habitat due to in-air noise or visual location and need for access by San Diego County and is the only presence of equipment and workers demolition and construction equipment. rookery in San Diego County and the during the proposed construction The barriers were placed at the site with only mainland rookery on the U.S. west activities is expected by the City of San input from NMFS Southwest Regional coast between the border of Mexico and Diego and NMFS to be quickly restored Office (SWRO) personnel so that they Point Mugu in Ventura County, CA. after construction activities end and all will hide as advantageously as possible More information on this population of equipment and barriers are removed. the construction activities that may be Pacific harbor seals can be found in the For these reasons, NMFS anticipates seen by pinnipeds. The barriers appear ‘‘Description of Marine Mammals in the that the proposed action would result in to dampen the acoustic sound sources, Specified Geographic Area of the no impacts to marine mammal habitat but do not prevent sound from Proposed Specified Activity.’’ beyond rendering the areas immediately permeating the environment. The

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barriers also appear to hide and reduce Prohibition of Construction During construction activities no longer exceed visual cues that may stimulate Pupping Season levels that are potentially harmful to behavioral reactions from the pinnipeds Construction shall be prohibited marine mammals. on the beach below. As the site is a during the Pacific harbor seal pupping Timing Constraints for In-Air Noise beach with construction along the cliff season (December 15th to May 15th) and and on flat areas above the cliff, a for an additional two weeks thereafter to To minimize in-air noise impacts on complete barrier cannot be constructed accommodate lactation and weaning of marine mammals, construction to hide all construction activities for the late season pups. Thus, construction activities shall be limited to the period project. Once the walls of the lifeguard shall be prohibited from December 15th when the species of concern would be station’s building are in place, much of to June 1st. least likely to be in the project area. The the construction activities will take construction window for construction place above the Children’s Pool beach Daily Construction Timing activities shall be from June 1 to (i.e., out of sight) as well as inside the Construction activities shall be December 15, 2015. The IHA may building (i.e., a visual and partial sound scheduled, to the maximum extent extend to June 1 through June 27, 2016 barrier). There would be no activities in practicable, during the daily period of to finish the construction activities if the ocean or closer to the water’s edge lowest haul-out occurrence, from needed. Avoiding periods when the and since harbor seals mate underwater approximately 8:30 a.m. to 3:30 p.m. highest number of marine mammal in the ocean, there will be no impacts However, construction activities may be individuals are in the action area is on mating activities. California sea lions extended from 7 a.m. to 7 p.m. to help another mitigation measure to protect and northern elephant seals are such assure that the project can be completed marine mammals from the proposed infrequent users of this area and their during the 2015 construction window. construction activities. rookeries are so far away (at least 104.6 Harbor seals typically have the highest km [65 miles] at offshore islands) that daily or hourly haul-out period during Potential Abandonment Survey there will be no adverse impact on these the afternoon from 3 p.m. to 6 p.m. After the first two months of species. Construction of Visual and Acoustic monitoring during construction As part of the public comment Barriers activities, the City of San Diego will take process for the issuance of the previous the mean number of observed harbor 2013 IHA, NMFS modified several of A visual and acoustic barrier would be erected and maintained for the seals at the Children’s Pool in a 24-hour the monitoring and mitigation measures period across that two months and included in the proposed IHA (78 FR duration of the project to shield construction activities from beach view. compare it to the mean of the lower 95 25958, May 3, 2013) for practicability percent confidence interval in Figure 1 The temporary barrier shall consist of 1⁄2 reasons, and also included several (see below). If the observed mean is to 3⁄4 inch (1.3 to 1.9 centimeters [cm]) additional measures in the final IHA (78 plywood constructed 1.8 to 2.4 m (6 to lower, the City of San Diego would shut- FR 40705, July 8, 2013). These included 8 ft) high depending on the location. down construction activities and work changing the pupping season from The City of San Diego does not believe with NMFS and other harbor seal December 15th to May 15th and that a complete barrier can be experts (e.g., Mark Lowry, Dr. Sarah prohibiting construction activities constructed to hide all of the proposed Allen, Dr. Pamela Yochem, and/or Dr. during this time; extending construction construction activities. Once the walls Brent Stewart) to develop and activities from 7:00 a.m. to 7:00 p.m. to of the lifeguard station building are in implement a revised mitigation plan to help assure that more work would be place, much of the proposed further reduce the number of takes and completed during the 2013 construction construction activities would take place potential impacts. Once a week every window; continuing monitoring for 60 on the bluff above the beach (thus out week thereafter, the City of San Diego days following the end of construction of sight) and inside the building, which will take the same mean of observed activities; and triggering a shut-down of would provide a visual and partial harbor seals across the previous three construction activities in the sound barrier. tide cycles (a tide cycle is unexpected event of abandonment of approximately 2 weeks) and compare it the Children’s Pool site. The mitigation Protected Species Observers to the 95% lower confidence interval in measure on scheduling the heaviest Trained PSOs would be used to Figure 1 for the same time period. If the construction activities (with the highest detect, document, and minimize observed mean is lower, the City of San sound levels) during the annual period impacts (i.e., possible shut-down of Diego would shut-down and take the of lowest haul-out occurrence (October noise-generating operations [turning off action described above. If abandonment to November) was originally included in the equipment so that in-air sounds of the site is likely, monitoring would be the City of San Diego’s Mitigated associated with construction no longer expanded away from the Children’s Negative Declaration when it was exceed levels that are potentially Pool to determine if animals have been anticipated that the City of San Diego harmful to marine mammals]) to marine temporarily displaced to known haul- would obtain an IHA in the summer of mammals. More information about this out sites in the southern California area 2012 and begin demolition and measure is contained in the ‘‘Proposed (e.g., north end of Torrey Pines, cave on construction activities in the fall of Monitoring’’ section (below). the exposed ocean side of Point Loma, 2012. This requirement has been etc.). For the purpose of this action, removed because it is no longer Establishment of Buffer Zones NMFS will consider the Children’s Pool practicable due to logistics, scheduling The City of San Diego shall establish site to possibly be abandoned if zero and to allow the planned activities to be buffer zones (i.e., where sound pressure harbor seals are present each day during completed before the next pupping levels are at or above 90 dB re 20 mPa the daytime and nighttime hours for at season. for harbor seals and/or at or above 100 least three tide cycles (a tide cycle is The activities proposed by the dB re 20 mPa for all pinniped species approximately 2 weeks), but this cannot applicant includes a variety of measures except harbor seals [for in-air noise]) be confirmed until observations calculated to minimize potential around the construction activities so continue to be zero during a full impacts on marine mammals, including: that in-air sounds associated with the pupping and molting season.

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More information regarding the City consideration of personnel safety, equipment, or other activities expected of San Diego’s monitoring and practicality of implementation, and to result in the take of marine mammals mitigation measures for the proposed impact on the effectiveness of the (this goal may contribute to 1, above, or construction activities at the Children’s activity. to reducing harassment takes only). Pool Lifeguard Station can be found in Any mitigation measure(s) prescribed (4) A reduction in the intensity of the IHA application. by NMFS should be able to accomplish, exposures (either total number or have a reasonable likelihood of Proposed Mitigation Conclusions number at biologically important time accomplishing (based on current or location) to received levels from NMFS has carefully evaluated the science), or contribute to the construction equipment, or other applicant’s mitigation measures and accomplishment of one or more of the activities expected to result in the take considered a range of other measures in general goals listed below: of marine mammals (this goal may the context of ensuring that NMFS (1) Avoidance or minimization of contribute to a, above, or to reducing the prescribes the means of effecting the injury or death of marine mammals severity of harassment takes only). least practicable impact on the affected wherever possible (goals 2, 3, and 4 may marine mammal species and stocks and contribute to this goal). (5) Avoidance of minimization of their habitat. NMFS’s evaluation of (2) A reduction in the numbers of adverse effects to marine mammal potential measures included marine mammals (total number or habitat, paying special attention to the consideration of the following factors in number at biologically important time food base, activities that block or limit relation to one another: or location) exposed to received levels passage to or from biologically • The manner in which, and the from construction equipment, or other important areas, permanent destruction degree to which, the successful activities expected to result in the take of habitat, or temporary destruction/ implementation of the measure is of marine mammals (this goal may disturbance of habitat during a expected to minimize adverse impacts contribute to 1, above, or to reducing biologically important time. to marine mammals; harassment takes only). (6) For monitoring directly related to • The proven or likely efficacy of the (3) A reduction in the number of mitigation—an increase in the specific measure to minimize adverse times (total number or number at probability of detecting marine impacts as planned; and biologically important time or location) mammals, thus allowing for more • The practicability of the measure individuals would be exposed to effective implementation of the for applicant implementation, including received levels from construction mitigation.

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Based on NMFS’s evaluation of the • Distribution and/or abundance construction. The City of San Diego (i.e., applicant’s proposed measures, as well comparisons in times or areas with PSOs) plans to make hourly counts of as other measures considered by NMFS concentrated stimuli versus times or the number of pinnipeds present and or recommended by the public, NMFS areas without stimuli; record sound or visual events that result has determined that the mitigation (4) An increased knowledge of the in behavioral responses and changes, measures provide the means of effecting affected species; and whether during construction or from the least practicable impact on marine (5) An increase in our understanding public stimuli. During these events, mammal species or stocks and their of the effectiveness of certain mitigation pictures and video will also be taken habitat, paying particular attention to and monitoring measures. when possible. The ‘‘Mitigated Negative rookeries, mating grounds, and areas of Proposed Monitoring Declaration’’ states ‘‘monitoring shall similar significance. assess behavior and potential behavioral The City of San Diego has developed responses to construction noise and Proposed Monitoring and Reporting a monitoring plan (see Appendix I, activities. Visual digital recordings and In order to issue an ITA for an Mitigated Negative Declaration in the photographs shall be used to document activity, section 101(a)(5)(D) of the IHA application) based on discussions individuals and behavioral responses to MMPA states that NMFS must, where between the project biologist, Dr. Doyle construction.’’ applicable, set forth ‘‘requirements Hanan, and NMFS biologists. The plan Monitors would have authority to pertaining to the monitoring and has been vetted by City of San Diego stop construction as necessary reporting of such taking.’’ The MMPA planners and reviewers. The plan has depending on sound levels, pinniped been formally presented to the public implementing regulations at 50 CFR presence, and distance from sound for review and comment. The City of 216.104 (a)(13) require that requests for sources. Daily monitoring reports would San Diego has responded in writing and ITAs include the suggested means of be maintained for periodic summary in public testimony (see City of San accomplishing the necessary monitoring reports to the City of San Diego and to Diego Council Hearing, December 14, and reporting that will result in NMFS. Observations would be entered 2011) to all public concerns. into and maintained on Hanan & increased knowledge of the species and The monitoring plan involves of the level of taking or impacts on Associates computers. The City of San surveying prior to construction Diego plans to follow the reporting populations of marine mammals that are activities, monitoring during expected to be present in the proposed requirements in the Mitigated Negative construction activities by NMFS- Declaration, which states that ‘‘the action area. approved PSOs with high-resolution Monitoring measures prescribed by biologist shall document field activity binoculars and handheld digital sound via the Consultant Site Visit Record. NMFS should accomplish one or more level meters (measuring devices in the of the following general goals: The Consultant Site Visit Record shall 30 to 130 dB re 20 mPa range), and post- be either emailed or faxed to the City of (1) An increase in the probability of construction monitoring. The City of detecting marine mammals, both within San Diego’s Mitigation Monitoring San Diego would include sound Coordination process (MMC) on the 1st the mitigation zone (thus allowing for measurements at and near the day of monitoring, the 1st week of each more effective implementation of the construction site in their initial survey month, the last day of monitoring, and mitigation) and in general to generate prior to the activities as a background immediately in the case of any more data to contribute to the analyses and baseline for the project. While no undocumented discovery. The project mentioned below; specific acoustic study is planned, the biologist shall submit a final (2) An increase in our understanding City of San Diego’s Mitigated Negative construction monitoring report to MMC of how many marine mammals are Declaration states that marine mammal within 30 days of construction likely to be exposed to levels from monitoring shall be conducted for three completion.’’ The MMC ‘‘coordinates construction equipment that we to five days prior to construction and the monitoring of development projects associate with specific adverse effects, shall include hourly systematic counts and requires that changes are approved such as behavioral harassment, TTS or of pinnipeds using the beach, Seal Rock, and implemented to be in conformance PTS; and associated reef areas. Monitoring with the permit requirements and to (3) An increase in our understanding three to five days prior to construction minimize any damage to the of how marine mammals respond to will provide baseline data regarding environment.’’ These documents will stimuli expected to result in take and recent haul-out behavior and patterns as also be sent to NMFS. Finally, the City how anticipated adverse effects on well as background noise levels near the of San Diego has modified its individuals (in different ways and to time of the proposed construction monitoring program to include 60 days varying degrees) may impact the activities. of monitoring post-construction population, species, or stock During the proposed construction activities. Following construction, the (specifically through effects on annual activities, monitoring shall assess City of San Diego would have a program rates of recruitment or survival) through behavior and potential behavioral of onsite PSOs that would randomly any of the following methods: responses to construction noise and select a day per week to monitor. • Behavioral observations in the activities. PSOs would observe the NMFS notes that the WAN’s La Jolla presence of stimuli compared to proposed construction activities from a Harbor Seal Webcam was attached to observations in the absence of stimuli station along the breakwater wall and the old (now demolished) lifeguard (need to be able to accurately predict from the base of the cliff below the station and is no longer available online received level, distance from source, construction area. PSOs would be on (http://www.wanconservancy.org/la_ and other pertinent information); site approximately 30 minutes before jolla_harbor_seal_earthcam.htm). The • Physiological measurements in the the start of proposed construction City of San Diego has stated that there presence of stimuli compared to activities and would remain on site is no suitable place to mount the camera observations in the absence of stimuli until 30 minutes after activities have at the construction site. Therefore, the (need to be able to accurately predict ceased. Visual digital recordings and City of San Diego cannot do periodic receive level, distance from the source, photographs shall be used to document checks using the webcam for monitoring and other pertinent information); individuals and behavioral responses to purposes as required by the 2013 IHA.

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However, the camera was not expected the authorization, and any long term injury, or mortality, should the to replace NMFS-qualified PSOs at the impacts from the project. applicant, contractor, monitor or any site making accurate counts, measuring A written log of dates and times of other individual associated with the sound levels and observing the public monitoring activity will be kept. The log construction project observe an injured and the construction, as well as the shall report the following information: or dead marine mammal, the incident harbor seals. In the old camera view, a • Time of observer arrival on site; (regardless of cause) will be reported to person may have been able to see visual • Time of the commencement of in- NMFS as soon as practicable. The report evidence of Level B harassment but air noise generating activities, and should include species or description of probably would not have been able to description of the activities; animal, condition of animal, location, • distinguish between harassment from Distances to all marine mammals time first found, observed behaviors (if construction activities and harassment relative to the sound source; alive) and photo or video, if available. • from the public since the camera had a Distances from the sound meter to In the unanticipated event that the limited scope and only showed the each sound-producing activity when City of San Diego discovers a live conducting sound measurements; Children’s Pool beach and pinnipeds • stranded marine mammal (sick and/or (usually a specific portion of the beach, For harbor seal observations, notes injured) at Children’s Pool, they shall but not the reef nor nearby beaches). on seal behavior during noise-generating immediately contact Sea World’s Consistent with NMFS procedures, activity, as described above, and on the stranded animal hotline at 1–800–541– the following marine mammal number and distribution of seals 7235. Sea World shall also be notified monitoring and reporting shall be observed in the project vicinity; if a dead stranded pinniped is found so • For observations of all marine performed for the proposed action: that a necropsy can be performed. In all mammals other than harbor seals, the (1) The PSO shall be approved by cases, NMFS shall be notified as well, time and duration of each animal’s NMFS prior to construction activities. but for immediate response purposes, presence in the project vicinity; the (2) The NMFS-approved PSO shall Sea World shall be contacted first. number of animals observed; the attend the project site prior to, during, Reporting Prohibited Take—In the behavior of each animal, including any and after construction activities cease unanticipated event that the specified response to noise-generating activities; activity clearly causes the take of a each day throughout the construction • Time of the cessation of in-air noise marine mammal in a manner prohibited window. generating activities; and (3) The PSO shall search for marine • Time of observer departure from by this IHA, such as an injury (Level A mammals within the Children’s Pool site. harassment), serious injury, or area. All monitoring data collected during mortality, the City of San Diego shall (4) The PSO shall be present during construction would be included in the immediately cease the specified construction activities to observe for the biological monitoring notes to be activities and immediately report the presence of marine mammals in the submitted. A final report summarizing incident to the Chief of the Permits and vicinity of the specified activity. All the construction monitoring and any Conservation Division, Office of such activity would occur during general trends observed would also be Protected Resources, NMFS, at 301– daylight hours (i.e., 30 minutes after submitted to NMFS within 90 days after 427–8401 and/or by email to sunrise and 30 minutes before sunset). monitoring has ended during the period [email protected], If inclement weather limits visibility of the lifeguard station construction. [email protected], and the within the area of effect, the PSO would West Coast Regional Stranding perform visual scans to the extent Proposed Reporting Coordinator (562–980–3230). The report conditions allow. The City of San Diego would notify must include the following information: (5) If marine mammals are sighted by NMFS Headquarters and the NMFS • Time, date, and location (latitude/ the PSO within the acoustic threshold Southwest Regional Office prior to longitude) of the incident; areas, the PSO shall record the number initiation of the construction activities. • The type of activity involved; of marine mammals within the area of A draft final report must be submitted • Description of the circumstances effect and the duration of their presence to NMFS within 90 days after the during and leading up to the incident; while the noise-generating activity is conclusion of the construction activities • Status of all sound source use in the occurring. The PSO would also note of the Children’s Pool Lifeguard Station. 24 hours preceding the incident; water whether the marine mammals appeared The report would include a summary of depth; environmental conditions (e.g., to respond to the noise and, if so, the the information gathered pursuant to the wind speed and direction, Beaufort sea nature of that response. The PSO shall monitoring requirements set forth in the state, cloud cover, and visibility); record the following information: Date IHA, including dates and times of • Description of marine mammal and time of initial sighting, tidal stage, operations and all marine mammal observations in the 24 hours preceding weather conditions, Beaufort sea state, sightings (dates, times, locations, the incident; species identification or species, behavior (activity, group species, behavioral observations description of the animal(s) involved; cohesiveness, direction and speed of [activity, group cohesiveness, direction • The fate of the animal(s); and travel, etc.), number, group and speed of travel, etc.], tidal stage, photographs or video footage of the composition, distance to sound source, weather conditions, Beaufort sea state animal (if equipment is available). number of animals impacted, and wind force, associated construction Activities shall not resume until construction activities occurring at time activities). A final report must be NMFS is able to review the of sighting, and monitoring and submitted to the Regional Administrator circumstances of the prohibited take. mitigation measures implemented (or within 30 days after receiving comments NMFS shall work with the City of San not implemented). The observations from NMFS on the draft final report. If Diego to determine the action necessary would be reported to NMFS. no comments are received from NMFS, to minimize the likelihood of further (6) A final report would be submitted the draft final report would be prohibited take and ensure MMPA summarizing all in-air acoustic effects considered to be the final report. compliance. The City of San Diego may from construction activities and marine While the IHA does not authorize not resume its activities until notified mammal monitoring during the time of injury (i.e., Level A harassment), serious by NMFS via letter, email, or telephone.

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Reporting an Injured or Dead Marine Monitoring Results From Previously California from August 6, 2014 to March Mammal with an Unknown Cause of Authorized Activities 15, 2015. Construction activities began on August 6, 2014 and were halted for Death—In the event that the City of San 2013 to 2014 Diego discovers an injured or dead the Pacific harbor seal pupping season marine mammal, and the lead PSO Hanan & Associates, Inc., on behalf of (December 15, 2014 to June 1, 2015). determines that the cause of the injury the City of San Diego, conducted marine During 127 days of visual and acoustic mammal and in-air sound monitoring at or death is unknown and the death is observations, Hanan & Associates six locations during demolition and relatively recent (i.e., in less than a counted a total of 63,598 Pacific harbor construction activities at the Children’s seals and 27,844 people. During the moderate state of decomposition as Pool Lifeguard Station in La Jolla, described in the next paragraph), the 2014 demolition and construction California from June 3, 2013 to February activities, Hanan & Associates observed City of San Diego would immediately 12, 2014. Demolition and construction report the incident to the Chief of the a total of 20,259 takes by Level B activities began on July 10, 2013 and harassment (i.e., alerts, movements, and Permits and Conservation Division, were halted for the Pacific harbor seal Office of Protected Resources, NMFS, at flushes) that could be attributed to pupping season (December 15, 2013 to demolition and construction activities 301–427–8401, and/or by email to June 1, 2014). During 115 days of visual (7,424 takes), the general public (10,000 [email protected], and acoustic observations, Hanan & takes), and other sources (2,835 takes). [email protected], and the Associates counted a total of 61,631 As of March 13, 2015, at least 60 harbor NMFS West Coast Regional Office (1– Pacific harbor seals and 26,037 people. seal pups (including 6 still or premature 866–767–6114), and/or to the West During the 2013 demolition and births) have been born at the Children’s Coast Regional Stranding Coordinator construction activities, Hanan & Associates observed a total of 15,673 Pool and there has been no indication (562–980–3230). The report must of abandonment. In addition to the include the same information identified takes by Level B harassment (i.e., alerts, movements, and flushes) that could be Pacific harbor seal sightings, PSOs above. Activities may continue while recorded 24 sightings of cetaceans (gray NMFS reviews the circumstances of the attributed to demolition and construction activities (5,095 takes), the whales, common and bottlenose incident. NMFS would work with the dolphins), 366 sightings of California City of San Diego to determine whether general public (8,639 takes), and other sources (1,939 takes). As of April 15, sea lions (at Seal Rock, Children’s Pool modification of the activities is 2014, at least 60 harbor seal pups beach, South Casa Beach, and on the appropriate. (including 2 still births) have been born reef), and 1 northern elephant seals (1 Reporting an Injured or Dead Marine at the Children’s Pool and there has juvenile on Children’s Pool beach) at the Mammal Not Related to the Activities— been no indication of abandonment. In Children’s Pool. One dead adult and one In the event that the City of San Diego addition to the Pacific harbor seal dead juvenile California sea lion were discovers an injured or dead marine sightings, PSOs recorded 11 sightings of sighted on the Children’s Pool beach mammal, and the lead PSO determines cetaceans (gray whales and bottlenose after the start of the beach closure and that the injury or death is not associated dolphins), 4 sightings of California sea after the construction activities stopped with or related to the activities lions (1 juvenile, 3 adult), and 2 for the pupping season. These authorized (e.g., previously wounded northern elephant seals (both juveniles) strandings were reported to NMFS. animal, carcass with moderate to at the Children’s Pool. Hanan & Associates recorded mean advanced decomposition, or scavenger Hanan & Associates recorded mean in-air sound levels of 68.9 dB re 20 mPa m damage), the City of San Diego shall in-air sound levels of 69.2 dB re 20 Pa (range of 51.5 to 97.2 dB re 20 mPa) (range of 55.6 to 93.7 dB re 20 mPa) report the incident to the Chief of the during non-construction activities and during non-demolition and construction Permits and Conservation Division, 71.3 dB re 20 mPa (range of 49.4 to 102.7 activities and 70.3 dB re 20 mPa (range Office of Protected Resources, NMFS, at dB re 20 mPa) during construction of 50.7 to 103.1 dB re 20 mPa) during activities. During 2014, measured sound 301–427–8401, and/or by email to demolition and construction activities. [email protected], levels from the construction equipment During 2013, measured sound levels reaching the pinnipeds did not exceed [email protected], and the from the demolition equipment reaching approximately 90 dB re 20 mPa at the NMFS West Coast Regional Office (1– the pinnipeds did not exceed haul-out area closest to the construction 866–767–6114) and/or to the West Coast approximately 90 dB re 20 mPa at the activities. Regional Stranding Coordinator (562– haul-out area closest to the demolition 980–3230) within 24 hours of the and construction activities, nor did they More information on the monitoring discovery. The City of San Diego shall exceed a peak of about 83 dB re 20 mPa results from the City of San Diego’s provide photographs or video footage (if at the mean hauling-out distance previous demolition and construction available) or other documentation of the (30.5 m). activities at the La Jolla Children’s Pool stranded animal sighting to NMFS and 2014 to 2015 Lifeguard Station can be found in the the Marine Mammal Stranding Network. Hanan & Associates, Inc., on behalf of final monitoring reports. The 2013 to Activities may continue while NMFS the City of San Diego, conducted marine 2014 and 2014 to 2015 monitoring reviews the circumstances of the mammal and in-air sound monitoring at reports can be found online at: http:// incident. seven locations during demolition and www.nmfs.noaa.gov/pr/permits/ construction activities at the Children’s incidental/ Pool Lifeguard Station in La Jolla, construction.htm#childrenspool.

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Estimated Take by Incidental pursuit, torment, or annoyance which (i) wild by causing disruption of behavioral Harassment has the potential to injure a marine patterns, including, but not limited to, mammal or marine mammal stock in the migration, breathing, nursing, breeding, Except with respect to certain wild [Level A harassment]; or (ii) has feeding, or sheltering [Level B activities not pertinent here, the MMPA the potential to disturb a marine harassment]. defines ‘‘harassment’’ as: Any act of mammal or marine mammal stock in the

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TABLE 2—NMFS’S CURRENT UNDERWATER AND IN-AIR ACOUSTIC EXPOSURE CRITERIA

Criterion Criterion definition Threshold

Underwater Impulsive (Non-Explosive) Sound

Level A harassment (injury) ...... Permanent threshold shift (PTS) (Any level 180 dB re 1 μPa-m (root means square [rms]) above that which is known to cause TTS). (cetaceans). 190 dB re 1 μPa-m (rms) (pinnipeds). Level B harassment ...... Behavioral disruption (for impulsive noise) ...... 160 dB re 1 μPa-m (rms). Level B harassment ...... Behavioral disruption (for continuous noise) ... 120 dB re 1 μPa-m (rms).

In-Air Sound

Level A harassment ...... NA ...... NA. Level B harassment ...... Behavioral disruption ...... 90 dB re 20 μPa (harbor seals). 100 dB re 20 μPa (all other pinniped species). NA (cetaceans). NA = Not available or not assessed.

The City of San Diego and NMFS than 1 m; and changing direction of males and 2,211 juvenile males, 2,842 anticipate takes of Pacific harbor seals, current movements by individuals as adult females and 2,000 juvenile California sea lions, and northern behavioral criteria for take by Level B females based on age and sex ratios elephant seals by Level B (behavioral) harassment. presented in Harkonen et al., 1999) over harassment only incidental to the With proposed construction activities the entire duration of the activities. An construction project at the Children’s scheduled to begin in June 2015, the unknown portion of the incidental takes Pool. No takes by injury (Level A City of San Diego expects a range of 0 will be from repeated exposures as harassment), serious injury, or mortality to 190 harbor seals to be present daily harbor seals leave and return to the during June and a seasonal decline are expected. NMFS will consider Children’s Pool area. A polynomial through November to about 0 to 50 pinnipeds behaviorally reacting to the curve fit to counts by month was used harbor seals present daily. If all of the construction activities by flushing into estimated harbor seals present are taken by the City of San Diego to estimate the the water, moving more than 1 m (3.3 by incidental harassment each day, number of harbor seals expected to be ft), but not into the water; becoming there could be a maximum of 10,000 hauled-out by day (see below and Figure alert and moving, but not moving more takes (i.e., approximately 2,947 adult 2 of the IHA application).

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Assuming the total seals predicted to the duration of the activities. The incidentally take (i.e., exposures) 10,000 haul-out daily at the Children’s Pool are estimated 600 individual Pacific harbor Pacific harbor seals, 100 California sea exposed to sound levels that are seals would be taken by Level B lions, and 25 northern elephant seals, considered Level B harassment during harassment multiple times during the which will equate to 600, 2, and 1 days where sound is predicted to exceed proposed construction activities. individuals, respectively, being exposed 90 dB at the construction site (65 days), Very few California sea lions and/or multiple times. More information on the there could be a maximum of northern elephant seals are ever number of takes authorized, and the approximately 10,000 incidental takes observed at the Children’s Pool (i.e., one approximate percentage of the stock for (i.e., exposures) of approximately up to or two individuals). The City of San the three species in the proposed action 600 individual Pacific harbor seals over Diego requests the authority to area can be found in Table 3 (below).

TABLE 3—SUMMARY OF THE AUTHORIZED INCIDENTAL TAKE BY LEVEL B HARASSMENT OF PINNIPEDS FOR THE CITY OF SAN DIEGO’S PROPOSED CONSTRUCTION ACTIVITIES GENERATING IN-AIR NOISE AT THE CHILDREN’S POOL LIFE- GUARD STATION IN LA JOLLA, CA

Take Estimated Approximate authorization number of percentage of Species (number of individuals Abundance estimated stock Population trend exposures) taken (individuals)

Pacific harbor seal ...... 10,000 600 30,968—California stock .. 1.93 Increased in California 1981 to 2004. California sea lion ...... 100 2 296,750—U.S. stock ...... <0.01 Increasing. Northern elephant seal ...... 25 1 179,000—California breed- <0.01 Increasing 3.8% annually ing stock. since 1988.

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Encouraging and Coordinating In making a negligible impact haul-out occurrence. The end date falls Research determination, NMFS evaluated factors approximately two weeks prior to Each construction phase and potential such as: January 1, the time after which most harassment activity will be evaluated as (1) The number of anticipated births occur, providing protection for to observed sound levels and any injuries, serious injuries, or mortalities; pregnant and nursing harbor seals that (2) The number, nature, and intensity, pinniped reaction by type of sound may give birth before January 1. and duration of Level B harassment; and Table 3 of this document outlines the source. Flushing would be documented (3) The context in which the takes by sex and age class. These data will number of Level B harassment takes that occur (i.e., impacts to areas of are anticipated as a result of these provide information for IHA permitting significance, impacts to local in future projects. Potential additional proposed activities. Due to the nature, populations, and cumulative impacts degree, and context of Level B mitigation (other than what is already when taking into account successive/ required) will be discussed and (behavioral) harassment anticipated and contemporaneous actions when added suggested in the final report. NMFS has described (see ‘‘Potential Effects on to baseline data); Marine Mammals’’ section above) in this encouraged the City of San Diego to (4) The status of the stock or species review and analyze any available data to notice, this activity is not expected to of marine mammals (i.e., depleted, not impact rates of annual recruitment or determine baseline information as well depleted, decreasing, increasing, stable, as evaluate the impacts from the survival for the affected species or stock impact relative to the size of the (i.e., California stock of Pacific harbor construction activities on the pinnipeds population); at the Children’s Pool. seals, U.S. stock of California sea lions, (5) Impacts on habitat affecting rates and California breeding stock of Impact on Availability of Affected of recruitment/survival; and northern elephant seals), particularly Species or Stock for Taking for (6) The effectiveness of monitoring given the proposed mitigation, Subsistence Uses and mitigation measures. monitoring, and reporting measures that No injuries (Level A harassment), would be implemented to minimize Section 101(a)(5)(D) of the MMPA serious injuries, or mortalities are requires NMFS to determine that the impacts to marine mammals. anticipated to occur as a result of the The Children’s Pool is one of the three authorization will not have an City of San Diego’s construction unmitigable adverse effect on the known haul-out sites for Pacific harbor activities, and none are authorized by seal in San Diego County and the only availability of marine mammal species NMFS. The proposed activities are not or stocks for subsistence use. There are rookery in San Diego County and the expected to result in the alteration of only mainland rookery on the U.S. west not relevant subsistence uses of marine reproductive behaviors, and the mammals implicated by this action. coast for this species between the border potentially affected species would be of Mexico and Point Mugu in Ventura Therefore, NMFS has determined that subjected to only temporary and minor the total taking of affected species or County, CA. For the other marine behavioral impacts. mammal species that may occur within stocks would not have an unmitigable Behavioral disturbance may adverse impact on the availability of the action area (i.e., California sea lions potentially occur incidental to the and northern elephant seals), there are such species or stocks for subsistence visual presence of humans and purposes. no known designated or important construction activities; however, feeding and/or reproductive areas. Many Analysis and Preliminary pinnipeds at this site have likely animals perform vital functions, such as Determinations adapted or become acclimated to human feeding, resting, traveling, and presence at this site. These ‘‘urbanized’’ Negligible Impact socializing, on a diel cycle (i.e., 24 hour harbor seals do not exhibit sensitivity at cycle). Behavioral reactions to noise Negligible impact is ‘‘an impact a level similar to that noted in harbor exposure (such as disruption of critical resulting from the specified activity that seals in some other regions affected by life functions, displacement, or cannot be reasonably expected to, and is human disturbance (Allen et al., 1984; avoidance of important habitat) are not reasonably likely to, adversely affect Suryan and Harvey, 1999; Henry and more likely to be significant if they last the species or stock through effects on Hammil, 2001; Johnson and Acevedo- more than one diel cycle or recur on annual rates of recruitment or survival’’ Gutierrez, 2007; Jansen et al., 2006; subsequent days (Southall et al., 2007). (50 CFR 216.103). A negligible impact Hanan & Associates, 2011). Therefore, However, Pacific harbor seals have been finding is based on the lack of likely there is a high likelihood that many of hauling-out at Children’s Pool during adverse effects on annual rates of the harbor seals present during the the year for many years (including recruitment or survival (i.e., population- proposed construction activities would during pupping season and while level effects). An estimate of the number not be flushed off of the beach or rocks, females are pregnant) while being of Level B harassment takes, alone, is as pinnipeds at this site are conditioned exposed to anthropogenic sound sources not enough information on which to to human presence and loud noises such as vehicle traffic, human voices, base an impact determination. In (Hanan, 2004; Hanan & Associates, etc. and other stimuli from human addition to considering estimates of the 2011) (see http://www.youtube.com/ presence. While studies have shown the number of marine mammals that might watch?v=4IRUYVTULsg). types of sound sources used during the be ‘‘taken’’ through behavioral As discussed in detail above, the construction activities have the harassment, NMFS must consider other proposed project scheduling avoids potential to displace marine mammals factors, such as the likely nature of any sensitive life stages for Pacific harbor from breeding areas for a prolonged responses (their intensity, duration, seals. Proposed project activities period (e.g., Lusseau and Bejder, 2007; etc.), the context of any responses producing in-air noise will commence Weilgart, 2007), based on the best (critical reproductive time or location, in June and end by December 15. The available information, this does not migration, etc.), as well as the number commencement date occurs after the seem to be the case for the Pacific and nature of estimated Level A end of the pupping season, affords harbor seals at the Children’s Pool. The harassment takes, the number of additional time to accommodate Pacific harbor seals have repeatedly estimated mortalities, and effects on lactation and weaning of season pups, hauled-out to pup over many years and habitat. and takes into account periods of lowest the NMFS Stock Assessment Reports

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(NMFS, 2011) for this stock have shown from the specified activity would have NMFS preliminarily finds that small that the population is increasing and is a negligible impact on the affected numbers of marine mammals will be considered stable. Additionally, the species in the specified geographic taken relative to the populations of the proposed construction activities would region. NMFS believes that the time affected species or stocks. See Table 2 increase sound levels in the period of the proposed construction for the proposed authorized take environment in a relatively small area activities, the requirement to implement numbers of marine mammals. surrounding the lifeguard station mitigation measures (e.g., prohibiting Endangered Species Act (compared to the range of the animals), construction activities during pupping and some animals may only be exposed season, scheduling operations to periods NMFS (Permits and Conservation to and harassed by sound for less than of the lowest haul-out occurrence, Division) has determined that an ESA a day. visual and acoustic barriers, and the section 7 consultation for the issuance NMFS’s practice has been to apply the addition of a new measure that helps of an IHA under section 101(a)(5)(D) of 90 dB re 20 mPa and 100 dB re 20 mPa protect against unexpected the MMPA for this activity is not received level threshold for in-air sound abandonment of the site), and the necessary for any ESA-listed marine levels to determine whether take by inclusion of the monitoring and mammal species under its jurisdiction, Level B harassment occurs. Southall et reporting measures, will reduce the as the proposed action would not affect al. (2007) provide a severity scale for amount and severity of the potential ESA-listed species. ranking observed behavioral responses impacts from the activity to the degree National Environmental Policy Act of both free-ranging marine mammals that will have a negligible impact on the and laboratory subjects to various types species or stocks in the action area. To meet NMFS’s National of anthropogenic sound (see Table 4 in Based on the analysis contained Environmental Policy Act (NEPA; 42 Southall et al. [2007]). NMFS has not herein of the likely effects of the U.S. C. 4321 et seq.) requirements for established a threshold for Level A proposed specified activity on marine the issuance of an IHA to the City of San harassment (injury) for marine mammals and their habitat, and taking Diego, NMFS prepared an mammals exposed to in-air noise, into consideration the implementation Environmental Assessment (EA) in 2013 however, Southall et al. (2007) of the proposed monitoring and for a similar activity titled recommends 149 dB re 20 mPa (peak mitigation measures, NMFS finds that Environmental Assessment on the flat) as the potential threshold for injury the total marine mammal take from the Issuance of an Incidental Harassment from in-air noise for all pinnipeds. No City of San Diego’s activities would Authorization to the City of San Diego in-air sounds from proposed have a negligible impact on the affected to Take Marine Mammals by construction activities would exceed marine mammal species or stocks. Harassment Incidental to Demolition 110 dB at the source and no measured and Construction Activities at the Small Numbers sounds approached that sound level in Children’s Pool Lifeguard Station in La 2013. As mentioned previously, NMFS Jolla, California to comply with the Of the 3 marine mammal species estimates that 3 species of marine Council of Environmental Quality (CEQ) under NMFS jurisdiction that may or mammals under its jurisdiction could be regulations and NOAA Administrative are known to likely occur in the action potentially affected by Level B Order (NAO) 216–6. NMFS will area, none are listed as threatened or harassment over the course of the IHA. evaluate the proposed action to endangered under the ESA. No It is estimated that up to 600 individual determine whether the 2013 EA incidental take has been requested to be Pacific harbor seals, 2 individual supports the City of San Diego’s 2015 authorized for ESA-listed species as California sea lions, and 1 northern IHA request. none are expected to be within the elephant seal would be taken (multiple Proposed Authorization action area. To protect these animals times) by Level B harassment, which (and other marine mammals in the would be approximately 1.93, less than As a result of these preliminary action area), the City of San Diego shall 0.01, and less than 0.01% of the determinations, NMFS proposed to schedule construction activities with respective California, U.S., and issue an IHA to the City of San Diego highest sound levels during the daily California breeding stocks. The for conducting construction activities at period of lowest haul-out occurrence; population estimates for the marine the Children’s Pool Lifeguard Station in limit activities to the hours of daylight; mammal species that may be taken by La Jolla, CA, provided the previously erect a temporary visual and acoustic Level B harassment were provided in mentioned mitigation, monitoring, and barrier; use PSOs and prohibit Table 2 of this document. reporting requirements are incorporated. construction activities during harbor NMFS has determined, provided that The duration of the IHA would not seal pupping season. No injury, serious the aforementioned proposed mitigation exceed one year from the date of its injury, or mortality is expected to occur and monitoring measures are issuance. The proposed IHA language is and due to the nature, degree, and implemented, that the impact of the provided below: context of the Level B harassment proposed construction activities at the The City of San Diego, Public Works anticipated, the proposed activity is not Children’s Pool Lifeguard Station in La Department, Engineering and Capital expected to impact rates of recruitment Jolla, CA, June 2015 to June 2016, may Projects Branch, Architectural or survival. result, at worst, in a temporary Engineering and Parks Division, 525 B Although behavioral modifications, modification in behavior and/or low- Street, Suite 750, MS 908A, San Diego, including temporarily vacating the area level physiological effects (Level B California 92101, is hereby authorized during the proposed construction harassment) of small numbers of certain under section 101(a)(5)(D) of the Marine activities, may be made by these species species of marine mammals. Based on Mammal Protection Act (16 U.S.C. to avoid the resultant acoustic the analysis contained herein of the 1371(a)(5)(D)), to harass small numbers disturbance, the availability of alternate likely effects of the specified activity on of marine mammals incidental to the areas within these areas for species and marine mammals and their habitat, and construction activities at the Children’s the short and sporadic duration of the taking into consideration the Pool Lifeguard Station, June 2015 activities, have led NMFS to determine implementation of the proposed through June 2016, contingent upon the that the taking by Level B harassment mitigation and monitoring measures, following conditions:

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1. Effective Dates adverse impact on affected marine breakwater wall as well as the base of This Authorization is valid from June mammal species or stocks: the cliff below the construction area. If inclement weather limits visibility 28, 2015 through June 27, 2016. Construction Prohibited During Pupping within the area of effect, the PSO will Season 2. Specified Geographic Region perform visual scans to the extent This Authorization is valid only for (a) The construction activities shall be conditions allow. The PSO will not have the construction activities at the prohibited during the Pacific harbor seal to monitor on days or portions of days Children’s Pool Lifeguard Station that pupping season at Children’s Pool when there will be little chance of shall occur in the following specified (December 15th to May 15th) and for an disturbance from construction activities geographic area: additional two weeks to accommodate (e.g., nothing visual, sound levels at The La Jolla Children’s Pool Lifeguard lactation and weaning of late season source less than 90 dB re 20 mPa, or all Station at 827 1⁄2 Coast Boulevard, La pups. Thus, construction shall be work activities inside the building). Jolla, California 92037 (32° 50′50.02″ prohibited from December 15th to June (e) The PSO shall visually scan the North, 117°16′42.8″ West), as specified 1st. action area for the presence of marine mammals at least 30 minutes prior to in the City of San Diego’s IHA Daily Construction Timing application. the start-up and continuously (b) The construction activities shall be throughout periods of in-air noise- 3. Species Authorized and Level of scheduled Monday through Friday; generating activities. Visual scans shall Takes however, they may continue on continue for at least 30 minutes after (a) The incidental taking of marine weekends to ensure completion of the each noise-generating episode has mammals, by Level B harassment only, project in 2015. To the maximum extent ceased. is limited to the following species in the practicable, the construction activities (f) The PSO shall use visual digital La Jolla, California area: shall be conducted from approximately recordings and photographs to (i) Pinnipeds—see Table 2 (above) for 8:30 a.m. to 3:30 p.m., during the daily document individuals and behavioral authorized species and take numbers. period of lowest haul-out occurrence; responses to the construction activities. (ii) If any marine mammal species are however, construction activities may be The PSO shall make hourly counts of encountered during construction extended from 7 a.m. to 7 p.m. (i.e., the number of pinnipeds present and activities that are not listed in Table 3 daylight hours) to help assure that the record sound or visual events that result (above) for authorized taking and are project is completed during the 2015 in behavioral responses and changes, likely to be exposed to sound pressure construction window. Harbor seals whether during construction activities levels (SPLs) at or above 90 decibels typically have the highest daily or or from public stimuli. During these (dB) re 20 mPa for harbor seals and/or at hourly haul-out period during the events, pictures and videos will be or above 100 dB re 20 mPa for all afternoon from 3 p.m. to 6 p.m. taken when possible to document individuals and behavioral responses. pinniped species except harbor seals Visual and Acoustic Barriers (for in-air noise), then the City of San (g) A PSO shall record the following Diego must shut-down operations to (c) A visual and acoustic barrier will information when a marine mammal is avoid take. be erected and maintained for the sighted: (b) The taking by injury (Level A duration of the project to shield (i) Species, group size, age/size/sex harassment), serious injury, or death of construction activities from beach view. categories (if determinable), behavior any of the species listed in Condition The temporary barrier shall consist of when first sighted and after initial 3(a) above, or the taking of any kind of 1.3 to 1.9 centimeter (1⁄2 to 3⁄4 inch) sighting, heading (if consistent), any other species of marine mammal, is plywood constructed 1.2 to 2.4 meters distribution, bearing and distance prohibited and may result in the (4 to 8 feet) high depending on the relative to the sound source(s), group modification, suspension or revocation location. The barriers will be placed at cohesiveness, duration of presence, of this Authorization. the site with input from NMFS West apparent reaction to the construction 4. The methods authorized for taking Coast Regional Office personnel so that activities (e.g., none, avoidance, by Level B harassment are limited to they will hide as advantageously as approach, etc.), direction and speed of acoustic-generating equipment sources possible the construction activities that travel, duration of presence, and if there (e.g., backhoe, dump truck, cement may be seen by pinnipeds. are other causes of potential disturbance truck, air compressor, electric screw Protected Species Observers occurring; guns, jackhammer, concrete saw, chop (ii) Date, time, location, activity of saw, and hand tools) without an (d) A NMFS-qualified, trained construction operations, monitoring and amendment to this Authorization: Protected Species Observer (PSO) shall mitigation measures implemented (or be used to detect, document, and not implemented), tidal stage, weather 5. Prohibited Take minimize potential impacts from conditions, Beaufort sea state, wind The taking of any marine mammal in construction activities. The PSO shall speed, visibility, and sun glare; and a manner prohibited under this attend the project site 30 minutes prior (iii) The data listed under Condition Authorization must be reported until 30 minutes after construction 6(g)(ii) shall also be recorded at the start immediately to the Office of Protected activities cease each day throughout the and end of each observation watch and Resources, National Marine Fisheries construction window. The PSO shall be during a watch whenever there is a Service (NMFS), at 301–427–8401. approved by NMFS prior to change in one or more variables. construction activities. The PSO shall (h) A PSO shall also record the time 6. Mitigation and Monitoring search for marine mammals using of arrival and departure on site, Requirements binoculars and/or the naked eye within commencement and cessation of in-air The City of San Diego is required to the Level B (behavioral) harassment noise construction activities, and implement the following mitigation and zones, which may vary upon the type of presence of humans on the beach. monitoring requirements when in-air sound being produced by the Whenever possible, the PSO should conducting the specified activities in construction activities. The PSO will determine as to whether or not the order to achieve the least practicable observe from a station along the harassment or pinnipeds is attributable

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to the construction activities and/or the and compare it to the mean of the lower of that exposure on the individuals that presence of the public on the beach and 95 percent confidence interval in Figure have been exposed. NMFS will consider around the Children’s Pool area. A PSO 3 (see above). If the observed mean is pinnipeds flushing into the water; shall record the number of people on lower, the City of San Diego shall shut- moving more than 1 m (3.3 ft), but not the beach and surrounding areas as well down construction activities and work into the water; becoming alert and as their location relative to the animals. with NMFS and other harbor seal moving, but not moving more than 1 m; experts (e.g., Mark Lowry, Dr. Sarah and changing direction of current Buffer Zones Allen, Dr. Pamela Yochem, and/or Dr. movement by individuals as behavioral (i) Buffer zones shall be established Brent Stewart) to develop and criteria for take by Level B harassment. (i.e., where sound pressure levels [SPLs] implement a revised mitigation plan to (iii) A description of the are at or above 90 decibels (dB) re 20 further reduce the number of takes and implementation and effectiveness of the: mPa for harbor seals and/or at or above potential impacts. Once a week every monitoring and mitigation measures of 100 dB re 20 mPa for all pinniped week thereafter, the City of San Diego the IHA. species except harbor seals [for in-air shall take the same mean of observed (b) Submit a final report to the Chief, noise]) around the construction harbor seals across the previous three Permits and Conservation Division, activities so that in-air sounds tide cycles (a tide cycle is Office of Protected Resources, NMFS, associated with the construction approximately 2 weeks) and compare it within 30 days after receiving comments activities no longer exceed levels that to the 95% lower confidence interval in from NMFS on the draft report. If NMFS are potentially harmful to marine Figure 3 for the same time period. If the decides that the draft report needs no mammals. observed mean is lower, the City of San comments, the draft report shall be considered to be the final report. In-Air Noise Monitoring Diego shall shut-down and take the action described above. If abandonment 8. In the unanticipated event that the (j) In-air noise monitoring and of the site is likely, monitoring shall be City of San Diego discovers a live reporting shall be performed during the expanded away from the Children’s stranded marine mammal (sick and/or construction activities at and near the Pool to determine if animals have been injured) at Children’s Pool, they shall Children’s Pool Lifeguard Station. The temporarily displaced to haul-out sites immediately contact Sea World’s PSO shall have access to handheld in the southern California area (e.g., stranded animal hotline at 1–800–541– digital sound level measuring devices. Torrey Pines, Point Loma, etc.). 7235. Sea World shall also be notified The study will characterize in-air sound for dead stranded pinnipeds so that a levels in the area related to (e.g., 7. Reporting Requirements necropsy can be performed. In all cases, construction equipment including The City of San Diego is required to: NMFS shall be notified as well, but for backhoe, dump truck, cement truck, air (a) Submit a draft report on all immediate responses purposes, Sea compressor, electric screw guns, activities and monitoring results to the World shall be contacted first. jackhammer, concrete saw, chop saw, Office of Protected Resources, NMFS, Reporting Prohibited Take and hand tools) and in the absence (as within 90 days of the completion of the a background and baseline [i.e., construction activities at the Children’s In the unanticipated event that the ambient] for the project) of all Pool Lifeguard Station. This report must specified activity clearly causes the take construction activities, and confirm or contain and summarize the following of a marine mammal in a manner identify harassment isopleths for all information: prohibited by this Authorization, such types of and construction activities (i) Dates, times, locations, weather, as an injury (Level A harassment), conducted. To better assess in-air sound sea conditions (including Beaufort sea serious injury or mortality, the City of propagation and source levels, the state and wind speed), and associated San Diego shall immediately cease the distance from the sound meter to each activities during all construction specified activities and immediately sound-producing activity when activities and marine mammal sightings; report the incident to the Chief of the conducting sound measurements shall (ii) Species, number, location, Permits and Conservation Division, be noted. Monitoring shall be conducted distance from the PSO, and behavior of Office of Protected Resources, NMFS, at three to five days prior to construction any marine mammals, as well as 301–427–8401 and/or by email to activities and shall include hourly associated construction activities, [email protected] and systematic counts of pinnipeds using observed throughout all monitoring [email protected] and the the beach, Seal Rock, and associated activities. West Coast Regional Stranding reef areas to provide baseline data (iii) An estimate of the number (by Coordinator (562–980–3230). The report regarding recent haul-out behavior and species) of marine mammals that: (A) must include the following information: patterns as well as background noise are known to have been exposed to the (a) Time, date, and location (latitude/ levels near the time and construction construction activities (based on visual longitude) of the incident; the type of activities. Monitoring shall continue for observation) at received levels greater activity involved; description of the 60 days following the end of demolition than or equal 90 dB re 20 mPa for harbor circumstances during and leading up to and construction activities. Following seals and 100 dB re 20 mPa for all other the incident; status of all sound source construction, the City of San Diego will pinniped species for in-air noise with a use in the 24 hours preceding the have a program where a PSO that will discussion of any specific behaviors incident; water depth; environmental randomly select a day per week to visit those individuals exhibited; and (B) conditions (e.g., wind speed and the Children’s Pool. may have been exposed (based on direction, Beaufort sea state, cloud reported values and modeling cover, and visibility); description of Potential Abandonment Survey measurements for the construction marine mammal observations in the 24 (k) After the first two months of equipment) to the construction activities hours preceding the incident; species monitoring during construction in-air noise at received levels greater identification or description of the activities, the City of San Diego shall than or equal 90 dB re 20 mPa for harbor animal(s) involved; the fate of the take the mean number of observed seals and 100 dB re 20 mPa for all other animal(s); and photographs or video harbor seals at the Children’s Pool in a pinniped species with a discussion of footage of the animal (if equipment is 24-hour period across the two months the nature of the probable consequences available).

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Activities shall not resume until Activities may continue while NMFS I. Background NMFS is able to review the reviews the circumstances of the NMFS’ authority to make the loan circumstances of the prohibited take. incident. resides in sections 1111 and 1112 of the NMFS shall work with the City of San 9. A copy of this Authorization must Merchant Marine Act, 1936 (46 App. Diego to determine what is necessary to be in the possession of all contractors U.S.C. 1279(f) and 1279(g)(MMA)(title minimize the likelihood of further and PSOs operating under the authority XI)). prohibited take and ensure MMPA of this IHA. The Program was authorized in the compliance. The City of San Diego may Request for Public Comments Consolidated Appropriations Act of not resume their activities until notified 2005 (Section 209 of Title II of Division by NMFS via letter or email, or via NMFS requests comment on our B of Pub. L. 108–447) and waives all of telephone. analysis, the draft authorization, and the fishing capacity reduction program any other aspect of the preliminary Reporting an Injured or Dead Marine requirements of the Magnuson-Stevens determinations and notice of the Mammal with an Unknown Cause of Act (Sections 312(b)–(e)) codified at 16 proposed IHA for the City of San Diego’s Death U.S.C. 1801 et seq. except for Sections construction activities at the La Jolla (b)(1)(C) and (d) which state: (1) It must In the event that the City of San Diego Children’s Pool Lifeguard Station. be cost-effective; and (2) it is subject to discovers an injured or dead marine Please include with your comments any a referendum approved by a majority of mammal, and the lead PSO determines supporting data or literature citations to permit holders. that the cause of the injury or death is help inform our final decision on the NMFS published proposed program unknown and the death is relatively City of San Diego’s request for an regulations on May 23, 2011 (76 FR recent (i.e., in less than a moderate state MMPA authorization. Concurrent with 29707), and final program regulations of decomposition as described in the the publication of this notice in the on October 6, 2011 (76 FR 61985), to next paragraph), the City of San Diego Federal Register, NMFS is forwarding implement the reduction program. will immediately report the incident to copies of this IHA application to the Subsequently, the Southeast the Chief of the Permits and Marine Mammal Commission and its Revitalization Association submitted a Conservation Division, Office of Committee of Scientific Advisors. capacity reduction plan to NMFS. Protected Resources, NMFS, at 301– NMFS approved the plan on February 427–8401, and/or by email to Dated: May 11, 2015. Perry F. Gayaldo, 24, 2012. NMFS published the list of [email protected] and eligible voters on March 1, 2012 (77 FR [email protected], and the Deputy Director, Office of Protected Resources, National Marine Fisheries Service. 12568) and the notice of referendum NMFS West Coast Regional Office (1– period on March 29, 2012 (77 FR 866–767–6114) and/or the West Coast [FR Doc. 2015–11994 Filed 5–18–15; 8:45 am] 19004). Interested persons should Regional Stranding Coordinator (562– BILLING CODE 3510–22–P review these for further program details. 980–3230). The report must include the NMFS conducted a referendum where same information identified in the the majority of permit holders voted to DEPARTMENT OF COMMERCE Condition 8(a) above. Activities may repay a fishing capacity reduction loan continue while NMFS reviews the to purchase the permits identified in the circumstances of the incident. NMFS National Oceanic and Atmospheric Administration reduction plan. will work with the City of San Diego to On May 7, 2012, NMFS published determine whether modifications in the RIN 0648–XD943 another Federal Register document (77 activities are appropriate. FR 26744) advising the public that Reporting an Injured or Dead Marine Fishing Capacity Reduction Program NMFS would tender the program’s Mammal Not Related to the Activities for the Southeast Alaska Purse Seine reduction payments to the 64 selected Salmon Fishery bidders who would permanently stop In the event that the City of San Diego fishing with the permits they had discovers an injured or dead marine AGENCY: National Marine Fisheries relinquished in return for reduction mammal, and the lead PSO determines Service (NMFS), National Oceanic and payments. Subsequently, NMFS that the injury or death is not associated Atmospheric Administration, disbursed $13,133,030 in reduction with or related to the activities Commerce. payments to the 64 selected bidders. authorized in Condition 2 to 4 of this ACTION: Notice of fee rate adjustment. NMFS published a Federal Register Authorization (e.g., previously wounded notice on July 16, 2012 (77 FR 41754) animal, carcass with moderate to SUMMARY: NMFS issues this notice to informing the public that fee collection advanced decomposition, or scavenger decrease the fee rate to repay the would begin on July 22, 2012. Since damage), the City of San Diego shall $13,133,030 reduction loan for the then all harvesters of Southeast Alaska report the incident to the Chief of the fishing capacity reduction program in purse seine salmon must pay the fee and Permits and Conservation Division, the Southeast Alaska purse seine all fish buyers of Southeast Alaska purse Office of Protected Resources, NMFS, at salmon fishery. seine salmon must collect the fee in 301–427–8401, and/or by email to DATES: The fee rate decrease is effective accordance with the applicable [email protected] and June 1, 2015. regulations. [email protected], and the ADDRESSES: Send questions about this NMFS published a notice in the NMFS West Coast Regional Office (1– notice to Paul Marx, Chief, Financial Federal Register on June 5, 2013 (78 FR 866–767–6114) and/or the West Coast Services Division, National Marine 33810) to decrease the fee rate from Regional Stranding Coordinator (562– Fisheries Service, 1315 East-West 3.0% of landed value and any 980–3230), within 24 hours of the Highway, Silver Spring, MD 20910– subsequent bonus payments to 1.5%, discovery. The City of San Diego shall 3282. effective June 1, 2013. provide photographs or video footage (if available) or other documentation of the FOR FURTHER INFORMATION CONTACT: Paul II. Purpose stranded animal sighting to NMFS and Marx, (301) 427–8771. The purpose of this notice is to adjust the Marine Mammal Stranding Network. SUPPLEMENTARY INFORMATION: the fee rate for the reduction fishery in

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accordance with the framework rule’s Application; DD Form 2947; OMB DEPARTMENT OF DEFENSE § 600.1013(b). Section 600.1013(b) Control Number 0720–0049. Office of the Secretary directs NMFS to recalculate the fee to a Type of Request: Reinstatement. rate that will be reasonably necessary to ensure reduction loan repayment within Number of Respondents: 16,000. Strategic Environmental Research and the specified 40-year term. Responses per Respondent: 2. Development Program, Scientific Advisory Board; Notice of Federal The initial fee applicable to the Annual Responses: 32,000. Southeast Alaska purse seine salmon Advisory Committee Meeting Average Burden per Response: 15 program’s reduction fishery was 3.0% of AGENCY: Department of Defense. landed value and any subsequent bonus minutes. ACTION: payments, which was decreased in June Annual Burden Hours: 8,000. Notice. 2013 to 1.5%. NMFS has determined Needs and Uses: The information SUMMARY: The Department of Defense is this fee rate is more than is needed to collection requirement is necessary to publishing this notice to announce an service the loan. Therefore, NMFS is evaluate eligibility and qualifications of open meeting of the Strategic decreasing the fee rate to 1.0% of landed former young adult dependents Environmental Research and value and any subsequent bonus applying for extended dependent Development Program, Scientific payments which NMFS has determined coverage under the TRICARE Young Advisory Board (SAB). This meeting is sufficient to ensure timely loan Adult program. will be open to the public. repayment. Fish buyers may continue to DATES: Tuesday, June 16, 2015, from use Pay.gov to disburse collected fee Affected Public: Individuals or 8:00 a.m. to 4:50 p.m. deposits at: http://www.pay.gov/paygov/ households. . Please visit the NMFS Web site for Frequency: On occasion. ADDRESSES: Renaissance Portsmouth- Norfolk Waterfront Hotel, 425 Water additional information at: http:// Respondent’s Obligation: Required to _ Street, Portsmouth, Virginia 23704. www.nmfs.noaa.gov/mb/financial obtain or retain benefits. services/buyback.htm. FOR FURTHER INFORMATION CONTACT: Dr. OMB Desk Officer: Ms. Meredith Anne Andrews, SERDP Office, 4800 III. Notice DeDona. Mark Center Drive, Suite 17D08, The new fee rate for the Southeast Written comments and Alexandria, VA 22350–3605; or by Alaska purse seine salmon fishery is recommendations on the proposed telephone at (571) 372–6565. effective June 1, 2015. information collection should be sent to SUPPLEMENTARY INFORMATION: This Fish sellers and fish buyers must pay Ms. Meredith DeDona at the Office of meeting is being held under the and collect the fee in the manner set out Management and Budget, Desk Officer provisions of the Federal Advisory in 50 CFR 600.1107 and the framework for DoD, Room 10236, New Executive Committee Act of 1972 (5 U.S.C. rule. Consequently, all harvesters and Office Building, Washington, DC 20503. Appendix, as amended), the fish buyers should read subpart L to 50 You may also submit comments, Government in the Sunshine Act of CFR 600.1013 to understand how fish identified by docket number and title, 1976 (5 U.S.C. 552b, as amended), and harvesters must pay and fish buyers by the following method: 41 CFR 102–3.150. This notice is must collect the fee. published in accordance with Section • Federal eRulemaking Portal: http:// Dated: May 14, 2015. 10(a)(2) of the Federal Advisory www.regulations.gov. Follow the Committee Act (Pub. L. 92–463). Basil Brown, instructions for submitting comments. Acting Director, Office of Management and Pursuant to 5 U.S.C. 552b and 41 CFR Budget, National Marine Fisheries Service. Instructions: All submissions received 102–3.140 through 102–3.165, and the [FR Doc. 2015–12092 Filed 5–18–15; 8:45 am] must include the agency name, docket availability of space, this meeting is number and title for this Federal BILLING CODE 3510–22–P open to the public. Seating is on a first- Register document. The general policy come basis. for comments and other submissions The purpose of the June 16, 2015 from members of the public is to make DEPARTMENT OF DEFENSE meeting is to review research and these submissions available for public development projects requesting Office of the Secretary viewing on the Internet at http:// Strategic Environmental Research and www.regulations.gov as they are Development Program funds as required [Docket ID: DoD–2015–HA–0009] received without change, including any by the SERDP Statute, U.S. Code - Title personal identifiers or contact 10, Subtitle A, Part IV, Chapter 172, Submission for OMB Review; information. Comment Request § 2904. The full agenda follows: DOD Clearance Officer: Mr. Frederick 8:00 a.m. Convene/Opening Remarks, ACTION: Notice. Licari. Approval of October 2014 Minutes; Dr. Joseph Hughes, Chair. SUMMARY: The Department of Defense Written requests for copies of the information collection proposal should 8:05 a.m. Program Update; Dr. Anne has submitted to OMB for clearance, the Andrews, Acting Executive following proposal for collection of be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Director. information under the provisions of the 8:20 a.m. Munitions Response Paperwork Reduction Act. Drive, East Tower, Suite 02G09, Alexandria, VA 22350–3100. Overview; Dr. Herb Nelson, DATES: Consideration will be given to all Munitions Response, Program comments received by June 18, 2015. Dated: May 14, 2015. Manager. FOR FURTHER INFORMATION CONTACT: Fred Aaron Siegel, 8:30 a.m. 15 MR01–039 (MR–2545): Licari, 571–372–0493. Alternate OSD Federal Register Liaison Sediment Volume Search Sonar SUPPLEMENTARY INFORMATION: Officer, Department of Defense. Development, (FY15 New Start); Title, Associated Form and OMB [FR Doc. 2015–12093 Filed 5–18–15; 8:45 am] Mr. Daniel Brown, Applied Number: TRICARE Young Adult BILLING CODE 5001–06–P Research Laboratory, The

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Pennsylvania State University, State Development Program, Scientific Permit Program can be found in separate College, PA. Advisory Board. The DFO will ensure notices of proposed rulemaking in the 9:15 a.m. Break that the written statements are provided Federal Register, the register 9:30 a.m. Resource Conservation and to the membership for their publications of each of the Climate Change Overview; Dr. John consideration. Contact information for Commission’s member states, and at Hall, Resource Conservation and the DFO can be obtained from the GSA’s www.drbc.net. Climate Change, Program Manager. FACA Database at http:// Written comments on draft dockets 9:50 a.m. RC–2245: Defense Coastal/ www.facadatabase.gov/. Time is allotted and resolutions scheduled for hearing Estuarine Research Program at the close of the meeting day for the on June 9 will be accepted through the (DCERP) Overview, (FY16 public to make comments. Oral close of the hearing that day. After the Continuing); Dr. Patricia comments are limited to 5 minutes per hearing on all scheduled matters has Cunningham, RTI International, person. been completed, and as time allows, an opportunity for public dialogue will Research Triangle Park, NC. Dated: May 14, 2015. 10:05 a.m. RC–2245: CB–4 Title: also be provided. Aaron Siegel, Predicting Sustainability of Coastal The public is advised to check the Military Training Environments; Dr. Alternate OSD Federal Register Liaison Commission’s Web site periodically Officer, Department of Defense. Jesse McNinch, ERDC Coastal prior to the hearing date, as items Hydraulics Lab, Duck, NC. [FR Doc. 2015–12098 Filed 5–18–15; 8:45 am] scheduled for hearing may be postponed 10:35 a.m. RC–2245: CC–1 Title: BILLING CODE 5001–06–P if additional time is deemed necessary Development of Uniform Historical to complete the Commission’s review, and Projected Climate to Support and items may be added up to ten days Integrated Coastal Ecosystem DELAWARE RIVER BASIN prior to the hearing date. In reviewing Research; Dr. Ryan Boyles, North COMMISSION docket descriptions, the public is also Carolina State University, Raleigh, asked to be aware that project details Notice of Public Hearing and Business NC. commonly change in the course of the Meeting 11:20 a.m. RC–2245: Development of Commission’s review, which is ongoing. Public Meeting. The public business Empirical Carbon Budget; Dr. Craig June 9–10, 2015. Tobias, University of Connecticut, meeting on June 10, 2015 will begin at Notice is hereby given that the 1:30 p.m. and will include: Adoption of Groton, CT. Delaware River Basin Commission will 12:05 p.m. Lunch the Minutes of the Commission’s March hold a public hearing on Tuesday, June 11, 2015 business meeting, 1:05 p.m. RC–2245: Translating 9, 2015. A business meeting will be held Science into Practice; Dr. Mike announcements of upcoming meetings the following day on Wednesday, June and events, a report on hydrologic Piehler, University of North 10, 2015. The hearing and business conditions, reports by the Executive Carolina, Morehead City, NC. meeting are open to the public and will Director and the Commission’s General 1:35 p.m. RC–2245: TAC Comments be held at the Washington Crossing Counsel, and consideration of any items and Project Management; Dr. Historic Park Visitor Center, 1112 River for which a hearing has been completed Patricia Cunningham, RTI Road, Washington Crossing, or is not required. International, Research Triangle Pennsylvania. There will be no opportunity for Park, NC. Public Hearing. The public hearing on additional public comment at the June 2:20 p.m. FY16 Statements of Need— June 9, 2015 will begin at 1:30 p.m. 10 business meeting on items for which Summaries in Preparation of New Hearing items will include: Draft a hearing was completed on June 9 or Start Projects to be Presented in dockets for the withdrawals, discharges a previous date. Commission September and October; SERDP and other water-related projects subject consideration on June 10 of items for Program Managers. to the Commission’s review; a which the public hearing is closed may 3:25 p.m. Break resolution apportioning among the result in either approval of the item (by 3:40 p.m. FY17 SON—Board Input; signatory parties the amounts required docket or resolution) as proposed, All. for support of the current expense and approval with changes, denial, or 4:05 p.m. Scenarios for Sea Level Rise capital budgets for the fiscal year ending deferral. When the Commissioners defer and Extreme Water Levels: Building June 30, 2016; a resolution approving an action, they may announce an on SERDP Research; Dr. John Hall, the annual current expense and capital additional period for written comment Resource Conservation and Climate budgets for the fiscal year ending June on the item, with or without an Change, Program Manager. 30, 2016; and a proposed rule, additional hearing date, or they may 4:50 p.m. Public Discussion/Adjourn published elsewhere in this issue of the take additional time to consider the Pursuant to 41 CFR 102–3.140, and Federal Register, amending DRBC’s input they have already received section 10(a)(3) of the Federal Advisory Administrative Manual Part III—Rules without requesting further public input. Committee Act of 1972, the public or of Practice and Procedure to provide for Any deferred items will be considered interested organizations may submit the One Process/One Permit Program. for action at a public meeting of the written statements to the Strategic The list of projects scheduled for Commission on a future date. Items Environmental Research and hearing, including project descriptions, heard during the March 10, 2015 Public Development Program, Scientific will be posted on the Commission’s Hearing on which the Commission has Advisory Board. Written statements may Web site, www.drbc.net, in a long form not yet acted include draft dockets D– be submitted to the committee at any of this notice at least ten days before the 2014–008–1 for the Columbia Gas time or in response to an approved hearing date. Draft resolutions Transmission Corporation, and D–2014– meeting agenda. scheduled for hearing also will be 022–1 for the Trancontinental Pipeline All written statements shall be posted at www.drbc.net ten or more Company, LLC. submitted to the Designated Federal days prior to the hearing. Additional Advance Sign-Up for Oral Comment. Officer (DFO) for the Strategic information related to the proposed rule Individuals who wish to comment for Environmental Research and to provide for the One Process/One the record at the public hearing on June

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9 or to address the Commissioners DEPARTMENT OF EDUCATION Department’s information collection informally during the public dialogue requirements and provide the requested [Docket No.: ED–2015–ICCD–0065] portion of the meeting that day as time data in the desired format. ED is allows, are asked to sign up in advance Agency Information Collection soliciting comments on the proposed by contacting Ms. Paula Schmitt of the Activities; Submission to the Office of information collection request (ICR) that Commission staff, at paula.schmitt@ Management and Budget for Review is described below. The Department of drbc.state.nj.us or by phoning Ms. and Approval; Comment Request; Education is especially interested in Schmitt at 609–883–9500 ext. 224. 2015–16 National Postsecondary public comment addressing the Addresses for Written Comment. Student Aid Study (NPSAS:16) Full following issues: (1) Is this collection Written comment on items scheduled Scale Institution Contacting And necessary to the proper functions of the for hearing may be delivered by hand at Enrollment List Collection Department; (2) will this information be the public hearing or in advance of the processed and used in a timely manner; hearing, either: By hand, U.S. Mail or AGENCY: Institute of Education Sciences/ (3) is the estimate of burden accurate; private carrier to: Commission National Center for Education Statistics (4) how might the Department enhance Secretary, P.O. Box 7360, 25 State Police (IES), Department of Education (ED). the quality, utility, and clarity of the Drive, West Trenton, NJ 08628; by fax to ACTION: Notice. information to be collected; and (5) how Commission Secretary, DRBC at 609– might the Department minimize the 883–9522; or by email (preferred) to SUMMARY: In accordance with the burden of this collection on the [email protected]. If Paperwork Reduction Act of 1995 (44 respondents, including through the use submitted by email in advance of the U.S.C. chapter 3501 et seq.), ED is of information technology. Please note hearing date, written comments on a proposing a revision of an existing that written comments received in docket should also be sent to Mr. information collection. response to this notice will be William Muszynski, Manager, Water DATES: Interested persons are invited to considered public records. Resources Management at submit comments on or before June 18, Title of Collection: 2015–16—National [email protected]. 2015. Postsecondary Student Aid Study Accommodations for Special Needs. ADDRESSES: Comments submitted in (NPSAS:16) Full Scale Institution Individuals in need of an response to this notice should be Contacting And Enrollment List accommodation as provided for in the submitted electronically through the Collection. Americans with Disabilities Act who Federal eRulemaking Portal at http:// OMB Control Number: 1850–0666. wish to attend the informational www.regulations.gov by selecting Type of Review: A revision of an meeting, conference session or hearings Docket ID number ED–2015–ICCD–0065 existing information collection. should contact the Commission or via postal mail, commercial delivery, Respondents/Affected Public: Secretary directly at 609–883–9500 ext. or hand delivery. If the regulations.gov Individuals or Households. 203 or through the Telecommunications site is not available to the public for any Total Estimated Number of Annual Relay Services (TRS) at 711, to discuss reason, ED will temporarily accept Responses: 4,478. how we can accommodate your needs. comments at [email protected]. Total Estimated Number of Annual Updates. Items scheduled for hearing Please note that comments submitted by Burden Hours: 4,081. are occasionally postponed to allow fax or email and those submitted after Abstract: The National Postsecondary more time for the Commission to the comment period will not be Student Aid Study (NPSAS), a consider them. Other meeting items also accepted; ED will ONLY accept nationally representative study of how are subject to change. Please check the comments during the comment period students and their families finance Commission’s Web site, www.drbc.net, in this mailbox when the regulations.gov postsecondary education, was first closer to the meeting date for changes site is not available. Written requests for implemented by the National Center for that may be made after the deadline for information or comments submitted by Education Statistics (NCES) in 1987 and filing this notice. postal mail or delivery should be has been fielded every 3 to 4 years Additional Information, Contacts. The addressed to the Director of the since. The next major data collection list of projects scheduled for hearing, Information Collection Clearance will occur in 2016 following a field test with descriptions, will be posted on the Division, U.S. Department of Education, collection in 2015. This submission is Commission’s Web site, www.drbc.net, 400 Maryland Avenue SW., LBJ, for the ninth cycle in the series, in a long form of this notice at least ten Mailstop L–OM–2–2E319, Room 2E103, NPSAS:16, which will also serve as the days before the hearing date. Draft Washington, DC 20202. base year study for the 2016 dockets and resolutions for hearing FOR FURTHER INFORMATION CONTACT: For Baccalaureate and Beyond Longitudinal items will be available as hyperlinks specific questions related to collection Study (B&B) which provides data on the from the posted notice. Additional activities, please contact Kashka various paths of recent college graduates public records relating to hearing items Kubzdela, 202–502–7411. into employment and additional may be examined at the Commission’s SUPPLEMENTARY INFORMATION: The education. The NPSAS:16 sample will offices by appointment by contacting Department of Education (ED), in include about 2,000 institutions and Carol Adamovic, 609–883–9500, ext. accordance with the Paperwork about 128,000 students. Institution 249. For other questions concerning Reduction Act of 1995 (PRA) (44 U.S.C. contacting will begin in October 2015 hearing items, please contact Project 3506(c)(2)(A)), provides the general and student data collection will be Review Section assistant Victoria public and Federal agencies with an conducted from January through Lawson at 609–883–9500, ext. 216. opportunity to comment on proposed, September 2016. A separate package to Dated: May 13, 2015. revised, and continuing collections of request clearance for student data Pamela M. Bush, information. This helps the Department collection (interviews and institution Commission Secretary and Assistant General assess the impact of its information record data) will be submitted in the fall Counsel. collection requirements and minimize 2015. This submission includes [FR Doc. 2015–12077 Filed 5–18–15; 8:45 am] the public’s reporting burden. It also contacting materials and collection of BILLING CODE 6360–01–P helps the public understand the enrollment lists from institutions

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selected to participate in the full-scale public and Federal agencies with an DEPARTMENT OF ENERGY study. opportunity to comment on proposed, Dated: May 13, 2015. revised, and continuing collections of Environmental Management Site- Specific Advisory Board, Hanford Kate Mullan, information. This helps the Department Acting Director, Information Collection assess the impact of its information AGENCY: Department of Energy. collection requirements and minimize Clearance Division, Office of the Chief Privacy ACTION: Notice of open meeting. Officer, Office of Management. the public’s reporting burden. It also [FR Doc. 2015–12040 Filed 5–18–15; 8:45 am] helps the public understand the SUMMARY: This notice announces a BILLING CODE 4000–01–P Department’s information collection meeting of the Environmental requirements and provide the requested Management Site-Specific Advisory data in the desired format. ED is Board (EM SSAB), Hanford. The Federal DEPARTMENT OF EDUCATION soliciting comments on the proposed Advisory Committee Act (Pub. L. 92– [Docket No.: ED–2015–ICCD–0066] information collection request (ICR) that 463, 86 Stat. 770) requires that public is described below. The Department of notice of this meeting be announced in Agency Information Collection Education is especially interested in the Federal Register. Activities; Comment Request; public comment addressing the DATES: Graduate Assistance in Areas of following issues: (1) Is this collection Wednesday, June 10, 2015, 8:30 a.m.– National Need (GAANN) Performance necessary to the proper functions of the 5:00 p.m. Report Department; (2) will this information be Thursday, June 11, 2015, 9:00 a.m.– 12:00 p.m. AGENCY: Department of Education (ED), processed and used in a timely manner; Office of Postsecondary Education (3) is the estimate of burden accurate; ADDRESSES: Red Lion Hanford House, (OPE). (4) how might the Department enhance 802 George Washington Way, Richland, WA 99352. ACTION: Notice. the quality, utility, and clarity of the information to be collected; and (5) how FOR FURTHER INFORMATION CONTACT: SUMMARY: In accordance with the might the Department minimize the Kristen Skopeck, Federal Coordinator, Paperwork Reduction Act of 1995 (44 burden of this collection on the Department of Energy Richland U.S.C. chapter 3501 et seq.), ED is respondents, including through the use Operations Office, 825 Jadwin Avenue, proposing a revision of an existing of information technology. Please note P.O. Box 550, A7–75, Richland, WA information collection. that written comments received in 99352; Phone: (509) 376–5803; or Email: DATES: Interested persons are invited to response to this notice will be [email protected]. submit comments on or before July 20, considered public records. SUPPLEMENTARY INFORMATION: 2015. Purpose of the Board: The purpose of Title of Collection: Graduate ADDRESSES: Comments submitted in the Board is to make recommendations response to this notice should be Assistance in Areas of National Need to DOE–EM and site management in the submitted electronically through the (GAANN) Performance Report. areas of environmental restoration, Federal eRulemaking Portal at http:// OMB Control Number: 1840–0748. waste management, and related www.regulations.gov by selecting Type of Review: A revision of an activities. Docket ID number ED–2015–ICCD–0066 existing information collection. Tentative Agenda: or via postal mail, commercial delivery, • Potential Draft Advice Respondents/Affected Public: Private or hand delivery. If the regulations.gov D Budget Priorities Sector, State, Local and Tribal site is not available to the public for any • Discussion Topics reason, ED will temporarily accept Governments. D Tank Vapor Implementation Plan comments at [email protected]. Total Estimated Number of Annual D Phoenix Tool—Tank Farm Please note that comments submitted by Responses: 291. Application fax or email and those submitted after Total Estimated Number of Annual D Tri-Party Agreement Agencies’ the comment period will not be Burden Hours: 3,273. Updates accepted; ED will ONLY accept D Hanford Advisory Board Committee comments during the comment period Abstract: Graduate Assistance in Reports in this mailbox when the regulations.gov Areas of National Need (GAANN) D Board Business site is not available. Written requests for grantees must submit a performance Public Participation: The meeting is information or comments submitted by report annually. The reports are used to open to the public. The EM SSAB, postal mail or delivery should be evaluate grantee performance. Further, Hanford, welcomes the attendance of addressed to the Director of the the data from the reports will be the public at its advisory committee Information Collection Clearance aggregated to evaluate the meetings and will make every effort to Division, U.S. Department of Education, accomplishments and impact of the accommodate persons with physical 400 Maryland Avenue SW., LBJ, GAANN Program as a whole. Results disabilities or special needs. If you Mailstop L–OM–2–2E319, Room 2E103, will be reported to the Secretary in require special accommodations due to Washington, DC 20202. order to respond to GPRA requirements. a disability, please contact Kristen FOR FURTHER INFORMATION CONTACT: For Dated: May 14, 2015. Skopeck at least seven days in advance specific questions related to collection of the meeting at the phone number Kate Mullan, activities, please contact Rebecca Ell, listed above. Written statements may be (202) 502–7779. Acting Director, Information Collection filed with the Board either before or Clearance Division, Office of the Chief Privacy SUPPLEMENTARY INFORMATION: The after the meeting. Individuals who wish Department of Education (ED), in Officer, Office of Management. to make oral statements pertaining to accordance with the Paperwork [FR Doc. 2015–12074 Filed 5–18–15; 8:45 am] agenda items should contact Kristen Reduction Act of 1995 (PRA) (44 U.S.C. BILLING CODE 4000–01–P Skopeck at the address or telephone 3506(c)(2)(A)), provides the general number listed above. Requests must be

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received five days prior to the meeting comment date. Anyone filing a motion Environmental Protection Agency has and reasonable provision will be made to intervene or protest must serve a copy posted its inventory and a summary of to include the presentation in the of that document on the Petitioner. the inventory on the EPA’s homepage at agenda. The Deputy Designated Federal The Commission encourages the following link: http://www.epa.gov/ Officer is empowered to conduct the electronic submission of protests and oam/inventory/inventory.htm. meeting in a fashion that will facilitate interventions in lieu of paper using the FOR FURTHER INFORMATION CONTACT: the orderly conduct of business. ‘‘eFiling’’ link at http://www.ferc.gov. Questions regarding the service contract Individuals wishing to make public Persons unable to file electronically inventory should be directed to Linear comments will be provided a maximum should submit an original and 5 copies Cherry in the Office of Acquisition of five minutes to present their of the protest or intervention to the Management, Policy, Training, and comments. Federal Energy Regulatory Commission, Oversight Division (3802R), Financial Minutes: Minutes will be available by 888 First Street NE., Washington, DC Analysis and Oversight Service Center, writing or calling Kristen Skopeck’s 20426 Environmental Protection Agency, 1200 office at the address or phone number This filing is accessible on-line at Pennsylvania Avenue NW., Washington, listed above. Minutes will also be http://www.ferc.gov, using the DC 20460; telephone number: (202) available at the following Web site: ‘‘eLibrary’’ link and is available for 564–4403; email address: cherry.linear@ http://www.hanford.gov/page.cfm/hab. review in the Commission’s Public epa.gov. Issued at Washington, DC, on May 13, Reference Room in Washington, DC. SUPPLEMENTARY INFORMATION: 2015. There is an ‘‘eSubscription’’ link on the LaTanya R. Butler, Web site that enables subscribers to General Information Deputy Committee Management Officer. receive email notification when a How can I get copies of this docket and document is added to a subscribed other related information? [FR Doc. 2015–12075 Filed 5–18–15; 8:45 am] docket(s). For assistance with any FERC BILLING CODE 6450–01–P Online service, please email 1. The EPA has established a docket [email protected], or call for this action under Docket ID No. EPA–HQ–OARM–2015–0283. Publicly DEPARTMENT OF ENERGY (866) 208–3676 (toll free). For TTY, call (202) 502–8659. available docket materials are available Federal Energy Regulatory Comment Date: 5:00 p.m. Eastern time either electronically through Commission on June 10, 2015. www.regulations.gov or in hard copy at the FY 2014 Service Contract Inventory Dated: May 13, 2015. [Docket No. EL15–65–000] Docket in the EPA Docket Center, (EPA/ Kimberly D. Bose, DC) EPA West, Room 3334, 1301 Southline Transmission, L.L.C., SU Secretary. Constitution Avenue NW., Washington, FERC, L.L.C.; Notice of Petition for [FR Doc. 2015–12080 Filed 5–18–15; 8:45 am] DC. The EPA Docket Center Public Declaratory Order BILLING CODE 6717–01–P Reading Room is open from 8:30 a.m. to Take notice that on May 11, 2015, 4:30 p.m., Monday through Friday, pursuant to Rule 207(a)(2) of the Federal excluding legal holidays. The telephone ENVIRONMENTAL PROTECTION number for the Public Reading Room is Energy Regulatory Commission’s AGENCY (Commission) Rules of Practice and (202) 566–1744, and the telephone Procedure, 18 CFR 385.207(a)(2) (2014), [EPA–HQ–OARM–2015–0283; FRL–9927– number for the FY 2014 Service Southline Transmission, L.L.C. 88–OARM] Contract Inventory Docket is (202) 566– 1752. (Southline) and SU FERC, L.L.C. (SU Public Availability of Environmental FERC), filed a petition for declaratory 2. Electronic Access. You may access Protection Agency FY 2014 Service this Federal Register document order requesting that the Commission: Contract Inventory (1) Find that Southline Transmission is electronically through the EPA Internet under the ‘‘Federal Register’’ listings at a passive entity and therefore not a AGENCY: Environmental Protection http://www.epa.gov/fedrgstr/. public utility within the meaning of the Agency Federal Power Act or an electric utility ACTION: Notice. Dated: May 14, 2015. company under the Public Utility John R. Bashista, Holding Company Act of 2005, (2) grant SUMMARY: In accordance with Section Director, Office of Acquisition Management. SU FERC negotiated rate authority, (3) 743 of Division C of the Consolidated [FR Doc. 2015–12102 Filed 5–18–15; 8:45 am] approve SU FERC’s capacity allocation Appropriations Act of 2010 (Pub. L. BILLING CODE 6560–50–P methodology, and (4) grant certain 111–117), the Environmental Protection waivers of FERC’s regulations. Agency is publishing this notice to Any person desiring to intervene or to advise the public of the availability of protest this filing must file in the FY 2014 Service Contract Inventory. FEDERAL DEPOSIT INSURANCE accordance with Rules 211 and 214 of This inventory provides information on CORPORATION the Commission’s Rules of Practice and service contract actions over $25,000 Procedure (18 CFR 385.211, 385.214). that were made in FY 2014. The Update to Notice of Financial Protests will be considered by the information is organized by function to Institutions for Which the Federal Commission in determining the show how contracted resources are Deposit Insurance Corporation Has appropriate action to be taken, but will distributed throughout the Agency. The Been Appointed Either Receiver, not serve to make protestants parties to inventory has been developed in Liquidator, or Manager the proceeding. Any person wishing to accordance with guidance issued by the AGENCY: Federal Deposit Insurance become a party must file a notice of Office of Management and Budget’s Corporation. intervention or motion to intervene, as Office of Federal Procurement Policy ACTION: Update listing of financial appropriate. Such notices, motions, or (OFPP), Service Contract Inventories institutions in liquidation. protests must be filed on or before the (December 19, 2011). The

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SUMMARY: Notice is hereby given that the Corporation has been appointed individual/failed/banklist.html or the Federal Deposit Insurance receiver for purposes of the statement of contact the Manager of Receivership Corporation (Corporation) has been policy published in the July 2, 1992 Oversight in the appropriate service appointed the sole receiver for the issue of the Federal Register (57 FR center. following financial institutions effective 29491). For further information Dated: May 11, 2015. as of the Date Closed as indicated in the concerning the identification of any listing. This list (as updated from time institutions which have been placed in Federal Deposit Insurance Corporation. to time in the Federal Register) may be liquidation, please visit the Corporation Pamela Johnson, relied upon as ‘‘of record’’ notice that Web site at www.fdic.gov/bank/ Regulatory Editing Specialist.

INSTITUTIONS IN LIQUIDATION [In alphabetical order]

FDIC Ref. No. Bank name City State Date closed

10514 ...... Edgebrook Bank ...... Chicago ...... IL 5/8/2015

[FR Doc. 2015–12069 Filed 5–18–15; 8:45 am] at least 72 hours prior to the meeting must be received at the Reserve Bank BILLING CODE 6714–01–P date. indicated or the offices of the Board of PERSON TO CONTACT FOR INFORMATION: Governors not later than June 11, 2015. Judith Ingram, Press Officer, Telephone: A. Federal Reserve Bank of Atlanta FEDERAL ELECTION COMMISSION (202) 694–1220. (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street, NE., Sunshine Act Meetings Shawn Woodhead Werth, Atlanta, Georgia 30309: Secretary and Clerk of the Commission. 1. United Community Banks, Inc., AGENCY: Federal Election Commission. [FR Doc. 2015–12159 Filed 5–15–15; 11:15 am] Blairsville, Georgia; to merge with DATE AND TIME: Thursday, May 21, 2015 BILLING CODE 6715–01–P Palmetto Bancshares, Inc., and thereby At 10:00 a.m. acquire The Palmetto Bank, both of PLACE: 999 E Street NW., Washington, Greenville, South Carolina. FEDERAL RESERVE SYSTEM DC (Ninth Floor). Board of Governors of the Federal Reserve STATUS: This meeting will be open to Formations of, Acquisitions by, and System, May 13, 2015. the public. Mergers of Bank Holding Companies Michael J. Lewandowski, ITEMS TO BE DISCUSSED: Associate Secretary of the Board. Correction and Approval of Minutes for The companies listed in this notice [FR Doc. 2015–12033 Filed 5–18–15; 8:45 am] March 19, 2015 have applied to the Board for approval, BILLING CODE 6210–01–P Audit Division Recommendation pursuant to the Bank Holding Company Memorandum on the Oakland Act of 1956 (12 U.S.C. 1841 et seq.) County Democratic Party (OCDP) (BHC Act), Regulation Y (12 CFR part FEDERAL RESERVE SYSTEM (A12–02) 225), and all other applicable statutes Audit Division Recommendation and regulations to become a bank Change in Bank Control Notices; Memorandum on Kevin McCarthy holding company and/or to acquire the Acquisitions of Shares of a Bank or for Congress (KMFC) (A13–02) assets or the ownership of, control of, or Bank Holding Company Audit Division Recommendation the power to vote shares of a bank or Memorandum on New American bank holding company and all of the The notificants listed below have City, Inc. (NAC) banks and nonbanking companies applied under the Change in Bank Presentation by the FEC Staff on owned by the bank holding company, Control Act (12 U.S.C. 1817(j)) and Enhanced Engagement with the including the companies listed below. § 225.41 of the Board’s Regulation Y (12 Public and Stakeholders The applications listed below, as well CFR 225.41) to acquire shares of a bank Notice to Respondents of Information as other related filings required by the or bank holding company. The factors Sharing by the Commission Board, are available for immediate that are considered in acting on the Proposed Statement of Policy Regarding inspection at the Federal Reserve Bank notices are set forth in paragraph 7 of the Public Disclosure of Closed indicated. The applications will also be the Act (12 U.S.C. 1817(j)(7)). Enforcement Files available for inspection at the offices of The notices are available for Motion to Open a Rulemaking in the Board of Governors. Interested immediate inspection at the Federal Response to Comments and persons may express their views in Reserve Bank indicated. The notices Testimony on the McCutcheon v. writing on the standards enumerated in also will be available for inspection at FEC ANPRM the BHC Act (12 U.S.C. 1842(c)). If the the offices of the Board of Governors. Proposed Directive 74 on the Timely proposal also involves the acquisition of Interested persons may express their Resolution of Enforcement Matters a nonbanking company, the review also views in writing to the Reserve Bank Management and Administrative includes whether the acquisition of the indicated for that notice or to the offices Matters nonbanking company complies with the of the Board of Governors. Comments Individuals who plan to attend and standards in section 4 of the BHC Act must be received not later than June 2, require special assistance, such as sign (12 U.S.C. 1843). Unless otherwise 2015. language interpretation or other noted, nonbanking activities will be A. Federal Reserve Bank of Kansas reasonable accommodations, should conducted throughout the United States. City (Dennis Denney, Assistant Vice contact Shawn Woodhead Werth, Unless otherwise noted, comments President) 1 Memorial Drive, Kansas Secretary and Clerk, at (202) 694–1040, regarding each of these applications City, Missouri 64198–0001:

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1. David L. Johnson and Sandra L. DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Castetter, both of Kansas City, Missouri; HUMAN SERVICES HUMAN SERVICES each individually to acquire over 10 percent; and David L. Johnson and Centers for Disease Control and Centers for Disease Control and Sandra L. Castetter, together with Park Prevention Prevention GP, LLC, North Kansas City, Missouri, [60Day–15–15AIS; Docket No. CDC–2015– acting in concert to acquire up to 24.99 Disease, Disability, and Injury 0037] percent of the voting shares CCSB Prevention and Control Special Financial Corp., parent of Clay County Emphasis Panel (SEP): Initial Review Proposed Data Collection Submitted Savings Bank, both of Liberty, Missouri. for Public Comment and In accordance with Section 10(a)(2) of Recommendations Board of Governors of the Federal Reserve the Federal Advisory Committee Act AGENCY: System, May 13, 2015. (Pub. L. 92–463), the Centers for Disease Centers for Disease Control and Prevention (CDC), Department of Health Michael J. Lewandowski, Control and Prevention (CDC) and Human Services (HHS). Assistant Secretary of the Board. announces a meeting for the initial ACTION: Notice with comment period. [FR Doc. 2015–12034 Filed 5–18–15; 8:45 am] review of applications in response to BILLING CODE 6210–01–P Funding Opportunity Announcement SUMMARY: The Centers for Disease (FOA) PS15–1505, Enhancing HIV Control and Prevention (CDC), as part of Prevention Communication and its continuing efforts to reduce public Mobilization Efforts through Strategic burden and maximize the utility of DEPARTMENT OF HEALTH AND Partnerships. government information, invites the HUMAN SERVICES Time and Date: 10:00 a.m.–1:00 p.m., EDT, general public and other Federal Panels 1–5; June 9, 2015 (CLOSED). agencies to take this opportunity to Centers for Disease Control and Place: Teleconference. comment on proposed and/or Prevention Status: The meeting will be closed to the continuing information collections, as public in accordance with provisions set required by the Paperwork Reduction Disease, Disability, and Injury forth in Section 552b(c) (4) and (6), Title 5 Act of 1995. This notice invites Prevention and Control Special U.S.C., and the Determination of the Director, comment on the proposed information Emphasis Panel (SEP): Initial Review Management Analysis and Services Office, collection entitled CDC Burden of CDC, pursuant to Public Law 92–463. Canine Brucellosis Information The meeting announced below Matters for Discussion: The meeting will Collection. This information collection concerns Building Local Community include the initial review, discussion, and will help to estimate canine brucellosis Health Leadership for Action on evaluation of applications received in disease burden in dogs, which will aid Preventing Chronic Disease, SIP 15–006, response to ‘‘Enhancing HIV Prevention in the determination of the public initial review. Communication and Mobilization Efforts health importance of human B. canis SUMMARY: This document corrects a through Strategic Partnerships’’ FOA PS15– infections, and the potential for notice that was published in the Federal 1505. zoonotic transmission. Register on May 5, 2015, Volume 80, Contact Person for more Information: Lisa DATES: Written comments must be Number 86, Page 25692. The time and R. Williams, Public Health Analyst, CDC, received on or before July 20, 2015. 1600 Clifton Road, NE., Mailstop E07, date should have read as follows: ADDRESSES: You may submit comments, Atlanta, Georgia 30333, Telephone: (404) identified by Docket No. CDC–2015– TIME AND DATE: 11:00 a.m.–6:00 p.m., 639–1877. 0037 by any of the following methods: May 28, 2015 (Closed). The Director, Management Analysis and • Federal eRulemaking Portal: Services Office, has been delegated the Regulation.gov. Follow the instructions FOR FURTHER INFORMATION CONTACT: authority to sign Federal Register notices Brenda Colley Gilbert, Ph.D., M.S.P.H., for submitting comments. pertaining to announcements of meetings and • Director, Extramural Research Program Mail: Leroy A. Richardson, other committee management activities, for Information Collection Review Office, Operations and Services, CDC, 4770 both the Centers for Disease Control and Centers for Disease Control and Buford Highway NE., Mailstop F–80, Prevention and the Agency for Toxic Prevention, 1600 Clifton Road NE., MS– Atlanta, Georgia 30341, Telephone: Substances and Disease Registry. D74, Atlanta, Georgia 30329. (770) 488–6295, [email protected]. Elaine L. Baker, Instructions: All submissions received The Director, Management Analysis Director, Management Analysis and Services must include the agency name and and Services Office, has been delegated Office, Centers for Disease Control and Docket Number. All relevant comments the authority to sign Federal Register Prevention. received will be posted without change notices pertaining to announcements of [FR Doc. 2015–12056 Filed 5–18–15; 8:45 am] to Regulations.gov, including any meetings and other committee personal information provided. For BILLING CODE 4163–18–P management activities, for both the access to the docket to read background Centers for Disease Control and documents or comments received, go to Prevention and the Agency for Toxic Regulations.gov. Substances and Disease Registry. Please note: All public comment should be submitted through the Federal eRulemaking Elaine L. Baker, portal (Regulations.gov) or by U.S. mail to Director, Management Analysis and Services the address listed above. Office, Centers for Disease Control and Prevention. FOR FURTHER INFORMATION CONTACT: To [FR Doc. 2015–12054 Filed 5–18–15; 8:45 am] request more information on the proposed project or to obtain a copy of BILLING CODE 4163–18–P the information collection plan and

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instruments, contact the Information personnel and to be able to respond to been ascertained. The Council of State Collection Review Office, Centers for a collection of information, to search and Territorial Epidemiologists Disease Control and Prevention, 1600 data sources, to complete and review approved a position statement in 2012 Clifton Road NE., MS–D74, Atlanta, the collection of information; and to that recommends increased focus on B. Georgia 30329; phone: 404–639–7570; transmit or otherwise disclose the canis, and urges CDC to support the Email: [email protected]. information. development of a human diagnostic SUPPLEMENTARY INFORMATION: assay. Under the Proposed Project Paperwork Reduction Act of 1995 (PRA) The purpose of this information (44 U.S.C. 3501–3520), Federal agencies CDC Burden of Canine Brucellosis collection request is to estimate the must obtain approval from the Office of Information Collection—New—National burden of canine brucellosis in the Management and Budget (OMB) for each Center for Emerging and Zoonotic United States, which will aid in the collection of information they conduct Infectious Diseases, Centers for Disease determination of the level of public or sponsor. In addition, the PRA also Control and Prevention (CDC). health importance of human B. canis requires Federal agencies to provide a Background and Brief Description infections, and the potential for 60-day notice in the Federal Register transmission of brucellosis from dogs. concerning each proposed collection of Canine brucellosis is a bacterial An estimate of disease burden in dogs information, including each new infection caused by the organism will provide an idea of potential proposed collection, each proposed Brucella canis. Few seroprevalence transmission between dogs and humans, extension of existing collection of studies have been done to estimate the and determine the need for future information, and each reinstatement of prevalence of canine brucellosis, most human public health studies, which is previously approved information of which were conducted over 25 years critical during this time of scarce collection before submitting the ago. Two recent reports from Oklahoma resources. and Wisconsin describe increasing collection to OMB for approval. To Veterinary diagnostic laboratories prevalence in dogs; however, the comply with this requirement, we are throughout the United States will be national burden is not known. B. canis publishing this notice of a proposed solicited to provide information on the is also pathogenic to humans, although data collection as described below. quantity of test requests and positive Comments are invited on: (a) Whether human infections are thought to be rare results for Brucella spp. in canines, the proposed collection of information in the United States. outsourcing of clinical testing, state- is necessary for the proper performance Unlike Brucella abortus, B. melitensis, wide policies for reporting of positive of the functions of the agency, including and B. suis, B. canis is not classified as results, and policies for human whether the information shall have a select agent. As a result, laboratory exposure to clinical specimens or practical utility; (b) the accuracy of the identification of the organism in isolates. agency’s estimate of the burden of the humans does not require reporting to proposed collection of information; (c) the Laboratory Response Network. The laboratories were identified ways to enhance the quality, utility, and Brucella species-specific data are not through multiple sources: A review of clarity of the information to be collected in the Nationally Notifiable the Animal and Plant Health Inspection collected; (d) ways to minimize the Disease Surveillance System at CDC, Service-approved Brucella diagnostic burden of the collection of information and there are no validated Brucella laboratories, the National Animal Health on respondents, including through the canis serological tests to diagnose Laboratory Network laboratories, the use of automated collection techniques disease in humans. For these reasons, American Association of Veterinary or other forms of information there are no national estimates of B. Laboratory Diagnosticians (AAVLD), technology; and (e) estimates of capital canis prevalence in humans or canines. and an Internet search. or start-up costs and costs of operation, Additionally, canine infections with The outcomes of this information maintenance, and purchase of services other Brucella species have been collection are to assess the burden of to provide information. Burden means reported in the literature. Zoonotic disease in the animal host (dogs, in this the total time, effort, or financial transmission is a concern with all case), as well as evaluate the knowledge resources expended by persons to Brucella species pathogenic to humans, and practices of occupational exposures generate, maintain, retain, disclose or and at least one human infection with to the organism. The information provide information to or for a Federal B. suis related to canine contact has collected will be used to guide a longer agency. This includes the time needed been reported. Neither the prevalence of term strategy for identification of human to review instructions; to develop, canine brucellosis nor the potential risk cases, understanding risk factors and acquire, install and utilize technology of zoonotic spread to humans is known. activities associated with zoonotic and systems for the purpose of There has been interest in human transmission, and eventually validation collecting, validating and verifying brucellosis caused by B. canis among of a human diagnostic assay. These information, processing and the public health community. However, strategies will be implemented using maintaining information, and disclosing the degree of public health importance other mechanisms. and providing information; to train of human B. canis infections has not yet The total annual burden is 129 hours.

ESTIMATED ANNUALIZED BURDEN HOURS

Average Number of Number of burden per Total Type of respondents Form name respondents responses per response burden respondent (in hrs.) (in hrs.)

Veterinary diagnostic laboratory staff Burden of Canine Brucellosis Infor- 119 1 1 119 mation Collection. Other laboratories ...... Burden of Canine Brucellosis Infor- 10 1 1 10 mation Collection.

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ESTIMATED ANNUALIZED BURDEN HOURS—Continued

Average Number of Number of burden per Total Type of respondents Form name respondents responses per response burden respondent (in hrs.) (in hrs.)

Total ...... 129

Leroy A. Richardson, performed for purposes of the compensation DEPARTMENT OF HEALTH AND Chief, Information Collection Review Office, program; and advice on petitions to add HUMAN SERVICES Office of Scientific Integrity, Office of the classes of workers to the Special Exposure Associate Director for Science, Office of the Cohort (SEC). Centers for Disease Control and Director, Centers for Disease Control and In December 2000, the President delegated Prevention Prevention. responsibility for funding, staffing, and [FR Doc. 2015–12094 Filed 5–18–15; 8:45 am] operating the Advisory Board to HHS, which World Trade Center Health Program subsequently delegated this authority to the BILLING CODE 4163–18–P Scientific/Technical Advisory CDC. NIOSH implements this responsibility for CDC. The charter was issued on August Committee: Notice of Charter Renewal 3, 2001, renewed at appropriate intervals, DEPARTMENT OF HEALTH AND This gives notice under Public Law HUMAN SERVICES most recently, August 3, 2013, and will expire on August 3, 2015. 111–347 (The James Zadroga 9/11 Centers for Disease Control and Purpose: This Advisory Board is charged Health and Compensation Act of 2010) Prevention with (a) providing advice to the Secretary, and the Federal Advisory Committee HHS, on the development of guidelines Act (Pub. L. 92–463) of October 6, 1972, Advisory Board on Radiation and under Executive Order 13179; (b) providing that the World Trade Center Health Worker Health (ABRWH or the advice to the Secretary, HHS, on the Program Scientific/Technical Advisory Advisory Board), National Institute for scientific validity and quality of dose reconstruction efforts performed for this Committee, Centers for Disease Control Occupational Safety and Health program; and (c) upon request by the and Prevention, Department of Health (NIOSH) Secretary, HHS, advising the Secretary on and Human Services, has been renewed In accordance with section 10(a)(2) of whether there is a class of employees at any for a 2-year period through May 12, the Federal Advisory Committee Act Department of Energy facility who were 2017. (Pub. L. 92–463), and pursuant to the exposed to radiation but for whom it is not For information, contact person for feasible to estimate their radiation dose, and requirements of 42 CFR 83.15(a), the on whether there is reasonable likelihood more information: Paul J. Middendorf, Centers for Disease Control and that such radiation doses may have Ph.D., Designated Federal Officer, Prevention (CDC), announces the endangered the health of members of this National Institute for Occupational following meeting of the class. Safety and Health, Centers for Disease aforementioned committee: Matters for Discussion: The agenda for the Control and Prevention, Department of Time and Date: 11:00 a.m.–2:00 p.m. EDT, conference call includes: NIOSH evaluation Health and Human Services, 2400 Tuesday, June 9, 2015. of SEC Petition for Westinghouse Electric Century Parkway NE., Mail Stop E–20, Place: Audio Conference Call via FTS Corp. facility in Bloomfield, New Jersey Atlanta, Georgia 30345, telephone 1 (January 1, 1950–March 1, 2011); Work Conferencing. The USA toll-free, dial-in (888) 982–4748; email: wtc-stac@ number is 1–866–659–0537 and the pass Group and Subcommittee Reports; SEC code is 9933701. Petitions Update for the July 2015 Advisory cdc.gov. Status: Open to the public. The public is Board Meeting; Plans for the July 2015 The Director, Management Analysis welcome to submit written comments in Advisory Board Meeting; and Advisory Board and Services Office, has been delegated advance of the meeting, to the contact person Correspondence. the authority to sign Federal Register below. Written comments received in The agenda is subject to change as notices pertaining to announcements of advance of the meeting will be included in priorities dictate. meetings and other committee the official record of the meeting. The public Contact Person for More Information: is also welcome to listen to the meeting by Theodore M. Katz, M.P.A., Designated management activities for both the joining the teleconference at the USA toll- Federal Officer, NIOSH, CDC, 1600 Clifton Centers for Disease Control and free, dial-in number, 1–866–659–0537 and Rd. NE., Mailstop: E–20, Atlanta, Georgia Prevention and the Agency for Toxic the passcode is 9933701. 30333, Telephone (513) 533–6800, Toll Free Substances and Disease Registry. Background: The Advisory Board was 1–800–CDC–INFO, Email [email protected]. established under the Energy Employees The Director, Management Analysis and Elaine L. Baker, Occupational Illness Compensation Program Services Office, has been delegated the Director, Management Analysis and Services Act of 2000 to advise the President on a authority to sign Federal Register notices Office, Centers for Disease Control and variety of policy and technical functions pertaining to announcements of meetings and Prevention. required to implement and effectively other committee management activities, for manage the new compensation program. Key [FR Doc. 2015–12058 Filed 5–18–15; 8:45 am] both the Centers for Disease Control and functions of the Advisory Board include BILLING CODE 4163–18–P Prevention and the Agency for Toxic providing advice on the development of probability of causation guidelines, which Substances and Disease Registry. have been promulgated by the Department of Elaine L. Baker, Health and Human Services (HHS) as a final Director, Management Analysis and Services rule; advice on methods of dose Office, Centers for Disease Control and reconstruction, which have also been Prevention. promulgated by HHS as a final rule; advice on the scientific validity and quality of dose [FR Doc. 2015–12059 Filed 5–18–15; 8:45 am] estimation and reconstruction efforts being BILLING CODE 4163–18–P

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DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Disease Control and Prevention, 1600 HUMAN SERVICES HUMAN SERVICES Clifton Road NE., MS–D74, Atlanta, Georgia 30329; phone: 404–639–7570; Centers for Disease Control and Centers for Disease Control and Email: [email protected]. Prevention Prevention SUPPLEMENTARY INFORMATION: Under the [60Day–15–0822; Docket No. CDC–2015– Paperwork Reduction Act of 1995 (PRA) Disease, Disability, and Injury 0035] (44 U.S.C. 3501–3520), Federal agencies Prevention and Control Special must obtain approval from the Office of Emphasis Panel (SEP): Initial Review Proposed Data Collection Submitted Management and Budget (OMB) for each for Public Comment and collection of information they conduct In accordance with Section 10(a)(2) of Recommendations or sponsor. In addition, the PRA also the Federal Advisory Committee Act AGENCY: Centers for Disease Control and requires Federal agencies to provide a (Pub. L. 92–463), the Centers for Disease Prevention (CDC), Department of Health 60-day notice in the Federal Register Control and Prevention (CDC) and Human Services (HHS). concerning each proposed collection of announces a meeting for the initial information, including each new ACTION: Notice with comment period. review of applications in response to proposed collection, each proposed Funding Opportunity Announcement SUMMARY: The Centers for Disease extension of existing collection of (FOA), RFA–CE–15–001, Research Control and Prevention (CDC), as part of information, and each reinstatement of Grants for Preventing Violence and its continuing efforts to reduce public previously approved information Violence related Injury (R01). burden and maximize the utility of collection before submitting the collection to OMB for approval. To Times and Dates: 08:30 a.m.–5:00 p.m., government information, invites the EDT, June 17–18, 2015 (Closed). general public and other Federal comply with this requirement, we are Place: Georgian Terrace, 659 Peachtree agencies to take this opportunity to publishing this notice of a proposed Road NE., Room 4, Atlanta, Georgia 30308. comment on proposed and/or data collection as described below. This meeting will also be held by continuing information collections, as Comments are invited on: (a) Whether teleconference. required by the Paperwork Reduction the proposed collection of information Status: The meeting will be closed to the Act of 1995. This notice invites is necessary for the proper performance public in accordance with provisions set comment on a proposed revision to the of the functions of the agency, including forth in Section 552b(c) (4) and (6), Title 5 approved information collection project whether the information shall have U.S.C., and the Determination of the Director, entitled ‘‘The National Intimate Partner practical utility; (b) the accuracy of the Management Analysis and Services Office, and Sexual Violence Survey (NISVS)’’. agency’s estimate of the burden of the CDC, pursuant to Public Law 92–463. This project collects information about proposed collection of information; (c) Matters for Discussion: The meeting will individual’s experiences of sexual ways to enhance the quality, utility, and include the initial review, discussion, and violence, stalking and intimate partner clarity of the information to be evaluation of applications received in violence. collected; (d) ways to minimize the burden of the collection of information response to ‘‘Research Grants for Preventing DATES: Written comments must be Violence and Violence Related Injury (R01)’’, received on or before July 20, 2015. on respondents, including through the FOA Number: CE–15–001. use of automated collection techniques ADDRESSES: You may submit comments, Contact Person for More Information: M. or other forms of information identified by Docket No. CDC–2015– Chris Langub, Ph.D., Scientific Review technology; and (e) estimates of capital 0035 by any of the following methods: Officer, CDC, 4770 Buford Hwy., NE., or start-up costs and costs of operation, Federal eRulemaking Portal: Mailstop E63, Atlanta, Georgia 30341–3724, maintenance, and purchase of services Regulation.gov. Follow the instructions Telephone: 770–488–4334. to provide information. Burden means for submitting comments. The Director, Management Analysis and the total time, effort, or financial Mail: Leroy A. Richardson, Services Office, has been delegated the resources expended by persons to Information Collection Review Office, authority to sign Federal Register notices generate, maintain, retain, disclose or Centers for Disease Control and pertaining to announcements of meetings and provide information to or for a Federal Prevention, 1600 Clifton Road NE., MS– other committee management activities, for agency. This includes the time needed both the Centers for Disease Control and D74, Atlanta, Georgia 30329. Instructions: All submissions received to review instructions; to develop, Prevention and the Agency for Toxic acquire, install and utilize technology Substances and Disease Registry. must include the agency name and Docket Number. All relevant comments and systems for the purpose of Elaine L. Baker, received will be posted without change collecting, validating and verifying to Regulations.gov, including any information, processing and Director, Management Analysis and Services maintaining information, and disclosing Office, Centers for Disease Control and personal information provided. For and providing information; to train Prevention. access to the docket to read background personnel and to be able to respond to [FR Doc. 2015–12055 Filed 5–18–15; 8:45 am] documents or comments received, go to Regulations.gov. a collection of information, to search BILLING CODE 4163–18–P data sources, to complete and review Please note: All public comment should be the collection of information; and to submitted through the Federal eRulemaking transmit or otherwise disclose the portal (Regulations.gov) or by U.S. mail to the address listed above. information. Proposed Project FOR FURTHER INFORMATION CONTACT: To request more information on the National Intimate Partner and Sexual proposed project or to obtain a copy of Violence Survey (NISVS)—Revision— the information collection plan and (OMB Control No. 0920–0822, instruments, contact the Information Expiration—6/30/2016), National Center Collection Review Office, Centers for for Injury Prevention and Control

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(NCIPC), Centers for Disease Control adult men and women aged 18 years or to improve both survey design and Prevention (CDC). older in the United States assessing (methods, sampling frame, recruitment, lifetime experiences of IPV, SV and mode of administration) and content/ Background and Brief Description stalking with a new and improved data question wording with the goals of In 2010, the National Intimate Partner collection tool. The revisions to the increasing response rates, reducing non- and Sexual Violence Surveillance survey are aimed at reducing the time response bias, and maximizing the System (NISVSS) reported that and complexity of the instrument, thus opportunities across Federal surveys for approximately 6.9 million women and reducing the burden on the respondent. covering populations of interest. This 5.6 million men experienced rape, The simplified structure of the change request also encompasses the physical violence and/or stalking by an instrument will also reduce the implementation of the panel’s intimate partner within the last year. complexity of the data set, making it recommendations to improve the The health care costs of Intimate Partner more assessable for public use. survey. Violence (IPV) exceed $5.8 billion each Additionally, in collaboration with the In the bi-annual data collection year, nearly $3.9 billion of which is for Department of Defense (DoD), NISVS periods, total of 170,000 households direct medical and mental health care will collect information regarding the will be screened. After determining services. experiences of IPV, SV and stalking eligibility and consent, 25,000 will In order to address this important among active duty women and men in complete the survey. The average public health problem, CDC the military and wives of active duty burden per screened respondent implemented, beginning in 2010, the men. This data collection will take place remains at three minutes (total burden National Intimate Partner and Sexual during the first three months of data in hours equals 8,500) while the average Violence Surveillance System that collection. burden per surveyed respondent is 25 produces national and state level To comply with OMB requirements, minutes (total burden in hours equals estimates of Intimate Partner Violence CDC is in the process of developing an 10,417). The survey will be conducted (IPV), Sexual Violence (SV) and stalking expert panel to address methodological among English or Spanish speaking on an annual basis. issues with the NISVS survey. The male and female adults (18 years and This revision request is multi-faceted. panel will meet multiple times over the older) living in the United States. CDC is requesting a continuation of data course of the next year. The members of There are no costs to respondents collection among non-institutionalized this panel will provide guidance on how other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS

Average Number of Number of burden per Total Type of respondent Form name respondents responses per response burden respondent (in hours) hours

Non-Participating Individuals NISVS Survey Instrument ...... 170,000 1 3/60 8,500 (Screened). Eligible Individuals (Surveyed) ...... NISVS Survey Instrument ...... 25,000 1 25/60 10,417

Total ...... 18,917

Leroy A. Richardson, Times and Dates: conduct of Study Section business and for Chief, Information Collection Review Office, 8:00 a.m.–5:00 p.m., June 16, 2015 (Closed) the study section to consider safety and Office of Scientific Integrity, Office of the 8:00 a.m.–5:00 p.m., June 17, 2015 (Closed) occupational health-related grant Associate Director for Science, Office of the Place: Embassy Suites, 1900 Diagonal applications. Director, Centers for Disease Control and Road, Alexandria, Virginia 22314, These portions of the meeting will be Prevention. Telephone: 703–684–5900, Fax: 703–684– closed to the public in accordance with [FR Doc. 2015–12095 Filed 5–18–15; 8:45 am] 0653. provisions set forth in Section 552b(c)(4) and Purpose: The Safety and Occupational BILLING CODE 4163–18–P (6), Title 5 U.S.C., and the Determination of Health Study Section will review, discuss, the Director, Management Analysis and and evaluate grant application(s) received in Services Office, Centers for Disease Control response to the Institute’s standard grants and Prevention, pursuant to Section 10(d) DEPARTMENT OF HEALTH AND review and funding cycles pertaining to HUMAN SERVICES research issues in occupational safety and Public Law 92–463. health, and allied areas. Agenda items are subject to change as Centers for Disease Control and It is the intent of NIOSH to support broad- priorities dictate. Prevention based research endeavors in keeping with the Contact Person for More Information: Price Institute’s program goals. This will lead to Connor, Ph.D., NIOSH Health Scientist, CDC, Safety and Occupational Health Study improved understanding and appreciation for 2400 Executive Parkway, Mailstop E–20, Section (SOHSS), National Institute for the magnitude of the aggregate health burden Atlanta, Georgia 30345, Telephone: (404) Occupational Safety and Health associated with occupational injuries and 498–2511, Fax: (404) 498–2571. (NIOSH or Institute) illnesses, as well as to support more focused The Director, Management Analysis and research projects, which will lead to Services Office, has been delegated the In accordance with section 10(a)(2) of improvements in the delivery of occupational authority to sign Federal Register notices safety and health services, and the pertaining to announcements of meetings and the Federal Advisory Committee Act prevention of work-related injury and illness. (Pub. L. 92–463), the Centers for Disease It is anticipated that research funded will other committee management activities for Control and Prevention (CDC) promote these program goals. announces the following committee Matters for Dicussion: The meeting will meeting. convene to address matters related to the

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both CDC and the Agency for Toxic Buford Highway NE., Mailstop F–80, of 1998, Pub. L. 105–285, [42 U.S.C. 604 Substances and Disease Registry. Atlanta, Georgia 30341, Telephone: note]) requires that organizations Elaine L. Baker, (770) 488–6295, [email protected]. operating AFI projects submit annual Director, Management Analysis and Services The Director, Management Analysis progress reports. Office, Centers for Disease Control and and Services Office, has been delegated This request is to create an AFI Prevention. the authority to sign Federal Register program specific Performance Progress [FR Doc. 2015–12057 Filed 5–18–15; 8:45 am] notices pertaining to announcements of Report (PPR) to replace the semiannual BILLING CODE 4163–18–P meetings and other committee standard form performance progress management activities, for both the report (SF–PPR) and the annual data Centers for Disease Control and report. The AFI PPR will collect data on DEPARTMENT OF HEALTH AND Prevention and the Agency for Toxic project activities and attributes similar HUMAN SERVICES Substances and Disease Registry. to the reports that it is replacing. The Office of Community Services (OCS) in Elaine L. Baker, Centers for Disease Control and the Administration for Children and Prevention Director, Management Analysis and Services Families (ACF) will use the data Office, Centers for Disease Control and Prevention. collected in the AFI PPR to prepare the Disease, Disability, and Injury annual AFI Report to Congress, to Prevention and Control Special [FR Doc. 2015–12053 Filed 5–18–15; 8:45 am] evaluate and monitor the performance Emphasis Panel (SEP): Initial Review BILLING CODE 4163–18–P of the AFI program overall and of individual projects, and to inform and The meeting announced below support technical assistance efforts. The concerns Integrating Self-Management DEPARTMENT OF HEALTH AND AFI PPR would fulfill AFI Act reporting Education with Cancer Survivorship HUMAN SERVICES requirements and program purposes. Care Planning, SIP 15–001, and Using The AFI PPR will be submitted Cancer Registry Data to Promote Administration for Children and quarterly: Three times per year using an Proactive Tobacco Cessation among Families abbreviated short form and one time Adult Cancer Survivors, SIP 15–003, Proposed Information Collection using a long form. Both draft data initial review. Activity; Comment Request collection instruments are available for SUMMARY: This document corrects a review online at https:// notice that was published in the Federal Proposed Projects idaresources.acf.hhs.gov/AFIPPR. Register on April 14, 2015 Volume 80, Note: This request does not affect Number 86, Page 19990. The time and Title: Assets for Independence financial reporting requirements for AFI date should have read as follows: Program Performance Progress Report. OMB No.: New. grantees. The SF–425 will still be DATES: Time and Date: 11:00 a.m.–6:00 required semiannually throughout the p.m., May 12, 2015 (Closed). Description grant project period with a final report FOR FURTHER INFORMATION CONTACT: The Assets for Independence (AFI) due 90 days after the grant project Brenda Colley Gilbert, Ph.D., M.S.P.H., Act (Title IV of the Community period ends. Director, Extramural Research Program Opportunities, Accountability, and Respondents: Assets for Operations and Services, CDC, 4770 Training and Educational Services Act Independence (AFI) program grantees.

ANNUAL BURDEN ESTIMATES

Average Number of Number of burden Total burden Instrument respondents responses per hours per hours respondent response

AFI PPR Short Form ...... 300 3 0.5 450 AFI PPR Long Form ...... 300 1 4 1200

Estimated Total Annual Burden acf.hhs.gov. All requests should be other forms of information technology. Hours: 1,650. identified by the title of the information Consideration will be given to In compliance with the requirements collection. comments and suggestions submitted of Section 506(c)(2)(A) of the Paperwork The Department specifically requests within 60 days of this publication. Reduction Act of 1995, the comments on (a) whether the proposed Karl Koerper, Administration for Children and collection of information is necessary Families is soliciting public comment for the proper performance of the Reports Clearance Officer. on the specific aspects of the functions of the agency, including [FR Doc. 2015–12096 Filed 5–18–15; 8:45 am] information collection described above. whether the information shall have BILLING CODE 4184–01–P Copies of the proposed collection of practical utility; (b) the accuracy of the information can be obtained and agency’s estimate of the burden of the comments may be forwarded by writing proposed collection of information; (c) to the Administration for Children and the quality, utility, and clarity of the Families, Office of Planning, Research information to be collected; and (d) and Evaluation, 370 L’Enfant ways to minimize the burden of the Promenade SW., Washington, DC 20447, collection of information on Attn: ACF Reports Clearance Officer. respondents, including through the use Email address: infocollection@ of automated collection techniques or

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DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND 301–796–3515, Georgiann.Ienzi@ HUMAN SERVICES HUMAN SERVICES fda.hhs.gov. Registration: If you wish to attend the Food and Drug Administration Food and Drug Administration public meeting or provide testimony [Docket No. FDA–2011–N–0802] during the open public hearing, please [Docket No. FDA–2014–N–0998] email your registration to Exploring Naloxone Uptake and Use; [email protected] by Agency Information Collection Public Meeting; Request for Comments June 22, 2015. Those without email Activities; Announcement of Office of access may register by contacting one of AGENCY: Food and Drug Administration, Management and Budget Approval; the contact persons (see Contact HHS. Regulations for In Vivo Persons). When registering, please ACTION: Notice of public meeting; Radiopharmaceuticals Used for provide complete contact information request for comments. for each attendee, including name, title, Diagnosis and Monitoring affiliation, address, email address, and The Food and Drug Administration telephone number. Registration is free AGENCY: Food and Drug Administration, (FDA), Center for Drug Evaluation and and will be on a first-come, first-served HHS. Research, in collaboration with the basis. Early registration is recommended ACTION: Notice. National Institutes on Drug Abuse, the because seating is limited. Registrants Centers for Disease Control and will receive confirmation once they Prevention, the Substance Abuse and SUMMARY: The Food and Drug have been accepted for the public Mental Health Services Administration, meeting. Onsite registration on the day Administration (FDA) is announcing and the Health Resources and Services that a collection of information entitled, of the public meeting will be permitted Administration, will hold a public based on space availability. If ‘‘Regulations for In Vivo meeting to discuss increasing the use of Radiopharmaceuticals Used for registration reaches maximum capacity, naloxone to reduce the incidence of FDA will post a notice closing Diagnosis and Monitoring’’ has been opioid drug overdose fatalities. During registration for the public meeting at: approved by the Office of Management the meeting, academic and government http://www.fda.gov/Drugs/NewsEvents/ and Budget (OMB) under the Paperwork experts, industry representatives, and ucm442236.htm. Reduction Act of 1995. patient advocates will discuss which Comments: Submit either electronic FOR FURTHER INFORMATION CONTACT: FDA populations are at-risk for opioid drug or written comments by September 1, PRA Staff, Office of Operations, Food overdose and how we can work together 2015. Submit electronic comments to and Drug Administration, 8455 to encourage the use of naloxone to http://www.regulations.gov. Submit reduce the risk of overdose from opioid Colesville Rd., COLE–14526, Silver written comments to the Division of drugs. Spring, MD 20993–0002, PRAStaff@ Dockets Management (HFA 305), Food Date and Time: The public meeting and Drug Administration, 5630 Fishers fda.hhs.gov. will be held on July 1, 2015, from 8 a.m. Lane, Rm. 1061, Rockville, MD 20852. It SUPPLEMENTARY INFORMATION: On to 5 p.m. and on July 2, 2015, from 8 is only necessary to send one set of January 08, 2015, the Agency submitted a.m. to 3 p.m. The open public hearing comments. Identify comments with the a proposed collection of information will be held between 1 p.m. and 2 p.m. docket number found in brackets in the on July 1, 2015, and between 1 p.m. and entitled, ‘‘Regulations for In Vivo heading of this document. Received 2 p.m. on July 2, 2015, during which Radiopharmaceuticals Used for comments may be seen in the Division speaker testimony will be accepted. We of Dockets Management between 9 a.m. Diagnosis and Monitoring’’ to OMB for will try to accommodate all persons and 4 p.m., Monday through Friday, and review and clearance under 44 U.S.C. who wish to testify; however, the will be posted to the docket at http:// 3507. An Agency may not conduct or duration of each speaker’s testimony www.regulations.gov. If you need sponsor, and a person is not required to may be limited by time constraints. special accommodations due to a respond to, a collection of information Those wishing to participate in the open disability, contact Mary Gross or unless it displays a currently valid OMB public hearing should limit their Georgiann Ienzi (see Contact Persons) at control number. OMB has now remarks to issues related to the uptake least 7 days in advance of the meeting. approved the information collection and of naloxone both in conventional SUPPLEMENTARY INFORMATION: has assigned OMB control number medical settings and outside of those 0910–0409. The approval expires on settings to reduce the incidence of I. Introduction April 30, 2018. A copy of the supporting opioid drug overdose fatalities. The number of prescriptions filled for statement for this information collection Location: The public meeting will be opioid drugs has increased drastically in is available on the Internet at http:// held at the FDA White Oak Campus, recent years. In 2009 nearly 257 million www.reginfo.gov/public/do/PRAMain. 10903 New Hampshire Ave., Building prescriptions were written for opioid 31 Conference Center, the Great Room drugs in the United States. This number Dated: May 13, 2015. (Rm. 1503), Silver Spring, MD 20993– rose to nearly 260 million in 2012. The Leslie Kux, 0002. increased availability of opioid drugs Associate Commissioner for Policy. Contact Person: Mary Gross, Center appears to be contributing significantly [FR Doc. 2015–12078 Filed 5–18–15; 8:45 am] for Drug Evaluation and Research, Food to abuse and overdose in the United BILLING CODE 4164–01–P and Drug Administration, 10903 New States. In 2013 there were Hampshire Ave., Silver Spring, MD approximately 16,235 deaths from 20993–0002, 301–796–3519, overdose involving opioid drugs. That [email protected]; or Georgiann same year, there were 8,257 deaths from Ienzi, Center for Drug Evaluation and overdose involving heroin. Research, Food and Drug Naloxone, a mu-opioid antagonist, is Administration, 10903 New Hampshire a medication that can rapidly reverse Ave., Silver Spring, MD 20993–0002, the overdose of both prescription opioid

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drugs (e.g., OxyContin) and illicit opioid specific bulk drug substances for this animal drugs. The FD&C Act does not drugs (e.g., heroin). It is currently the list. This notice describes the distinguish between compounding standard treatment for those information that should be provided to animal drugs from bulk drug experiencing overdose and is commonly the Agency in support of each substances 1 and any other used by trained medical personnel in nomination. manufacturing or processing of animal emergency departments and on DATES: To ensure that FDA considers drugs. Except with respect to the limited ambulances. Its use among nonmedical your nominations for the initial version exemption provided by the FD&C Act personnel has also increased in recent of the bulk drug substances list, submit described in this document, statutory years. The purpose of the public either electronic or written nominations provisions applicable to manufactured meeting is to explore issues surrounding for the bulk drug substances list by animal drugs under the FD&C Act also the uptake of naloxone to treat opioid August 17, 2015. apply to compounded animal drugs. drug overdose. The meeting agenda will After the comment period is closed, Section 512(a)(4) and (5) of the FD&C include topics on the clinical, nominations to add or remove bulk drug Act (21 U.S.C. 360b(a)(4) and (5)) regulatory, and legal implications of substances from the list may be provide a limited exemption from making naloxone more widely available. submitted to FDA by citizen petition certain requirements for use for compounded animal drugs made from FDA will post the agenda and additional under § 10.30 (21 CFR 10.30). public meeting material approximately already approved animal or human ADDRESSES: You may submit 2 days before the workshop at: http:// drugs. Such use is considered an extra- nominations by any of the following www.fda.gov/Drugs/NewsEvents/ label use and the FD&C Act provides methods. ucm442236.htm. that a compounded drug is exempt from Electronic Submissions the approval requirements and II. Transcripts requirements of section 502(f)(1) (21 Submit electronic nominations in the A transcript will be made available U.S.C. 352(f)(1)) of the FD&C Act, if it approximately 45 days after the public following way: • Federal eRulemaking Portal: http:// meets the conditions set out in the meeting. It will be accessible at http:// www.regulations.gov. Follow the statute and the extra-label use www.regulations.gov and may be instructions for submitting comments. regulations at 21 CFR part 530. viewed at the Division of Dockets Elsewhere in this issue of the Federal Management (see Comments). A Written Submissions Register, FDA is announcing the transcript will also be available in either Submit written nominations in the availability of a draft guidance for hardcopy or on CD–ROM, after following ways: industry #230 entitled ‘‘Compounding submission of a Freedom of Information • Mail/Hand delivery/Courier (for Animal Drugs from Bulk Drug 2 request. Written requests are to be sent paper submissions): Division of Dockets Substances’’ (GFI #230). The draft to Division of Freedom of Information Management (HFA–305), Food and Drug guidance describes conditions under (ELEM–1029), Food and Drug Administration, 5630 Fishers Lane, rm. which FDA does not generally intend to Administration, 12420 Parklawn Dr., 1061, Rockville, MD 20852. initiate enforcement action against Element Bldg., Rockville, MD 20857. State-licensed pharmacies, licensed Instructions: All submissions received veterinarians, and facilities registered as Dated: May 13, 2015. must include the Docket No. FDA– outsourcing facilities under section Leslie Kux, 2013–N–1524. All nominations received 503B of the FD&C Act (outsourcing Associate Commissioner for Policy. may be posted without change to http:// facilities) that compound animal drugs www.regulations.gov, including any [FR Doc. 2015–12061 Filed 5–18–15; 8:45 am] from bulk drug substances. BILLING CODE 4164–01–P personal information provided. For For pharmacies, these conditions additional information on submitting include receipt of a valid prescription nominations, see the ‘‘Request for for a compounded drug from a licensed DEPARTMENT OF HEALTH AND Nominations’’ heading of the veterinarian for an individually HUMAN SERVICES SUPPLEMENTARY INFORMATION section of identified animal patient before the this document. Food and Drug Administration Docket: For access to the docket to 1 FDA regulations define ‘‘bulk drug substance’’ [Docket No. FDA–2015–N–1196] read background documents or as ‘‘any substance that is represented for use in a nominations received, go to http:// drug and that, when used in the manufacturing, List of Bulk Drug Substances That May www.regulations.gov and insert the processing, or packaging of a drug, becomes an Be Used by an Outsourcing Facility To active ingredient or a finished dosage form of the docket number, found in brackets in the drug, but the term does not include intermediates Compound Drugs for Use in Animals; heading of this document, into the used in the synthesis of such substances.’’ 21 CFR Request for Nominations ‘‘Search’’ box and follow the prompts 207.3(a)(4). ‘‘Active ingredient’’ is defined as ‘‘any and/or go to the Division of Dockets component that is intended to furnish AGENCY: Food and Drug Administration, pharmacological activity or other direct effect in the Management, 5630 Fishers Lane, rm. HHS. diagnosis, cure, mitigation, treatment, or prevention 1061, Rockville, MD 20852. of disease, or to affect the structure or any function ACTION: Notice; request for nominations. FOR FURTHER INFORMATION CONTACT: Neal of the body of man or other animals. The term Bataller, Center for Veterinary Medicine, includes those components that may undergo SUMMARY: The Food and Drug chemical change in the manufacture of the drug Administration (FDA) intends to Food and Drug Administration (HFV– product and be present in the drug product in a develop a list of bulk drug substances 210), 7519 Standish Pl., Rockville, MD modified form intended to furnish the specified that may be used by outsourcing 20855, 240–402–5745, neal.bataller@ activity or effect.’’ 21 CFR 210.3(b)(7). Any fda.hhs.gov. component other than an active ingredient is an facilities registered under the Federal ‘‘inactive ingredient.’’ See 21 CFR 210.3(b)(8). Food, Drug, and Cosmetic Act (the SUPPLEMENTARY INFORMATION: Inactive ingredients used in compounded drug FD&C Act) to compound animal drugs, products commonly include flavorings, dyes, in accordance with FDA’s draft I. Background diluents, or other excipients. 2 GFI #230 can be found at http://www.fda.gov/ guidance for industry #230, Sections 503A (21 U.S.C. 353a) and AnimalVeterinary/ ‘‘Compounding Animal Drugs from Bulk 503B (21 U.S.C. 353b) of the FD&C Act GuidanceComplianceEnforcement/ Drug Substances.’’ You may nominate do not apply to the compounding of GuidanceforIndustry/ucm042450.htm.

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facility compounds the drug (with some used under section 512(a)(4) or (a)(5) of • Chemical grade of the ingredient; limited compounding of an animal drug the FD&C Act and part 530 (addressing • description of the strength, quality, product in advance of receipt of a extra-label use of approved animal and stability, and purity of the ingredient; prescription in quantities based on a human drugs) to treat the condition; • information about how the history of receipt of patient-specific • the drug cannot be compounded ingredient is supplied (e.g., powder, prescriptions for that drug product). from an approved animal or human liquid); and FDA recognizes that there may be some drug; • information about recognition of the limited circumstances in which a drug • immediate treatment with the substance in foreign pharmacopeias and compounded from one or more bulk compounded drug is necessary to avoid the status of its registration(s) in other drug substances should be available to animal suffering or death; and countries, including whether a veterinarian for office use and is • FDA has not identified a significant information has been submitted to USP developing a list of such animal drug safety concern specific to the use of the for consideration of monograph products and the bulk drug substances bulk drug substance to compound development. animal drugs (under the listed needed to make them applicable to B. Information on the Animal Drug drugs compounded by facilities conditions and limitations). Inactive ingredients need not appear Products That Will Be Compounded registered as outsourcing facilities under With the Bulk Drug Substance section 503B of the FD&C Act. The draft on Appendix A to be used in guidance proposes that outsourcing compounding animal drug products. • Information about the dosage form(s) into which the bulk drug facilities compound animal drugs only II. Request for Nominations from bulk drug substances that will be substance will be compounded; • listed in Appendix A of the final A. Active Ingredients information about the strength(s) of guidance, either pursuant to a the compounded product(s); and You may nominate specific bulk drug • veterinarian’s order or pursuant to a substances for inclusion on the list in information about the anticipated patient-specific prescription. When a Appendix A. Nominations will only be route(s) of administration of the facility registered as an outsourcing evaluated if they are for specific compounded product(s). facility under section 503B of the FD&C ingredients that meet the definition of a C. Need for the Animal Drug Products Act uses the listed bulk drug substances bulk drug substance in § 207.3(a)(4) (21 That Will Be Compounded With the to make the specified drug products CFR 207.3(a)(4)). Nominated substances Bulk Drug Substance pursuant to an order from a licensed that do not meet this definition will not veterinarian without a prescription for For FDA to be able to meaningfully be included on the list. evaluate a substance, the information an individually identified animal, FDA To determine if a bulk drug substance provided must be specific to the does not intend to take action under should be included in Appendix A, particular substance nominated and sections 512(a), 501(a)(5) (21 U.S.C. FDA needs the following information animal drug product to be compounded. 351(a)(5)), 502(f), and 501(a)(2)(B) as about the bulk drug substance being A ‘‘boilerplate’’ or general explanation long as such compounding is done in nominated and the animal drug of need for compounding with bulk accordance with any associated product(s) that will be compounded drug substances will not enable FDA to conditions described in GFI #230. using such substance: Although an outsourcing facility may conduct an adequate review. Unless fill a veterinarian’s order for 1. Confirmation That the Nominated adequate supporting data are submitted compounded animal drugs using bulk Substance Is a Bulk Drug Substance for a bulk drug substance, FDA will be drug substances listed on Appendix A A statement that the nominated unable to consider it for inclusion in without obtaining prescriptions for substance is an active ingredient that Appendix A. individually identified animal patients, meets the definition of ‘‘bulk drug Prescribers of compounded animal drugs produced by outsourcing facilities substance’’ in § 207.3(a)(4), and an drug products may be in the best remain subject to the requirements in explanation of why the substance is position to explain why a particular section 503(f) of the FD&C Act. considered an active ingredient when it bulk drug substance meets the criteria Therefore, an outsourcing facility is used in the identified compounded for including a bulk drug substance on cannot dispense a compounded drug to drug product(s), citing to specific Appendix A and are encouraged to the owner or caretaker of an animal sources that describe the active provide data in support of a nomination. patient without a prescription for that properties of the substance. The following information about need is individually identified animal patient. necessary to provide adequate support This list only applies to outsourcing 2. General Background on the Bulk Drug for nominations to the Appendix A list: • facilities. This list does not limit what Substance A statement identifying the species bulk drug substances State-licensed • Ingredient name; and condition(s) that the drug product pharmacies or licensed veterinarians • chemical name; to be compounded with the nominated can use in compounding drugs in • common name(s); and bulk drug substance is intended to treat; • • accordance with the conditions set forth identifying codes, as available, from a bibliography of safety and efficacy in the draft guidance, including the FDA’s Unique Ingredient Identifiers data for the drug compounded using the 3 condition pertaining to obtaining a used in the FDA/U.S. Pharmacopeial nominated substance, if available, patient-specific prescription. Convention (USP) Substance including any relevant peer-reviewed FDA intends to include a bulk drug Registration System, available at http:// veterinary literature; • substance on Appendix A only when all fdasis.nlm.nih.gov/srs/. Because a list of animal drug products, if of the following criteria are met: substance names can vary, this code, any, that are approved, conditionally • There is no marketed approved, where available, will be used by the approved, or index listed for the conditionally approved, or index-listed Agency to confirm the exact substance animal drug that can be used as labeled nominated and to identify multiple 3 FDA recognizes that the available safety and to treat the condition; nominations of the same substance so efficacy data supporting consideration of a bulk • drug substance for inclusion on the list may not be there is no marketed approved the information can be reviewed of the same type, amount, or quality as is required animal or human drug that could be together. to support a new animal drug application.

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condition(s) in the species that the drug will receive consideration for later 10.115(g)(5)), to ensure that FDA compounded with the nominated addition to Appendix A. considers your comment on the draft substance is intended to address; Individuals and organization may guidance before it begins work on the • if there are FDA-approved or index petition FDA to make additional final version of the guidance, submit listed drug products that address the amendments to Appendix A after it is either electronic or written comments same conditions in the same species, an published, in accordance with § 10.30. on the draft guidance by August 17, explanation, supported by relevant Interested persons may submit either 2015. Submit written or electronic veterinary literature, of why a electronic nominations to http:// comments on the proposed collection of compounded drug product is necessary www.regulations.gov or written information by August 17, 2015. (i.e., why the approved drug product is nominations to the Division of Dockets ADDRESSES: Submit written requests for not suitable for a particular patient Management (see ADDRESSES). It is only single copies of the draft guidance to the population); necessary to send one set of Policy and Regulations Staff (HFV–6), • a review of the veterinary literature nominations. Identify nominations with Center for Veterinary Medicine, Food to determine whether there are FDA- the docket number found in the brackets and Drug Administration, 7519 Standish approved animal or human drugs that in the heading of this document. Pl., Rockville, MD 20855. Send one self- could be prescribed as an extra-label use Received nominations may be seen in addressed adhesive label to assist that under section 512(a)(4) and (a)(5) of the the Division of Dockets Management office in processing your request. See FD&C Act and part 530 to treat the between 9 a.m. and 4 p.m., Monday the SUPPLEMENTARY INFORMATION section condition(s) in the species that the drug through Friday, and will be posted to for electronic access to the draft compounded with the nominated the docket at http:// guidance. substance is intended to address; www.regulations.gov. • Submit electronic comments on the if the bulk drug substance is an Dated: May 12, 2015. draft guidance, including comments active ingredient in an approved animal Leslie Kux, regarding the proposed collection of or human drug, an explanation, Associate Commissioner for Policy. information, to http:// supported by appropriate scientific data, www.regulations.gov. Submit written of why the animal drug product cannot [FR Doc. 2015–11983 Filed 5–18–15; 8:45 am] BILLING CODE 4164–01–P comments on the draft guidance, be compounded from the approved drug including comments regarding the under 21 CFR 530.13(b); proposed collection of information, to • an explanation, supported by the Division of Dockets Management relevant veterinary literature, of why the DEPARTMENT OF HEALTH AND (HFA–305), Food and Drug animal drug product to be compounded HUMAN SERVICES Administration, 5630 Fishers Lane, Rm. with the nominated bulk drug substance Food and Drug Administration 1061, Rockville, MD 20852. must be available to the veterinarian for FOR FURTHER INFORMATION CONTACT: immediate treatment to avoid animal [Docket Nos. FDA–2015–D–1176 and FDA– suffering or death. Nominations should 2003–D–0202] With regard to this draft guidance: include specific information Division of Compliance, Center for Compounding Animal Drugs From Veterinary Medicine, Food and Drug documenting that animal suffering or Bulk Drug Substances; Draft Guidance death will result if treatment is delayed Administration (HFV–230), 7519 for Industry; Availability; Withdrawal of Standish Pl., Rockville, MD 20855, 240– until a compounded animal drug can be Compliance Policy Guide; Section obtained pursuant to a prescription for 402–7001, CVMCompliance@ 608.400 Compounding of Drugs for fda.hhs.gov. an individually identified animal; and Use in Animals • a discussion of any safety concerns With regard to the proposed collection of information: FDA PRA Staff, Office of associated with use of the nominated AGENCY: Food and Drug Administration, bulk drug substance or finished HHS. Operations, Food and Drug Administration, 8455 Colesville Rd.; compounded product for the ACTION: Notice; withdrawal. condition(s) in the species that the COLE–14526, Silver Spring, MD 20993– compounded drug is intended to SUMMARY: The Food and Drug 0002; [email protected]. address. If there are any safety concerns, Administration (FDA) is announcing the SUPPLEMENTARY INFORMATION: an explanation, supported by veterinary availability of a draft guidance for I. Draft Guidance literature, of why the concerns should industry (GFI) #230 entitled FDA is announcing the availability of not preclude inclusion of that bulk drug ‘‘Compounding Animal Drugs from Bulk a draft GFI #230 entitled ‘‘Compounding substance on Appendix A. Drug Substances.’’ The draft guidance describes FDA’s policies with regard to Animal Drugs from Bulk Drug D. Nomination Process compounding animal drugs from bulk Substances.’’ The draft guidance For efficient consolidation and review drug substances. When final, the provides information to compounders of of nominations, nominators are guidance will reflect FDA’s current animal drugs and other interested encouraged to submit their nominations thinking on the issues addressed by the stakeholders on FDA’s application of in a format that explicitly addresses guidance. the Federal Food, Drug, and Cosmetic each item previously listed in the order FDA is also announcing the Act (the FD&C Act) with respect to the that they appear. To consider a bulk withdrawal of the compliance policy compounding of animal drugs from bulk 1 drug substance for inclusion in guide (CPG) entitled ‘‘Section 608.400 drug substances. Appendix A, FDA must receive Compounding of Drugs for Use in Animals,’’ which was issued in July 1 FDA regulations define ‘‘bulk drug substance’’ adequate supporting data for the as ‘‘any substance that is represented for use in a substance. FDA cannot guarantee that 2003. This 2003 CPG is being drug and that, when used in the manufacturing, all drugs nominated during the withdrawn because it is no longer processing, or packaging of a drug, becomes an nomination period will be considered consistent with FDA’s current thinking active ingredient or a finished dosage form of the on the issues it addresses. drug, but the term does not include intermediates for inclusion on Appendix A prior to its used in the synthesis of such substances.’’ 21 CFR initial publication. Nominations that are DATES: Although you can comment on 207.3(a)(4). ‘‘Active ingredient’’ is defined as ‘‘any not evaluated during this first phase any guidance at any time (see 21 CFR component that is intended to furnish

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Sections 503A (21 U.S.C. 353a) and that FDA does not generally intend to Outsourcing Facility to Compound 503B (21 U.S.C. 353b) of the FD&C Act take action under sections 512(a), Drugs for Use in Animals.’’ The notice do not apply to the compounding of 501(a)(5) (21 U.S.C. 351(a)(5)), also describes the information that animal drugs. The FD&C Act does not 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), and should be provided to the Agency in distinguish between compounding 502(f)(1) of the FD&C Act if a State- support of such nominations. licensed pharmacy or a licensed animal drugs from bulk drug substances II. Withdrawal of 2003 Compliance veterinarian compounds drugs intended and any other manufacturing or Policy Guide processing of animal drugs. Except with for use in animals from bulk drug respect to the limited exemption substances in accordance with all of the In a notice published in the Federal provided by the FD&C Act described in applicable conditions set out in the Register of July 14, 2003 (68 FR 41591), this document, statutory provisions guidance. In addition, the draft FDA announced the availability of CPG applicable to manufactured animal guidance provides that FDA does not Section 608.400 of the Compliance drugs under the FD&C Act also apply to generally intend to take action under Program Guidance Manual entitled, compounded animal drugs. sections 512(a), 501(a)(5), and 502(f)(1) ‘‘Compounding of Drugs for Use in Section 512(a)(4) and (5) of the FD&C of the FD&C Act if the drug product is Animals.’’ This document is being Act (21 U.S.C. 360b(a)(4) and (5)), compounded from a bulk drug withdrawn because it is no longer provide a limited exemption from substance by an outsourcing facility and consistent with FDA’s current thinking certain requirements for use for that meets all of the applicable on the issue it addresses. The current compounded animal drugs made from conditions set out in the guidance, and CPG does not focus on the three main already approved animal or human the drug product is compounded from a concerns FDA has about animal drug drugs. Such use is considered an extra- bulk drug substance that appears on compounding: compounding copies of label use and the FD&C Act provides Appendix A of the draft guidance. approved animal or human drugs from that a compounded drug is exempt from Importantly, the draft guidance bulk drug substances, compounding for the approval requirements and provides that FDA generally intends to food-producing animals from bulk drug requirements of section 502(f)(1) (21 enforce all other adulteration and substances, and compounding office U.S.C. 352(f)(1)) of the FD&C Act, if it misbranding provisions of the FD&C Act stock from bulk drug substances. meets the conditions set out in the against entities compounding animal Because the CPG does not reflect FDA’s statute and the extra-label use drugs from bulk drug substances. current thinking, to leave it in effect regulations at 21 CFR part 530. To ensure FDA can timely identify until this draft guidance is finalized This draft guidance does not address and address safety issues related to may confuse stakeholders about FDA’s the compounding of animal drugs from animal drugs compounded from bulk current enforcement priorities. approved animal or human drugs drug substances, one of the conditions, Stakeholders should be aware that, until pursuant to the extra-label provisions of if met, under which FDA does not this draft guidance is finalized, FDA the law, nor does it address the generally intend to take action for intends to look at the totality of the repackaging of approved animal drugs. violations of the provisions described circumstances when determining FDA is considering whether guidance is previously is that State-licensed whether to take enforcement action for needed on those issues, and if so, will pharmacies and veterinarians report any unlawful animal drug compounding publish separate guidances. In section product defect or serious adverse event activities. associated with animal drugs they III, FDA is asking for comment on III. Specific Topics for Comment specific questions about several issues compound from a bulk drug substance including the practice of compounding to FDA, within 15 days of becoming In addition to comments on the draft aware of them, using Form FDA 1932a. from approved animal and human drugs guidance as written, we are specifically FDA intends to use these adverse event and the repackaging of drugs for animal requesting comments on the following reports to identify animal drugs use to help determine whether issues: compounded from bulk drug substances • Should the final guidance address additional guidance is necessary on that present serious risks to animal the issue of FDA-approved animal and these topics. health. Unlike for human drugs, there This draft guidance describes human drugs that are in shortage or are are no State Departments of Health or conditions under which FDA does not otherwise unavailable (e.g., disruptions Federal Agencies, such as the Centers generally intend to initiate enforcement in the manufacture or supply chain; for Disease Control and Prevention action against State-licensed business decisions to stop marketing the (CDC), which are responsible for pharmacies, licensed veterinarians, and drug; drug is subject to Agency action identifying and tracing the source of facilities registered as outsourcing based on safety, effectiveness, or injury and/or disease in animals. facilities under section 503B of the manufacturing concerns)? If so: Adverse event reporting regarding drugs Æ How should these situations be FD&C Act (outsourcing facilities) that compounded from bulk drug substances addressed in the final guidance? compound animal drugs from bulk drug by compounding pharmacies and Æ How should the final guidance substances. The draft guidance provides veterinarians will provide a mechanism define the terms ‘‘shortage’’ and for FDA to identify and possibly prevent ‘‘unavailable’’? pharmacological activity or other direct effect in the Æ What criteria should FDA use to diagnosis, cure, mitigation, treatment, or prevention adverse events associated with of disease, or to affect the structure or any function compounded animal drugs. This is determine if an approved animal or of the body of man or other animals. The term another topic on which we are human drug is in shortage or otherwise includes those components that may undergo requesting specific comment in section unavailable? chemical change in the manufacture of the drug III. • Do United States Pharmacopeia and product and be present in the drug product in a 2 modified form intended to furnish the specified Elsewhere in this issue of the Federal National Formulary (USP–NF) activity or effect.’’ 21 CFR 210.3(b)(7). Any Register, FDA is publishing a notice component other than an active ingredient is an soliciting nominations for bulk drug 2 Chapters <795> ‘‘Pharmaceutical ‘‘inactive ingredient.’’ See 21 CFR 210.3(b)(8). Compounding—Nonsterile Preparations’’ and Inactive ingredients used in compounded drug substances that should be included in <797> ‘‘Pharmaceutical Compounding—Sterile products commonly include flavorings, dyes, Appendix A, ‘‘List of Bulk Drug Preparations’’ can be found in the combined United diluents, or other excipients. Substances That May Be Used By an Continued

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chapters <795> and <797> provide facilities are required to report adverse public submit reports, keep records, or suitable standards for animal drugs events associated with the drugs they provide information to a third party. compounded by veterinarians, and if compound. FDA believes it is important Section 3506(c)(2)(A) of the PRA, 44 not, what standards of safety, purity, to receive this information from State- U.S.C. 3506(c)(2)(A), requires Federal and quality should apply to animal licensed pharmacies and veterinarians Agencies to provide a 60-day notice in drugs compounded by veterinarians? because there are no other State the Federal Register for each proposed • Should licensed veterinarians be Departments of Health or Federal collection of information before able to sell or transfer an animal drug Agencies (e.g., the CDC) charged with submitting the collection to OMB for compounded from bulk drug substances identifying and tracing animal injuries approval. To comply with this by a State-licensed pharmacy or an or disease associated with an animal requirement, FDA is publishing this outsourcing facility to owners or drug compounded by these entities. notice of the proposed collection of caretakers of animals under the FDA has the following specific information set forth in this document. veterinarian’s care? questions with respect to this proposed With respect to the collection of • How should FDA apply the condition: information associated with this draft condition to identify an individual Æ How many State-licensed guidance, we invite comments on these patient when it is not possible to pharmacies and veterinarians topics: (1) Whether the proposed identify an individual animal (e.g., koi compound animal drugs from bulk drug collection of information is necessary in a koi pond)? substances and would potentially be for the proper performance of FDA’s • Should the final guidance include a reporting product defects and serious functions, including whether the condition on the amount or percentage adverse events to FDA? information will have practical utility; of compounded animal drugs that a Æ Are State-licensed pharmacies and (2) the accuracy of FDA’s estimate of the pharmacy or outsourcing facility can veterinarians reporting the same or burden of the proposed collection of ship in interstate commerce? If so, what similar information to any State information, including the validity of would a reasonable amount be? regulatory agency (e.g., State boards of the methodology and assumptions used; • Should facilities registered as pharmacy, State boards of veterinary (3) ways to enhance the quality, utility, outsourcing facilities under section medicine)? If so, how many reports on and clarity of the information to be 503B of the FD&C Act be able to average does each State-licensed collected; and (4) ways to minimize the compound animal drugs from bulk drug pharmacy and veterinarian submit to burden of the collection of information substances that do not appear on these State agencies each year? on respondents, including through the Appendix A for an individually Æ For purposes of the guidance, how use of automated collection techniques, identified animal patient under should FDA define the terms ‘‘product when appropriate, and other forms of conditions similar to those applicable to defect’’ and ‘‘serious adverse event’’? information technology. state-licensed pharmacies (i.e., the Æ Can FDA achieve the same Title: Compounding Animal Drugs conditions contained in section III.A. of objective of identifying and tracing the from Bulk Drug Substances (OMB the draft guidance)? source of injuries or disease associated Control Number 0910–NEW) • Is additional guidance needed to with an animal drug compounded from Description of Respondents: The address the repackaging of drugs for a bulk drug substance through means proposed collection of information animal use? other than product defect and serious would affect State-licensed pharmacies, Æ How widespread is the practice of adverse event reporting, and if so, what licensed veterinarians, and outsourcing repackaging drugs for animal use? other means? For example, would facilities that compound animal drugs Æ What types of drugs are repackaged reports of product defects alone achieve from bulk drug substances. for animal use, and why are they the same objective? Description: This draft guidance describes FDA’s current thinking repackaged? IV. Significance of Guidance Æ Have problems been identified with regarding compounding animal drugs repackaged drugs for animal use? This Level 1 draft guidance is being from bulk drug substances and describes • Is additional guidance needed to issued consistent with FDA’s good the conditions under which FDA does address the compounding of animal guidance practices regulation (21 CFR not generally intend to take action for drugs from approved animal or human 10.115). The draft guidance, when violations of the following sections of drugs under section 512(a)(4) or (a)(5) of finalized, will represent the current the FD&C Act: 512, 501(a)(5), 502(f)(1), the FD&C Act and part 530? thinking of FDA on compounding and, where specified, 501(a)(2)(B), when • Is additional guidance needed to animal drugs from bulk drug substances. a State-licensed pharmacy, licensed address the compounding of animal It does not establish any rights for any veterinarian, or an outsourcing facility drugs from bulk drug substances for person and is not binding on FDA or the compounds animal drugs from bulk food-producing animals? public. You can use an alternative drug substances. The draft guidance • As one condition under which FDA approach if it satisfies the requirements provides three sets of conditions, one does not generally intend to take action of the applicable statutes and for each entity: State-licensed for certain violations of the FD&C Act if regulations. pharmacies, licensed veterinarians, and outsourcing facilities. this and the other conditions are V. Paperwork Reduction Act of 1995 followed, FDA is proposing that State- This draft guidance only addresses licensed pharmacies and veterinarians This draft guidance contains proposed the compounding of animal drugs from report any product defect or serious information collection provisions that bulk drug substances. It does not apply adverse event associated with animal are subject to review by the Office of to the compounding of animal drugs drugs they compound from bulk drug Management and Budget (OMB) under from approved new animal or new substances to FDA within 15 days of the Paperwork Reduction Act of 1995 human drugs. Such compounding can becoming aware of the product defect or (the PRA) (44 U.S.C. 3501–3520). be conducted in accordance with the serious adverse event. Outsourcing ‘‘Collection of information’’ is defined provisions of section 512(a)(4) and (5) of in 44 U.S.C. 3502(3) and 5 CFR the FD&C Act and part 530. In addition, States Pharmacopeia and National Formulary 1320.3(c) and includes Agency requests this guidance does not address the (USP–NF), available at http://www.usp.org/. or requirements that members of the compounding of drugs intended for use

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in humans, which is addressed in other refers to proposed collections of that it is usual and customary for State- guidances. information regarding drugs made by an licensed pharmacies, veterinarians, and FDA estimates the burden of this outsourcing facility during the previous outsourcing facilities to keep such collection of information as follows: 6-month period as described in FDA’s records, and that this draft guidance notice of November 24, 2014 (79 FR imposes no additional recordkeeping Reporting 69857), announcing the availability of a burden beyond those usual and This draft guidance contains no new draft guidance entitled ‘‘Electronic customary for the respondents to this reporting provisions. This draft Reporting for Human Drug collection, with the exception of that guidance refers to previously approved Compounding Outsourcing Facilities.’’ described in section III.A.5. collections of information found in FDA The proposed collections of information Nonetheless, table 1, row 1 provides a regulations. These collections of in the draft guidance are subject to nominal estimate of potential information are subject to review by review by OMB under the PRA. As recordkeeping burden that respondents OMB under the PRA. The collections of required by the PRA, FDA published an may incur. FDA therefore specifically information regarding voluntary analysis of the information collection invites comment regarding whether reporting of adverse drug experiences or provisions of the draft guidance (79 FR these provisions impose any effort product/manufacturing defects on Form 69857 at 69858) and intends to submit beyond that which would normally be FDA 1932a, ‘‘Veterinary Adverse Drug them for OMB approval. incurred in absence of this draft Reaction, Lack of Effectiveness or guidance. Recordkeeping Product Defect Report,’’ have been A condition set forth in section approved under OMB control number Entities compounding animal drugs III.A.5. is that, if there is an FDA- 0910–0284; the information collection from bulk drug substances should keep approved animal or human drug with provisions regarding establishment adequate records to demonstrate that the same active ingredient(s), the registration under section 510 of the they are compounding such drugs in pharmacy determines that the FD&C Act (21 U.S.C. 360) have been accordance with all of the applicable compounded drug cannot be made from approved under OMB control number conditions described in the draft the FDA-approved drug(s), and 0910–0777. This draft guidance also guidance. FDA tentatively concludes documents that determination.

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Number of Number of records Total annual Average burden per Guidance section recordkeepers per recordkeeper records recordkeeping Total hours

III; general recordkeeping beyond 138,551 1 138,551 0.01 (30 seconds) ..... 1,386 usual & customary. III.A.5; documentation of deter- 75,000 84 .67 6,350,000 0.01 (30 seconds) ..... 63,500 mination that compound drug cannot be made from the FDA- approved drug(s).

Total ...... 64,886 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

For row 1, we base our burden drugs annually, and we also estimate keeping as part of usual and customary estimates on the American Veterinary that it will take approximately 30 business practice; therefore, no burden Medical Association’s Market Research seconds (0.01 hours) to document that has been estimated for the Statistics for 2013 for the total number the compounded drug cannot be made recordkeeping associated with this of veterinarians in practice minus those from the FDA-approved drug(s) for a condition. veterinarians in food animal exclusive total of 63,500 hours recordkeeping This draft guidance also refers to practice (63,500), the National burden. proposed collections of information Pharmacy Market Summary SK&A of A condition set forth in section currently undergoing the process of March 2010 for the total number of III.A.2. of the draft guidance is that OMB review under the PRA. pharmacy sites (75,000), and the State-licensed pharmacies can Recordkeeping by outsourcing facilities, number of registered outsourcing compound a drug in advance of receipt described in the draft guidance for facilities as of March 20, 2015 (51), for of a prescription in a quantity that does industry, ‘‘Current Good Manufacturing a total of 138,551 respondents.3 not exceed the amount of drug product Practice—Interim Guidance for Human For row 2, we estimate that Drug Compounding Outsourcing approximately 75,000 pharmacies will that the State-licensed pharmacy compounded pursuant to patient- Facilities Under Section 503B of the receive approximately 6,350,000 FD&C Act’’ announced July 2, 2014 (79 prescriptions for compounded animal specific prescriptions based on a history of receipt of such patient-specific FR 37743), will be reviewed by OMB in response to an information collection 3 prescriptions for that drug product over The AVMA’s Market Research Statistics—U.S. request associated with that guidance. Veterinarians—2013 can be found at this URL: any consecutive 14-day period within (https://www.avma.org/KB/Resources/Statistics/ the previous 6 months. The records Third-Party Disclosure Pages/Market-research-statistics-US- necessary for a State-licensed pharmacy veterinarians.aspx); the National Pharmacy Market Prescriptions or Orders for Drugs to review to determine that its Summary SK&A (March 2010) can be found at this Compounded From Bulk URL: http://www.skainfo.com/index.php; and the compounding practices are within the list of registered outsourcing facilities can be found condition set forth in section III.A.2 of This draft guidance contains new at this URL: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/ the draft guidance are records that State- third-party disclosures as reported in PharmacyCompounding/ucm378645.htm. licensed pharmacies would already be table 2. Row 1 reflects a potential

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burden associated with section III.C.9. In section III.A.4., the draft guidance is a component of a marketed FDA- regarding the following condition: The sets forth the following condition: If the approved animal or human drug, the veterinarian’s prescription or order drug contains a bulk drug substance that prescription or documentation states, in addition to the species, the is a component of any marketed FDA- accompanying the prescription contains condition(s) for which the substance is approved animal or human drug, there a statement that the change between the listed in Appendix A. At this time, is a change between the compounded compounded drug and the FDA- however, FDA has no data upon which drug and the comparable FDA-approved approved drug produces a clinical to base an estimated number of animal or human drug made for an difference for the individual identified prescriptions or orders to outsourcing identified individual patient that patient. For example, the veterinarian produces a clinical difference for that facilities until the referenced list of bulk could state that, ‘‘This compounded identified individual patient, as drugs (Draft Guidance; Appendix A) is drug is needed to treat [specifically determined by the veterinarian finalized. For purposes of this analysis, identified patient] because the approved prescribing the compounded drug for however, we are providing an estimate his/her patient under his/her care. If the drug product(s) cannot be divided or of 1 as a placeholder. drug contains a bulk drug substance that diluted into the small dose required.’’

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Number of Activity Number of disclosures per Total annual Average burden per Total hours respondents respondent disclosures disclosure

III.C.9; documentation of condition 1 1 1 0.017 (1 minute) ...... 0 .017 to be treated. Statements on prescription (Sec- 63,500 100 6,350,000 0.017 (1 minute) ...... 107,950 tion III.A.4 of the draft guidance).

Total ...... 107,950 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

For row 2, we estimate that as labeled or in an extra-label manner intended animal patient, the name of approximately 63,500 veterinarians will, under section 512(a)(4) and (5) and 21 the animal patient, and the name of the on average, each produce approximately CFR part 530 to appropriately treat the owner or caretaker of the animal patient. 100 prescriptions for compounded disease, symptom, or condition for It is usual and customary for State- animal drugs annually for a total of which this drug is being prescribed.’’ licensed pharmacies and licensed 6,350,000 prescriptions. We also (Section III.A.6.b). veterinarians to include such estimate that it will take approximately In addition, section III.C.3 of the draft information on the labels of 1 minute (0.017 hours) to include the guidance sets forth the condition that compounded drugs in the normal course statement discussed in section III.A.4 of the following statement appears of their activities; thus, the time it the draft guidance on each prescription verbatim on or with prescriptions or would take to provide this information for a total of 107,950 hours third-party orders for animal drugs compounded by is not included in the burden estimate disclosure burden, as reported in table outsourcing facilities from bulk drug reported in table 2. 1. substances listed on Appendix A: In addition, the draft guidance It is usual and customary for licensed • ‘‘This drug will not be dispensed indicates in section III.C.10. that, to veterinarians to write prescriptions in for or administered to food-producing meet the conditions of the guidance, the normal course of their activities. The animals.’’ (Section III.C.3). outsourcing facilities include on the conditions set forth in the guidance We tentatively conclude that these label of any compounded animal drug require veterinarians to include certain statements are ‘‘public disclosures of pursuant to a specific prescription or information on prescriptions for animals information originally supplied by the order: The active ingredient; the dosage drugs compounded from bulk Federal Government to the recipient for form, strength, and flavoring, if any; substances. It is usual and customary for the purpose of disclosure to the public’’ direction for use, as provided by the veterinarians to include much of this (5 CFR 1320.3(c)(2)) and are therefore veterinarian prescribing or ordering the information (except as noted not subject to review by OMB under the drug; the quantity or volume, whichever previously); therefore, the time it would PRA. Thus, the time it would take to is appropriate; the lot or batch number take to provide this information on provide this information is not included of the drug; special storage and handling prescriptions or documents in the burden estimate reported in table instructions; the date the drug was accompanying prescriptions is not 2. compounded; the beyond use date of the included in the burden estimate drug; the name of the veterinarian Labeling of Drugs Compounded From prescribing or ordering the drug; the reported in table 2. Bulk Drug Substances Sections III.A.3 and III.A.6.b of the inactive ingredients; and the address draft guidance set forth the conditions The draft guidance sets forth and phone number of the outsourcing that the following statements appear conditions for the labeling of animal facility that compounded the drug. It is verbatim on or with prescriptions for drugs compounded from bulk drug usual and customary for outsourcing animal drugs compounded from bulk substances. The draft guidance indicates facilities to include such information on drug substances: in sections III.A.11 and III.B.9 that, to the labels of compounded drugs in the • ‘‘This patient is not a food- meet the conditions of the guidance, normal course of their activities; thus, producing animal.’’ (Section III.A.3). State-licensed pharmacies and licensed the time it would take to provide this • ‘‘There are no FDA-approved veterinarians include on the label of any information is not included in the animal or human drugs that can be used compounded drug: The species of the burden estimate reported in table 2.

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The draft guidance indicates in through Friday, and will be posted to Background on the Review Committee, section III.C.10 that, to meet the the docket at http:// including the Review Committee’s Charter conditions of the guidance, outsourcing www.regulations.gov. can be accessed at http://www.ncvhs.hhs.gov/ facilities compounding animal drug subcommittees-work-groups/subcommittee- VII. Electronic Access on-standards/review-committee/. from bulk drug substances for office use Persons with access to the Internet Contact Person for More Information: in veterinary practices include on the Debbie M. Jackson, Acting Executive label of any compounded drug these may obtain the draft guidance at either Secretary, NCVHS, National Center for four statements: http://www.fda.gov/AnimalVeterinary/ Health Statistics, Centers for Disease Control • ‘‘Not for resale.’’ GuidanceComplianceEnforcement/ and Prevention, 3311 Toledo Road, Room • ‘‘For use only in [fill in species and GuidanceforIndustry/ucm042450.htm or 2339, Hyattsville, Maryland 20782, telephone any associated condition or limitation http://www.regulations.gov. (301) 458–4614 or Terri Deutsch, Centers for Medicare and Medicaid Services, Office of E- listed in Appendix A].’’ Dated: May 12, 2015. • ‘‘Compounded by [name of Health Standards and Services, 7500 Security Leslie Kux, outsourcing facility].’’ Boulevard, Baltimore, Maryland 21244, • ‘‘Adverse events associated with Associate Commissioner for Policy. telephone (410) 786–9462. Program this compounded drug should be [FR Doc. 2015–11982 Filed 5–18–15; 8:45 am] information as well as summaries of meetings and a roster of committee members are reported to FDA on a Form FDA 1932a.’’ BILLING CODE 4164–01–P We tentatively conclude that these available on the NCVHS home page of the HHS Web site: four label statements are ‘‘public http://ncvhs.us/, where further information disclosures of information originally DEPARTMENT OF HEALTH AND HUMAN SERVICES including an agenda will be posted when supplied by the Federal Government to available. the recipient for the purpose of National Committee on Vital and Health Should you require reasonable disclosure to the public’’ (5 CFR accommodation, please contact the CDC Statistics: Meeting 1320.3(c)(2)) and are therefore not Office of Equal Employment Opportunity on subject to review by OMB under the Pursuant to the Federal Advisory (301) 458–4EEO (4336) as soon as possible. PRA. Thus, the time it would take to Committee Act, the Department of Dated: May 13, 2015. provide this information is not included Health and Human Services (HHS) James Scanlon, in the burden estimate reported in table announces the following advisory Deputy Assistant Secretary for Planning and 2. committee meeting. Evaluation Science and Data Policy, Office This draft guidance also refers to Name: National Committee on Vital and of the Assistant Secretary for Planning and previously approved collections of Health Statistics (NCVHS) Review Evaluation. information. A condition set forth in Committee, pursuant to Section 1104(i) of the [FR Doc. 2015–12106 Filed 5–18–15; 8:45 am] sections III.A.7., III.B.6, and III.C.5 is Patient Protection and Affordable Care Act BILLING CODE 4151–05–P that any bulk drug substance used is (ACA). manufactured by an establishment that Time and Date: June 16, 2015, 9:00 a.m.– is registered under section 510 of the 5:00 p.m. EST; June 17, 2015, 8:00 a.m.–5:15 DEPARTMENT OF HEALTH AND FD&C Act (including a foreign p.m. EST. HUMAN SERVICES establishment that is registered under Place: U.S. Department of Health and Human Services, Centers for Disease Control Meetings of the Advisory Group on section 360(i) of the FD&C Act) and is and Prevention, National Center for Health accompanied by a valid certificate of Statistics, 3311 Toledo Road, Auditorium B Prevention, Health Promotion, and analysis. The information collection and C, Hyattsville, Maryland 20782, (301) Integrative and Public Health related to the disclosure of the 458–4524. AGENCY: Office of the Surgeon General certificate of analysis is approved under Status: Open. of the United States Public Health OMB control number 0910–0139. Purpose: The purpose of this hearing is to Before the proposed information obtain information from the health care Service, Office of the Assistant Secretary collection provisions contained in this industry on the currently adopted standards, for Health, Office of the Secretary, operating rules, code sets and identifiers draft guidance become effective, we will Department of Health and Human used in administrative simplification Services. publish a notice in the Federal Register transactions. announcing OMB’s decision to approve, The objectives of this hearing are as ACTION: Notice. modify, or disapprove the proposed follows: (1) Review currently adopted SUMMARY: information collection provisions. An standards, operating rules, code sets and In accordance with Section Agency may not conduct or sponsor, identifiers used in each of the HIPAA-named 10(a) of the Federal Advisory Committee and a person is not required to respond administrative simplification transactions Act, Public Law 92–463, as amended to, a collection of information unless it and evaluate the degree to which they meet (5 U.S.C. App.), notice is hereby given current industry business needs; and (2) that two meetings are scheduled for the displays a currently valid OMB control Identify transactions, standards, operating number. Advisory Group on Prevention, Health rules, code sets and identifiers used in Promotion, and Integrative and Public VI. Comments administrative simplification that require Health (the ‘‘Advisory Group’’). The changes, deletions or new versions in order Interested persons may submit either to meet industry needs. meetings will be open to the public. electronic comments regarding this draft We invite the public to prepare and submit Information about the Advisory Group guidance to http://www.regulations.gov written testimony on any and all areas and the agendas for these meetings can or written comments to the Division of covered by this hearing. We also invite be obtained by accessing the following Dockets Management (see ADDRESSES). It testifiers to prepare and submit more Web site: http:// is only necessary to send one set of extensive written testimony, in addition to www.surgeongeneral.gov/initiatives/ the oral testimony they will be providing prevention/advisorygrp/index.html. comments. Identify comments with during the hearing. Written testimonies Docket No. FDA–2015–D–1176. should be sent to Marietta Squire, Committee DATES: The first meeting will be held on Received comments may be seen in the Management Specialist, Centers for Disease June 11, 2015, from 11:30 a.m. to 2:30 Division of Dockets Management Control and Prevention, National Center for p.m. EST. The second meeting will be between 9 a.m. and 4 p.m., Monday Health Statistics, email [email protected]. held on August 31 from 9:00 a.m. to

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5:00 p.m. EST—September 1, 2015, from Individuals who wish to participate in Health, 6701 Rockledge Drive, Room 3198, 9:00 a.m. to 1:00 p.m. EST. the meetings and/or provide comments MSC 7808, Bethesda, MD 20892, 301–435– 2306, [email protected]. ADDRESSES: The first meeting on June must register by 12:00 p.m. EST on June 11, 2015, will be held via 4, 2015, for the meeting on June 11, Name of Committee: Infectious Diseases teleconference. The second meeting on 2015, and by 12:00 p.m. EST on August and Microbiology Integrated Review Group; 24, 2015, for the meeting on August 31– Host Interactions with Bacterial Pathogens August 31—September 1, 2015, will be Study Section. held in Washington, DC Teleconference September 1, 2015. In order to register, Date: June 5, 2015. and meeting location information will individuals must send their full name Time: 8:00 a.m. to 6:00 p.m. be published closer to the meeting dates and affiliation via email to Agenda: To review and evaluate grant at: http://www.surgeongeneral.gov/ [email protected]. applications initiatives/prevention/advisorygrp/ Individuals who need special assistance Place: Warwick Seattle Hotel, 401 Lenora index.html. and/or accommodations, i.e., sign Street, Seattle, WA 98121. Contact Person: Fouad A El-Zaatari, Ph.D., FOR FURTHER INFORMATION CONTACT: language interpretation or other reasonable accommodations, should Scientific Review Officer, Center for Office of the Surgeon General, 200 Scientific Review, National Institutes of Independence Ave. SW.; Washington, indicate so when they register. Members Health, 6701 Rockledge Drive, Room 3186, DC 20201; 202–205–9517; of the public who wish to have MSC 7808, Bethesda, MD 20892, (301) 435– [email protected]. materials distributed to the Advisory 1149, [email protected]. Group members at these scheduled SUPPLEMENTARY INFORMATION: The Name of Committee: Infectious Diseases meetings should submit those materials Advisory Group is a non-discretionary and Microbiology Integrated Review Group; by June 4, 2015, for the June meeting Vector Biology Study Section. federal advisory committee that was and by August 24, 2015, for the August/ Date: June 10, 2015. initially established under Executive September meeting. Time: 8:30 a.m. to 6:30 p.m. Order 13544, dated June 10, 2010, to Agenda: To review and evaluate grant comply with the statutes under Section Dated: May 6, 2015. applications. 4001 of the Patient Protection and Corinne M. Graffunder, Place: George Washington University Inn, Affordable Care Act, Public Law 111– Designated Federal Officer, Advisory Group 824 New Hampshire Ave., NW., Washington, 148. The Advisory Group was on Prevention, Health Promotion, and DC 20037. established to assist in carrying out the Integrative and Public Health, Office of the Contact Person: Liangbiao Zheng, Ph.D., Surgeon General. Scientific Review Officer, Center for mission of the National Prevention, Scientific Review, National Institutes of [FR Doc. 2015–12104 Filed 5–18–15; 8:45 am] Health Promotion, and Public Health Health, 6701 Rockledge Drive, Room 3214, Council (the Council). The Advisory BILLING CODE 4163–18–P MSC 7808, Bethesda, MD 20892, 301–402– Group provides recommendations and 5671, [email protected]. advice to the Council. DEPARTMENT OF HEALTH AND Name of Committee: Surgical Sciences, The Advisory Group was terminated Biomedical Imaging and Bioengineering on September 30, 2012, by Executive HUMAN SERVICES Integrated Review Group; Biomedical Order 13591, dated November 23, 2011. Imaging Technology A Study Section. National Institutes of Health Authority for the Advisory Group to be Date: June 11–12, 2015. re-established was given under Time: 8:00 a.m. to 5:00 p.m. Center for Scientific Review; Notice of Agenda: To review and evaluate grant Executive Order 13631, dated December Closed Meetings 7, 2012. Authority for the Advisory applications. Pursuant to section 10(d) of the Place: Hilton Washington/Rockville, 1750 Group to continue to operate until Rockville Pike, Rockville, MD 20852. September 30, 2015, was given under Federal Advisory Committee Act, as Contact Person: Ruth Grossman, DDS, Executive Order 13652, dated amended (5 U.S.C. App.), notice is Scientific Review Officer, Center for September 30, 2013. hereby given of the following meetings. Scientific Review, National Institutes of It is authorized for the Advisory The meetings will be closed to the Health, 6701 Rockledge Drive, Room 5215, Group to consist of no more than 25 public in accordance with the Bethesda, MD 20892, (301) 435–2409, non-federal members. The Advisory provisions set forth in sections [email protected]. Group currently has 21 members who 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: Interdisciplinary were appointed by the President. The as amended. The grant applications and Molecular Sciences and Training Integrated membership includes a diverse group of the discussions could disclose Review Group; Enabling Bioanalytical and licensed health professionals, including confidential trade secrets or commercial Imaging Technologies Study Section. integrative health practitioners who property such as patentable material, Date: June 11–12, 2015. and personal information concerning Time: 8:00 a.m. to 10:00 p.m. have expertise in (1) worksite health Agenda: To review and evaluate grant promotion; (2) community services, individuals associated with the grant applications. including community health centers; (3) applications, the disclosure of which Place: Washington Marriott Georgetown, preventive medicine; (4) health would constitute a clearly unwarranted 1221 22nd Street NW., Washington, DC coaching; (5) public health education; invasion of personal privacy. 20037. (6) geriatrics; and (7) rehabilitation Name of Committee: Infectious Diseases Contact Person: Kenneth Ryan, Ph.D., medicine. and Microbiology Integrated Review Group; Scientific Review Officer, Center for Meeting descriptions and relevant Pathogenic Eukaryotes Study Section. Scientific Review, National Institutes of materials will be published closer to the Date: June 4–5, 2015. Health, 6701 Rockledge Drive, Room 3218, Time: 8:30 a.m. to 5:00 p.m. MSC 7717, Bethesda, MD 20892, 301–435– meeting dates at: http:// 0229, [email protected]. www.surgeongeneral.gov/initiatives/ Agenda: To review and evaluate grant Name of Committee: Oncology 1-Basic prevention/advisorygrp/index.html. applications. Place: Marriott Wardman Park, Washington Translational Integrated Review Group, Members of the public have the DC Hotel, 2660 Woodley Road, NW., Tumor Microenvironment Study Section. opportunity to participate in each Washington, DC 20008. Date: June 15–16, 2015. meeting and/or provide comments to Contact Person: Tera Bounds, DVM, Ph.D., Time: 8:00 a.m. to 5:00 p.m. the Advisory Group. Public comment Scientific Review Officer, Center for Agenda: To review and evaluate grant will be limited to 3 minutes per speaker. Scientific Review National Institutes of applications.

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Place: Hotel Kabuki, 1625 Post Street, San Date: June 18, 2015. Scientific Review, National Institutes of Francisco, CA 94115. Time: 8:00 a.m. to 6:00 p.m. Health, 6701 Rockledge Drive, Room 4214, Contact Person: Angela Y Ng, Ph.D., MBA, Agenda: To review and evaluate grant MSC 7814, Bethesda, MD 20892, 301–435– Scientific Review Officer, Center for applications. 1781, [email protected]. Scientific Review, National Institutes of Place: Residence Inn Bethesda, 7335 Name of Committee: Genes, Genomes, and Health, 6701 Rockledge Drive, Room 6200, Wisconsin Avenue, Bethesda, MD 20814. Genetics Integrated Review Group; Genetic MSC 7804, Bethesda, MD 20892, 301–435– Contact Person: Wallace Ip, Ph.D., Variation and Evolution Study Section. 1715, [email protected]. Scientific Review Officer, Center for Date: June 18–19, 2015. Name of Committee: Molecular, Cellular Scientific Review, National Institutes of Time: 8:30 a.m. to 12:00 p.m. and Developmental Neuroscience Integrated Health, 6701 Rockledge Drive, Room 5128, Agenda: To review and evaluate grant Review Group; Cellular and Molecular MSC 7840, Bethesda, MD 20892, 301–435– applications. Biology of Neurodegeneration Study Section. 1191, [email protected]. Place: Pier 2620 Hotel, 2620 Jones Street, Date: June 16–17, 2015. Name of Committee: Digestive, Kidney and San Francisco, CA. Time: 8:00 a.m. to 4:00 p.m. Urological Systems Integrated Review Group; Contact Person: Ronald Adkins, Ph.D., Agenda: To review and evaluate grant Gastrointestinal Mucosal Pathobiology Study Scientific Review Officer, Center for applications. Section. Scientific Review, National Institutes of Place: Marriott-Courtyard Downtown, 500 Date: June 18–19, 2015. Health, 6701 Rockledge Drive, Room 2206, East First Street, Long Beach, CA 90802. Time: 8:00 a.m. to 6:00 p.m. MSC 7890, Bethesda, MD 20892, 301–435– Contact Person: Laurent Taupenot, Ph.D., Agenda: To review and evaluate grant 4511, [email protected]. Scientific Review Officer, Center for applications. Name of Committee: Center for Scientific Scientific Review, National Institutes of Place: Warwick Allerton Hotel, 701 N. Review Special Emphasis Panel; SBIB Health, 6701 Rockledge Drive, Room 4183, Michigan Avenue, Chicago, IL 60611. Clinical Pediatric and Fetal Applications. MSC 7850, Bethesda, MD 20892, 301–435– Contact Person: Jonathan K. Ivins, Ph.D., Date: June 18, 2015. 1203, [email protected]. Scientific Review Officer, Center for Time: 11:00 a.m. to 4:00 p.m. Name of Committee: Center for Scientific Scientific Review, National Institutes of Agenda: To review and evaluate grant Review Special Emphasis Panel; Member Health, 6701 Rockledge Drive, Room 2190, applications. Conflict: Cancer Therapeutics. MSC 7850, Bethesda, MD 20892, (301) 594– Place: National Institutes of Health, 6701 Date: June 16, 2015. 1245, [email protected]. Rockledge Drive, Bethesda, MD 20892, Time: 1:00 p.m. to 3:30 p.m. Name of Committee: Integrative, (Virtual Meeting). Agenda: To review and evaluate grant Functional and Cognitive Neuroscience Contact Person: John Firrell, Ph.D., applications. Integrated Review Group; Scientific Review Officer, Center for Place: National Institutes of Health, 6701 Neuroendocrinology, Neuroimmunology, Scientific Review, National Institutes of Rockledge Drive, Bethesda, MD 20892, Rhythms and Sleep Study Section. Health, 6701 Rockledge Drive, Room 5118, (Telephone Conference Call). Date: June 18–19, 2015. MSC 7854, Bethesda, MD 20892, 301–435– Contact Person: Careen K Tang-Toth, Time: 8:00 a.m. to 3:00 p.m. 2598, [email protected]. Ph.D., Scientific Review Officer, Center for Agenda: To review and evaluate grant Name of Committee: Center for Scientific Scientific Review, National Institutes of applications. Review Special Emphasis Panel; Small Health, 6701 Rockledge Drive, Room 6214, Place: Pier 5 Hotel, 711 Eastern Avenue, Business: Cell, Computational and Molecular MSC 7804, Bethesda, MD 20892, (301) 435– Baltimore, MD 21202. Biology. 3504, [email protected]. Contact Person: Michael Selmanoff, Ph.D., Date: June 19, 2015. Name of Committee: Digestive, Kidney and Scientific Review Officer, Center for Time: 8:00 a.m. to 6:00 p.m. Urological Systems Integrated Review Group; Scientific Review, National Institutes of Agenda: To review and evaluate grant Systemic Injury by Environmental Exposure. Health, 6701 Rockledge Drive, Room 5164, applications. Date: June 17–18, 2015. MSC 7844, Bethesda, MD 20892, 301–435– Place: Marriott Wardman Park Washington Time: 8:00 a.m. to 5:00 p.m. 1119, [email protected]. DC Hotel, 2660 Woodley Road, NW., Agenda: To review and evaluate grant Name of Committee: Biobehavioral and Washington, DC 20008. applications. Behavioral Processes Integrated Review Contact Person: Allen Richon, Ph.D., Place: Hyatt Regency Bethesda, One Group; Child Psychopathology and Scientific Review Officer, Center for Bethesda Metro Center, 7400 Wisconsin Developmental Disabilities Study Section. Scientific Review, National Institutes of Avenue, Bethesda, MD 20814. Date: June 18–19, 2015. Health, 6701 Rockledge Drive, Room 6184, Contact Person: Patricia Greenwel, Ph.D., Time: 8:00 a.m. to 6:00 p.m. MSC 7892, Bethesda, MD 20892, 301–379– Scientific Review Officer, Center for Agenda: To review and evaluate grant 9351, [email protected]. Scientific Review, National Institutes of applications. Name of Committee: Center for Scientific Health, 6701 Rockledge Drive, Room 2178, Place: Wyndham Grand Chicago Review Special Emphasis Panel; PAR 13– MSC 7818, Bethesda, MD 20892, 301–435– Riverfront, 71 East Wacker Drive, Chicago, IL 293: Gut Microbiota-Derived Factors in the 1169, [email protected]. 60601. Integrated Physiology and Pathophysiology Name of Committee: Population Sciences Contact Person: Jane A. Doussard- of Diseases within NIDDK’s mission. and Epidemiology Integrated Review Group, Roosevelt, Ph.D., Scientific Review Officer, Date: June 19, 2015. Societal and Ethical Issues in Research Study Center for Scientific Review, National Time: 9:00 a.m. to 11:00 a.m. Section. Institutes of Health, 6701 Rockledge Drive, Agenda: To review and evaluate grant Date: June 17, 2015. Room 3184, MSC 7848, Bethesda, MD 20892, applications. Time: 9:00 a.m. to 5:00 p.m. (301) 435–4445, [email protected]. Place: The Allerton Hotel, 701 North Agenda: To review and evaluate grant Name of Committee: Musculoskeletal, Oral Michigan Avenue, Chicago, IL 60611. applications. and Skin Sciences Integrated Review Group; Contact Person: Jonathan K. Ivins, Ph.D., Place: Sheraton Silver Spring, 8777 Oral, Dental and Craniofacial Sciences Study Scientific Review Officer, Center for Georgia Avenue, Silver Spring, MD 20910. Section. Scientific Review, National Institutes of Contact Person: Karin F Helmers, Ph.D., Date: June 18–19, 2015. Health, 6701 Rockledge Drive, Room 4040A, Scientific Review Officer, Center for Time: 8:00 a.m. to 1:00 p.m. MSC 7806, Bethesda, MD 20892, (301) 594– Scientific Review, National Institutes of Agenda: To review and evaluate grant 1245, [email protected]. Health, 6701 Rockledge Drive, Room 3148, applications. Name of Committee: Center for Scientific MSC 7770, Bethesda, MD 20892, (301) 254– Place: Embassy Suites Washington DC, Review Special Emphasis Panel; PAR 14– 9975, [email protected]. Convention Center, 900 10th St. NW., 242: Role of the Microflora in the Etiology of Name of Committee: Cell Biology Washington, DC 20001. Gastrointestinal Cancer. Integrated Review Group, Intercellular Contact Person: Yi-Hsin Liu, Ph.D., Date: June 19, 2015. Interactions Study Section. Scientific Review Officer, Center for Time: 11:00 a.m. to 1:00 p.m.

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Agenda: To review and evaluate grant with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications. 552b(c)(6), Title 5 U.S.C., as amended as amended. The grant applications/ Place: The Allerton Hotel, 701 North for the review, discussion, and contract proposals and the discussions Michigan Avenue, Chicago, IL 60611. Contact Person: Jonathan K. Ivins, Ph.D., evaluation of individual intramural could disclose confidential trade secrets Scientific Review Officer, Center for programs and projects conducted by the or commercial property such as Scientific Review, National Institutes of National Institute of Mental Health, patentable material, and personal Health, 6701 Rockledge Drive, Room 4040A, including consideration of personnel information concerning individuals MSC 7806, Bethesda, MD 20892, (301) 594– qualifications and performance, and the associated with the grant applications/ 1245, [email protected]. competence of individual investigators, contract proposals, the disclosure of Name of Committee: Center for Scientific the disclosure of which would which would constitute a clearly Review Special Emphasis Panel; constitute a clearly unwarranted unwarranted invasion of personal Epidemiology and Environment. invasion of personal privacy. privacy. Date: June 19, 2015. Time: 11:30 a.m. to 12:30 p.m. Name of Committee: Board of Scientific Name of Committee: National Institute on Agenda: To review and evaluate grant Counselors, National Institute of Mental Alcohol Abuse and Alcoholism Special applications. Health. Emphasis Panel; NIAAA MOBC PAR—R21 Place: National Institutes of Health, 6701 Date: June 15-16, 2015. applications. Rockledge Drive, Bethesda, MD 20892, Time: June 15, 2015, 2:20 p.m. to 5:45 p.m. Date: June 3, 2015. (Telephone Conference Call). Agenda: To review and evaluate personal Time: 11:00 a.m. to 1:00 p.m. Contact Person: Claire E. Gutkin, Ph.D., qualifications and performance, and Agenda: To review and evaluate grant MPH, Scientific Review Officer, Center for competence of individual investigators. applications. Scientific Review, National Institutes of Place: National Institutes of Health, Porter Place: NIAAA, NIH, 5635 Fishers Lane, Health, 6701 Rockledge Drive, Room 3106, Neuroscience Research Center, Room GE 610 Room CR2098, Rockville, MD 20852, MSC 7808, Bethesda, MD 20892, (301) 594– and 640, 35A Convent Drive, Bethesda, MD (Telephone Conference Call). 3139, [email protected]. 20892. Contact Person: Ranga Srinivas, Ph.D., Name of Committee: Center for Scientific Time: June 15, 2015, 7:30 p.m. to 9:00 p.m. Chief, Extramural Project Review Branch, Review Special Emphasis Panel; PAR 13– Agenda: To review and evaluate personal National Institute on Alcohol Abuse and 213: Outcome Measures for Use in Treatment qualifications and performance, and Alcoholism, NIH, 5635 Fishers Lane, Room Trials for Individuals with Intellectual and competence of individual investigators. 2085, Rockville, MD 20852, (301) 451–2067, Developmental Disabilities (R01). Place: Hyatt Regency Bethesda, One [email protected]. Date: June 19, 2015. Bethesda Metro Center, 7400 Wisconsin This notice is being published less than 15 Time: 2:30 p.m. to 3:00 p.m. Avenue, Bethesda, MD 20814. days prior to the meeting due to the timing Agenda: To review and evaluate grant Time: June 16, 2015, 9:00 a.m. to 5:05 p.m. limitations imposed by the review and applications. Agenda: To review and evaluate personal funding cycle. Place: Wyndham Grand Chicago qualifications and performance, and Name of Committee: National Institute on Riverfront, 71 East Wacker Drive, Chicago, IL competence of individual investigators. Alcohol Abuse and Alcoholism Special 60601. Place: National Institutes of Health, Porter Emphasis Panel; NIAAA MOBC PAR—R01. Contact Person: Jane A. Doussard- Neuroscience Research Center, Room GE Date: June 8, 2015. Roosevelt, Ph.D., Scientific Review Officer, 620/630 and 640, 35A Convent Drive, Time: 1:00 p.m. to 4:00 p.m. Center for Scientific Review, National Bethesda, MD 20892. Agenda: To review and evaluate grant Institutes of Health, 6701 Rockledge Drive, Contact Person: Jennifer E. Mehren, Ph.D., applications. Room 3184, MSC 7848, Bethesda, MD 20892, Executive Secretary, Division of Intramural Place: NIAAA, NIH, 5635 Fishers Lane, (301) 435–4445, [email protected]. Research Programs, National Institute of Room CR2098, Rockville, MD 20852, (Catalogue of Federal Domestic Assistance Mental Health, NIH, 35A Convent Drive, (Telephone Conference Call). Program Nos. 93.306, Comparative Medicine; Room GE 412, Bethesda, MD 20892–3747, Contact Person: Ranga Srinivas, Ph.D., 93.333, Clinical Research, 93.306, 93.333, 301–496–3501, [email protected]. Chief, Extramural Project Review Branch, 93.337, 93.393–93.396, 93.837–93.844, (Catalogue of Federal Domestic Assistance National Institute on Alcohol Abuse and 93.846–93.878, 93.892, 93.893, National Program No. 93.242, Mental Health Research Alcoholism, NIH, 5635 Fishers Lane, Room Institutes of Health, HHS) Grants, National Institutes of Health, HHS) 2085, Rockville, MD 20852, (301) 451–2067, [email protected]. Dated: May 13, 2015. Dated: May 13, 2015. Name of Committee: National Institute on David Clary, Carolyn Baum, Alcohol Abuse and Alcoholism Special Program Analyst, Office of Federal Advisory Program Analyst, Office of Federal Advisory Emphasis Panel; Review of Contract Committee Policy. Committee Policy. Proposals on Human Lab Paradigms. [FR Doc. 2015–12010 Filed 5–18–15; 8:45 am] [FR Doc. 2015–12008 Filed 5–18–15; 8:45 am] Date: June 11, 2015. BILLING CODE 4140–01–P BILLING CODE 4140–01–P Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate contract proposals. DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Place: NIAAA, NIH, 5635 Fishers Lane, Room CR2098, Rockville, MD 20852, HUMAN SERVICES HUMAN SERVICES (Telephone Conference Call). Contact Person: Ranga Srinivas, Ph.D., National Institutes of Health National Institutes of Health Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and National Institute of Mental Health; National Institute on Alcohol Abuse Alcoholism, NIH, 5635 Fishers Lane, Room Notice of Closed Meeting and Alcoholism; Notice of Closed 2085, Rockville, MD 20852, (301) 451–2067, Meetings Pursuant to section 10(d) of the [email protected]. Federal Advisory Committee Act, as Pursuant to section 10(d) of the (Catalogue of Federal Domestic Assistance amended (5 U.S.C. App.), notice is Federal Advisory Committee Act, as Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists hereby given of a meeting of the Board amended (5 U.S.C. App.), notice is and Clinicians; 93.272, Alcohol National of Scientific Counselors, National hereby given of the following meetings. Research Service Awards for Research Institute of Mental Health. The meetings will be closed to the Training; 92.273, Alcohol Research Programs; The meeting will be closed to the public in accordance with the 93.891, Alcohol Research Center Grants; public as indicated below in accordance provisions set forth in sections 93.701, ARRA Related Biomedical Research

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and Research Supports Awards, National Agenda: To review and evaluate grant Place: National Institutes of Health, Room Institutes of Health, HHS) applications. 4F100, 5601 Fishers Lane, Rockville, MD Dated: May 13, 2015. Place: Hilton Garden Inn Bethesda, 7301 20892. Waverly Street, Bethesda, MD 20814. Melanie J. Gray-Pantoja, Time: June 19, 2015, 8:00 a.m. to 5:00 p.m. Contact Person: Alexander Parsadanian, Agenda: To review and evaluate grant Program Analyst, Office of Federal Advisory Ph.D., Scientific Review Officer, National applications. Committee Policy. Institute on Aging, Gateway Building 2C/212, Place: National Institutes of Health, Room [FR Doc. 2015–12012 Filed 5–18–15; 8:45 am] 7201 Wisconsin Avenue, Bethesda, MD 4F100, 5601 Fishers Lane, Rockville, MD BILLING CODE 4140–01–P 20892, 301–496–9666, PARSADANIANA@ 20892. NIA.NIH.GOV. Contact Person: Maja Maric, Ph.D., Name of Committee: National Institute on Scientific Review Officer, Scientific Review DEPARTMENT OF HEALTH AND Aging Special Emphasis Panel, Novel Program, Division of Extramural Activities, HUMAN SERVICES Molecular Mechanism of Longevity. Room #3F21A, National Institutes of Health, Date: July 15, 2015. NIAID, 5601 Fishers Lane, MSC 9823, National Institutes of Health Time: 12:00 p.m. to 4:00 p.m. Rockville, MD 20852, (240) 669–5025, Agenda: To review and evaluate grant [email protected]. National Institute on Aging; Notice of applications. (Catalogue of Federal Domestic Assistance Closed Meetings Place: National Institute on Aging, Program Nos. 93.855, Allergy, Immunology, Gateway Building, Suite 2C212, 7201 and Transplantation Research; 93.856, Pursuant to section 10(d) of the Wisconsin Avenue, Bethesda, MD 20892, Microbiology and Infectious Diseases Federal Advisory Committee Act, as (Telephone Conference Call). Research, National Institutes of Health, HHS) amended (5 U.S.C. App.), notice is Contact Person: Bita Nakhai, Ph.D., Dated: May 13, 2015. hereby given of the following meetings. Scientific Review Branch, National Institute David Clary, The meetings will be closed to the on Aging, Gateway Bldg., 2C212, 7201 public in accordance with the Wisconsin Avenue, Bethesda, MD 20814, Program Analyst, Office of Federal Advisory Committee Policy. provisions set forth in sections 301–402–7701, [email protected]. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., (Catalogue of Federal Domestic Assistance [FR Doc. 2015–12006 Filed 5–18–15; 8:45 am] as amended. The grant applications and Program Nos. 93.866, Aging Research, BILLING CODE 4140–01–P the discussions could disclose National Institutes of Health, HHS) confidential trade secrets or commercial Dated: May 13, 2015. DEPARTMENT OF HEALTH AND property such as patentable material, Melanie J. Gray, HUMAN SERVICES and personal information concerning Program Analyst, Office of Federal Advisory individuals associated with the grant Committee Policy. National Institutes of Health applications, the disclosure of which [FR Doc. 2015–12013 Filed 5–18–15; 8:45 am] would constitute a clearly unwarranted Prospective Grant of Exclusive BILLING CODE 4140–01–P invasion of personal privacy. License: Biomarkers for Acute Name of Committee: National Institute on Ischemic Stroke Aging Special Emphasis Panel; Inflammation DEPARTMENT OF HEALTH AND AGENCY: National Institutes of Health, and AD. HUMAN SERVICES Date: June 18, 2015. HHS. Time: 8:00 a.m. to 4:00 p.m. National Institutes of Health ACTION: Notice. Agenda: To review and evaluate grant applications. National Institute of Allergy and SUMMARY: This is notice, in accordance Place: DoubleTree Bethesda, 8120 Infectious Diseases; Notice of Closed with 35 U.S.C. 209 and 37 CFR 404, that Wisconsin Avenue, Bethesda, MD 20814. Meeting the National Institutes of Health (NIH), Contact Person: Alexander Parsadanian, Department of Health and Human Ph.D., Scientific Review Officer, National Services (HHS), is contemplating the Institute on Aging, Gateway Building 2C/212, Pursuant to section 10(d) of the 7201 Wisconsin Avenue, Bethesda, MD Federal Advisory Committee Act, as grant of an exclusive license, to practice 20892, 301–496–9666, PARSADANIANA@ amended (5 U.S.C. App.), notice is the inventions embodied in the NIA.NIH.GOV. hereby given of the following meeting. following patent applications: Name of Committee: National Institute on The meeting will be closed to the 1. U.S. Provisional Patent Application Aging Special Emphasis Panel; Epigenetic public in accordance with the No. 61/307,233, filed 23 February RFA. provisions set forth in sections 2010 Date: June 23, 2015. HHS Ref. No.: E–023–2010/0–US–01 Time: 11:00 a.m. to 4:00 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and Titled: Biomarkers for Acute Ischemic Agenda: To review and evaluate grant Stroke applications. the discussions could disclose 2. PCT Patent Application No. PCT/ Place: National Institute on Aging, confidential trade secrets or commercial Gateway Building, Suite 2C212, 7201 property such as patentable material, US2011/025748, filed 22 February Wisconsin Avenue, Bethesda, MD 20892, and personal information concerning 2011 (Telephone Conference Call). individuals associated with the grant HHS Ref. No.: E–023–2010/0–PCT–02 Contact Person: BITA NAKHAI, Ph.D., applications, the disclosure of which Titled: Biomarkers for Acute Ischemic SCIENTIFIC REVIEW BRANCH, NATIONAL Stroke INSTITUTE ON AGING, GATEWAY BLDG., would constitute a clearly unwarranted invasion of personal privacy. 3. U.S. Patent Application No. 13/ 2C212, 7201 WISCONSIN AVENUE, 580,571, filed 22 August 2012 Bethesda, MD 20814, 301–402–7701, Name of Committee: National Institute of HHS Ref. No.: E–023–2010/0–US–03 [email protected]. Allergy and Infectious Diseases Special Titled: Biomarkers for Acute Ischemic Name of Committee: National Institute on Emphasis Panel; Investigator Initiated Stroke Aging Special Emphasis Panel, Vascular Program Project Applications. Contributions to AD. Time: June 11, 2015, 9:00 a.m. to 4:00 p.m. to VuEssence, Inc., a company Date: June 29, 2015. Agenda: To review and evaluate grant incorporated under the laws of the State Time: 8:00 a.m. to 4:00 p.m. applications. of Florida having its headquarters in

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Odessa, Florida. The patent rights in and objections submitted in response to Group; Biomaterials and Biointerfaces Study these inventions have been assigned to this notice will not be made available Section. the United States of America. for public inspection, and, to the extent Date: June 17–18, 2015. permitted by law, will not be released Time: 8:00 a.m. to 5:00 p.m. DATES: Only written comments and/or Agenda: To review and evaluate grant applications for a license received by under the Freedom of Information Act, applications. the NIH Office of Technology Transfer 5 U.S.C. 552. Place: Admiral Fell Inn, 888 South on or before June 18, 2015 will be Dated: May 12, 2015. Broadway, Baltimore, MD 21231. considered. Richard U. Rodriguez, Contact Person: Joseph D. Mosca, Ph.D., Scientific Review Officer, Center for ADDRESSES: Requests for a copy of the Acting Director, Office of Technology Scientific Review, National Institutes of patent applications, inquiries, Transfer, National Institutes of Health. Health, 6701 Rockledge Drive, Room 5158, comments and other materials relating [FR Doc. 2015–12005 Filed 5–18–15; 8:45 am] MSC 7808, Bethesda, MD 20892, (301) 408– to the contemplated license should be BILLING CODE 4140–01–P 9465, [email protected]. directed to: Jaime M. Greene, M.S., Name of Committee: Center for Scientific Office of Technology Transfer, National Review Special Emphasis Panel; BD2K: Institutes of Health, 6011 Executive DEPARTMENT OF HEALTH AND Biomedical Data Science Training Boulevard, Suite 325, Rockville, MD HUMAN SERVICES Coordination Center. 20852–3804; Telephone: (301) 435– Date: June 17, 2015. 5559; Email: [email protected]; National Institutes of Health Time: 2:00 p.m. to 4:00 p.m. Facsimile: (301) 402–0220. A signed Agenda: To review and evaluate grant confidentiality nondisclosure agreement Center for Scientific Review; Notice of applications. will be required to receive copies of any Closed Meetings Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, patent applications that have not been Pursuant to section 10(d) of the (Telephone Conference Call). published or issued by the United States Federal Advisory Committee Act, as Contact Person: Luis Espinoza, Ph.D., Patent and Trademark Office or the amended (5 U.S.C. App.), notice is Scientific Review Officer, Center for World Intellectual Property hereby given of the following meetings. Scientific Review, National Institutes of Organization. The meetings will be closed to the Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD 20892, 301–435– SUPPLEMENTARY INFORMATION: This public in accordance with the 0952, [email protected]. technology is directed to gene provisions set forth in sections biomarkers for the diagnosis and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review potential treatment of acute ischemic as amended. The grant applications and the discussions could disclose Group; Electrical Signaling, Ion Transport, stroke. Stroke is the third leading cause and Arrhythmias Study Section. of death in the United States, of which confidential trade secrets or commercial Date: June 18, 2015. 87% are ischemic stroke and result in property such as patentable material, Time: 7:00 a.m. to 7:00 p.m. death within 30 days in 8–12% of the and personal information concerning Agenda: To review and evaluate grant cases. Currently, recombinant tissue individuals associated with the grant applications. plasminogen activator (rtPA, trade name applications, the disclosure of which Place: Hilton Washington Embassy Row, alteplase), is the only FDA approved would constitute a clearly unwarranted 2015 Massachusetts Ave. NW., Washington, ischemic stroke treatment, and it is only invasion of personal privacy. DC 20036. effective when administered to patients Contact Person: Yuanna Cheng, MD, Ph.D., Name of Committee: Center for Scientific Scientific Review Officer, Center for within three hours from the onset of Review Special Emphasis Panel; Special Scientific Review, National Institutes of symptoms. Unfortunately, the median Topics in Gastroenterology. Health, 6701 Rockledge Drive, Room 4138, time from stroke symptom onset to Date: June 10, 2015. MSC 7814, Bethesda, MD 20892, (301) 435– presentation to the emergency Time: 2:00 p.m. to 6:30 p.m. 1195, [email protected]. department is 3–6 hours. Although Agenda: To review and evaluate grant applications. Name of Committee: Center for Scientific advances in neuroimaging and clinical Place: National Institutes of Health, 6701 Review Special Emphasis Panel; Electrical management have helped with patient Rockledge Drive, Bethesda, MD 20892, Signaling, Ion Transport and Arrhythmias survival rates, these techniques are not (Telephone Conference Call). Special Panel. infallible and at times result in Contact Person: Jonathan K. Ivins, Ph.D., Date: June 18, 2015. misdiagnosis. The biomarkers identified Scientific Review Officer, Center for Time: 7:00 a.m. to 7:00 p.m. in this technology may be used to Scientific Review, National Institutes of Agenda: To review and evaluate grant develop a diagnostic testing device for Health, 6701 Rockledge Drive, Room 4040A, applications. Place: Pier 5 Hotel, 711 Eastern Avenue, determining stroke subtype in the field. MSC 7806, Bethesda, MD 20892, (301) 594– 1245, [email protected]. Baltimore, MD 21202. The prospective exclusive license will Contact Person: Lawrence E. Boerboom, be royalty bearing and will comply with Name of Committee: Center for Scientific Review Special Emphasis Panel; NRCS Ph.D., Chief, CVRS IRG, Center for Scientific the terms and conditions of 35 U.S.C. Palliative Care and Survivorship. Review, National Institutes of Health, 6701 209 and 37 CFR part 404. The Date: June 11, 2015. Rockledge Drive, Room 4130, MSC 7814, prospective exclusive license may be Time: 11:00 a.m. to 8:00 p.m. Bethesda, MD 20892, (301) 435–8367, granted unless, within thirty (30) days Agenda: To review and evaluate grant [email protected]. from the date of this published notice, applications. Name of Committee: Bioengineering NIH receives written evidence and Place: Renaissance Long Beach Hotel, 111 Sciences & Technologies Integrated Review argument that establishes that the grant East Ocean Blvd., Long Beach, CA 90802. Group; Gene and Drug Delivery Systems of the license would not be consistent Contact Person: Martha L. Hare, Ph.D., RN, Study Section. Scientific Review Officer, Center for Date: June 18–19, 2015. with the requirements of 35 U.S.C. 209 Scientific Review, National Institutes of Time: 8:00 a.m. to 5:00 p.m. and 37 CFR part 404. Health, 6701 Rockledge Drive, Room 3154, Agenda: To review and evaluate grant Properly filed competing applications Bethesda, MD 20892, (301) 451–8504, applications. for a license filed in response to this [email protected]. Place: Doubletree Hotel Bethesda, notice will be treated as objections to Name of Committee: Bioengineering (Formerly Holiday Inn Select), 8120 the contemplated license. Comments Sciences & Technologies Integrated Review Wisconsin Avenue, Bethesda, MD 20814.

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Contact Person: Amy L. Rubinstein, Ph.D., Date: June 18–19, 2015. Name of Committee: Immunology Scientific Review Officer, Center for Time: 8:00 a.m. to 5:00 p.m. Integrated Review Group; Vaccines Against Scientific Review, National Institutes of Agenda: To review and evaluate grant Microbial Diseases Study Section. Health, 6701 Rockledge Drive, Room 5152, applications. Date: June 18–19, 2015. MSC 7844, Bethesda, MD 20892, 301–408– Place: Embassy Suites Alexandria, 1900 Time: 8:30 a.m. to 5:00 p.m. 9754, [email protected]. Diagonal Road, Alexandria, VA 22314. Agenda: To review and evaluate grant Name of Committee: Oncology 2— Contact Person: Paula Elyse Schauwecker, applications. Translational Clinical Integrated Review Scientific Review Officer, National Institutes Place: Embassy Suites DC Convention Group; Chemo/Dietary Prevention Study of Health, Center for Scientific Review, 6701 Center, 900 10th Street, Washington, DC Section. Rockledge Drive, Room 5211, Bethesda, MD 20001. Date: June 18, 2015. 20892, [email protected]. Contact Person: Jian Wang, MD, Ph.D., Time: 8:00 a.m. to 4:00 p.m. Name of Committee: Center for Scientific Scientific Review Officer, Center for Agenda: To review and evaluate grant Review Special Emphasis Panel; Small Scientific Review, National Institutes of applications. Business: Clinical Neurophysiology, Devices, Health, 6701 Rockledge Drive, Room 4218, Place: Renaissance Mayflower Hotel, 1127 Neuroprosthetics, and Biosensors. MSC 7812, Bethesda, MD 20892, (301) 435– Connecticut Avenue NW., Washington, DC Date: June 18–19, 2015. 2778, [email protected]. 20036. Time: 8:00 a.m. to 5:00 p.m. Name of Committee: Center for Scientific Contact Person: Sally A. Mulhern, Ph.D., Agenda: To review and evaluate grant Review Special Emphasis Panel; Cancer, Scientific Review Officer, Center for applications. Cardiovascular and Sleep Epidemiology Scientific Review, National Institutes of Place: The Fairmont Washington, DC, , Panel B Study Section. Health, 6701 Rockledge Drive, Room 6198, 2401 M Street NW., Washington, DC 20037. Date: June 18–19, 2015. MSC 7804, Bethesda, MD 20892, (301) 408– Contact Person: Cristina Backman, Ph.D., Time: 8:30 a.m. to 2:00 p.m. 9724, [email protected]. Scientific Review Officer, Center for Agenda: To review and evaluate grant Name of Committee: Oncology 2— Scientific Review, National Institutes of applications. Translational Clinical Integrated Review Health, 6701 Rockledge Drive, Room 5211, Place: Hyatt Regency Bethesda, One Group; Developmental Therapeutics Study MSC 7846, Bethesda, MD 20892, cbackman@ Bethesda Metro Center, 7400 Wisconsin Section. mail.nih.gov. Avenue, Bethesda, MD 20814. Date: June 18–19, 2015. Contact Person: Ellen K. Schwartz, EDD, Name of Committee: Center for Scientific Time: 8:00 a.m. to 5:00 p.m. Scientific Review Officer, Center for Review Special Emphasis Panel; Agenda: To review and evaluate grant Scientific Review, National Institutes of Fellowships: Behavioral Neuroscience. applications. Health, 6701 Rockledge Drive, Room 3144, Date: June 18–19, 2015. Place: Handlery Union Square Hotel, 351 Bethesda, MD 20892, 301–828–6146, Time: 8:00 a.m. to 5:00 p.m. Geary Street, San Francisco, CA 94102. [email protected]. Contact Person: Sharon K. Gubanich, Agenda: To review and evaluate grant Name of Committee: Center for Scientific Ph.D., Scientific Review Officer, Center for applications. Review Special Emphasis Panel; Member Scientific Review, National Institutes of Place: Doubletree by Hilton Chicago Conflict: Medical Imaging Investigations. Health, 6701 Rockledge Drive, Room 6214, Magnificent Mile, 300 E. Ohio Street, Date: June 18, 2015. MSC 7804, Bethesda, MD 20892, (301) 408– Chicago, IL 60611. Time: 11:45 a.m. to 4:00 p.m. 9512, [email protected]. Contact Person: Kristin Kramer, Ph.D., Scientific Review Officer, Center for Agenda: To review and evaluate grant Name of Committee: Brain Disorders and applications. Clinical Neuroscience Integrated Review Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5205, Place: National Institutes of Health, 6701 Group; Clinical Neuroimmunology and Brain Rockledge Drive, Bethesda, MD 20892, Tumors Study Section. MSC 7846, Bethesda, MD 20892, (301) 437– 0911, [email protected]. (Virtual Meeting). Date: June 18–19, 2015. Contact Person: Mehrdad Mohseni, MD, Time: 8:00 a.m. to 5:00 p.m. Name of Committee: Center for Scientific Scientific Review Officer, Center for Agenda: To review and evaluate grant Review Special Emphasis Panel; Small Scientific Review, National Institutes of applications. Business: Medical Imaging. Health, 6701 Rockledge Drive, Room 5211, Place: Melrose Hotel, 2430 Pennsylvania Date: June 18–19, 2015. MSC 7854, Bethesda, MD 20892, 301–435– Ave. NW., Washington, DC 20037. Time: 8:00 a.m. to 5:00 p.m. 0484, [email protected]. Contact Person: Jay Joshi, Ph.D., Scientific Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance Review Officer, Center for Scientific Review, applications. Program Nos. 93.306, Comparative Medicine; National Institutes of Health, 6701 Rockledge Place: Hilton Washington/Rockville, 1750 93.333, Clinical Research, 93.306, 93.333, Drive, Room 5196, MSC 7846, Bethesda, MD Rockville Pike, Rockville, MD 20852. 93.337, 93.393–93.396, 93.837–93.844, 20892, (301) 408–9135, [email protected]. Contact Person: Leonid V. Tsap, Ph.D., 93.846–93.878, 93.892, 93.893, National Scientific Review Officer, Center for Name of Committee: Cardiovascular and Institutes of Health, HHS) Respiratory Sciences Integrated Review Scientific Review, National Institutes of Group; Myocardial Ischemia and Metabolism Health, 6701 Rockledge Drive, Room 5128, Dated: May 13, 2015. Study Section. MSC 7854, Bethesda, MD 20892, (301) 435– Carolyn Baum, Date: June 18–19, 2015. 2507, [email protected]. Program Analyst, Office of Federal Advisory Time: 8:00 a.m. to 5:00 p.m. Name of Committee: Center for Scientific Committee Policy. Agenda: To review and evaluate grant Review Special Emphasis Panel; AREA grant [FR Doc. 2015–12014 Filed 5–18–15; 8:45 am] applications. review meeting. Place: The Fairmont Washington, DC, 2401 Date: June 18, 2015. BILLING CODE 4140–01–P M Street NW., Washington, DC 20037. Time: 8:00 a.m. to 5:00 p.m. Contact Person: Kimm Hamann, Ph.D., Agenda: To review and evaluate grant Scientific Review Officer, Center for applications. DEPARTMENT OF HEALTH AND Scientific Review, National Institutes of Place: National Institutes of Health, 6701 HUMAN SERVICES Health, 6701 Rockledge Drive, Room 4118A, Rockledge Drive, Bethesda, MD 20892, MSC 7814, Bethesda, MD 20892, 301–435– (Virtual Meeting). National Institutes of Health 5575, [email protected]. Contact Person: Michael L. Bloom, Ph.D., Name of Committee: Center for Scientific Scientific Review Officer, Center for National Institute of Mental Health; Review Special Emphasis Panel; Scientific Review, National Institutes of Notice of Closed Meetings Fellowships: Biophysical, Physiological, Health, 6701 Rockledge Drive, Room 6187, Pharmacological and Bioengineering MSC 7804, Bethesda, MD 20892, 301–451– Pursuant to section 10(d) of the Neuroscience. 0132, [email protected]. Federal Advisory Committee Act, as

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amended (5 U.S.C. App.), notice is Date: June 10, 2015. DEPARTMENT OF HEALTH AND hereby given of the following meetings. Time: 12:30 p.m. to 5:00 p.m. HUMAN SERVICES The meetings will be closed to the Agenda: To review and evaluate grant public in accordance with the applications. National Institutes of Health provisions set forth in sections Place: St. Gregory Hotel, 2033 M Street, NW, Washington, DC 20036. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Center For Scientific Review; Amended Contact Person: Aileen Schulte, Ph.D., Notice of Meeting as amended. The grant applications and Scientific Review Officer, Division of the discussions could disclose Extramural Activities, National Institute of Notice is hereby given of a change in confidential trade secrets or commercial Mental Health, NIH, Neuroscience Center, the meeting of the Musculoskeletal property such as patentable material, 6001 Executive Blvd., Room 6140, MSC 9608, Tissue Engineering Study Section, June and personal information concerning Bethesda, MD 20892–9608, 301–443–1225, 01, 2015, 8:00 a.m. to June 02, 2015, [email protected]. individuals associated with the grant 5:30 p.m., Residence Inn Bethesda, 7335 applications, the disclosure of which Name of Committee: National Institute of Wisconsin Avenue, Bethesda, MD 20814 Mental Health Special Emphasis Panel; would constitute a clearly unwarranted which was published in the Federal invasion of personal privacy. NAPLS—miRNA and Immune System Project. Register on May 13, 2015, 80 FR Pg Name of Committee: National Institute of Date: June 12, 2015. 27333. Mental Health Special Emphasis Panel; Time: 11:30 a.m. to 1:30 p.m. The meeting will be held on June 1, Mechanisms of OCD Treatment. Agenda: To review and evaluate grant 2015 at 8:00 a.m. and end at 6:00 p.m. Date: June 9, 2015. applications. Time: 3:00 p.m. to 5:00 p.m. The meeting location remains the same. Place: National Institutes of Health Agenda: To review and evaluate grant The meeting is closed to the public. Neuroscience Center, 6001 Executive applications. Dated: May 13, 2015. Boulevard, Rockville, MD 20852 (Telephone Place: National Institutes of Health, David Clary, Neuroscience Center, 6001 Executive Conference Call). Boulevard, Rockville, MD 20852, (Telephone Contact Person: David I. Sommers, Ph.D., Program Analyst, Office of Federal Advisory Conference Call). Scientific Review Officer, Division of Committee Policy. Contact Person: David I. Sommers, Ph.D., Extramural Activities, National Institute of [FR Doc. 2015–12009 Filed 5–18–15; 8:45 am] Scientific Review Officer, Division of Mental Health, National Institutes of Health, BILLING CODE 4140–01–P Extramural Activities, National Institute of 6001 Executive Blvd., Room 6154, MSC 9606, Mental Health, National Institutes of Health, Bethesda, MD 20892–9606, 301–443–7861, 6001 Executive Blvd., Room 6154, MSC 9606, [email protected]. Bethesda, MD 20892–9606, 301–443–7861, (Catalogue of Federal Domestic Assistance DEPARTMENT OF HOMELAND [email protected]. Program No. 93.242, Mental Health Research SECURITY Name of Committee: National Institute of Grants, National Institutes of Health, HHS) Mental Health Special Emphasis Panel; NIH U.S. Customs and Border Protection Dated: May 13, 2015. Pathway to Independence Awards (K99). [Docket No. USCBP–2015–0020] Date: June 10, 2015. Carolyn A. Baum, Time: 1:00 p.m. to 4:00 p.m. Program Analyst, Office of Federal Advisory Agenda: To review and evaluate grant Committee Policy. The U.S. Customs and Border Protection Airport and Seaport applications. [FR Doc. 2015–12007 Filed 5–18–15; 8:45 am] Place: National Institutes of Health Inspections User Fee Advisory BILLING CODE 4140–01–P Neuroscience Center, 6001 Executive Committee (UFAC); Correction Boulevard, Rockville, MD 20852 (Telephone Conference Call). AGENCY: U.S. Customs and Border Contact Person: David W. Miller, Ph.D., DEPARTMENT OF HEALTH AND Protection, Department of Homeland Scientific Review Officer, Division of HUMAN SERVICES Security (DHS). Extramural Activities, National Institute of ACTION: National Institutes of Health Committee Management; Notice Mental Health, NIH Neuroscience Center, of Federal Advisory Public Committee 6001 Executive Blvd., Room 6140, MSC 9608, Bethesda, MD 20892–9608, 301–443–9734, National Institute on Drug Abuse Meeting; correction. [email protected]. Amended; Notice of Meeting SUMMARY: U.S. Customs and Border Name of Committee: National Institute of Protection (CBP) published in the Mental Health Special Emphasis Panel; Notice is hereby given of a change in Federal Register on May 14, 2015 [80 Review of R25 Applications. the meeting of the National Institute on FR 27694], a document announcing that Date: June 10, 2015. Drug Abuse Special Emphasis Panel, the U.S. Customs and Border Protection Time: 12:00 p.m. to 4:30 p.m. June 4, 2015, 10:00 a.m. to June 4, 2015, Airport and Seaport Inspections User Agenda: To review and evaluate grant 12:00 p.m., National Institutes of Health, applications. Fee Advisory Committee (UFAC) will Neuroscience Center, 6001 Executive Place: National Institutes of Health meet on Tuesday, June 2, 2015, in Boulevard, Rockville, MD 20852, which Neuroscience Center, 6001 Executive Washington, DC. This document was published in the Federal Register Boulevard, Rockville, MD 20852 (Telephone corrects that May 14, 2015, document to Conference Call). on April 29, 2015, 80 83 FR 2015– reflect the correct time zone for the Contact Person: Rebecca Steiner Garcia, 10003. Ph.D., Scientific Review Officer, Division of meeting of Eastern Daylight Savings Extramural Activities, National Institute of The date of the meeting was changed (EDS) time rather than Eastern Standard Mental Health, NIH, Neuroscience Center, to June 11, 2015. The meeting is closed Time (EST) to prevent confusion, if any. to the public. 6001 Executive Blvd., Room 6149, MSC 9608, DATES: The UFAC will meet on Bethesda, MD 20892–9608, 301–443–4525, Dated: May 13, 2015. Tuesday, June 2, 2015, from 1:00 p.m. [email protected]. Carolyn Baum, to 2:30 p.m. EDT. Name of Committee: National Institute of Program Analyst, Office of Federal Advisory Mental Health Special Emphasis Panel; FOR FURTHER INFORMATION CONTACT: Ms. Committee Policy. Clinical Trials to Test the Effectiveness of Michele Snavely, Paralegal, Regulations Treatment, Preventive, and Services [FR Doc. 2015–12011 Filed 5–18–15; 8:45 am] and Rulings, Office of International Interventions. BILLING CODE 4140–01–P Trade, (202) 325–0354.

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Correction ACTION: Notice; request for comments. (email). Please include ‘‘1018–0127’’ in In notice document, FR Doc. 2015– the subject line of your comments. 11619, beginning on page 27694 in the SUMMARY: We (U.S. Fish and Wildlife FOR FURTHER INFORMATION CONTACT: To issue of Thursday, May 14, 2015, make Service) have sent an Information request additional information about the following corrections in the first Collection Request (ICR) to OMB for this ICR, contact Hope Grey at hope_ column on page 27695: review and approval. We summarize the [email protected] (email) or 703–358–2482 Remove ‘‘EST’’ and replace it with ICR below and describe the nature of the (telephone). You may review the ICR ‘‘EDT’’ the three (3) times that it appears collection and the estimated burden and online at http://www.reginfo.gov. Follow in the DATES: section. Please note that cost. This information collection is the instructions to review Department of all other information in the May 14, scheduled to expire on May 31, 2015. the Interior collections under review by 2015, notice is unchanged. We may not conduct or sponsor and a OMB. Dated: May 14, 2015. person is not required to respond to a collection of information unless it SUPPLEMENTARY INFORMATION: Joanne Roman Stump, displays a currently valid OMB control Information Collection Request Acting Director, Regulations and Disclosure number. However, under OMB Law Division, U.S. Customs and Border OMB Control Number: 1018–0127. Protection. regulations, we may continue to conduct or sponsor this information Title: Horseshoe Crab Tagging [FR Doc. 2015–12079 Filed 5–18–15; 8:45 am] collection while it is pending at OMB. Program. BILLING CODE 9111–14–P DATES: You must submit comments on Service Form Number(s): 3–2310 and or before June 18, 2015. 3–2311. DEPARTMENT OF THE INTERIOR Type of Request: Extension of ADDRESSES: Send your comments and currently approved collection. Fish and Wildlife Service suggestions on this information collection to the Desk Officer for the Description of Respondents: Tagging [FWS–R5–FHC–2015–N092; FF05F24400– Department of the Interior at OMB– agencies include Federal and State FXFR13350500000] OIRA at (202) 395–5806 (fax) or OIRA_ agencies, universities, and biomedical companies. Members of the general Information Collection Request Sent to [email protected] (email). Please provide a copy of your comments public provide recapture information. the Office of Management and Budget Respondent’s Obligation: Voluntary. (OMB) for Approval; Horseshoe Crab to the Service Information Collection Tagging Program Clearance Officer, U.S. Fish and Frequency of Collection: On occasion Wildlife Service, MS BPHC, 5275 when horseshoe crabs are tagged and AGENCY: Fish and Wildlife Service, Leesburg Pike, Falls Church, VA 22041– when horseshoe crabs are found or Interior. 3803 (mail), or [email protected] captured.

Number of Number of Completion Activity annual annual time per Annual burden respondents responses response hours

FWS Form 3–2310 ...... 1,160 2,750 10 minutes .. 458 FWS Form 3–2311 ...... 18 18 95 hours * .... 1,710

Totals ...... 1,178 2,768 ...... 2,168 * Average time required per response is dependent on the number of tags applied by an agency in 1 year. Agencies tag between 25 and 9,000 horseshoe crabs annually, taking between 2 to 5 minutes per crab to tag, record, and report data. Each agency determines the number of tags it will apply.

Estimated Annual Nonhour Burden as threatened under the Endangered in a Horseshoe Crab Cooperative Cost: None. Species Act. Tagging Program. The Maryland Fishery Abstract: Horseshoe crabs play a vital In 1998, the Atlantic States Marine Resources Office, U.S. Fish and Wildlife role commercially, biomedically, and Fisheries Commission (ASMFC), a Service, maintains the information that ecologically along the Atlantic coast. management organization with we collect under this program and uses Horseshoe crabs are commercially representatives from each State on the it to evaluate migratory patterns, harvested and used as bait in eel and Atlantic Coast, developed a horseshoe survival, and abundance of horseshoe conch fisheries. Biomedical companies crab management plan. The ASMFC crabs. along the coast also collect and bleed plan and its subsequent addenda Agencies that tag and release the crabs horseshoe crabs at their facilities. established mandatory State-by-State complete FWS Form 3–2311 (Horseshoe Limulus Amoebocyte Lysate is derived harvest quotas, and created the 1,500- Crab Tagging) and provide the Service from crab blood, which has no synthetic square-mile Carl N. Shuster, Jr., with: • substitute, and is used by Horseshoe Crab Sanctuary off the mouth Organization name. • pharmaceutical companies to test of Delaware Bay. Contact person name. sterility of products. Finally, migratory Restrictive measures have been taken • Tag number. shorebirds also depend on the eggs of in recent years, but populations are • Sex of crab. horseshoe crabs to refuel on their increasing slowly. Because horseshoe • Prosomal width. migrations from South America to the crabs do not breed until they are 9 years • Capture site, latitude, longitude, Arctic. One bird in particular, the red or older, it may take some time before waterbody, State, and date. knot, feeds primarily on horseshoe crab the population measurably increases. Members of the public who recover eggs during its stopover. Effective Federal and State agencies, universities, tagged crabs provide the following January 12, 2015, the red knot was listed and biomedical companies participate information using the online submission

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form (http://www.fws.gov/crabtag/) or DEPARTMENT OF THE INTERIOR nature and obstacles to greater contact via a toll-free telephone number: with nature; general knowledge of • Tag number. Fish and Wildlife Service nature and wildlife; concerns toward • Whether or not tag was removed. [FW–R5–NCTC–2015–N093; FF09X35000– selected environmental issues; and • Condition of crab. 156–FXGO16610900600] socio-demographic variables. Results • Date captured/found. will help improve the design and Proposed Information Collection; delivery of new or existing programs • Crab fate. • National Initiative To Understand and aimed at engaging the public in nature- Finder type. Connect Americans and Nature related activities (e.g., outreach and • Capture method. educational programming at national • Capture location. AGENCY: Fish and Wildlife Service, wildlife refuges and national fish • Reporter information. Interior. hatcheries). • Comments. ACTION: Notice; request for comments. II. Data If the public participant who reports the SUMMARY: We (U.S. Fish and Wildlife OMB Control Number: 1018–New. tagged crab requests information, we Service) will ask the Office of send data pertaining to the tagging Title: National Initiative to Management and Budget (OMB) to Understand and Connect Americans and program and tag and release information approve the information collection (IC) on the horseshoe crab that was found or Nature. described below. As required by the Service Form Number: None. captured. Paperwork Reduction Act of 1995 and Type of Request: Request for a new Comments Received and Our Responses as part of our continuing efforts to OMB control number. reduce paperwork and respondent Description of Respondents: Comments: On February 10, 2015, we burden, we invite the general public and Individuals. published in the Federal Register (80 other Federal agencies to take this Respondent’s Obligation: Voluntary. FR 7490) a notice of our intent to opportunity to comment on this IC. We Frequency of Collection: One time. request that OMB renew approval for may not conduct or sponsor and a Estimated Number of Respondents: this information collection. In that person is not required to respond to a 8,950. notice, we solicited comments for 60 collection of information unless it Estimated Number of Annual days, ending on April 13, 2015. We did displays a currently valid OMB control Responses: 8,950. not receive any comments. number. Completion Time per Response: 20 Request for Public Comments DATES: To ensure that we are able to minutes. consider your comments on this IC, we Estimated Annual Burden Hours: We again invite comments concerning must receive them by July 20, 2015. 2,983. this information collection on: ADDRESSES: Send your comments on the Estimated Annual Nonhour Burden • Whether or not the collection of IC to the Information Collection Cost: None. information is necessary, including Clearance Officer, U.S. Fish and whether or not the information will III. Comments Wildlife Service, MS BPHC, 5275 have practical utility; We invite comments concerning this Leesburg Pike, Falls Church, VA 22041– • information collection on: The accuracy of our estimate of the 3803 (mail); or [email protected] • Whether or not the collection of burden for this collection of (email). Please include ‘‘1018–New’’ in information is necessary, including information; the subject line of your comments. • Ways to enhance the quality, utility, whether or not the information will FOR FURTHER INFORMATION CONTACT: To and clarity of the information to be have practical utility; request additional information about • collected; and The accuracy of our estimate of the this IC, contact Hope Grey at hope_ • Ways to minimize the burden of the burden for this collection of [email protected] (email) or 703–358–2482 information; collection of information on (telephone). • respondents. Ways to enhance the quality, utility, Comments that you submit in SUPPLEMENTARY INFORMATION: and clarity of the information to be response to this notice are a matter of collected; and I. Abstract • Ways to minimize the burden of the public record. Before including your Nature and the outdoors have always collection of information on address, phone number, email address, been an important part of the fabric of respondents. or other personal identifying American life. But, there are major Comments that you submit in information in your comment, you questions about the present and future response to this notice are a matter of should be aware that your entire role of nature and the outdoors in our public record. We will include or comment, including your personal increasingly diverse, technologically summarize each comment in our request identifying information, may be made oriented, and rapidly changing society. to OMB to approve this IC. Before publicly available at any time. While For our programs to remain relevant to including your address, phone number, you can ask OMB in your comment to American life today and tomorrow, we email address, or other personal withhold your personal identifying must be aware of public sentiment identifying information in your information from public review, we toward the part nature plays in the comment, you should be aware that cannot guarantee that it will be done. quality of our lifestyles. your entire comment, including your Dated: May 13, 2015. It is for these reasons that we plan to personal identifying information, may Tina A. Campbell, use a quantitative survey to collect: be made publicly available at any time. Chief, Division of Policy, Performance, and Information on the attitudes that the While you can ask us in your comment Management Programs, U.S. Fish and Wildlife public maintains towards the natural to withhold your personal identifying Service. environment; the effects of contact with information from public review, we [FR Doc. 2015–12048 Filed 5–18–15; 8:45 am] nature on participants’ health and cannot guarantee that we will be able to BILLING CODE 4310–55–P quality of life; the extent of contact with do so.

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Dated: May 13, 2015. recommends policy, coordinates and Registered speakers who wish to Tina A. Campbell, reviews management actions, and expand on their oral statements, or Chief, Division of Policy, Performance, and provides organizational budget those who wished to speak but could Management Programs, U.S. Fish and Wildlife oversight. not be accommodated on the agenda, Service. may submit written statements to Meeting Agenda [FR Doc. 2015–12052 Filed 5–18–15; 8:45 am] Elizabeth Hadley up to 7 days after the • BILLING CODE 4310–55–P Designated Federal Officer (DFO) meeting. updates, election of officers, review of charter and bylaws, and administrative Meeting Minutes DEPARTMENT OF THE INTERIOR procedures, Summary minutes of the meeting will • TMC Chair update, be maintained by Elizabeth Hadley (see Fish and Wildlife Service • Executive Director’s update, • FOR FURTHER INFORMATION CONTACT). The TRRP Workgroup/Science minutes will be available for public [FWS–R8–FHC–2015–N102; Coordinator update, and Decision FXFR1334088TWG0W4–123–FF08EACT00] inspection within 14 days after the Support System update, meeting, and will be posted on the • TRRP Implementation update, 2015 Trinity River Adaptive Management TAMWG Web site at http:// sites, 2016 sites, and status of permits, Working Group; Public Meeting • Flow management, Water Year 2015 www.fws.gov/arcata. AGENCY: Fish and Wildlife Service, Central Valley Project water Dated: May 13, 2015. Interior. management update, BOR long-term fall Joseph C. Polos, flow plan update, and fall flow plan for ACTION: Notice. Supervisory Fish Biologist, Arcata Fish and Water Year 2015, Wildlife Office, Arcata, California. • SUMMARY: We, the U.S. Fish and Solicitor’s guidance on the TRRP [FR Doc. 2015–12070 Filed 5–18–15; 8:45 am] Wildlife Service, announce a public watershed efforts, BILLING CODE 4310–55–P • meeting of the Trinity River Adaptive FY 2016 Budget/work planning, • TMC current issues, Management Working Group (TAMWG). • TRRP background/refresher, DEPARTMENT OF THE INTERIOR The TAMWG is a Federal advisory • Gravel augmentation short-term committee that affords stakeholders the needs, and long-term gravel plan status, National Park Service opportunity to give policy, management, • TRRP Communications plan, and and technical input concerning Trinity status, [NPS–WASO–NRNHL–18228; River (California) restoration efforts to • Status of fish returns and goals of PPWOCRADI0, PCU00RP14.R50000] the Trinity Management Council (TMC). the TRRP, The TMC interprets and recommends • Joint meeting with TMC in August, National Register of Historic Places; policy, coordinates and reviews and Notification of Pending Nominations management actions, and provides • Public Comment. and Related Actions organizational budget oversight. The final agenda will be posted on the Nominations for the following DATES: Public meeting: TAMWG will Internet at http://www.fws.gov/arcata. properties being considered for listing meet from 9:30 a.m. to 4:45 p.m. Pacific or related actions in the National Time on Tuesday, June 16, 2015, and PUBLIC INPUT Register were received by the National from 9 a.m. to 2:30 p.m. Pacific Time on Park Service before April 25, 2015. Wednesday, June 17, 2015. Deadlines: You must contact Joseph Polos Pursuant to section 60.13 of 36 CFR part For deadlines on submitting written (FOR FURTHER 60, written comments are being material, please see ‘‘Public Input’’ If you wish to INFORMATION accepted concerning the significance of under SUPPLEMENTARY INFORMATION. CONTACT) no later than the nominated properties under the ADDRESSES: The in-person meeting will National Register criteria for evaluation. be held at the Weaverville Fire Hall, 125 Submit written information June 8, 2015. Comments may be forwarded by United Bremer Street, Weaverville, CA 96093. or questions for the States Postal Service, to the National FOR FURTHER INFORMATION CONTACT: TAMWG to consider Register of Historic Places, National Joseph C. Polos, U.S. Fish and Wildlife during the meeting. Park Service, 1849 C St. NW., MS 2280, Service, 1655 Heindon Road, Arcata, CA Washington, DC 20240; by all other 95521; telephone: 707–822–7201; email: Submitting Written Information or carriers, National Register of Historic [email protected]. Individuals with a Questions Places, National Park Service, 1201 Eye disability may request an Interested members of the public may St. NW., 8th floor, Washington, DC accommodation by sending an email to submit relevant information or 20005; or by fax, 202–371–6447. Written the point of contact. questions for the TAMWG to consider or faxed comments should be submitted SUPPLEMENTARY INFORMATION: In during the meeting. Written statements by June 3, 2015. Before including your accordance with the requirements of the must be received by the date listed in address, phone number, email address, Federal Advisory Committee Act, 5 ‘‘Public Input,’’ so that the information or other personal identifying U.S.C. App., we announce that the may be available to the TAMWG for information in your comment, you Trinity River Adaptive Management their consideration prior to this meeting. should be aware that your entire Working Group will hold a meeting. Written statements must be supplied to comment—including your personal Elizabeth Hadley in one of the following identifying information—may be made Background formats: One hard copy with original publicly available at any time. While The TAMWG affords stakeholders the signature, one electronic copy with you can ask us in your comment to opportunity to give policy, management, original signature, and one electronic withhold your personal identifying and technical input concerning Trinity copy via email (acceptable file formats information from public review, we River (California) restoration efforts to are Adobe Acrobat PDF, MS Word, cannot guarantee that we will be able to the TMC. The TMC interprets and PowerPoint, or rich text file). do so.

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Dated: April 30, 2015. Tulsa County DEPARTMENT OF JUSTICE J. Paul Loether, Elizabeth Manor, 1820 S. Boulder Ave., W., Chief, National Register of Historic Places/ Tulsa, 15000329 Drug Enforcement Administration National Historic Landmarks Program. Washington County [Docket No. 15–11] COLORADO Comer, C.A., House, (Bruce Goff Designed Karen S. Dunning, N.P.; Decision and Las Animas County Resources in Oklahoma MPS) 1316 North Order Santa Fe Trail Mountain Route Trail Creek, Dewey, 15000330 Segment—Delhi Vicinity I, (Santa Fe Trail On January 9, 2015, I, the MPS), Address Restricted, Delhi, 15000313 OREGON Administrator of the Drug Enforcement Santa Fe Trail Mountain Route Trail Jefferson County Administration, issued an Order to Segment—Delhi Vicinity II, (Santa Fe Trail Show Cause and Immediate Suspension MPS), Address Restricted, Delhi, 15000314 Madras Army Air Field North Hanger, 2028 of Registration to Karen S. Dunning, NW. Berg Dr., Madras, 15000331 Santa Fe Trail Mountain Route Trail N.P. (hereinafter, Respondent) of Kouts, Segment—Delhi Vicinity III, (Santa Fe TENNESSEE Indiana. The Order to Show Cause and Trail MPS), Address Restricted, Delhi, Immediate Suspension of Registration 15000315 Smith County proposed the revocation of ILLINOIS Moss Mounds, (Mississippian Cultural Respondent’s DEA Certificate of Resources of the Central Basin (AD 900– Registration MD2249161, pursuant to Sangamon County 1450) MPS), Address Restricted, Elmwood, which she was authorized to dispense Central Springfield Historic District 15000332 controlled substances in schedules II (Boundary Increase and Additional through V as a practitioner, and the Documentation), Roughly Jefferson, Williamson County denial of any application to renew or Jackson, 2nd & 7th Sts., Springfield, Glass Mounds Discontiguous Archeological 15000316 modify her registration, on the ground District, 4000 Golf Club Ln., Franklin, that she has committed acts which Strawbridge—Shepherd House, 5255 15000333 Shepherd Rd., Springfield, 15000317 render her ‘‘continued registration TEXAS inconsistent with the public interest.’’ KANSAS Show Cause Order, at 1. Bastrop County McPherson County More specifically, the Order alleged Lindquist, P.J., Building, 116 S. Main St., Hopewell School, (Rosenwald School that Respondent, who is an Advanced Lindsborg, 15000318 Building Program in Texas MPS), 690 TX Practice Nurse licensed by the Indiana 21 W., Cedar Creek, 15000334 State Board of Nursing, is not MISSOURI Harris County authorized under state law ‘‘to prescribe St. Louis Independent city controlled substances in Schedules III Stowers Building, 820 Fannin, Houston, Shell Building, The, 1221 Locust St., St. and IV for the purpose of weight Louis (Independent City), 15000319 15000335 reduction or to control obesity.’’ Show NEVADA Nueces County Cause Order, at 1. The Order then alleged that ‘‘between August 2007 and Carson City Independent city Galvan Ballroom, 1632 Agnes, Corpus Christi, 15000336 March 2014,’’ Respondent issued Nevada State Prison, 3301 E. 5th St., Carson prescriptions, ‘‘on multiple occasions,’’ City (Independent City), 15000320 Tarrant County for phendimetrazine, a schedule III NEW JERSEY Parker—Browne Company Building, 1212 E. controlled substance, and phentermine, Lancaster Ave., Fort Worth, 15000337 a schedule IV controlled substance, for Burlington County ‘‘the purpose of weight loss or to control Florence Public School No. 1, 203 W. 2nd St., Terry County obesity, in violation of state and federal Florence Township, 15000321 Abilene Courts, 633 S. 11th St., Abilene, law.’’ Id. at 2 (citing Ind. Code §§ 35– OHIO 15000338 48–3–11; 25–22.5–8–2(a); 21 CFR Franklin County Wichita County 1306.03 & 1306.04(a)). The order then set forth specific allegations regarding Drexel Theater, 2254 E. Main St., Bexley, Perkins, Joe and Lois, House, 3301 Harrison Respondent’s prescribing of the 15000322 St., Wichita Falls, 15000339 aforesaid controlled substances to nine Graham, A.B., House, 159 Clinton Heights Ave., Columbus, 15000323 WISCONSIN patients. Id. at 2–4. The Order also alleged that Theresa Building, 823 E. Long St., Columbus, Sauk County ‘‘beginning in February 2014 and for 15000324 Downtown Baraboo Historic District, several months thereafter,’’ Respondent United States Carriage Company, 309–319 S. Roughly bounded by 5th & 2nd Aves., 5th, 4th St., Columbus, 15000325 had violated federal law by issuing Ash, 1st, Oak & Birch Sts., Baraboo, controlled substance prescriptions for Hamilton County 15000340 weight loss medications that had been West Fourth Street Historic District Walworth County pre-signed by her collaborating (Boundary Increase), 309 Vine St., physician, as well as that between Cincinnati, 15000326 Wandawega Inn, W5453 Lake View Dr., February and August 2014, she issued Sugar Creek, 15000341 OKLAHOMA controlled substance prescriptions [FR Doc. 2015–12026 Filed 5–18–15; 8:45 am] ‘‘without a collaborative agreement’’ Kay County BILLING CODE 4312–51–P having been filed with the Indiana Hayes—Kennedy—Rivoli Theater Building, Board of Nursing. Id. at 4 (citing 21 CFR 122–124 S. Main, Blackwell, 15000327 1306.05 and 1306.03(a)(1); 848 Ind. Oklahoma County Admin. Code § 5–1–1(a)(7)). The Order Czech Hall of Oklahoma City—Lodge Laska, further alleged that Respondent had 515 SW. 6th St., Oklahoma City, 15000328 dispensed Bontril (phendimetrazine) to

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a patient at an unregistered location. Id. Respondent contends that the Nursing to either revoke or suspend a DEA Finally, the Order alleged that Board has only suspended her license registration. However, given the indefinite Respondent had failed to keep various and advanced practice nurse nature of the suspension of Respondent’s state license to practice medicine, the Acting records as required by DEA regulations. prescriptive authority for ninety (90) Deputy Administrator agrees with [the ALJ] Id. at 5. Based on the totality of days. Id. at 3. She further argues that the that revocation is appropriate in this case. Respondent’s misconduct, I concluded prior cases in which the Agency that her continued registration during revoked a practitioner’s registration Id. at 3 (quoting 62 FR at 12848). Notwithstanding the implication of the pendency of the proceeding ‘‘would based on a state’s suspension of the above passage, no decision of this constitute an imminent danger to the prescribing authority involved Agency has held that a suspension public health and safety’’ and therefore suspensions that ‘‘were of indefinite (rather than a revocation) is warranted ordered that her registration be rather than, as here, for a finite, definite, where a State has imposed a suspension immediately suspended. Id. at 6–7. and limited time’’ and that ‘‘[t]his of a fixed or certain duration. To the indefiniteness was the gravamen of the Following service of the Order, contrary, in the case of practitioners, decisions holding revocation to be the Respondent timely requested a hearing DEA has long and consistently appropriate remedy.’’ Id. (citing Anne on the allegations. The matter was interpreted the CSA as mandating the Lazar Thorn, 62 FR 12847, 12848 placed on the docket of the Office of possession of authority under state law (1997)). Administrative Law Judges and assigned to handle controlled substances as a Respondent also argues that the to Administrative Law Judge (ALJ) fundamental condition for obtaining temporary suspension of her license Christopher B. McNeil, who proceeded and maintaining a registration. See, e.g., ‘‘does not render her ‘no longer to conduct pre-hearing procedures. Leonard F. Faymore, 48 FR 32886, authorized by State law’ to dispense However, the next day, the 32887 (1983) (collecting cases). As the controlled substances. It only Government moved for summary Thorn decision further explained: disposition and to stay the proceeding, temporarily restrains her from asserting that the Indiana State Board of dispensing controlled substances.’’ Id. DEA has consistently interpreted the Controlled Substances Act to preclude a Nursing had ordered the emergency And she further argues that suspending her registration ‘‘mean[s] that she is not practitioner from holding a DEA registration suspension of Respondent’s nursing if the practitioner is without authority to license and advanced practice nurse holding a DEA Registration and would handle controlled substances in the state in prescriptive authority, and that she was fully satisfy statutory requirements.’’ Id. which he/she practices. This prerequisite has without authority to dispense controlled She thus contends that revoking her been consistently upheld. substances and to possess a DEA registration would be ‘‘arbitrary, * * * * * registration in the State. Mot. For capricious, a clear abuse of discretion The Acting Deputy Administrator finds Summ. Disp., at 1–3. As support for its and not in accordance with the law.’’ Id. that the controlling question is not whether Motion, the Government attached a at 4. a practitioner’s license to practice medicine printout from a license verification Web The ALJ correctly rejected these in the state is suspended or revoked; rather it is whether the Respondent is currently page maintained by the State of Indiana. contentions, explaining that the CSA defines the term ‘‘practitioner’’ to authorized to handle controlled substances See id. at Attachment A. The printout in the state. In the instant case, it is showed that Respondent’s Indiana ‘‘mean[] a physician, dentist, undisputed that Respondent is not currently Advanced Practice Nurse Prescriptive veterinarian . . . or other person authorized to handle controlled substances in Authority license was the subject of an licensed, registered, or otherwise the [state in which she practices medicine]. emergency suspension.1 Id. permitted, by the United States or the Therefore . . . Respondent is not currently Upon review of the Government’s jurisdiction in which [s]he practices to entitled to a DEA registration. Motions, the ALJ issued an Order for distribute [or] dispense a controlled 62 FR at 128438 (citing and quoting 21 Stay and for Respondent’s Response to substance in the course of professional U.S. C. 823(f) and 802(21) and collecting Allegations Concerning Respondent’s practice,’’ 21 U.S. C. 802(21), and that cases). Accordingly, in Thorn, the Lack of State Authority. R.D. at 2. under section 823(f), only a person who Agency rejected the Respondent’s Thereafter, Respondent timely filed her is authorized to dispense controlled contention that her registration should Response, in which she did not dispute substances and is therefore a be suspended rather than revoked. that her license was suspended but practitioner within the meaning of the As for Respondent’s contention that asserted that section 824(a)(3) Act can be registered. R.D., at 3; see also section 824(a) ‘‘gives a choice of ‘‘authorizes suspension or revocation of 21 U.S. C. 823(f) (‘‘The Attorney General remedies and clearly contemplates the a DEA registration based on the loss of shall register practitioners . . . to exercise of administrative discretion,’’ it State privileges’’ and thus ‘‘gives a dispense . . . controlled substances is acknowledged that the opening choice of remedies and clearly . . . if the applicant is authorized to sentence of section 824(a) provides that contemplates the exercise of dispense . . . controlled substances a registration ‘‘may be suspended or administrative discretion.’’ under the laws of the States in which he revoked by the Attorney General’’ upon Respondent’s Response, at 1. practices.’’). the Attorney General’s finding that one Respondent contends, however, that of the five grounds set forth exists. 21 the decision in Anne Lazar Thorn, M.D., 1 Subsequently, the Government also filed a copy U.S. C. 824(a). However, this general of the Summary Suspension Order issued to 62 FR 12847 (1997), stands for the grant of authority in imposing a Respondent by the Indiana State Board of Nursing. proposition that the Agency’s consistent sanction must be reconciled with the See Notice of Filing of Written Suspension Order practice of revoking registrations based CSA’s specific provisions which (Exhibit A). on a loss of state authority ‘‘rests on the I take official notice of the registration records of mandate that a practitioner hold this Agency, which establish that Respondent’s indefinite nature of a State suspension.’’ authority under state law in order to registration will not expire until June 30, 2016. See Respondent’s Resp., at 2–3. Respondent obtain and maintain a DEA registration. 21 CFR 1316.59(e). Respondent may refute this fact quotes the following passage from See Gozlon-Peretz v. United States, 498 by filing a properly supported motion for Thorn: reconsideration no later than ten (10) business days U.S. 395, 407 (1991) (‘‘A specific from the date of issuance of this Decision and [T]he Acting Deputy Administrator provision controls over one of more Order. recognizes that he has discretionary authority general application.’’); see also Bloate v.

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United States, 130 S.Ct. 1345, 1354 if the applicant or registrant lacks [s]tate the interest of efficiency, I grant a Motion to (2010) (quoting D. Ginsberg & Sons, Inc., authority to dispense controlled Stay the Proceedings and continue the v. Popkin, 285 U.S. 204, 208 (1932) substances’’). deadlines pending the resolution of the (‘‘General language of a statutory Motion for Summary Disposition. In response Order to the Government’s filing, I issued an Order provision, although broad enough to Pursuant to the authority vested in me for Stay and for Respondent’s Response to include it, will not be held to apply to Allegations Concerning Respondent’s Lack of a matter specifically dealt with in by 21 U.S. C. 824 as well as 28 CFR State Authority. In the Order, I required another part of the same enactment.’’)). 0.100(b), I order that DEA Certificate of Respondent to file a response to the Indeed, Respondent’s argument has Registration MD2249161 issued to Government’s Motion for Summary previously been tried and rejected. See Karen S. Dunning, N.P., be, and it Disposition no later than February 27, 2015. James L. Hooper, 76 FR 71371 (2011), hereby is, revoked. This Order is Additionally, I stayed the matter and held all pet. for rev. denied, Hooper v. Holder, effectively immediately.3 deadlines in abeyance. On February 27, 2015, I received 481 F. App’x 826 (4th Cir. 2012) Dated: May 1, 2015. (unpublished). As the Fourth Circuit Respondent’s Response to the Government’s Michele M. Leonhart, Motion for Summary Disposition. explained in Hooper: Administrator. Respondent first cites 21 U.S. C. 824(a)(3) to Section 824(a) does state that the DA may Michelle F. Gillice, Esq., Paul A. Dean, Esq., demonstrate that the Administrator has the ‘‘suspend or revoke’’ a registration, but the for the Government. choice of authorizing suspension or statute provides for this sanction in five Lakeisha C. Murdaugh, Esq., Scott L. King, revocation of Respondent’s registration. different circumstances, only one of which is Esq., for the Respondent. Respondent then asks that I consider loss of a State license. Because § 823(f) and suspending her registration based on the § 802(21) make clear that a practitioner’s ORDER GRANTING THE GOVERNMENT’S premise that the 90 day suspension of her registration is dependent upon the MOTION FOR SUMMARY DISPOSITION advanced practice nurse prescriptive practitioner having state authority to AND FINDINGS OF FACT, CONCLUSIONS authority is not equivalent to the indefinite dispense controlled substances, the DA’s OF LAW, AND RECOMMENDED DECISION suspensions in the case law cited by the decision to construe § 824(a)(3) as mandating OF THE ADMINISTRATIVE LAW JUDGE Government. revocation upon suspension of a state license Administrative Law Judge Christopher B. The substantial issue raised by the is not an unreasonable interpretation of the McNeil. On January 9, 2015, the Government rests on an undisputed fact. The CSA. Administrator of the Drug Enforcement Government asserts that Respondent’s DEA Id. at 828. Administration issued an Order to Show Certificate of Registration must be revoked Cause and Immediate Suspension of because Respondent does not have a nursing Moreover, while Respondent points to Respondent’s DEA Certificate of Registration, the fact that the suspension imposed by licensed issued by the state in which she No. MD2249161. The Order affords practices. Under DEA precedent, a the Board is ‘‘temporary’’ and only ‘‘for Respondent the opportunity to show cause practitioner’s DEA Certificate of Registration ninety (90) days,’’ Respondent’s Resp. at why Respondent’s DEA registration should for controlled substances must be summarily 3, the Board’s order was non-final. not be revoked pursuant to 21 U.S. C. 824(a), revoked if the applicant is not authorized to Thus, while Respondent may prevail on the grounds that Respondent’s continued handle controlled substances in the state in before the Board, the Board may also registration would be inconsistent with the which she maintains her DEA registration.1 impose an additional period of public interest. The Order also seeks to deny Pursuant to 21 U.S. C. 823(f), only a any pending applications for registration, ‘‘practitioner’’ may receive a DEA suspension or revoke her license and renewal or modification pursuant to 21 U.S. prescribing authority. registration. Under 21 U.S. C. 802(21), a C. 823(f). In addition, the Administrator ‘‘practitioner’’ must be ‘‘licensed, registered, Accordingly, consistent with the immediately suspended Respondent’s or otherwise permitted, by the United States Agency’s longstanding precedent, registration pursuant to 21 U.S. C. 824(d), or the jurisdiction in which he practices or 2 upon finding Respondent’s continued revocation remains warranted. See Gary does research, to distribute [or] dispense . . . registration constitutes an imminent danger Alfred Shearer, 78 FR 19009 (2013) controlled substance[s.]’’ Given this statutory to the public health and safety. (holding that revocation is warranted language, the DEA Administrator does not According to the Government’s Notice of even where a state order has summarily have the authority under the Controlled Service, Respondent was personally served Substances Act to maintain a practitioner’s suspended a practitioner’s controlled with the Order to Show Cause on January 14, registration if that practitioner is not substances authority and the state 2015. On February 18, 2015, the Office of agency’s order remains subject to authorized to dispense controlled Administrative Law Judges received 2 challenge in either administrative or Respondent’s Request for Hearing, dated substances. judicial proceedings); Winfield Drugs, February 13, 2015. On February 19, 2015, Inc., 52 FR 27070 (1987) (revoking this Office issued an Order for Prehearing 1 See 21 U.S. C. 801(21), 823(f), 824(a)(3); see also House of Medicine, 79 FR 4959, 4961 (DEA 2014); registration based on state emergency Statements and Order Setting the Matter for Hearing. Deanwood Pharmacy, 68 FR 41662–01 (DEA July suspension order notwithstanding state 14, 2003); Wayne D. Longmore, M.D., 77 FR 67669– On February 20, 2015, this office received 02 (DEA November 13, 2012); Alan H. Olefsky, order was under appeal, noting that the Government’s Motion for Summary ‘‘[r]espondent is not currently M.D., 72 FR 42127–01 (DEA August 1, 2007); Layfe Disposition and Motion to Stay Proceedings. Robert Anthony, M.D., 67 FR 15811 (DEA May 20, authorized to handle controlled The Government asserted that the Indiana 2002); George Thomas, PA–C, 64 FR 15811–02 substances in the [s]tate’’ and that ‘‘[a]s State Board of Nursing ordered an emergency (DEA April 1, 1999); Shahid Musud Siddiqui, M.D., a matter of law, the [DEA] does not have suspension of Respondent’s nursing license 61 FR 14818–02 (DEA April 4, 1996); Michael D. statutory authority . . . to issue or and her advanced practice nurse prescriptive Lawton, M.D., 59 FR 17792–01 (DEA April 14, 1994); Abraham A. Chaplan, M.D., 57 FR 55280– maintain a registration for a practitioner authority, effective immediately. Citing this lack of state authority, the Government 03 (DEA November 24, 1992). See also Bio Diagnosis Int’l, 78 FR 39327–03, 39331 (DEA July requested that the matter be forwarded to the 2 As for Respondent’s contention that the 1, 2013) (distinguishing distributor applicants from temporary suspension of her license ‘‘does not Administrator for a Final Order and that in other ‘‘practitioners’’ in the context of summary render her ‘no longer authorized by State law’ to disposition analysis). dispense controlled substances,’’ under Indiana 3 Based on the same findings that led me to 2 See Abraham A. Chaplan, M.D., 57 FR 55280– law, ‘‘[a] person who . . . practices nursing during conclude that Respondent’s continued registration 03, 55280 (DEA November 24, 1992), and cases the time the person’s license issued under this during the pendency of the proceeding constitutes cited therein. In Chaplan, DEA Administrator chapter . . . is suspended or revoked commits a an imminent danger to public health and safety, I Robert C. Bonner adopts the ALJ’s opinion that ‘‘the Class B misdemeanor.’’ Ind. Code § 25–23–1–27(5). conclude that the public interest necessitates that DEA lacks statutory power to register a practitioner Thus, Respondent is not currently authorized to this Order be effective immediately. 21 CFR unless the practitioner holds state authority to dispense controlled substances. 1316.67. handle controlled substances.’’ Id.

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Respondent alternatively asks that I DEPARTMENT OF JUSTICE practitioner’s license and his Certificate consider suspending her registration instead of Fitness to prescribe legend drugs in of revoking her registration. This exact issue Drug Enforcement Administration Tennessee. GX C, at 13–14; see also 21 was addressed in James L. Hooper, M.D.; U.S.C. 824(a)(1). The Show Cause Order Decision and Order.3 Dr. Hooper was subject Bobby D. Reynolds, N.P., Tina L. to a one-year suspension of his state license further alleged that Registrant Stout had Killebrew, N.P. and David R. Stout, failed to disclose that on September 3, to practice medicine after which his license N.P.; Decision and Orders would be automatically reinstated.4 In 2010, he had entered into a Consent comparison to Hooper, Respondent in this On November 25, 2013, the Deputy Order with the State Board, pursuant to case has a less persuasive case as there is no Assistant Administrator, Office of which the suspension was terminated, guarantee that her advanced practice nurse Diversion Control, Drug Enforcement but he was placed on probation for two prescriptive authority will be restored after years, his multistate privilege to practice 90 days. Dr. Hooper sought a suspension of Administration, issued Orders to Show Cause to Bobby D. Reynolds, N.P. in other party states was voided for the his DEA Registration for the same time period of his probation, he was ordered period his medical license was suspended. (hereinafter, Reynolds), of Limestone, DEA Administrator Michele M. Leonhart Tennessee; Tina L. Killebrew, N.P. to pay a civil penalty of $8,000, and agreed with Chief Administrative Law Judge (hereinafter, Killebrew), of Kingsport, other probationary terms were imposed. John J. Mulrooney, II who did not find Dr. Tennessee; and David R. Stout, N.P. GX C, at 14. Second, the Show Cause Hooper’s argument persuasive. Administrator (hereinafter, Stout), of Morristown, Order alleged that Registrant Stout had Leonhart, like Respondent in the case at Tennessee. GXs A, B, & C. ‘‘committed such acts as would render hand, cited to Anne Lazar Thorn, M.D.5 With respect to Applicant Reynolds, his registration inconsistent with the Administrator Leonhart cites the Acting public interest,’’ in that he had violated Deputy Administrator’s statement in Thorn the Show Cause Order proposed the denial of his application for registration state and federal law in prescribing that ‘‘the controlling question is not whether controlled substances to five patients a practitioner’s license to practice medicine as a practitioner, on the ground that his while employed as a nurse practitioner in the state is suspended or revoked; rather, registration ‘‘would be inconsistent with at the AMC.1 it is whether the Respondent is currently the public interest’’ as evidenced by his Following service of the Show Cause authorized to handle controlled substances in repeated violations of state and federal 6 Orders, all three individuals timely the state.’’ In Hooper, Administrator law in prescribing controlled substances Leonhart concludes that ‘‘even where a requested a hearing on the allegations of to seven patients while employed as a practitioner’s state license has been the respective Order. The matters were nurse practitioner at the Appalachian suspended for a period of certain duration, then placed on the docket of the Medical Center (AMC), a clinic located the practitioner no longer meets the statutory Agency’s Office of Administrative Law 7 in Johnson City, Tennessee. GX A, at 1– definition of a practitioner.’’ As detailed Judges, and assigned to the Chief above, only a ‘‘practitioner’’ may receive a 2 (citing 21 U.S.C. 823(f)(2), (4) & (5)). Administrative Law Judge, who DEA registration. Therefore, I cannot and will The Show Cause Order alleged that he consolidated the matters and proceeded not recommend the suspension of had made unintelligible entries in the to conduct prehearing procedures. Respondent’s DEA registration, but will medical records of three patients (N.S., instead recommend the registration be However, after extensive prehearing T.H., and A.W.), that he had violated revoked. litigation, each of the parties filed state law by referring N.S. to an written notices waiving his/her Order Granting the Government’s Motion for unlicensed mental health counselor, respective right to a hearing, see GXs Summary Disposition and Recommendation that he had violated state law by making LL, MM, and PP, and the ALJ I find there is no genuine dispute regarding false entries in N.S.’s chart, that he had terminated the proceeding.2 whether Respondent is a ‘‘practitioner’’ as failed to maintain complete records for that term is defined by 21 U.S. C. 802(21), T.H., and that he failed to properly and that based on the record the Government 1 Each Show Cause Order made extensive and has established that Respondent is not a maintain the patient record of C.S. to detailed allegations specific to each Applicant’s practitioner and is not authorized to dispense accurately reflect nursing problems and conduct, as well as to Registrant Stout’s conduct, interventions. GX A, at ¶¶ 5, 6, 7, 11, 12, in prescribing to the various patients. See GX A, at controlled substances in the state in which 2–26 (Reynolds OTSC); GX B, at 2–9 (Killebrew she seeks to practice with a DEA Certificate and 15. Order); GX C, at 2–14 (Stout Order). In its Request of Registration. I find no other material facts With respect to Applicant Killebrew, for Final Agency Action, the Government pursued at issue. Accordingly, I GRANT the the Show Cause Order proposed the only the allegations of unlawful prescribing by the Government’s Motion for Summary denial of her application for registration three practitioners, as well as the allegations (which Disposition. were raised in its prehearing statements) that as a practitioner, on the ground that her Applicant Reynolds had made material false Upon this finding, I ORDER that this case registration ‘‘would be inconsistent with be forwarded to the Administrator for final statements to a DEA Investigator. the public interest’’ as evidenced by her 2 disposition and I recommended that On March 27, 2014, NP Stout, through counsel, submitted a written request to the Government’s Respondent’s DEA Certificate of Registration repeated violations of state and federal law in prescribing controlled substances counsel seeking to withdraw his application to should be REVOKED and any pending renew his registration. GX RR. Government Counsel application for the renewal or modification of to three patients while employed as a promptly forwarded the request to the Deputy the same should be DENIED. nurse practitioner at the AMC. GX B, at Assistant Administrator. GX SS. According to Government Counsel, no action had been taken on Dated: March 9, 2015 1–2 (citing 21 U.S.C. 823(f)(2)(4) & (5)). With respect to Registrant Stout, the the request as of September 16, 2014, the date on Christopher B. McNeil, which the record was forwarded to this Office. Id. Show Cause Order proposed the Administrative Law Judge Nor has this Office been subsequently notified of revocation of his practitioner’s any action having been taken on the request. [FR Doc. 2015–12020 Filed 5–18–15; 8:45 am] registration and the denial of his I conclude that granting Stout’s request to BILLING CODE 4410–09–P pending application to renew his withdraw would be contrary to the public interest and that he has otherwise failed to show good registration on two grounds. GX C, at 1– cause. Here, the Government has expended 3 James L. Hooper, M.D.; Decision and Order, 76 2. First, the Order alleged that extensive resources in investigating the allegations, FR 71371–01, 71371 (DEA Nov. 17, 2011). Respondent had materially falsified his preparing for a hearing, and in engaging in pre- 4 Id. renewal application when he failed to hearing litigation; it was also fully prepared to go 5 Anne Lazar Thorn, Revocation of Registration to hearing on the allegations when Stout waived his M.D, 62 FR 12847, 12848 (DEA Mar. 18, 1997). disclose that on March 10, 2010, the right to a hearing. Moreover, Stout’s counsel has 6 Id. at 12848. Tennessee Board of Nursing had made no offer as to how long he would wait before 7 Hooper, 76 FR at 71372. summarily suspended his nurse Continued

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Thereafter, the Government filed a Killebrew submitted an application for Tennessee.’’ Id. at 8. What follows Request for Final Agency Action and a new registration; it is this application below is a discussion of the evidence forwarded the entire record to my Office which is the subject of the Show Cause with respect to patients N.S., T.H. and for review. Having reviewed the entire Order issued to her. Id. C.S. record, I find that the Government has David R. Stout, N.P., currently holds N.S. established that Registrant Stout has DEA Certificate of Registration committed such acts as would render MS0443046, pursuant to which he is N.S.’s first visit to AMC was on June his registration ‘‘inconsistent with the authorized to dispense controlled 8, 2004, when she presented public interest.’’ 21 U.S.C. 824(a)(4). substances in schedules II–V as a Mid- complaining of neck and back pain. See Accordingly, I will order that the Level Practitioner at the registered GX 2, at 102. N.S. apparently was seen registration issued to Registrant Stout be address of the AMC. GX 1, at 6. While on this visit by a practitioner other than revoked and that his pending his registration was due to expire on Mr. Reynolds,3 Mr. Stout, or Ms. application to renew his registration be February 28, 2011, on February 16, Killebrew. See GX 3, at 129–130. This denied. I further find that the 2011, Stout filed a renewal application. practitioner specifically noted that N.S. Government has established that Accordingly, his registration remains in had a ‘‘tender neck and low back with granting a new registration to effect pending the final order in this decreased range of motion, low back Applicants Reynolds and Killebrew matter. Id. tender to light touch’’ and prescribed a would be ‘‘inconsistent with the public The Government’s Evidence of thirty-day supply of thirty tablets of interest.’’ Id. § 823(f). Therefore, I will Misconduct Avinza 60 mg (morphine, a schedule II also order that their respective drug), as well as Zanaflex, which is a In support of the allegations, the applications be denied. I make the non-controlled muscle relaxant. See GX following findings of fact. Government submitted patient files for seven patients, pharmacy records for 2, at 102; GX 3, at 129. Findings four patients, along with various other According to the Expert, the documentation contained in N.S.’s file Jurisdictional Facts documents. The Government also provided these materials to Amy Bull, did not support the prescribing of a In 2002, Applicant Bobby D. Reynolds Ph.D., a Board Certified Family Nurse thirty-day supply of Avinza 60 mg and II, FNP, founded the Appalachian Practitioner, who is licensed in the prescription was below the standard Medical Center, a clinic located in Tennessee as both an Advanced Practice of care in Tennessee and outside the Johnson City, Tennessee; Reynolds Nurse and Registered Nurse. GX 40, at usual course of professional practice. owned the clinic until 2010, when it 2–3. Dr. Bull is an Assistant Professor of GX 68, at 8. As the Expert noted, N.S.’s was closed. GX 42, at 2–3. Reynolds Nursing at the Belmont University file contains radiologic reports (CT employed both Applicant Killebrew and School of Nursing and previously taught scans and plain radiographs of the neck Registrant Stout at AMC. Id. at the Vanderbilt University School of and lower back) from June 28, 2001 Reynolds was previously registered Nursing, where she served as Director of which appear to have been generated in under the Controlled Substances Act as the Family Nurse Practitioner Program, connection with N.S.’s prior visit to the a Mid-Level Practitioner, with authority was the coordinator for courses in emergency room (‘‘ER’’) due to a motor to dispense controlled substances in Advanced Pharmacotherapeutics and vehicle collision and which described schedules II–V at the registered address Health Assessment & Diagnostic previous surgery to the neck and of the AMC, which was located at 3010 Reasoning, and taught various courses. degenerative changes in the lower back. Bristol Highway, Johnson City, Id. at 1. Dr. Bull also continues to See id. at 8–9; GX 2, at 116–120. Tennessee. GX 1, at 1. However, this practice as a Nurse Practitioner at a registration expired on April 30, 2011. However, as the Expert then clinic in Dickinson, Tennessee. Id. at 2. On May 19, 2011, Reynolds filed a explained, these records were from Dr. Bull reviewed seven patient files. examinations that were performed renewal application; it is this GX 68, at 6–7. Based on her review, Dr. application which is the subject of the nearly three years before N.S.’s first Bull concluded that Reynolds, AMC visit. GX 68, at 9. The Expert then Show Cause Order issued to him. Id. Killebrew, and Stout acted outside of Tina L. Killebrew, F.N.P., was observed that N.S.’s file lacked any the usual course of professional practice employed as a nurse practitioner at documentation indicating what, if any, and lacked a legitimate medical purpose AMC from approximately June 2006 treatment she had received since the in prescribing controlled substances to through March 11, 2010. GX L, at 13– accident, nor contain any records of any the patients, see 21 CFR 1306.04(a), and 14 (Brief in Response to Amended Order prior treating physicians, nor any also violated Tennessee Board of December 30, 2013). She was also documentation relating to her substance Nursing Rule 1000–04.08, which sets previously registered as a Mid-Level abuse history. Id. Of further note, the forth the standards of nursing practice Practitioner with authority to dispense Expert observed that N.S. did not list controlled substances in schedules II–V for prescribing controlled substances to any medication she was then taking on at AMC’s address. Id. at 11. However, treat pain. Id. at 7–8. Dr. Bull the ‘‘New Patient Information Sheet’’ this registration expired on December specifically found that Reynolds, which she apparently completed at her 31, 2010. On or about August 30, 2011, Killebrew and Stout ‘‘repeatedly issued first visit, see GX 2, at 9–10; and the prescriptions . . . in the face of red flags record of her first visit does not reapplying. See GX RR (‘‘This proposal is in the that should have indicated to him [or document the she was taking any public’s interest because it saves time and money her] that these individuals were abusing medications. Id. at 102; GX 68, at 9. for valuable employees and staff. There will be no and/or diverting controlled substances need to review documents, there will be no need and without taking appropriate action to to issue decisions and there will be no delay in Mr. 3 According to the Expert, while Mr. Reynolds did Stout being able to show his good faith in hopes of prevent further abuse and/or diversion,’’ not see N.S. at her June 8, 2004 visit, he had clearly someday being able to reapply.’’). Finally, having and that in doing so, ‘‘their conduct fell reviewed the record of this visit as at the bottom reviewed the evidence, I conclude that the public far below the standard of care in of the visit note, there is a handwritten marking interest would be ill-served by allowing him to Tennessee and [was] contrary to which, based on her review of the patient files, the withdraw his application and thereby avoid the Expert determined was the signature, or abbreviated findings of fact and conclusions of law which are generally recognized and accepted signature of Reynolds. See GX 2 (ID) at 102; GX 68, clearly warranted by the evidence. practices of a nurse practitioner in at 10.

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According to the Expert, the absence The Expert noted that the attending at her July 7, 2004 visit. Id. at 115. of this information in the file indicates practitioner properly ordered a Urine According to the Expert, on the date of that the AMC practitioner did not know Drug Screen (UDS) for N.S. Id. the UDS, N.S. should have had Avinza what, if any, controlled substances N.S. According to the Expert, a UDS is a left from the prescription issued at her was then being prescribed, her complete particularly useful tool when the first visit and should have still been pain history, whether she was suffering practitioner is presented with a red flag taking the drug. See GX 2, at 102; GX from any coexisting diseases or indicating that the patient may not be in 3, at 129; GX 68, at 12–13. However, the conditions, who her prior treating compliance, such as when the patient UDS was negative for opiates, positive physicians were, whether she had ever presents at the office exhibiting the for benzodiazepines, and positive for tried non-controlled substances, or behaviors N.S. did on this visit. Id. As cocaine. Id.; GX 2, at 115. whether she had ever received other the Expert explained, a UDS can assist According to the Expert, these results treatment modalities to address her the practitioner in determining whether should have been a ‘‘huge red flag of reported pain, such as physical the patient has been taking the drug(s) abuse and diversion’’ for Mr. Reynolds rehabilitation. GX 68, at 9. The Expert that the practitioner has prescribed and because not only did N.S. test positive then concluded that absent this if the patient was ingesting non- for cocaine, she also tested positive for information, N.S. should not have been prescribed controlled substances, three different benzodiazepines, none of issued a controlled substance including illicit substances. Id. Thus, which had been prescribed to her at her prescription on her first visit, especially UDS results help practitioners to first visit. GX 68, at 13. The Expert a schedule II controlled substance such determine whether a patient is abusing further explained that the presence of as Avinza, which is a long-acting and/or diverting controlled substances. the three benzodiazepines, in addition formulation of morphine. Id. The Expert Id. to the presence of cocaine, were further explained that if a controlled While this other practitioner consistent with the somnolence, slurred substance such as Avinza had been appropriately ordered a UDS, according speech, and increased pulse rate that indicated, the starting adult dose would to the Expert, he then inappropriately were documented during the July 7, have been only 30mg daily (rather than issued to N.S. another prescription for 2004 visit. Id. The Expert also noted that 60mg which was prescribed).4 Id. thirty tablets of Avinza 60 mg at this N.S. tested negative for opiates, when On July 7, 2004, N.S. returned to AMC visit. Id. at 11–12. As the Expert found, she should have tested positive for the for a follow-up, but now was at this visit, N.S.’s file still lacked any Avinza which she should have still been complaining of a migraine headache. information of her prior treatment taking. Id. See GX 2, at 101. Again, N.S. was seen history and substance abuse history. Id. The Expert also noted that as of this by a practitioner other than Reynolds, at 12. According to the Expert, in the visit, Reynolds still had not acquired any information concerning N.S.’s prior Stout, or Killebrew. See GX 3, at 130. absence of this information, and in light treatment history or substance abuse Notably, the record states that N.S. of the fact that N.S. presented at this history. Id. Also, the file contains no displayed ‘‘Slurred speech + visit demonstrating slurred speech and documentation that Reynolds had Somnolence,’’ which, according to the somnolence, the issuance of the Avinza inquired of N.S. where she had been for Expert was a potential red flag that N.S. prescription was below the standard of the nearly three months since her July was abusing prescription drugs.5 GX 68, care in Tennessee and outside the usual 7, 2004 AMC visit. See generally GX 2. at 10. The Expert noted that the record course of professional practice and actually medically contraindicated According to the Expert, the standard of indicated that N.S. had Tachycardia, as given the mental status changes care required that Reynolds inquire her pulse rate was above the normal rate documented in her record. Id. at 12. The about N.S.’s absence and determine for adults (60–100 beats per minute) and Expert further explained that under the what, if anything, she had been doing was nearly 20 beats higher than at her circumstances presented by N.S., the during this time to address her reported previous visit. Id. at 11. According to standard of care and usual course of pain. GX 68, at 13. The Expert further the Expert, while Tachycardia occurs for professional practice required that the noted that while the note for this visit a variety of reasons, it can be caused by practitioner refer the patient for a was for the most part illegible, it drug withdrawal. Id. comprehensive evaluation (the appeared that Mr. Reynolds did not emergency room) to determine the address N.S.’s absence. See id; GX 2, at 4 The Expert acknowledged that as of the date of underlying cause of the symptoms of 100. N.S.’s first visit, the Tennessee Board of Nursing had yet to adopt BON Rule 1000–04–.08, and that her increased heart rate, slurred speech, Nonetheless, Reynolds issued N.S. the Rule did not go into effect until January 1, 2005. and somnolence. Id. Moreover, the another prescription for thirty tablets of GX 68, at 10. However, based on her knowledge and patient should not have received Avinza 60 mg. See GX 2, at 100; GX 3, experience, the Expert explained that advanced prescriptions (of any type) at this visit at 71. Based on the UDS results and nurse practitioners (‘‘APNs’’) in Tennessee were notation in N.S.’s record that she nevertheless employing the practices set forth in the until medical clearance was provided Rule when they prescribed controlled substances that she was not experiencing drug displayed ‘‘slurred speech & for the treatment of pain. Id. Thus, the practices intoxication or an acute neurologic somnolence,’’ the Expert concluded that articulated in the guidelines reflected what, in her event. Id. Moreover, because N.S. was Reynolds was on notice that she was opinion, was the standard of care in Tennessee for likely diverting the Avinza she obtained family nurse practitioners as of June 2004. Id. The not referred or transferred for further Expert explained that because of the lack of evaluation, she should not have at AMC for the purpose of obtaining the information of N.S.’s prior treatment history and received any controlled medications cocaine and the benzodiazepines. GX substance abuse history, it was below the standard until the urine drug screen results were 68, at 14. The Expert also explained that of care for a practitioner to issue N.S. a thirty-day at the time of these events, it was well supply of a schedule II controlled substance such available to the provider. Id. as morphine at her first visit. Id. Nearly three months later (on known in the Tennessee health care 5 According to the Expert, these symptoms could September 29, 2004), N.S. returned to community that prescription drug abuse represent several serious and even life-threatening AMC for her next visit and was seen by and diversion was a problem that was medical conditions given N.S.’s complaint of a Mr. Reynolds. See GX 2, at 100; GX 3, plaguing East Tennessee. Id. migraine headache. Also, N.S.’s slurred speech and somnolence could have been an indication that N.S. at 71. Prior to this visit, AMC had The Expert explained that the was having an acute neurologic event, such as a received the report of the results of the standard of care and usual course of hemorrhagic stroke. GX 68, at 10–11. UDS that had been administered to N.S. practice under these circumstances

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would not have been to issue N.S. an N.S.’s abuse and diversion, Reynolds had suffered, and that she had been sent additional thirty-day supply of had received an admission report on for mental health treatment on each of morphine, because ‘‘family nurse December 3, 2004 from Johnson City those two occasions. GX 68, at 17. practitioners were not then, and are now Medical Center (‘‘JCMC’’) which However, on reviewing N.S.’s patient not equipped, through their training and notified him that N.S. was hospitalized file, the Expert found (as do I) that experience, to address the complex for a drug overdose the same day. GX Reynolds did not contact: (1) The JCMC abuse and diversion issues N.S. was 68, at 15; GX 2, at 126–28. He also to obtain its records of N.S.’s multiple presenting.’’ Id. According to the Expert, received notification from JCMC upon previous overdoses; (2) Dr. Dube to rather than continuing to issue N.S. N.S.’s discharge on December 7, 2004. obtain records of the nature and extent prescriptions for more of the Avinza, the GX 2, at 158–61; GX 68, at 16. Reynolds of the treatment he had provided N.S., standard of care and usual course of evidently reviewed the report, as his including the controlled substances he practice required that Reynolds ‘‘cease signature marking appears at the bottom had prescribed her, (3) the IPP to obtain all controlled substances prescriptions of the report’s first page. GX 2, at 158. records regarding N.S.’s December 21, to her, and instead referred [sic] her for Notably, not only did the report state 2004 admission to that facility for a consultation with a pain management that N.S. had been admitted for a drug polysubstance abuse; and/or (4) the specialist who [was] equipped with the overdose, it also stated that N.S. had a pharmacy N.S. was using to fill her knowledge to treat a pain patient who history of multiple prior drug overdoses, prescriptions to determine if she was has exhibited such aberrant behavior.’’ the last one being in May 2004, one obtaining controlled substances Id. The Expert also explained that in the month before her first AMC visit, and a prescriptions from other practitioners. event that a local pain management history of multiple suicide attempts. Id. Id. According to the Expert, the practice did not have all of these at 126–27; 158–59. standard of care and usual course of specialists, Mr. Reynolds should have, Of further significance, the report professional practice for a family nurse in addition to sending her to a pain listed two different primary care practitioner required that Reynolds management specialist, referred her to a physicians for N.S., one of whom, Dr. obtain all of this information about mental health specialist to address her Michael Dube, was not an AMC N.S.’s history of overdoses, her suicide possible psychological/drug abuse practitioner. Id. at 159. Also, the report attempts, and her current issues. Id. The Expert thus concluded stated that she was taking Lortab, a hospitalizations, as well as information that Reynolds’ issuance of this combination drug containing about other practitioners from whom prescription was below the standard of hydrocodone (which was then a she may have been obtaining controlled care in Tennessee, outside the usual schedule III controlled substance); substance prescriptions, in order to course of professional practice, and for Xanax, a schedule IV controlled determine the proper course to take in other than a legitimate medical purpose. substance; and Soma (carisoprodol), her care. Id. Id. which was not federally scheduled at As the Expert previously explained, a N.S.’s file reflects that Reynolds, that time. Id. at 158. However, Reynolds family practice nurse practitioner is not Stout, and Killebrew each continued to had not previously prescribed any of issue N.S. controlled substance these three drugs to N.S. See generally qualified to treat the complex issues prescriptions on multiple occasions GX 2. presented by this type of patient. Thus, subsequent to September 29, 2004. In The report also stated that a urine the Expert also explained that in light of fact, N.S. remained an AMC patient for toxicology test was performed on N.S. the information contained in the over five more years and continued to and that she tested positive for opiates December 3, 2004 JCMC and the receive numerous controlled substances and benzodiazepines. Id. at 159. December 21, 2004 IPP admission prescriptions from AMC. See generally However, as before, AMC had not reports, the standard of care in GX 2. Based on the evidence of N.S.’s prescribed any benzodiazepines to N.S. Tennessee required that Reynolds cease abuse and/or diversion of controlled As the Expert explained, the report all further controlled substance substances that was documented in her should have been another enormous red prescriptions (which he already should file, the absence of documentation of flag to Reynolds that N.S. was have), send N.S. to an out-patient or in- any prior treatment for pain, and the continuing to abuse and divert patient detoxification program and refer absence of any substance abuse history, controlled substances and was engaging her to a pain management specialist. Id. the Expert opined that each and every in doctor-shopping by obtaining at 18. Thus, the Expert concluded that controlled substance prescription that controlled substances from multiple the issuance of the December 29, 2004 these three practitioners issued to N.S. sources (AMC and Dr. Dube), another Avinza prescription was outside the from September 29, 2004 forward was red flag of drug-seeking behavior. GX usual course of professional practice below the standard of care, not for a 68, at 16. and lacked a legitimate medical legitimate medical purpose, and outside As of the December 29 visit, Reynolds purpose. Id. the usual course of professional also was aware that the physician who Nevertheless, from January 2005 practice. GX 68, at 15. However, treated N.S. at JCMC had, three weeks through June 2005, Reynolds continued ‘‘because each of the three practitioners earlier, discharged N.S. to Indian Path to see N.S. at AMC on a monthly basis issued additional controlled substance Pavilion (‘‘IPP’’), a local, in-patient and continued to issue her monthly prescriptions notwithstanding the mental health facility. See GX 2, at 160. prescriptions for Avinza 60 mg. See GX existence of more red flags of N.S.’s In addition, on December 23, AMC 2, at 86–96; GX 3, at 76–79. According abuse and/or diversion of controlled received a fax showing that on to the Expert, the issuance of each of substances,’’ the Expert addressed the December 21, N.S. had been admitted these prescriptions was below the invalidity of those prescriptions. Id. again to IPP for ‘‘polysubstance abuse.’’ standard of care and outside the usual On December 29, 2004, N.S. returned See GX 2, at 153–56. Thus, as of N.S.’s course of professional practice as well. to AMC and saw Mr. Reynolds, who December 29 visit, Reynolds was on GX 68, at 18. As the Expert explained, issued her a prescription for eight notice that she may have suffered two N.S. should not have been treated and tablets of Avinza 60 mg. See GX 2, at 97; overdoses in an approximately three- prescribed controlled substances at a GX 3, at 76 According to the Expert, in week period, that these would have family practice in light of the drug abuse addition to the previous evidence of been the latest of several overdoses she and diversion issues she presented, and

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should have been referred to a According to the Expert, the decision BON Rule 1000–04–.08(4)(c)4. However, specialist. Id. of the nurse practitioners to address while Xanax is a highly abused and According to the Expert, on January 1, N.S.’s mental health issues by diverted drug in Tennessee, Reynolds, 2005, the Board of Nursing’s Rule 1000– prescribing Xanax, was below the Stout and Killebrew prescribed Xanax to 04–.08 went into effect. Id. As a result, standard of care and outside the usual N.S., ‘‘at numerous periodic intervals Reynolds was required to comply with course of professional practice. GX 68, over the course of the next several years the controlled substance prescribing at 19. As support for her opinion, the and in the face of mounting evidence of guidelines contained in that Rule. Expert cited a treatise which she stated her abuse of controlled substances, and However, as of January 6, 2005, was generally recognized and accepted without referring her for treatment by a Reynolds still had not obtained any as authoritative by Tennessee family specialist.’’ GX 68, at 21. The Expert information about her treatment history practitioners. Id. at 19–20 (citing thus concluded that the prescriptions for the three years immediately Constance R. Uphold & Mary Virginia issued by the three nurse practitioners preceding her first AMC visit on June 8, Graham, Clinical Guidelines in Family fell well below the standard of care and 2004. See TN BON Rule 1000–04– Practice, 4th Ed. (2003) (hereinafter, outside the usual course of their .08(4)(C)1; see also generally GX 2; GX ‘‘Uphold & Graham’’)). This treatise was professional practice. Id. 68, at 18. Moreover, Reynolds did not submitted as part of the record. See GX On July 1, 2005, Reynolds issued N.S. create a written treatment plan for N.S.; 41. prescriptions for 30 capsules of Avinza nor did he document that he had The Expert explained that ‘‘according 60 mg and 60 tablets of Xanax 1 mg. See considered the need for further testing, to Uphold & Graham, benzodiazepines, GX 2, at 86; GX 3, at 79. Reynolds consultations, referrals, or the use of such as Xanax, are effective only for the issued these prescriptions even though other treatment modalities. GX 2; GX 68, short-course treatment of generalized he had not obtained the results of the at 18. anxiety disorder, or GAD, and family UDS he ordered for N.S. during her June As the Expert explained, under the practitioners were cautioned against the 1, 2005 AMC visit (and apparently never new Rule, Reynolds was required to use of this class of drugs for greater than did based on a review of N.S.’s patient a two week period because they carry file). See GX 2, at 87. In fact, N.S.’s create and maintain a ‘‘written ‘the risk of dependence and withdrawal patient file does not contain any record treatment plan tailored for the syndrome.’ ’’ Id. at 20 (quoting GX 41, at of her even having been administered individual needs of the patient’’ that 8). The Expert then noted that ‘‘Uphold the UDS. GX 68, at 21; see also GX 2. ‘‘include[d] objectives such as pain and/ & Graham further instructs that if the In the Expert’s opinion, Reynolds’ or improved physical and psychological patient’s ‘anxiety [is] associated with issuance of these prescriptions was function’’ and was required to ‘‘consider another psychiatric condition, most below the standard of care and outside the need for further testing, often depression,’ the patient ‘should be the usual course of professional consultations, referrals, or use of other treated for the primary problem,’ and practice. GX 68, at 21. Based on the treatment modalities dependent on ‘most patients in this category should be evidence of N.S.’s abuse and diversion patient response[.]’’ GX 68, at 18 referred to a specialist if possible.’ ’’ GX of controlled substances set forth above, (quoting TN BON Rule 1000–04– 68, at 20 (quoting GX 41, at 9). and the fact that Reynolds had not .08(4)(c)2). As found above, in Additionally, ‘‘Uphold & Graham obtained the results for the UDS he December 2004, the JCMC and IPP had instructs that for ‘patients with anxiety ordered at N.S.’s previous visit, the forwarded to Reynolds information that is substance-induced’ whether by standard of care and usual course of establishing that N.S. had a substantial licit or illicit drugs, family nurse professional practice under these history of substance abuse which had practitioners are to ‘provide the patient circumstances would not have been to resulted in multiple drug overdoses and with counseling/referral to a drug issue N.S. further controlled substances suicide attempts. Based on the results of detoxification program.’ ’’ Id. According prescriptions. Id. at 22. Instead, it would the July 2004 UDS, he also had to the Expert, ‘‘Uphold & Graham have been to locate the results, and if information that N.S. may not have been emphasizes that two of the ‘categories of she had not taken the UDS, which taking the Avinza and possibly was patients [who] should be referred to would be a red flag based on her history, diverting the drug and that she was specialists for treatment’ are ‘[t]hose require her to provide one and cease all taking cocaine and benzodiazepines with high suicide risk’ and ‘[p]atients further controlled substances which had not been prescribed by his with comorbid conditions (primary prescribing until the results could be clinic. GX 68, at 19. The Expert thus anxiety disorder, substance abuse, reviewed. Id. (citing Board Rule 1008– concluded that Reynolds did not dementia).’ ’’ Id. (quoting GX 41, at 14). 04–08(2) & (4) (c)(2)). comply with the Rule and acted outside Thus, based on Uphold & Graham, the Likewise, on August 2, 2005, Mr. of the usual course of professional Expert concluded that ‘‘even assuming Reynolds issued N.S. prescriptions for practice when he issued the Avinza N.S. could have been treated for her 30 capsules of Avinza 60 mg and 60 prescription to N.S. Id. purported major depressive order in a tablets of Xanax 1 mg, each of which The evidence further shows that primary care setting, which she could was for a thirty-day supply. See GX 2, beginning on February 8, 2005, not, she should not have been started on at 85; GX 3, at 79. A note in the record Reynolds added Xanax 1 mg. to N.S.’s a benzodiazepine such as Xanax.’’ Id. of her August 2, 2005 visit states, ‘‘Pt. controlled substance regimen. See GX 2, (citing GX 41, at 15). The Expert further called to request refill on Xanax. Stated at 94; GX 3, at 77–79. Reynolds issued noted that AMC asserted that its she had taken all she had before due this prescription after diagnosing N.S. protocols were based on the Uphold & date. Script written for Xanax.’’ GX 2, at with ‘‘Major Depressive Disorder’’ and Graham Guidelines. Id. at 19–20 (citing 85 (emphasis added). Yet ‘‘GAD,’’ the latter being an abbreviation GX 39). notwithstanding the extensive evidence for ‘‘Generalized Anxiety Disorder.’’ The According to the Expert, Reynolds, that N.S. was abusing and diverting Xanax prescription issued on February Stout, and Killebrew were required controlled substances, Reynolds issued 8, 2005 was the first of numerous Xanax under Tennessee law to evaluate N.S. her the prescription and did not refer prescriptions N.S. received from for a continuation or change of her her to an outside specialist to address Reynolds, Stout, and Killebrew over the medications at each periodic interval at her aberrant behavior. See, e.g., GX 41, course of the next five years. See GX 2. which they evaluated her. GX 68, at 21; at 8–9, 14 (Uphold & Graham). The

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Expert thus concluded that Reynolds’ substances prescriptions, so that he status may have prohibited her from issuance of the prescription was below could determine the appropriate course possessing controlled substances. GX the standard of care and outside the of treatment. GX 68, at 26. Noting that 68, at 28. Nor did Killebrew document usual course of professional practice. under Board Rule 1000–04–.08, Stout having asked N.S. about how she had GX 68, at 22–23. was required to ‘‘evaluate[ ] the patient addressed her alleged pain during her Twenty days later, on August 22, for continuation or change of incarceration when she had told 2005, Mr. Reynolds issued N.S. a medications’’ and to include in the Killebrew that she was not receiving any prescription for 20 tablets of Xanax 0.5 patient record ‘‘progress toward pain medications. Id. According to the mg. See GX 2, at 84; GX 3, at 80. reaching treatment objectives, any new Expert, given N.S.’s history, the According to the Expert, this information about the etiology of the standard of care and usual course of prescription was an extremely early pain, and an update on the treatment professional practice under these refill, specifically, ten days early, in plan,’’ the Expert explained that an circumstances, would not have been to light of the fact that he had just issued Advanced Practice Nurse cannot issue her additional controlled N.S. a thirty-day supply of 60 tablets of evaluate a patient for the continuation substances prescriptions but to refer her Xanax 1 mg on August 2, 2005, and was or change of medications, or determine to a pain management practice to further evidence that N.S. was either the progress the patient is making address her purported back and neck abusing the Xanax by taking extra pills towards reaching treatment objectives, pain and possible continuing substance in contravention of his directions, or or even know what the patient’s abuse. Id. (citing GX 41, at 8–9, 14) was diverting the drugs he was treatment objectives are, without (Uphold & Graham). prescribing to her. GX 68, at 23. knowing the patient’s treatment history. On August 17, 2006, Stout prescribed Moreover, on September 2, 2005, Mr. Id. N.S. 75 tablets of Percocet 7.5/325 mg Reynolds issued N.S. prescriptions for The Expert thus concluded that when and 60 tablets of Xanax 0.5 mg. See GX 30 capsules of Avinza 60 mg and 60 Stout issued N.S. the Xanax and Kadian 2, at 75; GX 3, at 87. According to the tablets of Xanax 1 mg. See GX 2, at 82; prescriptions, he should have been medical record, on July 19, 2006, less GX 3, at 81. According to the Expert, aware of N.S.’s prior abuse and than a month before he issued N.S. Reynolds was then aware that N.S. had diversion of controlled substances these prescriptions, Stout had treated apparently not complied with his which was documented in her patient N.S. while he was working in the North August 24, 2005 request for her to come file. Id. Based on N.S.’s history, the Side Hospital emergency room (‘‘ER’’). into AMC for a pill count. See GX 68, Expert further concluded that the See GX 16, at 2–3. According to North at 24; GX 2, at 83. The Expert then standard of care and usual course of Side’s records, N.S. presented to the ER explained that the failure of a patient to professional practice under these on that date complaining of neck pain comply with a practitioner’s request for circumstances would not have been for from a fall. Stout noted in the record for a pill count, which is another tool Mr. Stout to issue her further controlled the ER visit that N.S. ‘‘[r]efused meds utilized to monitor the patient’s substances prescriptions but to cease . . . Wants stronger narcotics. Admits to compliance with a controlled further prescribing and refer her to an having long history of drug abuse. . . .’’ substances regimen, is another red flag outside specialist to address her In the ‘‘Impressions’’ section of this of possible abuse and/or diversion. GX aberrant behavior. Id. at 26–27 (citing report, Stout had also noted that N.S. 28, at 24. GX 41, at 8–9, 14) (Uphold & Graham). On October 3, 2005, Mr. Reynolds On July 20, 2006, Applicant Killebrew displayed ‘‘[d]rug seeking behavior.’’ Id. issued N.S. a prescription for 75 tablets issued her first controlled substances Moreover, N.S.’s AMC record of Xanax 1mg and 60 capsules of Kadian prescriptions to N.S.; the prescriptions included the note for her July 20 visit (a brand name for morphine) 30 mg. See were for 75 tablets of Percocet 7.5/325 (the day after Stout saw her in the ER). GX 2, at 80; GX 3, at 81. N.S.’s file mg (oxycodone/acetaminophen, a Thus, the Expert found that Stout contains a handwritten note dated schedule II controlled substance), and should also have been aware that N.S.’s September 13, 2005, which was just 60 tablets of Xanax 0.5 mg. See GX 2, previous visit was her first visit to AMC eleven days after Reynolds had at 76; GX 3, at 84. For the same reasons in seven months and that she had just prescribed to her a thirty-day supply of she identified in her discussion of the been released from jail and had 60 tablets of Xanax 1 mg, stating, ‘‘Pt validity of Stout’s initial prescriptions requested to be put back on pain requested Xanax 1 mg TID for anxiety to N.S., the Expert found that medications. GX 68, at 29; GX 2, at 76. attacks.’’ GX 68, at 25; GX 2, at 81. As Killebrew’s prescriptions were below The Expert further explained that ‘‘[a]s of this date, Reynolds was aware that the standard of care and outside the was the case with N.S.’s visit with N.S. should have had 19 days of Xanax usual course of professional practice. Killebrew, Stout did not question N.S. tablets remaining from the September GX 68, at 27. as why she had been incarcerated . . . 2nd prescription, and thus, she was The Expert further noted that this was whether it was drug-related, whether requesting additional Xanax well before N.S.’s first visit to AMC in nearly eight she was on probation, and, if so, she should have consumed the prior months, (her last visit having been a whether her probationary status may prescriptions and was also requesting an Dec. 1, 2005 visit with Reynolds), and have prohibited her from possessing increase from two (i.e., ‘‘BID’’) to three that Killebrew had noted in the record controlled substances. He also did not tablets a day (i.e., ‘‘TID’’). GX 68, at 25. of this visit that N.S. was ‘‘[j]ust question N.S. about how she had been On November 1, 2005, Registrant released from jail 7/6/06 . . . requesting addressing her alleged pain during her Stout issued his first controlled to be put back on pain meds she was on incarceration when she, based on her substance prescriptions to N.S.; the for back and neck pain.’’ Id. at 27–28 own report to Killebrew, had not prescriptions were for 75 tablets of (citing GX 2, at 76). The Expert noted, received pain medications.’’ GX 68, at Xanax 1 mg and 60 capsules of Kadian however, that Killebrew did not 29. Based on these circumstances 30 mg. See GX 2, at 79; GX 3, at 82. document having asked N.S. about the (including the amply documented According to the Expert, because this reason for her incarceration, history of N.S.’s abuse and/or was N.S.’s. first visit with Stout, it was specifically, whether it was drug- diversion), the Expert found that Stout’s incumbent on him to review N.S.’s file related, whether she was on probation, issuance of these prescriptions was before he issued her controlled and, if so, whether her probationary below the standard of care and outside

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the usual course of professional addition, Reynolds was aware of Stout’s AMC if she failed the UDS. Id. practice. Id. warning to N.S. during her October 11, Additionally, the standard of care and On October 11, 2006, Stout again saw 2006, visit that she would be discharged usual course of professional practice N.S. and issued her additional (‘‘d/c’’) if the results were negative would have been to attempt to refer N.S. prescriptions for 75 tablets of Percocet (which they were for oxycodone), or if to a mental health or an addiction 7.5 mg and 60 tablets of Xanax 0.5 mg. she was found to be abusing drugs, specialist to address her purported pain See GX 2, at 71, 73; GX 3, at 88. In which was established by her testing issues and her likely substance abuse addition to the previous documented positive for hydrocodone, a drug that issues. Id. at 33–34 (citing GX 41, at 8– incidents of N.S.’s abuse and/or she had not been prescribed at AMC. Id. 9, 14 (Uphold & Graham excerpts)). Yet diversion, N.S.’s file contained a note at 32. Stout failed to either discharge her or dated September 13, 2006, stating, The Expert thus found that the UDS refer her to a specialist. ‘‘[N.S.] selling perocet’s (sic.).’’ See GX results were further evidence of N.S.’s On February 27, 2007, Reynolds 2, at 74. Moreover, in the record of the continued abuse and/or diversion of issued N.S. prescriptions for 75 tablets visit, Stout wrote, ‘‘Confronted PT about controlled substances. Id. at 31. The of Percocet 7.5 mg and 60 tablets of ? selling meds. PT denies. States meds Expert further opined that the standard Xanax .5 mg. See GX 2, at 66; GX 3, at were stolen. Will do UDS today. of care and usual course of professional 93. At the time of the visit, Reynolds Advised PT if UDS (-) drugs/abuse practice under these circumstances was aware of the December 11, 2006 found would d/c. Has been taking meds would not have been to issue N.S. notes stating that neither Appalachian for past week per pt.’’ See GX 2, at 71, further controlled substance Pain Rehab nor Pain Med Associates 73. Also, Stout had N.S. sign a Pain prescriptions, but to discharge her from would see N.S. See GX 2, at 67. For the Management Agreement (‘‘PMA’’), the practice and to refer her to a pain same reasons discussed above, the which he and another AMC employee management practice to address her Expert concluded that Reynolds’ witnessed, and then issued her the purported pain issues or a substance issuance of the prescriptions was well controlled substance prescriptions. See abuse/addiction specialist to address below the standard of care and outside GX 2, at 11–12. her likely substance abuse issues. Id. at of the usual course of professional According to the Expert, the fact that 32. Thus, the Expert concluded that practice. GX 68, at 32. N.S. denied selling her drugs should not Reynolds’ issuance of these On June 1, 2007, Reynolds issued N.S. have overcome the evidence in her file, prescriptions was below the standard of additional controlled substances including the recent note of the report care and outside the usual course of prescriptions for 90 tablets of MS Contin that she was selling her drugs and the professional practice. Id. at 31 (citing 30 mg and 90 tablets of Xanax 0.5 mg. extensive evidence of her history of GX 41, at 8–9, 14) (Uphold & Graham)). See GX 3, at 96. Notwithstanding that abuse and/or diversion of controlled On December 11, 2006, Stout issued the quantity of both prescriptions had substances. GX 68, at 30. The Expert N.S. prescriptions for 75 tablets of been increased by fifty percent from thus concluded that Stout’s issuance of Percocet 7.5 mg and 60 tablets of N.S.’s previous visit, her patient file these prescriptions was below the Valium 5 mg. See GX 2, at 69; GX 3, at does not contain a record of Reynolds standard of care and outside the usual 91. At the time of the visit, Stout had having seen her on this date, nor any course of professional practice. Id.at 29– received the results of the UDS and was information as to why N.S. was not seen 30 (citing GX 41, at 8–9, 14 (Uphold & aware that N.S. had lied to him during on this occasion. See GX 2, at 63–64. Graham)). her October 11, 2006 visit, when she Based on the other documented The UDS results showed that N.S. told him she was taking her pain evidence of N.S.’s abuse and/or tested negative for oxycodone/ medications. N.S.’s patient record diversion, the Expert concluded that oxymorphone, despite the fact that she shows that Stout attempted to refer N.S. Reynolds’ issuance of these had been receiving oxycodone to two different pain management prescriptions was below the standard of (Percocet) prescriptions from AMC on a practices at this visit—‘‘Appalachian care and outside the usual course of monthly basis since July 20, 2006. See Pain Rehab’’ (Dr. Tchou) and ‘‘Pain med professional practice. GX 68, at 34–35 GX 2, at 71–75, 105–107; see also GX 3, associates.’’ See GX 2, at 67. However, (citing Rule 1000–04–.08(4)(c) (requiring at 4–5. The results also showed that N.S. N.S. had apparently already been seen periodic re-evaluation for continuing or tested positive for hydrocodone/ at those two practices and neither changing control substance hydromorphone, even though no one at practice was willing to again accept her prescriptions)). AMC had prescribed those drugs to her as a patient.6 Id. On July 2, 2007, after N.S. called in since she had returned to the practice. According to the Expert, this and said she had run out of GX 2, at 107. additional information should have prescriptions the day before, Killebrew On November 10, 2006, Reynolds saw been another red flag that N.S. was directed that prescriptions be called in N.S. and issued her additional abusing and or diverting controlled for 40 tablets of Lortab 10 mg prescriptions for 75 tablets of Percocet substances. GX 68, at 33. The Expert (hydrocodone/acetaminophen) and 30 7.5 mg and 60 tablets of Xanax 0.5 mg. thus concluded that under the tablets of Xanax 0.5 mg. See GX 2, at 63; See GX 2, at 70; GX 3, at 91. In addition circumstances, the standard of care and GX 3, at 96. While Killebrew should to the various recent notes in her file, usual course of professional practice have been aware of N.S.’s extensive Reynolds should have been aware of the would not have been to issue N.S. more history of abuse and diversion, October 18, 2006 results of the UDS prescriptions, but to enforce the terms of according to N.S.’s patient file, she administered to N.S. at the October 11, the Pain Management Agreement and to issued these prescriptions without 2006 visit. As the Expert explained, follow through on the warning Stout requiring that N.S. come in for an office based on the UDS results, Reynolds was had given N.S. during her October 11 visit and after being notified that N.S. aware that N.S. had lied to Stout during visit that she would be discharged from had called AMC and requested new her October 11, 2006 visit when she told prescriptions because she was out of her him that she was taking her pain 6 Notes in the file state that N.S. ‘‘has been double medications. See GX 2, at 63. The medications, and that she was likely dotted’’ at Appalachian Pain Rehab, which ‘‘means Expert further noted that N.S. evidently won’t see,’’ and that N.S. ‘‘already has been to Pain selling her Percocet because she tested med associates + can’t be seen there either!!’’ GX had not been seen at AMC since her negative for this drug. GX 68, at 31. In 2, at 67. May 3, 2007 office visit and that this

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was a further red flag given N.S.’s JCMC and diagnosed with, among other 3, at 107. Significantly, Reynolds issued history. GX 68, at 35. Moreover, once conditions, ‘‘polysubstance abuse.’’ See the prescriptions notwithstanding that again, there is no information in the file GX 2, at 139–140. Here again, the Expert N.S. had not been seen at AMC since documenting why N.S. could not have found that Reynolds’ issuance of these her December 22, 2008 visit with been seen. Id. The Expert thus prescriptions was below the standard of Killebrew. See GX 2, at 40–41. concluded that the issuance of the care and outside the usual course of Moreover, the record of the June 4, 2009 prescriptions was below the standard of professional practice and that she visit does not contain any care and outside of the usual course of should not have been issued any further documentation of what N.S. had been professional practice. Id. controlled substance prescriptions. GX doing to treat her purported pain over On November 16, 2007, Reynolds 68, at 37 (citing GX 41, at 8–9, 14 the course of the previous five plus issued N.S. prescriptions for 30 tablets (Uphold & Graham)). months. Id. at 38–39. The Expert also of Lortab 10 mg and 30 tablets of Xanax On December 22, 2008, Killebrew found that Reynolds should have been 0.5 mg. See GX 2, at 52; GX 3, at 102. issued N.S. prescriptions for 60 tablets aware that N.S.’s December 22, 2008 The Expert found that N.S. was seeking of Lortab 7.5 mg and 30 tablets of Xanax visit had been her first visit to AMC an early refill of her controlled 0.5 mg. See GX 2, at 40–41; GX 3, at 106. since February 2008, after she had substances, because fifteen days earlier, Notably, the chart indicates that this called AMC and informed staff that she Reynolds had prescribed her thirty-day was N.S.’s first visit to AMC since was two months pregnant and had supplies of 90 tablets each of Xanax 0.5 February 2008 because she was destroyed her medications. GX 68, at mg, MS Contin 30 mg, and Percocet 7.5/ pregnant, see GX 2, at 42–44, and that 39–40. 500 mg, each of which had a dosing of during the intervening ten months N.S As with the previous visit, the Expert ‘‘one po tid,’’ or one tablet three times had reportedly been receiving explained that the usual course of per day. See GX 68, at 36; GX 2, at 53– Suboxone/Subutex treatment from practice would have been for Reynolds 54; GX 3, at 102. N.S.’s early refill another practitioner and apparently had take steps to determine whether N.S. request presented another red flag of her been able to function during the had a legitimate medical need for the potential abuse and/or diversion of previous ten months without the need drugs prior to prescribing them. Id. at controlled substances, which Reynolds for Lortab and Xanax. Id. at 40. 40. These steps included asking N.S. ignored. GX 68, at 36. Moreover, N.S.’s According to the Expert, based on what she had been doing over the past Pain Management Agreement stated that N.S.’s representations, Killebrew should six months to address her purported ‘‘medications taken early due to reasons have taken steps to determine whether pain and, given her history of abuse and not discussed with your provider [will N.S. had a legitimate medical need for diversion, running a check of the not] be replaced early.’’ GX 2, at 5. Yet these drugs prior to prescribing them. Tennessee CSMD to determine if she Reynolds did not enforce the Pain GX 68, at 38–39. The Expert explained had been obtaining controlled Management Agreement. GX 68, at 36. that the usual course of professional substances from any other practitioners The Expert also concluded that given practice would have been for Killebrew over the past six months. Id. However, N.S.’s numerous prior red flags of drug to determine the name of the according to N.S.’s file, Reynolds did abuse and diversion, Reynolds should practitioner who had provided not conduct such a check. GX 2. The have taken steps to determine if she was Suboxone treatment to N.S. and contact Expert thus concluded that Reynolds’ in fact taking the drugs he had been that practitioner to determine the nature issuance of these prescriptions was prescribing, or if she was diverting and extent of the treatment and to below the standard of care and outside them. Id. at 37. The Expert explained obtain a copy of the records. Id. at 39. the usual course of professional that Reynolds should have required her The Expert also opined that given N.S.’s practice. GX 68, at 39–40 (citing TN to submit to a UDS, and that he also history of red flags, Killebrew should BON Rule 1000–04–.08(4)(c)(1, 2, 4)).7 should have checked the Tennessee have run a check of the Tennessee Controlled Substances Monitoring CSMD to determine if her 7 The Expert also explained that Reynolds’ Database (‘‘CSMD’’), which became representations were accurate and to decision to issue N.S. controlled substances available on January 1, 2007, in order to ensure that N.S. was not doctor- prescriptions on June 4, 2009 was contrary to the additional guidelines AMC was employing at that determine if she possibly was doctor- shopping. Id. However, according to time as part of its practice protocols. GX 68, at 40. shopping. Id. The Expert also noted that N.S.’s file, Killebrew did not do so. GX According to the Expert, she reviewed a February Reynolds did not ask why she was 2. The Expert also found that Killebrew 23, 2010 letter Reynolds had sent to a Tennessee seeking an early refill. Id. The Expert did not document any new illness or Department of Health Investigator, as well as several documents that were enclosed with the thus concluded that Reynolds’ issuance injury to N.S. as of this visit. GX 68, at letter, including copies of AMC’s practice protocols. of these prescriptions was below the 39. Also, on review of N.S.’s record, the Id.; see also GX 39. The Expert noted that Reynolds standard of care and outside the usual Expert concluded that Killebrew had stated in his letter that one of the attached course of professional practice. Id. at performed a cursory physical exam and documents was ‘‘a copy of the current treatment recommendations for chronic pain in the primary 36–37 (citing Board Rule 1000–04– that the lack of additional diagnostics or care setting as outlined by the American Family .08(4)(c) (2) & (4) and GX 41, at 8–9, 14 further evaluation by Killebrew further Physician in their [sic] November 2008 article (Uphold & Graham)). demonstrates that she failed to establish ‘Chronic Nonmalignant Pain in Primary Care’ ’’ On January 3, 2008, Reynolds issued N.S.’s need for controlled substances at which was authored by R. Jackman, J.M. Purvis, and B.S. Mallett (hereinafter, ‘‘Jackman article’’). GX 68, N.S. a prescription for 90 tablets of MS this visit. Id. Thus, the Expert at 40–41. According to Reynolds, AMC ‘‘currently Contin 30 mg, 90 tablets of Xanax 0.5 concluded that Killebrew’s issuance of [is] referencing this article in our charting notes and mg, and 30 tablets of Percocet 7.5 mg. these prescriptions was below the intend to add these guidelines as an Addendum to See GX 2, at 47–48; GX 3, at 103. standard of care and outside the usual our protocols when they are renewed in July 2010.’’ GX 39, at 1. In his record of N.S.’s June 4, 2009 visit, According to her file, on November 30, course of professional practice. Id. at Reynolds wrote: ‘‘[t]his patient’s pain has been 2007, N.S. had called and sought an 38–39 (citing TN BON Rule 1000–04– approached with specific attention to the American early refill. Moreover, documentation in .08(4)(c)1, 2, and 4). Family Physician’s November 2008 analysis that her file establishes that Reynolds should On June 4, 2009, Reynolds prescribed indicates nonmalignant pain should be addressed in the primary care setting.’’ GX 2, at 38. have known (having received reports on N.S. 60 tablets of MS Contin 30 mg, 30 The Expert noted that her review of N.S.’s file both December 22 and 26), that on tablets of Percocet 7.5 mg, and 90 tablets found that Reynolds overlooked several December 22, N.S. had been admitted to of Xanax 0.5 mg. See GX 2, at 38–39; GX recommendations contained within that article. GX

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On November 11, 2009, Reynolds According to N.S.’s file, her visits to noted, no such documentation exists in issued another prescription to N.S. for AMC ended in February 2010 after a N.S.’s file. 14 tablets of Xanax 0.25 mg. See GX 2, nearly six-year relationship with the Reynolds did acknowledge that on at 25; GX 3, at 108. According to N.S.’s practice. GX 2. Summarizing her December 3, 2004, N.S. was admitted to file, N.S. sought a refill claiming that the findings, the Expert noted that while a local hospital by a Dr. James for a drug Xanax Reynolds had prescribed to her during that time, N.S. presented overdose; he also stated that she was on October 29, 2009 had been stolen. numerous red flags of abuse and subsequently ‘‘transferred to Indian Path GX 2, at 25. According to the Expert, a diversion, the monitoring of her Pavilion and continued on her then patient reporting that her controlled controlled substances use by Reynolds, prescribed medications’’ and that ‘‘Dr. substances were stolen is another classic Stout, and Killebrew was woefully James added Soma and Lortab to the red flag of a patient’s potential abuse inadequate, and far below the standard AMC regimen.’’ GX 42, at 7. However, and/or diversion of controlled of care in Tennessee. GX 68, at 44. The Reynolds also asserted that after this substances. GX 68, at 43 (citing GX 39, Expert also observed that over the incident, N.S. ‘‘never had another at 11 (Jackman article’s examples of course of nearly six years, N.S. was only overdose incident while being treated at aberrant behavior)). asked to provide two UDSs, both of AMC’’ and ‘‘[s]he never again displayed According to the Expert, the standard which she failed by testing positive for signs of addiction to include requesting of care and the usual course of a drug she had not been prescribed at increases in medication without cause, professional practice would have been AMC (including cocaine on one of the going to numerous providers, aberrant for Reynolds to enforce the terms of tests), and testing negative for the drug behavior, contacting provider for N.S.’s Pain Management Agreement, which she had been prescribed. Id. medication after hours or on weekends, and refuse to provide her additional The Expert also noted that N.S. was early refills, or refusal to follow plans of controlled substances. GX 68, at 43–44 required to come into AMC for but a care.’’ Id. Finally, Reynolds further (quoting GX 2, at 5; ‘‘Lost or stolen single pill count, and there was no asserted that ‘‘[i]n October of 2006, she medicines will not be replaced’’). Also, documentation showing that she even passed drug screens and observation by according to the Expert, Reynolds complied with the request. Id. The AMC providers.’’ Id. should have required N.S. to submit to Expert then noted that even though the T.H. a UDS, and to run a check of the CSMD CSMD had been available since January T.H.’s initial visit was on October 3, to determine if N.S. was engaged in 1, 2007, the only time N.S.’s diversion. GX 68, at 44. According to 2005. See GX 17, at 4, 47. According to prescription history had been checked the record of this visit, T.H. was seen by N.S.’s file, Reynolds did not take either was on the date of her last visit in action and simply issued her an an AMC practitioner other than February 2010. Id.; see also GX 2, at Reynolds, Stout, or Killebrew. He additional Xanax prescription for 36 129–131. The Expert also observed that tablets of .25 mg. GX 2, at 25; GX 3, at reported that he was suffering from back there was no documentation that prior 70. The Expert thus concluded that pain, but said that it was not due to to the implementation of the CSMD, the Reynolds’ issuance of the prescription trauma or injury. Id. at 47; see also id practitioners had ever checked with was below the standard of care and at 4 (report of ‘‘Back Pain’’). T.H.’s N.S.’s pharmacy to ascertain whether outside the usual course of professional record does not, however, quantify the she was engaged in drug-seeking or practice. GX 68, at 43–44. extent of the pain he reported, nor diversionary behavior. GX 68, at 44. document how long he had been 68, at 41. These included the article’s statement that The Expert concluded by observing suffering from back pain. Id. at 47. T.H. ‘‘[o]pioids pose challenges with abuse, addiction, that none of these steps were taken, also reported a history of anxiety with diversion, lack of knowledge, concerns about notwithstanding that: (1) N.S. showed panic attacks. Id. According to the adverse effects, and fears of regulatory scrutiny. up at her second visit exhibiting These challenges may be overcome by adherence to intake paperwork that T.H. completed, the Federation of State Medical Board’s guidelines, somnolence and slurred speech; (2) he reported that he was not currently use of random urine drug screening, monitoring for failed the UDS that was administered at seeing any other provider, id. at 3, and aberrant behaviors, and anticipating adverse that visit, and (3) several months later, also reported that he was not taking any effects.’’ See id. (quoting GX 39, at 5). The Expert suffered a drug overdose that the further noted that the article also states that drugs other than asthma medications. ‘‘[w]hen psychiatric comorbidities are present, risk practitioners learned was the latest of Id. at 4. of substance abuse is high and pain management several prior drug overdoses, in addition According to the Expert, the record of may require specialized treatment or consultation. to multiple prior suicide attempts. Id. at T.H.’s first visit is noteworthy for the Referral to a pain management specialist can be 44–45. As the Expert found, Reynolds, helpful,’’ and that the evaluation of the patient must absence of any information about his include ‘‘[a] thorough social and psychiatric history Stout, and Killebrew ignored numerous history and potential for substance [that] may alert the physician to issues, such as warning signs that N.S. was abusing abuse. GX 68, at 45; GX 17, at 47. Also, current and past substance abuse, development and/or diverting controlled substances the record does not contain a written history, depression, anxiety, or other factors that may interfere with achieving treatment goals.’’ Id. that continued throughout her nearly treatment plan that documents The Expert also noted the article’s statement that six-year association with AMC, and they objectives for evaluating progress from ‘‘[f]or patients at high risk of diversion and abuse, continued to provide her with the use of controlled substances. GX 68, consider the routine use of random urine drug controlled substances when they knew at 45; GX 17, at 47. As the Expert screens to assess for presence of prescribed or should have known that she was medications and the absence of illicit substances.’’ explained, all of these issues were GX 68, at 42 (quoting GX 39, at 9 of 22) (emphasis acquiring the controlled substances for required to be, but were not addressed added). Finally, the Expert noted the article’s other than legitimate medical purposes. before T.H. was prescribed controlled statement that ‘‘[a]berrant behavior that may suggest Id. at 45. substances. GX 68, at 46 (citing TN BON medication misuse includes use of pain In a letter to a DEA Diversion medications other than for pain treatment, impaired Rule 1000–04–.08(4)(c)1 and 2). control (of self or of medication use), compulsive Investigator, Reynolds addressed AMC’s The Expert further found that the use of medication . . . selling or altering treatment of N.S. He asserted that N.S. record of T.H.’s first visit revealed the medications, calls for early refills, losing was kept on the same medication that first of several red flags of his potential prescriptions, drug-seeking behavior (e.g. doctor- she had been prescribed by a abuse and/or diversion of controlled shopping), or reluctance to try nonpharmacologic intervention.’’ Id. (quoting GX 39, at 11) (emphasis neurosurgeon who had referred her to substances. Id. These included that on added). AMC. GX 42, at 7. Yet as the Expert the initial intake form he completed,

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T.H. reported that he had ‘‘frequent or T.H. was asked to submit to a UDS to occasionally.’’ GX 17, at 57. recurring problems’’ with alcohol. GX see if he was taking the drugs he had Furthermore, Mr. Powell noted that 17, at 4. He also reported that either he been prescribed. Id. T.H.’s ‘‘chronic low back pain’’ had or a close family member had suffered The practitioner also diagnosed T.H. been going on for ‘‘two years.’’ Id. from ‘‘Alcoholism’’ and ‘‘Mental as suffering from anxiety and According to the record of his Feb. 21, Illness.’’ Id. depression. GX 17, at 46. According to 2006 visit, T.H. specifically ‘‘Requested According to the Expert, T.H.’s the Expert, diagnosing the potential Bob.’’ GX 17, at 43. The Expert found disclosure of issues with alcohol abuse source of a patient’s stress is critical in that the record of this visit is largely and mental illness were red flags of his determining the appropriate course of unintelligible due to Reynolds’ potential drug abuse; she also noted that treatment. GX 68, at 47. Thus, the incomprehensible handwriting. GX 68, the Pain Management Agreements decision to issue T.H. any controlled at 48. However, there is no evidence in which T.H. was required to sign substance prescriptions at this visit T.H.’s file that the facet blocks had been provided that ‘‘[t]he use of alcohol and based on the information he reported performed in the two and one-half opioid medications is contraindicated.’’ was contrary to the guidelines set forth months since he had seen Mr. Powell. GX 68, at 46 (citing GX 17, at 5). in TN BON Rule 1000–04–.08(4)(c)1,2,4, Id.; see also GX 17. In fact, there is no According to the Expert, T.H.’s and accordingly, below the standard of evidence in the file that the facet blocks disclosures should have been explored care and outside the usual course of were ever done. GX 17. Also, there is no further by the nurse practitioner who professional practice. Id. (citing GX 41 documentation of what, if anything, saw him, but according to the record (Uphold & Graham)). However, here T.H. had been doing to address his pain were not assessed. Id. The Expert again T.H. was issued prescriptions for for the past month when he would have further opined that without a further 45 Lortab 7.5 mg and 30 Xanax .5 mg. been out of the drugs prescribed by Mr. evaluation of these issues, the GX 17, at 46. Powell.8 See GX 68, at 48–49; GX 17, at practitioner should not have issued T.H. At T.H.’s third visit on November 28, 43. a prescription for controlled substances. 2005, the practitioner noted that he Id. discussed marriage counseling, thus Nonetheless, at the visit, Reynolds The Expert also explained that if T.H. indicating that he was having marital issued T.H. prescriptions for 60 tablets was in recovery from alcoholism, he problems. Id. at 45; GX 68, at 47. of OxyContin 40 mg, 30 tablets of Lortab should have been referred to a According to the Expert, this was 10 mg, and 90 Xanax 1 mg. See GX 17, comprehensive pain specialist program, another potential red flag with respect at 43; GX 5, at 13. According to the and should not have been treated by a to the prescribing of opioids given Expert, Reynolds’ issuance of these primary care nurse practitioner. Id. As T.H.’s reports of anxiety and depression, prescriptions was contrary to the the Expert explained: ‘‘ ‘[p]atients who as well as his prior report that he had guidelines set forth in TN BON Rule are alcohol dependent and who also lost his job. GX 68, at 47–48. T.H. was 1000–04–.08 and, accordingly, below have a psychiatric disorder should be referred to another provider (Dr. the standard of care in Tennessee and referred for treatment for the underlying Williams), and directed to return for a outside the usual course of professional disorder as these patients are usually follow-up visit in ‘‘2 months.’’ GX 17, at practice. GX 68, at 49. complex.’ ’’ Id. (quoting GX 41, at 23 45. He was also issued prescriptions 60 According to the Expert, Reynolds (Uphold & Graham)). Thus, according to Lortab 7.5 mg and 30 Xanax .5 mg. Id. lacked ‘‘an appropriate medical the Expert, the decision to issue him Nearly three months later on February justification for adding a prescription any controlled substance prescriptions 21, 2006, T.H. returned to AMC and saw for a schedule II controlled substance at this initial visit was contrary to the Reynolds. See GX 17, at 43. In the such as OxyContin 40 mg to treat guidelines set forth in TN BON Rule interim, on December 5, 2005, T.H. was [T.H.’s] purported pain,’’ given that the 1000–04–.08(4)(c)1 & 2, and seen at Dr. T. Williams’ pain clinic, Pain pain specialist (Mr. Powell) was of the accordingly, below the standard of care Medicine Associates. See GX 17, at 57– opinion that ‘‘T.H. did not require in Tennessee and outside the usual 58; 45–46. John Powell, a Physician anything more than a short-term course of professional practice. Id. at Assistant in Dr. Williams’ clinic, prescription for Lortab [then a schedule 46–47. Nonetheless, T.H. was issued identified a possible source of the III controlled substance], and for only as prescriptions for 30 Lortab 7.5 mg and ‘‘mechanical low back pain’’ that T.H. long as it took to get the facet blocks 30 Xanax .25 mg. GX 17, at 47. was reporting. GX 17, at 57. Notably, the completed.’’ Id. Also, even though During his second visit on October 25, pain clinic recommended that ‘‘facet Reynolds was now aware (based on Mr. 2005, T.H. reported that he had recently blocks should be undertaken as a Powell’s report) that T.H. had been lost his job and was looking for a new diagnostic procedure followed by having back problems for two years, one. He also reported increased stress, radiofrequency denervation if positive.’’ there was still no documentation or that he was not sleeping, and that he GX 17, at 58. Also, the pain clinic records of any prior treatments he had was having ‘‘roller coaster feelings.’’ Id. recommended that T.H. be prescribed received before he started at AMC in at 46. According to the Expert, ‘‘the 90 tablets of Lortab 10 mg, one tablet October 2005. See GX 68, at 49–50 reported loss of income by a patient three times a day, ‘‘until we can get the (citing TN BON Rule 1000–04–.08(4)(c)1 who is receiving opioids, such as above accomplished.’’ Id. (emphasis (requiring documentation of historical hydrocodone (Lortab), is also a red flag added). data that includes ‘‘pertinent of potential diversion. The practitioner Based on her review of the pain evaluations by another provider’’)). must consider the risk that the patient clinic’s letter, the Expert concluded that may try to sell those drugs to generate the clinic had issued T.H. a prescription 8 In his letter to the DI, Reynolds asserted that TH the income he no longer is obtaining for a thirty-day supply of Lortab 10 mg ‘‘returned to AMC on February 21, 2006 from pain from his job.’’ GX 68, at 47. The Expert to hold him over until he received the management on long-term medication, Oxy[C]ontin, noted, however, that there is no facet blocks. GX 68, at 48. In addition, 40 milligrams, twice daily, and Lortab, 10 documentation in the visit note that the and significantly, Mr. Powell milligrams, #30. This medication was continued until the patient’s death.’’ GX 42, at 4. There is, issue of how he was going to pay for his documented that T.H. had again however, no evidence in T.H.’s file (such as a treatments and medications was disclosed that he ‘‘had an alcohol discharge summary form Pain Medicine Associates) discussed, nor is there any evidence that problem in the past’’ and ‘‘still drinks which supports this assertion.

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The Expert also found that up to this together would not be the next step for there was also no information provided point, neither Reynolds nor the AMC a patient with uncontrolled pain. In this about the efficacy of the medications or practitioner who had treated T.H. at his situation, the patient’s medication [was] the functionality of the patient. GX 68, previous visits had adequately escalated to a long-acting opioid, such at 52 (citing TN BON Rule 1000– documented and evaluated his prior as OxyContin 10 mg twice daily, which 04.08(4)(c)). The Expert also noted that alcohol problems and the extent of his is done when pain management is while Stout acknowledged that T.H. was current consumption of alcohol. Id. at expected to be for a prolonged period of anxious and depressed, the visit notes 49 (citing TN BON Rule 1000–04– time.’’ Id. at 50–51. The Expert then had no additional information about the .08(4)(c)1 (requiring documentation of noted that Reynolds had prescribed a psychosocial situation of the patient. Id. historical data that includes ‘‘history of starting dose of 40mg twice daily, which The Expert also observed that Stout and potential for substance abuse’’)). is four times the normal starting dose, did not generate a written treatment The Expert also found it significant that and that ‘‘when starting a patient on a plan for T.H. and, as such, there was neither Reynolds nor his colleague had long-acting opioid, a short-acting opioid still no written treatment plan for T.H. sufficiently explored T.H.’s may be used for break-through pain, but Id. (citing TN BON Rule 1000– psychological problems, specifically, not typically at the initial prescribing of 04.08(4)(c)2). Nor did Stout evaluate or the anxiety and increased stress that the long-acting medication.’’ Id. at 51. assess T.H.’s history of, or potential for, T.H. previously had reported despite The Expert also explained that Lortab substance abuse. Id. (citing TN BON circling ‘‘anxious’’ and ‘‘depressed’’ in and OxyContin given in combination Rule 1000–04.08(4)(c)1). The Expert the examination section of the record of ‘‘may increase the risk of CNS and thus concluded that these prescriptions this visit. Id. at 49–50 (citing TN BON respiratory depression, profound were issued contrary to the guidelines Rule 1000–04–.08(4)(c)1 (requiring sedation and hypotension,’’ and that set forth in TN BON Rule 1000–04– documentation of historical data that Lortab and Xanax in combination ‘‘may .08(4)(c) and, accordingly, below the includes ‘‘pertinent coexisting diseases increase risk of CNS depression and standard of care and outside the usual and conditions’’ and ‘‘psychological cause psychomotor impairment’’ due to course of professional practice. Id. functions’’)). And the Expert noted that additive effects. Id. Also, according to On April 21, 2006, T.H. returned to Reynolds did not inquire about T.H.’s the Expert, OxyContin given in AMC and saw Reynolds, who issued current employment status, which, in combination with Xanax may result in him more prescriptions for 60 tablets of her view, could be significant if he was ‘‘vasodilation, severe hypotension, CNS OxyContin 40 mg, 30 tablets of Lortab still unemployed. Id. at 49. and respiratory depression, [and] 10 mg, and 60 tablets of Xanax 1 mg. The Expert observed that Reynolds’ psychomotor impairment due’’ to See GX 17, at 41; GX 5, at 13. Once failure to evaluate these issues prior to additive effects. Id. Finally, the Expert again, the Expert found that the record issuing the Xanax prescription was noted that the dose and the amount of for the visit was largely unintelligible. contrary to AMC’s own practice Xanax prescribed was excessive as it GX 68, at 52. She also observed that guidelines. Id. at 50. Specifically, the was six times the total daily dosage of while Reynolds documented that T.H. Expert explained that according to T.H.’s previous prescriptions and could was complaining of right upper Uphold & Graham, ‘‘ ‘[s]ubstance abuse be lethal, especially if taken in quadrant pain and referred him for can also produce anxiety.... Anxiety combination with two opioids. Id. possible ventral hernia, there did not can also occur as part of the withdrawal Citing Reynolds’ failure to perform a appear to be any documentation in the from the following: alcohol, cocaine, proper evaluation of T.H., the illogical file that the prior deficiencies in sedatives, hypnotics, anxiolytics.’ ’’ Id. and potentially dangerous escalation of complying with the guidelines of TN (quoting GX 41, at 5). Continuing, the opioid and benzodiazepine dosages in BON Rule 1000–04–.08 had been Expert explained that according to the prescriptions he issued, and the red corrected. Id. at 51–52. Also, no AMC Uphold & Graham, ‘‘ ‘[a]nxiety flags of potential drug abuse and practitioner, including Mr. Reynolds associated with other psychiatric diversion that T.H. presented, the and Mr. Stout, had created a written disorders (depression and alcohol Expert concluded that the prescriptions treatment plan for T.H, id. at 53 (citing dependence) is common. Discriminating he issued to T.H. at this visit were TN BON Rule 1000–04.08(4)(c)2); and between an anxiety disorder and a below the standard of care for a primary Reynolds still had not evaluated or depressive illness is quite difficult care provider and outside the usual assessed T.H.’s history of, or potential because of the overlap in symptoms.’ ’’ course of professional practice. Id. for, substance abuse. Id. (citing TN BON Id. at 50 (quoting GX 41, at 6.) The On March 22, 2006, T.H. returned for Rule 1000–04.08(4)(c)1). Expert thus concluded that ‘‘without a a follow-up visit and saw Stout. See GX According to the Expert, ‘‘opioids detailed evaluation of T.H.’s anxiety and 17, at 42. The Expert found that the typically would not be indicated in a psychosocial history and substance record of this visit was sparse, as ‘‘Stout case of new onset of abdominal pain, or abuse history (including a drug simply noted that T.H. was ‘‘[h]ere for even contraindicated pending an toxicology screen, or UDS), it was a follow-up. Denies recent trauma or evaluation of the cause of the pain.’’ Id. inappropriate for Mr. Reynolds to illness. No fever, chills, nvd,’’ and then Given that T.H. had reported losing his prescribe Xanax for the treatment for circled entries on the record indicating job, the Expert also found it significant anxiety. He lacked any understanding of that T.H. was anxious, depressed, and that the visit noted stated that he had a the etiology of that reported condition at had lower back pain and cervical pain. ‘‘$310 balance; ins no pay.’’ Id. (quoting that juncture.’’ Id. GX 68, at 51. GX 17, at 41). According to the Expert, The Expert also explained that the Stout issued T.H. additional this was a red flag for potential combination and quantity of prescriptions for 60 tablets of diversion which should have been prescriptions Reynolds issued at the OxyContin 40 mg, 30 tablets of Lortab explored because ‘‘it indicates that T.H. visit was further evidence that these 10 mg, and 60 tablets of Xanax 1 mg. [wa]s likely uninsured with increasing prescriptions were not issued in the See GX 17, at 42; GX 5, at 13. However, medical bills [and] [a] practitioner usual course of professional practice or the Expert found that Stout did not would have to be concerned about how for a legitimate medical purpose. Id. document any evidence of the T.H. was going to pay for not only the According to the Expert, ‘‘the appropriateness of therapy by failing to balance he owed to AMC, but also the combination of OxyContin and Lortab quantify or evaluate T.H.’s pain and that drugs he was being prescribed in the

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absence of insurance and possibly (still) any opioid medication or adjunctive On June 20, 2006, T.H. returned to a job.’’ Id. analgesia from other physicians . . . AMC and was again seen by Reynolds. The Expert also found that T.H. may result in termination of the doctor- GX 17, at 39. Once again, Reynolds presented another red flag in that, patient relationship.’ ’’ GX 68, at 54–55 issued T.H. more prescriptions for 60 according to the visit note, he did not (quoting GX 17, at 5). Indeed, in his tablets of OxyContin 40 mg, 30 tablets complain ‘‘of constipation.’’ Id. letter to a DEA Diversion Investigator, of Lortab 10 mg, and 60 tablets of Xanax According to the Expert, ‘‘[i]f T.H. Reynolds acknowledged that T.H. had 1 mg. See id.; GX 18, at 30. Moreover, actually was taking the amount of signed the Pain Management Agreement at this visit, T.H. presented a further red narcotics he had been prescribed, Mr. at his first visit to AMC. GX 42, at 4. flag—specifically, Reynolds learned that Reynolds should have expected T.H. to Notwithstanding T.H.’s clear violation T.H. was being treated with Suboxone, complain of constipation and need a of the Agreement, Reynolds issued him a schedule III controlled substance used prescription to treat this condition. more prescriptions for 60 tablets of to treat narcotic dependency, at the Absence of a constipation complaint OxyContin 40 mg, 30 tablets of Lortab same time he had been receiving may be a signal [that] T.H. was NOT 10 mg, and 60 tablets of Xanax 1 mg. narcotics from AMC. GX 17, at 39. As taking the drugs and instead was See GX 17, at 40; GX 18, at 30. As the the Expert found, the record of this visit diverting them.’’ Id. Expert explained, when Reynolds contains an entry apparently made by The Expert then explained that under issued these prescriptions, T.H. A.N., a Registered Nurse, stating: these circumstances, the standard of presented with multiple red flags in ‘‘ ‘observed note regarding Medicine care and usual course of professional addition to that of doctor shopping. Shoppe in Jonesboro TN & Suboxone 8 practice required that T.H. undergo a These included his financial, mental mg (Knoxville region) & Oxycodone 40 UDS to determine if he was taking the health, and alcohol issues. GX 68, at 55. mg from Appalachian Med Center & will drugs that were prescribed and not However, ‘‘T.H.’s file contains no consult proprietor of Appalachian Med diverting them. Id. However, the Expert indication that either Reynolds or Stout Center Bob Reynolds FNP regarding found that there was no documentation took the measures that a reasonable and urine screen possibly needed & how to in the visit note, or anywhere else in prudent practitioner would have taken, proceed in care of this pt. Contact T.H.’s file, that he was asked to submit such as to contact the other doctor [Dr. person at Medicine Shoppe is Jeff to a UDS at this visit. Id.; see also GX Dube] to confirm that he was no longer Street.’ ’’ GX 68, at 56–57 (quoting GX 17. The Expert thus concluded that seeing T.H. and to ascertain the nature 17, at 39). Reynolds’ issuance of the April 21, 2006 and extent of his treatment of T.H.’’ Id. In reviewing T.H.’s file, the Expert prescriptions was contrary to the Also, neither Reynolds nor Stout took observed that the note referenced by guidelines set forth in TN BON Rule ‘‘any other steps to ascertain the scope A.N. was not in the file. Id. at 57. The 1000–04–.08(4)(c) and, accordingly, of T.H.’s abuse and/or diversion of Expert also observed that T.H.’s file did below the standard of care and outside controlled substances,’’ such as by not contain any documentation the usual course of professional requiring him to provide a UDS. Id.; see indicating that Reynolds had practice. GX 68, at 53–54. also GX 17, at 5 & 40. Moreover, while investigated the information On May 22, 2006, T.H. returned to in the Pain Management Agreement, documented by the RN, such as AMC and was seen by both Reynolds T.H. had agreed to use only one documentation that Reynolds had and Stout. See GX 17, at 40.9 According pharmacy (the Hillcrest pharmacy), GX contacted the pharmacy about T.H.’s to the Expert, the handwriting of both 17, at 5; neither Reynolds nor Stout Suboxone treatment or obtained a Stout and Reynolds appears on the checked with the pharmacy to record of the prescriptions T.H. had record of this visit, even though the visit determine if he was, in fact, presenting presented and filled at the pharmacy. Id. noted was signed by Mr. Stout. GX 68, all of his AMC prescriptions there and And the Expert further explained that at 54. if he was also presenting controlled the fact that the Medicine Shoppe had During the visit, Stout noted that T.H. substances prescriptions from other prescription information for T.H. was reported that he had been seeing practitioners. See generally GX 17. also a red flag because T.H. had agreed another practitioner at the same time According to the Expert, ‘‘each of to use only the Hillcrest pharmacy to fill that he was obtaining controlled these steps was an action that a his prescriptions. See id. The Expert substances from AMC. GX 17, at 40. reasonable and prudent family nurse thus concluded that Reynolds’ issuance Specifically, Stout wrote: ‘‘[Patient] has practitioner would have taken when of the prescriptions was outside of the spoken with Bob Reynolds about seeing presented with this information, and usual course of professional Dr. Doobie [(sic)]. [Patient] states has not was required by the standard of care in practice.10 Id. at 56–57. seen since 4/2006.’’ Id. Tennessee.’’ GX 68, at 55–56. The On July 19, 2006, T.H. returned to As the Expert explained, this was Expert thus explained that under the AMC. Reynolds again issued him more another red flag for diversion and abuse, circumstances, the standard of care and prescriptions for 60 tablets of ‘‘which is commonly referred to as the usual course of professional practice OxyContin 40 mg, 30 tablets of Lortab ‘doctor-shopping.’ ’’ GX 68, at 54. required the enforcement of the terms of 10 mg, and 60 tablets of Xanax 1 mg. Moreover, ‘‘T.H.’s disclosure established the Pain Management Agreement, see See GX 17, at 38; GX 18, at 29. And once that he had violated the Pain GX 17, at 5 (pars. 1, 3, and 9); the again, Reynolds had received additional Management Agreement,’’ which cessation of the issuance of more information indicating that T.H. was included the provision that he would controlled substances prescriptions; the likely engaged in abuse. GX 68, at 58. ‘‘ ‘use only one physician to prescribe taking of measures to ascertain whether 10 and monitor all opioid medications and T.H. was diverting the drugs he had The Expert further explained that the usual adjunctive analgesics,’ ’’ and that course of professional practice required that the been prescribed by requiring a UDS and Pain Agreement be enforced, the cessation of ‘‘ ‘[a]ny evidence of . . . acquisition of contacting his pharmacy; and the controlled substance prescriptions, that the referral of T.H to either a pain Medicine Shoppe be contacted to follow-up on the 9 The Expert based her conclusion on the fact that items noted, that T.H. be required to submit a UDS, in course of reviewing the records, she had become management specialist and/or a and that T.H. be referred to either a pain familiar with the respective handwriting of psychological/addiction specialist. GX management specialist, and/or a psychological/ Reynolds, Stout, and Killebrew. GX 68, at 54. 68, at 56. addiction specialist. GX 68, at 57.

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More specifically, T.H.’s file contains The Expert further explained that prescriptions T.H. had filled, and order four documents that apparently were Reynolds should have been interested in T.H. to take a UDS to determine if he faxed to AMC from ‘‘Northside Admin,’’ knowing if the Zoloft prescriber was the was taking or diverting the controlled and appear to have been faxed on the same Knoxville-based practitioner who substances he had been issued or was same date.11 See GX 17, at 59–62. reportedly was providing T.H. with taking controlled substances he had not However, the date on the fax banner at Suboxone as mentioned in the RN’s note been prescribed at AMC.’’ GX 68, at 60. the top of each page is cut-off. See id. for T.H.’s previous visit. Id. On September 7, 2006, T.H. returned Notably, one of the documents was an Noting that there was no evidence to AMC and was seen by Stout, who April 21, 2006, letter from Dr. Michael that Reynolds had contacted Dr. Dube, issued him prescriptions for 60 tablets Dube informing T.H. that he ‘‘will no the Zoloft prescriber, the Hillcrest of OxyContin 40 mg, 45 tablets of Lortab longer be treated as a patient at Medical Pharmacy, or the Medicine Shoppe 10 mg, and 75 tablets of Xanax 1 mg. Care Clinic and/or Watauga Walk-in Pharmacy; nor evidence that he had See GX 17, at 36; GX 18, at 8. According Clinic.’’ See GX 17, at 61. A second required that T.H. provide a UDS; the to the Expert, Stout noted in the record document showed that as of March 31, Expert concluded that Reynolds’ of this visit that ‘‘[T.H.] got meds filled 2006, T.H. owed $230 to Medical Care issuance of the prescriptions was below early on 08/10/06—Rx dated 08/15/06.’’ Clinic. Id. at 59. A third document the standard of care and outside of the GX 68, at 61. As the Expert explained, showed that as of June 6, 2006, T.H. usual course of professional practice. Id. Stout was clearly aware of this red flag owed $2,976 to Pain Medicine at 58–59. The Expert further opined that and should have questioned if T.H. was Associates (Dr. Williams’ clinic), where under the circumstances, the standard taking more than the prescribed amount T.H. was seen on December 5, 2005, of care and usual course of professional or if he was selling the drugs. Id. having been referred by AMC. Id. at 60. practice would not be to issue T.H. Notwithstanding this, as well as the The fourth document showed that on additional controlled substances extensive other evidence in T.H.’s June 12, 2006, T.H. had received a prescriptions but to enforce the terms of record that he was either abusing and/ prescription for Zoloft, a non-controlled the Pain Management Agreement and or diverting controlled substances, Stout drug used to treat depression, from a cease further prescribing of controlled issued the prescription. GX 18, at 8. For medical doctor in Knoxville, Tennessee. substances to T.H. Id. at 59. the same reasons set forth with respect Id. at 62. On August 10, 2006, T.H. returned to to T.H.’s previous visit, the Expert As the Expert explained, the letter AMC, even though this was just twenty- concluded that Stout’s issuance of the from Dr. Dube confirmed the two days since his last visit. GX 17, at prescriptions was below the standard of information that Reynolds and Stout 37. Reynolds again saw T.H. and issued care and outside of the usual course of received at T.H.’s April 20, 2006 visit, him prescriptions for 10 tablets of professional practice. GX 68, at 61. namely, that he was seeing another Lortab 10 mg and 15 tablets of Xanax 1 On September 29, 2006, T.H. returned provider at the same time he was mg, which he authorized T.H. to fill on to AMC and was seen by Reynolds, who receiving controlled substances from that date, as well as prescriptions for 60 issued him prescriptions for 60 tablets AMC, and thus likely doctor-shopping. tablets of OxyContin 40 mg, 30 tablets of OxyContin 40 mg, 75 tablets of Xanax GX 68, at 58. The billing statements of Lortab 10 mg, and 60 tablets of Xanax 1 mg, and 45 Lortab 10 mg. GX 17, at from Medical Care Clinic (Dr. Dube’s 1 mg, which could not be filled until 35; GX 18, at 8. Once again, T.H. practice) and Pain Medicine Associates August 15, 2006. See GX 17, at 37; GX presented a red flag in that he was (Dr. Williams’ practice), ‘‘provide[d] 5, at 13. Reynolds issued these seeking an early refill of both his further evidence that T.H. was having prescriptions notwithstanding the OxyContin and Xanax prescriptions. GX significant financial difficulties.’’ Id. at evidence that T.H. was abusing and/or 68, at 62. According to the Expert, T.H. 58–59. According to the Expert, the fact diverting controlled substances should have had eight days left on the that T.H. was approximately $3000 in discussed above, and even though T.H. previous OxyContin prescription (which debt to two medical practices should was seeking an early refill of his Lortab was for a thirty-day supply) and at least have been viewed as another red flag of and Xanax prescriptions on this visit. three days left on the previous Xanax his possible diversion of controlled GX 68, at 60. As the Expert explained, prescription (which provided 75 tablets substances. Id. at 59. T.H. should have had eight days of with a dosing of one tablet every 8–12 As for the Zoloft prescription, the Xanax tablets remaining on the hours). See GX 68, at 62; GX 17, at 36; Expert observed that this was evidence prescription Reynolds issued him on GX 18, at 8. that T.H. was having his mental health July 19, 2006. Id. (citing GX 18, at 29). The Expert also noted that while T.H. issues addressed by another provider. Here again, T.H.’s early refill request had been receiving narcotics from AMC Id. As such, it was also a red flag that was another red flag that T.H. was for nearly one year and had yet to be T.H. was possibly obtaining controlled abusing and/or diverting the controlled subjected to a UDS, and T.H.’s file substances from another practitioner substances that Reynolds was documents that Reynolds sent him for after he was discharged by Dr. Dube. Id. prescribing to him. Id. For the same blood work after this visit to check his reason as stated above, the Expert blood counts, thyroid, and metabolic 11 The Expert acknowledged that the fax banner concluded that ‘‘the standard of care panel, see GX 16, at 50; Reynolds did on the copies in T.H.’s file was cut off. However, and usual course of professional not require that T.H. provide a UDS. GX the Expert explained that she had reviewed copies of the same four documents that were sent to practice under these circumstances 68, at 62. ‘‘Based on this new red flag another provider (see GX 22), which were provided would not be to issue T.H. additional and the prior information indicating by DEA, and that the date appearing on the fax controlled substances prescriptions.’’ Id. T.H.’s abuse and/or diversion of banner was July 5, 2006. It is clear, however that Rather, the standard of care and usual controlled substances,’’ the Expert these documents were faxed and received by AMC because the next day, one William Clever, another course of professional practice required concluded that ‘‘it was below the Advance Nurse Practitioner at AMC, wrote a letter that Reynolds ‘‘enforce the terms of the’’ standard of care and outside the usual to T.H. on AMC’s letterhead that he was Pain Contract, see GX 17, at 5 (par. 9), course of professional practice for ‘‘withdrawing from further professional attendance ‘‘cease issuing further controlled Reynolds to issue these prescriptions with you,’’ suggested that T.H. find ‘‘another provider without delay,’’ and that ‘‘after receipt of substances to T.H., contact Hillcrest without taking any steps to monitor his this letter, we will no longer be able to prescribe Pharmacy and Medicine Shoppe controlled substances use, including narcotics to you.’’ GX 21, at 1. pharmacy to determine the conducting a UDS and checking with

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his pharmacy for controlled substances accordingly, below the standard of care prescriptions for 60 tablets of prescriptions he was filling.’’12 Id. and outside the usual course of OxyContin 40 mg, 30 tablets of Lortab On January 3, 2007, T.H. went to professional practice. Id. at 64. 10 mg, and 75 tablets of Xanax 1 mg. AMC and saw Killebrew, who issued On March 2, 2007, T.H. visited AMC See GX 17, at 27; GX 18, at 25–26. Once him prescriptions for 60 tablets of and saw Stout, who issued him again, the Expert found that Stout’s OxyContin 40 mg, 30 tablets of Percocet prescriptions for 60 tablets of record of the visit was ‘‘very sparse,’’ as 10/325 mg, and 75 tablets of Xanax 1 OxyContin 40 mg, 30 tablets of Lortab it stated only: ‘‘Here for follow-up. PT mg. See GX 17, at 32; GX 18, at 28. 10 mg, and 75 tablets of Xanax 1 mg. denies trauma. Patient states back pain Killebrew noted in the record of this See GX 17, at 29; GX 18, at 27. The is controlled by pain medication. Denies visit that T.H. was ‘‘[g]etting Expert opined that Stout’s notes for this radiation of pain or urinary [d]ivorced,’’ complaining of increased visit were ‘‘sparse, at best’’ as they state incontinence. Denies chest pain or sob. anxiety due to his divorce, and was only that T.H. was ‘‘[h]ere for follow-up. Denies fever, chills, nvd.’’ GX 68, at 65. crying. See GX 17, at 32. The visit note Denies recent trauma or illness. Patient Once again, the Expert observed that the also documents that T.H. had lost six states pain medication is controlling his visit note did not document that Stout pounds since his last visit. Id. pain. Describes pain as 4/10 while on had discussed with T.H. his use of According to the Expert, this may pain medication. Denies fever, chills, alcohol (the ETOH portion of the form indicate that T.H. had depression given nvd.’’ GX 68, at 64 (quoting GX 17, at being blank), his anxiety,13 and his the information T.H. shared about his 29). The Expert also observed that the employment and financial situation. Id. divorce and Killebrew wrote him a visit notes contained no discussion of The Expert also found that there was prescription for an antidepressant T.H.’s anxiety issues which Killebrew still no evidence of a written treatment (Celexa) at this visit. GX 68, at 63 (citing had documented during the January 3, plan for T.H. identifying treatment GX 17, at 32). T.H. also reported that his 2007 visit. Id. The Expert also found objectives, or an update on the pain was a seven out of ten, which that there was ‘‘no documentation of treatment plan as required by TN BON indicates that the drug regimen he had any evaluation or assessment of the Rule 1000–04–.08(4)(c)2, 4; she also been prescribed previously at AMC was alcohol and financial red flags that were found that Stout failed to quantify T.H.’s not controlling his pain. Id. Killebrew presented at several prior visits,’’ that pain on this visit. Id. at 66. And once also had T.H. sign a new Pain Stout ‘‘neglected to inquire about again, the Expert found that Stout did Management Agreement, which she whether T.H. was now employed or not take any steps to monitor whether witnessed. GX 17, at 2. whether he was currently drinking T.H. was currently doctor-shopping and The Expert explained that based on alcohol’’ even though the form seeing other practitioners. Id. The the information T.H. reported at this contained a section for alcohol use Expert thus opined that Stout’s issuance visit, as well as the information in his (‘‘ETOH’’), nor elaborated on his of these prescriptions was contrary to file from prior visits, T.H. should have purported finding that T.H. was the guidelines set forth in Tennessee been considered a ‘‘high-risk patient for ‘‘anxious.’’ Id. BON Rule 1000–04–.08(4)(c), and managing chronic pain’’ and whose The Expert also found that there was accordingly, below the standard of care ‘‘care extend[ed] beyond the scope of’’ still no evidence that a written in Tennessee and outside the usual a nurse practitioner engaged in family treatment plan was created for T.H. course of professional practice. Id. practice ‘‘at this point.’’ GX 68, at 63. identifying objectives of treatment, or an On June 26, 2007, T.H. visited AMC The Expert further noted that a prudent update on the treatment plan as and saw Stout, who again issued him practitioner would have considered T.H. required by TN BON Rule 1000–04– prescriptions for 60 tablets of to be ‘‘a risk for suicide and diversion’’ .08(4)(c)2 & 4. Id. Moreover, the Expert OxyContin 40 mg, 30 tablets of Lortab and would have referred him ‘‘to a found that while on January 1, 2007, the 10 mg, and 75 tablets of Xanax 1 mg. mental health specialist and a Tennessee prescription monitoring See GX 17, at 23–24; GX 5, at 14–17. comprehensive pain management program (CSMD) had become available While the Expert noted that AMC had program.’’ Id. Yet, the Expert found no to practitioners to assist them in started using electronic medical records evidence in the file that Killebrew did determining whether their patients were and that Stout had noted that T.H. ‘‘is so. Id. seeing other providers, there was no satisfied with the current treatment The Expert also noted that there was evidence in the file that Stout plan,’’ she still found that there was no no documentation in T.H.’s file conducted a check on T.H. at this visit, documentation in the record of a written indicating that Killebrew had checked even though T.H.’s record documented treatment plan. GX 68, at 66 (citing TN with the pharmacy T.H. had identified multiple instances in which AMC BON Rule 1000–04–.08(4)(c)2). The on his pain contracts as the sole obtained information that T.H. was Expert further noted that while Stout pharmacy he would use to fill his engaged in doctor-shopping. Id. at 64– documented that T.H. reported he was prescriptions to determine if he still was 65. Nor did the Expert find any having ‘‘some increases [sic] problems engaging in doctor-shopping. Id. The evidence in the file that Stout had Expert also found no evidence that situationally lately with their [sic] checked with the pharmacy T.H. anxiety and depression,’’ Stout again Killebrew required him to submit to a identified on his pain contracts as the UDS. Id. at 63–64. Based on the red flags neglected to inquire about T.H.’s use of sole pharmacy he would use to fill his alcohol, which could have been the T.H. presented and Killebrew’s failure prescriptions to determine if he was to take these steps to monitor T.H.’s use source of his anxiety and depression doctor shopping. Id. at 65. The Expert problems. Id. (quoting GX 17, at 23); of controlled substances, the Expert thus opined that Stout’s issuance of opined that the issuance of the also citing GX 41, at 6 (Uphold & these prescriptions was contrary to the Graham). prescriptions was contrary to the guidelines set forth in Tennessee BON Board’s Rule 1000–04–.08(4)(c), and, According to the Expert, Stout’s Rule 1000–04–.08(4)(c), and, failure to address this issue was accordingly, below the standard of care contrary to the requirements of TN BON 12 Reynolds also saw T.H. on November 6 and in Tennessee and outside the usual December 4, 2006; at each visit, Reynolds issued him prescriptions for 60 OxyContin 40 mg, 30 course of professional practice. Id. 13 While the note stated that T.H. was ‘‘anxious,’’ Percocet 10/325 mg, and 75 Xanax 1 mg. GX 17, at On May 1, 2007, T.H. visited AMC the Expert explained that Stout ‘‘failed to elaborate 33–34; GX 18, at 9–10. and saw Stout, who again issued him on his finding.’’ GX 68, at 65.

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Rule 1000–04–.08(4)(c)2 because While the Expert noted that Killebrew forth in the paragraphs above.’’ GX 68, ‘‘[w]ithout knowing about the status of had documented in T.H.’s record that at 69–70. The Expert thus concluded his alcohol issues, Mr. Stout was she had provided him with information that Killebrew’s issuance of the unable, and in fact did not ‘consider on Alcoholics Anonymous and other additional controlled substance [the] need for further testing, recovery groups, id. (citing GX 17, at prescriptions was contrary to the consultations, referrals, or use of other 21); the Expert then explained that ‘‘a guidelines set forth in Tennessee BON treatment modalities.’ ’’ Id. at 67. Also, patient who is trying to quit alcohol is Rule 1000–04–.08(4)(c), and while Stout noted that T.H. was having not an appropriate patient for [a] accordingly, below the standard of care ‘‘work issues’’ and ‘‘financial primary care nurse practitioner to and outside the usual course of problems,’’ he failed to document attempt to manage his chronic pain’’ Id. professional practice. Id. at 70 (citing whether T.H. was in fact now employed The Expert thus found that ‘‘Killebrew Uphold & Graham, GX 41, at 14, 23). and capable of paying for his continued should have ceased issuing T.H. further On September 19, 2007, T.H. returned treatment (including medications). Id. controlled substance prescriptions and to AMC and saw Reynolds, who issued Moreover, the Expert found no evidence sent him for evaluation by a mental him prescriptions for 60 tablets of that Stout took any steps to monitor health specialist,’’ and further OxyContin 40 mg, 30 tablets of Percocet whether T.H. was currently doctor- concluded that Killebrew’s issuance of 10/650 mg, and 90 tablets of Valium 10 shopping and seeing other practitioners. the prescriptions was ‘‘contrary to the mg. See GX 17, at 17–18; GX 18, at 23. Id. The Expert thus opined that Stout’s guidelines set forth in Tennessee BON According to the Expert, Reynolds issuance of these prescriptions was Rule 1000–04–.08(4)(c), and issued these prescriptions without contrary to the guidelines set forth in accordingly, not consistent with the discussing with T.H. his visit at the Tennessee BON Rule 1000–04–.08(4)(c), standard of care and outside the usual mental health facility and did not obtain and accordingly, below the standard of course of professional practice.’’ Id. any records from the facility, even care in Tennessee and outside the usual On August 23, 2007, Killebrew again though the two previous visit notes course of professional practice. Id. saw T.H. and issued him prescriptions mentioned that T.H. had made such an On July 24, 2007, T.H. returned to for 60 tablets of OxyContin 40 mg, 30 appointment. GX 68, at 70. Reynolds AMC and saw Killebrew, who issued tablets of Lortab 10 mg, and 90 tablets also did not acquire any information him prescriptions for 60 tablets of of Valium 10 mg. See GX 17, at 19–20; from T.H. about his efforts to quit OxyContin 40 mg, 30 tablets of Lortab GX. 18, at 23. Killebrew noted in the alcohol, even though this was also visit record that T.H. had recently gone mentioned in the two previous visit 10 mg, and 90 tablets of Valium 10 mg. to the JCMC emergency room after notes, and Reynolds did not document See GX 17, at 21–22; GX 18, at 24. T.H. injuring his left leg. See GX 17, at 19. that he even addressed with T.H. his reported that his pain was a 4 out of 10, According to the Expert, this alcohol issues. Id.; GX 17, at 17–18. Nor that he was having problems with information was also a red flag is there any documentation that anxiety (which, according to the Expert suggestive of either abuse or an injury Reynolds discussed with T.H. his recent indicated that the Xanax was not caused by over sedation, as the latter visit to the Emergency Room and T.H.’s controlling his anxiety), and that he was could have resulted from T.H.’s file contains no record of his visit to the trying to quit alcohol. GX 17, at 21. T.H. combined ingestion of Valium (which ER. GX 17, at 17–18. also reported that he had made an she had previously prescribed to him) The Expert further noted that appointment with a local mental health and alcohol, or Valium alone, given the Reynolds ‘‘failed to take any other steps facility. Killebrew noted that T.H. high dosage (10 mg three times per day) to monitor T.H.’s controlled substances presented with ‘‘Hand tremors, anxious she had prescribed. GX 68, at 69 (citing use, despite the numerous red flags of today’’ and that he had an elevated GX 17, at 21–22; GX 18, at 24). potential drug abuse and diversion that blood pressure. Id. According to the The Expert further noted that T.H. had presented on prior visits.’’ GX Expert, these findings may have been Killebrew neither asked T.H. if he had 68, at 70. The Expert thus concluded signs of anxiety or alcohol/drug obtained any pain medications at his that ‘‘Reynolds’ issuance of the withdrawal. GX 68, at 68. JCMC ER visit, nor obtained any records additional controlled substance According to the Expert, alcohol from the JCMC to determine whether prescriptions was contrary to the abuse was a red flag and Killebrew T.H. had been given any prescriptions. guidelines set forth in Tennessee BON should have considered that if T.H. was Id. at 69. The Expert also found that Rule 1000–04–.08(4)(c), and abusing alcohol, he may also have been Killebrew neither contacted T.H.’s accordingly, below the standard of care abusing opioids and/or illicit pharmacy to obtain a recent dispensing and outside the usual course of substances. Id. (citing GX 41, at 20–21 history, nor conducted a check of the professional practice.’’ Id. (Uphold & Graham)). Relying on Uphold CSMD to see if he had been receiving On October 17, 2007, T.H. returned to & Graham, the Expert further noted that controlled substances from other AMC and again saw Reynolds, who ‘‘ ‘[p]atients who are alcohol dependent practitioners. Id. issued him more prescriptions for 60 and who also have a psychiatric While Killebrew again noted in the tablets of OxyContin 40 mg, 30 tablets disorder should be referred for record that T.H. was ‘‘trying to quit of Percocet 10 mg, 90 tablets of Xanax treatment for the underlying disorders [alcohol]’’ and ‘‘[h]as made an appt. 1 mg, and Celexa 20 mg (a non- as these patients are usually complex.’ ’’ with Frontier Health,’’ she did not controlled anti-depressant). See GX 17, Id. (quoting GX 41, at 23); see also GX document that she discussed with T.H. at 13–15; GX 19, at 2–6. In the visit note, 41, at 15 (stating that ‘‘[p]atients with his efforts to quit alcohol since his Reynolds documented that T.H. ‘‘has comorbid conditions (primary anxiety previous visit or that she had discussed had increased problems with depression disorder, substance abuse, dementia)’’ with T.H. whether he had been seen by and had ran out of his Prozac, he is should be referred to a specialist). the mental health clinic. GX 17, at 19. going to seek counseling at wmh and we According to the Expert, ‘‘Killebrew’s As the Expert found, Killebrew simply will restart antidepressant today.’’ GX findings on this visit are further issued T.H. ‘‘additional controlled 17, at 13. evidence that T.H. required care that substance prescriptions in the face of all Notably, T.H. had not previously been was beyond the scope of family practice of the red flags of T.H.’s abuse and prescribed Prozac by anyone at AMC. nurse practitioners.’’ GX 68, at 68. diversion of controlled substances set See generally GX 17, at 17–47.

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According to the Expert, this death by central nervous system According to the Expert, this information should have placed depression.’’ Id. information ‘‘should have been a red Reynolds ‘‘on notice that T.H. was Summarizing her findings, the Expert flag to Reynolds that C.S. misused and seeing another practitioner, in particular explained that during the two-year abused previous medications she had a mental health specialist.’’ GX 68, at period in which T.H. went to AMC, he been prescribed.’’ GX 68, at 76. Yet the 71. The Expert further explained that: presented ‘‘numerous red flags of abuse Expert found that ‘‘C.S’s file indicates [i]f a mental health specialist had taken over and diversion’’ and yet he ‘‘was never that Reynolds did not take any steps to care for T.H. and his depression was asked to take a UDS, nor was he ever follow-up on this information, such as worsening, as . . . Reynolds’ notes of this asked to come into AMC for a pill contacting the previous physician about visit reflect, then the usual course of practice count.’’ GX 68, at 72. The Expert also these entries and the nature, extent and would have been for the primary care nurse explained that while ‘‘the CSMD was duration of his treatment of C.S.’’ Id. practitioner to contact the specialist and have available for the last ten months of his Nor, according to the Expert, did the specialist manage T.H.’s care. Under AMC visits, none of the practitioners Reynolds ‘‘obtain any other information these circumstances, Mr. Reynolds, as the ever conducted a CSMD check for him.’’ related to C.S.’s history of[,] and primary care nurse practitioner, should not potential for[,] substance abuse, despite have changed T.H.’s antidepressant from Id. The Expert thus opined that ‘‘the Prozac to Celexa, and he should not have monitoring of [T.H.’s] controlled being placed on clear notice of such prescribed him Xanax and opioids, especially substances use by Mr. Reynolds, Mr. issues.’’ Id. The Expert also found that in the quantities he did, which have lethal Stout, and Ms. Killebrew was woefully Reynolds ‘‘failed to conduct a CSMD potential in someone with increasing inadequate, and far below the standard check, which would have provided him depression and history of alcohol use/abuse. of care in Tennessee.’’ Id. information about previous treatments with controlled substances and her Id. at 71–72. C.S. substance use and abuse history.’’ Id at According to the Expert, Reynolds On December 12, 2008, C.S. made her 76–77. should also have asked T.H. about his first visit to AMC and was seen by The Expert further found that use of Prozac, run a CSMD check, and Reynolds. GX 26, at 45–46. C.S. Reynolds ‘‘failed to create a patient required T.H. to submit to a UDS before completed a patient intake form stating record that appropriately documented issuing him more prescriptions. Id. at that she had shoulder, knee, and back C.S.’s medical history and pertinent 71. However, according to T.H.’s record, pain; she wrote that she had suffered historical data, such as pain history, Reynolds did none of these. See GX 17, injuries from a car accident which pertinent evaluations by other at 13–15; GX 68, at 71. Moreover, resulted in a metal rod in her femur and providers, history of and potential for according to the Expert, while T.H. a plate and screw in her ankle. Id. at 10– substance abuse, and pertinent would still have had several days left on 11. Notably, on this form, C.S. stated coexisting diseases and conditions. He his Valium 10 mg prescription, that she did not have a current also did not create a written treatment ‘‘Reynolds should have, but according healthcare provider and did not list any plan tailored for C.S.’s individual needs, to the record did not’’ instruct T.H. to medications that she was currently nor did he consider the need for further stop taking the drug even though taking. Id. at 10, 11. C.S. also signed a testing, consultations, or referrals, or the Reynolds had prescribed Xanax 1 mg Pain Management Agreement at this use of other treatment modalities.’’ Id. at along with the opioids (OxyContin and visit, which Reynolds also signed. Id. at 77 (citing Tenn. BON Rule 1000–.04– Percocet). GX 68, at 72 (citing GX 17, at 9. Reynolds prescribed a thirty-day .08(4)(c)1 & 2. The Expert thus 17–18; GX 18, at 23). According to the supply of 90 tablets of Percocet 7.5/500 concluded that Reynolds’ decision to Expert, ‘‘[a]dding 10 mg Valium to a mg (oxycodone/acetaminophen, a immediately start C.S. on a controlled drug regimen of OxyContin 40 mg, schedule II drug) and 60 tablets of substances regimen contravened the Percocet 10 mg, and Xanax 1 mg had the Valium 5 mg. See GX 26, at 45–46; GX guidelines of TN BON Rule 1000–04– potential to be a lethal combination 29, at 3. .08. Id. because of the respiratory depressing The Expert observed that while The Expert also noted that Reynolds effects of these drugs.’’ Id. The Expert Reynolds noted in the record that C.S. had written in C.S.’s record that her thus concluded that Reynolds’ issuance had ‘‘a longstanding [history] of back pain was being treated in accordance of the controlled substances pain,’’ ‘‘he did not have any information with the guidelines in the Jackman prescriptions at this visit ‘‘was contrary regarding treatment C.S. had been article, which AMC had purportedly to the guidelines set forth in Tennessee receiving for the fourteen months adopted for its treatment BON Rule 1000–04–.08(4)(c), and immediately preceding her first visit to protocols.15 Id. at 73. Consistent with accordingly, below the standard of care AMC.’’ GX 68, at 76 (citing GX 26, at her analysis and conclusions regarding and outside the usual course of 45). The Expert further observed that the N.S. and T.H., the Expert concluded that professional practice.’’ Id. only documentation of prior treatments Reynolds ignored several recommendations contained within that T.H. died the following day. GX 24, at in C.S.’s file were records Reynolds article in his treatment of C.S. Id. 2. According to the Medical Examiner’s obtained from a physician who treated These included that ‘‘[w]hen report, ‘‘[p]ostmortem blood toxicology her between June 2007 and October 25, 14 psychiatric comorbidities are present, showed oxycodone (and its metabolite) 2007. Id. Significantly, that physician risk of substance abuse is high and pain in a supratherapeutic to potentially had noted that C.S. ‘‘takes extra Rx pain management may require specialized lethal concentration, alprazolam in a pills in contrast to my treatment or consultation. Referral to a therapeutic to toxic concentration and recommendations’’ and that he did ‘‘not pain management specialist can be diazepam (and its metabolite) in a think she can self-medicate. . . .’’ GX helpful.’’ Id. (quoting GX 39, at 5) As the therapeutic concentration.’’ Id. at 1. The 26, at 58–61. Expert explained, the article then Medical Examiner thus concluded that instructed that the evaluation of the ‘‘[a]lthough the drugs may be present in 14 The file does include records indicating that from June–October 2007 C.S. was taking Percocet therapeutic to potentially lethal and Ativan, as well as Effexor, a non-controlled 15 See Robert P. Jackman, M.D., et al., ‘‘Chronic concentrations, the combined/ drug prescribed to treat major depressive disorder, Nonmalignant Pain in Primary Care,’’ American synergistic effects of the drugs caused anxiety and panic disorder. GX 26, at 58–61. Family Physician (Nov. 2008) (GX 39, at 5–12).

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patient must include ‘‘[a] thorough at 75. Moreover, based on her review ‘‘of the call from Genesis occurred two days social and psychiatric history [that] may C.S.’s patient file through her last visit after C.S. had called AMC seeking a alert the physician to issues, such as on November 30, 2009,’’ the Expert refill of Fastin, which Reynolds refused current and past substance abuse, concluded that both Reynolds and Stout to issue. GX 26, at 32. development history, depression, ‘‘failed to comply with the Rule’s According to the Expert, the anxiety, or other factors that may guidelines on subsequent visits by C.S.’’ telephone call from Genesis Healthcare interfere with achieving treatment Id. at 77. More specifically, the Expert was ‘‘a huge red flag.’’ GX 68, at 79. The goals.’’ Id. at 74. found that Reynolds and Stout ‘‘never Expert explained that it ‘‘should have According to the article, ‘‘[b]y acquired the information that was been alarming’’ to Reynolds ‘‘that C.S. identifying patients at risk of possible lacking at C.S.’s initial visit and, told another practice that she did not opioid misuse (e.g. persons with past or therefore, the controlled substances have a family practice when she had current substance abuse, persons with prescriptions they issued at subsequent been going to AMC monthly for the past psychiatric issues), physicians can visits were contrary to the Rule’s seven months’’ and that she was also choose to modify the monitoring plan or guidelines for the same reasons as the using a second name. Id. As the Expert to refer the patient to a pain specialist.’’ prescriptions issued on the initial visit.’’ explained, after the phone call, GX 39, at 5. The article further stated Id. Reynolds was aware that C.S. had that ‘‘[f]or patients at high risk of The Expert also found that ‘‘at each misled both AMC and the other diversion and abuse, consider the periodic interval, Reynolds and Stout practitioner, and likely was doctor- routine use of random urine drug failed to appropriately evaluate C.S. for shopping. Id. This was a violation of the screens to assess for presence of continuation or change of medication, terms of her Pain Management prescribed medications and the absence and include in the patient record her Agreement, which included the of illicit substances.’’ Id. at 9 (emphasis progress towards reaching treatment provision that: ‘‘I will not attempt to added). The article also advised that objectives, any new information about obtain any controlled medicines, ‘‘[a]berrant behavior that may suggest the etiology of the pain, and an update including opioid pain medicines, medication misuse includes use of pain on the treatment plan.’’ Id. at 77–78 controlled stimulants, or anti-anxiety medications other than for pain (citing TN BON Rule 1000–04– medicines from any other doctors.’’ Id. treatment, impaired control (of self or of .08(4)(c)4). The Expert thus concluded (quoting GX 26, at 9). medication use), compulsive use of that on C.S.’s subsequent visits, such as Yet, at her July 9, 2009 visit, Reynolds medication . . . selling or altering those of March 12, 2009 and April 10, did not discuss or otherwise confront medications, calls for early refills, losing 2009, when Stout prescribed 90 tablets C.S. about the information he had prescriptions, drug-seeking behavior of Percocet 7.5/500 mg, 60 tablets of received from Genesis. Id. (citing GX 26, (e.g. doctor-shopping), or reluctance to Valium 5 mg, and 30 tablets of Fastin 30 at 29–30). Moreover, C.S.’s patient try nonpharmacologic intervention.’’ Id. mg (phentermine, a schedule IV drug) to record contains no documentation that at 11 (emphasis added).16 her, he acted in contravention of the Reynolds addressed C.S.’s violation of Based on the guidance contained in Rule’s guidelines, as well as the her PMA, even though its terms the Jackman article, the Editorial, and standard of care. Id. at 78 (citing GX 26, provided that if she broke the the requirements set forth in TN BON 28–37, 40; GX 27, at 2, 4, 5; GX 29, at agreement, ‘‘my provider will stop Rule 1000–04–.08(4)(c), the Expert 4). prescribing controlled substances concluded that ‘‘Reynolds[’] issuance of The Expert also found that both immediately and only provide care for the controlled substances prescriptions Reynolds and Stout ignored red flags of life threatening and chronic medical to C.S. at her first visit was below the abuse and diversion that were presented conditions’’ and that she would ‘‘either standard of care and outside the usual to them at C.S.’s subsequent visits, and be discharged from th[e] practice or course of professional practice.’’ GX 68, did so even though C.S. had violated the [o]ffered only alternative treatments terms of her Pain Management such as non-narcotic medications and 16 The Jackman article was supplemented in the Agreement. Id. For example, on July 9, treatment center options.’’ Id. at 79–80 same edition of American Family Physician by an 2009, Reynolds issued C.S. (quoting GX 26, at 9); see also GX 26, Editorial, which provided additional guidance on the ‘‘risk of drug misuse, abuse, and addiction’’ that prescriptions for 45 tablets of at 29–30. exists when treating patient with long-term opioids, Roxicodone 15 mg (oxycodone), 60 Moreover, the medical record a topic that was not fully explored in the Jackman tablets of Valium 5 mg and 30 tablets of contains no evidence that Reynolds took article. See GX 49. The Editorial discussed the steps Fastin 37.5 mg. See GX 26, at 29–30; GX steps to monitor C.S.’s controlled physicians should take to ‘‘monitor’’ these risks, substances use, such as by conducting a including focusing on the patient’s medical history, 28, at 2. Reynolds issued these obtaining information from family members, prescriptions even though on June 12, check of the CSMD before issuing the focusing on physical signs of possible aberrant 2009, Reynolds documented that he had prescriptions. Id. at 79–80; see also GX drug-taking behavior, such as slurred speech, small received a phone call from a person at 26. He also did not require her to submit pupils, and unusual affect, and the use of urine drug screening that ‘‘should be positive for ‘‘Genesis Healthcare,’’ which was a to a UDS to determine if she was taking prescribed medications, negative for medications ‘‘new practice in Boones Creek’’; the drugs she had been prescribed at that have not been prescribed, and negative for according to the note, Reynolds was AMC and if there were any non-AMC illicit drugs.’’ Id. at 1–2. The Editorial, moreover, informed that C.S. had told Genesis prescribed drugs in her system. Id. at 80; emphasized that ‘‘[t]he current standard of care used by pain management specialists to treat Healthcare that ‘‘she did not have a GX 26. patients with chronic pain and aberrant drug-taking family practice [and] was seeking to ‘‘For all of these reasons,’’ the Expert behavior is an abstinence-oriented approach.’’ Id. at establish new [patient] care.’’ GX 26, at concluded that ‘‘Reynolds’ decision to 2. According to the Editorial, ‘‘[i]n this approach, 31. Reynolds was further informed that continue issuing [C.S.] controlled patients initially discontinue their opioid use for a ‘drug holiday.’ Formal inpatient or outpatient C.S. also used another name (‘‘goes by substance prescriptions on July 9, 2009 detoxification is sometimes required to stabilize [C.M.]).’’ Id. Reynolds received this call was contrary to [the] guidelines set forth opioid withdrawal syndrome. Following this, three days after he had seen C.S. at AMC in Tenn. BON Rule 1000–.04–.08, and patients are given multidisciplinary treatment for (on June 9, 2009), and had prescribed to accordingly, below the standard of care opioid dependency and chronic pain, including cognitive behavior therapy (i.e. for chronic pain and her 45 tablets of Roxicodone 15 mg and and outside the usual course of a substance abuse disorder) that is concurrent with 60 tablets of Valium 5 mg. See GX 26, professional practice.’’ GX 68, at 80. nonopioid pain management.’’ Id. at 33–34; GX 28, at 2. Of further note, Relying on the Jackman article and

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accompanying Editorial, the Expert obtained from AMC (Reynolds). Twenty-four therefore ‘‘below the standard of care further concluded that ‘‘the standard of days later, on June 3, 2009, C.S. presented to and outside the usual course of care and usual course of professional a different pharmacy, Wilson Pharmacy, the professional practice.’’ GX 68, at 84. practice . . . would have been to oxycodone and alprazolam prescriptions she Moreover, the Expert found that on obtained from the Boones Creek practitioner. September 30, 2009, another CSMD enforce the terms of C.S.’s [Pain Mgmt. Then, six days later, on June 9, 2009, which Contract], cease prescribing her would have been the thirty-day expiration report was obtained on C.S., presumably controlled substances, and refer her to a date of the May 11, 2009 prescriptions, C.S. by Stout who saw her on this date. GX pain management specialist and/or returned to Church Hill Drugs to present the 68, at 84; GX 26, at 49–52. Significantly, addiction specialist to address her drug- oxycodone and diazepam prescriptions she the report showed that on August 4–5, seeking behavior.’’ Id. obtained from AMC (Reynolds). Thus, the 2009, C.S. presented the prescriptions On August 4, 2009, C.S. returned to CSMP report alerted Stout to the fact that she received from Mr. Stout on August AMC and saw Stout, who issued her C.S. was consciously selecting different 4, 2005, see id. at 23–24; to two more prescriptions for 45 tablets of pharmacies at which to present prescriptions pharmacies, Cave’s Drugs and P&S Roxicodone 15 mg, 60 tablets of Valium for the same types of controlled substances Pharmacy. See id. at 49, 51. Stout, so as to avoid being detected for doctor- however, also ignored this additional 5 mg, and 30 tablets of Fastin 37.5 mg. shopping and to obtain early refills. See GX 26, at 27–28; GX 27, at 2; GX violation of the Pain Management 28, at 2 & 14. Stout issued these Id. at 81–82 (citing GX 26, at 49–57). Agreement and issued C.S. prescriptions prescriptions even though he had since Thus, the CSMD reports clearly for 45 Roxicodone 15 mg and 60 Valium received further evidence unequivocally showed that C.S. had violated the terms 5 mg. GX 68, at 84. showing that C.S. had engaged in of her Pain Management Agreement by On October 29, 2009, Reynolds saw doctor-shopping at both Genesis both doctor shopping and pharmacy C.S. and actually increased her Healthcare and a third practitioner, as shopping (i.e., filling her controlled Roxicodone prescription from 45 to 60 well as pharmacy-shopping. GX 68, at substance prescriptions at multiple tablets; he also issued her a prescription 80. Notably, on the date of this visit, pharmacies).17 Id. at 82. for 60 tablets of Valium 5 mg. GX 26, at AMC ran two CSMD queries to Notwithstanding the ‘‘information 22. Not only did he ignore the determine what controlled substances showing that C.S. was seeing three information regarding C.S.’s doctor and had been dispensed to C.S. during the different practices at the same time, was pharmacy shopping, he also did so period August 1, 2008, through August pharmacy-shopping, was in violation of while noting in the visit record: ‘‘No 4, 2009; the report was placed in C.S.’s her PMA, and was being treated for recent accidents or injuries and no AMC patient file. Id. (citing GX 26, at narcotics dependence for the several significant changes in current medical 54–57). The query was run using both months leading up to her first AMC condition. . . . Pt has no interest in of the names C.S. was known to have visit, which she had not disclosed to further intervention and is satisfied with used when she sought controlled AMC, Stout issued her the above- current treatment plan. . . .’’ Id. at 21. substances. Id. As the Expert explained, referenced controlled substances On November 30, 2009, C.S. made her this demonstrates that AMC and Stout prescriptions.’’ Id. last visit to AMC and saw Reynolds, were aware of the fact that C.S. used Indeed, according to C.S.’s file, during who again prescribed to her 60 tablets multiple names. Id. at 80–81. the visit, Stout did not even discuss the of Roxicodone 15 mg. Id. at 20. According to the Expert, the two CSMD reports with C.S. GX 26, at 27– Moreover, while the note contains the CSMD reports revealed the following 28. Nor did he require her to provide a same statement that there were ‘‘no information: UDS or subject her to a pill count, significant changes in current medical which, according to the Expert, would condition’’ and that the C.S. was (a) On June 3, 2009, C.M. received ‘‘satisfied with current treatment plan,’’ prescriptions for 56 oxycodone 7.5 mg and 15 have been reasonable responses to the Alprazolam 1 mg from the above-referenced red flag information he possessed. Id. Reynolds changed her prescription from practitioner in Boones Creek, Tennessee, The Expert thus found that Stout’s Valium to 90 dosage units of Xanax .5 which was six days before she visited AMC decision to issue her more controlled mg. Id. at 19–20. on June 9, 2009 and obtained prescriptions substance prescriptions on August 4, To be sure, the visit note states her for 45 tablets of Roxicodone 15 mg and 60 2009 was ‘‘contrary to guidelines set psychiatric condition as follows: tablets of Valium 5 mg from Reynolds. forth in Tenn. BON Rule 1000–.04–.08, ‘‘Patient states that they [sic] have had (b) On June 15, 2009, C.S. received a and accordingly, below the standard of some increases [sic] problems prescription for phentermine 37.5 mg, care and outside the usual course of situationally lately with anxiety and another schedule IV controlled substance for professional practice.’’ GX 68, at 83. depression. This seems to be related to weight loss, from a third different social stressors such as family problems, practitioner just six days after her June 9, Reynolds and Stout issued additional 2009 visit to AMC, and five days after controlled substances prescriptions for work issues, financial stressors and Reynolds refused her request to refill her oxycodone and benzodiazepines sometimes for no reason to mention.’’ prescription for Fastin. (Valium and Xanax) to C.S. on Id. at 19. Yet this was the exact same (c) C.S. had been treated for narcotic September 3, 2009, September 30, 2009, statement that Reynolds provided in his dependence during the several months October 29, 2009, and November 30, documentation of C.S.’s psychiatric preceding her first visit to AMC. Specifically, 2009. See GX 26, at 19–26. For the condition at her previous visit. See id. the CSMP report shows that C.S. was treated reasons previously stated, the Expert at 21. The record thus contains no with Suboxone throughout 2008. found that Reynolds’ and Stout’s explanation as to why Reynolds Significantly, the CSMP report showed that changed her prescription. on October 10, 2008, just two months before decisions to issuance C.S. more C.S. began as a patient at AMC, she was controlled substance prescription on C.S. died the next day. Her death issued a Suboxone prescription by Dr. Vance these dates was contrary to AMC’s certificate lists the cause of death as Shaw, AMC’s Medical Director. professed protocols and the Board’s ‘‘multiple drug toxicity—oxycocodone, (d) C.S. was pharmacy shopping, in Rule 1000–04.–.08(4)(c), and was benzodiazepines, carbamates.’’ 18 Id. at addition to doctor-shopping. On May 11, 5. 2009, C.S. presented to Church Hill Drugs 17 In her Pain Management Agreement, C.S. had prescriptions for a thirty-day supply of agreed to use only Church Hill Drugs to fill her 18 While not discussed above because it was not oxycodone and alprazolam that she had controlled substance prescriptions. See GX 26, at 9. a controlled substance during the period in which

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Summing up her conclusion with (1) The recommendation of the appropriate Factors II and IV—The Applicant’s respect to the latter prescriptions, the State licensing board or professional Experience in Dispensing Controlled Expert found that Reynolds and Stout disciplinary authority. Substances and Compliance with acted below the standard of care and (2) The applicant’s experience in Applicable Laws Related to Controlled outside the usual course of professional dispensing . . . controlled substances. Substances (3) The applicant’s conviction record under practice. GX 68, at 84. Consistent with Federal or State laws relating to the To effectuate the dual goals of her conclusions regarding the previous manufacture, distribution, or dispensing of conquering drug abuse and controlling prescriptions, the Expert concluded that controlled substances. both the legitimate and illegitimate Reynolds and Stout should have (4) Compliance with applicable State, traffic in controlled substances, ‘‘enforced the terms of the [Pain Federal, or local laws relating to controlled ‘‘Congress devised a closed regulatory Management Agreement], ceased issuing substances. system making it unlawful to her further controlled substances (5) Such other conduct which may threaten the public health and safety. manufacture, distribute, dispense, or prescriptions, and immediately referred possess any controlled substance except her to a pain management specialist Id. § 823(f). in a manner authorized by the CSA.’’ and/or addiction specialist for ‘‘These factors are . . . considered in Gonzales v. Raich, 545 U.S. 1, 13 (2005). 19 treatment.’’ Id. at 85. the disjunctive.’’ Robert A. Leslie, M.D., Consistent with the maintenance of the Discussion 68 FR 15227, 15230 (2003). I ‘‘may rely closed regulatory system, a controlled on any one or a combination of factors, substance may only be dispensed upon As found above, each of the NPs has and may give each factor the weight [I] a lawful prescription issued by a an application currently pending before deem[ ] appropriate in determining practitioner. Carlos Gonzalez, M.D., 76 the Agency, and by virtue of his having whether a registration should be FR 63118, 63141 (2011). filed a timely renewal application, Mr. revoked.’’ Id.; see also Volkman v. DEA, Fundamental to the CSA’s scheme is Stout also holds a registration. Pursuant 567 F.3d 215, 222 (6th Cir. 2009). While the Agency’s longstanding regulation, to Section 304(a) of the Controlled I must consider each factor, I am ‘‘not which states that ‘‘[a] prescription for a Substances Act (CSA), a registration to required to make findings as to all of the controlled substance [is not] effective ‘‘dispense a controlled substance . . . factors.’’ Volkman, 567 F.3d at 222; see [unless it is] issued for a legitimate may be suspended or revoked by the also Hoxie v. DEA, 419 F.3d 477, 482 medical purpose by an individual Attorney General upon a finding that (6th Cir. 2005); Morall v. DEA, 412 F.3d practitioner acting in the usual course of the registrant . . . has committed such 165, 173–74 (D.C. Cir. 2005). However, his professional practice.’’ 21 CFR acts as would render his registration even where an Applicant or Registrant 1306.04(a). This regulation further under section 823 of this title ultimately waives his right to a hearing provides that ‘‘an order purporting to be inconsistent with the public interest as on the allegations, the Government has a prescription issued not in the usual determined under such section.’’ 21 the burden of proving, by substantial course of professional treatment . . . is U.S.C. 824(a)(4). Thus, in determining evidence, that the requirements are met not a prescription within the meaning whether the revocation of an existing for both the denial of an application and and intent of [21 U.S.C. 829] and . . . registration is necessary to protect the the revocation or suspension of an public interest, the CSA directs that I the person issuing it, shall be subject to existing registration. 21 CFR consider the same five factors as I do in the penalties provided for violations of 1301.44(d)–(e). the provisions of law relating to determining whether the granting of an In this matter, I have considered all of application would be consistent with controlled substances.’’ Id. the factors. Based on the Government’s As the Supreme Court has explained, the public interest. These factors are: evidence with respect to factors two and ‘‘the prescription requirement . . . four, I conclude that each practitioner ensures patients use controlled C.S. was obtaining the prescriptions from AMC’s practitioners, the evidence shows that she had also has engaged in misconduct which substances under the supervision of a received Soma (carisoprodol) prescriptions at AMC establishes that granting his or her doctor so as to prevent addiction and on multiple occasions in the months prior to her application, and in the case of Stout, recreational abuse. As a corollary, [it] death. See GX 26, at 20, 22–23, 26–27, 30. Carisoprodol is a derivative of carbamate. It has continuing his registration, would be also bars doctors from peddling to since been placed in schedule IV of the Controlled ‘‘inconsistent with the public patients who crave the drugs for those Substance Act because of substantial evidence of its interest.’’ 20 21 U.S.C. 823(f) & 824(a)(4). prohibited uses.’’ Gonzales v. Oregon, abuse, particularly when taken in conjunction with 546 U.S. 243, 274 (2006) (citing United narcotics and benzodiazepines. See Placement of 20 As for factor one, the recommendation of the Carisoprodol Into Schedule IV, 76 FR 77330 (2011). States v. Moore, 423 U.S. 122, 135, 143 state licensing authority, while each of the 19 (1975)); United States v. Alerre, 430 In reviewing C.S.’s medical record, the Expert practitioners apparently retains his/her Advanced also found that on the nine occasions on which Practice Nurse license, the Tennessee Board of Reynolds saw C.S. between December 12, 2008 and Nursing has not made a recommendation to the factor is not dispositive either for, or against, the November 30, 2009, he created identical, verbatim Agency as to whether he/she should be granted a granting of Respondent’s application. Paul Weir records for each visit which included the following new DEA registration. Moreover, although each Battershell, 76 FR 44359, 44366 (2009) (citing entries: practitioner is currently licensed by the State and Edmund Chein, 74 FR 6580, 6590 (2007), pet. for ‘‘Pt reports having increased pain with movement thus satisfies an essential condition for obtaining rev. denied Chein v. DEA, 533 F.3d 828 (D.C. Cir. and decreased pain with rest’’; (and maintaining) a registration, see 21 U.S.C. 2008)). ‘‘Pt states their pain is a 4 out of 10 and that they 802(21) & 823(f), DEA has held repeatedly that the Regarding factor three, there is no evidence that have a better quality of life and are able to ‘do possession of state licensure ‘‘ ‘is not dispositive of Reynolds, Stout, or Killebrew has been convicted of more’’’; the public interest inquiry.’ ’’ George Mathew, 75 FR an offense related to the manufacture, distribution ‘‘Patient states that they have had a headache for 66138, 66145 (2010), pet. for rev. denied Mathew v. or dispensing of controlled substances. 21 U.S.C. the last 1–2 days, radiating from their neck and DEA, No. 10–73480, 472 Fed Appx. 453 (9th Cir. 823(f)(3). However, as there are a number of reasons around their temples. They relate it to increases in 2012); see also Patrick W. Stodola, 74 FR 20727, why a person may never be convicted of an offense stressors such as home, work, financial, or problems 20730 n.16 (2009); Robert A. Leslie, 68 FR 15227, falling under this factor, let alone be prosecuted for with their family. They note some nause (sic), 15230 (2003). As the Agency has long held, ‘‘the one, ‘‘the absence of such a conviction is of photophobia, and increased intensity with noise’’; Controlled Substances Act requires that the considerably less consequence in the public interest ‘‘Anxiety and depression noted in patients (sic) Administrator . . . make an independent inquiry’’ and thus, it is not dispositive. David A. mannerisms and actions during interview.’’ determination [from that made by state officials] as Ruben, 78 FR 38363, 38379 n.35 (2013) (citing GX 68, at 85 (quoting GX 26, at 19–46). Moreover, to whether the granting of controlled substance Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. Reynolds and Stout documented the exact same privileges would be in the public interest.’’ for rev. denied MacKay v. DEA, 664 F.3d 808 (10th physical exam findings at each of her visits. See id. Mortimer Levin, 57 FR 8680, 8681 (1992). Thus, this Cir. 2011)).

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F.3d 681, 691 (4th Cir. 2005), cert. U.S.C. 824(a)(4), even if [he] is merely pain, and an update on the treatment denied, 574 U.S. 1113 (2006) (stating gullible or naı¨ve.’’ Jayam Krishna-Iyer, plan.’’ Id. at (4)(c)(4). And the Expert that the prescription requirement 74 FR 459, 460 n.3 (2009); see also also testified that Advanced Nurse likewise stands as a proscription against Chau, 77 FR at 36007 (holding that even Practitioners were employing the doctors acting not ‘‘as a healer[,] but as if physician ‘‘did not intentionally practices set forth in the guidelines in a seller of wares.’’). divert controlled substances,’’ State prescribing controlled substance before Under the CSA, it is fundamental that Board Order ‘‘identified numerous the Rule became effective on January 1, a practitioner must establish and instances in which [physician] 2005. maintain a legitimate doctor-patient recklessly prescribed controlled As found above, the Government’s relationship in order to act ‘‘in the usual substances to persons who were likely Expert reviewed the medical records course of . . . professional practice’’ engaged in either self-abuse or maintained by AMC on patients N.S., and to issue a prescription for a diversion’’ and that physician’s T.H., and C.S. and concluded that in ‘‘legitimate medical purpose.’’ Paul H. ‘‘repeated failure to obtain medical issuing the prescriptions, Messrs. Volkman, 73 FR 30629, 30642 (2008), records for his patients, as well as to Reynolds and Stout, as well as Ms. pet. for rev. denied, 567 F.3d 215, 223– otherwise verify their treatment Killebrew, failed to comply with the 24 (6th Cir. 2009); see also Moore, 423 histories and other claims, created a Board’s Rule and the standard of care as U.S. at 142–43 (noting that evidence substantial risk of diversion and abuse’’) set forth in various practice guidelines established that the physician exceeded (citing MacKay, 75 FR at 49974). which the clinic asserted it followed. the bounds of professional practice, As explained by the Government’s Most importantly, the Government’s when ‘‘he gave inadequate physical Expert, in 2004, the Tennessee Board of Expert concluded that Reynolds, Stout, examinations or none at all,’’ ‘‘ignored Nursing promulgated Rule 1000–04–.08, and Killebrew had issued multiple the results of the tests he did make,’’ setting forth guidelines for determining controlled substance prescriptions and ‘‘took no precautions against . . . whether the prescribing practices of without a legitimate medical purpose misuse and diversion’’). The CSA, Advance Practice Nurses are within and outside of the usual course of however, generally looks to state law ‘‘the usual course of professional professional practice and thus also and standards of practice to determine practice for a legitimate purpose in violated 21 CFR 1306.04(a). whether a doctor and patient have compliance with applicable state and N.S. established a legitimate doctor-patient federal law’’; this rule became effective relationship. Volkman, 73 FR at 30642. on January 1, 2005.21 Board Rule 1000– N.S. was initially seen at AMC by Moreover, while a finding that a 04–.08(4); GX 68, at 10. This rule providers other than Reynolds, Stout, practitioner has violated 21 CFR provided that the patient’s medical and Killebrew. However, at the time of 1306.04(a) establishes that the record ‘‘shall include a documented her first visit with Reynolds, the latter practitioner knowing and intentionally medical history and physical knew that N.S. has previously been distributed a controlled substance in examination by the Advance Practice subjected to a UDS and tested positive violation of 21 U.S.C. 841(a)(1), ‘‘the Nurse . . . providing the medication.’’ for several benzodiazepines, even Agency’s authority to deny an Board Rule 1000–04–.08 (4)(c)(1). It though these drugs had not been application [and] to revoke an existing further stated that the ‘‘[h]istorical data prescribed to her by the other NPs at registration . . . is not limited to those shall include pain history, any pertinent AMC, as well as cocaine. She also tested instances in which a practitioner evaluations by another provider, history negative for opiates even though she intentionally diverts a controlled of and potential for substance abuse, had been prescribed Avinza (morphine) substance.’’ Bienvenido Tan, 76 FR pertinent coexisting diseases and at AMC, and on the date of the test, she 17673, 17689 (2011) (citing Paul J. conditions, psychological functions and should still have been taking the drug. Caragine, Jr., 63 FR 51592, 51601 the presence of a recognized medical Reynolds also knew that at N.S’s (1998)); see also Dewey C. MacKay, 75 indication for the use of a controlled previous visit, she had shown signs of FR at 49974. As Caragine explained: substance.’’ Id. somnolence, slurred speech, and rapid ‘‘[j]ust because misconduct is The Rule also provided that ‘‘[a] heart rate. Finally, N.S.’s file still lacked unintentional, innocent, or devoid of written treatment plan tailored for information concerning her prior improper motive, [it] does not preclude individual needs of the patient shall treatment history and substance abuse revocation or denial. Careless or include objectives such as pain relief history, and given that three months had negligent handling of controlled and/or improved physical and passed since N.S.’s previous visit, substances creates the opportunity for psychosocial function, and shall Reynolds should have asked N.S. where diversion and [can] justify’’ the consider need for further testing, she had been, but failed to do so. revocation of an existing registration or consultations, referrals or use of other Reynolds failed to refer her to a the denial of an application for a treatment modalities dependent on specialist who could have addressed her registration. 63 FR at 51601. patient response.’’ Id. at 4(c)(2). Also, aberrant behavior, and instead, issued ‘‘Accordingly, under the public the rule provided that ‘‘[a]t each her another Avinza prescription. interest standard, DEA has authority to periodic interval’’ at which the patient As found above, throughout the consider those prescribing practices of a is evaluated ‘‘for continuation or change lengthy course of her visits to AMC, physician, which, while not rising to the of medications, the patient record shall N.S. continued to engage in aberrant level of intentional or knowing include progress toward reaching behavior, which was largely ignored by misconduct, nonetheless create a treatment objectives, any new Reynolds, Stout, and Killebrew, who substantial risk of diversion.’’ MacKay, information about the etiology of the continued to prescribe controlled 75 FR at 49974; see also Patrick K. substances to her. These episodes Chau, 77 FR 36003, 36007 (2012). 21 See also Board Rule 1000–04–.08(1)(d) included overdoses resulting in Likewise, ‘‘[a] practitioner who ignores (defining ‘‘[p]rescribing pharmaceuticals or multiple hospitalizations including for the warning signs that [his] patients are practicing consistent with the public health and mental health treatment. Moreover, the welfare’’ as ‘‘[p]rescribing pharmaceuticals and either personally abusing or diverting practicing Advanced Practice Nursing for a discharge summary for the first of these, controlled substances commits ‘acts legitimate purpose in the usual course of which occurred while N.S. was inconsistent with the public interest,’ 21 professional practice’’). obtaining drugs at AMC, referenced her

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history of multiple overdoses and released from jail. However, Killebrew be called in for her; however, N.S. had suicide attempts; listed two physicians failed to ask why she had been not been seen at AMC in two months, as her primacy care providers (one of incarcerated and how she had addressed which according to the Expert, also whom was not affiliated with AMC); her pain issues during that period. raised a red flag. stated that N.S. was taking Killebrew nonetheless issued N.S. Thereafter, N.S’s behavior continued hydrocodone, Xanax, and carisoprodol, prescriptions for Percocet and Xanax. to present red flags, such as in none of which had been prescribed to Thereafter, N.S. continued to see November 2007, when she twice sought her at AMC; and reported the results of Reynolds and Stout (and occasionally refills of controlled substances, a UDS, which again showed she was Killebrew) and repeatedly obtained including refills which were fifteen days positive for benzodiazepines. more controlled substance prescriptions early; yet Reynolds issued her more Yet, notwithstanding these multiple while the practitioners ignored prescriptions. And the following month, red flags, Reynolds continued to additional red flags. For example, in N.S. was admitted to a local hospital prescribe Avinza to N.S. and did so August 2006, Stout prescribed Percocet which sent AMC both admission and without having obtained information and Xanax to N.S., even though the day discharge summaries; notably, the about her treatment before coming to before N.S.’s July 20 visit with summaries listed ‘‘polysubstance abuse’’ AMC, did not create a written treatment Killebrew, he had treated her while as one of her diagnoses. Yet, even after plan, and did not document that he had working in a local emergency room and receiving this information, Reynolds considered the need to refer her for documented that N.S. had admitted ‘‘to prescribed more MS Contin, Xanax, and further testing or consultations. having a long history of drug abuse’’ and Percocet to her. Thereafter, Reynolds added Xanax for displayed ‘‘drug seeking behavior.’’ Thereafter, N.S. became pregnant and N.S.’s anxiety, notwithstanding that Stout also failed to address with N.S. did not visit AMC between February because of her obvious psychiatric why she had been jailed and how she and late December 2008, and apparently issues, she should have been referred to addressed her pain issues while she was had received Suboxone or Subutex a specialist. As the Expert explained, incarcerated. treatment from a physician (who was this was contrary to the Uphold & Two months later, Stout issued N.S. not affiliated with AMC) during her Graham Guidelines, which Reynolds more Percocet and Xanax prescriptions, pregnancy. Yet, on N.S.’s return, claimed were the protocols that AMC even though her file contained a note Killebrew prescribed to her both 60 followed. (dated one month) earlier stating that Lortab 7.5 mg and 30 Xanax .5 mg. Following this, N.S. sought multiple she had been selling Percocet. N.S. However, Killebrew did not even obtain early refills for Xanax; Reynolds also denied this, claiming her medications the name of the physician who had had directed her to come in for a pill had been stolen, but then said she had provided the Suboxone/Subutex count, but N.S. failed to comply. Yet been taking her medications for the past treatment, let alone contact him/her. Reynolds continued to issue her more week. While Stout required that N.S. She also did not conduct a check of the Xanax, and even did so on an occasion take a UDS, she tested negative for State’s prescription monitoring when she should have had 19 days left oxycodone (which she claimed she was database, even though in the Expert’s on a prescription. taking) but positive for hydrocodone/ view, N.S’s history of doctor shopping As for Stout, while he did not hydromorphone, even though no one at warranted this. Moreover, Killebrew did prescribe to N.S. until seventeen months AMC had prescribed those drugs to her. not document that N.S. had incurred a into her visits to AMC, the Expert And notwithstanding these results, new illness or injury, and according to explained that because it was her first which showed that she was abusing the Expert, performed a cursory visit with him, he was obligated to and/or diverting, and demonstrated that physical exam. I thus adopt the Expert’s review her patient file before N.S. had lied to him, Stout issued her conclusion that Killebrew acted outside prescribing controlled substances to more Percocet and Xanax prescriptions. of the usual course of professional determine whether it was appropriate to Several months later, Stout attempted practice and lacked a legitimate medical continue or change her medications. to refer her to two different pain purpose in issuing the prescriptions. 21 The Expert thus concluded that Stout management practices. However, N.S. CFR 1306.04(a). should have been aware of N.S.’s history had already been seen at these practices Following this visit, N.S. did not of substance abuse and diversion, which and neither would accept her as a return to AMC for more than five was documented in her file, and that patient. Once again, Stout issued her months. Yet on her return, Reynolds Stout breached the standard of care and more prescriptions for Percocet and issued her prescriptions for even more acted outside of the usual course of Xanax, and several months later, potent controlled substances and in professional practice when he issued Reynolds issued more of the same even greater quantities (60 MS Contin her Xanax and Kadian prescriptions, prescriptions, ignoring the evidence that 30 mg, 30 Percocet 7.5 mg, 90 Xanax .5 rather than cease further prescribing and N.S. was abusing and diverting, and mg). However, Reynolds did not refer her to a specialist who could acted outside of the usual course of document how N.S. had managed her address her aberrant behavior. professional practice in doing so. purported pain since her last visit, While Killebrew did not see N.S. until Several months later, Reynolds failed to run a check on her with the July 2006, when she had been going to increased the quantity of N.S.’s CSMD, and failed to conduct a UDS on AMC for more than twenty-five months, prescriptions (she had been switched her. Once again, the Expert concluded the Expert found that she too acted from Percocet to morphine), by fifty that these prescription were issued in outside of the usual course of percent from those issued at the violation of 21 CFR 1306.04(a). professional practice because she was previous visit, and yet there is no As the Expert explained, over the obligated to review N.S.’s patient file evidence that Reynolds saw her on this course of the nearly six-year period in and should not have prescribed occasion and no explanation in her which N.S. obtained controlled controlled substances to her given her record as to why she was not seen. And substances at AMC, she presented history of drug abuse and diversion. the following month, N.S. called AMC numerous red flags (including Moreover, this was N.S.’s first visit to and stated that she had run out of her overdoses) and yet was subjected to AMC in seven months, and Killebrew prescriptions and Killebrew directed only two UDSs, both of which she noted that N.S. had recently been that prescriptions for Lortab and Xanax failed, and but a single pill count.

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Moreover, the only time her in issuing the prescriptions. 21 CFR I also agree with the Expert’s prescription history was obtained from 1306.04(a). conclusions that both Reynolds and the CSMD was on the date of her last At the next visit, T.H. saw Stout, who Stout acted outside of the usual course visit. Also, there were several episodes issued him more prescriptions for the of professional practice and lacked a in which N.S. had not appeared at AMC same three drugs. Yet as the Expert legitimate medical purpose when they for months on end, and yet was given explained, Stout did not properly issued various controlled substance more prescriptions without the treating evaluate T.H.’s pain and psychosocial prescriptions to C.S. As the Expert practitioner even attempting to verify situation, the efficacy of the drugs on noted, C.S. claimed that she had her explanation for her absence, asking his ability to function, did not develop suffered injuries in a car accident and her how she addressed her pain during a written treatment plan, and did not suffered from back pain (at a level of 4 her absence, contacting her purported evaluate T.H.’s history or potential for out of 10) as well as neck pain, although treating physicians, or performing an abuse. I agree with the Expert’s the records also state: ‘‘Pt has no interest adequate physical examination. I conclusion that Stout lacked a in further intervention and is satisfied therefore conclude that all three legitimate medical purpose and acted with current treatment plan.’’ The note practitioners acted outside of the usual outside of the usual course of for her first visit further stated that C.S. course of professional practice and professional practice in issuing the reported that she had ‘‘increase[d] lacked a legitimate medical purpose prescriptions. Id. problems situationally lately with their when they issued controlled substance During the course of the two years in anxiety and depression.’’ prescriptions to N.S. 21 CFR 1306.04(a). which T.H. visited AMC, he presented According to the Expert, at C.S.’s first I also conclude that all three multiple red flags. These included that: visit, Reynolds failed to create a patient practitioners acted outside of the usual (1) He was receiving high doses of record that appropriately documented narcotics and yet never complained of course of professional practice and her medical history, including her pain opioid-induced constipation; (2) he lacked a legitimate medical purpose in history, pertinent evaluations by other admitted that he was simultaneously issuing multiple controlled substance practitioners, her history of, and seeing another physician, yet neither prescriptions to T.H. As explained by potential for, substance abuse, and Reynolds nor Stout contacted the the Expert, from T.H.’s initial visit, the pertinent coexisting diseases and physician to determine the nature of the practitioners knew that T.H. had treatments. The Expert also found that treatment T.H. was receiving; (3) a problems with alcohol as well as mental he did not create a treatment plan which pharmacy reported that T.H. was health issues, and yet they failed to was tailored for her individual needs. receiving Suboxone treatment from still adequately evaluate his alcohol-related another physician (again, neither the prescriptions she issued were generally the issues and refer him to a specialist who Reynolds nor Stout contacted the same as those issued by Reynolds and Stout. With could properly address his mental physician); (4) T.H. was clearly using respect to T.H.’s first visit with Killebrew, the health issues. Expert opined that the information he reported multiple pharmacies notwithstanding regarding his impending divorce and increased Moreover, while T.H. was referred to that he had agreed to use only a single anxiety rendered him a ‘‘high-risk patient for a pain management clinic, which pharmacy; (5) AMC had received a fax managing chronic pain and whose care extended recommended that he undergo facet which included various documents beyond the scope of a nurse practitioner engaged in blocks and that he take only three family practice,’’ and that a ‘‘prudent practitioner establishing that T.H. had been treated would have considered T.H. to be a risk for suicide Lortab 10 mg per day and do so only for at three other clinics; (6) T.H. was being and diversion and would have referred him to a as long as it took to have the procedures treated for depression by a physician; mental health specialist and a comprehensive pain performed, T.H. returned to AMC where (7) T.H. owed approximately $3,000 to management program,’’ which Killebrew failed to he saw Reynolds, who failed to do. GX 68, at 63. two medical practices; (8) T.H. sought While the Expert’s discussion sounds in determine whether T.H. had ever multiple early refills; (9) and T.H. was malpractice, the Expert further noted that as of the undergone the procedures. Also, while trying to stop abusing alcohol. date of his first visit with Killebrew, T.H.’s file T.H. should have been out of the However, T.H. was never required to contained extensive evidence that he was abusing controlled substance prescribed by the and/or diverting controlled substances yet provide a UDS, was never subjected to Killebrew failed to take steps to monitor his use of pain management clinic for a month, a pill count, and a CSMD report was controlled substances. I thus agree with the Expert’s Reynolds made no inquiry as to how never obtained on him. Moreover, conclusion that Killebrew acted outside of the usual T.H. had managed his pain. Yet according to the Expert, at no point did course of professional practice when she prescribed to T.H. 60 OxyContin 40 mg, 30 Percocet 10 mg, Reynolds then proceeded to escalate any of the three practitioners (including T.H.’s prescriptions to 60 OxyContin 40 and 75 Xanax 1 mg. Id. at 63–64. Killebrew, who saw T.H. and prescribed Similarly, at T.H.’s second visit with her, he mg, 30 Lortab 10 mg, and 90 Xanax 1 to him on several occasions) create a reported that he was having problems with anxiety, mg. As the Expert explained, there was written treatment plan and properly that he trying quit alcohol, that he had made an no medical justification for adding evaluate his use of alcohol. Yet all three appointment at a mental health facility and had OxyContin 40 mg to T.H.’s medications, hand tremors; according to the Expert, the latter practitioners continued to prescribe was a sign of anxiety or alcohol/drug withdrawal. which she explained was four times the both OxyContin and either Percocet or Killebrew did not, however, refer T.H. for treatment normal starting dose. The Expert also Lortab, as well as Xanax, to T.H., up by specialists as was called for in the Uphold & explained that the amount of Xanax until the day before he overdosed and Graham practice guidelines which AMC had Reynolds prescribed was excessive as it previously adopted as its practice protocols. GX 39, died. Based on the Expert’s extensive at 15. Instead, she issued him more prescriptions, was six times the daily dosage T.H. had findings, I conclude that each of the these being for 60 OxyContin 40 mg, 30 Lortab 10 previously received and could be lethal practitioners acted outside of the usual mg, while changing his prescription for Xanax to 90 when taken with the narcotics that course of professional practice and Valium 10 mg. She also ignored other red flags Reynolds prescribed. The Expert further which were documented in T.H.’s patient file. At lacked a legitimate medical purpose T.H.’s next visit, Killebrew issued T. H. these same noted that Reynolds did not properly when they issued T.H. the prescriptions prescriptions, again ignoring the red flags he evaluate T.H.’s alcohol-related problems for multiple narcotics and presented and AMC’s practice protocols. Consistent with the Expert’s testimony, I conclude that or his anxiety. I agree with the Expert benzodiazepines.22 21 CFR 1306.04(a). that Reynolds lacked a legitimate Killebrew acted outside of the usual course of professional practice and lacked a legitimate medical purpose and acted outside of 22 It is noted that Ms. Killebrew’s involvement medical purpose in prescribing controlled the usual course of professional practice with T.H. was limited to only three visits and that substances to T.H. 21 CFR 1306.04(a).

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While Reynolds made an entry in the various practices. Neither Reynolds nor interest.’’ Hoxie v. DEA, 419 F.3d 477, medical record that he had performed a Stout documented having addressed 483 (6th Cir. 2005). To be actionable, the physical exam, notably, with the this incident with her. Instead, they Government is required to show that the exception of her vital signs, the physical continued to issue her more statement was false and material to the exam notes for each of her visits are prescriptions and never ran a UDS on investigation. See Roy S. Schwartz, 79 repeated verbatim. her. FR 34360, 34363 n.6 (2014); Belinda R. Notwithstanding that C.S. had Moreover, while AMC eventually Mori, 78 FR 36582, 36589 (2013). As the reported increased problems with obtained CSMD reports on her (two Supreme Court has explained, a false anxiety and depression, and according months after the above report), they statement is material if it ‘‘ ‘has a natural to the clinic’s protocols, presented a again ignored multiple items of tendency to influence, or was capable of higher risk of substance abuse, Reynolds information in those reports which influencing the decision of the did not refer her to a specialist and did showed that C.S. had been treated for decisionmaking body to which it was not document that he had even narcotic dependency prior to her first addressed.’ ’’ Kungys v. United States, considered doing so. Moreover, while visit at AMC (and had obtained 485 U.S. 755, 770 (1988) (quoting C.S. had reported injuries, she also Suboxone from three physicians), that Weinstock v. United States, 231 F.2d wrote on her intake form that she did she had recently obtained controlled 699, 701 (D.C. Cir. 1956)). The Court has not have a current health care provider. substances from two other physicians, further explained that: As the Expert explained, there is no and that she had also filled it has never been the test of materiality that evidence that Reynolds inquired as to prescriptions at multiple pharmacies in the misrepresentation . . . would more likely how she had addressed her pain if she violation of her pain agreement. Yet than not have produced an erroneous had no current provider. Moreover, Reynolds and Stout continued to issue decision, or even that it would more likely while Reynolds could have run a CSMD her prescriptions for both oxycodone than not have triggered an investigation. check to verify if C.S. had, in fact, and benzodiazepines up until her death. Rather, the test is whether the recently seen another provider, as well I therefore agree with the Expert’s misrepresentation . . . was predictably as obtain information as to her conclusion that both Reynolds and capable of affecting, i.e., had a natural tendency to affect, the official decision. substance abuse history, he did not do Stout acted outside of the usual course so. Of note, that report would have of professional practice and lacked a 485 U.S. at 770–71. ‘‘It makes no shown that in the period preceding her legitimate medical purpose when they difference that a specific falsification visit, she had obtained Suboxone from issued the prescriptions to C.S. 21 CFR did not exert influence so long as it had three different physicians. Reynolds 1306.04(a). the capacity to do so.’’ United States v. started her on Percocet and Valium. I In summary, I find that the Alemany Rivera, 781 F.2d 229, 234 (1st agree with the Expert’s conclusion that Government’s evidence with respect to Cir. 1985). the prescriptions lacked a legitimate factors two and four establishes that The Government first argues that medical purpose and were issued each of the three practitioners issued Reynolds made a materially false outside of the usual course of prescriptions in violation of the CSA’s statement when he wrote that N.S. ‘‘was professional practice. 21 CFR prescription requirement and engaged admitted to JCMC on December 3, 2004 1306.04(a). in the knowing diversion of controlled by Dr. . . . James with drug overdose. At some point, Reynolds did obtain substances. I further hold that the She was transferred to [IPP] . . . and C.S’s medical records from a physician Government has established by continued on her then prescribed who treated her over a five-month substantial evidence that the medications.’’ Req. for Final Agency period, which had ended more than misconduct of each practitioner is Action, at 42 (quoting GX 42, at 7). thirteen months before her first visit to sufficiently egregious to conclude that Based on an affidavit it obtained from AMC. Most significantly, the physician he/she has committed acts which render Dr. James, the Government argues that had documented that C.S. was taking his/her ‘‘registration inconsistent with Reynolds’ statement was false because more pain medications than he the public interest.’’ 21 U.S.C. 823(f) & Dr. James ‘‘did not continue N.S. on her recommended and explained that he did 824(a)(4). With respect to each of the then prescribed medications’’ but not think that she could ‘‘self- three practitioners, these findings are ‘‘ceased prescribing’’ all controlled medicate.’’ Yet both Reynolds and Stout sufficient to support the denial of their substances to her because she had ‘‘been continued to prescribe multiple applications, and in the case of Stout, to admitted [to JCMC] for a drug overdose, controlled substances including revoke his registration. had a history of multiple overdoses and Percocet, Valium, and phentermine to suicide attempts, and was [being C.S. Moreover, there is no evidence that Factor Five—Such Other Conduct transferred] to IPP for inpatient either Reynolds or Stout ever contacted Which May Threaten Public Health and psychiatric treatment.’’ Id. at 43. that physician. Safety Notwithstanding Dr. James’ statement The Expert further found that neither The Government also contends that (which may well have reflected her Reynolds nor Stout properly evaluated practitioner Reynolds engaged in instructions), the discharge summary for C.S. at her follow-up visits to determine actionable misconduct under this factor N.S.’s hospitalization (which was part of whether her medications should be when he wrote a letter to a DEA her patient file), lists Soma, Xanax, continued or changed. Moreover, both Diversion Investigator which contained MSCN (morphine), and Lortab as Reynolds and Stout repeatedly ignored various material false statements ‘‘medications to continue’’ and is blank red flags that C.S. was engaged in both regarding AMC’s treatment of N.S. I in the space for listing ‘‘medications to doctor and pharmacy shopping and thus agree with the Government. discontinue.’’ GX 2, at 160. While the violating her pain contract. These As recognized by the Sixth Circuit, form was apparently completed by a incidents included one in which ‘‘[c]andor during DEA investigations, nurse and not Dr. James, absent proof Reynolds received a phone call from regardless of the severity of the that Reynolds had otherwise obtained another clinic reporting that C.S. had violations alleged, is considered by the knowledge that Dr. James had instructed sought to become a patient, claiming DEA to be an important factor when that N.S.’s medications were to be that she did not have a family practice, assessing whether a [practitioner’s] discontinued, it was not unreasonable and that she also used two names at registration is consistent with the public for him to conclude that the nurse had

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accurately reflected Dr. James’ In his letter, Reynolds also stated that selling Percocet; (4) an Oct. 11, 2006 instructions on the discharge summary. Dr. James (the physician who admitted UDS which was positive for narcotics I thus reject the contention that N.S. to the JCMC for her December she had not been prescribed but Reynolds knowingly made a material 2004) ‘‘took the medical and social negative for narcotics which she had false statement when he wrote that N.S. history from [N.S.’s] family [and] not the been prescribed; (5) her false statement had been continued on her then- patient.’’ GX 42, at 7. The Government at that visit that she was taking the prescribed medications.23 notes that in the Admission Report, Dr. prescribed medications; (6) the Reynolds, however, also claimed that James documented that N.S. ‘‘has had December 2006 refusal of two different N.S. ‘‘never had another overdose multiple episode of over dose in the pain management practices, both of incident while being treated at AMC’’ past, the last one was in May 2004, which had previously seen her, to after a December 3, 2004 hospitalization when she was admitted to the Intensive accept her as a patient; (7) her having at Johnson City Medical Center. GX 42, Care Unit with drug overdose’’ and that sought (in November 2007) a refill at 7. The Government, however, N.S.’s ‘‘[h]istory [wa]s obtained mainly fifteen days early; (8) her admission to produced a copy of a report created from the emergency room records and a local hospital in late December 2007, upon N.S.’s admission to the Johnson the patient’s parents.’’ Req. for Final which diagnosed her with various City Medical Center on August 19, 2005, Agency Action, at 45. conditions including poly-substance which clearly stated that ‘‘[t]he patient The Government argues that taken abuse; (9) the more than five-month gap was transferred from Northside Hospital within the context of the letter, between her December 22, 2008 and because of unresponsiveness secondary Reynolds’ statement was materially false June 4, 2009 visit; and (10) her to drug overdose.’’ GX 14, at 29. and was made ‘‘for the purpose of November 2009 claim that her drugs The report further stated that N.S. had demonstrating that the history noted by had been stolen and she needed a refill. told her mother that she had taken five Dr. James . . . of ‘multiple over dose in Here again, Reynolds clearly knew of Soma tablets, that her mother found her the past’ was somehow inaccurate these various incidents and his unresponsive on the floor, that she was because’’ it had not been obtained statement was clearly made to excuse taken to Northside Hospital where ‘‘she ‘‘directly from N.S.’’ Id. Notably, in his the misconduct he and his fellow was found unresponsive to painful letter, Reynolds further asserted that practitioners engaged in by continuing stimuli . . . with pinpoint pupils,’’ and when, after the overdose incident, N.S to prescribe controlled substances to that Narcan, a drug used to counter the returned to AMC, ‘‘[s]he argued with N.S. in the face of her aberrant behavior. effects of opioids, ‘‘was not helpful.’’ Id. [him] that her overdose was a one-time I therefore find that the statement was The report also listed ‘‘[d]rug overdose’’ mistake she had made’’ which was materially false. under the attending physician’s caused by ‘‘domestic issues at home’’ Reynolds further stated that ‘‘[i]n October of 2006, [N.S.] passed drug impressions, and noted that she was to and that he ‘‘gave her the benefit of the screens and observations by MC be admitted to the ICU. Id. at 30. doubt’’ and prescribed more controlled providers.’’ GX 42, at 7. As found above, Finally, the attending physician listed substances to her. GX 42, at 7. Here again, I agree with the this statement was clearly false as N.S. Reynolds as N.S.’s primary care Government that the statement was tested positive for hydrocodone/ provider and listed him as a recipient of made to justify Reynolds’ decision to hydromorphone, even though no one at a copy of the report. Id. ignore the clear evidence that N.S. was AMC had prescribed these drugs to her, Based on the above, I conclude that a substance abuser and to excuse his and tested negative for oxycodone/ Reynolds knew that N.S. had been misconduct (as well as that of his fellow oxymorphone, even though she had hospitalized for a second overdose practitioners) in continuing to received a Percocet prescription at her incident after the December 3, 2004 prescribing controlled substances to her. previous visit to AMC. Here again, hospitalization and that his statement I further conclude that the statement Reynolds’ statement was false and was false. I further conclude that the was false and was capable of clearly made to excuse the misconduct statement was material because it was influencing the Agency’s investigation that he and his fellow practitioners clearly made by Reynolds to the DI in and was therefore material. engaged in by continuing to prescribe an attempt to excuse the misconduct he Next, the Government argues that controlled substances to N.S. and his fellow practitioners engaged in Reynolds made a material false Based on the multiple materially false when they continued to prescribe statement when he wrote that after the statements Reynolds made in his letter controlled substances to N.S. even when December 3, 2004 hospitalization, N.S. to a DEA Investigator, I further find that faced with knowledge that she was drug ‘‘ ‘never again displayed signs of Reynolds has engaged in additional abuser. See GX 42, at 2 (Reynolds’ letter addiction to include . . . aberrant conduct which may threaten public to DI; ‘‘I am including in this letter the behavior . . . [and] early refills.’ ’’ Req. health or safety. This finding provides a documents that I have developed to for Final Agency Action, at 44 (quoting further reason to deny Reynolds’ explain my actions and the rationale GX 42, at 7). As found above, the record application. behind the decisions that have been contains substantial evidence that N.S. called into question by the Office of displayed numerous signs of addiction Sanction General Counsel of Tennessee and I and aberrant behavior. These included: Under agency precedent, ‘‘where a assume the DEA.’’) As explained above, (1) Her nearly eight-month absence from registrant [or applicant] has committed that misconduct is clearly within the the practice (between Dec. 1, 2005 and acts inconsistent with the public Agency’s jurisdiction and his statement July 20, 2006) and her reappearance at interest, [he or] she must accept was clearly capable of influencing the AMC during which she told Killebrew responsibility for his [or her] . . . decision of the Agency to pursue this that she had been in jail; (2) Stout’s actions and demonstrate that he [or she] matter. having treated her the day before her . . . will not engage in future reappearance at AMC at a local misconduct.’’ Jayam Krishna-Iyer, 74 FR 23 Even were I to hold that a negligently made hospital’s ER and noting that she 459, 463 (2009); see also Medicine false statement is actionable under factor five, no Shoppe-Jonesborough, 73 FR 364, 387 argument has been made as to why Reynolds was wanted ‘‘stronger narcotics’’ and had negligent when he relied on the discharge ‘‘displayed drug seeking behavior’’; (3) a (2008). Here, each practitioner has summary. Sept. 13, 2006 report that N.S. was waived his/her right to a hearing and

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therefore the opportunity to present registration, be, and it hereby is, denied. of controlled substances may be [a] significant evidence to refute the Government’s This Order is effective June 18, 2015. factor’’ in determining ‘‘whether an applicant showing that he/she has committed acts Pursuant to the authority vested in me should be (or continue to be) entrusted with a DEA’’ which render his/her registration by 21 U.S.C. 823(f), as well as 28 CFR registration. R.D. at 37 (emphasis added). ‘‘inconsistent with the public interest,’’ 0.100(b), I order that the application of It is certainly true that evidence as to the volume of dispensings (whether by a prescriber or a 21 U.S.C. 823(f), and the only evidence Bobby D. Reynolds II, F.N.P., for a DEA pharmacy) has been admitted in these proceedings, in the record relevant to these issues is Certificate of Registration as an MLP— by both the Government to show the extent of Reynolds’ letter to the DI. Nurse Practitioner, be, and it hereby is, practitioner’s unlawful activities, and by Therein, Reynolds stated that he has denied. This Order is effective June 18, practitioners to show the extent of their lawful closed his practice and would not re- activities. That being said, neither the text of factor 2015. two, nor the legislative history of the 1984 open it; that he has taken 55 hours of Pursuant to the authority vested in me amendments which gave the Agency authority to continuing education in ethics, by 21 U.S.C. 823(f), as well as 28 CFR consider the public interest in determining whether boundaries, pharmacology and pain; 0.100(b), I order that the application of to grant an application or revoke (or suspend) an and offered to take ‘‘other training’’ to Tina L. Killebrew, F.N.P., for a DEA existing registration, compel the conclusion that Congress considered ‘‘the quantitative volume’’ of ensure the public safety and his Certificate of Registration as an MLP— an applicant’s or registrant’s dispensings to be a ‘‘compliance with DEA standards.’’ GX Nurse Practitioner, be, and it hereby is, significant factor in the public interest analysis. 42, at 2. Even were I to give weight to denied. This Order is effective June 18, The word ‘‘experience’’ has multiple meanings. Reynolds’s unsworn statement regarding 2015. Among those most relevant in assessing its meaning the remedial measures he has as used in the context of factor two are: (1) The Dated: April 30, 2015. undertaken, I would still deny his ‘‘direct observation of or participation in events as Michele M. Leonhart, a basis for knowledge,’’ (2) ‘‘the fact or state of application because he has presented no having been affected by or gained knowledge evidence that he acknowledges his Administrator. through direct observation or participation,’’ (3) misconduct. To the contrary, the [FR Doc. 2015–12038 Filed 5–18–15; 8:45 am] ‘‘practical knowledge, skill, or practice derived multiple material false statements BILLING CODE 4410–09–P from direct observation of or participation in events or in a particular activity,’’ and (4) ‘‘the length of Reynolds made in his letter establish such participation.’’ See Merriam-Webster’s that he does not accept responsibility Collegiate Dictionary 409 (10th ed. 1998); see also for his misconduct in prescribing to N.S. DEPARTMENT OF JUSTICE The Random House Dictionary of the English and others. Thus, I conclude that Language 681 (2d ed. 1987) (defining experience to Drug Enforcement Administration include ‘‘the process or fact of personally observing Reynolds has not refuted the encountering, or undergoing something,’’ ‘‘the Government’s prima facie showing that [Docket No. 13–35] observing, encountering, or undergoing of things granting his application would be generally as they occur in the course of time,’’ ‘‘inconsistent with the public interest.’’ JM Pharmacy Group, Inc., d/b/a ‘‘knowledge or practical wisdom gained from what 21 U.S.C. 823(f). So too, because there Farmacia Nueva and Best Pharma one has observed, encountered, or undergone’’). Corp; Decision and Order None of these meanings compels the conclusion is no evidence that either Stout or that Congress acknowledged that ‘‘the quantitative Killebrew has accepted responsibility On October 24, 2013, Chief volume’’ of a practitioner’s dispensing activity may for his/her misconduct, nor any be a significant consideration under this factor, and Administrative Law Judge John J. evidence that either Stout or Killebrew certainly none suggest that the Agency is required Mulrooney, II (hereinafter, ALJ), issued to count up the number of times an applicant or has undertaken remedial measures to the attached Recommended Decision. registrant has dispensed controlled substances in ensure that he/she will not re-offend in Neither the Government nor the making factual findings under this factor as the future, I also conclude that neither suggested by another ALJ. See Clair L. Pettinger, 78 Respondents filed exceptions to the one has refuted the Government’s prima FR 61592, 61597 (2013) (rejecting reasoning in Recommended Decision.1 ALJ’s recommended decision that factor two facie showing. Accordingly, I will order Having reviewed the entire record, I ‘‘requires evidence of both the qualitative and that the registration issued to Stout be have decided to adopt the ALJ’s findings quantitative volume of the Respondent’s revoked, and that the applications of experience’’ and that ‘‘[w]here evidence of the of fact including his credibility Reynolds, Stout, and Killebrew 24 be Respondent’s experience . . . is silent with respect determinations except as discussed denied. to the quantitative volume of the Respondent’s below.2 I also adopt the ALJ’s experience, and requires speculation to support an Orders adverse finding under Factor Two, this Factor should not be used to determine whether the 1 All citations to the Recommended Decision are Pursuant to the authority vested in me Respondent’s continued registration is inconsistent to the slip opinion as issued by the ALJ. with public interest.’’). by 21 U.S.C. 823(f) and 824(a)(4), as 2 In the Recommended Decision, the ALJ Prior to the 1984 amendment of section 823(f), well as 28 CFR 0.100(b), I order that observed that his factual findings ‘‘are entitled to the Agency’s authority to deny an application or significant deference.’’ R.D. at 34 (citing Universal DEA Certificate of Registration revoke a registration was limited to cases in which Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951)). MS0443046 issued to David R. Stout, a practitioner: (1) Had materially falsified an To make clear, the Agency is the ultimate factfinder application, (2) had been convicted of a State or N.P., be, and it hereby is, revoked. I and considers an ALJ’s factual findings ‘‘along with Federal felony offense related to controlled further order that the application of the consistency and inherent probability of substances, or (3) had his State license or testimony. The significance of [the ALJ’s] report, of David R. Stout, N.P., to renew his registration suspended, revoked, or denied. See S. course, depends largely on the importance of Rep. No. 98–225, at 266 (1983), as reprinted in 1984 credibility in the particular case.’’ Universal 24 While compared to Reynolds and Stout, U.S.C.C.A.N. 3182, 3448. Finding that the Camera, 340 U.S. at 496. See also Reckitt & Colman, Killebrew issued substantially fewer illegal ‘‘[i]mproper diversion of controlled substances’’ Ltd., v. Administrator, 788 F.2d 22, 26–27 (D.C. Cir. prescriptions, her misconduct still involved the was ‘‘one of the most serious aspects of the drug 1986). knowing diversion of controlled substances, and as abuse problem,’’ and yet ‘‘effective Federal action such, is sufficiently egregious to support the denial For reasons I have previously explained, see Top against practitioners ha[d] been severely inhibited of her application. See Jayam Krishna-Iyer, 74 FR Rx Pharmacy, 78 FR 26069, 26069 n.1 (2013), I do by the [then] limited authority to deny or revoke at 464 (‘‘[E]ven where the Agency’s proof not adopt the parenthetical following the ALJ’s practitioner registrations,’’ id., Congress concluded establishes that a practitioner has committed only citation to Paul Weir Battershell, 76 FR 44359, that ‘‘the overly limited bases in current law for a few acts of diversion, this Agency will not grant 44368 n.27 (2011). See R.D. at 36. denial or revocation of a practitioner’s registration [an application for] registration unless [she] accepts In his discussion of factor two (‘‘the applicant’s do not operate in the public interest.’’ Id. responsibility for [her] misconduct.’’); see also experience in . . . dispensing controlled The Senate Report thus explained that ‘‘the bill MacKay v. DEA, 664 F.3d 808, 822 (10th Cir. 2011) substances’’), the ALJ explained that this factor would amend 21 U.S.C. 824(f) [sic] to expand the (sustaining agency order revoking practitioner’s manifests Congress’s ‘‘acknowledgment that the authority of the Attorney General to deny a registration based on proof physician knowingly qualitative manner and the quantitative volume in practitioner’s registration application.’’ Id. The diverted drugs to two patients). which an applicant has engaged in the dispensing Continued

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conclusions of law that: (1) to this allegation, the evidence showed proceeding was terminated on June 29, Respondents’ principal (Mr. Moro that on November 30, 2011, the 2012. Id. Perez) materially falsified each Government executed a search warrant The evidence further showed that pharmacy’s application by failing to at the two pharmacies and that Mr. Respondent Farmacia Nueva did not disclose that he had previously Moro Perez, who had been arrested at complete a DEA Form 104. Tr. 72–74. surrendered for cause each pharmacy’s his residence, was taken to Best However, the Government submitted DEA registration, and (2) that Pharmacy, where he was presented with various emails, which were exchanged Respondents failed to demonstrate that a voluntary surrender form (DEA From between Farmacia Nueva’s counsel in they can be entrusted with a new 104), and that while the form was in proceeding No. 12–16 (and who also registration.3 However, for reasons English, its purpose and contents were represented Respondents in this explained below, I do not adopt the explained to Mr. Moro Perez by a proceeding) and a DEA attorney, whom ALJ’s conclusions that Respondents and Special Agent who spoke Spanish. Tr. the ALJ found, upon taking official their pharmacists violated their 175–77. notice of the Agency’s records, served as corresponding responsibility when they The evidence further showed that the the Agency’s counsel of record in that dispensed controlled substance DI (through the Special Agent who proceeding.5 GX 14, at 2–3; R.D. at 10. prescriptions issued by a physician translated for him) explained to Mr. The emails include a June 27, 2012 whose registration had expired. Moro Perez that the form ‘‘dealt with the email, which was sent at 8:52 a.m., by regulatory matter’’ and ‘‘his DEA DEA’s counsel to Respondent’s counsel The Material Falsification Allegations registration number,’’ and that it was stating: ‘‘Wondering if you’ve discussed As explained in the ALJ’s decision, ‘‘separate from any criminal allegations the surrender issue with your client yet. Mr. Moro Perez asserted that he did not that may be levied.’’ Id. at 177. The DI Please let me know if you have any materially falsify the applications also told Mr. Moro Perez that ‘‘[i]f he other questions, thanks.’’ GX 14, at 2. because he did not believe that the chose not to sign the form, then we Later that day (after exchanging emails surrenders were for cause.4 With respect would move for an order to show cause as to when they could discuss the proceeding.’’ Id. Mr. Moro Perez did not matter), Respondent’s counsel wrote to Report further explained that ‘‘in those cases in dispute this testimony. DEA counsel: ‘‘Ok, anyway, I discussed which registration is clearly contrary to the public The evidence further showed that the the case with my client. I think he will interest, the amendment would allow a swift and sure response to the danger posed to the public DEA Form 104, which was used by the surrender it voluntarily. Let me know health and safety by the registration of the DI to memorialize the surrender, where to find a form, or send it to me practitioner in question.’’ Id. at 267, as reprinted in contains two boxes which can be if you have one.’’ Id. 1984 U.S.C.C.A.N. at 3449. Accordingly, section checked with an accompanying DEA counsel then replied: ‘‘We can 823(f) was amended to provide the Agency with authority to deny an application based upon a statement. The first of these states, in do it without the form if you’d like, just finding that the issuance of a registration ‘‘would relevant part: ‘‘In view of my alleged send me an email stating your client be inconsistent with the public interest,’’ upon failure to comply with the Federal agrees to surrender his registration. I’ll consideration of the five public interest factors, requirements pertaining to controlled then file a joint motion to dismiss the including the experience factor. Id. See also 21 U.S.C. 824(a)(4). Nowhere in the Report’s substances, and as an indication of my proceeding.’’ Id. discussion of the amendments to sections 823 and good faith in desiring to remedy any The next day, Respondent’s counsel 824 is there any support for the notion that incorrect or unlawful practices on my emailed the following to DEA counsel: Congress deemed the quantitative volume of a part[.]’’ GX 14, at 1. According to the DI, ‘‘My client, Farmacia Nueva, has practitioner’s dispensings to be a significant decided to voluntarily surrender its consideration in making findings under the this box had been checked prior to the experience factor. form’s presentation to Mr. Moro Perez. DEA registration at issue in the case As in past cases, the parties may continue to Tr. 176. Mr. Moro Perez signed the form. Docket No. 12–16. Please prepare a joint introduce evidence as to the extent of both a Id.; see also GX 14, at 1. motion to dismiss the pending case. practitioner’s lawful or unlawful dispensing Thereafter, Mr. Moro Perez was Thank you.’’ Id. activities. However, under Agency precedent, proof In his testimony, Mr. Moro Perez of a single act of intentional or knowing diversion criminally charged with several remains sufficient to satisfy the Government’s violations of the Controlled Substances denied that he had knowingly or prima facie burden and to impose on a respondent, Act including possession with intent to intentionally falsified both applications. the obligation to produce evidence to show that it distribute, see 21 U.S.C. 841(a)(1), and He testified that he did not believe that can be entrusted with a registration. See Jayam the surrenders of either pharmacy’s Krishna-Iyer, 74 FR 459, 463 (2009); see also conspiracy to possess with intent to MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011) distribute. See id. § 860. However, on registration were for cause, maintaining (‘‘Although Dr. MacKay may have engaged in the March 23, 2012, the charges, on motion that upon the dismissal of the criminal legitimate practice of pain medicine for many of his of the Government, were dismissed with case against him, he believed ‘‘that there patients, the conduct found by the Deputy prejudice. RX 3. was no cause against’’ him. Tr. 211. Administrator with respect to K.D. and M.R. is sufficient to support her determination that his The ALJ took official notice that Throughout his testimony he repeatedly continued registration is inconsistent with the Respondents were previously the adhered to this position. However, as public interest.’’). I therefore do not adopt the ALJ’s subject of an Order to Show Cause the ALJ explained, at the time he statement that Congress acknowledged ‘‘the Proceeding, and that either one or both surrendered the Best Pharma quantitative volume’’ of a practitioner’s dispensings to be a ‘‘significant factor’’ in assessing a Respondents in this matter requested a registration, the criminal case would not practitioner’s experience. hearing on the allegations, which was be dismissed for another four months.6 3 I also adopt the ALJ’s legal conclusion that the deemed filed with the Office of Moreover, in signing the voluntary Government did not sustain the record keeping Administrative Law Judges on surrender form, Mr. Moro Perez clearly allegation. December 6, 2011, and assigned Docket acknowledged that he was doing so 4 Question 2 on the DEA Application asked: ‘‘Has the applicant ever surrendered (for cause) or had a No. 12–16. See R.D. at 10. The ALJ also ‘‘[i]n view of my alleged failure to federal controlled substance registration revoked, took official notice that the aforesaid suspended, restricted or denied, or is any such 5 While the ALJ provided Respondent with the action pending?’’ On each application, Mr. Moro association, partnership, or pharmacy, has any opportunity to refute the various facts of which he Perez answered no. GX 1 & 8. officer, partner, stockholder or proprietor . . . ever took official notice, Respondent did not do so. See Question 4 asked, in relevant part: ‘‘If the surrendered or had a federal control substance R.D. at 9 n.29. applicant is a corporation (other than a corporation registration revoked, suspended, restricted, or 6 The record does not establish the date on which whose stock is owned and traded by the public), denied . . . .? GX 1, at 1. the criminal case against Mr. Moro Perez was filed.

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comply with the Federal requirements Beyond this, as the ALJ recognized, if submitted for both Best Pharma and pertaining to controlled substances’’ and the dismissal of the criminal proceeding Farmacia Nueva. Id. These findings that he was consenting to the transformed the earlier surrender of Best provide reason alone to support the termination and revocation of the Best Pharma’s registration into a surrender denial of his applications, especially Pharma ‘‘registration without an order which was no longer ‘‘for cause,’’ given when coupled with the ALJ’s findings to show cause, a hearing, or any other that the same allegations were raised that Mr. Moro Perez’s testimony as to proceedings.’’ GX 14, at 1. Also, as the with respect to both pharmacies, there why he falsified the applications ‘‘is ALJ found, Mr. Moro Perez was would have been no reason for the simply not credible.’’ R.D. at 67. specifically told by the Diversion Agency to continue its pursuit of the The Corresponding Responsibility Investigator that the voluntary surrender Show Cause Proceeding against the Allegations form involved his pharmacy’s registration Mr. Moro Perez held for registration and was separate from any Farmacia Nueva. Yet the Agency did The ALJ also found that Respondents’ criminal allegations that could be levied pursue the Show Cause Proceeding pharmacists violated their against him. And most significantly, the against Farmacia Nueva’s registration corresponding responsibility under 21 Diversion Investigator then told Mr. until its principal agreed to surrender its CFR 1306.04, when, over the course of Moro Perez that if he did not sign the registration some three months after the some thirty-four months, they filled voluntary surrender form, he would dismissal of the criminal case against numerous controlled substance seek an Order to Show Cause. Mr. Moro Perez. In his testimony, Mr. prescriptions which were written by a Mr. Moro Perez thus knew that the DI Moro Perez offered no explanation as to physician who no longer possessed a was pursuing the voluntary surrender why, if the dismissal of the criminal valid DEA registration. While I adopt based on the latter’s belief that Best case against him rendered the surrender the ALJ’s finding that Respondents Pharma was engaged in unlawful of Best Pharma’s registration not ‘‘for dispensed the prescriptions at issue practices. And finally, in addition to the cause,’’ he subsequently agreed to when the physician no longer possessed DI’s testimony (which the ALJ found surrender Farmacia Nueva’s a DEA registration, I reject his legal credible) that he repeatedly explained to registration.8 conclusion that Respondents violated 21 Mr. Moro Perez that the voluntary In his testimony, Mr. Moro Perez also CFR 1306.04(a) because the Government surrender form addressed a regulatory denied that he knowingly or failed to prove that the pharmacists matter and was separate from any intentionally falsified the applications acted with the requisite scienter. criminal charges that might be filed, it because he completed them, ‘‘knowing However, based on Respondents’ is noted that the CSA explicitly and recognizing that you, the DEA admissions, I find that they committed provides that ‘‘[p]roceedings to deny, office, are aware of, [and] had acts inconsistent with the public revoke, or suspend . . . shall be knowledge and everything about me,’’ interest when they failed to verify that independent of, and not in lieu of, Tr. 218, including his arrest. However, the physician remained registered at any criminal prosecutions . . . under this whether Investigators at the local DEA time for some thirty-four months. subchapter or any other law of the office were aware of Mr. Moro Perez is With respect to this allegation, the United States.’’ 21 U.S.C. 824(c). irrelevant in assessing his scienter; evidence showed that a physician As the ALJ recognized, DEA having answered the liability question named Dr. Hector J. Aguilar-Amieva regulations do not define the meaning of ‘‘no,’’ the only issues that are relevant (hereinafter, Dr. Aguilar) had allowed the term ‘‘for cause’’ as used on the are whether he knew that he had his registration to expire and that his various application for registration surrendered his registrations and had registration had been retired by the forms. Moreover, the application does done so ‘‘for cause.’’ Because Mr. Moro Agency since January 31, 2009.10 The not define the term. Nonetheless, Perez clearly knew that he: (1) Had evidence further shows that between persons of ordinary intelligence cannot surrendered his registrations, (2) had January 30, 2009 and November 30, dispute that a surrender which occurs in done so in response to allegations that 2011 (when the search warrants were response to allegations of misconduct his pharmacies had committed executed at Respondents), Farmacia raised by the Agency’s Special Agents violations of the CSA, and (3) did so to Nueva filled 143 controlled substance and Diversion Investigators is ‘‘for avoid proceedings to revoke the prescriptions which were purportedly cause,’’ especially when those Agents registrations, he also clearly knew that issued by Dr. Aguilar (and which used and Investigators further advise the he had surrendered ‘‘for cause.’’ his DEA registration) and that Best registrant’s principal that if he/she I thus agree with the ALJ’s conclusion Pharmacy filled thirty-two controlled declines to surrender a registration, the that Mr. Moro Perez knowingly and substance prescriptions. GXs 5 & 10. Agency will nonetheless initiate materially falsified 9 the applications he Under 21 CFR 1306.03, a controlled proceedings to revoke it.7 substance prescription ‘‘may be issued having violated the CSA and was told that if he did only by an individual practitioner who 7 In its post-hearing brief, Respondents note that not surrender the registration, the Agency would is: (1) [a]uthorized to prescribe on the application, the phrase ‘‘for cause’’ is in pursue a proceeding to revoke its registration; as for controlled substances by the jurisdiction parentheses. Resp. Br. 22–23. Respondents then Farmacia Nueva’s registration, the Agency was in which he is licensed to practice his argue that ‘‘[i]t must be in parenthesis [sic] for some continuing to pursue a Show Cause Proceeding to reason [and] [t]he idea cannot be and should not be revoke its registration when Mr. Moro Perez agreed profession and (2) [e]ither registered or that any time an applicant who had surrendered his to surrender its registration. registration for some reason answers ‘no’ to this 8 Respondent makes no claim that Mr. Moro Perez 10 According to the DI, Dr. Aguilar’s registration question, that applicant is automatically falsifying was unaware that its attorney had surrendered expired after he was convicted of a federal criminal facts.’’ Id. at 23. Farmacia Nueva’s registration. Even if it had, ‘‘ ‘a offense; the record does not, however, establish the That is certainly true, as a pharmacy registrant principal is chargeable with the knowledge of, or offense of which he was convicted nor the date of may have surrendered its registration previously notice to, his agent that is received by the agent in his conviction. Moreover, while there was evidence because it went out of business but has since the due course of his employment and is related to that Dr. Aguilar’s office was only a three to four reopened, just as a physician registrant may have the matters within his authority.’ ’’ McMillan v. LTV minute walk from Farmacia Nueva, Tr. 250, and done so because he/she ceased professional practice Steel, Inc., 555 F.3d 218, 230 (6th Cir. 2009) that it was the closest pharmacy to his office, the but has since resumed practicing medicine. The (quoting Aetna Cas. & Sur. Co. v. Leahey Constr. Government provided no evidence that argument ultimately takes Respondents nowhere Co., 219 F.3d 519, 541 (6th Cir. 2000)). Respondents’ pharmacists were aware of any because Mr. Moro Perez surrendered Best 9 Respondents do not contend that the enforcement actions that were brought against Dr. Pharmacy’s registration after he was accused of falsifications were immaterial. Aguilar.

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exempted from registration [under] this Instead, Mr. Moro-Perez testified that prescriptions are clearly not issued for chapter.’’ Thus, Dr. Aguilar’s he and his pharmacists relied on the legitimate medical purposes, a prescriptions were unlawful.11 patients’ insurance carriers (to which pharmacist may not intentionally close Mr. Moro Perez testified that there they submitted claims for payment of his eyes and thereby avoid positive were ‘‘many times’’ when Respondents’ medications) to determine whether a knowledge of the real purpose of the pharmacists refused to fill Dr. Aguilar’s physician had valid licenses and prescription,’’ and thereafter fill the controlled substances prescriptions registrations by seeing if the claim was prescription ‘‘with impunity.’’ because ‘‘we knew that that patient paid. Id. at 200–1. Mr. Moro-Perez Bertolino, 55 FR at 4730 (citing United didn’t require the use of the conceded that the insurance companies States v. Kershmann, 555 F.2d 198 (8th medication.’’ Tr. 252; see also id. at 254. continued to pay claims for Cir. 1977); United States v. Hayes, 595 When questioned by the ALJ as to prescriptions issued by Dr. Aguilar until F.2d 258 (5th Cir. 1979)); accord Liberty whether he thought it was suspicious the date on which the search warrant Discount Drugs, Inc., 54 FR 30116, that many of Dr. Aguilar’s patients were was executed, which was nearly three 30117 (1989). See also Medic-Aid presenting controlled substance years after the latter’s registration had Pharmacy, 55 FR at 30044 (‘‘The prescriptions that he (and his been retired. Id. at 202. However, no administrative law judge concluded that pharmacists) would not fill, Mr. Moro evidence was adduced as to whether it is not necessary to find that [the Perez testified that ‘‘we have been very any claim for payment was rejected by pharmacist] in fact knew that many careful with the dispensing’’ and ‘‘the a patient’s insurer, and there was prescriptions presented to him were not amount of medications that were obviously no evidence as to whether in written for a legitimate medical dispensed, the percentage [was] very the event an insurer rejected a claim, it purpose, for there is no question that a low.’’ Id. at 253. Mr. Moro Perez then would disclose the reason it did so.14 conscientious pharmacist would have testified that he never called Dr. As the ALJ recognized, under DEA’s been suspicious of these prescriptions Aguilar, and when asked why, claimed longstanding regulation, a pharmacist and would have refused to fill them.’’). that he and his pharmacists reviewed has a corresponding responsibility to fill Thus, both Bertolino and Medic Aid the patient’s history and used their only those prescriptions which are Pharmacy applied the standard of professional judgment to evaluate ‘‘issued for a legitimate medical purpose deliberate ignorance or willful blindness whether a particular prescription was by [a] practitioner acting in the usual in assessing whether a pharmacist acted legitimate. Id. course of his professional practice.’’ 21 with the requisite scienter. See Seelig, When questioned further as to why he CFR 1306.04(a). Continuing, the 622 F.2d at 213 (‘‘the element of did not call Dr. Aguilar, Mr. Moro Perez regulation states that ‘‘the person knowledge may be inferred from proof testified: ‘‘Because I understood, I was knowingly filling such a purported that appellants deliberately closed their aware that the doctor’s license were [sic] prescription, as well as the person eyes to what would otherwise be up-to-date.’’ 12 Id. at 254. Mr. Moro-Perez issuing it, [is] subject to the penalties obvious to them’’); Kershmann, 555 F.3d and his pharmacists never attempted to provided for violations of the provisions at 200 (‘‘the element of knowledge may verify whether Dr. Aguilar held a of law relating to controlled be shown by deliberate ignorance’’). registration, id. at 193–94, even though, substances.’’ Id.15 (emphasis added). In addition to the obligation imposed according to the DI, they could have DEA has long interpreted this by 21 CFR 1306.04(a), ‘‘[a] prescription done so simply by calling the local DEA provision as prohibiting a pharmacist for a controlled substance may only be office.13 Id. at 20. from filling a prescription for a filled by a pharmacist, acting in the controlled substance when he either usual course of his professional 11 Respondents do not claim that Dr. Aguilar was ‘‘knows or has reason to know that the practice. . . .’’ 21 CFR 1306.06 exempt from registration, and under the CSA, had prescription was not written for a (emphasis added). Thus, the Agency has they claimed as much, they (and not the Government) would have had the burden of proof legitimate medical purpose.’’ Medic-Aid also repeatedly held that ‘‘a pharmacist on the issue. See 21 U.S.C. 885(a) (1). Pharmacy, 55 FR 30043, 30044 (1990) must exercise professional judgment 12 The ALJ was not impressed by this testimony, (emphasis added); see also Frank’s [and common sense] when filling a finding it to be ‘‘the obvious fruit of intentional Corner Pharmacy, 60 FR 17574, 17576 prescription.’’ Bertolino, 55 FR at 4730; equivocation.’’ R.D. at 20. That being said, the ALJ’s finding does not establish that Moro-Perez knew (1995); Ralph J. Bertolino, 55 FR 4729, see also Medicine Shoppe- that Dr. Aguilar was no longer registered (as 4730 (1990); United States v. Seelig, 622 Jonesborough, 73 FR 363, 381, pet. for opposed to simply being unaware of the status of F.2d 207, 213 (6th Cir. 1980). Thus, rev. denied, Medicine Shoppe- Aguilar’s license) when his pharmacies filled the proof of actual knowledge is not Jonesborough v. DEA, 300 Fed. App’x prescriptions and the ALJ made no such finding. Moreover, it is not even clear on the record whether necessary to establish that a pharmacist 409, 412 (6th Cir. 2008); Trinity Health Moro-Perez was testifying regarding Dr. Aguilar’s has violated his/her corresponding Care Corp., 72 FR 30849, 30854 (2007); DEA registration rather than his state license. responsibility to dispense only lawful 21 CFR 1306.06. Accordingly, the 13 The evidence also showed that since 2008, DEA prescriptions. Agency has held that ‘‘when a customer has provided a Web page, at which a DEA registrant can verify the registration status of another person However, in finding violations of the presents a suspicious prescription, at a or entity. Tr. 22. However, other than vague corresponding responsibility where minimum, a pharmacist has a duty to testimony suggesting that during an inspection an actual knowledge has not been proved, verify the prescription with the investigator would tell a registrant that the Web site the Agency has explained that ‘‘[w]hen prescriber.’’ Medicine Shoppe- is available, id. at 90, no evidence was put forward that this information was conveyed to Respondents. Jonesborough, 73 FR 364, 381; see also Nor did the Government provide any evidence as 14 Nor was any evidence put forward as to how Medicine Shoppe, 300 Fed. App’x at to what efforts have been made to notify the many of the Aguilar prescriptions were actually 412. community of registrants as to the Web page’s paid for with cash. Moreover, even if a prescriber tells a 15 availability. As the Supreme Court has explained, ‘‘the pharmacist that a prescription has been It is noted that in publishing its Interim Final prescription requirement . . . ensures patients use Rule on Electronic Prescriptions for Controlled controlled substances under the supervision of a issued for a legitimate medical purpose, Substances, the Agency explained that ‘‘[i]f a doctor so as to prevent addiction and recreational a pharmacist cannot ignore other pharmacy has doubts about a particular DEA abuse. As a corollary, [it] also bars doctors from evidence that the prescription has not registration, it can now check the registration peddling to patients who crave the drugs for those been issued for a legitimate medical through DEA’s Registration Validation Tool’’ which prohibited uses.’’ Gonzales v. Oregon, 546 U.S. 243, is available at the Agency’s Web site. See 75 FR 274 (2006) (citing United States v. Moore, 423 U.S. purpose or that the prescriber acted 16236, 16266 (2010). 122, 135 (1975)). outside of the usual course of his or her

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professional practice and dispense the that the prescribing practitioner is entering the prescription into the prescription. As one court of appeals properly registered with DEA.’’ Id. The pharmacy’s dispensing software. Id. has explained: Agency thus removed the requirement Thus, the pharmacists at each store had Verification by the issuing practitioner on from the Interim Final Rule, but ‘‘made knowledge that the physicians’ request of the pharmacist is evidence that the clear that a pharmacist continues to registrations had expired at the time pharmacist lacks knowledge that the have a corresponding responsibility to they filled most of the prescription was issued outside the scope of fill only those prescriptions that prescriptions.17 Id. Here again, liability professional practice. But it is not an conform in all respects with the was imposed on the pharmacies insurance policy against a fact finder’s requirements of the [CSA] and DEA consistent with the corresponding concluding that the pharmacist had the regulations, including the requirement requisite knowledge despite a purported but responsibility imposed on their that the prescribing practitioner be pharmacists.18 false verification. . . . What is required by [a properly registered.’’ Id. pharmacist] is the responsibility not to fill an As this pronouncement makes clear, a As the ALJ found, the Government order that purports to be a prescription but put forward no evidence that Mr. Moro- is not a prescription within the meaning of pharmacist is not obligated to verify the statute because he knows that the issuing whether every prescription he fills has Perez or any of his pharmacists had practitioner issued it outside the scope of been issued by a practitioner who holds actual knowledge that Dr. Aguilar’s medical practice. a valid DEA registration. Of course, if a registration was no longer valid at any pharmacist has actual knowledge that a point during the thirty-four month United States v. Hayes, 595 F.2d 258, prescriber does not hold a valid period in which they filled his 260 (5th Cir. 1979). See also Medicine registration, or acts with willful Shoppe, 300 Fed. App’x at 412 (quoting prescriptions. R.D. 51 n.86. The ALJ blindness to this fact, a pharmacist Bertolino, 55 FR at 4730) (‘‘ ‘When nonetheless concluded that the requisite violates the Controlled Substances Act if knowledge could be imputed to [pharmacists’] suspicions are aroused as he proceeds to dispense that reasonable professionals,’ they must at Respondents because their pharmacists prescription. 21 U.S.C. 843(a)(2). Thus, entirely failed to investigate whether Dr. least verify the prescription’s propriety, in United Prescription Services, I held and if not satisfied by the answer they Aguilar held a valid registration and that a pharmacy violated its thus were willfully blind to the fact that must ‘refuse to dispense.’ ’’); Holiday corresponding responsibility by CVS, L.L.C., d/b/a CVS/Pharmacy Nos. Aguilar was no longer registered and dispensing prescriptions issued by a could not write a controlled substance 219 & 5195, 77 FR 62316, 62341 (2012); physician, whose registration had prescription. R.D. at 53 (citing United East Main Street Pharmacy, 75 FR expired, where the pharmacy had on file 66149, 66163–64 (2010). a copy of the physician’s registration 17 Under an Agency regulation, every and thus, its pharmacists clearly knew, I also noted that as participants in a highly controlled substance prescription must regulated industry, the pharmacies were required to or were willfully blind to the fact, that keep abreast of regulatory developments which contain ‘‘the name, address and the physician was issuing prescriptions affect their industry and that with respect to the registration number of the practitioner’’ on an expired registration and that the physician whose registration was revoked, who issued it. 21 CFR 1306.05(a). prescriptions were therefore illegal.16 72 publication of the Decision and Order in the However, the Agency’s regulation does Federal Register ‘‘provided [the pharmacies] with FR at 50408. reason to know’’ that upon the effective date, the not require that a practitioner provide More recently, in Holiday CVS, L.L.C., physician ‘‘would no longer be authorized to issue the expiration date of his registration on 77 FR 62316 (2012), two pharmacies controlled substance prescriptions.’’ 77 FR at 62317 a prescription. See id. continued to fill prescriptions written (citations omitted). Moreover, no Agency regulation by two physicians whose registrations 18 In the Show Cause Order, the Government cited requires that a pharmacist ascertain that Medicine Shoppe—Jonesborough, 73 FR 364 (2008), had expired. Moreover, the registration as authority for the violation. In Medicine Shoppe— each prescription presented to him/her of one of the physicians had been Jonesborough, a pharmacy was found to have filled has been issued by a practitioner who revoked following a proceeding under over 124 controlled substances prescriptions which possesses a valid DEA registration. 21 U.S.C. 824(a)(4) and the Agency’s were written by a veterinarian who no longer Indeed, the Agency recognized this possessed either a state license or a DEA Decision and Order had been published registration. Id. at 381. However, I did not decide much in 2010, when it promulgated its in the Federal Register (as well as on whether the pharmacy violated its corresponding Interim Final Rule on Electronic the DEA Office of Diversion Control’s responsibility because it dispensed the Prescriptions for Controlled Substances. public Web site) approximately one prescriptions when the veterinarian lacked either See 75 FR 16236, 16266 (2010). Therein, state authority or a DEA registration. Id. Rather, I month before the Order became found that even if the pharmacy’s pharmacist-in- the Agency noted that it had proposed effective. Id. Yet both pharmacies charge was unaware that the veterinarian no longer requiring pharmacies ‘‘to confirm that continued to dispense prescriptions possessed a DEA registration and state license, it the [prescriber’s] DEA registration . . . issued by this physician, including violated its corresponding responsibility based on was valid at the time’’ the prescription the expert testimony that the pharmacy had ignored some which were issued more than five various circumstances that provided knowledge to was signed. Id. However, several months after the Order became effective. its pharmacists that the prescriptions were not commenters objected ‘‘that pharmacies Id. Finally, the evidence also showed issued for legitimate medical purposes (including are not required to check DEA that the pharmacies used a company that the prescriptions were presented on a daily registrations for paper prescriptions wide information management system basis by the veterinarian’s brother and were for drugs, which according to the expert, would be unless they suspect something is wrong which obtained updated registration toxic for certain animals). Id. with a prescription.’’ Id. data from a third party aggregator However, in a footnote, I explained that ‘‘[a] In its response (which appears to be (which obtained it from DEA) on a pharmacy has a duty to periodically check to see missing pertinent text), the Agency weekly basis and that a prescribing that a practitioner retains the authority to practice medicine and dispense a controlled substance.’’ Id. stated that it ‘‘agrees with those physician’s registration status was at n.45. Because of the evidence that the pharmacy commenters that expressed the view displayed to the pharmacist when had violated 21 CFR 1306.04(a), I deemed it that, when filling a paper prescription, unnecessary to decide whether the pharmacy had it is not necessary for a pharmacist who 16 In United Prescription Services, this particular violated this duty. However, I noted my agreement receives an electronic prescription for a physician’s registration had expired on February 28, with the ALJ’s reasoning that failing ‘‘to do so could 2003, and yet the pharmacy was still dispensing threaten public health and safety because there is controlled substance to check the CSA prescriptions written by him in September and usually a good reason for why a practitioner has lost database in every instance to confirm October 2004. See 72 FR at 50408. his or her state license and DEA registration.’’ Id.

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States v. Katz, 445 F.3d 1023, 1031 (8th Aguilar was writing on an expired abundance of agency case law applying Cir. 2006)).19 registration. the reasonable pharmacist standard, did Recently, however, the Supreme To be sure, in his testimony, Mr. the Government call an expert to testify Court made clear that ‘‘a willfully blind Moro-Perez admitted that his that the standards of professional defendant is one who takes deliberate pharmacists had rejected controlled pharmacy practice require that a actions to avoid confirming a high substance prescriptions issued by Dr. pharmacist who is confronted with probability of wrongdoing and who can Aguilar ‘‘many times,’’ because based on prescriptions from a particular almost be said to have actually known the patients’ histories, they did not physician which he/she suspects lack a the critical facts.’’ Global-Tech consider the prescriptions to be legitimate medical purpose, must also Appliances, Inc., v. SEB S.A., 131 S.Ct. legitimate for the respective patients. determine whether the physician 2060, 2070–71 (2011) (emphasis added) This admission might well have possesses a valid DEA registration.22 (citing and quoting G. Williams, established willful blindness with In its post-hearing brief, the Criminal Law § 57, p.159 (2d ed. 1961) respect to whether the Aguilar Government argues for the first time that (‘‘A court can properly find willful prescriptions which Respondents filled Respondents’ pharmacists also violated blindness only where it can almost be lacked a legitimate medical purpose— their corresponding responsibility said that the defendant actually had the Government challenged the because the prescriptions they filled knew.’’)); see also id. at 2069 (quoting dispensing of any of the post-January also lacked a legitimate medical with approval American Law Institute, 31, 2009 prescriptions on this basis. But purpose. As the Government argues, Model Penal Code § 202(7) (Proposed it did not. Most importantly, it does not ‘‘Mr. Moro-Perez’s most egregious Official Draft 1962) (‘‘defining establish that Moro-Perez or any of his conduct involves filling prescriptions ‘knowledge of the existence of a pharmacists subjectively believed that for Dr. Aguilar-Amieva despite the fact particular fact’ to include a situation in there was a high probability that Aguilar that he had previously flagged prior which ‘a person is aware of a high no longer had a registration.20 prescriptions as being illegitimate.’’ probability of [the fact’s] existence, As for whether Respondents’ Gov. Post-Hrng. Br. at 22. The unless he actually believed that it does pharmacists violated their obligation to Government then argues that not exist’’’)). act within the usual course of ‘‘Respondent[s] deliberately ignored In Global-Tech, the Supreme Court professional practice, see 21 CFR their own internal warnings when they further explained that even proof that a 1306.06, because their suspicions as to continued to fill other prescriptions for defendant was reckless in that he knew Dr. Aguilar’s lack of registration should Dr. Aguilar-Amieva,’’ that ‘‘Moro-Perez ‘‘of a substantial and unjustified risk of have been aroused as reasonable failed to conduct any investigation to wrongdoing’’ does not establish willful pharmacists and they failed to resolve this flag,’’ and that ‘‘[a]ny blindness. Id. at 2071. Rather, to investigate, the evidence is simply reasonable and prudent pharmacist establish willful blindness, proof is insufficient to establish a violation. would not have continued to fill required that: ‘‘(1) the defendant must Notably, the Government does not cite prescriptions without further subjectively believe that there is high to any statute, Board regulation, or investigation.’’ Id. at 23. probability that a fact exists and (2) the decision of either the Board or the Even ignoring that raising this theory defendant must take deliberate actions courts which requires a pharmacist to for the first time in its post-hearing brief to avoid learning of that fact.’’ Id. at verify the status of a DEA registration is too late to provide fair notice (given 2070 (emphasis added). (or medical license) upon being that the testimony did not occur until Here, the Government offered no presented with a prescription which he/ Moro-Perez was cross-examined by his evidence to establish that Mr. Moro- she suspects lacks a legitimate medical own counsel), the Government did not Perez, or any other of Respondents’ purpose.21 Nor, notwithstanding the put on any evidence to show that any pharmacists, subjectively believed that of the Aguilar prescriptions filled by there was a high probability that Dr. 20 Although both the Government and ALJ made Aguilar was issuing prescriptions on an much of Moro-Perez’s admission, ‘‘many’’ is an Respondents declined to fill. Because there is no expired registration. Moreover, indefinite term and the record does not clarify just regulation which required Respondents to the check how many prescriptions were rejected by notwithstanding that Respondents put the registration status of Dr. Aguilar, nor any Respondents, and as of what date their pharmacists testimony that the accepted standards of forward no evidence that it was were aware of this. professional practice required that they do so, I do objectively reasonable to determine if 21 The ALJ also reasoned that ‘‘[t]he absence of Dr. not adopt the ALJ’s discussion that Dr. Aguilar’s Dr. Aguilar possessed a valid Aguilar’s [registration] is the most glaring of red lack of a registration was ‘‘the most glaring of red registration by relying on whether the flags that could and should have been recognized flags’’ which should have been discovered. by the Respondent upon the exercise of even the 22 As found above, in the Interim Rule on patients’ insurance companies paid for most minimal due diligence. Conclusively resolving Electronic Prescribing, the Agency noted that their prescriptions, there is no evidence such a fundamental red flag was a mandatory several commenters had objected to the proposal that a claim for payment of any of Dr. condition precedent to the legal dispensing of a that the DEA registration must be verified for all Aguilar’s prescriptions was ever rejected control substance. . . .’’ R.D. at 52. electronic prescriptions, noting ‘‘that pharmacies The term ‘‘red flag’’ is not defined in either the are not required to check DEA registrations for by a patient’s insurer. Indeed, CSA or DEA regulations. However, in the context paper prescriptions unless they suspect something notwithstanding the ALJ’s finding (with of a pharmacy, a red flag is simply a circumstance is wrong with a prescription.’’ 75 FR at 16266. which I agree) that this was an arising during the presentation of a prescription, While this may reflect the accepted standards of ‘‘irresponsible practice’’ and ‘‘illogical which creates a reasonable suspicion that the professional pharmacy practice, the Interim Rule prescription is not valid and which imposes on a did not explain who the commenters were and manner’’ of determining a physician’s pharmacist the obligation to conduct further inquiry whether they speak for the profession as a whole. registration status, he made no finding into whether the prescription is valid or to not fill Moreover, absent proof of either: (1) That a that Moro-Perez (or any other it all. See Holiday CVS, 77 FR at 62332. dispensing was simply a drug deal, or (2) that the pharmacist) ‘‘subjectively believe[d] that Here, there was no evidence that Respondents’ pharmacy violated an explicit duty set forth in a pharmacists ever received any information that Dr. statute, regulation, or case law, the standards of there was a high probability’’ that Dr. Aguilar was no longer registered such as through a professional practice must generally be established tip, the grapevine, or having seen media coverage on the record in any case. Accordingly, I place no 19 See also United States v. Lawson, 682 F.2d 480, of Aguilar’s putative arrest or trial. Moreover, while weight on the statement suggesting that a 482 (4th Cir. 1982); United States v. Seelig, 622 F.2d a red flag includes additional facts developed pharmacist is required to check a prescriber’s 207, 213 (6th Cir. 1980); United States v. during the investigation of other red flags, here, the registration if he/she suspects there is something Kershmann, 555 F.2d 198, 200–01 (8th Cir. 1977). red flag was the illegality of the prescriptions wrong with a prescription.

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Respondents also lacked a legitimate In their post-hearing brief, intentional or knowing. Moreover, while medical purpose.23 Indeed, there is no Respondents nonetheless concede that Respondents do not dispute that their evidence to refute Moro-Perez’s by dispensing the Aguilar prescriptions failure to verify Dr. Aguilar’s testimony (which the ALJ apparently they committed acts inconsistent with registration at any time during the found credible) that he and his the public interest, Resp. Post-Hrng. Br. aforesaid period constitutes conduct pharmacists declined to fill many 18, because ‘‘it was wrong for him which may threaten the public health prescriptions and thus complied, (at [Moro-Perez] and [the] pharmacies to and safety, the lack of specific guidance least with respect to those rely on [an] insurance company’s as to what steps are necessary to comply prescriptions), with their corresponding system to notify [them] if a doctor’s with this duty diminishes its responsibility. license is expired, suspended, or egregiousness to some degree. Finally, As for its contention that no revoked.’’ Id. at 19. Respondents further Mr. Moro-Perez’s material falsification reasonable and prudent pharmacist concede that doing so constitutes ‘‘such of the applications and failure to accept would have filled the prescriptions, other conduct which may threaten responsibility for the falsifications, here again, there is no evidence as to public health and safety.’’ Id. at 25. provide reason alone to deny the what a reasonable and prudent I agree. As the ALJ found (and given applications. pharmacist would have done when Respondent’s concession), it was not While it is indisputable that failing to confronted with this information. Nor is objectively reasonable for Respondents’ verify a controlled-substance there any expert testimony as to at what pharmacist to rely on whether insurance prescriber’s credentials at any time point (i.e., after how many companies rejected a claim for payment during a three year period is a breach of prescriptions), this information would of a prescription to determine whether the duty set forth in Medicine Shoppe— have prompted further investigation.24 a physician held a valid registration. Jonesborough, I conclude that if the And as explained above, more than a Agency intends to enforce this duty in 23 Notably, in this portion of its brief, the year prior to the conduct at issue here, other cases, it must provide the Government makes no reference to the status of Dr. I explained (albeit in a dictum) that ‘‘[a] regulated community with guidance as Aguilar’s registration. See Gov. Post-Hrng. Br. 22– 23. pharmacy has a duty to periodically to its scope. However, while such While the Government obtained the prescriptions check to see that a practitioner retains guidance can be announced in an during its investigation, it did not raise this theory the authority to practice medicine and adjudicatory proceeding, the process of in the Show Cause Order, which, with regard to dispense a controlled substance.’’ adjudication is not well suited for doing Respondents’ dispensings, rested entirely on the Medicine Shoppe-Jonesborough, 73 FR so. See I Richard J. Pierce, Jr., allegations that they dispensed ‘‘prescriptions for controlled substances issued by a medical doctor at 381 n.45. However, because it was not Administrative Law Treatise § 6.8, at who did not possess a valid DEA registration.’’ ALJ necessary to decide the case, Medicine 368–74 (4th ed. 2002). Accordingly, I Ex. 1, at 2. Moreover, in neither of its pre-hearing Shoppe—Jonesborough did not set forth decline to set forth how frequently a statements, did the Government provide notice that the specific parameters of this duty. See pharmacy must verify that a prescriber it was challenging the dispensings of the Aguilar prescriptions on the ground that they were issued id. is registered. for other than a legitimate medical purpose. See ALJ I nonetheless conclude that In sum, I reject the allegations that Exs. 4 & 8. Respondents breached this duty because Respondents violated Federal law and 24 Even were I to apply the ‘‘reason to know’’ their pharmacists failed to verify that DEA regulations when they dispensed standard of the common law, see Novicki v. Cook, 946 F.2d 938, 941 (D.C. Cir. 1991), which requires Dr. Aguilar remained registered at any controlled substance prescriptions proof of something less than either actual time during the thirty-four month ‘‘issued by a medical doctor who did knowledge or willful blindness, the Government period between the expiration of his not possess a valid DEA registration.’’ would not prevail on its contention that registration and the execution of the Show Cause Order (ALJ Ex. 1), at 2 ¶¶ Respondents violated 21 CFR 1306.04(a) because the prescriptions were issued under an expired search warrants. However, I place only 4 & 8 (citing 21 U.S.C. 843(a)(2); 21 CFR registration. In Novicki, the D.C. Circuit looked to nominal weight on this aspect of 1306.04).25 However, I find that the Restatement (Second) of Agency (1958) and the Respondents’ misconduct. The Respondents breached their duty to Restatement (Second) of Torts (1965) to give Government did not prove that periodically verify Dr. Aguilar’s meaning to the term. See id. (quoting Restatement (Second) of Agency § 9 cmt. d (1958) and citing Respondents’ misconduct was registration status. See Medicine Restatement (Second) of Torts § 12(1)). As the Shoppe-Jonesborough, 73 FR at 381 Restatement of Agency explains, Restatement (Second) of Agency § 9 cmt. d (1958); n.45. A person has reason to know of a fact if he has see also Restatement (Second) of Torts § 12, cmt. a Most significantly, I also adopt the information from which a person of ordinary (‘‘ ‘Reason to know’ means that the actor has intelligence, or of the superior intelligence which knowledge of facts from which a reasonable man of ALJ’s findings that Mr. Moro-Perez such person may have, would infer that the fact in ordinary intelligence or one of the superior materially falsified the application of question exists or that there is such a substantial intelligence of the actor would either infer the each Respondent by failing to disclose chance of its existence that, if exercising reasonable existence of the fact in question or would regard its that he had previously surrendered each care with reference to the matter in question, his existence as so highly probable that his conduct action would be predicated upon the assumption of would be predicated upon the assumption that the pharmacy’s registration for cause, as its possible existence. The inference drawn need fact did exist.’’). well as the ALJ’s findings that Mr. not be that the fact exists; it is sufficient that the Because he is a licensed pharmacist (as are Moro-Perez has not acknowledged his likelihood of its existence is so great that a person presumably his other pharmacists), Mr. Moro-Perez misconduct in doing so. See R.D. at 53 of ordinary intelligence, or of the superior is a ‘‘person of superior intelligence or training.’’ intelligence which the person in question has, Thus, it would be appropriate to consider whether (finding that Mr. Moro-Perez ‘‘insistence would, if exercising ordinary prudence under the a person possessing the mental capacity and that his false response to an application circumstances, govern his conduct as if the fact attainments of Mr. Moro-Perez and his pharmacists query regarding whether each pharmacy existed, until he could ascertain its existence or would, based on the knowledge that Dr. Aguilar had ever surrendered a [registration] for non-existence. . . . A person of superior was issuing prescriptions which lacked a legitimate intelligence or training has reason to know a fact medical purpose, draw the further inference that he cause was some sort of reasonable if a person with his mental capacity and was no longer registered. Here again, because the attainments would draw such an inference from the Government did not sponsor any expert testimony, 25 I also do not adopt the ALJ’s discussion in the facts know to him. On the other hand, ‘‘reason to there is no evidence as to whether, based on the Recommendation section of his decision regarding know’’ imports no duty to ascertain facts not to be prescriptions that he/she was rejecting, a reasonable the egregiousness of Respondents’ conduct in filling deduced as inferences from facts already known; pharmacist would have inferred that Aguilar was the Aguilar prescriptions and the Agency’s interest one has reason to know a fact only if a reasonable not registered or would have regarded the existence in deterring similar misconduct. Nor do I adopt the person in his position would infer such fact from of this fact ‘‘as so highly probable’’ that he would ALJ’s discussion rejecting Respondents’ arguments other facts already known to him. have refused to dispense the prescriptions. which were offered in mitigation of this violation.

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misunderstanding is simply not credible The Allegations 1) The owner of Farmacia Nueva and Best and defeats the Respondents’ efforts to In its OSC,3 the Government alleges that Pharma is Mr. Julio E. Moro-Perez (Moro- meet the Government’s case’’). the COR applications filed on behalf of both Perez). Accordingly, I will deny each registrants should be denied as contrary to 2) Farmacia Nueva previously held DEA COR BF9534187 as a retail pharmacy in Respondent’s application. the public interest.4 In its subsequently filed Prehearing Statement,5 the Government Schedules II–V. Order supplemented its theory in support of denial 3) Best Pharma previously held DEA COR with additional allegations that the COR FB1971565 as a retail pharmacy in Schedules Pursuant to the authority vested in me applications filed on behalf of each II–V. by 21 U.S.C. 823(f) and 28 CFR 0.100(b), Respondent contained material 4) Neither Farmacia Nueva nor Best Pharma currently possesses a DEA COR. I order that the application of JM falsifications 6 in that each application stated that the respective registrant had never 5) On October 10, 2012, Moro-Perez Pharmacy Group Inc., d/b/a Farmacia applied on behalf of Farmacia Nueva for a Nueva, for a DEA Certificate of surrendered a COR for cause, when, in fact, both had. DEA COR as a retail pharmacy in Schedules Registration as a retail pharmacy, be, In support of the denial it seeks regarding II–V at URB Raholisa #3, San Sebastian, and it hereby is, denied. I further order an application for a COR filed by JM Puerto Rico 00685. that the application of Best Pharma Pharmacy Corp., d/b/a Farmacia Nueva 6) On October 10, 2012, Moro-Perez Corp, for a DEA Certificate of (Farmacia Nueva or FN), based on the public applied on behalf of Best Pharma for a DEA Registration as a retail pharmacy, be, interest, the Government avers that this COR as a retail pharmacy in Schedules II–V Respondent: (1) ‘‘filled approximately 160 at Carr 111 KM 5.2 Bo. Pueblo, Ave La Moca and it hereby is, denied. This Order is 300, Moca, Puerto Rico 00685. effective immediately. prescriptions for controlled substances issued by a medical doctor who did not 7) A COR previously issued to Dr. Hector Dated: April 29, 2015. possess a valid DEA registration in violation J. Aguilar-Amieva, M.D. (Dr. Aguilar) was retired by DEA on January 31, 2009. Michele M. Leonhart, of’’ 21 U.S.C. 843(a)(2) and 21 CFR 1306.04 8) A criminal case against Moro-Perez, case Administrator. (2013); and (2) ‘‘failed to keep records of approximately twenty-seven (27) no. 3:11–CR–00532–006, was dismissed with Anthony Yim, Esq., for the Government. prescriptions for controlled substances’’ from prejudice by the United States District Court for the District of Puerto Rico on March 23, Vladimir Mihailovich, Esq., for the November 2009 through November 2011 in 2012, upon petition from the United States Respondent. violation of 21 U.S.C. 827(b)(1) and 21 CFR Attorney’s Office for the District of Puerto 1304.04.7 RECOMMENDED RULINGS, FINDINGS OF Rico.11 The Government alleges that the granting FACT, CONCLUSIONS OF LAW, AND of the COR application filed by Best Pharma DECISION OF THE ADMINISTRATIVE The Evidence Corp. (Best Pharma or BP) is inconsistent LAW JUDGE with the public interest in that this The Government’s Evidence Chief Administrative Law Judge John J. Respondent: (1) ‘‘filled approximately thirty- The Government’s case-in-chief rested on Mulrooney, II. On June 19, 2013, the Deputy- two (32) prescriptions for controlled the testimony of four witnesses: DEA Assistant Administrator of the Drug substances issued by a medical doctor who Diversion Investigator (DI) Ghensy Antoine, Enforcement Administration (DEA) issued an did not possess a valid DEA registration, in DEA Digital Forensic Examiner (DFE) Amy L. Order to Show Cause (OSC) proposing to violation of’’ 21 U.S.C. 843(a)(2) and 21 CFR Herrmann, DI George Taylor, and Moro- deny applications for two DEA Certificates of 1306.04; and (2) ‘‘failed to keep records of Perez, the owner/president of Farmacia Registration (COR) submitted on behalf of approximately seven (7) prescriptions for Nueva and Best Pharma. two pharmacies 1 (collectively, the controlled substances’’ from November 2009 DI Ghensy Antoine testified that in the Respondents). In its OSC and its prehearing through November 2011 in violation of 21 course of his duties as a DI in the Ponce, 8 Puerto Rico DEA field office, he was assigned statements, the Government avers that the U.S.C. 827(b)(1) and 21 CFR 1304.04. as the lead investigator for the COR applications should be denied because they Additionally, the Government alleges that both Farmacia Nueva and Best Pharma applications filed by Moro-Perez on behalf of were submitted with material falsifications,2 ‘‘materially falsified’’ their applications for the Respondents. Tr. 13–14, 76. Antoine and because granting the applications would DEA CORs.9 explained that these COR applications were be inconsistent with the public interest as designated for investigation because the that term is defined under the Controlled The Stipulations of Fact Respondents had a history of ‘‘some issues Substances Act (CSA). 21 U.S.C. 823(f) The Government and the Respondents, with some minor violations.’’ Tr. 15. (2006). On July 18, 2013, the Respondents, through counsel, have entered into Specifically, regarding Farmacia Nueva, through counsel, filed a timely request for stipulations 10 regarding the following Antoine stated that his application 12 hearing, which was conducted in Arlington, matters: investigation preliminarily revealed that on Virginia, on September 3, 2013. The issue ultimately to be adjudicated by 3 ALJ Ex. 1. Exibit 7(ID) and one prescription event purportedly the Administrator, with the assistance of this 4 21 U.S.C. 824(a)(4). detailed in Proposed Government Exhibit 12(ID) do recommended decision, is whether the 5 ALJ Ex. 4. not refer to controlled substances. ALJ Ex. 11. Notwithstanding the purported exhibit substitution 6 21 U.S.C. 824(a)(1). record as a whole establishes by substantial set forth in the Joint Stipulations, at the hearing, the 7 evidence that the Respondents’ applications ALJ Ex. 1, at 2. Government (errantly) represented that it had for registrations with the DEA should be 8 Id. withdrawn Proposed Government Exhibit 12(ID). denied on the grounds alleged by the 9 ALJ Ex. 8, at 1. Tr. 97–98. Regrettably, the record is further Government. 10 On August 28, 2013 (three business days prior confounded by the fact that none of the seven non- to the commencement of the hearing in this matter), controlled prescription events referenced in the After carefully considering the testimony Joint Stipulations are depicted in the substituted elicited at the hearing, the admitted exhibits, a telephonic status conference (Status Conference) was conducted with the parties, wherein, inter alia, Government Exhibits 7 or 12(ID). The parties also the arguments of counsel, and the record as the Government concurred with Best Pharma’s agreed to forego objections to numerous proposed a whole, I have set forth my recommended position that several prescription events initially exhibits. ALJ Ex. 11. findings of fact and conclusions of law alleged by the Government as involving controlled 11 The parties stipulated to this after the issuance below. substances actually described substances that were of the Prehearing Ruling in this matter. The not controlled. The next day, the Government filed Respondents, through counsel, telephonically a document styled ‘‘Joint Stipulations’’ (Joint communicated their assent to this stipulation on 1 The two registrants were jointly captioned on a Stipulations) wherein the parties mutually agreed to August 26, 2013, the business day after the single OSC, and neither party petitioned for the substitution of previously-noticed versions of Government proposed it in its Supplemental severance. Proposed Government Exhibits 7(ID) and 12(ID), Prehearing Statement. ALJ Ex. 8. 2 21 U.S.C. 824(a)(1) (2006) (providing a statutory and stipulated that six prescription events 12 Farmacia Nueva’s COR application was basis for discretionary revocation). purportedly detailed in Proposed Government received into the record. Gov’t Ex. 1.

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November 30, 2011, the pharmacy had been prescription scrips issued by Dr. Aguilar,16 Although Antoine’s testimony was by no the subject of a DEA-executed federal and that, during that period of time, Dr. means a model of clarity, it appears that criminal search warrant,13 which resulted in Aguilar did not possess a valid COR. Tr. 17– when the DI compared the Dr. Aguilar- an immediate suspension order.14 Tr. 14, 16. 18. DI Antoine stated that Dr. Aguilar’s authorized controlled substance dispensing DI Antoine testified that he learned that, registration number had been retired by DEA events in the computer data with copies of between January 30, 2009 and November 30, since January 31, 2009, following an the seized hard-copy scrips, he was unable to 2011, Farmacia Nueva had dispensed 143 investigation and a federal criminal match twenty-two dispensing events in the controlled substances 15 based on conviction, and that the status of his COR data with corresponding hard-copy scrips. would have been uploaded to the DEA Tr. 23–25, 91. Antoine added that, in the Diversion Web site on the date it was retired. course of his investigation, he also sent 13 From the outset of the Government’s case as Tr. 53–55. According to DI Antoine, there Moro-Perez a January 30, 2013 letter detailed in the OSC and its Prehearing Statement, were multiple, readily-available means for (Administrative Request for Information), the Government signaled its intention to rely upon Farmacia Nueva personnel to have over the signature of his DEA supervisor, a theory of incomplete recordkeeping at Farmacia Nueva, and made known that its case in this regard ascertained that Dr. Aguilar lacked federal requesting ‘‘[c]opies of [p]rescriptions issued would be principally established by an evaluation authorization to prescribe controlled by [Dr. Aguilar] within the period of January of records seized during the course of a search substances at the time the prescriptions were 31, 2009 to November 30, 2011, including warrant executed at the pharmacy on November 30, filled. Tr. 20. Antoine related that Farmacia any information related to the dispensing of 2011 and supplemented by an administrative Nueva personnel could have checked Dr. such prescriptions.’’ Tr. 31–33; Gov’t Ex. 4. request for information. ALJ Exs. 1, 4, at 4. Aguilar’s COR status by accessing a link that Moro-Perez responded to the Administrative Although it could hardly be a surprise that details is ‘‘clearly visible’’ 17 on the DEA Diversion Request for Information in a letter,20 dated surrounding the adequacy of the execution of the Web site,18 by consulting a list of registrants March 4, 2013 (Response to Administrative Farmacia Nueva search warrant could be an issue, updated regularly by the Department of Request for Information), which included instead of presenting testimony from anyone present when the warrant was executed, the Commerce, by contacting the local DEA field copies of additional prescription scrips. Tr. Government elected to present hearsay testimony office directly, or by contracting with a 36. The Response to Administrative Request about the details of the operation from only DI private company. Tr. 20–21. for Information represented that ‘‘all of the Antoine, who was not present during the execution. Antoine testified that he also learned that, requested prescriptions’’ were included with Tr. 113–18. Over Respondents’ timely (and in 2008, DEA had issued a letter the correspondence. Gov’t Ex. 4, at 3. DI ultimately correct) objection, the Government admonishing Farmacia Nueva ‘‘for failure to Antoine presented a document (Government elicited details of conversations that occurred comply with federal requirements of the FN Aguilar Scrips) that he described as between DI Antoine and DIs Rosa Smith and Jose [CSA]’’ (Letter of Admonition). Tr. 19. The copies 21 of controlled substance scrips Rodriguez, who apparently were present at Letter of Admonition, which was received obtained by the search warrant and later Farmacia Nueva when the search warrant was 19 executed. DI Antoine was not certain about when into evidence, presents as having been sent supplemented by Moro-Perez in the the conversation(s) took place. Tr. 119–20; see also on April 3, 2008, from the DEA Caribbean Response to Administrative Request for ALJ Ex. 24, at 7 n.1. The Government offered no Division to Moro-Perez regarding Farmacia Information. Tr. 36–39; Gov’t Ex. 5. Antoine indication that DIs or other personnel present at the Nueva and, on its face, purports to have been testified that when he compared the Aguilar search warrant execution were in any way sent via certified mail. Gov’t Ex. 3. The Letter dispensing events recorded in the Farmacia unavailable and tendered no indicia of reliability of Admonition informs Moro-Perez that DEA Nueva computer data (FN Computer Data) to that would merit consideration of this hearsay investigators discovered numerous record- the Government FN Aguilar Scrips, he was testimony in support of a substantial evidence keeping discrepancies during a March 2008 unable to locate twenty-two Aguilar scrips finding. See Mireille Lalanne, M.D., 78 FR 47750, investigation, to wit: (1) Failure to take a 44752 (2013) (holding that the proponent of a that, based on the FN Computer Data, should hearsay statement in DEA administrative biennial inventory; (2) failure to record on have been there. Tr. 48. Antoine testified that proceedings bears the burden to demonstrate DEA Form 222 the number of containers he used a sorting function to create a sufficient reliability to warrant consideration as received and date on which such containers spreadsheet from the FN Computer Data that substantial evidence); see also Kevin Dennis, M.D., were received; (3) failure to record the date listed every transaction from the scrips 78 FR 52787, 52796 (2013) (‘‘[H]earsay may be of receipt of controlled substances on contained in the Government FN Aguilar substantial evidence depending on its truthfulness, commercial invoices; and (4) failure to Scrips package, or as he put it, ‘‘exactly a reasonableness, and credibility; hearsay statements submit DEA Form 41. Id. Each noticed mirror of what’s included [in the Government are highly probative where declarants are violation is accompanied by a corresponding disinterested witnesses, statements are essentially FN Aguilar Scrips].’’ Tr. 44–47; Gov’t Ex. 6. consistent, and counsel had access to the statements statutory and/or regulatory basis. Id. Thus, the spreadsheet (Government FN prior to the agency hearing.’’). DEA applies the law Although the Letter of Admonition directs Aguilar Scrips Spreadsheet) 22 contains every in the relevant Circuit. Lalanne, 78 FR at 47751 & Farmacia Nueva to ‘‘[p]lease advise this dispensing event transaction depicted in the n.4. Precedent in the applicable Circuits are in office in writing within thirty (30) days, the Government FN Aguilar Scrips 23 document accord. Echostar Commc’ns Corp. v. FCC, 292 F.3d action taken or planned, to correct [the listed] created by the seized scrips and 749, 753 (D.C. Cir. 2002) (holding that hearsay violations,’’ Antoine testified that, although supplemented by Moro-Perez pursuant to the evidence at an administrative hearing may be used DEA has no record of any further Request for Information. DI Antoine testified to support substantial evidence finding where it correspondence related to this admonition, bears sufficient indicia of reliability and is reliable that he used the sorting feature to tease out and trustworthy); Hoska v. U.S. Dep’t of the Army, the matter was closed without further action. the dispensing events in the Government FN 677 F.2d 131, 138 (D.C. Cir. 1982) (holding that Tr. 82–86. Computer Data that did not have a hearsay statements admitted at an administrative On the issue of Farmacia Nueva’s records, corresponding scrip in the Government FN hearing that were tested for reliability and found DI Antoine testified that he was furnished Aguilar Scrips and made a spreadsheet wanting were thus insufficient to support a with data from the pharmacy’s computer and (Government FN Aguilar No-Scrip List).24 substantial evidence finding); NLRB v. Serv. Wood hard copies of prescriptions seized from Heel Co., 124 F.2d 470, 472 (1st Cir. 1941) (finding Farmacia Nueva at the time of a November 20 The Government presented a copy of the hearsay evidence adduced at an administrative 30, 2011 search warrant execution. Tr. 23–24. hearing sufficiently trustworthy to be considered in Response to the Administrative Request for a substantial evidence finding where corroborated Information in a translated format as well as a copy and consistent with attendant circumstances). 16 DI Antoine testified that documentary of the original Spanish-language version. Gov’t Ex. Inasmuch as the Government did not even attempt references to Dr. Aguilar and Dr. Hector Aquilar 4, at 2–3. to demonstrate any indicia of reliability regarding refer to the same individual. Tr. 19. 21 DI Antoine testified that hard-copy scrips the hearsay statements from DIs Smith and 17 Tr. 87–89. seized from Farmacia Nueva during the execution Rodriguez received through DI Antoine, those 18 DI Antoine testified that he was unable to recall of the search warrant were photocopied. Tr. 37. statements cannot be properly considered here, and the name of the database, but was sure that it was 22 Gov’t Ex. 6. were not considered in support of substantial free and available to registrants and accessible as a 23 Gov’t Ex. 5. evidence. link on the DEA Diversion Web site and that it has 24 Although not explained during the course of 14 An indictment issued against Moro-Perez was been up and running continuously since 2008. Tr. the hearing, the three pages that comprise the ultimately dismissed with prejudice. Stip. 8; Tr. 76– 21–22. A registrant must sign into the system to Government FN Aguilar No-Scrip List must be 77. review the available information. Id. placed side-by-side and read across. Gov’t Ex. 7. 15 Tr. 78. 19 Tr. 34. Needless to say, this format is not optimal.

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Gov’t Ex. 7. Thus, the Government FN voluntarily surrender my Drug Enforcement however, relate to DI Antoine that they Aguilar No-Scrip List reflects twenty-four 25 Administration Certificate of Registration. believed that the owner planned to install a Aguilar-authorized controlled substance ... ’’Id. computer monitor in each pharmacy to dispensing events at Farmacia Nueva where The DEA Farmacia Nueva Declaration facilitate some measure of access to verify the the combined efforts of DI Antoine’s seized states that Farmacia Nueva surrendered its COR status of prescribing practitioners, and records and Moro-Perez’s supplemented COR for cause on June 28, 2012. Gov’t Ex. 2, that there was also a plan to check prescriber records still did not yield a copy of a scrip. at 2. Also offered in support of the statuses once per month. Tr. 112. PIC Castro DI Antoine testified that he also conducted proposition that Farmacia Nueva surrendered told Antoine that she had recommendations the COR application 26 investigation of Best for cause in 2012 was a copy of what for the handling of controlled substances that Pharma. Tr. 52. According to Antoine, Best purports to be email correspondence (printed she would like to make to the pharmacy Pharma was also the subject of an executed out under DI Antoine’s email header) owner. Id. criminal search warrant on November 30, between the Respondents’ present counsel DI Antoine’s testimony was, at times, 2011, and prescription scrips were likewise and an individual to whom counsel was difficult to understand and not always clear. seized from its pharmacy, scanned into DEA seeking to surrender its COR. Gov’t Ex. 14, That said, his testimony was sufficiently computers, and returned. Tr. 50, 52, 60–61; at 2–4. Although the Government presented detailed, plausible, and internally consistent Gov’t Ex. 10. As was the case at Farmacia no explanation or context regarding the email to be deemed credible in this recommended Nueva, data from the Best Pharma computers traffic or any witness testimony regarding the decision. was extracted by DEA, and the data was participants, the exhibit (which was received queried by DI Antoine to yield controlled The Government also presented the in the absence of objection), on its face, testimony of DFE Amy Herrmann, a digital substance dispensing events on scrips includes this unambiguous statement: authorized by Dr. Aguilar from the time his forensic examiner employed by DEA. DFE My client, Farmacia Nueva, has decided to Herrmann has been a DFE at the DEA Digital COR was retired up to and including the date voluntarily surrender its DEA registration at the search warrant was executed. Tr. 65–69; Evidence Laboratory since March 2008, and issue in the case Docket No. 12–16. Please holds degrees in Information Technology, Gov’t Ex. 11. Antoine testified that an prepare a joint motion to dismiss the pending examination of the seized documents Network Security-Computer Forensics, and case. revealed that, like Farmacia Nueva, Best Financial Services. Tr. 122–25; Gov’t Ex. 13. Pharma dispensed controlled substances on Id. at 2. Official notice is taken that the same DFE Herrmann is certified as a Global prescriptions issued by Dr. Aguilar during a Respondents captioned in this matter were Information Assurance Forensic Examiner time when the doctor did not possess a COR. also the subject of DEA administrative and as an Information Systems Security Tr. 52–53. In his testimony, DI Antoine re- proceedings under Docket Number 2012–16 Professional. Gov’t Ex. 13. In the absence of affirmed the aforementioned methods that (Case 2012–16), an action that was objection, DFE Herrmann was accepted as an Best Pharma staff members had at their commenced with a request for hearing filed expert in the field of digital forensics.30 Tr. disposal to ascertain Dr. Aguilar’s COR on December 6, 2011, and which culminated 126. status. Tr. 55. in a termination order dated June 29, 2012.28 DFE Herrmann stated that she was Antoine also indicated that when he Further notice is taken that the records of the assigned to the investigations concerning the compared the Best Pharma computer-stored Agency reflect that the recipient of the email Respondent pharmacies that were conducted dispensing events with the controlled served as the Government counsel of record in November 2011. Id. She explained that substance prescription scrips seized in in Case 2012–16. DEA has no record of a DEA another DFE who works in her office, Ryan connection with the search warrant, he was Form 104 executed on behalf of Farmacia Gladieux,31 extracted the information from unable to identify ‘‘four or five’’ scrips that Nueva, but Antoine testified that it is his the Farmacia Nueva computer by imaging the corresponded to dispensing events. Tr. 96. understanding that the email surrender computer to a wiped and sterile DEA hard Government-supplied declarations from occurred while the case was in active drive. Tr. 128–29. Herrmann testified that the the DEA Registration and Program Support administrative enforcement proceedings. Tr. Section Chief reflect that a COR was issued 72–74. In his testimony, DI Antoine 30 DFE Herrmann’s CV was received into the to Farmacia Nueva in 2005 and to Best explained that while it is his ‘‘practice [to] always get a [DEA Form] 104,’’ and that he record. Gov’t Ex. 13. Pharma in 2010. Gov’t Exs. 2, 9. The DEA 31 During the Direct Examination of DFE Best Pharma Declaration indicates that Best has procured a DEA Form 104 in all but one case where he has accepted a registrant’s Herrmann, the Government offered into evidence a Pharma surrendered its COR for cause on declaration from DFE Ryan Gladieux. Tr. 133–37; December 14, 2011. Gov’t Ex. 9. The surrender for cause, it was his understanding Gov’t Ex. 15. In his declaration, Gladieux states that Government also submitted a DEA Form 104 of the law that the email correspondence he made complete copies of the hard drives seized (Best Pharma Surrender Form) that indicates offered by the Government in this case was during the investigations of Farmacia Nueva and that Moro-Perez executed a voluntary sufficient to memorialize the event. Tr. 73– Best Pharma on November 30, 2011. Gov’t Ex. 15. surrender for cause on November 30, 2011.27 74. Gladieux declares that the copies of the hard drives DI Antoine stated that he visited Farmacia are complete and accurate. Id. In objecting to the Gov’t Ex. 14, at 1. On the Best Pharma admission of the declaration, the Respondents Surrender Form, Moro-Perez signed below a Nueva and Best Pharma on August 14, 2013 (twenty days prior to the commencement of raised the (fair) point that in contrast to the checked box, which provides: ‘‘In view of my declarant, who had actual knowledge as to how the alleged failure to comply with the Federal the hearing in this matter), and spoke with evidence was extracted, DFE Herrmann, ‘‘has requirements pertaining to controlled Nelson Vale and Miriam Castro Andujar, the testified only to the things she has heard from substances, and as an indication of my good respective pharmacists-in-charge (PICs).29 Tr. someone that that happened.’’ Tr. 135–36; see also faith in desiring to remedy any incorrect or 106–11. According to Antoine, in response to Tr. 149–50. In explaining its election to present a unlawful practices on my part . . . I hereby his query of them on the subject, both PICs declaration in lieu of testimony from Gladieux, the indicated that they were aware of no written Government acknowledged that Gladieux was procedures issued for their respective available, but stated ‘‘[t]he reason was that the 25 Although DI Antoine described twenty-two [G]overnment felt that a declaration would have Aguilar dispensing events without corresponding pharmacies on the subject of the handling of controlled substances. Tr. 107. The PICs did, been sufficient insofar as that it was properly scrip copies, the Government FN Aguilar No-Scrip noticed in the prehearing statement and that an List sets forth twenty-four dispensing events. Id. indicia of reliability would have been given during While no explanation regarding this disparity was 28 The Administrative Procedure Act and the DEA this hearing [sic].’’ Tr. 135. Regarding the offered at the hearing, the extra two entries appear regulations authorize the identification, recognition, Government’s proposed transcript errata correction to be refills of previously-filled prescriptions. In and inclusion of material facts in the administrative (ALJ Ex. 20, at 2) in this regard, the version set forth any event, the variance, whatever its genesis, was record by the taking of official notice. 5 U.S.C. in the official transcript is consistent with my inconsequential to the resolution of the ultimate 556(e); 21 CFR 1316.59(e); Attorney General’s recollection. Gladieux’s declaration was received issues presented in this case. Manual on the Administrative Procedure Act § 7(d) into the record over the Respondents’ hearsay 26 The Best Pharma COR application was received (1947). To the extent either party seeks to challenge objection, and although all parties were granted into the record. Gov’t Ex. 8. the factual predicate of the official notice taken in leave to present his live testimony, none did. Tr. 27 Although no explanation has been tendered to this matter, it may file an appropriate motion no 136. As explained more fully, infra, the explain this disparity, the anomaly does not impact later than fifteen days from the issuance of this Respondents’ objection more correctly reflected on any issue dispositive to a resolution of the ultimate recommended decision. the weight to be afforded the content of the exhibit issues in this case. 29 See Fed. R. Evid. 801(d)(2)(E). than it did on the document’s admissibility.

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technique employed by Gladieux 32 for matters of which she did have first-hand owner of both Farmacia Nueva and Best imaging the computer makes a complete copy knowledge, her testimony was sufficiently Pharma. Tr. 192, 219, 222, 238. He stated that of all data contained therein and provides an detailed, plausible, and internally consistent he has been a pharmacist since he completed alert to indicate if certain files are to be fully credited in this recommended his training at medical school in Puerto Rico unreadable.33 Tr. 139–41. DFE Gladieux then decision. in 1999, worked as a pharmacist at another provided the hard drive to the DEA office in George Taylor, a DI stationed at the DEA pharmacy, and served as chief pharmacist at Ponce where it was checked in as non-drug Des Moines Resident Office, was called as a Farmacia Nueva. Tr. 194, 202, 223–24. He evidence. Tr. 131. From there it was witness for the Government regarding his acknowledged that he had received training forwarded to the DEA laboratory in Lorton, role as the team leader in charge of executing regarding the prevention of the unauthorized Virginia, and checked into the digital the search warrant at Best Pharma on distribution of controlled substances, and evidence vault. Tr. 122–23, 131. Herrmann November 30, 2011. Tr. 168–69. DI Taylor that he learned in his training that the stated that she then created a virtual machine testified that his team of seven to nine federal pharmacy is ‘‘ultimately responsible for with which to run Farmacia Nueva’s RX30 and local agents and analysts seized all ensuring the integrity and the veracity of the program,34 enabling her to access the prescription records, controlled substances, prescription.’’ Tr. 194. He also acknowledged program as if she were accessing it from and other specific items listed on the that, from February 2009 to October 2011, Farmacia Nueva’s own computer at the warrant. Tr. 170, 172. DI Taylor stated that both Respondent pharmacies filled moment the data was extracted.35 Tr. 141–42. the search warrant team was assisted by a prescriptions for (the un-registered) Dr. 37 Herrmann testified that she generated a Best Pharma pharmacist who directed Aguilar. Tr. 193. Farmacia Nueva filled report of all prescriptions dispensed by the them where to find the items listed on the approximately 143 prescriptions, and Best pharmacy from January 1, 2009 to December warrant. Tr. 170. Controlled substances were Pharma filled approximately 32 31, 2011, and converted the report into an seized and inventoried on the premises, and prescriptions. Id. Moro-Perez conceded that hard copies of controlled substance scrips Excel file. Tr. 142–43. According to at no point during that time period did any and other records were collected and Herrmann, she ran another report of the same of the pharmacies attempt to verify the COR transported back to the staging area and then data, but excluded any prescriptions that status of any of the doctors for whom they to the DEA Ponce Resident Office. Tr. 170– were noted as ‘‘on hold’’ (no-holds run). Tr. filled prescriptions. Tr. 194. 71, 187. Taylor testified that, with the 143–44. The no-holds run generated fewer During the course of Moro-Perez’s dispensing events than the first report, but guidance of the Best Pharma pharmacist (who he assessed as cooperative), it is his testimony, he described the physical layout she never attempted to run a report to isolate and operational procedures utilized at the the dispensing events in the ‘‘on hold’’ opinion that the team seized all controlled substance prescription scrips that were on Respondent pharmacies. Regarding Farmacia status. Tr. 145–47. Some of the dispensing Nueva, Moro-Perez explained that the three- event transaction numbers in the no-holds hand at the pharmacy, including paperwork from the prescription counter. Tr. 186–88. story establishment is manned by twenty-two run are preceded by the letter ‘‘H.’’ See Gov’t employees and that Nelson Vale is and has Ex. 7. When Herrmann was queried about DI Taylor also testified that he was with been the pharmacist-in-charge (PIC) since whether the ‘‘H’’ indicated that these events Moro-Perez at the time the latter signed the 2010. Tr. 224–25. According to Moro-Perez, really were ‘‘on hold,’’ she conceded that she Best Pharma Surrender Form. Tr. 175; Gov’t Best Pharma is located in a two-story did not understand what the ‘‘H’’ meant and Ex. 14, at 1. On November 30, 2011, DI building with sixteen employees. Tr. 240–41. that she did not know why some transaction Taylor, accompanied by DEA Special Agent The departments in each store are divided numbers bore that designator. Tr. 152–53, Juan Hernandez, signed the form as a witness between the various floors. Tr. 224, 240. 161–62. Whatever ‘‘H’’ meant, DFE Herrmann and presented it to Moro-Perez while the 38 Moro-Perez testified that his role as a testified that the report she ran on the data latter was in custody. Tr. 175; Gov’t Ex. 14, pharmacist and company president requires from the Farmacia Nueva computer excluded at 1. DI Taylor directed Special Agent that he ensure that every prescription has a any dispensing event that was in an ‘‘on Hernandez to explain, in Spanish, to Moro- hold’’ status. Tr. 143–44, 151–52, 160–61. Perez that the form was a voluntary surrender regular and legal use; that all administrative DFE Herrmann testified that she used of his controlled substances privileges. Tr. duties are carried out; and that each ‘‘essentially the same steps’’ 36 employed on 176, 184. Special Agent Hernandez also read prescription is dispatched faithfully to the the Farmacia Nueva computer data to analyze the entire form to Moro-Perez in Spanish. Tr. patient as the doctor prescribed it. Tr. 226– the information extracted from Best Pharma’s 178. DI Taylor testified that Moro-Perez 27. He then explained the following RX30 program. Tr. 147. Regarding those questioned him regarding the nature of the procedure for when a patient enters the FN surrender and whether it was related to the pharmacy with a prescription: The patient, criminal charges against him. Tr. 179. DI 32 first, turns in his prescription at the Herrmann acknowledged that she had no Taylor stated that he explained that the pharmacy’s receiving area. Tr. 227. Next, a personal knowledge of exactly what Gladieux did and/or how well he did it beyond reading reports surrender specifically related to the DEA pharmacy employee verifies the prescription, he prepared. Tr. 149–50. registration number and was separate from the name on the prescription, the address of 33 The imaged files copy each piece of data from any criminal allegations, and he testified that the patient, the date, the medication, the the original, and a DEA program creates something he dealt only with the regulatory matter. DI quantity to be dispatched, the instructions on called a ‘‘hash’’ for every file. Tr. 128. The hash is Taylor explained to Moro-Perez that if he did how to use the medication, the doctor’s an algorithm that uniquely fits a piece of data and not sign the form, the DEA would move for signature, and, if it is a prescription for a creates a certain value. Tr. 132. If a piece of data an OSC proceeding. Tr. 176–77. DI Taylor controlled substance, the DEA license, the is altered in any way from the original data stated that in his conversations with Moro- AMSSCA license,40 and the state medical extracted from the computer, the hash value will Perez, he never linked the voluntary registration or license as found on the change, notifying the DEA of the alteration. Tr. 132, surrender to the ongoing criminal pharmacy’s RX30 program. Tr. 227–28, 230. 148. Herrmann testified that she verified that all investigation. Tr. 177. hash values matched when she commenced her The employee then verifies if the 39 analysis of the data extracted from the computer. Moro-Perez also testified at the hearing. prescription and medication are Tr. 133. Herrmann clarified that although error is He stated that he is the president and original bioequivalent. Tr. 228. If the patient accepts always a possibility, the software she utilized is the medication, the back of the prescription designed to alert the examiner if the reports 37 DI Taylor testified that a female Best Pharma is stamped and signed, and then the patient generated do not match the amount of records pharmacist assisted his team in the execution of the signs the document to acknowledge contained in the data. Tr. 154–56. search warrant, but he was unable to recall her 34 acceptance of the exchange of medication. Id. RX30 appears to be a software program that name. Tr. 170. Next, pharmacy personnel enter the patient’s enables pharmacies to manage and record their 38 It is clear from DI Taylor’s testimony that Moro- name, phone number, address, driver’s dispensing events. Tr. 91, 138, 142. Perez was in custody in the rear of a government 35 Herrmann acknowledged that the reports could vehicle when he signed the Best Pharma Surrender license, and medical plan information into have been run using Farmacia Nueva’s computer Form. Tr. 179–83. The Respondents have raised no instead of from an image of the data extracted from issue related to the voluntariness of the Surrender the Government as part of its case-in-chief. Tr. 190– the computer. Tr. 163–65. Form execution, and no genuine issue in this regard 191, 268. 36 There is no indication in the record why is supported by the record evidence. 40 Regrettably, neither side provided any Herrmann characterized the steps as ‘‘essentially’’ 39 Although Moro-Perez was noticed as a witness additional details as to what this organization is, or the same. by the Respondents, his testimony was elicited by what the letters stand for.

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the RX30 system. Tr. 228–29. The the insurance companies never represented Although, in a prehearing motion,48 prescription is then scanned, and the that reliance upon the benefits claim Farmacia Nueva averred that multiple pharmacy enters the doctor’s information. Tr. determination was an appropriate method to dispensing events set forth in the 229. The pharmacy staff verifies that all of check COR status.43 Tr. 202. Moro-Perez Government FN Aguilar No-Scrip List the prescriber’s information (including COR stated that he does not know why the document were the result of typographical and license numbers) is found in the system, insurance companies kept reimbursing based errors, an analysis of the documents does not and enters the medication, including the on Dr. Aguilar’s controlled substance bear this out. Both of the purportedly amount to be dispensed and the dosage prescriptions when he no longer had a COR, mistyped dispensing events (00735388 & instructions. Id. After obtaining and entering and he even agreed that the Respondent 00784686) were actually supplied by the all this information, the pharmacy staff pharmacies would likely never have stopped Respondent in the Moro-Perez FN Aguilar submits the information to the appropriate dispensing (unregistered) Dr. Aguilar’s Found Scrips document.49 insurance carrier, which will determine prescriptions if the DEA had not executed its A detailed analysis of the dispensing event whether it will reimburse based on the search warrant on November 30, 2011. Tr. exhibits from both sides presents a nuanced information submitted. Id. The pharmacy 202–03. Moro-Perez acknowledged that the and initially confusing picture that would staff then counts out the medication, puts it Respondents made a mistake and that they have benefitted greatly from explanation at in a basket, and presents it to a pharmacist erred in not calling the DEA to verify Dr. the hearing. An examination of the Moro- for verification. Id. Upon successful Aguilar’s COR. Tr. 201–02. Perez FN Aguilar Scrips 50 and the Moro- verification, the prescription is placed in When questioned regarding the Perez FN Aguilar Found Scrips 51 documents dispatch, and the pharmacy contacts the Government’s list of purportedly missing reveals that they contain all but two of the patient who signs for the prescription, prescriptions from Farmacia Nueva,44 Moro- dispensing events depicted in the collects the medication, receives instructions Perez insisted that, when he was told that the Government FN Aguilar No-Scrip List 52 that on use, and pays any applicable deductible. DEA identified those scrips as missing, he was created by DI Antoine.53 This testimony Tr. 229–30. queried the system by medication name and was offered by Farmacia Nueva in support of Moro-Perez stated that Best Pharma uses was able to locate and identify all but one of its contention that Moro-Perez, with some the same process of dispensing prescriptions the missing scrips in the Farmacia Nueva level of diligence, was able to retrieve all of as Farmacia Nueva. Tr. 245. He testified that Computer and found a hard copy of the the scrips that DEA identified to him as Farmacia Nueva dispenses 500 prescriptions single missing (apparently unscanned) scrip missing. per day, with controlled substances in the pharmacy.45 Tr. 203–05. Copies of the One of the two unaccounted-for dispensing accounting for approximately 10–15% of imaged Dr. Aguilar scrips he purportedly events bears a dispensing event number those sales. Tr. 244–45. Best Pharma printed from the pharmacy computer and preceded by an ‘‘H’’ (H00751567). Gov’t Ex. dispenses 200–300 prescriptions per day, supplemented with the single hard-copy 7. No witness who testified at the hearing with approximately 10–15% of those sales scrip were received into the record (Moro- explained the significance of an ‘‘H’’ affixed derived from controlled substances. Tr. 245. Perez FN Aguilar Scrips). Resp’t Exs. 1, 2. to a dispensing event number, but since a Moro-Perez testified that, for prescriber Also received into evidence was a package of second ‘‘H’’-designated number (H00784094) 54 COR verification, his Respondent pharmacies imaged prescription scrips that Moro-Perez was eventually paired with a scrip by have relied upon a system of entering testified he produced by querying the Moro-Perez, it seems unlikely that the ‘‘H’’ information into their internal computers, dispensing event numbers corresponding to presents a reasonable explanation for the submitting the information to medical the Dr. Aguilar controlled substance scrips scrip’s absence. DFE Herrmann testified that insurance providers through pharmacy that DEA alleged as missing (Moro-Perez FN ‘‘hold’’ was a status setting available within software, and basing the assumption of up- Aguilar Found Scrips).46 Resp’t Ex. 4; Tr. the RX30 software structure, but she did not to-date doctor licensing on the receipt of 263. The Moro-Perez FN Aguilar Found insurance provider ‘‘confirmation’’ 41 of Scrips document contains nine scrips that, contained in the Moro-Perez FN Aguilar Found payment approval. Tr. 195–96, 230–32. according to Moro-Perez, he was able to Scrips document (Resp’t Ex. 4, at 184–90)) refer to create by querying the Farmacia Nueva RX30 non-controlled substances. As a result of the Moro-Perez represented that both pharmacies Respondents’ motion, the Government substituted purchased the RX30 system for their system with the dispensing event numbers the current version of Government Exhibit 7, which computers from a company named Ontime that DEA told him they were unable to match evidently omits reference to the non-controlled Soft, Inc. Tr. 196–97, 244. Pharmacy staff with Government FN Aguilar Scrips.47 substances. inputted a list of prescribing doctors and the 48 ALJ Ex. 10, at 2. In their motion, the doctors’ information into the program. Tr. insurance companies, this step added little to the Respondents represented that when the 199–200. Moro-Perez then explained that, aggregate safeguards in place. typographical errors are factored into the equation, when a patient visits one of the pharmacies 43 Actually, the record contains no evidence that ‘‘no prescription is missing.’’ Id. at 3. with a prescription, the following would objectively support a decision to rely on this 49 Resp’t Ex. 4, at 191, 192. information is entered into the system and approach or even support a conclusion that this 50 Resp’t Ex. 1–2. then transmitted to the insurance providers: method would be an effective manner to garner this 51 Resp’t Ex. 4. the patient, the patient’s information, the information. 52 Gov’t Ex. 7. 44 doctor’s information, the medication, the Gov’t Ex. 7. 53 The following is a list of each entry found in 45 amount of medication, the directions for The supplemented scrip was identified by the Government FN Aguilar No-Scrip List (Gov’t Ex. Moro-Perez as page 143 of Respondents Exhibit 2. 7), which listed the prescriptions missing from using the medication, and the amount of days According to Moro-Perez, the computer that the medication will be supplied. Tr. 201. Farmacia Nueva. After each listed prescription automatically affixes identifier information at the event number entry, a corresponding citation to Moro-Perez eventually admitted that the top of each prescription image it produces. Tr. 235. where that prescription can be found in the pharmacies’ method of ensuring the validity The scrip that Moro-Perez added to the package Respondents’ exhibits (if at all) is provided: of the prescribing doctors’ DEA licenses was does not have the identifier heading on it. Resp’t #00581227: Resp’t Ex. 2, at 165; #00592053: Resp’t to check, prior to dispensing, that the Ex. 2, at 143. Ex. 2, at 167; #00594763: Resp’t Ex. 2, at 168; insurance company was willing to reimburse 46 The witness testified that the first five pages of #00603582: Resp’t Ex. 2, at 169; #00615341: Resp’t based on the electronically-transmitted the package contain Best Pharma scrips (identified Ex. 2, at 170; #00680204: Resp’t Ex. 2, at 143–44; claim. Tr. 200–01. He even conceded that by 5-digit dispensing event numbers) and the #00696609: Resp’t Ex. 1, at 49; #00735388: Resp’t although this was the method they employed balance reflects Farmacia Nueva scrips (identified Exs. 1, at 52, 4, at 191; #00739096: Resp’t Ex. 1, at by 6-digit dispensing event numbers). Tr. 260–65. 28; #00740774: Resp’t Ex. 1, at 29; #00748164: to verify the prescribers’ registration status,42 47 However, only two of the nine scrips (Resp’t Resp’t Ex. 1, at 31; #00750564: Resp’t Ex. 1, at 92; Ex. 4, at 191, 192) contained in the Moro-Perez FN #H00751567: no record; #00760079: Resp’t Ex. 1, at 41 The witness never made clear what information Aguilar Found Scrips document correspond to 93; #00760079: Resp’t Ex. 1, at 93; #00784105: was actually being transmitted or confirmed in the Aguilar Farmacia Nueva dispensing events listed by Resp’t Ex. 2, at 123; #00784686: Resp’t Ex. 4, at 192; ‘‘confirmation.’’ the Government as missing scrips in its Government #00785359: Resp’t Ex. 2, at 124; #00785837: Resp’t 42 Moro-Perez also said that pharmacy staff FN Aguilar No-Scrip List. Gov’t Ex. 7. This is likely Ex. 2, at 125; #00785837: Resp’t Ex. 2, at 125; checked prescriber licenses in the RX30 system. Tr. the result of a pre-hearing motion submitted by the #00798150: Resp’t Ex. 2, at 126; #00805523: no 230–31. However, since the pharmacies’ internal Respondents (ALJ Ex. 10) wherein they pointed out record; #00806899: Resp’t Ex. 2, at 127; systems were only updated by pharmacy staff, who that numerous scrips noticed by the Government #H00784094: Resp’t Ex. 4, at 190. relied exclusively on payment approvals from (apparently including seven of the nine FN scrips 54 Resp’t Ex. 4, at 190.

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know what it signified. Tr. 144–46. Moro- deemed illegitimate. Tr. 252. Moro-Perez 216–17, 219. Moro-Perez explained that he Perez likewise offered no explanations about explained that, quite often, ‘‘many’’ patients never wanted to lie to DEA because ‘‘[t]hey the significance of an ‘‘H’’ before a brought controlled substance prescriptions are aware of the arrest that they executed.’’ dispensing event number, or ‘‘hold’’ status.55 issued by Dr. Aguilar where the Farmacia Tr. 216. Later in his testimony, Moro-Perez The second missing dispensing event Nueva pharmacists ‘‘knew that that patient offered this: (00805523) was never matched up with a didn’t require the use of that medication Really in relation to this particular case I’ll corresponding scrip. [and] we told them that we were not going repeat again. I answered no knowing and to dispense the prescription.’’ Id. Moro-Perez testified that DEA personnel recognizing that you, the DEA office, are Notwithstanding the close proximity of Dr. left the Respondent pharmacies in aware of, had knowledge and everything Aguilar’s practice to Farmacia Nueva (three considerable disarray after the simultaneous about me. Therefore, I have never had to four minutes on foot), and the frequency execution of the search warrants, and that the intentions [sic] to lie. I’m going to say the agents left ‘‘a lot of controlled [substance] with which the pharmacy declined to truth, and that’s the truth. prescriptions’’ in drawers at ‘‘both dispense controlled substances he pharmacies.’’ Tr. 243–44. At the hearing, prescribed, Moro-Perez provided the Tr. 218–19. Moro-Perez clarified that the when Moro-Perez was shown the astonishing revelation that he never rationale he used for answering Question 2 Government’s Administrative Request for contacted Dr. Aguilar about any of his (bad) in the negative on the Farmacia Nueva Information to Farmacia Nueva 56 in which prescriptions. Tr. 252–54. When pressed as to application was the same approach employed DEA requested the pharmacy to supply why Dr. Aguilar’s routine prescribing by him when answering the same question in copies of all prescriptions issued by Dr. misconduct did not arouse any heightened the Best Pharma application. Tr. 222. Aguilar during the period in question and scrutiny on the part of his pharmacies, Moro- Although Moro-Perez acknowledged at the dispensed by the pharmacy, he responded Perez offered that ‘‘if you analyze the amount hearing that Question 2 was erroneously that he ‘‘provided [DEA] everything that the of medications that were dispensed, the answered,61 he expressed no remorse. In like system provided and all the prescriptions percentage is very low.’’ Tr. 253. In other manner, he stood by his ability to retrieve were submitted.’’ Tr. 206–08. words, the Respondents knew Dr. Aguilar required records from the Respondent Moro-Perez explained that RX30 creates a was regularly providing illegal controlled pharmacies’ computers and questioned the separate number for each dispensing event, substance prescriptions to Respondents’ thoroughness of DEA’s search warrant and that once that number is created, it customers, but no one on staff checked his execution, see Tr. 243–44. On the other hand, cannot be altered or manipulated manually.57 registration in any serious way or even took he readily accepted that the procedure Tr. 235. He offered his assurance that he has the minimal step of reaching out to speak previously employed for ensuring that not nor would ever attempt to do so. Id. with him about his prescribing practices controlled-substance prescribers had valid Moro-Perez indicated that Farmacia Nueva because ‘‘the percentage [was] very low.’’ Id. CORs was a ‘‘mistake.’’ Tr. 236. He offered has had the same computer for about five Moro-Perez stated that he never contacted Dr. that if the Respondent pharmacies are years and that it has never left the pharmacy Aguilar because ‘‘I was aware that the granted CORs, they would take several except for when the DEA took possession of doctor’s license was up to date.’’ Tr. 253–54. preventative steps to ensure that the doctors it for about five days at the time the search In addition to the fact that Dr. Aguilar was who wrote prescriptions for dispensing at the warrant was executed. Tr. 232–33. Best not, in fact, ‘‘up to date’’ on his DEA pharmacy had the requisite authority to do Pharma’s computers have also been in the registration, Moro-Perez’s answer is patently so.62 Id. Moro-Perez represented that if the business since it opened, and inasmuch as illogical and presents as intentional pharmacies were again registered, an DEA extracted data from them on the date of equivocation. employee would verify the registration status the search warrant execution, these At the hearing, Moro-Perez identified a of prescribing physicians with the computers have never left the pharmacy. Tr. printed copy of the online registration appropriate DEA Web site every month. Tr. 242. application that he submitted on behalf of 236–37. He also represented that he is Moro-Perez testified that Farmacia Nueva Farmacia Nueva. Tr. 210; Gov’t Ex. 1; see also ‘‘establishing a new system of computers so Stip. 5. He confirmed that he understood the dispensed approximately two to three the pharmacy will be able to study the application and Question 2 (asking whether prescriptions authorized by Dr. Aguilar every patient file and the doctor’s file’’ and the applicant had ever surrendered a COR for two weeks and that there was sometimes a ‘‘demand’’ documentation that the patient is cause), agreed that he entered a ‘‘no’’ few months between prescriptions. Tr. 250. being treated by a specialist ‘‘mostly on the response, and explained that his reason for He also explained that Farmacia Nueva was narcotic medications, the pain medications doing so was because he understood that, ‘‘in about a three-to-four minute walk from Dr. and any other that we understand that is relation to the criminal case, there was no Aguilar’s office.58 Tr. 250–51. Stunningly, being used for alleged medical use [sic].’’ Tr. cause against me.’’ 59 Tr. 211. Moro-Perez Moro-Perez testified that personnel at 237–38. Moro-Perez also offered that the conceded that no one from DEA told him that Farmacia Nueva ‘‘many times’’ declined to current PICs of both Farmacia Nueva and his former criminal case (which was actually fill controlled substance prescriptions Best Pharma have spent a significant number dismissed three months prior to the authorized by Dr. Aguilar because they were surrender) was linked in any way to the of years practicing in the field. Tr. 241–42. surrender,60 but he insisted that he believed The testimony of Moro-Perez cannot be 55 To the extent that the Respondents’ closing that Farmacia Nueva’s surrender was deemed entirely credible. There were times brief avers that the ‘‘H’’ described in the record associated with his criminal case because during his testimony where he offered refers to a dispensing event being in a ‘‘hold’’ status ‘‘all this is a consequence of the dispatch of answers that were intentionally equivocal (ALJ Ex. 24, at 8, 17), that assertion is simply not and made no sense. For example, when asked supported in the record. This record does not the medications of Dr. Aguilar.’’ Tr. 212–13. The witness persisted in this answer, even why no increased scrutiny or contact resulted contain an explanation of the meaning of an ‘‘H’’ from ‘‘many’’ instances where Dr. Aguilar’s before a dispensing event transaction number. when pressed by the Government about how patients attempted to fill bad prescriptions at 56 Gov’t Ex. 4. he could think that the nature of the the pharmacies and were refused, Moro-Perez 57 Although the relevance of this testimony was Farmacia Nueva surrender could be affected likely linked to dispel any notion that Moro-Perez by an event (the indictment dismissal) that responded that no action was taken because or other pharmacy personnel could have manually preceded it. Tr. 212–13, 215. In response to the percentages were very low and because 63 placed an ‘‘H’’ before certain dispensing event a question asked by the Government, Moro- he knew Aguilar’s licenses were current. numbers, the lack of any witness to explain what Perez responded that if Question 2 did not These answers were inconsistent with his an ‘‘H’’ signifies greatly diminishes the utility of contain the words ‘‘for cause,’’ he would earlier recognition that the responsibility for this testimony. Stated differently, since the record accurate dispensing rests with the never says what the ‘‘H’’ signifies, it does not much have answered ‘‘yes’’ to the question. Tr. matter whether anyone could have manually added it to the transaction numbers or anywhere else. 59 A copy of the March 28, 2012 federal criminal 61 Tr. 216. 58 Moro-Perez testified that, of the dozen or so indictment dismissal where Moro-Perez was a 62 Although he directed his initial comments pharmacies in San Sebastian that dispensed defendant was received into the record (Resp’t Ex. regarding remedial steps to Farmacia Nueva, Moro- controlled substances, Farmacia Nueva was the 3) and was also the subject of testimony (Tr. 212) Perez testified that the same measures would be pharmacy located closest to Dr. Aguilar’s office. Tr. and a stipulation between the parties (Stip. 8). taken at Best Pharma. Tr. 245–46. 251. 60 Tr. 213, 218–19. 63 Tr. 250–54.

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pharmacy,64 bear little relation to the The Respondents’ Evidence training regarding anti-diversion efforts or question, and are the obvious fruit of In addition to the testimony from Moro- anti-illegal distribution efforts. Tr. 281–82. intentional equivocation. In like manner, Perez that was elicited on cross examination, Vale likewise acknowledged that the planned Moro-Perez initially testified that when the Respondents’ presented the testimony of remedial measures stem from enforcement claims were submitted to insurance carriers, Mr. Nelson Vale. Tr. 268. Mr. Vale testified actions already taken by DEA as well as a the pharmacies would receive a that he has worked at Farmacia Nueva since desire to avoid the specter of future ‘‘confirmation’’ that the prescribers had valid February 2009 and has served as the chief sanctions. Tr. 282. licenses. Tr. 196. Later in his testimony, it pharmacist since August 2010. Tr. 272. Vale Mr. Vale’s testimony was sufficiently became apparent that the ‘‘confirmation’’ acknowledged that he was employed at the plausible, detailed, and internally consistent from the insurance providers informed the pharmacy during the time period when it to be deemed credible in this recommended pharmacy staff only that the reimbursement was dispensing controlled substances on Dr. decision. claim would be approved. Tr. 200–01. It was Aguilar’s expired COR. Tr. 281. Before Additional facts required for a disposition the same sort of equivocation employed working at Farmacia Nueva, he worked as a of this case are set forth below. when Moro-Perez testified that pharmacy pharmacist and chief pharmacist at two The Analysis staff would check prescriber licenses through Walgreens pharmacies. Tr. 272–73. Vale RX30, a system that depended exclusively on testified that his role at Farmacia Nueva The Government alleges two bases for input from staff who depended exclusively requires ensuring ‘‘that the medication is denial of the Respondents’ applications: (1) on the fact that claims were being dispensed properly’’ and that the pharmacy that Respondents’ owner/president, Moro- approved.65 When questioned as to why, at maintains a correct inventory. Tr. 273. Perez, materially falsified the Respondents’ the hearing, he was able to produce scrips Consistent with other witnesses who have applications for CORs; and (2) that the that were apparently not forwarded to DEA testified on the subject, Vale stated that the granting of the Respondents’ applications as part of his compliance with the Request pharmacy uses the RX30 program, that the would be inconsistent with the public for Information, Moro-Perez never explained system automatically assigns dispensing interest. These bases are addressed below, in why the new scrips were so late in coming event numbers to each prescription, and that seriatim. or suggested that DEA did not have the the program cannot be manipulated to Material Falsification complete set he forwarded, but merely change the dispensing event numbers once continued to insist that he ‘‘provided them they have been assigned. Tr. 273–74. Vale The Government has alleged that the everything that the [RX30] system provided, testified that a prescription dispensing event Respondents’ respective applications for and all the prescriptions were submitted.’’ can be looked up on the RX30 program by CORs should be denied because each Tr. 208. These answers presented its dispensing event number, by the type of application contains a material 68 inconsistencies, were less than complete, and medication, or by the doctor’s name. Tr. 276. falsification, which, under the CSA, is a were certainly less than candid. Similarly, Further, Vale indicated that he could identify ground for a sanction against an existing when explaining his rationale for answering all prescriptions in the system that were COR. 21 U.S.C. 824(a)(1). The Agency may ‘‘no’’ to application Question 2, Moro-Perez authorized by Dr. Aguilar. Tr. 277. He also revoke or suspend a DEA COR upon a finding adhered to the position that the nature of the stated that, ‘‘to the best of his knowledge,’’ that the registrant has materially falsified any June 2012 Farmacia Nueva surrender was no one has ever tried to manipulate the application filed to obtain it. Id. Under the somehow altered by the dismissal of a numbers for Farmacia Nueva’s RX30 theory that the law would not require criminal indictment against him (not the program, that he has never tried to do so, and issuance of a COR that should be revoked ab pharmacies) that occurred three months that he was never directed to do so. Tr. 276– initio, a long line of Agency precedent has earlier. It is inescapably illogical to insist that 77. consistently held that the grounds for the an event which occurred prior to the Vale described the dispensing process at revocation or suspension of an existing surrender would somehow alter its Farmacia Nueva. Tr. 274. Vale’s account of registration are also properly considered in characterization from ‘‘for cause’’ to FN pharmacy operations was in substantial adjudicating an application for a COR. The otherwise. Inasmuch as Moro-Perez is an accord to the explanation provided by his Lawsons, Inc., 72 FR 74334, 74335 (2007); educated and experienced pharmacist, to boss, Moro-Perez. Tr. 274–75. Samuel S. Jackson, D.D.S., 72 FR 23848, suggest that this non sequitor was the result Vale also testified that he and Moro-Perez 23852 (2007); Dan E. Hale, D.O., 69 FR of naivete´ or inexperience is patently have discussed remedial improvements they 69402, 69405–06 (2004); Anthony D. unreasonable. The answer was deceitful, intend to implement if Farmacia Nueva is Funches, 64 FR 14267, 14268 (1999); Alan R. intentionally so, and he well knew it. granted its COR. Tr. 278. Among their plans Schankman, M.D., 63 FR 45260, 45260 Similarly, when explaining his position on is the future pursuit of a strict policy (1998); Kuen H. Chen, M.D., 58 FR 65401, the negative response entered on Question 2, regarding dispensing controlled substances, a 65402 (1993). Thus, in the same way that Moro-Perez qualified his testimony by twice ‘‘program’’ 67 that will alert pharmacy materially falsifying an application provides adding that DEA knew about his arrest. Tr. personnel when a physician’s license is an independent basis for revoking an existing 216, 218–19. Again, this is a non-answer, expired in real time, and a plan to have staff registration without proof of any other since the arrest, the indictment dismissal, access the DEA Web site at least once a misconduct, it also provides an independent and DEA’s knowledge about those events do month to ascertain prescriber COR status. Tr. and adequate ground for denying an not bear any relation to the issue he was 278–79. application for a new COR. The Lawsons, 72 addressing, to wit, the ‘‘no’’ response to the Vale conceded that these safety measures FR at 74338. It is settled Agency precedent question of whether the Respondents’ could have been implemented before the that ‘‘[s]ince DEA must rely on the registrations had been surrendered for cause. execution of the search warrant on November truthfulness of information supplied by Thus, Moro-Perez tendered testimony that 30, 2011. Tr. 280. He also admitted that, applicants in registering them to handle was at times implausible and inconsistent, since November 30, 2011, he has not asked controlled substances, falsification cannot be and he substituted intentional equivocation DEA whether they provide training against tolerated,’’ Bobby Watts, M.D., 58 FR 46995, for detail. His testimony, then, cannot be illegal distribution and he has not taken any 46995 (1993), and that a ‘‘cavalier attitude deemed fully credible in this recommended toward the importance of accurately decision. That is not to say that all of his evidence.’’ ALJ Ex. 23, at 27. This misses the point. executing [a registration] application suggests testimony is not worthy of belief, but in those It is not that his testimony is lacking in credibility a lack of concern for the responsibilities places where his testimony conflicts with because it is incongruous with testimony elicited by inherent in a DEA registration.’’ Chen, 58 FR other record evidence, it must be considered the Government, but, rather, it is worthy of at 65402. with heightened vigilance.66 diminished credibility based on a dispassionate To serve as a basis for an adverse review of its own merits. application determination, it is incumbent 67 No further explanation was offered as to what 64 Tr. 194. upon the Government to establish that an sort of a ‘‘program’’ is contemplated, how it would applicant has provided false information in 65 Tr. 229–31. work, or how it would alert pharmacy staff when 66 The Government has argued in its closing brief a prescriber’s COR expires. This proposal was his or her application, and that the false that Moro-Perez ‘‘frequently gave evidence that described by the witness in terms that seemed more directly conflicted with the Government’s ethereal than concrete. 68 ALJ Ex. 4, at 3–5.

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information provided is material. 21 U.S.C. The evidence of record here clearly lack of documentation to justify prescriptions 824(a)(1). The Government must prove that demonstrates that Best Pharma surrendered constituted circumstances sufficient to the false information is material by ‘‘clear, its registration through the execution of a establish that COR applicant knew or should unequivocal, and convincing’’ evidence. Hoi DEA Form 104. Gov’t Ex. 14, at 1. However, have known that his COR surrender, which Y. Kam, M.D., 78 FR 62694, 62696 (2013) with respect to Farmacia Nueva, the occurred two years earlier, was ‘‘for cause’’); (quoting Kungys v. United States, 485 U.S. Government has tendered neither a DEA see also Robert M. Brodkin, D.P.M., 77 FR 759, 772 (1988)). A material falsification Form 104 nor ‘‘any signed writing indicating 73678, 73679 (2012) (holding that an requires a showing that a statement tendered a desire to surrender a registration.’’ 21 CFR executed DEA Form 104 and subsequent in a COR application is one that ‘‘ ‘has a 1301.52(a) (emphasis supplied). The federal and state disciplinary proceedings natural tendency to influence, or was capable Government tendered an unsigned email were circumstances sufficient to characterize of influencing, the decision of the exchange and brought no witness with any a surrender as ‘‘for cause’’). The Best Pharma decisionmaking body to which it was personal knowledge about the circumstances Surrender Form was executed by Moro-Perez addressed.’ ’’ The Lawsons, 72 FR at 74338 underlying the exchange or even one able to while the investigators were executing a (citing Kungys, 485 U.S. at 770); see also identify the participants. However, the search warrant at the pharmacy, and they Robles v. United States, 279 F.2d 401, 404 existence and validity of the Farmacia Nueva explained to him that the Form 104 ‘‘dealt (9th Cir. 1960), cert. denied, 365 U.S. 836 surrender was never challenged at the with the regulatory matter [and that i]f he (1961). Proof that any Government decision, hearing. Additionally, the identification chose not to sign the form then [DEA] would including the decision regarding the (through official notice regarding move for an order to show cause registration application, was actually Government counsel and notice of proceeding.’’ Tr. 177. Thus, unrefuted influenced is not required. The Lawsons, 72 appearance of FN’s current counsel) of the testimony establishes that DI Taylor, through FR at 74339. The touchstone is whether the names on the face of the email traffic, an interpreter, told Moro-Perez that the statement had the capacity to influence. See coupled with the fact that Farmacia Nueva surrender related only to the administrative United States v. Alemany Rivera, 781 F.2d filed an application for a new COR, provide proceedings, and not any criminal case. 229, 234 (1st Cir. 1985), cert. denied, 475 a sufficiently reliable basis upon which to There was no evidence as to why Moro-Perez U.S. 1086 (1986); Alvin Darby, M.D., 75 FR conclude that the COR was surrendered and would not take the DI at his word that the 26993, 26998 (2010). Since a materiality that Farmacia Nueva accepts that as fact. In surrender related only to administrative determination turns on an analysis of the any event, the language employed in the issues, not a criminal case. The Farmacia relevant substantive law, Kungys, 485 U.S. at surrender/termination provision 69 cited Nueva surrender was effected by counsel via 772, the allegedly false statement must be above appears more focused on fixing an email while administrative revocation analyzed in the context of the application effective date for when a surrender ripens proceedings were apparently underway requirements sought by DEA and provided by into a termination than on circumscribing the before the Agency. Gov’t Ex. 14, at 2–4. The the applicant. The falsification must relate to exclusive means to surrender a COR.70 circumstances surrounding each surrender a ground that could affect the decision, not Whether the surrenders were ‘‘for cause’’ is provided sufficient notice to Moro-Perez that merely a basis upon which an investigation yet even more nuanced. Neither the Best DEA was intent upon seeking revocation could be initiated. Darryl J. Mohr, M.D., 77 Pharma Surrender Form nor Farmacia based on what its agents perceived to be FR 34998, 34998 n.2 (2012); Harold Edward Nueva’s email exchange contain the words serious regulatory violations. While the record is not optimal in this regard, there is Smith, M.D., 76 FR 53961, 53964 (2011); ‘‘for cause.’’ Gov’t Ex. 14. In fact, the only 71 Scott C. Bickman, M.D., 76 FR 17694, 17701 mention of a surrender ‘‘for cause’’ is set sufficient, unrefuted evidence to establish (2011). The entire application will be forth in two regulatory sections devoted to that the BP and FN CORs were surrendered for cause and that Moro-Perez had reason to examined to determine whether there was an security matters, each of which provides that: 72 intention to deceive the agency. See Jackson, know this was the case. For purposes of [the two security The COR surrenders for cause that were 72 FR at 23852–53. subsections], the term ‘‘for cause’’ means a Furthermore, the correct analysis hinges on errantly denied in Question 2 of the surrender in lieu of, or as a consequence of, Respondents’ applications were founded in whether the applicant knew or should have any federal or state administrative, civil, or known that he or she submitted a false controlled substance recordkeeping and criminal action resulting from an corresponding responsibility violations application. Hale, 69 FR at 69406; The investigation of [a current or prospective Drugstore, 61 FR 5031, 5032 (1996); Watts, 58 employee’s] handling of controlled 71 In their closing brief, the Respondents argue FR at 46995. Although even an unintentional substances. . . . falsification can serve as a basis for adverse that DI Antoine testified that he did not know what 21 CFR 1301.76(a), 1309.72(a). There is no action regarding a registration, lack of intent ‘‘for cause’’ meant. ALJ Ex. 24, at 13, 23. Even the ‘‘for cause’’ definition set forth in the record citation (Tr. 105–06) provided by the to deceive and evidence that the falsification regulations related to COR surrender. 21 CFR Respondents makes clear that Antoine testified that was not intentional or negligent are all 1301.52. he did not know why the words ‘‘for cause’’ were relevant considerations. Funches, 64 FR at Agency precedent has looked into the in parentheses, not that he did not know what the 14268. circumstances surrounding a surrender to phrase meant. In any event, highlighting this point The Government has alleged that each of does nothing to further the Respondents’ position. determine whether it was properly the Respondent pharmacies surrendered a If placement of the phrase ‘‘for cause’’ somehow characterized as being ‘‘for cause’’ and COR for cause and that, when Moro-Perez renders it optional or diminishes its import, that whether a registrant is properly charged with stated otherwise on their COR applications, would leave Question 2 as asking whether a COR understanding that characterization. See, e.g., he knew or should have known that his had ever been surrendered (for any reason). A ‘‘no’’ Shannon L. Gallentine, D.P.M., 76 FR 45864, answer tendered in response to a question statement in this regard was untrue. In their 45866 (2011) (holding that the signing of a interpreted thus would be false here irrespective of closing brief, the Respondents assert that DEA Form 104 during a search warrant the Respondents’ illogical association of the ‘‘for ‘‘the Government did not submit any execution where the investigator was asking cause’’ clause to his indictment dismissal. evidence to prove that Farmacia Nueva’s 72 questions about prescribing practices and In its brief, the Government points out that registration was revoked or surrendered (for Moro-Perez ‘‘never contacted [DI Antoine] to cause).’’ ALJ Ex. 24, at 22. Although the inquire as to what ‘for cause’ meant.’’ ALJ Ex. 23, record evidence tells a story somewhere 69 21 CFR 1301.52(a). at 6. To be clear, there was no burden on Moro- between the parties’ contentions, it is the 70 The Agency Final Rule promulgating the Perez to contact DEA to ascertain the meaning of Government’s view that is better supported. modification stated that the language is designed to the language in the BP voluntary surrender form or ‘‘clarify that a voluntary surrender of a registration the consequences of the surrender effected by The DEA regulations related to COR signed by a registrant using any format has the legal counsel during the FN administrative proceedings. termination provide, in pertinent part, that: effect of immediately terminating the registrant’s The language and circumstances of the voluntary In the case of a surrender, termination shall registration without any further action by DEA.’’ surrender were sufficiently clear to find that the occur upon receipt by any [DEA employee] Voluntary Surrender of Certificate of Registration, surrender here was ‘‘for cause’’ and that Moro-Perez of a duly executed DEA Form 104 or any 76 FR 61563, 61563 (Oct. 5, 2011). Thus, the knew it, whether he made inquiry or not. If the signed writing indicating the desire to primary focus appears to have been on providing language and circumstances were not sufficiently clarity regarding the date upon which the surrender clear, the absence of any efforts by Moro-Perez to surrender a registration. became effective, not the nature of the instruments contact DI Antoine would not advance the 21 CFR 1301.52(a). required to make the surrender valid. Government’s case in any measure.

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uncovered by DEA in the course of a criminal Liability Question 2, since both CORs were previously been a surrender for cause being search warrant execution, and those surrendered for cause by Moro-Perez prior to transformed into a surrender not for cause. violations would have supported the denial the filing of the applications, the ‘‘no’’ Then, as if this gift was not good enough, he of the Respondents’ applications. See Kam, response in each application is indisputably also asserted that not only did the dismissal 78 FR at 62697 & n.7 (holding that a material untrue. The principal issue remaining is of the indictment (against himself) forgive the falsification, to be material, must be such that whether the negative response entered by sins of one of his pharmacies, but somehow the truthful disclosure of the facts would Moro-Perez on each application was it preemptively pardoned another pharmacy have supported the denial of the objectively reasonable. that surrendered for cause after the date of Respondent’s application). One of the CORs Moro-Perez testified that, while he now dismissal by characterizing that surrender as was surrendered during the course of DEA acknowledges that he should have answered ‘‘not for cause.’’ But this cannot be. If the administrative hearing procedures. As the surrender for cause questions in the dismissal of indictment really cleaned up all discussed more fully, infra, allegations that affirmative, he misunderstood the question at issues surrounding Moro-Perez and his the dispensing of controlled substance the time, and there was never an intention on pharmacies, why would there even need to prescriptions authorized by an unregistered his part to deceive DEA. Tr. 216–17. be a subsequent surrender of Farmacia physician that resulted in their surrender for Specifically, Moro-Perez posits that the Nueva’s COR? And, in light of the subsequent cause provided ‘‘actionable grounds’’ dismissal of an indictment against him led surrender of Farmacia Nueva’s COR, why sufficient to merit a COR sanction. Kam, 78 him to believe that the surrenders of the two would it be reasonable to believe that the FR at 62697. Hence, it is beyond argument CORs by the Respondents were not for cause. dismissal of the criminal charges against that the alleged falsifications, if established, Tr. 211–13. When viewed against a backdrop Moro-Perez magically deemed a subsequent ‘‘had the capacity to influence the Agency’s of the timeline of events delineated in the surrender for cause as a surrender not for decision to grant [the] application[s]’’ and, evidence of record, Moro-Perez’s explanation cause? thus, were material. Id. makes no sense. There is simply no logical manner in Regarding Moro-Perez’s position that he As set forth in the table below, Moro-Perez which a rational person (much less an was confused about the whether the surrendered the Best Pharma COR at the time educated, experienced registrant holder) surrenders retained their ‘‘for cause’’ of his arrest during the early morning hours would or could reason that a surrender that character based on his indictment dismissal, of November 30, 2011. Tr. 72, 175, 181; Gov’t was ‘‘for cause’’ when effected, could the timeline of events is key. Moro-Perez Exs. 2, at 2, 14, at 2–4. The indictment somehow morph into one that was not ‘‘for testified that he has owned Farmacia Nueva referenced by Moro-Perez was dismissed on cause’’ by an action (the dismissal) that and Best Pharma since each establishment March 23, 2012, some four months later. Stip. preceded it. Even if it were assumed, was opened. Tr. 192, 222, 238. A COR was 8; Resp’t Ex. 3; Tr. 212. The Farmacia Nueva arguendo, that Moro-Perez’s account that he issued to Farmacia Nueva in 2005 and to Best COR was surrendered for cause by counsel subjectively believed the dismissal of an Pharma in 2010. Gov’t Exs. 2, 9. The Best on June 28, 2012, three months after the indictment against him (not the Respondents) Pharma Surrender Form was executed by indictment dismissal and seven months 73 74 could somehow change the character of the Moro-Perez on November 30, 2011. Gov’t following the Best Pharma surrender for surrender for cause, no indictment dismissal Ex. 14, at 1. The DEA COR applications that cause. Gov’t Exs. 2, 14. The online COR or other operative fact occurred after the are the subject of these proceedings include applications that are the subject of these surrender of Farmacia Nueva’s COR that four liability questions that require the proceedings were submitted by Moro-Perez could alter its character. Thus, even if credit applicant to choose a ‘‘yes’’ or ‘‘no’’ answer. on October 10, 2012, eleven months after the were afforded to Moro-Perez’s account that it The second liability question (Liability for-cause surrender of Best Pharma’s COR, was the dismissal of the indictment against Question 2) contains the following language: four months following the Farmacia Nueva him that led him to believe that the Has the applicant ever surrendered (for for-cause surrender, and (most significantly) surrenders of the CORs were not for cause, cause) or had a federal controlled substance seven months following the dismissal of the this theory of ignorance, even in its best registration revoked, suspended, restricted or indictment against Moro-Perez. Gov’t Exs. 1, (most naı¨ve) light, only covers the Best denied, or is any such action pending? 8; Stips. 5, 6. Pharma surrender that was signed before the Gov’t Exs. 1, 8. Moro-Perez included a ‘‘no’’ indictment dismissal, not the Farmacia response to Liability Question 2 on the Date Event Nueva surrender, which occurred three online application he submitted for each months after the dismissal. Even putting Respondent. Gov’t Exs. 1, 8. Notwithstanding November 30, 2011 Best Pharma COR aside the reality that, as a veteran registrant the less-than-ideal sentence structure in Surrender Form Exe- holder, Moro-Perez had the experience and cuted by Moro- bore the responsibility to understand the 73 Moro-Perez testified at the hearing with the Perez. meaning of his answers to the applications he benefit of a Spanish-language interpreter. Tr. 191. March 23, 2012 ...... Indictment Against was filing, he failed to present a logical Uncontroverted record evidence establishes that the Moro-Perez Dis- theory of subjective ignorance that Best Pharma Surrender Form was read and missed. corresponds with the facts. At the hearing, explained to Moro-Perez in Spanish at the time it June 28, 2012 ...... Farmacia Nueva COR Moro-Perez acknowledged that he was executed. Tr. 175–78. At the hearing, the Surrendered by Respondents raised no issue regarding any understood the question concerning the Counsel via Email. surrender for cause and his response to it. Tr. impediment presented by language regarding Moro- October 10, 2012 .... Respondents’ COR Ap- Perez’s execution of the Best Pharma Surrender 210–11. The indictment dismissal occurred Form or the COR applications he filed on their plications Submitted prior to the surrender for cause, and there is behalf. The Farmacia Nueva COR surrender was by Moro-Perez. simply no rational view of the facts that effected via email by its present counsel, who could lead any reasonable person, much less possessed sufficient command of the Spanish As is apparent in the table above, the an experienced COR holder, to believe that language to communicate with Moro-Perez indictment dismissal, the single event to the surrender was suddenly no longer ‘‘for throughout these proceedings and to offer which Moro-Perez ascribes the confusion that cause’’ due to a dismissal that came first. It numerous challenges during the hearing to spawned his false answers on the COR translations supplied by the official hearing is not insignificant that Moro-Perez (not the interpreter. See, e.g., Tr. 195–96, 200, 206, 214–15, applications, occurred between the for-cause Respondents) was captioned in the 220, 224. Thus, this record does not support any surrenders of Best Pharma and Farmacia indictment, and, given the timeline of events, level of cognizable confusion on the part of Moro- Nueva. The Farmacia Nueva surrender the dismissal added no level of cognizable Perez borne of a language barrier in understanding happened after the indictment dismissal 75 confusion here. Moro-Perez’s assertions to the COR surrenders or the filed applications. and was effected through counsel. In effect, the contrary are simply not credible. The 74 The Government also provided a certification Moro-Perez testified that he believed that the ‘‘provision of truthful information is by the Chief of the DEA Registration and Program dismissal of the criminal charges (against absolutely essential to effectuating th[e] Support Section (Farmacia Nueva Certification) that himself) somehow washed away the sins of statutory purpose’’ of determining whether the same voluntary surrender took place on Best Pharma, resulting in what had December 14, 2011. Gov’t Ex. 9, at 2. Although no the granting of an application is consistent explanation was offered for the disparity, the date with the public interest. Darby, 75 FR at variance does not impact the outcome of the case. 75 Gov’t Ex. 14, at 2. 26998 (quoting Peter A. Ahles, M.D., 71 FR

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50097, 50098 (2006)); see VI Pharmacy, 69 DEA, 412 F.3d 165, 173–74 (D.C. Cir. 2005); George Mathew, M.D., 75 FR 66138, 66140, FR 5584, 5585 (2004); Terrence E. Murphy, Joy’s Ideas, 70 FR 33195, 33197 (2005); Henry 66145, 66148 (2010); George C. Aycock, M.D., M.D., 61 FR 2841, 2846 (1996). This finding, J. Schwarz, Jr., M.D., 54 FR 16422, 16424 74 FR 17529, 17543 (2009); Abbadessa, 74 FR standing alone, is sufficient to recommend (1989). Moreover, the Agency is ‘‘not at 10078; Krishna-Iyer, 74 FR at 463; denial of both applications. Cf. Gallentine, 76 required to make findings as to all of the Medicine Shoppe, 73 FR at 387. FR at 45866. It is clear that the Respondents, factors,’’ Hoxie v. DEA, 419 F.3d 477, 482 While the burden of proof at this through their common owner, Moro-Perez, (6th Cir. 2005); Morall, 412 F.3d at 173, and administrative hearing is a preponderance-of- knew or should have known 76 that the is not required to discuss consideration of the-evidence standard, see Steadman v. SEC, answers provided to Question 2 were false, each factor in equal detail, or even every 450 U.S. 91, 100–02 (1981), the Agency’s and that their COR applications contained factor in any given level of detail. Trawick v. ultimate factual findings will be sustained on material falsifications. The absence of any DEA, 861 F.2d 72, 76 (4th Cir. 1988) (holding review to the extent they are supported by logical basis for confusion and the past that the Administrator’s obligation to explain ‘‘substantial evidence.’’ Hoxie, 419 F.3d at experience of Moro-Perez as a registrant the decision rationale may be satisfied even 481. While ‘‘‘the possibility of drawing two holder and pharmacist preponderantly if only minimal consideration is given to the inconsistent conclusions from the evidence’’’ support a finding that the misrepresentations relevant factors and that remand is required does not limit the Administrator’s ability to were intentional, not negligent.77 The only when it is unclear whether the relevant find facts on either side of the contested Respondents are accountable for the actions factors were considered at all). The balancing issues in the case, Shatz v. U.S. Dep’t of of Moro-Perez as their owner/president,78 of the public interest factors ‘‘is not a contest Justice, 873 F.2d 1089, 1092 (8th Cir. 1989) and, even standing alone, the denial of the in which score is kept; the Agency is not (quoting Trawick, 861 F.2d at 77), all Respondents’ COR applications is adequately required to mechanically count up the factors ‘‘important aspect[s] of the problem,’’ such as supported on this record based on the and determine how many favor the a respondent’s defense or explanation that material falsifications set forth in the filed Government and how many favor the runs counter to the Government’s evidence, applications. registrant. Rather, it is an inquiry which must be considered, Wedgewood Vill. Public Interest Determination: The Standard focuses on protecting the public Pharmacy v. DEA, 509 F.3d 541, 549 (D.C. interest. . . .’’ Jayam Krishna-Iyer, 74 FR 459, Cir. 2007); see Humphreys v. DEA, 96 F.3d The Government also seeks denial of the 462 (2009). 658, 663 (3d Cir. 1996). The ultimate Respondents’ respective COR applications In the adjudication of an application for a disposition of the case ‘‘must be ‘in based on a theory that each has committed DEA COR, the DEA has the burden of proving accordance with’ the weight of the evidence, acts inconsistent with the public interest. that the requirements for registration are not not simply supported by enough evidence ‘to Pursuant to 21 U.S.C. 823(f), the satisfied. 21 CFR 1301.44(d). Where the justify, if the trial were to a jury, a refusal to Administrator 79 is permitted to deny an Government has sustained its burden and application for a COR if persuaded that an direct a verdict when the conclusion sought established that an applicant has committed applicant ‘‘has committed such acts as would to be drawn from it is one of fact for the acts inconsistent with the public interest, render [its] registration . . . inconsistent jury.’’’ Steadman, 450 U.S. at 99 (quoting that applicant must present sufficient with the public interest.’’ 80 The following Consolo v. Fed. Mar. Comm’n, 383 U.S. 607, mitigating evidence to provide assurance that factors have been provided by Congress in 620 (1966)). it can be entrusted with the responsibility determining ‘‘the public interest’’: Regarding the exercise of discretionary commensurate with such a registration. (1) The recommendation of the appropriate authority, the courts have recognized that Steven M. Abbadessa, D.O., 74 FR 10077, State licensing board or professional gross deviations from past agency precedent 10078, 10081 (2009); Medicine Shoppe- disciplinary authority. must be adequately supported, Morall, 412 (2) The applicant’s experience in Jonesborough, 73 FR 364, 387 (2008); F.3d at 183, but mere unevenness in dispensing, or conducting research with Jackson, 72 FR at 23853. Where the application does not, standing alone, render respect to controlled substances. Government has met this burden, the a particular discretionary action (3) The applicant’s conviction record under registrant must show an acceptance of unwarranted. Chein v. DEA, 533 F.3d 828, Federal or State laws relating to the responsibility for its misconduct and a 835 (D.C. Cir. 2008) (citing Butz v. Glover manufacture, distribution, or dispensing of demonstration that corrective measures have Livestock Comm’n Co., 411 U.S. 182, 188 controlled substances. been undertaken to prevent the re-occurrence (1973)), cert. denied, 555 U.S. 1139 (2009). It (4) Compliance with applicable State, of similar acts. Jeri Hassman, M.D., 75 FR is well settled that since the Administrative Federal, or local laws relating to controlled 8194, 8236 (2010). In determining whether Law Judge has had the opportunity to substances. and to what extent a sanction is appropriate, observe the demeanor and conduct of hearing (5) Such other conduct which may threaten consideration must be given to both the witnesses, the factual findings set forth in the public health and safety. egregiousness of the offense established by this recommended decision are entitled to the Government’s evidence and the Agency’s 21 U.S.C. 823(f) (2006 & Supp. III 2010). significant deference, Universal Camera interest in both specific and general ‘‘[T]hese factors are considered in the Corp. v. NLRB, 340 U.S. 474, 496 (1951), and deterrence. David A. Ruben, M.D., 78 FR disjunctive.’’ Robert A. Leslie, M.D., 68 FR that this recommended decision constitutes 38363, 38364, 38385 (2013). 15227, 15230 (2003). Any one or a an important part of the record that must be Normal hardships to the practitioner, and combination of factors may be relied upon, considered in the Agency’s final decision, even the surrounding community, which are and when exercising authority as an Morall, 412 F.3d at 179. However, any attendant upon the denial of a registration, impartial adjudicator, the Administrator may recommendations set forth herein regarding properly give each factor whatever weight are not a relevant consideration. Linda Sue the exercise of discretion are by no means she deems appropriate in determining Cheek, M.D., 76 FR 66972, 66972–73 (2011); binding on the Administrator and do not whether an application for a registration Gregory D. Owens, D.D.S., 74 FR 36751, limit the exercise of that discretion. 5 U.S.C. should be denied. Id.; David H. Gillis, M.D., 36757 (2009). The Agency’s conclusion that 557(b) (2006); River Forest Pharmacy, Inc. v. 58 FR 37507, 37508 (1993); see Morall v. past performance is the best predictor of DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); future performance has been sustained on Attorney General’s Manual on the review in the courts, Alra Labs., Inc. v. DEA, 76 Administrative Procedure Act § 8(a) (1947). See Hale, 69 FR at 69406; The Drugstore, 61 FR 54 F.3d 450, 452 (7th Cir. 1995), as has the 5031, 5032 (1996); Watts, 58 FR at 46995. Agency’s consistent policy of strongly Factors 1, 3, and 5: The Recommendation of 77 See Funches, 64 FR at 14268. weighing whether a registrant who has the Appropriate State Licensing Board or 78 See Top Rx Pharmacy, 78 FR 26069, 26081–82 Professional Disciplinary Authority; Any (2013); EZRX, LLC, 69 FR 63178, 63181 (2004); committed acts inconsistent with the public interest has accepted responsibility and Conviction Record Under Federal or State Plaza Pharmacy, 53 FR 36910, 36911 (1988); Laws Relating to the Manufacture, Syncon Pharm., Inc., 53 FR 15155, 15156 (1988); demonstrated that he or she will not engage see also Neil Labs., Inc. v. Ashcroft, 217 F. Supp. in future misconduct, Hoxie, 419 F.3d at 483; Distribution, or Dispensing of Controlled 2d 80, 87–88 (D.D.C. 2002). see also Ronald Lynch, M.D., 75 FR 78745, Substances; Such Other Conduct Which May Threaten the Public Health and Safety 79 This authority has been delegated pursuant to 78754 (2010) (holding that the Respondent’s 28 CFR 0.100(b) and 0.104. attempts to minimize misconduct Regarding Factor 1, the record contains no 80 21 U.S.C. 824(a)(4). undermined acceptance of responsibility); evidence of a recommendation by any state

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licensing board, body, or authority related to of any evidence of criminal prosecution is 823(f)(5). 72 FR 42118, 42126 n.16 (2007). the Respondent pharmacies. However, the somewhat diminished by the myriad of Regarding the List I catch-all language, the fact that a state has not acted against a considerations that are factored into a Administrator, in Holloway, stated: registrant’s state authority is not dispositive decision to initiate, pursue, and dispose of [T]he Government is not required to prove in this administrative determination as to criminal proceedings by federal, state, and that the [r]espondent’s conduct poses a threat whether continuation of its registration is local prosecution authorities. See Robert L. to public health and safety to obtain an consistent with the public interest. Patrick Dougherty, M.D., 76 FR 16823, 16833 n.13 adverse finding under factor five. See T. W. Stodola, M.D., 74 FR 20727, 20730 (2009); (2011); Dewey C. Mackay, M.D., 75 FR 49956, Young, 71 [FR] at 60572 n.13. Rather, the Krishna-Iyer, 74 FR at 461. It is well- 49973 (2010) (‘‘[W]hile a history of criminal statutory text directs the consideration of established Agency precedent that ‘‘state convictions for offenses involving the ‘‘such other factors as are relevant to and [authority] is a necessary, but not sufficient distribution or dispensing of controlled consistent with the public health and safety.’’ condition for registration.’’ John H. Kennedy, substances is a highly relevant consideration, 21 U.S.C. 823(h)(5). This standard thus grants M.D., 71 FR 35705, 35708 (2006) (quoting there are any number of reasons why a the Attorney General broader discretion than Leslie, 68 FR at 15230). DEA bears an registrant may not have been convicted of that which applies in the case of other independent responsibility to determine such an offense, and thus, the absence of registrants such as practitioners. See id. whether a registration is in the public such a conviction is of considerably less § 823(f)(5) (directing consideration of ‘‘[s]uch interest. Mortimer B. Levin, D.O., 55 FR 8209, consequence in the public interest inquiry.’’), other conduct which may threaten the public 8210 (1990). The ultimate responsibility to aff’d, Mackay v. DEA, 664 F.3d 808 (10th Cir. health and safety’’). 2011); Ladapo O. Shyngle, M.D., 74 FR 6056, determine whether a registration is consistent Id.82 Thus, the Agency has recognized that, 6057 n.2 (2009). Therefore, on the present with the public interest has been delegated while the fifth factor applicable to List I record, the absence of criminal convictions exclusively to the DEA, not to entities within chemical distributors—21 U.S.C. 823(h)(5)— state government. Edmund Chein, M.D., 72 (Factor 3), like the absence of a encompasses all ‘‘factors,’’ the Factor Five FR 6580, 6590 (2007), aff’d, Chein v. DEA, recommendation from any state licensing applied to practitioners—21 U.S.C. 533 F.3d 828 (D.C. Cir. 2008), cert. denied, authorities (Factor 1), militates neither for 823(f)(5)—considers only ‘‘conduct.’’ 555 U.S. 1139 (2009). Congress vested nor against the COR denials sought by the However, because § 823(f)(5) only implicates authority to enforce the CSA in the Attorney Government. ‘‘such other conduct,’’ it necessarily follows General, not state officials. Stodola, 74 FR at The fifth statutory public interest factor that conduct considered in Factors One 20735 n.31. Thus, on these facts, the absence directs consideration of ‘‘[s]uch other through Four may not be considered in of a recommendation by a state licensing conduct which may threaten the public Factor Five. board does not weigh for or against a health and safety.’’ 21 U.S.C. 823(f)(5) The Government has not alleged any determination as to whether granting the (emphasis added). Existing Agency precedent conduct against either Respondent in these Respondents’ applications would be has long held that this factor encompasses proceedings that implicates Factor Five. consistent with the public interest. See Roni ‘‘conduct which creates a probable or Indeed, those portions of each party’s closing Dreszer, M.D., 76 FR 19434, 19444 (2011) possible threat (and not only an actual briefs dedicated to Factor Five are (‘‘[T]he fact that the record contains no [threat]) . . . to public health and safety.’’ exclusively (and mistakenly) devoted to a evidence of a recommendation by a state Dreszer, 76 FR at 19434 n.3; Michael J. Aruta, discussion of the burdens established under licensing board does not weigh for or against M.D., 76 FR 19420, 19420 n.3 (2011); Beau Agency precedent and the exercise of some a determination as to whether continuation Boshers, M.D., 76 FR 19401, 19402 n.4 of the appropriate discretionary of the Respondent’s DEA certification is (2011); Jacobo Dreszer, 76 FR 19386, 19386 considerations. Accordingly, consideration of consistent with the public interest.’’). n.3 (2011). Agency precedent has generally the record evidence under Factors One, Regarding the third factor (convictions embraced the principle that any conduct that Three, and Five weigh neither for nor against relating to the manufacture, distribution, or is properly the subject of Factor Five must the Governments’ petition to deny the dispensing of controlled substances), the have a nexus to controlled substances and Respondents’ COR applications. record in this case does not contain evidence the underlying purposes of the CSA. Terese, that the Respondents, their owner, or any Inc., 76 FR 46843, 46848 (2011); Tony T. Bui, Factors 2 and 4: The Respondents’ pharmacist or key employee of either M.D., 75 FR 49979, 49989 (2010) (stating that Experience in Dispensing Controlled pharmacy has been convicted of (or charged prescribing practices related to a non- Substances, and Compliance With with) a crime related to any of the controlled controlled substance such as human growth Applicable State, Federal, or Local Laws substance activities designated in the CSA.81 hormone may not provide an independent Relating to Controlled Substances The standard of proof in a criminal case is basis for concluding that a registrant has The Government’s public-interest-factors more stringent than the standard required at engaged in conduct which may threaten case seeking COR application denials for an administrative proceeding, and the public health and safety); cf. Paul Weir both Respondents is based exclusively on elements of both federal and state crimes Battershell, N.P., 76 FR 44359, 44368 n.27 conduct properly considered under Factors relating to controlled substances are not (2011) (noting that although a registrant’s Two and Four. The Government alleges and always co-extensive with conduct that is non-compliance with the Food, Drug, and relies on recordkeeping and dispensing relevant to a determination of whether Cosmetic Act is not relevant under Factor activity conducted by the Respondent registration is within the public interest. Five, consideration of such conduct may pharmacies’ pharmacists, staff, and Still, evidence that a registrant has been properly be considered on the narrow issue management. convicted of crimes related to controlled of assessing a respondent’s future compliance Regarding Factor Two, in requiring an substances is a factor to be evaluated in with the CSA). examination of an applicant’s experience in reaching a determination as to whether he or Similar ‘‘catch-all’’ language is employed dispensing controlled substances, Congress she should be entrusted with a DEA by Congress in the CSA related to the manifested an acknowledgement that the certificate. The probative value of an absence Agency’s authorization to regulate controlled qualitative manner and the quantitative substance manufacturing and List I chemical volume in which an applicant has engaged in 81 The parties stipulated that Moro-Perez was distribution, but the language is by no means the dispensing of controlled substances may indicted, but that the indictment was ultimately identical. 21 U.S.C. 823(d)(6), (h)(5). Under be significant factors to be evaluated in dismissed. Stip. 8; Resp’t Ex. 3. The indictment the language utilized by Congress in those reaching a determination as to whether an itself was not offered into the record. The mere fact provisions, the Agency may consider ‘‘such applicant should be (or continue to be) that Moro-Perez was the subject of a criminal other factors as are relevant to and consistent entrusted with a DEA COR. In some (but not indictment does not establish culpability for the with the public health and safety.’’ 21 U.S.C. all) cases, viewing an applicant’s actions acts charged by the indictment, and the dismissal 823(h)(5) (emphasis added). In Holloway in this matter has been considered only under the Distributing, the Agency held this catch-all narrow mens rea theory upon which the 82 In Bui, the Agency clarified that ‘‘an adverse Respondents offered it. See Paul Weir Battershell, language to be broader than the language finding under [Factor Five did not require a] N.P., 76 FR 44359, 44364 n.17 (2011) (concluding directed at practitioners under ‘‘other showing that the relevant conduct actually that an indictment is an instrument containing conduct which may threaten the public constituted a threat to public safety.’’ 75 FR at accusations, not proof of a respondent’s actions). health and safety’’ utilized in 21 U.S.C. 49988 n.12.

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against a backdrop of how its regulated Shoppe, 73 FR at 384; United Prescription substance business of a pharmacy.’’’ (quoting activities have been performed within the Servs., Inc., 72 FR 50397, 50407–08 (2007); Carriage Apothecary, 52 FR 27599, 27599 scope of its registration can provide a EZRX, LLC, 69 FR 63178, 63181 (2004); Role (1987))); S & S Pharmacy, Inc., 46 FR 13051, contextual lens to assist in a fair adjudication of Authorized Agents in Communicating 13052 (1981) (holding that the corporate of whether registration is in the public Controlled Substance Prescriptions to pharmacy acts through the agency of its PIC). interest. In this regard, however, the Agency Pharmacies, 75 FR 61613, 61617 (Oct. 16, Knowledge obtained by the pharmacists and has applied principles of reason, coupled 2010); Issuance of Multiple Prescriptions for other employees acting within the scope of with its own expertise, in the application of Schedule II Controlled Substances, 72 FR their employment may be imputed to the this factor. For example, the Agency has 64921, 69424 (Nov. 19, 2007)). Settled pharmacy itself. See United States v. 7326 taken the reasonable position that this factor Agency precedent has interpreted this Highway 45 N., 965 F.2d 311, 316 (7th Cir. can be outweighed by acts held to be corresponding responsibility as prohibiting 1992) (‘‘Only knowledge obtained by inconsistent with the public interest, and the filling of a prescription where the corporate employees acting within the scope will be afforded scant weight in the face of pharmacist or pharmacy ‘‘knows or has of their employment is imputed to the proven allegations of intentional diversion. reason to know’’ that the prescription is corporation.’’). Agency precedent has Krishna-Iyer, 74 FR at 463; see also Hassman, invalid. E. Main St. Pharmacy, 75 FR 66149, consistently held that the registration of a 75 FR at 8235 (acknowledging Agency 66163 (2010); Bob’s Pharmacy & Diabetic pharmacy may be revoked as the result of the precedential rejection of the concept that Supplies, 74 FR 19599, 19601 (2009) (citing unlawful activity of the pharmacy’s owners, conduct inconsistent with the public interest Medicine Shoppe, 73 FR at 381); see also majority shareholders, officers, managing is rendered less so by comparing it with a United Prescription Servs., 72 FR at 50407– pharmacist, or other key employees. Holiday respondent’s legitimate activities that 08 (finding a violation of corresponding CVS, 77 FR at 62340; EZRX, 69 FR at 63181; occurred in substantially higher numbers); responsibility where the pharmacy ‘‘had Plaza Pharmacy, 53 FR 36910, 36911 (1988). Paul J. Cargine, Jr., 63 FR 51592, 51560 ample reason to know’’ that the practitioner Thus, it is necessary and appropriate to (1998) (‘‘[E]ven though the patients at issue was not acting in the usual course of analyze the relevant conduct of each are only a small portion of Respondent’s professional practice). The pharmacy pharmacy’s personnel, including Moro-Perez, patient population, his prescribing of registrant’s responsibility under the who serves as the owner/president of each.85 controlled substances to these individuals regulations is not coextensive or identical to The DEA regulations provide that a raises serious concerns regarding [his] ability the duties imposed upon a prescriber, but is, controlled substance prescription may only to responsibly handle controlled substances rather, a corresponding one. 21 CFR be issued by a practitioner with state and in the future.’’). Similarly, in Cynthia M. 1306.04(a). The Government has averred that federal authority to do so. 21 CFR 1306.03(a). Cadet, M.D., the Agency determined that for a period of over two years, the For a controlled substance prescription to be existing List I precedent 83 clarifying that Respondents filled controlled substance effective, it must be issued by a practitioner. experience related to conduct within the prescriptions for Dr. Aguilar, a physician 21 CFR 1306.04(a). To be a ‘‘practitioner’’ scope of the COR sheds light on a who did not possess a valid COR. These under the CSA in this context, an individual practitioner’s knowledge of applicable rules allegations impact both Factor 2 84 and Factor must possess authority to prescribe and regulations would not be applied to 4. controlled substances. 21 U.S.C. 802(21). cases where intentional diversion allegations To show a violation of a pharmacy Thus, a controlled substance prescription were sustained. 76 FR 19450, 19450 n.3 registrant’s corresponding responsibility, issued by one who lacks authority to (2011). The Agency’s approach in this regard ‘‘the Government must establish three prescribe is issued by a non-practitioner and has been sustained on review. Mackay, 664 elements: (1) the registrant dispensed a is ineffective. A pharmacy registrant who F.3d at 819. controlled substance; (2) a red flag was or dispenses a controlled substance based on an Regarding Factor Four (compliance with should have been recognized at or before the ineffective prescription, in the face of a red laws related to controlled substances), to time the controlled substance was dispensed; flag that was recognized or should have been effectuate the dual goals of conquering drug and (3) the question created by the red flag recognized, has violated its regulatory abuse and controlling both legitimate and was not resolved conclusively prior to the corresponding responsibility. 21 CFR illegitimate traffic in controlled substances, dispensing of the controlled substance.’’ 1306.14; Holiday CVS, 77 FR at 62341. The ‘‘Congress devised a closed regulatory system Holiday CVS, 77 FR at 62341. ‘‘The steps question then devolves to whether Dr. making it unlawful to manufacture, necessary to resolve the red flag conclusively Aguilar’s lack of a COR is a red flag that distribute, dispense, or possess any will perforce be influenced by the nature of should have been recognized. As discussed, controlled substance except in a manner the circumstances giving rise to the red flag.’’ infra, this question must be answered in the affirmative. authorized by the CSA.’’ Gonzales v. Raich, Id. (emphasis added). When considering On the present record, it is beyond 545 U.S. 1, 13 (2005). Under the regulations, whether a pharmacy has violated its argument that controlled substances were ‘‘[t]he responsibility for the proper corresponding responsibility, the Agency dispensed by the Respondent pharmacies on prescribing and dispensing of controlled considers whether the entity, not the scrips issued by (unregistered) Dr. Aguilar substances is upon the prescribing pharmacist, can be charged with the requisite (Element 1). The remaining issues concern practitioner, but a corresponding knowledge. See United Prescription Servs., whether this was done in the face of an responsibility rests with the pharmacist who 72 FR at 50407 (finding that the Respondent unresolved red flag that should have been fills the prescription.’’ 21 CFR 1306.04(a). pharmacy violated its corresponding recognized 86 before the prescriptions were Under this language, a pharmacist has a duty responsibility because ‘‘an entity which voluntarily engages in commerce [to] other filled (Elements 2 & 3). ‘‘to fill only those prescriptions that conform The unrefuted evidence of record in all respects with the requirements of the States is properly charged with knowledge of the laws regarding the practice of medicine establishes that, for over two years, the [CSA] and DEA regulations, including the Respondent pharmacies filled controlled requirement that the prescribing practitioner in those States’’ (emphasis added)); see also Pharmboy Ventures Unlimited, Inc., 77 FR substance prescriptions without checking be properly registered.’’ Electronic COR status beyond insurance payment Prescriptions for Controlled Substances, 75 33770, 33771 n.2 (2012) (‘‘DEA has long held that it can look behind a pharmacy’s confirmation. From Antoine’s testimony, it FR 16236, 16266 (Mar. 31, 2010). In short, a appears that, from the period of January 31, pharmacist has a ‘‘corresponding ownership structure ‘to determine who makes decisions concerning the controlled 2009 to November 30, 2011, Dr. Aguilar’s responsibility under Federal law’’ to lack of a DEA COR had no perceptible impact dispense only lawful prescriptions. Liddy’s on either the enthusiasm with which he 84 Pharmacy, L.L.C., 76 FR 48887, 48895 (2011). This case contained no allegation (or evidence) issued controlled substance prescriptions, ‘‘The corresponding responsibility to ensure of intentional diversion, but the Respondents the dispensing of valid prescriptions extends offered no evidence or argument regarding the 85 Tr. 192, 219, 222, 223, 226, 238. to the pharmacy itself.’’ Holiday CVS, 77 FR length and character of their experience in dispensing controlled substances. ALJ Ex. 24, at 24– 86 The Government has not alleged or proved 62316, 62341 (2012) (citing Medicine 25. Thus, it is unnecessary to determine whether actual knowledge on the part of Moro-Perez or the such evidence would have been relevant to a staff at the Respondent pharmacies that Dr. Aguilar 83 See, e.g., Volusia Wholesale, 69 FR 69409, disposition of the case. See Cadet, 76 FR at 19450 lacked a valid COR at the time the dispensing 69410 (2004). n.3; Krishna-Iyer, 74 FR at 463. events in issue occurred.

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nor the Respondents’ willingness to fill them. 2006). The absence of Dr. Aguilar’s COR is never looked into Dr. Aguilar’s practice or Tr. 17. As acknowledged by Moro-Perez the most glaring of red flags that could and COR status in any way. Tr. 252–54. Instead, during his testimony, during that thirty-four should have been recognized by the the Respondents blithely continued to fill Dr. month period, Farmacia Nueva and Best Respondents upon the exercise of even the Aguilar’s prescriptions—and presumably, the Pharma made no attempt (that was most minimal due diligence. Conclusively pharmacies continued to receive payments. reasonably calculated for success) to resolving such a fundamental red flag was a Tr. 250–52. Thus, it is clear on the present ascertain whether Dr. Aguilar (or apparently mandatory condition precedent to the legal record that even though Dr. Aguilar had any other physician for whom they were dispensing of a controlled substance, and the repeatedly given the professional staff filling controlled substance prescriptions) Respondents’ failure to do so (on multiple working at both Respondent pharmacies had a valid COR. Tr. 194. Moro-Perez occasions) was a clear breach of their reason to suspect his bona fides as a testified that his pharmacy staff assumed the corresponding responsibility under the legitimate controlled substance prescriber, validity of all prescriber CORs if insurance regulations. 21 CFR 1306.04(a). ‘‘It would be none of the Respondents’ personnel was carriers provided notification that the difficult to imagine a duty of a pharmacy inspired to employ even the minimal effort patients were covered and the claims related registrant that is more fundamental to the law that would have been required to check the to the prescription would be paid. Tr. 196. and spirit of the CSA than the obligation to status of his registration. Over and over He indicated that the pharmacies would only ensure that controlled substance again, the Respondents’ pharmacists have had reason to know that a doctor’s COR prescriptions are issued only on the authority rendered their professional judgment that Dr. had expired if, regarding a particular scrip, of those empowered to prescribe by the Aguilar was writing unsupported controlled the insurance company signaled its intent to DEA.’’ Holiday CVS, 77 FR at 62341; see also substance prescriptions that were so decline payment. Tr. 201. At no point during Liddy’s Pharmacy, 76 FR at 48895. Absent sufficiently irregular that they were refused, the hearing did Moro-Perez give any basis to confirmation of a COR, a prescription written yet they did not check into his authority establish that insurance providers would by one without COR authority would beyond ensuring insurance carrier approvals know whether medical practitioners were authorize the routine distribution of for payments. It is a testament to the authorized to prescribe controlled dangerous narcotics on the approval of Respondents’ irresponsibility (and exclusive substances, much less why insurance anyone from the uninformed to the focus on remuneration) that Moro-Perez companies would have a legal or contractual malevolent. The DEA’s Pharmacist’s Manual acknowledged that if the DEA had not duty (or even an inclination) to pass on COR specifically provides that controlled executed its search warrant on November 30, information to dispensing pharmacies. Moro- substance prescriptions may only be issued 2011, Farmacia Nueva would still be filling Perez testified that his pharmacies relied on by a practitioner who is, inter alia, Dr. Aguilar’s (unauthorized) controlled the approvals they received from insurance ‘‘[r]egistered with DEA or exempted from substance prescriptions. Tr. 202–03. providers, but he did not even attempt to registration.’’ DEA, Pharmacist’s Manual § IX The Government’s evidence established describe why such a practice was rational or (2010). that, for thirty-four months, Farmacia Nueva supported by any level of common sense, It is hardly insignificant that more than filled over 140 prescriptions for controlled much less why such a practice could be a serving merely as the owner/president of substances written by Dr. Aguilar on his responsible discharge of the authority of a both pharmacies, Moro-Perez has been a expired COR. Gov’t Ex. 5. Similarly, the registrant. The only notification apparently trained pharmacist since 1999. He Government’s evidence demonstrated that provided by the insurance companies’ acknowledged at the hearing that he had during the same period, Best Pharma filled notifications is that the claim would be received training regarding the lawful 32 controlled substance prescriptions written paid—and that is apparently the point at procedures for handling controlled by Dr. Aguilar. Gov’t Ex. 10. Respondents which these registrants’ interest in the substances. Tr. 194. In addition to the readily clearly violated their ‘‘fundamental’’ duties subject waned. available means for checking COR statuses under the CSA by failing to ensure that Dr. The responsibility for ensuring the outlined by DI Antoine, it is worthy of note Aguilar’s COR was valid. Holiday CVS, 77 FR authority of the practitioner writing the that, with minimal effort, Aguilar’s office at 62341. In so doing, they breached their controlled substance prescription is abjectly could have been contacted or even (in light corresponding responsibilities as pharmacy integral to the pharmacy registrant’s of its close proximity to FN) visited.87 The registrants under Federal law to dispense corresponding responsibility. The Respondent pharmacies knowingly pursued a only lawful prescriptions. Liddy’s Pharmacy, uncontroverted evidence of record course of deliberate ignorance, satisfying 76 FR at 48895. establishes that, as DEA pharmacy themselves in a sort of collective shrug that Thus, in addition to Element 1, the registrants, the Respondents could have if there was ever a problem with a Government’s evidence preponderantly checked the COR status of Dr. Aguilar (and physician’s COR, the insurance company established that the absence of a valid COR all prescribing doctors) by accessing a link on would deny the claim. Tr. 201. Passively is a ‘‘red flag’’ that should have been known the DEA Diversion Web site, by consulting a waiting to receive an insurance carrier claim prior to dispensing (Element 2), and that list of current registrants that is regularly rejection is not a responsible manner to (inasmuch as the deficiency revolved around updated by the Department of Commerce, by discharge the duties of a registrant, and it Dr. Aguilar’s lack of a valid registration) it contacting the local DEA office, or by certainly does not satisfy a registrant’s was not and could not have been adequately contracting with a private company to obligation to ensure the authority of the resolved prior to dispensing controlled perform due diligence in this regard. Tr. 20– issuer of the prescription. It is merely an substances (Element 3). Having established 21. The Respondents’ irresponsible practice effective manner to ensure payment. all three elements, there is no question that of ending their COR inquiry at the moment The practice of relying on insurance carrier each Respondent violated its corresponding an insurance company agrees to remit claim rejections as the principal means of responsibility under the regulations. payment speaks volumes on the subject of due diligence is particularly egregious here. The record of both pharmacies indicates a whether these Respondents should be Moro-Perez testified that both pharmacies clear disregard for following proper legal entrusted with the responsibility of a denied ‘‘many’’ of the controlled substance procedures designed to protect the public controlled substance registrant. That the prescriptions written by Dr. Aguilar based on from the dangers of the unregulated Respondents chose a patently ineffective and a review of the scrips submitted by his dispensing of controlled substances. illogical manner to check COR statuses patients. Tr. 252–53. The pharmacies Furthermore, both pharmacies displayed a cannot absolve them of their responsibility to declined to fill these prescriptions based on lack of motivation to follow through even the ensure this most basic of requirements. The the (repeated) professional judgment of the most basic of procedures, such as verifying Agency has never been, and cannot be, pharmacists that the scrips were invalid. Tr. a prescribing physician’s COR. The persuaded by a policy of ‘‘see no evil, hear 252. Yet, even armed with the knowledge Government’s evidence that the Respondent no evil.’’ Cf. Gonzalez, 76 FR at 63142. Even that Dr. Aguilar was engaged in writing pharmacies continued, for thirty-four in a criminal context regarding prescriptions ‘‘many’’ illegitimate controlled substance months, to recklessly fill Dr. Aguilar’s illegitimately issued, the courts have held prescriptions that could not legally be filled, controlled substance prescriptions when he that a factfinder ‘‘may consider willful Moro-Perez testified that his pharmacies was unregistered and when they had actual blindness as a basis for knowledge.’’ United knowledge that he was writing ‘‘many’’ States v. Katz, 445 F.3d 1023, 1031 (8th Cir. 87 Tr. 250–51. illegitimate prescriptions negatively impacts

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both Factor 2 (experience in dispensing) and the Agency found 89 that Ideal Pharmacy’s November 30, 2011. Gov’t Ex. 5; Resp’t Exs. Factor 4 (compliance with federal controlled failure to maintain accurate records 1, 2. It is uncontroverted that the RX30 substance laws) and militates strongly in constituted an act that rendered its continued system employed at Farmacia Nueva favor of the application denial sought by the registration inconsistent with the public automatically affixes an informational Government.88 interest. Id. at 51416. Taken together, Ideal heading at the top of each copy of a scrip that The Government’s allegations regarding and Terese indicate that, when considering has been scanned into the system. Tr. 263. missing records/poor recordkeeping also recordkeeping violations, the Agency has Both the Government’s version and Farmacia relate to considerations under Factor Four. It coupled consideration of the degree of Nueva’s version contain scrip copies that is beyond argument that accurate and reliable severity of the non-compliance with an display the informational heading and copies 92 records are an obvious bedrock safeguard that analysis of whether the registrant has both that do not. DI Antoine testified that he is essential to ensure the integrity of the acknowledged culpability and demonstrated assembled the Government’s version of Dr. closed regulatory system designed by credible efforts aimed at correction. The Aguilar’s Farmacia Nueva scrips from Congress. See Gonzales v. Raich, 545 U.S. at current state of the Agency’s precedent, thus, material seized at the search warrant 13. ‘‘Recordkeeping is one of the central provides a logical framework upon which the execution and from material forwarded by features of the CSA’s closed system of current evidence can be evaluated. Moro-Perez in response to DEA’s distribution. . . . ‘A registrant’s accurate and DEA regulations provide that ‘‘[e]very Supplemental Information Request. Tr. 23–25. diligent adherence to this obligation is registrant required to keep records pursuant 90 Moro-Perez, for his part, testified that he absolutely essential to protect against the to § 1304.03 shall maintain on a current was able to generate a copy of all but one of diversion of controlled substances.’ ’’ basis a complete and accurate record of each every Aguilar controlled substance Satinder Dang, M.D., 76 FR 51424, 51429 substance . . . imported, received, sold, delivered, exported, or otherwise disposed of prescription scrip through a query of the (2011) (internal punctuation and citations Farmacia Nueva RX30 program. Tr. 203–04, omitted) (quoting Paul H. Volkman, 73 FR by him/her, except that no registrant shall be required to maintain a perpetual inventory.’’ 248; Resp’t Exs. 1, 2. While it strains 30630, 30644 (2008)). There is no question credulity that Moro-Perez would that the maintenance of accurate records by 21 CFR 1304.21(a). The regulations also mandate that ‘‘every . . . record[] required to intentionally hold back material that could registrants is key to DEA’s ability to fulfill its have conceivably cleared up the issue of obligations to regulate controlled substances. be kept under this part must be kept by the registrant and be available, for at least 2 years missing scrips until the hearing process See Volkman, 73 FR at 30644, aff’d, Volkman commenced, the Government (who bears the v. U.S. DEA, 567 F.3d 215, 224 (6th Cir. from the date of such . . . records, for inspection and copying by authorized burden on this issue) presented no testimony 2009) (specifically upholding the DEA or other evidence that would explain why its Administrator’s reliance on recordkeeping employees of the [DEA].’’ Id. § 1304.04(a). Pharmacy registrants, such as the version should be deemed the more complete violations in denying a COR application). Respondents used to be, are required to one. The Government presented no testimony Thus, where established by reliable evidence, maintain separate records of Schedule II from anyone who was present at the search recordkeeping deficiencies may provide a controlled substances, and to maintain warrant execution at Farmacia Nueva. reason—‘‘which is sufficient by itself’’—to records of controlled substances listed in Likewise, instead of calling DFE Gladieux, find that the granting of a registration would Schedules III–V ‘‘either separately from all who extracted the digital information, the be inconsistent with the public interest. Id. other records of the pharmacy or in such Government presented a terse, barebones DEA has also held that non-compliance with 93 form that the information required is readily declaration. Gov’t Ex. 15. recordkeeping obligations can lend retrievable from the ordinary business On the state of the present record, there is ‘‘substantial credence’’ to allegations that a records of the pharmacy.’’ Id. § 1304.04(h). no way to determine which party has registrant is engaged in ‘‘massive diversion.’’ Readily retrievable is defined in the presented the more persuasive set of the Aguilar prescription scrips maintained at Grider Drug #1 & Grider Drug #2, 77 FR regulations as records kept ‘‘in such a Farmacia Nueva. DFE Herrmann, the DEA 44069, 44101 (2012). However, the Agency manner that they can be separated out from digital forensic examiner who analyzed the has also held that where non-egregious all other records in a reasonable time . . . .’’ data pulled from FN’s RX30 program, recordkeeping errors are acknowledged and 21 CFR 1300.01(b). acknowledged the possibility of a ‘‘margin for remedied promptly, revocation may not On this record, the Government’s error,’’ 94 but testified that she was able to always be required. Terese, 76 FR at 46848. allegations regarding alleged infirmities in create a duplicate of the Farmacia Nueva In Terese, substantial evidence established the Respondents’ recordkeeping are simply that the registrant had failed to conduct an computer as it existed on the day the data not supported by the presentation it made at was extracted from it. Tr. 141–42. The initial inventory as required under 21 CFR the hearing. It is uncontroverted that both 1304.11(b), failed to execute a power of Government initially alleged that Best pharmacies used a computer program called Pharma and Farmacia Nueva did not attorney form as required by 21 CFR ‘‘RX30’’ to manage and record prescriptions 1305.05(a), and failed to include dates on maintain controlled substance scrips and corresponding dispenses. Tr. 234, 244. authorized by Dr. Aguilar, but withdrew and/ DEA Forms 222 as required by 21 CFR While DI Antoine testified that, consistent 1305.13(e). Id. In declining to revoke Terese’s or did not proceed on all of the Best Pharma with the Government’s allegations, there scrips 95 and many of the Farmacia Nueva registration, the Agency, emphasizing that were missing records from the computer the registrant had accepted responsibility for scrips when the Respondents pointed out in systems of both pharmacies,91 the a prehearing motion 96 that the noticed scrips its violations and had instituted corrective Government only offered exhibits relating to actions, determined that, under the included non-controlled substances. the missing records at Farmacia Nueva. Gov’t Farmacia Nueva was able to produce circumstances, the three recordkeeping Exs. 5–7. violations did not render its continued purported copies of scrips for all but two Exhibits supplied by both the Government (H00751567 & 00805523) of the (reduced registration inconsistent with the public and Farmacia Nueva purport to constitute number of) Aguilar scrips that the interest. Id. at 46848. In Ideal Pharmacy copies of all controlled substance Government alleged as missing.97 Resp’t Exs. Care, Inc., an audit of the registrant’s records prescription scrips filled for Dr. Aguilar’s showed a shortage of 150,000 dosage units of patients between January 31, 2009 to 92 hydrocodone, 83,000 dosage units of Resp’t Ex. 2, at 143–44; Gov’t Ex. 5, at 1–6. 93 alprazolam, and 1.6 million milliliters of At the hearing, Government counsel 89 represented that Gladieux was local and available, promethazine with codeine. 76 FR 51415, The registrant in Ideal waived its right to a hearing and presented no evidence to the Agency but not called as a witness because he felt that the 51416 (2011). However, in contrast to Terese, on its behalf. Ideal, 76 FR at 51415. declaration was sufficient. Tr. 135–37. 90 Section 1304.03(a) provides that ‘‘[e]ach 94 Tr. 155. 88 In view of the lengthy (34-month) period of registrant shall maintain the records and 95 In its closing brief, the Government made no time during which the scrips of (unregistered) Dr. inventories and shall file the reports required by mention of the Best Pharma recordkeeping Aguilar were filled, it is not necessary to discern this part, except as exempted by this section.’’ 21 allegations. ALJ Ex. 24, at 25. exactly when the duty to re-check COR credentials CFR 1304.03(a). The record contains no contention 96 ALJ Ex. 10. emerges. A more precise divination of that issue that any of the § 1304.03 exemptions apply in this 97 So much of the Government’s evidence in this may require resolution on different facts in another case. regard was withdrawn or readily contradicted by case. 91 Tr. 23–25, 96. Continued

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1–2, 4. While admittedly true that Farmacia submitted COR applications that bear Even if the tacit admissions of wrongdoing by Nueva did little to explain the origin, material falsifications 99 and have committed Moro-Perez were embraced as sufficient structure, or reliability of its own scrip- acts that are inconsistent with the public acceptance of responsibility to carry the related exhibits, the Government produced interest. 21 U.S.C. 823(f). Accordingly, the pharmacies’ burden (a dubious proposition), no credible challenge to Farmacia Nueva’s Government has sustained its prima facie the showing of remedial measures is too purported scrip copies and declined to burden to establish that the Respondents’ weak to carry the day. In like manner, the challenge their admission into evidence. Tr. COR applications should be denied. Hence, intentional decision by an experienced 249, 257, 264–65. Even though he was not under established Agency precedent, the registrant to have his staff substitute unavailable, DFE Gladieux, the technician burden is shifted to the Respondents to insurance approvals for COR checks over the who imaged the Farmacia Nueva computer, demonstrate that each can be entrusted with course of over two years is bad enough, but was not called as a witness to explain the a DEA registration. when coupled with the actual knowledge by data extraction process or defend its integrity ‘‘[T]o rebut the Government’s prima facie the Respondent pharmacies that Dr. Aguilar and completeness. It is also worth noting case, [the Respondents are] required not only had written ‘‘many’’ bad controlled substance here that Moro-Perez never explained why, if to accept responsibility for [the established] prescriptions, it elevates the level of the FN scrips in question did exist and were misconduct, but also to demonstrate what egregiousness to a point where it militates available from the outset, they were not corrective measures [have been] undertaken powerfully in favor of denial of the CORs. forwarded to the Government with his to prevent the re-occurrence of similar acts.’’ While true that the Government’s failure to Response to Government Administrative Hassman, 75 FR at 8236; see Hoxie, 419 F.3d sustain its recordkeeping allegations Request for Information,98 wherein he at 483; Lynch, 75 FR at 78754 (holding that substantially diminishes the gravity to be provided the assurance that ‘‘all of the a respondent’s attempts to minimize attached to the 2008 Letter of Admonition,101 requested prescriptions’’ were included—a misconduct undermined acceptance of it is still relevant that Moro-Perez had been position he re-affirmed during his testimony. responsibility); Mathew, 75 FR at 66140, counseled once by the Agency to exercise an Tr. 206–08. Still, the Government presented 66145, 66148; Aycock, 74 FR at 17543; appropriate level of care, and that the no evidence whatsoever in support of its BP Abbadessa, 74 FR at 10078; Krishna-Iyer, 74 Agency’s warning did not inspire sufficient recordkeeping allegations, and, with respect FR at 463; Medicine Shoppe, 73 FR at 387. vigilance to check the COR status of a to Farmacia Nueva, its evidence was The acceptance of responsibility is a prescribing physician who was engaged in confusing and wholly unpersuasive. It would condition precedent for the Respondents to writing ‘‘many’’ bad controlled substance be virtually impossible on the present record prevail once the Government has established prescriptions. To grant registrations in the to assign one party’s batch of copied, its prima facie case. Mathew, 75 FR at 66148. face of such conduct would be a statement purported prescriptions more credibility than This feature of the Agency’s interpretation of to the regulated community of pharmacy the other party’s batch in any manner that its statutory mandate on the exercise of its registrants that employing a patently infirm could be logically defended on appeal. In this discretionary function under the CSA has system of COR checks for prescribing mutually confusing contest of admitted been sustained on review. Mackay, 664 F.3d physicians can serve as an effective shield to evidence, it was the Government that bore at 822. In determining whether and to what the consequences of failure to exercise due the burden to establish the violations of the extent a sanction, such as denial of an care. Thus, the Agency’s interests in laws it had alleged. Regarding the application, is appropriate, consideration deterrence also weigh in favor of denial of recordkeeping allegations, its burden was must be given to both the egregiousness of the requested registrations. simply not carried. the offenses established by the Government’s In their closing brief, the Respondents Accordingly, to the extent the Government evidence and the Agency’s interest in both argue that mitigation is found in: (1) what alleged that the Respondents violated 21 specific and general deterrence. Ruben, 78 FR they posit as a relatively modest number of U.S.C. 827(b)(1) and 21 CFR 1304.04 by at 38364, 38385. dispensed prescriptions issued by failing to maintain controlled substance The issue of acceptance of responsibility (unregistered) Dr. Aguilar; (2) ‘‘minimal’’ scrips authorized by Dr. Aguilar, those presents something of a mixed bag for the pecuniary gain to the registrants that resulted allegations are not sustained. Respondents. Moro-Perez, the owner/ in filling Dr. Aguilar’s scrips; (3) their That said, the Respondents’ actions in president of both Respondent pharmacies, continuing representation that the filling Dr. Aguilar’s controlled substance spoke on their behalf and, through counsel, Respondents’ pharmacists actually turned prescriptions over the course of over two and represented their interests. As discussed in down ‘‘many’’ of Dr. Aguilar’s controlled more detail, supra, the pharmacies are a half years without checking his (expired) substance prescription that were illegitimate; responsible for his actions. See EZRX, 69 FR COR status in any logical manner, even (4) the fact that forty employees working at at 63181; Plaza Pharmacy, 53 FR at 36911. though pharmacy personnel had rejected the Respondent pharmacies stand to lose Moro-Perez acknowledged that he and his ‘‘many’’ of his prescriptions as illegitimate, their jobs upon an unfavorable decision by staff substituted what was essentially balance powerfully in favor of denying both the Agency on the applications; and (5) that affirmative payment notification by COR applications under Factors Two and the Government offered no evidence that any insurance carriers in place of their Four. of the scrips in question were for other than responsibility to ensure that prescribing a legitimate medical purpose. ALJ Ex. 24, at Recommendation physicians, such as Dr. Aguilar, have valid 20–21, 26. None of these arguments, all but CORs. The representations rendered by Based on the foregoing, the Government one of which are offered under an apparent has established that the Respondents have Moro-Perez and echoed by Farmacia Nueva PIC Nelson Vale regarding their intent to be theory that ‘‘it could have been worse,’’ are more careful and purchase computer screens persuasive on the present record. evidence offered by the Respondent that it would While the Respondents characterize the be difficult to assign persuasive weight to even the in the future were too amorphous to provide evidence sufficient to engender enough number of the Dr. Aguilar scrips during the two instances where the Respondent did not relevant period as modest in comparison to produce corresponding scrips. Stated differently, confidence that the pharmacies should be the Government’s evidentiary presentation in this entrusted with CORs in the future. The the pharmacies’ other business, their regard was simply too shaky and shifting to merit Farmacia Nueva and Best Pharma PICs told numbers (even if assumed as accurate) do not sufficient confidence to sustain the allegations. But DI Antoine that, as recently as two weeks further their cause. These dispensing events even if the Government’s evidence was deemed prior to this hearing, no written controlled were executed during a time when the sufficiently reliable to believe that two Aguilar substance handling procedures had been pharmacies had no rational system for scrips were not maintained in accordance with the promulgated by either pharmacy.100 Tr. 107. checking the COR status of any of the regulations, Agency precedent provides support for prescribers whose scrips they were filling. To the proposition that, standing alone, these two compare the Dr. Aguilar scrips with the missing scrips would not have been a sufficient 99 21 U.S.C. 824(a)(1). scrips of other physicians while the violation to merit the application denial the 100 While Moro-Perez made a fleeting reference to Government seeks. See Terese, 76 FR at 46848 a ‘‘continuing education’’ that he participated in pharmacy was not checking anyone’s COR (determining that three recordkeeping violations after the execution of the search warrant (Tr. 203), that were acknowledged and timely corrected were there was no evidence as to what the class covered 101 Gov’t Ex. 3. Indeed, none of the deficiencies insufficient to warrant COR revocation). or whether it was in any way related to controlled cited in the Letter of Admonition are the basis of 98 Gov’t Ex. 4, at 2–3. substance diversion issues. any allegation in these proceedings.

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status confounds logic. Stated differently, the precedent that normal hardships to the DEPARTMENT OF JUSTICE level of care exercised on Dr. Aguilar’s scrips practitioner, and even the surrounding was the same as every other controlled community, which are attendant upon the Drug Enforcement Administration substance scrip issued during the relevant denial of a registration, are not a relevant period. The Agency has revoked based on as consideration in determining whether status [Docket No. 14–27] few as two acts of intentional diversion, and as a COR registrant is in the public interest it held that one such act can be sufficient. within the meaning of the CSA. Cheek, 76 FR Maryanne Phillips-Elias, M.D.; Decision MacKay, 75 FR at 4997; Krishna-Iyer, 74 FR at 66972–73; Owens, 74 FR at 36757; and Order at 463. While the dispensing acts proven on Abbadessa, 74 FR at 10078. this record may not have been intentional, On October 23, 2014, Administrative Finally, insofar as the Respondents point to Law Judge (ALJ) Christopher McNeil there were certainly well more than one or the fact that the Government’s theory of the issued the attached Recommended two. case and its evidence have never relied on Similarly, that the Respondents argue the absence of a legitimate medical purpose Decision. Therein, the ALJ found that it (without specific figures) that they have (LMP) for any of the scrips in question, it is was undisputed that Respondent’s made ‘‘minimal’’ pecuniary gain due to their certainly true that the Agency has looked at Nevada Controlled Substance lack of care helps their respective causes not the LMP issue where prescriptions were Registration had been revoked and that at all. A reduced profit margin is no more issued by a prescriber who lacked proper she does not possess authority to persuasive evidence in the context of a registrant pharmacy as it would be in the authorization. Kam, 78 FR at 62698. dispense controlled substances in case of a street dealer in illicit drugs. The However, that the Government has advanced Nevada, the State in which she holds focus is on maintaining a closed regulatory no LMP evidence does not mitigate the her DEA registration. R.D. at 6; see also system that protects the public from the evidence that was received regarding the id. at 2. The ALJ thus concluded that unlawful distribution of controlled Respondents’ breach in their respective Respondent is no longer a practitioner substances. Gonzales, 545 U.S. at 13. A duties of due care in ensuring that controlled within the meaning of the Controlled registrant’s voluntary decision to abandon substance prescriptions were authorized by a Substances Act and is therefore not practitioner with a valid COR. the most basic of its registrant obligations entitled to be registered. He therefore Regarding the material false should not result in any profit. Further, as is recommended that I ‘‘deny true with the Respondents’ argument misrepresentations intentionally placed into regarding the relative percentage of scrips the COR applications, Moro-Perez doggedly Respondent’s application for a DEA that can be attributed to Dr. Aguilar, in an adhered to his illogical position that he was Certificate of Registration.’’ R.D. at 9. environment where no serious COR checking reasonable in representing on the COR There is, however, no evidence that was employed, there is no basis in reason for applications that neither pharmacy had ever an application is currently pending evaluating the money Moro-Perez’s surrendered a registration for cause. By before the Agency. Rather, the pharmacies made from prescriptions Moro-Perez’s intractable logic, the dismissal Government seeks the revocation of authorized by Dr. Aguilar as compared to of an indictment against him (not either Respondent’s registration, which does those by other practitioners. Who knows pharmacy) that occurred after the for-cause not expire until March 31, 2017, and which of the issuing prescribers were surrender of Best Pharma’s COR, but before authorizes her to dispense controlled actually registered? Hence, that the the for-cause surrender of Farmacia Nueva’s ‘‘pecuniary benefits gained’’ from dispensing substances in schedules II through V, at COR, rendered both surrenders no longer ‘‘for registered premises located in controlled substances on Dr. Aguilar’s scrips cause.’’ Moro-Perez is an experienced COR ‘‘is minimal’’ 102 means nothing and mitigates holder and an educated, veteran pharmacist. Henderson, Nevada. Order to Show nothing. His insistence that his false response to an Cause, at 1. As discussed in detail, supra, the application query regarding whether each Pursuant to 21 U.S.C. 824(a)(3), ‘‘[a] Respondents argument that they turned pharmacy had ever surrendered a COR for registration . . . to . . . dispense a down ‘‘many’’ of Dr. Aguilar’s prescriptions cause was some sort of reasonable controlled substance . . . may be they thought to be illegitimate actually misunderstanding is simply not credible and suspended or revoked by the Attorney exacerbates the pharmacies’ positions. defeats the Respondents’ efforts to meet the General upon a finding that the Turning down ‘‘many’’ prescriptions from Dr. Government’s case. The false registrant . . . has had [her] State Aguilar that pharmacists determined to be misrepresentation regarding the errant denial illegitimate should have caused increased license or registration suspended, of the Respondents’ prior surrenders for circumspection about dispensing on revoked, or denied by competent State cause are sufficiently egregious on their face Aguilar’s scrips. Instead, even by their own authority and is no longer authorized by to warrant sanction, and the denial of the account, the pharmacies identified Dr. State law to engage in the . . . Respondents’ applications here serve the Aguilar as a problematic prescriber, never dispensing of controlled substances.’’ Agency’s interest in deterring false checked his COR status, and kept dispensing statements on the applications that it This Agency has further held that many of the prescriptions he authorized. depends upon in its decisionmaking. notwithstanding that this provision In their closing brief, the Respondents ask The Respondents have, thus, failed to rebut grants the Agency authority to suspend that, in making its decision on the COR the Government’s prima facie case regarding or revoke a registration, other provisions applications, the Agency consider that ‘‘[t]here are . . . more than 40 employees either material falsification of their of the Controlled Substances Act ‘‘make among two pharmacies whose welfare applications or a balancing of the public plain that a practitioner can neither depend on their jobs at the pharmacies [and interest factors. Further, consideration of the obtain nor maintain a DEA registration that in] small towns like San Sebastian and egregiousness of the offenses, coupled with unless the practitioner currently has Moca in Puerto Rico, this means a lot.’’ ALJ the Agency’s interest in both specific authority under state law to handle Ex. 24, at 21 (internal transcript citations deterrence regarding these pharmacies, and controlled substances.’’ James L. omitted). Even setting aside for a moment general deterrence among the regulated community, supports the denial of both COR Hooper, 76 FR 71371, 71372 (2011), pet. Moro-Perez’s testimony that controlled for rev. denied, Hooper v. Holder, 481 F. substances account for only 10–15% of the applications. Accordingly, the Respondents’ respective applications for DEA Certificates App’x 826 (4th Cir. 2012). prescription medications dispensed at each These provisions include section of the Respondent pharmacies,103 any blame of Registration should be DENIED. 102(21), which defines the term for the lost jobs must properly be laid at the Dated: October 24, 2013. ‘‘practitioner’’ to ‘‘mean[ ] a physician feet of the Respondents themselves, and s/JOHN J. MULROONEY, II, Moro-Perez in particular. It is settled Agency . . . licensed, registered, or otherwise Chief Administrative Law Judge. permitted, by . . . the jurisdiction in 102 ALJ Ex. 24, at 21. [FR Doc. 2015–12043 Filed 5–18–15; 8:45 am] which [s]he practices . . . to distribute, 103 Tr. 244–45. BILLING CODE 4410–09–P dispense, [or] administer . . . a

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controlled substance in the course of regulations provide that she is entitled RECOMMENDED RULING, FINDINGS professional practice,’’ 21 U.S.C. to a hearing, Resp. Reply at 3; OF FACT, CONCLUSIONS OF LAW, 802(21), as well as section 303(f), which ‘‘summary judgment has been used for AND DECISION OF THE directs that ‘‘[t]he Attorney General more than 100 years to resolve legal ADMINISTRATIVE LAW JUDGE shall register practitioners . . . to ‘actions in which there is no genuine Nature of the Case and Procedural dispense . . . controlled substances issue as to any material fact’ and has History . . . if the applicant is authorized to never been deemed to violate Due dispense . . . controlled substances Process.’’ Ramsey, 76 FR at 20036 Administrative Law Judge under the laws of the State in which (citing Fed. R. Civ. P. 56 (Advisory Christopher B. McNeil. Maryanne [s]he practices.’’ Id. § 823(f). Based on Committee Notes—1937 Adoption) and Phillips-Elias, M.D., the respondent in these provisions, the Agency has long Codd v. Velger, 429 U.S. 624, 627 this case, is registered with the DEA as a practitioner in Schedules II through V held that revocation is warranted even (1977)). Respondent was provided with where a state order has summarily under Drug Enforcement Administration the opportunity to dispute the material suspended a practitioner’s controlled (DEA) certificate registration number fact which is dispositive of the substances authority and the state FP2501648 at 9065 S. Peco Rd., Ste. 250, agency’s order remains subject to Government’s allegation that she lacks Henderson, NV 89074.1 The registration challenge in either administrative or authority to dispense controlled number expires by its own terms on judicial proceedings.1 See Gary Alfred substances in the State in which she is March 31, 2017.2 registered and therefore cannot Shearer, 78 FR 19009 (2013); On September 17, 2014, the Deputy Carmencita E. Gallora, 60 FR 47967 remained registered. I thus reject her Administrator of the Drug Enforcement (1995). contention that the use of summary Administration, Office of Diversion Respondent argues that she ‘‘should disposition denied her fundamental Control, filed an Order to Show Cause be given a hearing to present evidence fairness. as to why the DEA should not revoke to refute the legitimacy of the Accordingly, for reasons explained her current certificate of registration, revocation’’ of her state registration by above and with the caveat that there is deny any applications for renewal or the Nevada Pharmacy Board. no application pending before the modification, and deny any application Respondent’s Reply to the Govt.’s Mot. Agency, I adopt the ALJ’s factual finding for any other DEA registration pursuant for Summary Judgment, at 2. According that Respondent’s Nevada controlled to 21 U.S.C. 823(f) and 21 U.S.C. to Respondent, the Nevada Board’s substance registration has been revoked 824(a)(3).3 As grounds for revocation, Order is invalid ‘‘because the Board and therefore she does not possess the Government alleges that Respondent never identified the specific grounds for authority under Nevada law to dispense does not have authority to handle which [her] license should be revoked controlled substances. I further adopt controlled substances in Nevada, the in Nevada.’’ Id. at 3. the ALJ’s legal conclusion that State in which Respondent is registered Respondent thus seeks to collaterally with the DEA.4 attack the Nevada Board’s Order. Respondent is no longer a practitioner within the meaning of the CSA and is On September 26, 2014, Respondent, However, ‘‘‘DEA has repeatedly held through her Attorneys, Ashley K. that a registrant cannot collaterally therefore not entitled to be registered. However, because there is no Kagasoff, Esq., and Michael Khouri, attack the results of a state criminal or 5 application currently pending before the Esq., filed a timely request for hearing. administrative proceeding in a Respondent does not dispute that her Agency, I do not adopt those portions of proceeding brought under section 304 controlled substance registration was his opinion which discuss whether [21 U.S.C. 824] of the CSA.’’’ Calvin revoked by the Nevada State Board of Ramsey, 76 FR 20034, 20036 (2011) Respondent’s application should be Pharmacy.6 Instead, Respondent asserts (quoting Hicham K. Riba, 73 FR 75773, granted or denied, including his that the Nevada State Board of 75774 (2008) (other citations omitted)); Recommendation that I deny her Pharmacy acted on grounds that did not see also Shahid Musud Siddiqui, 61 FR application. Instead, for reasons warrant discipline and that the Board’s 14818 (1996); Robert A. Leslie, 60 FR explained above, I will order that decision was arbitrary.7 Respondent has 14004 (1995). Respondent must Respondent’s registration be revoked. a writ, Maryanne Phillips v. Nevada therefore seek relief from the State 8 Order State Board of Pharmacy, pending in Board’s Order in those administrative the First Judicial Court of Carson City and judicial forums provided by the Pursuant to the authority vested in me County, Nevada to set aside the decision State. Her various contentions as to the by 21 U.S.C. 824(a) and 28 CFR 0.100(b) to revoke Respondent’s registration.9 validity of the Nevada Pharmacy I order that DEA Certificate of Respondent asks me to delay any Board’s order are therefore not material Registration FP2501648 issued to hearing until the writ is resolved.10 to this Agency’s resolution of whether Alternatively, if the delay is not granted, she is entitled to maintain her DEA Maryanne Phillips-Elias be, and it hereby is, revoked. This Order is Respondent expresses her wish to registration. continue with the hearing as planned.11 As for her argument that the Agency’s effectively immediately. use of summary disposition to revoke Dated: May 1, 2015 1 her DEA registration has denied her Order to Show Cause dated Sept. 17, 2014 at 1. Michele M. Leonhart, 2 Id. ‘‘fundamental fairness’’ because DEA Administrator. 3 Id. 4 Id. 1 I thus also reject Respondent’s contention that Brian Bayly, Esq., for the Government. 5 Respondent’s Request for Hearing dated Sept. because she ‘‘has not acted [in a manner] Michael Khouri, Esq., and Ashley K. 23, 2014 at 1, received by DEA Sept. 26, 2014. inconsistent with [the] public interest as laid out 6 Id. in’’ section 823(f), ‘‘DEA has discretion to carve out Kagasoff, Esq., for the Respondent. 7 Id. an exception in this case’’ to the CSA’s requirement 8 that she possess state authority to hold a DEA Case No. 14–OC–00064. registration. Resp. Reply, at 4. As explained above, 9 Respondent’s Request for Hearing at 1. this is a requirement imposed by statute which DEA 10 Id. has no authority to waive. 11 Id.

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I received the Government’s Motion registration.20 Unless from the pleadings pursuant to 21 U.S.C. 824(a)(3) and 21 for Summary Judgment on October 8, now before me there is a material issue U.S.C. 823(f).28 2014, with proof of service upon regarding Respondent’s authority to Respondent believes that she should Respondent, accompanied by handle controlled substances in Nevada, be given a hearing to present evidence supporting documentation.12 In my the application must be denied to refute the legitimacy of the revocation Order of September 30, 2014, I directed summarily, without a hearing. following the resolution of Respondent’s writ to demonstrate that the Nevada the Government to provide evidence to Respondent’s Contentions support the allegation that Respondent State Board of Pharmacy relied on lacks state authority to handle In Respondent’s Reply to the Motion insufficient grounds to revoke her state 29 controlled substances.13 The factual for Summary Judgment, Respondent controlled substance registration. never disputes the Government’s premise relied upon by the Government However, the case before me is contention that she is not currently in support of its motion is that presented under a grant of authority to licensed by the State of Nevada to Respondent does not have a controlled recommend that the Administrator dispense controlled substances.21 either continue or revoke Respondent’s substance registration issued by the Instead, Respondent asserts three legal Certificate of Registration for controlled Nevada State Board of Pharmacy, the arguments. Respondent’s first legal substances. Pursuant to 21 U.S.C. 823(f), state in which Respondent is argument is that Respondent should be 14 the DEA may grant such an application registered. Additionally, in the same given a hearing to present evidence to only to a ‘‘practitioner.’’ Under 21 Order, I provided Respondent the refute the legitimacy of the revocation.22 U.S.C. 802(21), a ‘‘practitioner’’ must be opportunity to respond to the Respondent states her belief that the ‘‘licensed, registered, or otherwise Government’s Motion for Summary matter should be determined following permitted, by the United States or the 15 Judgment. That response was due the resolution of Respondent’s writ and jurisdiction in which he practices or seven business days after service of the that the Nevada State Board of does research, to distribute [or] dispense Government’s motion on opposing Pharmacy relied on insufficient grounds . . . controlled substance[s.]’’ Given this parties.16 On October 17, 2014, I to revoke her state controlled substance statutory language, the DEA received Respondent’s timely registration.23 Respondent’s second Administrator does not have the response.17 The Government exercised argument is that she has been denied authority under the Controlled its right to reply to the response and fundamental fairness by the DEA.24 Substances Act to grant a registration to submitted a reply on October 22, Respondent writes that ‘‘it does not a practitioner if that practitioner is not 2014.18 Drawing from the motion and make any sense that Respondent is authorized to dispense controlled briefs submitted, I find as follows: given the right to a hearing only to get substances.30 denied one, once the request is The fact that Respondent is currently Issue made.’’ 25 Finally, Respondent asserts in the process of appealing what she The substantial issue raised by the that the DEA has discretion to do what views as an unjust decision of the Government rests on an undisputed fact. is in the best interest of promoting the Nevada State Board of Pharmacy does 26 The Government asserts that public interest. After stating the five not change this outcome. As the Respondent’s application must be public interest factors provided by 21 Government notes, the assertion that she summarily denied because Respondent U.S.C. 823(f), Respondent declares that might prevail in overturning the Board’s does not have a controlled substance allowing her to retain her license is not revocation order is ‘‘highly 27 speculative.’’ 31 Even if Respondent was registration issued by the state in which inconsistent with the public interest. very likely to succeed on appeal, she intends to practice.19 Under DEA Scope of Authority summary disposition is still precedent, a practitioner’s DEA On September 17, 2014, the Deputy appropriate. As the Government notes Certificate of Registration for controlled Administrator of the Drug Enforcement in its Reply in Support of its Motion for substances must be summarily revoked Administration, Office of Diversion Summary Judgment, ‘‘[a]ll that matters if the applicant is not authorized to Control, filed an Order to Show Cause is that Respondent lacks state authority handle controlled substances in the proposing to deny the application to dispense or distribute controlled state in which she maintains DEA substances.’’ 32 Under no circumstances 20 See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also is the DEA authorized to provide a 12 Government’s Motion for Summary Judgment House of Medicine, 79 FR 4959, 4961 (DEA 2014); doctor, such as Respondent, the ability dated Oct. 7, 2014 at 1–18, received by DEA Oct. Deanwood Pharmacy, 68 FR 41662–01 (DEA July 8, 2014. 14, 2003); Wayne D. Longmore, M.D., 77 FR 67669– to dispense controlled substances when 13 Order for Briefing on Allegations Concerning 02 (DEA November 13, 2012); Alan H. Olefsky, the doctor does not possess their state Respondent’s Lack of State Authority dated Sept. M.D., 72 FR 42127–01 (DEA August 1, 2007); Layfe controlled substance registration. This 30, 2014 at 1. Robert Anthony, M.D., 67 FR 15811 (DEA May 20, limitation is not without meaning. In 14 2002); George Thomas, PA–C, 64 FR 15811–02 Government’s Motion for Summary Judgment the first subchapter of the Controlled at 1–3. (DEA April 1, 1999); Shahid Musud Siddiqui, M.D., 15 Order for Briefing on Allegations Concerning 61 FR 14818–02 (DEA April 4, 1996); Michael D. Substances Act (CSA), 21 U.S.C. 801, Respondent’s Lack of State Authority at 2. Lawton, M.D., 59 FR 17792–01 (DEA April 14, 1994); Abraham A. Chaplan, M.D., 57 FR 55280– 16 Id. 28 Order to Show Cause at 1. 03 (DEA November 24, 1992). See also Bio 17 29 Reply to the Government’s Motion for Respondent Maryanne Phillips-Elias, M.D. Diagnosis Int’l, 78 FR 39327–03, 39331 (DEA July Summary Judgment at 2–3. Reply to the Government’s Motion for Summary 1, 2013) (distinguishing distributor applicants from 30 Judgment and Declaration of Ashley K. Kagasoff in other ‘‘practitioners’’ in the context of summary See Abraham A. Chaplan, M.D., 57 FR 55280– Support Thereof dated Oct. 16, 2014 at 1. Note that disposition analysis). 03, 55280 (DEA November 24, 1992), and cases the fax was received at 6:00pm E.D.T. on October cited therein. In Chaplan, DEA Administrator 21 Reply to the Government’s Motion for 16, 2014. As the document was received after Robert C. Bonner adopts the ALJ’s opinion that ‘‘the Summary Judgment at 2. normal business hours, the document is treated as DEA lacks statutory power to register a practitioner 22 if it was received on October 17, 2014. Regardless, Id. unless the practitioner holds state authority to the response was timely received. 23 Id. at 2–3. handle controlled substances.’’ Id. 18 Government’s Reply in Support of its Motion 24 Id. at 3. 31 Government’s Motion for Summary Judgment to Summary Judgment dated Oct. 22, 2014 at 1. 25 Id. at 3. 19 Government’s Motion for Summary Judgment 26 Id. at 4. 32 Government’s Reply in Support of its Motion at 1–2. 27 Id. to Summary Judgment at 2.

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Congress acknowledged that controlled lose her DEA certificate of registration.38 agreed, a plenary, adversary substances when utilized improperly Quoting the Declaration of Ashley administrative proceeding involving ‘‘have a substantial and detrimental Kagasoff,39 Respondent cites statements evidence, cross-examination of effect on the health and general welfare such as that she has never been witnesses, etc., is not obligatory—even of the American people.’’ 33 Mandating convicted of a federal or state crime to though a pertinent statute prescribes a that a practitioner possess state support the notion that not revoking her hearing. In such situations, the rationale authority before providing a practitioner DEA COR is consistent with the public is that Congress does not intend the privilege to handle controlled interest.40 Such statements made by administrative agencies to perform substances lowers the risk of diversion Respondent are unpersuasive. If meaningless tasks (citations omitted).43 by illegitimate or unqualified Respondent is successful in her writ and In this context, I am further guided by practitioners. her state license to dispense controlled prior decisions before the DEA Respondent also alleges that she has substances is restored, she is welcome involving certificate holders who lacked been denied fundamental fairness by the to immediately apply for a new DEA licenses to distribute or dispense DEA.34 Specifically, Respondent cites certificate of registration. If controlled substances. On the issue of that fact that the Government’s Order to Respondent’s application for a new whether an evidentiary hearing is Show Cause provides her notice of the registration is opposed by the DEA and required, ‘‘it is well settled that when opportunity of a hearing to show cause Respondent exercises her right to a there is no question of material fact why the DEA should not revoke her hearing, it is at that time—not before involved, there is no need for a plenary, DEA certificate of registration, but later that time—that a DEA ALJ will hear administrative hearing.’’ 44 Under this denies her a hearing.35 Although evidence from both Respondent and the guidance, the Government’s motion Respondent may believe it is unfair that Government as to whether the must be sustained unless a material fact the DEA denies her a hearing after registration is consistent with the public question has been presented. issuing an Order to Show Cause, interest. The sole determinative fact now Respondent has failed to show that any before me is that Respondent lacks a disputed material fact is involved Facts Nevada controlled substance regarding her state controlled substance Given this body of law, the material registration. In order for a doctor to registration. If Respondent through her fact here, indeed the sole fact of receive a DEA registration authorizing Reply to Government’s Motion for consequence, is whether Respondent is her to dispense controlled substances Summary Judgment demonstrated that authorized by the State of Nevada to under 21 U.S.C. 823(f), she must meet there was a dispute as to the material dispense controlled substances. Where, the definition of ‘‘practitioner’’ as found fact of whether her state controlled as here, no material fact is in dispute, in the Controlled Substances Act.45 substance registration was revoked, I there is no need for an evidentiary Such a person must be ‘‘licensed, would not have dismissed this case hearing and summary disposition is registered, or otherwise permitted by without a comprehensive hearing. appropriate.41 The sole question of fact . . . the jurisdiction in which he However, the inability for the DEA to before me can be addressed, and has practices . . . to distribute, dispense, grant Respondent a DEA certificate of been addressed, by the pleadings [or] administer . . . a controlled registration without a valid state submitted to me by the parties. Our substance in the course of professional controlled substance registration record includes no dispute regarding the practice.’’ 46 Delegating to the Attorney prevents further consideration of this Government’s contention that the General the authority to determine who matter. authority of Dr. Phillips-Elias to may or may not be registered to perform Respondent’s final argument is that dispense controlled substances in these duties, Congress permitted such the DEA has discretion to act in the Nevada was revoked by the Nevada registration only to ‘‘practitioners’’ as public interest to not revoke State Board of Pharmacy on June 13, defined by the Controlled Substances Respondent’s federal certificate of 2014.42 The reasons for the revocation Act.47 registration.36 In her Reply to are not material, given the statutory As cited by the Government in its Government’s Motion for Summary language set forth above. Motion for Summary Judgment, there is Judgment, Respondent correctly notes substantial authority both through Analysis, Findings of Fact and that to determine whether a DEA agency precedent and through decisions Conclusions of Law certificate of registration is in the public of courts in review of that precedent, interest, a DEA ALJ must consider the In determining whether to grant the holding that a doctor’s DEA controlled factors enumerated under 21 U.S.C. Government’s Motion for Summary substance registration is dependent 823(f).37 Respondent proceeds to apply Disposition, I am required to apply the upon the doctor having a state license 48 the factors to her specific situation to principle of law that holds such a to dispense controlled substances. make the argument that she should not motion may be granted in an Under the doctrine before me, the administrative proceeding if no material Government meets its burden of 33 Controlled Substances Act. 21 U.S.C. 801(1). question of fact exists: 1970. It is settled law that when no fact 43 NLRB v. International Assoc. of Bridge, 549 34 F.2d 634, 638 (9th Cir. 1977) (quoting United States Reply to the Government’s Motion for question is involved or the facts are Summary Judgment at 3. Respondent’s allegation v. Consolidated Mines & Smelting Co., Ltd., 455 does not directly allege a violation of her F.2d 432, 453 (9th Cir. 1971)). constitutional right to due process. Respondent’s 38 Reply to the Government’s Motion for 44 See Michael G. Dolin, M.D., 65 FR 5661 (DEA failure to make a conspicuous claim regarding due Summary Judgment at 4–5. February 4, 2000); Jesus R. Juarez, M.D., 62 FR process has led to a waiver of this constitutional 39 See Declaration of Ashley K. Kagasoff in 14945 (DEA March 28, 1997); see also Philip E. claim. However, if Respondent chooses to submit Support Thereof. Kirk, M.D., 48 FR 32887 (DEA July 19, 1983), aff’d exceptions to this order referencing her 40 Reply to the Government’s Motion for sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir. constitutional right to due process, she may succeed Summary Judgment at 4. 1984). in preserving the issue for appeal. 41 See Michael G. Dolin, M.D., 65 FR 5661 (DEA 45 21 U.S.C. 802(21). 35 Id. at 3; Order to Show Cause at 1. February 4, 2000); see also Philip E. Kirk, M.D., 48 46 Id. 36 Reply to the Government’s Motion for FR 32887 (DEA July 19, 1983), aff’d sub nom. Kirk 47 21 U.S.C. 823(f). Summary Judgment at 4–5. v. Mullen, 749 F.2d 297 (6th Cir. 1984). 48 Government’s Motion for Summary Judgment 37 Id. at 4. See also 21 U.S.C. 823(f). 42 Order to Show Cause at 1. at 1–3 and cases cited therein.

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establishing grounds to deny an Accordingly, I GRANT the On March 2, the Government filed its application for registration upon Government’s Motion for Summary Motion for Summary Disposition with sufficient proof establishing the Disposition. the Office of Administrative Law Judges. applicant does not possess a state Upon this finding, I ORDER that this Motion for Summ. Disp., at 1. In the controlled substance registration. That case be forwarded to the Administrator Certificate of Service, the Government proof is in the record before me, and it for final disposition and I represented that it had served the warrants the summary revocation of RECOMMEND the Administrator DENY Motion by facsimile, but not by first Respondent’s DEA Certificate of Respondent’s application for a DEA class mail or email.1 Id. at 4. In its Registration. Certificate of Registration. Objections, Respondent asserts that he I am mindful of the arguments raised Dated: October 23, 2014. ‘‘did not respond to the DEA Motion for by Respondent in her Reply to the Summary Disposition because he was Christopher B. McNeil, Government’s Motion for Summary unaware of any such motion until the Judgment, including the fact that Administrative Law Judge. ALJ’s Order granting such motion.’’ Respondent is currently appealing the [FR Doc. 2015–12023 Filed 5–18–15; 8:45 am] Objections, at 1. revocation of her state controlled BILLING CODE 4410–09–P As stated above, on March 11, the ALJ substance registration.49 These issued his Recommended Decision. difficulties do not, however, change the Therein, the ALJ noted that the fact that without a state controlled DEPARTMENT OF JUSTICE Government had attached a copy of the substance registration, Respondent is Emergency Order of Suspension issued Drug Enforcement Administration not a ‘‘practitioner’’ and cannot be by the Kentucky Board of Medical granted a Certificate of Registration. Licensure; the Order, which was issued Some care should be taken to assure [Docket No. 15–13] on November 24, 2014, suspended the parties that the actions taken in this Respondent’s Kentucky medical license Sharad C. Patel, M.D.; Decision and administrative proceeding conform to ‘‘effectively immediately upon its Order constitutional requirements. I have receipt.’’ Mot. For Supp. Disp., examined the parties’ contentions with On March 11, 2015, Administrative Attachment 1, at 18. an eye towards ensuring all tenets of Law Judge (ALJ) Christopher B. McNeil In his Recommended Decision, the due process have been adhered to. issued the attached Recommended ALJ noted that Respondent had not filed There is, however, no authority for me Decision (cited as R.D.). Thereafter, on a response to the Government’s motion. to evaluate the facts that underlie April 1, Respondent filed a pleading R.D. at 2. However, the ALJ also noted Respondent’s contentions. In the entitled as ‘‘Objections to Findings of that in his hearing request, Respondent proceedings now before me, the only Fact, Conclusions of Law, and had ‘‘admit[ted] that his license is material question was answered by Recommended Decision of the temporary [sic] suspended’’ but that ‘‘he Respondent in her Request for Hearing. Administrative Law Judge (hereinafter, expects to prevail before the medical Further, while the Order to Show Cause Resp. Objections). Therein, Respondent board at an upcoming hearing on May sets forth a non-exhaustive summary of objected to the entry of the ALJ’s 18, 2015.’’ Id. at 3. As explained in his facts and law relevant to a Recommended Decision, on the ground decision, the ALJ found that there was determination that granting this that ‘‘he was never properly, or no dispute that Respondent ‘‘is not application would be inconsistent with sufficiently, served with the authorized to handle controlled the public interest under 21 U.S.C. [Government’s] initial motion’’ for substances in the State in which he 823(f), the conclusion, order and summary disposition and therefore ‘‘did maintains his registration’’ and is recommendation that follow are based not respond to the . . . [m]otion . . . therefore not a practitioner within the solely on a finding that Respondent is because he was unaware of any such meaning of the Controlled Substances not a ‘‘practitioner’’ as that term is motion until the ALJ’s Order granting Act. Id. The ALJ thus recommended that defined by 21 U.S.C. 802(21), and I such motion.’’ Objections, at 1. Respondent’s registration be revoked make no finding regarding whether Respondent argues that in his request and that any pending application be granting this application would or for hearing, his attorneys provided both denied. would not be inconsistent with the a mailing address and email address for Thereafter, the ALJ forwarded the public interest. receiving the ‘‘notices to be sent record to me, noting in his letter that Order Granting the Government’s pursuant to the proceeding.’’ 21 CFR Respondent’s objections were not timely Motion for Summary Disposition and 1316.47(a); Objections at 1. Respondent filed. Letter from ALJ to Administrator Recommendation did not, however, provide a fax number. (Apr. 7, 2015), at 2. The ALJ also Id. at 2. provided a copy of a Transmission I find there is no genuine dispute Verification Report showing that the regarding whether Respondent is a Thereafter, Respondent received the ALJ’s Order for Briefing on Allegations Recommended Decision was ‘‘practitioner’’ as that term is defined by successfully faxed to Respondent’s 21 U.S.C. 802(21), and that based on the Concerning Respondent’s Lack of State Authority’’ by First Class Mail. Id. The record the Government has established 1 Respondent’s contention regarding the that Respondent is not a practitioner ALJ’s Order specified the date (Mar. 2, inadequacy of service is not without merit. Of note, and is not authorized to dispense 2015) by which the Government was to Respondent did not consent to the service of controlled substances in the state in provide its evidence and arguments (as pleadings by facsimile and the ALJ’s Order for well as its motion for summary Briefing on Allegation Concerning Respondent’s which she seeks to operate under a DEA Lack of State Authority did not authorize service of Certificate of Registration. I find no disposition) in support of its contention pleadings in this manner. Moreover, while the use other material facts at issue, for the that Respondent does not possess ‘‘state of electronic means has the advantage of faster reasons set forth in the Government’s authority to handle controlled service—at least where the transmission is substances,’’ as well as the date by successful—a hard copy should still be sent by Motion for Summary Disposition. mail, courier, or third party commercial carrier which Respondent was to file his unless the serving party contacts the other party 49 Reply to the Government’s Motion for response (Mar. 9) to any such motion. and affirmatively determines that the entire Summary Judgment at 2–3. Id. document was received.

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counsel on March 11. Thus, added). Based on these provisions, the least 45 days before the date on which the Respondent’s Objections (which I have Agency has long held that revocation is existing registration is due to expire, and the treated as his Exceptions) were not warranted even where a state order has Administrator has issued no order on the received until day twenty-one, one day summarily suspended a practitioner’s application on the date on which the existing 2 registration is due to expire, the existing of after they were due. See 21 CFR controlled substances authority and the the applicant shall automatically be extended 1316.66(a). Having offered no state agency’s order remains subject to and continue in effect until the date on explanation for why his Objections were challenge in either administrative or which the Administrator so issues his/her late, I agree with the ALJ’s finding that judicial proceedings. See Gary Alfred order. Respondent’s Objections were out of Shearer, 78 FR 19009 (2013); see also time. Newcare Home Health Services, 72 FR 21 CFR 1301.36(i) (emphasis added). In any event, in his Objections, 42126, 42127 n.2 (2007) (collecting To be sure, the regulation also Respondent does not dispute that he cases and holding that ‘‘ALJ properly provides that a registration may be remains without authority to handle rejected . . . request for stay’’ and that extended ‘‘under the circumstances controlled substances in State of ‘‘[i]t is not DEA’s policy to stay contemplated in this section even Kentucky. Objections, at 3. Rather, he proceedings under section 304 while through the registrant failed to apply for seeks a delay in responding to the registrant litigate in other forums’’). reregistration at least 45 days before Government’s Motion until July 1, 2015 According to the allegations of the expiration of the existing registration, on the ground that the State’s Show Cause Order, Respondent’s with or without request by the ‘‘suspension is temporary [and] was not registration was not due to expire until registrant, if the Administrator finds issued after a full and fair hearing on the March 31, 2015. Thus, at the time the that such extension is not inconsistent issues,’’ and that ‘‘[t]he sole support for ALJ issued his decision, Respondent with the public health and safety.’’ 21 the Government’s Motion . . . is the still held a DEA registration. However, CFR 1301.36(i). However, based on the temporary action taken by the state at the time the case was forwarded to Kentucky Board’s Emergency medical board.’’ Id. He further contends my Office, the record contained no Suspension order and the extensive that he ‘‘is vigorously defending himself evidence as to whether Respondent had findings (which include allegations from the unwarranted suspension of his filed a timely renewal (or even an related to his prescribing of controlled Kentucky medical license and believes untimely renewal) application and substances) made therein, I find that the he will ultimately prevail’’ and have his whether his registration remained in extension of Respondent’s registration medical license and state controlled effect.3 would be ‘‘inconsistent with the public substance authority restored. Id. In his request for hearing, Respondent health and safety.’’ See Paul H. However, the Agency has long held contended that ‘‘he is prohibited from Volkman, 73 FR 30630, 30641 (2008) that ‘‘a practitioner can neither obtain applying for his DEA certificate until (declining to extend registration of nor maintain a DEA registration unless the Kentucky medical board acts upon practitioner subject to order to show the practitioner currently has authority his suspension.’’ R.D. at 3. The ALJ cause who did not file his renewal under state law to handle controlled rejected Respondent’s contention, application until nineteen days before substances.’’ James L. Hooper, 76 FR stating that under 21 CFR 1301.36(i), expiration of the registration but finding 71371 (2011), pet. for rev. denied, ‘‘the existing registration of an applicant that the application remained pending Hooper v. Holder, 481 F. App’x 826 (4th for reregistration will be automatically before the Agency). Cir. 2012). This holding is derived from extended until the Administrator issues Accordingly, I hold that Respondent’s the plain meaning of two provisions of her order if the applicant applies for registration has expired but that his the Controlled Substances Act. reregistration.’’ Id. application remains pending before the The first is section 102(21), which According to the registration records Agency. However, because Respondent defines the term ‘‘practitioner’’ to of the Agency—of which I have taken is not currently authorized to dispense ‘‘mean[ ] a physician . . . licensed, official notice 4—Respondent filed a controlled substances under the laws of registered, or otherwise permitted, by renewal application on March 23, eight the State of Kentucky, the State in . . . the jurisdiction in which he days before the expiration date of his which he seeks registration, he is not practices . . . to distribute, dispense, registration. However, contrary to the entitled to be registered. See 21 U.S.C. [or] administer . . . a controlled ALJ’s explanation of 21 CFR 1301.36(i), 823(f) & 802(21). substance in the course of professional where a registrant-applicant has been I therefore adopt the ALJ’s finding practice.’’ 21 U.S.C. 802(21). The second issued an order to show cause, the that Respondent is not currently is section 303(f), which sets forth the regulation actually provides: authorized to dispense controlled criteria for obtaining a practitioner’s [i]n the event an applicant for reregistration substances in Kentucky, the State in registration and which explicitly (who is doing business under a registration which he seeks registration, and is provides that ‘‘[t]he Attorney General previously granted and not revoked or therefore not a practitioner within the shall register practitioners . . . to suspended) has applied for reregistration at meaning of the CSA. I further adopt the dispense . . . controlled substances ALJ’s order granting the Government’s ... if the applicant is authorized to 3 Even in summary disposition proceedings Motion for Summary Disposition. dispense . . . controlled substances which are based on a lack of state authority, the ALJ However, I adopt the ALJ’s under the laws of the State in which he is obligated to make a finding establishing that the Agency has jurisdiction. Moreover, where it is Recommendation only with respect to practices.’’ Id. § 823(f) (emphasis unclear whether a respondent may have allowed his the denial of Respondent’s pending registration to expire during the course of the application to renew his registration. 2 It is further noted that Respondent did not mail proceeding, the ALJ is obligated to determine his Objections until March 31, 2015. Objections, at whether the respondent has filed a renewal Order 4. DEA’s regulation provides that ‘‘[d]ocuments application before forwarding the record to the shall be dated and deemed filed upon receipt by the Administrator. Pursuant to the authority vested in me Hearing Clerk.’’ 21 CFR 1316.45. This case does not 4 See 21 CFR 1316.59(e). Respondent may refute by 21 U.S.C. 823(f) and 28 CFR 0.100(b), raise any issue of delay being attributable to the my finding by filing a properly supported motion physical address of the Office of Administrative for reconsideration no later than fifteen (15) I order that the application of Sharad C. Law Judges being different from the mailing address calendar days from the date of issuance of this Patel, M.D., for a DEA Certificate of of that Office. Decision and Order. Registration as a practitioner, be, and it

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hereby is, denied. This Order is Respondent’s Request for Hearing, Order Granting the Government’s Motion for effectively immediately. Respondent admits that his license is Summary Disposition and Recommendation temporary suspended. Respondent further Dated: May 1, 2015. I find there is no genuine dispute regarding states that he expects to prevail before the whether Respondent is a ‘‘practitioner’’ as Michele M. Leonhart, medical board at an upcoming hearing on that term is defined by 21 U.S.C. 802(21), and Administrator. May 18, 2015. Finally he notes that his DEA that based on the record the Government has Certificate of Registration will expire by its Brian Bayly, Esq., for the Government. established that Respondent is not a own terms on March 31, 2015, and alleges practitioner and is not authorized to dispense Marc S. Murphy, Esq., and Michael Denbow, that he is prohibited from applying for his Esq., for the Respondent. controlled substances in the state in which DEA certificate until the Kentucky medical he seeks to practice with a DEA Certificate Order Granting the Government’s Motion for board acts upon his suspension. of Registration. I find no other material facts Summary Disposition and Findings of Fact, The substantial issue raised by the at issue. Accordingly, I GRANT the Conclusions of Law, and Recommended Government rests on an undisputed fact. The Government’s Motion for Summary Decision of the Administrative Law Judge Government asserts that Respondent’s DEA Disposition. Certificate of Registration must be revoked Administrative Law Judge Christopher B. Upon this finding, I ORDER that this case because Respondent does not have a medical McNeil. On January 29, 2015, the Deputy be forwarded to the Administrator for final license issued by the state in which he Assistant Administrator of the Drug disposition and I recommended that practices — a fact which Respondent does Enforcement Administration issued an Order Respondent’s DEA Certificate of Registration to Show Cause as to why the DEA should not not deny. Under DEA precedent, a should be REVOKED and any pending revoke DEA Certificate of Registration practitioner’s DEA Certificate of Registration application for the renewal or modification of Number FP2719245 issued to Sharad C. for controlled substances must be summarily the same should be DENIED. revoked if the applicant is not authorized to Patel, M.D., the Respondent in this matter. Dated: March 11, 2015. The Order seeks to revoke Respondent’s handle controlled substances in the state in 1 registration pursuant to 21 U.S.C. 824(a)(3) which he maintains his DEA registration. Christopher B. McNeil, and 823(f), and to deny any pending Pursuant to 21 U.S.C. 823(f), only a Administrative Law Judge. ‘‘practitioner’’ may receive a DEA applications for renewal or modification of [FR Doc. 2015–12025 Filed 5–18–15; 8:45 am] registration. Under 21 U.S.C. 802(21), a such registration, and deny any applications BILLING CODE 4410–09–P for any new DEA registrations pursuant to 21 ‘‘practitioner’’ must be ‘‘licensed, registered, U.S.C. 823(f). As grounds for denial, the or otherwise permitted, by the United States or the jurisdiction in which he practices or Government alleges that Respondent is DEPARTMENT OF JUSTICE ‘‘without authority to handle controlled does research, to distribute [or] dispense . . . controlled substance[s.]’’ Given this statutory substances in Kentucky, the state in which Drug Enforcement Administration [Respondent is] registered with the DEA.’’ language, the DEA Administrator does not On February 20, 2015, the DEA’s Office of have the authority under the Controlled [Docket No. 13–34] Administrative Law Judges received Substances Act to maintain a practitioner’s Respondent’s written request for a hearing, registration if that practitioner is not Annicol Marrocco, M.D.; Decision and which is dated February 19, 2015. authorized to dispense controlled Order Respondent states that his medical license is substances.2 As noted by the Government in ‘‘temporarily suspended’’ by the state’s its Motion for Summary Disposition, On May 17, 2013, the Deputy medical board and that he plans to challenge Respondent’s concern regarding the Assistant Administrator, Office of the suspension in an upcoming state impending expiration of his DEA registration Diversion Control, Drug Enforcement administrative hearing scheduled for May 18, is unfounded. Under 21 CFR 1301.36(i), incorrectly cited by the Government as 21 Administration, issued an Order to 2015. Show Cause to Annicol Marrocco, M.D., On February 23, 2015 this Office issued an CFR 1306.36(i), the existing registration of an Order for Briefing on Allegations Concerning applicant for reregistration will be (hereinafter, Respondent), of Mahwah, Respondent’s Lack of State Authority. In the automatically extended until the New Jersey. ALJ Ex. 1. The Show Cause Order, I mandated that the Government Administrator issues her order if the Order proposed the revocation of provide evidence to support the allegation applicant applies for reregistration.3 Respondent’s DEA Certificate of that Respondent lacks state authority to As detailed above, only a ‘‘practitioner’’ Registration BM8059102, which handle controlled substances and if may receive a DEA registration. Therefore, I authorized her to dispense controlled appropriate file a motion for summary will recommend the revocation of substances in schedules II through V, at Respondent’s DEA registration. disposition no later than 2:00 p.m. Eastern the registered address of Olean General Standard Time (EST) on March 2, 2015. On Hospital, 515 Main Street, Olean, New March 2, 2015, the Government timely 1 See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also submitted a brief in support of the allegation House of Medicine, 79 FR 4959, 4961 (DEA Jan. 30, York 14760, on the ground that her regarding state authority and filed a Motion 2014); Deanwood Pharmacy, 68 FR 41662–01 (DEA ‘‘continued registration is inconsistent for Summary Disposition. According to the July 14, 2003); Wayne D. Longmore, M.D., 77 FR with the public interest.’’ Id. (citing 21 Government’s brief, the Board of Medical 67669–02 (DEA Nov. 13, 2012); Alan H. Olefsky, U.S.C. 823(f) and 824(a)(4)). Licensure of the Commonwealth of Kentucky M.D., 72 FR 42127–01 (DEA Aug. 1, 2007); Layfe The Show Cause Order specifically issued an Emergency Order of Suspension Robert Anthony, M.D., 67 FR 15811 (DEA May 20, 2002); George Thomas, PA–C, 64 FR 15811–02 alleged that between January 2008 and suspending Respondent’s license to practice (DEA Apr. 1, 1999); Shahid Musud Siddiqui, M.D., August 2009, Respondent issued medicine, effective November 24, 2014. The 61 FR 14818–02 (DEA April 4, 1996); Michael D. approximately twenty-one prescriptions Government attached the emergency order Lawton, M.D., 59 FR 17792–01 (DEA Apr. 14, 1994); pertaining to Respondent to the Motion for Abraham A. Chaplan, M.D., 57 FR 55280–03 (DEA to S.C. for oxycodone, a schedule II Summary Disposition. Based on this Nov. 24, 1992). See also Bio Diagnosis Int’l, 78 FR controlled substance, ‘‘outside the usual suspension, the Government moved for a 39327–03, 39331 (DEA July 1, 2013) (distinguishing course of professional practice and for summary disposition of these proceedings. distributor applicants from other ‘‘practitioners’’ in other than a legitimate medical In my Order for Briefing on Allegations the context of summary disposition analysis). purpose.’’ Id. (citing 21 U.S.C. 841(a) 2 See Abraham A. Chaplan, M.D., 57 FR 55280– Concerning Respondent’s Lack of State and 21 CFR 1306.04(a)). The Show Authority, I also provided Respondent the 03, 55280 (DEA Nov. 24, 1992), and cases cited therein. In Chaplan, DEA Administrator Robert C. Cause Order further alleged that opportunity to respond to the Government’s Bonner adopts the ALJ’s opinion that ‘‘the DEA allegations with a brief due not later than Respondent failed to maintain medical lacks statutory power to register a practitioner records supporting the prescriptions, in 2:00 p.m. EST on March 9, 2015. As of today, unless the practitioner holds state authority to no brief was received and therefore the handle controlled substances.’’ Id. violation of Florida law; that she was in Government’s Motion for Summary 3 See also Ronald J. Riegel, D.V.M., 63 FR 67132– a personal relationship with S.C.; and Disposition will stand unopposed. In 01, 67132 (DEA Dec. 4, 1998). that she ‘‘did not examine S.C. except to

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listen to his heart and lungs.’’ Id. at 1– On November 12, 2013, the ALJ 1306.05(a)’’; (4) Respondent issued 2, 4–5 (citing Fla. Admin Rule 64B8– issued his Recommended Decision. multiple prescriptions for schedule II 9.003 and 64B8–9.013). Therein, the ALJ found that the controlled substances which lacked ‘‘the Next, the Show Cause Order alleged Government had established a prima earlier date on which’’ the prescription that Respondent had failed to both date facie case that Respondent’s continued could be filled, in violation of and include S.C.’s address on multiple registration would be inconsistent with 1306.12(b)(1); and (5) Respondent prescriptions, in violation of 21 CFR the public interest and that she had violated the State of Florida’s 1306.05(a). Id. at 2. The Show Cause failed to rebut the Government’s ‘‘Standards for the Use of Controlled Order then alleged that Respondent had showing. R.D. at 75. The ALJ thus Substances for the Treatment of Pain,’’ violated DEA regulations that, while recommended that Respondent’s as well as the State’s regulation allowing a practitioner to issue multiple registration be revoked. Id. regarding the adequacy of medical prescriptions for a schedule II With respect to factor one—the records. Id. at 73. controlled substance, limit the quantity recommendation of the state licensing The ALJ further concluded that of the prescriptions to a 90-day supply, authority—the ALJ found that ‘‘[i]ssuing controlled substance require that a prescription include the ‘‘Respondent has a history of substantial prescriptions in one state under a DEA earliest date on which it can be filled, and material disciplinary action taken registration issued for practice in and require that each prescription be by the medical licensing boards of three another state is a violation of 21 U.S.C. issued for a legitimate medical purpose. states’’ and that the boards of Florida 822(e) and 21 CFR 1301.12(a) and Id. at 2–4 (citing 21 CFR 1306.12(b)(1)). and New York have ‘‘permanently (b)(3).’’ Id. at 74. While noting that an Next, the Show Cause Order alleged limit[ed] [her] authority to prescribe Agency regulation exempts an official of that Respondent ‘‘violated Federal law controlled substances.’’ Id. at 72. The various federal agencies and the armed on at least forty-nine occasions’’ by ALJ thus concluded that ‘‘maintaining forces from these requirements, the ALJ issuing controlled substance Respondent’s unrestricted DEA found that because Respondent was a prescriptions while practicing as a registration would be inconsistent with contract-physician she was not exempt the public interest.’’ Id. under the regulation. Id. Based on his contract emergency room physician at With respect to factor two— finding that ‘‘[b]etween December 28, the Northern Navajo Medical Center in Respondent’s experience in dispensing 2012 and June 8, 2013, Respondent Shiprock, New Mexico, while being controlled substances—the ALJ found issued prescriptions for controlled registered in New York. Id. at 5. The ‘‘that despite eighteen years of substances from her principal place of Government further alleged that experience as an emergency medicine business or professional practice in ‘‘[i]ssuing controlled substance physician, Respondent lacked the Shiprock, New Mexico,’’ while ‘‘using prescriptions in one state under a DEA experience necessary to identify and the DEA registration that was issued to registration issued for another state is a appropriately respond to drug-seeking her for her practice in New York,’’ the violation of 21 U.S.C. 822(e) . . . which behavior.’’ Id. The ALJ also found that ALJ concluded that Respondent violated require[s] separate registrations for Respondent ‘‘lacked the experience these provisions. Id. The ALJ thus found separate locations.’’ Id. (also citing 21 necessary to appreciate the need to that factor four supports a finding that CFR 1301.12(a) & (b)(3)). The contact the DEA when questions arose Respondent’s continued registration Government also alleged that regarding the need for in-state ‘‘would be inconsistent with the public Respondent knowingly and willfully certification after she relocated her interest.’’ Id. violated these provisions, alleging that principal place of business or The ALJ further found that factor ‘‘DEA personnel informed you and your professional practice from New York to five—such other conduct which may attorney that to move your DEA New Mexico.’’ Id. The ALJ thus found threaten public health and safety— registration to New Mexico you must that factor two supports a finding that supports the conclusion that first be properly licensed to practice Respondent’s continued registration is Respondent’s continued registration medicine in New Mexico’’ and that she ‘‘inconsistent with the public interest.’’ ‘‘would be inconsistent with the public ‘‘ha[s] never held a New Mexico Id. interest.’’ Id. at 74–75. As support for medical license.’’ Id. Finally, the Show As for factor four—compliance with his conclusion, the ALJ found that Cause Order alleged that Respondent applicable laws related to controlled Respondent lacked ‘‘candor with the’’ ‘‘no longer maintain[s] a medical substances—the ALJ found that Agency, that she ‘‘willful[ly] fail[ed] to practice at [her] registered address’’ and Respondent violated 21 CFR 1306.04(a) determine her obligations when that she violated DEA regulations by by issuing multiple prescriptions for relocating from New York to New ‘‘[f]ail[ing] to keep [her] registered schedule II controlled substances, Mexico,’’ and that she ‘‘refus[ed] to address current with the’’ Agency. Id. including OxyContin and oxycodone to cooperate with the [Agency’s] inquiry (citing 21 CFR 1301.51). S.C., while in a personal relationship regarding liability issues in her renewal Respondent timely requested a with him, and that she acted outside the application.’’ Id. at 75. hearing on the allegations; the matter usual course of professional practice in Finally, the ALJ found that was then placed on the docket of the issuing the prescriptions and lacked a Respondent ‘‘failed to affirmatively Office of Administrative Law Judges and legitimate medical purpose. R.D. 69–70. acknowledge specific acts of improper assigned to Administrative Law Judge The ALJ further found that: (1) prescribing,’’ as well as that she had Christopher B. McNeil (hereinafter, Respondent issued the prescriptions ‘‘failed to establish by credible and ALJ). ALJ Ex. 2. Following pre-hearing ‘‘without maintaining medical records substantial evidence effective steps procedures, the ALJ conducted a or justifying the prescriptions in taken in remediation as would warrant hearing on August 21 and September 11, violation of 21 CFR 1306.04(a)’’; (2) a sanction other than revocation.’’ Id. 2013, at which both parties called Respondent issued OxyContin The ALJ thus found that ‘‘the witnesses to testify and introduced prescriptions, which were undated, in Government has established cause to documentary evidence. Following the violation of 21 CFR 1306.05(a); (3) revoke Respondent’s . . . registration.’’ hearing, both parties submitted briefs Respondent issued OxyContin Id. containing their proposed findings of prescriptions, which ‘‘lacked the Both parties filed exceptions to the fact and conclusions of law. patient’s address, in violation of 21 CFR ALJ’s Recommended Decision. Having

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considered the record in its entirety, The State further alleged that On December 31, 2014, Respondent including the parties’ exceptions, I ‘‘Respondent prescribed [R]oxycodone, applied for a renewal of this registration conclude that the Government has oxycodone, and/or OxyContin to Patient and sought to change her registered established that granting Respondent’s S.C., in an inappropriate manner and/or location to the Northern Navajo Medical application would be inconsistent with in excessive quantities, which is outside Center, P.O. Box 160, Highway 491 the public interest and that Respondent the course of Respondent’s professional North, Shiprock, New Mexico. See has failed to rebut the Government’s practice.’’ Id. at 11–12. The State thus Government’s Notice of Respondent’s prima facie case. Accordingly, I will alleged that Respondent violated Florida Filing of Renew Application and adopt the ALJ’s recommendation that I law ‘‘by prescribing controlled Change of Address Request, at 6–8. deny any pending application for a new substances other than in the course of Thereafter, on January 23, 2015, registration. I make the following factual her professional practice.’’ Id. at 12 Respondent submitted a letter seeking to findings. (citing Fla. Stat. § 458.331(1)(q)). change her registered location to Findings Finally, the State alleged that Doctors Express Urgent Care, 1444 W. Respondent violated Florida law by Passyunk Ave, Philadelphia, PA. Id. at Respondent’s Licensure Status, the ‘‘fail[ing] to maintain complete medical 8. State Board Actions, and Registration records that justify the course of However, at the time Respondent Status treatment [that she] provided to . . . submitted her renewal application, the Respondent is a board-certified S.C.’’ Id. at 10; see also id. at 11 (citing Agency had issued the Order to Show physician in emergency medicine. See Fla. Stat. § 458.331(1)(m)). Cause. A DEA regulation applicable to RX A, at 2. Respondent completed her Pursuant to the Settlement Agreement an applicant who has been served with residency in emergency medicine in she entered into with Florida, an Order to Show Cause provides: 1998 and since then has worked at Respondent received a letter of concern, In the event that an applicant for hospitals in New Jersey, Pennsylvania, was fined $5,000, and was required to reregistration (who is doing business under a New York, Florida, and New Mexico. Id. reimburse the Florida Department of registration previously granted and not at 1–2. While Respondent holds an Health’s costs of investigating and revoked or suspended) has applied for active license in New York, Florida, and reregistration at least 45 days before the date prosecuting the matter in an amount on which the existing registration is due to Pennsylvania, she has been disciplined between $5,587.55 and $6,587.55. GX 8, by the medical boards of each of these expire, the existing registration of the at 2–3. Respondent was also required to applicant shall automatically be extended States, based on her prescribing of perform 25 hours of community service, and continue in effect until the date on controlled substances to S.C., with as well as to attend ten (10) hours of which the Administrator so issues his/her whom she had a personal relationship Continuing Medical Education (CME) in order. The Administrator may extend any while she was practicing in Florida. See ‘‘Appropriate Prescribing Practices’’ and other existing registration under the GX 9, 11, 12, 13. two (2) hours of CME in ‘‘Proper circumstances contemplated in this section In the Settlement Agreement she Medical Record Keeping.’’ Id. at 4–5. even though the registrant failed to apply for reregistration at least 45 days before entered into with the Florida Board, Finally, the Board prohibited ‘‘Respondent neither admit[ted] nor expiration of the existing registration, with or Respondent from ‘‘prescrib[ing] without request by the registrant, if the denie[d] the allegations of fact controlled substances to persons with contained in the [Board’s] Administrator finds that such extension is whom [she] is in a personal, familial or not inconsistent with the public health and Administrative Complaint.’’ GX 8, at 2. non-familial, relationship.’’ GX 8, at 2– safety. However, she did ‘‘admit[] that the facts 5.2 alleged in the Administrative 21 CFR 1301.36(i). Complaint, if proven,1 would constitute As of the hearing, Respondent was Respondent did not file her renewal violations of Chapter 458, Florida working as a contract physician at the application more than 45 days before Statutes, as alleged in the Northern Navajo Medical Center, a her registration was due to expire and Administrative Complaint.’’ Id. facility of the Indian Health Service thus her registration was not More specifically, the State alleged (IHS), which is located in Shiprock, automatically extended pending the that ‘‘Respondent failed to meet the New Mexico; Respondent has worked at issuance of this Decision and Final prevailing standard of care in regard to this hospital since August 2012. RX A, Order. Based on my review of the record Patient S.C. in one or more of the at 1; Tr. 163. Respondent is not licensed in this matter, I further conclude that following ways.’’ GX 7, at 9. The State to practice medicine by the State of New the extension of her registration would alleged that Respondent ‘‘fail[ed] to Mexico. RX A, at 2. be ‘‘inconsistent with the public health adequately assess and/or diagnose Respondent also held DEA Certificate and safety.’’ Id. Accordingly, I hold that Patient S.C. with chronic pain,’’ Registration BM8059102, pursuant to her registration expired on January 31, ‘‘fail[ed] to appropriately treat . . . which she was authorized to dispense 2015. See Ralph J. Chambers, 79 FR S.C.,’’ ‘‘fail[ed] to use alternative controlled substances in schedules II 4962 (2014) (citing Paul H. Volkman, 73 treatment methods,’’ ‘‘prescrib[ed] S.C. through V, at the registered location of FR 30630, 30641 (2008)). However, I an inappropriate and/or excessive Olean General Hospital, 515 Main St., conclude that her application remains quantity of [R]oxicodone, oxycodone, Olean, New York 14760. GX 20, at 1. pending before the Agency. See id. and/or OxyContin,’’ ‘‘fail[ed] to obtain This registration had an expiration date The Allegations That Respondent laboratory results and/or diagnostic of January 31, 2015. Id. Unlawfully Prescribed Controlled scans to collaborate [sic] or monitor Substances to S.C. S.C.’s condition,’’ and ‘‘fail[ed] to 2 Based on the Florida Board’s action, New York Between February 2007 and August properly monitor and/or follow up on State Board for Professional Medical Conduct . . . S.C.’s condition.’’ Id. at 9–10 (citing imposed a ‘‘Censure and Reprimand,’’ prohibited 2009, Respondent worked as an ER Fla. Stat. § 458.331(1)(t)). her from prescribing to persons with whom she is physician at the Physicians Regional in a relationship, placed her on probation for three Medical Center in Naples, Florida. RX years, and fined her $1500. GX 11. Also, based on 1 These allegations largely track what the the actions of the Florida and New York Boards, the A, at 1. According to Respondent, in Government alleged and I find proved in this Pennsylvania State Board of Medicine imposed a August 2007, she met S.C., a budding matter. See GX 7, at 1–7. $5000 civil penalty on her. GX 13. reality TV star, when he came to the ER

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with a broken hand and she treated him Id. When then asked by the Government from the pain management specialist by splinting his hand and prescribing if subsequent to the August 2007 ER who had previously treated him and Percocet to him.3 Tr. 207–08. A week or visit, she ‘‘had met with him in a ‘‘then copied the prescription off the two later, Respondent was told by an x- clinical capacity prior to’’ issuing the bottles.’’ Id. at 217. Respondent further ray technician that S.C. worked for January 18 prescription, Respondent denied having made a diagnosis of Ticket Master and that he was hosting answered: chronic pain, stating that ‘‘that was a fund-raising event at a local coffee I don’t understand what you mean, clinical established already’’ by S.C.’s ‘‘prior shop. Id. at 211. Respondent went to the capacity. We developed a friendship, and we physician[].’’ Id. at 229. coffee shop to see if she could get tickets . . . were involved in a relationship, at that While Respondent admitted that she from S.C for an upcoming football game. time. So, you know, I had gotten to know him ‘‘was not familiar with treating chronic Id. Thereafter, Respondent and S.C. personally. I knew his family, and you know, pain,’’ she did not contact the pain entered into a personal relationship. Id. we had discussed a lot of his medical Respondent did not prescribe any conditions, I had discussed with him and his management doctor who had previously controlled substances to S.C. until family. treated S.C., explaining that S.C. had January 18, 2008, when she wrote him told her that ‘‘he was no longer involved Id. with his care, and he did not wish to a prescription for 90 tablets of When then asked where she had . . . see that physician any longer.’’ Id. oxycodone 30mg. GX 1, at 1. conducted her physical examinations of at 218–19. Respondent explained that Respondent did not recall exactly where S.C., Respondent stated ‘‘[e]ither by my she relied on what S.C. and his family she wrote the prescription (this having home or his home.’’ Id. 215. When had told her, as well as some of his occurred at either her home or S.C.’s) asked how she had assessed his pain medical records, although she did not but acknowledged that it was not at level, Respondent testified: ‘‘Just by look through all of his records. Id. either of the hospitals (both of which asking him and just seeing how his were located in Fort Myers, Florida) overall well-being was.’’ Id. at 215–16. When then asked how she knew that which were listed on the prescription Respondent then asserted that S.C. had his prior physician would have form she used. Tr. 213. When asked told her that ‘‘he was in excruciating continued S.C. on controlled whether she performed a physical exam pain. He couldn’t function without substances, Respondent answered that on this occasion, Respondent testified: being on his pain medicine.’’ Id. at 216. ‘‘[w]hen you’re on controlled substances I conducted a physical exam. I don’t know Respondent admitted, however, that she you just don’t stop . . . you have to go if it was on that specific date, but prior to me did not create ‘‘any formal records’’ for through either a weaning process or— issuing this prescription, I had gotten to the prescriptions. Id. Nor did she create that’s why it requires a specialist to . . . know him very well, and I learned more a written treatment plan for S.C. Id. at continue treating once you’re up to a about his chronic pain syndrome, and he was certain number of high dose pain a smoker. So, I did, I had listened to his heart 218. She further admitted that she did and lungs many times before.4 not order any additional tests, because medication.’’ Id. at 234–35. She also she was ‘‘work[ing] outside [the] claimed that his family told her that S.C. 3 Over the Government’s objection, the ALJ emergency department’’ and that ‘‘that did not have a history of substance allowed Respondent to testify by telephone from was already conducted by his pain abuse. Id. at 232. Respondent her lawyer’s office, rather than in person or by management specialist.’’ Id. at 232–33. acknowledged that it ‘‘was [her] error’’ appearing at a DEA facility which has Video- Teleconferencing (VTC) capability. Gov. When then asked what was the to accept S.C.’s word instead of Exceptions, at 2–6. The Government took exception medical purpose of the prescription, contacting his prior physician. Id. at to this ruling. Respondent testified that S.C. ‘‘was in a 219. She further maintained that she While the Government makes no claim that pain management clinic, up until about trusted S.C., that ‘‘his family backed up Respondent’s counsels acted improperly at any time his story,’’ and that she had ‘‘no reason during her testimony, it is manifest that where a November or December of 2007, and he witness is allowed to testify by telephone, notes was transitioning. He said he lost his to believe at the time’’ that she ‘‘was could be passed to the witness during the testimony medical insurance. He was trying to find being deceived.’’ Id. at 220. She also without the ALJ or Government Counsel ever being a new treating physician for his chronic stated that she was in ‘‘a very good aware of this. So too, the use of telephone testimony raises a greater risk that during breaks in the pain.’’ Id. at 216. According to friendship’’ with S.C. and that over proceeding, the witness could discuss her Respondent, S.C. told her that he had time, she ‘‘lost the physician/patient testimony with others. back fractures and neck injuries from relationship’’ and ‘‘was not objective.’’ I find the Government’s exception to be well doing acting stunts and motorcycle Id. taken. This is not to say that every witness must testify either in person or by VTC. However, a racing. Id. at 246. On or about February 7, 2008, respondent will invariably be a highly important, if Respondent further explained that Respondent wrote S.C. three undated not the most important witness in a proceeding, and S.C. was ‘‘starting to do a lot of traveling prescriptions for OxyContin 80mg.5 See thus, under no circumstance is it proper to allow at that time’’ as he was auditioning for a respondent to testify by telephone. As for other GX 1, at 3, 5, and 7. The prescriptions, witnesses, with the exception of a witness who various ‘‘acting jobs,’’ and that he asked which authorized the dispensing of 100 testifies only as to the authentication or foundation her if she could help him out until he dosage units q12h, 200 dosage units of proposed exhibits, the taking of testimony by could get insurance and ‘‘see another q8h, and 100 dosage units q8h, all telephone is disfavored and may be used only upon provider.’’ Id. at 216–17; 234. According a showing that exceptional circumstances exist and lacked S.C.’s address. See id. Moreover, that the failure to obtain a witness’s testimony will to Respondent, she looked at the labels none of the prescriptions listed ‘‘the result in a denial of due process. of the prescriptions S.C. had received earliest date on which’’ it could be filled 4 At several other points in her testimony, as required by 21 CFR 1306.12(b)(1)(ii). Respondent described the physical exam as had my stethoscope with me, and you know, listening to S.C.’s heart and lungs, and made no whenever I saw him, I just did a general, you See id. Based on Respondent’s dosing reference to any other tests she did. For example, know—was able to generally assess his overall when asked ‘‘How often did you perform a physical health and well-being, just from interacting with 5 The prescriptions were written on the examination of S.C. in the course of issuing him and speaking to his family. prescription forms of the Physicians Regional prescriptions to him?,’’ she answered: Tr. 244–45. Notably, only after Respondent was Medical Center and were sequentially numbered I can’t say for certain, but I did listen—like I said, asked by the Government if she specifically from 007424 through 007426. GX 1, at 3–7. While I mean, he was a smoker, so I did listen to his . . . examined S.C.’s back and neck did she assert that the prescriptions were undated, the evidence shows heart and lungs, which is one of the main exams she palpated him ‘‘along the spine and surrounding that prescription number 007425 for 200 OxyContin on a physical, on a regular basis, because I usually areas.’’ Id. at 263. 80mg. was filled on February 7, 2008. Id. at 4.

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instructions, the prescriptions provided I know I was very distracted when I would ‘‘he wanted to make sure he didn’t run S.C. with 149 days’ supply of the drug. write the prescriptions, because it was either out of pain medication while he was The evidence further shows that S.C. at his home or my home, and he had a three- there.’’ Id. She also testified that she filled the prescription for 200 tablets at year-old child. It was usually—it was usually was unaware that she could write ‘‘do at his home. not fill until a certain date’’ on the a cost of $2,328.00. Id. at 4. Yet He had a three-year-old, or a four-year-old, Respondent repeatedly claimed that she at the time. There were two dogs, a monkey prescriptions. Id. ‘‘was trying to offer a short-term, fix for in the house. There was a loud . . . his father Following his appearance on the MTV his situation’’ because ‘‘[h]e was short was hard of hearing, so . . . the TV was on show and his return to Florida on money,’’ Tr. 236, even though he was very loud, and it was a very distracting (sometime around October 2008), S.C. working at a local radio station. Id. at environment. I don’t . . . you know, I cannot was ‘‘getting a lot of opportunities to 238–39. Respondent further claimed explain exactly why the date wasn’t on them, travel, to do commercials, to do that S.C. had told her that an office visit because I know that the date needs to be on auditions,’’ and contracts. Id. at 249. with a pain management specialist cost them. So, I can just . . . go back in my mind According to Respondent, S.C. asked and know that it was very distracting. ‘‘about $400 or $500’’ not counting the her if she could continue to help him cost of any prescriptions, and that she Tr. 222. Later in her testimony, out ‘‘because he was doing a lot of trusted what he told her. Id. at 239. She Respondent explained that S.C. had two travelling’’ and it was hard for him to also claimed that she was unfamiliar German Shepherds, and that there was find ‘‘a physician in a different state.’’ with the cost of various drugs. Id. at also a mutt (which he apparently did Id. Respondent agreed to do so and 237. not own) that was allowed to come into resumed prescribing to him. In her Regarding the OxyContin 80mg the house. Id. at 340. And then there testimony, Respondent did not explain prescriptions, Respondent stated that was the monkey, which according to why given S.C.’s success, he could not she had ‘‘probably not’’ physically Respondent, was ‘‘three or four feet’’ tall afford health insurance and find a pain examined S.C. ‘‘because [she] had done and ‘‘dangerous,’’ but was nonetheless management specialist. it in the past.’’ Tr. 231. Respondent then allowed to run free in the house. Id. at On January 20, 2009, Respondent claimed that she had assessed S.C.’s 340–41. resumed prescribing to S.C., issuing him pain level by ‘‘his appearance and how As for why she had written the three a prescription for 40 Roxicodone 30mg, he would tell me he was feeling.’’ Id. oxycodone 30mg prescriptions which with a dosing instruction of TID or one Respondent did not create a record for were filled on March 10, Respondent tablet, three times a day. GX 1, at 15. the prescriptions. Id. at 231–32. offered the following testimony: Between February 3 and March 6, 2009, Notwithstanding the quantity of drugs I’m just trying to recall, because also, on Respondent issued S.C. the following provided by these prescriptions, on or multiple times, I was told the prescriptions prescriptions, all of which had a dosing about March 10, 2008,6 Respondent were either lost or destroyed by the animals instruction of TID, or one tablet three issued S.C. three more prescriptions, in the house, by the monkey . . . the monkey times a day: each of which was for 450 oxycodone was . . . he would take the pill bottle, open Date Drug and quantity 30mg, with a dosing instruction to take it, and throw it in the pool, or you know, various different times . . . I was told that up to 15 tablets per day ‘‘as needed for they were lost or stolen or left behind at the 2/3/09 ...... 90 Roxicodone 30mg. pain.’’ GX 1, at 9, 11, and 13. As before, different hotels he was staying at. 2/3/09 ...... 90 Roxicodone 30mg. the prescriptions were not dated, did I just can’t—you know, it’s unclear, which 2/9/09 ...... 90 Roxicodone 30mg. not include S.C.’s address, and lacked set of prescriptions it may have occurred 2/9/09 ...... 90 Roxicodone 30mg. the earliest date on which they could be with, but it happened on numerous 2/9/09 ...... 90 Roxicodone 30mg. filled.7 Id. The evidence further shows occasions, which is why there is [sic] a 2/10/09 ...... 90 Roxicodone 30mg. number of prescriptions. 2/10/09 ...... 90 Roxicodone 30mg. that S.C. filled each of the prescriptions 2/10/09 ...... 90 Roxicodone 30mg. on March 10, 2008, and paid $280.74 for Id. at 240–41. Respondent further 2/20/09 ...... 90 Roxicodone 30mg. each one. Id. at 10, 12, and 14. maintained that S.C.’s stories regarding 2/20/09 ...... 90 Roxicodone 30mg. Here again, Respondent could not the monkey were believable because he 3/6/09 ...... 90 Roxicodone 30mg. state ‘‘for certain’’ that she performed a ‘‘would try to rip up my clothes and my 3/6/09 ...... 280 Roxicodone 15mg. physical exam on S.C. when she issued shoes and he would take anything and these prescriptions. Tr. 244. However, just try to shred it.’’ Id. at 341. See GX 1, at 17–35. Respondent testified that she issued the As a further reason for why she wrote Based on Respondent’s dosing prescriptions at S.C.’s home because the multiple prescriptions, Respondent instruction of TID, a single oxycodone ‘‘this was when he was getting ready to explained that there were occasions in 30mg prescription would have provided go to Los Angeles for his acting job.’’ Id. which S.C. would call and tell her that S.C. with a thirty-day supply; thus, a at 245. She also testified that she the pharmacy was either ‘‘out of stock single prescription issued on February assessed S.C.’s pain level by ‘‘[j]ust 3rd, should have lasted him through for a particular brand name or particular 8 interacting with him, asking how he was dosage.’’ Id. at 241; see also id. at 245 March 5th. However, the prescriptions feeling,’’ and by S.C. letting her know (‘‘this was around the time where he Respondent wrote S.C. between whether he ‘‘was having a good day or told me the prescriptions were being February 3 and March 6 authorized the a bad day.’’ Id. at 245–46. destroyed or lost or left at one pharmacy dispensing of 990 tablets of oxycodone As for why she did not date the or another, because they weren’t in 30mg, an eleven-month supply; the prescriptions and include S.C.’s stock’’). prescription for 280 oxycodone 15mg address, Respondent testified that: At this point, S.C. apparently left the 8 It is acknowledged that the pharmacy which area and went off to pursue his acting filled one of the February 3, 2009 prescriptions 6 Here again, the prescriptions were written on career. Tr. 227. As for why she had dispensed only 54 tablets on that date. GX 1, at 17– the forms of the Physicians Regional Medical Center issued the multiple OxyContin 18. However, even if S.C. was unable to obtain the and were numbered 009325, 009326, and 009329. prescriptions, Respondent testified that remaining 46 tablets from the pharmacy within 72 GX 1, at 9, 11, and 13. hours as required by DEA’s regulation, see 21 CFR 7 If the drugs were actually taken at fifteen tablets S.C. had told her that he was going to 1306.13(a), Respondent did not explain why it was per day, the prescriptions would have provided an be in Los Angeles for ‘‘three to six necessary to write S.C. a second prescription on additional 90 days’ supply. months’’ to film a show for MTV and that date for a full 90 tablets.

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provided S.C. with more than another As for why she issued three On further questioning by her counsel, 1.5 month’s supply of the drug. prescriptions on February 9, 2009 and inconsistent with her earlier As for why Respondent issued instead of a single prescription for 270 testimony that the last prescription she multiple prescriptions on February 3, tablets, Respondent answered that ‘‘[t]he wrote for S.C. was in August 2009, id. 2009, Respondent testified that ‘‘that particular pharmacy . . . didn’t have at 267, Respondent denied having they were not in stock at the particular that quantity in stock’’ so she split the written S.C. any more prescriptions pharmacy that he initially went to,’’ so prescriptions. Id. at 260–61. Again, ‘‘after the last emergency room visit.’’ S.C. ‘‘called me or told me that he had Respondent could not recall if she had Id. at 349. Yet the evidence shows that left the prescription [and] needed a new conducted a physical exam on S.C. on S.C.’s last ER visit was on July 3, 2009, one, so he could bring it to whatever this date, id. at 262, and acknowledged see GX 15, and the evidence further other pharmacy he was using.’’ Tr. 251. that she did not create a medical record shows that on July 31, 2009, Respondent However, the evidence shows only that for these prescriptions or a written issued S.C. a prescription for 30 the pharmacy partially filled the treatment plan. Id. at 264. She claimed, Roxicodone 15mg. GX 1, at 36. prescription in the amount of 54 tablets. however, that she had assessed his pain The evidence further showed that GX 1, at 17. Respondent then asserted level in the same manner as before, and Respondent and S.C. drove to a Publix that she ‘‘never realized that [the that she had discussed the risks and pharmacy where the prescription was prescriptions] were being filled’’ and benefits of using controlled substances filled. Tr. 97–98. Respondent remained that she ‘‘thought they were either being on this occasion. Id. at 265, 273. in the car while S.C. went in to the store destroyed’’ or ‘‘not being filled at all.’’ Respondent further testified that she to fill the prescription. Id. at 98. Id. at 251–52. However, Respondent used the same approach in assessing According to the pharmacist, ‘‘S.C. was never called any of the pharmacies S.C. S.C.’s need for oxycodone for all of the very chatty and used a lot of small talk’’ used and ‘‘never got word from the prescriptions (other than the one she about being on a reality TV show ‘‘as if pharmacist that they were being filled.’’ wrote during his ER visit). Id. at 274. he was trying to distract’’ her. Id. at 97, Id. at 252; see also id. at 241 (‘‘I was Moreover, when asked why she had 105. After the pharmacist handed the never phoned by any of these issued these three prescriptions given filled prescription to S.C., he ‘‘eagerly pharmacists, telling me that these that she had issued two similar took the prescription . . . and quickly prescriptions were being filled. I had no prescriptions only six days earlier, headed to the back of the store.’’ Id. at idea, because I did not have any records Respondent testified that she believed 97. Finding S.C.’s behavior suspicious, of the number of prescriptions I that S.C. had begun having seizures and the pharmacist called the hospital ER to wrote.’’). was becoming forgetful. Id. at 266. verify the prescription and was told that Respondent then testified that she did Continuing, Respondent testified that: ‘‘I Respondent was under investigation not find S.C.’s claim suspicious because believe he was—he may have been and was asked to fax the prescription to in the ER, ‘‘there were multiple times having seizures, which I found out in the ER and to call the sheriff. Id. at 101. where patients would’’ complain that a May, when I went over [to] his house The pharmacist then asked an assistant pharmacy would not have a particular . . . and he was acting confused . . . store manager to go into the bathroom narcotic or dosage. Id. at 252. When and he was in a post-seizure state . . . and check on S.C. GX 6. asked why the pharmacies would not and I . . . told [his] mom that he was While the pharmacist was still on the have just returned the prescriptions to having seizures.’’ Id. at 266–67. phone, S.C. reappeared at the pharmacy S.C. if the drug was out of stock, However, Respondent then testified that counter and asked if there was a Respondent testified that she thought ‘‘this was actually in—it was around problem with the prescription. Tr. 98. 10 ‘‘that is how they operated down there’’ May.’’ Id. at 267. Still later in her The pharmacist told S.C. that she and added that she ‘‘was new to the testimony, Respondent explained that ‘‘need[ed] to clarify the prescription State.’’ Id. at 253. However, Respondent ‘‘it was my understanding that he was and’’ asked him if she could have it has been licensed in Florida since being truthful and they were truly lost back; S.C. complied. Id. The pharmacist August 2004 and had worked there or misplaced or destroyed or left at the then counted the tablets and found that since at least December 2004.9 RX A, at pharmacist and never filled. Id. at 274. two were missing. Id. S.C. then told the The evidence shows that the two 1–2. Respondent could not recall pharmacist that ‘‘if there are any February 3 prescriptions were filled on whether she had ever had another questions regarding this prescription the February 3 and 5, and that three patient ask for a replacement doctor is my girlfriend and she is out in February 9 prescriptions were filled on prescription claiming that a pharmacist the car.’’ Id. February 9, 11, and 16. GX 1, at 18, 19, had said a drug was out of stock and yet The pharmacist then proceeded to the 21, 23, and 25. So too, the evidence kept the prescription. Id. at 254–55. parking lot and found Respondent in a shows that the three prescriptions car; the pharmacist asked Respondent Regarding the February 3, 2009 Respondent wrote on February 10, were for her driver’s license, and after prescriptions, Respondent again could filled on February 13, 14, and 17; the determining that it was Respondent, not recall if she had done a physical two prescriptions she wrote on February asked if she had written the examination. Id. at 255. While 20, were filled on February 21 and 25; prescription. Id. Respondent ‘‘said Respondent claimed that she had and the two prescriptions she wrote on ‘yes.’’’ Id. The pharmacist then returned assessed S.C.’s pain level in the same March 6, were filled on March 6 and 9. to the pharmacy and found that ‘‘S.C. manner as before, she admitted that she See id. at 26–35. was still there’’; S.C. ‘‘was very anxious did not create a medical record or a On questioning by her counsel, and ask[ed] if he was going to be written treatment plan. Id. at 255–56. Respondent testified that she did not arrested.’’ Id. The pharmacist went back Nor could she specifically recall if, on become aware that S.C. had been inside the pharmacy, called the ER this occasion, she had discussed the arrested for doctor-shopping ‘‘until after again and verified that Respondent was risks and benefits of using controlled the case was already over.’’ Tr. 348–49. substances. Id. at 256. still employed there. Id. at 98–99. After 10 The evidence shows that S.C. was hospitalized being told that she was, the pharmacist 9 Prior to working in Naples, Respondent worked for seizures on two occasions, May 28, 2009, and gave the prescription back to S.C. and at a hospital in Fort Myers. RX A, at 1–2. July 3, 2009. See GX 15 & 16. called the sheriff. Id. at 99.

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Respondent testified that she still Discussion not adopt the ALJ findings that believes that the prescriptions she Section 303(f) of the Controlled Respondent violated federal law by issued S.C. were within the usual course Substances Act (CSA) provides that an issuing prescriptions while working as a of professional practice and for a application for a practitioner’s contract physician at the Northern legitimate medical purpose. Id. at 277. registration may be denied ‘‘if the Navajo Medical Center without being However, Respondent then stated that Attorney General determines that the registered in New Mexico, I find that ‘‘[i]n hindsight . . . my judgment was issuance of such registration . . . would Respondent acted outside the usual impaired because of the relationship I be inconsistent with the public course of professional practice and had with the individual,’’ the interest.’’ 21 U.S.C. 823(f). With respect lacked a legitimate medical purpose in prescriptions ‘‘were not within . . . the to a practitioner, the Act requires the issuing the prescriptions to S.C. standards of my medical practice.’’ Id. consideration of the following factors in Notwithstanding her claim that her Yet Respondent later asserted that she making the public interest conduct in prescribing to S.C. is an ‘‘was definitely manipulated and taken determination: aberration, I find it to be egregious. And advantage of. I was victimized.’’ Id. at based on her insistence that even now, (1) The recommendation of the appropriate 350. she still believes these prescriptions State licensing board or professional were legitimate, I conclude that Respondent also testified that at the disciplinary authority. (2) The applicant’s experience in Respondent has failed to produce time she wrote the prescriptions she sufficient evidence to demonstrate why believed they were ‘‘medically dispensing . . . controlled substances. (3) The applicant’s conviction record under she should be entrusted with a necessary’’ because there was a ‘‘prior Federal or State laws relating to the registration.13 diagnosis of chronic pain.’’ Id. And manufacture, distribution, or dispensing of when asked whether, ‘‘[s]itting here controlled substances. Factors Two and Four—Respondent’s today, knowing what you do today, do (4) Compliance with applicable State, Experience in Dispensing Controlled you still believe that they were Federal, or local laws relating to controlled Substances and Compliance With medically necessary at the time?’’ substances. Applicable Laws Related to Controlled Respondent answered: ‘‘[y]es.’’ Id. (5) Such other conduct which may threaten Substances the public health and safety. Respondent did acknowledge that she To effectuate the dual goals of violated Florida’s regulations by failing Id. § 823(f). conquering drug abuse and controlling ‘‘These factors are . . . considered in to ‘‘keep proper documentation of each both the legitimate and illegitimate the disjunctive.’’ Robert A. Leslie, M.D., visit.’’ Id. at 351. She then maintained traffic in controlled substances, 68 FR 15227, 15230 (2003). It is well that through the continuing medical ‘‘Congress devised a closed regulatory settled that I ‘‘may rely on any one or education course she was required to system making it unlawful to a combination of factors[,] and may give take under the Florida Board’s Order, ‘‘I manufacture, distribute, dispense, or each factor the weight [I] deem[] realize that will never happen again.’’ possess any controlled substance except appropriate in determining whether a Id.11 registration should be revoked. Id.; see 13 I acknowledge that Respondent remains also MacKay v. DEA, 664 F.3d 808, 816 licensed in various States, including Pennsylvania, 11 During its examination of Respondent, the (10th Cir. 2011); Volkman v. DEA, 567 the State where she seeks registration and therefore Government asked her if her attorney had spoken meets the CSA’s prerequisite for holding a ‘‘with a DEA representative about whether [she] F.3d 215, 222 (6th Cir. 2009); Hoxie v. practitioner’s registration in that State. See 21 needed to obtain a DEA registration in New DEA, 419 F.3d 477, 482 (6th Cir. 2005). U.S.C. 823(f) (‘‘The Attorney General shall register Mexico.’’ Tr. 199. Respondent’s counsel objected, Moreover, while I am required to practitioners . . . to dispense . . . controlled asserting that this was a privileged communication consider each of the factors, I ‘‘need not substances . . . if the applicant is authorized to and the ALJ sustained the objection. Id.; see also dispense . . . controlled substances under the laws R.D. at 39 (‘‘I sustained [Respondent’s] objection to make explicit findings as to each one.’’ of the State in which he practices.’’). the question, finding that the response was likely MacKay, 664 F.3d at 816 (quoting However, the possession of state authority ‘‘‘is to call for the disclosure of information protected Volkman, 567 F.3d at 222 (quoting not dispositive of the public interest inquiry.’’’ by the attorney client privilege. I continue to Hoxie, 419 F.3d at 482)).12 George Mathew, 75 FR 66138, 66145 (2010), pet. for believe the sought-after response would likely have rev. denied Mathew v. DEA, No. 10–73480, slip op. called for [Respondent] to disclose what Mr. Leider In this matter, I have considered all of at 5 (9th Cir., Mar. 16, 2012); see also Patrick W. [her attorney] did or did not tell her in the course the factors and conclude that the Stodola, 74 FR 20727, 20730 n.16 (2009). As the of his representation of her.’’). Government’s evidence with respect to Agency has long held, ‘‘the Controlled Substances Notably, in his Recommended Decision, the ALJ factors two (Respondent’s experience in Act requires that the Administrator . . . make an did not cite a single case to support his ruling and independent determination [from that made by state I conclude that his ruling was erroneous. ‘‘The dispensing controlled substances), four officials] as to whether the granting of controlled privilege ‘protects only those disclosures necessary (Respondent’s compliance with substance privileges would be in the public to obtain informed legal advice which might not applicable laws related to controlled interest.’’ Mortimer Levin, 57 FR 8680, 8681 (1992). have been made absent the privilege.’ ’’ In re Walsh, substances), and five (such other Accordingly, this factor is not dispositive either for, 623 F.2d 489,494 (7th Cir. 1980) (quoting Fisher v. or against, the granting of Respondent’s United States, 425 U.S. 391, 403 (1976)). Moreover, conduct) establishes that she ‘‘has applications. Paul Weir Battershell, 76 FR 44359, ‘‘‘when an attorney conveys to his client facts committed such acts as would render 44366 (2011) (citing Edmund Chein, 72 FR 6580, acquired from other persons or sources, those facts [her] registration under section 823 of 6590 (2007), pet. for rev. denied Chein v. DEA, 533 are not privileged.’ ’’ See In re Sealed Case, 737 F.2d this title inconsistent with the public F.3d 828 (D.C. Cir. 2008)). 94, 100 (D.C. Cir. 1984)) (quoting Brinton v. As for factor three, there is no evidence that Department of State, 636 F.2d 600, 604 (D.C. Cir. interest.’’ 21 U.S.C. 824(a)(4). While I do Respondent has been convicted of an offense 1980) (footnote omitted)). Because the question did ‘‘relating to the manufacture, distribution or not ask Respondent to disclose what facts she had 12 ‘‘In short, this is not a contest in which score dispensing of controlled substances.’’ 21 U.S.C. communicated to her lawyer or the legal advice she is kept; the Agency is not required to mechanically 823(f)(3). However, there are a number of reasons received from her lawyer, the ALJ erred in barring count up the factors and determine how many favor why even a person who has engaged in misconduct the testimony. See United States v. DeFazio, 899 the Government and how many favor the registrant. may never have been convicted of an offense under F.2d 626, 635 (7th Cir. 1990) (holding that where Rather, it is an inquiry which focuses on protecting this factor, let alone prosecuted for one. Dewey C. attorney ‘‘testified only to what [an] IRS agent said the public interest; what matters is the seriousness MacKay, 75 FR 49956, 49973 (2010), pet. for rev. to him, and that he later relayed those statements of the registrant’s misconduct.’’ Jayam Krishna-Iyer, denied MacKay v. DEA, 664 F.3d 808 (10th Cir. to [defendant,] [t]he content of this testimony is 74 FR 459, 462 (2009). Accordingly, as the Tenth 2011). The Agency has therefore held that ‘‘the unprivileged because it did not reveal, either Circuit has recognized, findings under a single absence of such a conviction is of considerably less directly or implicitly, legal advice given [defendant] factor can support the revocation of a registration. consequence in the public interest inquiry’’ and is or any client confidences’’). MacKay, 664 F.3d at 821. therefore not dispositive. Id.

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in a manner authorized by the CSA.’’ mixing, or otherwise preparing . . . any and agreements; and 9. [p]eriodic Gonzales v. Raich, 545 U.S. 1, 13 (2005). controlled substance, other than in the reviews.’’ Id. at 64B8–9.013(f). Consistent with the maintenance of the course of the physician’s professional While Respondent asserted that she closed regulatory system, a controlled practice.’’ Fla. Stat. § 458.331(q). The did a physical examination and that she substance may only be dispensed upon statute further explains that knew ‘‘about [S.C.’s] chronic pain a lawful prescription issued by a ‘‘prescribing, dispensing . . . or syndrome’’ from talking to both him and practitioner. Carlos Gonzalez, M.D., 76 otherwise preparing . . . controlled his parents, Tr. 214, the fact remains FR 63118, 63141 (2011). substances, inappropriately or in that she failed to document and Fundamental to the CSA’s scheme is excessive or inappropriate quantities is maintain any medical records to support the Agency’s longstanding regulation, not in the best interest of the patient and the prescriptions. Indeed, she which states that ‘‘[a] prescription for a is not in the course of the physician’s specifically denied having diagnosed controlled substance [is not] effective professional practice.’’ Id.; see also Fla. S.C. as having chronic pain, asserting [unless it is] issued for a legitimate Stat. § 893.05(1) (‘‘A practitioner, in that the diagnosis ‘‘was established medical purpose by an individual good faith and in the course of his or her already’’ by S.C.’s ‘‘prior physician,’’ id. practitioner acting in the usual course of professional practice only, may at 229, and that she wrote the his professional practice.’’ 21 CFR prescribe . . . a controlled prescriptions by ‘‘cop[ying] the 1306.04(a). This regulation further substance[.]’’). prescription off the bottles’’ S.C. showed provides that ‘‘an order purporting to be As found above, while Respondent her. Id. at 217. Yet, notwithstanding that a prescription issued not in the usual neither admitted nor denied the factual those prescriptions were legally course of professional treatment . . . is allegations of the Administrative required to contain the name of the not a prescription within the meaning Complaint which was filed against her prescribing physician, see 21 CFR and intent of [21 U.S.C. 829] and . . . by the Florida Board, she did admit that 1306.14(a), and no claim is made that the person issuing it, shall be subject to if those facts were proven, they would they did not, Respondent never called 15 the penalties provided for violations of establish violations of the Florida S.C.’s prior physician. the provisions of law relating to Statutes as alleged in the Complaint, When then asked how she knew if controlled substances.’’ Id. including not only that she failed to Respondent’s prior physician would As the Supreme Court has explained, meet the prevailing standard of care, but have continued S.C. on narcotic ‘‘the prescription requirement . . . also that she prescribed controlled controlled substances, Respondent ensures patients use controlled substances other than in the course of replied that ‘‘[w]hen you’re on substances under the supervision of a controlled substances you just don’t her professional practice. See GX 8, at doctor so as to prevent addiction and stop . . . you have to go through either 2 (citing Fla. Stat. Chap. 458). In this recreational abuse. As a corollary, [it] a weaning process—that’s why it proceeding, the material facts set forth also bars doctors from peddling to requires a specialist to . . . continue in the Board’s complaint have been patients who crave the drugs for those treating once you’re up to a certain proven. prohibited uses.’’ Gonzales v. Oregon, number of high dose pain medication.’’ Moreover, under the Florida Board of 546 U.S. 243, 274 (2006) (citing United Tr. 234–35. Unexplained by Respondent States v. Moore, 423 U.S. 122, 135, 143 Medicine’s then-existing Standards for is why she wrote S.C. prescriptions (1975)); United States v. Alerre, 430 the Use of Controlled Substances for the totaling 400 dosage units of OxyContin F.3d 681, 691 (4th Cir. 2005), cert. Treatment of Pain: 80mg, given her testimony that a patient denied, 574 U.S. 1113 (2006) (stating A complete medical history and physical who is on a ‘‘high dose [of] pain that the prescription requirement examination must be conducted and medication,’’ ‘‘requires a specialist,’’ id., likewise stands as a proscription against documented in the medical record. The which she is not, as well as her doctors acting not ‘‘as a healer[,] but as medical record should document the nature admission that she ‘‘was not familiar a seller of wares’’). and intensity of the pain, current and past with treating chronic pain.’’ Id. at 218. treatment for pain, underlying or coexisting Under the CSA, it is fundamental that disease or conditions, the effect of the pain Moreover, Respondent repeatedly a practitioner must establish and on physical and psychological function, and provided S.C. with prescriptions which maintain a legitimate doctor-patient history of substance abuse. The medical enabled him to obtain schedule II relationship in order to act ‘‘in the usual record also should document the presence of controlled substances including course of . . . professional practice’’ one or more recognized medical indications OxyContin 80mg and oxycodone 30mg, and to issue a prescription for a for the use of a controlled substance. drugs which are among the most highly ‘‘legitimate medical purpose.’’ Paul H. Fla. Admin R. 64B8–9.013(3)(a).14 abused and diverted controlled Volkman, 73 FR 30629, 30642 (2008), The State’s Standards also required a substances, in quantities which greatly pet. for rev. denied, 567 F.3d 215, 223– physician ‘‘to keep accurate and exceeded both her own dosing 24 (6th Cir. 2009); see also Moore, 423 complete records to include, but not be instructions and DEA regulations. As U.S. at 142–43 (noting that evidence limited to: 1. [t]he medical history and found above, on or about February 7, 2008, Respondent issued S.C. established that the physician exceeded physical examination, including history prescriptions for 400 dosage units of the bounds of professional practice, of drug abuse or dependence, as OxyContin 80mg. Putting aside that when ‘‘he gave inadequate physical appropriate; 2. [d]iagnostic, therapeutic, Respondent wrote two different dosing examinations or none at all,’’ ‘‘ignored and laboratory results; 3. [e]valuations instructions on the three prescriptions the results of the tests he did make,’’ and consultations; 4. [t]reatment and ‘‘took no precautions against . . . objectives; 5. [d]iscussion of risks and 15 Respondent also testified that she looked at misuse and diversion’’). The CSA, benefits; 6.[t]reatments; 7. [m]edications however, generally looks to state law to S.C.’s medical records. Thus, she clearly had (including date, type, dosage, and available to her information as to Respondent’s determine whether a doctor and patient quantity prescribed); 8. [i]nstructions prior physician. While Respondent testified that have established a legitimate doctor- S.C. was no longer seeing this physician because patient relationship. Volkman, 73 FR at ‘‘he lost his medical insurance,’’ id. at 216, as well 14 This version of the Standards was promulgated as that ‘‘he did not wish to . . . see that physician 30642. in 1999, amended in both 2002 and 2003, and any longer,’’ id. at 219, because she never called the In Florida, a physician is barred from remained in effect until a new version of the physician, she had no idea if S.C. had told her the ‘‘prescribing, dispensing, administering, Standards was promulgated in 2010. truth or if his prior physician had discharged him.

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(one prescription calling for one tablet None of these explanations provides a CFR 1306.05(a) (‘‘All prescriptions for every 12 hours, the other two calling for persuasive justification that mitigates controlled substances shall be dated as one tablet every eight hours), these her misconduct. As for the first one, of, and signed on, the day when issued dosing instructions provided S.C. with surely the Los Angeles area has an and shall bear the full name and address more than a 149-day supply of the ample supply of pain management of the patient . . . .’’). As for why she drug.16 However, under DEA specialists who could have treated S.C. did not date the prescriptions and regulations, Respondent could lawfully were he to run out of medication. include S.C.’s address on them, prescribe a maximum of a 90-day Moreover, even if S.C. was a legitimate Respondent offered the ludicrous supply. See 21 CFR 1306.12(b)(1). patient, given her testimony that explanation that because of a young Notwithstanding that she had written patients on high doses of narcotics child, the dogs, the monkey, and S.C.’s the three OxyContin prescriptions only require a specialist to continue their hard-of-hearing father (who required one month earlier and that if treatment, Respondent’s decision to that the volume on the TV be ‘‘very Respondent took the drugs in provide S.C. with an eight-month loud’’), ‘‘it was a very distracting accordance with her dosing supply of oxycodone when she had no environment.’’ Tr. 222. Yet somehow instructions, he would have had at least ability to supervise his medication Respondent was able to include on the a four-month supply of the drug use—not that that ever appeared to be prescriptions the drug name, the dosage remaining, on or about March 10, 2008, a concern to her—reflects a stunning strength, the quantity, a dosing Respondent wrote S.C. three more disregard for her obligations as a instruction, as well as her DEA number, prescriptions. Each of these prescriber of controlled substances. See printed name and signature. In short, I prescriptions authorized the dispensing Gonzales, 546 U.S. at 274 (‘‘the do not find her testimony credible as to of 450 dosage units of oxycodone 30mg, prescription requirement . . . ensures why the prescriptions were undated. and, with a dosing instruction of up to patients use controlled substances While Respondent apparently ceased 15 tablets or 450 milligrams per day, under the supervision of a doctor so as her prescribing to S.C. while he was in provided S.C. with an additional thirty- to prevent addiction and recreational Los Angeles, she resumed prescribing to day supply. By comparison, the abuse’’). him in January 2009, notwithstanding OxyContin prescriptions provided a As for the explanation that S.C. told that with his opportunities and the daily dose of 160 or 240mg per day. her that he needed additional ‘‘contracts he was getting,’’ S.C. Assuming S.C. took the full fifteen prescriptions because the pharmacies presumably could have afforded to see tablets per day, the three March 10, were out of either the branded a pain management specialist. Tr. 249. 2008 prescriptions provided S.C. with medication (such as OxyContin) or the As found above, between February 3 an additional 90-day supply of particular dosage strength, or that he left and March 6, 2009, Respondent issued the prescription at the pharmacy, S.C. eleven prescriptions for 90 oxycodone. Thus, based on her own Respondent never called any of the Roxicodone (oxycodone) 30mg. dosing instructions, the February and pharmacies to verify S.C.’s claims. Tr. Moreover, on several dates, Respondent March 2008 prescriptions provided S.C. 241 & 252. Moreover, even if the issued S.C. two or more prescriptions. with nearly an eight-month supply of pharmacies S.C. used were out of Based on her dosing instruction of oxycodone. OxyContin, Respondent offered no one tablet, three times per day, the As for why she issued these six explanation as to why, in a one-month prescriptions authorized the dispensing prescriptions, Respondent offered period, she increased S.C.’s daily dose of 990 tablets of oxycodone 30mg, or an multiple explanations. First, regarding of oxycodone from either 160 or 240mgs eleven-month supply of the drug. the OxyContin prescriptions, per day (depending upon which Moreover, on March 6, Respondent Respondent testified that S.C. had told prescription she wrote) to 450mgs per issued S.C. a prescription for 280 her he was going to be in Los Angeles day. Roxicodone 15 mg (also with a dosing for three to six months filming a show Then there is Respondent’s testimony instruction of one tablet, three times per for MTV and did not want to run out of that she believed S.C. when he told her day). Thus, between February 3 and medication. Tr. 227. Second, she that his pet monkey was opening his March 6, 2009, Respondent’s asserted that S.C. told her that the pill bottles and throwing the drugs in prescriptions provided S.C. with more monkey ‘‘would take the pill bottle, the pool. While Respondent initially than a one-year supply of oxycodone if open it, and throw it in the pool.’’ Id. offered this far-fetched story to explain he actually took the drugs as directed. at 240–41. Third, she claimed that S.C why she had written the three undated As for why she issued S.C. the two required additional prescriptions oxycodone 30mg prescriptions, all of February 3 prescriptions, Respondent because the pharmacy was either out of which were filled on the same date testified that S.C. had called her and stock of the particular brand or dosage, (March 10, 2008) and bore serial told her that the pharmacy he initially or that he left the prescription at the numbers suggesting they were all went to was out of stock and that he left pharmacy. Id. at 241 & 245. written in close temporal proximity, she the prescription there. Once again, offered no testimony to the effect that Respondent merely accepted S.C.’s 16 This calculation was based on Respondent’s she had asked to see the pill bottles to story, which was only partially true, and actual dosing instructions for each prescription. determine if the prescriptions had did not call the pharmacy. These three prescriptions would have provided a 200-day supply of the drug had I calculated this actually been filled. Moreover, While Respondent maintained that figure using a dosing instruction of one tablet every Respondent eventually backtracked on she did not find this suspicious because twelve hours for all three prescriptions, which is this testimony, explaining that it was some of her ER patients had complained consistent with the manufacturer’s prescribing ‘‘unclear[] which set of prescriptions it that a pharmacy would not have a instructions. See Physician’s Desk Reference 2707 (61st ed. 2007) (‘‘It is most appropriate to increase may have occurred with.’’ Tr. 241. particular drug, she could not recall if the q12h dose, not the dosing frequency. There is Accordingly, I find this testimony she had ever had another patient claim no clinical information on dosing intervals shorter incredible. that he/she needed a new prescription than q12h.’’); see also id. (‘‘The intent of the Respondent further violated DEA because the pharmacist had kept it. titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia regulations because she failed to date When then asked why the pharmacist with acceptable side effects for as long as pain relief the three March 2008 prescriptions and would not have simply returned the is necessary.’’). include S.C.’s address on them. See 21 prescription to S.C., Respondent

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asserted that was ‘‘how they operated prescriptions with full knowledge that an aberrant set of circumstances that are down there’’ and that she ‘‘was new to S.C. was going off to California for unlikely to ever be repeated.’’ Id. the State,’’ even though she had worked several months and that she would have It is acknowledged that except for the in Florida for more than four years at no ability to monitor him. And she matters at issue here, Respondent has that point. Yet the evidence shows that failed to create any medical records and practiced medicine as an ER physician every single prescription she issued to a written treatment plan. for approximately sixteen years and S.C. in this period was filled, see GX 1, As for the 2009 prescriptions, dispensed controlled substances at 17–35, and while the first February 3 notwithstanding that she had not without incident. It also acknowledged prescription was only partially filled ‘‘treated’’ S.C. in nearly ten months, she that two of her co-workers wrote letters (with the pharmacy dispensing 54 could not recall if she had done a attesting to her ability as a clinician. See tablets), even if the pharmacy could not physical exam. Moreover, within a one- RX P & R. fill the remaining portion of the month period, she provided him with I nonetheless reject her contention prescription within 72 hours, see 21 more than a one-year supply of that her misconduct is an aberration. As CFR 1306.13(a), there was no need for oxycodone based on her own dosing the evidence shows, Respondent Respondent to issue him a second instructions. As for her testimony that engaged in two separate bouts of prescription for a full 90 tablets. she believed the various excuses S.C. unlawful prescribing. Indeed, while her As for why she then issued S.C. three offered for why he needed additional prescribings to S.C. in the February– more prescriptions just six days later prescriptions, and did so even when the March 2008 time period were egregious (on Feb. 9), Respondent initially excuse was patently absurd, the ALJ did (providing him with 1750 tablets of claimed that S.C. had begun having not find this credible. Nor do I. And highly abused schedule II narcotics), in seizures and was becoming forgetful, here again, she failed to create any January 2009, she resumed prescribing but then acknowledged that this did not medical records and a written treatment to him, providing him with more than happen until three months later. Other plan. another 1,000 pills of this highly abused than in her earlier ludicrous testimony I therefore conclude that with the narcotic in a one-month period. that the monkey was throwing S.C.’s exception of the Percocet prescription Moreover, notwithstanding her admitted drugs in the pool or that Respondent she wrote when she treated S.C. in the lack of familiarity with treating chronic was leaving the drugs in his hotel room, ER, Respondent repeatedly acted pain, and that while S.C. was in LA, she or the drugs had been stolen—none of outside of the usual course of had months to reflect on her prescribing which was documented in a medical professional practice and lacked a practices with respect to him as well as record because she maintained none on legitimate medical purpose when she to familiarize herself with Florida’s S.C.—Respondent failed to address why prescribed oxycodone (including standards for using controlled she issued S.C. three more prescriptions OxyContin) to him. See 21 CFR substances to treat pain, Respondent the next day. So too, Respondent failed 1306.04(a). While Respondent contends resumed prescribing to S.C. a highly to address why she wrote the multiple ‘‘that her actions were not for personal abused narcotic in unlawful quantities, prescriptions on February 20 and March gain,’’ Resp. Post-Hrng. Br. at 36, to see 21 CFR 1306.12(b)(1), that also 6. greatly exceeded what was medically In her testimony, Respondent sustain a violation, the Government was not required to prove that she provided necessary according to her own dosing maintained ‘‘that over time’’ she ‘‘lost instructions. the physician/patient relationship.’’ Tr. the prescriptions in exchange for either money or to obtain S.C.’s affection. In I therefore find that the Government’s 220. To the contrary, the evidence evidence with respect to factors two and suggests that the only time she sum, I conclude that Respondent knowingly diverted controlled four establishes that Respondent has prescribed to S.C. pursuant to a valid committed such acts as to render her doctor-patient relationship was in substances when she prescribed to S.C. ‘‘registration inconsistent with the August 2007, when she treated him for I also conclude that Respondent public interest.’’ 17 I further find that his broken hand in the ER. Her violated Agency regulations requiring testimony as to whether she performed that she: (1) Date the prescriptions as of the date of their issuance, 21 CFR 17 While I have considered the allegation that physical examinations of S.C. was Respondent violated the CSA by issuing exceedingly vague and changed, both as 1306.05(a); (2) include S.C.’s address on prescriptions while working at the Northern Navajo to the dates she performed these exams the prescriptions, see id. ; (3) where Medical Center without being licensed by New and the scope of the exams. Indeed, she issuing multiple prescriptions for Mexico and registered with DEA in that State, I schedule II drugs, not prescribe more decline to rule on the allegation because several explicitly denied having even made a material issues have not been adequately addressed. diagnosis, id. at 229, claiming that S.C.’s than a 90-day supply, 21 CFR While the Government elicited testimony from a prior physician had done that, and yet 1306.12(b)(1); and (4) where issuing registration program specialist to the effect that in she proceeded to provide him with multiple prescriptions, ‘‘provide[] order for Respondent to obtain a registration in New written instructions on each Mexico, she was required to obtain a New Mexico prescriptions for more than 1750 tablets medical license, it is unclear whether New Mexico of two of the most highly abused prescription . . . indicating the earliest has authority to require a federal contract physician prescription narcotics (400 OxyContin date on which a pharmacy may fill each to be licensed in the State if she works solely at an 80mg and 1350 oxycodone 30mg) prescription. Id. 1306.12(b)(ii). She also IHS facility. The limited case law suggests to the violated Florida law and regulations by contrary. See Taylor v. United States, 821 F.2d without even calling S.C.’s prior 1428, 1431 (9th Cir. 1987) (noting that under the physician. She also offered no failing to create medical records. Supremacy Clause, a State ‘‘lacks power to require explanation for the inconsistency Respondent nonetheless argues that licensing of federal health care providers and between the dosing instructions on the she ‘‘has had a long career in emergency physicians’’ and that ‘‘[t]he United States has . . . essentially deemed [an] Army [h]ospital and its staff various OxyContin prescriptions or for medicine and has had no instances of fit to provide health care services’’); United States increasing S.C.’s daily dose of malpractice or disciplinary action prior v. Composite State Bd. of Medical Examiners, 656 oxycodone from 240mgs (per the to the instant case.’’ Resp. Exceptions, at F.2d 131, 135 n.4 (5th Cir. 1981) (citing Sperry v. OxyContin prescriptions) to 450mgs per 11. She further contends that ‘‘[t]he Florida ex rel. Florida Bar, 373 U.S. 379 (1963)). Cf. 25 U.S.C. 1621t (‘‘Licensed health professionals day (per the oxycodone 30 events surrounding her relationship employed by a tribal health program shall be prescriptions) only one month later. with S.C. and her treatment of his exempt, if licensed in any State, from the licensing Moreover, she provided the first set of purported medical conditions represent requirements of the State in which the tribal health

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Respondent’s misconduct was egregious answer [the DI’s] questions to resolve Accordingly, I find that substantial and makes out a prima facie case for the liability issues she noted on her evidence supports a finding that denying her application. renewal application in the absence of an Respondent lacked candor when she attorney, and made no attempt to testified in this proceeding. See Hoxie v. Factor Five—Such Other Conduct arrange a subsequent meeting with [the DEA, 419 F.3d 477, 483 (‘‘Candor during Which May Threaten Public Health and DI], with or without counsel.’’ R.D. at DEA investigations properly is Safety 65–66. The ALJ thus reasoned that considered by the DEA to be an The ALJ also found that Respondent ‘‘Respondent’s failure to cooperate . . . important factor when assessing engaged in actionable misconduct under suggests a substantial and willful whether a . . . registration is consistent this factor. More specifically, the ALJ disregard for her duty to comply with with the public interest.’’). Thus, I found, inter alia, that: (1) Respondent DEA directives as a regulated entity’’ conclude that the record supports a lacked candor in her testimony and ‘‘[t]his conduct threatens public finding that Respondent lacked candor regarding her prescribings to S.C.; and health and safety.’’ Id. at 66. when she testified in this proceeding (2) she failed to cooperate with DEA I find the ALJ’s reasoning and that she has committed such other Investigators who were investigating her unpersuasive. Respondent was entitled conduct which may threaten public 2012 renewal application. R.D. at 63–66. to consult with her attorney before health and safety. 21 U.S.C. 823(f)(5). Of these, I conclude that only the first answering the DI’s questions and had no finding is supported by substantial obligation to agree to an interview Sanction evidence. without her attorney being present. Under Agency precedent, where, as As for the second contention, the Moreover, the DI offered no testimony to here, ‘‘the Government has proved that evidence showed that during the course the effect that he made any further [an applicant] has committed acts of investigating her renewal application, attempt to interview her, let alone that inconsistent with the public interest, the Agency Investigators went to a hospital she rebuffed a further interview request [applicant] must ‘‘ ‘present sufficient at which Respondent was then working or that she agreed to an interview and mitigating evidence to assure the and asked to speak to her about the then failed to follow through. Administrator that [she] can be ‘‘yes’’ answer she had provided to one Accordingly, I reject the ALJ’s finding entrusted with the responsibility carried of the liability questions on the and conclusion as unsupported by by such a registration.’ ’’’ ’’ Medicine application. Tr. 388. Respondent substantial evidence. Shoppe-Jonesborough, 73 FR 364, 387 declined to answer any questions However, I agree with the ALJ’s legal (2008) (quoting Samuel S. Jackson, 72 without an attorney being present. Id. conclusion that Respondent lacked FR 23848, 23853 (2007) (quoting Leo R. While the Investigators then explained candor in her testimony. More Miller, 53 FR 21931, 21932 (1988))). ‘‘this was not a criminal investigation’’ specifically, as ultimate factfinder, see 5 ‘‘Moreover, because ‘past performance is and that it ‘‘was purely regulatory in U.S.C. 557(b), I do not find credible her the best predictor of future scope’’ as it involved the Florida Board testimony that she did not know performance,’ ALRA Labs, Inc. v. DEA, matter, Respondent again refused ‘‘to ‘‘exactly why’’ she did not include the 54 F.3d 450, 452 (7th Cir. 1995), [DEA] discuss the matter.’’ Id. at 390. The DI date and S.C.’s address on the has repeatedly held that where [an then testified that he was never able to OxyContin 80mg and Oxycodone 30mg applicant] has committed acts complete his interview of Respondent. prescriptions other than that S.C.’s inconsistent with the public interest, the Id. at 391; 398. house was a ‘‘very distracting’’ [applicant] must accept responsibility Based on this evidence, the ALJ found environment. Tr. 222. As found above, for [her] actions and demonstrate that that Respondent ‘‘flatly refused to notwithstanding her assertion, [she] will not engage in future Respondent was not so distracted that misconduct.’’ Medicine Shoppe, 73 FR program performs the services described in the she failed to include on the at 387; see also Jackson, 72 FR at 23853; contract or compact of the tribal health program under the Indian Self-Determination and Education prescriptions such required information John H. Kennedy, 71 FR 35705, 35709 Assistance Act.’’). However, this determination is as the name of the drug, its dosage (2006); Prince George Daniels, 60 FR not within the Agency’s authority. strength, the quantity, and her signature. 62884, 62887 (1995). See also Hoxie v. Moreover, the Government does not address Id. DEA, 419 F.3d at 483 (‘‘admitting fault’’ whether a physician is nonetheless required to Nor do I find credible her testimony is ‘‘properly consider[ed]’’ by DEA to be obtain a registration specific to an IHS facility if the State lacks authority to require a physician to obtain that she palpated S.C.’s back and neck an ‘‘important factor[]’’ in the public a license in that State, or whether a physician who as part of the physical exams she interest determination). does not possess a license in the State where the claimed to have performed. Id. at 263. So too, in making the public interest facility is located and is not required to possess As found above, at several earlier points determination, ‘‘this Agency places such a license, can nonetheless obtain a registration for that location. in her testimony, Respondent described great weight on an [applicant’s] candor, Because I find that the Government has otherwise the physical exam she performed as both during an investigation and in [a] proved that Respondent’s continued registration is listening to S.C.’s heart and lungs, subsequent proceeding.’’ Robert F. inconsistent with public interest and that she has making no mention of having palpated Hunt, 75 FR 49995, 50004 (2010) (citing failed to produce sufficient evidence to rebut this conclusion, I decline to remand the matter or issue any part of S.C. See id. at 214 & 244– The Lawsons, Inc., t/a The Medicine a briefing order. On this record, I decline to adopt 45. Indeed, she asserted that she Shoppe Pharmacy, 72 FR 74334, 74338 the ALJ’s conclusions of law (# 8, 9, and 10) that palpated S.C.’s back and neck only after (2007) (quoting Hoxie, 419 F.3d at 483 Respondent violated federal law because she issued prescriptions while practicing at the Northern the Government specifically asked her if (‘‘Candor during DEA investigations Navajo Medical Center without being registered in she did. Id. at 263. properly is considered by the DEA to be New Mexico and that she is not exempt from Finally, I do not find credible an important factor when assessing registration in that State. See R.D. 74. I also decline Respondent’s testimony that she wrote whether a . . . registration is consistent to adopt the ALJ’s finding that Respondent’s ‘‘decision to rely exclusively on representations the multiple oxycodone 30mg with the public interest.’’))). made to her by her future employers constitutes a prescriptions because she actually Moreover, while an applicant must willful and reckless disregard for her duty to believed S.C.’s claim that the monkey accept responsibility and demonstrate inquire of the DEA regarding the need for re- had taken the pill bottle, managed to that she will not engage in future registration and in-state licensure,’’ R.D. at 64, and that this is actionable misconduct under factor five. open it, and then threw the medication misconduct in order to establish that her Id. in the pool. Id. at 240–41, 341. registration is consistent with the public

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interest, DEA has repeatedly held these In his decision, the ALJ acknowledged While this testimony would have are not the only factors that are relevant that Respondent produced some supported a finding that Respondent has in determining the appropriate sanction. evidence of remedial measures she has accepted responsibility for her See, e.g., Joseph Gaudio, 74 FR 10083, undertaken. R.D. at 68. More misconduct, at other points, she offered 10094 (2009); Southwood specifically, the evidence shows that testimony that substantially undermines Pharmaceuticals, Inc., 72 FR 36487, Respondent completed a four-day this conclusion. Notwithstanding her 36504 (2007). Obviously, the course in controlled substance earlier admission that she lost the egregiousness and extent of an management and a two-day course in doctor/patient relationship (not that she applicant’s misconduct are significant medical record keeping. RXs F & I. ever had one outside of S.C.’s ER visit), factors in determining the appropriate However, based on Respondent’s she then testified that ‘‘I was definitely sanction. See Jacobo Dreszer, 76 FR testimony, the ALJ also found that ‘‘it is manipulated and taken advantage of. I 19386, 19387–88 (2011) (explaining that far from clear that the courses have was victimized.’’ Tr. 350. Respondent’s a respondent can ‘‘argue that even brought about changes in [her] that statement is simply irreconcilable with though the Government has made out a would support continued DEA the obligations imposed on a physician prima facie case, his conduct was not so registration.’’ R.D. at 68. As the ALJ who is entrusted with the authority to egregious as to warrant revocation’’); explained, ‘‘[e]ven now, Respondent prescribe controlled substances. Paul H. Volkman, 73 FR 30630, 30644 would attribute her action to being So too, notwithstanding her testimony (2008); see also Gregory D. Owens, 74 victimized by . . . SC’s conduct, while that the prescriptions ‘‘were not within FR 36751, 36757 n.22 (2009). averring that she believed, at the time, Moreover, as I have noted in several that her prescription practice was . . . the standards of my medical cases, ‘‘ ‘[n]either Jackson, nor any other compliant with DEA regulations.’’ Id. practice’’ and her having taken a course agency decision, holds . . . that the The ALJ thus concluded that in controlled substance management, Agency cannot consider the deterrent ‘‘Respondent has [not] admitted to the Respondent testified that she still value of a sanction in deciding whether full extent of her . . . misconduct.’’ Id. believes she issued the prescriptions for a registration should be revoked’ ’’ or an Respondent takes exception to the a legitimate medical purpose. Tr. 277. application should be denied. Gaudio, ALJ’s conclusion that she has failed to Still later in her testimony—and after 74 FR at 10094 (quoting Southwood, 72 accept responsibility for her maintaining that she was victimized by FR at 36504 (2007)); see also Robert misconduct, contending that this ‘‘is S.C.—she again testified that knowing Raymond Reppy, 76 FR 61154, 61158 contradicted by the facts in the record.’’ what she knows today, she still believes (2011); Michael S. Moore, 76 FR 45867, Exceptions, at 2. Respondent argues that that the prescriptions were medically 45868 (2011). This is so, both with she ‘‘readily admitted to losing the necessary. Id. at 277–78. respect to the respondent in a particular physician-patient relationship when In short, this suggests that Respondent case and the community of registrants. treating S.C.’’ and that she ‘‘also has learned nothing from the various See Gaudio, 74 FR at 10095 (quoting admitted that she violated Florida law state board proceedings, the course she Southwood, 71 FR at 36504). Cf. and standards of practice when she took in controlled substance McCarthy v. SEC, 406 F.3d 179, 188–89 treated S.C. without creating a medical management, or this Proceeding. (2d Cir. 2005) (upholding SEC’s express record, [a] written treatment plan, etc.’’ Accordingly, I have no confidence that adoptions of ‘‘deterrence, both specific Id. at 3–4. she will refrain from similar acts were and general, as a component in It is acknowledged that at various she to become love struck with a drug analyzing the remedial efficacy of points in her testimony, Respondent abuser or diverter in the future. Her sanctions’’).18 admitted to several professional failings. equivocal testimony provides For example, she admitted that it was substantial evidence to support a 18 Thus, in Gaudio, ‘‘I explained that ‘even when her error to accept S.C.’s word rather finding that she does not accept a proceeding serves a remedial purpose, an than call his prior physician. She also responsibility for her misconduct. administrative agency can properly consider the testified that she ‘‘lost the physician/ need to deter others from engaging in similar acts.’ ’’ patient relationship’’ and ‘‘was not As explained above, notwithstanding 74 FR at 10094 (quoting Southwood, 72 FR at her contention that her prescribing to 36504) (citing Butz v. Glover Livestock Commission objective.’’ Still later, she testified that Co., Inc., 411 U.S. 182, 187–88 (1973)); cf. ‘‘[i]n hindsight . . . my judgment was S.C. is an aberration, I find that her McCarthy, 406 F.3d at 189 (‘‘Although general impaired because of the relationship I misconduct was egregious. Moreover, as deterrence is not, by itself, sufficient justification had with the individual’’ and that the found above, Respondent lacked candor for expulsion or suspension, we recognize that it in her testimony. Accordingly, I may be considered as part of the overall remedial prescriptions ‘‘were not within . . . the inquiry.’’); Paz Securities, Inc., et al. v. SEC, 494 standards of my medical practice.’’ And conclude that denial of her application F.3d 1059, 1066 (D.C. Cir. 2007) (agreeing with she also admitted that she violated is necessary to protect the public McCarthy). In Gaudio, I further noted that the Florida’s regulations by failing to ‘‘keep interest. ‘‘[c]onsideration of the deterrent effect of a potential sanction is supported by the CSA’s purpose of proper documentation.’’ Order protecting the public interest, see 21 U.S.C. 801, and the broad grant of authority conveyed in the safety’’) contain the limiting words of ‘‘[t]he Pursuant to the authority vested in me statutory text, which authorizes the [suspension or] applicant.’’ As the Supreme Court has held, by 21 U.S. C. 823(f), as well as 28 CFR revocation of a registration when a registrant ‘has ‘‘[w]here Congress includes particular language in committed such acts as would render [his] one section of a statute but omits it in another 0.100(b), I order that the application of registration . . . inconsistent with the public section of the same Act, it is generally presumed Annicol Marrocco, M.D., for a DEA interest,’ id. § 824(a)(4), and [which] specifically that Congress acts intentionally and purposely in Certificate of Registration as a directs the Attorney General to consider [‘such the disparate inclusion or exclusion.’’ Russello v. practitioner be, and it hereby is, denied. other conduct which may threaten public health United States, 464 U.S. 16, 23 (1983). Thus, the text and safety,’ id. § 823(f)].’’ 74 FR at 10094 (quoting of factors four and five suggest that these factors are This Order is effective June 18, 2015. Southwood, 72 FR at 36504). not limited to assessing the specific practitioner’s Dated: May 4, 2015. Unlike factors two (‘‘[t]he applicant’s experience compliance with applicable laws and whether she in dispensing’’) and three (‘‘[t]he applicant’s has engaged in ‘‘such other conduct’’ (such as Michele M. Leonhart, conviction record’’), neither factor four giving false testimony), but rather, authorizes the Administrator. (‘‘Compliance with applicable laws related to Agency to also consider the effect of a sanction on [FR Doc. 2015–12035 Filed 5–18–15; 8:45 am] controlled substances’’) nor factor five (‘‘Such other inducing compliance with federal law by other conduct which may threaten public health and practitioners. BILLING CODE 4410–09–P

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DEPARTMENT OF JUSTICE permitting electronic submission of collection: The estimated public burden responses. associated with this collection is [OMB Number 1105–0092] 720,000 hours. Overview of This Information If additional information is required Agency Information Collection Collection Activities; Proposed eCollection contact Jerri Murray, Department 1. Type of Information Collection: eComments Requested; Extension Clearance Office, United States Extension of a currently approved Without Change of a Previously Department of Justice, Justice collection. Approved Collection; September 11th Management Division, Policy and 2. The Title of the Form/Collection: Planning staff, Two Constitution Square, Victim Compensation Fund Claimant Eligibility and Compensation Form. Eligibility and Compensation Form 145 N Street NE., 3E.405B, Washington, 3. The agency form number, if any, DC 20530. and the applicable component of the AGENCY: September 11th Victim Dated: May 14, 2015. Compensation Fund, Department of Department sponsoring the collection: Jerri Murray, Justice. N/A. Civil Division. 4. Affected public who will be asked Department Clearance Officer for PRA, U.S. ACTION: 60-day notice. or required to respond, as well as a brief Department of Justice. SUMMARY: The Department of Justice abstract: [FR Doc. 2015–12065 Filed 5–18–15; 8:45 am] (DOJ), Civil Division, September 11th The September 11th Victim BILLING CODE 4410–12–P Victim Compensation Fund, will be Compensation Fund of 2001 provides submitting the following information compensation to any individual (or collection request to the Office of beneficiary of a deceased individual) DEPARTMENT OF JUSTICE Management and Budget (OMB) for who was physically injured or killed as [OMB Number 1122–0008] review and approval in accordance with a result of the terrorist-related aircraft the Paperwork Reduction Act of 1995. crashes of September 11, 2001. The Agency Information Collection DATES: Comments are encouraged and information collected from the Activities; Proposed eCollection will be accepted for 60 days until July Eligibility and Compensation Form will eComments Requested; Revision of a 20, 2015. be used to determine whether claimants Currently Approved Collection; Semi- will be eligible for compensation from Annual Progress Report for Grantees FOR FURTHER INFORMATION CONTACT: If the Fund, and if so, the amount of From the Enhanced Training and you have additional comments compensation they will be awarded. Services To End Violence Against and especially on the estimated public The Form consists primarily of two Abuse of Women Later in Life Program burden or associated response time, main sections: Eligibility and (Training Program) suggestions, or need a copy of the Compensation. proposed information collection The Eligibility section seeks the AGENCY: Office on Violence Against instrument with instructions or information required by the Zadroga Act Women, Department of Justice. additional information, please contact to determine whether a claimant is ACTION: 60-day notice. Nell McCarthy, Deputy Special Master, eligible for the Fund, including SUMMARY: The Department of Justice, September 11th Victim Compensation information related to: participation in Office on Violence Against Women Fund, 1100 L Street NW., Washington, lawsuits related to September 11, 2001; (OVW) will be submitting the following DC 20531 (phone: 1–855–885–1555). presence at a 9/11 crash site between information collection request to the SUPPLEMENTARY INFORMATION: Written September 11, 2001 and May 30, 2002; Office of Management and Budget comments and suggestions from the and physical harm suffered as a result (OMB) for review and approval in public and affected agencies concerning of the air crashes and/or debris removal. accordance with the Paperwork the proposed collection of information The Compensation section seeks the Reduction Act of 1995. are encouraged. Your comments should information required by the Zadroga Act address one or more of the following to determine the amount of DATES: Comments are encouraged and four points: compensation for which the claimant is will be accepted for 60 days until July —Evaluate whether the proposed eligible. Specifically, the section seeks 20, 2015. collection of information is necessary information regarding the out-of-pocket FOR FURTHER INFORMATION CONTACT: If for the proper performance of the losses (including medical expenses) you have additional comments functions of the Fund, including incurred by the claimant that are especially on the estimated public whether the information will have attributable to the 9/11 air crashes or burden or associated response time, practical utility; debris removal; the claimant’s loss of suggestions, or need a copy of the —Evaluate the accuracy of the agency’s earnings or replacement services that proposed information collection estimate of the burden of the are attributable to the 9/11 air crashes or instrument with instructions or proposed collection of information, debris removal; and any collateral additional information, please contact including the validity of the source payments (such as insurance Cathy Poston, Office on Violence methodology and assumptions used; payments) that the claimant received as Against Women, at 202–514–5430 or —Evaluate whether and if so how the a result of the terrorist–related aircraft [email protected]. quality, utility, and clarity of the crashes of September 11, 2001 or debris SUPPLEMENTARY INFORMATION: Written information to be collected can be removal efforts. comments and suggestions from the enhanced; and 5. An estimate of the total number of public and affected agencies concerning —Minimize the burden of the collection respondents and the amount of time the proposed collection of information of information on those who are to estimated for an average respondent to are encouraged. Your comments should respond, including through the use of respond: It is estimated that 72,000 address one or more of the following appropriate automated, electronic, respondents will complete the form in four points: mechanical, or other technological an average of 10 hours. (1) Evaluate whether the proposed collection techniques or other forms 6. An estimate of the total public collection of information is necessary of information technology, e.g., burden (in hours) associated with the for the proper performance of the

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functions of the agency, including sections that pertain to the different are encouraged. Your comments should whether the information will have types of activities in which grantees address one or more of the following practical utility; may engage. A Training Program grantee four points: (2) Evaluate the accuracy of the will only be required to complete the (1) Evaluate whether the proposed agency’s estimate of the burden of the sections of the form that pertain to its collection of information is necessary proposed collection of information, own specific activities. for the proper performance of the including the validity of the (6) An estimate of the total public functions of the agency, including methodology and assumptions used; burden (in hours) associated with the whether the information will have (3) Enhance the quality, utility, and collection: The total annual hour burden practical utility; clarity of the information to be to complete the data collection forms is (2) Evaluate the accuracy of the collected; and 36 hours, that is 18 grantees completing agency’s estimate of the burden of the (4) Minimize the burden of the a form twice a year with an estimated proposed collection of information, collection of information on those who completion time for the form being one including the validity of the are to respond, including through the hour. methodology and assumptions used; use of appropriate automated, If additional information is required (3) Enhance the quality, utility, and electronic, mechanical, or other contact: Jerri Murray, Department clarity of the information to be technological collection techniques or Clearance Officer, United States collected; and other forms of information technology, Department of Justice, Justice (4) Minimize the burden of the e.g., permitting electronic submission of Management Division, Policy and collection of information on those who responses. Planning Staff, Two Constitution are to respond, including through the use of appropriate automated, Overview of This Information Square, 145 N Street NE., 3E.405B, electronic, mechanical, or other Collection Washington, DC 20530. technological collection techniques or Dated: May 13, 2015. (1) Type of Information Collection: other forms of information technology, Revision of a currently approved Jerri Murray, e.g., permitting electronic submission of collection Department Clearance Officer for PRA, U.S. responses. (2) Title of the Form/Collection: Semi- Department of Justice. Annual Progress Report for Grantees [FR Doc. 2015–12046 Filed 5–18–15; 8:45 am] Overview of This Information from the Enhanced Training and BILLING CODE 4410–FX–P Collection Services to End Violence Against and (1) Type of Information Collection: Abuse of Women Later in Life Program Revision of a currently approved (Training Program) DEPARTMENT OF JUSTICE collection (4) Agency form number, if any, and [OMB Number 1122–0012] (2) Title of the Form/Collection: Semi- the applicable component of the Annual Progress Report for Education, Department of Justice sponsoring the Agency Information Collection Training and Enhanced Services to End collection: Form Number: 1122–0008. Activities; Proposed eCollection Violence Against and Abuse of Women U.S. Department of Justice, Office on eComments Requested; Revision of a with Disabilities Grant Program Violence Against Women Currently Approved Collection (Disability Grant Program) (5) Affected public who will be asked (3) Agency form number, if any, and or required to respond, as well as a brief AGENCY: Office on Violence Against the applicable component of the abstract: The affected public includes Women, Department of Justice. Department of Justice sponsoring the the approximately 18 grantees of the ACTION: 60-day notice. collection: Form Number: 1122–0012. Training Program. Training Program U.S. Department of Justice, Office on SUMMARY: The Department of Justice, grants may be used for training Violence Against Women Office on Violence Against Women programs to assist law enforcement (4) Affected public who will be asked (OVW) will be submitting the following officers, prosecutors, and relevant or required to respond, as well as a brief information collection request to the officers of Federal, State, tribal, and abstract: The affected public includes Office of Management and Budget local courts in recognizing, addressing, the approximately 18 grantees of the (OMB) for review and approval in investigating, and prosecuting instances Disability Grant Program. Grantees accordance with the Paperwork of elder abuse, neglect, and exploitation include states, units of local Reduction Act of 1995. and violence against individuals with government, Indian tribal governments disabilities, including domestic violence DATES: Comments are encouraged and or tribal organizations and non- and sexual assault, against older or will be accepted for 60 days until July governmental private organizations. The disabled individuals. Grantees fund 20, 2015. goal of this program is to build the projects that focus on providing training FOR FURTHER INFORMATION CONTACT: If capacity of such jurisdictions to address for criminal justice professionals to you have additional comments such violence against individuals with enhance their ability to address elder especially on the estimated public disabilities through the creation of abuse, neglect and exploitation in their burden or associated response time, multi-disciplinary teams. Disability communities and enhanced services to suggestions, or need a copy of the Grant Program recipients will provide address these crimes. proposed information collection training, consultation, and information (5) An estimate of the total number of instrument with instructions or on domestic violence, dating violence, respondents and the amount of time additional information, please contact stalking, and sexual assault against estimated for an average respondent to Cathy Poston, Office on Violence individuals with disabilities and respond/reply: It is estimated that it will Against Women, at 202–514–5430 or enhance direct services to such take the approximately 18 respondents [email protected]. individuals. (Training Program grantees) SUPPLEMENTARY INFORMATION: Written (5) An estimate of the total number of approximately one hour to complete a comments and suggestions from the respondents and the amount of time semi-annual progress report. The semi- public and affected agencies concerning estimated for an average respondent to annual progress report is divided into the proposed collection of information respond/reply: It is estimated that it will

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take the approximately 18 respondents shows that workers leased from Adecco LLC, ANAND PAG, Incremental Sysems (Disability Program grantees) Employment were employed on-site at Corporation And @Business, Inc., approximately one hour to complete a Eaton Corporation, Cooper Power Rosemead, California semi-annual progress report. The semi- Systems, Power Delivery Division, TA–W–83,309B annual progress report is divided into Olean, New York. The Department has Southern California Edison, A Subsidiary Of Edison International, IT Department, sections that pertain to the different determined that these workers were Including On-Site Leased Workers From types of activities in which grantees sufficiently under the control of Eaton INFOSYS, IGATE/PATNI, Cognizant, may engage. A Disability Program Corporation, Cooper Power Systems, Info Tech, Collabera, Deloitte, IBM, IJUS grantee will only be required to Power Delivery Division, Olean, New LLC, ANAND PAG, Incremental Sysems complete the sections of the form that York to be considered leased workers. Corporation And @Business, Inc., Irvine, pertain to its own specific activities. The intent of the Department’s California (6) An estimate of the total public certification is to include all workers of TA–W–83,309C burden (in hours) associated with the the subject firm who were adversely Southern California Edison, A Subsidiary collection: The total annual hour burden affected by a shift in production abroad Of Edison International, IT Department, to complete the data collection forms is of components and protective Including On-Site Leased Workers From INFOSYS, IGATE/PATNI, Cognizant, 36 hours, that is 18 grantees completing equipment consisting of surge arresters. Info Tech, Collabera, Deloitte, IBM, IJUS a form twice a year with an estimated Based on these findings, the LLC, ANAND PAG, Incremental Sysems completion time for the form being one Department is amending this Corporation And @Business, Inc., hour. certification to include workers leased Alhambra, California If additional information is required from Adecco Employment working on- TA–W–83,309D contact: Jerri Murray, Department site at the Olean, New York location of Southern California Edison, A Subsidiary Clearance Officer, United States the subject firm. Of Edison International, IT Department, Department of Justice, Justice The amended notice applicable to Including On-Site Leased Workers From Management Division, Policy and TA–W–83,312 is hereby issued as INFOSYS, IGATE/PATNI, Cognizant, Planning Staff, Two Constitution follows: Info Tech, Collabera, Deloitte, IBM, IJUS Square, 145 N Street NE., 3E.405B, LLC, ANAND PAG, Incremental Sysems All workers from Eaton Corporation, Cooper Corporation And @Business, Inc., Washington, DC 20530. Power Systems, Power Delivery Division, Rancho Cucamonga, California Dated: May 13, 2015. including on-site leased workers from TA–W–83,309E Jerri Murray, Adecco Employment, Olean, New York, who Southern California Edison, A Subsidiary became totally or partially separated from Of Edison International, IT Department Clearance Officer for PRA, U.S. employment on or after December 18, 2012, DEPARTMENT, Including On-Site Department of Justice. through January 27, 2016, and all workers in Leased Workers From INFOSYS, IGATE/ [FR Doc. 2015–12045 Filed 5–18–15; 8:45 am] the group threatened with total or partial PATNI, Cognizant, Info Tech, Collabera, BILLING CODE 4410–FX–P separation from employment on date of Deloitte, IBM, IJUS LLC, ANAND PAG, certification through two years from the date Incremental Sysems Corporation And @ of certification, are eligible to apply for Business, Inc., Fullerton, California DEPARTMENT OF LABOR adjustment assistance under Chapter 2 of TA–W–83,309F Title II of the Trade Act of 1074, as amended. Southern California Edison, A Subsidiary Employment and Training Signed at Washington, DC, this 17th day of Of Edison International, IT Department, Administration April 2015. Including On-Site Leased Workers From Michael W. Jaffe, INFOSYS, IGATE/PATNI, Cognizant, [TA–W–83,312] Info Tech, Collabera, Deloitte, IBM, IJUS Certifying Officer, Office of Trade Adjustment LLC, ANAND PAG, Incremental Sysems Eaton Corporation, Cooper Power Assistance. Corporation And @Business, INC., San Systems, Power Delivery Division, [FR Doc. 2015–12051 Filed 5–18–15; 8:45 am] Clemente, California Including On-Site Leased Workers BILLING CODE 4510–FN–P TA–W–83,309G From Adecco Employment, Olean, New Southern California Edison, A Subsidiary York; Amended Certification Of Edison International, IT Department, Regarding Eligibility To Apply for DEPARTMENT OF LABOR Including On-Site Leased Workers From Worker Adjustment Assistance INFOSYS, IGATE/PATNI, Cognizant, Employment and Training Info Tech, Collabera, Deloitte, Ibm, Ijus In accordance with Section 223 of the Administration Llc, Anand Pag, Incremental Sysems Trade Act of 1974, as amended (‘‘Act’’), Corporation And @Business, INC., 19 U.S.C. 2273, the Department of Labor Amended Certification Regarding Pomona, California TA–W–83,309H issued a Certification of Eligibility to Eligibility To Apply for Worker Adjustment Assistance Southern California Edison, A Subsidiary Apply for Worker Adjustment Of Edison International, IT Department, Assistance on January 27, 2014, TA–W–83,309 Including On-Site Leased Workers From applicable to workers of Eaton Southern California Edison, A Subsidiary INFOSYS, IGATE/PATNI, Cognizant, Corporation, Cooper Power Systems, Of Edison International, It Department, Info Tech, Collabera, Deloitte, IBM, IJUS Power Delivery Division, Olean, New Including On-Site Leased Workers From LLC, ANAND PAG, Incremental Sysems York. The workers were engaged in Infosys, IGATE/PATNI, Cognizant, Info Corporation And @Business, Inc., La activities related to the production of Tech, Collabera, Deloitte, IBM, IJUS LLC, Palma, California components and protective equipment Anand Pag, Incremental Sysems TA–W–83,309I consisting of surge arresters. The notice Corporation And @Business, Inc., Southern California Edison, A Subsidiary Of Edison International, IT Department, was published in the Federal Register Irwindale, California TA–W–83,309A Including On-Site Leased Workers From on February 24, 2014 (79 FR 10187). Southern California Edison, A Subsidiary INFOSYS, IGATE/PATNI, Cognizant, At the request of the State of New Of Edison International, IT Department, Info Tech, Collabera, Deloitte, IBM, IJUS York, the Department reviewed the Including On-Site Leased Workers From LLC, ANAND PAG, Incremental Sysems certification for workers of the subject INFOSYS, IGATE/PATNI, Cognizant, Corporation And @Business, Inc., firm. Information from the subject firm Info Tech, Collabera, Deloitte, IBM, IJUS Westminster, California

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In accordance with Section 223 of the Corporation, and @Business, Inc., Irwindale, At the request of a State Workforce Trade Act of 1974, as amended (‘‘Act’’), California (TA–W–83,309), Rosemead, Official, the Department reviewed the 19 U.S.C. § 2273, the Department of California (TA–W–83,309A), Irvine, certification for workers of the subject Labor issued a Certification of Eligibility California (TA–W–83,309B), Alhambra, California (TA–W–83,309C), Rancho firm. The workers were engaged in the to Apply for Worker Adjustment Cucamonga, California (TA–W–83,309D), production of gelatin and other food Assistance on May 2, 2014, applicable Fullerton, California (TA–W–83,309E), San ingredients. to workers of Southern California Clemente, California (TA–W–83,309F), The investigation confirmed that Edison, a subsidiary of Edison Pomona, California (TA–W–83,309G), La workers leased from Kelly Services were International, IT Department, Irwindale, Palma, California (TA–W–83,309H), employed on-site at Kraft Foods Group California (TA–W–83,309), Southern Westminster, California (TA–W–83,309I), Global, Woburn, Massachusetts. The California Edison, a subsidiary of Norwalk, California (TA–W–83,309K), San Department has determined that these Edison International, IT Department, at Dimas, California (TA–W–83,309K), Compton, California (TA–W–83,309L), workers were sufficiently under the the locations identified above. The Rialto, California (TA–W–83,309M), Fontana, control of the subject firm to be Department’s Notice of Determination California (TA–W–83,309N), Long Beach, considered leased workers. was published in the Federal Register California (TA–W–83,309O), Ontario, Based on these findings, the on May 21, 2014 (Volume 79 FR 29214). California (TA–W–83,309P), Thousand Oaks, Department is amending this At the request of a company official California (TA–W–83,309Q), Big Creek, certification to include workers leased of @Business, Inc., the Department California (TA–W–83,309R), Bishop, from Kelly Services working on-site at California (TA–W–83,309S), Hesperia, reviewed the certification for workers of Kraft Foods Group Global, Woburn, the subject firm. The workers were California (TA–W–83,309T), Bakersfield, California (TA–W–83,309U), Romoland, Massachusetts. engaged in activities related to the California (TA–W–83,309V), Cathedral City, The amended notice applicable to supply of information technology California (TA–W–83,309W), Santa Clarita, TA–W–85,664 is hereby issued as services. California (TA–W–83,309X), Tulare, follows: The company reports that workers California (TA–W–83,309Y), Ventura, All workers of Kraft Foods Group Global, leased from @Business, Inc. were California (TA–W–83,309Z), Victorville, Inc., Woburn, Massachusetts (TA–W–85,664) California (TA–W–83,309AA), and Boulder employed on-site at Southern California and Kelly Services, working on-site at Kraft City, Nevada (TA–W–83,309BB), who Edison, a subsidiary of Edison Foods Group Global, Inc., Woburn, became totally or partially separated from International, IT Department, Irwindale, Massachusetts (TA–W–85,664A), who California (TA–W–83,309), Rosemead, employment on or after December 18, 2012 through May 2, 2016, and all workers in the became totally or partially separated from California (TA–W–83,309A), Irvine, group threatened with total or partial employment on or after November 20, 2013 California (TA–W–83,309B), Alhambra, separation from employment on date of through January 28, 2017, are eligible to California (TA–W–83,309C), Rancho certification through two years from the date apply for adjustment assistance under Cucamonga, California (TA–W– of certification, are eligible to apply for Chapter 2 of Title II of the Trade Act of 1974, 83,309D), Fullerton, California (TA–W– adjustment assistance under Chapter 2 of as amended, and are also eligible to apply for alternative trade adjustment assistance under 83,309E), San Clemente, California (TA– Title II of the Trade Act of 1974, as amended.’’ Section 246 of the Trade Act of 1974, as W–83,309F), Pomona, California (TA– amended. W–83,309G), La Palma, California (TA– Signed in Washington, DC this 28th day of W–83,309H), and Westminster, April, 2015. Signed in Washington, DC, this 15th day of California (TA–W–83,309I). The Michael W. Jaffe, April, 2015. Department has determined that these Certifying Officer, Office of Trade Adjustment Michael W. Jaffe, workers were sufficiently under the Assistance. Certifying Officer, Office of Trade Adjustment control of the subject firm to be [FR Doc. 2015–12050 Filed 5–18–15; 8:45 am] Assistance. considered leased workers. BILLING CODE 4510–FN–P [FR Doc. 2015–12083 Filed 5–18–15; 8:45 am] Based on these findings, the BILLING CODE 4510–FN–P Department is amending this certification to include leased workers DEPARTMENT OF LABOR from @Business, Inc. working on-site at DEPARTMENT OF LABOR Southern California Edison, a subsidiary Employment and Training of Edison International, IT Department, Administration Employment and Training Administration Irwindale, California (TA–W–83,309), [TA–W–85,664A] Rosemead, California (TA–W–83,309A), Notice of Revised Determination on Irvine, California (TA–W–83,309B), Kelly Services Working On-Site Kraft Reconsideration Alhambra, California (TA–W–83,309C), Foods Group Global, Inc. Woburn, Rancho Cucamonga, California (TA–W– Massachusetts; Amended Certification [TA–W–85,429] 83,309D), Fullerton, California (TA–W– Regarding Eligibility To Apply for San Bernardino Sun, A Subsidiary of 83,309E), San Clemente, California (TA– Worker Adjustment Assistance California Newspaper Partnership, W–83,309F), Pomona, California (TA– Magazine Advertisement Unit, San W–83,309G), La Palma, California (TA– In accordance with Section 223 of the Bernandino, California W–83,309H), and Westminster, Trade Act of 1974, as amended (‘‘Act’’), [TA–W–85,429A] 19 U.S.C. § 2273, the Department of Inland Valley Daily Bulletin, A Subsidiary California (TA–W–83,309I). of California Newspaper Partnership, The amended notice applicable to Labor issued a Certification of Eligibility to Apply for Worker Adjustment Magazine Advertisement Unit, Ontario, TA–W–83,309 is hereby issued as California follows: Assistance on January 28, 2015, applicable to workers from Kraft Foods By application dated November 3, ‘‘All workers of Southern California Group Global, Woburn, Massachusetts. 2014, the State of California requested Edison, a subsidiary of Edison International, IT Department, including on-site leased The Department’s Notice of administrative reconsideration of the workers from Infosys, iGate/Patni, Cognizant, Determination was published in the Negative Determination Regarding Info Tech, Collabera, Deloitte, IBM, IJUS LLC, Federal Register on February 18, 2015 Eligibility to Apply for Worker Anand Pag, Incremental Systems (80 FR 8695). Adjustment Assistance and Alternative

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Trade Adjustment Assistance applicable advertisements (or like or directly DEPARTMENT OF LABOR to workers and former workers of San competitive articles). Bernardino Sun, a subsidiary of In accordance with Section 246 the Employment and Training California Newspapers Partnership, San Trade Act of 1974, as amended (‘‘Act’’), Administration Bernardino, California (SBSUN) and 26 U.S.C. 2813, the Department herein [TA–W–83,035; TA–W–83,035A; TA–W– Inland Valley Daily Bulletin, a presents the results of its investigation 83,035B] subsidiary of California Newspapers regarding certification of eligibility to Partnership, Ontario, California (IVDB). apply for alternative trade adjustment Hewlett Packard Company, HP SBSUN and IVDB are engaged in the assistance (ATAA) for older workers. Enterprise Services, America Sales production of newspapers. The group eligibility requirements for Operations, Omaha, Nebraska; Hewlett On October 6, 2014, the Department workers of a firm under Section 246 Packard Company, Order Management, issued a determination which identified (a)(3)(A)(ii) of the Trade Act are satisfied America Sales Operations, Omaha, SBSUN and IVDB as one firm located in if the following criteria are met: Nebraska; Hewlett Packard Company, Ontario, California, and stated that the (I) Whether a significant number of Technology & Operations, Sales subject firm did not shift production of workers in the workers’ firm are 50 Operations, Ww Sales Transformation, newspapers, or like or directly years of age or older; Quote To Order, Quote And competitive articles, to a foreign (II) Whether the workers in the Configuration Including Remote country; did not increase imports of workers’ firm possess skills that are not Workers From Arkansas, California, newspapers, or like or directly easily transferable; and Colorado, Florida, Idaho, competitive articles; and is neither a (III) The competitive conditions Massachusetts And Texas And Supplier or Downstream Producer to a within the workers’ industry (i.e., Including Leased Workers From Modis firm that employer a worker group conditions within the industry are Omaha, Nebraska; Amended eligible to apply for Trade Adjustment adverse). Certification Regarding Eligibility To Section 246(a)(3)(A)(ii)(I) has been Assistance (TAA) under Section 222(a) Apply for Worker Adjustment met because a significant number of of the Trade Act of 1974, as amended. Assistance workers in the firms are 50 years of age The request for reconsideration or older. Section 246(a)(3)(A)(ii)(II) has In accordance with Section 223 of the included new information which been met because the workers in the Trade Act of 1974, as amended (‘‘Act’’), clarifies that SBSUN and IVADB are workers’ firms possess skills that are not 19 U.S.C. 2273, the Department of Labor different entities and supported the easily transferrable. Section issued a Certification of Eligibility to petitioner’s allegation that magazine 246(a)(3)(A)(ii)(III) has been met because Apply for Worker Adjustment advertisement production shifted from conditions within the workers’ industry Assistance on September 12, 2013, California to a foreign country. are adverse. applicable to workers of Hewlett During the reconsideration Packard Company, HP Enterprise Conclusion investigation, the Department carefully Services, America Sales Operations, reviewed new and previously-submitted After careful review of information Omaha, Nebraska (TA–W–83,035). The information from several separated obtained during the initial and workers were engaged in activities workers, the State of California, the reconsideration investigations, I related to the supply of Order subject firm, and public sources. The determine that workers of SBSUN–MAU management services and post sales Department also reviewed industry and IVCB–MAU, who are engaged in customer activities. trends with regards to like or directly employment related to the production of During the course of a subsequent competitive articles. advertisements, meet the worker group Trade Adjustment Assistance (TAA) Consequently, the Department certification criteria under Section investigation, the Department reviewed determines that the subject worker 222(a) of the Act, 19 U.S.C. 2272(a). In the certification (TA–W–83,035) for group was incorrectly identified to accordance with Section 223 of the Act, workers of the subject firm and received consist of workers and former workers 19 U.S.C. 2273, I make the following additional information regarding the of one firm instead of two affiliated certification: aforementioned certification. firms—SBSUN and IVDB—and clarifies All workers of San Bernardino Sun, a The investigation revealed that that that the subject worker groups consist of subsidiary of California Newspapers workers of Hewlett Packard Company, workers within the ‘‘Magazine Partnership, Magazine Advertisement Unit, Order Management, America Sales Advertisement Unit’’ of the after- San Bernardino, California (TA–W–85,429), Operations, Omaha, Nebraska (TA–W– mentioned firms (SBSUN–MAU and and Inland Valley Daily Bulletin, a 83,035A) and Hewlett Packard IVCB–MAU, respectively). The subsidiary of California Newspapers Company, Technology & Operations, Department also determines that, with Partnership, Magazine Advertisement Unit, Sales Operations, WW Sales regards to SBSUN–MAU and IVCB– Ontario, California (TA–W–85,429A), who became totally or partially separated from Transformation, Quote to Order, Quote MAU, the group eligibility criteria have employment on or after July 15, 2013 through and Configuration, including remote been met. two years from the date of this certification workers from Arkansas, California, Section 222(a)(1) has been met are eligible to apply for adjustment assistance Colorado, Florida, Idaho, Massachusetts, because a significant number or under Section 223 of the Trade Act of 1974, and Texas, including leased workers proportion of the workers in SBSUN– and are eligible to apply for alternative trade from Modis, Omaha, Nebraska (TA–W– MAU and IVCB–MAU have become adjustment assistance under Section 246 of 83,035B) supplied support services to the Trade Act of 1974. totally or partially separated. the subject firm and reported to the Section 222(a)(2)(B) has been met Signed at Washington, DC, this 28th day of subject firm. because the employment declines April 2015. Based on these findings, the within SBSUN–MAU and IVCB–MAU Del Min Amy Chen, Department is amending this are related to the shift in production of Certifying Officer, Office of Trade Adjustment certification (TA–W–83,035) to include magazine advertisements to a foreign Assistance. the workers of Hewlett Packard country followed by likely or actual [FR Doc. 2015–12082 Filed 5–18–15; 8:45 am] Company, Order Management, America increased imports of magazine BILLING CODE 4510–FN–P Sales Operations, Omaha, Nebraska

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(TA–W–83,035A) and Hewlett Packard ADDRESSES: A copy of this ICR with approved by the OMB under the PRA Company, Technology & Operations, applicable supporting documentation; and displays a currently valid OMB Sales Operations, WW Sales including a description of the likely Control Number. In addition, Transformation, Quote to Order, Quote respondents, proposed frequency of notwithstanding any other provisions of and Configuration, including remote response, and estimated total burden law, no person shall generally be subject workers from Arkansas, California, may be obtained free of charge from the to penalty for failing to comply with a Colorado, Florida, Idaho, Massachusetts, RegInfo.gov Web site at http:// collection of information that does not and Texas, and including leased www.reginfo.gov/public/do/ display a valid Control Number. See 5 workers from Modis, Omaha, Nebraska PRAViewICR?ref_nbr=201502-1220-005 CFR 1320.5(a) and 1320.6. The DOL (TA–W–83,035B). (this link will only become active on the obtains OMB approval for this The amended notice applicable to day following publication of this notice) information collection under Control TA–W–83,035 is hereby issued as or by contacting Michel Smyth by Number 1220–0168. follows: telephone at 202–693–4129, TTY 202– OMB authorization for an ICR cannot 693–8064, (these are not toll-free be for more than three (3) years without All workers of Hewlett Packard Company, _ _ HP Enterprise Services, America Sales numbers) or by email at DOL PRA renewal, and the current approval for Operations, Omaha, Nebraska (TA–W– [email protected]. this collection is scheduled to expire on 83,035); Hewlett Packard Company, Order Submit comments about this request August 31, 2015. The DOL seeks to Management, America Sales Operations, by mail or courier to the Office of extend PRA authorization for this Omaha, Nebraska (TA–W–83,035A); and Information and Regulatory Affairs, information collection for three (3) more Hewlett Packard Company, Technology & Attn: OMB Desk Officer for DOL–BLS, years, without any change to existing Operations, Sales Operations, WW Sales Office of Management and Budget, requirements. The DOL notes that Transformation, Quote to Order, Quote and Room 10235, 725 17th Street NW., Configuration, including remote workers existing information collection from Arkansas, California, Colorado, Florida, Washington, DC 20503; by Fax: 202– requirements submitted to the OMB 395–5806 (this is not a toll-free receive a month-to-month extension Idaho, Massachusetts, and Texas, and _ including leased workers from Modis, number); or by email: OIRA while they undergo review. For Omaha, Nebraska (TA–W–83,035B), who [email protected]. Commenters additional substantive information became totally or partially separated from are encouraged, but not required, to about this ICR, see the related notice employment on or after August 28, 2012 send a courtesy copy of any comments published in the Federal Register on through September 12, 2015, and all workers by mail or courier to the U.S. in the group threatened with total or partial February 10, 2015 (80 FR 7500). Department of Labor-OASAM, Office of Interested parties are encouraged to separation from employment on the date of the Chief Information Officer, Attn: certification through two years from the date send comments to the OMB, Office of of certification, are eligible to apply for Departmental Information Compliance Information and Regulatory Affairs at adjustment assistance under Chapter 2 of Management Program, Room N1301, the address shown in the ADDRESSES Title II of the Trade Act of 1974, as amended. 200 Constitution Avenue, NW., section within thirty (30) days of Washington, DC 20210; or by email: publication of this notice in the Federal Signed in Washington, DC, this 23rd day _ _ of April, 2015. DOL PRA [email protected]. Register. In order to help ensure For Further Information: Contact Del Min Amy Chen, appropriate consideration, comments Michel Smyth by telephone at 202–693– should mention OMB Control Number Certifying Officer, Office of Trade Adjustment 4129, TTY 202–693–8064, (these are not Assistance. _ 1220–0168. The OMB is particularly toll-free numbers) or by email at DOL interested in comments that: [FR Doc. 2015–12049 Filed 5–18–15; 8:45 am] _ PRA [email protected]. • Evaluate whether the proposed BILLING CODE 4510–FN–P Authority: 44 U.S. C. 3507(a)(1)(D). collection of information is necessary for the proper performance of the SUPPLEMENTARY INFORMATION: This ICR functions of the agency, including DEPARTMENT OF LABOR seeks to extend PRA authority for the whether the information will have General Inquiries to State Agency Office of the Secretary practical utility; Contacts information collection. The • Evaluate the accuracy of the Agency Information Collection BLS awards funds to State Agencies in agency’s estimate of the burden of the Activities; Submission for OMB order to assist them in operating either proposed collection of information, Review; Comment Request; General or both the Labor Market Information including the validity of the Inquiries to State Agency Contacts and the Occupational Safety and Health methodology and assumptions used; Statistics Federal/State Cooperative • Enhance the quality, utility, and ACTION: Notice. Statistical Programs. To ensure a timely clarity of the information to be flow of data and to be able to evaluate collected; and SUMMARY: The Department of Labor and improve the programs, it is • Minimize the burden of the (DOL) is submitting the Bureau of Labor necessary to conduct ongoing collection of information on those who Statistics (BLS) sponsored information communications between the BLS and are to respond, including through the collection request (ICR) titled, ‘‘General State partners dealing with, for example, use of appropriate automated, Inquiries to State Agency Contacts,’’ to deliverables, program enhancements, electronic, mechanical, or other the Office of Management and Budget and administrative issues. The BLS technological collection techniques or (OMB) for review and approval for Authorizing Statute authorizes this other forms of information technology, continued use, without change, in information collection. See 29 U.S.C. e.g., permitting electronic submission of accordance with the Paperwork 1 & 2. responses. Reduction Act of 1995 (PRA), 44 U.S. C. This information collection is subject Agency: DOL–BLS. 3501 et se. Public comments on the ICR to the PRA. A Federal agency generally Title of Collection: General Inquiries are invited. cannot conduct or sponsor a collection to State Agency Contacts. DATES: The OMB will consider all of information, and the public is OMB Control Number: 1220–0168. written comments that agency receives generally not required to respond to an Affected Public: State, Local, and on or before June 18, 2015. information collection, unless it is Tribal Governments.

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Total Estimated Number of respondents, including through the use • Other activities to promote these Respondents: 54. of automated collection techniques or ends. Total Estimated Number of other forms of information technology; NSF’s core purpose resonates clearly Responses: 23,890. and (d) ways to minimize the burden of in everything it does: Promoting Total Estimated Annual Time Burden: the collection of information on achievement and progress in science 15,927 hours. respondents, including through the use and engineering and enhancing the Total Estimated Annual Other Costs of automated collection techniques or potential for research and education to Burden: $0. other forms of information technology. contribute to the Nation. While NSF’s Dated: May 12, 2015. DATES: Written comments should be vision of the future and the mechanisms Michel Smyth, received by July 20, 2015 to be assured it uses to carry out its charges have of consideration. Comments received Departmental Clearance Officer. evolved significantly over the last six after that date will be considered to the [FR Doc. 2015–11984 Filed 5–18–15; 8:45 am] decades, its ultimate mission remains extent practicable. BILLING CODE 4510–24–P the same. ADDRESSES: Written comments regarding the information collection and Use of the Information: The regular submission of proposals to the NATIONAL SCIENCE FOUNDATION requests for copies of the proposed information collection request should be Foundation is part of the collection of Comment Request: National Science addressed to Suzanne Plimpton, Reports information and is used to help NSF Foundation Proposal/Award; Clearance Officer, National Science fulfill this responsibility by initiating Information—NSF Proposal and Award Foundation, 4201 Wilson Blvd., Rm. and supporting merit-selected research Policies and Procedures Guide 1265, Arlington, VA 22230, or by email and education projects in all the to [email protected]. The draft NSF scientific and engineering disciplines. AGENCY: National Science Foundation. Proposal and Award Policies and NSF receives more than 50,000 ACTION: Request for comment notice. Procedures Guide may be found at: proposals annually for new projects, http://www.nsf.gov/bfa/dias/policy/. and makes approximately 11,000 new SUMMARY: The National Science FOR FURTHER INFORMATION CONTACT: awards. Foundation (NSF) is announcing plans Suzanne Plimpton on (703) 292–7556 or to request renewed clearance of this Support is made primarily through send email to [email protected]. grants, contracts, and other agreements collection. In accordance with the Individuals who use a requirement of Section 3506(c)(2)(A) of awarded to approximately 2,000 telecommunications device for the deaf colleges, universities, academic the Paperwork Reduction Act of 1995, (TDD) may call the Federal Information we are providing opportunity for public consortia, nonprofit institutions, and Relay Service (FIRS) at 1–800–877– small businesses. The awards are based comment on the NSF Proposal and 8339, which is accessible 24 hours a mainly on merit evaluations of Award Policies and Procedures Guide day, 7 days a week, 365 days a year proposals submitted to the Foundation. (PAPPG). The primary purpose of this (including federal holidays). revision is to implement NSF’s new SUPPLEMENTARY INFORMATION: The Foundation has a continuing Public Access Policy, as well as to commitment to monitor the operations revise the PAPPG to incorporate a Title of Collection: ‘‘National Science Foundation Proposal/Award of its information collection to identify number of other policy-related changes. and address excessive reporting burdens The draft NSF PAPPG is now Information—NSF Proposal and Award Policies and Procedures Guide’’. as well as to identify any real or available for your review and apparent inequities based on gender, consideration on the NSF Web site at OMB Approval Number: 3145–0058. race, ethnicity, or disability of the http://www.nsf.gov/bfa/dias/policy/. Expiration Date of Approval: proposed principal investigator(s)/ To facilitate review, revised text has November 30, 2017. been highlighted in yellow throughout Type of Request: Intent to seek project director(s) or the co-principal the document to identify significant approval to extend with revision an investigator(s)/co-project director(s). changes. A brief comment explanation information collection for three years. Burden on the Public: The Foundation of the change also is provided. Proposed Project: The National estimates that an average of 120 hours NSF is particularly interested in Science Foundation Act of 1950 (Pub. L. is expended for each proposal public comment on the policy changes 81–507) sets forth NSF’s mission and submitted. An estimated 50,000 purpose: that are identified in the PAPPG. After proposals are expected during the obtaining and considering public To promote the progress of science; to course of one year for a total of comment, NSF will prepare the advance the national health, prosperity, and 6,000,000 public burden hours welfare; to secure the national defense . submission requesting OMB clearance annually. of this collection for no longer than 3 .. . years. The Act authorized and directed NSF Dated: May 14, 2015. In addition to the type of comments to initiate and support: Suzanne H. Plimpton, identified above, comments also are • Basic scientific research and Reports Clearance Officer, National Science invited on: (a) Whether the proposed research fundamental to the engineering Foundation. collection of information is necessary process; [FR Doc. 2015–12086 Filed 5–18–15; 8:45 am] for the proper performance of the • Programs to strengthen scientific BILLING CODE 7555–01–P functions of the Agency, including and engineering research potential; whether the information shall have • Science and engineering education practical utility; (b) the accuracy of the programs at all levels and in all the Agency’s estimate of the burden of the various fields of science and proposed collection of information; (c) engineering; ways to enhance the quality, utility, and • Programs that provide a source of clarity of the information on information for policy formulation; and

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NUCLEAR REGULATORY I. Obtaining Information and identifying or contact information that COMMISSION Submitting Comments they do not want to be publicly disclosed in their comment submission. A. Obtaining Information [NRC–2015–0108] Your request should state that the NRC Please refer to Docket ID NRC–2015– does not routinely edit comment Information Collection: Disposal of 0108 when contacting the NRC about submissions to remove such information High-Level Radioactive Wastes in the availability of information for this before making the comment Geologic Repositories action. You may obtain publicly- submissions available to the public or available information related to this entering the comment into ADAMS. AGENCY: Nuclear Regulatory action by any of the following methods: Commission. • Federal rulemaking Web site: Go to II. Background http://www.regulations.gov and search In accordance with the Paperwork ACTION: Renewal of existing information for Docket ID NRC–2015–0108. Reduction Act of 1995 (44 U.S.C. collection; request for comment. • NRC’s Agencywide Documents Chapter 35), the NRC is requesting Access and Management System SUMMARY: The U.S. Nuclear Regulatory public comment on its intention to (ADAMS). Commission (NRC) invites public request the OMB’s approval for the You may obtain publicly-available information collection summarized comment on the renewal of Office of documents online in the ADAMS Public Management and Budget (OMB) below. Documents collection at http:// 1. The title of the information approval for an existing collection of www.nrc.gov/reading-rm/adams.html. collection: Title 10 of the Code of information. The information collection To begin the search, select ‘‘ADAMS Federal Regulations (10 CFR) Part 60, is entitled, ‘‘Disposal of High-Level Public Documents’’ and then select ‘‘Disposal of High-Level Radioactive Radioactive Wastes in Geologic ‘‘Begin Web-based ADAMS Search.’’ For Wastes in Geologic Repositories.’’ Repositories.’’ NRC regulations require problems with ADAMS, please contact 2. OMB approval number: 3150–0127. States and Indian tribes to submit the NRC’s Public Document Room (PDR) 3. Type of submission: Extension. certain information to the NRC if they reference staff at 1–800–397–4209, 301– 4. The form number, if applicable: request consultation with the NRC staff 415–4737, or by email to pdr.resource@ Not applicable. concerning the review of a potential nrc.gov. The supporting statement is 5. How often the collection is required repository site, or wish to participate in available in ADAMS under Accession or requested: The information need only a license application review for a No. ML15104A080. be submitted one time. potential repository. • NRC’s PDR: You may examine and 6. Who will be required or asked to DATES: Submit comments by July 20, purchase copies of public documents at respond: State or Indian tribes, or their 2015. Comments received after this date the NRC’s PDR, Room O1–F21, One representatives, requesting consultation will be considered if it is practical to do White Flint North, 11555 Rockville with the NRC staff regarding review of so, but the Commission is able to ensure Pike, Rockville, Maryland 20852. a potential high-level radioactive waste consideration only for comments • NRC’s Clearance Officer: A copy of geologic repository site, or wishing to received on or before this date. the collection of information and related participate in a license application instructions may be obtained without review for a potential geologic ADDRESSES: You may submit comments charge by contacting NRC’s Clearance repository (other than a potential by any of the following methods: geologic repository site at Yucca • Officer, Tremaine Donnell, Office of Federal Rulemaking Web site: Go to Information Services, U.S. Nuclear Mountain, Nevada, which is regulated http://www.regulations.gov and search Regulatory Commission, Washington, under 10 CFR part 63). for Docket ID NRC–2015–0108. Address DC 20555–0001; telephone: 301–415– 7. The estimated number of annual questions about NRC dockets to Carol 6258; email: INFOCOLLECTS.Resource@ responses: 1; however, none are Gallagher; telephone: 301–415–3463; NRC.GOV. expected in the next 3 years. email: [email protected]. For 8. The estimated number of annual technical questions, contact the B. Submitting Comments respondents: 1; however, none are individual listed in the FOR FURTHER Please include Docket ID NRC–2015– expected in the next 3 years. INFORMATION CONTACT section of this 0108 in the subject line of your 9. The estimated number of hours document. comment submission, in order to ensure needed annually to comply with the • Mail comments to: Tremaine that the NRC is able to make your information collection requirement or Donnell, Office of Information Services, comment submission available to the request: 121; however, none are Mail Stop: T–5 F53, U.S. Nuclear public in this docket. expected in the next 3 years. Regulatory Commission, Washington, The NRC cautions you not to include 10. Abstract: Part 60 of 10 CFR DC 20555–0001. identifying or contact information in requires States and Indian tribes to For additional direction on obtaining comment submissions that you do not submit certain information to the NRC information and submitting comments, want to be publicly disclosed in your if they request consultation with the see ‘‘Obtaining Information and comment submission. The NRC will NRC staff concerning the review of a Submitting Comments’’ in the post all comment submissions at potential repository site, or wish to SUPPLEMENTARY INFORMATION section of http://www.regulations.gov as well as participate in a license application this document. enter the comment submissions into review for a potential repository (other ADAMS, and the NRC does not than the Yucca Mountain, Nevada site, FOR FURTHER INFORMATION CONTACT: routinely edit comment submissions to which is regulated under 10 CFR part Tremaine Donnell, Office of Information remove identifying or contact 63). Representatives of States or Indian Services, U.S. Nuclear Regulatory information. tribes must submit a statement of their Commission, Washington, DC 20555– If you are requesting or aggregating authority to act in such a representative 0001; telephone: 301–415–6258; email: comments from other persons for capacity. The information submitted by [email protected]. submission to the NRC, then you should the States and Indian tribes is used by SUPPLEMENTARY INFORMATION: inform those persons not to include the Director of the Office of Nuclear

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Material Safety and Safeguards as a comment on this proposed collection of available documents online in the basis for decisions about the information of Office of Management ADAMS Public Documents collection at commitment of NRC staff resources to and Budget (OMB) approval for a http://www.nrc.gov/reading-rm/ the consultation and participation proposed collection of information. The adams.html. To begin the search, select efforts. The NRC anticipates conducting information collection is entitled, ‘‘ADAMS Public Documents’’ and then a public rulemaking to revise portions of ‘‘Destinations of Released Patients select ‘‘Begin Web-based ADAMS 10 CFR part 60 in the near future (i.e., Following Treatment with Iodine-131 Search.’’ For problems with ADAMS, within the next 5 years). If, as part of and Estimation of Doses to Members of please contact the NRC’s Public this rulemaking, revisions are made the Public at Locations other than Document Room (PDR) reference staff at affecting the information collection Conventional Residences Receiving 1–800–397–4209, 301–415–4737, or by requirements, the NRC will follow OMB Such Patients.’’ email to [email protected]. A copy requirements for obtaining approval for DATES: Submit comments by July 20, of the collection of information and any revised information collection 2015. Comments received after this date related instructions may be obtained requirements. [Note: All of the will be considered if it is practical to do without charge by accessing ADAMS information collection requirements so, but the Commission is able to ensure Accession No.: ML15086A164. The pertaining to Yucca Mountain were consideration only for comments supporting statement available in included in 10 CFR Part 63, and were received on or before this date. ADAMS under Accession No. approved by OMB under control ADDRESSES: You may submit comments ML15086A166. number 3150–0199. The Yucca by any of the following methods: • NRC’s PDR: You may examine and Mountain site is regulated under 10 CFR • Federal Rulemaking Web site: Go to purchase copies of public documents at part 63 (66 FR 55792, November 2, http://www.regulations.gov and search the NRC’s PDR, Room O1–F21, One 2001).] for Docket ID NRC–2015–0102. Address White Flint North, 11555 Rockville III. Specific Requests for Comments questions about NRC dockets to Carol Pike, Rockville, Maryland 20852. Gallagher; telephone: 301–415–3463; The NRC is seeking comments that • NRC’s Clearance Officer: A copy of email: [email protected]. For address the following questions: the collection of information and related technical questions, contact the 1. Is the proposed collection of instructions may be obtained without individual listed in the FOR FURTHER information necessary for the NRC to charge by contacting NRC’s Clearance INFORMATION CONTACT section of this properly perform its functions? Does the Officer, Tremaine Donnell, Office of document. information have practical utility? Information Services, U.S. Nuclear • Mail comments to: Tremaine 2. Is the estimate of the burden of the Regulatory Commission, Washington, Donnell, Office of Information Services, information collection accurate? Mail Stop: T–5 F53, U.S. Nuclear DC 20555–0001; telephone: 301–415– 3. Is there a way to enhance the Regulatory Commission, Washington, 6258; email: INFOCOLLECTS.Resource@ quality, utility, and clarity of the DC 20555–0001. NRC.GOV. information to be collected? For additional direction on obtaining 4. How can the burden of the B. Submitting Comments information and submitting comments, information collection on respondents see ‘‘Obtaining Information and Please include Docket ID NRC–2015– be minimized, including the use of Submitting Comments’’ in the 0102 in the subject line of your automated collection techniques or SUPPLEMENTARY INFORMATION section of comment submission, in order to ensure other forms of information technology? this document. that the NRC is able to make your Dated at Rockville, Maryland, this 13th day FOR FURTHER INFORMATION CONTACT: comment submission available to the of May 2015. Tremaine Donnell, Office of Information public in this docket. For the Nuclear Regulatory Commission. Services, U.S. Nuclear Regulatory The NRC cautions you not to include Tremaine Donnell, Commission, Washington, DC 20555– identifying or contact information in NRC Clearance Officer, Office of Information 0001; telephone: 301–415–6258; email: comment submissions that you do not Services. [email protected]. want to be publicly disclosed in your [FR Doc. 2015–12018 Filed 5–18–15; 8:45 am] SUPPLEMENTARY INFORMATION: comment submission. The NRC will BILLING CODE 7590–01–P post all comment submissions at I. Obtaining Information and http://www.regulations.gov as well as Submitting Comments enter the comment submissions into NUCLEAR REGULATORY A. Obtaining Information ADAMS, and the NRC does not COMMISSION routinely edit comment submissions to Please refer to Docket ID NRC–2015– remove identifying or contact [NRC–2015–0102] 0102 when contacting the NRC about information. the availability of information for this Information Collection: Destinations of If you are requesting or aggregating Released Patients Following Treatment action. You may obtain publicly- comments from other persons for with Iodine-131 and Estimation of available information related to this submission to the NRC, then you should Doses to Members of the Public at action by any of the following methods: • inform those persons not to include Locations other than Conventional Federal rulemaking Web site: Go to identifying or contact information that Residences Receiving Such Patients http://www.regulations.gov and search for Docket ID NRC–2015–0102. A copy they do not want to be publicly AGENCY: Nuclear Regulatory of the collection of information and disclosed in their comment submission. Commission. related instructions may be obtained Your request should state that the NRC ACTION: Proposed information without charge by accessing Docket ID does not routinely edit comment collection: Request for comment. NRC–2015–0102 on this Web site. submissions to remove such information • NRC’s Agencywide Documents before making the comment SUMMARY: The U.S. Nuclear Regulatory Access and Management System submissions available to the public or Commission (NRC) invites public (ADAMS): You may obtain publicly- entering the comment into ADAMS.

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II. Background 2. Is the estimate of the burden of the POSTAL REGULATORY COMMISSION information collection accurate? In accordance with the Paperwork [Docket No. CP2014–78; Order No. 2482] Reduction Act of 1995 (44 U.S.C. 3. Is there a way to enhance the Chapter 35), the NRC is requesting quality, utility, and clarity of the New Postal Product public comment on its intention to information to be collected? AGENCY: request the OMB’s approval for the 4. How can the burden of the Postal Regulatory Commission. information collection summarized information collection on respondents ACTION: Notice. below. be minimized, including the use of SUMMARY: The Commission is noticing a 1. The title of the information automated collection techniques or recent Postal Service filing concerning a collection: Destinations of Released other forms of information technology? modification to a Global Expedited Patients Following Treatment with Dated at Rockville, Maryland, this 13th day Package Services 3 negotiated service Iodine-131 and Estimation of Doses to of May 2015. agreement. This notice informs the Members of the Public at Locations For the Nuclear Regulatory Commission. public of the filing, invites public other than Conventional Residences Tremaine Donnell, comment, and takes other Receiving Such Patients. administrative steps. 2. OMB approval number: An OMB NRC Clearance Officer, Office of Information control number has not yet been Services. DATES: Comments are due: May 20, assigned to this proposed information [FR Doc. 2015–12017 Filed 5–18–15; 8:45 am] 2015. collection. BILLING CODE 7590–01–P ADDRESSES: Submit comments 3. Type of submission: New. electronically via the Commission’s 4. The form number, if applicable: Filing Online system at http:// NA. OFFICE OF PERSONNEL www.prc.gov. Those who cannot submit 5. How often the collection is required MANAGEMENT comments electronically should contact or requested: One-time. President’s Commission on White the person identified in the FOR FURTHER 6. Who will be required or asked to INFORMATION CONTACT section by respond: Institutions that treat thyroid House Fellowships Advisory Committee: Closed Meeting telephone for advice on filing cancer patients with I–131 and the alternatives. thyroid cancer patients who have been AGENCY: President’s Commission on FOR FURTHER INFORMATION CONTACT: treated. White House Fellowships, U.S. Office of 7. The estimated number of annual David A. Trissell, General Counsel, at Personnel Management. responses: 5,175 (175 for treating 202–789–6820. institutions and 5000 for individuals). ACTION: Notice of meeting. SUPPLEMENTARY INFORMATION: 8. The estimated number of annual Table of Contents respondents: 5,175. SUMMARY: The President’s Commission 9. The estimated number of hours on White House Fellowships (PCWHF) I. Introduction needed annually to comply with the was established by an Executive Order II. Notice of Filings information collection requirement or in 1964. The PCWHF is an advisory III. Ordering Paragraphs request: 1,675 (175 hours for treating committee composed of Special I. Introduction institution and 1500 hours for Government Employees appointed by On May 12, 2015, the Postal Service individuals). the President. The Advisory Committee filed notice that it has agreed to a 10. Abstract: Although most patients meet in June to interview potential Modification to the existing Global return to their home after receiving candidates for recommendation to Expedited Package Services 3 negotiated diagnostic or therapeutic of Iodine-131, become a White House Fellow. service agreement approved in this some patients released by the licensee The meeting is closed. docket.1 In support of its Notice, the may stay at another location (such as a Name of Committee: President’s Postal Service includes a redacted copy hotel) for a few days. However, the Commission on White House of the Modification and a certification of extent of this practice is unclear. The Fellowships Selection Weekend. compliance with 39 U.S.C. 3633(a), as same uncertainty exists regarding Date: June 11–14, 2015. required by 39 CFR 3015.5. Notice, patients returning to nursing homes and Time: 7:00 a.m.–9:30 p.m. Attachment 1 and 2. other institutional settings. Therefore, The Postal Service also filed the one of the main objectives of this study Place: St. Regis Hotel, 16th & K Street, unredacted Modification and supporting is to obtain reliable statistical data that Washington, DC 20006. financial information under seal. Notice provides good estimates of the Agenda: The Commission will at 2. The Postal Service seeks to prevalence of these practices. The Interview 30 National Finalists for incorporate by reference the Application second objective is to determine, by selection of new class of White House for Non-Public Treatment originally measurements, the external and internal Fellows. filed in this docket for the protection of doses received by members of the Location: St. Regis Hotel, 16th and K information that it has filed under seal. general public at hotels, nursing homes, Street NW., Washington, DC 20006. Id. or other institutional settings that FOR FURTHER INFORMATION CONTACT: The Modification updates the receive treated patients immediately Jennifer Y. Kaplan, 712 Jackson Place customer’s mailing and contact after their release. NW., Washington, DC 20503, Phone: information, revises the choice of III. Specific Requests for Comments 202–395–4522. payment method, and replaces Annex 1, The NRC is seeking comments that President’s Commission on White House which contains new rates. Id. at 1; Id. address the following questions: Fellowships. Attachment 1. The rates in the 1. Is the proposed collection of Jennifer Y. Kaplan, Director. 1 Notice of the United States Postal Service of information necessary for the NRC to Filing Modification to Global Expedited Package properly perform its functions? Does the [FR Doc. 2015–12085 Filed 5–18–15; 8:45 am] Services 3 Negotiated Service Agreement, May 12, information have practical utility? BILLING CODE 6325–44–P 2015 (Notice).

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Modification are intended to go into 2015, NYSE MKT LLC (the ‘‘Exchange’’ in Penny Pilot issues; and from $0.90 to effect on June 1, 2015. Notice at 1. The or ‘‘NYSE MKT’’) filed with the $0.95 for Non-Customers in non-Penny Postal Service asserts that the Securities and Exchange Commission Pilot issues. In addition, the Exchange Modification will not impair the ability (‘‘SEC’’ or ‘‘Commission’’) the proposed proposes to decrease the Initiating of the contract to comply with 39 U.S.C. rule change as described in Items I, II, Participant Credit by $0.05 for Penny 3633. Id. Attachment 2. and III below, which Items have been Pilot issues—from $0.40 to $0.35; and prepared by the Exchange. The $0.10 for non-Penny Pilot issues—from II. Notice of Filings Commission is publishing this notice to $0.80 to $0.70. The Exchange also The Commission invites comments on solicit comments on the proposed rule proposes to introduce a rebate for whether the changes presented in the change from interested persons. certain Initiating Participants that Postal Service’s Notice are consistent qualify for the ACE Program. with the policies of 39 U.S.C. 3632, I. Self-Regulatory Organization’s Specifically, as proposed, those ATP 3633, or 3642, 39 CFR 3015.5, and 39 Statement of the Terms of Substance of Holders who qualify for Tiers 2, 3, 4 or CFR part 3020, subpart B. Comments are the Proposed Rule Change 5 of the ACE Program would receive a due no later than May 20, 2015. The The Exchange proposes to modify the $0.12 per contract rebate for up to 5,000 public portions of these filings can be NYSE Amex Options Fee Schedule Customer contracts per CUBE Order accessed via the Commission’s Web site (‘‘Fee Schedule’’) related to fees and executed in a CUBE Auction (the ‘‘ACE (http://www.prc.gov). credits associated with the Customer Initiating Participant Rebate’’ or The Commission appoints James F. Best Execution Auction (‘‘CUBE ‘‘Rebate’’). The proposed Rebate is Callow to represent the interests of the Auction’’ or ‘‘Auction’’). The Exchange payable in addition to any other fees or general public (Public Representative) proposes to implement the fee change credits accrued from the CUBE Auction in this docket. effective May 1, 2015. The text of the (e.g., in addition to the Initiating proposed rule change is available on the Participant Credit for both Penny and III. Ordering Paragraphs Exchange’s Web site at www.nyse.com, non-Penny Pilot issues). Thus, as It is ordered: at the principal office of the Exchange, proposed, the maximum potential CUBE 1. The Commission reopens Docket and at the Commission’s Public credit for Penny Pilot issues is $0.47 No. CP2014–78 for consideration of Reference Room. ($0.12 Rebate + $0.35 Initiating matters raised by the Postal Service’s Participant Credit) and for non-Penny Notice. II. Self-Regulatory Organization’s Pilot issues is $0.82 ($0.12 Rebate + 2. Pursuant to 39 U.S.C. 505, the Statement of the Purpose of, and $0.70 Initiating Participant Credit). The Commission appoints James F. Callow Statutory Basis for, the Proposed Rule ACE Initiating Participant Rebate is to serve as an officer of the Commission Change available regardless of whether the (Public Representative) to represent the In its filing with the Commission, the CUBE Order trades with the Contra interests of the general public in this self-regulatory organization included Order or RFR Response(s), whereas the proceeding. statements concerning the purpose of, current Initiating Participant Credits are 3. Comments are due no later than and basis for, the proposed rule change payable only for each CUBE Order May 20, 2015. and discussed any comments it received contract that does not trade with the 4. The Secretary shall arrange for on the proposed rule change. The text Contra Order. publication of this order in the Federal of those statements may be examined at The proposed amendments to CUBE Register. the places specified in Item IV below. Auction pricing are designed to By the Commission. The Exchange has prepared summaries, incentivize market participants that set forth in sections A, B, and C below, have committed a certain amount of Shoshana M. Grove, of the most significant parts of such volume to the Exchange to provide even Secretary. statements. more liquidity through CUBE Auctions. [FR Doc. 2015–11990 Filed 5–18–15; 8:45 am] This additional volume and liquidity A. Self-Regulatory Organization’s BILLING CODE 7710–FW–P would benefit all Exchange participants Statement of the Purpose of, and the through increased opportunities to trade Statutory Basis for, the Proposed Rule as well as enhancing price discovery Change SECURITIES AND EXCHANGE and price improvement. COMMISSION 1. Purpose 2. Statutory Basis [Release No. 34–74956; File No. SR– The purpose of this filing is to amend The Exchange believes that the NYSEMKT–2015–38] 3 Section I.G. of the Fee Schedule to proposed rule change is consistent with modify existing CUBE fees and credits Section 6(b) of the Act,5 in general, and Self-Regulatory Organizations; NYSE and to add a new rebate for CUBE MKT, LLC; Notice of Filing and furthers the objectives of Sections participants who qualify for Tiers 2, 3, 6(b)(4) and (5) of the Act,6 in particular, Immediate Effectiveness of Proposed 4 or 5 of the Amex Customer Rule Change Modifying the NYSE 4 because it provides for the equitable Engagement (‘‘ACE’’) Program. The allocation of reasonable dues, fees, and Amex Options Fee Schedule Related to Exchange proposes to implement the fee Fees and Credits Associated With the other charges among its members, change effective May 1, 2015. issuers and other persons using its Customer Best Execution Auction The Exchange proposes to increase facilities and does not unfairly the fees associated with RFR Responses May 13, 2015. discriminate between customers, participating in the Auction by $0.05— Pursuant to Section 19(b)(1) of the issuers, brokers or dealers. Securities Exchange Act of 1934 from $0.55 to $0.60 for Non-Customers The Exchange believes that the (‘‘Act’’),1 and Rule 19b–4 thereunder,2 proposed changes to CUBE Auction fees 3 See Fee Schedule, Section I.G., available at, notice is hereby given that on May 1, https://www.theice.com/publicdocs/nyse/markets/ are reasonable, equitable and not amex-options/NYSE_Amex_Options_Fee_ 1 15 U.S.C. 78s(b)(1). Schedule.pdf. 5 15 U.S.C. 78f(b). 2 17 CFR 240.19b–4. 4 See id., Section I.E. 6 15 U.S.C. 78f(b)(4) and (5).

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unfairly discriminatory. First, the more volume and liquidity to the participants that do not participate in proposal to increase the fees associated Exchange generally, and to CUBE the ACE Program. with RFR Responses that participate in Auctions specifically, which will Additionally, the Exchange believes the CUBE applies equally to all non- benefit all market participants the proposed changes are consistent Customer ATP Holders that choose to (including those that do not participate with the Act because they may attract participate in the CUBE, and access to in the ACE Program) through increased greater volume and liquidity to the the Exchange is offered on terms that are opportunities to trade at potentially Exchange, which would improve its not unfairly discriminatory. In addition, improved prices as well as enhancing overall competitiveness and strengthen the proposed RFR Response fees are price discovery. Furthermore, the its market quality for all market within the range of fees charged to non- proposed Rebate is reasonably designed participants. Customers on other exchanges for and not unfairly discriminatory because For these reasons, the Exchange executions within similar electronic it [sic] available regardless of the parties believes that the proposal is consistent crossing mechanisms. For example, the that trade with the CUBE Order (i.e., with the Act. BOX Options Exchange LLC (‘‘BOX’’) whether the CUBE Order trades with the Contra Order or otherwise). B. Self-Regulatory Organization’s charges Professional Customers and Statement on Burden on Competition Broker Dealers who respond to an In addition, the proposal to offer an auction with Improvement Orders $0.72 additional incentive to participate in the In accordance with Section 6(b)(8) of per contract in Penny issues and $1.12 CUBE Auction to those ATP Holders the Act,11 the Exchange does not believe per contract in non-Penny issues, while that have achieved certain monthly that the proposed rule change will charging BOX Market Makers who volume thresholds is also not new or impose any burden on competition that respond either $0.55 in Penny issues or novel. For example, the MIAX Options is not necessary or appropriate in $0.95 in non-Penny issues.7 Exchange (‘‘MIAX’’) offers an additional furtherance of the purposes of the Act. The Exchange believes that the per contract rebate on certain agency The Exchange believes the proposed proposal to reduce the current Initiating orders executed in its electronic auction amendments to CUBE Auction pricing Participant Credits are reasonable, mechanism (‘‘PRIME’’), which provides are pro-competitive as the fees are to equitable and non-discriminatory for a maximum credit of $0.12 per incentivize increases in volume and because they apply equally to all ATP contract, based on a member achieving liquidity to the Exchange, which would 9 Holders that choose to participate in the certain monthly volume thresholds. In benefit all of Exchange participants CUBE, and access to the Exchange is addition, the proposal to cap the Rebate through increased opportunities to trade offered on terms that are not unfairly at 5,000 Customer contracts per CUBE as well as enhancing price discovery. discriminatory. Finally, the proposed Order is likewise consistent with the The Exchange also believes that the CUBE Auction credits for Penny and practice of other exchanges. For proposed ACE Initiating Participant non-Penny issues to be paid to Initiating example, the Chicago Board of Options Rebate would enhance the Participants for each CUBE Order Exchange (‘‘CBOE’’) caps the number of competiveness of the Exchange relative contract that does not trade with the contracts submitted to its price to other exchanges that offer similar Contra Order are within the range of improvement auction that are eligible rebates tied to volume incentives.12 for additional volume rebates at 1,000 The Exchange notes that it operates in rebates paid on other exchanges for 10 executions within similar electronic contracts. The Exchange notes that a highly competitive market in which crossing mechanisms. For example, the although the proposed Rebate applies market participants can readily favor solely to Customer orders, it is International Securities Exchange, LLC competing venues. In such an nonetheless equitable and not unfairly (‘‘ISE’’) pays a Price Improvement environment, the Exchange must discriminatory because it would Mechanism (‘‘PIM’’) Break-up Rebate of continually review, and consider enhance the incentives to ATP Holders $0.35 per contract in Select Symbols adjusting, its fees and credits to remain to transact Customer orders on the (i.e., Penny Pilot issues) and $0.80 per competitive with other exchanges. For Exchange and an increase in Customer contract in Non-Select Symbols (i.e., the reasons described above, the order flow would bring greater volume non-Penny Pilot issues) for contracts Exchange believes that the proposed and liquidity to the Exchange. Increased submitted to a PIM that do not trade rule change reflects this competitive volume to the Exchange benefits all with their contra order.8 environment. market participants by providing more Similarly, the proposed changes to trading opportunities and tighter C. Self-Regulatory Organization’s CUBE Auction credits are reasonable, spreads, even to those market Statement on Comments on the equitable and not unfairly Proposed Rule Change Received From discriminatory. Specifically, the ACE 9 See MIAX fee schedule, Priority Customer Members, Participants, or Others Initiating Participant Rebate is based on Rebate Program, available at, http:// the amount of business transacted on www.miaxoptions.com/content/fees (providing a No written comments were solicited the Exchange and is designed to attract $0.10 per contract rebate for all Priority Customer or received with respect to the proposed orders executed in the PRIME Auction and rule change. providing that any Member or applicable affiliate 7 See BOX fee schedule, available at, http:// that qualifies for MIAX’s Priority Customer Rebate _ _ III. Date of Effectiveness of the boxexchange.com/assets/BOX Fee Schedule.pdf. Program volume tiers 3, 4, or 5 will be credited an Proposed Rule Change and Timing for The BOX fee schedule has several parts that must additional $0.02 per contract for each Priority be taken collectively to arrive at the all-in cost of Customer order executed in the PRIME Auction as Commission Action responding to an auction. For example, a Broker a PRIME Agency Order over a threshold of The foregoing rule change is effective Dealer who responds to an auction with an 1,500,000 contracts in a month, subject to certain Improvement Order will pay $0.72 per contract in enumerated exceptions). upon filing pursuant to Section Penny issues. The $0.72 fee represents the 10 See CBOE fee schedule, Volume Incentive 19(b)(3)(A) 13 of the Act and Improvement Order fee of $0.37 from Section I of Program (‘‘VIP’’), available at, http:// subparagraph (f)(2) of Rule 19b–414 the fee schedule, plus the $0.35 fee to add liquidity www.cboe.com/publish/feeschedule/ in Penny issues quoted with an MPV of $0.01 from CBOEFeeSchedule.pdf (providing that VIP credits 11 Section II of the schedule. on orders executed electronically in Automated 15 U.S.C. 78f(b)(8). 8 See ISE fee schedule, available at, http:// Improvement Mechanism will be capped at 1,000 12 See supra n. 9, 10. www.ise.com/assets/documents/OptionsExchange/ contracts per order for simple executions and 1,000 13 15 U.S.C. 78s(b)(3)(A). legal/fee/ISE_fee_schedule.pdf. contracts per leg for complex executions). 14 17 CFR 240.19b–4(f)(2).

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thereunder, because it establishes a due, 10:00 a.m. and 3:00 p.m. Copies of such Members 5 of the Exchange pursuant to fee, or other charge imposed by the filing also will be available for EDGA Rule 15.1(a) and (c) (‘‘Fee Exchange. inspection and copying at the principal Schedule’’) to: (i) Decrease the rebate for At any time within 60 days of the offices of the Exchange. All comments orders yielding Flag BY, which routes to filing of such proposed rule change, the received will be posted without change; the BATS Y-Exchange, Inc. (‘‘BYX’’) and Commission summarily may the Commission does not edit personal removes liquidity using routing temporarily suspend such rule change if identifying information from strategies Destination Specific (‘‘DIRC’’), it appears to the Commission that such submissions. You should submit only ROUC, ROUE, ROBB, or ROCO; 6 (ii) action is necessary or appropriate in the information that you wish to make amend the criteria for the MidPoint public interest, for the protection of available publicly. All submissions Discretionary Order Add Volume Tier; investors, or otherwise in furtherance of should refer to File Number SR– and (iii) make an immaterial, non- the purposes of the Act. If the NYSEMKT–2015–38, and should be substantive change. Changes to the fee Commission takes such action, the submitted on or before June 9, 2015. schedule pursuant to this proposal are Commission shall institute proceedings effective upon filing. 15 For the Commission, by the Division of under Section 19(b)(2)(B) of the Act to Trading and Markets, pursuant to delegated The text of the proposed rule change determine whether the proposed rule authority.16 is available at the Exchange’s Web site change should be approved or Robert W. Errett, at www.batstrading.com, at the disapproved. Deputy Secretary. principal office of the Exchange, and at the Commission’s Public Reference IV. Solicitation of Comments [FR Doc. 2015–12063 Filed 5–18–15; 8:45 am] Room. Interested persons are invited to BILLING CODE 8011–01–P submit written data, views, and II. Self-Regulatory Organization’s arguments concerning the foregoing, Statement of the Purpose of, and including whether the proposed rule SECURITIES AND EXCHANGE Statutory Basis for, the Proposed Rule change is consistent with the Act. COMMISSION Change Comments may be submitted by any of In its filing with the Commission, the the following methods: [Release No. 34–74948; File No. SR–EDGA– 2015–18] Exchange included statements Electronic Comments concerning the purpose of and basis for Self-Regulatory Organizations; EDGA the proposed rule change and discussed • Use the Commission’s Internet Exchange, Inc.; Notice of Filing and any comments it received on the comment form (http://www.sec.gov/ Immediate Effectiveness of a Proposed proposed rule change. The text of these rules/sro.shtml); or Rule Change Related To Fees for Use statements may be examined at the • Send an email to rule-comments@ of EDGA Exchange, Inc. places specified in Item IV below. The sec.gov. Please include File Number SR– Exchange has prepared summaries, set NYSEMKT–2015–38 on the subject line. May 13, 2015. forth in Sections A, B, and C below, of Paper Comments Pursuant to Section 19(b)(1) of the the most significant parts of such Securities Exchange Act of 1934 (the • Send paper comments in triplicate statements. ‘‘Act’’),1 and Rule 19b–4 thereunder,2 to Secretary, Securities and Exchange notice is hereby given that on April 30, (A) Self-Regulatory Organization’s Commission, 100 F Street, NE., 2015, EDGA Exchange, Inc. (the Statement of the Purpose of, and Washington, DC 20549–1090. ‘‘Exchange’’ or ‘‘EDGA’’) filed with the Statutory Basis for, the Proposed Rule All submissions should refer to File Securities and Exchange Commission Change Number SR–NYSEMKT–2015–38. This (‘‘Commission’’) the proposed rule 1. Purpose file number should be included on the change as described in Items I, II and III The Exchange proposes to: (i) subject line if email is used. To help the below, which Items have been prepared Decrease the rebate for orders yielding Commission process and review your by the Exchange. The Exchange has Flag BY, which routes to BYX and comments more efficiently, please use designated the proposed rule change as removes liquidity using routing only one method. The Commission will one establishing or changing a member strategies DIRC, ROUC, ROUE, ROBB, or post all comments on the Commission’s due, fee, or other charge imposed by the ROCO; (ii) amend the criteria for the Internet Web site (http://www.sec.gov/ Exchange under Section 19(b)(3)(A)(ii) MidPoint Discretionary Order Add rules/sro.shtml). Copies of the of the Act 3 and Rule 19b–4(f)(2) Volume Tier; and (iii) make an submission, all subsequent thereunder,4 which renders the immaterial, non-substantive change. amendments, all written statements proposed rule change effective upon with respect to the proposed rule filing with the Commission. The Flag BY change that are filed with the Commission is publishing this notice to Commission, and all written In securities priced at or above $1.00, solicit comments on the proposed rule the Exchange currently provides a communications relating to the change from interested persons. proposed rule change between the rebate of $0.00160 per share for Commission and any person, other than I. Self-Regulatory Organization’s Members’ orders that yield Flag BY, those that may be withheld from the Statement of the Terms of Substance of which routes to BYX and removes public in accordance with the the Proposed Rule Change provisions of 5 U.S.C. 552, will be 5 The term ‘‘Member’’ is defined as ‘‘any The Exchange filed a proposal to registered broker or dealer, or any person associated available for Web site viewing and amend its fees and rebates applicable to with a registered broker or dealer [sic], that has printing in the Commission’s Public been admitted to membership in the Exchange. A Member will have the status of a ‘‘member’’ of the Reference Room, 100 F Street, NE., 16 17 CFR 200.30–3(a)(12). Exchange as that term is defined in Section 3(a)(3) Washington, DC 20549 on official 1 15 U.S.C. 78s(b)(1). of the Act.’’ See Exchange Rule 1.5(n). business days between the hours of 2 17 CFR 240.19b–4. 6 The DIRC, ROUC, ROUE, ROBB, or ROCO 3 15 U.S.C. 78s(b)(3)(A)(ii). routing strategies are set forth in Exchange Rule 15 15 U.S.C. 78s(b)(2)(B). 4 17 CFR 240.19b–4(f)(2). 11.11(g).

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liquidity using routing strategies DIRC, Exchange at the midpoint of the which BATS Trading passed through to ROUC, ROUE, ROBB, or ROCO. The National Best Bid or Offer (‘‘NBBO’’). the Exchange and the Exchange Exchange proposes to amend its Fee provided its Members. When BATS Non-Substantive Changes Schedule to decrease the rebate for Trading routes to BYX, it will now be orders that yield Flag BY to $0.00150 The Exchange also proposes to make provided a rebate of $0.00150 per share. per share in securities priced at or above an immaterial, non-substantive change The Exchange does not levy additional $1.00.7 The proposed change represents to its Fee Schedule by removing ‘‘, Inc.’’ fees or offer additional rebates for orders a pass through of the rate BATS from the reference to the Exchange in that it routes to BYX through BATS Trading, Inc. (‘‘BATS Trading’’), the the heading of the Fee Schedule. This Trading. Therefore, the Exchange Exchange’s affiliated routing broker- non-substantive change is intended to believes that the proposed change to dealer, is provided for routing orders to make the reference to the Exchange in Flag BY is equitable and reasonable BYX that remove liquidity. The the heading of the Fee Schedule because it accounts for the pricing proposed change is in response to BYX’s consistent with the manner in which its changes on BYX, which enables the May 2015 fee change where BYX affiliated exchanges 10 are referenced in Exchange to provide its Members the decreased its rebate from $0.00160 per their respective fee schedules. applicable pass-through rebate. Lastly, share to $0.00150 per share for orders in Implementation Date the Exchange notes that routing through securities priced at or above $1.00.8 BATS Trading is voluntary and believes When BATS Trading routes to and The Exchange proposes to implement that the proposed change is non- removes liquidity from BYX, it will now these amendments to its Fee Schedule discriminatory because it applies receive a standard rebate of $0.00150 on May 1, 2015. uniformly to all Members. per share. BATS Trading will pass 2. Statutory Basis MidPoint Discretionary Order Add through the rebate provided by BYX to The Exchange believes that the Volume Tier the Exchange and the Exchange, in turn, proposed rule change is consistent with will pass through this rate to its The Exchange believes amending the the objectives of Section 6 of the Act,11 Members. criteria for the MidPoint Discretionary in general, and furthers the objectives of Order Add Volume Tier represents an 12 MidPoint Discretionary Order Add Section 6(b)(4), in particular, as it is equitable allocation of reasonable dues, Volume Tier designed to provide for the equitable fees, and other charges among Members The Exchange proposes to amend the allocation of reasonable dues, fees and and other persons using its facilities criteria for the MidPoint Discretionary other charges among its Members and because it is designed to further Order Add Volume Tier. Under the tier, other persons using its facilities. The incentivize Members to increase their a Member qualifies for a reduced fee of Exchange also notes that it operates in use of MidPoint Discretionary orders on $0.0003 per share where that Member: a highly-competitive market in which EDGA. MidPoint Discretionary Orders (i) Adds an ADV of at least 0.25% of the market participants can readily direct increase displayed liquidity on the TCV including non-displayed orders order flow to competing venues if they Exchange while also enhancing that add liquidity; and (ii) adds or deem fee levels at a particular venue to execution opportunities at the mid- removes an ADV of at least 1,500,000 be excessive. The proposed rule change point of the NBBO. Promotion of shares yielding fee codes DM or DT. Fee reflects a competitive pricing structure displayed liquidity at the NBBO code DM is applied to Non-Displayed designed to incent [sic] market enhances market quality for all orders that add liquidity using MidPoint participants to direct their order flow to Members. Members utilizing MidPoint Discretionary orders 9 and fee code DT the Exchange. The Exchange believes Discretionary orders provide liquidity at is applied to Non-Displayed orders that that the proposed rates are equitable and the midpoint of the NBBO increasing remove liquidity using MidPoint non-discriminatory in that they apply the potential for an order to receive Discretionary Orders. Orders that yield uniformly to all Members. The price improvement, and easing the tier’s fee code DM or fee code DT that do not Exchange believes the fees and credits criteria so that Members may be eligible meet to the criteria of the MidPoint remain competitive with those charged for a decreased fee is a reasonable Discretionary Order Add Volume Tier by other venues and therefore continue means by which to encourage the use of are charged a fee of $0.00050 per share. to be reasonable and equitably allocated such orders. In addition, the Exchange The Exchange now proposes to decrease to Members. believes that by encouraging the use of the ADV requirement to require that a Flag BY MidPoint Discretionary orders by easing Member add or remove an ADV of at The Exchange believes that its the tier’s criteria, Members seeking price least 500,000 shares yielding fee codes proposal to decrease the rebate for improvement would be more motivated DM or DT. Easing the criteria of the orders that yield Flag BY represents an to direct their orders to EDGA because MidPoint Discretionary Order Add equitable allocation of reasonable dues, they would have a heightened Volume Tier is intended to further fees, and other charges among Members expectation of the availability of incentive Members to submit an and other persons using its facilities. liquidity at the midpoint of the NBBO. increased number of MidPoint Prior to the BYX’s May 2015 fee change, The Exchange also believes that the Discretionary orders to the Exchange, BYX provided BATS Trading a rebate of proposed addition of the MidPoint thereby increasing the liquidity on the $0.00160 per share to remove liquidity Discretionary Order Add Volume Tier is in securities priced at or above $1.00, non-discriminatory because it will be 7 The Exchange does not propose to amend its fee available to all Members. for orders that yield Flag BY in securities priced below $1.00. 10 The Exchange’s affiliated exchanges are BATS Non-Substantive Changes 8 See BYX Exchange Fee Schedule Changes Exchange, Inc., BATS Y-Exchange, Inc., and EDGX Effective May 1, 2015 available at http:// Exchange, Inc. (‘‘EDGX’’). The Exchange The Exchange believes that the non- cdn.batstrading.com/resources/fee_schedule/2015/ understands that EDGX also intends to file a substantive change to its Fee Schedule BATS-BYX-Exchange-BZX-Exchange-EDGA- proposed rule change with the Commission making is reasonable because it is not designed Exchange-and-EDGX-Exchange-Fee-Schedule- a similar change to how EDGX is referenced in the Changes-Effective-May-1–2015.pdf. heading of its fee schedule. to amend any fee, nor alter the manner 9 See Exchange Rule 11.8(e) for a description of 11 15 U.S.C. 78f. in which it assesses fees or calculates MidPoint Discretionary orders. 12 15 U.S.C. 78f(b)(4). rebates. This non-substantive change to

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the Fee Schedule is intended to make midpoint of the NBBO and better market Commission process and review your the reference to the Exchange in the quality at the Exchange. comments more efficiently, please use heading of the Fee Schedule consistent only one method. The Commission will Non-Substantive Changes with the manner in which its affiliated post all comments on the Commission’s exchanges are referenced in their The Exchange believes that the non- Internet Web site (http://www.sec.gov/ respective fee schedules, thereby substantive change to the Fee Schedule rules/sro.shtml). Copies of the removing impediments to and will not affect intermarket nor submission, all subsequent perfecting the mechanism of a free and intramarket competition because the amendments, all written statements open market and a national market change is not designed to amend any fee with respect to the proposed rule system, and, in general, protecting or alter the manner in which the change that are filed with the investors and the public interest. Exchange assesses fees or calculates Commission, and all written rebates. (B) Self-Regulatory Organization’s communications relating to the Statement on Burden on Competition (C) Self-Regulatory Organization’s proposed rule change between the Statement on Comments on the Commission and any person, other than The Exchange believes its proposed those that may be withheld from the amendments to its Fee Schedule would Proposed Rule Change Received From Members, Participants or Others public in accordance with the not impose any burden on competition provisions of 5 U.S.C. 552, will be that is not necessary or appropriate in The Exchange has not solicited, and available for Web site viewing and furtherance of the purposes of the Act. does not intend to solicit, comments on printing in the Commission’s Public The Exchange does not believe that the this proposed rule change. The Reference Room, 100 F Street NE., proposed change represents a significant Exchange has not received any Washington, DC 20549, on official departure from previous pricing offered unsolicited written comments from business days between the hours of by the Exchange or pricing offered by Members or other interested parties. 10:00 a.m. and 3:00 p.m. Copies of the the Exchange’s competitors. III. Date of Effectiveness of the filing will also be available for Additionally, Members may opt to inspection and copying at the principal disfavor the Exchange’s pricing if they Proposed Rule Change and Timing for Commission Action office of the Exchange. All comments believe that alternatives offer them received will be posted without change; better value. Accordingly, the Exchange The foregoing rule change has become the Commission does not edit personal does not believe that the proposed effective pursuant to Section 19(b)(3)(A) identifying information from change will impair the ability of of the Act 13 and paragraph (f) of Rule 14 submissions. You should submit only Members or competing venues to 19b–4 thereunder. At any time within information that you wish to make maintain their competitive standing in 60 days of the filing of the proposed rule available publicly. All submissions the financial markets. change, the Commission summarily may should refer to File Number SR–EDGA– temporarily suspend such rule change if Fee Code BY 2015–18 and should be submitted on or it appears to the Commission that such before June 9,2015. The Exchange believes that its action is necessary or appropriate in the proposal to pass through the amended public interest, for the protection of For the Commission, by the Division of rebate for orders that yield Flags BY investors, or otherwise in furtherance of Trading and Markets, pursuant to delegated authority.15 would increase intermarket competition the purposes of the Act. because it offers customers an Robert W. Errett, alternative means to route to BYX for IV. Solicitation of Comments Deputy Secretary. the same rebate that they would be Interested persons are invited to [FR Doc. 2015–12016 Filed 5–18–15; 8:45 am] provided if they entered orders on that submit written data, views, and BILLING CODE 8011–01–P trading center directly. The Exchange arguments concerning the foregoing, believes that its proposal would not including whether the proposed rule burden intramarket competition because change is consistent with the Act. SECURITIES AND EXCHANGE the proposed rebate would apply Comments may be submitted by any of COMMISSION uniformly to all Members. the following methods: [Release No. 34–74951; File No. SR– MidPoint Discretionary Order Add Electronic Comments NYSEARCA–2015–38] Volume Tier • Use the Commission’s Internet Self-Regulatory Organizations; NYSE The Exchange believes that its comment form (http://www.sec.gov/ Arca, Inc.; Notice of Filing of Proposed proposal to ease the criteria for the rules/sro.shtml); or Rule Change Adopting New Equity MidPoint Discretionary Order Add • Send an email to rule-comments@ Trading Rules Relating to Trading Volume Tier would increase intermarket sec.gov. Please include File Number SR– Sessions, Order Ranking and Display, competition because it would further EDGA–2015–18 on the subject line. and Order Execution To Reflect the incentivize Members to send an Implementation of Pillar, the increased amount MidPoint Paper Comments Exchange’s New Trading Technology Discretionary orders to the Exchange in • Send paper comments in triplicate Platform order to qualify for the tier’s decreased to Brent J. Fields, Secretary, Securities fee. The Exchange believes that its and Exchange Commission, 100 F Street May 13, 2015. proposal would neither increase nor NE., Washington, DC 20549–1090. Pursuant to Section 19(b)(1) 1 of the decrease intramarket competition All submissions should refer to File Securities Exchange Act of 1934 (the because the MidPoint Discretionary Number SR–EDGA–2015–18. This file ‘‘Act’’) 2 and Rule 19b–4 thereunder,3 Order Add Volume Tier would apply number should be included on the uniformly to all Members and the ability subject line if email is used. To help the 15 17 CFR 200.30–3(a)(12). of some Members to meet the tier would 1 15 U.S.C. 78s(b)(1). only benefit other Members by 13 15 U.S.C. 78s(b)(3)(A). 2 15 U.S.C. 78a. contributing to increased liquidity at the 14 17 CFR 240.19b–4(f). 3 15 CFR 240.19b–4.

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notice is hereby given that, on April 30, The Exchange will be submitting from rules applicable to trading on the 2015, NYSE Arca, Inc. (the ‘‘Exchange’’ proposed rule changes to correspond to current NYSE Arca equities trading or ‘‘NYSE Arca’’) filed with the the anticipated migration to Pillar, system. However, with Pillar, the Securities and Exchange Commission which would be done in phases. During Exchange would introduce new (the ‘‘Commission’’) the proposed rule the first phase, ETP Holders would terminology. Further, because the change as described in Items I, II, and continue to connect to existing NYSE Exchange would operate both its current III below, which Items have been Arca gateways to access the Pillar trading system for some symbols and prepared by the self-regulatory trading platform. In the second phase, the Pillar trading platform for other organization. The Commission is the Exchange will introduce new symbols, until rollout of Pillar across all publishing this notice to solicit customer gateways and connectivity as symbols is complete, the Exchange is comments on the proposed rule change well as additional order type processing. proposing to add all new rule text for from interested persons. To implement the first phase of Pillar proposed Rules 7.34P, 7.36P, and 7.37P. migration, the Exchange will be I. Self-Regulatory Organization’s Because these rules and related submitting more than one rule filing. proposed terminology changes would be Statement of the Terms of Substance of The Exchange will later submit rule the foundation for all other rule changes the Proposed Rule Change filings to implement the second phase of that will be proposed in connection The Exchange proposes to adopt new Pillar migration. During the first phase of Pillar with Pillar, the Exchange believes that equity trading rules relating to Trading filing for these rule changes before other Sessions, Order Ranking and Display, implementation, the Exchange would roll out the new technology platform rule changes will provide the public and Order Execution to reflect the notice of how Pillar would operate implementation of Pillar, the Exchange’s over a period of time based on a range generally. new trading technology platform. The of symbols. Because orders entered in text of the proposed rule change is symbols not yet migrated to Pillar Proposed Use of ‘‘P’’ Modifier available on the Exchange’s Web site at would continue to operate under www.nyse.com, at the principal office of current rules, the Exchange will keep its To reflect how the ‘‘P’’ modifier the Exchange, and at the Commission’s current rules, pending complete would operate, the Exchange proposes Public Reference Room. migration of symbols to Pillar and to add rule text immediately following retirement of the current trading system, the reference to ‘‘Rule 7 Equities II. Self-Regulatory Organization’s and add new rules that would be Trading,’’ and before ‘‘Section 1. Statement of the Purpose of, and applicable to symbols that trade on the General Provisions’’ that would provide Statutory Basis for, the Proposed Rule Pillar trading platform. As proposed, the that rules with a ‘‘P’’ modifier would be Change new rules governing trading on Pillar operative for symbols that are trading on In its filing with the Commission, the would have the same numbering as the Pillar trading platform. As further self-regulatory organization included current rules, but with the modifier ‘‘P’’ proposed, if a symbol is trading on the statements concerning the purpose of, appended to the rule number. For Pillar trading platform, a rule with the and basis for, the proposed rule change example, Rule 7.34, governing Trading same number as a rule with a ‘‘P’’ and discussed any comments it received Sessions, would remain unchanged and modifier would no longer be operative on the proposed rule change. The text continue to apply to any trading in for that symbol and the Exchange would symbols on the current trading platform. of those statements may be examined at announce by Trader Update when Proposed Rule 7.34P would govern the places specified in Item IV below. symbols are trading on the Pillar trading Trading Sessions for trading in symbols The Exchange has prepared summaries, platform. migrated to the Pillar platform. Once all set forth in sections A, B, and C below, symbols have migrated to the Pillar Similarly, the Exchange proposes to of the most significant parts of such platform, the Exchange will file a rule add rule text following the title ‘‘Rule 1 statements. proposal to delete rules that are no Definitions’’ that provides that A. Self-Regulatory Organization’s longer operative. definitions with a paragraph designation Statement of the Purpose of, and In this filing, the Exchange proposes that includes a ‘‘P’’ modifier would be Statutory Basis for, the Proposed Rule to adopt new Pillar rules relating to operative for symbols trading on the Change Trading Sessions (NYSE Arca Equities Pillar trading platform. A definition Rule 7.34 (‘‘Rule 7.34’’)), Order Ranking with the same paragraph designation as 1. Purpose and Display (NYSE Arca Equities Rule a definition with a ‘‘P’’ modifier would On January 29, 2015, the Exchange 7.36 (‘‘Rule 7.36’’)), and Order not be operative for symbols trading on announced the implementation of Pillar, Execution (NYSE Arca Equities Rule Pillar. Finally, to provide clarity that which is an integrated trading 7.37 (‘‘Rule 7.37’’)). As proposed, the definitions that do not have a version technology platform designed to use a new rules would be NYSE Arca Equities with a ‘‘P’’ modifier would apply across single specification for connecting to the Rules 7.34P (Trading Sessions) (‘‘Rule all symbols, regardless of the trading equities and options markets operated 7.34P’’), 7.36P (Order Ranking and platform, the Exchange proposes to state by NYSE Arca and its affiliates, New Display) (‘‘Rule 7.36P’’), and 7.37P explicitly that definitions that do not York Stock Exchange LLC (‘‘NYSE’’) and (Order Execution) (‘‘Rule 7.37P’’). These have a companion version with a ‘‘P’’ NYSE MKT LLC (‘‘NYSE MKT’’). NYSE three rules would set forth the modifier would continue to be operative foundation of the Exchange’s equity Arca Equities will be the first trading for all symbols. system to migrate to Pillar.4 NYSE Arca trading model in Pillar, including the Equities trading on Pillar would be an hours of operation, how orders would The Exchange believes that adding all-electronic price-time priority be ranked and displayed, and how these explanations regarding the ‘‘P’’ equities trading platform. orders would be executed. modifier in Exchange rules would As discussed in greater detail below, provide transparency regarding which rules and definitions would be operative 4 See Trader Update dated January 29, 2015, the Exchange is not proposing that the available here: http://www1.nyse.com/pdfs/ core functionality of rules applicable to depending on the trading platform on Pillar_Trader_Update_Jan_2015.pdf. trading on Pillar would be different which a symbol is trading.

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Trading Sessions exchanges denote time in their rules. determined by the Corporation and that Rule 7.34 governs trading sessions. As The Exchange similarly believes that the Exchange would maintain on its set forth in Rule 7.34(a), the Exchange references to seconds in proposed Rule Web site which securities for which the has three trading sessions: 7.34P are unnecessary, as none of the Core Trading Session would extend to (1) the Opening Session, which begins other Exchange rules for the beginning 1:15:00 p.m. Because the Exchange does and end of trading sessions use seconds. not have any securities for which the at 1:00:00 a.m. Pacific Time and • concludes at the commencement of the Third, the Exchange proposes that Core Trading Session extends to 1:15:00 Core Trading Session. The Opening Rule 7.34P(a)(1) regarding Early Trading p.m. Pacific Time, nor does it plan to Auction and Market Order Auction Sessions would be more detailed than provide for such an extended Core occur during the Opening Session; Rule 7.34 by adding text that is Trading Session for any securities, the (2) the Core Trading Session, which currently in Rule 7.35(a)(1), without any Exchange proposes not to include this 6 begins at 6:30:00 a.m. Pacific Time or at substantive differences. Specifically, provision in proposed Rule 7.34P. the conclusion of the Market Order the Exchange proposes to include in • 7 Finally, the Exchange proposes that Auction, whichever comes later, and Rule 7.34P(a)(1) that the Corporation text currently found in Rules 7.34(a)(4), would begin accepting orders 30 concludes at 1:00:00 p.m. Pacific Time; 7.34(a)(5), and 7.34(b) not be included minutes before the Early Trading and in proposed Rule 7.34P. Rules 7.34(a)(4) Session begins. Because this rule text (3) the Late Trading Session, which and (5) currently describe how the concerns when orders may be entered, begins following the conclusion of the Exchange handles trading halts in the Exchange believes that it should be Core Trading Session and concludes at specified securities that occur during included in the rule governing trading 5:00:00 p.m. Pacific Time. different trading sessions. The Exchange sessions for Pillar. Proposed Rule Proposed Rule 7.34P(a)(1)–(3) would believes that rule text relating to halts 7.34P(a)(1) would further provide that similarly provide for three trading should be centralized in a single rule the Early Open Auction would begin the sessions, but with several proposed and will be proposing in a separate rule Early Trading Session. differences from Rule 7.34(a): • filing to add the text of current Rule • First, the Exchange proposes non- Fourth, the Exchange proposes to provide that the Core Open Auction 7.34(a)(4) and (5) to proposed Rule substantive differences in the names of 7.18P. Rule 7.34(b) sets forth Market the trading sessions on the Pillar trading would occur during the Core Trading Session. Rule 7.34(a) currently provides Maker obligations to enter Q Orders for platform. Specifically, for Pillar, the securities in which they are registered. Exchange proposes to call its three that the Market Order Auction occurs during the Opening Session. Because The Exchange believes that this topic is trading sessions the ‘‘Early Trading not related to trading sessions directly Session,’’ the ‘‘Core Trading Session,’’ this auction is intended to open trading 8 and that this rule text should be and the ‘‘Late Trading Session.’’ The for the Core Trading Session, the Exchange believes it should be included with the definition of Q Orders Exchange believes that the use of the and therefore will be proposing in a term ‘‘Early Trading Session,’’ rather considered part of the Core Trading Session, rather than the Early Trading separate rule filing to add the text of than the ‘‘Opening Session,’’ better current Rule 7.34(b) to proposed Rule describes when the session occurs, Session. The Exchange therefore proposes to specify in proposed Rule 7.31P.9 Because Rule 7.34(a)(4) defines which is before the Core Trading the term ‘‘Derivative Securities Product’’ Session, and therefore would be clearer 7.34P(a)(2) that the Core Open Auction would begin the Core Trading Session. and because that definition would not to market participants. In addition, the be included in proposed Rule 7.34P, the Exchange proposes the auction that The Exchange further proposes to specify that the Core Trading Session Exchange proposes to add a new opens the ‘‘Early Trading Session’’ would end at the conclusion of Core definition to Rule 1.1 to define the terms would be called the ‘‘Early Open Trading Hours or the Core Closing Derivative Securities Product and UTP Auction,’’ instead of the ‘‘Opening Auction, whichever comes later. The Derivative Securities Product. As Auction’’ and that the auction that proposed cross reference to Core proposed, the term ‘‘Derivative opens the ‘‘Core Trading Session’’ Trading Hours, which is defined in Rule Securities Product’’ would mean a would be called the ‘‘Core Open 1.1(j), takes into consideration that the security that meets the definition of Auction’’ instead of the ‘‘Market Order Core Trading Session may end earlier ‘‘derivative securities product’’ in Rule Auction.’’ The Exchange believes that than 4:00 p.m. when the Exchange has 19b–4(e) under the Securities Exchange the auctions that open the respective an early scheduled close, e.g., the day Act of 1934 10 and a ‘‘UTP Derivatives sessions should be named to reflect both before Christmas. Securities Product’’ would mean a the name of the session and that it is an • Fifth, the Exchange proposes not to Derivative Securities Product that trades opening auction for the respective include in proposed Rule 7.34P the text on the Exchange pursuant to unlisted session. currently in Rule 7.34 relating to trading privileges. • Second, the Exchange proposes that extended Core Trading Session hours. The Exchange proposes to include the all time references for the trading Rules 7.34(a)(3)(A) and (B) provide that sessions would be to Eastern Time, and text of Rule 7.34(c) in proposed Rule the Core Trading Session for specified 7.34P(b) with non-substantive would not include references to securities concludes at 1:15:00 p.m. 5 differences and to provide more detail. seconds. The Exchange’s current rules Pacific Time unless otherwise for trading sessions use references to Rule 7.34(c) provides that any Day Pacific Time. In today’s national trading Order entered into the NYSE Arca 6 In a separate rule filing, the Exchange will Marketplace 11 may remain in effect for environment, the Exchange believes that propose Rule 7.35P, which would govern auctions use of Eastern Time would reduce in Pillar. 9 investor confusion by conforming 7 The term ‘‘Corporation’’ is defined in Rule 1.1(k) The Exchange will be submitting a separate rule as NYSE Arca Equities, Inc., as described in the filing to propose Rule 7.31P, which would govern references to time to how all other NYSE Arca Equities, Inc.’s Certification of orders and modifiers in Pilar. Incorporation and Bylaws. 10 17 CFR 240.19b–4(e) 5 The Exchange also proposes to change the time 8 Rule 7.35 currently specifies that the Market 11 The term ‘‘NYSE Arca Marketplace’’ is defined in the definition of Core Trading Hours, which is Order Auction occurs at 9:30 a.m., which is the in Rule 1.1(e) as the electronic securities defined in Rule 1.1(j), from Pacific to Eastern Time same time that the Core Trading Session begins for communication and trading facility designated by references. securities that do not have an auction. Continued

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one or more consecutive trading 7.34(d) describes which orders are designation would result in a rejection sessions on a particular day and that for permitted in each session. The of the order. The Exchange further each Day Order entered, the User 12 Exchange proposes to revise how this proposes to add that Market Pegged must designate for which trading topic is described in proposed Rule Orders entered before or during the session(s) the order will remain in 7.34P(c) to provide generally that orders Early Trading Session would be rejected effect. Proposed Rule 7.34P(b) would are eligible to participate in a session, regardless of the session designated for instead provide that any order entered unless otherwise provided in the rule. the order.13 For example, a Market into the NYSE Arca Marketplace must Accordingly, rule text in Rule 7.34(d) Order, Q Order, or Primary Pegged include a designation for which trading that specifies order types that are Order designated for the Core Trading session(s) the order would remain in eligible to participate in a particular Session only that is entered at 8:00 a.m. effect. session would not be included in new Eastern Time would be accepted, but a Proposed new Rule 7.34P(b) would Rule 7.34P because the proposed new Market Pegged Order designated for the also provide that an order would be text would make it unnecessary to Core Trading Session only entered at the eligible to participate only in the specify the order types eligible to same time would be rejected. designated trading session(s) and may participate in a particular session. Those • Proposed Rule 7.34P(c)(1)(B) would remain in effect for one or more order types that would not be eligible to specify that Limit Orders designated consecutive trading sessions on a participate in each of the Exchange’s IOC and Cross Orders would not be particular day. The Exchange further three trading sessions are described eligible to participate in the Early Open proposes to add that unless otherwise below. Auction and would be rejected if specified, an order designated for a later With respect to the Early Trading entered before the Early Open Auction trading session would be accepted but Session, the Exchange proposes in new concludes. The reference to Limit not eligible to trade until the designated Rule 7.34P(c)(1) to provide that, unless Orders designated IOC includes any trading session begins. For example, if otherwise specified in proposed order with an IOC instruction, including an order is entered at 8:00 a.m. Eastern paragraphs (c)(1)(A)—(E) of the new MPL Orders. Limit Orders designated Time and is designated for the Core rule, orders and modifiers defined in IOC and Cross Orders are not currently Trading Session only, it would be Rule 7.31P that have been designated for eligible to participate in auctions, accepted but would not participate in the Early Trading Session would be accordingly, this proposed rule change the Early Trading Session. As discussed eligible to participate in the Early does not represent new functionality. in more detail below, proposed Rule Trading Session. The Exchange believes However, the Exchange believes that the 7.34P(c) would specify orders that may that the proposed rule text makes clear proposed change promotes transparency not be entered either during or in that unless specified in paragraphs in Exchange rules regarding when an advance of a designated trading session. (c)(1)(A)–(E) of new Rule 7.34P, all order would be accepted or rejected. In addition, the Exchange proposes to orders and modifiers in Rule 7.31P, if • Proposed Rule 7.34P(c)(1)(C) would add that an order designated solely for designated for the Early Trading specify that Limit Orders designated a trading session that has already ended Session, would be eligible to participate IOC and Cross Orders entered before or would be rejected. For example, an in the Early Trading Session. during the Early Trading Session and order entered at 10:00 a.m. Eastern Time Unlike under current rules, the designated for the Core Trading Session that is designated only for the Early Exchange proposes that Tracking Orders only would be rejected if entered before Trading Session would be rejected. The would be eligible to participate in the the Core Open Auction concludes. The Exchange believes that the proposed Early Trading Session on the Pillar Exchange believes that this proposed changes would provide transparency in trading platform. Because the Exchange rule would provide transparency Exchange rules of when orders may be routes orders during the Early Trading because orders designated IOC must be entered and when orders would be Session and because Tracking Orders eligible for an immediate execution and rejected. are intended to be passive liquidity on are not eligible for auctions, and an IOC The Exchange also proposes to add in the Exchange to interact with an order order designated with a later trading Rule 7.34P(b)(2) and (3) that an order before it is routed, the Exchange session is by its terms inconsistent. with a day time-in-force instruction believes that Tracking Orders should be • Proposed Rule 7.34P(c)(1)(D) would entered before or during the Early available in the Early Trading Session. provide that for securities that are not Trading Session would be deemed Accordingly, rule text from Rule eligible for an auction on the Exchange, designated for the Early Trading Session 7.34(d)(1)(C) would not be included in Market Orders designated for Core and the Core Trading Session and that new Rule 7.34P(c)(1). Trading Session and Auction-Only an order with a day time-in-force The Exchange proposes that the Orders would be routed directly to the instruction entered during the Core following orders and modifiers in Rule primary listing market on arrival. This Trading session would be deemed 7.31P would not be eligible to proposed treatment of Market Orders designated for the Core Trading Session. participate in the Early Trading Session: and Auction-Only Orders in securities The Exchange believes that the • Proposed Rule 7.34P(c)(1)(A) would that are not eligible for an auction on proposed rule text provides provide that Market Orders, Q Orders, the Exchange would be different from transparency regarding which sessions and Pegged Orders would not be eligible current functionality.14 Currently, during which an order may be eligible to participate in the Early Trading to participate. Session, which is current functionality. 13 As set forth in proposed Rule 7.34P(b), orders The Exchange proposes to describe The Exchange further proposes to that are entered during the Early Trading Session the processes currently set forth in Rule specify that any Market Orders, Q and designated for a later session only would be accepted and become eligible to trade once the 7.34(d) in proposed Rule 7.34P(c). Rule Orders, and Pegged Orders that include designated trading session begins. a designation for the Early Trading 14 Proposed Rule 7.34P(c)(1)(D) would also the Board of Directors through which orders of Session would be rejected. Such orders represent a change to current Exchange Users are consolidated for execution and/or display. would be rejected if they also include a functionality regarding MOC Orders and LOC 12 The term ‘‘User’’ is defined in Rule 1.1(yy) as Orders. Currently, the Exchange does not accept any ETP Holder or Sponsored Participant who is designation for another trading session; such orders before 9:30 a.m. Eastern Time. On the authorized to obtain access to the NYSE Arca the designation for the Early Trading Pillar trading platform, the Exchange would accept Marketplace pursuant to Rule 7.29. Session whether alone or with another such orders during the Early Trading Session, and

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Market Orders or Auction-Only Orders to participate in the Core Trading delayed opening if it is not open by are routed to the primary listing market Session. The proposed exceptions to the 10:00 a.m. Eastern Time. on arrival only if they include a general rule would be: • Proposed Rule 7.34P(c)(2)(B) would ‘‘Primary Only’’ order designation. The • Proposed Rule 7.34P(c)(2)(A) would provide that Auction-Only Orders in Exchange proposes that on the Pillar provide that Market Orders in securities securities that are not eligible for an trading platform, during the Early that are not eligible for the Core Open auction on the Exchange would be Trading Session, a Market Order or Auction would be routed to the primary accepted and routed directly to the Auction-Only Order in a security that is listing market until the first opening primary listing market. This proposed not eligible for an auction on the print of any size on the primary listing rule text is a continuation of the Exchange would be routed to the market or 10:00 a.m. Eastern Time, treatment of such orders as described in primary listing market regardless of whichever is earlier. This proposed rule proposed Rule 7.34P(c)(1)(D) in that whether it includes a Primary Only text is based on current Rule 7.35(c), during the Core Trading Session, the designation. The Exchange believes that which states that for all exchange-listed Exchange would continue to accept and this proposed functionality would be securities for which the Exchange does route such orders directly to the primary consistent with the expectations of a not conduct a Market Order Auction, listing market. This proposal represents User with respect to such orders, which ‘‘the Corporation will route all Market a change from current practice, as Rule would not be eligible for an execution Orders to the primary market until the 7.31(t) currently provides that the on the Exchange. The Exchange first opening print on the primary Exchange does not route Auction-Only proposes to further provide that any market.’’ This current rule makes clear orders to other exchanges. Instead, the order routed directly to the primary that the Exchange refrains from Exchange currently rejects Auction- listing market on arrival, which processing Market Orders until the Only Orders in securities that are not includes the above-described orders and primary listing market has printed a eligible for an auction on the Exchange, Primary Only Orders, would be transaction, and not just opened for unless they include a Primary Only cancelled if that market is not accepting trading based on an opening quote. Order designation. In Pillar, the orders. Because this rule relates to how orders Exchange would accept such orders and • Proposed Rule 7.34P(c)(1)(E) would are treated during a trading session, the route them to the primary listing provide that MOO Orders, MOC Orders, Exchange believes that it is more market.16 LOC Orders, and Primary Only Orders appropriately included in proposed With respect to the Late Trading designated for the Early Trading Session Rule 7.34P(c) than in a rule governing Session, the Exchange proposes in new would be rejected. This represents auctions. Rule 7.34P(c)(3) to provide that unless current functionality. LOO Orders may In moving the rule text, the Exchange otherwise specified in proposed be designated for the Early Trading is proposing two substantive paragraphs (c)(3)(A)–(C) of the new rule, System in order to participate in a differences. First, to specify that the first orders and modifiers defined in Rule reopening auction following a trading opening print may include an odd-lot 7.31P that have been designated for the halt. LOO Orders in securities not transaction, the Exchange proposes to Late Trading Session would be eligible eligible for an auction on the Exchange provide in Rule 7.34P(c)(2)(A) that to participate in the Late Trading that are designated for an Early Trading Market Orders in securities that are not Session. The Exchange believes that this Session would be routed to the primary eligible for the Core Open Auction proposed rule text makes clear that listing market, consistent with proposed would be routed to the primary listing unless specified in paragraphs (c)(3)(A)– Rule 7.34P(c)(1)(D) . The Exchange market until the first print of any size (C) of new Rule 7.34P, all orders and proposes to include this text in on the primary listing market. The modifiers in Rule 7.31P, if designated proposed Rule 7.34P in order to provide Exchange believes it is appropriate to for the Late Trading Session, would be transparency of when an order would be include an odd-lot transaction print eligible to participate in the Late rejected. because such a transaction indicates Trading Session. With respect to the Core Trading that trading has begun on the primary Unlike under current rules, the Session, the Exchange proposes in new listing market. Second, the Exchange Exchange proposes that Tracking Orders Rule 7.34P(c)(2) to provide that, unless proposes to provide for an outside time would be eligible to participate in the otherwise specified in proposed frame for when the Exchange would Late Trading Session, as they would be paragraphs (c)(2)(A)–(B) of the new rule, stop routing Market Orders to the in the Early Trading Session, on the orders and modifiers defined in Rule primary listing market and begin Pillar trading platform. Because the Exchange routes orders during the Late 7.31P and 7.44P that have been processing those orders on the Trading Session and because Tracking designated for the Core Trading Session Exchange. As proposed, the Exchange Orders are intended to be passive would be eligible to participate in the would continue routing Market Orders liquidity on the Exchange to interact Core Trading Session.15 The Exchange to the primary listing market until the with an order before it is routed, the believes that the proposed rule text first print of any size on such market or Exchange believes that Tracking Orders makes clear that, unless specified in 10:00 a.m. Eastern Time, whichever is earlier. The Exchange believes that if the should be available in the Late Trading paragraphs (c)(2)(A)–(B) of new Rule primary listing market has not opened Sessions. Accordingly, rule text from 7.34P, all orders and modifiers in Rule for trading by 10:00 a.m. Eastern Time current Rule 7.34(d)(3)(C) would not be 7.31P and 7.44P, if designated for the and has not halted the security, the included in new Rule 7.34P(c)(3). Core Trading Session, would be eligible Exchange should begin processing The Exchange proposes that the Market Orders in all securities. The following orders and modifiers in Rule if for a security that is not eligible for an auction on the Exchange, route such orders to the primary proposed time of 10:00 a.m. Eastern 7.31P would not be eligible to listing market if such market is accepting orders. Time is based on NYSE Rule 123D and participate in the Late Trading Session: 15 The Exchange notes that orders and modifiers NYSE MKT Rule 123D—Equities, which described in Rule 7.44 governing the Retail provide for delayed opening procedures 16 Because the treatment of Auction-Only Orders Liquidity Program (‘‘RLP’’) are eligible to for NYSE- and NYSE MKT-listed in securities that are not eligible for any auction on participate in the Core Trading Session only. The the Exchange would be covered in proposed Rule Exchange will submit a separate rule filing to adopt securities. Specifically, under those 7.34P, the Exchange would propose that new Rule Rule 7.44P to govern RLP in Pillar. rules, a security is considered in a 7.31P not include this same topic.

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• Proposed Rule 7.34P(c)(3)(A) would Order Process. The rule further provides Execution and Routing), described provide that Market Orders, Q Orders, that the NYSE Arca Marketplace will below. The Exchange believes that these and Pegged Orders would not be eligible also disseminate current consolidated proposed definitions would provide to participate in the Late Trading quotation/last sale information, and transparency regarding how the Session, which is current functionality. such other market information as may Exchange operates, and would serve as The rule would further provide that be available from time to time pursuant the foundation for amendments to Market Orders, Q Orders, and Pegged to agreement between the Corporation orders and modifiers that will be in Orders that include a designation for the and other market centers. proposed Rule 7.31P. Late Trading Session would be rejected. Rule 7.36(a) sets forth that orders of • Proposed Rule 7.36P(a)(1) would For example, if a Market Order, Q Users are ranked and maintained in the define the term ‘‘display price’’ to mean Order, or Pegged Order were entered Display Order Process and/or the the price at which a Limit Order is during the Core Trading Session and Working Order Process of the NYSE displayed, which may be different from designated for both the Core and Late Arca Book 17 according to price-time the limit price or working price of the Trading Session, because it includes a priority, such that within each price order. For example, Rule 7.31 provides designation for the Late Trading level, orders are organized by the time for order types that may be displayed at Session, such order would be rejected. of entry in the manner described in the prices that are different from the limit The Exchange believes that this rule. price, such as a PNP Blind Order.18 The proposed rule text provides Rule 7.36(a)(1) describes the Display Exchange proposes to define the term transparency in Exchange rules of when Order Process and Rule 7.36(a)(2) ‘‘display price’’ in Pillar to explain these an order would be accepted or rejected. describes the Working Order Process. existing concepts uniformly in • Proposed Rule 7.34P(c)(3)(B) would Rule 7.36(a)(3) sets forth that if an order Exchange rules applicable to trading on provide that orders that route directly to has been modified in size, the order the Pillar trading platform. the primary listing market on arrival retains priority if the modification • Proposed Rule 7.36P(a)(2) would would be cancelled if that market is not involves a decrease in the size of the define the term ‘‘limit price’’ to mean accepting orders, which is current order, but if the modification increases the highest (lowest) specified price at functionality. the size of the order or changes the which a Limit Order to buy (sell) is • Proposed Rule 7.34P(c)(3)(C) would price, the order will be treated as a new eligible to trade. The limit price is provide that MOO Orders, MOC Orders, order and receive a new time priority. designated by the User. As noted in the LOC Orders, and Primary Only Orders Rule 7.36(b) provides that, except as proposed definitions of display price designated for the Late Trading Session provided in Rule 7.7, all orders and working price, the limit price would be rejected. This represents displayed in the Display Order Process designated by the User may differ from current functionality. LOO Orders may are displayed on an anonymous basis. the price at which the order would be be designated for the Late Trading Finally, Rule 7.36(c) provides that the displayed or eligible to trade. System in order to participate in a best-ranked displayed orders to buy • Proposed Rule 7.36P(a)(3) would reopening auction following a trading (sell) in the NYSE Arca Book and the define the term ‘‘working price’’ to halt. LOO Orders in securities not aggregate size of such orders are mean the price at which an order is eligible for an auction on the Exchange collected and made available to eligible to trade at any given time, that are designated for an Early Trading quotation vendors for dissemination which may be different from the limit Session would be routed to the primary pursuant to Rule 11Ac1–1 under the price or display price of an order. The listing market. The Exchange proposes Exchange Act. The rule further provides new term ‘‘working price’’ identifies for to include this text in proposed Rule that if non-marketable odd-lot sized all orders the price at which an order is 7.34P in order to provide transparency orders can be aggregated to equal at least eligible to trade at any given time. Some of when an order would be rejected. a round lot, such odd-lot sized orders exchanges refer to this concept as the Proposed Rule 7.34P(d) regarding will be displayed as the best ranked price at which an order is ‘‘ranked.’’ 19 customer disclosures is based on Rule displayed orders to sell (buy) at the least The Exchange believes that the term 7.34(e) with non-substantive differences aggressive price at which such odd-lot ‘‘working price’’ would provide clarity to conform terminology with the sized orders can be aggregated to equal regarding the price at which an order proposed changes to new Rule 7.34P, at least a round lot. may be executed at any given time. including use of the term ‘‘Early Trading Proposed Rule 7.36P would describe Specifically, the Exchange believes that Session’’ instead of ‘‘Opening Session,’’ for the Pillar trading platform order use of the term ‘‘working’’ denotes that ‘‘Core Open Auction’’ instead of ranking and display of orders, without this is a price that is subject to change, ‘‘Market Order Auction,’’ and ‘‘Limit any substantive differences from Rule depending on circumstances. The Order’’ instead of ‘‘Limited Price 7.36. As discussed in detail below, the Exchange will be using this term in Order.’’ Exchange believes that the proposed connection with orders and modifiers Finally, proposed Rule 7.34P(e) is new rule text provides transparency when it files a separate rule filing to based on Rule 7.34(f) without any with respect to how the Exchange’s adopt Rule 7.31P. • substantive differences and would price-time priority model would operate Proposed Rule 7.36P(a)(4) would provide that trades on the NYSE Arca through the use of new terminology define the term ‘‘working time’’ to mean Marketplace executed and reported applicable to all orders on the Pillar the effective time sequence assigned to outside of the Core Trading Session trading platform. would be designated as .T trades. Rule 7.36P(a) would set forth 18 See Rule 7.31(e)(4). The Exchange notes that in definitions for purposes of all of Rule 7 connection with Pillar, the Exchange will be Order Ranking and Display renaming the PNP Blind Order as an ‘‘Arca Only Equities Trading on the Pillar trading Order,’’ which will be proposed in a separate rule Rule 7.36 governs order ranking and platform, including Rule 7.37P (Order filing to adopt new Rule 7.31P. See Trader Update display for the current Arca trading dated March 2, 2015, available here: https:// system. The rule provides that the NYSE 17 The term ‘‘NYSE Arca Book’’ is defined in Rule www.nyse.com/publicdocs/nyse/markets/nyse/ Pillar_Trader_Update_Mar_2015.pdf. Arca Marketplace shall display to Users 1.1(a) as the NYSE Arca Marketplace’s electronic file of orders, which contain all of the User’s orders 19 See, e.g., BATS Exchange, Inc. Rule and other market participants all non- in each of the Display Order, Working Order, and 11.9(g)(1)(A) (referring to where an order is marketable limit orders in the Display Tracking Order Processes. ‘‘ranked’’ as the price of an order).

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an order for purposes of determining its Finally, proposed Rule 7.36P(b)(3) if the non-displayed order has an earlier priority ranking. The Exchange proposes would be comparable to Rule 7.36(c) working time. to use the term ‘‘working time’’ in its regarding dissemination, without any To provide transparency regarding the rules for trading on the Pillar trading substantive differences. The Exchange Exchange’s ranking process, the platform instead of terms such as ‘‘time proposes to use the term ‘‘will’’ in Exchange proposes to set forth in Rule Proposed Rule 7.36P(b)(3) instead of sequence’’ or ‘‘time priority,’’ which are 7.36P additional detail regarding each ‘‘shall.’’ In addition, the Exchange used in rules governing trading on the step. Proposed Rule 7.36P(d) would would not include in proposed Rule Exchange’s current system. The describe how orders are ranked based Exchange believes that use of the term 7.36P rule text from the second sentence on price. Specifically, as proposed, all ‘‘working’’ denotes that this is a time of the preamble to Rule 7.36. The orders would be ranked based on the assigned to an order for purpose of Exchange is a participant in the CQ Plan working price of an order. Orders to buy ranking and is subject to change, and CTA Plan for Tape A- and B-listed would be ranked from highest working depending on circumstances. securities and a participant in the price to lowest working price and orders Proposed Rule 7.36P(b) would govern Nasdaq UTP Plan for Tape C-listed securities. The respective governing to sell would be ranked from lowest the display of non-marketable Limit working price to highest working price. Orders on the Pillar trading system and documents of those plans set forth the Exchange’s obligations regarding The rule would further provide that if is intended to be comparable to the the working price of an order changes, preamble to Rule 7.36, without any dissemination of quotes and last-sale information and thus, the Exchange the price priority of an order would substantive differences. As proposed, change. This price priority is current the Exchange would display all non- does not believe it is necessary to duplicate a subset of those requirements functionality, but the new rule would marketable Limit Orders, unless the use the proposed term ‘‘working price.’’ order or modifier instruction specifies in its rules. Finally, the Exchange proposes to cite to the governing federal The Exchange believes the proposed that all or a portion of the order is not rule by referencing Rule 602 of rule text provides transparency to be displayed. Regulation NMS 21 instead of Rule regarding the price-ranking process at The Exchange proposes to define in 11Ac1–1 under the Exchange Act, the Exchange. proposed Rule 7.36P(b)(1) what it means which was superseded by Regulation Proposed Rule 7.36P(e) would for an order to be displayed for ranking NMS. describe the proposed priority purposes. As proposed, an order would Proposed Rule 7.36P(c) would categories for ranking purposes. As be considered displayed for ranking describe the Exchange’s general process proposed, at each price point, all orders purposes if the price, side, and size of for ranking orders and would be would be assigned a priority category. If the order are disseminated via a market comparable to the text immediately at a price point there are no orders in data feed, which includes a proprietary following Rule 7.36(a), without any market data feed of the Exchange. As a priority category, the next category substantive differences. As proposed, would have first priority. The proposed further proposed, odd-lot sized Limit Rule 7.36P(c) would provide that all rules applicable to the Pillar trading Orders and the displayed portion of non-marketable orders would be ranked platform would not use the terms Reserve Orders would be considered and maintained in the NYSE Arca Book ‘‘Display Order Process,’’ ‘‘Working displayed for ranking purposes. This according to price-time priority in the Order Process’’ and ‘‘Tracking Order proposed rule text is intended to following manner: (1) Price; (2) priority provide transparency in Exchange rules category; (3) time; and (4) ranking Process’’ for describing priority regarding which orders are considered restrictions applicable to an order or categories. The Exchange does not displayed for ranking purposes, and modifier condition. Accordingly, orders believe that Rule 7.36P, which sets forth therefore eligible to be considered would be first ranked by price. Next, at the general rule regarding ranking, Priority 2—Display Orders (described each price level, orders would be should provide specifics for one or more below). Specifically, odd-lot sized assigned a priority category. Orders in order types and therefore the Exchange orders are displayed on the Exchange’s each priority category would be will address separately in new Rule proprietary data feed and would be required to be exhausted before moving 7.31P governing orders and modifiers displayed on the public feed if to the next priority category. Within which priority category correlates to aggregated to equal a round lot or more each priority category, orders would be order types and modifiers. Accordingly, would thus be considered ‘‘displayed’’ ranked by time. These general details regarding which proposed orders for purposes of priority ranking. requirements for order ranking are priority categories would be assigned to the display and reserve portions of Proposed Rule 7.36P(b)(2) would be applicable to all orders, unless an order Reserve Orders, which is in Rule 7.36, comparable to Rule 7.36(b) without any or modifier has a specified exception to will be addressed in new Rule 7.31P substantive differences and would this ranking methodology, as described and therefore not be included in provide that except as otherwise in more detail below. The Exchange is proposed Rule 7.36P, except as permitted by Rule 7.7,20 all non- proposing this ranking description marketable displayed Limit Orders instead of using the concepts of a described below. would be displayed on an anonymous Display Order Process, Working Order The proposed priority categories basis. The Exchange proposes not to Process, and Tracking Order Process in would be: include reference to the Display Order Rule 7.36. However, substantively there • would be no difference in how the Proposed Rule 7.36P(e)(1) would Process in Rule 7.36P(b)(2) because, as specify ‘‘Priority 1—Market Orders,’’ discussed above, the Exchange is not Exchange ranks orders on the Pillar trading platform from how it ranks which provides that unexecuted Market proposing to use that terminology in Orders would have priority over all Pillar. orders in in the current trading system. For example, a non-displayed order other same-side orders with the same working price. This proposed priority is 20 would always be ranked after a Rule 7.7 provides that bids and offers displayed order at the same price, even the same as current Exchange priority disseminated by the Exchange will not include an rules under which resting Market ETP Holder’s identify unless the ETP Holder affirmatively elects to disclosed its identify. 21 17 CFR 242.602. Orders have priority over other orders at

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the same price.22 Circumstances when to an Away Market 23 on arrival would from: (A) Sell to sell short; (B) sell to sell an unexecuted Market Order would be not be assigned a working time unless short exempt; (C) sell short to sell; (D) eligible to execute against an incoming and until any unexecuted portion of the sell short to sell short exempt; (E) sell contra-side order include when a order returns to the NYSE Arca Book. short exempt to sell; and (F) sell short Market Order has exhausted all interest The Exchange notes that this is the exempt to sell short. This rule text at the NBBO and is waiting for an NBBO current process for assigning a working would use for the Pillar trading platform update before executing again, pursuant time to an order and proposes to include rules the same rule text as in Rule to Rule 7.31(a), or when a Market Order it in Exchange rules to provide 7.16(f)(viii), without any substantive is held unexecuted because it has transparency regarding what is differences. The Exchange proposes to reached a trading collar, pursuant to considered the working time of an order include the text from Rule 7.16(f)(viii) Rule 7.31(a)(3)(A). In such that was fully routed on arrival. regarding order priority when changing circumstances, the unexecuted Market Æ Proposed Rule 7.36P(f)(1)(B) would order marking to Rule 7.36P to Order(s) would have priority over all specify that for an order that is partially consolidate ranking in a single rule. other resting orders at that price. routed to an Away Market on arrival, Proposed Rule 7.36P(g) would specify • Proposed Rule 7.36P(e)(2) would the portion that is not routed would be that the Exchange would enforce specify ‘‘Priority 2—Display Orders.’’ assigned a working time. If any ranking restrictions applicable to This proposed priority category would unexecuted portion of the order returns specified order or modifier instructions. replace the ‘‘Display Order Process.’’ As to the NYSE Arca Book and joins any These order and modifier instructions proposed, non-marketable Limit Orders remaining resting portion of the original would be identified in proposed new with a displayed working price would order, the returned portion of the order Rules 7.31P and 7.44P, which the have second priority. For an order that would be assigned the same working Exchange will submit in a rule filing has a display price that differs from the time as the resting portion of the order. prior to implementing the Pillar trading working price of the order, if the If the resting portion of the original platform. working price is not displayed, the order has already executed and any In addition, the Exchange proposes a order would not be ranked Priority 2 at unexecuted portion of the order returns definition in Rule 1.1(aP) of NYSE Arca the working price. to the NYSE Arca Book, the returned Book that would be applicable to the Pillar rules. The proposed definition • Proposed Rule 7.36P(e)(3) would portion of the order would be assigned would differ from the current definition specify ‘‘Priority 3—Non-Display a new working time. This process for of NYSE Arca Book in Rule 1.1(a) in that Orders.’’ This priority category would assigning a working time to partially it would not include references to the be used in Pillar rules, rather than the routed orders is the same as currently terms ‘‘Display Order Process,’’ ‘‘Working Order Process.’’ As proposed, used by the Exchange. The Exchange proposes to include this detail in ‘‘Working Order Process,’’ and non-marketable Limit Orders for which ‘‘Tracking Order Process,’’ which as the working price is not displayed, Exchange rules to provide transparency regarding what is considered the discussed above, are terms that will not including the reserve interest of Reserve be used in Pillar. As proposed, new Orders, would have third priority. working time of an order. • Rule 1.1(aP) would provide that the • Proposed Rule 7.36P(e)(4) would Proposed Rule 7.36P(f)(2) would provide that an order would be assigned term ‘‘NYSE Arca Book’’ refers to the specify ‘‘Priority 4—Tracking Orders.’’ NYSE Arca Marketplace’s electronic file This priority category would replace the a new working time any time the working price of an order changes. This of orders, which contains all orders ‘‘Tracking Order Process,’’ as discussed entered on the NYSE Arca Marketplace. in further detail below in connection proposed rule text would be based on with proposed Rule 7.37P. As proposed, the rule text in Rule 7.36(a)(3), without Order Execution and Routing any substantive differences. A change to Tracking Orders would have fourth Current Rule 7.37, titled ‘‘Order the working price could be because of priority. Execution,’’ governs order execution a User’s instruction or because the order Proposed Rule 7.36P(f) would set and routing at the Exchange. The or modifier has a price that can change forth that within each priority category, preamble to the rule provides that like- based on a reference price, such as an orders would be ranked based on time priced orders, bids and offers shall be MPL Order, which is priced based on priority. matched for execution following steps 1 the PBBO. • Proposed Rule 7.36P(f)(1) would through 4 of the rule, provided, • Proposed Rule 7.36P(f)(3) would provide that an order is assigned a however, for an execution to occur in provide that an order would be assigned working time based on its original entry any Order Process, the price must be a new working time if the size of the time, which is the time an order is first equal to or better than (1) the PBBO, in order increases and that an order would placed on the NYSE Arca Book. This the case of a Limit Order or Q Order or retain its working time if the size of the proposed process of assigning a working (2) the NBBO in the case of an Inside order is decreased. This proposed rule time to orders is current functionality Limit Order, a Pegged Limit Order, or a text would be based on rule text in the and is substantively the same as current Market order. If such an order is not first and second sentences of Rule references to the ‘‘time of original order executable within those parameters, the 7.36(a)(3), without any substantive entry’’ found in several places in Rule rule provides that it may be routed to differences. 7.36. To provide transparency in • Proposed Rule 7.36P(f)(4) would away markets as provided in Rule Exchange rules, the Exchange further provide that an order retains its working 7.37(d). The rule then sets forth steps 1 proposes to include in proposed Rule time if the order marking is changed 7.36P(f) how the working time would be through 4. Step 1 is the Display Order determined for orders that are routed. 23 The Exchange proposes Rule 1.1(ffP), which Process, which provides that incoming As proposed: would define the term ‘‘Away Market.’’ The orders are first matched for execution Æ Proposed Rule 7.36P(f)(1)(A) would proposed definition is based on the existing against other orders in the Display specify that an order that is fully routed definition of ‘‘NOW Recipient,’’ which is a term Order process. The rule provides further that the Exchange would not be using in Pillar. For Pillar, the proposed definition of ‘‘Away Market’’ specificity regarding how certain orders 22 This priority is currently specified in Rule would reference the term ‘‘alternative trading are ranked. The rule also sets forth that 7.16(f)(viii). system’’ instead of ECN. the size of an incoming Reserve Order

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includes both the displayed and reserve Arca Book. The rule also provides that transparency that an order that is size and the size of the portion of the when an order is outside the NYSE Arca intended to route on arrival would not Reserve Order resident in the Display Marketplace, it will not have time be subject to order execution at the Order Process is equal to its displayed standing in the NYSE Arca Book. Exchange. size. If an incoming marketable order is Finally, with respect to routing, the rule Proposed Rule 7.37P(a)(2) would not executed in its entirety, the provides that for an order that is eligible provide that, unless an order qualifies remaining part of the order is routed to to route away, Users may instruct NYSE for an exception to the Order Protection the ‘‘Working Order’’ process. The rule Arca to bypass any market centers that Rule in Rule 611 of Regulation NMS,24 further provides that an incoming order are not posting Protected Quotations orders will not trade at prices that that is not marketable enters the within the meaning of Regulation NMS. would trade through a protected Working Order Process to execute Rule 7.37(e), (f), and (g) set forth how quotation.25 Proposed Rule 7.37P(a)(3) against any Discretionary Orders at or the Exchange operates consistent with would provide that Limit Orders would better than the NBBO. Regulation NMS for locking and be executed at prices equal to or better Step 2 is the Working Order Process, crossing quotations and specified than the PBBO and proposed Rule which provides that incoming exceptions to Regulation NMS, 7.37P(a)(4) would provide that Market marketable orders are matched against including the self-help exception; ISO Orders and Inside Limit Orders would orders in the Working Order process by Exception; single price openings, be executed at prices equal to or better the order of ranking of the orders in the reopenings, and closing transactions; than the NBBO. The proposed rule for Working Order Process. The rule sets benchmark trades; stopped orders; and the Pillar trading platform is based on forth how specified orders, such as the contingent order exemption. existing requirements as set forth in the Discretionary Orders, interact within the Commentary .01 to Rule 7.37 sets preamble to Rule 7.37 and is consistent Working Order Process. The rule further forth the Exchange’s use of data feeds with the order processing of Market provides that if the incoming marketable for the handling, execution, and routing Orders, Limit Orders, and Inside Limit order has not been executed in its of orders, as well as for regulatory Orders as set forth in Rule 7.31. entirety, the remaining portion of the compliance. As discussed above, the Exchange The Exchange proposes Rule 7.37P to order shall be routed to the Tracking proposes to eliminate the terminology describe the order execution and routing Order Process. associated with the Display Order rules for the Pillar trading platform. Step 3 is the Tracking Order Process, Process, Working Order Process, and Proposed Rule 7.37P would not be which is currently available during Core Tracking Order Process. Therefore, substantively different from Rule 7.37. Trading Hours only. In the Tracking similar to proposed Rule 7.36P, the The Exchange proposes that the title for Order Process, if an order that is eligible Exchange would not include these terms new Rule 7.37P would be ‘‘Order to route to an away market has not been in new Rule 7.37P. Moreover, the executed in its entirety under Steps 1 Execution and Routing.’’ The title of Exchange does not believe that it is through 2, the NYSE Arca Marketplace Rule 7.37 is ‘‘Order Execution.’’ The necessary to restate in new Rule 7.37P shall match and execute any remaining Exchange believes that because Rule the Exchange’s ranking process, which part of such order in the Tracking Order 7.37P, like Rule 7.37, would include the would be set forth in proposed Rule Process in time/price priority. Exchange’s routing procedures, Step 4 sets forth the Exchange’s referencing to ‘‘Routing’’ in the rule’s 7.36P. In addition, consistent with the process for routing away and specifies title would provide additional Exchange’s proposed approach to new certain orders that are not eligible to be transparency in Exchange rules Rule 7.34P and 7.37P, the Exchange routed. For orders that are eligible to be regarding what topics would be covered proposes to eliminate, where feasible, routed, the rule specifies that if the in new Rule 7.37P. reference to specific order types and order is designated as a Market, Inside Proposed Rule 7.37P(a) and its instead state the Exchange’s general Limit, or Pegged Order, the Exchange subsections would set forth the order execution methodology. Any shall utilize all available quotes in the Exchange’s order execution process and exceptions to such general requirements routing determination, or if the order is would cover the same subject as the would be set forth in connection with designated as a Limit Order, the preamble to Rule 7.37, without any specific order or modifier definitions in Exchange shall utilize available substantive differences. As proposed, an proposed Rule 7.31P. Accordingly, the Protected Quotations in the routing incoming marketable order would be Exchange will not include in new Rule determination. The rule sets forth matched for execution against contra- 7.37P the process currently referred to additional detail that orders will be side orders in the NYSE Arca Book as ‘‘Step 3’’ and instead, details routed as Intermarket Sweep Orders according to the price-time priority regarding how Tracking Orders would (‘‘ISO’’) and any remaining portion of ranking of the resting orders, subject to operate would be included in proposed the order will be ranked and displayed specified parameters. Proposed Rule Rule 7.36P(e)(3), as discussed above in the NYSE Arca Book pursuant to Rule 7.37P(a)(1) would provide that orders regarding ranking priority assigned to 7.36. that are routed to an Away Market on Tracking Orders, and new Rule 7.31P. The rule further provides that an arrival would not be assigned a working Proposed Rule 7.37P(b) would set order that is routed away shall remain time or be matched for execution on the forth the Exchange’s order routing outside the NYSE Arca Marketplace for NYSE Arca Book. This provision would process and is intended to cover the a prescribed period of time and may be apply to orders that the Exchange routes same subject as Rule 7.37(d), which is executed in whole or in part subject to based on the time an order is entered, the applicable trading rules of the e.g., a Market Order in a security that is 24 17 CFR 242.611. 25 The term ‘‘trade through’’ is defined in Rule relevant market center or market not eligible for an auction on the 1.1(fff) as the purchase or sale of an NMS stock participant and that when an order Exchange that is entered during the during regular trading hours, either as principal or remains outside the NYSE Arca Early Trading Session, or an order with agent, at a price that is lower than a Protected Bid Marketplace, it will have no time an instruction to route directly to the or higher than a Protected Offer. The term ‘‘protected quotation’’ is defined in Rule 1.1(eee) as standing relative to other orders primary market on arrival, e.g., a a quotation that is a Protected Bid or a Protected received from Users at the same price Primary Only Order. The Exchange Offer, and those terms are defined in the rule as that may be executed against the NYSE believes that the proposed rule provides well.

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currently referred to as ‘‘Step 4’’ in NMS,27 as provided for in proposed listing market on arrival pursuant to order processing, without any Rule 7.37P(a)(2). The Exchange believes Rule 7.34P or designated to route to the substantive differences. Proposed Rule that including this level of detail in the primary listing market pursuant to Rule 7.37P(b) would provide that unless an rule provides transparency regarding the 7.31P, requests to cancel would be order has an instruction not to route, potential for an order to be routed to routed to the primary listing market, after being matched for execution with more than one price level on an Away which is current functionality. any contra-side orders in the NYSE Arca Market. The Exchange believes that New Rule 7.37P(b)(7)(C) would Book pursuant to proposed Rule routing to depth of Away Markets provide, as currently set forth in Rule 7.37P(a), marketable orders would be provides a greater opportunity for an 7.31(x) regarding Primary Only Orders, routed to Away Markets. order to be executed in full. for MOC Orders or LOC Orders in The proposed rule would then set • Proposed Rule 7.37P(b)(5) would NYSE- or NYSE MKT-listed securities, forth additional details regarding provide that, except for orders routed to requests to cancel or reduce in size that routing: the primary listing market on arrival are electronically entered after the times • Proposed Rule 7.37P(b)(1) would pursuant to Rule 7.34P or designated to specified in NYSE Rules 123C(3)(b) and provide that an order that cannot meet route to the primary listing market NYSE MKT Rule 123C(3)(b)—Equities the pricing parameters of proposed Rule pursuant to Rule 7.31P, orders routed to and Supplementary Material .40 to 7.37P(a) may be routed to Away Away Markets would be sent as IOC those rules would be rejected.28 The Market(s) before being matched for ISOs. This routing is based on current Exchange proposes to include this text execution against contra-side orders in Rule 7.37(d)(2)(B)(i) with no substantive in proposed Rule 7.37P(b)(7) because it the NYSE Arca Book. The Exchange differences. concerns how the Exchange would believes that this proposed rule text • Proposed Rule 7.37P(b)(6) would process requests to cancel orders with provides transparency that an order may provide that after any order or portion instructions to route on arrival. By be routed before being matched for thereof that has been routed would not including this rule text in proposed execution, for example, to prevent be eligible to trade on the NYSE Arca Rule 7.37P, the proposed processing of locking or crossing or trading through a Book, unless all or a portion of the order electronically entered requests to cancel protected quotation. returns unexecuted. This routing MOC or LOC Orders in NYSE- or NYSE • Proposed Rule 7.37P(b)(2) would methodology is current functionality MKT-listed securities would also apply provide that if an order with an and covers that same subject as current to such orders that do not include a instruction not to route would trade Rule 7.37(d)(2)(C) and (D), with no Primary Only Order designation, but through or lock or cross a protected substantive differences. In contrast to which, pursuant to Rule 7.34P, would quotation and is not eligible for an Rule 7.37(d)(2)(C) and (D), however, the be routed to the primary listing market exception to either Rule 610 or 611 of Exchange proposes that Rule 7.37P(b)(6) on arrival. The Exchange believes that Regulation NMS,26 it would cancel, re- would focus on the fact that once the proposed changes would provide price, or be held undisplayed on the routed, an order would not be eligible transparency regarding how requests to NYSE Arca Book, as provided for in to trade on the Exchange, rather than cancel orders that have been routed Rules 7.31P and 7.44P. stating the obvious that it would be would be processed in Pillar, which • Proposed Rule 7.37P(b)(3) would subject to the routing destination’s would not be substantively different provide that orders eligible to route trading rules once routed. In addition, from how the Exchange’s current would be routed to all available Away because, as discussed above, the trading system operates. Markets unless the order includes an working time assigned to orders that are • Proposed Rule 7.37P(b)(8) would instruction to bypass market centers that routed is being proposed to be address provide that an order marked ‘‘short’’ are not displaying protected quotations. in new Rule 7.36P(f)(1)(A) and (B), the when a short sale price test restriction This rule text covers the subject matter Exchange believes it would be is in effect would not be routed. Instead of current Rule 7.37(d)(2)(A), duplicative to restate this information in of routing, the Exchange would reprice 7.37(d)(2)(B), and 7.37(d)(4), with no new Rule 7.37P. or cancel the order consistent with Rule substantive differences. As with current • Proposed Rule 7.37P(b)(7) would 7.16, which will be proposed as Rule functionality, proposed Rule 7.37P(b)(1) set forth how the Exchange would 7.16P in a separate rule filing for Pillar. specifies that all Away Markets, as process requests to cancel orders that The Exchange believes the specific defined in proposed Rule 1.1(ffP), have been routed. Rule 7.37(d)(2)(E) routing methodologies for an order type would be considered as part of the currently provides that requests from or modifier should be included with routing determination unless the User Users to cancel their orders while the how the order type is defined, which has opted out of routing to Away order is routed away to another market will be in Rule 7.31P. Accordingly, the Markets that do not display protected center or market participant and Exchange does not believe it needs to quotations. remains outside the NYSE Arca specify in new Rule 7.37P whether an • Proposed Rule 7.37P(b)(4) would Marketplace shall be processed, subject order is eligible to route, and if so, provide that Limit Orders that are to the applicable trading rules of the whether there are any specific routing routed to Away Market(s) may be routed relevant market center or market to more than one price level, up (down) participant. 28 NYSE Rule 123C(3)(b) and NYSE MKT Rule to the limit price of an order to buy The Exchange proposes to specify in 123C(3)(b)—Equities provide that between 3:45 p.m. and 3:58 p.m., MOC and LOC Orders may be (sell). This represents current routing new Rule 7.37P(b)(7)(A) that requests to cancelled or reduced in size only to correct a functionality and means that a Limit cancel orders that are eligible to be legitimate error, and NYSE Rule 123C(3)(c) and Order may be routed to more than just matched for execution against orders in NYSE MKT Rule 123C(3)(c) provide that MOC and the top of book bid or offer of an Away the NYSE Arca Book would not be LOC Orders may not be cancelled or reduced in size at all after 3:58 p.m. Supplementary Material .40 to Market, provided that the order would processed unless and until all or a those rules provides, among other things, that the not be routed to prices that are outside portion of the order returns unexecuted. times specified in those rules will be adjusted based of the limit price of the order and New Rule 7.37P(b)(7)(B) would specify on the early scheduled closing time and references to 4:00 p.m. mean the early scheduled close, 3:45 consistent with Rule 611 of Regulation that for orders routed to the primary p.m. means 15 minutes before the early scheduled close, and 3:58 p.m. means two minutes before the 26 17 CFR 242.610 and 17 CFR 242.611. 27 17 CFR 242.611. early scheduled close.

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instructions applicable to the order and Regulation NMS 30 and related Second, the Exchange proposes not to therefore will not be carrying over such Securities and Exchange Commission include the second sentence of Rule specifics that are included in Rule 7.37. staff guidance regarding this 7.37(g)(3) relating to how the Exchange The remaining proposed rule text of exception 31 does not require trading would conduct a single-price reopening Rule 7.37P is based on Rule 7.37, with centers to use the self-help exception if in proposed Rule 7.37P(f)(3). To reduce limited non-substantive differences: a destination trading trading center fails investor confusion and promote • Proposed Rule 7.37P(c) would to respond within one second to an transparency in its rules, the Exchange provide that after executing with incoming IOC order, but state that such believes that its rule governing auctions eligible contra-side interest on the NYSE a failure would justify use of the should set forth how the Exchange Arca Book and/or returning unexecuted exception. Rather, a trading center is conducts a single-price auction to after routing to Away Market(s), any free to adopt reasonable policies and reopen a stock following a trading halt. unexecuted non-marketable portion of procedures consistent with the flexible Third, the Exchange proposes not to an order would be ranked consistent purposes of the self-help exception. include current Rule 7.37(g)(5) text with new Rule 7.36P. This rule Because the Exchange does not use the regarding Stopped Orders because the represents current functionality and is method described in the second Exchange does not currently, and will based on Rule 7.37(d)(3) without any sentence of current Rule 7.37(f)(1) to not in Pillar, support Stopped Orders on substantive differences. determine whether to declare self-help, the Exchange. Finally, the Exchange • Proposed Rule 7.37P(d) would set the Exchange proposes not to include it proposes not to include current Rule forth the Exchange’s use of data feeds, in new Rule 7.37P(f)(1). Second, Rule 7.37(g)(6) text regarding transactions and includes the rule text that is 7.37(f)(1)(B) provides that the Exchange other than ‘‘regular-way’’ contracts currently set forth in Commentary .01 to follows ‘‘published NYSE Arca policies because in Pillar, the Exchange would Rule 7.37, without any substantive and procedures for electing the self-help not execute any orders on terms other differences. Proposed Rule 7.37P(d)(1) exception.’’ Because the Exchange than standardized terms and conditions, would not include the clause ‘‘away publishes those policies and procedures i.e., ‘‘regular way’’ contracts. market quotes disseminated by’’ as internally only, to reduce investor Proposed Rule 7.37P(f)(5) regarding unnecessary language, with the confusion, the Exchange proposes to the Contingent Order Exemption from proposed rule text using the proposed modify the text in proposed Rule the Order Protection Rule is based on defined term ‘‘Away Markets’’ as 7.37P(f)(1)(B) to provide instead that the rule text from Rule 7.37(h) regarding follows, ‘‘[t]he Exchange receives data Exchange would follow ‘‘established Exemptions with different rule feeds directly from broker dealers for NYSE Arca policies and procedures for numbering and one substantive purposes of routing interest to Away electing the self-help exception.’’ difference. Rule 7.37(g)(2) specifies the Markets that are not displaying Proposed Rules 7.37P(f)(2)–(4) are requirements to meet the qualified protected quotations.’’ based on the rule text from Rule 7.37(g) contingent trade exemption to Rule • Proposed Rule 7.37P(e) would set regarding Additional Exceptions to the 611(a) of Regulation NMS 32 and are forth the same rule text from Rule Order Protection Rule, with non- based on the requirements specified in 7.37(e) regarding locking or crossing substantive differences to reflect the Commission’s Order granting an quotations in NMS stocks with a non- different rule numbering and update the exemption for qualified contingent substantive difference to update a cross- rule text to reflect current operations. trades.33 Rule 7.37(f)(2)(G) currently reference in the rule to rule numbering First, the Exchange proposes not to specifies the original requirement that in Rule 7.37P. The Exchange proposes include the first and third sentences of the exempted transaction must be part an additional non-substantive difference Rule 7.37(g)(1) in proposed Rule of a contingent trade that involves at to specify in Rule 7.37P(e)(3) that the 7.37P(f)(2)(A) relating to the Intermarket least 10,000 shares or has a market value prohibition against Locking and Sweep Order Exception because when of at least $200,000. The Commission Crossing Quotations in paragraph Rule executing or displaying ISOs that it later modified the exemption for 7.37P(e)(2) would not apply in the receives from ETP Holders, it is the qualified contingent trades to remove circumstances specified in Rules responsibility of the entering broker that size condition.34 The Exchange 7.37P(e)(3)(A)–(C). Proposed Rules dealer and not the Exchange to therefore proposes not to include in its 7.37P(e)(3)(A)–(C) is rule text that is simultaneously route ISOs. Therefore, proposed Rule 7.37P(f)(2)(D) the size identical to Rule 7.37(e)(3)(A)–(C). the current rule text does not represent requirement. • Proposed Rule 7.37P(f) would set how the Exchange operates, nor does it * * * * * forth the exceptions to the Order reflect the requirements of Regulation As discussed above, because of the Protection Rule 29 and would enumerate NMS. The Exchange proposes technology changes associated with the the self-help exception in Rule additional non-substantive differences migration to the Pillar trading platform, 7.37P(f)(1), which is based on Rule to the rule text relating to this exception the Exchange will announce by Trader 7.37(f) regarding Self-Help Exceptions, to update references, for example, to Update when rules with a ‘‘P’’ modifier with two proposed modifications. The refer to NYSE Arca’s best bid or best will become operative and for which Exchange would not include the second offer rather than its own protected symbols. The Exchange believes that sentence of Rule 7.37(f)(1), which quotation and remove reference to the keeping existing rules on the book provides that the Exchange will ‘‘NYSE Arca System.’’ disregard another Trading Center’s bid 32 17 CFR 242.611(a). and offer if the other Trading Center has 30 17 CFR 611(b)(1). 33 See Securities Exchange Act Release No. 54389 repeatedly failed to respond within one 31 See Question 4.07, ‘‘Responses to Frequently (August 31, 2006), 71 FR 52829 (September 7, 2006) Asked Questions Concerning Rule 611 and Rule 610 (Order Granting an Exemption for Qualified second to an incoming IOC order after of Regulation NMS,’’ available at https:// Contingent Trades from Rule 611(a) of Regulation adjusting for order transmission time, in www.sec.gov/divisions/marketreg/nmsfaq610- NMS under the Securities Exchange Act of 1934). new Rule 7.37P(f)(1). The self-help 11.htm (‘‘Beyond this basic parameter of repeated 34 See Securities Exchange Act Release No. 57620 exception set forth in Rule 611(b)(1) of failure to turn around an IOC order within one (April 4, 2008), 73 FR 19271 (April 9, 2008) (Order second, trading centers are free to adopt reasonable Modifying the Exemption for Qualified Contingent policies and procedures that are consistent with the Trades from Rule 611(a) of Regulation NMS under 29 17 CFR 242.611(b). flexible purposes of the self-help exception.’’). the Securities Exchange Act of 1934).

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pending the full migration of Pillar will promote transparency in Exchange rules consistent terminology that will serve as reduce confusion because it will ensure and make them easier to understand the foundation for additional Pillar- that the rules governing trading on a because these proposed definitions will related rule proposals. The Exchange trading platform will continue to be serve as the foundation for additional also believes that adding more detail available pending the full migration. rule changes to support Pillar. regarding current functionality in new The Exchange further believes that 2. Statutory Basis Rules 7.34P, 7.36P, and &.37P, as moving specified rule text that relates to described above, would promote The proposed rule change is specific order types that is set forth in transparency by providing notice of consistent with Section 6(b) of the Rules 7.34, 7.36 and 7.37 to proposed when orders would be accepted, routed, Securities Exchange Act of 1934 (the Rule 7.31P (which will be the subject of rejected, cancelled, or be assigned a ‘‘Act’’),35 in general, and furthers the a separate filing), and therefore not working time by the Exchange. objectives of Section 6(b)(5),36 in include such detail in proposed Rules particular, because it is designed to 7.34P, 7.36P and 7.37P, would make B. Self-Regulatory Organization’s prevent fraudulent and manipulative Exchange rules easier to navigate Statement on Burden on Competition acts and practices, to promote just and because information regarding how a The Exchange does not believe that equitable principles of trade, to foster specific order type would operate would the proposed rule change will impose cooperation and coordination with be in a single location in the Exchange’s any burden on competition that is not persons engaged in facilitating rule book. necessary or appropriate in furtherance transactions in securities, to remove With respect to proposed Rule 7.34P, of the purposes of the Act. The impediments to, and perfect the the Exchange believes that the proposed proposed change is not designed to mechanism of, a free and open market changes to functionality would remove address any competitive issue but rather and a national market system and, in impediments to and perfect the to adopt new rules to support the general, to protect investors and the mechanism of a fair and orderly market. Exchange’s new Pillar trading platform. public interest. The Exchange believes First, the Exchange believes that As discussed in detail above, with this that the proposed rules to support Pillar because an auction that opens a trading rule filing, the Exchange is not would remove impediments to and session should occur within that trading proposing to change its core perfect the mechanism of a free and session, it would remove impediments functionality regarding its price-time open market because the proposed rule to and perfect the mechanism of a fair priority model, and in particular, how it set would promote transparency in and orderly market for the Core Open would rank, display, execute or route Exchange rules by using consistent Auction to occur during the Core orders in Pillar. Rather, the Exchange terminology governing equities trading, Trading Session instead of the Early believes that the proposed rule change thereby ensuring that members, Trading Session. Second, the Exchange would promote consistent use of regulators, and the public can more believes that the proposed change to terminology to support the Pillar trading easily navigate the Exchange’s rulebook route to the primary listing market platform making the Exchange’s rules and better understand how equity Market Orders and Auction-Only Orders easier to navigate. trading is conducted on the Exchange. in symbols that are not eligible for an Adding new rules with the modifier ‘‘P’’ execution on the Exchange would C. Self-Regulatory Organization’s to denote those rules that would be remove impediments to and perfect the Statement on Comments on the operative for the Pillar trading platform mechanism of a free and open market by Proposed Rule Change Received From would remove impediments to and ensuring that such orders reach a Members, Participants, or Others perfect the mechanism of a free and destination where they may be eligible No written comments were solicited open market by providing transparency to obtain an execution or participate in of which rules govern trading once a an auction. This is current functionality, or received with respect to the proposed symbol has been migrated to the Pillar but it is only available for orders that rule change. platform. have been designated as ‘‘Primary III. Date of Effectiveness of the The Exchange believes that the Only.’’ Expanding this functionality to Proposed Rule Change and Timing for proposed restructuring in new Rules orders that do not include that Commission Action 7.34P, 7.36P, and 7.37P would remove designation would also protect investors impediments to and perfect the and the public interest by enabling such Within 45 days of the date of mechanism of a free and open market by interest to reach a destination where it publication of this notice in the Federal assuring consistency of terms used in is more likely to obtain an execution Register or up to 90 days (i) as the the Exchange’s rulebook. The proposed opportunity or participate in an auction. Commission may designate if it finds revisions to the Exchange’s equity Finally, the Exchange believes that such longer period to be appropriate trading rules to reflect terminology making Tracking Orders available and publishes its reasons for so finding associated with Pillar would remove during the Early and Late Trading or (ii) as to which the self-regulatory impediments to and perfect a free and Sessions would remove impediments to organization consents, the Commission open market because the proposed and perfect the mechanism of a free and will: changes are designed to simplify the open market by providing additional (A) By order approve or disapprove structure of the Exchanges rules and execution opportunities on the the proposed rule change, or permit the use of consistent terminology Exchange through the availability of (B) institute proceedings to determine throughout numerous rules, without additional passive liquidity. whether the proposed rule change changing the underlying functionality. With respect to proposed Rules 7.36P should be disapproved. and 7.37P, as discussed above, the For example, the Exchange believes the IV. Solicitation of Comments proposed definitions set forth in Rule Exchange is not proposing any 7.36P, i.e., display price, limit price, functional changes to how it ranks, Interested persons are invited to working price, and working time, displays, executes, or routes orders. The submit written data, views, and Exchange believes, however, that the arguments concerning the foregoing, 35 15 U.S.C. 78f(b). proposed rule text promotes including whether the proposed rule 36 15 U.S.C. 78f(b)(5). transparency through the use of change is consistent with the Act.

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Comments may be submitted by any of SECURITIES AND EXCHANGE implementation, the Clearing House the following methods: COMMISSION will from time to time adjust the haircuts applicable to Permitted Cover Electronic Comments [Release No. 34–74955; File No. SR–ICEEU– 2015–007] under the methodology set forth in the • Use the Commission’s Internet policy. comment form (http://www.sec.gov/ Self-Regulatory Organizations; ICE The general aims of the proposed rules/sro.shtml); or Clear Europe Limited; Order Approving Haircut Policy are to ensure that the Clearing House can efficiently liquidate • Send an email to rule-comments@ Proposed Rule Change Relating to Collateral and Haircut Policy all forms of Permitted Cover, that sec.gov. Please include File Number SR– appropriate prices are used for valuation NYSEARCA–2015–38 on the subject May 13, 2015. of Permitted Cover and that appropriate line. I.Introduction haircuts (including, as applicable, cross- Paper Comments currency haircuts) are used. The On March 13, 2015, ICE Clear Europe proposed Haircut Policy would codify • Send paper comments in triplicate Limited (‘‘ICE Clear Europe’’ or certain general principles considered by to Secretary, Securities and Exchange ‘‘Clearing House’’) filed with the the Clearing House in accepting assets Commission, 100 F Street NE., Securities and Exchange Commission as Permitted Cover, including Washington, DC 20549–1090. (‘‘Commission’’) a proposed rule change availability of pricing information, the pursuant to Section 19(b)(1) of the existence of liquid and active markets All submissions should refer to File Securities Exchange Act of 1934 for buyers and sellers of those assets, the Number SR–NYSEARCA–2015–38. This (‘‘Act’’),1 and Rule 19b–4 thereunder,2 existence of sufficient price history, the file number should be included on the to implement a new collateral and ability to liquidate Permitted Cover subject line if email is used. haircut policy (the ‘‘Haircut Policy’’) without causing a market disruption, To help the Commission process and applicable to Permitted Cover posted by compliance with legal and regulatory review your comments more efficiently, Clearing Members to meet the Clearing requirements and sufficient operational please use only one method. The House’s Margin and Guaranty Fund and technological framework to handle Commission will post all comments on requirements. The proposed rule change deposit, liquidation and return of such the Commission’s Internet Web site was published for comment in the assets as Permitted Cover. (http://www.sec.gov/rules/sro.shtml). Federal Register on March 31, 2015.3 Under the proposed Haircut Policy, Copies of the submission, all subsequent The Commission did not receive cash collateral must be in one of several amendments, all written statements comment letters regarding the proposed specified currencies underlying with respect to the proposed rule change. For the reasons discussed contracts cleared by the Clearing House. change that are filed with the below, the Commission is granting Additional general requirements would Commission, and all written approval of the proposed rule change. apply to financial instruments, communications relating to the II. Description of the Proposed Rule including prohibitions on acceptance of proposed rule change between the Change instruments that have non-‘‘vanilla’’ Commission and any person, other than features such as embedded options, those that may be withheld from the ICE Clear Europe proposes to instruments issued by a Clearing public in accordance with the implement a Haircut Policy, which Member or its affiliate, instruments provisions of 5 U.S.C. 552, will be would codify and consolidate certain issued by a CCP or by entities that available for Web site viewing and existing practices of the Clearing House provide critical services to the Clearing printing in the Commission’s Public with respect to Permitted Cover. The House (other than central banks) and Reference Room, 100 F Street NE., proposed Haircut Policy is designed (i) certain credit-based limits. Such limits Washington, DC 20549, on official to set out overall principles with respect would require that the issuer is rated at business days between the hours of to the assets accepted by the Clearing least ‘‘BBB¥’’ by S&P (or its 10:00 a.m. and 3:00 p.m. Copies of the House as Permitted Cover; (ii) to equivalent), the average yield on the filing will also be available for establish a framework for determining asset over the previous three months is inspection and copying at the NYSE’s absolute and relative limits, as not greater than 8%, and the 5-year CDS principal office and on its Internet Web applicable, on the value of the collateral spread of the issuer has not exceeded site at www.nyse.com. All comments that may be posted by a Clearing 500 basis points over the previous three received will be posted without change; Member as Permitted Cover; (iii) to months. The proposed Haircut Policy the Commission does not edit personal establish a value-at-risk (‘‘VaR’’) based provides that where market conditions identifying information from methodology for determining haircuts warrant, or where the Clearing House’s submissions. You should submit only for all Permitted Cover; (iv) to mitigate sovereign risk model indicates information that you wish to make wrong-way risk from Permitted Cover; deteriorating credit below a certain ¥ available publicly. All submissions (v) to address sources for pricing threshold (i.e., ‘‘BBB ’’ by S&P), the should refer to File Number SR– Permitted Cover; and (vi) to set out Clearing House may remove securities NYSEARCA–2015–38, and should be certain related monitoring, reviewing from the list of Permitted Cover and/or submitted on or before June 9, 2015. and reporting procedures. The Haircut vary applicable haircuts. ICE Clear Policy would apply to Permitted Cover Europe will notify Clearing Members For the Commission, by the Division of provided for all product classes (F&O, and other market participants of such Trading and Markets, pursuant to delegated CDS and FX).4 Following actions by Circular. ICE Clear Europe authority.37 maintains the current List of Permitted Robert W. Errett, 1 15 U.S.C. 78s(b)(1). Deputy Secretary. 2 17 CFR 240.19b–4. posted with respect to Guaranty Fund requirements, [FR Doc. 2015–12028 Filed 5–18–15; 8:45 am] 3 Securities Exchange Act Release No. 34–74579 certain additional requirements apply to Guaranty (Mar. 25, 2015), 80 FR 17132 (Mar. 31, 2015) (SR– BILLING CODE 8011–01–P Fund contributions under the Rules and Finance ICEEU–2015–007). Procedures. Those additional requirements are not 4 ICE Clear Europe notes that although the Haircut proposed to be changed in connection with the 37 17 CFR 200.30–3(a)(12). Policy generally also applies to Permitted Cover Haircut Policy.

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Cover (along with haircut rates, limits position in sovereign CDS with respect The proposed Haircut Policy also sets and restrictions) on its Web site at to a sovereign exceeds a specified a minimum haircut level of 3% in order https://www.theice.com/publicdocs/ threshold, the Clearing House may to avoid pro-cyclical variation in clear_europe/list-of-permitted- decline to accept government bonds of haircuts and will review this minimum covers.pdf. that sovereign or any other sovereign level annually under the Haircut Policy. The proposed Haircut Policy contains bonds that exhibit certain correlations In addition, a haircut add-on of up to a methodology for setting absolute with such government bonds. 1% will be applied during the period limits on the value of non-cash The Haircut Policy also addresses until the next monthly review to issuers Permitted Cover that can be posted by potential wrong-way risk arising from presenting increased credit risk. The a Clearing Member.5 Absolute collateral Permitted Cover more generally. The add-on is applied once the issuer’s CDS limits would apply across a group of Clearing House will monitor collateral spread exceeds a specified level, and affiliated Clearing Members and apply on a daily basis. Where the Clearing increases in steps of 0.25% up to a across all product categories cleared by House considers there to be strong maximum of 1% where the CDS spread that group. The policy also sets out general wrong-way risk between a exceeds higher thresholds. The add-on relative (or concentration) limits for Clearing Member and the asset it is is generally designed to anticipate Permitted Cover provided by a Clearing posting, the Clearing House will ask the potential haircut increases as part of the Member. ICE Clear Europe publishes on member to change the composition of next monthly review cycle. its Web site the current absolute and collateral to mitigate that risk. The proposed policy also imposes relative limits on government bonds The Haircut Policy establishes a VaR- cross-currency haircuts to address the provided as Permitted Cover. In based methodology for determining exchange rate risk faced by the Clearing addition, the policy sets out procedures haircuts for Permitted Cover. Under the House where the Permitted Cover is for monitoring of limits on a daily basis proposed Haircut Policy, the Clearing denominated in a different currency and for remediation of breach of a limit House will calculate six different from the currency of the applicable by a Clearing Member. The risk estimations of VaR for each applicable margin requirement. Under the management department will monitor risk factor. Each estimation is calculated proposed Haircut Policy, cross-currency all collateral limits on a daily basis using a 99.9% confidence interval haircuts are determined using the same using a collateral breakdown report (applicable to Permitted Cover posted methodology described above for other which flags limit breaches. Breaches with respect to all product categories). haircuts, but are subject to a minimum will be reviewed internally and the The proposed haircut will be based on haircut of 4.5%. Cross-currency haircuts relevant Clearing Member will be the largest VaR of the 6 estimations. The will be applied in addition to any contacted. Breaches can be remediated policy specifies relevant price sources applicable haircut for the relevant form by posting additional collateral, removal that will be used for the calculation of of Permitted Cover. of collateral that is in breach of a limit, haircuts for each type of Permitted The Clearing House will monitor or both of the above. Cover. Haircuts will be determined Permitted Cover on a daily and intraday The policy also provides for a risk- using the bid prices of Permitted Cover basis. The Clearing House may, under based reduction in absolute limits for assets, in order to account for higher its existing Rules and the Haircut government bonds based on the credit liquidation costs in stressed markets. Policy, take action to mitigate any default swap (‘‘CDS’’) spread for the The applicable haircuts will be change in risk, including by increasing relevant issuer in order to mitigate reviewed on a monthly basis, or more haircuts, calling for additional wrong-way risk arising from government frequently where the risk management collateral, reducing concentration limits bonds accepted as Permitted Cover. department deems it necessary. and removing an asset from eligibility as Once the spread exceeds a specified Under the proposed policy, the risk Permitted Cover. The Clearing House level for a particular issuer, the absolute management department may further will monitor the value of Permitted limit for Permitted Collateral of that adjust the haircut determined under the Cover deposited with it on a real time issuer would be reduced pursuant to a model as it determines prudent in light basis. Any change in a member’s intra- defined formula. If the spread exceeds a of additional qualitative and day cover value that is greater than 3% second level, the absolute limit will be quantitative factors, including: the will be flagged immediately by the Risk reduced to 5% of the otherwise Clearing House’s credit assessment of Management intraday monitoring applicable original limit. Spread levels the issuer, current market conditions system that is monitored by the Risk are determined using a five-day average and volatility, expected future volatility, Management team throughout the to avoid excessive volatility. The the liquidity of the underlying market business day. Any breach will be for the asset, including bid/ask spread, specified parameters will be reviewed investigated and appropriate action wrong way risk considerations, VaR on a quarterly basis. taken where necessary. The Clearing Specific wrong-way risk arising in estimates determined for a period of House also will backtest haircuts based connection with clearing of Western stressed market conditions, and other on price moves observed in the markets European sovereign CDS is addressed factors that might affect the liquidity or on a daily basis, and review haircut through a requirement that U.S. dollar value of an asset in stressed market levels if a price move breaches an denominated collateral be provided for conditions. ICE Clear Europe anticipates existing haircut. The Clearing House initial margin and that a portion of the that such adjustments to the value will prepare daily reports with respect calculated under the model would be CDS Guaranty Fund be U.S. dollar- to Permitted Cover for purposes of used only in exceptional circumstances based (determined based on the ratio internal monitoring and provide and would expect to use such between the dollar-denominated and monthly reports to the relevant Risk adjustments to increase haircuts in Euro-denominated initial margin Committees and Board Risk Committee. stressed market circumstances. ICE The Clearing House will review the requirements for CDS). In addition, Clear Europe has stated that it will make Haircut Policy on an annual basis where the member’s aggregate short judicious use of current market (which will include review by the Board 5 The Clearing House does not impose absolute or information to override the model but Risk Committee) or where there is a relative limits on the use of U.S. Treasury securities anticipates exercising this ability in less material change to the risk exposure of as Permitted Cover. than 5% of haircut rates. the Clearing House. The Haircut Policy

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also will be independently reviewed forms of accepted Permitted Cover to (the ‘‘Commission’’) the proposed rule annually under the Clearing House’s satisfy its payment obligations in the change as described in Items I, II, and model governance framework. event of a Clearing Member default. The III below, which Items have been Commission therefore finds that the prepared by the self-regulatory III. Discussion and Commission proposed rule change is designed to organization. The Commission is Findings promote the prompt and accurate publishing this notice to solicit Section 19(b)(2)(C) of the Act 6 directs clearance and settlement of securities comments on the proposed rule change the Commission to approve a proposed transactions and, to the extent from interested persons. rule change of a self-regulatory applicable, derivative agreements, organization if the Commission finds contracts, and transactions and, in I. Self-Regulatory Organization’s that such proposed rule change is general, to protect investors and the Statement of the Terms of Substance of consistent with the requirements of the public interest in accordance with the Proposed Rule Change Act and the rules and regulations Section 17A(b)(3)(F) of the Act.9 The Exchange proposes to amend the thereunder applicable to such self- NYSE Arca Equities Schedule of Fees regulatory organization. Section IV. Conclusion and Charges for Exchange Services 17A(b)(3)(F) of the Act 7 requires, among On the basis of the foregoing, the (‘‘Fee Schedule’’) to reduce fees for other things, that the rules of a clearing Commission finds that the proposal is routing certain retail orders to away agency are designed to promote the consistent with the requirements of the market centers. The Exchange proposes prompt and accurate clearance and Act and in particular with the to implement the changes on May 1, settlement of securities transactions requirements of Section 17A of the 2015. The text of the proposed rule and, to the extent applicable, derivative Act 10 and the rules and regulations change is available on the Exchange’s agreements, contracts, and transactions thereunder. Web site at www.nyse.com, at the and, in general, to protect investors and It is therefore ordered, pursuant to principal office of the Exchange, and at the public interest. Section 19(b)(2) of the Act,11 that the the Commission’s Public Reference The Commission finds that the proposed rule change (File No. SR– Room. proposed rule change is consistent with ICEEU–2015–007) be, and hereby is, Section 17A of the Act 8 and the rules approved.12 II. Self-Regulatory Organization’s thereunder applicable to ICE Clear Statement of the Purpose of, and For the Commission, by the Division of Statutory Basis for, the Proposed Rule Europe. The proposed Haircut Policy Trading and Markets, pursuant to delegated will codify the general principles and authority.13 Change limitations for assets accepted by ICE Robert W. Errett, In its filing with the Commission, the Clear Europe as Permitted Cover. The Deputy Secretary. self-regulatory organization included proposed policy also provides a statements concerning the purpose of, framework for ensuring that appropriate [FR Doc. 2015–12032 Filed 5–18–15; 8:45 am] BILLING CODE 8011–01–P and basis for, the proposed rule change prices are used to value Permitted Cover and discussed any comments it received and establishes a VaR-based on the proposed rule change. The text methodology, utilizing six different SECURITIES AND EXCHANGE of those statements may be examined at estimations for each applicable risk COMMISSION the places specified in Item IV below. factor and calculating each estimation The Exchange has prepared summaries, using a 99.9% confidence interval, for [Release No. 34–74947; File No. SR– set forth in sections A, B, and C below, NYSEArca–2015–39] determining haircuts to ensure that the of the most significant parts of such value of Permitted Cover held by ICE Self-Regulatory Organizations; NYSE statements. Clear Europe is sufficient to cover the Arca, Inc.; Notice of Filing and Clearing House’s Margin and Guaranty A. Self-Regulatory Organization’s Immediate Effectiveness of Proposed Fund requirements. The policy also Statement of the Purpose of, and the Rule Change Amending the NYSE Arca provides a methodology for setting Statutory Basis for, the Proposed Rule Equities Schedule of Fees and absolute and relative concentration Change Charges for Exchange Services To limits on particular bonds a Clearing Reduce Fees for Routing Certain Retail 1. Purpose Member may provide as Permitted Orders to Away Market Centers Cover to guard against liquidity and The Exchange proposes to amend the Fee Schedule to reduce fees for routing concentration risks and establishes May 13, 2015. certain retail orders to away market several measures designed to mitigate Pursuant to Section 19(b)(1) 1 of the centers. The Exchange proposes to wrong-way-risk. In addition, the Securities Exchange Act of 1934 (the implement the changes on May 1, 2015. proposed policy provides procedures for 2 3 ‘‘Act’’) and Rule 19b–4 thereunder, The Exchange currently charges the regular review and monitoring of notice is hereby given that, on April 30, $0.0029 per share for all orders in Tape Permitted Cover and associated haircuts 2015, NYSE Arca, Inc. (the ‘‘Exchange’’ A Securities that are routed outside the and permits the Clearing House to or ‘‘NYSE Arca’’) filed with the Book to the NYSE; and $0.0035 per respond promptly to changes in market Securities and Exchange Commission share for all orders in Tape B Securities conditions by modifying haircuts or and Tape C Securities that are routed other limits on Permitted Cover. 9 15 U.S.C. 78q–1(b)(3)(F). outside the Book to any away market Accordingly, the Commission believes 10 15 U.S.C. 78q–1. center. that the Haircut Policy is designed to 11 15 U.S.C. 78s(b)(2). 12 In approving the proposed rule change, the The Exchange proposes to reduce the appropriately value Permitted Cover fees for certain orders, i.e., for Primary and enable ICE Clear Europe to Commission considered the proposal’s impact on efficiency, competition and capital formation. 15 Until 9:45 Orders 4 and Primary After efficiently and effectively liquidate all U.S.C. 78c(f). 13 17 CFR 200.30–3(a)(12). 4 A Primary Until 9:45 Order is an Order entered 6 15 U.S.C. 78s(b)(2)(C). 1 15 U.S.C. 78s(b)(1). for participation on the primary market until 9:45 7 15 U.S.C. 78q–1(b)(3)(F). 2 15 U.S.C. 78a. a.m. Eastern Time (6:45 a.m. Pacific Time) after 8 15 U.S.C. 78q–1. 3 17 CFR 240.19b–4. Continued

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3:55 Orders 5 that are designated as Specifically, the Exchange proposes to that markets and price discovery retail orders and meet the requirements charge a fee of $0.0010 per share for all optimally function through the of Rule 7.44(a)(3), but which are not Primary Until 9:45 Orders and Primary interactions of diverse flow types, it also executed in the Retail Liquidity After 3:55 Orders that are designated as believes that growth in internalization Program 6 (‘‘Retail Orders’’). Under Rule Retail Orders and that are routed to the has required differentiation of retail 7.44(a)(3), a Retail Order is an agency primary listing market. The Exchange order flow from other order flow types. order or a riskless principal order that proposes to include this fee in three The proposed new fee is set at a level meets the criteria of Financial Industry places in the Basic Rates section of the to incentivize ETP Holders to continue Regulatory Authority, Inc. Rule 5320.03 Fee Schedule for each of Tape A, Tape to direct a subset of Retail Orders to the that originates from a natural person B, and Tape C securities by adding text Exchange, rather than to an over-the- and is submitted to the Exchange by a following the existing rate for routing 7 counter market. The Exchange believes Retail Member Organization (‘‘RMO’’), orders that provides ‘‘except that that, because Retail Orders are likely to provided that no change is made to the Primary Until 9:45 Orders and Primary reflect long-term investment intentions, terms of the order with respect to price After 3:55 Orders that are designated as they promote price discovery and or side of market and the order does not Retail Orders and routed to the primary originate from a trading algorithm or dampen volatility. Accordingly, the listing market will be charged $0.0010 presence of Retail Orders on the any other computerized methodology. per share (fee).’’ An ETP Holder may designate an order The proposed changes are not Exchange, or if routed, on the primary a Retail Order either (1) by designating otherwise intended to address any other listing market for those securities, has certain order entry ports at the Exchange issues, and the Exchange is not aware of the potential to benefit all market as ‘‘Retail Order Ports’’ and attesting, in any problems that ETP Holders would participants. For this reason, the a form and/or manner prescribed by the have in complying with the proposed Exchange believes that the proposed Exchange, that all orders submitted to changes. pricing is equitable and not unfairly the Exchange via such Retail Order discriminatory and would continue to Ports are Retail Orders; or (2) by means 2. Statutory Basis encourage greater retail participation on of a specific tag in the order entry The Exchange believes that the the Exchange and other registered message.8 proposed rule change is consistent with exchanges. 9 Section 6(b) of the Act, in general, and The pricing proposed herein is not which time the order is cancelled on the primary furthers the objectives of Sections designed to permit unfair market and entered on the NYSE Arca Book. The 6(b)(4) and (5) of the Act,10 in particular, Primary Until 9:45 Order may be Day only and may discrimination, but instead to promote a not be designated as GTC or GTD. Orders that because it provides for the equitable competitive process around retail return to the NYSE Arca Book after routing to the allocation of reasonable dues, fees, and executions such that retail investors primary market retain their original order attributes. other charges among its members, would receive better prices. The See NYSE Arca Equities Rule 7.31(f)(2). issuers and other persons using its 5 proposed change is also equitable and A Primary After 3:55 Order is an Order entered facilities and does not unfairly for participation on the Exchange until 3:55 p.m. not unfairly discriminatory because it discriminate between customers, Eastern Time (12:55 p.m. Pacific Time) after which would contribute to investors’ time the order is cancelled on the Exchange and an issuers, brokers or dealers. order is entered for participation on the primary The Exchange believes that the confidence in the fairness of their market. The Primary After 3:55 Order may be Day proposed fee changes are reasonable as transactions and because it would only and may not be designated as GTC or GTD. benefit all investors by deepening the Orders that route to the primary market at 3:55 p.m. they are designed to attract additional Eastern Time retain their original order attributes. retail order flow to the Exchange that Exchange’s liquidity pool, supporting See NYSE Arca Equities Rule 7.31(f)(2) [sic]. include an instruction to route to the the quality of price discovery, 6 The Retail Liquidity Program is a pilot program primary listing market at designated promoting market transparency and designed to attract additional retail order flow to improving investor protection. the Exchange for NYSE Arca-listed securities and times. In addition, the proposed fees are securities traded pursuant to unlisted trading equitable and not unfairly Finally, the Exchange believes that it privileges (‘‘UTP Securities’’) while also providing discriminatory because they will apply is subject to significant competitive the potential for price improvement to such order uniformly to all similarly situated ETP flow. See Rule 7.44. See Securities Exchange Act forces, as described below in the Release No. 71176 (December 23, 2013), 78 FR Holders. Exchange’s statement regarding the 79524 (December 30, 2013) (SR–NYSEArca–2013– The Exchange notes that a significant burden on competition. For these 107). percentage of the orders of individual reasons, the Exchange believes that the 7 ‘‘RMO’’ is defined in Rule 7.44(a)(2) as an ETP investors are executed over-the- proposal is consistent with the Act. Holder that is approved by the Exchange to submit counter.11 While the Exchange believes Retail Orders. However, an order designated as a Retail Order of an RMO for purposes of the Retail approximately 25.4% of share volume in September Liquidity Program is separate from the designation require the ETP Holder to (i) exercise due diligence 2009). See also Mary Jo White, Focusing on of an order as a Retail Order for purposes of existing before entering a Retail Order to assure that entry Fundamentals: The Path to Address Equity Market pricing tiers in the Fee Schedule. See Securities as a Retail Order is in compliance with the Structure (Speech at the Security Traders Exchange Act Release No. 71722 (March 13, 2014), requirements specified by the Exchange, and (ii) Association 80th Annual Market Structure 78 [sic] FR 15376 (March 19, 2014) (SR–NYSEArca– monitor whether orders entered as Retail Orders Conference, Oct. 2, 2013) (available on the 2014–22) (‘‘Arca Retail Approval Order’’ [sic]). The meet the applicable requirements. If the ETP Holder Commission’s Web site) (‘‘White Speech’’); Mary L. proposed rule change solely concerns Retail Orders represents Retail Orders from another broker-dealer Schapiro, Strengthening Our Equity Market outside the Retail Liquidity Program that are customer, the ETP Holder’s supervisory procedures Structure (Speech at the Economic Club of New currently defined in the Fee Schedule as ‘‘Retail must be reasonably designed to assure that the York, Sept. 7, 2010) (available on the Commission’s Orders’’. orders it receives from such broker-dealer customer Web site) (‘‘Schapiro Speech’’). In her speech, Chair 8 See, e.g., Securities Exchange Act Release No. that it designates as Retail Orders meets the White noted a steadily increasing percentage of 68322 (November 29, 2012), 77 FR 72425 definition of a Retail Order. trading that occurs in ‘‘dark’’ venues, which appear (December 5, 2012) (SR–NYSEArca–2012–129). ETP 9 15 U.S.C. 78f(b). to execute more than half of the orders of long-term Holders designating orders as Retail Orders by 10 15 U.S.C. 78f(b)(4) and (5). investors. Similarly, in her speech, only three years using a tag in the order entry message are required 11See Concept Release on Equity Market earlier, Chair Schapiro noted that nearly 30 percent to have written policies and procedures reasonably Structure, Securities Exchange Act Release No. of volume in U.S.-listed equities was executed in designed to assure that it only designates orders as 61358 (January 14, 2010), 75 FR 3594 (January 21, venues that do not display their liquidity or make Retail Orders if all requirements of a Retail Order 2010) (‘‘Concept Release’’) (noting that dark pools it generally available to the public and the are met. The written policies and procedures and internalizing broker-dealers executed percentage was increasing nearly every month.

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B. Self-Regulatory Organization’s action is necessary or appropriate in the submissions. You should submit only Statement on Burden on Competition public interest, for the protection of information that you wish to make In accordance with Section 6(b)(8) of investors, or otherwise in furtherance of available publicly. All submissions the Act,12 the Exchange believes that the the purposes of the Act. If the should refer to File Number SR– proposed rule change would not impose Commission takes such action, the NYSEArca–2015–39 and should be any burden on competition that is not Commission shall institute proceedings submitted on or before June 9, 2015. 15 necessary or appropriate in furtherance under Section 19(b)(2)(B) of the Act to For the Commission, by the Division of of the purposes of the Act. Instead, the determine whether the proposed rule Trading and Markets, pursuant to delegated Exchange believes that the proposed change should be approved or authority.16 disapproved. fees would increase competition for Robert W. Errett, retail order flow among execution IV. Solicitation of Comments Deputy Secretary. venues and encourage additional Interested persons are invited to [FR Doc. 2015–12062 Filed 5–18–15; 8:45 am] execution opportunities on the submit written data, views, and BILLING CODE 8011–01–P Exchange and other registered arguments concerning the foregoing, exchanges. The Exchange believes the including whether the proposed rule proposed fee change also would not change is consistent with the Act. SECURITIES AND EXCHANGE impose any burden on competition Comments may be submitted by any of COMMISSION among market participants. To the the following methods: contrary, because Primary Until 9:45 Sunshine Act Meeting Orders and Primary After 3:55 Orders Electronic Comments are designed to route to the primary • Use the Commission’s Internet Notice is hereby given, pursuant to listing market during designated times, comment form (http://www.sec.gov/ the provisions of the Government in the the Exchange believes that the proposed rules/sro.shtml); or Sunshine Act, Public Law 94–409, that fee would promote inter-exchange • Send an email to rule-comments@ the Securities and Exchange competition by proving an incentive for sec.gov. Please include File Number SR– Commission will hold a Closed Meeting ETP Holders to route such orders to the NYSEArca–2015–39 on the subject line. on Thursday, May 21, 2015 at 2:00 p.m. Exchange, which would also benefit the primary listing markets that would Paper Comments Commissioners, Counsel to the Commissioners, the Secretary to the receive the orders when routed. • Send paper comments in triplicate Commission, and recording secretaries The Exchange notes that it operates in to Robert W. Errett, Deputy Secretary, will attend the Closed Meeting. Certain a highly competitive market in which Securities and Exchange Commission, staff members who have an interest in market participants can readily favor 100 F Street NE., Washington, DC the matters also may be present. competing venues. In such an 20549–1090. environment, the Exchange must All submissions should refer to File The General Counsel of the continually review, and consider Number SR–NYSEArca–2015–39. This Commission, or her designee, has adjusting, its fees and credits to remain file number should be included on the certified that, in her opinion, one or competitive with other exchanges. For subject line if email is used. To help the more of the exemptions set forth in 5 the reasons described above, the Commission process and review your U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) Exchange believes that the proposed comments more efficiently, please use and 17 CFR 200.402(a)(3), (5), (7), 9(ii) rule change promotes a competitive only one method. The Commission will and (10), permit consideration of the environment. post all comments on the Commission’s scheduled matter at the Closed Meeting. C. Self-Regulatory Organization’s Internet Web site (http://www.sec.gov/ Commissioner Stein, as duty officer, Statement on Comments on the rules/sro.shtml). Copies of the voted to consider the items listed for the Proposed Rule Change Received From submission, all subsequent Closed Meeting in closed session. Members, Participants, or Others amendments, all written statements The subject matter of the Closed with respect to the proposed rule No written comments were solicited Meeting will be: Institution and change that are filed with the or received with respect to the proposed settlement of injunctive actions; Commission, and all written rule change. Institution and settlement of communications relating to the administrative proceedings; III. Date of Effectiveness of the proposed rule change between the Adjudicatory matter; and Other matters Proposed Rule Change and Timing for Commission and any person, other than relating to enforcement proceedings. Commission Action those that may be withheld from the At times, changes in Commission The foregoing rule change is effective public in accordance with the provisions of 5 U.S.C. 552, will be priorities require alterations in the upon filing pursuant to Section scheduling of meeting items. 19(b)(3)(A) 13 of the Act and available for Web site viewing and subparagraph (f)(2) of Rule 19b–4 14 printing in the Commission’s Public For further information and to thereunder, because it establishes a due, Reference Room, 100 F Street NE., ascertain what, if any, matters have been fee, or other charge imposed by the Washington, DC 20549, on official added, deleted or postponed, please Exchange. business days between the hours of contact the Office of the Secretary at At any time within 60 days of the 10:00 a.m. and 3:00 p.m. Copies of the (202) 551–5400. filing of such proposed rule change, the filing will also be available for Dated: May 14, 2015. inspection and copying at the principal Commission summarily may Brent J. Fields, office of the Exchange. All comments temporarily suspend such rule change if Secretary. it appears to the Commission that such received will be posted without change; the Commission does not edit personal [FR Doc. 2015–12183 Filed 5–15–15; 11:15 am] 12 15 U.S.C. 78f(b)(8). identifying information from BILLING CODE 8011–01–P 13 15 U.S.C. 78s(b)(3)(A). 14 17 CFR 240.19b–4(f)(2). 15 15 U.S.C. 78s(b)(2)(B). 16 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE revise the quoting obligations for for which it accepts Preferenced Orders. COMMISSION Preferred Market Makers. Specifically, Finally, the Exchange proposes to add the Exchange proposes to (i) decrease the language ‘‘non-adjusted options [Release No. 34–74952; File No. SR–BOX– 2015–19] the percentage of time a Preferred series’’ to indicate that Preferred Market Market Maker is required to Maker will not be obligated to maintain Self-Regulatory Organizations; BOX continuously quote from 99% to 90%; continuous quotes in adjusted options Options Exchange LLC; Notice of (ii) decrease the percentage of series the series and to define the term adjusted Filing and Immediate Effectiveness of Preferred Market Maker is required to options series. Compliance with the a Proposed Rule Change To Adjust the continuously quote; and (iii) modify the Preferred Market Maker’s continuous Preferred Market Maker Quoting series the continuous quoting quoting requirement will still be Obligations obligations apply to for Preferred Market determined on a monthly basis; and this Makers. Each of these changes, which does not relieve a Preferred Market May 13, 2015. are described in detail below, will make Maker from meeting this quoting Pursuant to Section 19(b)(1) of the BOX’s Preferred Market Maker requirement on a daily basis, nor does Securities Exchange Act of 1934 (the obligations more consistent with the it prohibit the Exchange from taking ‘‘Act’’),1 and Rule 19b–4 thereunder,2 comparable market maker obligations at disciplinary action against a Preferred notice is hereby given that on May 5, other options exchanges.3 Market Maker for failing to meet this 2015, BOX Options Exchange LLC (the BOX Rule 7300 currently provides requirement each trading day. ‘‘Exchange’’) filed with the Securities that during trading hours, a Preferred The Exchange does not believe that and Exchange Commission Market Maker 4 must maintain a the proposed rule change will adversely (‘‘Commission’’) the proposed rule continuous two-sided market, pursuant affect the quality of the Exchange’s change as described in Items I and II to Rule 8050(c)(1), throughout the market or lead to a material decrease in below, which Items have been prepared trading day, in option classes for which liquidity. Rather, the Exchange believes by the self-regulatory organization. The it accepts Preferenced Orders, for 99% that lowering the continuous quoting Commission is publishing this notice to of the time the Exchange is open for requirements may increase liquidity by solicit comments on the proposed rule trading in each such option class; attracting more Preferred Market Makers change from interested persons. provided, however, that for purposes of to the Exchange. Preferred Market I. Self-Regulatory Organization’s this requirement, a Preferred Market Makers will still have to meet Statement of the Terms of the Substance Maker is not required to quote in intra- heightened quoting requirements when of the Proposed Rule Change day add-on series or series that have a compared to the quoting requirements time to expiration of nine months or of Market Makers on the Exchange.5 The Exchange proposes to amend more in the classes for which it receives Additionally, the Exchange Rules will BOX Rule 7300 (Preferenced Orders) to Preferenced Orders and a Market Maker continue to impose a number of other adjust the Preferred Market Maker may still be a Preferred Market Maker in obligations on Preferred Market Makers quoting obligations. The text of the any such series if the Market Maker proposed rule change is available from to ensure that they create and maintain otherwise complies with Rule a fair and orderly market in the option the principal office of the Exchange, at 7300(a)(2). 6 the Commission’s Public Reference classes to which they are assigned. The rule also provides that if a The Exchange believes this proposal Room and also on the Exchange’s technical failure or limitation of a will make the quoting requirements of Internet Web site at http:// system of the Exchange prevents a Preferred Market Makers more boxexchange.com. Preferred Market Maker from comparable to those at other options II. Self-Regulatory Organization’s maintaining, or prevents a Preferred exchanges and is therefore essential for Statement of the Purpose of, and Market Maker from communicating to competitive purposes.7 Statutory Basis for, the Proposed Rule the Exchange, timely and accurate Change electronic quotes in an option class, the 2. Statutory Basis duration of such failure will be The Exchange believes that the In its filing with the Commission, the disregarded in determining whether the self-regulatory organization included proposal is consistent with the Preferred Market Maker has satisfied requirements of Section 6(b) of the statements concerning the purpose of, this requirement. The Exchange may and basis for, the proposed rule change Securities Exchange Act of 1934 (the also consider other exceptions to this ‘‘Act’’), in general, and Section 6(b)(5) of and discussed any comments it received obligation based on a demonstrated on the proposed rule change. The text the Act, in particular, in that it is legal or regulatory requirement or other designed to prevent fraudulent and of these statements may be examined at mitigating circumstances. the places specified in Item IV below. manipulative acts and practices, to The Exchange first proposes to reduce promote just and equitable principles of The self-regulatory organization has the percentage of time which a Preferred prepared summaries, set forth in trade, to foster cooperation and Market Maker is required to provide coordination with persons engaged in Sections A, B, and C below, of the most continuous quotes in an appointed significant aspects of such statements. facilitating transactions in securities, to options class to 90% of the time. The remove impediments to and perfect the A. Self-Regulatory Organization’s Exchange then proposes to amend the mechanism of a free and open market Statement of the Purpose of, and continuous quoting obligation for and a national market system, and, in Statutory Basis for, the Proposed Rule Preferred Market Makers from 100% to Change 99% of the options series of each class 5 Under BOX Rule 8050(e) on a daily basis a Market Maker must post valid quotes at least sixty 1. Purpose 3 See MIAX Rule 514 and 604(e)(2); CBOE Rule percent (60%) of the time that the classes are open The Exchange proposes to amend 1.1(ccc); Phlx Rule 1014(b)(ii)(D)(1); and ISE Rule for trading. 6 BOX Rule 7300 (Preferenced Orders) to 804(e)(2)(iii). For example, in order to receive the allocation 4 The term ‘‘Preferred Market Maker’’ means a preference the Preferred Market Maker must also be Market Maker designated as such by a Participant quoting at the NBBO at the time the Preferenced 1 15 U.S.C. 78s(b)(1). with respect to an order submitted by such Order was received. 2 17 CFR 240.19b–4. Participant to BOX. See BOX Rule 7300. 7 See supra, note 3.

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general to protect investors and the effective pursuant to Section 19(b)(3)(A) available for Web site viewing and public interest. In particular, the of the Act 9 and Rule 19b–4(f)(6) printing in the Commission’s Public proposed rule change removes thereunder.10 Reference Room, 100 F Street NE., impediments to and perfects the At any time within 60 days of the Washington, DC 20549 on official mechanisms of a free and open market filing of the proposed rule change, the business days between the hours of and a national market system because it Commission summarily may 10:00 a.m. and 3:00 p.m. Copies of such is similar with the continuous quoting temporarily suspend such rule change if filing also will be available for standards in place on other options it appears to the Commission that such inspection and copying at the principal exchanges. The Exchange believes the action is necessary or appropriate in the office of the Exchange. All comments proposed rule change will not diminish, public interest, for the protection of received will be posted without change; and in fact may increase market making investors, or otherwise in furtherance of the Commission does not edit personal activity and liquidity on the Exchange the purposes of the Act. If the identifying information from by establishing a quoting compliance Commission takes such action, the submissions. You should submit only standard that is reasonable and is Commission shall institute proceedings information that you wish to make similar to those already in place on to determine whether the proposed rule available publicly. All submissions other options exchanges. Specifically, should be approved or disapproved. should refer to File Number SR–BOX– the Exchange believes that the proposed 2015–19, and should be submitted on or IV. Solicitation of Comments quoting requirements will encourage before June 9, 2015. greater participation by Market Makers Interested persons are invited to For the Commission, by the Division of to provide quotes on the Exchange as submit written data, views, and Trading and Markets, pursuant to delegated Preferred Market Makers. These arguments concerning the foregoing, authority.11 additional responses should encourage including whether the proposed rule Robert W. Errett, greater competition on the Exchange, change is consistent with the Act. Deputy Secretary. which should, in turn, benefit and Comments may be submitted by any of [FR Doc. 2015–12029 Filed 5–18–15; 8:45 am] protect investors and the public interest the following methods: through the potential for greater volume BILLING CODE 8011–01–P Electronic Comments of orders and executions. • Use the Commission’s Internet SECURITIES AND EXCHANGE B. Self-Regulatory Organization’s comment form (http://www.sec.gov/ COMMISSION Statement on Burden on Competition rules/sro.shtml); or The Exchange does not believe that • Send an email to rule-comments@ [Release No. 34–74954; File No. SR–Phlx– the proposed rule change will impose sec.gov. Please include File Number SR– 2015–29] any burden on competition not BOX–2015–19 on the subject line. necessary or appropriate in furtherance Self-Regulatory Organizations; Paper Comments of the purposes of the Act. The NASDAQ OMX PHLX LLC; Notice of proposed rule change applies to all • Send paper comments in triplicate Designation of Longer Period for Preferred Market Makers. Additionally, to Brent J. Fields, Secretary, Securities Commission Action on Proposed Rule the proposed rule change is and Exchange Commission, 100 F Street Change To Amend and Restate Certain substantially similar to the rules in NE., Washington, DC 20549–1090. Rules That Govern the NASDAQ PSX 8 place at other options exchanges, All submissions should refer to File May 13, 2015. which the exchange believes may Number SR–BOX–2015–19. This file On March 20, 2015, NASDAQ OMX enhance, rather than burden, number should be included on the PHLX LLC (‘‘Phlx’’) filed with the competition among the options subject line if email is used. To help the Securities and Exchange Commission exchanges. Commission process and review your (‘‘Commission’’), pursuant to Section C. Self-Regulatory Organization’s comments more efficiently, please use 19(b)(1) of the Securities Exchange Act Statement on Comments on the only one method. The Commission will of 1934 (‘‘Act’’) 1 and Rule 19b–4 Proposed Rule Change Received From post all comments on the Commission’s thereunder,2 a proposed rule change to Members, Participants, or Others Internet Web site (http://www.sec.gov/ amend and restate certain Phlx rules rules/sro.shtml). Copies of the that govern NASDAQ OMX PSX in The Exchange has neither solicited submission, all subsequent order to provide a clearer and more nor received comments on the proposed amendments, all written statements detailed description of certain aspects of rule change. with respect to the proposed rule its functionality. The proposed rule III. Date of Effectiveness of the change that are filed with the change was published for comment in Proposed Rule Change and Timing for Commission, and all written the Federal Register on April 6, 2015.3 Commission Action communications relating to the The Commission received no comment proposed rule change between the Because the proposed rule change letters regarding the proposed rule Commission and any person, other than does not (i) significantly affect the change. those that may be withheld from the 4 protection of investors or the public Section 19(b)(2) of the Act provides public in accordance with the interest; (ii) impose any significant that within 45 days of the publication of provisions of 5 U.S.C. 552, will be burden on competition; and (iii) become notice of the filing of a proposed rule operative for 30 days from the date on change, or within such longer period up 9 15 U.S.C. 78s(b)(3)(A). to 90 days as the Commission may which it was filed, or such shorter time 10 17 CFR 240.19b–4(f)(6). As required under Rule as the Commission may designate if 19b-4(f)(6)(iii), the Exchange provided the 11 17 CFR 200.30–3(a)(12). consistent with the protection of Commission with written notice of its intent to file 1 15 U.S.C. 78s(b)(1). investors and the public interest, the the proposed rule change, along with a brief description and the text of the proposed rule 2 17 CFR 240.19b–4. proposed rule change has become change, at least five business days prior to the date 3 See Securities Exchange Act Release No. 74618 of filing of the proposed rule change, or such (March 31, 2015), 80 FR 18452. 8 See supra, note 3. shorter time as designated by the Commission. 4 15 U.S.C. 78s(b)(2).

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designate if it finds such longer period 19b–4 under the Act,3 which renders disqualification’’ as defined in the Act. to be appropriate and publishes its the proposal effective upon receipt of The rule also requires a member to reasons for so finding or as to which the this filing by the Commission. The report whenever the member or an self-regulatory organization consents, Commission is publishing this notice to associated person of the member is the Commission shall either approve the solicit comments on the proposed rule involved in the sale of any financial proposed rule change, disapprove the change from interested persons. instrument, the provision of any proposed rule change, or institute investment advice or the financing of proceedings to determine whether the I. Self-Regulatory Organization’s any such activities with any person that proposed rule change should be Statement of the Terms of Substance of is subject to a ‘‘statutory disapproved. The 45th day for this filing the Proposed Rule Change disqualification’’ as defined in the Act. is May 21, 2015. FINRA is proposing to amend FINRA The report must include the name of the The Commission is extending the 45- Rule 4530 (Reporting Requirements) to person subject to the statutory day time period for Commission action provide an exception from the disqualification and details concerning on the proposed rule change. The requirements of paragraph (a)(1)(H) of the disqualification. In addition, the Commission finds that it is appropriate the rule for dealings with a member or report must be submitted to FINRA to designate a longer period within associated person subject to statutory within 30 calendar days after the which to take action on the proposed disqualification, if that member or member knows or should have known rule change so that it has sufficient time associated person has been approved (or of the event. to consider the proposed rule change. is otherwise permitted pursuant to The definition of ‘‘statutory Accordingly, pursuant to Section FINRA rules and the federal securities disqualification’’ under the Act 19(b)(2) of the Act 5 and for the reasons laws) to be a member or to be associated includes, among other events, findings stated above, the Commission with a member. by the SEC, Commodity Futures Trading designates July 5, 2015, as the date by The text of the proposed rule change Commission or a self-regulatory which the Commission should either is available on FINRA’s Web site at organization that a person: (1) Willfully approve or disapprove, or institute http://www.finra.org, at the principal violated the federal securities or proceedings to determine whether to office of FINRA and at the commodities laws, or the Municipal disapprove, the proposed rule change. Commission’s Public Reference Room. Securities Rulemaking Board rules; (2) willfully aided, abetted, counseled, For the Commission, by the Division of II. Self-Regulatory Organization’s Trading and Markets, pursuant to delegated commanded, induced or procured such authority.6 Statement of the Purpose of, and violations; or (3) failed to supervise Statutory Basis for, the Proposed Rule Robert W. Errett, another person who commits violations Change 5 Deputy Secretary. of such laws or rules. Thus, for [FR Doc. 2015–12031 Filed 5–18–15; 8:45 am] In its filing with the Commission, instance, a member is currently required to report under FINRA Rule BILLING CODE 8011–01–P FINRA included statements concerning the purpose of and basis for the 4530(a)(1)(H) each time the member is proposed rule change and discussed any involved in the sale of any financial SECURITIES AND EXCHANGE comments it received on the proposed instrument, such as participating in a COMMISSION rule change. The text of these statements selling syndicate or selling group, with may be examined at the places specified a member that has been found to have [Release No. 34- 74953; File No. SR–FINRA– in Item IV below. FINRA has prepared willfully violated the federal securities 2015–011] summaries, set forth in sections A, B, laws. This would be true even if the Self-Regulatory Organizations; and C below, of the most significant member that is subject to the willful Financial Industry Regulatory aspects of such statements. violation has been approved, or is otherwise permitted pursuant to FINRA Authority, Inc.; Notice of Filing and A. Self-Regulatory Organization’s rules and the federal securities laws, to Immediate Effectiveness of a Proposed Statement of the Purpose of, and continue in membership Rule Change Relating to the Reporting Statutory Basis for, the Proposed Rule notwithstanding the disqualification.6 Requirements of FINRA Rule Change 4530(a)(1)(H) For the following reasons, FINRA 1. Purpose believes that there is no regulatory value May 13, 2015. FINRA Rule 4530 requires members to Pursuant to Section 19(b)(1) of the 5 See 15 U.S.C. 78c(a)(39). report to FINRA specified events, such 6 In general, persons subject to a statutory Securities Exchange Act of 1934 as statutory disqualifications, and (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 disqualification would be required to obtain quarterly statistical and summary approval from FINRA to enter or remain in the notice is hereby given that on May 5, information regarding written customer securities industry. A firm seeking to continue in 2015, Financial Industry Regulatory membership, notwithstanding the existence of such complaints.4 FINRA uses the Authority, Inc. (‘‘FINRA’’) filed with the a disqualification, generally would be required to information for regulatory purposes to Securities and Exchange Commission file an MC–400A application with FINRA. identify and initiate investigations of Similarly, a firm seeking to sponsor (i.e., employ or (‘‘SEC’’ or ‘‘Commission’’) the proposed firms, offices and associated persons associate with) a disqualified person generally rule change as described in Items I and would be required to file an MC–400 application that may pose a risk. with FINRA. However, as described in Regulatory II below, which Items have been FINRA Rule 4530(a)(1)(H) requires a prepared by FINRA. FINRA has Notice 09–19 (April 2009), a firm would not be member to report whenever the member required to file an application for approval for designated the proposed rule change as itself or an associated person of the specific disqualifying events. For instance, a firm constituting a ‘‘non-controversial’’ rule member is subject to a ‘‘statutory that is subject to a statutory disqualification based change under paragraph (f)(6) of Rule on a willful violation of the federal securities laws would not be required to file an MC–400A 3 17 CFR 240.19b–4(f)(6). application with FINRA if the sanction is no longer 5 15 U.S.C. 78s(b)(2). 4 The specified events and customer complaint in effect. Such a firm would be permitted to 6 17 CFR 200.30–3(a)(31). information must be electronically reported to continue in membership notwithstanding the 1 15 U.S.C. 78s(b)(1). FINRA via an application on FINRA’s Firm disqualification and without having to file an 2 17 CFR 240.19b–4. Gateway. application with FINRA for approval.

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in requiring a firm to report dealings person that has been approved or is At any time within 60 days of the with a disqualified member or otherwise permitted to be a member or filing of the proposed rule change, the associated person that has been associated with a member. Commission summarily may approved or is otherwise permitted to be temporarily suspend such rule change if C. Self-Regulatory Organization’s a member or associated with a member. Statement on Comments on the it appears to the Commission that such First, FINRA is aware of the statutory Proposed Rule Change Received from action is necessary or appropriate in the disqualification status of such members Members, Participants, or Others public interest, for the protection of and associated persons. Second, Written comments were neither solicited investors, or otherwise in furtherance of disqualified members and associated nor received. the purposes of the Act. If the persons that have been approved to be Commission takes such action, the members or associated with members III. Date of Effectiveness of the Commission shall institute proceedings typically are subject to special Proposed Rule Change and Timing for to determine whether the proposed rule supervisory conditions, and FINRA Commission Action should be approved or disapproved. periodically examines them to ensure Because the proposed rule change IV. Solicitation of Comments compliance with the supervisory does not (i) significantly affect the conditions and to monitor for other protection of investors or the public Interested persons are invited to problems. interest; (ii) impose any significant submit written data, views and Therefore, FINRA is proposing to burden on competition; and (iii) become arguments concerning the foregoing, amend Rule 4530(a)(1)(H) to exclude operative for 30 days from the date on including whether the proposed rule activities with a disqualified member or which it was filed, or such shorter time change is consistent with the Act. associated person that has been as the Commission may designate, the Comments may be submitted by any of approved (or is otherwise permitted proposed rule change has become the following methods: pursuant to FINRA rules and the federal effective pursuant to Section 19(b)(3)(A) Electronic Comments securities laws) to be a member or of the Act 8 and Rule 19b–4(f)(6) • Use the Commission’s Internet associated with a member. thereunder.9 FINRA has filed the proposed rule A proposed rule change filed comment form (http://www.sec.gov/ change for immediate effectiveness. The pursuant to Rule 19b–4(f)(6) under the rules/sro.shtml); or • Send an email to rule-comments@ implementation date of the proposed Act 10 normally does not become sec.gov. Please include File Number SR– rule change will be the date of filing. operative for 30 days after the date of its FINRA–2015–011 on the subject line. 2. Statutory Basis filing. However, Rule 19b–4(f)(6)(iii)11 permits the Commission to designate a Paper Comments FINRA believes that the proposed rule shorter time if such action is consistent • Send paper comments in triplicate change is consistent with the provisions with the protection of investors and the 7 to Secretary, Securities and Exchange of Section 15A(b)(6) of the Act, which public interest. FINRA requested the requires, among other things, that Commission, 100 F Street NE., Commission to waive the 30-day Washington, DC 20549–1090. FINRA rules must be designed to operative delay so it can implement the prevent fraudulent and manipulative proposed rule change immediately. All submissions should refer to File acts and practices, to promote just and FINRA stated that waiver of the Number SR–FINRA–2015–011. This file equitable principles of trade, and, in operative delay would eliminate number should be included on the general, to protect investors and the unnecessary reporting requirements subject line if email is used. To help the public interest. FINRA believes that the relating to dealings with members or Commission process and review your proposed rule change will further these associated persons that are subject to a comments more efficiently, please use purposes by eliminating unnecessary statutory disqualification where FINRA only one method. The Commission will reporting of information to FINRA and already has access to information post all comments on the Commission’s allowing FINRA to use its resources regarding the status of such persons and Internet Web site (http://www.sec.gov/ more efficiently. FINRA also believes they have either been approved or are rules/sro.shtml). Copies of the that the proposed rule change will serve otherwise permitted to be a member or submission, all subsequent to reduce potential compliance burdens associated with a member. The amendments, all written statements on firms without compromising the Commission believes the waiver of the with respect to the proposed rule regulatory information available to operative delay is consistent with the change that are filed with the FINRA. protection of investors and the public Commission, and all written interest. Therefore, the Commission communications relating to the B. Self-Regulatory Organization’s proposed rule change between the Statement on Burden on Competition hereby waives the operative delay and designates the proposal operative upon Commission and any person, other than FINRA does not believe that the filing.12 those that may be withheld from the proposed rule change will result in any public in accordance with the burden on competition that is not 8 15 U.S.C. 78s(b)(3)(A). provisions of 5 U.S.C. 552, will be necessary or appropriate in furtherance 9 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– available for Web site viewing and of the purposes of the Act. 4(f)(6)(iii) requires a self-regulatory organization to printing in the Commission’s Public The proposed rule change would provide the Commission with written notice of its Reference Room, 100 F Street NE., reduce potential compliance burdens on intent to file the proposed rule change, along with a brief description and text of the proposed rule Washington, DC 20549, on official firms by eliminating the requirement change, at least five business days prior to the date business days between the hours of under FINRA Rule 4530(a)(1)(H) to of filing of the proposed rule change, or such 10:00 a.m. and 3:00 p.m. Copies of the report to FINRA each instance where a shorter time as designated by the Commission. filing also will be available for firm or an associated person is involved FINRA has fulfilled this requirement. 10 inspection and copying at the principal in a financial activity with a 17 CFR 240.19b–4(f)(6). 11 17 CFR 240.19b–4(f)(6)(iii). office of FINRA. All comments received disqualified member or associated 12 For purposes only of waiving the 30-day operative delay, the Commission has also efficiency, competition, and capital formation. See 7 15 U.S.C. 78o–3(b)(6). considered the proposed rule’s impact on 15 U.S.C. 78c(f).

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will be posted without change; the the Exchange pursuant to EDGX Rule fee code BY to $0.00150 per share in Commission does not edit personal 15.1(a) and (c) (‘‘Fee Schedule’’) to: (i) securities priced at or above $1.00.7 The identifying information from decrease the rebate for orders yielding proposed change represents a pass submissions. You should submit only fee code BY, which routes to the BATS through of the rate BATS Trading, Inc. information that you wish to make Y-Exchange, Inc. (‘‘BYX’’) and removes (‘‘BATS Trading’’), the Exchange’s available publicly. All submissions liquidity using routing strategies affiliated routing broker-dealer, is should refer to File Number SR–FINRA– Destination Specific (‘‘DIRC’’), ROUC, or provided for routing orders to BYX that 2015–011 and should be submitted on ROUE; 6 (ii) decrease the standard rate remove liquidity. The proposed change or before June 9, 2015. charged for removing liquidity from the is in response to BYX’s May 2015 fee For the Commission, by the Division of Exchange from $0.0030 per share to change where BYX decreased its rebate Trading and Markets, pursuant to delegated $0.0029 per share; and (iii) make a few from $0.00160 per share to $0.00150 per authority.13 non-substantive clarifying changes. share for orders in securities priced at Robert W. Errett, Changes to the fee schedule pursuant to or above $1.00.8 When BATS Trading Deputy Secretary. this proposal are effective upon filing. routes to and removes liquidity from The text of the proposed rule change [FR Doc. 2015–12030 Filed 5–18–15; 8:45 am] BYX, it will now receive a standard is available at the Exchange’s Web site rebate of $0.00150 per share. BATS BILLING CODE 8011–01–P at www.batstrading.com, at the Trading will pass through the rebate principal office of the Exchange, and at provided by BYX to the Exchange and SECURITIES AND EXCHANGE the Commission’s Public Reference the Exchange, in turn, will pass through COMMISSION Room. this rate to its Members. II. Self-Regulatory Organization’s Standard Removal Rate Change [Release No. 34–74950; File No. SR–EDGX– Statement of the Purpose of, and 2015–22] Statutory Basis for, the Proposed Rule In securities priced at or above $1.00, Change the Exchange currently charges a fee or Self-Regulatory Organizations; EDGX $0.0030 per share when removing Exchange, Inc.; Notice of Filing and In its filing with the Commission, the liquidity. The Exchange now proposes Immediate Effectiveness of a Proposed Exchange included statements to decrease the standard rate charged for Rule Change Related to Fees for Use concerning the purpose of and basis for removing liquidity from the Exchange of EDGX Exchange, Inc. the proposed rule change and discussed from $0.0030 per share to $0.0029 per any comments it received on the share in securities priced at or above May 13, 2015. proposed rule change. The text of these $1.00.9 The standard removal rate Pursuant to Section 19(b)(1) of the statements may be examined at the applies unless a Member’s transaction is Securities Exchange Act of 1934 (the places specified in Item IV below. The assigned a fee code other than a 1 2 ‘‘Act’’), and Rule 19b–4 thereunder, Exchange has prepared summaries, set standard fee code. If a Member’s notice is hereby given that on April 30, forth in Sections A, B, and C below, of transaction is assigned a fee code other 2015, EDGX Exchange, Inc. (the the most significant parts of such than a standard fee code, the rates listed ‘‘Exchange’’ or ‘‘EDGX’’) filed with the statements. in the Fee Codes table of the Fee Securities and Exchange Commission (A) Self-Regulatory Organization’s Schedule will apply. (‘‘Commission’’) the proposed rule Statement of the Purpose of, and The standard rate for removing change as described in Items I, II and III Statutory Basis for, the Proposed Rule liquidity from the Exchange will be below, which Items have been prepared Change $0.0029 per share and no lower fees will by the Exchange. The Exchange has be available if a Member qualifies for a 1. Purpose designated the proposed rule change as tier included in footnote 1 of the Fee one establishing or changing a member The Exchange proposes to: (i) Schedule. Therefore, the Exchange due, fee, or other charge imposed by the Decrease the rebate for orders yielding proposes to make a series of changes to Exchange under Section 19(b)(3)(A)(ii) fee code BY, which routes to BYX and the Fee Schedule as a result of of the Act 3 and Rule 19b–4(f)(2) removes liquidity using routing 4 decreasing the standard rate to $0.0029 thereunder, which renders the strategies DIRC, ROUC, or ROUE; (ii) per share. First, the Exchange proposes proposed rule change effective upon decrease the standard rate charged for to amend footnote 1 to remove filing with the Commission. The removing liquidity from the Exchange references to reduced fees for removing Commission is publishing this notice to from $0.0030 per share to $0.0029 per or routing liquidity from the Exchange. solicit comments on the proposed rule share; and (iii) make a few non- Under footnote 1, if a Member satisfies change from interested persons. substantive clarifying changes. the respective tier’s criteria, they would I. Self-Regulatory Organization’s Fee Code BY be charged a reduced fee of: (i) $0.0029 Statement of the Terms of Substance of per share under Mega Tier 1; (ii) In securities priced at or above $1.00, the Proposed Rule Change $0.0029 per share under Mega Tier 2; or the Exchange currently provides a (iii) $$0.00295 per share under Mega The Exchange filed a to amend its fees rebate of $0.00160 per share for and rebates applicable to Members 5 of Members’ orders that yield fee code BY, 7 The Exchange does not propose to amend its fee which routes to BYX and removes for orders that yield fee code BY in securities priced 13 17 CFR 200.30–3(a)(12). liquidity using routing strategies DIRC, below $1.00. 1 15 U.S.C. 78s(b)(1). ROUC, or ROUE. The Exchange 8 See BYX Exchange Fee Schedule Changes 2 17 CFR 240.19b–4. proposes to amend its Fee Schedule to Effective May 1, 2015 available at http:// 3 15 U.S.C. 78s(b)(3)(A)(ii). cdn.batstrading.com/resources/fee_schedule/2015/ 4 17 CFR 240.19b–4(f)(2). decrease the rebate for orders that yield BATS-BYX-Exchange-BZX-Exchange-EDGA- 5 The term ‘‘Member’’ is defined as ‘‘any Exchange-and-EDGX-Exchange-Fee-Schedule- registered broker or dealer, or any person associated Exchange as that term is defined in Section 3(a)(3) Changes-Effective-May-1-2015.pdf. with a registered broker or dealer [sic], that has of the Act.’’ See Exchange Rule 1.5(n). 9 The Exchange does not propose to amend its been admitted to membership in the Exchange. A 6 The DIRC, ROUC, and ROUE routing strategies standard rate for orders in securities priced below Member will have the status of a ‘‘member’’ of the are set forth in Exchange Rule 11.11(g). $1.00.

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Tier 3.10 Going forward, Members will the standard or tiered rebate/removal rate for customer internalization thus be charged the standard removal rate of rates. Therefore, Members currently allows the Exchange to continue to $0.0029 per share regardless of whether incur a total transaction cost of $0.0010 discourage potential wash sales. they satisfy the criteria for Mega Tier 1 per share for both sides of an execution Non-Substantive Changes or Mega Tier 2. Members will also be for customer internalization. charged the reduced standard removal Prior to the proposed reduction of the The Exchange also proposes to make rate of $0.0029 per share, rather than standard removal rate proposed herein, the below non-substantive clarifying $0.00295 per share, if they satisfy the the Exchange charged a standard rate of changes to its Fee Schedule. First, the criteria for Mega Tier 3. Therefore, the $0.0030 per share for orders that remove Exchange proposes to remove ‘‘, Inc.’’ Exchange proposes to delete the liquidity and a standard rebate of from the reference to the Exchange in references under footnote 1 to reduced $0.0020 per share for orders that add the heading of the Fee Schedule. This fees for removing of routing liquidity liquidity resulting in a maker/taker non-substantive change is intended to from the Exchange as Members will be spread of $0.0010 per share, equal to the make the reference to the Exchange in charged the reduced standard removal total transaction cost of $0.0010 per the heading of the Fee Schedule rate regardless of whether they meet any share for both sides of an execution for consistent with the manner in which its of the above referenced tiers’ criteria. As customer internalization. Going affiliated exchanges 14 are referenced in a result of the above changes, the forward, the Exchange proposes to their respective fee schedules. Second, Exchange also proposes to remove charge a standard rate of $0.0029 per the Exchange proposes to remove an language from footnote 1 listing the fee share for orders that remove liquidity incorrect reference to footnote 4 under codes eligible for reduced removal fees and will continue to provide a standard the standard removal rate as footnote 4 provided by the add volume tiers rebate of $0.0020 per share for orders provides for a rebate of $0.0034 per included in footnote 1 as this language that add liquidity resulting in a maker/ share for Members meeting criteria would be no longer necessary. taker spread of $0.0009 per share. under the Exchange’s Retail Order tier. Second, the Exchange proposes to In order to ensure that the Footnote 4 is, therefore, inapplicable to delete references to footnote 1 from: (i) internalization fee is in line with the the standard removal rate. Third, the the standard rate for removing liquidity proposed maker/taker spread of $0.0009 Exchange proposes to remove a in securities priced above $1.00; and (ii) for the standard add rate (rebate of reference to fee code PI from the standard fee codes 6, 7, BB, N, RT, and $0.0020) and standard removal rate Standard Rates table as fee code PI was W. These fee codes provide for the (proposed $0.0029 fee per share), the previously removed from the Fee Codes standard removal rate when removing Exchange proposes to reduce the fee and Associated Fees section of the Fee liquidity from the Exchange. Footnote 1 charged for internalized trades executed Schedule on January 16, 2015 and is no references reduced fees charged for on the Exchange from $0.00050 per longer available.15 Lastly, the Exchange removing liquidity if the criteria share to $0.00045 per share under fee proposes to add a reference to footnote included in the tiers within footnote 1 codes 5, EA, and ER. The amended fee 1 to fee code ZA, which provides for a are satisfied. The Exchange believes of $0.00045 per share for fee codes 5, rebate of $0.0032 per share for Retail references to footnote 1 discussed above EA, and ER would result in total Orders 16 that add liquidity. Footnote 1 are no longer necessary as the standard transaction cost of $0.0009 per share for states that the rebates to add liquidity both sides of an execution for customer rate for removing liquidity from the provided by the add volume tiers listed internalization, equal to the maker/taker Exchange will be $0.0029 per share and in the footnote are applicable to various spread of $0.0009 for the standard add no lower fees will be available if a fee codes, including fee code ZA. and removal rates discussed above. For Member qualifies for a tier included in Therefore, the Exchange believes that both tiered and standard rates, the footnote 1. adding a reference to footnote 1 charge for Members inadvertently Lastly, as a result of reducing the following fee code ZA will improve the matching with themselves will continue standard rate, the Exchange proposes to understandability of the Exchange’s Fee to be no more favorable than each amend fee codes 5, EA, and ER to Schedule because footnote 1 does maker/taker spread.13 The applicable reduce the fee charged for internalized expressly apply to that fee code. trades executed on the Exchange from share for an internalized trade executed on the Implementation Date $0.0005 per share to $0.00045 per share. Exchange that adds liquidity during Regular For customer internalization, which Trading Hours. Fee code ER provides for a fee of The Exchange proposes to implement occurs when two orders presented to the $0.0005 per share for an internalized trade executed these amendments to its Fee Schedule Exchange from the same Member (i.e., on the Exchange that removes liquidity during immediately. Regular Trading Hours. MPID) are presented separately and not 13 In addition, the Exchange notes that under in a paired manner, but nonetheless footnote 7 of the Fee Schedule, a Member that adds would be charged $0.0001 per share per side of an 11 10,000,000 shares or more of average daily volume execution (total of $0.0002 per share) or $0.0045 per inadvertently match with one another, share per side (total of $0.0009 per share) instead the Exchange currently charges (‘‘ADV’’) would be charged a rate of $0.0001 per share per side for customer internalization. The of capturing the maker/taker spreads resulting from $0.00050 per share per side of an Exchange has a variety of tiered rebates ranging achieving the tiered rebates. execution (for adding liquidity and for from $0.0025–$0.0034 per share, which makes its 14 The Exchange’s affiliated exchanges are BATS removing liquidity) for fee codes 5, EA, maker/taker spreads range from $0.0006 (standard Exchange, Inc., BATS Y-Exchange, Inc., and EDGA Exchange, Inc. (‘‘EDGA’’). The Exchange and ER.12 This charge occurs in lieu of removal rate—Mega Tier 1 rebate), $0.00035 (standard removal rate—Market Depth Tier 1 understands that EDGX also intends to file a rebate), $0.0003 (standard removal rate—Mega Tier proposed rule change with the Commission making 10 The Exchange does not propose to amend the 2, Mega Tier 3, Mega-Step-Up Tier 1,and Investor a similar change to how EDGA is referenced in the rebates provide by or the criteria necessary to Tier rebate),), $0.0002 (standard removal rate—Ultra heading of its fee schedule. satisfy Mega Tier 1, Mega Tier 2, or Mega Tier 3. Tier rebate), $0.0001 (standard removal rate—Mega 15 See Securities Exchange Act Release No. 74165 11 Members are advised to consult Exchange Rule Step-Up Tier 2 rebate), $0 (standard removal rate— (January 28, 2015), 80 FR 5854 (February 3, 2015) 12.2 respecting fictitious trading. Market Depth Tier 2 rebate), ¥$0.0001 (standard (SR–EDGX–2015–04) (Notice of Filing and 12 Fee codes 5 provides for a fee of $0.0005 per removal rate—Mega Step-Up Tier 3 and Super Tier), Immediate Effectiveness of a Proposed Rule Change share per each side of an internalized trade ¥$0.0002 (standard removal rate—Tape B Step Up to Make Non-Substantive Amendments and executed on the Exchange during the Pre-Market Tier), and ¥$0.0004 (standard removal rate— Clarifications to the Fee Schedule). Trading Session and Post-Market Trading Session. Growth Tier rebate). As a result of the customer 16 ‘‘Retail Order’’ is defined under Exchange Rule Fee code EA also provides for a fee of $0.0005 per internalization charge, Members who internalized 11.21(a).

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2. Statutory Basis made throughout the Fee Schedule, rate is non-discriminatory in that it The Exchange believes that the represent an equitable allocation of applies uniformly to all Members. proposed rule change is consistent with reasonable dues, fees and other charges Non-Substantive Changes the objectives of Section 6 of the Act,17 as it will enable the Exchange to The Exchange believes that the non- in general, and furthers the objectives of decrease trading cost for Members who substantive clarifying changes to its Fee Section 6(b)(4),18 in particular, as it is remove liquidity from the Exchange. Schedule are reasonable because they designed to provide for the equitable Decreasing the standard removal rate is are not designed to amend any fee, nor allocation of reasonable dues, fees and designed to attract additional liquidity alter the manner in which it assesses other charges among its Members and to the Exchange, thereby increasing other persons using its facilities. The depth of the Exchange’s order book, fees or calculates rebates. These Exchange also notes that it operates in resulting in improved price discovery proposed changes to the Fee Schedule a highly-competitive market in which for all investors. The rate is also are intended to make the reference to the Exchange in the heading of the Fee market participants can readily direct equitable and reasonable as compared to Schedule consistent with the manner in order flow to competing venues if they the fees for removing liquidity charged which its affiliated exchanges are deem fee levels at a particular venue to by The Nasdaq Stock Market LLC referenced in their respective fee be excessive. The proposed rule change (‘‘Nasdaq’’) (removal rate of $0.0030 per schedules, while the clarifying changes reflects a competitive pricing structure share) and NYSE Arca, Inc. (‘‘NYSE to remove reference to footnote 4 under designed to incent [sic] market Arca’’) (removal rate of $0.0030 per participants to direct their order flow to the standard removal rate and add a share for Tape A and Tape C reference to footnote 1 to fee code ZA the Exchange. The Exchange believes securities).19 The Exchange believes that the proposed rates are equitable and are intended to add clarity to the Fee references to footnote 1 as well as Schedule and avoid investor confusion. non-discriminatory in that they apply removing the fees to remove liquidity uniformly to all Members. The Therefore, the Exchange believes these from Mega Tier 1, Mega Tier 2, and changes will remove impediments to Exchange believes the fees and credits Mega Tier 3, as referenced above, are remain competitive with those charged and perfect the mechanism of a free and also equitable and reasonable because open market and a national market by other venues and therefore continue such provisions are no longer necessary to be reasonable and equitably allocated system, and, in general, protect as the standard rate for removing all to Members. investors and the public interest. liquidity from the Exchange will be Fee Code BY $0.0029 per share, which is equal to or (B) Self-Regulatory Organization’s Statement on Burden on Competition The Exchange believes that its lower than the current removal rated proposal to decrease the rebate for provided for in those tiers. The The Exchange believes its proposed orders that yield fee code BY represents proposed standard removal rate is also amendments to its Fee Schedule would an equitable allocation of reasonable non-discriminatory in that it applies not impose any burden on competition dues, fees, and other charges among uniformly to all Members. that is not necessary or appropriate in Members and other persons using its The Exchange believes that decreasing furtherance of the purposes of the Act. facilities. Prior to the BYX’s May 2015 the fee for customer internalization from The Exchange does not believe that the fee change, BYX provided BATS $0.00050 to $0.00045 per share per side proposed change represents a significant departure from previous pricing offered Trading a rebate of $0.00160 per share of an execution for fee codes EA, ER, by the Exchange or pricing offered by to remove liquidity in securities priced and 5 represents an equitable allocation the Exchange’s competitors. at or above $1.00, which BATS Trading of reasonable dues, fees, and other Additionally, Members may opt to passed through to the Exchange and the charges as it is designed to discourage disfavor the Exchange’s pricing if they Exchange provided its Members. When Members from inadvertently matching believe that alternatives offer them BATS Trading routes to BYX, it will with one another and potential wash now be provided a rebate of $0.00150 better value. Accordingly, the Exchange sales. The revised fee also allows the per share. The Exchange does not levy does not believe that the proposed Exchange to offset its administrative, additional fees or offer additional change will impair the ability of clearing, and other operating costs rebates for orders that it routes to BYX Members or competing venues to through BATS Trading. Therefore, the incurred in executing such trades. maintain their competitive standing in Exchange believes that the proposed Finally, the fee is equitable and the financial markets. reasonable because it total transaction change to fee code BY is equitable and Fee Code BY reasonable because it accounts for the cost of for both sides of an execution for pricing changes on BYX, which enables customer internalization will continue The Exchange believes that its the Exchange to provide its Members to be equal to the maker/taker spread of proposal to pass through the amended the applicable pass-through rebate. $0.0009 for the standard add and rebate for orders that yield fee code BY Lastly, the Exchange notes that routing removal rates discussed above.20 The would increase intermarket competition through BATS Trading is voluntary and Exchange believes that the proposed because it offers customers an believes that the proposed change is alternative means to route to BYX for non-discriminatory because it applies 19 See Nasdaq, Price List—Trading & the same rebate that they would be uniformly to all Members. Connectivity, available at http:// provided if they entered orders on that www.nasdaqtrader.com/ trading center directly. The Exchange Standard Removal Rate Change Trader.aspx?id=PriceListTrading2. See also the NYSE Arca Schedule of Fees and Charges for believes that its proposal would not The Exchange believes that its Exchange Services, dated April 20, 2015 available burden intramarket competition because proposal to lower the standard removal at https://www.nyse.com/publicdocs/nyse/markets/ the proposed rebate would apply rate from $0.0030 per share to $0.0029 nyse-arca/NYSE_Arca_Marketplace_Fees.pdf. uniformly to all Members. per share, as well as related changes 20 In each case, the internalization fee is no more favorable to the Member than each prevailing Standard Removal Rate Change maker/taker spread. The Exchange will continue to 17 15 U.S.C. 78f. ensure that the internalization fee is no more The Exchange believes that its 18 15 U.S.C. 78f(b)(4). favorable than each prevailing maker/taker spread. proposal to lower the standard removal

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rate from $0.0030 per share to $0.0029 Electronic Comments SECURITIES AND EXCHANGE per share will also assist in increasing • COMMISSION competition in that its proposed rebate Use the Commission’s Internet comment form (http://www.sec.gov/ [Release No. 34–74949; File No. SR–EDGX– is lower than the standard fees for 2015–18] removing liquidity offered by Nasdaq rules/sro.shtml); or (removal rate of $0.0030 per share) and • Send an email to rule-comments@ Self-Regulatory Organizations; EDGX NYSE Arca (removal rate of $0.0030 per sec.gov. Please include File Number SR– Exchange, Inc.; Notice of Filing of share for Tape A and Tape C EDGX–2015–22 on the subject line. Proposed Rule Change To Establish securities).21 Rules Governing the Trading of The Exchange believes that its Paper Comments Options on the EDGX Options internalization rates for securities priced • Send paper comments in triplicate Exchange $1.00 and above will also not burden to Brent J. Fields, Secretary, Securities May 13, 2015. intermarket or intramarket competition and Exchange Commission, 100 F Street as the proposed rates are no more Pursuant to Section 19(b)(1) of the NE., Washington, DC 20549–1090. favorable than Members achieving the Securities Exchange Act of 1934 1 2 maker/taker spreads between the All submissions should refer to File (‘‘Act’’), and Rule 19b–4 thereunder, standard add and remove rates on the Number SR–EDGX–2015–22. This file notice is hereby given that, on April 30, Exchange. number should be included on the 2015, EDGX Exchange, Inc. (the ‘‘Exchange’’ or ‘‘EDGX’’) filed with the subject line if email is used. To help the Non-Substantive Changes Securities and Exchange Commission Commission process and review your (‘‘SEC’’ or ‘‘Commission’’) the proposed The Exchange believes that the comments more efficiently, please use proposed non-substantive clarifying rule change as described in Items I, II, only one method. The Commission will and III below, which Items have been changes to the Fee Schedule will not post all comments on the Commission’s affect intermarket nor intramarket prepared by the Exchange. The Internet Web site (http://www.sec.gov/ Commission is publishing this notice to competition because these changes are rules/sro.shtml). Copies of the not designed to amend any fee or alter solicit comments on the proposed rule submission, all subsequent change from interested persons. the manner in which the Exchange amendments, all written statements assesses fees or calculates rebates. with respect to the proposed rule I. Self-Regulatory Organization’s (C) Self-Regulatory Organization’s change that are filed with the Statement of the Terms of Substance of Statement on Comments on the Commission, and all written the Proposed Rule Change Proposed Rule Change Received From communications relating to the The Exchange filed a proposal to Members, Participants or Others proposed rule change between the adopt rules to govern the trading of options on the Exchange (referred to The Exchange has not solicited, and Commission and any person, other than those that may be withheld from the herein as ‘‘EDGX Options Exchange’’ or does not intend to solicit, comments on ‘‘EDGX Options’’). As described more this proposed rule change. The public in accordance with the provisions of 5 U.S.C. 552, will be fully below, the EDGX Options Exchange has not received any Exchange will operate a fully unsolicited written comments from available for Web site viewing and printing in the Commission’s Public automated, Customer priority/pro rata Members or other interested parties. allocation model. The fundamental Reference Room, 100 F Street NE., premise of the proposal is that the III. Date of Effectiveness of the Washington, DC 20549, on official Exchange will operate its options Proposed Rule Change and Timing for business days between the hours of Commission Action market in a similar manner to the 10:00 a.m. and 3:00 p.m. Copies of the options exchange operated by the The foregoing rule change has become filing will also be available for Exchange’s affiliate, BATS Exchange, effective pursuant to Section 19(b)(3)(A) inspection and copying at the principal Inc. (‘‘BZX Options’’), with the 22 of the Act and paragraph (f) of Rule office of the Exchange. All comments exception of the proposed priority 23 19b–4 thereunder. At any time within received will be posted without change; model and certain other limited 60 days of the filing of the proposed rule the Commission does not edit personal differences. change, the Commission summarily may identifying information from The text of the proposed rule change temporarily suspend such rule change if submissions. You should submit only is available at the Exchange’s Web site it appears to the Commission that such information that you wish to make at www.batstrading.com, at the action is necessary or appropriate in the available publicly. All submissions principal office of the Exchange, and at public interest, for the protection of should refer to File Number SR–EDGX– the Commission’s Public Reference investors, or otherwise in furtherance of 2015–22 and should be submitted on or Room. the purposes of the Act. before June 9, 2015. II. Self-Regulatory Organization’s IV. Solicitation of Comments For the Commission, by the Division of Statement of the Purpose of, and Interested persons are invited to Trading and Markets, pursuant to delegated Statutory Basis for, the Proposed Rule submit written data, views, and authority.24 Change arguments concerning the foregoing, Robert W. Errett, In its filing with the Commission, the including whether the proposed rule Deputy Secretary. Exchange included statements change is consistent with the Act. [FR Doc. 2015–12027 Filed 5–18–15; 8:45 am] concerning the purpose of and basis for Comments may be submitted by any of BILLING CODE 8011–01–P the proposed rule change and discussed the following methods: any comments it received on the proposed rule change. The text of these 21 See supra note 19. 22 15 U.S.C. 78s(b)(3)(A). 1 15 U.S.C. 78s(b)(1). 23 17 CFR 240.19b–4(f). 24 17 CFR 200.30–3(a)(12). 2 17 CFR 240.19b–4.

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statements may be examined at the preference; the financial resources 90% of the time the Market Maker is places specified in Item IV below. The available to the Market Maker; the required to provide quotes in an Exchange has prepared summaries, set Market Maker’s experience, expertise appointed options series on a given forth in Sections A, B, and C below, of and past performance in making trading day, or such higher percentage the most significant parts of such markets, including the Market Maker’s as the Exchange may announce in statements. performance in other securities; the advance. Substantial or continued Market Makers [sic] operational failure by an Options Market Maker to A. Self-Regulatory Organization’s capability; and the maintenance and meet any of its obligations and duties, Statement of the Purpose of, and enhancement of competition among will subject the Options Market Maker Statutory Basis for, the Proposed Rule Market Makers in each security in to disciplinary action, suspension, or Change which they are registered, including revocation of the Options Market 1. Purpose pursuant to the performance standards Maker’s registration in one or more 3 The Exchange is proposing to adopt a set forth in proposed Rule 22.2(i). options series. series of rules in connection with EDGX An unlimited number of Market Options Market Makers receive Options, which will be a facility of the Makers may be registered in each class certain benefits for carrying out their Exchange. EDGX Options will operate unless the number of Market Makers duties. For example, a Market Maker an electronic trading system developed registered to make a market in a may be designated by the Exchange as to trade options (‘‘System’’) that will particular option class should be limited a Primary Market Maker or may have provide for the electronic display and whenever, in the Exchange’s judgment, orders directed to it in its capacity as a execution of orders, as described below. quotation system capacity in an option Directed Market Maker, in each case All Exchange Members will be eligible class or classes is not sufficient to receiving a priority advantage over other to participate in EDGX Options support additional Market Makers in non-Customer orders to the extent provided that the Exchange specifically such class or classes. The Exchange will applicable priority overlays have been authorizes them to trade in the System. not restrict access in any particular implemented, as described below. In The System will provide a routing option class until such time as the addition, a lender may extend credit to service for orders when trading interest Exchange has submitted objective a broker-dealer without regard to the is not present on EDGX Options, and standards for restricting access to the restrictions in Regulation T of the Board will comply with the obligations of the SEC for its review and approval. of Governors of the Federal Reserve EDGX Options Market Makers will be Options Order Protection and Locked/ System if the credit is to be used to required to electronically engage in a Crossed Market Plan. finance the broker-dealer’s activities as course of dealing to enhance liquidity a specialist or market maker on a EDGX Options Members available on EDGX Options and to assist national securities exchange. Thus, an The Exchange will authorize any in the maintenance of fair and orderly Options Market Maker has a Exchange Member who meets certain markets. Among other things, an corresponding obligation to hold itself enumerated qualification requirements Options Market Maker would have to out as willing to buy and sell options for to obtain access to EDGX Options (any satisfy the following responsibilities and its own account on a regular or such Member, an ‘‘Options Member’’). duties during trading: (1) On a daily continuous basis to justify this favorable There will be two basic types of basis maintain a two-sided market on a treatment. The Exchange believes that Options Members, Options Order Entry continuous basis in at least 75% of the the proposed 90% continuous quoting Firms (‘‘OEFs’’) and Options Market individual options series in which it is requirement for all Market Makers is Makers. Options Market Makers, in turn, registered; (2) engage, to a reasonable consistent with that typically required will be eligible to participate as Directed degree under the existing of Primary Market Makers and market Market Makers, Primary Market Makers circumstances, in dealings for their own makers of similar status. and Market Makers. OEFs will be those accounts when there exists, or it is Every Options Member shall at all Options Members representing orders as reasonably anticipated that there will times maintain membership in another agent on EDGX Options and non-market exist, a lack of price continuity, a registered options exchange that is not maker participants conducting temporary disparity between the supply registered solely under Section 6(g) of proprietary trading as principal. Options of (or demand for) a particular option the Securities Exchange Act of 1934 or Market Makers are Options Members contract, or a temporary distortion of the in FINRA. OEF’s that transact business registered with the Exchange as Options price relationships between option with customers must at all times be Market Makers. contracts of the same class; (3) compete members of FINRA. Pursuant to To become an Options Market Maker, with other Market Makers in all series proposed EDGX Rule 17.2(g), every an Options Member is required to in which the Market Maker is registered Options Member will be required to register by filing a written application to trade; and (4) maintain minimum net have at least one registered Options with the Exchange, and then must capital in accordance with Commission Principal who satisfies the criteria of register to make markets in individual and the Exchange rules. The Exchange that Rule, including the satisfaction of a series of options. Pursuant to proposed proposes to specify numerically the proper qualification examination. An Rule 22.2, the Exchange may appoint meaning of ‘‘continuous’’ with respect OEF may only transact business with one Primary Market Maker per option to Market Makers’ obligation to Public Customers if such Options class. Market Makers may select from maintain continuous, two-sided quotes. Member also is an Options Member of among any option issues traded on the For the purposes of Rule 22.6, the another registered national securities Exchange to request appointment as a Exchange will consider the continuous exchange or association with which the Primary Market Maker, subject to the quoting requirement fulfilled if a Market Exchange has entered into an agreement approval of the Exchange. In Maker provides two-sided quotes for under Rule 17d-2 under the Exchange considering the approval of the Act pursuant to which such other 3 The Exchange notes that proposed Rule 22.2 is exchange or association shall be the appointment of a Primary Market Maker based in part on BZX Options Rule 22.2 (paragraphs in each security, the Exchange will (a) and (b)) and in part on Amex Rule 923NY designated options examining authority consider: the Market Maker’s (paragraphs (c) through (i)). for the OEF.

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As provided in EDGX Rule 16.2, $3.00 or higher, ten (10) cents; and (3) the previous six months. The existing Exchange Rules applicable to if the options series is trading pursuant replacement issues, as applicable, the EDGX equity market contained in to the Penny Pilot program one (1) cent would be added to the Penny Pilot Chapters I through XV of the Exchange if the options series is trading at less Program on the second trading day Rules will apply to Options Members than $3.00, five (5) cents if the options following January 1 and July 1 of each unless a specific Exchange Rule series is trading at $3.00 or higher, year. The Exchange will employ the applicable to the options market except for QQQQ, SPY, or IWM where same parameters to prospective (Chapters XVI through XXIX of the the minimum quoting increment will be replacement issues as approved and Exchange Rules) governs or unless the one cent for all series. In addition, the applicable under the Penny Pilot context otherwise requires. Options Exchange is proposing that the Program, including excluding high- Members can therefore provide minimum trading increment for options priced underlying securities. The sponsored access to the EDGX Options contracts traded on EDGX Options will replacement issues will be announced Exchange to a nonmember (‘‘Sponsored be one (1) cent for all series. The in Information Circulars distributed to Participant’’) pursuant to Rule 11.3 of Exchange also proposes to offer trading Members. the Exchange Rules. of Mini Options, and that the minimum Order Types. The proposed System trading increment for Mini Options Execution System will make available to Options Members shall be the same as the minimum the following order types: Limit Orders, The Exchange’s options trading trading increment permitted for Minimum Quantity Orders, Market system will leverage the Exchange’s standard options on the same Orders, Price Improving Orders, Book current state of the art technology, underlying security. Only Orders, Post Only Orders, and including its customer connectivity, Penny Pilot Program. Upon initial Intermarket Sweep Orders, with messaging protocols, quotation and operation of EDGX Options the characteristics and functionality similar execution engine, order router, data Exchange proposes to commence to what is currently approved for use on feeds, and network infrastructure. This trading, pursuant to the Penny Pilot BZX Options. Each of the proposed approach minimizes the technical effort Program (the ‘‘Penny Pilot’’), all classes rules regarding the order types and required for existing Exchange Members that are, on that date, traded by other order type modifiers described below is to begin trading options on the EDGX options exchanges pursuant to the substantively identical to the applicable Options Exchange. The EDGX Options Penny Pilot, which is currently rule for a corresponding order type or Exchange will closely resemble the scheduled to expire on June 30, 2015, order type modifier offered by BZX Exchange’s affiliate, BZX Options, but unless extended. Options with the exception of the Post will differ in that EDGX Options will The Exchange represents that it has Only Order, to which the Exchange has maintain a pro rata allocation model the necessary system capacity to proposed some substantive with execution priority dependent on support any additional series listed as modification. The Exchange has also the capacity of an order (e.g., Customer part of the Penny Pilot. proposed minor corrections and or non-Customer) as well as status as a The Exchange agrees to submit semi- improvements to the descriptions of the Primary Market Maker or Directed annual reports to the Commission that IOC and FOK time-in-force and Price Market Maker, as applicable. The will include sample data and written Improving Orders, as compared to the proposed model for EDGX Options is analysis of information collected from corresponding BZX Options Rules. The similar to other options exchanges such April 1 through September 30, and from Exchange notes that it has not proposed as NYSE Amex Options (‘‘Amex’’), the October 1 through March 31, for each initially to adopt all of the order types MIAX Options Exchange (‘‘MIAX’’), and year, for the ten most active and twenty and order type modifiers currently other exchanges, which are sometimes least active option classes added to the offered by BZX Options.4 The Exchange referred to as ‘‘classic’’ exchanges. Penny Pilot. In addition, for comparison Like the Exchange system for equities, purposes, the reports include data from has not proposed to adopt any new all trading interest entered into the a control group consisting of the ten order types or order type modifiers that System will be automatically least active option classes from the are not currently offered by BZX executable. Orders entered into the initial group of 63 option classes in the Options. ‘‘Limit Orders’’ are orders to buy or System will be displayed either with program. This report will include, but is sell an option at a specified price or attribution or anonymously. The not limited to: (1) Data and written better. A limit order is marketable when, Exchange will become an exchange analysis on the number of quotations for a limit order to buy, at the time it member of the Options Clearing generated for options included in the is entered into the System, the order is Corporation (‘‘OCC’’). The System will report; (2) an assessment of the priced at the current inside offer or be linked to OCC for the Exchange to quotation spreads for the options higher, or for a limit order to sell, at the transmit locked-in trades for clearance included in the report; (3) an assessment time it is entered into the System, the and settlement. of the impact of the Penny Pilot on the Hours of Operation. The Exchange capacity of the Exchange’s automated order is priced at the inside bid or will begin accepting orders at 8:00 a.m. systems; (4) data reflecting the size and lower. Eastern Time, as described below. The depth of markets; and (5) any capacity ‘‘Minimum Quantity Orders’’ are options trading system will operate problems or other problems that arose orders that require that a specified between the hours of 9:30 a.m. Eastern related to the operation of the Penny minimum quantity of contracts be Time and 4:00 p.m. Eastern Time, with Pilot and how the Exchange addressed obtained, or the order is cancelled. all orders being available for execution them. Minimum Quantity Orders will only during that timeframe. Additionally, the Exchange proposes execute against multiple, aggregated Minimum Quotation and Trading that any Penny Pilot issues that have orders if such execution would occur Increments. The Exchange is proposing been delisted may be replaced on a simultaneously. The Exchange will only to apply the following quotation semi-annual basis by the next most 4 The Exchange has not proposed to adopt stop increments: (1) If the options series is actively traded multiply listed options orders or stop limit orders, reserve orders, partial trading at less than $3.00, five (5) cents; classes that are not yet included in the post only at limit orders or the WAIT time-in-force, (2) if the options series is trading at Penny Pilot, based on trading activity in each of which is offered by BZX Options.

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honor a specified minimum quantity on Post Only Order that is not subject to ‘‘Fill-or-Kill’’ or ‘‘FOK’’ shall mean, a Book Only Order entered with a time- the Price Adjust process, as described for an order so designated, a limit order in-force designation of Immediate or below, that would lock or cross a that is to be executed in its entirety as Cancel and will disregard a minimum Protected Quotation of another options soon as it is received and, if not so quantity on any other order. exchange or the Exchange will be executed, cancelled. A limit order ‘‘Market Orders’’ are orders to buy or cancelled. The Exchange notes that Post designated as FOK is not eligible for sell at the best price available at the time Only Orders on BZX Options are routing away pursuant to Rule 21.9. of execution. Market Orders to buy or permitted to remove liquidity under One Second Exposure Period. sell an option traded on EDGX Options certain circumstances and can be Proposed Rule 22.12 would prohibit will be rejected if they are received designated for the display-price sliding Options Members from executing as when the underlying security is subject process under BZX Options Rules. The principal on EDGX Options orders they to a ‘‘Limit State’’ or ‘‘Straddle State’’ as Exchange has not proposed to adopt represent as agent unless (i) agency defined in the Plan to Address these features. orders are first exposed on EDGX Extraordinary Market Volatility ‘‘Intermarket Sweep Orders’’ or Options for at least one (1) second or (ii) Pursuant to Rule 608 of Regulation NMS ‘‘ISOs’’ are orders that shall have the the Options Member has been bidding under the Act (the ‘‘Limit Up-Limit meaning provided in proposed Rule or offering on EDGX Options for at least Down Plan’’).5 Any portion of a Market 27.1, which relates to intermarket one (1) second prior to receiving an Order that would execute at a price trading. Such orders may be executed at agency order that is executable against more than $0.50 or 5 percent worse than one or multiple price levels in the such bid or offer. As noted above, the national best bid and offer System without regard to Protected proposed Rule 22.12 would require (‘‘NBBO’’) at the time the order initially Quotations at other options exchanges Options Members to expose their reaches EDGX Options, whichever is (i.e., may trade through such customers’ orders on the Exchange for at greater, will be cancelled. quotations). The Exchange relies on the least one second under certain ‘‘Price Improving Orders’’ are orders marking of an order by a User as an ISO circumstances. During this one second to buy or sell an option at a specified order when handling such order, and exposure period, other Options price at an increment smaller than the thus, it is the entering Options Members will be able to enter orders to minimum price variation in the Member’s responsibility, not the trade against the exposed order. In security. Price Improving Orders may be Exchange’s responsibility, to comply adopting a one-second order exposure entered in increments as small as (1) with the requirements relating to ISOs. period, the Exchange is proposing a one cent. Price Improving Orders shall ISOs are not eligible for routing requirement that is consistent with the be displayed at the minimum price pursuant to Rule 21.9. Rules of other options exchanges, variation in that security and shall be Time in Force Designations. Options including BZX Options.7 Thus, the rounded up for sell orders and rounded Members entering orders into the exposure period will allow Options 6 down for buy orders. Unless a User has System may designate such orders to Members that are members of other entered instructions not to do so, Price remain in force and available for display options exchanges to comply with Rule Improving Orders will be subject to the and/or potential execution for varying 22.12 without programming separate ‘‘display-price sliding process,’’ as periods of time. Unless cancelled time parameters into their systems for described below. The display-price earlier, once these time periods expire, order entry or compliance purposes. sliding process is contained in proposed the order (or the unexecuted portion The Exchange believes that market thereof) is returned to the entering Rule 21.1(h). participants are sufficiently automated ‘‘Book Only Orders’’ are orders that party. that a one second exposure period are to be ranked and executed on the ‘‘Good Til Day’’ or ‘‘GTD’’ shall mean, allows an adequate time for market Exchange pursuant to Rule 21.8 (Order for orders so designated, that if after participants to electronically respond to Display and Book Processing) or entry into the System, the order is not an order. Also, it is possible that market cancelled, as appropriate, without fully executed, the order (or the participants might wait until the end of routing away to another options unexecuted portion thereof) shall the exposure period, no matter how exchange. A Book Only Order will be remain available for potential display long, before responding. Thus, the subject to the display-price sliding and/or execution for the amount of time Exchange believes that any longer than process unless a User has entered during such trading day specified by the one second would not further the instructions not to use the display-price entering User unless canceled by the protection of investors or market sliding process. entering party. ‘‘Post Only Orders’’ are orders that are ‘‘Immediate Or Cancel’’ or ‘‘IOC’’ participants, but rather, would to be ranked and executed on the shall mean, for an order so designated, potentially increase market risk to Exchange pursuant to proposed Rule a limit order that is to be executed in investors and other market participants 21.8 or cancelled, as appropriate, whole or in part as soon as such order by creating a longer period of time for without routing away to another options is received. The portion not so executed the exposed order to be subject to exchange except that the order will not immediately on the Exchange or another market risk. The technology for the Exchange’s remove liquidity from the EDGX options exchange is cancelled and is not trading system for EDGX Options will Options Book. A Post Only Order posted to the EDGX Options Book. IOC be comparable to the technology used cannot be designated with instructions limit orders that are not designated as for the trading system currently used for to use the display-price sliding process, Book Only Orders and that cannot be equities trading on the Exchange today. and any such order will be rejected. A executed in accordance with Rule 21.8 on the System when reaching the The Exchange has had ample experience with that trading system to believe that 5 Securities Exchange Act Release No. 67091 (May Exchange will be eligible for routing 31, 2012), 77 FR 33498 (June 6, 2012) (order away pursuant to Rule 21.9. one second is an adequate exposure approving the Plan on a pilot basis). ‘‘DAY’’ shall mean, for an order so 6 As proposed in Rule 16.1(a)(63), the term 7 See, e.g., Chicago Board Options Exchange ‘‘User’’ means any Options Member or Sponsored designated, a limit order to buy or sell (‘‘CBOE’’) Rules 6.45A, 6.45B, 6.74A and 6.74B; Participant who is authorized to obtain access to the which, if not executed expires at market International Securities Exchange (‘‘ISE’’) Rule System pursuant to Rule 11.3 (Access). close. 717(d); NOM Chapter VII, Sec. 12.

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period. Further, the Exchange believes process (the ‘‘Opening Process’’) technology and functionality currently that many of its current Members will beginning at 8:00 a.m. Eastern Time or approved for use in the Exchange’s be Options Members and that such immediately upon trading being halted equities trading system and the current Members have demonstrated an in an option series due to the primary Exchange’s affiliate, BZX Options. ability to respond to orders in a timely listing market for the applicable Specifically, the System will allow fashion. underlying security declaring a Options Members to enter market orders Match Trade Prevention Modifiers. As regulatory trading halt, suspension, or and priced limit orders to buy and sell is true for BZX Options, the Exchange pause with respect to such security (a options listed on EDGX Options. The will allow Options Members to use ‘‘Regulatory Halt’’) and will continue to orders will be designated for display Match Trade Prevention (‘‘MTP’’) accept market and limit orders and (price and size) in the order display Modifiers. Any incoming order quotes until such time as the Opening service of the System. designated with an MTP modifier will Process is initiated in that option series Book Processing/Priority. After the be prevented from executing against a (the ‘‘Order Entry Period’’), other than opening, trades on the Exchange will resting opposite side order also index options. The Exchange will not occur when a buy order/quote and a sell designated with an MTP modifier and accept IOC or FOK orders for queuing order/quote match on the Exchange’s originating from the same market prior to the completion of the Opening order book. The System shall execute participant identifier (‘‘MPID’’), Process. The Exchange will convert all trading interest within the System in Exchange Member identifier, trading ISOs entered for queuing prior to the price priority, meaning it will execute group identifier, or Exchange Sponsored completion of the Opening Process into all trading interest at the best price level Participant identifier. non-ISOs. within the System before executing Re-Pricing Mechanisms. The After the first transaction on the trading interest at the next best price. Exchange, like BZX Options, proposes primary listing market after 9:30 a.m. Pursuant to proposed Rule 21.8(c), after to offer two re-pricing mechanisms for Eastern Time in the securities considering price priority, all orders are Users of EDGX Options, the display- underlying the options as reported on matched according to pro-rata priority. price sliding process and the Price the first print disseminated pursuant to In addition, Customer, Primary Market Adjust process. In turn, under each type an effective national market system plan Maker and/or Directed Market Maker of price sliding, Users will be able to (‘‘First Listing Market Transaction’’) or priority overlays are also available at the select between either single price the Regulatory Halt has been lifted, the Exchange’s discretion on a class-by- sliding or multiple price sliding. The related option series will be opened class basis pursuant to proposed Rule Exchange will offer display-price sliding automatically as described below. The 21.8(d). For example, (i) the Customer (including multiple display-price System will determine a single price at Overlay provides Customers with sliding) and Price Adjust (including which a particular option series will be priority over all non-Customer interest multiple Price Adjust) to ensure opened (the ‘‘Opening Price’’) as at the same price; (ii) the Directed compliance with locked and crossed calculated by the System within 30 Market Maker overlay (which may only market rules relevant to participation on seconds of the First Listing Market be in effect if the Customer Overlay is EDGX Options. The proposed display- Transaction or the Regulatory Halt being also in effect) provides the Directed price sliding functionality for EDGX lifted. Where there are no contracts in Market Maker with priority over other Options is identical to functionality for a particular series that would execute at Market Makers for a certain percentage BZX Options, with the exception of any price, the System shall open such of contracts allocated at the same price language related to Post Only Order options for trading without determining (60% or 40% depending upon the functionality, which is not applicable. an Opening Price. After establishing an number of other Market Makers at the Specifically, as noted above, the Opening Price that is also a Valid Price,8 NBBO) and for small size orders; and Exchange omitted language regarding orders and quotes in the System that are (iii) the Primary Market Maker overlay Post Only Orders contained in the BZX priced equal to or more aggressively (which may only be in effect if the Options description of display-price than the Opening Price will be matched Customer Overlay is also in effect) sliding because the Exchange has based on the Exchange’s proposed provides Primary Market Makers with proposed to reject orders that are priority rule, Rule 21.8. Matches will priority over other Market Makers for a designated as Post Only Orders and occur until there is no remaining certain percentage of contracts allocated subject to display-price sliding. volume or there is an imbalance of at the same price (60% or 40% Similarly, because the Exchange has not orders. All orders and quotes or portions depending upon the number of other proposed to adopt functionality that thereof that are matched pursuant to the Market Makers at the NBBO) and for results in executions of Post Only Opening Process will be executed at the small size orders. Orders against resting liquidity under Opening Price. An imbalance of orders After executions resulting from the certain circumstances, the Exchange has on the buy side or sell side may result Priority Overlays described above, omitted from the Exchange’s proposed in orders that are not executed in whole Orders and Quotes within the System Price Adjust rule certain language or in part. Such orders will be handled for the accounts of non-Customers, contained in the corresponding BZX in time sequence, beginning with the including Professional Customers, have Options rule regarding such order with the oldest time stamp and next priority. If there is more than one circumstances. may, in whole or in part, be placed on highest bid or more than one lowest Market Opening Procedures. The the EDGX Options Book, cancelled, offer in the Consolidated Book for the System shall open options, other than executed, or routed in accordance with account of a non-Customer, then such index options, for trading after 9:30 a.m. proposed Rule 21.9. bids or offers will be afforded priority Eastern Time as described below. With Order Display/Matching System. on a ‘‘size pro rata’’ basis. respect to index options, the System Other than the differences with respect In allocating the participation shall open such options for trading at to the market model described below, entitlements set forth in proposed Rule 9:30 a.m. Eastern Time. the System will be based upon 21.8 to the Directed Market Maker and As proposed, the Exchange will the Primary Market Maker, the accept market and limit orders and 8 Valid Price is defined in proposed Rule following shall apply. In a class of quotes for inclusion in the opening 21.7(a)(2). options where both the Primary Market

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Maker and the Directed Market Maker existing interest at the execution price. affiliated with the Exchange (‘‘Routing participation entitlements are in effect Moreover, no market participant can Services’’). and an Options Member has directed an execute a greater number of contracts EDGX Options will offer a variety of order to a Directed Market Maker: (a) if than is associated with its interest at a routing options that will be identical to the Directed Market Maker’s priority given price. Accordingly, the Primary the routing options offered by BZX quote is at the NBBO, the Directed Market Maker and the Directed Market Options. Routing options may be Market Maker’s participation Maker participation entitlements combined with all available order types entitlement will supersede the Primary contained in the proposed Rule are not and times-in-force, with the exception Market Maker’s participation guarantees. of order types and times-in-force whose entitlements for an order directed to The Exchange believes that proposed terms are inconsistent with the terms of such Directed Market Maker; (b) if the Rule 21.8 governing priority on the a particular routing option. The System Directed Market Maker’s priority quote Exchange is consistent with other will consider the quotations only of is not at the NBBO, the Primary Market options exchanges that have similar accessible markets. The term ‘‘System Maker’s participation entitlement will market models, including Amex and routing table’’ refers to the proprietary apply to that order, provided the MIAX.9 process for determining the specific Primary Market Maker’s priority quote Routing. The EDGX Options Exchange options exchanges to which the System is at the NBBO: and (c) if neither the will support orders that are designated routes orders and the order in which it Directed Market Maker’s nor the to be routed to the NBBO as well as routes them. The Exchange reserves the Primary Market Maker’s priority quote orders that will execute only within right to maintain a different System is at the NBBO then executed contracts EDGX Options. Orders that are routing table for different routing will be allocated in accordance with the designated to execute at the NBBO will options and to modify the System pro-rata allocation methodology as be routed to other options markets to be routing table at any time without notice. described in paragraphs (c) and (e) executed when the Exchange is not at The proposed System routing options above without regard to any the NBBO consistent with the Options are Parallel D, Parallel 2D, Destination participation entitlement. If an Order Protection and Locked/Crossed Specific and Directed ISO. The incoming order has not been directed to Market Plan. Subject to the exceptions Exchange notes that Destination a Directed Market Maker by an Options contained in proposed Rule 27.2(b), the Specific and Directed ISO are both Member, however, then the Primary System will ensure that an order will offered by BZX Options but that such Market Maker’s participation not be executed at a price that trades options are currently listed in both the entitlement will apply to that order, through another options exchange. An routing section and the order provided the Primary Market Maker’s order that is designated by an Options description section. The Exchange priority quote is at the NBBO. Member as routable will be routed in believes that these options are more As proposed and as noted above, the compliance with applicable Trade- appropriately listed as routing participation entitlements of proposed Through restrictions. Any order entered strategies, and thus has proposed to Rule 21.8 shall not be in effect unless with a price that would lock or cross a include them in Rule 21.9. the Customer Overlay is also in effect Protected Quotation that is not eligible The Exchange also proposes to offer and the participation entitlements shall for either routing, or the display-price two optional Re-Route instructions, only apply to any remaining balance sliding process or the Price Adjust Aggressive Re-Route and Super after Customer orders have been process will be cancelled. Aggressive Re-Route, either of which satisfied. EDGX Options shall route orders in can be assigned to routable orders. Neither the Primary Market Maker nor options via BATS Trading, Inc. (‘‘BATS Pursuant to the Aggressive Re-Route the Directed Market Maker may be Trading’’), which serves as the instruction, to the extent the unfilled allocated a total quantity greater than Outbound Router of the Exchange, as balance of a routable order has been the quantity they are quoting at the defined in current Rule 2.11. The posted to the EDGX Options Book, execution price. If the Primary Market function of the Outbound Router will be should the order subsequently be Maker’s or the Directed Market Maker’s to route orders in options listed and crossed by another accessible options allocation of an order pursuant to its open for trading on EDGX Options to exchange, the System shall route the participation entitlement is greater than other options exchanges pursuant to order to the crossing options exchange. its pro-rata share of priority quotes at EDGX Options rules solely on behalf of Pursuant to the Super Aggressive Re- the best price at the time that the EDGX Options. The Outbound Router is Route instruction, to the extent the participation entitlement is granted, subject to regulation as a facility of the unfilled balance of a routable order has neither the Primary Market Maker nor Exchange, including the requirement to been posted to the EDGX Options Book, the Directed Market Maker shall receive file proposed rule changes under should the order subsequently be locked any further allocation of that order. Section 19 of the Act. Use of BATS or crossed by another accessible options In establishing the counterparties to a Trading or Routing Services (as exchange, the System shall route the particular trade, the participation described below) to route orders to other order to the locking or crossing options entitlements must first be counted market centers is optional. Parties that Exchange. against the Primary Market Maker’s do not desire to use BATS Trading or Data Feed; Anonymity. The System highest priority bids and offers or the other Routing Services provided by the will include a proprietary data feed, Directed Market Maker’s highest priority Exchange must designate orders as not Multicast PITCH, which will display bids or offers. available for routing. depth of book quotations and execution The proposed participation In the event the Exchange is not able information based on orders received by entitlements only apply to the allocation to provide order routing services EDGX Options using the minimum price of executions among competing Market through its affiliated broker-dealer, the variation applicable to that security. The Maker priority quotes existing on the Exchange will route orders to other Exchange will make available to all EDGX Options Book at the time the options exchanges in conjunction with market participants through the Options order is received by the Exchange. No one or more routing brokers that are not Price Reporting Authority (‘‘OPRA’’) an market participant is allocated any indication that there is Customer portion of an execution unless it has an 9 See, e.g., Amex Rule 964NY; MIAX Rule 514. interest included in the best bid and

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offer disseminated by the Exchange. The the Risk Monitor Mechanism should equipment; (2) the locking or crossing Exchange will also identify Customer help liquidity providers generally, quotation was displayed at a time when orders and trades as such on messages market makers and other participants there is a Crossed Market; or (3) the disseminated by the Exchange through alike, in managing risk and providing Member simultaneously routed an ISO its Multicast PITCH data feed. To the deep and liquid markets to investors. to execute against the full displayed size extent a User has submitted an of any locked or crossed Protected Bid Options Order Protection and Locked/ Attributable Order, which is the default or Protected Offer. Crossed Market Plan Rules property for all orders entered into the Securities Traded on EDGX Options System, the Multicast PITCH data feed The Exchange will participate in the will indicate the User’s MPID along approved Options Order Protection and General Listing Standards. The with the price and size of their order or Locked/Crossed Market Plan (‘‘Plan’’), Exchange proposes to adopt listing quote. and therefore will be required to comply standards for Options traded on EDGX The intra-day transaction reports with the obligations of Participants Options (Chapter XIX) as well as for produced by the System will indicate under the Plan. The Exchange proposes Index Options (Chapter XXIX) that are the details of the transactions, and will to adopt rules relating to the Plan that identical to the approved rules of BZX not reveal contra party identities. are substantially similar to the rules in Options.10 The Exchange will join the However, the Exchange does anticipate place on all of the options exchanges Options Listings Procedures Plan and generating daily, weekly and/or that are Participants to the Plan. will list and trade options already listed monthly reports containing aggregate The Plan replaced the Plan for the on other options exchanges. The information regarding Market Maker Purpose of Creating and Operating an Exchange will gradually phase-in its and Customer executions, and thus, has Intermarket Option Linkage (‘‘Old trading of options, beginning with a proposed to make clear in Rule 21.10 Plan’’). The Old Plan required its selection of actively traded options. At that such identifying information will participant exchanges to operate a least initially, the Exchange does not be made available. The Exchange stand-alone system or ‘‘Linkage’’ for plan to develop new options products or believes that this practice is common on sending order-flow between exchanges listing standards. other options exchanges that operate to limit trade-throughs, and the Linkage $1 Strike Program. Pursuant to market models similar to that proposed was operated by the Options Clearing proposed Rule 19.6, Supplementary by the Exchange. Corporation (‘‘OCC’’). The Plan Material .02, the interval between strike Risk Monitor Mechanism. The essentially applies the Regulation NMS prices of series of options on individual Exchange also proposes to offer to all price-protection provisions to the stocks may be $1.00 or greater (‘‘$1 Users of EDGX Options the ability to options markets. Similar to Regulation Strike Prices’’) provided the strike price establish certain risk control parameters NMS, the Plan requires the Plan is $50 or less, but not less than $1. The via the Exchange’s Risk Monitor Participants to adopt rules ‘‘reasonably listing of $1 strike prices shall be Mechanism. The proposed Risk Monitor designed to prevent Trade-Throughs,’’ limited to option classes overlying no Mechanism is identical to that offered while exempting Intermarket Sweep more than one hundred fifty (150) by BZX Options pursuant to Rule 21.16. Orders (‘‘ISOs’’) from that prohibition. individual stocks (the ‘‘$1 Strike Price The Risk Monitor Mechanism provides The Plan’s definition of an ISO is Program’’) as specifically designated by protection from the risk of multiple essentially the same as under Regulation EDGX Options. As proposed, EDGX executions across multiple series of an NMS. The remaining exceptions to the Options may list $1 Strike Prices on any option or across multiple options. The trade-through prohibition, discussed other option classes if those classes are risk to Users is not limited to a single more specifically below, either track specifically designated by other national series in an option or even to all series those under Regulation NMS or securities exchanges that employ a of an option; Users that quote in correspond to unique aspects of the similar $1 Strike Price Program under multiple series of multiple options have options market, or both. their respective rules. significant exposure, requiring them to The Rules in proposed Chapter XXVII To be eligible for inclusion into the $1 offset or hedge their overall positions. conform to the requirements of the Plan. Strike Price Program, an underlying In particular, the Risk Monitor Rule 27.1 sets forth the defined terms security must close below $50 in the Mechanism will be useful for EDGX for use under the Plan. Rule 27.2 primary market on the previous trading Options Market Makers, who are prohibits trade-throughs and exempts day. After a security is added to the $1 required to continuously quote in ISOs from that prohibition. Rule 27.2 Strike Price Program, EDGX Options assigned options. Quoting across many also contains additional exceptions to may list $1 Strike Prices from $1 to $50 series in an option creates the the trade-through prohibition that track that are no more than $5 from the possibility of ‘‘rapid fire’’ executions the exceptions under Regulation NMS closing price of the underlying on the that can create large, unintended or correspond to unique aspects of the preceding day. For example, if the principal positions that expose the EDGX Options Exchange, or both. underlying security closes at $13, EDGX Market Maker to unnecessary market Proposed Rule 27.3 sets forth the Options may list strike prices from $8 to risk. The Risk Monitor Mechanism is general prohibition against locking/ $18. EDGX Options may not list series intended to assist such Users in crossing other eligible exchanges as well with $1 intervals within $0.50 of an managing their market risk. as several exceptions that permit locked existing strike price in the same series, Though the Risk Monitor Mechanism markets in limited circumstances; such except that strike prices of $2, $3, $4, $5 will be most useful to Market Makers, exceptions have been approved by the and $6 shall be permitted within $0.50 the Exchange proposes to offer the Commission for inclusion in the rules of of an existing strike price for classes functionality to all participant types. other options exchanges. Specifically, also selected to participate in the $0.50 There may be other firms that trade on the exceptions to the general prohibition Strike Program. Additionally, for an a proprietary basis and provide liquidity on locking and crossing occur when (1) option class selected for the $1 Strike to the Exchange; these firms could the locking or crossing quotation was Price Program, EDGX Options may not potentially benefit, similarly to Market displayed at a time when the Exchange Makers, from the Risk Monitor was experiencing a failure, material 10 See Rules of BZX Options, Chapters XIX and Mechanism. The Exchange believes that delay, or malfunction of its systems or XXIX.

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list $1 Strike Prices on any series having to Rule 19.6, Mini Option contracts Exchange will review series that are greater than nine (9) months until could be listed on SPDR S&P 500 outside of a range of five (5) strikes expiration. A security shall remain in (‘‘SPY’’), Apple Inc. (‘‘AAPL’’), SPDR above and five (5) strikes below the the $1 Strike Price Program until Gold Trust (‘‘GLD’’), Google Inc. current price of the ETF, and delist otherwise designated by EDGX Options. (‘‘GOOG’’), and Amazon.com Inc. series with no open interest in both the For options classes selected to (‘‘AMZN’’). Strike prices for Mini call and the put series having a (1) strike participate in the $1 Strike Program, the Options shall be set at the same level as higher than the highest price with open Exchange will, on a monthly basis, for regular options. For example, a call interest in the put and/or call series for review series that were originally listed series strike price to deliver 10 shares of a given expiration month; and (2) strike under the $1 Strike Program with strike stock at $125 per share has a total lower than the lowest strike price with prices that are more than $5 from the deliverable value of $1250 and the strike open interest in the put and/or the call current value of an options class and price will be set at 125. No additional series for a given expiration month. delist those series with no open interest series of Mini Options may be added if Notwithstanding the delisting policy, in both the put and the call series the underlying security is trading at $90 customer requests to add strikes and/or having a: (1) strike higher than the or less. The underlying security must maintain strikes in Quarterly Options highest strike price with open interest in trade above $90 for five consecutive Series eligible for delisting shall be the put and/or call series for a given days prior to listing Mini Options granted. expiration month; and (2) strike lower contracts in an additional expiration The Exchange also may list Quarterly than the lowest strike price with open month. Option Series based on an underlying interest in the put and/or call series for Quarterly Options Series Program. index pursuant to similar provisions in a given expiration month. If the Pursuant to proposed Rule 19.6, Rule 29.11. There are two noteworthy Exchange identifies series for delisting Interpretation and Policy .04 and distinctions between the rules for listing pursuant to this policy, the Exchange proposed Rule 29.11(g) the Exchange Quarterly Options Series based on an shall notify other options exchanges may list and trade options series that ETF versus Quarterly Options Series with similar delisting policies regarding expire at the close of business on the based on an index. First, whereas the the eligible series for delisting, and shall last business day of a calendar quarter initial listing of Quarterly Options work jointly with such other exchanges (‘‘Quarterly Options Series’’). As Series based on an underlying ETF is to develop a uniform list of series to be proposed, the Exchange may list restricted to strike prices within $5 from delisted so as to ensure uniform series Quarterly Options Series for up to five the previous day’s closing price of the delisting of multiply listed options (5) currently listed options classes that underlying security, the initial listing of classes. are either options on exchange traded strikes for Quarterly Options Series Notwithstanding the above delisting funds (‘‘ETF’’) or index options. In based on an underlying index is policy, the Exchange may grant member addition, the Exchange may also list restricted to: (i) a price that is within requests to add strikes and/or maintain Quarterly Options Series on any options thirty percent (30%) of the current strikes in series of options classes traded classes that are selected by other index value, and (ii) no more than five pursuant to the $1 Strike Program that securities exchanges that employ a strikes above and five strikes below the are eligible for delisting. similar program under their respective value of the underlying index. Second, In addition to $1 strikes as proposed rules. whereas the Exchange may list up to 60 above, the Exchange proposes to offer The Exchange may list series that additional strike prices for each options trading on series of options with expire at the end of the next consecutive Quarterly Options Series based on an $0.50, $2.50 and $5.00 strike price four (4) calendar quarters, as well as the ETF, there is no firm cap on the intervals, consistent with other options fourth quarter of the next calendar year. additional listing of strikes for Quarterly exchanges, including BZX Options. For example, if the Exchange is trading Options Series based on an underlying With regard to the impact on system Quarterly Options Series in the month index; rather, additional strike prices capacity, the Exchange has analyzed its of May 2016, it may list series that may be listed provided the new listings capacity and represents that it and the expire at the end of the second, third, do not result in more than five strike Options Price Reporting Authority have and fourth quarters of 2016, as well as prices on the same side of the the necessary systems capacity to the first and fourth quarters of 2017. underlying index value as the new handle the additional traffic associated Following the second quarter 2016 listings. with the listing and trading of option expiration, the Exchange could add The interval between strike prices on series that may be listed and traded in series that expire at the end of the Quarterly Options Series shall be the the strike price intervals described second quarter of 2017. same as the interval for strike prices for above, including $0.50, $1, $2.50 and For each class of ETF options selected series in that same options class that $5.00 strikes. for the Quarterly Options Series expire in accordance with the normal Mini Options. After an option class on program, the Exchange may list strike monthly expiration cycle. a stock, Exchange-Traded Fund Share, prices within $5 from the previous day’s With regard to the impact on system Trust Issued Receipt, Exchange Traded closing price of the underlying security capacity, the Exchange has analyzed its Note, and other Index Linked Security at the time of initial listing. capacity and represents that it and the with a 100 share deliverable has been Subsequently, the Exchange may list up Options Price Reporting Authority have approved for listing and trading on the to 60 additional strike prices that are the necessary systems capacity to Exchange, the Exchange proposes to within thirty percent (30%) of the handle the additional traffic associated permit listing of series of option previous day’s close, or more than 30% with the listing and trading of options contracts with a 10 share deliverable on away from the previous day’s close series pursuant to the above-described that stock, Exchange-Traded Fund provided demonstrated customer Quarterly Options Series program. Share, Trust Issued Receipt, Exchange interest exists for such series. Short Term Option Series Program. Traded Note, and other Index Linked The Exchange has also proposed a The Exchange plans to operate a Short- Security for all expirations opened for delisting policy with respect to Term Options Series Program similar to trading on the Exchange. Pursuant to Quarterly Options Series in ETF other Short Term Options Programs, proposed Interpretation and Policy .07 options. On a monthly basis, the including that of BZX Options. Pursuant

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to proposed Rule 19.6, Interpretation deliveries (Chapter XXIII); records, Regulation and Policy .05 for equity options and reports and audits (Chapter XXIV); The Exchange will leverage many of Rule 29.11(h) for index options in, the minor rule violations (Chapter XXV); the structures it established to operate a Exchange intends to open for trading on doing business with the public (Chapter national securities exchange in any Thursday or Friday that is a XXVI); and margin (Chapter XXVIII). compliance with Section 6 of the business day (‘‘Short Term Option The Exchange notes that certain Exchange Act. As described in more Opening Date’’) series of options on that requirements that will be applicable to detail below, there will be three class that expire on each of the next five Options Members are contained in other elements of that regulation: (1) the (5) Fridays that are business days and sections of the Exchange’s existing Exchange will join the existing options are not Fridays in which monthly Rules. For example, the Exchange has industry agreements pursuant to Section options series or Quarterly Options included applicable rules requiring 17(d) of the Exchange Act, as it has with Series expire (‘‘Short Term Option options principal registration into respect to its equities market, (2) the Expiration Dates’’). As proposed, the proposed EDGX Rule 17.2(g) but also Exchange’s Regulatory Services Exchange may have no more than a total proposes to include reference to Agreement (‘‘RSA’’) with FINRA will of five Short Term Option Expiration applicable registration requirements that govern many aspects of the regulation Dates. If EDGX Options is not open for are already contained in EDGX Rule 2.5. and discipline of Members that business on the respective Thursday or The Exchange also proposes to expand participate in options trading, just as it Friday, the Short Term Option Opening EDGX Rule 2.5 to clearly include does for equities market regulation, and Date will be the first business day options principal registration. The (3) the Exchange will perform options immediately prior to that respective listing regulation, as well as authorize Thursday or Friday. Similarly, if EDGX Exchange intends to require Authorized Options is not open for business on the Traders of Options Members to comply Options Members to trade on EDGX Friday that the options are set to expire, with existing Exchange registration Options, and conduct surveillance of requirements applicable to all options trading as it does today for the Short Term Option Expiration Date 11 will be the first business day Authorized Traders. Accordingly, the equities. Section 17(d) of the Exchange Act and immediately prior to that Friday. Exchange has not proposed specific As proposed, the Exchange may select rules applicable to registration of the related Exchange Act rules permit up to fifty (50) option classes in which representatives other than options SROs to allocate certain regulatory Short Term Option Series may be principals. responsibilities to avoid duplicative traded. In addition to those fifty option As is true for BZX Options, with oversight and regulation. Under classes the Exchange may also list Short respect to Position Limits (Rule 18.7) Exchange Act Rule 17d–1, the SEC Term Option Series on any option and Exercise Limits (Rule 18.9), the designates one SRO to be the Designated classes that are selected by other Exchange is proposing to apply the Examining Authority, or DEA, for each securities exchanges that employ a limits established pursuant to the rules broker-dealer that is a member of more similar program. For each option class of the CBOE, although the Exchange than one SRO. The DEA is responsible eligible for participation in the Short will establish such limits for products for the financial aspects of that broker- Term Option Series Program, the not traded on the CBOE. By expressly dealer’s regulatory oversight. Because Exchange may open up to thirty (30) incorporating an already-approved EDGX Options Members also must be Short Term Option Series for each limit, the Exchange will ensure that an members of at least one other SRO, the expiration date in that class. The appropriate limit is in place at all times Exchange would generally not be Exchange may also open Short Term without the need to continually adjust designated as the DEA for any of its Option Series that are opened by other its rule manually or to disrupt the members. securities exchanges in option classes operations of its Members. Rule 17d–2 under the Act permits selected by such exchanges under their SROs to file with the Commission plans respective short term option rules. National Market System under which the SROs allocate among As noted above, the remaining each other the responsibility to receive The EDGX Options Exchange will parameters of the proposed Short Term regulatory reports from, and examine operate as a full and equal participant Options Program are identical to those and enforce compliance with specified in the national market system for of BZX Options and similar to those provisions of the Act and rules options trading established under operated by other options exchanges. thereunder and SRO rules by, firms that With regard to the impact on system Section 11A of the Exchange Act, just as are members of more than one SRO capacity, the Exchange has analyzed its its equities market participates today. (‘‘common members’’). If such a plan is capacity and represents that it and the The EDGX Options Exchange will declared effective by the Commission, Options Price Reporting Authority have become a member of OPRA, the Options an SRO that is a party to the plan is the necessary systems capacity to Linkage Authority (‘‘OLA’’), the Options relieved of regulatory responsibility as handle the additional traffic associated Regulatory Surveillance Authority to any common member for whom with the listing and trading of option (‘‘ORSA’’), and the Options Listing responsibility is allocated under the series pursuant to the Short Term Procedures Plan (‘‘OLPP’’). plan to another SRO. Option Series Program. The Exchange expects to participate All of the options exchanges and in those plans on the same terms FINRA have entered into the Options Conduct and Operational Rules for currently applicable to current members Sales Practices Agreement, a Rule 17d– Options Members of those plans, and it expects little or no 2 agreement. Under this Agreement, the EDGX proposes to adopt rules that are plan impact due to the fact that the examining SROs will examine firms that nearly identical to the approved rules of Exchange’s market will operate in a are common members of the Exchange other options exchanges, including BZX manner similar to several other existing and the particular examining SRO for Options. Thus, EDGX proposes to adopt options exchanges. compliance with certain provisions of rules that are based on the rules of BZX the Act, certain of the rules and Options regarding: Business Conduct 11 See Exchange Rule 2.5, Interpretation and regulations adopted thereunder, certain Rules (Chapter XVIII); exercises and Policy .01 and Exchange Rule 11.4. examining SRO rules, and certain EDGX

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Options Rules. In addition, EDGX remediating ‘‘obvious errors’’ by and character of incoming order flow and Options Rules contemplate participation among its Options Members. EDGX transactions during Limit and Straddle in this Agreement by requiring that any proposed rules (Chapter XX) regarding States, and (3) review any complaints Options Member also be a member of at halts, unusual market conditions, from Members and their customers least one of the examining SROs. extraordinary market volatility, obvious concerning executions during Limit and For those regulatory responsibilities errors, and audit trail are identical to the Straddle States. The Exchange also that fall outside the scope of any Rule approved rules of BZX Options.12 agrees to provide to the Commission 17d–2 agreements, the Exchange will The Exchange notes that the obvious data requested to evaluate the impact of retain full regulatory responsibility error rule of BZX Options was recently the inapplicability of the Obvious Error under the Exchange Act. However, as approved 13 and that other options and Catastrophic Error provisions, noted above, the Exchange has entered exchanges are in the process of including data relevant to assessing the into an RSA with FINRA, pursuant to implementing similar rules. The various analyses noted above. which FINRA personnel operate as Exchange has not proposed any changes In connection with this proposal, the agents for the Exchange in performing as compared to the recently approved Exchange will provide to the certain of these functions. As is the case obvious error rule of BZX Options. Commission and the public a dataset with the EDGX equities market, the Thus, in addition to the general containing the data for each Straddle Exchange will supervise FINRA and provisions for reviewing and handling State and Limit State in NMS Stocks continue to bear ultimate regulatory transactions that potentially qualify for underlying options traded on the responsibility for the EDGX Options adjustment or nullification as Obvious Exchange beginning in the month Exchange. The Exchange intends to Errors or Catastrophic Errors, the during which the proposal is approved, amend the existing RSA in order to Exchange proposes to adopt limited to those option classes that have capture certain aspects of regulation Interpretation and Policy .01 to provide at least one (1) trade on the Exchange specifically applicable to EDGX Options for how the Exchange will treat Obvious during a Straddle State or Limit State. and the regulation and discipline of and Catastrophic Errors in response to For each of those option classes Options Members. the Limit Up-Limit Down Plan, which is affected, each data record will contain As a member of the Intermarket applicable to all NMS stocks, as defined the following information: Surveillance Group, the Exchange will in Regulation NMS Rule 600(b)(47).14 • comply with the specifications of the As proposed, during a pilot period to Stock symbol, option symbol, time at the Consolidated Options Audit Trail coincide with the pilot period for the start of the Straddle or Limit State, an System (‘‘COATS’’) in submitting data indicator for whether it is a Straddle or Limit Plan, including any extensions to the State. for purposes of creating a consolidated pilot period for the Plan, an execution Æ For activity on the Exchange: audit trail. The Exchange will also will not be subject to review as an Æ Executed volume, time-weighted quoted receive COATS data for purposes of its Obvious Error or Catastrophic Error bid-ask spread, time-weighted average quoted surveillance operations. pursuant to paragraph (c) or (d) of the depth at the bid, time-weighted average Consistent with the Exchange’s Proposed Rule if it occurred while the quoted depth at the offer; existing regulatory structure, the underlying security was in a ‘‘Limit Æ high execution price, low execution Exchange’s Chief Regulatory Officer State’’ or ‘‘Straddle State,’’ as defined in price; Æ shall have general supervision of the the Plan. During a Limit or Straddle number of trades for which a request for regulatory operations of EDGX Options, State, options prices may deviate review for error was received during Straddle including responsibility for overseeing and Limit States; substantially from those available Æ an indicator variable for whether those the surveillance, examination, and immediately prior to or following such options outlined above have a price change enforcement functions and for States. Thus, determining a Theoretical exceeding 30% during the underlying stock’s administering all regulatory services Price in such situations would often be Limit or Straddle State compared to the last agreements applicable to EDGX Options. very subjective, creating unnecessary available option price as reported by OPRA Similarly, the Exchange’s existing uncertainty and confusion for investors. before the start of the Limit or Straddle State Regulatory Oversight Committee will be Because of this uncertainty, the (1 if observe 30% and 0 otherwise). Another responsible for overseeing the adequacy Exchange is proposing to provide in indicator variable for whether the option and effectiveness of Exchange’s Rule 20.6 that the Exchange will not price within five minutes of the underlying regulatory and self-regulatory review transactions as Obvious Errors or stock leaving the Limit or Straddle state (or organization responsibilities, including halt if applicable) is 30% away from the price Catastrophic Errors when the before the start of the Limit or Straddle State. those applicable to EDGX Options. underlying security is in a Limit or Finally, as is true with respect to Straddle State. In addition, the Exchange shall equities, the Exchange, and FINRA The Exchange represents that it will provide to the Commission and the pursuant to the RSA referenced above, conduct its own analysis concerning the public assessments relating to the will perform automated surveillance of elimination of the Obvious Error and impact of the operation of the Obvious trading on EDGX Options for the Catastrophic Error provisions during Error rules during Limit and Straddle purpose of maintaining a fair and Limit and Straddle States and agrees to States as follows: (1) Evaluate the orderly market at all times. Specifically, provide the Commission with relevant statistical and economic impact of Limit EDGX Options will be monitored to data to assess the impact of this and Straddle States on liquidity and identify unusual trading patterns and proposed rule change. As part of its market quality in the options markets; determine whether particular trading analysis, the Exchange will evaluate (1) and (2) Assess whether the lack of activity requires further regulatory the options market quality during Limit Obvious Error rules in effect during the investigation by FINRA. and Straddle States, (2) assess the Straddle and Limit States are In addition, the Exchange will oversee problematic. The timing of this the process for determining and 12 See BZX Options Rules Chapter XX; see also submission would coordinate with implementing trade halts, identifying Rules of NOM, Chapter V, and BOX, Chapter V. Participants’ proposed time frame to 13 See Securities Exchange Act Release No. 74556 and responding to unusual market (March 20, 2015), 80 FR 16031 (March 26, 2015) submit to the Commission assessments conditions, and administering the (SR–BATS–2014–067). as required under Appendix B of the Exchange’s process for identifying and 14 17 CFR 242.600(b)(47). Plan. The Exchange notes that the pilot

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program is intended to run concurrent rules included in Rule 25.3 are the same an innovative, low-cost competitor such with the pilot period of the Plan, which as the rules included in the MRVPs of as EDGX Options will promote currently expires to October 23, 2015. BZX Options and other options competition, spurring existing markets The Exchange proposes to reflect this exchanges.19 to improve their own execution systems date in the Proposed Rule. Upon implementation of this and reduce trading costs. The basis for the majority of the rules Minor Rule Violation Plan proposal, the Exchange will include the enumerated options trading rule of EDGX Options are [sic] the approved The Exchange’s disciplinary rules, violations in the Exchange’s standard rules of BZX Options, which have including Exchange Rules applicable to quarterly report of actions taken on already been found to be consistent with ‘‘minor rule violations,’’ are set forth in minor rule violations under the MRVP. the Act. For instance, the Exchange does Chapter VIII of the Exchange’s current The quarterly report includes: the not believe that any of the proposed Rules. Such disciplinary rules will Exchange’s internal file number for the order types or order type functionality apply to Options Members and their case, the name of the individual and/or raise any new or novel issues that have associated persons. organization, the nature of the violation, not previously been considered. Thus, The Commission approved the EDGX the specific rule provision violated, the the Exchange further believes that the Exchange’s Minor Rule Violation Plan functionality that it proposes to offer is 15 sanction imposed, the number of times (‘‘MRVP’’) in 2010. The Exchange’s the rule violation has occurred, and the consistent with Section 6(b)(5) of the MRVP specifies those uncontested date of disposition. Act,22 because the System is designed to minor rule violations with sanctions not Although the Exchange has not be efficient and its operation exceeding $2,500 that would not be proposed fees for EDGX Options in transparent, thereby facilitating subject to the provisions of Rule 19d– transactions in securities, removing 16 connection with this proposal, the 1(c)(1) under the Act requiring that an Exchange does anticipate filing a impediments to and perfecting the SRO promptly file notice with the separate proposal prior to the launch of mechanism of a free and open market Commission of any final disciplinary EDGX Options to establish applicable and a national market system. As noted action taken with respect to any person fees. The Exchange notes that pursuant above, the Exchange will participate in or organization.17 The Exchange’s to both the Act and existing Exchange the approved Options Order Protection MRVP includes the policies and Rule 15.1, the Exchange has the and Locked/Crossed Market Plan, and procedures included in Exchange Rule authority to prescribe dues, fees, therefore will be required to comply 8.15 (Imposition of Fines for Minor assessments and other charges with the obligations of Participants Violation(s) of Rules) and in Rule 8.15, (collectively, ‘‘Fees’’) so long as such under the Plan. Interpretation and Policy .01. Similarly, the Exchange proposes to The Exchange proposes to amend its Fees are equitably allocated, reasonable and not unreasonably discriminatory. adopt initial and continued listing MRVP and Rule 8.15, Interpretation and standards for equity and index options Policy .01 to include proposed Rule 25.3 2. Statutory Basis that are substantially similar to the (Penalty for Minor Rule Violations).18 listing standards adopted by BZX The rules included in proposed Rule The Exchange believes that the proposed rule change is consistent with Options and other options exchanges. 25.3 as appropriate for disposition 20 The Exchange has also proposed to under the Exchange’s MRVP are: the provisions of the Act, in general and with Section 6(b)(5) of the Act,21 in adopt rules that are substantially similar violations of applicable Position Limit to those of BZX Options with respect to and Exercise Limit rules; order entry particular, in that it is designed to promote just and equitable principles of the Penny Pilot Program and various violations regarding restrictions on other strike price programs, including orders entered by Market Makers; trade, to foster cooperation and coordination with persons engaged in the program regarding the listing of violations of Market Maker continuous $0.50, $1, $2.50 and $5.00 strikes, the regulating, clearing, settling, processing bid and offer rules; violations of rules Quarterly Options Series Program and information with respect to, and applicable to expiring exercise the Short Term Options Series program. facilitating transactions in securities, to declarations; and violations of Exchange The Exchange believes that general remove impediments to and perfect the requirements to provide trade data. The consistency amongst options exchanges mechanism of a free and open market with respect to the series of options 15 and a national market system, and, in See Release No. 34–62036 (May 5, 2010), 75 FR available for listings and trading is 26822 (May 12, 2010) (File No. 4–594) (‘‘MRVP general, to protect investors and the Order’’). consistent with Section 6(b)(5) of the public interest; and are not designed to 23 16 Act, in particular, in that it is designed 17 CFR 240.19d–1(c)(1). permit unfair discrimination between 17 to promote just and equitable principles The Commission adopted amendments to customers, issuers, brokers, or dealers. paragraph (c) of Rule 19d-1 to allow SROs to submit of trade, to foster cooperation and As described above, the fundamental for Commission approval plans for the abbreviated coordination with persons engaged in reporting of minor disciplinary infractions. See premise of the proposal is that the regulating, clearing, settling, processing Release No. 34–21013 (June 1, 1984), 49 FR 23828 Exchange will operate its options (June 8, 1984). Any disciplinary action taken by an information with respect to, and market in a similar manner to its SRO against any person for violation of a rule of the facilitating transactions in securities, to affiliated options exchange, BZX SRO which has been designated as a minor rule remove impediments to and perfect the violation pursuant to such a plan filed with and Options, with the exception of the mechanism of a free and open market declared effective by the Commission will not be priority model and certain other limited considered ‘‘final’’ for purposes of Section 19(d)(1) and a national market system, and, in differences. The Exchange believes that of the Act if the sanction imposed consists of a fine general, to protect investors and the EDGX Options will benefit individual not exceeding $2,500 and the sanctioned person has public interest by avoiding unnecessary not sought an adjudication, including a hearing, or investors, options trading firms, and the confusion. otherwise exhausted his administrative remedies. options market generally. The entry of 18 In the MRVP Order, the Commission noted that The Exchange believes that the rules the Exchange proposed that any amendments to of EDGX Options as well as the 19 See BZX Options Rule 25.3; see also, NOM, Rule 8.15.01 made pursuant to a rule filing proposed method of monitoring for submitted under Rule 19b–4 of the Act would Chapter X, Section 7, and BOX, Chapter X, Section automatically be deemed a request by the Exchange 2. for Commission approval of a modification to its 20 15 U.S.C. 78a et seq. 22 15 U.S.C. 78f(b)(5). MRVP. See MRVP Order, supra note 15, at note 5. 21 15 U.S.C. 78f(b)(5). 23 15 U.S.C. 78f(b)(5).

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compliance with and enforcing such competes for the privilege of providing IV. Solicitation of Comments rules is also consistent with the Act, market services to broker-dealers. The particularly Sections 6(b)(1), 6(b)(5) and Exchange’s ability to compete in this Interested persons are invited to 6(b)(6) of the Act, which require, in part, environment is based in large part on submit written data, views and that an exchange have the capacity to the quality of its trading systems, the arguments concerning the foregoing, enforce compliance with, and provide overall quality of its market and its including whether the proposed rule appropriate discipline for, violations of attractiveness to the largest number of change is consistent with the Act. the rules of the Commission and of the investors, as measured by speed, Comments may be submitted by any of exchange.24 The Exchange has proposed likelihood and cost of executions, as the following methods: to adopt rules necessary to regulation well as spreads, fairness, and Electronic Comments Options Members that are nearly transparency. identical to the approved Rules of BZX The Exchange notes that most U.S. • Use the Commission’s Internet Options as well as numerous other options exchanges are owned and comment form (http://www.sec.gov/ options exchanges. The Exchange operated by companies that operate rules/sro.shtml); or proposes to regulate activity on EDGX more than one options exchange.28 The • Send an email to rule-comments@ Options in the same way it regulates primary reason to operate multiple sec.gov. Please include File Number SR– activity on its equities market, options exchanges, as is true with specifically through various Exchange respect to the proposed launch of EDGX EDGX–2015–18 on the subject line. specific functions, an RSA with FINRA, Options, is that it allows an exchange Paper Comments as well as participation in industry operator to offer multiple market plans, including plans pursuant to Rule models, including a price-time market • Send paper comments in triplicate 17d–2 under the Exchange Act. and a pro rata market, often with to Secretary, Securities and Exchange More specifically, the Exchange’s Customer priority as a critical Commission, 100 F Street NE., MRVP, as proposed to be amended, is component of the latter. Accordingly, Washington, DC 20549–1090. also consistent with Sections 6(b)(1), the proposed rule change is intended to All submissions should refer to File 6(b)(5) and 6(b)(6) of the Act, which enhance competition by allowing the Number SR–EDGX–2015–18. This file require, in part, that an exchange have Exchange to compete with existing the capacity to enforce compliance with, options exchanges that operate models number should be included on the and provide appropriate discipline for, based on Customer priority and pro rata subject line if email is used. To help the violations of the rules of the allocations. Commission process and review your Commission and of the exchange.25 In comments more efficiently, please use addition, because amended Rule 8.15 The proposed rule change will reduce overall trading costs and increase price only one method. The Commission will will offer procedural rights to a person post all comments on the Commission’s sanctioned for a violation listed in competition, both pro-competitive developments, and will promote further Internet Web site (http://www.sec.gov/ proposed Rule 25.3, the Exchange will rules/sro.shtml). Copies of the provide a fair procedure for the initiative and innovation among market centers and market participants. submission, all subsequent disciplining of members and associated amendments, all written statements persons, consistent with Section 6(b)(7) C. Self-Regulatory Organization’s with respect to the proposed rule of the Act.26 The proposal to include the Statement on Comments on the change that are filed with the rules listed in proposed Rule 25.3 in the Proposed Rule Change Received From Commission, and all written Exchange’s MRVP is also consistent Members, Participants, or Others communications relating to the with the public interest, the protection of investors, or otherwise in furtherance Written comments were neither proposed rule change between the of the purposes of the Act, as required solicited nor received. Commission and any person, other than those that may be withheld from the by Rule 19d–1(c)(2) under the Act,27 III. Date of Effectiveness of the public in accordance with the because it should strengthen the Proposed Rule Change and Timing for Exchange’s ability to carry out its Commission Action provisions of 5 U.S.C. 552, will be oversight and enforcement available for Web site viewing and responsibilities as an SRO in cases Within 45 days of the date of printing in the Commission’s Public where full disciplinary proceedings are publication of this notice in the Federal Reference Room, 100 F Street NE., unsuitable in view of the minor nature Register or within such longer period Washington, DC 20549, on official of the particular violation. up to 90 days (i) as the Commission may business days between the hours of designate if it finds such longer period 10:00 a.m. and 3:00 p.m. Copies of the B. Self-Regulatory Organization’s to be appropriate and publishes its filing also will be available for Statement on Burden on Competition reasons for so finding or (ii) as to which inspection and copying at the principal The Exchange does not believe that the Exchange consents, the Commission office of the Exchange. All comments the proposed rule change will result in will: (a) By order approve or disapprove received will be posted without change; any burden on competition that is not such proposed rule change, or (b) the Commission does not edit personal institute proceedings to determine necessary or appropriate in furtherance identifying information from of the purposes of the Act. The whether the proposed rule change submissions. You should submit only Exchange operates in an intensely should be disapproved. information that you wish to make competitive global marketplace for available publicly. All submissions transaction services. Relying on its array 28 The IntercontinentalExchange Group, Inc. of services and benefits, the Exchange (‘‘ICE’’) operates two options exchanges, Amex and should refer to File Number SR–EDGX– Arca; NASDAQ OMX Group, Inc. operates three 2015–18 and should be submitted on or options exchanges, NOM, Phlx and NASDAQ OMX 24 before June 9, 2015. 15 U.S.C. 78f(b)(1), 78f(b)(5) and 78f(b)(6). BX; International Securities Exchange Holding, Inc. 25 15 U.S.C. 78f(b)(1), 78f(b)(5) and 78f(b)(6). operates two options exchanges, ISE and ISE 26 15 U.S.C. 78f(b)(7). Gemini; and CBOE Holdings operates two options 27 17 CFR 240.19d–1(c)(2). exchanges, CBOE and C2 Options Exchange.

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For the Commission, by the Division of the proposed rule change and discussed tier and to modify the volume Trading and Markets, pursuant to delegated any comments it received on the calculations for both equity and options authority.29 proposed rule change. The text of these volume for securities on all three Tapes. Robert W. Errett, statements may be examined at the First, the Exchange is increasing the Deputy Secretary. places specified in Item IV below. The required percentage of Consolidated [FR Doc. 2015–12022 Filed 5–18–15; 8:45 am] Exchange has prepared summaries, set Volume of equities executed from 0.40 BILLING CODE 8011–01–P forth in sections A, B, and C below, of percent to 0.60 percent per member for the most significant aspects of such one or more of that member’s MPIDs. statements. Second, NASDAQ is retaining the SECURITIES AND EXCHANGE existing link between equities and COMMISSION A. Self-Regulatory Organization’s options trading, but it is modifying the Statement of the Purpose of, and measure of options volume. [Release No. 34–74946; File No. SR– Statutory Basis for, the Proposed Rule NASDAQ–2015–052] Specifically, the Exchange is modifying Change the rule to incorporate language from Self-Regulatory Organizations; The 1. Purpose the Liquidity in Penny Pilot Options Tier 8 under Chapter XV, Section 2 of NASDAQ Stock Market LLC; Notice of NASDAQ is proposing to amend the Nasdaq Options Market. Filing and Immediate Effectiveness of NASDAQ Rule 7018(1), (2) and (3) to Additionally, the Exchange plans to Proposed Rule Change To Modify modify fees assessed for execution and credit members that add liquidity of NASDAQ Rule 7018 Governing Fees routing securities listed on NASDAQ 1.25 percent or more of average daily and Credits Assessed For Execution (‘‘Tape C’’), NYSE (‘‘Tape A’’) and on volume (‘‘ADV’’) for the industry in the and Routing exchanges other than NASDAQ and the customer clearing range 3 in Equity and NYSE (‘‘Tape B’’), respectively, May 13, 2015. ETF Options 4 based upon volume Pursuant to Section 19(b)(1) of the (together, the ‘‘Tapes’’). The Exchange is added by that member in the Customer,5 Securities Exchange Act of 1934 proposing two categories of changes to Professional,6 Firm,7 Non-NOM Market (‘‘Act’’),1 and Rule 19b–4 thereunder,2 credits paid regarding midpoint Maker 8 and Broker-Dealer 9 notice is hereby given that on May 7, liquidity: (1) Changes to the calculation classifications as those classifications 2015, The NASDAQ Stock Market LLC of Equity and Options-linked volume are defined in NOM rules. (‘‘Nasdaq’’ or ‘‘Exchange’’) filed with the when the Exchange pays rebates to Non-Displayed Volume. Currently, Securities and Exchange Commission members that provide liquidity via NASDAQ Rule 7018 provides for credits (‘‘SEC’’ or ‘‘Commission’’) the proposed midpoint orders that are executed; and for the execution of non-displayed rule change as described in Items I, II, (2) adding a tier of credits for midpoint liquidity (other than via Supplemental and III, below, which Items have been liquidity provided via non-displayed prepared by the Exchange. The orders that are executed. These changes 3 The term ‘‘customer clearing range’’ refers to a Commission is publishing this notice to are described in greater detail below. clearing designation determined by the Options Equity and Options-Linked Volume. Clearing Corporation that applies throughout the solicit comments on the proposed rule With respect to credits paid for options industry. change from interested persons. 4 This proposed rule change applies to the same members adding liquidity via midpoint categories of options (Penny Pilot, Non-Penny Pilot, I. Self-Regulatory Organization’s orders, the Exchange currently pays a Equity and ETF options) and the same participant Statement of the Terms of the Substance credit of $0.0030 per share executed for liquidity (Customer, Professional, Firm, Non-NOM of the Proposed Rule Change members (i) with shares of liquidity Market Maker and Broker-Dealer) that are identified in Chapter XV, Section 2 of the Nasdaq Options The Exchange proposes to modify provided in all securities during the Market Rules, Tier 8. NASDAQ Rule 7018(a)(1), (2), and (3), month representing at least 0.40% of 5 As defined in Chapter XV of the Nasdaq Options governing fees and credits assessed for Consolidated Volume during the month, Market Rules, the term ‘‘Customer’’ or (‘‘C’’) applies through one or more of its Nasdaq to any transaction that is identified by a Participant execution and routing securities listed for clearing in the Customer range at The Options on NASDAQ (subsection 1), the New Market Center MPIDs, and (ii) that Clearing Corporation (‘‘OCC’’) which is not for the York Stock Exchange (‘‘NYSE’’) qualifies for the Nasdaq Options Market account of broker or dealer or for the account of a (subsection 2) and on exchanges other Customer and Professional Rebate to ‘‘Professional’’ (as that term is defined in Chapter add Liquidity in Penny Pilot Options I, Section 1(a)(48)). than NASDAQ and NYSE (subsection 6 Tier 8 under Chapter XV, Section 2 of As defined in Chapter XV of the Nasdaq Options 3). NASDAQ will implement the Market Rules, the term ‘‘Professional’’ or (‘‘P’’) proposed fees on May 1, 2015. the Nasdaq Options Market rules during means any person or entity that (i) is not a broker The text of the proposed rule change the month through one or more of its or dealer in securities, and (ii) places more than 390 Nasdaq Options Market MPIDs. The Tier orders in listed options per day on average during is available on the Exchange’s Web site a calendar month for its own beneficial account(s) at http://nasdaq.cchwallstreet.com, at 8 program requires that a ‘‘Participant pursuant to Chapter I, Section 1(a)(48). All the principal office of the Exchange, and adds Customer, Professional, Firm, Non- Professional orders shall be appropriately marked NOM Market Maker and/or Broker- by Participants. at the Commission’s Public Reference 7 Room. Dealer liquidity in Penny Pilot Options As defined in Chapter XV of the Nasdaq Options and/or Non-Penny Pilot Options of Market Rules, the term ‘‘Firm’’ or (‘‘F’’) applies to any transaction that is identified by a Participant for II. Self-Regulatory Organization’s 0.75% or more of total industry clearing in the Firm range at OCC. Statement of the Purpose of, and customer equity and ETF option ADV 8 As defined in Chapter XV of the Nasdaq Options Statutory Basis for, the Proposed Rule contracts per day in a month.’’ The Tier Market Rules, the term ‘‘Non-NOM Market Maker’’ Change 8 credit is designed to reward members or (‘‘O’’) is a registered market maker on another options exchange that is not a NOM Market Maker. In its filing with the Commission, the that add liquidity broadly across A Non-NOM Market Maker must append the proper Exchange included statements NASDAQ’s equity and options trading Non-NOM Market Maker designation to orders concerning the purpose of and basis for platform whether for trading NASDAQ, routed to NOM. NYSE or Amex or other exchange-listed 9 As defined in Chapter XV of the Nasdaq Options Market Rules, the term ‘‘Broker-Dealer’’ or (‘‘B’’) 29 17 CFR 200.30–3(a)(12). securities. applies to any transaction which is not subject to 1 15 U.S.C. 78s(b)(1). NASDAQ is proposing to retain the any of the other transaction fees applicable within 2 17 CFR 240.19b–4. credit rate of $0.0030 for this activity a particular category.

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Orders) when the member provides for members to add additional liquidity NASDAQ’s determination is incorrect, certain levels of liquidity and also to the NASDAQ Market Center. NASDAQ would expect its share of provides certain levels of options Liquidity is critical to the trading trading in Tape C securities to decline liquidity simultaneously. The credits efficiency and quality of the exchange, due to intense competition in the currently range from $0.0025 to $0.0005 and changes to enhance liquidity should market. depending upon the orders types used be viewed favorably by all participants. Further, all participants may qualify and the amount of liquidity provided, This change will be applied equally to to be eligible for these rebates, provided where midpoint liquidity is highest all similarly situated members and they transact the requisite amount of valued. therefore should not be considered liquidity. It is reasonable to emphasize The Exchange is modifying three discriminatory, much less unfairly customer liquidity in options trading rebate tiers and adding a new rebate tier discriminatory. because it offers unique benefits to the across Tapes A and B only; Tape C NASDAQ also believes that it is market, which benefits all market securities will remain unmodified. reasonable, equitably allocated and not participants. Customer liquidity benefits Specifically, the Exchange will raise the unfairly discriminatory to retain the all options market participants by credit from $0.0020 to $0.0022 per share existing link between equities and providing more trading opportunities, executed for midpoint orders if the options trading, to modify the measure which attracts market makers. An member provides an average daily of options volume. As with the previous increase in the activity of these market volume of 6 million or more shares change, the Exchange is requiring participants in turn facilitates tighter through midpoint orders during the members to add additional liquidity spreads, which may cause an additional month, and from $0.0017 to $0.0020 per (1.25 versus 0.75 percent of ADV), and corresponding increase in order flow share executed for midpoint orders if to apply the same numerator (volume from other market participants. the member provides an average daily added by that member in the Customer, B. Self-Regulatory Organization’s volume between 5 million and less than Professional, Firm, Non-NOM Market Statement on Burden on Competition 6 million shares through midpoint Maker and Broker-Dealer classifications) orders during the month. Additionally, and denominator (total volume in the NASDAQ does not believe that the the Exchange is adding a new rebate tier customer clearing range in Equity and proposed rule changes will result in any of $0.0018 per share executed for ETF Options) for that calculation. burden on competition that is not midpoint orders if the member provides Again, it is important for the Exchange necessary or appropriate in furtherance an average daily volume between 1 to encourage members to add liquidity of the purposes of the Act, as million and less than 5 million shares to the platforms NASDAQ operates and amended.12 NASDAQ notes that it through midpoint orders during the fair to modify fees to accomplish that operates in a highly competitive market month Finally, the Exchange is retaining important goal. in which market participants can the rebate tier of $0.0014 per share The Exchange also believes it is readily favor competing venues if they executed for midpoint orders but reasonable, equitably allocated and not deem fee levels at a particular venue to lowering the volume requirement from unfairly discriminatory to adjust rebate be excessive, or rebate opportunities 5 million to 1 million shares average tiers for non-displayed liquidity for available at other venues to be more daily volume of midpoint liquidity Tapes A and B. NASDAQ notes that favorable. In such an environment, provided during the month. each of the four changes results in NASDAQ must continually adjust its higher rebates per executed share in the fees to remain competitive with other 2. Statutory Basis future for the same volume of shares exchanges and with alternative trading NASDAQ believes that the proposed previously executed. Three of the four systems that have been exempted from rule change is consistent with the changes are modifications to existing compliance with the statutory standards provisions of Section 6 of the Act,10 in tiers and the fourth is the insertion of a applicable to exchanges. Because general, and with Sections 6(b)(4) and new volume tier, each of which is competitors are free to modify their own 6(b)(5) of the Act,11 in particular, in that designed to reward more generously the fees in response, and because market it provides for the equitable allocation provision of midpoint liquidity on participants may readily adjust their of reasonable dues, fees and other NASDAQ. Midpoint liquidity is order routing practices, NASDAQ charges among members and issuers and valuable to the efficient operation and believes that the degree to which fee other persons using any facility or competitiveness of the Exchange, and changes in this market may impose any system which NASDAQ operates or particularly beneficial to investors burden on competition is extremely controls, and is not designed to permit matching at the midpoint. limited. unfair discrimination between NASDAQ believes it is not unfairly In this instance, the changes to customers, issuers, brokers, or dealers. discriminatory to apply these changes to liquidity credits for midpoint liquidity NASDAQ believes that the changes Tapes A and B versus Tape C because and to equity and options-lined credits across all tapes to the calculation of the they will be absolute rather than relative do not impose a burden on competition Equity and Options-linked credit of requirements. As an absolute standard, because NASDAQ’s execution services $0.0030 for members that provide the liquidity requirements will apply are completely voluntary and subject to midpoint liquidity are reasonable, uniformly to all Market Makers eligible extensive competition both from other equitably allocated and not unfairly to participate in the program. All exchanges and from off-exchange discriminatory. First, it is reasonable members have incentives available and venues. In sum, if the changes proposed and equitable to increase the required equal opportunity to earn the higher herein are unattractive to market percentage of Consolidated Volume of rebates for adding more liquidity in participants, it is likely that NASDAQ equities executed from 0.40 percent to Tapes A and B securities. NASDAQ has will lose market share as a result. 0.60 percent per member for one or determined that modifying the Accordingly, NASDAQ does not believe more of that member’s MPIDs. This incentives is more necessary for Tape A that the proposed changes will impair change is designed to create incentives and B securities than for Tape C the ability of members or competing securities due to differences in order execution venues to maintain 10 15 U.S.C. 78f. NASDAQ’s share of trading and the total 11 15 U.S.C. 78f(b)(4) and (5). volume traded in the market. If 12 15 U.S.C. 78f(b)(8).

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their competitive standing in the communications relating to the established pursuant to Executive Order financial markets. proposed rule change between the 13540 and focused on coordinating the Commission and any person, other than efforts of Federal agencies to improve C. Self-Regulatory Organization’s those that may be withheld from the capital, business development Statement on Comments on the public in accordance with the opportunities and pre- established Proposed Rule Change Received From provisions of 5 U.S.C. 552, will be Federal contracting goals for small Members, Participants, or Others available for Web site viewing and business concerns owned and No written comments were either printing in the Commission’s Public controlled by veterans (VOB’s) and solicited or received. Reference Room, 100 F Street NE., service-disabled veterans (SDVOSB’S). III. Date of Effectiveness of the Washington, DC 20549 on official Moreover, the Task Force shall Proposed Rule Change and Timing for business days between the hours of coordinate administrative and Commission Action 10:00 a.m. and 3:00 p.m. Copies of such regulatory activities and develop filing also will be available for proposals relating to ‘‘six focus areas’’: The foregoing rule change has become inspection and copying at the principal (1) Access to capital (loans, surety effective pursuant to Section offices of the Exchange. All comments bonding and franchising); (2) Ensure 13 19(b)(3)(A)(ii) of the Act. received will be posted without change; achievement of pre-established At any time within 60 days of the the Commission does not edit personal contracting goals, including mentor filing of the proposed rule change, the identifying information from prote´ge´ and matching with contracting Commission summarily may submissions. You should submit only opportunities; (3) Increase the integrity temporarily suspend such rule change if information that you wish to make of certifications of status as a small it appears to the Commission that such available publicly. All submissions business; (4) Reducing paperwork and action is: (i) Necessary or appropriate in should refer to File Number SR– administrative burdens in accessing the public interest; (ii) for the protection NASDAQ–2015–052, and should be business development and of investors; or (iii) otherwise in submitted on or before June 9, 2015. entrepreneurship opportunities; (5) furtherance of the purposes of the Act. For the Commission, by the Division of Increasing and improving training and If the Commission takes such action, the counseling services; and (6) Making Commission shall institute proceedings Trading and Markets, pursuant to delegated authority.14 other improvements to support veteran’s to determine whether the proposed rule business development by the Federal should be approved or disapproved. Robert W. Errett, government. IV. Solicitation of Comments Deputy Secretary. Additional Information: Advance Interested persons are invited to [FR Doc. 2015–12015 Filed 5–18–15; 8:45 am] notice of attendance is requested. submit written data, views, and BILLING CODE 8011–01–P Anyone wishing to attend and/or make arguments concerning the foregoing, a presentation to the Task Force must including whether the proposed rule contact Cheryl Simms by June 5, 2015 change is consistent with the Act. SMALL BUSINESS ADMINISTRATION by email in order to be placed on the Comments may be submitted by any of agenda. Comments for the record should the following methods: Interagency Task Force on Veterans be applicable to the ‘‘six focus areas’’ of Small Business Development; Federal the Task Force and emailed prior to the Electronic Comments Register Meeting Notice meeting for inclusion in the public • Use the Commission’s Internet record. Comments will be limited to five AGENCY: comment form (http://www.sec.gov/ U.S. Small Business minutes in the interest of time and to rules/sro.shtml); or Administration. accommodate as many presenters as • Send an email to rule-comments@ ACTION: Notice of open Federal possible. Written comments should be sec.gov. Please include File Number SR– Interagency Task Force meeting. emailed to Cheryl Simms, Program NASDAQ–2015–052 on the subject line. Liaison for the Task Force, Office of DATES: Date and Time: June 11, 2015, Veterans Business Development at Paper Comments from 9:00 a.m. to 12:00 noon. [email protected]. If participants • Send paper comments in triplicate ADDRESSES: SBA Headquarters, 409 3rd need accommodations because of a to Brent J. Fields, Secretary, Securities Street SW., Washington, DC 20416, in disability or require additional and Exchange Commission, 100 F Street the Eisenhower Conference Room B, information, please contact Cheryl NE., Washington, DC 20549–1090. Concourse Level. Simms, Program Liaison at (202) 205- All submissions should refer to File SUMMARY: 6773, or by email at vetstaskforce@ Number SR–NASDAQ–2015–052. This Purpose: This public meeting is to sba.gov. For more information, please file number should be included on the discuss recommendations identified by visit our Web site at www.sba.gov/vets. subject line if email is used. To help the the Interagency Task Force (IATF) to Dated: May 8, 2015. further enable veteran entrepreneurship Commission process and review your Miguel J. L’Heureux, policy and programs. In addition, the comments more efficiently, please use SBA Committee Management Officer. only one method. The Commission will Task Force will allow public comment [FR Doc. 2015–12042 Filed 5–18–15; 8:45 am] post all comments on the Commission’s regarding the focus areas. Internet Web site (http://www.sec.gov/ SUPPLEMENTARY INFORMATION: Pursuant BILLING P rules/sro.shtml). Copies of the to section 10(a) (2) of the Federal submission, all subsequent Advisory Committee Act (5 U.S.C., SMALL BUSINESS ADMINISTRATION amendments, all written statements Appendix 2), SBA announces the with respect to the proposed rule meeting of the Interagency Task Force Meeting of the Advisory Committee on change that are filed with the on Veterans Small Business Veterans Business Affairs Commission, and all written Development. The Task Force is AGENCY: U.S. Small Business 13 15 U.S.C. 78s(b)(3)(A)(ii). 14 17 CFR 200.30–3(a)(12). Administration.

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ACTION: Notice of open Federal Advisory Dated: May 8, 2015. be reviewed at http://www.dot.gov/ Committee meeting. Miguel J. L’Heureux, privacy. SBA Committee Management Officer. Docket: Background documents or SUMMARY: The SBA is issuing this notice [FR Doc. 2015–12037 Filed 5–18–15; 8:45 am] comments received may be read at to announce the location, date, time, BILLING CODE P http://www.regulations.gov at any time. and agenda for the next meeting of the Follow the online instructions for Advisory Committee on Veterans accessing the docket or go to the Docket Business Affairs. The meeting will be DEPARTMENT OF TRANSPORTATION Operations in Room W12–140 of the open to the public. West Building Ground Floor at 1200 DATES: Wednesday, June 10, 2015 from Federal Aviation Administration New Jersey Avenue SE., Washington, 9 a.m. to 4 p.m. DC, between 9 a.m. and 5 p.m., Monday [Summary Notice No. 2015–15] through Friday, except Federal holidays. ADDRESSES: U.S. Small Business FOR FURTHER INFORMATION CONTACT: Administration, 409 3rd Street SW., Petition for Exemption; Summary of Keira Jones (202) 267–4024, Office of Washington, DC 20416. Petition Received; Gus Christopher Toulatos Rulemaking, Federal Aviation Room: Eisenhower Conference room Administration, 800 Independence A, located on the Concourse Level AGENCY: Federal Aviation Avenue SW., Washington, DC 20591. Floor. Administration (FAA), DOT. This notice is published pursuant to ACTION: Notice. SUPPLEMENTARY INFORMATION: Pursuant 14 CFR 11.85. to section 10(a) (2) of the Federal SUMMARY: This notice contains a Issued in Washington, DC, on May 14, Advisory Committee Act (5 U.S.C., summary of a petition seeking relief 2015. Appendix 2), SBA announces the from specified requirements of Title 14 Lirio Liu, meeting of the Advisory Committee on of the Code of Federal Regulations. The Director, Office of Rulemaking. Veterans Business Affairs. The Advisory purpose of this notice is to improve the Petition for Exemption Committee on Veterans Business Affairs public’s awareness of, and participation serves as an independent source of in, the FAA’s exemption process. Docket No.: FAA–2015–0646 advice and policy recommendation to Neither publication of this notice nor Petitioner: Gus Christopher Toulatos the Administrator of the U.S. Small the inclusion or omission of information Section(s) of 14 CFR Affected: §§ 61.17 Business Administration. in the summary is intended to affect the (b)(1), 61.39 (b)(1), and 61.156 Purpose: The full committee meeting legal status of the petition or its final Description of Relief Sought will focus on business opportunities for disposition. Mr. Toulatos seeks relief from veterans and service disabled veterans. DATES: Comments on this petition must § 61.17(b)(1) to allow for the Several topics include government identify the petition docket number and reinstatement of his expired temporary procurement and business development. must be received on or before June 8, airman certificate so that he may obtain For information regarding our veterans’ 2015. resources and partners, please visit our a permanent ATP certificate with an Web site at www.sba.gov/vets. ADDRESSES: Send comments identified airplane category multiengine class by docket number FAA–2015–0646 Additional Information: The meeting rating. Mr. Toulatos also requests relief using any of the following methods: is open to the public, however, advance from § 61.39(b)(1) to allow for the • Federal eRulemaking Portal: Go to notice of attendance is requested. validation of his successful completion http://www.regulations.gov and follow Anyone wishing to attend and/or make of the practical test for an ATP the online instructions for sending your a presentation to the Advisory certificate even though it was completed comments electronically. with an expired knowledge test report. Committee must contact Cheryl Simms, • Mail: Send comments to Docket As an alternative to the relief requested by June 4, 2015, by email below in order Operations, M–30; U.S. Department of to be placed on the agenda. Comments for §§ 61.17 and 61.39, Mr. Toulatos Transportation. seeks relief from § 61.156 to enable him for the Record including verbal • (DOT), 1200 New Jersey Avenue to apply for the knowledge test for an presentations, should be emailed prior SE., Room W12–140, West Building to the meeting for inclusion in the ATP certificate with an airplane Ground Floor, Washington, DC 20590– category multiengine class rating public record comments will be limited 0001. to five minutes in the interest of time • without completing the ATP CTP. Mr. Hand Delivery or Courier: Take Toulatos would then complete a new and to accommodate as many presenters comments to Docket Operations in as possible. Written comments should ATP certificate check. Room W12–140 of the West Building Project No.: AFS–15–877–E be emailed to Cheryl Simms, Program Ground Floor at 1200 New Jersey Liaison, Office of Veterans Business Project Officer: Avenue SE., Washington, DC, between 9 lllllllllllllllllll Development, U.S. Small Business a.m. and 5 p.m., Monday through Administration, 409 3rd Street SW., ARM–101:KJones:3/20/2015:Doc# Friday, except Federal holidays. 43190 Washington, DC 20416. • Fax: Fax comments to Docket ARM–1/100/104:Program Office AFS– Additionally, if participants need Operations at 202–493–2251. 200 accommodations because of a disability Privacy: In accordance with 5 U.S.C. or require additional information, please 553(c), DOT solicits comments from the MR. GREGORY WINSTON, ESQ. contact Cheryl Simms, Designated public to better inform its rulemaking COUNSEL FOR GUS TOULATOS Federal Official for the Advisory process. DOT posts these comments, GUS CHRISTOPHER TOULATOS Committee on Veterans Business Affairs without edit, including any personal 1977 ANNAPOLIS EXCHANGE at (202) 205–6773; or by email at information the commenter provides, to PARKWAY, SUITE 300 [email protected]. For more http://www.regulations.gov, as ANNAPOLIS, MARYLAND 21401 information, please visit our Web site at described in the system of records [FR Doc. 2015–12089 Filed 5–18–15; 8:45 am] www.sba.gov/vets. notice (DOT/ALL–14 FDMS), which can BILLING CODE 4910–13–P

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DEPARTMENT OF TRANSPORTATION individuals identified in this notice. All From 1993 until 2011, NCHRP 350 data and information must include the guidelines were used. The MASH was Federal Highway Administration docket number that appears in the published in 2009 and since January 1, [Docket No. FHWA–2015–0008] heading of this document. All data and 2011, all new or significantly changed information received will be available devices must meet the MASH criteria. Manual for Assessing Safety Hardware for examination and copying at the Not unlike other industries, each (MASH) Transition above address from 9 a.m. to 5 p.m., e.t., successive version of guidelines is Monday through Friday, except Federal meant to encourage manufacturers to AGENCY: Federal Highway holidays. Those desiring notification of advance the state of roadside safety Administration (FHWA), Department of receipt of data and information must hardware and to develop devices that Transportation (DOT). include a self-addressed, stamped work with a changing vehicle fleet ACTION: Notice; request for comment. postcard or you may print the under a wider range of conditions. acknowledgment page that appears after Because of the extensive development SUMMARY: In issuing Federal-aid submitting comments electronically. and testing required, it typically takes eligibility letters for roadside safety Anyone is able to search the electronic many years after roadside safety hardware, the Federal Highway form of all information in any one of our hardware guidelines are established for Administration (FHWA) currently dockets by the name of the individual products meeting those guidelines to be makes determinations of continued submitting the information (or signing widely available on the market. eligibility for modifications to devices the information, if submitted on behalf Accordingly, when AASHTO adopted tested to the National Cooperative of an association, business, or labor MASH, it did not intend or require that Highway Research Program Report 350 union). The DOT solicits comments devices designed to meet previous (NCHRP 350). In an effort to facilitate from the public to better inform its criteria would need to be retested to the implementation of the Manual for activities. The DOT posts these meet the newly developed criteria. Assessing Safety Hardware (MASH), comments, without edit, including any Instead, a new generation of devices FHWA intends to discontinue issuing personal information the commenter would need to be developed to meet the eligibility letters for requests received provides, to www.regulations.gov, as newly adopted criteria. In the six years after December 31, 2015, for modified described in the system of records since the MASH was published, NCHRP 350-tested devices that do not notice (DOT/ALL–14 FDMS), which can however, there have not been a involve full scale crash testing to the be reviewed at www.dot.gov/privacy. significant number of MASH-tested MASH. Modifications to NCHRP 350- FOR FURTHER INFORMATION CONTACT: devices developed and brought to tested devices that have, in the past, Michael Griffith, Office of Safety, 202– market. As a result and to encourage the been based on engineering analysis or 366–9469, [email protected], development and installation of MASH- finite element modeling will no longer Federal Highway Administration, 1200 compliant devices, FHWA and receive FHWA eligibility letters. New Jersey Avenue SE., Washington, AASHTO agree it is time to begin the Effective January 1, 2016, all changes to DC 20590. For legal questions, please transition to requiring that new NCHRP 350-tested devices will require contact Jennifer Mayo, Assistant Chief installations of roadway safety hardware testing under MASH in order to receive Counsel, FHWA Office of the Chief comply with the MASH criteria. a Federal-aid eligibility letter from Counsel, (202) 366–1523, or via email at FHWA. Purpose of This Notice [email protected], Federal DATES: Data and information must be Highway Administration, 1200 New The FHWA provides technical submitted to FHWA on or before June Jersey Avenue SE., Washington, DC assistance to States by issuing Federal- 18, 2015. 20590. aid eligibility letters for devices deemed ADDRESSES: Mail or hand deliver data SUPPLEMENTARY INFORMATION: crashworthy. The FHWA also makes and information to the U.S. Department determinations of continued eligibility of Transportation, Dockets Management Background for modified devices that have existing Facility, Room W12–140, 1200 New Guardrails, guardrail end terminals, eligibility letters. The purpose of this Jersey Avenue SE., Washington, DC and other roadside safety hardware are notice is to seek the input of industry, 20590, or fax comments to (202) 493– tested to criteria established by the State Departments of Transportation, 2251. Alternatively, you may submit or American Association of State Highway and the broader highway community on retrieve information online through the and Transportation Officials (AASHTO) the impact of FHWA no longer issuing Federal eRulemaking portal at http:// through its committee structure in eligibility letters after December 31, www.regulations.gov. The Web site is which FHWA participates. The States 2015, for modified NCHRP 350-tested available 24 hours each day, 365 days are guided by the AASHTO Roadside devices that do not involve full scale each year. Electronic submission and Design Guide (RDG) in their decisions crash testing to MASH. Modifications to retrieval help and guidelines are regarding what roadside safety hardware NCHRP 350-tested devices that have, in available under the help section of the to install on their roadways. In order for the past, been based on engineering Web site. An electronic copy of this a State to receive FHWA reimbursement analysis or finite element modeling will document may also be downloaded for roadside safety hardware, the no longer receive FHWA eligibility from the Government Printing Office’s hardware must be crashworthy, letters. Please provide any information Web site at: http://www.gpoaccess.gov meaning that it meets the testing and that FHWA should be aware of and the Office of the Federal Register’s evaluation guidelines in effect at the regarding impacts of this change. Web site at: http://www.archives.gov/ time that hardware was developed. By taking this action, FHWA believes federal_register. Please note that the Roadside safety hardware guidelines it will facilitate the implementation of Federal eRulemaking portal is unable to and testing criteria have evolved over MASH. Later this year, AASHTO is receive videos or any document larger the last several decades with changes in expected to take action regarding a than 10MB. If you would like to submit the vehicle fleet and the emergence of schedule for requiring that new a video or a document that is 10MB or new hardware designs. From 1981 until installations of roadway safety hardware larger, please directly contact one of the 1993, NCHRP 230 guidelines were used. comply with the MASH criteria.

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Authority: 23 U.S.C. 148 and 315. SUMMARY: This document grants in full exterior lights will flash if unauthorized Issued on: May 13, 2015. the Jaguar Land Rover North America entry is attempted by opening the hood, Gregory G. Nadeau, LLC’s, (Jaguar Land Rover) petition for doors or luggage compartment. Jaguar Deputy Administrator, Federal Highway an exemption of the Jaguar XF vehicle Land Rover’s submission is considered Administration. line in accordance with 49 CFR part a complete petition as required by 49 [FR Doc. 2015–12021 Filed 5–18–15; 8:45 am] 543, Exemption from the Theft CFR 543.7, in that it meets the general Prevention Standard. This petition is requirements contained in § 543.5 and BILLING CODE 4910–22–P granted because the agency has the specific content requirements of determined that the antitheft device to § 543.6. DEPARTMENT OF TRANSPORTATION be placed on the line as standard Jaguar Land Rover stated that the equipment is likely to be as effective in Smart Key is programmed and Federal Motor Carrier Safety reducing and deterring motor vehicle synchronized to the vehicle through Administration theft as compliance with the parts- means of an identification key code and marking requirements of the Theft a randomly generated secret code that Sunshine Act Meetings; Unified Carrier Prevention Standard (49 CFR part 541). are unique to each vehicle. Jaguar Land Registration Plan Board of Directors DATES: The exemption granted by this Rover further stated that the notice is effective beginning with model immobilizer device is armed AGENCY: Federal Motor Carrier Safety year (MY) 2016. automatically when the Smart Key is Administration (FMCSA), DOT. removed from the vehicle. FOR FURTHER INFORMATION CONTACT: Mr. ACTION: Notice of Unified Carrier Jaguar Land Rover also stated that Hisham Mohamed, Office of Registration Plan Board of Directors there are three methods the driver can International Policy, Fuel Economy and Meeting. approach the vehicle and start the Consumer Programs, NHTSA, W43–437, TIME AND DATE: The meeting will be engine. Method one is through 1200 New Jersey Avenue SE., held on June 10, 2015, from 9:00 a.m.to automatic detection of the Smart Key Washington, DC 20590. Mr. Mohamed’s 12:00 Noon, Eastern Daylight Time. via a remote frequency challenge phone number is (202) 366–0307. His response sequence. Jaguar stated that PLACE: This meeting will be open to the fax number is (202) 493–2990. public at the Read House Hotel, 827 when the driver approaches the vehicle SUPPLEMENTARY INFORMATION: In a Broad Street, Chattanooga, TN 37402 and pulls the driver’s door handle (after petition dated March 23, 2015, Jaguar and via conference call. Those not authentication of the correct Smart Key), Land Rover requested an exemption attending the meeting in person may the doors will unlock. Specifically, from the parts-marking requirements of call 1–877–422–1931, passcode when the ignition start button is the Theft Prevention Standard (49 CFR 2855443940, to listen and participate in pressed, a search to find and part 541) for the MY 2016 Jaguar XF this meeting. authenticate the Smart Key commences vehicle line. The petition requested an STATUS: Open to the public. within the vehicle interior. If successful, exemption from parts-marking pursuant this information is passed by a coded MATTERS TO BE CONSIDERED: The to 49 CFR part 543, Exemption from data transfer to the BCM via the Remote Unified Carrier Registration Plan Board Vehicle Theft Prevention Standard, Function Actuator. The BCM in turn, of Directors (the Board) will continue its based on the installation of an antitheft will pass the ‘‘valid key’’ status to the work in developing and implementing device as standard equipment for an instrument cluster, via a coded data the Unified Carrier Registration Plan entire vehicle line. transfer. The BCM sends the key valid and Agreement and to that end, may Under § 543.5(a), a manufacturer may message to the PCM which initiates a consider matters properly before the petition NHTSA to grant an exemption coded data transfer authorizing the Board. for one vehicle line per model year. In engine to start. Method two is FOR FURTHER INFORMATION CONTACT: Mr. its petition, Jaguar Land Rover provided accomplished by unlocking the vehicle Avelino Gutierrez, Chair, Unified a detailed description and diagrams of with the Smart Key unlock button. As Carrier Registration Board of Directors at the identity, design, and location of the the driver approaches the vehicle, the (505) 827–4565. components of the antitheft device for Smart Key unlock button is pressed and Issued on: May 12, 2015. the XF vehicle line. Jaguar Land Rover the doors will unlock. Once the driver Larry W. Minor, stated that its XF vehicles will be presses the ignition start button, the Associate Administrator, Office of Policy, equipped with a passive, transponder operation process is the same as method Federal Motor Carrier Safety Administration. based, electronic engine immobilizer one. Method three is accomplished by device as standard equipment beginning [FR Doc. 2015–12209 Filed 5–15–15; 4:15 pm] using the emergency key blade. If the with the 2016 model year. Key BILLING CODE 4910–EX–P Smart Key has a discharged battery or is components of its antitheft device will damaged, there is an emergency key include a power train control module blade that can be removed from the DEPARTMENT OF TRANSPORTATION (PCM), instrument cluster, body control Smart Key and used to unlock the doors. module (BCM), remote frequency When the ignition start button is National Highway Traffic Safety receiver (RFR), remote frequency pressed a search is commenced to find Administration actuator (RFA), immobilizer antenna and authenticate the Smart Key within unit (IAU), Smart Key, door control the vehicle. Once the Smart Key is Petition for Exemption From the units (DCU), and a visual and audible docked in the correct position and the Vehicle Theft Prevention Standard; perimeter alarm system. Jaguar Land ignition start button is pressed again, Jaguar Land Rover North America, Rover also stated that the audible and the BCM and Smart key completes a LLC visual perimeter alarm system will be coded data exchange via the IAU. If AGENCY: National Highway Traffic installed as standard equipment and can successful, the BCM passes the valid Safety Administration, NHTSA, be armed with the Smart Key or key status to the instrument cluster, via Department of Transportation, DOT. programmed to be passively armed. a coded data transfer. The BCM then Jaguar Land Rover further stated that the sends the key valid message to the PCM ACTION: Grant of petition for exemption. siren will sound and the vehicle’s which initiates a coded data transfer. If

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successful, the engine will be these low theft rates further demonstrate device is necessary in order to notify authorized to start. the effectiveness of its immobilizer law enforcement agencies of new In addressing the specific content device. Additionally, as further vehicle lines exempted from the parts- requirements of 543.6, Jaguar Land evidence of the effectiveness of its marking requirements of the Theft Rover provided information on the immobilizer device, Jaguar Land Rover Prevention Standard. reliability and durability of its proposed submitted a Highway Loss Data Institute If Jaguar Land Rover decides not to device. To ensure reliability and news release (July 19, 2000) showing an use the exemption for this line, it must durability of the device, Jaguar Land average reduction in theft losses of formally notify the agency. If such a Rover conducted tests based on its own about 50 percent for vehicles installed decision is made, the line must be fully specified standards. Jaguar Land Rover with an immobilizer device. marked according to the requirements provided a detailed list of the tests Based on the supporting evidence under 49 CFR parts 541.5 and 541.6 conducted (i.e., temperature and submitted by Jaguar Land Rover on its (marking of major component parts and humidity cycling, high and low device, the agency believes that the replacement parts). temperature cycling, mechanical shock, antitheft device for the XF vehicle line NHTSA notes that if Jaguar Land random vibration, thermal stress/shock is likely to be as effective in reducing Rover wishes in the future to modify the tests, material resistance tests, dry heat, and deterring motor vehicle theft as device on which this exemption is dust and fluid ingress tests). Jaguar Land compliance with the parts-marking based, the company may have to submit Rover stated that it believes that its requirements of the Theft Prevention a petition to modify the exemption. Part device is reliable and durable because it Standard (49 CFR 541). The agency 543.7(d) states that a part 543 exemption complied with specified requirements concludes that the device will provide applies only to vehicles that belong to for each test. Additionally, Jaguar Land the five types of performance listed in a line exempted under this part and Rover stated that its key recognition § 543.6(a)(3): promoting activation; equipped with the antitheft device on sequence includes more than a billion attracting attention to the efforts of an which the line’s exemption is based. code combinations, which include unauthorized person to enter or move a Further, part 543.9(c)(2) provides for the encrypted data that are secure against vehicle by means other than a key; submission of petitions ‘‘to modify an copying. Jaguar Land Rover also stated preventing defeat or circumvention of exemption to permit the use of an that the coded data transfer between its the device by unauthorized persons; antitheft device similar to but differing modules use a unique secure identifier, preventing operation of the vehicle by from the one specified in that a random number and a secure public unauthorized entrants; and ensuring the exemption.’’ algorithm. Jaguar Land Rover further reliability and durability of the device. The agency wishes to minimize the explained that since its XF vehicle line Pursuant to 49 U.S.C. 33106 and 49 administrative burden that part will utilize push button vehicle ignition, CFR 543.7 (b), the agency grants a 543.9(c)(2) could place on exempted petition for exemption from the parts- it does not have a conventional vehicle manufacturers and itself. The marking requirements of part 541 either mechanical key barrel and therefore agency did not intend in drafting part in whole or in part, if it determines that, believes that forcibly bypassing the key- 543 to require the submission of a based upon substantial evidence, the locking system would be virtually modification petition for every change standard equipment antitheft device is impossible. to the components or design of an Jaguar Land Rover also stated that the likely to be as effective in reducing and antitheft device. The significance of current generation Jaguar XF vehicle deterring motor vehicle theft as many such changes could be de line produced since MY 2009, is compliance with the parts-marking minimis. Therefore, NHTSA suggests installed with an engine immobilizer requirements of part 541. The agency that if the manufacturer contemplates device as standard equipment. Jaguar finds that Jaguar Land Rover has Land Rover noted that since the current provided adequate reasons for its belief making any changes, the effects of generation Jaguar XF vehicles have only that the antitheft device for its XF which might be characterized as de been available with an engine vehicle line is likely to be as effective minimis, it should consult the agency immobilizer, there is no comparative in reducing and deterring motor vehicle before preparing and submitting a data available for the XF vehicle line theft as compliance with the parts- petition to modify. without an immobilizer. However, marking requirements of the Theft Authority: 49 U.S.C. 33106; delegation of Jaguar Land Rover stated that the Prevention Standard (49 CFR part 541). authority at 49 CFR 1.50. immobilizer is substantially similar to This conclusion is based on the Under authority delegated in 49 CFR part the antitheft device installed on the information Jaguar Land Rover provided 1.95. Jaguar XK, Jaguar XJ, Land Rover LR2, about its device. Raymond R. Posten, Land Rover Range Rover Evoque, and For the foregoing reasons, the agency Associate Administrator for Rulemaking. hereby grants in full Jaguar Land Rover’s Land Rover Discovery Sport vehicle [FR Doc. 2015–12072 Filed 5–18–15; 8:45 am] lines previously granted an exemption petition for exemption for the Jaguar BILLING CODE 4910–59–P by the agency. Jaguar Land Rover stated Land Rover XF vehicle line from the that based on the MY 2012 final theft parts-marking requirements of 49 CFR data published by NHTSA, the Jaguar part 541. The agency notes that 49 CFR Land Rover vehicles equipped with part 541, Appendix A–1, identifies DEPARTMENT OF THE TREASURY immobilizers had a theft rate of 0.76 per those lines that are exempted from the thousand vehicles, comparatively below Theft Prevention Standard for a given Internal Revenue Service NHTSA’s overall theft rate of 1.13 thefts model year. 49 CFR part 543.7(f) per thousand vehicles for MY 2012 contains publication requirements Proposed Collection; Comment passenger vehicles stolen in CY 2012. incident to the disposition of all part Request for Form 3949–A The theft rates for the Jaguar XK, XJ, 543 petitions. Advanced listing, AGENCY: Internal Revenue Service (IRS), Land Rover Evoque, and Land Rover including the release of future product Treasury. LR2 using an average of 3 MY’s data are nameplates, the beginning model year ACTION: Notice and request for 1.0803, 0.9199, 0.5501 and 0.4141, for which the petition is granted and a comments. respectively. Jaguar Land Rover believes general description of the antitheft

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SUMMARY: The Department of the Books or records relating to a collection Please send separate comments for each Treasury, as part of its continuing effort of information must be retained as long specific information collection listed to reduce paperwork and respondent as their contents may become material below. You must reference the burden, invites the general public and in the administration of any internal information collection’s title, form other Federal agencies to take this revenue law. Generally, tax returns and number, reporting or record-keeping opportunity to comment on proposed tax return information are confidential, requirement number, and OMB number and/or continuing information as required by 26 U.S.C. 6103. (if any) in your comment. collections, as required by the Request for Comments: Comments FOR FURTHER INFORMATION CONTACT: To Paperwork Reduction Act of 1995, submitted in response to this notice will obtain additional information, or copies Public Law 104–13 (44 U.S.C. be summarized and/or included in the of the information collection and 3506(c)(2)(A)). Currently, the IRS is request for OMB approval. All instructions, or copies of any comments soliciting comments concerning Form comments will become a matter of received, contact Elaine Christophe, at 3949–A, Information Referral. public record. Comments are invited on: Internal Revenue Service, Room 6129, DATES: Written comments should be (a) Whether the collection of 1111 Constitution Avenue NW., received on or before July 20, 2015 to be information is necessary for the proper Washington, DC 20224, or through the assured of consideration. performance of the functions of the internet, at [email protected]. ADDRESSES: Direct all written comments agency, including whether the SUPPLEMENTARY INFORMATION: to Christie Preston, Internal Revenue information shall have practical utility; Request for Comments Service, room 6129, 1111 Constitution (b) the accuracy of the agency’s estimate Avenue NW., Washington, DC 20224. of the burden of the collection of The Department of the Treasury and information; (c) ways to enhance the FOR FURTHER INFORMATION CONTACT: the Internal Revenue Service, as part of quality, utility, and clarity of the Requests for additional information or their continuing effort to reduce information to be collected; (d) ways to copies of the form and instructions paperwork and respondent burden, minimize the burden of the collection of should be directed to R. Joseph Durbala, invite the general public and other information on respondents, including (202) 317–5746, or at Internal Revenue Federal agencies to take this through the use of automated collection Service, Room 6129, 1111 Constitution opportunity to comment on the techniques or other forms of information Avenue NW., Washington, DC 20224, or proposed or continuing information technology; and (e) estimates of capital through the internet at collections listed below in this notice, or start-up costs and costs of operation, [email protected]. as required by the Paperwork Reduction maintenance, and purchase of services Act of 1995, (44 U.S.C. 3501 et seq.). SUPPLEMENTARY INFORMATION: to provide information. Title: Information Referral. Request For Comments: Comments OMB Number: 1545–1960. Approved: May 11, 2015. submitted in response to this notice will Form Number: 3949–A. Christie Preston, be summarized and/or included in our Abstract: Form 3949–A is used by IRS Reports Clearance Officer. request for Office of Management and certain taxpayer/investors to wishing to [FR Doc. 2015–11998 Filed 5–18–15; 8:45 am] Budget (OMB) approval of the relevant information collection. All comments report alleged tax violations. The form BILLING CODE 4830–01–P will be designed capture the essential will become a matter of public record. information needed by IRS for an initial Please do not include any confidential evaluation of the report. Upon return, DEPARTMENT OF THE TREASURY or inappropriate material in your the Service will conduct the same back- comments. end processing required under present Internal Revenue Service We invite comments on: (a) Whether IRM guidelines. Submission of the the collection of information is information to be included on the form Proposed Information Collection; necessary for the proper performance of is entirely voluntary on the part of the Comment Request the agency’s functions, including whether the information has practical caller and is not a requirement of the AGENCY: Internal Revenue Service (IRS), utility; (b) the accuracy of the agency’s Tax Code. Treasury. Current Actions: There is no change estimate of the burden of the collection ACTION: Notice and request for in the paperwork burden previously of information; (c) ways to enhance the comments. approved by OMB. This form is being quality, utility, and clarity of the submitted for renewal purposes only. SUMMARY: The Department of the information to be collected; (d) ways to Type of Review: Extension of a Treasury, as part of its continuing effort minimize the burden of the collection of currently approved collection. to reduce paperwork and respondent information on respondents, including Affected Public: Individuals and burden, invites the general public and the use of automated collection Households. other Federal agencies to take this techniques or other forms of information Estimated Number of Respondents: opportunity to comment on proposed technology; and (e) estimates of capital 215,000. and/or continuing information or start-up costs and costs of operation, Estimated Time per Respondent: 15 collections, as required by the maintenance, and purchase of services minutes. Paperwork Reduction Act of 1995, to provide the requested information. Estimated Total Annual Burden Public Law 104–13 (44 U.S.C. Currently, the IRS is seeking comments Hours: 53,750. 3506(c)(2)(A)). concerning the following forms, and The following paragraph applies to all reporting and record-keeping of the collections of information covered DATES: Written comments should be requirements: by this notice: received on or before July 20, 2015 to be Title: Income, Excise, and Estate and An agency may not conduct or assured of consideration. Gift Taxes Effective Dates and Other sponsor, and a person is not required to ADDRESSES: Direct all written comments Issues Arising Under the Employee respond to, a collection of information to Christie A. Preston, Internal Revenue Benefit Provisions of the Tax Reform unless the collection of information Service, Room 6129, 1111 Constitution Act of 1984. displays a valid OMB control number. Avenue NW., Washington, DC 20224. OMB Number: 1545–0916.

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Regulation Project Number: T.D. 8073 Approved: May 11, 2015. Current Actions: There are no changes (temporary regulations) and EE–96–85 Christie A. Preston, to the burden previously approved by (noticed of proposed rulemaking). IRS Reports Clearance Officer. OMB. Abstract: The regulations provide [FR Doc. 2015–12127 Filed 5–18–15; 8:45 am] Type of Review: Extension of a rules relating to effective dates and BILLING CODE 4830–01–P currently approved collection. certain other issues arising under sections 91, 223, and 511–561 of the Tax Affected Public: Business or other for- profit organizations. Reform Act of 1984. The regulations DEPARTMENT OF THE TREASURY affect qualified employee benefit plans, Estimated Number of Responses: welfare benefit funds, and employees Internal Revenue Service 1,700. receiving benefits through such plans. Estimated Number of Respondents: 34 Proposed Collection; Comment Current Actions: There are no changes hours, 3 minutes. being made at this time. Request for Form 5452 Type of Review: Extension of a Estimated Total Annual Burden AGENCY: Internal Revenue Service (IRS), currently approved collection. Hours: 57,885. Treasury. Affected Public: Business or other for- The following paragraph applies to all profit organizations, not-for-profit ACTION: Notice and request for of the collections of information covered institutions, and individuals. comments. by this notice: Estimated Number of Respondents: SUMMARY: The Department of the An agency may not conduct or 7,800. Treasury, as part of its continuing effort sponsor, and a person is not required to Estimated Time per Respondent: 31 to reduce paperwork and respondent respond to, a collection of information minutes. burden, invites the general public and unless the collection of information Estimated Total Annual Burden other Federal agencies to take this displays a valid OMB control number. Hours: 4,000. opportunity to comment on proposed Books or records relating to a collection Title: Excise Tax Under Section and/or continuing information of information must be retained as long 4980B, 4980D, 4980E & 4980G. collections, as required by the as their contents may become material OMB Number: 1545–2146. Paperwork Reduction Act of 1995, in the administration of any internal Regulation Project Number: TD 9457 Public Law 104–13 (44 U.S.C. revenue law. Generally, tax returns and (REG–120476–07). 3506(c)(2)(A)). Currently, the IRS is Abstract: This final regulation provide tax return information are confidential, soliciting comments concerning Form the requirement for filing of the return as required by 26 U.S.C. 6103. 5452, Corporate Report of Nondividend and the time for filing a return for the Request for Comments: Comments Distributions. payment of the excise taxes under submitted in response to this notice will section 4980B, 4980D, 4980E, and DATES: Written comments should be be summarized and/or included in the 4980G. received on or before July 20, 2015 to be request for OMB approval. All Current Actions: There is no change to assured of consideration. comments will become a matter of this existing regulation. ADDRESSES: Direct all written comments public record. Comments are invited on: Type of Review: Extension of a to Christie Preston, Internal Revenue (a) Whether the collection of currently approved collection. Service, Room 6129, 1111 Constitution information is necessary for the proper Affected Public: Business or other for- Avenue NW., Washington, DC 20224. performance of the functions of the profit organizations, not-for-profit FOR FURTHER INFORMATION CONTACT: agency, including whether the organizations, and individuals. Requests for additional information or information shall have practical utility; Estimated Number of Respondents: copies of the form and instructions (b) the accuracy of the agency’s estimate 5,000. should be directed to R. Joseph Durbala of the burden of the collection of Estimated Time per Respondent: .50 at Internal Revenue Service, Room 6129, information; (c) ways to enhance the hours. 1111 Constitution Avenue NW., quality, utility, and clarity of the Estimated Total Annual Burden Washington, DC 20224, or at (202) 317– information to be collected; (d) ways to Hours: 2,500. 5746, or through the internet at minimize the burden of the collection of The following paragraph applies to all [email protected]. information on respondents, including of the collections of information covered SUPPLEMENTARY INFORMATION: through the use of automated collection by this notice: Title: Corporate Report of techniques or other forms of information An agency may not conduct or sponsor, Nondividend Distributions. technology; and (e) estimates of capital and a person is not required to respond to, OMB Number: 1545–0205. or start-up costs and costs of operation, a collection of information unless the Form Number: 5452. maintenance, and purchase of services collection of information displays a valid Abstract: Form 5452 is used by to provide information. OMB control number. Books or records corporations to report their nontaxable relating to a collection of information must distributions as required by Internal Approved: May 11, 2015. be retained as long as their contents may Christie Preston, become material in the administration of any Revenue Code section 604(d)(2). The IRS, Reports Clearance Office. internal revenue law. Generally, tax returns information is used by IRS to verify that and tax return information are confidential, the distributions are nontaxable as [FR Doc. 2015–12002 Filed 5–18–15; 8:45 am] as required by 26 U.S.C. 6103. claimed. BILLING CODE 4830–01–P

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Part II

Department of Labor

Office of the Secretary 29 CFR Part 18 Rules of Practice and Procedure for Administrative Hearings Before the Office of Administrative Law Judges; Final Rule

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DEPARTMENT OF LABOR promulgated its rules in 1983. full notice and comment protections of Moreover, the need to update the the APA. One commenter argued that Office of the Secretary OALJ’s procedural rules was evident as because the rules contain provisions for the OALJ’s authority to hear sanctions, they ‘‘substantially alter the 29 CFR Part 18 whistleblower cases increased. The new rights and interests of parties’’ which RIN 1290–AA26 procedural rules are analogous to the triggers the APA’s requirements for FRCP used in the United States district public notice and comment. This Rules of Practice and Procedure for courts and are intended to provide more comment principally relied on the Administrative Hearings Before the guidance and clarity to parties vacated decision of the Court of Appeals Office of Administrative Law Judges practicing before the OALJ. for the District of Columbia in Air The Department provided an Transp. Ass’n of Am. v. Dep’t of AGENCY: Office of the Secretary, Labor. opportunity for the public to comment Transp., 900 F.2d 369 (1990), cert. ACTION: Final rule. even though the changes are to rules of granted, 498 U.S. 1023 (1991), vacated, agency organization, procedure and 933 F.2d 1043 (1991). The other SUMMARY: This is the final text of practice, which are exempt from the commenter stated that the OALJ rules of regulations governing practice and notice and public comment practice and procedure constitute procedure for proceedings before the requirements of the Administrative agency rules with the ‘‘force and effect United States Department of Labor, Procedure Act (APA). See 5 U.S.C. of law’’ that must be published for Office of Administrative Law Judges 553(b)(3)(A). The comment period public comment in accordance with the (OALJ). The regulations were first ended on February 4, 2013. The Supreme Court’s decisions in United published as a final rule in 1983 and Department reviewed and responded to States v. Mead Corp., 533 U.S. 218 were modeled on the Federal Rules of each pertinent comment submitted. See (2001), and Christensen v. Harris Cnty., Civil Procedure (FRCP). A Notice of infra Part 3. Accordingly, the NPRM 529 U.S. 576 (2000). Proposed Rulemaking was published in amending 29 CFR part 18, subpart A, The Department disagrees with these the Federal Register on December 4, that was published on December 4, claims. In decisions issued subsequent 2012 requesting public comment on 2012, is being adopted as a final rule to its vacated ruling in Air Transp. proposed revisions to and with the changes made below. Ass’n of Am., the D.C. Circuit has reorganization of these regulations. The The Department has found that a stressed that the ‘‘ ‘critical feature’ ’’ of a revisions make the regulations more handful of departmental specific rule that satisfies the so-called accessible and useful to parties. The program regulations reference these ‘‘procedural exception ‘is that it covers revisions also harmonize administrative rules, and that these references may agency actions that do not themselves hearing procedures with the current now be inaccurate due to shifts in alter the rights or interests of parties, FRCP and with the types of claims now numbering. The Department plans to although it may alter the manner in heard by OALJ, which increasingly correct these references in the near which the parties present themselves or involve whistleblower and other future through technical corrections, their viewpoints to the agency.’ ’’ James workplace retaliation claims, in which will be published in the Federal V. Hurson Assoc., Inc. v. Glickman, 229 addition to a longstanding caseload of Register. F.3d 277, 280 (2000) (quoting JEM Broad occupational disease and injury claims. II. Summary of General Comments on Co. v. FCC, 22 F.3d 320, 326 (D.C. Cir. The Department received sixteen the Notice of Proposed Rulemaking 1994)). The Court further held in comments to the proposed rule. This Hurson that ‘‘an otherwise procedural rule responds to those comments and The Department received several rule does not become a substantive one, establishes the final text of the revised general comments regarding the for notice and comment purposes, regulations. proposed changes to the OALJ rules of simply because it imposes a burden on practice and procedure. Each comment DATES: regulated parties.’’ Id. at 281. As nothing is addressed as follows: in the new rules alters the ‘‘substantive Effective Date: This rule is effective Compliance with the APA. The June 18, 2015. criteria’’ by which claims and Department stated in the NPRM that complaints are adjudicated in the Compliance Date: This rule is while the proposed changes consist of effective June 18, 2015. hearing before the OALJ, they are within amendments to rules of agency the procedural rules exemption. See id. FOR FURTHER INFORMATION CONTACT: organization, procedure and practice at 280–81; JEM Broad Co., 22 F.3d at Todd Smyth at the U.S. Department of that are exempt from the notice and 237; Nat’l Whistleblower Ctr. v. Nuclear Labor, Office of Administrative Law public comment requirements of the Regulatory Comm’n, 208 F.3d 256, 262 Judges, 800 K Street NW., Suite 400- APA, the Department wished to provide (D.C. Cir. 2000), cert. denied, 531 U.S. North, Washington, DC 20001–8002; the public with an opportunity to 1070 (2001). The Supreme Court’s telephone (202) 693–7300. comment on any aspect of the proposed decisions in Mead Corp. and SUPPLEMENTARY INFORMATION: rule. Accordingly, the proposed changes Christensen cited by the other were published in the Federal Register, I. Background commenter respectively address and public comment was invited. Two whether a U.S. Customs Service On December 4, 2012, the Department commenters challenged the classification ruling and Department of published a Notice of Proposed Department’s reference to the APA’s Labor opinion letter, neither of which Rulemaking (NPRM) with a request for procedural rules exception and claimed were issued after APA notice and comments amending 29 CFR part 18, that the Department thus misinformed comment rulemaking, are entitled to subpart A. Rules of Practice and the public and chilled the pool of public deference under Chevron, U.S.A., Inc. v. Procedure for Hearings Before the Office comment on the proposed rule changes. Natural Res. Def. Council, Inc., 467 U.S. of Administrative Law Judge, 77 FR These commenters asserted that the 837 (1984). These decisions do not 72142 (Dec. 4, 2012). The Department public harm resulting from this alleged address the scope of the APA’s proposed to amend comprehensively its error could only be remedied by procedural rules exception. procedural rules to reflect the changes withdrawing the proposed rules and The Department moreover voluntarily to civil litigation since the OALJ reissuing them in conformity with the published the rule changes in

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accordance with the notice and evidence or by technical or formal rules conflict between section 926 and any of comment requirements of the APA of procedure, except as provided by this the new rules. consistent with the procedure chapter; but may make such Section 927(b) in relevant part recommended by the Administrative investigation or inquiry or conduct such provides that if any person in a LHWCA Conference of the United States to avoid hearing in such manner as to best proceeding ‘‘disobeys or resists any controversy over the scope of the APA’s ascertain the rights of the parties.’’ 33 lawful order or process, or misbehaves notice and comment exceptions. See U.S.C. 923(a). See also 20 CFR 702.339, during a hearing or so near the place The Procedural and Practice Rule 725.455(b). The Benefits Review Board thereof as to obstruct the same, or Exemption from the APA Notice-and- (BRB) and courts of appeals have neglects to produce, after having been Comment Rulemaking Requirements, 1 nevertheless applied provisions of the ordered to do so, any pertinent book, CFR 305.92–1 (1995) (ACUS OALJ Rules of Practice and Procedure, paper, or document, or refuses to appear Recommendation 92–1, available at particularly in regard to discovery after having been subpoenaed, or upon www.acus.gov/sites/default/files/ issues, in proceedings governed by appearing refuses to take the oath as a documents/92-1/pdf). The commenters section 923(a) of the LHWCA in the witness, or after having taken the oath provided no evidence to support their absence of any conflict with a particular refuses to be examined according to claim that the Department’s voluntary LHWCA or BLBA rule. See, e.g., law,’’ the adjudicatory official ‘‘shall compliance with the APA’s notice and Johnson v. Royal Coal Co., 326 F.3d 421, certify the facts to the district court comment requirements in accordance 426 (4th Cir. 2003); Keener v. Peerless having jurisdiction in the place in with the ACUS recommendation in any Eagle Coal Co., 23 Black Lung Rep. which he is sitting (or to the United manner chilled or otherwise influenced (Juris) 1–229, 1–243 (Ben. Rev. Bd. States District Court for the District of public comment. They also cited no Columbia’’ for summary contempt legal authority for their position that the 2007) (en banc); Cline v. Westmoreland Coal Co., 21 Black Lung Rep. (Juris) 1– proceedings). 33 U.S.C. 927(b). The Department’s mere reference to the Department agrees with the commenters procedural rules exception vitiated the 69, 1–76 (Ben. Rev. Bd. 1997); see also Prince v. Island Creek Coal Co., BRB No. that section 927(b) provides the district NPRM. The Department’s receipt of courts with the exclusive power to multiple comments indicates that the 01–0448 BLA, 2002 WL 34707263 (Ben. Rev. Bd. Jan. 24, 2002) (reading 29 CFR punish contumacious conduct public was neither ‘‘chilled’’ nor consisting of a refusal to comply with a deterred from submitting items for 18.14 and 20 CFR 725.455 as judge’s order, lawful process or consideration. Thus, there is no basis for complementary rules providing the ALJ subpoena, or hearing room misbehavior withdrawing and reissuing the rules with broad discretion to direct in proceedings under the LHWCA. See changes. discovery), aff’d, 76 Fed.Appx. 67, 2003 Conflicts with the LHWCA and BLBA. WL 22176988 (6th Cir. Sept. 19, 2003). Goicochea v. Wards Cove Packing Co., Two commenters argued that several It would be inappropriate and contrary 37 Ben. Rev. Bd. Serv. (MB) 4, 6 (2003) provisions in the new rules providing to well-established precedent to add a (vacating dismissal of claim as sanction for imposition of sanctions conflict with textual exception to all of the proposed for claimant’s refusal to comply with a provisions of the Longshore and Harbor disclosure and discovery rules for judge’s discovery order). To the extent Workers’ Compensation Act (LHWCA), LHWCA and BLBA cases. Moreover, that any of the new rules conflict with 33 U.S.C. 901–950, which are also § 18.10(a) provides that ‘‘[t]o the extent section 927(b), the latter controls. See 29 applicable to claims adjudicated under that these rules may be inconsistent CFR 18.10(a). However, there are several the Black Lung Benefits Act (BLBA), 30 with a governing statute, regulation, or situations addressed by the new rules U.S.C. 901–945, and therefore those executive order, the latter controls.’’ 29 involving conduct that likely would fall provisions should either be deleted or CFR 18.10(a). outside the categories of contumacy rewritten to specifically state that they requiring certification to a district court Section 926 of the LHWCA provides for a section 927(b) summary contempt are not applicable to proceedings under that ‘‘[i]f the court having jurisdiction of the LHWCA and BLBA. The proceeding. See A–Z Intn’l v. Phillips, proceedings in respect of any claim or commenters identified sections 926, 323 F.3d 1141, 1146–47 (9th Cir. 2003) compensation order determines that the 927(b) and 931 of the LHWCA, 33 U.S.C. (holding that the district court lacked proceedings in respect of such claim or 926, 927(b), 931, as conflicting with the section 927(b) jurisdiction over conduct order have been instituted or continued new rules containing sanction that did not involve a refusal ‘‘to provisions. One commenter also without reasonable ground, the costs of comply with a summons, writ, warrant, suggested that some of the new rules such proceedings shall be assessed or mandate issued by the ALJ’’). See, may contravene section 923(a) of the against the party who has so instituted e.g., 29 CFR 18.35(c) (sanctions for LHWCA, 33 U.S.C. 923(a). The or continued such proceedings.’’ 33 violations of § 18.35(b) relating to the Department believes however that any U.S.C. 926. Congress intended claimants representations made when presenting a conflicts between the rules and the to be subject to costs ‘‘if they brought motion or other paper to the judge), LHWCA and, for that matter, any other their unreasonable claims into court’’ 18.50(d)(3) (sanctions for violations of statute governing administrative hearing when it enacted section 926. Metro. § 18.50(d)(1) pertaining to certifications proceedings before the OALJ, are Stevedore Co. v. Brickner, 11 F.3d 887, made when signing disclosures and already addressed appropriately in the 890 (9th Cir. 1993). The Department discovery requests, responses and rules and do not warrant either recognizes that federal courts have the objections), 18.56(d)(1) (sanctions for wholesale rescission or rewriting. The exclusive power to impose section 926 violations of the duty under Department also believes that the sanctions when a party brings a § 18.56(c)(1) to protect a person subject commenters overstated the alleged frivolous claim under the LHWCA. Id. at to a subpoena from undue burden), conflicts between the new rules and the 890–91; see also Boland Marine & Mfg. 18.57(c) (sanctions for failures to LHWCA. Co. v. Rihner, 41 F.3d 997, 1004 (5th disclose information, supplement an Section 923(a) of the LHWCA Cir. 1995). However, to the extent that earlier response or to admit as required provides that officials conducting any of the new rules conflict with by §§ 18.50(c), 18.53 and 18.63(a)), hearings ‘‘shall not be bound by section 926, the latter controls. See 29 18.57(d) (sanctions for a party’s failure common law or statutory rules of CFR 18.10(a). There is therefore no to attend its own deposition, serve

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answers to interrogatories, or respond to under which magistrate judges have Choosing which portions to adopt and a request for inspection), 18.64(d)(2) general authority to order non- which to omit allows for flexible case (sanctions for impeding, delaying or dispositive discovery sanctions while management, given the less formal frustrating a deposition), 18.64(g) contempt charges must be referred to a nature of administrative proceedings, (sanctions for failing to attend or district court judge. See Grimes v. City which never involve juries. These proceed with a deposition or serve a and County of San Francisco, 951 F. 2d changes offer greater clarity and subpoena on a non-party deponent 236, 240–41 (9th Cir. 1991) (discussing uniformity so parties can focus on the when another party, expecting the the scope and limits of magistrate merits of their disputes with less deposition to be taken, attends), judges’ sanction authority); see also distraction from litigating points of 18.72(h) (sanctions for submitting in bad Dodd v. Crown Cent. Petroleum Corp., procedure. To attain these objectives, faith an affidavit or declaration in 36 Ben. Rev. Bd. Serv. (MB) 85, 89 n.6 the new rules contain a number of support of or in opposition to a motion (2002) (affirming, as not inconsistent provisions, similar to their FRCP for summary decision). To the extent with section 927(b), judge’s imposition counterparts, which authorize judges to these provisions address violations of of sanctions pursuant to 29 CFR take actions necessary to regulate and the procedural rules falling outside the 18.6(d)(2) for claimant’s noncompliance ensure the integrity of the hearing scope of section 927(b), there is no with a discovery order). The Department process. See 29 CFR 18.12(b)(10), conflict with the statute. therefore believes that the commenters’ 18.35(c), 18.50(d)(3), 18.56(c)(1), The Department also rejects the proposal to exempt LHWCA and BLBA 18.57(a)(2)(A), 18.57(b), 18.57(c), commenters’ argument that section proceedings from the judge’s authority 18.57(d)(1), 18.57(d)(3), 18.57(e), 927(b) provides the exclusive remedy under the APA to regulate the course of 18.57(f), 18.64(d)(2), 18.64(g), 18.72(h), for any misconduct or rules violation the hearing is neither warranted by the 18.87. Two commenters asserted that occurring in LHWCA and BLBA statute nor consistent with the efficient these litigation sanction provisions proceedings. Section 927(b), 44 Stat. and impartial conduct of administrative exceed a judge’s authority under the 1438 (Mar. 4, 1927) (codified as hearings. APA, and attempt to arrogate contempt Section 931(a)(1) of the LHWCA amended at 33 U.S.C. 927), was power and claim ‘‘inherent judicial provides that ‘‘[a]ny claimant or originally enacted in 1927, decades authority’’ that is vested exclusively in representative of a claimant who before the passage of the APA which the Article III courts. The Department knowingly and willfully makes a false also governs adjudications under the believes these assertions misunderstand statement or representation for the the challenged rules and their intent. LHWCA and the BLBA. 33 U.S.C. purpose of obtaining a benefit or 919(d); 30 U.S.C. 932(a); Dir., OWCP, payment under this chapter shall be The prior rules authorized judges to Dep’t of Labor v. Greenwich Collieries, guilty of a felony, and on conviction sanction a broad range of inappropriate 512 U.S. 267, 280–81 (1994); see also thereof shall be punished by a fine not conduct during the course of an Lane v. Hollow Coal Co. v. Dir., OWCP, to exceed $10,000, by imprisonment not administrative proceeding. A judge Dep’t of Labor, 137 F.3d 799, 802–03 to exceed five years, or by both.’’ 33 could overrule an objection to a (4th Cir. 1998) (requiring ALJ’s decision U.S.C. 931(a)(1). Section 931(c) discovery request (such as request for to contain findings and conclusions, in similarly provides that ‘‘[a] person admission or an interrogatory) and accordance with 5 U.S.C. 557(c)(3)(A)); including, but not limited to, an compel a response. 29 CFR 18.6(d)(1). If Cole v. East Kentucky Collieries, 20 employer, his duly authorized agent, or that objecting party thereafter failed to Black Lung Rep. (Juris) 1–50, 1–54 (Ben. an employee of an insurance carrier answer or answered evasively, the judge Rev. Bd. 1996) (discussing statutory who knowingly and willfully makes a could order that a matter be treated as mechanism whereby APA applies to false statement or representation for the admitted. Id. If a party failed to comply BLBA claims); Toyer v. Bethlehem Steel purpose of reducing, denying, or with a subpoena, discovery order or any Corp., 28 Ben. Rev. Bd. Serv. (MB) 347, terminating benefits to an injured other order, the judge could take other 351 (1994) (emphasizing APA employee, or his dependents pursuant just actions, including (i) drawing applicability in all LHWCA to section 909 of this title if the injury adverse inferences; (ii) ruling that the adjudications). Notably, the APA’s grant results in death, shall be punished by a matter concerning which the subpoena of authority to ‘‘regulate the course of fine not to exceed $10,000, by or order was issued be taken as the hearing,’’ 5 U.S.C. 556(c)(5), imprisonment not to exceed five years, established adversely to a non- provides a judge with an independent or by both.’’ 33 U.S.C. 931(c). As there complying party; (iii) excluding basis to take such actions as are is no provision in the new rules that evidence a non-complying party offered; necessary to ensure parties a fair and authorizes a judge to impose a fine or (iv) ruling that a non-complying party impartial adjudication. Such authority other penalty for a knowing and could not object to the use of secondary includes the power to compel discovery willfully false statement or evidence to establish what evidence it and impose sanctions for non- representation for the purpose of withheld should have shown; or (v) compliance pursuant to the OALJ rules obtaining or opposing a benefit under ruling that all or part of a pleading be of practice and procedure. See Williams the LHWCA, there is no conflict stricken, or that a decision be rendered v. Consolidation Coal Co., BRB No. 04– between section 931 and any of the new against the non-complying party. 29 0756 BLA, 2005 WL 6748152, at *8 rules. CFR 18.6(d)(2). The prior rules also (Ben. Rev. Bd. Aug. 8, 2005), appeal Authority to Regulate the Conduct of recognized that judges have ‘‘all powers denied, 453 F.3d 609 (4th Cir. 2006), Administrative Proceedings; Sanctions. necessary to the conduct of fair and cert. denied, 549 U.S. 1278 (2007). The The Department announced in the impartial hearings including, but not bifurcation of general adjudicatory NPRM that it intended to bring the limited to . . . [w]here applicable, take authority and contempt powers between OALJ rules of practice and procedure any appropriate action authorized by administrative law judges and the into closer alignment with the FRCP. the Rules of Civil Procedure for the district courts under the LHWCA is Doing so takes advantage of the mature United States District Courts, issued analogous to adjudication in the federal precedent the federal courts have from time to time and amended courts after passage of the Federal developed and the broad experience pursuant to 28 U.S.C. 2072. . . .’’ 29 Magistrates Act, 28 U.S.C. 604, 631–39, they have in applying the FRCP. CFR 18.29(a)(8). The new rules preserve

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this longstanding authority to impose the new rules use the term ‘‘sanction’’ substantive statute applicable to the appropriate litigation sanctions, see 29 to describe remedies that can be applied proceeding for procedural violations CFR 18.12(b)(10), 18.57(b), and when a party fails to fulfill its duties, that frustrate efficient administrative additional provisions for sanctions were these remedies do not extend to the full adjudication. The Department’s ALJs made as discussed above in §§ 18.35(c), panoply of powers available to Article used a broad range of sanctions for the 18.50(d)(3), 18.56(c)(1), 18.57(c), III judges under their inherent powers or nearly 30 years under the prior rules, 18.57(d), 18.64(d)(2), 18.64(g), 18.72(h). under FRCP 11, which encompass the including the dismissal of a claim or The new rules provide greater clarity authority to require an errant lawyer to defense, as well as lesser evidentiary and direction on the scope and participate in seminars or education sanctions. Curley v. Grand Rapids Iron limitations on a judge’s authority to programs, or order a fine payable to the & Metal Co., ARB No. 00–013, ALJ No. sanction a party’s unjustified failure to court. See Fed. R. Civ. P. 11 advisory 1999–STA–39 (ARB Feb. 9, 1999) carry out duties that the procedural committee’s note (discussion of 1993 (affirming ALJ’s authority to dismiss rules establish. amendments). employment protection claim for The Department’s appellate boards Nonetheless, the APA empowers abandonment, based on complainant’s and judges have no Article III status or ALJs, ‘‘[s]ubject to published rules of the failure to participate in prehearing powers. See, e.g., Temp. Emp’t Serv. v. agency and within its powers . . . to conference or reply to order to show Trinity Marine Group, Inc., 261 F.3d regulate the course of a hearing.’’ 5 cause why the matter should not be 456, 460–61 (5th Cir. 2001); Schmit v. U.S.C. 556(a)(3), (c)(5). That authority is dismissed for failure to comply with a ITT Fed. Elec. Int’l, 986 F.2d 1103, statutorily explicit. The appellate courts lawful order); see also Dodd v. Crown 1109–10 (7th Cir. 1993); Gibas v. moreover have upheld orders that Cent. Petroleum Corp., BRB No. 02– Saginaw Mining Co., 748 F.2d 1112, impose litigation sanctions on parties 0821, slip op. at 9–10 (Ben. Rev. Bd. 1117 (6th Cir. 1984). The APA vests no who violate an administrative agency’s Aug. 7, 2003) (affirming the dismissal contempt powers in ALJs. The procedural rules. See Roadway Exp., for abandonment of a pro se litigant’s Department acknowledges that FRCP 11 Inc. v. U.S. Dept. of Labor, 495 F.3d 477, claim under the authority of 29 CFR itself does not vest ALJs with authority 484 (7th Cir. 2007) (‘‘[A]gency’s rules 18.29(a), which affords ALJs ‘‘all to impose the sanctions embodied in unambiguously permit the ALJ to necessary powers to conduct fair and that rule because it is a rule of the impose, as a discovery sanction, an impartial hearings and to take any Article III trial courts. Nor was it clear order excluding evidence that a non- appropriate action authorized by the whether FRCP 11 had been generally complying party wishes to introduce in Federal Rules of Civil Procedure,’’ incorporated into the prior rules by 29 support of its claim.’’); In re Bogese, 303 where claimant failed to attend the final CFR 18.1(a). Metro. Stevedore Co. v. F.3d 1362, 1367–68 (Fed. Cir. 2002) hearing, stated he would not participate, Brickner, 11 F.3d 887, 891 (9th Cir. (Patent and Trademark Office, like other sustained objections to discovery the 1993) (expressing in dicta doubts about administrative agencies, may impose claimant sought, and denied the incorporation). FRCP 11 was reasonable deadlines and requirements claimant’s motion to recuse the ALJ); unavailable for incorporation in on parties appearing before it and has Matthews v. LaBarge, Inc., ARB No. 08– Longshore claims, however. Boland broad authority to sanction undue delay 038, ALJ No. 2007–SOX–56 (ARB Nov. Marine & Mfg. Co. v. Rihner, 41 F.3d by holding a patent unenforceable); 26, 2008) (adopting ALJ’s decision to 997 (5th Cir. 1995) (Section 26 of the Atlantic Richfield Co. v. U.S. Dep’t of dismiss under 29 CFR 18.6(d)(2) Longshore Act confines an award of Energy, 769 F.2d 771, 793 (D.C. Cir. because ALJ found that pro se costs when proceedings are ‘‘instituted 1984) (rejecting argument that complainant failed to comply with or continued without reasonable administrative agency ‘‘cannot impose discovery orders repeatedly, willfully, grounds’’ to proceedings that have made evidentiary sanctions—of course, short intentionally, and in bad faith); their way into the Article III courts. of a fine or imprisonment—when Administrator v. Global Horizons Therefore, neither FRCP 11 nor section necessary to preserve the integrity of an Manpower, Inc., ARB No. 09–016, ALJ 26(f) may be incorporated into authorized adjudicative proceeding’’). No. 2008–TAE–3 (ARB Dec. 21, 2010) Longshore Act proceedings at the As the court of appeals in Atlantic (affirming ALJ’s order granting, as a Department through the text of 29 CFR Richfield Co. stated, discovery sanction under 29 CFR 18.1(a) on the theory that the ‘‘situation It seems to us incongruous to grant an 18.6(d)(2)(v) and 18.29(a)(8), all the back [is] not provided for or controlled by agency authority to adjudicate—which pay and civil penalties the statute.’’); Metro. Stevedore Co., 11 F.3d involves vitally the power to find the Administrator of the Wage and Hour material facts—and yet deny authority to at 891 (finding that under section 26 of assure the soundness of the fact finding Division had sought against employer the Longshore Act only courts can process. Without an adequate evidentiary for ‘‘willful, contumacious disregard of assess costs against a claimant who sanction, a party served with a discovery the discovery process as well as institutes or continues a proceeding in order in the course of an administrative disregard of the ALJ’s multiple warnings the courts without reasonable grounds); adjudicatory proceeding has no incentive to and orders’’); Administrator v. Global R.S. [Simons] v. Va. Int’l Terminals, 42 comply, and often times has every incentive Horizons, Inc., ARB No. 11–058, ALJ Ben. Rev. Bd. Serv. (MB) 11, 14 (2008) to refuse to comply. No. 2005–TAE–1 & 2005–TLC–6, 2013 (rejecting an argument that an ALJ could 769 F.2d at 796. The adjudicatory duties WL 2450031, at *4–8 (DOL Admin. Rev. assess attorney’s fees against an of an ALJ are in many ways Bd. May 31, 2013) (affirming an ALJ’s employer that were unavailable under ‘‘functionally comparable’’ to those of a summary judgment awarding worker’s section 28 of the Longshore Act by using federal district court judge. Butz v. back pay, repayment of impermissible FRCP 11 instead); Valdez v. Crosby & Economou, 438 U.S. 478, 513–14 (1978). deductions from pay, and awarding the Overton, 34 Ben. Rev. Bd. Serv. (MB) 69, It would be incongruous to deprive an Administrator civil penalties, which 77 (2000) (applying the holdings in ALJ of any procedural tools that assure were based in large part on 145 factual Boland Marine & Mfg. Co. and Metro. the integrity and soundness of the allegations deemed admitted as the Stevedore Co.); Crum v. Wolf Creek adjudicative process. The tools include result of three orders that imposed Collieries, 18 Black Lung Rep. (Juris) 1– the authority to impose litigation sanctions for misconduct in discovery). 80, 1–83 (Ben. Rev. Bd. 1994). Though sanctions that do not conflict with the But see Goichochea v. Wards Cove

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Packing Co., 37 Ben. Rev. Bd. Serv. a comment regarding whistleblower Helicopter Textron, Inc., ARB No. 12– (MB) 4, 7 (2003) (holding that in a claim adjudications generally, which 110, ALJ No. 2009–AIR–20 (Sept. 19, for Longshore disability compensation suggested that the procedural rules 2012). The new rules provide uniform benefits, the remedy for disobeying an should reflect the remedial purpose of procedures for case management, but order compelling discovery is the the whistleblower statutes under the simultaneously permit judges the procedure described in section 27(b) of OALJ’s jurisdiction. The Department flexibility to tailor procedures to the Longshore Act). notes that the new rules are procedural specific cases through appropriate The Department kept in mind the rules intended to apply to all orders. So, for example, where a pro se limits on the authority of an proceedings before OALJ and not any complainant requires additional administrative agency to impose specific class of proceeding. To the guidance, under the new rule the judge sanctions when it fashioned the extent a particular agency seeks the may issue more focused or detailed litigation sanction provisions. Section application of specific procedural rules, orders, as necessary. The new rules 558(b) of the APA, cited by some it is incumbent on that agency to provide more detailed procedural commenters, states that ‘‘[a] sanction incorporate such rules into its own information (particularly regarding may not be imposed or a substantive regulations. For instance, proceedings discovery and other pre-hearing rule or order issued except within the under the Employee Retirement Income requirements) than had been the case jurisdiction delegated to the agency and Security Act of 1974 (ERISA), 29 U.S.C. previously. The Department therefore authorized by law.’’ 5 U.S.C. 558(b); see 1132, define specific procedures at 29 declines to adopt the commenter’s also Am. Bus. Ass’n v. Slater, 231 F.3d CFR 2570, subpart C. suggestion. 1, 7 (D.C. Cir. 2000) (holding that the The Department received a similar Discovery Rules Regarding Department of Transportation lacked comment suggesting that the OALJ Electronically Stored Information. One statutory authority to require a bus ‘‘should strive for better whistleblower commenter voiced some general company to pay monetary damages to protection than U.S. District Courts’’ concerns that the rules should clarify disabled passengers they failed to because the OALJ has garnered issues related to discovery of accommodate); Windhauser v. Trane, specialized knowledge and the process electronically stored information (ESI), ARB No. 05–127, OALJ No. 2005–SOX– is less formal in an agency adjudication. specifically providing that both sides 17, 2007 WL 7139497, at *2–3 (DOL The comment however did not offer any have access to discovery of ESI and that Admin. Rev. Bd. Oct 31, 2007) concrete proposal for changes to the text ESI is treated the same as paper (reversing ALJs imposition of monetary of the new rules. Any program-specific documents. The Department believes sanctions against whistleblower change moreover should be addressed to those concerns are adequately addressed complainant because such sanctions the particular agency charged with in § 18.61, which states that there is no ‘‘are, by statute, in the jurisdiction of the administering the particular program. differentiation in the access to ESI or federal district courts’’). The Slater Effect on Pro Se Litigants. One paper discovery. Thus, the rule provides court distinguished between sanctions commenter asserted that the new rules the ALJ with the ability to manage that require express statutory authority will make litigation of whistleblower discovery and minimize gamesmanship under section 558(d) of the APA claims harder on pro se parties. The in discovery of both paper documents because they are directed at modifying commenter noted that, although the and ESI. ‘‘primary conduct,’’ such as a bus OALJ rules of practice and procedure Electronic Filing. One commenter company’s failure to accommodate are analogous to the FRCP, there are urged that the OALJ adopt and disabled passengers, and litigation some differences: For example, implement electronic case filing (ECF) sanctions designed to protect the whistleblowers do not ordinarily have or, in the alternative, allow facsimile integrity of the agency’s administrative to plead a claim through a complaint. filing and remove the maximum page processes. Id. The Slater court The commenter remarked that the limitation on faxes. Those concerns recognized an agency has ‘‘a limited Administrative Review Board (ARB) and were also specifically raised in the power to impose sanctions that are not other appellate authorities have comments to proposed § 18.30 and are expressly authorized by statute, but only construed pro se complainants’ fully addressed in that response. ones designed to ‘protect the integrity of positions liberally and with a degree of However, the general answer is that the its own processes.’ ’’ Id. (quoting Touche judicial latitude. The commenter also implementation of ECF is a resource Ross & Co. v. SEC, 609 F.2d 570, 582 (2d suggested that the Department’s constrained policy decision. Until the Cir. 1979)); see also Davy v. SEC, 792 comments should make clear that Department implements ECF, F.2d 1418, 1421 (9th Cir. 1986). The decisions on the merits are the goal, and promulgating rules about ECF would provisions for the limited sanctions in compliance with procedural rules lead to confusion. the new rules are not directed to any should ‘‘bend where necessary to meet Offer of Judgment. One commenter party’s primary conduct—which would that goal.’’ suggested that the OALJ’s rules should be the subject matter of the The Department agrees that concerns include one analogous to FRCP 68, Offer proceeding—but to violations of relating to the ability of pro se litigants of Judgment, and should expressly cut procedural rules that compromise the to submit and litigate complaints off attorney’s fees and other litigation integrity of the administrative hearing deserve consideration. As the ARB has costs when a claimant refuses an offer process. These litigation sanctions are enunciated, a pro se litigant’s presumed and fails to obtain a more favorable consistent with the Department’s lack of familiarity with litigation result. regulatory authority under section procedures may require The Department declines to adopt the 556(c)(5) of the APA, do not require accommodation. For example, a pro se commenter’s suggestion. An offer of additional express statutory litigant must be informed of the judgment is significant matter that could authorization under section 558(b) of consequences of failing to respond to affect an otherwise successful the APA, and do not amount to an dispositive motions, Motarjemi v. Metro. complainant’s right to recover attorneys’ exercise of Article III courts’ contempt Council, Metro. Transit Div., ARB No. fees as costs. Marek v. Chesny, 473 U.S. or sanction powers. 08–135, ALJ No. 2008–NTS–2 (ARB 1 (1985). No analog to FRCP 68 appears Remedial Purpose of Whistleblower Sept. 17, 2010), and an untimely filing in the OALJ’s previous rules. The Adjudications. The Department received may be considered, Wallum v. Bell Department stated its intention to align

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its procedural rules more closely with Future statutory and regulatory the LHWCA.’’ The Department disagrees the FRCP, but did not give any notice changes in the numerous administered with the comment that the provision on that an offer of judgment rule was programs, including the LHWCA, BLBA, referring contumacious conduct to contemplated. The Department believes employment discrimination, federal court should be retained in the the final rule should not include an ‘‘whistleblower’’ and immigration new rules since controlling program offer of judgment provision for three cannot be foreseen. For instance, recent statutes provide for such referral action interrelated reasons. litigation has highlighted a BLBA- when appropriate. See, e.g., 20 CFR First, doing so would not have given specific issue—one involving the 725.351(c). interested parties sufficient notice that disclosure of non-testifying expert The commenter also proposed such a rule was contemplated, and it is opinions—that may deserve further deleting § 18.12(b)(10) listing the unclear that doing so now could be consideration. See generally Fox v. Elk authority of an ALJ to ‘‘take actions regarded a logical outgrowth of the rules Run Coal Co., 739 F.3d 131 (4th Cir. authorized by the FRCP’’ because the proposed. See 5 U.S.C. 553(b)(3); Ass’n 2014). Nothing in these rules would language would include all sanctions of Private Sector Colls. & Univs. v. prevent the Department from adopting a authorized by the FRCP and penalty Duncan, 681 F.3d 427, 461 (D.C. Cir. procedural rule that applies only in sanctioning authority is reserved to the 2012). Second, the OALJ issues no BLBA claim adjudications or other federal courts by the LHWCA and judgments; it is not a court, although it program-specific contexts. Moreover, BLBA. Section 18.12(b)(10) was a shares many attributes with Article III listing variations in procedural succinct restatement of prior federal courts. FRCP 68 would have to requirements for the numerous § 18.29(a)(8). The Department agrees be substantially altered to adapt to the programs in each new rule defeats the that the brevity in which prior context of administrative adjudication, purpose of the new rules and would § 18.29(a)(8) was restated could be as there is no clerk who could enter a require constant rulemaking activity to construed as excessively broad. To judgment in the way FRCP 68(a) reflect legislative changes. The ensure consistency, the new contemplates (‘‘The clerk must then Department thus disagrees with the § 18.12(b)(10) is rewritten to closely enter judgment.’’). Finally, FRCP 68 is submitted proposals to individually align with prior § 18.29(a)(8) by subject to varying interpretations in the identify superseding statutory, returning the words ‘‘where applicable’’ courts of appeals on how the defense regulatory or executive order provisions to the rule. should address attorney’s fees in the collectively in the new § 18.10 or § 18.22 Representatives. The text of an offer, when the substantive separately in those new rules where a Department narrowed the rule on statute at issue directs the adjudicator to conflict may exist. representatives appearing before OALJ assess those fees as an item of costs. See One commenter suggested that the to reflect the two classes of Charles Alan Wright et al., Federal lack of an appeal process in regard to a representatives who routinely appear— practice and Procedure § 3005.1 (3d ed. judge’s decision to modify, waive or attorneys and non-attorney 2014). Any rule the Department adopts suspend a procedural rule in new representatives. The rule sets forth the should make a choice between the § 18.10(c) ‘‘appears arbitrary and qualifications required to appear as a competing theories, to make the rule capricious.’’ The Department disagrees. representative of a party, the minimum nationally uniform, and as useful to First, while the case is at the OALJ, no duties required of a representative, and litigants as possible. Those choices will rule may be waived, modified or prohibited actions of any representative. not be made without the benefit of suspended without notice to the parties. One comment suggested that the public comment. Second, doing so requires the judge to proposed rule setting forth the make two determinations: That the qualifications for an attorney III. Summary of Specific Comments on specific alteration of the rule ‘‘will not representative is overreaching and the Notice of Proposed Rulemaking prejudice a party,’’ and ‘‘will serve the conflicts with 5 U.S.C. 500(b). That The Department received several ends of justice.’’ Finally, a party may provision states in relevant part: ‘‘An comments regarding specific sections in raise before the appropriate appellate individual who is a member in good the NPRM. Each comment is addressed authority on direct review of the final standing of the bar of the highest court as follows: order any error in modifying a rule. of a State may represent a person before § 18.10 Scope and purpose. One § 18.12 Proceedings before an agency on filing with the agency a commenter expressed concern that the administrative law judge. The written declaration that he is currently principles expressed in section 923 of Department combined the designation qualified as provided by this subsection the LHWCA, providing that the LHWCA provisions of prior § 18.25 and the and is authorized to represent the hearing process is not bound by formal authority provisions of prior § 18.29(a). particular person in whose behalf he rules of evidence but conducted in a The Department specifically clarified in acts.’’ Id. The commenter suggested manner to best ascertain the rights of the the NPRM that the enumerated powers nothing more should be required of an parties, may be circumvented by mirrored those set forth in section 556 attorney representative seeking to procedural rules not addressed in the of the APA and that the enforcement represent a party before OALJ. The LHWCA and BLBA and respective provision of prior § 18.29(b) was deleted commenter believed that the proposed implementing regulations. The due to its contents of referring § 18.22 (a)–(d) imposed additional commenter suggested part 18 explains contumacious conduct to an appropriate requirements inconsistent with 5 U.S.C. what sections do not apply to LHWCA federal court is set forth in applicable 500(b). or BLBA proceedings ‘‘to avoid statutes, such as Section 927(b) of the The Department has made revisions to confusion.’’ Another commenter LHWCA. the new rule in response to this suggested adding a paragraph ‘‘(d)’’ to One commenter proposed that prior comment. The Department deleted the § 18.10, which would specifically state § 18.29(b) should not be deleted ‘‘even following sentence from § 18.22(a): ‘‘The that in proceedings under the LHWCA though the content is contained in notice of appearance shall also include and BLBA the following list of proposed applicable statutes [because] this the statements and documentation rules would not apply: §§ 18.12, 18.23, provision clearly delineates an required for admission to appear for the 18.35, 18.50, 18.56, 18.57, 18.64, 18.70, administrative law judge’s restricted applicable category of representation 18.72, 18.80, and 18.87. powers, especially under statutes like found in subdivision (b) of this section.’’

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The Department has added the rules of conduct in their licensing would be making the initial following in its place: ‘‘Any attorney jurisdictions ‘‘could result in the determination as to whether an attorney representative must include in the different standards for the submission of had committed any enumerated notice of appearance the license evidence, discovery, and other criminal act or professional misconduct. registration number(s) assigned to the substantive and procedural matters.’’ The Department considered the attorney.’’ Essentially the only The Department disagrees. Rules of comments and has amended the rule by requirement that an attorney professional conduct are generally consolidating the grounds upon which representative must follow in order to considered rules of reason and should an attorney or representative may be represent a party before the Department be interpreted with reference to the law disqualified or disciplined into one is to file a notice of appearance and itself. Different rules of conduct should section—new § 18.23(a)(1). New include the appropriate attorney license not apply based on specific substantive § 18.23(a)(1) now sets forth three registration number. Filing the notice of or procedural law. At a minimum, distinct grounds for disqualification: (1) appearance by the attorney attorneys should always be held to the suspension of a license to practice law representative will constitute an standards of conduct where they are by any court or agency of the United attestation that: (a) The attorney is a licensed to practice law. The States, or by the highest court of a State member of a bar in good standing of the Department declines to strike the or similar governmental unit; (2) highest court of a State, Commonwealth, paragraph. disbarment from the practice of law by or Territory of the United States, or the The new rule also defines prohibited consent or resignation from the bar of a District of Columbia; and (b) no actions of all representatives appearing court or agency while an investigation disciplinary proceeding is pending before the Department in paragraph (d). into allegations of misconduct is against the attorney in any jurisdiction The prohibited actions include such pending; or (3) committing an act, where the attorney is licensed to things as: threatening, coercing or omission, or contumacious conduct that practice law. The Department has intimidating a party; knowingly making violates the procedural rules, an amended § 18.22(b)(1)(i) to reflect this false or misleading statements; or applicable statute, an applicable change. causing unreasonable delay. These again regulation, or a judge’s order(s). The Department disagrees with the derive from the SSA regulations. 20 CFR Accordingly, the previous sections comment that sections (c) and (d) 404.1740(c). One comment suggested providing for disqualification upon conflict with 5 U.S.C. 500. Section (c) that the paragraph should be stricken conviction of a felony (proposed sets forth the minimum requirements because it adds confusion and may § 18.23(a)(1)(i)) or certain enumerated expected of any representative during require attorneys to act contrary to the misdemeanors (proposed the course of a proceeding before the interests of their clients or the rules of § 18.23(a)(1)(ii)) are removed from the Department, and section (d) delineates conduct required by their licensing new rule. Such conduct however may prohibited actions of any representative jurisdictions. The Department declines still be grounds for disqualification in appearing in a proceeding before the to strike the paragraph. the new rules to the extent that new Department. Neither section prescribes § 18.23 Disqualification and § 18.23(a)(1)(i) through (iii) apply. any additional requirements for an discipline of representatives. The The Department also consolidated the attorney representative to appear on proposed rule contemplated two paths disqualification and discipline behalf of a party before the Department. for disqualification and disciplinary procedure into one section—new The Department set forth the proceedings of attorney representatives § 18.23(a)(2). The new consolidated minimum duties required of all appearing before the OALJ. One path ‘‘Disqualification procedure’’ states that representatives appearing before the regulated lawyers who were authorized in all instances the Chief Judge provides OALJ in § 18.22(c). These duties to practice before the Department notice and an opportunity to be heard originate from the rules of conduct and through admission to the bar of the prior to taking any action. The provision standards of responsibility imposed by highest court of a state or similar deletes language pertaining to requests the Social Security Administration governmental unit, but lost the right to for hearing but also recognizes that, in (SSA) on representatives appearing practice law in their licensing appropriate instances, additional before the SSA. See 20 CFR 404.1740(b). jurisdiction because of a criminal proceedings may be necessary, within While the Department realizes that the conviction or proven professional the Chief Judge’s discretion. non-adversarial nature of SSA hearings misconduct. The second path involved Other comments questioned the may require more detailed procedures, misconduct of a representative before timeline for disciplinary proceedings the basic duties included in the new the OALJ. One comment questioned the and the status of cases while rule are elementary to any hearing Department’s authority to initiate disciplinary proceedings are pending process and serve as a baseline disciplinary proceedings at all. The against an attorney. The Department foundation for conducting hearings NPRM spells out the Department’s notes that the new rule contemplates a promptly, efficiently, and fairly. The authority to discipline attorneys in great fast track with an initial response time new rule also states that an attorney detail and need not be restated herein. of 21 days. The Department believes representative must adhere to the rules The Supreme Court has recognized such that the Chief Judge should have the of conduct applicable where the authority as early as 1923 in a case discretion to decide whether an attorney attorney is licensed to practice law. In involving the Board of Tax Appeals can continue to represent a party before setting forth this standard, the where it upheld the Board’s power to the Department during the pendency of Department understands that hearings adopt rules of practice for professionals any disciplinary proceeding on a case- often occur outside of a jurisdiction to protect the integrity of its by-case basis. where an attorney may be licensed to administrative procedures and the Two commenters suggested that the practice law, and imposing an public generally. See Goldsmith v. Department maintain a national unfamiliar standard of conduct on an United States Bd. of Tax Appeals, 270 database of non-attorney representatives attorney would not be ideal. U.S. 117 (1926). Other comments disciplined by the Department. The One comment suggested that suggested that the wording of the rule Department declines to amend the part paragraph (c) should be stricken because was not clear and suggested that as 18 regulations to establish such a requiring attorneys to adhere to the drafted, it appeared that the OALJ database because OALJ already

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publishes formal disciplinary decisions accommodate electronic filing and limitation stated in § 18.30(b)(3)(i)(A) is on its Web site in the same manner as service, which is now commonplace in confined to situations in which the other judge decisions. See, e.g., In the federal courts and adjudicatory party is unable to obtain prior Matter of the Qualifications of Edwin H. agencies. Commenters urged that the permission to file by facsimile because Rivera, 2009–MIS–2 (ALJ Feb. 6, 2009) OALJ adopt an electronic filing system, the judge is unavailable. The 12 page (denying non-attorney representative or at least adopt a more liberal stance limitation is a sensible limitation to the authority to appear in a toward accepting email and facsimile discourage reliance on last hour filings representative capacity before OALJ). transmissions. by facsimile. Thus, the Department § 18.24 Briefs from amicus curiae. The Department acknowledges that declines to revise § 18.30(b)(3)(i)(A) to The proposed rule sets forth the general implementation of a dedicated remove the 12 page limitation on procedure for accepting a brief from an electronic filing system and electronic facsimile filings made without the amicus curiae. The Department received service system for OALJ adjudications judge’s permission. two comments suggesting that the would be beneficial. However, because One commenter suggested that the deadline for an amicus brief is too short. the OALJ does not have a dedicated OALJ’s rules of practice and procedure The proposed rule required such briefs electronic filing and service system, the provide for electronic service between by the close of the hearing unless rules of practice and procedure parties, stating that if a representative otherwise directed by the presiding necessarily focus on traditional filing wishes to receive all service by email, judge. The comments pointed out that and service. that individual should be able to so state no transcript is immediately available Several commenters urged that, in the in the record and then receive all when the hearing closes and it may be absence of the availability of electronic subsequent service by email. Section better for an amicus curiae to review the filing, OALJ accept documents filed by 18.30(a)(2)(ii)(E) already accommodates brief of the party the amicus supports to email. The Department declines to this suggestion. That regulation states allow the amicus curiae to focus on new adopt a regulation that permits filing by that ‘‘[a] paper is served under this arguments. The Department considered email for routine filings with the OALJ. section by . . . sending it by electronic the comments and agrees that setting the Email is not a substitute for a dedicated means if the person consented in deadline at the close of the hearing is electronic filing system in which writing—in which event service is impractical. The Department has administrative issues such as document complete upon transmission, but is not management, storage, security, and amended the new rule by deleting any effective if the serving party learns that access can be systematically addressed. specific deadline for an amicus brief, it did not reach the person to be served The proposed regulation at § 18.30(b)(4) and instead states that the deadline will . . . .’’ be set by the presiding judge. accommodates special circumstances by One commenter stated that the rule, The Department has also received authorizing the judge to ‘‘allow papers comments suggesting that it require to be filed, signed, or verified by as written, creates a paradox that a time amicus curiae to make disclosures electronic means.’’ sensitive filing could be filed with the similar to those found in U.S. Supreme Alternatively, several commenters OALJ by facsimile, but served by mail Court Rule 37.4. Such disclosures urged that the OALJ accept documents on the opposing party. This commenter include whether counsel for a party filed by facsimile transmission without suggested that adopting a service authored any part of an amicus brief and a page limitation. The Department requirement that allows for email the identity of anyone who made declines to adopt a regulation that service would resolve this problem. As monetary contributions to the permits filing by facsimile for routine noted above, the regulation permits preparation of the brief other than the filings with the OALJ. Facsimile parties to agree to receipt of service of amicus curiae or its members. The technology is not a substitute for papers by electronic means. The Department declines to adopt the traditional mail or hand delivery of Department declines to revise the rule to specialized disclosure requirements. filings or for a dedicated electronic require electronic service on another Any specialized requirement can be filing system. When § 18.3 of the prior party in situations where the filing party considered by the presiding judge and rules was amended in 1994 to permit was granted permission to file a paper made part of a briefing order depending filing by facsimile in certain with the OALJ electronically. on the facts of any particular case. circumstances, the Department § 18.31 Privacy protection for filings § 18.30 Service and filing. discussed why, although the use of and exhibits. One commenter suggested Commenters suggested that the list of facsimile machines is often convenient that the privacy requirement should be documents not to be filed until used in to parties, it is not administratively inapplicable to any document created the proceeding or ordered by a judge practical for routine matters. See prior to the effective date of the final (§ 18.30(b)(1)) should be amended to Amendment of Filing and Service rule in BLBA cases. The commenter add the notice and copy of ‘‘documents Requirements in Proceedings Before the stated that medical records containing only’’ subpoenas that are required to be Office of Administrative Law Judges, 59 social security numbers and other served on other parties by § 18.56(b)(1). FR 41874 (Aug. 15, 1994). Although protected information are created long That suggested change is consistent information technology has advanced before a claim is filed and it would be with the purpose of both the prior and considerably since 1994, it is still true burdensome to redact this information. proposed rule and reflects current that most filings before the OALJ are not The FRCP Advisory Committee noted common practice. The new rule is thus time sensitive and that the Department in its comments to FRCP 5.2 that ‘‘[i]t changed to add paragraph (b)(1)(vi) with is not in a position to bear the cost of is electronic availability, not the form of the following language: ‘‘the notice (and receiving and printing large numbers of the initial filing, that raises the privacy the related copy of the subpoena) that facsimile transmissions. The new rule at and security concerns addressed in the must be served on parties under rule § 18.30(b)(3)(i) accommodates special E-Government Act.’’ Fed. R. Civ. P. 5.2 18.56(b)(1) before a ‘documents only’ circumstances by allowing a party to file advisory committee’s note (discussion subpoena may be served on the person by facsimile if permitted by the judge. of 2007 amendments). The FRCP commanded to produce the material.’’ One commenter stated a concern that focuses on electronic records, but Several commenters argued that the a judge could reject a facsimile filing applies the same restrictions to hard- OALJ’s rules do not adequately that exceeded 12 pages. The 12 page copy documentation, reasoning that the

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number of paper filings will diminish post facto delays in such cases. federal rule, which was revised in 1993 over time. However, changing the term ‘‘legal after the U.S. Supreme Court ruled that The Department declines to adopt the holiday’’ to include any day on which the previous language could not be commenter’s suggestion. The privacy the district office in which the interpreted to include a named interests of individuals whose personal document is to be filed is closed or offender’s firm. Pavelic & LeFlore v. records appear before the OALJ otherwise inaccessible to the filing party Marvel Entm’t Grp., 493 U.S. 120 (1989). outweigh the burden placed on those would provide a clearer standard and Thus, the provision is in accord with who represent them. Many of these avoid uncertainty over whether an ex federal practice and the Department records can be scanned and searched for post facto delay may be granted. The declines to strike or modify the the sensitive information, reducing the new rule is thus changed as follows: provision in § 18.35(c)(1) concerning time and effort required to complete this (4) ‘‘Legal holiday’’ defined. ‘‘Legal law firm joint responsibility. redaction. The commenter’s suggestion holiday’’ means the day set aside by statute One commenter observed that that this rule apply only to records for observing New Year’s Day, Martin Luther § 18.35(c)(4) provides no guidance as to created after the effective date of the King Jr.’s Birthday, Washington’s Birthday, what type of sanction ‘‘suffices to deter final rule would severely limit its Memorial Day, Independence Day, Labor repetition of the conduct or comparable utility. The parties may choose to waive Day, Columbus Day, Veterans’ Day, conduct.’’ The Department agrees that the protection of the rule if it would be Thanksgiving Day, or Christmas Day, any day § 18.35(c)(4) should be amended to unduly burdensome to redact the declared a holiday by the President or provide more specific guidance. records, or the parties may petition the Congress, and any day on which the office in Paragraph (c)(4) of the rule is revised, which the document is to be filed is closed judge for a waiver of the rule. or otherwise inaccessible. containing the following language: ‘‘A § 18.32 Computing and extending sanction imposed under this section time. Commenters noted that setting § 18.35 Signing motions and other may include, but is not limited to, 4:30 p.m. as the default deadline for papers; representations to the judge; striking part or all of the offending filing on a specific date is inconsistent sanctions. New § 18.35 is modeled after document, forbidding the filing of any with other rules of practice and sets a FRCP 11. It states the standards further documents, excluding related trap for the unwary practitioner who attorneys and parties must meet when evidence, admonishment, referral of may reasonably expect that the deadline filing motions or other documents with counsel misconduct to the appropriate would be 11:59 p.m. They suggested OALJ and provides sanctioning licensing authority, and including the changing the time to 11:59 p.m. authority for violations of this section. sanctioned activity in assessing the The FRCP allows for electronic filing Several commenters pointed out that quality of representation when up to 11:59 p.m., but still sets the close the LHWCA and BLBA contain specific determining an appropriate hourly rate of local business hours as the deadline statutory provisions dealing with and billable hours when adjudicating for hardcopy delivery. The commenters’ resistance to an order, misconduct attorney fees.’’ suggestions primarily relate to online during hearings, and discovery § 18.50 General provisions governing and facsimile filing. The OALJ violations. They suggest amending disclosure and discovery. Under the continues to rely on hardcopy delivery § 18.35(c) to state that the sanctions new rule, a party may seek discovery at as the default authorized means of filing provisions are not applicable to LHWCA any time after a judge issues an initial and allows electronic or facsimile filing and BLBA cases. The Department notice or order and, unless the judge on only as authorized by order or declines to adopt the commenters’ motion orders otherwise, the methods of regulation. Since both e-filing and suggestion for the reasons detailed discovery may be used in any sequence facsimile filing include time stamps that above in section II, ‘‘Conflicts with the regardless of the discovery conducted show exactly when a document arrived LHWCA and BLBA.’’ by other parties. The parties’ required at the facsimile machine or server of the Several commenters objected to initial disclosures would be made recipient, the office need not be open to § 18.35(c) in its entirety, suggesting that within 21 days after entry of an initial determine when a document arrives. the section is essentially an attempt by notice or order acknowledging that the Since e-filing or facsimile filing is only the OALJ to exercise contempt power, case has been docketed for adjudication, allowed with the permission of the which is limited to courts and may not and the rule includes a provision judge, counsel can request extended be conferred upon administrative exempting certain proceedings and filing hours when they request agencies. Section 18.35(c) however is parties from the initial disclosure permission to file in that manner. The not identical to FRCP 11(c)(4) and does requirements. The Department received Department therefore declines to adopt not seek to invest OALJ judges with two comments focusing on the timing of the suggestion. powers beyond the APA’s grant of disclosures and discovery in LHWCA Commenters also observed that the authority to impose appropriate and BLBA cases. One commenter urged language at (a)(4) including as a legal sanctions where necessary to regulate that discovery should be available holiday any other day declared a and ensure the integrity of the hearing following transfer of the case to the holiday by the President or Congress is process. Thus, for the reasons detailed OALJ or at any time upon stipulation of overly broad and should be amended to above in section II, ‘‘Authority to the parties, asserting that initial notices include in the definition the provision Regulate the Conduct of Administrative and orders have historically taken three that federal offices are closed to normal Proceedings; Sanctions,’’ the months to issue and that discovery business. They suggested providing for Department declines to delete § 18.35(c). during this period of time will be extensions where a party is prevented One commenter argued that there is unavailable under the new rule, from filing or requesting an extension by no authority to hold a law firm jointly resulting in unnecessary delay. This local circumstances, such as natural responsible for a violation committed by commenter also suggested that the disasters or other events that require its partner, associate, or employee and timing for initial disclosures be set at 35 closure of government facilities. failing to further define the days following transfer of the case to the FRCP 6(a)(3) addresses the problem circumstance that would justify an OALJ. Citing similar concerns about by including a provision for the exception. The provision for law firm delay, the other commenter suggested inaccessibility of the clerk’s office. The joint responsibility in § 18.35(c)(1) is that discovery should be available at new rules allow for judges to grant ex taken directly from the corresponding any time after a claim is filed.

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The Department disagrees with these objective of promulgating a uniform set of ESI should be proportional to what is proposals. The use of a judge’s initial of procedural rules. at stake in the litigation. 77 FR 72146 notice or order as the case event One comment proposes that pro se (citing FRCP 26(b)(2)(C)(iii)) (citing The allowing parties to commence discovery parties be included in the list of parties Sedona Conference, The Sedona promotes uniformity and predictability who are exempted from the required Principles: Second Edition, Best as it is the first reliable indication to the initial disclosures under paragraph Practices Recommendations & parties that the case is actually before (c)(1)(iii) unless an ALJ orders the party Principles for Addressing Electronic the OALJ. The Department believes that to provide disclosures. The Department Document Production 17 (Jonathan M. use of the date of transfer from the rejects this proposal as inconsistent Redgrave et al. ed., 2d ed. 2007) District Director, Office of Workers’ with the efficient, impartial and fair (‘‘Electronic discovery burdens should Compensation Programs is potentially adjudication of cases. The FRCP be proportional to the amount in confusing because this procedure is provides no such exemption for pro se controversy and the nature of the case. only applicable in LHWCA and BLBA litigants aside from those persons in Otherwise, transaction costs due to cases. See 20 CFR 702.317, 725.421. The government custody. See Fed. R. Civ. P. electronic discovery will overwhelm the transfer or referral is an internal 26(a)(1)(B)(iii). Having a separate set of ability to resolve disputes fairly in administrative function that lacks the rules for unrepresented parties or litigation.’’)). Second, the proposal clarity of the initial notice of order from requiring a judge to provide them with would override paragraph (b)(3)(iii), the judge in terms of informing parties legal guidance is inappropriate. See Pik which is based on FRCP 26(f)(3)(C) that a case has been docketed for v. Credit Suisse AG, ARB No. 11–034, making any issues about disclosure or adjudication. The Department further ALJ No. 2011–SOX–6 (ARB May 31, discovery of ESI, including the form or believes that allowing discovery at any 2012) (citing Rays Lawn & Cleaning forms in which it should be produced, time after a claim is filed is problematic Sys., ARB No. 06–112, ALJ No. 2005– a required item in discovery plans. This as this would inevitably lead to SCA–7 (ARB Aug. 29, 2008)); Olsen v. proposal also conflicts with § 18.51(b)(2) development of discovery disputes Triple A Mach. Shops, Inc., 25 Ben. Rev. which, like FRCP 26(b)(2)(B) upon before the case is assigned to a judge. Bd. Serv. (MB) 40, 46 n.4 (1991), aff’d which it is based, provides that ESI While the Department is sensitive to the mem. sub nom. Olsen v. Dir., OWCP, discovery issues are to be determined by expressed concern regarding delays in 996 F.2d 1226 (9th Cir. 1993). the judge on a motion to compel or for the issuance of an initial notice or order, Two comments expressed a concern protective order. In sum, the this is a matter that is better addressed that it is burdensome and/or irrelevant Department’s new rules on disclosure through internal policy directives rather to require an expert witness’s written and discovery of ESI track the than creation of a special rule of report to list all other cases in which the provisions in the FRCP which were witness testified as an expert during the procedure or exception. Finally, the developed after consideration of the previous four years and the amount he Department believes that the new competing interests at stake with regard or she was paid. See General Provisions disclosure and discovery rules, taken as to ESI, and the Department is not Governing Disclosure and Discovery, 77 a whole, provide parties with sufficient persuaded that a different approach is FR 72159 (proposed Dec. 4, 2014) flexibility to ensure that all authorized necessary or desirable in proceedings (proposed § 18.50(c)(2)(ii)(E) and (F)). and appropriate discovery will be before the OALJ. These commentators stated that parties available prior to adjudication. The Department received one are not likely to have this information. comment concerning the timing of One comment raised a concern with The Department disagrees. While the initial disclosures for parties who are the sequence of discovery in LHWCA parties themselves may not have such served or joined later. The commenter cases by asserting that the logical first information, surely an expert witness proposed adding the following sentence step is for a claimant to produce a would. Moreover, the rule allows for an to the end of paragraph (c)(1)(v): medical report followed by the exception to this requirement where ‘‘Copies of all prior disclosures shall be deposition of the report’s author. The stipulated or ordered by the judge. This served on the newly joined party within commenter suggested that the new rule exception could be invoked in those 14 days of the joinder.’’ Such an could allow a claimant to manipulate unusual cases where the required addition is helpful because it is the discovery process by delaying information might not be reasonably common in LHWCA and BLBA cases for production of a medical report which obtainable. These requirements track additional parties to be joined after the might result in a respondent having FRCP 26(a)(2)(B), and the Department is commencement of the OALJ proceeding. insufficient time to identify a rebuttal not persuaded by these comments that Therefore, the Department has added expert. To blunt this potential tactic, the any deviation in the OALJ rules is the following sentence to the end of commenter proposed that the rule justified. paragraph (c)(1)(v) in the final rule: require a claimant to produce a medical Two commenters urged adoption of a Copies of all prior disclosures must be report and disclose any experts early in rule that would require parties to served on a newly served or joined party the process. The Department believes provide ESI in a searchable electronic within 21 days of the service or joinder. that this concern is adequately format rather than paper copies when Two comments advocated adoption of addressed in the provisions of the rule the requested information is available in early discovery protocols similar to the governing disclosure of experts, see 29 electronic form. The commentators cited pilot project that has been implemented CFR 18.50(c)(2)and through the judge’s federal case law in support, stating that by some federal district courts to broad discretion to oversee disclosure parties have been required to provide streamline discovery and reduce costs and discovery in an impartial manner ESI in electronic format when requested in certain employment discrimination that affords all parties a full and fair in that form. While acknowledging the cases. See Federal Judicial Center, Pilot opportunity to be heard. Moreover, cited precedent, the Department rejects Project Regarding Initial Discovery adoption of this proposal would create the proposal for a rule mandating Protocols for Employment Cases a special rule, applicable only in benefit production of ESI in electronic format Alleging Adverse Action (2011), cases such as those arising under the whenever requested in that form. First, available at www.fjc.gov/public/pdf.nsf/ LHWCA and BLBA, which is such a rule may violate the principle lookup/discempl.pdf/$file/ inconsistent with the Department’s recognized in the NPRM that discovery discempl.pdf. Incorporating a pilot

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project designed for a limited class of procedural rule and, instead, must be ‘‘smoking gun’’ evidence of unlawful cases into a set of uniform rules of left to case-by-case adjudication. motivation is rare, and he suggests that practice and procedure is not desirable. Another comment stated that the it would be helpful if the comments To the extent such initiatives may be exceptions established by paragraph accompanying the final rule are beneficial in certain cases, the (d)(3)(i) through (iii) to the general rule balanced to recognize that while judges Department has concluded that the embodied in paragraphs (c)(1) and (2) have discretion to limit unnecessary determination to adopt such procedures which protect against disclosure of discovery, they also have a duty to is best left to the discretion of communications between a party’s enforce discovery when it is necessary individual judges and/or discovery representative and an expert witness are to prove a relevant point. The plans developed by parties pursuant to not adequate to ensure access to commenter did not suggest any change paragraph (b)(3). evidence of fraud, abuse or influence in the proposed rule establishing the One comment proposed that such as a party’s attorney writing the scope of discovery and its limits. The paragraph (d)(3) should be revised to expert’s report. The commenter Department notes that the discussion of explicitly state that it does not apply to suggested that the exceptions should be the changes in the disclosure and LHWCA and BLBA proceedings because broadened to ensure disclosure of such discovery rules in the NPRM contains 33 U.S.C. 927(b) expressly provides a evidence or that paragraphs (c)(1) and several references to limitations on the procedure (i.e., certification of facts to a (c)(2) should be eliminated. The scope of discovery which were federal district court for summary Department’s new rules addressing necessitated by recent changes in the contempt proceedings) for addressing disclosure of communications between FRCP that were incorporated into the discovery violations. A party’s failure to a party’s representative and an expert new § 18.51. However, the Department comply with the certification track the provisions of FRCP 26(b)(3) believes the new rule, like FRCP 26(b) requirements likely would not involve and (4), which were revised in 2010. upon which it is based, appropriately refusal to comply with an order and, While the Civil Rules Advisory balances competing discovery interests. therefore would not be cognizable as Committee stated that the revisions to Another commenter similarly contempt subject to section 927(b). See FRCP 26 were intended to alter pre- suggested with respect to whistleblower A–Z Intn’l v. Phillips, 323 F.3d 1141, amendment case law that required cases that the rules should encourage 1146–47 (9th Cir. 2003) (holding that disclosure of all attorney-expert early exchange of discoverable the district court lacked section 927(b) communications and draft reports in information, prompt resolution of jurisdiction over conduct that did not favor of limiting disclosure to discovery disputes and broad discovery involve a refusal ‘‘to comply with a communications of a factual nature in of probative information. This summons, writ, warrant, or mandate order to protect the theories and mental commenter also did not advocate any issued by the ALJ.’’). The Department impressions of counsel, the Advisory particular change in the proposed rule. therefore rejects this proposal and has Committee emphasized that the ‘‘facts The Department believes that the new not made any change to paragraph or data’’ exception should be interpreted disclosure and discovery rules, taken as (d)(3). broadly to require disclosure of ‘‘any a whole, are designed to accomplish the § 18.51 Discovery scope and limits. facts or data ‘considered’ by the expert commenter’s recommended objectives One comment suggested that the in forming the opinions to be expressed, in a fair and impartial manner. The language of paragraph (a) defining the not only those relied upon by the Department further believes that scope of discovery could be read as expert.’’ Fed. R. Civ. P. 26 advisory adoption of special disclosure and precluding discovery of prior medical committee’s note (discussion of 2010 discovery rules for a particular category records. The commenter focused this amendments); see also Sara Lee Corp. v. of cases is neither necessary nor concern on the second sentence of the Kraft Foods, Inc., 273 FRD. 416, 419 desirable as judges have discretion to rule which states that ‘‘the judge may (N.D. Ill. 2011); Fialkowski v. Perry, No. resolve discovery disputes in a manner order discovery of any matter relevant to 11–5139, 2012 WL 2527020, at *5 (E.D. that is consistent with the requirements the subject matter involved in the Pa. Jun. 29, 2012) (holding that even if of the particular governing statute and proceeding.’’ The commenter preferred the requested documents are considered implementing regulations. The language limiting discovery to matters ‘‘communications’’ between a party’s Department therefore has not made any ‘‘relevant to the subject matter of the attorney and an expert within the change to the new rules based on this proceeding’’ and, alternatively, meaning of FRCP 26(b)(4)(C), they are comment. suggested that the record should clearly discoverable to the extent that they fall § 18.55 Using depositions at state that prior medical records are within the exceptions listed in FRCP hearings. Two commenters suggested relevant to a party’s claim or defense 26(b) (4)(C)(ii) and (iii), for ‘‘facts and that the new rule should be revised to when medical questions are at issue. data’’ that the expert considered and for permit wider use of depositions at The Department rejects this proposal as ‘‘assumptions’’ that the expert relied hearings. One commenter proposed essentially seeking a substantive on). The Department believes that the addition of a paragraph that would determination that prior medical rule adequately addresses the concern permit unconditional use of depositions records are discoverable without raised in the comment, and no change at hearings in the absence of any limitation in all proceedings as long as has been made in the final rule. objection. The commenter submitted there is some medical issue in play. The Department received a comment that this revision would better align the While such records may well be stating that some of the commentary in rule with current practice and relevant and discoverable in many cases the NPRM relating to limitations on the procedure. Another commenter urged where medical issues are raised, it is not scope of discovery could lead judges to deletion of the requirement of showing difficult to foresee situations where believe that limiting discovery is more unavailability as a pre-condition to the production of a person’s prior medical important than providing whistleblower admission of deposition testimony from records might not be required. In the complainants with access to the a lay or non-expert witness. This Department’s view, determinations as to evidence they need to prove their commenter asserted that the the scope of discovery with respect to claims. This commenter pointed out unavailability requirement is overly specific categories of information cannot that discovery is critical in burdensome and particularly so for be properly addressed in a general whistleblower litigation where benefits claimants who have fewer

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resources to pay witnesses to attend legal scrutiny. The Department has currently controlled by 28 U.S.C. 1821. hearings. The Department agrees. therefore deleted paragraph (a)(3) from See Dishman v. Cleary, 279 FRD. 460, Allowing unconditional use of the new rule. This revision renders 466 (N.D. Ill. 2012); Fisher v. Ford Motor depositions in the absence of an moot the concerns raised by the other Co., 178 FRD. 195, 197 (N.D. Ohio objection comports with current commenter about the need for 1998). The Department does not believe practice and procedure and reduces the additional protective procedures to that it is prudent to incorporate specific potential financial burden of producing protect parties from abusive subpoena statutory references into the rule as live witnesses on all parties. While the practices by parties’ representatives in statutory provisions are subject to proponent of using the deposition of a the event they were authorized to issue change which would lead to potential non-expert witness at hearing would subpoenas. confusion until the rule could be still be required to demonstrate The Department received a comment amended. Further, the Department notes unavailability in the face of an that paragraph (b)(1) dealing with that the discovery subcommittee to the objection, the Department believes that service of subpoenas be revised to track Civil Rules Advisory Committee the unavailability provisions of the rule, a change in FRCP 45(a)(4), upon which undertook an exhaustive survey of which track FRCP 32(a)(4), are the rule is patterned, that was published commentary regarding FRCP sufficiently broad to minimize the recommended to the U.S. Supreme 45. See Federal Rules of Practice & burden of producing live witnesses. Court by the Committee on Rules of Procedure, Survey of Issues Regarding Accordingly, the new rule has been Practice and Procedure of the Judicial Federal Rule of Civil Procedure 45 revised and renumbered to add a new Conference of the United States in its (2009), available at www.uscourts.gov/ paragraph allowing unconditional use of report of September 2012. See Federal uscourts/RulesAndPolicies/rules/ depositions at hearings in the absence of Rules of Practice & Procedure, Report of MemoreRule45issues.pdf. Review of the an objection. the Judicial Conference Committee on survey discloses no published concern § 18.56 Subpoenas. The Department Rules of Practice and Procedure to the or comment or other criticism related to received two comments regarding the Chief Justice of the United States and the use of ‘‘allowed by law.’’ The second commenter proposed a provisions of paragraph (a) relating to Members of the Judicial Conference of requirement that notice of a subpoena(s) issuance of subpoenas. One of the the United States 23 (2012), available at relating to medical or financial commenters proposed that the rule state www.uscourts.gov/uscourts/ information include a statement that any attorney authorized to practice RulesAndPolicies/rules/Reports/ST09– certifying that the information will not under the rules may issue subpoenas 2012.pdf. To maintain harmony with the FRCP, the commenter proposed that be used or disclosed for any purpose and that the judge may issue subpoenas other than the litigation or proceeding on written application of a non-attorney. paragraph (b)(1) be amended to read as follows: for which the information was requested The other comment urged that and will be destroyed or returned at the paragraph (a)(3), which would permit a By whom; tendering fees; serving a copy of end of the litigation or proceeding. The judge by order in a specific proceeding certain subpoenas. Any person who is at least 18 years old and not a party may serve commenter stated that this additional to authorize an attorney representative provision is necessary to protect against to issue and sign subpoenas, be revised a subpoena. Serving a subpoena requires delivering a copy to the named person and, inadvertent disclosure of sensitive to exempt LHWCA and BLBA if the subpoena requires that person’s information. The Department rejects this proceedings because 33 U.S.C. 927(a) attendance, tendering with it the fees for 1 proposal, noting that the handling of expressly delegates subpoena issuance day’s attendance and the mileage allowed by sensitive information obtained during authority to judges who cannot sub- law. Service may also be made by certified discovery should be addressed in delegate such authority to persons mail with return receipt. Fees and mileage parties’ discovery plans under outside the Department. The need not be tendered when the subpoena issues on behalf of the United States or any § 18.50(b)(3) and that any unresolved Department is persuaded by this latter issues relating to sensitive information argument that the authority to issue of its officers or agencies. If the subpoena commands the production of documents, may more appropriately be addressed by subpoenas should remain with the electronically stored information, or tangible the judge on a case-by-case basis under judge. The comment cited two cases— things or the inspection of premises before the protective order procedures in FTC v. Gibson, 460 F.2d 605 (5th Cir. the formal hearing, then before it is served on § 18.52. 1972), and United States v. Marshall the person to whom it is directed, a notice One commenter proposed that Durbin & Co. of Haleyville, 363 F.2d 1 and a copy of the subpoena must be served paragraph (c)(1), requiring a judge to (5th Cir. 1966),—where sub-delegation on each party. impose an appropriate sanction on a of statutory subpoena authority to The Department adopts this proposal as party or representative who violates the subordinate employees of an agency was consistent with the objective of bringing duty to avoid imposing an undue upheld based on reorganization plans, the OALJ rules of practice and burden on a person subject to a authorized by the Reorganization Act of procedure into alignment with the FRCP subpoena, be revised to explicitly state 1949, 5 U.S.C. 901–912, that specifically where appropriate. Paragraph (b)(1) in that it does not apply to LHWCA and provided for the challenged sub- the final rule has been amended BLBA proceedings which are subject to delegation of subpoena power. See also accordingly. the summary contempt procedure Lewis v. NLRB, 357 U.S. 10, 14–15 The Department received two established by 33 U.S.C. 927(b). The (1958) (upholding sub-delegation of additional comments regarding Department declines to adopt the subpoena authority to the Board’s paragraph (b)(1). One commenter raised commenter’s suggestion for the reasons regional directors). Unlike the cited a concern that the phrase ‘‘allowed by detailed above in section II, ‘‘Conflicts cases, there is no reorganization plan law’’ is vague and should be replaced by with the LHWCA and BLBA.’’ under which the Department’s judges a reference to the particular controlling § 18.57 Failure to make disclosures have been authorized to sub-delegate law. The language in question is taken or to cooperate in discovery; sanctions. statutory subpoena authority. verbatim from FRCP 45(a)(4) and is Two comments proposed revising the Consequently, a question exists as to intended to be interpreted in a manner rule to specifically exempt LHWCA and whether the sub-delegation authorized consistent with the federal rule under BLBA cases from the sanction by paragraph (a)(3) would withstand which witness fees and expenses are provisions which, the commenters

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argued, are preempted by section 927(b) One commenter suggested that the which can be incorporated into a of the LHWCA. One of the commenters text of the rule on physical and mental prehearing order. To ensure the party additionally argued that these sanction examinations should mandate a three- examined has the examination report provisions violate the ‘‘separation of step procedure before an examination promptly, however the Department powers’’ doctrine by usurping contempt can be noticed: (1) The parties must agrees that the party who retained the powers solely vested in the Article III attempt to resolve all issues informally examiner and receives the examination courts. The Department declines to before an examination is noticed; (2) if report must serve a copy of the adopt the commenters’ suggestions for agreement cannot be reached, the party examination report on the party the reasons detailed above in section II, that intends to notice an examination examined no later than seven days after ‘‘Conflicts with the LHWCA and BLBA.’’ must request a telephone or other it receives the report. § 18.62 Physical and Mental prehearing conference with the judge to § 18.64 Depositions by oral Examinations. One commenter discuss whether an examination is examination. One commenter asserted suggested that § 18.62(a)(1) should be needed, and any specific procedure or that an ALJ cannot impose the sanctions amended to restrict an examination to limitations on the examination that may enumerated in § 18.57 in LHWCA and the mental or physical ‘‘condition in be appropriate; and (3) before the BLBA adjudications for the types of controversy.’’ prehearing conference, the party misconduct described in § 18.64(d)(2) The Department declines to adopt the proposing the examination must state and (g). Therefore, the commenter commenter’s suggestion. The suggested with particularity why the examination suggested that the Department add an text would offer no meaningful limit is needed, why the deposition of the exception to the rules for these cases. because the medical examiner does not party to be examined is insufficient to The Department declines to amend know how the issues have been framed address the issues the examination § 18.64 to provide such an exception for in litigation. The party who retains an would address, and describe what will the reasons detailed above in section II, examiner and notices the examination occur at the examination. ‘‘Authority to Regulate the Conduct of however knows the scope of the report The Department declines to adopt the Administrative Proceedings; Sanctions’’ it retains an examiner to prepare. The commenter’s proposal. First, the parties and ‘‘Conflicts with the LHWCA and Department believes it is preferable to ordinarily should have discussed BLBA.’’ § 18.64 Depositions by oral rely on the language taken from FRCP whether an examination is appropriate, examination and § 18.65 Depositions 35(a), which requires the party who and its scope, when they frame the proposed discovery plan early in the by written questions. One commenter notices an examination to specify the case, just as happens in the U.S. district stated that proposed §§ 18.64 and 18.65 ‘‘time, place, manner, conditions, and courts. Second, the claims at the OALJ refer to an ‘‘officer,’’ but do not clarify scope of the examination,’’ and to frequently involve a physical or mental the ‘‘officer’s’’ relations to the disclose the ‘‘person or persons who condition that serves as one of the bases deposition proceeding. FRCP 30(b)(5) will perform it.’’ The notice must also raised for relief—an issue that is and 31(b) use the term ‘‘officer’’ to describe the examination in a way that litigated less often in U.S. district describe the court reporter who informs the party to be examined of its courts. It makes sense therefore for the administers the oath, takes and certifies scope. That party may object if the default assumption in the rules to be the testimony, states that the deposition conditions or scope of the examination that an examination is appropriate in is complete when it ends, and reads the stray into areas that are not in cases before the OALJ, even though written deposition questions. The controversy. FRCP 35 allows such examinations only Department agrees with the commenter Two commenters argued that the final upon motion for good cause before the that the title to §§ 18.64(b)(5) and rule should retain the 30-day notice U.S. district courts. 18.65(b) should be altered to clarify that requirement found in previous One commenter suggested that the ‘‘officer’’ is the ‘‘deposition officer.’’ § 18.19(4)(d). One commenter stated that § 18.62(c)(1) be amended to require that § 18.70 Motions for dispositive the new 14-day notice requirement the examination report (1) be delivered action. One commenter objected would unreasonably burden the to the examined party within 21 days, generally to the use of motions to claimant. Specifically, the shorter notice (2) be delivered no fewer than 45 days dismiss in proceedings where there are period would make it harder for the before the hearing, and (3) fulfill the shifting burdens of proof or where the claimant to arrange for time off from requirements of expert testimony found claimant benefits from legal work, travel plans, and other matters. in proposed § 18.50(c)(2)(ii) [required presumptions. The commenter argued The commenters also asserted that for witnesses who must provide a specifically that § 18.70(c) should be § 18.62(a)(4) would not give sufficient written report]. stricken or made not applicable to cases time to object to the examination notice The Department declines to adopt under the LHWCA because such a rule with particularity. The person to be these additional requirements. Section would require claimants to plead with examined may have to consult with 18.62 establishes a procedure to set an more specificity than required under the others (such as experts or a treating examination. It should not be conflated Act, and noted that an injury and timely physician) to frame and serve a specific with the separate disclosures a party filing are presumed. The Department objection. must make before final hearing, declines to strike or modify § 18.70(c). The Department agrees with the particularly about the testimony of That section states that a party is commenters’ suggestions. Therefore, experts. The examiner may not be a trial permitted to move to dismiss part or all § 18.62(a)(3) is amended to provide a witness. The examination report may be of the matter ‘‘for reasons recognized notice period of 30 days in advance of only a portion of the data an expert under controlling law.’’ The new section an examination when the parties do not witness who testifies at final hearing is not intended to modify existing law agree to a shorter notice in their rely on to reach an opinion. Section controlling the standard for dispositive proposed discovery plan, by stipulation, 18.50(c)(2)(ii) has an independent effect. motions, including motions challenging or through informal discussion. Section With respect to the timing of reports, the the sufficiency of a pleading. Moreover, 18.62(a)(4) is amended to extend the parties should build into the discovery § 18.10(a) states that ‘‘[t]o the extent that time to serve an objection from 7 days plan an appropriate period for the these rules may be inconsistent with a to 14 days. examiner to write and serve a report, governing statute, regulation, or

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executive order, the latter controls.’’ procedural mechanism is opposition to summary judgment. OALJ Thus, a party’s motion to dismiss under disproportionately adverse to the judges have the power necessary to § 18.70(c) does not upset any statutory interests of whistleblower complainants. conduct fair and impartial proceedings, or regulatory presumptions or shifting Any rulemaking proposing a regulation and are capable of dealing with a burdens of proof. discouraging summary decision in parties’ raising of new arguments in § 18.72 Summary decision. One whistleblower cases is within the reply briefs without a specific rule. For commenter argued for the development responsibility and purview of the example, in Du Jardin v. Morrison of a rule that would allow ALJs to enter agency which has programmatic and Knudsen Corp., 1993–TSC–3 (ALJ Nov. summary decision in a condensed order policy responsibility over whistleblower 29, 1993), the ALJ refused to consider that is compliant with the APA, but cases, and not the OALJ, whose role is new arguments raised by the respondent which does not require a complete adjudicatory. Moreover, the ARB has in a reply brief to the complainant’s recitation of all evidence. The issued several decisions that provide response to the respondent’s motion for commenter argued that such a summary ample guidance to the public and to summary decision. In Inman v. Fannie ruling would minimize judges’ judges on the standards specific to Mae, 2007–SOX–47 (ALJ Mar. 5, 2008), workload and allow for quicker summary decision motions in rev’d and remanded on other grounds, adjudications. The commenter whistleblower cases. See Evans v. Inman v. Fannie Mae, ARB No. 08–060, suggested that the rules permit such a E.P.A., ARB No. 08–059, ALJ No. 2008– ALJ No. 2007–SOX–47 (ARB June 28, summary ruling upon agreement of the CAA–3 (ARB Apr. 30, 2010); Hasan v. 2011), the ALJ permitted the parties because without such a Enercon Serv., Inc., ARB No. 10–061, complainant to file a surreply on a provision in the rules, parties will have ALJ Nos. 2004–ERA–22 and 27 (ARB motion for summary decision. The concerns about whether such an order July 28, 2011); Lee v. Parker-Hannifin Department notes that under FRCP 56, would be deemed deficient by the BRB. Corp., Advanced Prod. Bus. Unit, ARB on which § 18.72 is modeled, there is no Because the APA specifies what must be No. 10–021, ALJ No. 2009–SWD–3 (ARB right to file a surreply. Although the included in an ALJ’s decision and order, Feb. 29, 2012); Franchini v. Argonne commenter stated that many circuit the Department declines to modify Nat’l Lab., ARB No. 11–006, ALJ No. courts allow surreply briefs, it did not § 18.72 to provide for a condensed 2009–ERA–14 (ARB Sept. 26, 2012); see identify those circuits. Our review of decision on summary decision. Section also Guillory v. Domtar Indus., 95 F.3d federal appellate court rules and circuit 18.72(a) provides that the judge should 1320, 1326 (5th Cir. 1996) (‘‘Though court local rules found that the rules state on the record the reasons for summary judgment is rarely proper generally do not mention surreply granting or denying a motion for when an issue of intent is involved, the briefs, or only allow them upon leave of summary decision or partial summary presence of an intent issue does not the court. See, e.g., Dist. N.M. Local R. decision. automatically preclude summary Civ. P. 7.4(b) (2013); Dist. N.H. Local R. Two commenters stated that the use judgment; the case must be evaluated 7.1e(3) (2013). of summary adjudications is like any other to determine whether a Two commenters suggested that the inconsistent with the goal of fair genuine issue of material fact exists.’’). timing aspects of § 18.72 will be administrative proceedings for Another commenter objected that troublesome for whistleblower whistleblowers and should be rarely, if motions for summary judgment allow complainants, for whom the efficiency ever, used. The commenters argued that cases to be framed by the party that does and cost of opposing motions for summary decisions based on written not have the burden of proof at trial, and summary judgment is of paramount submissions favor employers over that under § 18.72, the moving party importance. Motions for summary employees and increase costs. The gets the last word. The commenter decision are usually filed by commenters argued that summary described complainants being respondents, and consequently, when decisions deprive the ALJ of the ‘‘sandbagged’’ by primary briefs that such motions are filed near to the opportunity to determine the credibility provide abbreviated or unclear hearing date, complainants are of the witnesses, which is important in statements of facts or arguments, which disadvantaged because they are severely cases where motive and intent are are tactically written to prevent cogent burdened by the need to respond to the critical issues. The commenters or complete responses. Then, motion and prepare for the evidentiary recommended that § 18.72 state that complainants are faced with reply briefs hearing within a short time period. The summary judgment is generally that clarify or even add arguments and commenters recommended that: (1) considered inappropriate in provide additional authorities in Substantive summary motions aimed at administrative proceedings. support of those arguments. The eliminating claims or types of damages The Department declines to revise commenter stated that many circuit should be filed no later than 90 days § 18.72 to state that summary decision is courts deal with this problem by prior to a hearing date; (2) counsel inappropriate in administrative allowing surreply briefs, or by expressly responding to such motions should have proceedings, in general, or in limiting reply briefs to the four corners 21 to 30 days to file their responsive whistleblower proceedings, in of the arguments made by the non- pleadings; and (3) all such motions particular. The utility of a summary moving party in opposition to summary should be resolved at least 30 days prior decision procedure for agencies having judgment. Thus, the commenter to a hearing date. a substantial caseload of formal suggested a rule that specifically allows The Department declines to revise adjudications has long been recognized. for a surreply, makes clear that the reply § 18.72 to require summary decision See Summary Decision in Agency and surreply may only respond to motions be filed no later than 90 days Adjudication,1 CFR 305.70–3 (1995) material in the opposing submission, prior to a hearing date. Prior § 18.40(a) (ACUS Recommendation 70–3, available and states that all ‘‘new’’ material be provided that a party may file a motion at www.acus.gov/sites/default/files/ disregarded by the court. for summary decision at least 20 days documents/70–3.pdf). Section 18.72 is a The Department declines to revise before the date fixed for any hearing. procedural rule applicable to the many § 18.72 to expressly allow surreply With the new § 18.72, the Department types of adjudications conducted by the briefs, or to expressly limit reply briefs increased the timeframe for filing OALJ, and is neutral on the question of to the four corners of the arguments motions for summary decision to 30 whether summary decision as a made by the non-moving party in days before the date fixed for the formal

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hearing. In the OALJ’s experience, this § 18.84 Official notice. The reasoned that attorneys typically review timeframe would generally afford Department clarifies procedures in the transcript as they write the brief, sufficient time for all parties and the § 18.84 that a judge may follow when and that counsel can be more helpful in judge to address the motion. As noted taking judicial notice. The rule provides this regard after they have reviewed the in the new § 18.10(a), the OALJ rules of that official notice may be taken of any transcript in preparation for their brief. practice and procedure are to be adjudicative fact or other matter subject The Department declines to extend the administered to secure the just, speedy, to judicial notice, and the parties must date for motions to correct. The and inexpensive determination of every be given an adequate opportunity to Department contemplates that parties proceeding. In whistleblower cases, in show the contrary of the matter noticed. would have a corrected transcript at the particular, the regulations direct that A commenter objected to a practice by time they prepare their brief. Also, the hearings are to commence ALJs in BLBA claims of taking official rule allows for correction of errors expeditiously. See, e.g., 20 CFR notice of the Dictionary of Occupational discovered during preparation of a brief, 1979.107(b). Moreover, if necessary, Titles (4th ed. Rev. 1991). He contended as the rule provides that a judge may § 18.72 gives the ALJ the discretion to that such practice invades upon the correct errors in the transcript at any adjust deadlines, as appropriate. province of a medical expert who must time before issuing a decision and upon One comment argued that § 18.72(h) consider job duties and tasks in notice to the parties. should be revised to explicitly state that assessing whether a pulmonary § 18.92 Decision and order. The it does not apply in proceedings under impairment would or would not prevent Department revised the prior § 18.57 the LHWCA and the BLBA because 33 the performance of such tasks. Although into two sections, § 18.91, Post-hearing U.S.C. 927(b) expressly provides a the Department agrees with the Briefs; and § 18.92, Decision and Order. procedure (i.e., certification of facts to a commenter that a matter subject to The language that the Department federal district court for summary judicial notice is a matter whose deleted stated that the ALJ was to issue contempt proceedings) for resistance of accuracy cannot be reasonably a decision within a ‘‘reasonable time’’ a lawful order, misconduct during questioned, it declines to identify after receiving the parties’ filings or hearings, and discovery violations. The specific matters for which official notice within 30 days after receiving the commenter thus argued that the is not appropriate. The rule states that parties’ consent findings. Two sanctions listed in the § 18.72(h) are parties must be given an adequate commenters submitted concerns about unavailable to ALJs presiding in opportunity to show the contrary of the the new § 18.92. They observed that, hearings under the LHWCA or BLBA. matter noted. The Department under the current practice, parties ‘‘have The Department declines to adopt the accordingly declines to amend this no mechanism or ability to know when commenters’ suggestion for the reasons provision. decisions will be issued,’’ and expressed § 18.87 Standards of conduct. The detailed above in section II, ‘‘Conflicts concern that delays adversely impact Department relocated the prior § 18.36 with the LHWCA and BLBA.’’ both employers and employees. The to § 18.87 and divided the prior Department has determined that § 18.80 Prehearing statement. The paragraph (b) into two paragraphs: (b) questions about how long it takes the Department added a requirement that a Exclusion for misconduct, and (c) OALJ’s judges to issue their decisions participating party file a prehearing Review of representative’s exclusion. A are best handled as matters of policy statement at least 21 days prior to the commenter contended that the rule and resource allocation. The date set for hearing. Prior § 18.7 did not should be revised to explicitly state that Department therefore declines to adopt have a requirement for filing prehearing § 18.87 does not apply in proceedings the commenters’ suggestions that statements. under the LHWCA and BLBA. The § 18.92 be amended to include a A commenter proposed that the time commenter reasoned that rules of timeframe for issuance of a judge’s for filing the prehearing statement be procedure apply only to the extent that decision. extended to 45 days prior to hearing to they are consistent with the BLBA or its § 18.93 Motion for reconsideration. allow the parties time to ascertain if implementing regulations, and since the The prior rule contained no general additional discovery is needed, and to LHWCA and BLBA contain a specific provision on motions for prevent the need for continuances to statutory provision dealing with the reconsideration of decisions and orders. conduct discovery on witnesses and resistance of an order, misconduct The Department added a new provision evidence not timely disclosed. The during hearings, and discovery stating that motions for reconsideration commenter argued that the additional violations, 33 U.S.C. 927(b), the of a decision and order must be filed time will preclude post trial depositions sanction provisions under either the within 10 days after service of the to rectify untimely disclosed Rules of Practice and Procedure before decision on the moving party. information. The Department declines the OALJ or the FRCP do not apply. The One commenter suggested that the to extend the date for submission of the commenter also objected to the rule provision be amended to permit prehearing statement and notes that the because Congress did not vest the OALJ motions for reconsideration to be filed rule allows for the judge to order a with contempt powers. The Department within 30 days, instead of the 10 days different time frame, if appropriate. declines to adopt the commenters’ in the new rule. The commenter stated A commenter objected to the suggestion for the reasons detailed that the BLBA regulation permits such statement in the NPRM that the above in section II, ‘‘Conflicts with the motions to be filed within 30 days. 20 Department proposed to add a new LHWCA and BLBA.’’ CFR 725.479(b). In the commenter’s regulation at § 18.80(e) requiring a party § 18.88 Transcript of proceedings. view, its proposal will provide for to file objections to an opposing party’s Section 18.88(b) of the new rule states uniformity among all types of cases. The proposed exhibits or use of deposition that motions to correct the official commenter also indicated that a longer testimony within 14 days of being transcript must be filed within 14 days time period for such motions will served, and that failure to object waives of the receipt of the transcript unless the obviate the need to submit motions for an objection unless the judge finds good judge permits additional time. A extensions of time to file motions for cause for failure to object. The NPRM is commenter suggested that motions to reconsideration, and will provide in error. The new rule does not include correct be filed seven days after filing of practitioners and their clients with such a provision. the post-hearing brief. The commenter sufficient time to make informed

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decisions about whether to even file statutes within the OALJ’s purview state petition for review, if a motion for motions for reconsideration. Broad that the ALJ’s decision and order is reconsideration is not submitted, a party motions aimed at all issues will thus be final, unless a petition for review is filed may thereby inadvertently foreclose its avoided and the resulting burden on with the ARB within a specific time, options regarding appeal. The ALJs will be reduced. less than 30 days from service of the Department therefore declines to adopt As the commenter correctly indicated, ALJ’s decision and order. See, e.g., 29 the commenter’s suggestion regarding and as mentioned in the NPRM, the new CFR 1978.109(e)(specifying 14 days for the number of days within which rule is modeled after FRCP 59(e), which cases under the Surface Transportation motions for reconsideration can be filed. gives parties 28 days from the date of Assistance Act); 29 CFR 1980.110(e) IV. Cross Referencing Chart entry of a judgment to file a motion to (specifying 10 days for cases under the alter or amend the judgment. A motion Sarbanes-Oxley Act); 29 CFR To assist in the transition to the for reconsideration may be filed in 1992.110(a)(specifying 10 days for cases revised Subpart A, the chart below BLBA cases within 30 days. 20 CFR under the National Transit Systems provides cross references between the 725.479(b). Compensation orders in Security Act/Federal Railroad Safety new section and section title, and the LHWCA cases similarly are final 30 Act). Permitting a party to move for old section and section title of each rule. days after filing unless other reconsideration after the date that a The chart also provides cross references proceedings are instituted. petition for review must be filed with to the corresponding FRCP rule, where The Department considered other the ARB would be inconsistent with the applicable. Finally, the chart lists the timeframes for motions for Department’s position regarding finality sections from the old Subpart A that reconsideration that were more in line of ALJ decisions in such cases. have been deleted. with FRCP 59(e) or 20 CFR 725.479(b). Additionally, if the deadline for However, some of the Department’s submitting a motion for reconsideration Part 18, Subpart A—Cross Referencing regulations pertaining to specific is after the deadline for submitting a Chart

Federal Rule of New section New section title Old section Old section title Civil Procedure

General Provisions

18.10 ...... Scope and purpose ...... 18.1/18.26 ...... Scope of rules and conduct of hearings Fed. R. Civ. P. 1. 18.11 ...... Definitions ...... 18.2 ...... Definitions. 18.12 ...... Proceedings before administrative law 18.25/18.29(a) Proceedings before administrative law judge. judge/authority of the administrative law judge. 18.13 ...... Settlement judge procedure ...... 18.9 ...... Consent order or settlement; settlement judge procedure. 18.14 ...... Ex parte communication ...... 18.38 ...... Ex parte communications. 18.15 ...... Substitution of administrative law judge 18.30 ...... Unavailability of administrative law Fed. R. Civ. P. 63. judge. 18.16 ...... Disqualification ...... 18.31 ...... Disqualification. 18.17 ...... Legal assistance ...... 18.35 ...... Legal assistance.

Parties and Representatives

18.20 ...... Parties to a proceeding ...... 18.10 ...... Parties, how designated. 18.21 ...... Party appearance and participation ...... 18.39/18.34(a) 18.39, Waiver of right to appear and failure to participate or to appear— text was incorporated into proposed ‘‘participation’’ rule. 18.22 ...... Representatives ...... 18.34 ...... Representatives. 18.23 ...... Disqualification of representatives. 18.24 ...... Briefs from amicus curiae ...... 18.12 ...... Amicus curiae.

Service, Format and Timing of Filings and Other Papers

18.30 ...... Service and filing ...... 18.3 ...... Service and filing ...... Fed. R. Civ. P. 5. 18.31 ...... Privacy protection for filings and exhib- ...... Fed. R. Civ. P. 5.2. its. 18.32 ...... Computing and extending time ...... 18.4 ...... Time computations ...... Fed. R. Civ. P. 6. 18.33 ...... Motions and other papers ...... 18.6 ...... Motions and requests ...... Fed. R. Civ. P. 7(b) & 43(c). 18.34 ...... Format of papers filed. 18.35 ...... Signing motions and other papers; rep- ...... Fed. R. Civ. P. 11. resentations to the judge; sanctions. 18.36 ...... Amendments after referral to the Office 18.5 ...... Responsive pleadings—answer and re- of Administrative Law Judges. quest for hearings.

Prehearing Procedure

18.40 ...... Notice of hearing ...... 18.27 ...... Notice of hearing. 18.41 ...... Continuances and changes in place of 18.28 ...... Continuances. hearing. 18.42 ...... Expedited proceedings ...... 18.42 ...... Expedited proceedings. 18.43 ...... Consolidation; separate hearings ...... 18.11 ...... Consolidation of hearings ...... Fed. R. Civ. P. 42.

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Federal Rule of New section New section title Old section Old section title Civil Procedure

18.44 ...... Prehearing conference ...... 18.8 ...... Prehearing conferences ...... Fed. R. Civ. P. 16.

Disclosure and Discovery

18.50 ...... General provisions governing disclo- ...... Fed. R. Civ. P. 26 (a), (d), sure and discovery. (f), (g). 18.51 ...... Discovery scope and limits ...... 18.14 ...... Scope of discovery ...... Fed. R. Civ. P. 26 (b). 18.52 ...... Protective orders ...... 18.15 ...... Protective orders ...... Fed. R. Civ. P. 26 (c). 18.53 ...... Supplementing disclosures and re- 18.16 ...... Supplementation of responses ...... Fed. R. Civ. P.26 (e). sponses. 18.54 ...... Stipulations about discovery and proce- 18.17 ...... Stipulations regarding discovery ...... Fed. R. Civ. P. 29. dure. 18.55 ...... Using depositions at hearings ...... 18.23 ...... Use of depositions at hearings ...... Fed. R. Civ. P. 32. 18.56 ...... Subpoena ...... 18.24 ...... Subpoenas ...... Fed. R. Civ. P. 45. 18.57 ...... Failure to make disclosures or to co- 18.21 ...... Motion to compel discovery ...... Fed. R. Civ. P. 37. operate in discovery; sanctions.

Types of Discovery

18.60 ...... Interrogatories to parties ...... 18.18 ...... Written interrogatories to parties/ ...... Fed. R. Civ. P. 33. 18.61 ...... Producing documents, electronically 18.19 ...... Production of documents and other evi- Fed. R. Civ. P. 34. stored information, and tangible dence; entry upon land for inspection things, or entering onto land, for in- and other purposes; and physical spection and other purposes. and mental examination. 18.62 ...... Physical and mental examinations ...... 18.19 ...... Production of documents and other evi- Fed. R. Civ. P. 35. dence; entry upon land for inspection and other purposes; and physical and mental examination. 18.63 ...... Requests for admission ...... 18.20 ...... Admissions ...... Fed. R. Civ. P. 36. 18.64 ...... Depositions by oral examination ...... 18.22 ...... Depositions by oral examinations ...... Fed. R. Civ. P. 30. 18.65 ...... Depositions by written questions ...... Fed. R. Civ. P. 31.

Disposition Without Hearing

18.70 ...... Motions for dispositive action. 18.71 ...... Approval of settlement or consent find- 18.9. ings. 18.72 ...... Summary decision...... 18.40/18.41 .... 18.40, Motion for summary decision Fed. R. Civ. P. 56. merged with 18.41, Summary deci- sion.

Hearing

18.80 ...... Prehearing statement ...... 18.7 ...... Prehearing statements. 18.81 ...... Formal hearing ...... 18.43 ...... Formal hearings ...... Fed. R. Civ. P. 43(a). 18.82 ...... Exhibits ...... 18.47/18.48 Exhibits/records in other proceedings/ 18.49/18.50. designation of parts of documents/ authenticity. 18.83 ...... Stipulations ...... 18.51 ...... Stipulations. 18.84 ...... Official notice ...... 18.45 ...... Official notice. 18.85 ...... Privileged, sensitive, or classified mate- 18.46/18.56 .... In camera and protective orders/re- rial. stricted access. 18.86 ...... Hearing room conduct ...... 18.37 ...... Hearing room conduct. 18.87 ...... Standards of conduct ...... 18.36 ...... Standards of conduct. 18.88 ...... Transcript of proceedings ...... 18.52 ...... Record of hearings.

Post Hearing

18.90 ...... Closing the record; subsequent mo- 18.54/18.55 .... Closing the record /receipt of docu- tions. ments after hearing. 18.91 ...... Post-hearing brief...... 18.57 ...... Decision of the administrative law judge and post-hearing briefs. 18.92 ...... Decision and order...... 18.57 ...... Decision of the administrative law judge and post-hearing briefs. 18.93 ...... Motion for reconsideration ...... Fed. R. Civ. P. 59 (e). 18.94 ...... Indicative ruling on a motion for relief ...... Fed. R. Civ. P. 62.1. that is barred by a pending petition for review. 18.95 ...... Review of Decision ...... 18.58 ...... Appeals.

Deleted Sections

Deleted ...... 18.13 ...... Discovery methods. Deleted ...... 18.32 ...... Separation of functions.

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Federal Rule of New section New section title Old section Old section title Civil Procedure

Deleted ...... 18.33 ...... Expedition. Deleted ...... 18.53 ...... Closing of hearings. Deleted ...... 18.59 ...... Certification of official record.

List of Subjects in 29 CFR Part 18 18.43 Consolidation; separate hearings. rules may be inconsistent with a 18.44 Prehearing conference. Administrative practice and governing statute, regulation, or procedure, Labor. Disclosure and Discovery executive order, the latter controls. If a 18.50 General provisions governing specific Department of Labor regulation Signed: At Washington, DC, this 7th of governs a proceeding, the provisions of May, 2015. disclosure and discovery. 18.51 Discovery scope and limits. that regulation apply, and these rules Thomas E. Perez, 18.52 Protective orders. apply to situations not addressed in the Secretary of Labor. 18.53 Supplementing disclosures and governing regulation. The Federal Rules For the reasons set forth in the responses. of Civil Procedure (FRCP) apply in any preamble, amend part 18 of title 29 of 18.54 Stipulations about discovery situation not provided for or controlled procedure. the Code of Federal Regulations as 18.55 Using depositions at hearings. by these rules, or a governing statute, follows: 18.56 Subpoena. regulation, or executive order. 18.57 Failure to make disclosures or to (b) Type of proceeding. Unless the PART 18—RULES OF PRACTICE AND cooperate in discovery; sanctions. governing statute, regulation, or PROCEDURE FOR ADMINISTRATIVE Types of Discovery executive order prescribes a different HEARINGS BEFORE THE OFFICE OF procedure, proceedings follow the ADMINISTRATIVE LAW JUDGES 18.60 Interrogatories to parties. 18.61 Producing documents, electronically Administrative Procedure Act, 5 U.S.C. 551 through 559. ■ 1. The authority citation for part 18 stored information, and tangible things, (c) Waiver, modification, and continues to read as follows: or entering onto land, for inspection and other purposes. suspension. Upon notice to all parties, Authority: 5 U.S.C. 301; 5 U.S.C. 551–553; 18.62 Physical and mental examinations. the presiding judge may waive, modify, 5 U.S.C. 571 note; E.O. 12778; 57 FR 7292. 18.63 Requests for admission. or suspend any rule under this subpart ■ 2. Revise subpart A to read as follows: 18.64 Depositions by oral examination. when doing so will not prejudice a party 18.65 Depositions by written questions. and will serve the ends of justice. Subpart A—General Disposition Without Hearing § 18.11 Definitions. Sec. 18.70 Motions for dispositive action. 18.71 Approval of settlement or consent For purposes of these rules, these General Provisions findings. definitions supplement the definitions 18.10 Scope and purpose. 18.72 Summary decision. in the Administrative Procedure Act, 5 18.11 Definitions. Hearing U.S.C. 551. 18.12 Proceedings before administrative 18.80 Prehearing statement. Calendar call means a meeting in law judge. 18.81 Formal hearing. which the judge calls cases awaiting 18.13 Settlement judge procedure. 18.82 Exhibits. hearings, determines case status, and 18.14 Ex parte communication. 18.83 Stipulations. assigns a hearing date and time. 18.15 Substitution of administrative law 18.84 Official notice. judge. Chief Judge means the Chief 18.85 Privileged, sensitive, or classified 18.16 Disqualification. Administrative Law Judge of the United material. 18.17 Legal assistance. States Department of Labor Office of 18.86 Hearing room conduct. Administrative Law Judges and judges Parties and Representatives 18.87 Standards of conduct. 18.88 Transcript of proceedings. to whom the Chief Judge delegates 18.20 Parties to a proceeding. authority. 18.21 Party appearance and participation. Post Hearing Docket clerk means the Chief Docket 18.22 Representatives. 18.90 Closing the record; subsequent Clerk at the Office of Administrative 18.23 Disqualification of representatives. motions. 18.24 Briefs from amicus curiae. Law Judges in Washington, DC. But 18.91 Post-hearing brief. once a case is assigned to a judge in a Service, Format, and Timing of Filings and 18.92 Decision and order. district office, docket clerk means the Other Papers 18.93 Motion for reconsideration. 18.94 Indicative ruling on a motion for docket staff in that office. 18.30 Service and filing. relief that is barred by a pending petition Hearing means that part of a 18.31 Privacy protection for filings and for review. proceeding consisting of a session to exhibits. 18.95 Review of decision decide issues of fact or law that is 18.32 Computing and extending time. 18.33 Motions and other papers. General Provisions recorded and transcribed and provides 18.34 Format of papers filed. the opportunity to present evidence or 18.35 Signing motions and other papers; § 18.10 Scope and purpose. argument. representations to the judge; sanctions. (a) In general. These rules govern the Judge means an administrative law 18.36 Amendments after referral to the procedure in proceedings before the judge appointed under the provisions of Office of Administrative Law Judges. United States Department of Labor, 5 U.S.C. 3105. Prehearing Procedure Office of Administrative Law Judges. Order means the judge’s disposition 18.40 Notice of hearing. They should be construed and of one or more procedural or substantive 18.41 Continuances and changes in place of administered to secure the just, speedy, issues, or of the entire matter. hearing. and inexpensive determination of every Proceeding means an action before the 18.42 Expedited proceedings. proceeding. To the extent that these Office of Administrative Law Judges

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that creates a record leading to an otherwise, settlement negotiations engage in ex parte communications on adjudication or order. under this section must be completed the merits of a case with the judge. Representative means any person within 60 days from the date of the permitted to represent another in a settlement judge’s appointment. The § 18.15 Substitution of administrative law judge. proceeding before the Office of settlement judge may request that the Administrative Law Judges. Chief Judge extend the appointment. (a) Substitution during hearing. If the The negotiations will be terminated if a judge is unable to complete a hearing, § 18.12 Proceedings before administrative party withdraws from participation, or if a successor judge designated pursuant law judge. the settlement judge determines that to § 18.12 may proceed upon certifying (a) Designation. The Chief Judge further negotiations would be familiarity with the record and designates the presiding judge for all unproductive or inappropriate. determining that the case may be proceedings. (d) Powers of the settlement judge. completed without prejudice to the (b) Authority. In all proceedings The settlement judge may convene parties. The successor judge must, at a under this part, the judge has all powers settlement conferences; require the party’s request, recall any witness necessary to conduct fair and impartial parties or their representatives to attend whose testimony is material and proceedings, including those described with full authority to settle any disputed and who is available to testify in the Administrative Procedure Act, 5 disputes; and impose other reasonable again without undue burden. The U.S.C. 556. Among them is the power requirements to expedite an amicable successor judge may also recall any to: resolution of the case. other witness. (1) Regulate the course of proceedings (e) Stay of proceedings before (b) Substitution following hearing. If in accordance with applicable statute, presiding judge. The appointment of a the judge is unable to proceed after the regulation or executive order; settlement judge does not stay any hearing is concluded, the successor (2) Administer oaths and affirmations aspect of the proceeding before the judge appointed pursuant to § 18.12 and examine witnesses; presiding judge. Any motion to stay may issue a decision and order based (3) Compel the production of must be directed to the presiding judge. upon the existing record after notifying documents and appearance of witnesses the parties and giving them an within a party’s control; (f) Settlement conferences. Settlement conferences may be conducted by opportunity to respond. Within 14 days (4) Issue subpoenas authorized by of receipt of the judge’s notice, a party law; telephone, videoconference or in person at the discretion of the settlement judge may file an objection to the judge (5) Rule on offers of proof and receive issuing a decision based on the existing relevant evidence; after considering the nature of the case, location of the participants, availability record. If no objection is filed, the (6) Dispose of procedural requests and objection is considered waived. Upon similar matters; of technology, and efficiency of administration. good cause shown, the judge may order (7) Terminate proceedings through supplemental proceedings. dismissal or remand when not (g) Confidentiality. All discussions inconsistent with statute, regulation, or with the settlement judge are § 18.16 Disqualification. executive order; confidential; none may be recorded or transcribed. The settlement judge must (a) Disqualification on judge’s (8) Issue decisions and orders; initiative. A judge must withdraw from (9) Exercise powers vested in the not disclose any confidential communications made during a proceeding whenever he or she Secretary of Labor that relate to considers himself or herself proceedings before the Office of settlement proceedings, except as required by statute, executive order, or disqualified. Administrative Law Judges; and (b) Request for disqualification. A (10) Where applicable take any court order. The settlement judge may party may file a motion to disqualify the appropriate action authorized by the not be subpoenaed or called as a witness judge. The motion must allege grounds FRCP. in any hearing of the case or any subsequent administrative proceedings for disqualification, and include any § 18.13 Settlement judge procedure. before the Department to testify to appropriate supporting affidavits, (a) How initiated. The Office of statements made or conduct during the declarations or other documents. The Administrative Law Judges provides settlement discussions. presiding judge must rule on the motion settlement judges to aid the parties in (h) Report. The parties must promptly in a written order that states the grounds resolving the matter that is the subject inform the presiding judge of the for the ruling. of the controversy. Upon a joint request outcome of the settlement negotiations. § 18.17 Legal assistance. by the parties or upon referral by the If a settlement is reached, the parties The Office of Administrative Law judge when no party objects, the Chief must submit the required documents to Judges does not appoint representatives, Judge may appoint a settlement judge. A the presiding judge within 14 days of refer parties to representatives, or settlement judge will not be appointed the conclusion of settlement discussions provide legal assistance. when settlement proceedings would be unless the presiding judge orders inconsistent with a statute, regulation, otherwise. Parties and Representatives or executive order. (i) Non-reviewable decisions. Whether § 18.20 Parties to a proceeding. (b) Appointment. The Chief Judge has a settlement judge should be appointed, discretion to appoint a settlement judge, the selection of a particular settlement A party seeking original relief or who must be an active or retired judge. judge, and the termination of action is designated a complainant, The settlement judge will not be proceedings under this section are claimant or plaintiff, as appropriate. A appointed to hear and decide the case matters not subject to review by party against whom relief or other or approve the settlement without the Department officials. action is sought is designated a parties’ consent and the approval of the respondent or defendant, as appropriate. Chief Judge. § 18.14 Ex parte communication. When participating in a proceeding, the (c) Duration of settlement proceeding. The parties, their representatives, or applicable Department of Labor’s agency Unless the Chief Judge directs other interested persons must not is a party or party-in-interest.

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§ 18.21 Party appearance and judge’s approval. Such an attorney must (e) Withdrawal of appearance. A participation. file a written statement that establishes representative who desires to withdraw (a) In general. A party may appear and why the failure to maintain good after filing a notice of appearance or a participate in the proceeding in person standing is not disqualifying. The judge party desiring to withdraw the or through a representative. may deny approval for the appearance appearance of a representative must file (b) Waiver of participation. By filing of such an attorney after providing a motion with the judge. The motion notice with the judge, a party may waive notice and an opportunity to be heard. must state that notice of the withdrawal the right to participate in the hearing or (iii) Disclosure of discipline. An has been given to the party, client or the entire proceeding. When all parties attorney representative must promptly representative. The judge may deny a waive the right to participate in the disclose to the judge any action representative’s motion to withdraw hearing, the judge may issue a decision suspending, enjoining, restraining, when necessary to avoid undue delay or and order based on the pleadings, disbarring, or otherwise currently prejudice to the rights of a party. evidence, and briefs. restricting the attorney in the practice of (c) Failure to appear. When a party law in any jurisdiction where the § 18.23 Disqualification of representatives. has not waived the right to participate attorney is licensed to practice law. (a) Disqualification—(1) Grounds for in a hearing, conference or proceeding (2) Non-attorney representative. An disqualification. Representatives but fails to appear at a scheduled individual who is not an attorney as qualified under § 18.22 may be hearing or conference, the judge may, defined by paragraph (b)(1) of this disqualified for: after notice and an opportunity to be section may represent a party or (i) Suspension of a license to practice heard, dismiss the proceeding or enter subpoenaed witness upon the judge’s law or disbarment from the practice of a decision and order without further approval. The individual must file a law by any court or agency of the United proceedings if the party fails to establish written request to serve as a non- States, highest court of a State, good cause for its failure to appear. attorney representative that sets forth Commonwealth, or Territory of the the name of the party or subpoenaed United States, or the District of § 18.22 Representatives. witness represented and certifies that Columbia; (a) Notice of appearance. When first the party or subpoenaed witness desires (ii) Disbarment from the practice of making an appearance, each the representation. The judge may law on consent or resignation from the representative must file a notice of require that the representative establish bar of a court or agency while an appearance that indicates on whose that he or she is subject to the laws of investigation into an allegation of behalf the appearance is made and the the United States and possesses misconduct is pending; or proceeding name and docket number. communication skills, knowledge, (iii) Committing an act, omission, or Any attorney representative must character, thoroughness and preparation contumacious conduct that violates include in the notice of appearance the reasonably necessary to render these rules, an applicable statute, an license registration number(s) assigned appropriate assistance. The judge may applicable regulation, or the judge’s to the attorney. inquire as to the qualification or ability order(s). (b) Categories of representation; of a non-attorney representative to admission standards—(1) Attorney (2) Disqualification procedure. The render assistance at any time. The judge Chief Judge must provide notice and an representative. Under these rules, may deny the request to serve as non- ‘‘attorney’’ or ‘‘attorney representative’’ opportunity to be heard as to why the attorney representative after providing representative should not be means an individual who has been the party or subpoenaed witness with admitted to the bar of the highest court disqualified from practice before the notice and an opportunity to be heard. Office of Administrative Law Judges. of a State, Commonwealth, or Territory (c) Duties. A representative must be The notice will include a copy of the of the United States, or the District of diligent, prompt, and forthright when document that provides the grounds for Columbia. dealing with parties, representatives and the disqualification. Unless otherwise (i) Attorney in good standing. An the judge, and act in a manner that directed, any response must be filed attorney who is in good standing in his furthers the efficient, fair and orderly within 21 days of service of the notice. or her licensing jurisdiction may conduct of the proceeding. An attorney The Chief Judge’s determination must represent a party or subpoenaed witness representative must adhere to the be based on the reliable, probative and before the Office of Administrative Law applicable rules of conduct for the substantial evidence of record, Judges. The filing of the Notice of jurisdiction(s) in which the attorney is including the notice and response. Appearance required in paragraph (a) of admitted to practice. this section constitutes an attestation (d) Prohibited actions. A (b) Notification of disqualification that: representative must not: action. When an attorney representative (A) The attorney is a member of a bar (1) Threaten, coerce, intimidate, is disqualified, the Chief Judge will in good standing of the highest court of deceive or knowingly mislead a party, notify the jurisdiction(s) in which the a State, Commonwealth, or Territory of representative, witness, potential attorney is licensed to practice and the the United States, or the District of witness, judge, or anyone participating National Lawyer Regulatory Data Bank Columbia where the attorney has been in the proceeding regarding any matter maintained by the American Bar licensed to practice law; and related to the proceeding; Association Standing Committee on (B) No disciplinary proceeding is (2) Knowingly make or present false Professional Discipline, by providing a pending against the attorney in any or misleading statements, assertions or copy of the decision and order. jurisdiction where the attorney is representations about a material fact or (c) Application for reinstatement. A licensed to practice law. law related to the proceeding; representative disqualified under this (ii) Attorney not in good standing. An (3) Unreasonably delay, or cause to be section may be reinstated by the Chief attorney who is not in good standing in delayed without good cause, any Judge upon application. At the his or her licensing jurisdiction may not proceeding; or discretion of the Chief Judge, represent a party or subpoenaed witness (4) Engage in any other action or consideration of an application for before the Office of Administrative Law behavior prejudicial to the fair and reinstatement may be limited to written Judges, unless he or she obtains the orderly conduct of the proceeding. submissions or may be referred for

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further proceedings before the Chief (ii) The name and address of each transmission time and an indication that Judge. person or representative being served; no error in transmission occurred. (iii) The name of the party filing the (iii) Upon a party’s request or judge’s § 18.24 Briefs from amicus curiae. paper and the party’s representative, if order, the filing party must provide for The United States or an officer or any; review the original transmitted agency thereof, or a State, Territory, (iv) The date of service; and document from which the facsimile was Commonwealth, or the District of (v) How the paper was served. produced. Columbia may file an amicus brief (b) Filing with Office of (4) Electronic filing, signing, or without the consent of the parties or Administrative Law Judges—(1) verification. A judge may allow papers leave of the judge. Any other amicus Required filings. Any paper that is to be filed, signed, or verified by curiae may file a brief only by leave of required to be served must be filed electronic means. the judge, upon the judge’s request, or within a reasonable time after service if the brief states that all parties have with a certificate of service. But § 18.31 Privacy protection for filings and consented to its filing. A request for disclosures under § 18.50(c) and the exhibits. leave to file an amicus brief must be following discovery requests and (a) Redacted filings and exhibits. made by written motion that states the responses must not be filed until they Unless the judge orders otherwise, in an interest of the movant in the proceeding. are used in the proceeding or the judge electronic or paper filing or exhibit that The deadline for submission of an orders filing: contains an individual’s social-security amicus brief will be set by the presiding (i) Notices of deposition, number, taxpayer-identification judge. (ii) Depositions, number, or birth date, the name of an (iii) Interrogatories, individual known to be a minor, or a Service, Format, and Timing of Filings (iv) Requests for documents or financial-account number, the party or and Other Papers tangible things or to permit entry onto nonparty making the filing must redact § 18.30 Service and filing. land; all such information, except: (a) Service on parties—(1) In general. (v) Requests for admission, and (1) The last four digits of the social- (vi) The notice (and the related copy Unless these rules provide otherwise, all security number and taxpayer- of the subpoena) that must be served on papers filed with OALJ or with the identification number; the parties under rule 18.56(b)(1) before judge must be served on every party. (2) The year of the individual’s birth; (2) Service: how made—(i) Serving a a ‘‘documents only’’ subpoena may be (3) The minor’s initials; and party’s representative. If a party is served on the person commended to (4) The last four digits of the represented, service under this section produce the material. financial-account number. must be made on the representative. The (2) Filing: when made—in general. A (b) Exemptions from the redaction judge also may order service on the paper is filed when received by the requirement. The redaction requirement party. docket clerk or the judge during a does not apply to the following: (ii) Service in general. A paper is hearing. (1) The record of an administrative or served under this section by: (3) Filing how made. A paper may be agency proceeding; (A) Handing it to the person; filed by mail, courier service, hand (2) The official record of a state-court (B) Leaving it; delivery, facsimile or electronic proceeding; (1) At the person’s office with a clerk delivery. (3) The record of a court or tribunal, or other person in charge or, if no one (i) Filing by facsimile—(A) When if that record was not subject to the is in charge, in a conspicuous place in permitted. A party may file by facsimile redaction requirement when originally the office; or only as directed or permitted by the filed; and (2) If the person has no office or the judge. If a party cannot obtain prior (4) A filing or exhibit covered by office is closed, at the person’s dwelling permission because the judge is paragraph (c) of this section. or usual place of abode with someone of unavailable, a party may file by (c) Option for filing a reference list. A suitable age and discretion who resides facsimile up to 12 pages, including a filing that contains redacted information there. statement of the circumstances may be filed together with a reference (C) Mailing it to the person’s last precluding filing by delivery or mail. list that identifies each item of redacted known address—in which event service Based on the statement, the judge may information and specifies an is complete upon mailing; later accept the document as properly appropriate identifier that uniquely (D) Leaving it with the docket clerk if filed at the time transmitted. corresponds to each item listed. The the person has no known address; (B) Cover sheet. Filings by facsimile reference list must be filed under seal (E) Sending it by electronic means if must include a cover sheet that and may be amended as of right. Any the person consented in writing—in identifies the sender, the total number reference in the case to a listed which event service is complete upon of pages transmitted, and the matter’s identifier will be construed to refer to transmission, but is not effective if the docket number and the document’s title. the corresponding item of information. serving party learns that it did not reach (C) Retention of the original (d) Waiver of protection of identifiers. the person to be served; or document. The original signed A person waives the protection of (F) Delivering it by any other means document will not be substituted into paragraph (a) of this section as to the that the person consented to in the record unless required by law or the person’s own information by filing or writing—in which event service is judge. offering it without redaction and not complete when the person making (ii) Any party filing a facsimile of a under seal. service delivers it to the agency document must maintain the original (e) Protection of material. For good designated to make delivery. document and transmission record until cause, the judge may order protection of (3) Certificate of service. A certificate the case is final. A transmission record material pursuant to §§ 18.85 and 18.52. of service is a signed written statement is a paper printed by the transmitting that the paper was served on all parties. facsimile machine that states the § 18.32 Computing and extending time. The statement must include: telephone number of the receiving (a) Computing time. The following (i) The title of the document; machine, the number of pages sent, the rules apply in computing any time

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period specified in these rules, a judge’s by affidavits, declarations, or other (f) Renewed or repeated motions. A order, or in any statute, regulation, or evidence; and motion seeking the same or executive order that does not specify a (5) If required by paragraph (c)(4) of substantially similar relief previously method of computing time. this section, include a memorandum of denied, in whole or in part, must (1) When the period is stated in days points and authority supporting the include the following information: or a longer unit of time: movant’s position. (1) The earlier motion(s), (i) Exclude the day of the event that (b) Form. The rules governing (2) When the respective motion was triggers the period; captions and other matters of form made, (ii) Count every day, including apply to motions and other requests. (3) The judge to whom the motion intermediate Saturdays, Sundays, and (c) Written motion before hearing. (1) was made, legal holidays; and A written motion before a hearing must (4) The earlier ruling(s), and (iii) Include the last day of the period, be served with supporting papers, at (5) The basis for the current motion. but if the last day is a Saturday, Sunday, least 21 days before the time specified (g) Motion hearing. The judge may or legal holiday, the period continues to for the hearing, with the following order a hearing to take evidence or oral run until the end of the next day that exceptions: argument on a motion. is not a Saturday, Sunday, or legal (i) When the motion may be heard ex holiday. parte; § 18.34 Format of papers filed. (2) ‘‘Last day’’ defined. Unless a (ii) When these rules or an Every paper filed must be printed in different time is set by a statute, appropriate statute, regulation, or black ink on 8.5 x 11-inch opaque white regulation, executive order, or judge’s executive order set a different time; or paper and begin with a caption that order, the ‘‘last day’’ ends at 4:30 p.m. (iii) When an order sets a different includes: local time where the event is to occur. time. (a) The parties’ names, (3) ‘‘Next day’’ defined. The ‘‘next (2) A written motion served within 21 (b) A title that describes the paper’s day’’ is determined by continuing to days before the hearing must state why purpose, and count forward when the period is the motion was not made earlier. (c) The docket number assigned by measured after an event and backward (3) A written motion before hearing the Office of Administrative Law Judges. when measured before an event. must state that counsel conferred, or If the Office has not assigned a docket (4) ‘‘Legal holiday’’ defined. ‘‘Legal attempted to confer, with opposing number, the paper must bear the case holiday’’ means the day set aside by counsel in a good faith effort to resolve number assigned by the Department of statute for observing New Year’s Day, the motion’s subject matter, and Labor agency where the matter Martin Luther King Jr.’s Birthday, whether the motion is opposed or originated. If the case number is an Washington’s Birthday, Memorial Day, unopposed. A statement of consultation individual’s Social Security number Independence Day, Labor Day, is not required with pro se litigants or then only the last four digits may be Columbus Day, Veterans’ Day, with the following motions: used. See § 18.31(a)(1). Thanksgiving Day, or Christmas Day; (i) To dismiss; (ii) For summary decision; and § 18.35 Signing motions and other papers; and any day on which the district office representations to the judge; sanctions. in which the document is to be filed is (iii) Any motion filed as ‘‘joint,’’ (a) Date and signature. Every written closed or otherwise inaccessible. ‘‘agreed,’’ or ‘‘unopposed.’’ (b) Extending time. When an act may (4) Unless the motion is unopposed, motion and other paper filed with OALJ or must be done within a specified time, the supporting papers must include must be dated and signed by at least one the judge may, for good cause, extend affidavits, declarations or other proof to representative of record in the the time: establish the factual basis for the relief. representative’s name—or by a party (1) With or without motion or notice For a dispositive motion and a motion personally if the party is unrepresented. if the judge acts, or if a request is made, relating to discovery, a memorandum of The paper must state the signer’s before the original time or its extension points and authority must also be address, telephone number, facsimile expires; or submitted. A judge may direct the number and email address, if any. The (2) On motion made after the time has parties file additional documents in judge must strike an unsigned paper expired if the party failed to act because support of any motion. unless the omission is promptly of excusable neglect. (d) Opposition or other response to a corrected after being called to the (c) Additional time after certain kinds motion filed prior to hearing. A party to representative’s or party’s attention. of service. When a party may or must act the proceeding may file an opposition or (b) Representations to the judge. By within a specified time after service and other response to the motion within 14 presenting to the judge a written motion service is made under days after the motion is served. The or other paper—whether by signing, § 18.30(a)(2)(B)(iii) or (iv), 3 days are opposition or response may be filing, submitting, or later advocating added after the period would otherwise accompanied by affidavits, declarations, it—the representative or unrepresented expire under paragraph (a) of this or other evidence, and a memorandum party certifies that to the best of the section. of the points and authorities supporting person’s knowledge, information, and the party’s position. Failure to file an belief, formed after an inquiry § 18.33 Motions and other papers. opposition or response within 14 days reasonable under the circumstances: (a) In general. A request for an order after the motion is served may result in (1) It is not being presented for any must be made by motion. The motion the requested relief being granted. improper purpose, such as to harass, must: Unless the judge directs otherwise, no cause unnecessary delay, or needlessly (1) Be in writing, unless made during further reply is permitted and no oral increase the cost of the proceedings; a hearing; argument will be heard prior to hearing. (2) The claims, defenses, and other (2) State with particularity the (e) A motions made at hearing. A legal contentions are warranted by grounds for seeking the order; motion made at a hearing may be stated existing law or by a nonfrivolous (3) State the relief sought; orally unless the judge determines that argument for extending, modifying, or (4) Unless the relief sought has been a written motion or response would best reversing existing law or for establishing agreed to by all parties, be accompanied serve the ends of justice. new law;

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(3) The factual contentions have Prehearing Procedure § 18.44 Prehearing conference. evidentiary support or, if specifically so (a) In general. The judge, with or § 18.40 Notice of hearing. identified, will likely have evidentiary without a motion, may order one or support after a reasonable opportunity (a) In general. Except when the more prehearing conferences for such for further investigation or discovery; hearing is scheduled by calendar call, purposes as: and the judge must notify the parties of the (1) Expediting disposition of the (4) The denials of factual contentions hearing’s date, time, and place at least proceeding; are warranted on the evidence or, if 14 days before the hearing. The notice (2) Establishing early and continuing specifically so identified, are reasonably is sent by regular, first-class mail, unless control so that the case will not be based on belief or a lack of information. the judge determines that circumstances protracted because of lack of (c) Sanctions—(1) In general. If, after require service by certified mail or other management; notice and a reasonable opportunity to means. The parties may agree to waive (3) Discouraging wasteful prehearing respond, the judge determines that the 14-day notice for the hearing. activities; paragraph (b) of this section has been (b) Date, time, and place. The judge (4) Improving the quality of the violated, the judge may impose an must consider the convenience and hearing through more thorough appropriate sanction on any necessity of the parties and the preparation; and representative, law firm, or party that witnesses in selecting the date, time, (5) Facilitating settlement. violated the rule or is responsible for the and place of the hearing. (b) Scheduling. Prehearing violation. Absent exceptional conferences may be conducted in § 18.41 Continuances and changes in person, by telephone, or other means circumstances, a law firm must be held place of hearing. jointly responsible for a violation after reasonable notice of time, place (a) By the judge. Upon reasonable and manner of conference has been committed by its partner, associate, or notice to the parties, the judge may employee. given. change the time, date, and place of the (c) Participation. All parties must (2) Motion for sanctions. A motion for hearing. participate in prehearing conferences as sanctions must be made separately from (b) By a party’s motion. A request by directed by the judge. A represented any other motion and must describe the a party to continue a hearing or to party must authorize at least one of its specific conduct that allegedly violates change the place of the hearing must be attorneys or representatives to make paragraph (b) of this section. The made by motion. stipulations and admissions about all motion must be served under § 18.30(a), (1) Continuances. A motion for matters that can reasonably be but it must not be filed or be presented continuance must be filed promptly anticipated for discussion at the to the judge if the challenged paper, after the party becomes aware of the prehearing conference, including claim, defense, contention, or denial is circumstances supporting the possible settlement. withdrawn or appropriately corrected continuance. In exceptional (d) Matters for consideration. At the within 21 days after service or within circumstances, a party may orally conference, the judge may consider and another time the judge sets. request a continuance and must take appropriate actions on the (3) On the judge’s initiative. On his or immediately notify the other parties of following matters: her own, the judge may order a the continuance request. (1) Formulating and simplifying the representative, law firm, or party to (2) Change in place of hearing. A issues, and eliminating frivolous claims show cause why conduct specifically motion to change the place of a hearing or defenses; described in the order has not violated must be filed promptly. (2) Amending the papers that had paragraph (b) of this section. framed the issues before the matter was (4) Nature of a sanction. A sanction § 18.42 Expedited proceedings. referred for hearing; imposed under this section may A party may move to expedite the (3) Obtaining admissions and include, but is not limited to, striking proceeding. The motion must stipulations about facts and documents part or all of the offending document, demonstrate the specific harm that to avoid unnecessary proof, and ruling forbidding the filing of any further would result if the proceeding is not in advance on the admissibility of documents, excluding related evidence, expedited. If the motion is granted, the evidence; admonishment, referral of counsel formal hearing ordinarily will not be (4) Avoiding unnecessary proof and misconduct to the appropriate licensing scheduled with less than 7 days notice cumulative evidence, and limiting the authority, and including the sanctioned to the parties, unless all parties consent number of expert or other witnesses; activity in assessing the quality of to an earlier hearing. (5) Determining the appropriateness representation when determining an and timing of dispositive motions under appropriate hourly rate and billable § 18.43 Consolidation; separate hearings. §§ 18.70 and 18.72; hours when adjudicating attorney fees. (a) Consolidation. If separate (6) Controlling and scheduling (5) Requirements for an order. An proceedings before the Office of the discovery, including orders affecting order imposing a sanction must describe Administrative Law Judges involve a disclosures and discovery under the sanctioned conduct and explain the common question of law or fact, a judge §§ 18.50 through 18.65; basis for the sanction. may: (7) Identifying witnesses and (d) Inapplicability to discovery. This (1) Join for hearing any or all matters documents, scheduling the filing and section does not apply to disclosures at issue in the proceedings; exchange of any exhibits and prehearing and discovery requests, responses, (2) Consolidate the proceedings; or submissions, and setting dates for objections, and motions under §§ 18.50 (3) Issue any other orders to avoid further conferences and for the hearing; through 18.65. unnecessary cost or delay. (8) Referring matters to a special (b) Separate hearings. For master; § 18.36 Amendments after referral to the convenience, to avoid prejudice, or to (9) Settling the case and using special Office of Administrative Law Judges. expedite and economize, the judge may procedures to assist in resolving the The judge may allow parties to amend order a separate hearing of one or more dispute such as the settlement judge and supplement their filings. issues. procedure under § 18.13, private

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mediation, and other means authorized parties must consider the nature and information, and tangible things that the by statute or regulation; basis of their claims and defenses and disclosing party has in its possession, (10) Determining the form and content the possibilities for promptly settling or custody, or control and may use to of prehearing orders; resolving the case; make or arrange for support its claims or defenses, unless (11) Disposing of pending motions; the disclosures required by paragraph the use would be solely for (12) Adopting special procedures for (c) of this section; discuss any issues impeachment; and managing potentially difficult or about preserving discoverable (C) A computation of each category of protracted proceedings that may involve information; and develop a proposed damages claimed by the disclosing complex issues, multiple parties, discovery plan. The representatives of party—who must also make available difficult legal questions, or unusual record and all unrepresented parties for inspection and copying as under proof problems; that have appeared in the case are § 18.61 the documents or other (13) Consolidating or ordering jointly responsible for arranging the evidentiary material, unless privileged separate hearings under § 18.43; conference, for attempting in good faith or protected from disclosure, on which (14) Ordering the presentation of to agree on the proposed discovery plan, each computation is based, including evidence early in the proceeding on a and for submitting to the judge within materials bearing on the nature and manageable issue that might, on the 14 days after the conference a written extent of injuries suffered. evidence, be the basis for disposing of report outlining the plan. The judge may (ii) Proceedings exempt from initial the proceeding; order the parties or representatives to disclosure. The following proceedings (15) Establishing a reasonable limit on attend the conference in person. are exempt from initial disclosure: the time allowed to present evidence; (3) Discovery plan. A discovery plan (A) A proceeding under 29 CFR part and must state the parties’ views and 20 for review of an agency (16) Facilitating in other ways the proposals on: determination regarding the existence or just, speedy, and inexpensive (i) What changes should be made in amount of a debt, or the repayment disposition of the proceeding. the timing, form, or requirement for schedule proposed by the agency; (e) Reporting. The judge may direct disclosures under paragraph (c) of this (B) A proceeding before the Board of that the prehearing conference be section, including a statement of when Alien Labor Certification Appeals under recorded and transcribed. If the initial disclosures were made or will be the Immigration and Nationality Act; conference is not recorded, the judge made; and should summarize the conference (ii) The subjects on which discovery (C) A proceeding under the proceedings on the record at the hearing may be needed, when discovery should regulations governing certification of H– or by separate prehearing notice or be completed, and whether discovery 2 non-immigrant temporary agricultural order. should be conducted in phases or be employment at 20 CFR part 655, subpart limited to or focused on particular B; Disclosure and Discovery issues; (D) A rulemaking proceeding under (iii) Any issues about disclosure or the Occupational Safety and Health Act § 18.50 General provisions governing of 1970; and disclosure and discovery. discovery of electronically stored information, including the form or (E) A proceeding for civil penalty (a) Timing and sequence of forms in which it should be produced; assessments under Employee discovery—(1) Timing. A party may seek (iv) Any issues about claims of Retirement Income Security Act of 1974, discovery at any time after a judge privilege or of protection as hearing- 29 U.S.C. 1132. issues an initial notice or order. But if preparation materials, including—if the (iii) Parties exempt from initial the judge orders the parties to confer parties agree on a procedure to assert disclosure. The following parties are under paragraph (b) of this section: these claims after production—whether exempt from initial disclosure: (i) The time to respond to any to ask the judge to include their (A) In a Black Lung benefits pending discovery requests is extended agreement in an order; proceeding under 30 U.S.C. 901 et seq., until the time agreed in the discovery (v) What changes should be made in the representative of the Office of plan, or that the judge sets in resolving the limitations on discovery imposed Workers’ Compensation Programs of the disputes about the discovery plan, and under these rules and what other Department of Labor, if an employer has (ii) No party may seek additional limitations should be imposed; and been identified as the Responsible discovery from any source before the (vi) Any other orders that the judge Operator and is a party to the parties have conferred as required by should issue under § 18.52 or § 18.44. proceeding, see 20 CFR 725.418(d); and paragraph (b) of this section, except by (c) Required disclosures—(1) Initial (B) In a proceeding under the stipulation. disclosure—(i) In general. Except as Longshore and Harbor Workers’ (2) Sequence. Unless, on motion, the exempted by paragraph (c)(1)(ii) of this Compensation Act, 33 U.S.C. 901–950, judge orders otherwise for the parties’ section or otherwise ordered by the or an associated statute such as the and witnesses’ convenience and in the judge, a party must, without awaiting a Defense Base Act, 42 U.S.C. 1651–1654, interests of justice: discovery request, provide to the other the representative of the Office of (i) Methods of discovery may be used parties: Workers’ Compensation Programs of the in any sequence; and (A) The name and, if known, the Department of Labor, unless the (ii) Discovery by one party does not address and telephone number of each Solicitor of Labor or the Solicitor’s require any other party to delay its individual likely to have discoverable designee has elected to participate in discovery. information—along with the subjects of the proceeding under 20 CFR (b) Conference of the parties; planning that information—that the disclosing 702.333(b), or unless an employer or for discovery—(1) In general. The judge party may use to support its claims or carrier has applied for relief under the may order the parties to confer on the defenses, unless the use would be solely special fund, as defined in 33 U.S.C. matters described in paragraphs (b)(2) for impeachment; 908(f). and (3) of this section. (B) A copy—or a description by (iv) Time for initial disclosures—in (2) Conference content; parties’ category and location—of all general. A party must make the initial responsibilities. In conferring, the documents, electronically stored disclosures required by paragraph

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(c)(1)(i) of this section within 21 days (F) A statement of the compensation judge must strike it unless a signature is after an initial notice or order is entered to be paid for the study and testimony promptly supplied after the omission is acknowledging that the proceeding has in the case. called to the representative’s or party’s been docketed at the OALJ unless a (iii) Witnesses who do not provide a attention. different time is set by stipulation or a written report. Unless otherwise (3) Sanction for improper judge’s order, or a party objects during stipulated or ordered by the judge that certification. If a certification violates the conference that initial disclosures the witness is not required to provide a this section without substantial are not appropriate in the proceeding written report, this disclosure must justification, the judge, on motion or on and states the objection in the proposed state: his or her own, must impose an discovery plan. In ruling on the (A) The subject matter on which the appropriate sanction, as provided in objection, the judge must determine witness is expected to present expert § 18.57, on the signer, the party on what disclosures, if any, are to be made opinion evidence; and whose behalf the signer was acting, or and must set the time for disclosure. (B) A summary of the facts and both. opinions to which the witness is (v) Time for initial disclosures—for § 18.51 Discovery scope and limits. parties served or joined later. A party expected to testify. (iv) Supplementing the disclosure. (a) Scope in general. Unless otherwise that is first served or otherwise joined limited by a judge’s order, the scope of later in the proceeding must make the The parties must supplement these disclosures when required under discovery is as follows: Parties may initial disclosures within 21 days after obtain discovery regarding any being served or joined, unless a different § 18.53. (3) Prehearing disclosures. In addition nonprivileged matter that is relevant to time is set by stipulation or the judge’s to the disclosures required by any party’s claim or defense—including order. Copies of all prior disclosures paragraphs (c)(1) and (2) of this section, the existence, description, nature, must be served on a newly served or a party must provide to the other parties custody, condition, and location of any joined party within 21 days of the and promptly file the prehearing documents or other tangible things and service or joinder. disclosures described in § 18.80. the identity and location of persons who (vi) Basis for initial disclosure; (4) Form of disclosures. Unless the know of any discoverable matter. For unacceptable excuses. A party must judge orders otherwise, all disclosures good cause, the judge may order make its initial disclosures based on the under this paragraph (c) must be in discovery of any matter relevant to the information then reasonably available to writing, signed, and served. subject matter involved in the it. A party is not excused from making (d) Signing disclosures and discovery proceeding. Relevant information need its disclosures because it has not fully requests, responses, and objections—(1) not be admissible at the hearing if the investigated the case or because it Signature required; effect of signature. discovery appears reasonably calculated challenges the sufficiency of another Every disclosure under paragraph (c) of to lead to the discovery of admissible party’s disclosures or because another this section and every discovery request, evidence. All discovery is subject to the party has not made its disclosures. response, or objection must be signed by limitations imposed by paragraph (b)(4) (2) Disclosure of expert testimony—(i) at least one of the party’s representatives of this section. In general. A party must disclose to the in the representative’s own name, or by (b) Limitations on frequency and other parties the identity of any witness the party personally if unrepresented, extent—(1) When permitted. By order, who may testify at hearing, either live and must state the signer’s address, the judge may alter the limits in these or by deposition. The judge should set telephone number, facsimile number, rules on the number of depositions and the time for the disclosure by prehearing and email address, if any. By signing, a interrogatories or on the length of order. representative or party certifies that to depositions under § 18.64. The judge’s (ii) Witnesses who must provide a the best of the person’s knowledge, order may also limit the number of written report. Unless otherwise information, and belief formed after a requests under § 18.63. stipulated or ordered by the judge, this reasonable inquiry: (2) Specific limitations on disclosure must be accompanied by a (i) With respect to a disclosure, it is electronically stored information. A written report—prepared and signed by complete and correct as of the time it is party need not provide discovery of the witness—if the witness is one made; and electronically stored information from retained or specially employed to (ii) With respect to a discovery sources that the party identifies as not provide expert testimony in the case or request, response, or objection, it is: reasonably accessible because of undue one whose duties as the party’s (A) Consistent with these rules and burden or cost. On motion to compel employee regularly involve giving warranted by existing law or by a discovery or for a protective order, the expert testimony. The report must nonfrivolous argument for extending, party from whom discovery is sought contain: modifying, or reversing existing law, or must show that the information is not (A) A complete statement of all for establishing new law; reasonably accessible because of undue opinions the witness will express and (B) Not interposed for any improper burden or cost. If that showing is made, the basis and reasons for them; purpose, such as to harass, cause the judge may nonetheless order unnecessary delay, or needlessly discovery from such sources if the (B) The facts or data considered by the increase the cost of litigation; and requesting party shows good cause, witness in forming them; (C) Neither unreasonable nor unduly considering the limitations of paragraph (C) Any exhibits that will be used to burdensome or expensive, considering (b)(4) of this section. The judge may summarize or support them; the needs of the case, prior discovery in specify conditions for the discovery. (D) The witness’s qualifications, the case, the amount in controversy, and (3) Inadvertently disclosed privileged including a list of all publications the importance of the issues at stake in or protected information. By requesting authored in the previous 10 years; the action. electronically stored information, a (E) A list of all other cases in which, (2) Failure to sign. Other parties have party consents to the application of during the previous 4 years, the witness no duty to act on an unsigned Federal Rule of Evidence 502 with testified as an expert at trial, a hearing, disclosure, request, response, or regard to inadvertently disclosed or by deposition; and objection until it is signed, and the privileged or protected information.

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(4) When required. On motion or on conducted only after the report is for it. After being notified, a party must his or her own, the judge must limit the provided, unless the parties stipulate promptly return, sequester, or destroy frequency or extent of discovery otherwise. the specified information and any otherwise allowed by these rules when: (2) Hearing-preparation protection for copies it has; must not use or disclose (i) The discovery sought is draft reports or disclosures. Paragraphs the information until the claim is unreasonably cumulative or duplicative, (c)(1) and (2) of this section protect resolved; must take reasonable steps to or can be obtained from some other drafts of any report or disclosure retrieve the information if the party source that is more convenient, less required under § 18.50(c)(2), regardless disclosed it before being notified; and burdensome, or less expensive; of the form in which the draft is may promptly present the information (ii) The party seeking discovery has recorded. to the judge for an in camera had ample opportunity to obtain the (3) Hearing-preparation protection for determination of the claim. The information by discovery in the action; communications between a party’s producing party must preserve the or representative and expert witnesses. information until the claim is resolved. (iii) The burden or expense of the Paragraphs (c)(1) and (2) under this proposed discovery outweighs its likely section protect communications § 18.52 Protective orders. benefit, considering the needs of the between the party’s representative and (a) In general. A party or any person case, the amount in controversy, the any witness required to provide a report from whom discovery is sought may file parties’ resources, the importance of the under § 18.50(c)(2)(B), regardless of the a written motion for a protective order. issues at stake in the action, and the form of the communications, except to The motion must include a certification importance of the discovery in resolving the extent that the communications: that the movant has in good faith the issues. (i) Relate to compensation for the conferred or attempted to confer with (c) Hearing preparation: Materials— expert’s study or testimony; other affected parties in an effort to (1) Documents and tangible things. (ii) Identify facts or data that the resolve the dispute without the judge’s Ordinarily, a party may not discover party’s representative provided and that action. The judge may, for good cause, documents and tangible things that are the expert considered in forming the issue an order to protect a party or prepared in anticipation of litigation or opinions to be expressed; or person from annoyance, embarrassment, for hearing by or for another party or its (iii) Identify assumptions that the oppression, or undue burden or representative (including the other party’s representative provided and that expense, including one or more of the party’s attorney, consultant, surety, the expert relied on in forming the following: indemnitor, insurer, or agent). But, opinions to be expressed. (1) Forbidding the disclosure or subject to paragraph (d) of this section, (4) Expert employed only for hearing discovery; those materials may be discovered if: preparation. Ordinarily, a party may (2) Specifying terms, including time (i) They are otherwise discoverable not, by interrogatories or deposition, and place, for the disclosure or under paragraph (a) of this section; and discover facts known or opinions held discovery; (ii) The party shows that it has by an expert who has been retained or (3) Prescribing a discovery method substantial need for the materials to specially employed by another party in other than the one selected by the party prepare its case and cannot, without anticipation of litigation or to prepare seeking discovery; undue hardship, obtain their substantial for hearing and whose testimony is not (4) Forbidding inquiry into certain equivalent by other means. anticipated to be used at the hearing. matters, or limiting the scope of (2) Protection against disclosure. A But a party may do so only: disclosure or discovery to certain judge who orders discovery of those (i) As provided in § 18.62(c); or matters; materials must protect against (ii) On showing exceptional (5) Designating the persons who may disclosure of the mental impressions, circumstances under which it is be present while the discovery is conclusions, opinions, or legal theories impracticable for the party to obtain conducted; of a party’s representative concerning facts or opinions on the same subject by (6) Requiring that a deposition be the litigation. other means. sealed and opened only on the judge’s (3) Previous statement. Any party or (e) Claiming privilege or protecting order; other person may, on request and hearing-preparation materials—(1) (7) Requiring that a trade secret or without the required showing, obtain Information withheld. When a party other confidential research, the person’s own previous statement withholds information otherwise development, or commercial about the action or its subject matter. If discoverable by claiming that the information not be revealed or be the request is refused, the person may information is privileged or subject to revealed only in a specified way; move for a judge’s order. A previous protection as hearing-preparation and statement is either: material, the party must: (8) Requiring that the parties (i) A written statement that the person (i) Expressly make the claim; and simultaneously file specified documents has signed or otherwise adopted or (ii) Describe the nature of the or information in sealed envelopes, to approved; or documents, communications, or be opened as the judge directs. (ii) A contemporaneous stenographic, tangible things not produced or (b) Ordering discovery. If a motion for mechanical, electrical, or other disclosed—and do so in a manner that, a protective order is wholly or partly recording—or a transcription of it—that without revealing information itself denied, the judge may, on just terms, recites substantially verbatim the privileged or protected, will enable order that any party or person provide person’s oral statement. other parties to assess the claim. or permit discovery. (d) Hearing preparation: experts—(1) (2) Information produced. If Deposition of an expert who may testify. information produced in discovery is § 18.53 Supplementing disclosures and A party may depose any person who has subject to a claim of privilege or of responses. been identified as an expert whose protection as hearing-preparation (a) In general. A party who has made opinions may be presented at trial. If material, the party making the claim a disclosure under § 18.50(c)—or who § 18.50(c)(2)(B) requires a report from must notify any party that received the has responded to an interrogatory, the expert the deposition may be information of the claim and the basis request for production, or request for

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admission—must supplement or correct anyone who, when deposed, was the used as allowed by the applicable rules its disclosure or response: party’s officer, director, managing agent, of evidence. (1) In a timely manner if the party or designee under § 18.64(b)(6) or (b) Objections to admissibility. Subject learns that in some material respect the § 18.65(a)(4). to paragraph (d)(3) of this section, an disclosure or response is incomplete or (5) Deposition of expert, treating objection may be made at a hearing to incorrect, and if the additional or physician, or examining physician. A the admission of any deposition corrective information has not otherwise party may use for any purpose the testimony that would be inadmissible if been made known to the other parties deposition of an expert witness, treating the witness were present and testifying. during the discovery process or in physician or examining physician. (c) Form of presentation. Unless the writing; or (6) Unavailable witness. A party may judge orders otherwise, a party must (2) As ordered by the judge. use for any purpose the deposition of a provide a transcript of any deposition (b) Expert witness. For an expert witness, whether or not a party, if the testimony the party offers, but the judge whose report must be disclosed under judge finds: may receive the testimony in § 18.50(c)(2)(B), the party’s duty to (i) That the witness is dead; nontranscript form as well. supplement extends both to information (ii) That the witness is more than 100 (d) Waiver of objections—(1) To the included in the report and to miles from the place of hearing or is notice. An objection to an error or irregularity in a deposition notice is information given during the expert’s outside the United States, unless it waived unless promptly served in deposition. Any additions or changes to appears that the witness’s absence was this information must be disclosed by writing on the party giving the notice. procured by the party offering the (2) To the officer’s qualification. An the time the party’s prehearing deposition; disclosures under § 18.50(c)(3) are due. objection based on disqualification of (iii) That the witness cannot attend or the officer before whom a deposition is § 18.54 Stipulations about discovery testify because of age, illness, infirmity, to be taken is waived if not made: procedure. or imprisonment; (i) Before the deposition begins; or (iv) That the party offering the Unless the judge orders otherwise, the (ii) Promptly after the basis for deposition could not procure the parties may stipulate that: disqualification becomes known or, (a) A deposition may be taken before witness’s attendance by subpoena; or with reasonable diligence, could have any person, at any time or place, on any (v) on motion and notice, that been known. notice, and in the manner specified—in exceptional circumstances make it (3) To the taking of the deposition— which event it may be used in the same desirable—in the interests of justice and (i) Objection to competence, relevance, way as any other deposition; and with due regard to the importance of or materiality. An objection to a (b) Other procedures governing or live testimony in an open hearing—to deponent’s competence—or to the limiting discovery be modified— but a permit the deposition to be used. competence, relevance, or materiality of stipulation extending the time for any (7) Limitations on use—(i) Deposition testimony—is not waived by a failure to form of discovery must have the judge’s taken on short notice. A deposition make the objection before or during the approval if it would interfere with the must not be used against a party who, deposition, unless the ground for it time set for completing discovery, for having received less than 14 days’ might have been corrected at that time. (ii) Objection to an error or hearing a motion, or for hearing. notice of the deposition, promptly moved for a protective order under irregularity. An objection to an error or § 18.55 Using depositions at hearings. § 18.52(a)(2) requesting that it not be irregularity at an oral examination is (a) Using depositions—(1) In general. taken or be taken at a different time or waived if: If there is no objection, all or part of a place—and this motion was still (A) It relates to the manner of taking deposition may be used at a hearing to pending when the deposition was taken. the deposition, the form of a question or the extent it would be admissible under (ii) Unavailable deponent; party could answer, the oath or affirmation, a party’s the applicable rules of evidence as if the not obtain a representative. A conduct, or other matters that might deponent were present and testifying. deposition taken without leave of the have been corrected at that time; and (B) It is not timely made during the (2) Over objection. Notwithstanding judge under the unavailability provision of § 18.64(a)(2)(i)(C) must not be used deposition. any objection, all or part of a deposition (iii) Objection to a written question. may be used at a hearing against a party against a party who shows that, when served with the notice, it could not, An objection to the form of a written on these conditions: question under § despite diligent efforts, obtain a 18.65 is waived if not (i) The party was present or served in writing on the party representative to represent it at the represented at the taking of the submitting the question within the time deposition. deposition or had reasonable notice of for serving responsive questions or, if (8) Using part of a deposition. If a it; the question is a recross-question, party offers in evidence only part of a (ii) It is used to the extent it would be within 7 days after being served with it. admissible under the applicable rules of deposition, an adverse party may (4) To completing and returning the evidence if the deponent were present require the offeror to introduce other deposition. An objection to how the and testifying; and parts that in fairness should be officer transcribed the testimony—or (iii) The use is allowed by paragraphs considered with the part introduced, prepared, signed, certified, sealed, (a)(3) through (9) of this section. and any party may itself introduce any endorsed, sent, or otherwise dealt with (3) Impeachment and other uses. Any other parts. the deposition—is waived unless a party may use a deposition to contradict (9) Deposition taken in an earlier motion to suppress is made promptly or impeach the testimony given by the action. A deposition lawfully taken may after the error or irregularity becomes deponent as a witness, or for any other be used in a later action involving the known or, with reasonable diligence, purpose allowed by the applicable rules same subject matter between the same could have been known. of evidence. parties, or their representatives or (4) Deposition of party, agent, or successors in interest, to the same extent § 18.56 Subpoena. designee. An adverse party may use for as if taken in the later action. A (a) In general. (1) Upon written any purpose the deposition of a party or deposition previously taken may also be application of a party the judge may

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issue a subpoena authorized by statute any of its officers or agencies. If the significant expense resulting from or law that requires a witness to attend subpoena commands the production of compliance. and to produce relevant papers, books, documents, electronically stored (3) Quashing or modifying a documents, or tangible things in the information, or tangible things or the subpoena—(i) When required. On witness’ possession or under the inspection of premises before the formal timely motion, the judge must quash or witness’ control. hearing, then before it is served on the modify a subpoena that: (2) Form and contents—(i) person to whom it is directed, a notice (A) Fails to allow a reasonable time to Requirements—in general. Every and copy of the subpoena must be comply; subpoena must: served on each party. (B) Requires a person who is neither (A) State the title of the matter and (2) Service in the United States. a party nor a party’s officer to travel show the case number assigned by the Subject to paragraph (c)(3)(i)(B) of this more than 100 miles from where that Office of Administrative Law Judges or section, a subpoena may be served at person resides, is employed, or regularly the Office of Worker’s Compensation any place within a State, transacts business in person—except Programs. In the event that the case Commonwealth, or Territory of the that, subject to paragraph (c)(3)(ii)(C) of number is an individual’s Social United States, or the District of this section, the person may be Security number only the last four Columbia. commanded to attend the formal numbers may be used. See § 18.31(a)(1); (3) Service in a foreign country. 28 hearing; (B) Bear the signature of the issuing U.S.C. 1783 governs issuing and serving (C) Requires disclosure of privileged judge; a subpoena directed to a United States or other protected matter, if no (C) Command each person to whom it national or resident who is in a foreign exception or waiver applies; or is directed to do the following at a country. (D) Subjects a person to undue specified time and place: attend and (4) Proof of service. Proving service, burden. testify; produce designated documents, when necessary, requires filing with the (ii) When permitted. To protect a electronically stored information, or judge a statement showing the date and person subject to or otherwise affected tangible things in that person’s manner of service and the names of the by a subpoena, the judge may, on possession, custody, or control; or persons served. The statement must be motion, quash or modify the subpoena permit the inspection of premises; and certified by the server. if it requires: (D) Set out the text of paragraphs (c) (c) Protecting a person subject to a (A) Disclosing a trade secret or other and (d) of this section. subpoena—(1) Avoiding undue burden; confidential research, development, or (ii) Command to attend a sanctions. A party or representative commercial information; deposition—notice of the recording responsible for requesting, issuing, or (B) Disclosing an unretained expert’s method. A subpoena commanding serving a subpoena must take reasonable opinion or information that does not attendance at a deposition must state steps to avoid imposing undue burden describe specific occurrences in dispute the method for recording the testimony. on a person subject to the subpoena. and results from the expert’s study that (iii) Combining or separating a The judge must enforce this duty and was not requested by a party; or command to produce or to permit impose an appropriate sanction. (C) A person who is neither a party inspection; specifying the form for (2) Command to produce materials or nor a party’s officer to incur substantial electronically stored information. A permit inspection—(i) Appearance not expense to travel more than 100 miles command to produce documents, required. A person commanded to to attend the formal hearing. electronically stored information, or produce documents, electronically (iii) Specifying conditions as an tangible things or to permit the stored information, or tangible things, or alternative. In the circumstances inspection of premises may be included to permit the inspection of premises, described in paragraph (c)(3)(ii) of this in a subpoena commanding attendance need not appear in person at the place section, the judge may, instead of at a deposition or hearing, or may be set of production or inspection unless also quashing or modifying a subpoena, out in a separate subpoena. A subpoena commanded to appear for a deposition order appearance or production under may specify the form or forms in which or hearing. specified conditions if the serving party: electronically stored information is to be (ii) Objections. A person commanded (A) Shows a substantial need for the produced. to produce documents or tangible things testimony or material that cannot be (iv) Command to produce; included or to permit inspection may serve on the otherwise met without undue hardship; obligations. A command in a subpoena party or representative designated in the and to produce documents, electronically subpoena a written objection to (B) Ensures that the subpoenaed stored information, or tangible things inspecting, copying, testing or sampling person will be reasonably compensated. requires the responding party to permit any or all of the materials or to (d) Duties in responding to a inspection, copying, testing, or sampling inspecting the premises—or to subpoena—(1) Producing documents or of the materials. producing electronically stored electronically stored information. These (b) Service—(1) By whom; tendering information in the form or forms procedures apply to producing fees; serving a copy of certain requested. The objection must be served documents or electronically stored subpoenas. Any person who is at least before the earlier of the time specified information: 18 years old and not a party may serve for compliance or 14 days after the (i) Documents. A person responding a subpoena. Serving a subpoena requires subpoena is served. If an objection is to a subpoena to produce documents delivering a copy to the named person made, the following rules apply: must produce them as they are kept in and, if the subpoena requires that (A) At any time, on notice to the the ordinary course of business or must person’s attendance, tendering with it commanded person, the serving party organize and label them to correspond the fees for 1 day’s attendance and the may move the judge for an order to the categories in the demand. mileage allowed by law. Service may compelling production or inspection. (ii) Form for producing electronically also be made by certified mail with (B) These acts may be required only stored information not specified. If a return receipt. Fees and mileage need as directed in the order, and the order subpoena does not specify a form for not be tendered when the subpoena must protect a person who is neither a producing electronically stored issues on behalf of the United States or party nor a party’s officer from information, the person responding

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must produce it in a form or forms in § 18.57 Failure to make disclosures or to (iii) Striking claims or defenses in which it is ordinarily maintained or in cooperate in discovery; sanctions. whole or in part; a reasonably usable form or forms. (a) Motion for an order compelling (iv) Staying further proceedings until (iii) Electronically stored information disclosure or discovery—(1) In general. the order is obeyed; (v) Dismissing the proceeding in produced in only one form. The person On notice to other parties and all whole or in part; or responding need not produce the same affected persons, a party may move for an order compelling disclosure or (vi) Rendering a default decision and electronically stored information in order against the disobedient party; more than one form. discovery. The motion must include a certification that the movant has in good (2) For not producing a person for (iv) Inaccessible electronically stored faith conferred or attempted to confer examination. If a party fails to comply information. The person responding with the person or party failing to make with an order under § 18.62 requiring it need not provide discovery of disclosure or discovery in an effort to to produce another person for electronically stored information from obtain it without the judge’s action. examination, the judge may issue any of sources that the person identifies as not (2) Specific motions—(i) To compel the orders listed in paragraph (b)(1) of reasonably accessible because of undue disclosure. If a party fails to make a this section, unless the disobedient burden or cost. On motion to compel disclosure required by § 18.50(c), any party shows that it cannot produce the discovery or for a protective order, the other party may move to compel other person. person responding must show that the disclosure and for appropriate (c) Failure to disclose, to supplement information is not reasonably accessible sanctions. an earlier response, or to admit. If a party fails to provide information or because of undue burden or cost. If that (ii) To compel a discovery response. A identify a witness as required by showing is made, the judge may party seeking discovery may move for §§ 18.50(c) and 18.53, or if a party fails nonetheless order discovery from such an order compelling an answer, to admit what is requested under sources if the requesting party shows designation, production, or inspection. § 18.63(a) and the requesting party later good cause, considering the limitations This motion may be made if: proves a document to be genuine or the of § 18.51(b)(4)(iii). The judge may (A) A deponent fails to answer a matter true, the party is not allowed to specify conditions for the discovery. question asked under §§ 18.64 and use that information or witness to 18.65; (2) Claiming privilege or protection— supply evidence on a motion or at a (B) A corporation or other entity fails (i) Information withheld. A person hearing, unless the failure was to make a designation under withholding subpoenaed information substantially justified or is harmless. In §§ 18.64(b)(6) and 18.65(a)(4); under a claim that it is privileged or addition to or instead of this sanction, (C) A party fails to answer an subject to protection as hearing- the judge, on motion and after giving an interrogatory submitted under § 18.60; preparation material must: opportunity to be heard may impose or other appropriate sanctions, including (A) Expressly make the claim; and (D) A party fails to respond that any of the orders listed in paragraph (B) Describe the nature of the inspection will be permitted—or fails to (b)(1) of this section. withheld documents, communications, permit inspection—as requested under (d) Party’s failure to attend its own or tangible things in a manner that, § 18.61. deposition, serve answers to without revealing information itself (iii) Related to a deposition. When interrogatories, or respond to a request privileged or protected, will enable the taking an oral deposition, the party for inspection—(1) In general—(i) parties to assess the claim. asking a question may complete or Motion; grounds for sanctions. The (ii) Information produced. If adjourn the examination before moving judge may, on motion, order sanctions information produced in response to a for an order. if: subpoena is subject to a claim of (3) Evasive or incomplete disclosure, (A) A party or a party’s officer, privilege or of protection as hearing- answer, or response. For purposes of director, or managing agent—or a person paragraph (a) of this section, an evasive preparation material, the person making designated under §§ 18.64(b)(6) and or incomplete disclosure, answer, or the claim may notify any party that 18.65(a)(4)—fails, after being served response must be treated as a failure to received the information of the claim with proper notice, to appear for that disclose, answer, or respond. and the basis for it. After being notified, person’s deposition; or (b) Failure to comply with a judge’s a party must promptly return, sequester, (B) A party, after being properly order—(1) For not obeying a discovery or destroy the specified information and served with interrogatories under order. If a party or a party’s officer, any copies it has; must not use or § 18.60 or a request for inspection under director, or managing agent—or a § 18.61, fails to serve its answers, disclose the information until the claim witness designated under §§ 18.64(b)(6) is resolved; must take reasonable steps objections, or written response. and 18.65(a)(4)—fails to obey an order (ii) Certification. A motion for to retrieve the information if the party to provide or permit discovery, sanctions for failing to answer or disclosed it before being notified; and including an order under § 18.50(b) or respond must include a certification may promptly present the information paragraph (a) of this section, the judge that the movant has in good faith to the judge in camera for a may issue further just orders. They may conferred or attempted to confer with determination of the claim. The person include the following: the party failing to act in an effort to who produced the information must (i) Directing that the matters embraced obtain the answer or response without preserve the information until the claim in the order or other designated facts be the judge’s action. is resolved. taken as established for purposes of the (2) Unacceptable excuse for failing to (e) Failure to obey. When a person proceeding, as the prevailing party act. A failure described in paragraph fails to obey a subpoena, the party claims; (d)(1)(i) of this section is not excused on adversely affected by the failure may, (ii) Prohibiting the disobedient party the ground that the discovery sought when authorized by statute or by law, from supporting or opposing designated was objectionable, unless the party apply to the appropriate district court to claims or defenses, or from introducing failing to act has a pending motion for enforce the subpoena. designated matters in evidence; a protective order under § 18.52(a).

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(3) Types of sanctions. Sanctions may attorney or non-attorney representative request is directed must respond in include any of the orders listed in who objects must sign any objections. writing within 30 days after being paragraph (b)(1) of this section. (c) Use. An answer to an interrogatory served. A shorter or longer time may be (e) Failure to provide electronically may be used to the extent allowed by stipulated to under § 18.54 or be ordered stored information. Absent exceptional the applicable rules of evidence. by the judge. circumstances, a judge may not impose (d) Option to produce business (ii) Responding to each item. For each sanctions under these rules on a party records. If the answer to an interrogatory item or category, the response must for failing to provide electronically may be determined by examining, either state that inspection and related stored information lost as a result of the auditing, compiling, abstracting, or activities will be permitted as requested routine, good-faith operation of an summarizing a party’s business records or state an objection to the request, electronic information system. (including electronically stored including the reasons. (f) Procedure. A judge may impose information), and if the burden of (iii) Objections. An objection to part sanctions under this section upon: deriving or ascertaining the answer will of a request must specify the part and (1) A separately filed motion; or be substantially the same for either permit inspection of the rest. (2) Notice from the judge followed by party, the responding party may answer (iv) Responding to a request for a reasonable opportunity to be heard. by: production of electronically stored Types of Discovery (1) Specifying the records that must information. The response may state an be reviewed, in sufficient detail to objection to a requested form for § 18.60 Interrogatories to parties. enable the interrogating party to locate producing electronically stored (a) In general—(1) Number. Unless and identify them as readily as the information. If the responding party otherwise stipulated or ordered by the responding party could; and objects to a requested form—or if no judge, a party may serve on any other (2) Giving the interrogating party a form was specified in the request—the party no more than 25 written reasonable opportunity to examine and party must state the form or forms it interrogatories, including all discrete audit the records and to make copies, intends to use. subparts. Leave to serve additional compilations, abstracts, or summaries. (v) Producing the documents or interrogatories may be granted to the electronically stored information. extent consistent with § 18.51. § 18.61 Producing documents, Unless otherwise stipulated or ordered (2) Scope. An interrogatory may relate electronically stored information, and by the judge, these procedures apply to tangible things, or entering onto land, for to any matter that may be inquired into inspection and other purposes. producing documents or electronically under § 18.51. An interrogatory is not stored information: objectionable merely because it asks for (a) In general. A party may serve on (A) A party must produce documents an opinion or contention that relates to any other party a request within the as they are kept in the usual course of fact or the application of law to fact, but scope of § 18.51: business or must organize and label the judge may order that the (1) To produce and permit the them to correspond to the categories in interrogatory need not be answered requesting party or its representative to the request; until designated discovery is complete, inspect, copy, test, or sample the (B) If a request does not specify a form or until a prehearing conference or some following items in the responding for producing electronically stored other time. party’s possession, custody, or control: information, a party must produce it in (b) Answers and objections—(1) (i) Any designated documents or a form or forms in which it is ordinarily Responding party. The interrogatories electronically stored information— maintained or in a reasonably usable must be answered: including writings, drawings, graphs, form or forms; and (i) By the party to whom they are charts, photographs, sound recordings, (C) A party need not produce the directed; or images, and other data or data same electronically stored information (ii) If that party is a public or private compilations—stored in any medium in more than one form. corporation, a partnership, an from which information can be obtained (c) Nonparties. As provided in association, or a governmental agency, either directly or, if necessary, after § 18.56, a nonparty may be compelled to by any officer or agent, who must translation by the responding party into produce documents and tangible things furnish the information available to the a reasonably usable form; or or to permit an inspection. party. (ii) Any designated tangible things; or (2) Time to respond. The responding (2) To permit entry onto designated § 18.62 Physical and mental examinations. party must serve its answers and any land or other property possessed or (a) Examination by notice—(1) In objections within 30 days after being controlled by the responding party, so general. A party may serve upon served with the interrogatories. A that the requesting party may inspect, another party whose mental or physical shorter or longer time may be stipulated measure, survey, photograph, test, or condition is in controversy a notice to to under § 18.54 or be ordered by the sample the property or any designated attend and submit to an examination by judge. object or operation on it. a suitably licensed or certified (3) Answering each interrogatory. (b) Procedure—(1) Contents of the examiner. Each interrogatory must, to the extent it request. The request: (2) Contents of the notice. The notice is not objected to, be answered (i) Must describe with reasonable must specify: separately and fully in writing under particularity each item or category of (i) The legal basis for the examination; oath. items to be inspected; (ii) The time, place, manner, (4) Objections. The grounds for (ii) Must specify a reasonable time, conditions, and scope of the objecting to an interrogatory must be place, and manner for the inspection examination, as well as the person or stated with specificity. Any ground not and for performing the related acts; and persons who will perform it; and stated in a timely objection is waived (iii) May specify the form or forms in (iii) How the reasonable unless the judge, for good cause, which electronically stored information transportation expenses were excuses the failure. is to be produced. calculated. (5) Signature. The person who makes (2) Responses and objections—(i) (3) Service of notice. Unless otherwise the answers must sign them, and the Time to respond. The party to whom the agreed by the parties, the notice must be

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served no fewer than 30 days before the party states that it has made reasonable examination in this country after that examination date. inquiry and that the information it time; or (4) Objection. The person to be knows or can readily obtain is (ii) If the deponent is confined in examined must serve any objection to insufficient to enable it to admit or prison. the notice no later than 14 days after the deny. (b) Notice of the deposition; other notice is served. The objection must be (5) Objections. The grounds for formal requirements—(1) Notice in stated with particularity. objecting to a request must be stated. A general. Except as stipulated or (b) Examination by motion. Upon party must not object solely on the otherwise ordered by the judge, a party objection by the person to be examined ground that the request presents a who wants to depose a person by oral the requesting party may file a motion genuine issue for hearing. questions must give reasonable written to compel a physical or mental (6) Motion regarding the sufficiency of notice to every other party of no fewer examination. The motion must include an answer or objection. The requesting than 14 days. The notice must state the the elements required by paragraph party may move to determine the time and place of the deposition and, if (a)(2) of this section. sufficiency of an answer or objection. known, the deponent’s name and (c) Examiner’s report—(1) Delivery of Unless the judge finds an objection address. If the name is unknown, the the report. The party who initiated the justified, the judge must order that an notice must provide a general examination must deliver a complete answer be served. On finding that an description sufficient to identify the copy of the examination report to the answer does not comply with this person or the particular class or group party examined no later than seven days section, the judge may order either that to which the person belongs. after it receives the report, together with the matter is admitted or that an (2) Producing documents. If a like reports of all earlier examinations of amended answer be served. The judge subpoena duces tecum is to be served the same condition. may defer final decision until a on the deponent, the materials (2) Contents. The examiner’s report prehearing conference or a specified designated for production, as set out in must be in writing and must set out in time before the hearing. the subpoena, must be listed in the detail the examiner’s findings, including (b) Effect of an admission; notice or in an attachment. If the notice diagnoses, conclusions, and the results withdrawing or amending it. A matter to a party deponent is accompanied by of any tests. admitted under this section is a request for production under § 18.61, § 18.63 Requests for admission. conclusively established unless the the notice must comply with the (a) Scope and procedure—(1) Scope. judge, on motion, permits the admission requirements of § 18.61(b). A party may serve on any other party a to be withdrawn or amended. The judge (3) Method of recording—(i) Method written request to admit, for purposes of may permit withdrawal or amendment stated in the notice. The party who the pending action only, the truth of any if it would promote the presentation of notices the deposition must state in the matters within the scope of § 18.51 the merits of the action and if the judge notice the method for recording the relating to: is not persuaded that it would prejudice testimony. Unless the judge orders (i) Facts, the application of law to fact, the requesting party in maintaining or otherwise, testimony may be recorded or opinions about either; and defending the action on the merits. An by audio, audiovisual, or stenographic (ii) The genuineness of any described admission under this section is not an means. The noticing party bears the documents. admission for any other purpose and recording costs. Any party may arrange (2) Form; copy of a document. Each cannot be used against the party in any to transcribe a deposition. matter must be separately stated. A other proceeding. (ii) Additional method. With prior notice to the deponent and other parties, request to admit the genuineness of a § 18.64 Depositions by oral examination. document must be accompanied by a any party may designate another copy of the document unless it is, or has (a) When a deposition may be taken— method for recording the testimony in been, otherwise furnished or made (1) Without leave. A party may, by oral addition to that specified in the original available for inspection and copying. questions, depose any person, including notice. That party bears the expense of (3) Time to respond; effect of not a party, without leave of the judge the additional record or transcript responding. A matter is admitted unless, except as provided in paragraph (a)(2) of unless the judge orders otherwise. within 30 days after being served, the this section. The deponent’s attendance (4) By remote means. The parties may party to whom the request is directed may be compelled by subpoena under stipulate—or the judge may on motion serves on the requesting party a written § 18.56. order—that a deposition be taken by answer or objection addressed to the (2) With leave. A party must obtain telephone or other remote means. For matter and signed by the party or its leave of the judge, and the judge must the purpose of this section, the attorney. A shorter or longer time for grant leave to the extent consistent with deposition takes place where the responding may be stipulated to under § 18.51(b): deponent answers the questions. § 18.54 or be ordered by the judge. (i) If the parties have not stipulated to (5) Deposition officer’s duties—(i) (4) Answer. If a matter is not admitted, the deposition and: Before the deposition. Unless the parties the answer must specifically deny it or (A) The deposition would result in stipulate otherwise, a deposition must state in detail why the answering party more than 10 depositions being taken be conducted before a person having cannot truthfully admit or deny it. A under this section or § 18.65 by one of power to administer oaths. The officer denial must fairly respond to the the parties; must begin the deposition with an on- substance of the matter; and when good (B) The deponent has already been the-record statement that includes: faith requires that a party qualify an deposed in the case; or (A) The officer’s name and business answer or deny only a part of a matter, (C) The party seeks to take the address; the answer must specify the part deposition before the time specified in (B) The date, time, and place of the admitted and qualify or deny the rest. § 18.50(a), unless the party certifies in deposition; The answering party may assert lack of the notice, with supporting facts, that (C) The deponent’s name; knowledge or information as a reason the deponent is expected to leave the (D) The officer’s administration of the for failing to admit or deny only if the United States and be unavailable for oath or affirmation to the deponent;

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(E) The identity of all persons present; to any objection. An objection must be changes the deponent makes during the and stated concisely in a nonargumentative 30-day period. (F) The date and method of service of and nonsuggestive manner. A person (f) Certification and delivery; exhibits; the notice of deposition. may instruct a deponent not to answer copies of the transcript or recording; (ii) Conducting the deposition; only when necessary to preserve a filing—(1) Certification and delivery. avoiding distortion. If the deposition is privilege, to enforce a limitation ordered The officer must certify in writing that recorded nonstenographically, the by the judge, or to present a motion the witness was duly sworn and that the officer must repeat the items in under paragraph (d)(3) of this section. deposition accurately records the paragraphs (b)(5)(i)(A) and (B) of this (3) Participating through written witness’s testimony. The certificate section at the beginning of each unit of questions. Instead of participating in the must accompany the record of the the recording medium. The deponent’s oral examination, a party may serve deposition. Unless the judge orders and attorneys’ appearance or demeanor written questions in a sealed envelope otherwise, the officer must seal the must not be distorted through recording on the party noticing the deposition, deposition in an envelope or package techniques. who must deliver them to the officer. bearing the title of the action and (iii) After the deposition. At the end The officer must ask the deponent those marked ‘‘Deposition of [witness’s of a deposition, the officer must state on questions and record the answers name]’’ and must promptly send it to the record that the deposition is verbatim. the party or the party’s representative complete and must set out any (d) Duration; sanction; motion to who arranged for the transcript or stipulations made by the attorneys about terminate or limit—(1) Duration. Unless recording. The party or the party’s custody of the transcript or recording otherwise stipulated or ordered by the representative must store it under and of the exhibits, or about any other judge, a deposition is limited to 1 day conditions that will protect it against pertinent matters. loss, destruction, tampering, or (6) Notice or subpoena directed to an of 7 hours. The judge must allow additional time consistent with deterioration. organization. In its notice or subpoena, (2) Documents and tangible things— a party may name as the deponent a § 18.51(b) if needed to fairly examine the deponent or if the deponent, another (i) Originals and copies. Documents and public or private corporation, a tangible things produced for inspection partnership, an association, a person, or any other circumstance impedes or delays the examination. during a deposition must, on a party’s governmental agency, or other entity request, be marked for identification and must describe with reasonable (2) Sanction. The judge may impose an appropriate sanction, in accordance and attached to the deposition. Any particularity the matters for party may inspect and copy them. But examination. The named organization with § 18.57, on a person who impedes, delays, or frustrates the fair examination if the person who produced them wants must then designate one or more to keep the originals, the person may: officers, directors, or managing agents, of the deponent. (3) Motion to terminate or limit—(i) (A) Offer copies to be marked, or designate other persons who consent attached to the deposition, and then to testify on its behalf; and it may set Grounds. At any time during a deposition, the deponent or a party may used as originals—after giving all parties out the matters on which each person a fair opportunity to verify the copies by designated will testify. A subpoena move to terminate or limit it on the ground that it is being conducted in bad comparing them with the originals; or must advise a nonparty organization of (B) Give all parties a fair opportunity faith or in a manner that unreasonably its duty to make this designation. The to inspect and copy the originals after annoys, embarrasses, or oppresses the persons designated must testify about they are marked—in which event the deponent or party. If the objecting information known or reasonably originals may be used as if attached to deponent or party so demands, the available to the organization. This the deposition. paragraph (b)(6) does not preclude a deposition must be suspended for the (ii) Order regarding the originals. Any deposition by any other procedure time necessary to obtain an order. party may move for an order that the allowed by these rules. (ii) Order. The judge may order that originals be attached to the deposition (c) Examination and cross- the deposition be terminated or may pending final disposition of the examination; record of the examination; limit its scope and manner as provided proceeding. objections; written questions—(1) in § 18.52. If terminated, the deposition (3) Copies of the transcript or Examination and cross-examination. may be resumed only by the judge’s recording. Unless otherwise stipulated The examination and cross-examination order. or ordered by the judge, the officer must of a deponent proceed as they would at (e) Review by the witness; changes— retain the stenographic notes of a the hearing under the applicable rules of (1) Review; statement of changes. On deposition taken stenographically or a evidence. After putting the deponent request by the deponent or a party copy of the recording of a deposition under oath or affirmation, the officer before the deposition is completed, the taken by another method. When paid must record the testimony by the deponent must be allowed 30 days after reasonable charges, the officer must method designated under paragraph being notified by the officer that the furnish a copy of the transcript or (b)(3)(i) of this section. The testimony transcript or recording is available in recording to any party or the deponent. must be recorded by the officer which: (4) Notice of filing. A party who files personally or by a person acting in the (i) To review the transcript or the deposition must promptly notify all presence and under the direction of the recording; and other parties of the filing. officer. (ii) If there are changes in form or (g) Failure to attend a deposition or (2) Objections. An objection at the substance, to sign a statement listing the serve a subpoena. A judge may order time of the examination—whether to changes and the reasons for making sanctions, in accordance with § 18.57, if evidence, to a party’s conduct, to the them. a party who, expecting a deposition to officer’s qualifications, to the manner of (2) Changes indicated in the officer’s be taken, attends in person or by an taking the deposition, or to any other certificate. The officer must note in the attorney, and the noticing party failed aspect of the deposition—must be noted certificate prescribed by paragraph (f)(1) to: on the record, but the examination still of this section whether a review was (1) Attend and proceed with the proceeds; the testimony is taken subject requested and, if so, must attach any deposition; or

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(2) Serve a subpoena on a nonparty (1) Take the deponent’s testimony in (4) A waiver of any right to challenge deponent, who consequently did not response to the questions; or contest the validity of the order attend. (2) Prepare and certify the deposition; entered into in accordance with the and agreement. § 18.65 Depositions by written questions. (3) Send it to the party, attaching a (a) When a deposition may be taken— copy of the questions and of the notice. § 18.72 Summary decision. (1) Without leave. A party may, by (c) Notice of completion or filing—(1) (a) Motion for summary decision or written questions, depose any person, Completion. The party who noticed the partial summary decision. A party may including a party, without leave of the deposition must notify all other parties move for summary decision, identifying judge except as provided in paragraph when it is completed. each claim or defense—or the part of (a)(2) of this section. The deponent’s (2) Filing. A party who files the each claim or defense—on which attendance may be compelled by deposition must promptly notify all summary decision is sought. The judge subpoena under § 18.56. other parties of the filing. shall grant summary decision if the (2) With leave. A party must obtain movant shows that there is no genuine Disposition Without Hearing leave of the judge, and the judge must dispute as to any material fact and the grant leave to the extent consistent with § 18.70 Motions for dispositive action. movant is entitled to decision as a § 18.51(b): (a) In general. When consistent with matter of law. The judge should state on (i) If the parties have not stipulated to statute, regulation or executive order, the record the reasons for granting or the deposition and: any party may move under § 18.33 for denying the motion. (A) The deposition would result in disposition of the pending proceeding. (b) Time to file a motion. Unless the more than 10 depositions being taken If the judge determines at any time that judge orders otherwise, a party may file under this section or § 18.64 by a party; subject matter jurisdiction is lacking, a motion for summary decision at any (B) The deponent has already been the judge must dismiss the matter. time until 30 days before the date fixed deposed in the case; or (b) Motion to remand. A party may for the formal hearing. (C) The party seeks to take a move to remand the matter to the (c) Procedures—(1) Supporting factual deposition before the time specified in referring agency. A remand order must positions. A party asserting that a fact § 18.50(a); or include any terms or conditions and cannot be or is genuinely disputed must (ii) If the deponent is confined in should state the reason for the remand. support the assertion by: prison. (c) Motion to dismiss. A party may (i) Citing to particular parts of (3) Service; required notice. A party move to dismiss part or all of the matter materials in the record, including who wants to depose a person by for reasons recognized under controlling depositions, documents, electronically written questions must serve them on law, such as lack of subject matter stored information, affidavits or every other party, with a notice stating, jurisdiction, failure to state a claim declarations, stipulations (including if known, the deponent’s name and upon which relief can be granted, or those made for purposes of the motion address. If the name is unknown, the untimeliness. If the opposing party fails only), admissions, interrogatory notice must provide a general to respond, the judge may consider the answers, or other materials; or description sufficient to identify the motion unopposed. (ii) Showing that the materials cited person or the particular class or group (d) Motion for decision on the record. do not establish the absence or presence to which the person belongs. The notice When the parties agree that an of a genuine dispute, or that an adverse must also state the name or descriptive evidentiary hearing is not needed, they party cannot produce admissible title and the address of the officer before may move for a decision based on evidence to support the fact. whom the deposition will be taken. stipulations of fact or a stipulated (2) Objection that a fact is not (4) Questions directed to an record. supported by admissible evidence. A organization. A public or private party may object that the material cited corporation, a partnership, an § 18.71 Approval of settlement or consent to support or dispute a fact cannot be association, or a governmental agency findings. presented in a form that would be may be deposed by written questions in (a) Motion for approval of settlement admissible in evidence. accordance with § 18.64(b)(6). agreement. When the applicable statute (3) Materials not cited. The judge (5) Questions from other parties. Any or regulation requires it, the parties need consider only the cited materials, questions to the deponent from other must submit a settlement agreement for but the judge may consider other parties must be served on all parties as the judge’s review and approval. materials in the record. follows: cross-questions, within 14 days (b) Motion for consent findings and (4) Affidavits or declarations. An after being served with the notice and order. Parties may file a motion to affidavit or declaration used to support direct questions; redirect questions, accept and adopt consent findings. Any or oppose a motion must be made on within 7 days after being served with agreement that contains consent personal knowledge, set out facts that cross-questions; and recross-questions, findings and an order that disposes of would be admissible in evidence, and within 7 days after being served with all or part of a matter must include: show that the affiant or declarant is redirect questions. The judge may, for (1) A statement that the order has the competent to testify on the matters good cause, extend or shorten these same effect as one made after a full stated. times. hearing; (d) When facts are unavailable to the (b) Delivery to the deposition officer; (2) A statement that the order is based nonmovant. If a nonmovant shows by officer’s duties. Unless a different on a record that consists of the paper affidavit or declaration that, for procedure is ordered by the judge, the that began the proceeding (such as a specified reasons, it cannot present facts party who noticed the deposition must complaint, order of reference, or notice essential to justify its opposition, the deliver to the officer a copy of all the of administrative determination), as it judge may: questions served and of the notice. The may have been amended, and the (1) Defer considering the motion or officer must promptly proceed in the agreement; deny it; manner provided in § 18.64(c), (e), and (3) A waiver of any further procedural (2) Allow time to obtain affidavits or (f) to: steps before the judge; and declarations or to take discovery; or

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(3) Issue any other appropriate order. (2) The issues of law to be determined (c) Exchange of exhibits. When (e) Failing to properly support or with reference to the appropriate written exhibits are offered in evidence, address a fact. If a party fails to properly statute, regulation, or case law; one copy must be furnished to the judge support an assertion of fact or fails to (3) A precise statement of the relief and to each of the parties at the hearing, properly address another party’s sought; unless copies were previously furnished assertion of fact as required by (4) The stipulated facts that require no with the list of proposed exhibits or the paragraph (c) of this section, the judge proof; judge directs otherwise. If the judge may: (5) The facts disputed by the parties; does not fix a date for the exchange of (1) Give an opportunity to properly (6) A list of witnesses the party exhibits, the parties must exchange support or address the fact; expects to call; copies of exhibits at the earliest (2) Consider the fact undisputed for (7) A list of the joint exhibits; practicable time before the hearing purposes of the motion; (8) A list of the party’s exhibits; begins. (9) An estimate of the time required (3) Grant summary decision if the (d) Authenticity. The authenticity of a for the party to present its case-in-chief; motion and supporting materials— document identified in a pre-hearing including the facts considered and (10) Any additional information that exhibit list is admitted unless a party undisputed—show that the movant is may aid the parties’ preparation for the files a written objection to authenticity entitled to it; or hearing or the disposition of the at least 7 days before the hearing. The (4) Issue any other appropriate order. proceeding, such as the need for judge may permit a party to challenge a (f) Decision independent of the specialized equipment at the hearing. document’s authenticity if the party motion. After giving notice and a (d) Joint prehearing statement. The establishes good cause for its failure to reasonable time to respond, the judge judge may require the parties to file a file a timely written objection. may: joint prehearing statement rather than (e) Substitution of copies for original (1) Grant summary decision for a individual prehearing statements. exhibits. The judge may permit a party nonmovant; (e) Signature. The prehearing to withdraw original documents offered (2) Grant the motion on grounds not statement must be in writing and in evidence and substitute accurate raised by a party; or signed. By signing, an attorney, copies of the originals. (3) Consider summary decision on the representative, or party makes the (f) Designation of parts of documents. judge’s own after identifying for the certifications described in § 18.50(d). When only a portion of a document parties material facts that may not be contains relevant matter, the offering genuinely in dispute. § 18.81 Formal hearing. party must exclude the irrelevant parts (a) Public. Hearings are open to the (g) Failing to grant all the requested to the greatest extent practicable. relief. If the judge does not grant all the public. But, when authorized by law relief requested by the motion, the judge and only to the minimum extent (g) Records in other proceedings. may enter an order stating any material necessary, the judge may order a hearing Portions of the record of other fact—including an item of damages or or any part of a hearing closed to the administrative proceedings, civil actions other relief—that is not genuinely in public, including anticipated witnesses. or criminal prosecutions may be dispute and treating the fact as The order closing all or part of the received in evidence, when the offering established in the case. hearing must state findings and explain party shows the copies are accurate. (h) Affidavit or declaration submitted why the reasons for closure outweigh § 18.83 Stipulations. in bad faith. If satisfied that an affidavit the presumption of public access. The or declaration under this section is order and any objection must be part of (a) The parties may stipulate to any submitted in bad faith or solely for the record. facts in writing at any stage of the delay, the judge—after notice and a (b) Taking testimony. Unless a closure proceeding or orally on the record at a reasonable time to respond—may order order is issued under paragraph (a) of deposition or at a hearing. These sanctions or other relief as authorized this section, the witnesses’ testimony stipulations bind the parties unless the by law. must be taken in an open hearing. For judge disapproves them. good cause and with appropriate Hearing (b) Every stipulation that requests or safeguards, the judge may permit requires a judge’s action must be written § 18.80 Prehearing statement. testimony in an open hearing by and signed by all affected parties or contemporaneous transmission from a (a) Time for filing. Unless the judge their representatives. Any stipulation to different location. orders otherwise, at least 21 days before extend time must state the reason for the (c) Party participation. For good cause the hearing, each participating party date change. and with appropriate safeguards, the must file a prehearing statement. judge may permit a party to participate (c) A proposed form of order may be (b) Required conference. Before filing in an open hearing by contemporaneous submitted with the stipulation; it may a prehearing statement, the party must transmission from a different location. consist of an endorsement on the confer with all other parties in good stipulation of the words, ‘‘Pursuant to faith to: § 18.82 Exhibits. stipulation, it is so ordered,’’ with (1) Stipulate to the facts to the fullest (a) Identification. All exhibits offered spaces designated for the date and the extent possible; and in evidence must be marked with a signature of the judge. (2) Revise exhibit lists, eliminate designation identifying the party § 18.84 Official notice. duplicative exhibits, prepare joint offering the exhibit and must be exhibits, and attempt to resolve any numbered and paginated as the judge On motion of a party or on the judge’s objections to exhibits. orders. own, official notice may be taken of any (c) Contents. Unless ordered (b) Electronic data. By order the judge adjudicative fact or other matter subject otherwise, the prehearing statement may prescribe the format for the to judicial notice. The parties must be must state: submission of data that is in electronic given an adequate opportunity to show (1) The party’s name; form. the contrary of the matter noticed.

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§ 18.85 Privileged, sensitive, or classified reasonable standards of orderly or offer responsive evidence, and a new material. ethical conduct, failure to act in good evidentiary hearing may be set. (a) Exclusion. On motion of any faith, or violation of the prohibition (c) Motions after the decision. After interested person or the judge’s own, the against ex parte communications. The the decision and order is issued, the judge may limit the introduction of judge must state the basis for the judge retains jurisdiction to dispose of material into the record or issue orders exclusion. appropriate motions, such as a motion to protect against undue disclosure of (c) Review of representative’s to award attorney’s fees and expenses, a privileged communications, or sensitive exclusion. Any representative excluded motion to correct the transcript, or a or classified matters. The judge may from a proceeding may appeal to the motion for reconsideration. admit into the record a summary or Chief Judge for reinstatement within 7 extract that omits the privileged, days of the exclusion. The exclusion § 18.91 Post-hearing brief. sensitive or classified material. order is reviewed for abuse of The judge may grant a party time to (b) Sealing the record. (1) On motion discretion. The proceeding from which file a post-hearing brief with proposed of any interested person or the judge’s the representative was excluded will not findings of fact, conclusions of law, and own, the judge may order any material be delayed or suspended pending the specific relief sought. The brief must that is in the record to be sealed from review by the Chief Judge, except for a refer to all portions of the record and public access. The motion must propose reasonable delay to enable the party to authorities relied upon in support of the fewest redactions possible that will obtain another representative. each assertion. protect the interest offered as the basis § 18.88 Transcript of proceedings. for the motion. A redacted copy or § 18.92 Decision and order. (a) Hearing transcript. All hearings summary of any material sealed must be At the conclusion of the proceeding, must be recorded and transcribed. The made part of the public record unless the judge must issue a written decision parties and the public may obtain copies the necessary redactions would be so and order. extensive that the public version would of the transcript from the official be meaningless, or making even a reporter at rates not to exceed the § 18.93 Motion for reconsideration. applicable rates fixed by the contract redacted version or summary available A motion for reconsideration of a with the reporter. would defeat the reason the original is decision and order must be filed no later (b) Corrections to the transcript. A than 10 days after service of the sealed. party may file a motion to correct the (2) An order that seals material must decision on the moving party. official transcript. Motions for state findings and explain why the correction must be filed within 14 days reasons to seal adjudicatory records § 18.94 Indicative ruling on a motion for of the receipt of the transcript unless the relief that is barred by a pending petition for outweigh the presumption of public judge permits additional time. The review. access. Sealed materials must be placed judge may grant the motion in whole or in a clearly marked, separate part of the (a) Relief pending review. If a timely part if the corrections involve record. Notwithstanding the judge’s motion is made for relief that the judge substantive errors. At any time before order, all parts of the record remain lacks authority to grant because a issuing a decision and upon notice to subject to statutes and regulations petition for review has been docketed the parties, the judge may correct errors pertaining to public access to agency and is pending, the judge may: in the transcript. records. (1) Defer considering the motion; Post Hearing (2) Deny the motion; or § 18.86 Hearing room conduct. (3) State either that the judge would Participants must conduct themselves § 18.90 Closing the record; subsequent motions. grant the motion if the reviewing body in an orderly manner. The consumption remands for that purpose or that the of food or beverage, and rearranging (a) In general. The record of a hearing motion raises a substantial issue. closes when the hearing concludes, courtroom furniture are prohibited, (b) Notice to reviewing body. The unless the judge directs otherwise. If unless specifically authorized by the movant must promptly notify the clerk any party waives a hearing, the record judge. Electronic devices must be of the reviewing body if the judge states closes on the date the judge sets for the silenced and must not disrupt the that he or she would grant the motion proceedings. Parties, witnesses and filing of the parties’ submissions. (b) Motion to reopen the record. (1) A or that the motion raises a substantial spectators are prohibited from using issue. video or audio recording devices to motion to reopen the record must be (c) Remand. The judge may decide the record hearings. made promptly after the additional evidence is discovered. No additional motion if the reviewing body remands § 18.87 Standards of conduct. evidence may be admitted unless the for that purpose. (a) In general. All persons appearing offering party shows that new and § 18.95 Review of decision. in proceedings must act with integrity material evidence has become available and in an ethical manner. that could not have been discovered The statute or regulation that (b) Exclusion for misconduct. During with reasonable diligence before the conferred hearing jurisdiction provides the course of a proceeding, the judge record closed. Each new item must be the procedure for review of a judge’s may exclude any person—including a designated as an exhibit under decision. If the statute or regulation party or a party’s attorney or non- § 18.82(a) and accompanied by proof does not provide a procedure, the attorney representative—for that copies have been served on all judge’s decision becomes the Secretary’s contumacious conduct such as refusal to parties. final administrative decision. comply with directions, continued use (2) If the record is reopened, the other [FR Doc. 2015–11586 Filed 5–18–15; 8:45 am] of dilatory tactics, refusal to adhere to parties must have an opportunity to BILLING CODE 4510–20–P

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Part III

The President

Notice of May 15, 2015—Continuation of the National Emergency With Respect to Burma

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Federal Register Presidential Documents Vol. 80, No. 96

Tuesday, May 19, 2015

Title 3— Notice of May 15, 2015

The President Continuation of the National Emergency With Respect to Burma

On May 20, 1997, the President issued Executive Order 13047, certifying to the Congress under section 570(b) of the Foreign Operations, Export Financing, and Related Programs Appropriations Act, 1997 (Public Law 104– 208), that the Government of Burma had committed large-scale repression of the democratic opposition in Burma after September 30, 1996, thereby invoking the prohibition on new investment in Burma by United States persons contained in that section. The President also declared a national emergency pursuant to the International Emergency Economic Powers Act, 50 U.S.C. 1701–1706, to deal with the unusual and extraordinary threat to the national security and foreign policy of the United States constituted by the actions and policies of the Government of Burma. The actions and policies of the Government of Burma continue to pose an unusual and extraordinary threat to the national security and foreign policy of the United States. For this reason, the national emergency declared on May 20, 1997, and the measures adopted to deal with that emergency in Executive Orders 13047 of May 20, 1997; 13310 of July 28, 2003; 13448 of October 18, 2007; 13464 of April 30, 2008; 13619 of July 11, 2012; and 13651 of August 6, 2013, must continue in effect beyond May 20, 2015. Therefore, in accordance with section 202(d) of the National Emer- gencies Act (50 U.S.C. 1622(d)), I am continuing for 1 year the national emergency with respect to Burma declared in Executive Order 13047. This notice shall be published in the Federal Register and transmitted to the Congress.

THE WHITE HOUSE, May 15, 2015. [FR Doc. 2015–12290

Filed 5–18–15; 11:15 am] Billing code 3295–F5

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Reader Aids Federal Register Vol. 80, No. 96 Tuesday, May 19, 2015

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING MAY

Federal Register/Code of Federal Regulations At the end of each month the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. Presidential Documents 3 CFR 309...... 27269 Executive orders and proclamations 741–6000 Proclamations: 10 CFR 9261...... 25571 The United States Government Manual 741–6000 Proposed Rules: 9262...... 25573 50...... 25237 Other Services 9263...... 25575 430...... 26198 Electronic and on-line services (voice) 741–6020 9264...... 25577 431 ...... 24841, 26199, 26475, Privacy Act Compilation 741–6064 9265...... 25579 27601 Public Laws Update Service (numbers, dates, etc.) 741–6043 9266...... 25889 TTY for the deaf-and-hard-of-hearing 741–6086 9267...... 25891 12 CFR 9268...... 25893 4...... 28346 9269...... 25895 5...... 28346 ELECTRONIC RESEARCH 9270...... 26177 7...... 28346 World Wide Web 9271...... 26179 9272...... 26433 14...... 28346 24...... 28346 Full text of the daily Federal Register, CFR and other publications 9273...... 26435 32...... 28346 is located at: www.fdsys.gov. 9274...... 26817 9275...... 27235 34...... 28346 Federal Register information and research tools, including Public 9276...... 27237 100...... 28346 Inspection List, indexes, and Code of Federal Regulations are 9277...... 27239 116...... 28346 located at: www.ofr.gov. 9278...... 27241 143...... 28346 144...... 28346 E-mail 9279...... 27849 Administrative Orders: 145...... 28346 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is Memorandums: 146...... 28346 an open e-mail service that provides subscribers with a digital Memorandum of April 150...... 28346 form of the Federal Register Table of Contents. The digital form 16, 2015 ...... 25207 152...... 28346 of the Federal Register Table of Contents includes HTML and Memorandum of April 159...... 28346 PDF links to the full text of each document. 29, 2015 ...... 27555 160...... 28346 To join or leave, go to http://listserv.access.gpo.gov and select Notices: 161...... 28346 Online mailing list archives, FEDREGTOC-L, Join or leave the list Notice of May 6, 162...... 28346 (or change settings); then follow the instructions. 2015 ...... 26815 163...... 28346 Notice of May 8, 174...... 28346 PENS (Public Law Electronic Notification Service) is an e-mail 192...... 28346 service that notifies subscribers of recently enacted laws. 2015 ...... 27067 Notice of May 13 193...... 28346 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 2015 ...... 27851 620...... 26822 and select Join or leave the list (or change settings); then follow Notice of May 15 701...... 25924 the instructions. 2015 ...... 27805 704...... 25932 1207...... 25209 FEDREGTOC-L and PENS are mailing lists only. We cannot 5 CFR 1806...... 25581 respond to specific inquiries. 2418...... 24779 Proposed Rules: Reference questions. Send questions and comments about the 704...... 27108 Federal Register system to: [email protected] 7 CFR 745...... 27109 The Federal Register staff cannot interpret specific documents or Ch. 0 ...... 25901 13 CFR regulations. 205...... 25897 Proposed Rules: CFR Checklist. Effective January 1, 2009, the CFR Checklist no 210...... 26181 127...... 24846 longer appears in the Federal Register. This information can be 235...... 26181 found online at http://bookstore.gpo.gov/. 925...... 27243 985...... 27245 14 CFR 4284...... 26788 Ch. I ...... 27853 FEDERAL REGISTER PAGES AND DATE, MAY Proposed Rules: 39 ...... 24789, 24791, 25589, 25591, 27069, 27072, 27074, 24779–25206...... 1 210...... 26846 27077, 27081, 28172 25207–25570...... 4 215...... 26846 220...... 26846 71 ...... 24793, 27563, 28537 25571–25896...... 5 235...... 26846 91...... 26822, 28538 25897–26180...... 6 319...... 24838 97...... 25594, 25595 26181–26436...... 7 900...... 25969 121...... 25215 26437–26816...... 8 1218...... 26469 135...... 25215 26817–27068...... 11 Proposed Rules: 27069–27236...... 12 9 CFR 39 ...... 24850, 24852, 24854, 27237–27554...... 13 107...... 26819 24856, 25247, 25249, 25254, 27555–27850...... 14 317...... 28153 25627, 25630, 26484, 26487, 27851–28152...... 15 417...... 27557 26490, 26492, 27114, 27116, 28153–28536...... 18 Proposed Rules: 27601, 27605, 27607 28537–28806...... 19 3...... 24840 71 ...... 24858, 24860, 24861,

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26496, 26497, 26870, 26872, 1926...... 25366 180 ...... 24824, 25950, 25953, 42...... 25989 27119 4022...... 27857 28201 54...... 25989 300...... 27859 63...... 25989 15 CFR 30 CFR 450...... 25235 64...... 25989 30...... 27853 1206...... 24794 721...... 26448 902...... 28539 1210...... 24794 Proposed Rules: 48 CFR Proposed Rules: 52 ...... 24872, 24874, 26210, 4...... 26499 32 CFR 27121, 27127, 27275, 27276, Ch. 1...... 26422, 26429 734...... 25798 320...... 25230 28209, 28215 1...... 26423 740...... 25798 635...... 28545 60...... 28215, 28571 4...... 26427 742...... 25798 706...... 28555 80...... 26212 15...... 26424 744...... 25798 Proposed Rules: 81...... 24874 22...... 26423, 26427 772...... 25798 2002...... 26501 300...... 27883 39...... 26427 774...... 25798 704...... 26518 42...... 26426 33 CFR 745...... 27621 52...... 26423, 26427 16 CFR 100 ...... 27086, 27087, 27858, 1600...... 27276 1328...... 27266 3...... 25940 1352...... 27266 28175, 28176, 28556 41 CFR 4...... 25940 117 ...... 24814, 24815, 25232, Proposed Rules: 1120...... 25216 25233, 25598, 26182, 26183, 300–3...... 27259 1...... 26883 301–10...... 27259 2...... 26883 17 CFR 26442, 27099, 27563, 28184, 28185, 28558 301–70...... 27259 7...... 26883 Proposed Rules: 11...... 26883 165 ...... 24816, 25599, 26443, 42 CFR 32...... 26200 26445, 27087, 27100, 27565, 23...... 26883 229...... 26330 28176, 28186, 28556, 28559 37...... 27862 25...... 26883 240...... 26330, 27444 Proposed Rules: 86...... 26464 52...... 26883 242...... 27444 100...... 27616, 28569 121...... 26464 501...... 25994 423...... 25958 18 CFR 117...... 27619 516...... 25994 147...... 24863, 25256 Proposed Rules: 538...... 25994 Proposed Rules: 165 ...... 24866, 24869, 25634, 412...... 25012, 25637 552...... 25994 352...... 25633 26511, 26514, 28205, 28207 418...... 25832 1823...... 26519 410...... 28539 1842...... 27278 34 CFR 43 CFR 19 CFR 1846...... 26519 Ch. III ...... 26830 Proposed Rules: 1852...... 26519, 27278 181...... 26828 Ch. VI...... 27036 2...... 27623 47...... 27134 20 CFR Proposed Rules: 48...... 27134 49 CFR Ch. III...... 27868, 27874 Proposed Rules: 27...... 26196 668...... 28484 655...... 25633 44 CFR 37...... 26196 64...... 24830, 27261 171...... 26644 21 CFR 36 CFR 67...... 27567, 27570 172...... 26644 242...... 28187 890...... 25226 173...... 26644 1308...... 27854 Proposed Rules: 45 CFR 174...... 26644 Proposed Rules: 1192...... 27275 1355...... 27263 179...... 26644 310...... 25166 37 CFR Proposed Rules: Proposed Rules: 1308...... 27611 98...... 25260 391...... 25260 42...... 28561 170...... 25637 22 CFR Ch. X...... 27281 38 CFR 1206...... 25637 1300...... 27280 51...... 27856 1210...... 25637 1313...... 27280 Proposed Rules: 63...... 24819 1211...... 25637 121...... 25821 77...... 25233 1216...... 25637 Proposed Rules: 1217...... 25637 50 CFR 24 CFR 17...... 27878 1218...... 25637 10...... 26467 91...... 25901 1220...... 25637 86...... 26150 93...... 25901 39 CFR 1222...... 25637 100...... 28187 20...... 26447 1226...... 25637 402...... 26832 25 CFR 111...... 25528 2556...... 25637 622...... 24832, 25966 226...... 26994 Proposed Rules: 635 ...... 24836, 25609, 26196, 3001...... 26517 47 CFR 27863 26 CFR 1...... 27572, 28203 648 ...... 25110, 25143, 25160 1...... 25230, 26437 40 CFR 2...... 27107 660...... 25611, 27588 53...... 25230 9...... 26448 73...... 27572 679...... 25625, 25967 602...... 25230 49...... 25068 74...... 27862 680...... 28539 Proposed Rules: 52 ...... 24821, 26183, 26189, 90...... 25604 Proposed Rules: 1 ...... 25970, 26500, 26873 26461, 27102, 27251, 27255, Proposed Rules: 223...... 25272 28193 1...... 27626 224...... 25272 29 CFR 80...... 26191, 26463 20...... 25977 300...... 28572 18...... 28768 174 ...... 25601, 25943, 25946 36...... 25989 648 ...... 25656, 28217, 28575

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in today’s List of Public enacted public laws. To Laws. subscribe, go to http:// LIST OF PUBLIC LAWS Public Laws Electronic listserv.gsa.gov/archives/ Last List May 4, 2015 Notification Service publaws-l.html (PENS) Note: No public bills which Note: This service is strictly have become law were for E-mail notification of new received by the Office of the PENS is a free electronic mail laws. The text of laws is not Federal Register for inclusion notification service of newly available through this service. PENS cannot respond to specific inquiries sent to this address.

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