Federal Register Vol. 82, No.55,
Federal Register Volume 82, Issue 55 (March 23, 2017)
Federal Register Volume 82, Issue 55 (March 23, 2017)
| Page Range | 14811-14985 | |
| FR Document |
![III
Contents Federal Register
Vol. 82, No. 55
Thursday, March 23, 2017
Agency for Toxic Substances and Disease Registry Commodity Futures Trading Commission
NOTICES NOTICES
Proposed Substances to be Evaluated for Set 31 Meetings; Sunshine Act, 14882
Toxicological Profiles, 14900–14901
Community Development Financial Institutions Fund
Agricultural Marketing Service NOTICES
PROPOSED RULES Agency Information Collection Activities; Proposals,
U.S. Standards for Grades of Shelled Walnuts and Walnuts Submissions, and Approvals, 14941
in the Shell, 14832
NOTICES Corporation for National and Community Service
Meetings: NOTICES
Fruit and Vegetable Industry Advisory Committee, 14865 Agency Information Collection Activities; Proposals,
Submissions, and Approvals, 14882–14883
Agriculture Department
Defense Department
See Agricultural Marketing Service
NOTICES
See Forest Service
Meetings:
Judicial Proceedings Since Fiscal Year 2012 Amendments
Census Bureau Panel, 14883–14884
NOTICES
Agency Information Collection Activities; Proposals, Drug Enforcement Administration
Submissions, and Approvals, 14869–14871 RULES
Schedules of Controlled Substances:
Centers for Disease Control and Prevention Placement of FDA-Approved Products of Oral Solutions
NOTICES Containing Dronabinol [(-)-delta-9-trans-
Meetings: tetrahydrocannabinol (delta-9-THC)] in Schedule II,
Clinical Laboratory Improvement Advisory Committee; 14815–14820
Cancellation, 14901 PROPOSED RULES
Disease, Disability, and Injury Prevention and Control Schedules of Controlled Substances:
Special Emphasis Panel; Initial Review, 14901–14902 Temporary Placement of 4-Fluoroisobutyryl Fentanyl into
Schedule I, 14842–14845
Children and Families Administration NOTICES
NOTICES Bulk Manufacturers of Controlled Substances; Registrations:
Single-Source Grants: Noramco, Inc., Isosciences, AMRI Rensselaer, Inc., et al.,
Office of Refugee Resettlement’s Unaccompanied 14913
Children’s Program, 14903 Decisions and Orders:
Wesley Pope, M.D., 14944–14985
Importers of Controlled Substances; Applications:
Civil Rights Commission
Wildlife Laboratories, Inc., 14914
NOTICES
Importers of Controlled Substances; Registrations:
Meetings:
Fisher Clinical Services, Inc.; Sigma-Aldrich
Arkansas Advisory Committee, 14869
International; GMBH-Sigma Aldrich Co., LLC; et al.,
West Virginia Advisory Committee, 14868–14869
14913–14914
Coast Guard Education Department
RULES NOTICES
Drawbridge Operations: Agency Information Collection Activities; Proposals,
Des Allemands Bayou, Des Allemands, LA, 14820 Submissions, and Approvals:
National Assessment of Educational Progress 2018–2019,
Commerce Department 14885
See Census Bureau School Survey on Crime and Safety 2018 and 2020,
See Foreign-Trade Zones Board 14884
sradovich on DSK3GMQ082PROD with FRONT MATTER CN
See International Trade Administration
See National Institute of Standards and Technology Energy Department
See National Oceanic and Atmospheric Administration See Federal Energy Regulatory Commission
NOTICES
Agency Information Collection Activities; Proposals, Environmental Protection Agency
Submissions, and Approvals, 14871 RULES
Agency Information Collection Activities; Proposals, Air Quality State Implementation Plans; Approvals and
Submissions, and Approvals: Promulgations:
Generic Clearance for Collection of Qualitative Feedback Louisiana; Volatile Organic Compounds Rule Revision
on Agency Service Delivery, 14872 and Stage II Vapor Recovery, 14822–14828
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Document Created: 2018-02-01 14:44:10
Document Modified: 2018-02-01 14:44:10
| Page and Subject | |
|---|---|
| 82 FR 14913 - Government in the Sunshine Act Meeting Notice | |
| 82 FR 14912 - Government in the Sunshine Act Meeting Notice | |
| 82 FR 14900 - Sunshine Act Meeting | |
| 82 FR 14882 - Sunshine Act Meetings | |
| 82 FR 14896 - Environmental Financial Advisory Committee; Request for Nominations of Candidates to the Environmental Financial Advisory Board; Reopening of Request for Nominations | |
| 82 FR 14895 - Combined Notice of Filings #2 | |
| 82 FR 14889 - Combined Notice of Filings #1 | |
| 82 FR 14904 - Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention; Draft Guidance for Industry; Availability | |
| 82 FR 14938 - Norfolk Southern Railway Company-Abandonment Exemption-in Roanoke, Va. | |
| 82 FR 14882 - Proposed Information Collection; Comment Request | |
| 82 FR 14910 - Cowlitz Indian Tribe Liquor Ordinance | |
| 82 FR 14912 - Indian Gaming; Extension of Tribal-State Class III Gaming Compact (Rosebud Sioux Tribe and the State of South Dakota) | |
| 82 FR 14910 - Indian Gaming; Extension of Tribal-State Class III Gaming Compact (Crow Creek Sioux Tribe and the State of South Dakota) | |
| 82 FR 14885 - Agency Information Collection Activities; Comment Request; National Assessment of Educational Progress (NAEP) 2018-2019 | |
| 82 FR 14941 - Community Development Financial Institutions Fund | |
| 82 FR 14820 - Drawbridge Operation Regulation; Des Allemands Bayou, Des Allemands, LA | |
| 82 FR 14815 - Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II | |
| 82 FR 14874 - Ferrovanadium From the Republic of Korea: Final Determination of Sales at Less Than Fair Value | |
| 82 FR 14872 - Foreign-Trade Zone (FTZ) 148-Knoxville, Tennessee; Authorization of Production Activity; CoLinx, LLC (Bearing Units); Crossville, Tennessee | |
| 82 FR 14884 - Agency Information Collection Activities; Comment Request; School Survey on Crime and Safety (SSOCS) 2018 and 2020 | |
| 82 FR 14876 - 1-Hydroxyethylidene-1, 1-Diphosphonic Acid From the People's Republic of China: Final Determination of Sales at Less Than Fair Value | |
| 82 FR 14872 - Countervailing Duty Investigation of 1-Hydroxyethylidene-1, 1-Diphosphonic Acid From the People's Republic of China: Final Affirmative Determination | |
| 82 FR 14939 - Notice of Availability of the Federal Aviation Administration Written Re-Evaluation, Adoption, and Finding of No Significant Impact and Record of Decision of Department of Navy's Final Environmental Impact Statement for the Navy's Environmental Assessment for the Mariana Islands Range Complex Airspace | |
| 82 FR 14820 - Release of VA Records Relating to HIV | |
| 82 FR 14916 - Advisory Committee for Biological Sciences; Notice of Meeting | |
| 82 FR 14938 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Robert Rauschenberg” Exhibition | |
| 82 FR 14938 - Notice of Public Meeting | |
| 82 FR 14893 - Village of North Bennington; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 82 FR 14887 - Village of North Bennington; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 82 FR 14892 - ANR Storage Company; Notice of Request Under Blanket Authorization | |
| 82 FR 14889 - Arkansas Electric Cooperative Corporation; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 82 FR 14887 - Littleville Power Company, Inc.; Hitchcock Hydro, LLC; Notice of Application for Transfer of License and Soliciting Comments, Motions To Intervene, and Protests | |
| 82 FR 14893 - Commission Information Collection Activities (Ferc Form 73 and Ferc-600); Consolidated Comment Request; Extension | |
| 82 FR 14880 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting | |
| 82 FR 14881 - Fisheries of the Gulf of Mexico and the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting | |
| 82 FR 14882 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting | |
| 82 FR 14917 - Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4 Containment Hydrogen Igniter Changes | |
| 82 FR 14865 - Fruit and Vegetable Industry Advisory Committee | |
| 82 FR 14896 - Vista Energy Storage, LLC; Notice of Filing | |
| 82 FR 14888 - Commission Information Collection Activities (FERC-588), Comment Request; Extension | |
| 82 FR 14890 - Transcontinental Gas Pipe Line Company, LLC; Notice of Intent To Prepare an Environmental Assessment for the Proposed St. James Supply Project and Request for Comments on Environmental Issues | |
| 82 FR 14885 - PacifiCorp; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Preliminary Terms and Conditions, and Preliminary Fishway Prescriptions | |
| 82 FR 14916 - South Carolina Electric & Gas Company, Virgil C. Summer Nuclear Station, Units 2 and 3; Qualified Data Processing System and Safety Display | |
| 82 FR 14920 - Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4 Nuclear Instrumentation System Excore Detector Surface Material Inspection Clarification | |
| 82 FR 14848 - Carrier Safety Fitness Determination | |
| 82 FR 14871 - Submission for OMB Review; Comment Request | |
| 82 FR 14870 - Submission for OMB Review; Comment Request | |
| 82 FR 14869 - Submission for OMB Review; Comment Request | |
| 82 FR 14915 - Advisory Committee for Engineering; Notice of Meeting | |
| 82 FR 14914 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Federal-State Unemployment Insurance Program Data Exchange Standardization | |
| 82 FR 14908 - Endangered and Threatened Wildlife and Plants; Incidental Take Permit Application and Environmental Assessment for Commercial Mixed-Use Development; Miami-Dade County, FL | |
| 82 FR 14883 - Judicial Proceedings Since Fiscal Year 2012 Amendments Panel; Notice of Federal Advisory Committee Meeting | |
| 82 FR 14940 - Motorcyclist Advisory Council to the Federal Highway Administration | |
| 82 FR 14903 - Center for Devices and Radiological Health: Experiential Learning Program | |
| 82 FR 14908 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Inter-Agency Alien Witness and Informant Record | |
| 82 FR 14879 - National Cybersecurity Center of Excellence (NCCoE) Capabilities Assessment for Securing Manufacturing Industrial Control Systems for the Manufacturing Sector | |
| 82 FR 14850 - Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; 2017 Tribal Fishery for Pacific Whiting | |
| 82 FR 14868 - Chequamegon Resource Advisory Committee | |
| 82 FR 14865 - Lee Canyon Ski Area Master Development Plan Phase I Environmental Impact Statement. Humboldt-Toiyabe National Forest, Spring Mountains National Recreation Area, Clark County, Nevada | |
| 82 FR 14853 - Fisheries of the Exclusive Economic Zone Off Alaska; Integrating Electronic Monitoring Into the North Pacific Observer Program | |
| 82 FR 14907 - National Cancer Institute; Notice of Closed Meetings | |
| 82 FR 14906 - Center for Scientific Review; Notice of Closed Meetings | |
| 82 FR 14905 - Center for Scientific Review; Notice of Closed Meeting | |
| 82 FR 14919 - Information Collection: NRC Form 749, “Manual License Verification Report” | |
| 82 FR 14828 - Suspension of Community Eligibility | |
| 82 FR 14903 - Announcement of the Award of One Single-Source Expansion Supplement Grant Within the Office of Refugee Resettlement's Unaccompanied Children's Program | |
| 82 FR 14868 - Agenda and Notice of Public Meetings of the West Virginia Advisory Committee | |
| 82 FR 14932 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to “Tick-Worse” Functionality | |
| 82 FR 14936 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change Amending Rule 968NY To Make Permanent a Program That Allows Transactions To Take Place at a Price That Is Below $1 per Option Contract | |
| 82 FR 14934 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Amending Rule 6.80 To Make Permanent a Program That Allows Transactions To Take Place at a Price That Is Below $1 per Option Contract | |
| 82 FR 14926 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change Related to Rules Regarding the Responsibility for Ensuring Compliance With Priority and Allocation Requirements and Trade-Through Prohibitions in Open Outcry Trading | |
| 82 FR 14925 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of a Proposed Rule Change, Security-Based Swap Submission or Advance Notice Relating to the CDS End-of-Day Price Discovery Policy | |
| 82 FR 14932 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of Longer Period for Commission Action on Proposed Rule Change Amending Rules 7.29E and 1.1E To Provide for a Delay Mechanism | |
| 82 FR 14929 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Schedule of Fees To Modify the Member Order Routing Program | |
| 82 FR 14922 - Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend MIAX PEARL Rules 517A, Aggregate Risk Manager for EEMs (“ARM-E”), and 517B, Aggregate Risk Manager for Market Makers (“ARM-M”) | |
| 82 FR 14900 - Proposed Substances To Be Evaluated for Set 31 Toxicological Profiles | |
| 82 FR 14902 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review | |
| 82 FR 14901 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review | |
| 82 FR 14901 - Clinical Laboratory Improvement Advisory Committee (CLIAC) | |
| 82 FR 14913 - Importer of Controlled Substances Registration | |
| 82 FR 14914 - Importer of Controlled Substances Application: Wildlife Laboratories, Inc. | |
| 82 FR 14842 - Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl Into Schedule I | |
| 82 FR 14913 - Bulk Manufacturer of Controlled Substances Registration | |
| 82 FR 14846 - Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities | |
| 82 FR 14896 - Product Cancellation Order for Certain Pesticide Registrations and Amendments To Terminate Uses | |
| 82 FR 14944 - Wesley Pope, M.D.; Decision and Order | |
| 82 FR 14941 - Proposed Collection; Comment Request | |
| 82 FR 14942 - Proposed Collection; Comment Request | |
| 82 FR 14906 - National Institute of General Medical Sciences; Notice of Closed Meeting | |
| 82 FR 14872 - Renewal of Currently Approved Information Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
| 82 FR 14907 - Georgia; Amendment No. 5 to Notice of a Major Disaster Declaration | |
| 82 FR 14869 - Notice of Public Meeting of the Arkansas Advisory Committee To Discuss Civil Rights Topics in the State | |
| 82 FR 14837 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
| 82 FR 14835 - Airworthiness Directives; The Boeing Company Airplanes | |
| 82 FR 14839 - Proposed Amendment of Class E Airspace, Soldotna, AK | |
| 82 FR 14940 - Petition for Exemption; Summary of Petition Received | |
| 82 FR 14832 - Airworthiness Directives; Dassault Aviation Airplanes | |
| 82 FR 14841 - Proposed Amendment of Class E Airspace Areas, and Establishment of Class E Airspace; Bishop, CA | |
| 82 FR 14813 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
| 82 FR 14811 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
| 82 FR 14845 - Approval and Promulgation of Implementation Plans; Louisiana; Volatile Organic Compounds Rule Revision and Stage II Vapor Recovery | |
| 82 FR 14822 - Approval and Promulgation of Implementation Plans; Louisiana; Volatile Organic Compounds Rule Revision and Stage II Vapor Recovery | |
| 82 FR 14832 - U.S. Standards for Grades of Shelled Walnuts and Walnuts in the Shell |
Issue
Agricultural Marketing Service
Forest Service
Census Bureau
Foreign-Trade Zones Board
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
U.S. Citizenship and Immigration Services
Fish and Wildlife Service
Indian Affairs Bureau
Drug Enforcement Administration
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Community Development Financial Institutions Fund
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective March 23, 2017. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of March 23, 2017.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.
This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPs, Takeoff Minimums and/or ODPs. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective March 23, 2017. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of March 23, 2017.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.
This rule amends title 14 of the Code of Federal Regulations, part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part § 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d),
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, title 14, Code of Federal Regulations, part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Drug Enforcement Administration, Department of Justice.
Interim final rule, with request for comments.
On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-
The effective date of this rulemaking is March 23, 2017. Interested persons may file written comments on this rulemaking in accordance with 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before April 24, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
Interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),” may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before April 24, 2017.
To ensure proper handling of comments, please reference “Docket No. DEA-344” on all correspondence, including any attachments.
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Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-8953.
Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at
If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
An electronic copy of this document and supplemental information, including the complete Department of Health and Human Services and Drug Enforcement Administration eight-factor analyses, to this interim final rule are available at
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. In accordance with 21 CFR 1308.44(a) through (c), requests for a hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing may be submitted only by interested persons, defined as those “adversely affected or aggrieved by any rule or proposed rule
Please note that pursuant to 21 U.S.C. 811(a), the purpose and subject matter of the hearing are restricted to “(A) find[ing] that such drug or other substance has a potential for abuse, and (B) mak[ing] with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed * * *.” Requests for a hearing and waivers of participation in the hearing should be submitted to DEA using the address information provided above.
Under the Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114-89), which was signed into law on November 25, 2015, DEA is required to commence an expedited scheduling action with respect to certain new drugs approved by the FDA. As provided in 21 U.S.C. 811(j), this expedited scheduling is required where both of the following conditions apply: (1) The Secretary of HHS has advised DEA that a New Drug Application (NDA) has been submitted for a drug that has a stimulant, depressant, or hallucinogenic effect on the central nervous system, and that it appears that such drug has an abuse potential and (2) the Secretary recommends that DEA control the drug in schedule II, III, IV, or V pursuant to 21 U.S.C. 811(a) and (b). In these circumstances, DEA is required to issue an interim final rule controlling the drug within 90 days.
The law further states that the 90-day timeframe starts the later of (1) the date DEA receives the HHS scientific and medical evaluation/scheduling recommendation or (2) the date DEA receives notice of the NDA approval by HHS. In addition, the law specifies that the rulemaking shall become immediately effective as an interim final rule without requiring the DEA to demonstrate good cause therefor. Thus, the purpose of subsection (j) is to speed the process by which DEA schedules newly approved drugs that are currently either in schedule I or not controlled (but which have sufficient abuse potential to warrant control) so that such drugs may be marketed without undue delay following FDA approval.
Subsection (j) further provides that the interim final rule shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, DEA must issue a final rule in accordance with the scheduling criteria of subsections 21 U.S.C. 811(b), (c), and (d) and 21 U.S.C. 812(b).
Syndros is an oral solution that contains 5 mg of dronabinol (delta-9-THC) per mL of solution. Dronabinol is the generic name (International Nonproprietary Name, INN) for the (-) delta-9-trans isomer of tetrahydrocannabinol (THC), the primary psychoactive substance in marijuana. On June 1, 2015, Insys Therapeutics (Sponsor) submitted an NDA to the U.S. Food and Drug Administration (FDA) for Syndros, an oral formulation of dronabinol. The FDA accepted the NDA filing for Syndros on August 6, 2015 and approved the NDA on July 5, 2016. On December 28, 2016, the DEA received notification that HHS/FDA approved Syndros for the treatment of anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS), and for the treatment of nausea and vomiting resulting from cancer chemotherapy in patients who failed to respond to conventional anti-emetic therapies.
On December 28, 2016, the HHS provided the DEA with a scientific and medical evaluation and scheduling recommendation related to dronabinol. Because DEA's authority to issue this interim final rule under subsection 811(j) is limited to drugs that are the subject of an approved NDA, and because the NDA was limited to an oral solution containing dronabinol, DEA's discussion here of the scheduling criteria is likewise limited to oral solutions containing dronabinol in FDA-approved drug products.
In response, the DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by the HHS, along with all other relevant data, and completed its own eight-factor review document pursuant to 21 U.S.C. 811(c). The DEA concluded that FDA-approved dronabinol oral solutions met the 21 U.S.C. 812(b)(2) criteria for placement in schedule II of the CSA.
Pursuant to subsection 811(j), and based on the HHS recommendation, NDA approval by HHS/FDA, and DEA's determination, DEA is issuing this interim final rule to schedule FDA-approved dronabinol oral solution as a schedule II controlled substance under the CSA.
Included below is a brief summary of each factor as analyzed by the HHS and the DEA, and as considered by the DEA in its scheduling action. Please note that both the DEA and HHS analyses are available in their entirety under “Supporting Documents” in the public docket for this interim final rule at
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According to HHS, although Syndros oral solution and Marinol capsules have
The 2014 and 2015 Monitoring the Future (MTF)
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In vitro manipulation studies with Syndros and Marinol (positive control) were conducted by the Sponsor. It was found that Syndros oral solution and Marinol capsules differ in their physiochemical properties. Specifically, Syndros, unlike Marinol, can be manipulated such that the dronabinol can be evaporated into residues that can be reconstituted for smoking or abused intravenously. According to HHS, Syndros contains a large amount of dronabinol (150 mg of dronabinol in 30 mL of solution) and would be an easily accessible source for abuse via the oral route.
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Oral consumption of dronabinol, compared to inhaled THC, may result in psychoactive effects that are delayed and stronger with an increased risk of experiencing serious adverse events. When dronabinol (THC) is smoked, the drug rapidly reaches the brain and psychoactive effects are felt within minutes of inhalation, which allows the subject to control the dose more readily. Due to the absorption and metabolism by the liver following oral ingestion of dronabinol, it takes longer for an individual to feel the psychoactive effects. Therefore, the individual may underestimate the ingestion amount needed to feel the psychoactive effects
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The CSA lists the findings required to place a drug or other substance in any particular Schedule (I, II, III, IV, or V). 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for Health of the HHS and review of all available data, the Acting Administrator of the DEA, pursuant to 21 U.S.C. 812(b)(2), finds that:
1. FDA-approved products containing dronabinol in an oral solution have a high potential for abuse. The physicochemical properties of Syndros allow extraction of dronabinol for abuse through oral or inhalation (smoking or vaping) routes. Dronabinol is not easily extractable from Marinol. Oral abuse of dronabinol-containing products is associated with hallucinations, mood alterations, and paranoia. The 2015 MTF Survey reported that 6.1 percent of the 12th graders used e-cigarettes to vaporize marijuana or cannabinoid substances. Similarly, the 2014 Summer Styles Survey, 16 percent of current marijuana users indicated that they have consumed dronabinol containing edibles or drinks. These data collectively indicate FDA-approved oral solutions containing dronabinol have high potential for abuse.
2. FDA-approved products containing dronabinol in an oral solution have a currently accepted medical use in treatment in the United States. The FDA approved an oral solution containing dronabinol (Syndros) for the treatment of anorexia associated with weight loss in patients with AIDS, and for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
3. FDA-approved products containing dronabinol in an oral solution may lead to severe physical dependence. Following discontinuation of dronabinol at a dose 210 mg/day (25 times higher than the recommended daily dose for anorexia associated with weight loss in AIDS patients) for 12 to 16 consecutive days, withdrawal symptoms including irritability, insomnia, and restlessness were observed at 12 hours after discontinuation. These withdrawal symptoms worsened to include hot flashes, sweating, rhinorrhea, loose stools, hiccoughs, and anorexia at 24 hours after discontinuation of dronabinol. The withdrawal symptoms decreased gradually over the next 48 hours and patients reported having disturbed sleep for several weeks after discontinuation of dronabinol.
Based on these findings, the Acting Administrator of the DEA concludes that FDA-approved products containing dronabinol [(-)-delta-9-trans tetrahydrocannabinol (delta-9-THC)] in an oral solution warrant control in schedule II of the CSA. 21 U.S.C. 812(b)(2).
Preliminarily, it should be noted that any form of dronabinol other than in an FDA-approved drug product remains a schedule I controlled substance, and those who handle such material remain subject to the regulatory controls, and administrative, civil, and criminal sanctions, applicable to schedule I controlled substances set forth in the CSA and DEA regulations. However, for those who handle dronabinol oral solution exclusively in the form of an FDA-approved drug product, the following is a summary of the schedule II regulatory requirements that apply as a result of this interim final rule:
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Any person who becomes registered with the DEA to handle FDA-approved products containing dronabinol in an oral solution must take an initial inventory of all stocks of controlled
After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including FDA-approved products containing dronabinol in an oral solution) on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
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As explained above, under 21 U.S.C. 811(j), where a new drug is (1) approved by the Department of Health and Human Services (HHS) and (2) HHS recommends control in CSA schedule II-V, the DEA is required to issue an interim final rule scheduling the drug within 90 days. Additionally, the law specifies that the rulemaking shall become immediately effective as an interim final rule without requiring the DEA to demonstrate good cause. Therefore, the standard notice-and-comment requirements of section 553 of the APA, 5 U.S.C. 553, do not apply to this scheduling action.
In accordance with 21 U.S.C. 811(j), this scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
In accordance with 5 U.S.C. 603(a), “[w]henever an agency is required by [5 U.S.C. 553], or any other law, to publish general notice of proposed rulemaking for any proposed rule, or publishes a notice of proposed rulemaking for an interpretive rule involving the internal revenue laws of the United States, the agency shall prepare and make available for public comment an initial regulatory flexibility analysis.” As noted in the above discussion regarding applicability of the Administrative Procedure Act, the notice-and-comment requirements of section 553 of the APA, 5 U.S.C. 553, do not apply to this scheduling action. Consequently, the RFA does not apply to this interim final rule.
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501
This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, the DEA amends 21 CFR part 1308 as follows:
21 U.S.C. 811, 812, 871(b), unless otherwise noted.
(f) * * *
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Burlington Northern Santa Fe Railroad swing span drawbridge across Des Allemands Bayou, mile 14.0, at Des Allemands, St. Charles and Lafourche Parishes, Louisiana. The deviation is necessary to install two open-deck spans for increased reliability of bridge operations. This deviation allows the bridge to remain in the closed-to-navigation position for two (2) separate, two-day periods.
This deviation is effective from 6 a.m. on April 20, 2017 through 12 noon on April 28, 2017.
The docket for this deviation, [USCG-2017-0100] is available at
If you have questions on this temporary deviation, call or email Giselle MacDonald, Bridge Management Specialist, Coast Guard; telephone 504-671-2128, email
The Burlington Northern Santa Fe Railroad Company requested a temporary deviation from the operating schedule for the swing span drawbridge across Des Allemands Bayou, mile 14.0, at Des Allemands, St. Charles and Lafourche Parishes, Louisiana. The deviation was requested to install two open-deck spans, one on each side of the existing swing span, to increase the reliability of bridge opening and closing operations.
The draw currently operates under 33 CFR 117.440(b). The draw of the Burlington Northern Santa Fe Railroad Bridge, Mile 14.0, shall open on signal Monday through Friday from 7 a.m. to 3 p.m. At all other times the draw shall open on signal if at least 4 hours notice is given.
For purposes of this deviation, the bridge will remain closed to navigation for two separate dates, 30 hours each, from 6 a.m. April 20, 2017 through 12 noon, April 21, 2017 and from 6 a.m., April 27, 2017 through 12 noon, April 28, 2017. During this deviation, vessels will not be allowed to pass through the bridge. The bridge has a vertical clearance of 3 feet above mean high water in the closed-to-navigation position and unlimited in the open-to-navigation position. Navigation on the waterway consists of tugs with tows, fishing vessels and recreational craft.
The Coast Guard will inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is amending its medical regulations governing the release of VA medical records. Specifically, VA is eliminating the restriction on sharing a negative test result for the human immunodeficiency virus (HIV) with veterans' outside providers. HIV testing is a common practice today in healthcare and the stigma of testing that may have been seen in the 1980s when HIV was first discovered is no longer prevalent. Continuing to protect negative HIV tests causes delays and an unnecessary burden on veterans when VA tries to share electronic medical information with the veterans' outside providers through electronic health information exchanges. For this same reason, VA will also eliminate restrictions on negative test results of sickle cell anemia. This final rule eliminates the current barriers to electronic medical information exchange.
This final rule is effective April 24, 2017.
Stephania H. Griffin, Director, Information Access and Privacy Office (10P2C), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420; (704) 245-2492. (This is not a toll-free number.)
In a document published in the
Section 7332 of 38 United States Code (U.S.C.) states that records of the identity, diagnosis, prognosis, or treatment of any patient or subject which are maintained in connection with the performance of any program or activity (including education, training, treatment, rehabilitation, or research) of any patient or subject relating to drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus (HIV), or sickle cell anemia shall only be disclosed under certain circumstances. The intent of section 7332 is to protect the medical records of those veterans who are undergoing treatment or have a positive diagnosis for the conditions stated in this section. Due to the stigma that was associated with HIV and HIV testing at the time the regulation was first published, VA determined that the results of HIV testing should be protected regardless of the outcome of the test. Currently, HIV testing is considered part of routine health care under VA policy, similar to other types of diagnostic laboratory testing, and while oral informed consent is still required, no pre-testing counseling is required.
The continued protection of negative HIV tests has posed significant obstacles to the sharing of medical information between VA and non-VA medical providers, and also places an undue burden on veterans. If VA conducts an HIV test on a veteran, VA is prevented from electronically disclosing the veteran's medical information to the veteran's non-VA medical provider, even if the test result is negative, unless VA first obtains a specific written authorization that meets title 38 regulatory requirements from the veteran to share the medical information. Medical information sharing is crucial to treating a veteran who has outside medical providers and is significant in making certain that a veteran is not prescribed a medication that may negatively interact with other medications. Under section 7332, information about sickle cell anemia is also considered protected medical information. As with negative HIV test results, the prohibition on sharing negative test results for sickle cell anemia has posed challenges for the timely provision of medical care. This rulemaking eliminates the current restrictions on sharing with community providers negative test results of veterans for HIV and sickle cell anemia and is in line with the intent of the statute. As for positive HIV or sickle cell anemia test results, VA will continue to require a qualifying written authorization from the veteran prior to disclosure of such information.
We received five comments in support of the proposed rule. All commenters agreed that the electronic exchange of negative HIV and sickle cell anemia test results between medical providers is a critical to adequately address patient care. A commenter stated “By removing the restriction on disclosure of negative test result for HIV, this proposed rule will play a significant role in ensuring that all veterans, including LGBT veterans, have access to efficient care, while also helping combat the stigma associated with HIV testing.” We thank the commenters for their support of the rule.
Based on the rationale set forth in the Supplementary Information to the proposed rule and in this final rule, VA is adopting the proposed rule with no edits.
Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.
This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will impose no burden on small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking would be exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”
The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.
The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on March 16, 2017, for publication.
Administrative practice and procedure, Archives and records, Cemeteries, Claims, Courts, Crime, Flags, Freedom of information, Government contracts, Government employees, Government property, Infants and children, Inventions and patents, Parking, Penalties, Privacy, Reporting and recordkeeping requirements, Seals and insignia, Security measures, Wages.
For the reasons set out in the preamble, Department of Veterans Affairs is amending 38 CFR part 1 as follows:
38 U.S.C. 501(a), and as noted in specific sections.
(a) * * *
(1) * * *
(i) Would identify a patient as an alcohol or drug abuser, an individual who tested positive for or is infected with the human immunodeficiency virus (HIV), hereafter referred to as HIV, or an individual who tested positive for or has sickle cell anemia, either directly, by reference to other publicly available information, or through verification of such an identification by another person; and
Environmental Protection Agency (EPA).
Direct final rule.
Under the Federal Clean Air Act (CAA or the Act) the Environmental Protection Agency (EPA) is approving the revisions submitted by the State of Louisiana controlling emissions of volatile organic compounds (VOCs) and changes to the Stage II gasoline vapor recovery rule as part of the Louisiana State Implementation Plan (SIP).
This rule is effective on May 22, 2017 without further notice, unless the EPA receives relevant adverse comment by April 24, 2017. If the EPA receives such comment, the EPA will publish a timely withdrawal in the
Submit comments, identified by Docket No. EPA-R06-
Tracie Donaldson, (214) 665-6633;
Throughout this document, “we,” “our,” or “us” each mean “the EPA.”
Section 110 of the CAA requires states to develop and submit to the EPA a SIP to ensure that state air quality meets National Ambient Air Quality Standards (NAAQS). The NAAQS currently address six criteria pollutants: carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin through air pollution regulations and control strategies. The EPA-approved SIP provisions and control strategies are federally enforceable. States revise the SIP as needed and submit revisions to the EPA for review and approval.
Volatile Organic Compound is a term used to describe a class of chemicals that react in the atmosphere in the presence of sunlight to form ozone. Sources include vehicle exhaust, gasoline vapors, oil-based paints and industrial operations. A regulatory definition of Volatile Organic Compounds can be found at 40 CFR 51.100(s). The definition in Louisiana can be found in LAC 33:III, Chapter 1, section 111. Oxygen in the atmosphere reacts with VOCs and Oxides of Nitrogen to form ozone, a key component of urban smog. Inhaling even low levels of ozone can trigger a variety of health problems including chest pains, coughing, nausea, throat irritation, and congestion. It also can worsen bronchitis and asthma. Exposure to ozone can also reduce lung capacity in healthy adults.
On July 5, 2011, the EPA approved numerous revisions
As detailed in the Technical Support Document (TSD) accompanying this action, the LDEQ submitted SIP revisions to the VOC regulations found in LAC 33:III, chapters 1, 21, 22 and 25 which are addressed in this action.
The August 29, 2013 Volatile Organic Compounds Rule Revisions promulgated during 2008-2010. LAC 33:III chapters 1: Section 111, 21: Sections 2103, 2107, 2108, 2121, 2125, 2131, 2132, 2145, 2147, 22: Section 2201 and 25: Sections 2511, 2521, 2531 are addressed in this approval. The revision to section 523 was addressed previously (81 FR 51342).
The November 3, 2014 Permit Rule SIP Revisions were promulgated during 2011-2013. LAC 33:III chapter 21: Section 2132 is addressed in this approval. The submittal also included revisions to regulations in LAC 33:III chapters 2, 3, 5, and 6 but those revisions will not be acted upon here. The chapter 2 revisions were withdrawn in a chapter 2 “repeal and replace” submission dated February 23, 2016. Revisions to chapter 5, sections 525, 527 and 529 were withdrawn by Louisiana on July 14, 2016. Revisions to sections 317 and 319 will be addressed at a later date. The remaining sections have been addressed in a separate
Please refer to Table 1 for a list of subchapters, divisions, and key sections proposed for revision in the Louisiana SIP by the LDEQ.
The revisions to sections 111, 2121, 2125, 2131, 2145, 2147 and 2201 are all limited to outline/numbering changes and wording corrections. These revisions are ministerial in nature and are approvable.
The revisions to sections 2107, 2108, 2511, 2521 and 2531 concern notifications to the department and due dates for reporting. These changes improve the enforceability of the regulations and are therefore, approvable.
The revisions to section 2132 include numbering/outline and wording corrections as well as provide a Stage II vapor recovery exemption for facilities that exclusively fuel or refuel vehicles with onboard refueling vapor recovery (ORVR). The Louisiana SIP requires Stage II vapor recovery at gasoline dispensing facilities in Ascension, East Baton Rouge, Iberville, Livingston, Pointe Coupee, and West Baton Rouge parishes. Background information on Stage II vapor recovery is provided in the TSD. The submitted revision would provide an exemption from Stage II vapor recovery requirements for facilities used
Under CAA section 110(l), Stage II vapor recovery programs cannot be revised or removed unless it is demonstrated that revision or removal of such program from the SIP would not interfere with any applicable requirement concerning attainment and reasonable further progress or any other applicable requirement under the CAA. While Louisiana's submittal is not requesting the withdrawal of its Stage II rule for these parishes, this SIP revision is requesting revisions to Louisiana's Stage II requirements, and thus this revision must be shown to satisfy 110(l) of the CAA.
This SIP revision is approvable because all the vehicles whose initial fueling and refueling is being excluded from Stage II vapor recovery rules are equipped with ORVR, an equivalent vapor recovery system. In order for a system to constitute Stage II and ORVR, the systems must demonstrate a 95 percent or greater VOC control efficiency; thus, there will be no increase in emissions as a result of this SIP revision. During the phase-in of ORVR controls, which began in 1997, Stage II vapor recovery has provided VOC reductions in ozone nonattainment
Not only are there no increases in VOC emissions from this rule, but the parishes are in attainment of the 1-hour, 1997, and 2008 ozone standards. On March 26, 2009, EPA proposed a determination of attainment of the 1-hour ozone standard for the BR area comprised of the Ascension, East Baton Rouge, Iberville, Livingston, and West Baton Rouge parishes. A final determination was published in the
The rule does not increase VOC emissions, it does not apply to facilities fueling/refueling vehicles with less than 100% ORVR, and all the affected parishes are in attainment for the 1-hour, 1997, and 2008 ozone standards; therefore, we find that these revisions will not interfere with any applicable requirement concerning attainment and reasonable further progress or any other applicable requirement under the CAA.
This revision is consistent with our guidance memo dated December 12, 2006,
The ORVR systems are considered to be as efficient as Stage II vapor recovery equipment in reducing emissions from fueling and refueling. In relevant part, the Page Memorandum states that if a SIP revision demonstrates that 95 percent of the new vehicles fueled at an automobile assembly plant are equipped with ORVR, and that this level of ORVR use would not decrease, then EPA can determine that widespread use of ORVR has been achieved for the fleet of motor vehicles that are fueled at that facility. Page Memorandum, page 2. The CAA allows EPA to revise or waive the Section 182(b)(3) Stage II gasoline vapor recovery rules, after determining ORVR emissions control systems are in widespread use throughout the motor vehicle fleet. Louisiana revised its Stage II vapor recovery rule to exclude initial fueling and refueling of motor vehicles 100% equipped with ORVR.
Under Louisiana's changes, the only facilities excluded from Stage II vapor recovery rules are those which fuel/refuel 100% vehicles that are equipped with ORVR. Because only facilities that fuel/refuel 100% ORVR equipped vehicles are subject to Louisiana's rule changes, the criteria for widespread use for this fleet of vehicles is achieved. Furthermore, EPA made the determination on May 16, 2012 that there was widespread use throughout the country (77 FR 28772). A detailed discussion of this guidance and the 100(l) demonstration is provided in the TSD. A copy of this memo is included in the docket. This revision is approvable.
The submitted revisions to section 2103 provide an exemption from the “submerged fill pipe” provisions for a limited number of tanks at a specific facility. These tanks contain a highly corrosive material and the submerged fill pipe must be higher than 6 inches from the bottom of the tank for safety considerations. Please see our detailed evaluation and the RACT determination beginning on page 5 of the TSD. The filling of these tanks represents a very low volume of VOC emissions due to the presence of vapor loss control devices and will not have a significant effect or interfere with maintenance or attainment of any NAAQS.
A complete summary is referenced in the Technical Support Document (TSD), “Louisiana Administrative Code (LAC) Title 33 Environmental Quality Part III—Air,” a copy of which is posted in the docket of this action.
We are approving rule revisions to LAC 33:III for chapters 1, 21, 22 and 25 for the 2008-2010 VOC Rule revisions submittal and chapter 21 for the 2011-2013 Permit Rule revisions submittal into the Louisiana SIP as they appear in Table 1 above.
The EPA is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comments. However, in the proposed rules section of this
We are also making a ministerial correction to the table in 40 CFR 52.970(c) to reflect accurately the inclusion of sections 1101 and 1109 within Chapter 11, which addresses Control of Emissions from Smoke in the EPA-approved SIP on March 3, 1989 (54 FR 9795).
In this action, the EPA is including in a final rule regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, the EPA is incorporating by reference revisions to the Louisiana regulations as described above. The EPA has made, and will continue to make, these documents generally available electronically through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Samuel Coleman was designated the Acting Regional Administrator on January 20, 2017 through the order of succession outlined in Regional Order R6-1110.1, a copy of which is included in the docket for this action.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions and additions read as follows:
(c) * * *
Federal Emergency Management Agency, DHS.
Final rule.
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the
The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.
If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Patricia Suber, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 400 C Street SW., Washington, DC 20472, (202) 646-4149.
The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of
In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.
Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is amended as follows:
42 U.S.C. 4001
Agricultural Marketing Service, USDA.
Reopening of comment period.
Notice is hereby given that Agricultural Marketing Service (AMS) is reopening the comment period on the proposed rule that invited comments on the revision of the U.S. Standards for Grades of Shelled Walnuts and U.S. Standards for Grades of Walnuts in the Shell published in the
Comments on the proposed rule published in the
Interested persons are invited to submit comments on the proposed rule via the Internet at:
David G. Horner at the address above, telephone: (540) 361-1120, fax: (540) 361-1199, or email:
A proposed rule was published in the
The 60-day comment period provided in the proposed rule closed January 24, 2017. The comment period for the proposed rule is reopened until April 24, 2017. AMS is reopening the public comment period for 30 days to ensure that interested persons have sufficient time to review and comment on the proposed rule.
7 U.S.C. 601-674.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Dassault Aviation Model MYSTERE-FALCON 50 airplanes and FALCON 2000 airplanes. This proposed AD was prompted by a report indicating that during ground maintenance, a Model FALCON 2000 airplane experienced a loss of hydraulic pressure affecting both hydraulic systems due to damage to both brake hoses on the main landing gear (MLG). This proposed AD would require an inspection for certain brake hoses, installation of protective wraps or installation of certain brake hoses, and replacement of certain brake hoses. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by May 8, 2017.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone: 201-440-6700; Internet:
You may examine the AD docket on the Internet at
Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2013-0255, dated October 23, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Dassault Aviation Model MYSTERE-FALCON 50 airplanes and FALCON 2000 airplanes. The MCAI states:
During ground maintenance, a Falcon 2000 aeroplane experienced a loss of hydraulic pressure, affecting both hydraulic systems.
The investigation results revealed that this event was due to damage to both brake hoses on the same main landing gear (MLG), which chafed against the torque link assembly during MLG extension/retraction cycle. The Part Numbers (P/N) of the affected brake hoses are P/N AE705317-1 and P/N 00-200-1268, which are made of a braided stainless steel sleeve.
This condition, if not detected and corrected, could lead to loss of braking during landing or a rejected take-off, possibly resulting in a runway excursion. In addition, there is a risk of fire if the leaking brake hydraulic fluid reaches hot parts.
For the reasons described above, this [EASA] AD requires a one-time inspection of the brake hoses to identify the P/N and determine the presence of protection against chafing and, depending on findings, installation of protective wraps or replacement of the brake hoses with serviceable parts that have a Dacron sleeve protection.
You may examine the MCAI in the AD docket on the Internet at
Dassault has issued the following service information:
• Dassault Service Bulletin F50-510, Revision 2, dated December 20, 2012; and Dassault Service Bulletin F2000-382, Revision 2, dated May 12, 2011. This service information describes procedures for an inspection of the brake hoses to identify whether brake hoses having certain part numbers are installed, and installation of protective wraps on the brake hoses or installation of certain brake hoses that are fitted with Dacron sleeves. These documents are distinct since they apply to different airplane models.
• Dassault Service Bulletin F50-518, dated April 14, 2011; and Dassault Service Bulletin F2000-368, dated May 29, 2009. This service information describes replacement of certain brake hoses. These documents are distinct since they apply to different airplane models.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 302 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary installations and replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of airplanes that might need these installations and replacements:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 8, 2017.
None.
This AD applies to Dassault Aviation Model MYSTERE-FALCON 50 airplanes and FALCON 2000 airplanes, certificated in any category, all serial numbers.
Air Transport Association (ATA) of America Code 32, Landing gear.
This AD was prompted by a report indicating that during ground maintenance, a Model FALCON 2000 airplane experienced a loss of hydraulic pressure affecting both hydraulic systems due to damage to both brake hoses on the main landing gear (MLG). We are issuing this AD to detect and correct unprotected brake hoses, which could lead to loss of braking during landing or a rejected take-off, and result in a runway excursion and a risk of fire if the leaking brake hydraulic fluid reaches hot parts.
Comply with this AD within the compliance times specified, unless already done.
Within 9 months after the effective date of this AD, inspect the brake hoses to identify whether any brake hose having part number (P/N) AE705317-1 or P/N 00-200-1268 is installed. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number of the brake hose can be conclusively determined from that review.
If, during the inspection required by paragraph (g) of this AD, it is determined that any brake hose having P/N AE705317-1 or P/N 00-200-1268 is installed, do the actions specified in paragraph (h)(1) or (h)(2) of this AD.
(1) Install protective wraps on the brake hoses, in accordance with the Accomplishment Instructions of Dassault Service Bulletin F50-510, Revision 2, dated December 20, 2012; or Dassault Service Bulletin F2000-382, Revision 2, dated May 12, 2011; as applicable.
(2) Install brake hoses having P/N 00-200-1534 that are fitted with Dacron sleeves, in accordance with the Accomplishment Instructions of Dassault Service Bulletin F50-518, dated April 14, 2011; or Dassault Service Bulletin F2000-368, dated May 29, 2009; as applicable.
Within 6,000 flight cycles, or within 149 months, whichever occurs first after the effective date of this AD: Replace brake hoses having P/N AE705317-1 and P/N 00-200-1268 with brake hoses having P/N 00-200-1534 that are fitted with Dacron sleeves, in accordance with the Accomplishment Instructions of Dassault Service Bulletin F50-518, dated April 14, 2011; or Dassault Service Bulletin F2000-368, dated May 29, 2009; as applicable. Once brake hoses having P/N 00-200-1534 are fitted in an MLG leg, no further action is required for that MLG leg, as specified in paragraph (j) of this AD.
If, during the inspection required by paragraph (g) of this AD, it is determined that the airplane is equipped with an MLG leg assembly with a part number specified in table 1 to paragraph (j) of this AD, the requirement of paragraph (h) of this AD is not applicable, provided that the MLG leg assembly has not been modified in service after its installation on an airplane.
The parts specified in table 1 to paragraph (j) of this AD are known to be delivered with brake hoses having P/N 00-200-1534 that are fitted with Dacron sleeves.
As of the effective date of this AD, no person may install a brake hose having P/N AE705317-1 or P/N 00-200-1268 on any airplane, unless the brake hose has been inspected to verify that protective wraps are installed on the hose, in accordance with the Accomplishment Instructions of Dassault Service Bulletin F50-510, Revision 2, dated December 20, 2012; or Dassault Service Bulletin F2000-382, Revision 2, dated May 12, 2011; as applicable.
As of the effective date of this AD, no person may install, on any airplane, a brake hose having P/N AE705317-1 or P/N 00-200-1268, or an MLG leg or shock absorber equipped with a brake hose having P/N AE705317-1 or P/N 00-200-1268, after the actions in paragraphs (h)(2) or (i) of this AD are done.
This paragraph provides credit for actions required by paragraphs (h)(1) and (k) of this AD, if those actions were performed before the effective date of this AD using Dassault Service Bulletin F50-510, Revision 1, dated December 15, 2010; or Dassault Service Bulletin F2000-382, Revision 1, dated December 15, 2010.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2013-0255, dated October 23, 2013, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone: 201-440-6700; Internet:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 737-300, -400, and -500 series airplanes. This proposed AD was prompted by a report of fatigue cracking found in a certain fuselage frame common to the water tank support intercostal clip located between certain stringers. This proposed AD would require inspections for any cracking of a certain fuselage frame, and repair if necessary. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by May 8, 2017.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
You may examine the AD docket on the Internet at
Galib Abumeri, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5324; fax: 562-627-5210; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We have received a report of fatigue cracking found in a certain fuselage frame, Station (STA) 947.5 on the right side, common to the water tank support intercostal clip located between certain stringers, S-24R and S-25R. Ten cracks were reported on airplanes having line
We reviewed Boeing Alert Service Bulletin 737-53A1357, dated August 9, 2016. The service information describes procedures for inspections for any cracking of a certain fuselage frame, and repair if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously. For information on the procedures and compliance times, see this service information at
We estimate that this proposed AD affects 140 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary repairs that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this repair:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 8, 2017.
None.
This AD applies to The Boeing Company Model 737-300, -400, and -500 series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 737-53A1357, dated August 9, 2016.
Air Transport Association (ATA) of America Code 53; Fuselage.
This AD was prompted by a report of fatigue cracking found in a certain fuselage frame common to the water tank support intercostal clip located between certain stringers. We are issuing this AD to detect and correct cracking, which could grow in size and result in a severed frame. Multiple adjacent severed frames would result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Before the accumulation of 34,000 total flight cycles or within 6,000 flight cycles after the effective date of this AD, whichever occurs later, do a high frequency eddy current (HFEC) inspection for any cracking in the fuselage frame at station (STA) 947.5 common to the water tank support intercostal clip located between stringer S-24R and S-25R, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1357, dated August 9, 2016.
(1) If no cracking is found, repeat the inspection thereafter at intervals not to exceed 12,000 flight cycles.
(2) If any cracking is found: Before further flight, repair in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1357, dated August 9, 2016.
Accomplishing the repair in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1357, dated August 9, 2016, terminates the inspection requirements of paragraph (g) of this AD.
(1) The Manager, Los Angeles Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
(1) For more information about this AD, contact Galib Abumeri, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5324; fax: 562-627-5210; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc. Model BD-100-1A10 airplanes. This proposed AD was prompted by a report that the equipment racks were not designed to support the weight of all the equipment and the secondary direct current power centers. This proposed AD would require modifying the equipment racks. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by May 8, 2017.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email:
You may examine the AD docket on the Internet at
Aziz Ahmed, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2016-26, dated September 14, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model BD-100-1A10 airplanes. The MCAI states:
During a recent design review, a Bombardier equipment supplier discovered that the weight of the Secondary Direct Current (DC) Power Center was incorrectly reported to the structural partner(s) via their equipment interface drawing. Consequently, the left-hand side (LHS) and right-hand side (RHS) equipment racks were not designed to support the actual weight of all the equipment and the Secondary DC Power Centers under all loading conditions. In the event of a high energy emergency landing or runway excursion, the structural failure of the LHS or RHS equipment racks may result in the blockage of the emergency escape route for the pilot(s) and crew if this condition is not corrected.
Required actions include modifying the equipment racks. You may examine the MCAI in the AD docket on the Internet at
We reviewed Bombardier Service Bulletin 100-25-39, dated October 26, 2015; and Bombardier Service Bulletin 350-25-002, dated October 26, 2015. This service information describes procedures for modifying the equipment racks. These documents are distinct since they apply to airplanes having different serial numbers. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD affects 161 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 8, 2017.
None.
This AD applies to Bombardier, Inc. Model BD-100-1A10 airplanes, certificated in any category, serial numbers (S/Ns) 20003 through 20532 inclusive.
Air Transport Association (ATA) of America Code 25, Equipment/Furnishings.
This AD was prompted by a recent design review of the equipment racks which revealed that the left-hand side (LHS) and right-hand side (RHS) equipment racks were not designed to support the actual weight of all the equipment and the secondary direct current power centers under all loading conditions. We are issuing this AD to prevent structural failure of the LHS or RHS equipment racks in the event of a high energy emergency landing or runway excursion, which could result in blockage of the emergency exit for the flightcrew.
Comply with this AD within the compliance times specified, unless already done.
Within 90 months after the effective date of this AD, do the modification required by paragraph (g)(1) or (g)(2) of this AD, as applicable.
(1) For airplanes having S/Ns 20003 through 20500 inclusive: Modify the equipment racks having part numbers (P/Ns) K1000070316-003 (LHS) and K1000070316-004 (RHS), in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 100-25-39, dated October 26, 2015.
(2) For airplanes having S/Ns 20501 through 20532 inclusive: Modify the equipment rack having P/N K1000070316-004 (RHS only), in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 350-25-002, dated October 26, 2015.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2016-26, dated September 14, 2016, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify Class E airspace extending upward from 700 feet above the surface at Soldotna Airport, Soldotna, AK. After review of the airspace, the FAA found redesign is necessary due to procedure modifications. The FAA also proposes to remove the reference to the Soldotna nondirectional radio beacon (NDB) in the legal description. This action would enhance the safety and management of IFR operations at the airport.
Comments must be received on or before May 8, 2017.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1-800-647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2016-9588; Airspace Docket No. 16-AAL-5, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Robert LaPlante, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4566.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-9588/Airspace Docket No. 16-AAL-5.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface at Soldotna Airport, Soldotna, AK. This proposed action is necessary because the airspace as configured exceeds the minimum size required for the current arrivals. The portion of airspace within a 10.1-mile radius of the Soldotna Airport and within 4 miles either side of the 270 degree bearing of the Soldotna NDB would be revised from 4 miles to 2.4 miles and the reference to the NDB would be changed to the Soldotna Airport. The portion of airspace extending from the 10.1-mile radius to 21 miles west of the Soldotna Airport would be modified to 11 miles west of the airport. The portion of airspace within 4 miles south of the 090 degree bearing of the Soldotna Airport would be revised to 3.5 miles.
Class E airspace designations are published in paragraph 6004, 6005, and 6006, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the Environmental Review.
This proposal will criteria of the Regulatory Flexibility Act.be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 10.1-mile radius of the Soldotna Airport and within 2.4 miles either side of the 270° bearing of the Soldotna Airport, AK, extending from the 10.1-mile radius to 11 miles west of the Soldotna Airport, AK, and within 3.5 miles either side of the 090° bearing of the Soldotna Airport, AK, extending from the 10.1-mile radius to 14.3 miles east of the Soldotna Airport, AK; and that airspace extending upward from 1,200 feet above the surface
Federal Aviation Administration (FAA), DOT.
Notice of Proposed Rulemaking (NPRM).
This action proposes to modify Class E surface area airspace, and modify Class E airspace extending upward from 700 feet above the surface at Bishop Airport (formerly Eastern Sierra Regional Airport), Bishop, CA. The FAA proposes also to establish Class E surface area airspace designated as an extension at this airport. After a review, the FAA found these modifications are necessary for the safety and management of Instrument Flight Rules aircraft operations at the airport.
Comments must be received on or before May 8, 2017.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1-800-647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2016-9474; Airspace Docket No. 16-AWP-24, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Bishop Airport, Bishop, CA.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-9474/Airspace Docket No. 16-ANM-24”. The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E surface area airspace, modifying Class E airspace extending upward from 700 feet above the surface, and establishing Class E surface area airspace designated as an extension, at Bishop Airport (formerly Eastern Sierra Regional Airport), Bishop, CA.
Class E surface area airspace would be modified to within a 5-mile radius (from a 4.2-mile radius) of Bishop Airport, with 2 segments extending from the 5-mile radius to 6.9 miles northwest of the airport, and 9.6 miles north-northwest of the airport, respectively.
Class E airspace extending upward from 700 feet above the surface would
These airspace modifications are necessary for the safety and management of IFR operations in standard instrument approach and departure procedures at the airport. The airport name would be changed to be in concert with the FAA's aeronautical database.
Class E airspace designations are published in paragraph 6002, 6004, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Within a 5-mile radius of Bishop Airport.
That airspace extending upward from the surface within 1.2 miles each side of a 315° bearing from Bishop Airport extending from the 5-mile radius of the airport to 6.9 miles northwest of the airport, and within 1.2 miles each side of a 337° bearing from the airport extending from the 5 mile radius of the airport to 9.6 miles northwest of the airport.
That airspace upward from 700 feet above the surface within a 6.7-mile radius of Bishop Airport, and within 4 miles west and 3.2 miles east of a 337° bearing from the airport extending from the 6.7-mile radius of the airport to 15.2 miles northwest of the airport. That airspace upward from 1,200 feet above the surface within 3 miles southwest and 11.5 miles northeast of a 157° bearing from the Bishop Airport extending from the airport to 10.4 miles southeast of the airport.
Drug Enforcement Administration, Department of Justice.
Notice of intent.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to issue a temporary order to schedule the synthetic opioid,
The date of this notice of intent is March 23, 2017.
Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
This notice of intent is issued pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). DEA intends to issue a temporary order to add 4-fluoroisobutyryl fentanyl to Schedule I
The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.
Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308.
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into Schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 CFR part 1308. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance into Schedule I of the CSA.
To find that placing a substance temporarily into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary scheduling may only be placed in Schedule I. 21 U.S.C. 811(h)(1). Substances in Schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1).
The chemical structure of 4-fluoroisobutyryl fentanyl was first described in 1999 in the scientific literature. No approved medical use has been identified for 4-fluoroisobutyryl fentanyl, nor has it been approved by the FDA for human consumption. The recent identification of 4-fluoroisobutyryl fentanyl in drug evidence and the identification of this substance in association with fatal overdose events indicate that this substance is being abused for its opioid properties.
Available data and information for 4-fluoroisobutyryl fentanyl, summarized below, indicate that this synthetic opioid has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The DEA's three-factor analysis is available in its entirety under “Supporting and Related Material” of the public docket for this action at
The recreational abuse of fentanyl-like substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. 4-Fluoroisobutyryl fentanyl has recently been encountered by law enforcement and public health officials and the adverse health effects and outcomes are demonstrated by fatal overdose cases. The documented negative effects of 4-fluoroisobutyryl fentanyl are consistent with those of other opioids. On October 1, 2014, the DEA implemented STARLiMS (a web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and
The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by other federal, state and local forensic laboratories across the country. According to NFLIS, the only report of 4-fluoroisobutyryl fentanyl from state or local forensic laboratories was recorded in August 2016 in Pennsylvania. Due to normal lag time in reporting, NFLIS data from August through November 2016 is incomplete.
Evidence suggests that the pattern of abuse of fentanyl analogues, including 4-fluoroisobutyryl fentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of 4-fluoroisobutyryl fentanyl have been encountered in powder form and packaged similar to that of heroin. 4-Fluoroisobutyryl fentanyl has been encountered as a single substance as well as in combination with other substances of abuse, including heroin, fentanyl, furanyl fentanyl, methamphetamine, and cocaine. 4-Fluoroisobutyryl fentanyl has been connected to fatal overdoses, in which insufflation and intravenous routes of administration are documented.
Reports collected by the DEA demonstrate 4-fluoroisobutyryl fentanyl is being abused for its opioid properties. This abuse of 4-fluoroisobutyryl fentanyl has resulted in morbidity and mortality (
The population likely to abuse 4-fluoroisobutyryl fentanyl overlaps with the population abusing prescription opioid analgesics and heroin. This is evidenced by the routes of drug administration and drug use history documented in 4-fluoroisobutyryl fentanyl fatal overdose cases. Because abusers of 4-fluoroisobutyryl fentanyl are likely to obtain this substance through unregulated sources, the identity, purity, and quantity are uncertain and inconsistent, thus posing significant adverse health risks to the end user. Individuals who initiate (
4-Fluoroisobutyryl fentanyl exhibits pharmacological profiles similar to that of fentanyl and other μ-opioid receptor agonists. The toxic effects of 4-fluoroisobutyryl fentanyl in humans are demonstrated by overdose fatalities involving this substance. Abusers of 4-fluoroisobutyryl fentanyl may not know the origin, identity, or purity of this substance, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone.
Based on information received by the DEA, the abuse of 4-fluoroisobutyryl fentanyl leads to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. As with any non-medically approved opioid, the health and safety risks for users are great. The public health risks attendant to the abuse of heroin and opioid analgesics are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses.
4-Fluoroisobutyryl fentanyl has been associated with numerous fatalities. At least 62 confirmed overdose deaths involving 4-fluoroisobutyryl fentanyl abuse have been reported from Maryland in 2016. As the data demonstrates, the potential for fatal and non-fatal overdoses exists for 4-fluoroisobutyryl fentanyl and 4-fluoroisobutyryl fentanyl poses an imminent hazard to the public safety.
In accordance with 21 U.S.C. 811(h)(3), based on the available data and information, summarized above, the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of 4-fluoroisobutyryl fentanyl poses an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for 4-fluoroisobutyryl fentanyl in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in Schedule I. Substances in Schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for 4-fluoroisobutyryl fentanyl indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated January 5, 2017, notified the Assistant Secretary of the DEA's intention to temporarily place this substance in Schedule I.
This notice of intent initiates a temporary scheduling process and provides the 30-day notice pursuant to section 201(h) of the CSA, 21 U.S.C. 811(h), of DEA's intent to issue a temporary scheduling order. In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein set forth the grounds for his determination that it is necessary to temporarily schedule 4-fluoroisobutyryl fentanyl in Schedule I of the CSA, and finds that placement of this synthetic opioid substance into Schedule I of the CSA is necessary in order to avoid an imminent hazard to the public safety.
The temporary placement of 4-fluoroisobutyryl fentanyl into schedule I
The CSA sets forth specific criteria for scheduling a drug or other substance. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in Schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the
Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the alternative, even assuming that this notice of intent might be subject to section 553 of the APA, the Administrator finds that there is good cause to forgo the notice and comment requirements of section 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.
Although the DEA believes this notice of intent to issue a temporary scheduling order is not subject to the notice and comment requirements of section 553 of the APA, the DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Administrator will take into consideration any comments submitted by the Assistant Secretary with regard to the proposed temporary scheduling order.
Further, the DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget.
This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, the DEA proposes to amend 21 CFR part 1308 as follows:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
(h) * * *
(10)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions submitted by the State of Louisiana controlling emissions of volatile organic compounds (VOCs) and changes to the Stage II gasoline vapor recovery rule as part of the Louisiana State Implementation Plan (SIP).
Written comments should be received on or before April 24, 2017.
Submit your comments, identified by EPA-R06-OAR-2013-0167, at
Tracie Donaldson, (214) 665-6633
In the final rules section of this
For additional information, see the direct final rule which is located in the rules section of this
Environmental Protection Agency (EPA).
Notice of filing of petitions and request for comment.
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before April 24, 2017.
Submit your comments, identified the docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Robert McNally, Biopesticides and Pollution Prevention Division (BPPD) (7511P), main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 174 and part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available at
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petitions so that the public has an opportunity to comment on these requests for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petitions may be obtained through the petition summaries referenced in this unit.
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21 U.S.C. 346a.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of withdrawal.
FMCSA withdraws its January 21, 2016, notice of proposed rulemaking (NPRM), which proposed a revised methodology for issuance of a safety fitness determination (SFD) for motor carriers. The new methodology would have determined when a motor carrier is not fit to operate commercial motor vehicles (CMVs) in or affecting interstate commerce based on the carrier's on-road safety data; an investigation; or a combination of on-road safety data and investigation information. FMCSA had recently announced that, rather than move to a final rule, a Supplemental Notice of Proposed Rulemaking (SNPRM) would be the next step in the rulemaking process. However, after reviewing the record in this matter, FMCSA withdraws the NPRM and cancels the plans to develop a Supplemental Notice of Proposed Rulemaking. The Agency must receive the Correlation Study from the National Academies of Science, as required by the Fixing America's Surface Transportation (FAST) Act, assess whether and, if so, what corrective actions are advisable, and complete additional analysis before determining whether further rulemaking action is necessary to revise the safety fitness determination process.
The NPRM “Carrier Safety Fitness Determination,” RIN 2126-AB11, published on January 21, 2016 (81 FR 3562), is withdrawn as of March 23, 2017.
Ms. Barbara Baker, (202) 366-3397,
On January 21, 2016, FMCSA published an NPRM proposing revisions to the current methodology for issuance of a SFD for motor carriers as required by 49 U.S.C. 31144 (81 FR 3562).
The essential elements of the proposed rule included determining safety fitness from not only a comprehensive compliance investigation, but also considering roadside inspections data. Adding roadside inspections to the proposal included a minimum number of inspections and violations to be used for the SFD, as well as providing failure standards, and elimination of the current three-tier rating system (
The Agency received 153 initial comment period submissions and 17 reply comment period submissions in response to the NPRM. After considering the comments, FMCSA announced that, rather than move to a final rule, a SNPRM would be the next step in the rulemaking process.
In the NPRM, FMCSA proposed to eliminate the current three ratings of satisfactory, conditional and unsatisfactory. Instead, the Agency proposed only one rating of “unfit.” Commenters including John Brannum, C.H. Robinson, Greyhound Lines, Advocates for Highway and Auto Safety (Advocates), Road Safe America, Truck Safety Coalition and the American Association for Justice supported the termination of the three-tier rating system. These commenters supported the fact that this change would not allow conditional carriers to operate without improving their operations and would make it much clearer for the shipping community to determine which carriers may or may not operate. Specifically, C. H. Robinson noted it has long recommended a two-tiered structure that more clearly signals to shippers, and other industry stakeholders, which carriers should not be hired due to safety concerns. It said all stakeholders seek clear direction from FMCSA, and FMCSA desires stakeholders to properly use data collected by FMCSA. David Gee, an owner of a motor carrier and a broker, commented that the Agency should use the rulemaking to affirm that the shipper and broker community can rely upon the agency's ultimate safety fitness determination in making carrier selections free from state law negligence suits. Greyhound stated it agrees that the change will do away with the misperception that a “satisfactory” rating is a sign of operational approval.
However, commenters including the National Motor Freight Traffic Association (NMFTA), Minnesota Trucking Association, School Bus, Inc., National School Transportation Association, and the American Trucking Associations, Inc. (ATA), opposed the proposed change. ATA wrote that the proposal to remove the term “safety rating” may have negative, perhaps unanticipated, consequences. Specifically, ATA explained that there will be no means to distinguish fleets whose safety management controls have been verified during compliance reviews (
Further, ATA suggested that FMCSA consider three labels: Assessed—Unfit, Assessed—Not Unfit, and Not Assessed. ATA noted that a tiered naming convention such as this could help eliminate confusion and leave third parties better informed.
Some commenters also asserted that FMCSA, contrary to the position expressed in the NPRM, had a statutory duty to determine the fitness of all motor carriers, not just those that are unfit. These commenters claimed that the provisions of 49 U.S.C. 31144 require such actions.
Advocates expressed concern that, as proposed, one of the assessment methods would only reach the worst 1 percent or 4 percent of carriers, depending on the various categories. Advocates believe that the failure standards were “artificially selected” based on the Agency's resources “instead of making safety the highest priority.” Advocates recommended that the SFD process should identify each and every motor carrier that is unsafe and needs to be determined “Unfit.” Contrarily, to support the Agency's proposal, the International Brotherhood of Teamsters offered that the Agency should only be expected to determine the safety fitness of as many carriers as possible, given existing resources.
Advocates further commented that if the agency plans to use the absolute performance measure based on a snapshot of data to establish the thresholds, there must be a plan to continually update this data to encourage improvements in safety on par with increases in on-road safety, both within the industry and on-road in general.
Knight Transportation agreed with the Agency's proposal that carrier fitness should not be based on relative peer performance. NMFTA added that the assignment of absolute failure standards for the individual categories would provide a carrier with a better method to track and assess its safety compliance based on the roadside inspections, and sooner identify an area which might require additional attention. The International Brotherhood of Teamsters noted that, under the proposed methodology, carriers will benefit from being judged solely on their own performance rather than other companies' safety performance. Intermodal Association of North America also believes that moving to an absolute measurement approach is an improved method over the existing, relative measurements of the Compliance, Safety, and Accountability program.
The American Bus Association questioned how FMCSA can issue a regulatory proposal to change the long standing safety fitness determination process for motor carriers, without providing the failure standards in the NPRM.
C.H. Robinson commended the decision to move away from a percentile ranking and establish firm, fixed safety data targets as represented by the “absolute measure” thresholds that began to be published in August 2014. C.H. Robinson found, however, that FMCSA has not educated stakeholders well about how absolute measures are formulated and specifically why absolute measures vary greatly across peer groups. C.H. Robinson suggests FMCSA fully explain absolute measures to shippers, brokers and other stakeholders, to reduce the risk that small business carriers will be adversely impacted. C.H. Robinson believes the potential adverse impact to small carriers regarding this confusion is significant.
In addition, the Alliance for Safe, Efficient and Competitive Truck Transportation (ASCETT) noted that, with declining inspection rates, continued evidence of enforcement anomalies, electronic logging devices (ELDs) and speed limiters, a new NPRM and opportunity for notice and comment is needed. ASCETT further commented that the Agency will have to recalibrate the failure measures through rulemaking to justify new enforcement thresholds. However, ASCETT questioned if the recalibrations would be worth the expense.
Some commenters noted that applying the methodologies to more current data would change the population of carriers that would be identified as proposed unfit. Commenters noted that the number of inspections has decreased since 2011. Additionally, some commenters pointed out that by the end of 2017, ELDs will be mandatory. This change will alter the violations in the Hours of Service category. Also, these commenters stated that if speed limiters become mandated for heavy vehicles this would result in changes to violations.
Some commenters alleged that some costs associated with declaring additional carriers “unfit” were not considered in the economic analysis. According to these commenters, other costs to consider in addition to those currently in the economic analysis include: Impacts to non-driver staff; costs for improving performance to come into compliance (
Three commenters suggested that FMCSA should consider changes to the proposed rule for small entities, including retaining the “corrective action plan” provision in the current regulation. In addition, some commenters recommended that FMCSA allow for reduced reporting requirements and timetables for small carriers.
On February 15, 2017, a letter from 62 national and regional organizations of motor carriers urged Secretary of Transportation Elaine L. Chao to withdraw the NPRM; a copy of the letter has been added to the docket.
The organizations argued that the proposed rule utilizes SMS data and methodologies, which Congress directed the National Academies of Science to review in the Fixing America's Surface Transportation Act, Public Law 114-94 (FAST Act) (Dec. 4, 2015). The National Academies of Science final report is expected in June 2017. The organizations representing motor property and passenger carriers believe it is ill-advised to develop a new SFD system until the report is received and any necessary reforms are made through corrective actions to the foundational data and methodologies that support
Based on the current record, including comments received in response to the NPRM and the February 2017 correspondence to Secretary Chao, FMCSA has decided to withdraw the January 2016 NPRM and, accordingly, cancels the plans to develop a SNPRM as announced by the Agency on January 12, 2017. If FMCSA determines changes to the safety fitness determination process are still necessary and advisable in the future, a new rulemaking would be initiated that will incorporate any appropriate recommendations from the National Academies of Science and the comments received through this rulemaking. The NPRM concerning motor carrier safety fitness determinations is withdrawn.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS issues this proposed rule for the 2017 Pacific whiting fishery under the authority of the Pacific Coast Groundfish Fishery Management Plan (FMP), the Magnuson Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and the Pacific Whiting Act of 2006, as amended. This proposed rule would allocate 17.5 percent of the U.S. Total Allowable Catch (TAC) of Pacific whiting for 2017 to Pacific Coast Indian tribes that have a treaty right to harvest groundfish.
Comments on this proposed rule must be received no later than April 24, 2017.
You may submit comments on this document, identified by NOAA-NMFS-2017-0005, by either of the following methods:
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Miako Ushio, phone: 206-526-4644, and email:
This proposed rule is accessible via the Internet at the Office of the Federal Register Web site at
The regulations at 50 CFR 660.50(d) address the implementation of the treaty rights that Pacific Coast treaty Indian tribes have to harvest groundfish in their usual and accustomed fishing areas in U.S. waters. Section 660.50(d) provides that an allocation or regulation specific to the tribes shall be initiated by a written request from a Pacific Coast treaty Indian tribe with treaty fishing rights in the area covered by the FMP at the beginning of the biennial harvest specifications and management measures process. The Secretary will develop tribal allocations and regulations in consultation with the affected tribe(s) and, insofar as possible, with tribal consensus. The procedures that NMFS employs in implementing tribal treaty rights under the FMP were designed to provide a framework process by which NMFS can accommodate tribal treaty rights by setting aside appropriate amounts of fish in conjunction with the Pacific Fishery Management Council process for determining harvest specifications and management measures.
Since the FMP has been in place, NMFS has been allocating a portion of the U.S. TAC (called Optimum Yield (OY) or Annual Catch Limit (ACL) prior to 2012) of Pacific whiting to the tribal fishery, following the process established in 50 CFR 660.50(d). The tribal allocation is subtracted from the U.S. Pacific whiting TAC before allocation to the non-tribal sectors.
There are four tribes that can participate in the tribal Pacific whiting fishery: The Hoh Tribe, the Makah Tribe, the Quileute Tribe and the Quinault Indian Nation (collectively, the “Treaty Tribes”). The Hoh Tribe has not expressed an interest in participating to date. The Quileute Tribe and Quinault Indian Nation have expressed interest in commencing participation in the Pacific whiting fishery. However, to date, only the Makah Tribe has prosecuted a tribal fishery for Pacific whiting, having harvested Pacific whiting since 1996 using midwater trawl gear. Tribal allocations have been based on discussions with the Tribes regarding their intent for those fishing years. Table 1 below provides a history of U.S. TACs and annual tribal allocation in metric tons (mt).
In 2009, NMFS, the states of Washington and Oregon, and the Treaty Tribes started a process to determine the long-term tribal allocation for Pacific whiting; however, no long-term allocation has been determined. In order to ensure Treaty Tribes continue to receive allocations, this rule proposes the 2017 tribal allocation of Pacific whiting. This interim allocation is not intended to set precedent for future allocations.
In exchanges between NMFS and the Treaty Tribes during January 2017, the Makah Tribe indicated their intent to participate in the tribal Pacific whiting fishery in 2017, and requested 17.5 percent of the U.S. TAC. The Quileute Tribe and the Quinault Indian Nation indicated that they are not planning to participate in 2017. NMFS proposes a tribal allocation that accommodates the Makah request, specifically 17.5 percent of the U.S. TAC. NMFS believes that the current scientific information regarding the distribution and abundance of the coastal Pacific whiting stock suggests that the 17.5 percent is within the range of the tribal treaty right to Pacific whiting.
The Joint Management Committee, which was established pursuant to the Agreement between the Government of the United States of America and the Government of Canada on Pacific Hake/Whiting (the Agreement), is anticipated to recommend the coastwide and corresponding U.S./Canada TACs no later than March 25, 2017. The U.S. TAC is 73.88 percent of the coastwide TAC. Until this TAC is set, NMFS cannot propose a specific amount for the tribal allocation. The Pacific whiting fishery typically begins in May, and the final rule establishing the Pacific whiting specifications for 2017 is anticipated to be published by early May. Therefore, in order to provide for public input on the tribal allocation, NMFS is issuing this proposed rule without the final 2017 TAC. However, to provide a basis for public input, NMFS is describing a range of potential tribal allocations in this proposed rule, applying the proposed approach for determining the tribal allocation to a range of potential TACs derived from past harvest levels.
In order to project a range of potential tribal allocations for 2017, NMFS is applying its proposed approach for determining the tribal allocation to the range of U.S. TACs over the last 10 years, 2007 through 2016 (plus or minus 25 percent to capture variability in stock abundance). The range of U.S. TACs in that time period was 135,939 mt (2009) to 367,553 mt (2016). Applying the 25 percent variability results in a range of potential TACs of 101,954 mt to 459,441 mt for 2017. Therefore, using the proposed allocation rate of 17.5 percent, the potential range of the tribal allocation for 2017 would between 17,842 and 80,402 mt.
This proposed rule would be implemented under authority of section 305(d) of the Magnuson-Stevens Act, which gives the Secretary responsibility to “carry out any fishery management plan or amendment approved or prepared by him, in accordance with the provisions of this Act.” With this proposed rule, NMFS, acting on behalf of the Secretary, would ensure that the FMP is implemented in a manner consistent with treaty rights of four Treaty Tribes to fish in their “usual and accustomed grounds and stations” in common with non-tribal citizens. See
NMFS has preliminarily determined that the management measures for the 2017 Pacific whiting tribal fishery are consistent with the national standards of the Magnuson-Stevens Act and other applicable laws. In making the final determination, NMFS will take into account the data, views, and comments received during the comment period.
The Office of Management and Budget has determined that this proposed rule is not significant for purposes of Executive Order 12866.
As required by section 603 of the Regulatory Flexibility Act (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was prepared. The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A summary of the analysis follows. A copy of this analysis is available from NMFS.
Under the RFA, the term “small entities” includes small businesses, small organizations, and small governmental jurisdictions. A small organization is any nonprofit enterprise that is independently owned and operated and is not dominant in its field. Small governmental jurisdictions such as governments of cities, counties, towns, townships, villages, school districts, or special districts are considered small jurisdictions if their populations are less than 50,000 (5 U.S.C. 601). The Small Business Administration has established size criteria for entities involved in the fishing industry (13 CFR 121.201). A wholesale business primarily engaged in servicing the fishing industry is a small business if it employs 100 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide. A business primarily engaged in seafood processing is a small business if it is independently owned and operated, not dominant in its field of operation, and employs 750 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide. For purposes of this rulemaking, NMFS is applying the seafood processor standard to catcher processors (C/Ps) because like mothership (MS) processor vessels, Pacific whiting C/Ps earn the majority of the revenue from processed seafood product. For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (50 CFR 200.2, December 29, 2015). A business primarily engaged in commercial fishing (NAICS code 11411) is classified by NMFS as a small business if it is independently owned and operated, is not dominant in its field of operation (including affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.
This proposed rule would affect how Pacific whiting is allocated to the following sectors/programs: Tribal, Shorebased Individual Fishing Quota (IFQ) Program Trawl Fishery, MS Coop Program—Whiting At-sea Trawl Fishery, and C/P Coop Program—Whiting At-sea Trawl Fishery. The amount of Pacific whiting allocated to these sectors is based on the U.S. TAC.
Currently, the Shorebased IFQ Program is composed of 172 Quota Share permits/accounts, 152 vessel accounts, and 44 first receivers, only a portion of which participate in the Pacific whiting fishery, listed below. These regulations also directly affect participants in the MS Coop Program, a general term to describe the limited
This rule will allocate fish between tribal and non-tribal harvesters (a mixture of small and large businesses). Tribal fisheries consist of a mixture of fishing activities that are similar to the activities that non-tribal fisheries undertake. Tribal harvests may be delivered to both shoreside plants and motherships for processing. These processing facilities also process fish harvested by non-tribal fisheries. The effect of the tribal allocation on non-tribal fisheries will depend on the level of tribal harvests relative to their allocation and the reapportionment process. If the tribes do not harvest their entire allocation, there are opportunities during the year to reapportion unharvested tribal amounts to the non-tribal fleets. For example, in 2016 NMFS reapportioned 34,000 mt of the original 64,322 mt tribal allocation. This reapportionment was based on conversations with the tribes and the best information available at the time, which indicated that this amount would not limit tribal harvest opportunities for the remainder of the year. In 2016, the tribal Pacific whiting catch was approximately 2,500 mt in a fishery that spanned late August to mid-October. This reapportioning process allows unharvested tribal allocations of Pacific whiting to be fished by the non-tribal fleets, benefitting both large and small entities. Following are the revised Pacific whiting allocations for 2016 after the reapportionment: The Tribal allocation was 30,322 mt; the C/P Coop allocation was 114,149 mt; the MS Coop allocation was 80,575 mt; and the Shorebased IFQ Program allocation was 141,007 mt.
For the years 2011 to 2016, the total Pacific whiting fishery (tribal and non-tribal) averaged harvests of approximately 292,000 mt annually. As the U.S. Pacific whiting TAC has been highly variable during this time, so have harvests and ex-vessel revenues. The prices for Pacific whiting are largely determined by the world market because most of the Pacific whiting harvested in the U.S. is exported.
In the last year for which detailed economic information is available, the MS fleet had $46.4 million in wholesale revenue, generated $42 million in income and supported 926 jobs on the west coast from Pacific whiting (2014 Economic Data Collection (EDC) Mothership Report). The C/P fleet, which had $99.2 million in wholesale revenue in 2014, generated $142 million in income and supported 1,895 jobs on the west coast from Pacific whiting (2014 Economic Data Collection (EDC) C/P Report). In 2014, eight shoreside Pacific whiting companies processed 61,000 mt of Pacific whiting, for a wholesale revenue of $71 million.
Impacts to Makah catcher vessels who elect to participate in the tribal fishery are measured with an estimate of ex-vessel revenue. In lieu of more complete information on tribal deliveries, total ex-vessel revenue is estimated with the 2016 average IFQ ex-vessel price of Pacific whiting, which was $165 per mt. At that price, the proposed 2017 Tribal allocation (potentially 17,842-80,402 mt) would have an ex-vessel value between $2.9 million and $13.2 million.
NMFS considered two alternatives for this action: The “No-Action” alternative and the “Proposed Action” alternative. NMFS did not consider a broader range of alternatives to the proposed allocation. The tribal allocation is based primarily on the requests of the tribes. These requests reflect the level of participation in the fishery that will allow them to exercise their treaty right to fish for Pacific whiting. Under the Proposed Action alternative, NMFS proposes to set the tribal allocation percentage at 17.5 percent, as requested by the tribes. This would yield a tribal allocation of between 17,842 and 80,402 mt for 2017. Consideration of a percentage lower than the tribal request of 17.5 percent is not appropriate in this instance. As a matter of policy, NMFS has historically supported the harvest levels requested by the tribes. Based on the information available to NMFS, the tribal request is within their tribal treaty rights. A higher percentage would arguably also be within the scope of the treaty right. However, a higher percentage would unnecessarily limit the non-tribal fishery.
Under the No-Action alternative, NMFS would not make an allocation to the tribal sector. This alternative was considered, but the regulatory framework provides for a tribal allocation on an annual basis only. Therefore, the no-action alternative would result in no allocation of Pacific whiting to the tribal sector in 2017, which would be inconsistent with NMFS' responsibility to manage the fishery consistent with the tribes' treaty rights. Given that there is a tribal request for allocation in 2017, this alternative received no further consideration.
NMFS believes this proposed rule would not adversely affect small entities. The reapportioning process allows unharvested tribal allocations of Pacific whiting to be fished by the non-tribal fleets, benefitting both large and small entities. NMFS has prepared an IRFA and is requesting comments on this conclusion (see
There are no reporting, recordkeeping or other compliance requirements in the proposed rule.
No Federal rules have been identified that duplicate, overlap, or conflict with this action.
Pursuant to Executive Order 13175, this proposed rule was developed after meaningful consultation and collaboration with tribal officials from the area covered by the FMP. Consistent with the Magnuson-Stevens Act at 16 U.S.C. 1852(b)(5), one of the voting members of the Pacific Council is a representative of an Indian tribe with federally recognized fishing rights from the area of the Council's jurisdiction. In addition, NMFS has coordinated specifically with the tribes interested in the Pacific whiting fishery regarding the issues addressed by this rule.
Fisheries, Fishing, Indian fisheries.
For the reasons set out in the preamble, 50 CFR part 660 is proposed to be amended as follows:
16 U.S.C. 1801
(f) * * *
(4)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes regulations to implement Amendment 114 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area and Amendment 104 to the Fishery Management Plan for Groundfish of the Gulf of Alaska (GOA), (collectively referred to as the FMPs). If approved, Amendments 114/104 and this proposed rule would integrate electronic monitoring (EM) into the North Pacific Observer Program. The proposed rule would establish a process for owners or operators of vessels using nontrawl gear to request to participate in the EM selection pool and the requirements for vessel owners or operators while in the EM selection pool. This action is necessary to improve the collection of data needed for the conservation, management, and scientific understanding of managed fisheries. Amendments 114/104 are intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the FMPs, and other applicable laws.
Comments must be received no later than May 22, 2017.
Per section 313 of the Magnuson-Stevens Act, NMFS will conduct public hearings to accept oral and written comments on the proposed rule in Oregon, Washington, and Alaska during the public comment period.
The first public hearing will be held in conjunction with the April meeting of the North Pacific Fishery Management Council on April 6, 2017, 6 p.m. to 8 p.m., Alaska local time, at the Hilton Hotel, 500 W. 3rd. Ave., Anchorage, AK 99501.
The second public hearing will be on April 18, 2017, 10 a.m. to 12 p.m., Pacific daylight time, at the International Pacific Halibut Commission Office, 2320 West Commodore Way, Suite 300, Seattle, WA 98199.
The third public hearing will be held on April 19, 2017, 1 p.m. to 3 p.m., Pacific daylight time, at the Hatfield Marine Science Center, Lavern Weber Room, 2030 SE. Marine Science Drive, Newport, OR 97365.
You may submit comments on this document, identified by NOAA-NMFS-2016-0154 by any of the following methods:
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• Submit oral or written comments to NMFS at the public hearings listed in this proposed rule under
Electronic copies of Amendments 114/104 and the Draft Environmental Assessment/Regulatory Impact Review prepared for this action (collectively the “Analysis”) may be obtained from
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this rule may be submitted by mail to NMFS at the above address; by email to
Gretchen Harrington or Jennifer Watson, 907-586-7228.
NMFS manages the groundfish fisheries in the exclusive economic zone under the FMPs. The North Pacific Fishery Management Council (Council) prepared the FMPs under the authority of the Magnuson-Stevens Act, 16 U.S.C. 1801
Management of the Pacific halibut fisheries in and off Alaska is governed by an international agreement, the Convention Between the United States of America and Canada for the Preservation of the Halibut Fishery of the Northern Pacific Ocean and Bering Sea (Convention), which was signed in Ottawa, Canada, on March 2, 1953, and was amended by the Protocol Amending the Convention, signed in Washington, DC, on March 29, 1979. The Convention is implemented in the United States by the Northern Pacific Halibut Act of 1982.
This proposed rule would implement Amendments 114/104 to the FMPs. The Council has submitted Amendments 114/104 for review by the Secretary of Commerce, and a Notice of Availability (NOA) of these amendments was published in the
This proposed rule and Amendments 114/104 to the FMPs amend the Council's fisheries research plan prepared under the authority of section 313 of the Magnuson-Stevens Act. NMFS published regulations
People wanting to make an oral statement for the record at the public hearing are encouraged to provide a written copy of their statement and present it to NMFS at the hearing. If attendance at the public hearing is large, the time allotted for individual oral statements may be limited. Oral and written statements receive equal consideration. There are no limits on the length of written comments submitted to NMFS.
Respondents do not need to submit the same comments on the NOA, this proposed rule, and at a public hearing. All relevant written and oral comments received by the end of the applicable comment period, whether specifically directed to the FMP amendments, this proposed rule, or both, will be considered by NMFS in the approval/disapproval decision for Amendments 114/104 and addressed in the response to comments in the final decision.
The North Pacific Observer Program (Observer Program) is an integral component in the management of North Pacific fisheries. The Observer Program was created with the implementation of the Magnuson-Stevens Act in the mid-1970s and has evolved from primarily observing foreign fleets to observing domestic fleets. The Observer Program provides the regulatory framework for NMFS-certified observers (observers) to be deployed on board vessels to obtain information necessary for the conservation and management of the groundfish and halibut fisheries. The information collected by observers contributes to the best available scientific information used to manage the fisheries in furtherance of the purposes and national standards of the Magnuson-Stevens Act. Observers collect biological samples and information on total catch, including bycatch, and interactions with protected species. Managers use data collected by observers to manage groundfish catch and bycatch limits established in regulation and to document fishery interactions with protected resources. Managers also use data collected by observers to inform the development of management measures that minimize bycatch and reduce fishery interactions with protected resources. Scientists use observer-collected data for stock assessments and marine ecosystem research.
In 2013, the Council and NMFS restructured the Observer Program to address longstanding concerns about statistical bias of observer-collected data and cost inequality among fishery participants with the funding and deployment structure under the previous Observer Program (77 FR 70062, November 21, 2012). The restructured Observer Program established two observer coverage categories: Partial and full. All groundfish and halibut vessels and processors are included in one of these two categories. NMFS requires fishing sectors in the full coverage category to have all operations observed. The full coverage category includes most catcher/processors, all motherships, and those catcher vessels participating in a catch share program with a transferrable prohibited species catch (PSC) limit. Owners of vessels or processors in the full coverage category must arrange and pay for required observer coverage from a permitted observer provider. This proposed rule would not change the full coverage category.
The partial coverage category includes fishing sectors (vessels and processors) that are not required to have an observer at all times. The partial coverage category includes catcher vessels, shoreside processors, and stationary floating processors when they are not participating in a catch share program with a transferrable PSC limit. Small catcher/processors that meet certain criteria are also in the partial coverage category.
NMFS contracts with an observer provider and determines when and where observers are deployed, based on a scientific sampling design, in the partial coverage category. Each year, NMFS develops an annual deployment plan (ADP) that describes how NMFS plans to deploy observers to vessels and processors in the partial coverage category in the upcoming year.
The ADP describes the scientific sampling design NMFS uses to generate unbiased estimates of total and retained catch, and catch composition in the groundfish and halibut fisheries. The ADP provides flexibility to improve deployment to meet scientifically based estimation needs while accommodating the realities of a dynamic fiscal environment. NMFS's goal is to achieve a representative sample of fishing events, and to do this without exceeding funds collected through the observer fee. This is accomplished by the random deployment of observers in the partial coverage category. NMFS adjusts the ADP each year after a scientific evaluation of data collected under the Observer Program to evaluate the impact of changes in observer deployment and to identify areas where improvements are needed to collect the data necessary to conserve and manage the groundfish and halibut fisheries.
To summarize the ADP process, each year in October, NMFS develops a draft ADP that describes how NMFS plans to deploy observers to vessels in the partial coverage category in the upcoming year. The draft ADP describes the deployment methods NMFS plans to use to collect observer data on discarded and retained catch, including the information used to estimate catch composition and marine mammal and seabird interactions in the groundfish and halibut fisheries. The draft ADP also describes how NMFS will deploy observers to shoreside processing plants or stationary floating processors in the partial coverage category. The Council reviews the draft ADP and considers public comment when developing its recommendations about the draft ADP. The Council may recommend adjustments to observer deployment to prioritize data collection based on conservation and management needs. After NMFS conducts a scientific evaluation of the Council's recommendations, NMFS adjusts the draft ADP as appropriate and finalizes the ADP in December for release prior to the start of the fishing year. NMFS posts the ADP on the NMFS Alaska Region Web site (
Each year, NMFS also develops an Annual Report that evaluates how well various aspects of the program are achieving program goals, identifies areas where improvements are needed, and includes preliminary recommendations regarding the upcoming ADP. The Council and its Scientific and Statistical Committee (SSC) review the Annual Report in June. This timing allows NMFS and the Council to consider the results of past performance in developing the ADP for the following year. NMFS posts the Annual Report on the NMFS Alaska Region Web site (
The Observer Declare and Deploy System (ODDS) is an Internet-based
The restructured Observer Program created a new system of fees to pay for the cost of implementing observer coverage in the partial coverage category. Vessels and processors included in the partial coverage category pay a fee of 1.25 percent of the ex-vessel value of fishery landings to NMFS to fund the deployment of observers in the partial coverage category. Under section 313 of the Magnuson-Stevens Act, the fees shall not exceed 2 percent of the fishery ex-vessel value.
The restructured Observer Program expanded the vessels subject to observer coverage to include groundfish vessels less than 60 ft LOA and halibut vessels that had not been previously required to carry an observer. Expanding observer coverage to the approximately 950 previously unobserved vessels improved NMFS' ability to estimate total catch in all Federal fisheries in the North Pacific.
Even before implementing the restructured Observer Program, many vessel owners and operators new to the Observer Program were opposed to carrying an observer (77 FR 70062, November 21, 2012). Vessel owners and operators explained that there is limited space on board for an additional person or limited space in the vessel's life raft.
Some vessel owners, operators, and industry representatives advocated for the use of EM instead of having an observer on board their vessels (77 FR 70062, November 21, 2012). To address their concerns, the Council and NMFS have been actively engaged in developing EM as a tool to collect fishery data in the nontrawl fisheries. Over the past several years, NMFS and industry participants have undertaken cooperative research to test the applicability and reliability of EM systems. An EM system uses cameras, video storage devices, and associated sensors to record and monitor fishing activities.
In 2013, NMFS developed, and the Council adopted, the Strategic Plan for Electronic Monitoring and Electronic Reporting in the North Pacific to guide integration of monitoring technologies into North Pacific fisheries management and provide goals and benchmarks to evaluate attainment of goals (available on the Alaska Fisheries Science Center Web site at
In 2014, the Council appointed the EM Workgroup to develop an EM program to integrate into the Observer Program. The EM Workgroup provides a forum for stakeholders, including the commercial fishery participants, NMFS, Alaska Department of Fish and Game, and EM service providers, to cooperatively and collaboratively design, test, and develop EM systems, and to identify key decision points related to operationalizing and integrating EM systems into the Observer Program in a strategic manner. The EM Workgroup developed a cooperative research program to inform evaluation of multiple EM program design options and consider various EM integration approaches to achieve management needs.
The cooperative research includes analytical and fieldwork components to address the following four elements: Deployment of EM systems for operational testing, research and development of EM technologies, development of infrastructure to support EM implementation, and analyses to support EM implementation. This approach enabled the EM Workgroup to identify and resolve implementation issues associated with integrating EM into the Observer Program. Data and analysis produced on costs, data quality, risks, operational procedures, and vessel compatibility informed decisions on implementation phases, future investments in technology, and the tools that will best meet NMFS, Council, and stakeholder management objectives. The cooperative research program was implemented through research projects and pre-implementation plans in 2015, 2016, and 2017. The cooperative research to date has shown that data from EM systems can effectively identify almost all of the species or species groupings required for management, that the systems are sufficiently reliable, and that image quality is generally high. Additional information on the work of the EM Workgroup is provided in the Analysis (see
Based on input received from the EM Workgroup, and through the Council process, the Council and NMFS developed this proposed action to provide an option for participants in the partial coverage category using nontrawl gear to choose to be in the EM selection pool instead of an observer selection pool. EM selection pool means the defined group of vessels from which NMFS will randomly select the vessels required to use an EM system.
In recommending this action, the Council used the term “fixed gear” to describe vessels using pot or longline gear. The Council's use of this term is broader than the definition of fixed gear in Federal regulations at § 679.2, which defines fixed gear as including only hook-and-line gear and pot gear in the halibut or sablefish fishery. The Council intended for EM to be an option available to vessels using any type of gear other than trawl gear, and not to limit the potential use of EM to only those vessels using hook-and-line gear or pot gear in the halibut or sablefish fishery. To meet the intent of the Council, this proposed rule uses “nontrawl gear” except when quoting the Council in this preamble, or when specifically referring to fixed gear used in the halibut and sablefish fisheries. Federal regulations at § 679.2 define nontrawl gear as pot and longline gear. Longline gear is defined at § 679.2 as including hook-and-line, jig, troll, and handline or the taking of fish by means of such a device. The Council focused the cooperative research on hook-and-line gear and pot gear. Additional cooperative research would be necessary to expand EM to other gear types, as explained in section 3.5 of the Analysis (see
In December 2016, the Council adopted Amendments 114/104. The Council and NMFS developed EM for data collection for the nontrawl gear fisheries to address their desire for an alternative way to collect fisheries data in consideration of the operating requirements in these fisheries. EM systems can collect at-sea data for NMFS to estimate discards of fish, including halibut, and mortality of seabirds. EM has the potential to reduce economic and operational costs associated with deploying human observers throughout coastal Alaska. EM has the potential to reduce monitoring costs relative to observer coverage because it does not require deploying a person on the vessel and eliminates the logistical and travel expenses that this deployment generates. Through the use of EM, it may be possible to cost effectively obtain at-sea data from a broader cross-section of the nontrawl gear fleet and increase NMFS' and the Council's flexibility to respond to the scientific and management needs of
To carry out their responsibilities for conserving and managing groundfish resources, the Council and NMFS must have high quality, timely, and cost-effective data to support management and scientific information needs. In part, this information is collected through a comprehensive fishery monitoring program for the groundfish and halibut fisheries off Alaska, with the goals of verifying catch composition and quantity, including of those species discarded at sea, and collecting biological information on marine resources. While a large component of this monitoring program relies on the use of human observers, the Council and NMFS have been on the path of integrating technology into our fisheries monitoring systems for many years, with electronic reporting systems in place, and operational EM in a compliance capacity in some fisheries. More recently, research and development has focused on being able to use EM as a direct catch estimation tool in fixed gear fisheries.
The fixed gear fisheries are diverse in their fishing practices and vessel and operational characteristics, and they operate over a large and frequently remote geographical distribution. The Council recognizes the benefit of having access to an assorted set of monitoring tools in order to be able to balance the need for high-quality data with the costs of monitoring and the ability of fishery participants, particularly those on small vessels, to accommodate human observers on board. EM technology has the potential to allow discard estimation of fish, including halibut PSC and mortality of seabirds, onboard vessels that have difficulty carrying an observer or where deploying an observer is impracticable. EM technology may also reduce economic, operational and/or social costs associated with deploying human observers throughout coastal Alaska. Through the use of EM, it may be possible to affordably obtain at-sea data from a broader cross-section of the fixed gear groundfish and halibut fleet.
The integration of EM into the Council's fisheries research plan is not intended to supplant the need for human observers. There is a continuing need for human observers as part of the monitoring suite, and there will continue to be human observer coverage at some level in the fixed gear fisheries, to provide data that cannot be collected via EM (
The Council and NMFS have considerable annual flexibility to provide observer coverage to respond to the scientific and management needs of the fisheries. By integrating EM as a tool in the fisheries monitoring suite, the Council seeks to preserve and increase this flexibility. Regulatory change is needed to specify vessel operator responsibilities for using EM technologies, after which the Council and NMFS will be able to deploy human observer and EM monitoring tools tailored to the needs of different fishery sectors through the Annual Deployment Plan.
This proposed rule would establish the process and structure for use of an EM system to monitor catch and bycatch on those vessels using nontrawl gear in the partial coverage category of the Observer Program that choose to be in the EM selection pool. An EM system uses cameras, video storage devices, and associated sensors to record and monitor fishing activities. To implement EM, NMFS would set up a contract or grant with one or multiple EM service providers to install and service EM equipment, and to collect and review EM data. The contract or grant would specify hardware and field service specifications, EM data review requirements, and data and archiving requirements. “EM service provider” means any person, including their employees or agents, that NMFS contracts with to provide EM services, or to review, interpret, or analyze EM data.
EM data would supplement observer data from other nontrawl gear vessels. Some data necessary for catch estimation, fishery management, and stock assessment cannot be collected from EM systems. NMFS would obtain this data from observers on board other nontrawl gear vessels that are fishing in similar areas and at similar time periods. The Council and NMFS would make EM system and observer deployment decisions following the sampling design in the ADP, and subsequently analyze the deployment data in the Annual Report.
NMFS and the Council would define the criteria in the ADP for vessels to be eligible to participate in EM. The criteria for being in the EM selection pool may include, but are not limited to, gear type, vessel length, area fished, number of trips or total catch, sector, target fishery, and home or landing port.
Participation in the EM selection pool would be voluntary. Any owner or operator of a vessel that meets the EM selection pool criteria could annually request to be in the EM selection pool using the process established in this proposed rule if they are willing to comply with the provisions established under this proposed rule. While there are additional responsibilities for the owner or operator of a vessel in the EM selection pool to install and maintain the EM system, NMFS' intent is largely to allow the vessel to continue its normal fishing practice and allow the cameras to capture data observations that an EM service provider then extracts onshore through video review.
NMFS intends to use discretionary appropriated funds from its budget for EM system deployment until observer fees are available to fund EM system deployment and NMFS issues a contract with one or more EM service providers. Once observer fee proceeds are available and the contract is issued, NMFS would use the observer fee proceeds collected from partial coverage category participants to pay for both EM system deployment and observer deployment in the partial coverage category. Section 313 of the Magnuson-Stevens Act authorizes the Council to use the fees collected under that section to pay for the cost of implementing the fisheries research plan, including stationing EM systems on vessels and for inputting collected data. The annual decision to apportion fees between observer deployment and EM system deployment would be made by the Council and NMFS during the ADP process.
Through the ADP process, the Council and NMFS will consider how to optimize observer and EM system deployment for fisheries in the partial coverage category each year, based on an analysis of the costs, budget, monitoring goals, and fishing effort in the partial coverage category. The ADP process is explained above under North Pacific Observer Program. Work is ongoing to develop the necessary annual analysis for determining the criteria for the EM selection pool and balancing EM system deployment with deployment of observers within budget limits.
The amount of fee revenues collected would determine the level of costs that NMFS could incur to deploy EM systems and to deploy observers. The Analysis provides a detailed discussion of the potential costs of EM system deployment (see
Because it is likely that NMFS would establish a contract for multiple years and some of the deployment decisions have a significant impact on EM service provider costs (for example, the number and location of primary service ports), NMFS and the Council may make some deployment decisions for the duration of the contract, rather than annually in the ADP. Similarly, NMFS anticipates that the EM system will change over time as technological improvements are made. These technological changes could be accommodated in the contract or grant.
An important part of the ADP analysis will be identifying and understanding gaps in observer data when a portion of the partial coverage vessels participates in the EM selection pool. Appendix 1 of the Analysis (see
This proposed rule would implement the requirements described below to allow owners or operators of vessels using nontrawl gear to choose to use an EM system in place of an observer.
This proposed rule would establish the process by which vessel owners or operators could join the EM selection pool (see proposed § 679.51(f)(1)). Owners or operators of vessels that use nontrawl gear and are in the partial coverage category could request to be in the EM selection pool. Each year, vessel owners would have the opportunity to join or leave the EM selection pool through an application available through ODDS. Vessel owners that want to be in the EM selection pool would need to request in ODDS to participate in EM by November 1 to use EM in the following calendar year. NMFS would notify the vessel owner through ODDS whether that vessel has been approved or denied for the EM selection pool. NMFS would deny vessels if those vessels did not meet the EM selection pool criteria specified in the regulations and described in the ADP. Vessel owners would have the opportunity to appeal NMFS' decision denying the request to be in the EM selection pool (see proposed § 679.51(f)(1)(vii)).
The November 1 deadline would balance the interest of potential EM participants to have an opportunity to review the draft ADP available in October and its description of the EM selection pool before joining the EM selection pool with NMFS' interest in determining the number and types of vessels assigned to the EM selection pool before finalizing the ADP in December.
NMFS would approve a request for placement in the EM selection pool based on criteria specified in the regulations and described in the ADP. Criteria may include, but are not limited to, availability of EM systems, vessel gear type, vessel length, area fished, number of trips or total catch, sector, target fishery, and home or landing port. NMFS, in consultation with the Council, will establish the EM selection pool criteria based on the scientific sampling design, budget and cost considerations, and data collection goals.
Once NMFS has approved a vessel for participation in the EM selection pool, that vessel would be in the EM selection pool for the entire calendar year following the November 1 application deadline. The vessel would remain in the EM selection pool each subsequent year until the vessel owner or operator requests to leave or NMFS removes the vessel from the EM selection pool because it no longer meets the EM selection pool criteria or NMFS disapproves the vessel monitoring plan (VMP). A VMP is the document that describes how fishing operations on the vessel will be conducted and how the EM system and associated equipment will be configured to meet the data collection objectives and purpose.
Vessels would either be in the EM selection pool or in an observer selection pool. Vessels would not be subject to both EM coverage and observer coverage.
The vessel owner or operator would use ODDS to submit a request to leave the EM selection pool by November 1 for the following calendar year (see proposed § 679.51(f)(1)(ix)).
NMFS may also remove a vessel from the EM selection pool for the following calendar year. NMFS would remove a vessel if NMFS disapproves the vessel's VMP or if the vessel no longer meets the EM selection pool criteria. Vessels would not be able to leave the EM selection pool during a calendar year in order to maintain the sampling design used for that year.
Once a vessel is approved for the EM selection pool, the vessel owner or operator would make the vessel available to the NMFS-contracted EM service provider for installation of all required EM system components. During the installation, it would be the vessel owner's responsibility to assist the EM service provider with planning the best wiring routes and installing sensors that interface with the vessel's equipment, such as hydraulic oil pressure and engine oil pressure. The specifications for the EM components that would be installed would be defined in the contract between NMFS and the EM service provider. The EM service provider would install cameras in locations that meet the catch accounting objectives annually specified in the ADP.
If a vessel already has an EM system, it could use that EM system or it could modify that EM system as necessary to meet the specifications in the VMP. That vessel owner or operator would need to work with the EM service provider to develop and submit a VMP to NMFS Alaska Region. For example, a vessel may have an existing EM system on board because that vessel participates in another federally managed fishery that has an EM program.
Once approved for the EM selection pool and prior to registering a fishing trip in ODDS, the vessel owner or operator must develop a VMP with the EM service provider and submit it to NMFS for approval (see proposed § 679.51(f)(4)). A vessel in the EM selection pool would be required to have a copy of a valid NMFS-approved VMP on board before that vessel goes fishing. If NMFS does not approve the VMP, NMFS will issue an IAD to the vessel owner or operator that will explain the basis for the disapproval. The vessel owner or operator may file an administrative appeal under the administrative appeals procedures set out at 15 CFR part 906.
The vessel owner or operator would work with the EM service provider to develop a VMP. The VMP would describe how fishing operations on the vessel are conducted, including how gear is set, how catch is brought on board, and where catch is retained and discarded. The VMP would also describe how the EM system and associated equipment would be
NMFS would provide a VMP template for guidance to the EM service provider and the vessel owner or operator on the elements NMFS would require in the final approved VMP. NMFS would make this VMP template available on the NMFS Alaska Region Web site at
Once the VMP is complete and the vessel owner or operator agrees to comply with the components of the VMP, the vessel owner or operator must sign and submit the VMP to NMFS via email or other electronic means. NMFS would review the VMP for completeness and may request additional clarification. If the VMP meets the requirements established in the VMP template, NMFS would approve the VMP for the calendar year. The vessel owner or operator would be required to keep a copy of the VMP aboard the vessel and make it available to NOAA Office of Law Enforcement (NOAA OLE) or other NMFS-authorized officer or personnel upon request.
After reviewing the data from a fishing trip selected for EM coverage, NMFS may determine that the approved camera location(s) in the VMP or fishing activities conducted by the vessel crew outlined in the VMP do not allow for the data collection necessary for catch accounting. Additionally, the vessel operator may want to have a camera moved if it impedes his or her ability to fish, or the operator may reconfigure the vessel to change fishing activities during the season that would warrant changes to the VMP. Whether requested by the vessel owner or operator or by NMFS, the vessel owner or operator would be required to make any changes to the VMP with the assistance of the EM service provider. The NMFS contract with the EM service provider would describe the permissible changes. These permissible changes would likely be limited to actions that enhanced data collection or maintained the same quality of data in cases where camera locations impede the ability to fish or vessel reconfigurations occur. These amendments to the VMP would be signed and submitted to NMFS. The vessel would be allowed to begin another fishing trip, provided that NMFS has received the VMP amendments in writing. If the amended VMP did not meet the data collection needs, NMFS would inform the EM service provider and the vessel owner or operator that the VMP would need to be updated before another trip selected for EM coverage could begin.
Once in the EM selection pool and after the vessel has an approved VMP, the vessel operator would register fishing trips in ODDS (see proposed § 679.51(f)(2)). ODDS would notify the vessel operator when the vessel is selected to use the EM system and instructions would be provided in ODDS. The ADP would specify the EM selection rate—the portion of trips that are sampled—for each calendar year. NMFS and the Council may change the EM selection rate from one calendar year to the next to achieve efficiency, cost savings, and data collection goals. EM selection rates would not change during a calendar year.
Vessel owners or operators would be required to maintain the EM system in working order, including ensuring the EM system is powered and functioning throughout the trip, keeping cameras clean and unobstructed, and ensuring the system is not tampered with (see proposed § 679.51(f)(5)). The vessel owner or operator would also need to ensure that power is maintained to the EM system at all times when the vessel is underway or the engine is operating. The vessel operator would also be required to conduct a system function test before each trip to ensure the EM system is working properly before departing.
Before each set is retrieved the vessel operator would need to verify that all components of the EM system are functioning. Instructions for completing this verification would be provided in the vessel's VMP.
Vessel owners or operators would be prohibited from tampering with the EM system or harassing the EM service provider. Additional prohibitions exist to ensure the EM system functions and the data from the systems is usable for fisheries management (see proposed § 679.7(j)).
The VMP would list EM system malfunctions that are considered high priority to the data collection objectives and those malfunctions that are considered low priority to the data collection objectives. The VMP would also provide guidance about the procedures to follow if either of these types of malfunctions were detected. The proposed regulations describe the responsibilities of the vessel owner or operator in case an EM system malfunctions (see proposed § 679.51(f)(5)(vi)).
If a high priority malfunction were detected during the pre-departure function test, the vessel would be required to remain in port for up to 72 hours to allow an EM service provider time to conduct repairs. Remaining in port for up to 72 hours would allow time for an EM service provider to travel to most remote ports in Alaska and give him or her the necessary time needed to conduct repairs. If the repairs could not be completed within this time frame, NMFS would release the vessel from EM coverage for that trip and the vessel operator would be allowed to depart. However, the vessel owner or operator would be required to repair the malfunction prior to departing on a subsequent fishing trip, and the vessel would automatically be selected for EM coverage for that fishing trip.
If a low priority malfunction were detected during the pre-departure function test, the vessel operator would be allowed to depart on the selected trip as long as the procedures for low priority malfunctions described in the vessel's VMP were followed. At the end of the trip the vessel operator would be required to work with the EM service provider to repair the malfunction. The vessel operator could not depart on another trip selected for EM coverage with this malfunction unless the vessel operator had contacted the EM service provider.
If an EM system malfunction were to occur during a fishing trip selected for EM coverage, prior to retrieving the set the vessel operator would be required to attempt to correct the problem using the provisions described in the vessel's VMP. If the malfunction could not be repaired at sea, the vessel operator would be required to contact the EM service provider at the end of the trip.
At the end of the fishing trip selected for EM coverage, the vessel owner or operator would close the trip in ODDS and follow the instructions in ODDS. The vessel owner or operator would be required to submit the video data storage devices to NMFS within 2 business days of completing the fishing trip selected for EM coverage, using a method that requires a signature for delivery and provides notification of delivery. Additional documentation described in the vessel's VMP would need to be submitted along with the video data storage devices. Specific instructions for shipping video data storage devices would be included in the vessel's VMP (see proposed § 679.51(f)(5)(vii)). The video storage devices would need to be submitted within 2 business days so that timely review of the data could occur and be provided for the management of the fishery.
Currently, under § 679.7(f)(4), unless a vessel has an observer aboard and maintains the applicable daily logbook, the vessel cannot retain halibut or sablefish in excess of the total amount of unharvested IFQ or CDQ applicable to that vessel for the IFQ regulatory area in which the vessel is operating and that is currently held by all IFQ or CDQ permit holders aboard the vessel. This proposed rule would expand the exception to a vessel in the EM selection pool. This proposed rule provides that the owner or operator of a vessel in the EM selection pool, that complies with the requirements of § 679.51(f)(6) and maintains the applicable daily logbook, could retain halibut or sablefish in excess of the total amount of unharvested IFQ or CDQ applicable to that vessel for the IFQ regulatory area in which the vessel is operating and that is currently held by all IFQ or CDQ permit holders aboard the vessel. If a vessel is not part of the EM selection pool and is not selected for observer coverage for that fishing trip, the vessel owner or operator would continue to be prohibited from retaining halibut or sablefish in excess of the total amount of unharvested IFQ or CDQ applicable to that vessel for the IFQ regulatory area in which the vessel is operating.
Under proposed § 679.51(f)(6), a vessel owner or operator in the EM selection pool would use ODDS to identify when he or she intends to fish in multiple areas and to commit to using a functioning EM system on the whole trip, even if the vessel was not selected for EM coverage. The vessel owner or operator would be required to meet all the same responsibilities as if the vessel's fishing trip had been selected for EM coverage in ODDS. These include having a copy of a valid NMFS-approved VMP on board before the vessel goes fishing, maintaining the EM system in working order, and submitting the required information at the end of the trip. All these requirements are described in more detail above.
Because the EM system in this instance would be used as a compliance monitoring tool, some additional regulatory requirements would apply to the vessel owner and operator. The EM system would be required to be powered continuously during the entire fishing trip. The vessel owner or operator would need to describe in the VMP the alternative methods the vessel would use to show that the vessel had not moved or fished if the vessel owner or operator intends to power down the EM system during periods of non-fishing, such as at night when the vessel crew is sleeping. These alternative methods could include using VMS or installing a sensor that records when the engine is powered down.
Additionally, if during a fishing trip an EM system malfunction occurred that did not allow recording of essential information about where the vessel was fishing and what amount of halibut or sablefish catch was coming aboard, the vessel operator would be required to cease fishing immediately and to contact NOAA OLE. This requirement is necessary because information about the location of fishing and the amount caught in each area is paramount to allowing vessels to fish in multiple areas using the EM system exception at § 679.7(f)(4).
NMFS proposes to revise regulations for clarity and efficiency, as follows—
• Remove expired regulations at §§ 679.7(j) and 679.23(d)(5), and remove § 679.23(d)(4), which was previously removed and reserved. Section 679.7(j) was only applicable through December 31, 2002 (67 FR 64315; October 18, 2002). Section 679.23(d)(5) was only applicable through July 17, 2001 (66 FR 31845; June 13, 2001). This proposed rule would revise § 679.7(j) to list prohibitions to ensure the EM system functions and the data from the systems are usable for fisheries management.
• Correct regulation citations in § 679.21(a)(2)(ii) and (a)(3) that cross reference paragraphs that NMFS moved in previous rulemaking.
• Remove the word “observer” from the phrase “partial observer coverage category” in § 679.51(a)(1) because, with this proposed rule, the partial coverage category would include EM and observers.
• Revise § 679.51(a)(1)(ii)(B) to remove reference to vessel and trip selection pools because, with this proposed rule, NMFS is adding the EM selection pool.
• Remove § 679.51(a)(1)(iii)(D)(
• Remove the expired deadline for the Bering Sea and Aleutian Islands (BSAI) trawl catcher vessel placement in the full observer coverage category at § 679.51(a)(4)(iii).
Pursuant to sections 304(b) and 305(d) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the FMPs, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration of comments received during the public comment period.
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866.
An RIR was prepared to assess all costs and benefits of available regulatory alternatives. A copy of this analysis is available from NMFS (see
This IRFA was prepared for this proposed rule, as required by section 603 of the Regulatory Flexibility Act (RFA), to describe why this action is being proposed; the objectives and legal basis for the proposed rule; the number of small entities to which the proposed rule would apply; any projected reporting, recordkeeping, or other compliance requirements of the proposed rule; any overlapping, duplicative, or conflicting Federal rules;
The entities directly regulated by this action are those entities that harvest groundfish and halibut using nontrawl gear and are subject to observer coverage in the partial coverage category of the Observer Program. These directly regulated entities include vessels that fished with nontrawl gear in State waters only if those vessels had an Federal Fisheries Permit (FFP), which makes them subject to Federal observer regulations. Since participation in the EM selection pool is voluntary, only those vessels that choose to participate in the EM selection pool would be directly regulated by this proposed rule.
For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.
The estimated number of vessels that use nontrawl gear in the partial coverage category that are small entities might be overstated. Conversely, the number of non-small entities might be understated. The RFA requires a consideration of affiliations between entities for the purpose of assessing whether an entity is classified as small. The estimates below do not take into account all affiliations between entities. There is not a strict one-to-one correlation between vessels and entities; many persons and firms are known to have ownership interests in more than one vessel, and many of these vessels with different ownership are otherwise affiliated with each other. Vessels that have types of affiliation that are not tracked in available data (
In 2015, 981 vessels (
Table 1 provides a count of small and non-small entities (
This proposed rule adds additional reporting, recordkeeping, and other compliance requirements for vessels that choose to participate in the EM selection pool and vessels that choose to use the exemption in § 679.7(f)(4) to harvest IFQ or CDQ halibut and sablefish. No small entity is subject to reporting requirements that are in addition to or different from the requirements that apply to all directly regulated entities.
No unique professional skills are needed for the vessel owners or operators to comply with the reporting and recordkeeping requirements associated with this proposed rule. Vessel owners or operators would request to be placed in the EM selection pool using ODDS, a tool already used by directly regulated small entities. If they choose to participate in the EM selection pool, vessel owners and operators would be required to assist with the installation of the EM system and conduct basic maintenance to ensure the EM equipment remains functional. Vessel operators would meet with an EM service technician to develop a VMP for their vessel, in which the operator's responsibilities will be clearly defined. These responsibilities can generally be fulfilled by a crewmember of the vessel who already is fulfilling similar functions during fishing activity. The vessel owner or operator would be required to submit the VMP to NMFS for approval.
Vessel owners or operators in the EM selection pool that choose to use the proposed exemption in § 679.7(f)(4) would need to notify NMFS using ODDS when they intend to fish in multiple areas and commit to using a functioning EM system on the whole trip, even if the vessel was not selected for EM coverage. The vessel owner or operator would be required to meet all
No duplication, overlap, or conflict between this proposed action and existing Federal rules has been identified.
No significant alternatives were identified that would accomplish the stated objectives, are consistent with applicable statutes, and that would minimize any significant economic impact of the proposed rule on small entities. The Council and NMFS considered three alternatives. Alternative 1, the no action alternative, would not allow vessels to use an EM system instead of an observer. Alternative 2 would allow the use of EM for catch estimation on vessels in the EM selection pool and allow EM as a monitoring tool when fishing IFQ in multiple areas. Alternative 3 would allow the use of EM for compliance monitoring of vessel operator logbooks used for catch estimation.
The preferred alternative, Alternative 2, was designed to minimize the impacts to small entities from the status quo requirement to carry an observer when selected under the partial coverage category. Alternative 2 provides vessels that meet specific criteria the choice to join the EM selection pool instead of observer selection. Vessels in the EM selection pool would be required to use EM when randomly selected. Relative to Alternative 1 (no action), Alternative 2 provides nontrawl gear catcher vessel operators with the opportunity to participate in fishery monitoring and comply with the Observer Program regulations without carrying a human observer. Alternative 2 could also open new avenues to improve fishery data by collecting at-sea discard information from vessels less than 40 ft LOA, which is not currently gathered.
This proposed rule would not increase the fees that NMFS collects from directly regulated entities. The Analysis prepared for this action identifies the operational costs of participating in the EM program (see
Relative to Alternative 2, Alternative 3 would increase recordkeeping burdens on small entities by requiring skippers to fill out catch logbooks while operating their vessels and could also necessitate expanded dockside monitoring to verify logbooks, which could slow down shoreside operations and potentially increase overall costs at the programmatic level.
This proposed rule contains collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. These requirements have been submitted to OMB for approval under OMB control number 0648-0318 (North Pacific Observer Program). The public reporting burden for the collection-of-information requirements in this proposed rule includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The proposed rule would allow vessel owners or operators to use the existing ODDS to submit a request to be placed in the EM selection pool. In addition, the proposed rule would allow vessel owners or operators in the EM selection pool to submit a request to be removed from the EM selection pool. Public reporting burden per response for these new options in ODDS is estimated to average 5 minutes. If NMFS denies a request to place a vessel in the EM selection pool, the vessel owner may submit an administrative appeal to NMFS. Public reporting burden per response for an administrative appeal is estimated to average 4 hours.
The proposed rule would require all vessel owners and operators in the EM selection pool to register a fishing trip in ODDS. Public reporting burden per response to register a fishing trip in ODDS if a vessel is assigned to the EM selection pool is estimated to average 15 minutes.
The proposed rule would require vessels owners who request to be placed in the EM selection pool to submit a VMP to NMFS. Public reporting burden per response for the VMP is estimated to average 48 hours.
The proposed rule would require all vessel owners and operators in the EM selection pool to close the fishing trip in ODDS. Public reporting burden per response to close a fishing trip in ODDS is estimated to average 5 minutes.
The proposed rule also would require vessel owners selected to carry EM to submit video data storage devices and associated documentation to the EM data reviewer within 2 business days of the end of the fishing trip. Public reporting burden per response is estimated to average 1 hour.
Vessel owners or operators wanting to use EM to fish under the proposed exception in § 679.7(f)(4) would be required to notify NMFS through ODDS. Public reporting burden per response to register a fishing trip in ODDS is estimated to average 15 minutes. The addition of the option to indicate that the vessel will to use EM to fish under the exception in § 679.7(f)(4) during an upcoming fishing trip is not expected to increase the average response time to register a trip in ODDS.
Public comment is sought regarding (1) whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (2) the accuracy of the burden estimate; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to NMFS Alaska Region at the
Alaska, Fisheries, Recordkeeping and reporting requirements.
For the reasons set out in the preamble, 50 CFR part 679 is proposed to be amended as follows:
16 U.S.C. 773
(3)
(iv)
(f) * * *
(4) Except as provided in § 679.40(d), retain IFQ or CDQ halibut or IFQ or CDQ sablefish on a vessel in excess of the total amount of unharvested IFQ or CDQ, applicable to the vessel category and IFQ or CDQ regulatory area(s) in which the vessel is deploying fixed gear, and that is currently held by all IFQ or CDQ permit holders aboard the vessel, unless the vessel has an observer aboard under subpart E of this part or the vessel participates in the EM selection pool and complies with the requirements at § 679.51(f), and maintains the applicable daily fishing log prescribed in the annual management measures published in the
(g)
(j)
(2) Fish with an EM system without a copy of a valid NMFS-approved VMP on board.
(3) Fail to comply with a NMFS-approved VMP.
(4) Fail to conduct a function test prior to departing port on a fishing trip as required at § 679.51(f)(5)(vi)(A).
(5) Depart on a fishing trip selected for EM coverage without a functional EM system, unless procedures at § 679.51(f)(5)(vi)(A)(
(6) Fail to follow procedures at § 679.51(f)(5)(vi)(B) prior to each set on a fishing trip selected for EM coverage.
(7) Fail to make the EM system, associated equipment, logbooks and other records available for inspection upon request by NMFS, OLE, or other NMFS-authorized officer.
(8) Fail to submit a video data storage device as specified under § 679.51(f)(5)(vii).
(9) Tamper with, bias, disconnect, damage, destroy, alter, or in any other way distort, render useless, inoperative, ineffective, or inaccurate any component of the EM system, associated equipment, or data recorded by the EM system.
(10) Assault, impede, intimidate, harass, sexually harass, bribe, or interfere with an EM service provider.
(11) Interfere or bias the sampling procedure employed in the EM selection pool including either mechanically or manually sorting or discarding catch outside of the camera view or inconsistent with the NMFS-approved VMP.
(12) Fail to meet vessel owner and operator responsibilities specified at § 679.51 (f)(5).
(a) * * *
(2) * * *
(ii) After allowing for sampling by an observer, if an observer is aboard, sort its catch immediately after retrieval of the gear and, except for salmon prohibited species catch in the BS pollock fisheries and GOA groundfish fisheries under paragraph (f) or (h) of this section, or any prohibited species catch as provided (in permits issued) under the PSD program at § 679.26, return all prohibited species, or parts thereof, to the sea immediately, with a minimum of injury, regardless of its condition.
(3)
(a) * * *
(1)
(C) A catcher/processor placed in the partial coverage category under paragraph (a)(3) of this section; or
(ii)
(B)
(D)
(4) * * *
(iii)
(f)
(1)
(ii)
(iii)
(iv)
(v)
(B) Once the vessel owner or operator receives notification of approval from NMFS, the vessel owner or operator must comply with the vessel owner or operator responsibilities in paragraphs (f)(4) and (f)(5) of this section and all further instructions set forth by ODDS.
(vi)
(vii)
(viii)
(A) NMFS disapproves the VMP under paragraph (f)(4) of this section;
(B) The vessel owner or operator notifies NMFS that the vessel intends to leave the EM selection pool in the following fishing year under paragraph (f)(1)(ix) of this section; or
(C) The vessel no longer meets the EM selection pool criteria specified by NMFS.
(ix)
(x)
(2)
(ii) ODDS will notify the vessel operator whether the trip is selected for EM coverage and provide a receipt number corresponding to this notification. Trip registration is complete when the vessel operator receives the receipt number.
(iii) An operator may embark on a fishing trip registered with ODDS:
(A)
(B)
(3)
(i) A fishing trip selected for EM coverage may not begin until all previously harvested fish have been offloaded.
(ii) Within 24 hours of the end of the fishing trip selected for EM coverage, the vessel operator must use ODDS to close the fishing trip and follow the instructions in ODDS for submitting the video data storage devices and associated documentation as outlined in paragraph (5)(vii) of this section.
(4)
(i) The vessel owner or operator must sign and submit the VMP to NMFS each calendar year.
(ii) NMFS will approve the VMP for the calendar year if it meets all the requirements specified in the VMP template available through the NMFS Alaska Region Web site
(iii) If the VMP does not meet all the requirements specified in the VMP template, NMFS will provide the vessel owner or operator the opportunity to submit a revised VMP that meets all the
(iv) If NMFS does not approve the revised VMP, NMFS will issue an IAD to the vessel owner or operator that will explain the basis for the disapproval. The vessel owner or operator may file an administrative appeal under the administrative appeals procedures set out at 15 CFR part 906.
(v) If changes are required to the VMP to improve the data collection of the EM system or address fishing operation changes, the vessel owner or operator must work with NMFS and the EM service provider to alter the VMP. The vessel owner or operator must sign the updated VMP and submit these changes to the VMP to NMFS prior to departing on the next fishing trip selected for EM coverage.
(5)
(i) Make the vessel available for the installation of EM equipment by an EM service provider.
(ii) Provide access to the vessel's systems and reasonable assistance to the EM service provider.
(iii) Maintain a copy of a NMFS-approved VMP aboard the vessel at all times when the vessel is fishing.
(iv) Comply with all elements of the VMP when selected for EM coverage in ODDS.
(v) Maintain the EM system, including the following:
(A) Ensure power is maintained to the EM system at all times when the vessel is underway.
(B) Ensure the system is functioning for the entire fishing trip and that camera views are unobstructed and clear in quality and catch and discards may be completely viewed, identified, and quantified.
(C) Ensure EM system components are not tampered with, disabled, destroyed, or operated or maintained improperly.
(vi) Complete pre-departure function test and daily verification of EM system.
(A) Prior to departing port, the vessel operator must conduct a system function test following the instructions from the EM service provider. The vessel operator must verify that the EM system has adequate memory to record the entire fishing trip.
(
(
(B) During a fishing trip selected for EM coverage, before each set is retrieved the vessel operator must verify all cameras are recording and all sensors and other required EM system components are functioning as instructed in the vessel's VMP.
(
(
(vii) When instructed by ODDS after closing a fishing trip selected for EM coverage, the vessel operator must submit video data storage devices and associated documentation identified in the vessel's VMP to NMFS using a method that requires a signature for delivery and provides a return receipt or delivery notification to the sender. The video data storage devices and associated documentation described in the vessel's VMP must be postmarked no later than 2 business days after the end of the fishing trip.
(viii) Make the EM system and associated equipment available for inspection upon request by OLE, a NMFS-authorized officer, or other NMFS-authorized personnel.
(6)
(i) Meet the requirements described in paragraph (f) of this section.
(ii) Register in ODDS that he or she intends to fish in multiple regulatory areas using the exception in § 679.7(f)(4).
(iii) Ensure the EM system is powered continuously during the fishing trip. If the EM system is powered down during periods of non-fishing, the VMP must describe alternate methods to ensure location information about the vessel is available for the entire fishing trip, as specified in the VMP template available through the NMFS Alaska Region Web site
(iv) If an EM system malfunction occurs during a fishing trip that does not allow the recording of retrieval location information and imagery of catch as described in the vessel's VMP, the vessel operator must cease fishing and contact OLE immediately.
Agricultural Marketing Service, USDA.
Notice of public meeting.
Pursuant to the Federal Advisory Committee Act, the Agricultural Marketing Service (AMS) is announcing a meeting of the Fruit and Vegetable Industry Advisory Committee (Committee). The meeting is being convened to examine the full spectrum of fruit and vegetable industry issues and provide recommendations and ideas to the Secretary of Agriculture on how the U.S. Department of Agriculture (USDA) can tailor programs and services to better meet the needs of the U.S. produce industry. The meeting is open to the public. This notice sets forth the schedule and location for the meeting.
Tuesday, May 9, 2017, from 8:30 a.m. to 5:00 p.m. Eastern Time, and Wednesday, May 10, 2017, from 8:30 a.m. to 1:00 p.m., Eastern Time.
The Committee meeting will be held in the Potomac Rooms V and VI on the Ballroom Level at the Hyatt Regency Crystal City Hotel, 2799 Jefferson Davis Highway, Arlington, Virginia 22202.
Marlene Betts, USDA, AMS, Specialty Crops Program; Telephone: (202) 720-5057; Email:
Pursuant to the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2), the Secretary of Agriculture (Secretary) established the Committee in 2001 to examine the full spectrum of issues faced by the fruit and vegetable industry and to provide suggestions and ideas to the Secretary on how USDA can tailor its programs to meet the fruit and vegetable industry's needs. The committee was re-chartered in July 2015 for a two-year period.
The AMS Deputy Administrator for the Specialty Crops Program serves as the Committee's Executive Secretary, leading the effort to administer the Committee's activities. Representatives from USDA mission areas and other government agencies affecting the fruit and vegetable industry are periodically called upon to participate in the Committee's meetings as determined by the Committee. AMS is giving notice of the Committee meeting to the public so that they may attend and present their views. The meeting is open to the public.
Agenda items may include, but are not limited to, welcome and introductions, administrative matters, progress reports from committee working groups chairs and/or vice chairs, potential working group recommendations discussion and proposal, and presentations by subject matter experts as requested by the Committee.
Forest Service, USDA.
Notice of intent to prepare an Environmental Impact Statement.
The USDA Forest Service has received a proposal from Lee Canyon ski area to implement the first phase of their accepted master development plan (MDP). Lee Canyon is a mountain resort located 30 miles northwest of Las Vegas, Nevada, in the Spring Mountains National Recreation Area (SMNRA). The MDP is a multi-year plan for improvement and expansion of facilities at the ski area, which operates under a Forest Service special use permit. The Forest Service will prepare an environmental impact statement (EIS) to analyze and disclose the potential environmental consequences of authorizing Lee Canyon to implement the first phase of the MDP, which would include updating existing facilities and developing new winter and summer recreation opportunities within the existing ski area permit boundary. Construction would begin soon after the signing of the record of decision (ROD), and would be completed within 5 years.
Comments concerning the scope of the analysis must be received in writing within 45 days following the publication of this notice of intent in the
Electronic comments are encouraged. Send comments to
For additional information concerning this project, please contact Chris Linehan, Interdisciplinary Team Leader, at 702-515-5401 or
This Web site will be used to post all public documents during the environmental review process and announce opportunities for public participation and comment.
This notice of intent initiates the scoping process, which guides the development of the EIS. The Forest Service will be seeking information, comments, and assistance from federal, state, and local agencies, American Indian Tribes, as well as other individuals and organizations that may be interested in or affected by the proposed project. Comments on the proposed project should be in writing and should be specific to the proposed action, describing as clearly and completely as possible any issues or concerns the commenter has with the proposal. Comments received, including the names and addresses of those who comment, will become part of the public record for this EIS and will be available on request for public inspection (see
In 1962, the Forest Service issued the first special use permit for Lee Canyon ski area to the Clark County Board of Commissioners, establishing one the older ski areas in the West with two rope tows, a cable ski sled, and a warming hut operated by the Las Vegas Ski Club. Over the next 20 years, ownership changed and the existing Chair 1 (Sherwood) lift and lifts in the approximate locations of Chairs 2 and 3 (Bluebird and Rabbit Peak) were constructed. The existing base area structures were also built and expanded during this time period. Powdr Corp. acquired an ownership interest in Lee Canyon in 2004. Since that time Chairs 2 and 3 were replaced and the snowmaking reservoir was built, but the overall character of the resort remains dated.
In May of 2011, Lee Canyon submitted a MDP to the Forest Service with the goals of modernizing the ski area and developing underutilized portions of the permit area. The Forest Service accepted the MDP in June of 2011.
Extensive customer surveys conducted by Lee Canyon and other resorts indicate that visitors are increasingly seeking a more diverse range of recreational activities, particularly for families, that includes year-round opportunities and more adventurous options. The Forest Service response to this trend includes our 2012 introduction of the
Also, passage of the
• Update and renovate ski area infrastructure, particularly run-down base facilities, to meet current standards and the expectations of today's recreation market.
• Improve balance on several levels: Between lift and run capacity, between on-mountain and base-area capacity, and between overall ski area capacity and growing recreational demand from Las Vegas and the surrounding area.
• Develop year-round recreational opportunities to meet increasing demand by recreationists of various types and skill levels.
New ski runs in this pod would incorporate design features to make them less visually striking, including feathered edges, tree islands, and strategic placement to make them less visible from sensitive viewpoints. Traverses would be cut to provide access to the lower terminal and to the lower terminals of Chairs 1 and 2 as well as the base area.
Skiers would use Chair 2 to access the Chair 8 pod. The conceptual ski runs in this pod were adjusted to minimize visual impact, as discussed above for Chair 5.
The intent of these glading projects is to open up areas that are currently too densely forested for most skiers to navigate comfortably. Smaller trees, infirm or damaged trees, and white fir trees would be the priorities for removal. Work would be done by hand or, in some areas, using equipment such as feller-bunchers.
The infrastructure necessary to complete this system expansion
This mountain coaster would be installed west of the base area. The top of the circuit would be near the summit of the 9,270-foot peak above the Bristlecone Trail, and the downhill track would run down the slope to the southeast. The loading/unloading terminal would be in the mid-mountain area. The mountain coaster would pass over trails and sensitive habitat with bridge spans so collisions with trail users or impacts to sensitive plant and animal habitats could be avoided.
All trails, with the exception of the dual-use trail described in the next section, would be restricted to downhill traffic. Cross-country trails are intended to be ridden on a cross-country, or XC-style, mountain bike. Downhill trails are intended to be ridden on a downhill style mountain bike. In terms of construction, the downhill trail would be wider and would include technical features (
Uphill access for lift-served mountain biking would be via Chair 2. There would be 4 miles of easier trails, 6.25 miles of intermediate trails, 1.75 miles of advanced trails, and 1 mile of expert/downhill trail.
Installation would require a 30-foot corridor clear of trees, but much of the alignment would lie above treetop height, in natural openings, or along cleared ski trails. Only launch and landing towers would be required, as the cable between them would be a free, unsupported span. The four steel launch and landing towers would be up to 25 feet high, and the cable height would range up to 150 feet above the ground, depending on the ground contour.
A new, two-way access road, about 1,500 feet long with a 20-foot-wide, paved surface, would be developed from the existing overflow lot to the new lot. It would run along the western edge of the parking lot, with entries to the lot near the northwest corner and the southwest corner.
To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the DEIS should be as specific as possible. It is also helpful if comments refer to specific pages or sections of the DEIS. Comments may also address the adequacy of the DEIS or the merits of the alternatives formulated and discussed in the DEIS. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at
Forest Service, USDA.
Notice of meeting.
The Chequamegon Resource Advisory Committee (RAC) will meet in Park Falls, Wisconsin. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information can be found at the following Web site:
The meeting will be held on Tuesday, April 4, 2017, at 10:00 a.m. (CST).
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the Chequamegon National Forest Park Falls Office, 1170 4th Avenue South, Park Falls, Wisconsin.
Written comments may be submitted as described under
Leesha Horward-McCauley, RAC Coordinator, by phone at 715-748-4875, or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to review and approve project submissions.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by March 10, 2017, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Leesha Howard-McCauley, RAC Coordinator, Medford-Park Fall Ranger District, 850 N. 8th, Hwy. 13, Medford, Wisconsin 54451; by email to
Commission on Civil Rights.
Announcement of monthly planning meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the West Virginia Advisory Committee (Committee) to the Commission will convene by conference call on Friday, April 7, 2017, at 12:00 p.m. (EST) on. The purpose of meetings are to continue discussing topics for civil rights project.
Friday, April 7, 2017 from 12:00 p.m. EST to 1:00 p.m. EST.
Ivy L. Davis, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-888-601-3861 and password: 636552. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.
Members of the public are invited to submit written comments; the comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Planning Meeting
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Arkansas Advisory Committee (Committee) will hold a meeting on Monday, April 3, 2017, at 12:00 noon CST for the purpose of a discussion on civil rights topics affecting the state.
The meeting will be held on Monday, April 3, 2017, at 12:00 noon. CST.
David Barreras, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-427-9415, conference ID: 6982990. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
The SOC-QBPO is an electronic questionnaire. The field representatives (FRs) either call or visit the respondents to enter their survey responses into a laptop computer using the Computer Assisted Personal Interviewing (CAPI) software formatted for the SOC-QBPO. We will continue to use the current CAPI questionnaire with modifications to the form for the purpose of improving the process of accurately classifying permitted units and to eliminate the collection of information deemed no longer necessary for the proper sample selection for the SOC. The overall length of the interview will not change. The sample size slightly increased due to the increase in total number of permit-issuing jurisdictions.
The Census Bureau FRs use the SOC-QBPO to obtain information on the operating procedures of a permit office. This enables them to locate, classify, list, and sample building permits for residential construction. These permits are used as the basis for the sample selected for SOC. The Census Bureau also uses the information to verify and update the geographic coverage of permit offices.
Failure to collect this information would make it difficult, if not impossible, to accurately classify and sample building permits for the SOC. Data for two principal economic indicators are produced from the SOC: New Residential Construction (housing starts and housing completions) and New Residential Sales. Government agencies use these statistics to evaluate economic policy, measure progress towards the national housing goal, make policy decisions, and formulate legislation. For example, the Board of Governors of the Federal Reserve System uses data from this survey to evaluate the effect of interest rates in this interest-rate sensitive area of the economy. The Bureau of Economic Analysis (BEA) uses the data in developing the Gross Domestic Product (GDP). The private sector and other data users from Department of Housing and Urban Development (HUD) and the National Association of Home Builders (NAHB) use the information for estimating the demand for housing, building materials and the many products used in new housing and to schedule production, distribution, and sales efforts. The financial community uses the data to estimate the demand for short-term (construction loans) and long-term (mortgages) borrowing.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
This collection allows the Census Bureau to collaborate on the implementation of a key National Academies recommendation for improving the measurement of business dynamics in the U.S. economy, which recommended:
“The Census Bureau Survey of Business Owners (SBO) should be conducted on an annual basis. The survey should include both a longitudinal component and a flexible, modular design that allows survey content to change over time. In addition, the Census Bureau should explore the possibility of creating a public-use (anonymized) SBO or a restricted access version of the data file.”
The ASE includes all nonfarm employer businesses filing Internal Revenue Service (IRS) tax forms as individual proprietorships, partnerships, or any type of corporation, and with receipts of $1,000 or more. The ASE samples approximately 290,000 employer businesses. The sample is stratified by metropolitan statistical area (MSA), frame, and age of business. The Census Bureau selects large companies with certainty. These companies are selected based on volume of sales, payroll, or number of paid employees. All certainty cases are sure to be selected and represent only themselves.
The ASE has been conducted for survey years 2014 and 2015 and will continue for 2016 per the agreement between the Census Bureau and the survey sponsors. There are no final plans to conduct the ASE beyond survey year 2016. However, the Census Bureau is exploring options to maintain this collection for future survey years.
Content for the ASE includes questions from the 2012 SBO (form SBO-1) with additional questions on sources of capital and financial barriers that are asked each survey year. The ASE also includes a series of new questions each survey year based on a relevant business topic determined prior to data collection. Each year the new module of questions is submitted to the Office of Management and Budget (OMB) for approval. The Census Bureau is requesting approval to field the 2016 ASE. The module selected for the 2016 ASE focuses on business advice and
The ASE collection is electronic only. Those selected for the survey receive an initial letter informing the respondents of their requirement to complete the survey as well as instructions on accessing the survey. The 2016 ASE initial mail is scheduled for June 2017. Responses will be due approximately 40 days from initial mail. Select respondents will receive a due date reminder approximately one week before responses are due.
Additionally, there will be two follow-up letter mailings to nonrespondents after the due date. Select nonrespondents will receive a certified mailing for the second follow-up if needed. Closeout of mail operations is scheduled for November 2017. Upon the close of the collection period, the response data will be processed, edited, reviewed, tabulated, and released publicly.
The survey will collect data on the gender, ethnicity, race, and veteran status for up to four persons owning the majority of rights, equity, or interest in the business. These data are needed to evaluate the extent and growth of business ownership by women, minorities, and veterans in order to provide a framework for assessing and directing federal, state, and local government programs designed to promote the activities of disadvantaged groups.
This data is widely used by private firms and individuals to evaluate their own businesses and markets. Additionally, the data will be used by entrepreneurs to write business plans and loan application letters, by the media for news stories, by researchers and academia for determining firm characteristics, and by the legal profession in evaluating the concentration of minority businesses in particular industries and/or geographic areas. The ASE statistics are used by government program officials, industry organization leaders, economic and social analysts, researchers, and business entrepreneurs. Additional examples of data use include:
• The Small Business Administration (SBA) and the Minority Business Development Agency (MBDA) to assess business assistance needs and allocate available program resources.
• Local government commissions on small and disadvantaged businesses to establish and evaluate contract procurement practices.
• Federal, state and local government agencies as a framework for planning, directing and assessing programs that promote the activities of disadvantaged groups.
• The National Women's Business Council to assess the state of women's business ownership for policymakers, researchers, and the public at large.
• Consultants and researchers to analyze long-term economic and demographic shifts, and differences in ownership and performance among geographic areas.
• Individual business owners to analyze their operations in comparison to similar firms, compute their market share, and assess their growth and future prospects.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Office of the Chief Information Officer, Office of the Secretary, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The purpose of this notice is to allow for 60 days of public comment.
Written comments must be submitted on or before May 22, 2017.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Jennifer Jessup at
Executive Order 12862 directs Federal agencies to provide service to the public that matches or exceeds the best service available in the private sector. In order to work continuously to ensure that the Department of Commerce (DOC) programs are effective and meet our customers' needs we use a generic clearance process to collect qualitative feedback on our service delivery. This collection of information is necessary to enable DOC to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between DOC and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance.
This request is an extension of the `generic fast-track' process offered to all government agencies by OMB in 2010. Fast-track means each request receives approval five days after submission, if no issues are brought to DOC's attention by OMB within the five days.
The primary method of collection will be the Internet (electronically), paper format, email, fax, interviews, etc.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice sill be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
On November 17, 2016, CoLinx, LLC submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facilities within FTZ 148—Sites 2, 6, 8 and 9, in Crossville, Tennessee.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Department) determines that
Effective March 23, 2017.
Javier Barrientos or Matthew Renkey, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone 202.482.2243 or 202.482.2312, respectively.
The petitioner in this investigation is Compass Chemical International LLC (Petitioner). In addition to the Government of China (GOC), the mandatory respondents in this investigation are Nanjing University of Chemical Technology Changzhou Wujin Water Quality Stabilizer Factory (Wujin Water) and Shandong Taihe Water Treatment Technologies Co., Ltd. (Taihe Technologies). The Department has determined that Taihe Technologies is affiliated with Shandong Taihe Chemicals Co., Ltd. (Taihe Chemicals), a trading company, and will refer to them collectively as “Taihe Companies.”
The Department published its
The Department is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (Act). For each of the subsidy programs found to be countervailable, we determine that there is a subsidy (
The product covered by this investigation is HEDP from the PRC. For a complete description of the scope of this investigation,
All issues raised in the comments filed by interested parties to this proceeding are discussed in the Issues and Decision Memorandum. A list of the issues raised by interested parties and responded to by the Department in the Issues and Decisions Memorandum are attached at Appendix I to this notice.
For purposes of this final determination, we relied on facts available, and because certain respondents did not act to the best of their ability in responding to the Department's requests for information, we drew an adverse inference, where appropriate, in selecting from among the facts otherwise available.
In accordance with section 705(c)(1)(B)(i)(I) of the Act, we calculated an estimated individual countervailable subsidy rate for each producer/exporter of the subject merchandise individually investigated.
In accordance with section 705(c)(5)(A) of the Act, for companies not individually investigated, we applied an “all-others” rate, which is normally calculated by weighting the subsidy rates of the individual companies selected as mandatory respondents by those companies' exports of the subject merchandise to the United States. Under section 705(c)(5)(A)(i) of the Act, the all-others rate excludes zero and
We intend to disclose to parties in this proceeding the calculations performed for this final determination within five days of the date of public announcement of our final determination, in accordance with 19 CFR 351.224(b).
As a result of our
If the U.S. International Trade Commission (ITC) issues a final affirmative injury determination, we will issue a CVD order and reinstate the suspension of liquidation under section 706(a) of the Act, requiring a cash deposit of estimated CVDs for such entries of subject merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.
In the event that the ITC issues a final negative injury determination, this notice will serve as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or, alternatively, conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation that is subject to sanction.
This determination is published pursuant to sections 705(d) and 777(i) of the Act.
The merchandise covered by this investigation includes all grades of aqueous acidic (non-neutralized) concentrations of HEDP, also referred to as hydroxyethylidenendiphosphonic acid, hydroxyethanediphosphonic acid, acetodiphosphonic acid, and etidronic acid. The Chemical Abstract Service (CAS) registry number for HEDP is 2809-21-4.
The merchandise subject to this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheading 2931.90.9043. It may also enter under HTSUS subheadings 281.19.6090 and 2931.90.9041. While HTSUS subheadings and the CAS registry number are provided for convenience and customs purposes only, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (“the Department”) determines that imports of ferrovanadium from the Republic of Korea are being, or are likely to be, sold in the United States at less than fair value (“LTFV”). The final estimated weighted-average dumping margins of sales at LTFV are listed below in the section entitled “Final Determination Dumping Margins.” The period of investigation (“POI”) is January 1, 2015, through December 31, 2015.
Effective March 23, 2017.
Karine Gziryan or Eli Lovely, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4081 or (202) 482-1593.
The Department published in the
The product covered by this investigation is all ferrovanadium regardless of grade (
As noted in the
All issues raised in the case and rebuttal briefs that were submitted by parties in this investigation are addressed in the Issues and Decision Memorandum accompanying this notice, which is hereby adopted by this notice. A list of the issues addressed in the Issues and Decision Memorandum is attached to this notice in the Appendix.
As provided in section 782(i) of the Act, in November 2016, the Department verified the sales and cost data reported by Korvan Ind., Co., Ltd. (“Korvan”), the sole cooperating mandatory respondent in this investigation. We used standard verification procedures, including an examination of relevant accounting and production records, and original source documents provided by Korvan.
Based on our analysis of the comments received and our findings at verification, we made certain changes to the dumping margin calculation for Korvan. For a discussion of these changes,
Section 735(c)(5)(A) of the Act provides that the estimated “all-others” rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or
The Department determines that the following estimated weighted-average dumping margins exist:
We intend to disclose to parties in this proceeding the calculations performed for this final determination within five days of the date of public announcement of our final determination, in accordance with 19 CFR 351.224(b).
Pursuant to section 735(c)(1)(B) of the Act, the Department will instruct U.S. Customs and Border Protection (“CBP”) to continue to suspend liquidation of all entries of ferrovanadium from the Republic of Korea which were entered, or withdrawn from warehouse, for consumption on or after November 1, 2016, the date of publication of the
Pursuant to section 733(d) of the Act and 19 CFR 351.205(d), we will instruct CBP to require cash deposits equal to the weighted-average amount by which the normal value exceeds U.S. price, as indicated in the table above, as follows: (1) The cash deposit for the mandatory respondents listed above will be the respondent-specific weighted-average dumping margin listed for the respondent in the table above; (2) if the exporter is not a mandatory respondent identified above, but the producer is, the cash deposit rate will be the weighted-average dumping margin established for the producer of the subject merchandise; and (3) the rate for all other producers or exporters will be the all others rate listed in the table above.
In accordance with section 735(d) of the Act, we will notify the U.S. International Trade Commission (“ITC”) of our final determination. As our final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will determine within 45 days of the final determination whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports, or sales (or the likelihood of sales) for importation, of the subject merchandise. If the ITC determines that such injury exists, the Department will issue an antidumping duty order directing CBP to assess, upon further-instruction by the Department, antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.
This notice will serve as a reminder to parties subject to APOs of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the-regulations and the terms of an APO is a sanctionable violation.
This determination and notice are issued and published in accordance with sections 735(d) and 777(i) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Department) determines that 1-Hydroxyethylidene-1, 1-Diphosphonic Acid (HEDP) from the People's Republic of China (PRC) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The final weighted-average dumping margins for the investigation on HEDP from the PRC are listed in the “Final Determination Margins” section of this notice.
Effective March 23, 2017.
Omar Qureshi or Kenneth Hawkins, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5307 or (202) 482-6491, respectively.
On November 4, 2016, the Department published its
The period of investigation (POI) is July 1, 2015, through December 31, 2015. This period corresponds to the two most recent fiscal quarters prior to the month of the filing of the petition, which was January 2016.
The merchandise covered by this investigation includes all grades of aqueous acidic (non-neutralized) concentrations of 1-hydroxyethylidene-1, 1-diphosphonic acid (HEDP), also referred to as hydroxyethylidenendiphosphonic acid, hydroxyethanediphosphonic acid, acetodiphosphonic acid, and etidronic acid. The Chemical Abstract Service (CAS) registry number for HEDP is 2809-21-4.
The merchandise subject to this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheading 2931.90.9043. It may also enter under HTSUS subheadings 2811.19.6090 and 2931.90.9041. While HTSUS subheadings and the CAS registry number are provided for convenience and customs purposes only, the written description of the scope of this investigation is dispositive.
We addressed all issues raised by parties in case and rebuttal briefs in the Issues and Decision Memorandum.
As provided in section 782(i) of the Act, in December 2016, the Department conducted verification of the information submitted by Shandong Taihe Chemical Co., Ltd. (Taihe), Nanjing University of Chemical Technology Changzhou Wujin Water Quality Stabilizer Factory and Nantong Uniphos Chemicals Co., Ltd. (collectively, WW Group) for use in the final determination. We issued our verification reports on January 19, 2017.
Based on the Department's verifications of Taihe and WW Group, we made changes from the
For Taihe, the Department did not use a net realizable value calculation in Taihe's margin calculation. Additionally, for Taihe, we included inventory carrying costs for all sales where warehousing expenses were reported. The Department also included indirect selling expenses in Taihe's margin calculation.
The Department also made the necessary calculation adjustment to international freight, domestic brokerage, and domestic inland freight where the expenses are calculated on a gross weight basis for both Taihe and WW Group. Lastly, the Department made the necessary calculation adjustment for marine insurance surrogate value for Taihe and WW Group.
As explained in the
In selecting the AFA rate for the PRC-wide entity, the Department's practice is to select a rate that is sufficiently adverse to ensure that the uncooperative party does not obtain a more favorable result by failing to cooperate than if it had fully cooperated.
In calculating rates for non-individually investigated respondents in the context of non-market economy cases, the Department looks to section 735(c)(5)(A)-(B) of the Tariff Act of 1930, (as amended) (the Act), which provides instructions for calculating the all-others rate in an investigation. Section 735(c)(5)(A) of the Act provides that the estimated all-others rate shall be equivalent to the weighted average of the estimated weighted-average dumping margins calculated for exporters and producers individually investigated, excluding any margins that are zero,
Apart from the mandatory respondents in this investigation, two other PRC exporters of the subject merchandise during the POI established entitlement to a separate rate.
The Department determines that the estimated final weighted-average dumping margins are as follows:
We intend to disclose to parties the calculations performed in this proceeding within five days of any public announcement of this notice in accordance with 19 CFR 351.224(b).
In accordance with section 735(c)(1)(B) of the Act, we will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of HEDP from the PRC, as described in the “Scope of the Investigation” section, entered, or withdrawn from warehouse, for consumption on or after November 4, 2016, the date of publication of the
Pursuant to section 735(c)(1)(B)(ii) of the Act, the Department will instruct CBP to require a cash deposit
We normally adjust antidumping duty cash deposit rates by the amount of export subsidies, where appropriate. In the companion CVD investigation, we have found that the WW Group did not receive export subsidies.
Pursuant to section 777A(f) of the Act, we normally adjust preliminary cash deposit rates for estimated domestic subsidy pass-through, where appropriate. However, in this case there is no basis to grant a domestic subsidy pass-through adjustment.
In accordance with section 735(d) of the Act, we notified the International Trade Commission (ITC) of the final affirmative determination of sales at LTFV. As the Department's final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will determine, within 45 days, whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of HEDP for sale from the PRC, or sales (or the likelihood of sales) for importation, of HEDP from the PRC. If the ITC determines that such injury does not exist, this proceeding will be terminated and all securities posted will be refunded or canceled. If the ITC determines that such injury does exist, the Department will issue an antidumping duty order directing CBP to assess, upon further instruction by the Department, antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.
This notice also serves as a reminder to the parties subject to administrative protective order (APO) of their responsibility concerning the disposition of propriety information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This determination is issued and published in accordance with sections 735(d) and 777(i)(1) of the Act.
National Institute of Standards and Technology, Department of Commerce.
Notice.
The National Institute of Standards and Technology (NIST) invites organizations to provide products and technical expertise to support and demonstrate security platforms for the
Interested parties must contact NIST to request a letter of interest template to be completed and submitted to NIST. Letters of interest will be accepted on a first come, first served basis. Collaborative activities will commence as soon as enough completed and signed letters of interest have been returned to address all the necessary components and capabilities of the project, but no earlier than April 24, 2017. When the use case has been completed, NIST will post a notice on the NCCoE Manufacturing sector program Web site at
The NCCoE is located at 9700 Great Seneca Highway, Rockville, MD 20850. Letters of interest must be submitted to
Jim McCarthy via email at
Interested parties should contact NIST using the information provided in the
• ICS behavioral anomaly detection tools.
• Human Machine Interfaces (HMIs).
• Programmable Logic Controllers (PLCs).
• Security Information and Event Management (SIEM) platform.
Each responding organization's letter of interest should identify how their products address one or more of the following desired solution characteristics in the High-Level Architectures section of the
• Detection of anomalous conditions.
• Process and/or device damage prevention.
• SIEM-based alerting/alarming capability.
In their letters of interest, responding organizations need to understand and commit to provide:
1. Access for all participants' project teams to component interfaces and the organization's experts necessary to make functional connections among security platform components; and
2. Support for development and demonstration of the
Additional details about the
Under the terms of the consortium CRADA, NIST will support development of interfaces among participants' products by providing IT infrastructure, laboratory facilities, office facilities, collaboration facilities, and staff support to component composition, security platform documentation, and demonstration activities.
The dates of the demonstration of the
For additional information on NCCoE governance, business processes, and operational structure, visit the NCCoE Web site
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Mid-Atlantic Fishery Management Council (Council) will hold public meetings of the Council and its Committees.
The meetings will be held on Tuesday, April 11 through Thursday, April 13, 2017. For agenda details, see
The meetings will be held at the Icona Golden Inn, 7849 Dune Drive, Avalon, NJ 08202; telephone: (609) 368-5155.
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The following items are on the agenda, though agenda items may be addressed out of order (changes will be noted on the Council's Web site when possible).
• Review draft metrics for river herring and shad conservation.
• Report on the state of the Mid-Atlantic portion of the Northeast Large Marine Ecosystem, continue discussion and development of EAFM Risk Matrix, and discuss next steps in EAFM development/implementation.
• Review amendment development and scoping plans.
• Review SSC, Monitoring Committee, Advisory Panel, and staff recommendations regarding 2018-20 specifications.
• Adopt recommendations for 2018-20.
• Review SSC, Monitoring Committee, Advisory Panel, and staff recommendations regarding 2018-19 specifications.
• Adopt recommendations for 2018-19.
• Presentation, discussion and comment.
• Challenges faced in 2016-17 and plans for 2017-18.
• Consider previous action on IFM Amendment.
• Possible adoption of IFM Amendment.
The day will conclude with Committee Reports, the Executive Director's Report, the Science Report, brief reports from the National Marine Fisheries Service's GARFO and the Northeast Fisheries Science Center, NOAA's Office of General Counsel, the ASMFC, the New England and South Atlantic Fishery Council's liaisons and the Regional Planning Body Report, and discuss any continuing and/or new business.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 48 Post-Data Workshop webinar for Southeastern U.S. black grouper.
The SEDAR 48 assessment process of Southeastern U.S. black grouper will consist of a Data Workshop, an Assessment Workshop and a series of assessment webinars, and a Review Workshop. See
The SEDAR 48 post-Data Workshop webinar will be held April 11, 2017, from 1 p.m. to 3 p.m. Eastern Time.
The meeting will be held via webinar. The webinar is open to members of the public. Those interested in participating should contact Julie A. Neer at SEDAR (see
Julie A. Neer, SEDAR Coordinator; (843) 571-4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data Workshop, (2) a series of assessment webinars, and (3) A Review Workshop. The product of the Data Workshop is a report that compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The assessment webinars produce a report that describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The product of the Review Workshop is an Assessment Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, HMS Management Division, and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.
The items of discussion during the pre-data workshop webinar are as follows:
Panelists will present finalized data for review and recommendation.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The River Herring and Shad Advisory Panel of the Mid-Atlantic Fishery Management Council (Council) will hold a meeting.
The meeting will be held on Friday, April 7, 2017, beginning at 1 p.m. For agenda details, see
The meeting will be held via webinar with a telephone-only connection option. Details will be posted at
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The purpose of the meeting is to gather input from the Advisory Panel on Council efforts to develop metrics for evaluating progress on river herring and shad conservation.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
11:00 a.m., Thursday, March 30, 2017.
Three Lafayette Centre, 1155 21st Street NW., Washington, DC, 9th Floor Commission Conference Room.
Closed.
Surveillance, enforcement, and examinations matters. In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's Web site at
Christopher Kirkpatrick, 202-418-5964.
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed.
Currently, CNCS is soliciting comments concerning AmeriCorps Commission Support Application Instructions. State commissions will respond to the questions included in this ICR in order to apply for funding through these grants and to report on progress and performance measures.
Copies of the information collection request can be obtained by contacting the office listed in the addresses section of this notice.
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1)
(2) By hand delivery or by courier to the CNCS mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time Monday through Friday, except Federal holidays.
(3) Electronically through
James Stone, (202) 606-6885, or by email at
CNCS is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or
These application instructions will be used by applicants for funding through AmeriCorps State and National Commission Support grants.
CNCS seeks to renew its Commission Support Application Instructions with no changes. The Application Instructions will be used on an annual basis by State Service Commissions to report on progress and apply for funding. CNCS proposes to continue to use the currently cleared application until the renewal is approved by OMB.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
General Counsel of the Department of Defense, Department of Defense.
Notice of Federal Advisory Committee meeting.
The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Judicial Proceedings Since Fiscal Year 2012 Amendments Panel will take place.
Open to the public, Friday, April 7, 2017, from 9:00 a.m. to 4:15 p.m.
One Liberty Center, 875 N. Randolph Street, Suite 1432, Arlington, Virginia 22203.
Maria Fried, 703-571-2664 (Voice), 703-693-3903 (Facsimile),
This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140. Contact: Ms. Julie Carson, Judicial Proceedings Panel, One Liberty Center, 875 N. Randolph Street, Suite 150, Arlington, Virginia 22203. Email:
Department of Education (ED), National Center for Education Statistics (NCES).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before May 22, 2017.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact NCES Information Collections at
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before May 22, 2017.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact NCES Information Collections at
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Deadline for filing motions to intervene and protests, comments, recommendations, preliminary terms and conditions, and preliminary prescriptions: 60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.
The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, recommendations, preliminary terms
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted for filing and is now ready for environmental analysis.
l.
PacifiCorp also proposes to increase the project's minimum flow releases and ramping rates limits, as well as extending the project boundary to include the inverted siphon and access roads.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Register online at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must (1) bear in all capital letters the title “PROTEST”, “MOTION TO INTERVENE”, “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “PRELIMINARY TERMS AND CONDITIONS,” or “PRELIMINARY FISHWAY PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
o. Procedural Schedule:
The application will be processed according to the following revised Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.
p. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.
q.
On February 9, 2017, Littleville Power Company, Inc. (transferor) and Hitchcock Hydro, LLC (transferee) filed an application for the transfer of license of the Glendale Hydroelectric Project No. 2801. The project is located on the Housatonic River in Berkshire County, Massachusetts. The project does not occupy Federal lands.
The applicants seek Commission approval to transfer the license for the Glendale Hydroelectric Project from the transferor to the transferee.
On February 28, 2017, the Village of North Bennington, Vermont, filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Lake Paran Dam Hydroelectric Project (Lake Paran Project or project) to be located on Paran Creek, near the Village of North Bennington, in Bennington County, Vermont. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed Lake Paran Project would consist of: (1) The existing 120-foot-long, 10-foot-concrete gravity Lake Paran Dam and spillway; (2) an existing 35-acre impoundment with a normal maximum water surface elevation 646.65 feet above mean sea level; (3) a new intake structure; (4) a new 250-foot-long, 36-inch diameter penstock; (5) a new 20-foot-long, 10-foot-wide concrete and wood powerhouse containing a single 58-kilowatt turbine-generator unit; (6) a new 1,000-foot-long, 12.47-kilovolt transmission line; and (7) appurtenant facilities. The estimated annual generation of the Lake Paran Project would be 281.84 megawatt-hours.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
Federal Energy Regulatory Commission.
Notice of information collection and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the information collection FERC-588 (Emergency Natural Gas Transportation, Sale and Exchange Transactions) and will be submitting FERC-588 to the Office of Management and Budget (OMB) for review of the information collection requirements.
Comments in consideration of the collection of information are due May 22, 2017.
You may submit comments identified by Docket No. IC17-5-000 by either of the following methods:
•
•
Ellen Brown may be reached by email at
A temporary operation, or emergency, is defined as any situation in which an actual or expected shortage of gas supply would require an interstate pipeline company, intrastate pipeline, or local distribution company, or Hinshaw pipeline to curtail deliveries of gas or provide less than the projected level of service to the customer. The natural gas companies which provide the temporary assistance to the companies which are having the “emergency” must file the necessary information described in Part 284, Subpart I of the Commission's Regulations with the Commission, so that it may determine if their assisting transaction/operation qualifies for exemption. The assisting company may or may not be under the Commission's jurisdiction and if their assisting actions qualify for the exemption, they will not become subject to the Commission's jurisdiction for such actions.
A report within forty-eight hours of the commencement of the transportation, sale or exchange, a request to extend the sixty-day term of the emergency transportation, if needed, and a termination report are required. The data required to be filed for the forty-eight hour report is specified by 18 CFR 284.270.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On January 4, 1017, Arkansas Electric Cooperative Corporation (AECC), filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the River Mountain Pumped Storage Project, at the U.S. Army Corps of Engineers (Corps) Lake Dardanelle on the Arkansas River in Logan County, Arkansas. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of: (1) A 120-foot-high compacted rock fill embankment surrounding; (2) a 208-acre upper reservoir, with an impervious liner, having 11,650 acre-foot gross storage capacity; (3) a intake/outlet structure in the upper reservoir; (4) a 680-foot-long, 30-foot-diameter,
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and competing applications may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the St. James Supply Project involving construction and operation of facilities by Transcontinental Gas Pipe Line Company, LLC (Transco) in St. James, Pointe Coupee, and St. Helena Parishes, Louisiana. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington, DC on or before April 14, 2017.
If you sent comments on this project to the Commission before the opening of this docket on February 6, 2017, you will need to file those comments in Docket No. CP17-58-000 to ensure they are considered as part of this proceeding.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings where compensation would be determined in accordance with state law.
Transco provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC Web site (
For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the
(2) You can file your comments electronically by using the
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP17-58-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy
The St. James Supply Project would deliver 161,500 dekatherms per day of firm transportation capacity from Transco's existing mainline Compressor Station 65 in St. Helena Parish, Louisiana to the planned Yuhuang Chemical Plant in St. James Parish, Louisiana. Transco would use its existing Southeast Lateral Pipeline (SELA) to deliver gas to the chemical plant. Proposed construction would provide bi-directional flow of natural gas on the SELA pipeline and a secondary source of natural gas to the chemical plant using an existing interconnection on Transco's mainline with the Texas Eastern Transmission Company Pipeline in Pointe Coupee Parish, Louisiana.
The St. James Supply Project would consist of the following facilities:
• 0.7 mile of 20-inch-diameter pipeline;
• one new pig receiver site;
• two new meter and regulating (M&R) stations (Old River Road and Cajun Road M&R Stations);
• a new interconnection to the chemical plant site;
• one new valve and piping to tie the Old River Road M&R Station into the SELA pipeline; and
• piping and valve modifications at existing Transco Compressor Stations 63 and 65.
The general location of the project facilities is shown in appendix 1.
Construction of the proposed facilities would disturb about 77.8 acres of land for the aboveground facilities and the pipeline. Following construction, Transco would maintain about 12.0 acres for permanent operation of the project's facilities; the remaining acreage would be restored and revert to former uses.
The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us
In the EA we will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:
• Geology and soils;
• water resources and wetlands;
• fisheries, vegetation, and wildlife;
• endangered and threatened species;
• land use;
• cultural resources;
• air quality and noise;
• public safety; and
• cumulative impacts.
We will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we may also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before making our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.
With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate with us in the preparation of the EA.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the applicable State Historic Preservation Office (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.
If we publish and distribute the EA, copies will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).
In addition to involvement in the EA scoping process, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Instructions for becoming an intervenor are in the “Document-less Intervention Guide” under the “e-filing” link on the Commission's Web site. Motions to intervene are more fully described at
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Finally, public sessions or site visits will be posted on the Commission's calendar located at
Take notice that on March 7, 2017 ANR Storage Company (ANR Storage), 700 Louisiana Street, Houston, Texas 77002-2700, filed in Docket No. CP17-71-000 a prior notice request pursuant to sections 157.205 and 157.216 of the Commission's regulations under the Natural Gas Act (NGA) and ANR Storage's authorization in Docket No. CP82-523-000, 21 FERC ¶ 62,109 (1982), for authorization to abandon one injection/withdrawal (I/W) well at its Cold Springs 12 Storage Field in Kalkaska County, Michigan, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at
Any questions concerning this application may be directed to Linda Farquhar, Manager, Project Determinations & Regulatory Administration, ANR Storage Company, 700 Louisiana Street, Suite 700, Houston, Texas, 77002-2700, at (832) 320-5685 or fax (832) 320-6685 or
Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenter's will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenter's will not be required to serve copies of filed documents on all other parties. However, the non-party commentary, will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web site (
On February 28, 2017, the Village of North Bennington, Vermont, filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Firehouse Dam Hydroelectric Project (Firehouse Project or project) to be located on Paran Creek, near the Village of North Bennington, in Bennington County, Vermont. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
Federal Energy Regulatory Commission, Department of Energy.
Notice of information collections and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the requirements and burden of the information collections described below.
Comments on the collections of information are due May 22, 2017.
You may submit comments (identified by Docket No. IC17-8-000) by either of the following methods:
•
•
Please reference the specific collection number and/or title in your comments.
Ellen Brown may be reached by email at
The submitted data are used by the Commission to assist in the selection of appropriate service lives and book depreciation rates. Book depreciation rates are used by oil pipeline companies to compute the depreciation portion of their operating expense which is a component of their cost of service which in turn is used to determine the transportation rate to assess customers. FERC staff's recommended book depreciation rates become legally binding when issued by Commission order. These rates remain in effect until a subsequent review is requested and the outcome indicates that a modification is justified. The Commission implements these filings in 18 CFR parts 347 and 357.
For the natural gas industry, section 14(a) of the NGA
For public utilities, section 307(a) of the FPA
Section 215(d)(5) of the FPA
For hydropower projects, section 19 of the FPA
For qualifying facilities, section 210(h)(2)(B) of PURPA
For oil pipelines, in Part 1 of the Interstate Commerce Act, sections 1, 6 and 15 (recodified by Pub. L. 95-473 and found as an appendix to Title 49 U.S.C.),
In Order No. 602,
The data in complaints filed by interested/affected parties regarding jurisdictional oil, natural gas, electric and hydropower operations, facilities, and services are used by the Commission in establishing a basis to make an initial determination regarding the merits of the complaint and whether or not to undertake further investigation. Investigations may range from whether there is undue discrimination in rates or services to questions regarding market power of
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on March 14, 2017, pursuant to section 211 of the Federal Power Act
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Environmental Protection Agency (EPA).
Notice: Extension of nominee solicitation.
The Environmental Protection Agency (EPA) issued a notice in the
Nominations identified by docket identification (ID) number FRL-9957-61-OW must be received on or before March 31, 2017.
Follow the detailed instructions as provided under
Submit nomination materials by electronic mail to: Alecia F. Crichlow, Membership Coordinator, Environmental Financial Advisory Board,
This document extends the nomination period established in the
To submit nominations, or access the docket, please follow the detailed instructions as provided under
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's order for the cancellations and amendments to terminate uses, voluntarily requested by the registrants and accepted by the Agency, of the products listed in Table 1 and Table 2 of Unit II, pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation order follows a November 18, 2016
The cancellations and amendments are effective March 23, 2017.
Christopher Green, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-0367; email address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0577, is available at
In the November 18, 2016 notice, EPA indicated that it would issue an order implementing the cancellations and amendments to terminate uses, unless the Agency received substantive comments within the 30-day comment period that would merit its further review of these requests, or unless the registrants withdrew their requests. The Agency received one comment on this notice from a registrant to withdraw one cancellation request for registration 100-1052, because it was inadvertently sent to the agency and it is not listed in this notice and will not be cancelled. Also two comments were received for the following registration numbers that were listed for product cancellation in the November 18, 2016 notice in error and are not listed in this notice, the following product registrations are not being cancelled: 2792-45, 61842-20, 61842-21, 61842-22, 61842-23, 61842-24 and 61842-32. Also, a comment was received for registration number 66222-32 that was listed in error with the incorrect product name and active ingredient, and it is not listed in this notice and will not be cancelled. Accordingly, EPA hereby issues in this notice a cancellation order granting the requested cancellations and amendments to terminate uses. Any distribution, sale, or use of the products subject to this cancellation order is permitted only in accordance with the terms of this order, including any existing stocks provisions.
This notice announces the cancellations and amendments to terminate uses, as requested by registrants, of products registered under FIFRA section 3 (7 U.S.C. 136a). These registrations are listed in sequence by registration number in Tables 1 and 2 of this unit.
Table 3 of this unit includes the names and addresses of record for all registrants of the products in Tables 1 and 2 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed above.
During the public comment period provided, EPA received four comments in response to the November 18, 2016
Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)(1)), EPA hereby approves the requested cancellations and amendments to terminate uses of the registrations identified in Tables 1 and 2 of Unit II. Accordingly, the Agency hereby orders that the product registrations identified in Tables 1 and 2 of Unit II, are canceled and amended to terminate the affected uses. The effective date of the cancellations that are subject of this notice is March 23, 2017. Any distribution, sale, or use of existing stocks of the products identified in Tables 1 and 2 of Unit II, in a manner inconsistent with any of the provisions for disposition of existing
Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Existing stocks are those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the action. The existing stocks provision for the products subject to this order is as follows.
For voluntary cancellations, the registrants may continue to sell and distribute existing stocks of products listed in Table 1 until March 23, 2018, which is 1 year after publication of this cancellation order in the
Now that EPA has approved product labels reflecting the requested amendments to terminate uses, registrants are permitted to sell or distribute products listed in Table 2 of Unit II, under the previously approved labeling until September 24, 2018, a period of 18 months after publication of the cancellation order in this
7 U.S.C. 136
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that at 10:26 a.m. on Tuesday, March 21, 2017, the Board of Directors of the Federal Deposit Insurance Corporation met in closed session to consider matters related to the Corporation's supervision, corporate, and resolution activities.
In calling the meeting, the Board determined, on motion of Vice Chairman Thomas M. Hoenig, seconded by Director Thomas J. Curry (Comptroller of the Currency), concurred in by Director Richard Cordray (Director, Consumer Financial Protection Bureau), and Chairman Martin J. Gruenberg, that Corporation business required its consideration of the matters which were to be the subject of this meeting on less than seven days' notice to the public; that no earlier notice of the meeting was practicable; that the public interest did not require consideration of the matters in a meeting open to public observation; and that the matters could be considered in a closed meeting by authority of subsections (c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10) of the “Government in the Sunshine Act” (5 U.S.C. 552b(c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10).
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).
Notice; request for comments.
The Agency for Toxic Substances and Disease Registry (ATSDR) located in the Department of Health and Human Services (HHS) is initiating the development of its 31st set of toxicological profiles (Set 31). Today's announcement invites voluntary public nominations of substances for profile development. ATSDR is soliciting public nominations of substances found on the Substance Priority List (SPL) at
Comments must be submitted April 24, 2017.
You may submit nominations, identified by Docket No. ATSDR-2017-0003, by any of the following methods:
*
*
For further information, please contact Commander Jessilynn B. Taylor, Division of Toxicology and Human Health Sciences, 1600 Clifton Rd. NE., MS F-57, Atlanta, GA 30329, Email:
The Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9601
Each year, ATSDR develops a list of substances to be considered for toxicological profile development. The Set 31 nomination process includes consideration of all substances on ATSDR's SPL, as well as other substances nominated by the public. The 275 substances on the SPL will be considered for Set 31 Toxicological Profile development. This list may be found at the following Web site:
ATSDR also will consider the nomination of any substance that is not on the SPL under the authority of the Comprehensive, Environmental Response, Compensation, and Liability Act (CERCLA) to “. . . establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances” under CERCLA Section 104(i)(1)(B), to respond to requests for consultation under section 104(i)(4), and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.
Today's document invites voluntary public nominations for substances included on the SPL and for substances not listed on the SPL. All nominations should include the full name of the nominator, affiliation, and email address. When nominating a non-SPL substance, please include the rationale for the nomination. Please note that email addresses will not be posted in the docket found at
ATSDR will evaluate all data and information associated with nominated substances and will determine the final list of substances to be chosen for toxicological profile development. Substances will be chosen according to ATSDR's specific guidelines for selection. These guidelines can be found in the
Please ensure that your comments are submitted within the specified nomination period. Nominations received after the closing date will be marked as late and may be considered only if time and resources permit.
The meeting announced below concerns the Centers for Disease Control and Prevention (CDC) initial review of applications in response to Funding Opportunity Announcement (FOA) GH14-002, Addressing Emerging Infectious Diseases in Bangladesh; and FOA GH16-003, Conducting Public Health Research in Thailand: Technical collaboration with the Ministry of Public Health in the Kingdom of Thailand (MOPH).
This publication corrects a notice that was published in the
The meeting announced below concerns the Centers for Disease Control and Prevention (CDC) initial review of applications in response to Funding Opportunity Announcements (FOA) GH13-001, Strengthening Disease Prevention Research Capacity for Public Health Action in Guatemala and the Central American Region; FOA GH14-002, Addressing Emerging Infectious Diseases in Bangladesh; and FOA GH16-003, Conducting Public Health Research in Thailand: Technical collaboration with the Ministry of Public Health in the Kingdom of Thailand (MOPH).
Hylan Shoob, Scientific Review Officer, Center for Global Health (CGH) Science Office, CGH, CDC, 1600 Clifton Road NE., Mailstop D-69, Atlanta, Georgia 30033, Telephone: (404) 639-4796,
The Director, Management Analysis and Services Office, has been delegated the authority to sign
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement, RFA-CE-17-002, Development and Evaluation of Sports Concussion Prevention Strategies.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA) DD17-001, Coordinating Center for Research to Promote the Health of Children with Birth Defects and People with Developmental and Other Disabilities.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of application in response to Funding Opportunity Announcement (FOA) PAR15-353, Centers for Agricultural Safety and Health.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS).
Notice of Award of one single-source expansion supplement grant under the Unaccompanied Children's (UC) Program.
ACF, ORR, announces the award of one single-source expansion supplement grant for a total of $1,768,571 under the UC Program.
Expansion supplement grants will support activities from February 1, 2017, through March 31, 2017.
Jallyn Sualog, Director, Division of Children's Services, Office of Refugee Resettlement, 330 C Street SW., Washington, DC 20201. Email:
The following supplement grant will support the immediate need for additional capacity of shelter services to accommodate the increasing number of UC referred by the Department of Homeland Security (DHS) into ORR care. The increase in the UC population necessitates the need for expansion of services to expedite the release of UC. In order to be prepared for an increase in referrals for shelter services, ORR will solicit proposals from one grantee to accommodate the extensive amount of referrals from DHS.
ORR has specific requirements for the provision of services. Award recipients must have the infrastructure, licensing, experience, and appropriate level of trained staff to meet those requirements. The expansion of the existing shelter services program through this supplemental award is a key strategy for ORR to be prepared to meet its responsibility of safe and timely release of UC referred to its care by DHS and so that the U.S. Border Patrol can continue its vital national security mission to prevent illegal migration and trafficking, and protect the borders of the United States.
(A) Section 462 of the Homeland Security Act of 2002, which in March 2003, transferred responsibility for the care and custody of Unaccompanied Alien Children from the Commissioner of the former Immigration and Naturalization Service (INS) to the Director of ORR of HHS.
(B) The Flores Settlement Agreement, Case No. CV85-4544RJK (C.D. Cal. 1996), as well as the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (Pub. L. 110-457), which authorizes post release services under certain conditions to eligible children. All programs must comply with the Flores Settlement Agreement, Case No. CV85-4544-RJK (C.D. Cal. 1996), pertinent regulations and ORR policies and procedures.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2017 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH's employees, or to contact CDRH for more information regarding the ELP.
Submit either electronic or written requests for participation in the ELP by dates specified in the ELP Web site at:
Submit either electronic requests to
Christian Hussong, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5261, Silver Spring, MD 20993-0002, 240-402-2246,
CDRH is responsible for helping to ensure the safety and effectiveness of medical devices marketed in the United States. Furthermore, CDRH assures that patients and providers have timely and continued access to high-quality, safe, and effective medical devices. For 2016-2017, CDRH has identified Partnering with Patients and Promoting a Culture of Quality and Organizational Excellence as strategic priorities, specifically having the perspective of our stakeholders and understanding implementation of these within their
CDRH is committed to advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and helping to ensure consumer confidence in medical devices marketed in the United States and throughout the world. The ELP is intended to provide CDRH staff with an opportunity to understand the policies, laboratory and manufacturing practices, and the challenges addressing patient perspective/input, quality system management, and other challenges that impact the device development life cycle. This component is a collaborative effort to enhance communication and facilitate the premarket review process. The Center is committed to understanding current industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advances the development and evaluation of innovative devices, and to monitoring the performance of marketed devices.
These formal training visits are not intended for FDA to inspect, assess, judge, or perform a regulatory function (
CDRH encourages applicants to consider including opportunities to discuss how patient perspective and effective quality systems management contribute to the success of the device development life cycle. Additional information regarding the CDRH ELP, including the table of areas of interest, submission dates and deadlines, a sample request, and an example of the site visit agenda, is available on CDRH's Web site at:
In this training program, groups of CDRH staff will observe operations in the areas of research, device development, in making coverage decisions and assessments, incorporating patient information and reimbursement, manufacturing, academia, and health care facilities. The areas of interest for visits include various topics identified by managers at CDRH. These areas of interest are listed publicly and are intended to be updated quarterly.
To submit a proposal addressing one of the Center's training needs, visit the link for the table of areas of interest to be addressed at:
Once you have determined an area of interest to address in your ELP proposal, follow the instructions in section III to properly fill out the site visit request template and agenda provided at:
CDRH will be responsible for CDRH staff travel expenses associated with the site visits. CDRH will not provide funds to support the training provided by the site to the ELP. Selection of potential facilities will be based on CDRH's priorities for staff training and resources available to fund this program. In addition to logistical and other resource factors, all sites must have a successful compliance record with FDA or another Agency with which FDA has a memorandum of understanding (if applicable). If a site visit involves a visit to a separate physical location of another firm under contract with the site, that firm must agree to participate in the ELP and must also have a satisfactory compliance history, and must be listed in the proposal along with a Facility Establishment Identifier number (FEI #) if applicable.
Submit proposals for participation with the docket number found in the brackets in the heading of this document. Received requests may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
Additional information regarding the CDRH ELP, including a sample request and an example of a site visit agenda and submission deadlines, is available on CDRH's Web site at:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 21, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Ozlem Belen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 22, Rm. 6118, Silver Spring, MD 20993-0002, 301-796-0676.
FDA is announcing the availability of a draft guidance for industry entitled “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of DGF in kidney transplantation.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on developing drugs for the prevention of DGF in kidney transplant. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively.
Persons with access to the Internet may obtain the draft guidance at either
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Georgia (FEMA-4297-DR), dated January 26, 2017, and related determinations.
Effective February 15, 2017.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Georgia is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of January 26, 2017.
Colquitt County for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
U.S. Citizenship and Immigration Services, DHS.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until May 22, 2017.
All submissions received must include the OMB Control Number 1615-0046 in the body of the letter, the agency name and Docket ID USCIS-2006-0062. To avoid duplicate submissions, please use only
(1)
(2)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
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Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
Under the Endangered Species Act of 1973, as amended (Act),
To ensure consideration, please send your written comments by May 22, 2017.
• Atlanta Regional Office, Ecological Services, U.S. Fish and Wildlife Service, 1875 Century Boulevard, Atlanta, GA 30345.
• South Florida Ecological Services Office, U.S. Fish and Wildlife Service, 1339 20th Street, Vero Beach, FL 32960.
Mr. David Dell, Regional HCP Coordinator, Atlanta (see
Under the Endangered Species Act of 1973, as amended (Act), we, the U.S. Fish and Wildlife Service, announce the receipt and availability of a proposed habitat conservation plan (HCP), accompanying incidental take permit (ITP) application, and environmental assessment (EA) related to an application from Coral Reef Retail LLC, Coral Reef Residential Phase I LLC, Ramdev LLC, and the University of Miami (applicants) for a permit associated with construction of the Coral Reef Commons mixed-use development (project) in Miami-Dade County, Florida. We invite the public to comment on these documents.
The applicants' proposed HCP describes the mitigation and minimization measures proposed to address the impacts to the covered species. Per the National Environmental Policy Act (42 U.S.C. 4321
The covered species are the following:
Because the project would likely have adverse effects on several plant species, the HCP includes conservation measures for the following plant species:
The EA assesses the likely environmental impacts associated with the project, including the environmental consequences of the no-action and the proposed action alternatives. The proposed action alternative is issuance of the ITP and implementation of the HCP as submitted by the applicants. The HCP area is comprised of a 137.9-acre tract, of which 86.49 acres are proposed for development, in addition to a separate 50.96-acre tract proposed for off-site mitigation. These tracts lie in an area known as the Richmond Pine Rocklands. Construction of the project would impact 86.49 acres of pine rockland habitat and would take covered species that occupy the area.
The minimization and mitigation measures proposed in the HCP include the setting aside and maintenance of 51.41 acres of conservation areas within the 137.9-acre tract, supplemented by 3.88 acres of intermediate conservation “stepping stones” to provide for movement of covered species among the conservation areas. In addition to the conservation areas, the 50.96-acre tract would serve as off-site mitigation and be protected and maintained as habitat for the covered species. The conservation and off-site mitigation areas would be managed by prescribed fire, other vegetation control measures, and removal of exotic invasive species. The areas also would be protected, as appropriate, by association covenants, deed restrictions, and/or conservation easements.
We specifically request information, views, and opinions from the public on our proposed Federal action, including identification of any other aspects of or impacts to the human environment not already identified in the EA prepared pursuant to the NEPA regulations at 40 CFR 1506.6. Further, we specifically solicit information regarding the adequacy of the HCP per 50 CFR parts 13 and 17.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The covered species historically occurred in the Richmond pine rockland habitats. Portions of the HCP covered area consist of pine rockland habitat that is either currently occupied by the covered species or suitable for restoration as habitat for the species.
We will evaluate the ITP application, including the HCP, and any comments we receive to determine whether the application meets the requirements of section 10(a)(1)(B) of the Act. We will also evaluate whether a section 10(a)(1)(B) ITP should be issued, as well as conduct an intra-Service consultation pursuant to section 7 of the Act. We will use the results of this consultation and the above findings in our final analysis to determine whether to issue the ITP. If we determine that the requirements are met, we will issue the ITP for incidental take of the covered species.
We provide this notice under section 10 of the Act (16 U.S.C. 1531
Bureau of Indian Affairs, Interior.
Notice.
This notice announces the extension of the Class III gaming compact between the Crow Creek Sioux Tribe and the State of South Dakota.
Effective March 23, 2017.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
An extension to an existing tribal-state Class III gaming compact does not require approval by the Secretary if the extension does not modify any other terms of the compact. 25 CFR 293.5. The Crow Creek Sioux Tribe and the State of South Dakota have reached an agreement to extend the expiration of their existing Tribal-State Class III gaming compact until June 28, 2017. This publishes notice of the new expiration date of the compact.
Bureau of Indian Affairs, Interior.
Notice.
This notice publishes the liquor ordinance of the Cowlitz Indian Tribe. The liquor ordinance regulates and controls the possession, sale, manufacture, and distribution of alcohol in conformity with the laws of the State of Washington. Enactment of this ordinance will help provide a source of revenue to strengthen Tribal government, provide for the economic viability of Tribal enterprises, and improve delivery of Tribal government services.
This code shall become effective March 23, 2017.
Mr. Greg Norton, Tribal Government Specialist, Northwest Regional Office, Bureau of Indian Affairs, 911 NE 11th Avenue, Portland, Oregon 97232, Telephone: (503) 231-6702, Fax: (503) 231-2201.
Pursuant to the Act of August 15, 1953, Public Law 83-277, 67 Stat. 586, 18 U.S.C. 1161, as interpreted by the Supreme Court in
This notice is published in accordance with the authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs. I certify that the Tribal Council of the Cowlitz Indian Tribe duly adopted the Cowlitz Tribal Liquor Ordinance by Ordinance No. 16-02 dated October 27, 2016.
This ordinance is enacted pursuant to the Act of August 15, 1953, 67 Stat. 586, codified at 18 U.S.C. 1161, by the authority of the Cowlitz Tribal Council enumerated in Article VIII of the Constitution of the Cowlitz Tribe of Indians to enact legislation and regulate activities of businesses operating on the Tribe's lands, and in conformity with applicable Washington State laws and all attendant agreements with the State of Washington.
The purpose of this ordinance is to regulate and control the possession, sale, manufacture, and distribution of liquor within the Tribe's reservation, trust lands, and all Indian Country as defined in 18 U.S.C. 1151, in order to permit alcohol sales by tribally owned and operated enterprises and lessees and at other tribally approved special events. The enactment of this ordinance will increase the ability of the Cowlitz Tribe to control the manufacture, distribution, sale, and possession of liquor on the Tribe's lands and will provide an important source of revenue for the continued operation and strengthening of the Cowlitz tribal government, the delivery of tribal governmental services, and the economic viability of tribal enterprises.
This shall be known as the “Cowlitz Tribal Liquor Ordinance” and shall be codified as Ordinance No. 16-02 of the Cowlitz Tribal Code.
This ordinance shall apply to all lands now or in the future under the governmental authority of the Tribe, including the Tribe's reservation, trust lands, and Indian Country as defined under 18 U.S.C. 1151.
By adopting this Ordinance, the Tribe hereby regulates the sale, manufacturing, distribution, possession, and consumption of liquor while ensuring that such activity conforms with applicable laws of the State of Washington as required by 18 U.S.C. 1161 and the United States.
The Tribal Council enacts this Ordinance, based on the following findings:
(a) The manufacture, distribution, possession, sale, and consumption of liquor in the Tribe's Indian Country are matters of special concern to the Tribe.
(b) Federal law currently prohibits the introduction of liquor into or manufacture of spirits in Indian Country, except as provided in 18 U.S.C. 1161, except in accordance with State law and the duly enacted law of the Tribe.
(c) The Cowlitz Tribe recognizes that a need exists for strict tribal regulation and control over liquor transactions within its lands because of the many potential problems associated with the unregulated or inadequately regulated manufacture, distribution, sale, possession, and consumption of liquor. The Tribal Council finds that tribal control and regulation of liquor is necessary to achieve maximum economic benefit to the Tribe, to protect the health and welfare of tribal members, and to address specific concerns relating to alcohol use on tribal lands.
(d) It is in the best interests of the Tribe to enact an ordinance governing liquor transactions on its lands.
As used in this ordinance, the following words shall have the following meanings unless the context clearly requires otherwise:
(a) “Alcohol” means that substance known as ethyl alcohol, hydrated oxide of ethyl, ethanol, or spirits of wine, which is commonly produced by the fermentation or distillation of grain, starch, molasses, or sugar, or other substances including all dilutions and mixtures of this substance from whatever source or by whatever process produced.
(b) “Beer” means any beverage such as beer, ale, lager beer, stout, and porter obtained by the alcoholic fermentation of an infusion or decoction of pure hops, or pure extract of hops and pure barley malt or other wholesome grain or cereal in pure water and containing not more than eight percent of alcohol by weight, and not less than one-half of one percent of alcohol by volume. For the purposes of this ordinance, any such beverage containing more than eight percent of alcohol by weight shall be referred to as “strong beer.”
(c) “Indian Country” means the Tribe's reservation, trust lands, and all other lands as defined in 18 U.S.C. 1151.
(d) “Liquor” includes the four varieties of liquor herein defined (alcohol, spirits, wine, and beer), includes all fermented, spirituous, vinous, or malt liquor or combinations thereof, and mixed liquor, a part of which is fermented, spirituous, vinous or malt liquor, or otherwise intoxicating; and every liquid or solid or semisolid or other substance, patented or not containing alcohol, spirits, wine, or beer, and all drinks or drinkable liquids and all preparations or mixtures capable of human consumption, and any liquid, semisolid, solid, or other substance, which contains more than one percent of alcohol by weight shall be conclusively deemed to be intoxicating. Liquor does not include confections or food products that contain one percent or less of alcohol by weight. “Malt Liquor” means beer, strong beer, ale, stout and porter.
(e) “Sale” and “Sell” includes exchange, barter and traffic; and also includes the selling or supplying or distributing by any means whatsoever of liquor, or of any liquid known or described as beer or by any name whatsoever commonly used to describe malt or brewed liquor or of wine by any person to any person.
(f) “Spirits” means any beverage, which contains alcohol obtained by distillation, including wines exceeding twenty-four percent of alcohol by weight.
(g) “State” means the State of Washington.
(h) “Tribal Council” means the Cowlitz Tribal Council, which is the governing body of the Tribe.
(i) “Tribe” means the Cowlitz Indian Tribe, a federally recognized sovereign Indian tribe.
(j) “Wine” means any alcoholic beverage obtained by fermentation of fruits, (grapes, berries, apples, et cetera) or other agricultural product containing sugar, to which any saccharine substances may have been added before, during or after fermentation, and containing not more than twenty-four percent of alcohol by volume, including sweet wines fortified with wine spirits, such as port, sherry, muscatel, and angelica, not exceeding twenty-four percent of alcohol by volume and not less than one-half of one percent of alcohol by volume. For purposes of this ordinance, any beverage containing no more than fourteen percent of alcohol by volume when bottled or packaged by the manufacturer shall be referred to as “table wine,” and any beverage containing alcohol in an amount more than fourteen percent by volume when bottled or packaged by the manufacturer shall be referred to as “fortified wine.” However, “fortified wine” shall not include: (i) Wines that are both sealed or capped by cork closure and aged two years or more; and (ii) wines that contain more than fourteen percent alcohol by volume solely as a result of the natural fermentation process and that have not been produced with the addition of wine spirits, brandy, or alcohol.
The introduction and possession of liquor shall be lawful within Indian Country, provided that such introduction or possession is in conformity with the laws of the Tribe and the applicable laws of and the Tribe's agreements with the State.
The sale of liquor shall be lawful within Indian Country, provided that such sales are in conformity with the laws of the Tribe and the applicable laws of and agreements with the State.
The manufacture of liquor shall be lawful within Indian Country, provided that such manufacture is in conformity with the laws of the Tribe and the applicable laws of and agreements with the State.
The legal age for possession or consumption of alcohol within Indian Country shall be the same as that of the State, which is currently 21 years. No person under the age of 21 years of age shall purchase, possess, or consume any liquor.
The Tribal Council shall have the power to establish procedures and standards for tribal licensing of liquor manufacture, distribution, and sale within Indian Country, including the setting of a license fee schedule, and shall have the power to publish and enforce such standards. For license applicants that are not tribally owned, no tribal license shall issue except upon showing of satisfactory proof that the applicant is duly licensed by the State. The fact that an applicant for a tribal license possesses a license issued by the State however shall not provide the applicant with an entitlement to a tribal license.
The Tribal Council shall have the power to develop, enact, promulgate, and enforce regulations as necessary for the enforcement of this Ordinance and to protect the public health, welfare, and safety of the Tribe, provided that all such regulations shall conform to and not be in conflict with any applicable tribal, Federal, or State law. Regulations enacted pursuant to this Ordinance may include provisions for suspension or revocation of tribal liquor licenses, reasonable search and seizure provisions, and civil and criminal penalties for violations of this Ordinance to the full extent permitted by Federal law and consistent with due process.
Tribal law enforcement personnel and security personnel duly authorized by the Tribal Council shall have the authority to enforce this Ordinance by confiscating any liquor sold, possessed, distributed, manufactured, or introduced within Indian Country in violation of this Ordinance or of any regulations duly adopted pursuant to this Ordinance.
The Tribal Council shall have the exclusive jurisdiction to hold hearings on violations of this Ordinance and any procedures or regulations adopted pursuant to this Ordinance; to promulgate appropriate procedures governing such hearings; to determine and enforce penalties or damages for violations of this Ordinance; and to delegate to a subordinate hearing officer or panel or to the Cowlitz Tribal Court the authority to take any or all of the foregoing actions on its behalf.
Nothing contained in this Statute is intended to, nor does in any way, limit or restrict the Tribe's ability to impose any tax upon the sale or consumption of alcohol. The Tribe retains the right to impose such taxes by appropriate statute to the full extent permitted by Federal law.
Nothing contained in this Ordinance is intended to, nor does in any way, limit, alter, restrict, or waive the sovereign immunity of the Tribe or any of its agencies, agents, or officials from unconsented suit or action of any kind.
All acts and transactions under this Ordinance shall be in conformity with the laws of the State to the extent required by 18 U.S.C. 1161 and with all Federal laws regarding liquor in Indian Country.
This Ordinance shall be effective as of the date on which the Secretary of the Interior certifies this Statute and publishes the same in the
All prior enactments of the Tribal Council, including tribal resolutions, policies, regulations, or statutes pertaining to the subject matter set forth in this Ordinance are hereby rescinded.
This Ordinance may only be amended pursuant to an amendment duly enacted by the Tribal Council and certification by the Secretary of the Interior and publication in the
If any part or provision of this Ordinance is held invalid, void, or unenforceable by a court of competent jurisdiction, such adjudication shall not be held to render such provisions inapplicable to other persons or circumstances. Further, the remainder of the Ordinance shall not be affected and shall continue to remain in full force and effect.
Bureau of Indian Affairs, Interior.
Notice.
This notice announces the extension of the Class III gaming compact between the Rosebud Sioux Tribe and the State of South Dakota.
Effective March 23, 2017.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
An extension to an existing tribal-state Class III gaming compact does not require approval by the Secretary if the extension does not modify any other terms of the compact. 25 CFR 293.5. The Rosebud Sioux Tribe and the State of South Dakota have reached an agreement to extend the expiration date of their existing Tribal-State Class III gaming compact to July 31, 2017. This publishes notice of the new expiration date of the compact.
United States International Trade Commission.
March 28, 2017 at 11:00 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 701-TA-318 and 731-TA-538 and 561 (Fourth Review) (Sulfanilic Acid from China and India). The Commission is currently scheduled to complete and file its determinations and views of the Commission by April 17, 2017.
5.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
United States International Trade Commission.
March 30, 2017 at 11:00 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Vote in Inv. No. 731-TA-1314 (Final) (Phosphor Copper from Korea). The Commission is currently scheduled to complete and file its determination and views of the Commission by April 17, 2017.
5.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Notice of registration.
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of controlled substances.
The companies listed below applied to be registered as manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices.
The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each of the company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed persons.
Notice of registration.
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
The companies listed below applied to be registered as importers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for these notices.
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I or II controlled substances to the above listed persons.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before April 24, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 24, 2017.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on February 2, 2017, Wildlife Laboratories, Inc., 1230 W. Ash Street, Suite D, Windsor, Colorado 80550-8055 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import the listed controlled substances for sale to its customers.
Notice.
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, “Federal-State Unemployment Insurance Program Data Exchange Standardization,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before April 24, 2017.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
44 U.S.C. 3507(a)(1)(D).
This ICR seeks to extend PRA authority for the Federal-State Unemployment Insurance Program Data Exchange Standardization information collection requirements codified in regulations 20 CFR parts 619 and 625. The Middle Class Tax Relief and Job Creation Act of 2012 required the ETA to use eXtensible Markup Language as a data exchange standard. The regulatory provisions require a State to implement this standard for automated systems that exchange electronic information to support the Unemployment Insurance system. These automated systems, developed through a collaborative effort with states and the National Association of Workforce Agencies, have replaced manual paper processing with automated exchanges of information between states as well as those between states and employers. Social Security Act section 911authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on March 31, 2017. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
Advisory Committee for Engineering #1170.
April 18, 2017; 12:15 p.m. to 5:30 p.m. April 19, 2017; 8:30 a.m. to 12:50 p.m.
National Science Foundation, 4201 Wilson Boulevard, Room 1235, Arlington, Virginia 22230.
Open.
Evette Rollins, National Science Foundation, 4201 Wilson Boulevard, Suite 505, Arlington, Virginia 22230; 703-292-8300.
To provide advice, recommendations and counsel on major goals and policies pertaining to engineering programs and activities.
In accordance with the Federal Advisory Committee Act (Pub., L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
Please contact Rachel Evans at
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment No. 60 to Combined Licenses (COL), NPF-93 and NPF-94. The COLs were issued to South Carolina Electric & Gas Company on behalf of itself and the South Carolina Public Service Authority (both hereafter called the licensee); for construction and operation of the Virgil C. Summer Nuclear Station (VCSNS), Units 2 and 3, located in Fairfield County, South Carolina.
The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
The exemption and amendment were issued on February 9, 2017.
Please refer to Docket ID NRC-2008-0441 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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Paul Kallan, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2809; email:
The NRC is granting an exemption from paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the
Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license
Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VCSNS Units 2 and 3 (COLs NPF-93 and NPF-94). The exemption documents for VCSNS Units 2 and 3 can be found in ADAMS under Accession Nos. ML17027A255 and ML17027A266, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-93 and NPF-94 are available in ADAMS under Accession Nos. ML17027A245 and ML17027A252, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption document issued to VCSNS Units 2 and Unit 3. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:
1. In a letter dated October 24, 2016, the licensee requested from the Commission an exemption from the provisions of 10 CFR part 52, appendix D, Section III.B, as part of license amendment request 16-17, “Qualified Data Processing System and Safety Display Description (LAR 16-17).”
For the reasons set forth in Section 3.1, “Evaluation of Exemption,” of the NRC staff's Safety Evaluation, which can be found in ADAMS under Accession No. ML17027A292, the Commission finds that:
A. The exemption is authorized by law;
B. the exemption presents no undue risk to public health and safety;
C. the exemption is consistent with the common defense and security;
D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and
F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.
2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined Licenses as described in the licensee's request dated October 24, 2016. This exemption is related to, and necessary for, the granting of License Amendment No. 60, which is being issued concurrently with this exemption.
3. As explained in Section 5.0, “Environmental Consideration,” of the NRC staff's Safety Evaluation (ADAMS Accession No. ML17027A292), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.
4. This exemption is effective as of the date of its issuance.
By letter dated October 24, 2016, the licensee requested that the NRC amend the COLs for VCSNS, Units 2 and 3, COLs NPF-93 and NPF-94. The proposed amendment is described in Section I of this
The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that the licensee requested on October 24, 2016. The exemption and amendment were issued on February 9, 2017, as part of a combined package to the licensee (ADAMS Accession No. ML17027A223).
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment No. 61 to Combined Licenses (COLs), NPF-91 and NPF-92. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, Authority of Georgia, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia.
The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
The exemption and amendment were issued on December 22, 2016.
Please refer to Docket ID NRC-2008-0252 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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Chandu Patel, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3025; email:
The NRC is granting an exemption from Paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the
The amendment authorizes changes to the VEGP Units 3 and 4 UFSAR: (1) To add two additional hydrogen igniters to the in-containment refueling water storage tank roof vents; (2) to remove control of the hydrogen igniters from the protection and safety monitoring system; (3) to clarify the controls available for the hydrogen igniters at the remote shutdown workstation; and (4) to make changes to the design aspects of the hydrogen igniters to maintain consistency within various licensing documents. Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemption met all applicable regulatory criteria set forth in 10 CFR 50.12, 10 CFR 52.7, and Section VIII.A.4 of appendix D to 10 CFR part 52. The license amendment was found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML16096A449.
Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML16096A431 and ML16096A433, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML16096A424 and ML16096A427, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption document issued to VEGP Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:
1. In a letter dated February 6, 2015, and supplemented by letter dated September 15, 2015, the licensee requested from the Commission an exemption to allow departures from Tier 1 information in the certified DCD incorporated by reference in 10 CFR part 52, appendix D, as part of license amendment request 15-003, “Containment Hydrogen Igniter Changes.”
For the reasons set forth in Section 3.1 of the NRC staff's Safety Evaluation, which can be found in ADAMS under Accession No. ML16096A449, the Commission finds that:
A. The exemption is authorized by law;
B. the exemption presents no undue risk to public health and safety;
C. the exemption is consistent with the common defense and security;
D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and
F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.
2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information related to hydrogen igniter, as described in the licensee's request dated February 6, 2015, and supplemented by letter dated September 15, 2015. This exemption is related to, and necessary for the granting of License Amendment No. 61, which is being issued concurrently with this exemption.
3. As explained in Section 5.0 of the NRC staff's Safety Evaluation (ADAMS Accession No. ML16096A449), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.
4. This exemption is effective as of the date of its issuance.
By letter dated February 6, 2015 (ADAMS Accession No. ML15037A715), as supplemented by letter dated September 15, 2015 (ADAMS Accession No. ML15258A555), the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this document.
The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations.
A notice of consideration of issuance of amendment to facility operating license or COL, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
A request for a hearing was filed on May 2, 2016, by the Blue Ridge Environmental Defense League (“BREDL”) and its chapter, Concerned Citizens of Shell Bluff (ADAMS Accession No. ML16124B062). The Atomic Safety and Licensing Board (ASLB) denied BREDL's request for hearing in an order dated September 16, 2016 (ADAMS Accession No. ML16259A157). Subsequently, on October 11, 2016, BREDL appealed the ASLB decision (ADAMS Accession No. ML16285A548). On February 16, 2017, the Commission affirmed the ASLB's decision (ADAMS Accession No. ML17047A149).
Under its regulations, the Commission may issue and make an amendment immediately effective, notwithstanding the pendency before it of a request for a hearing from any person, in advance of the holding and completion of any required hearing, where it has made a final determination that no significant hazards consideration is involved.
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that the licensee requested on February 6, 2015, and supplemented by letter dated September 15, 2015. The exemption and amendment were issued on December 22, 2016, as part of a combined package to the licensee (ADAMS Accession No. ML16096A345).
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Renewal of existing information collection; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, NRC Form 749, “Manual License Verification Report.”
Submit comments by May 22, 2017. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2016-0183 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2016-0183 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized below.
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The NRC is seeking comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the estimate of the burden of the information collection accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment No. 66 to Combined Licenses (COLs), NPF-91 and NPF-92. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, Authority of Georgia, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia.
The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
The exemption and amendment were issued on January 19, 2017.
Please refer to Docket ID NRC-2008-0252 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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Chandu Patel, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3025; email:
The NRC is granting an exemption from Paragraph B of Section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to
Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML16320A277 and ML16320A282, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML16320A258 and ML16320A265, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption document issued to VEGP Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:
1. In a letter dated July 25, 2016, as supplemented by letters dated September 23, 2016, and October 13, 2016, the licensee requested from the Commission an exemption to allow departures from Tier 1 information in the certified DCD incorporated by reference in 10 CFR part 52, Appendix D, as part of license amendment request 16-010, “Nuclear Instrumentation System Excore Detector Surface Material Inspection Clarification.”
For the reasons set forth in Section 3.1 of the NRC staff's Safety Evaluation, which can be found at ADAMS Accession No. ML16320A370, the Commission finds that:
A. The exemption is authorized by law;
B. the exemption presents no undue risk to public health and safety;
C. the exemption is consistent with the common defense and security;
D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and
F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.
2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined Licenses as described in the licensee's request dated July 25, 2016, as supplemented by letters dated September 23, 2016, and October 13, 2016. This exemption is related to, and necessary for the granting of License Amendment No. 66, which is being issued concurrently with this exemption.
3. As explained in Section 5.0 of the NRC staff's Safety Evaluation (ADAMS Accession No. ML16320A370), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.
4. This exemption is effective as of the date of its issuance.
By letter dated July 25, 2016 (ADAMS Accession No. ML16207A496), and supplemented by the letters dated September 23, 2016 (ADAMS Accession No. ML16267A429), and October 13, 2016 (ADAMS Accession No. ML16287A662), the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this document.
The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or COL, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that the licensee requested on July 25, 2016, as supplemented by letters dated September 23, 2016, and October 13, 2016. The exemption and amendment were issued on January 19, 2017, as part of a combined package to the licensee (ADAMS Accession No. ML16320A230).
For the Nuclear Regulatory Commission.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend Exchange Rules Rule 517A, Aggregate Risk Manager for EEMs (“ARM-E”), and 517B, Aggregate Risk Manager for Market Makers (“ARM-M”).
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Exchange Rules 517A, ARM-E, and 517B, ARM-M by adopting and adding proposed Interpretations and Policies .01 to Rule 517A to state that the MIAX PEARL System
ARM-E protects MIAX PEARL EEMs and assists them in managing risk by maintaining a counting program (“EEM Counting Program”) for each participating EEM who has submitted an order in an EEM Specified Option Class
The EEM may also establish for each EEM Specified Option Class an EEM Allowable Engagement Percentage (the “Allowable Engagement Percentage”), which is a number of contracts, divided by the size of the orders, executed within the Specified Time Period, equal to or over which the ARM-E will be triggered. When an execution of an EEM ARM Contract from an EEM ARM Eligible Order occurs, the System will look back over the EEM Specified Time Period to determine whether the sum of contract executions from such EEM ARM Eligible Order during such EEM Specified Time Period triggers the ARM-E.
The System will engage ARM-E in a particular EEM Specified Option Class when the EEM Counting Program has determined that an EEM has executed during the EEM Specified Time Period a number of EEM ARM Contracts from an EEM ARM Eligible Order equal to or above their EEM Allowable Engagement Percentage. ARM-E will then, until the EEM sends a notification to the System of the intent to reengage and submits a new order in the EEM Specified Option Class: (i) Automatically cancel the EEM ARM Eligible Orders in all series of that particular EEM Specified Option Class and (ii) reject new orders by the EEM in all series of that particular EEM Specified Option Class submitted using the MEO Interface
ARM-M protects MIAX PEARL Market Makers and assists them in managing risk by maintaining a counting program (“MM Counting Program”) for each Market Maker who has submitted an order in an option class (an “MM Option Class”) delivered via the MEO Interface (an “MM ARM Eligible Order”). The MM Counting Program counts the number of contracts executed by a Market Maker from an MM ARM Eligible Order (the “MM ARM Contracts”) within a specified time period that has been established by the Market Maker or as a default setting, as defined below (the “MM Specified Time Period”). The MM Specified Time Period cannot exceed 15 seconds whether established by the Market Maker or as a default setting as described below.
The Market Maker may also establish for each MM Option Class an MM Allowable Engagement Percentage. Unlike ARM-E, under which there is no default setting, the Exchange will establish a default MM Specified Time
The System will engage ARM-M in a particular MM Option Class when the MM Counting Program has determined that a Market Maker has executed during the MM Specified Time Period a number of MM ARM Contracts from an MM ARM Eligible Order equal to or above their MM Allowable Engagement Percentage. ARM-M will then, until the Market Maker sends a notification to the System of the intent to reengage and submits a new order in the MM Option Class: (i) Automatically cancel the MM ARM Eligible Orders in all series of that particular MM Option Class and (ii) reject new orders by the Market Maker in all series of that particular MM Option Class submitted using the MEO Interface.
The Exchange is proposing to adopt and add Interpretations and Policies .01 to Rule 517A, to state that the System will not include in a specific EEM's EEM Counting Program contracts executed as a result of an IOC order submitted by such EEM.
In a parallel proposal, the Exchange is also proposing to adopt and add Interpretations and Policies .02 to Rule 517B, to state that the System will not include in a specific Market Maker's MM Counting Program contracts executed as a result of an IOC submitted by such Market Maker.
ARM-E and ARM-M are designed to assist MIAX PEARL EEMs and Market Makers in managing their risk associated with liquidity they send to the Exchange. Thus, the EEM and MM Counting Programs will include all contracts executed from orders, other than those orders designated as IOC, whether the EEM or MM is acting as maker or taker, in the calculation of the Allowable Engagement Percentage applicable to the affected EEM Specified Option Class or Market Maker in the MM Option Class.
If, however, the same EEM or Market Maker submits an IOC order in the EEM Specified Option Class or MM Option Class that is executed against another order resting on the MIAX PEARL Book, the number of contracts executed from such IOC order would not be included in the calculation of the submitting EEM or Market Maker's Allowable Engagement Percentage in the EEM Specified Option Class or MM Option Class, as applicable. In such a situation, the affected EEM or Market Maker is not at any undue or unintended risk caused by the EEM or Market Maker's submission of the IOC order.
The number of contracts executed from an order resting on the Book, is, however, included in the calculation of the Allowable Engagement Percentage applicable to the EEM or Market Maker that submitted that order. A resting order is subject to the risk of exposure that ARM-E and ARM-M are designed to mitigate. Therefore the Exchange believes that it is reasonable to include contracts executed from a resting order, which has a longer time-in-force than an IOC order and is thus a greater risk than an IOC order submitted for execution against it. Additionally, in the case of a partial execution, the remaining contracts in a resting order are still at market risk, while remaining contracts from the partial execution of an IOC order are cancelled if not executed, thus obviating the need for ARM-E or ARM-M protection. Conversely, in the Exchange's experience, an IOC order is an order that is designed to target specific, identifiable liquidity resting on the Book that the entering Member desires to trade with (remove), and thus the Member entering the IOC order does not require the risk management protection of the ARM, as the Member entering the IOC order made an affirmative decision to attempt to executed that transaction.
The Exchange therefore believes that the inclusion of the number of contracts executed by way of an IOC order submitted by an EEM or Market Maker would unnecessarily and artificially inflate the calculation of the Allowable Engagement Percentage, and thus ARM-E or ARM-M could serve to preclude or prevent the further execution of contracts from orders resting on the MIAX PEARL Book (for which ARM-E or ARM-M has been triggered unnecessarily by an IOC order they submitted) that were submitted by the affected EEM or Market Maker and otherwise remain intended for execution.
The purpose of the proposed rule change is to enable individual EEMs and Market Makers to enhance their risk management for an individual option class or for multiple classes as market conditions warrant, based on their own risk tolerance level and order submission or quoting behavior. EEMs and Market Makers will be able to more precisely customize their risk management within the MIAX PEARL System through the use of IOC orders without triggering ARM-E or ARM-M before their actual risk tolerance levels relating to the number of contracts executed within a specified time period have been reached. The proposed rule change will provide greater ability for EEMs and Market Makers to adapt more exact and precise risk controls based on the EEM or Market Maker's risk tolerance levels.
The Exchange notes that the proposed rule is similar to a rule that is currently operative on MIAX Options (“MIAX Options”). Specifically, Interpretations and Policies .01 to MIAX Options Rule 612, Aggregate Risk Manager, states that the System does not include contracts traded through the use of an eQuote
The inclusion of the number of contracts executed by way of an IOC order, which is substantially similar to an IOC eQuote with respect to its time-in-force, would unnecessarily and artificially inflate the calculation of the Allowable Engagement Percentage in ARM-E and ARM-M in the same manner in which an IOC eQuote affects the ARM calculation on MIAX Options. This is a similar rationale for the instant proposal to exclude IOC orders on MIAX PEARL from the calculation of the Allowable Engagement Percentage in ARM-E and ARM-M.
The Exchange will announce the implementation date of the proposed rule change by Regulatory Circular to be published no later than 60 days following the operative date of the proposed rule. The implementation date will be no later than 60 days following the issuance of the Regulatory Circular.
MIAX PEARL believes that its proposed rule change is consistent with Section 6(b) of the Act
Significantly, the proposed rule change removes impediments to and perfects the mechanisms of a free and open market and a national market system and, in general, protects investors and the public interest because it enhances a risk management tool that is currently available to MIAX PEARL EEMs and Market Makers. The exclusion of contracts executed from IOC orders submitted by an EEM or Market Maker from the calculation of their Allowable Engagement Percentage will enable MIAX PEARL EEMs and Market Makers to more efficiently tailor the risk management tools provided by the Exchange by ensuring them that contracts executed from orders that are not part of their risk management strategy will not artificially inflate their Allowable Engagement Percentage. This tailored approach further protects investors and the public interest by enabling the maximum number of contracts in an EEM Specified Option Class or an MM Option Class to be executed without unnecessary interruption, all within the EEM or Market Maker's risk tolerance level based upon the actual Allowable Engagement Percentage.
As stated above, the proposed exclusion of IOC orders from the calculation of the Allowable Engagement Percentage is substantially similar to the exclusion of IOC eQuotes from that calculation in the MIAX Options ARM protection feature.
The exclusion of the number of contracts executed by way of IOC orders from the calculation of the Allowable Engagement Percentage also serves to remove impediments to and perfect the mechanisms of a free and open market and a national market system by enhancing EEMs' and Market Makers' confidence in the Exchange's ability to assist them in the accurate measuring of their management of risk, which may result in deeper liquidity on the Exchange's Book, serving to benefit and protect investors and the public interest.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
On the contrary, the Exchange believes that the proposed rule change will foster competition by providing Exchange EEMs and Market Makers with the ability to enhance and specifically customize their use of the Exchange's risk management tools in order to compete for executions and order flow.
As to inter-market competition, the Exchange believes that the proposed rule change should promote competition because it is designed to provide Exchange EEMs and Market Makers with accuracy and flexibility to modify their risk exposure in order to protect them from unusual market conditions or events that may increase their exposure in the market.
For all the reasons stated, the Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, and believes the proposed change will in fact enhance competition.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The principal purpose of the changes is to modify certain aspects of ICE Clear Europe's CDS End-of-Day Price Discovery Policy (the “EOD Price Discovery Policy”).
In its filing with the Commission, ICE Clear Europe included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICE Clear Europe has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the rule change is to incorporate certain enhancements to the EOD Price Discovery Policy. These revisions do not require any changes to the ICE Clear Europe Clearing Rules.
ICE Clear Europe proposes revising its EOD Price Discovery Policy to implement a new direct price submission process for Clearing Members. Currently, ICE Clear Europe uses an intermediary agent to implement functions of its price discovery process. Under the current process, Clearing Members make required price submissions to the intermediary agent. These prices are then input into ICE Clear Europe's price settlement methodology to determine settlement prices. ICE Clear Europe is proposing to remove the intermediary agent from the price settlement process. In doing so, ICE Clear Europe will require Clearing Members to submit prices directly to the clearing house. The prices will continue to be input into ICE Clear Europe's price settlement methodology to determine settlement prices. ICE Clear Europe is not otherwise changing the price settlement methodology itself.
The proposed revisions to the EOD Price Discovery Policy are described in detail as follows: Under the revised policy, ICE Clear Europe requires Clearing Members to establish direct connectivity with the clearing house and use a FIX API to submit required prices. ICE Clear Europe is revising the EOD Price Discovery Policy to remove references to the intermediary agent and the Valuation Service API (and related message terminology), which will be decommissioned with the launch of the new Clearing Member direct price submission process. The revisions also add references to the new FIX API message terminology which will be utilized under the new Clearing Member direct price submission process. Such changes are reflected throughout the EOD Price Discovery Policy. ICE Clear Europe has also updated the EOD Price Discovery Policy to specify that ICE Clear Europe will send the unsolicited FIX API messages directly to each Clearing Member.
Under the new Clearing Member direct price submission process, ICE Clear Europe will consolidate the price discovery process across index and single-name CDS. As such, new FIX API messages will include information for both index and single-name CDS. Previously, the price discovery process provided files separately for each product type. ICE Clear Europe has also updated the submission requirements for the CDX.NA.HY index to note that prices may be submitted in either price or upfront format; previously, only price format was accepted.
ICE Clear Europe has updated the EOD Price Discovery Policy to reflect the replacement of existing firm trade data files with new FIX API firm trade messages. ICE Clear Europe also made minor changes to the timings of certain steps in the price settlement process; no changes were made to the actual settlement submission windows.
ICE Clear Europe has also updated the process for distribution of end-of-day prices set forth in the EOD Price Discovery Policy. Under the new process, ICE Clear Europe will publish separate messages for Clearing Members, listing end-of-day prices for single-name and index CDS. The end-of-day prices provided will not change and will continue to be based on a Clearing Members' cleared positions. ICE Clear Europe will continue to publish end-of-day prices for every listed risk sub-factor's most actively traded instrument, and to distribute daily end-of-day prices for all cleared instruments through Markit.
ICE Clear Europe believes that the changes described herein are consistent with the requirements of Section 17A of the Act
ICE Clear Europe does not believe the proposed changes to the rules would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purpose of the Act. ICE Clear Europe is adopting the amendments to the EOD Price Discovery Policy in order to enhance certain aspects of the price discovery process. The amendments will apply uniformly across all Clearing Members, and will not change the nature of information to be submitted by Clearing Members. ICE Clear Europe does not believe the amendments would materially affect the cost of clearing, adversely affect access to clearing in CDS Contracts for Clearing Members or their customers, or otherwise adversely affect competition in clearing services. As a result, ICE Clear Europe does not believe that the amendments would impose any impact or burden on competition that is not appropriate in furtherance of the purpose of the Act.
Written comments relating to the proposed changes to the rules have not been solicited or received. ICE Clear Europe will notify the Commission of any written comments received by ICE Clear Europe.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, security-based swap submission or advance notice is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2017-003 and should be submitted on or before April 13, 2017.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On December 1, 2016, the Chicago Board Options Exchange, Incorporated (the “Exchange” or “CBOE”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons and to institute proceedings under Section 19(b)(2)(B) of the Exchange Act
According to the Exchange, currently, if a transaction executed on the trading floor is executed at a price that violates the priority and allocation provisions of 6.45A(b) and 6.45B(b) (“Book Priority”) or the trade-through prohibitions set forth in CBOE Rule 6.81 (“Trade-Through”), the Exchange enforces the violations against both parties to the transaction.
The Exchange observes that generally, Floor Brokers initiate transactions on the Exchange's trading floor by representing orders and executing the orders against bids and offers of other in-crowd market participants, including Market-Makers.
The Exchange represents that this rule change, consistent with the Options Intermarket Linkage Plan,
As previously noted, the Commission received two comment letters on the proposed rule change, and a response from CBOE.
One commenter suggests that the Exchange explain how PAR operates, and how the Exchange validates trades and conducts surveillances for purposes of regulating Book Priority and Trade-Through violations.
Other commenters (in a joint letter submitted by nine CBOE market participants) support the proposal and assert that the proposed rule change seeks to assign responsibility for ensuring compliance with open outcry priority and allocation requirements and trade-through prohibitions in a “fair, reasonable, and logical manner,” particularly in the case of an open-outcry trade initiated by a Floor Broker and responded to by a Market-Maker, because Market-Makers “generally lack access to” the tools and alerts CBOE offers to Floor Brokers that help assure compliance with those rules.
In its response letter, the Exchange asserts that the Nasdaq Letter does not address the substance of the proposal but rather offers general comment regarding open outcry trading.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Exchange Act
Pursuant to Section 19(b)(2)(B) of the Exchange Act,
The Commission also is instituting proceedings to allow for additional analysis and input concerning the proposed rule change's consistency with Section 6(b)(5) of the Exchange Act,
Specifically, the Commission is concerned whether the proposed rule change could adversely impact the ability of the Exchange, consistent with Section 6(b)(1) of the Exchange Act, to comply, and to enforce compliance by its members on the CBOE trading floor, with applicable rules and regulations, including the Book Priority and Trade-Through provisions. In particular, the Commission wishes to consider further whether CBOE has sufficiently demonstrated how absolving from liability for Book Priority and Trade-Through rule violations one party to a trade (
Further, the Exchange's stated justification for its proposal, which relies on the control an initiator has over the execution and price of the order as well as the fact that CBOE supplies its Floor Brokers with a system (PAR) that helps automate the necessary pre-trade checks, appears inconsistent with continuing to hold
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues identified above, as well as any other concerns they may have with the proposal. In particular, the Commission invites the written views of interested persons concerning whether the proposal is consistent with Sections 6(b)(1), 6(b)(5), or any other provision of the Exchange Act, or the rules and regulations thereunder. Although there do not appear to be any issues relevant to approval or disapproval that would be facilitated by an oral presentation of views, data, and arguments, the Commission will consider, pursuant to Rule 19b-4, any request for an
Interested persons are invited to submit written data, views, and arguments regarding whether the proposal should be approved or disapproved by April 13, 2017. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by April 27, 2017. The Commission asks that commenters address the sufficiency of the Exchange's statements in support of the proposal, in addition to any other comments they may wish to submit about the proposed rule change.
Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend its Schedule of Fees to allow members to opt in to MORP for specific sessions rather than on a member-wide basis, and to increase MORP rebates for members that participate in the program.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On April 1, 2015, the Exchange launched the Member Order Routing Program (“MORP”),
Currently, to be eligible to participate in MORP, an Electronic Access Member (“EAM”) must: (1) Provide to its clients, systems that enable the electronic routing of option orders to all of the U.S. options exchanges, including ISE; (2) interface with ISE to access the Exchange's electronic options trading platform; (3) offer to its clients a customized interface and routing functionality such that ISE will be the default destination for all unsolicited
Importantly, today an EAM must opt in to MORP for all of its business, and cannot segment its business to be eligible for MORP for only specific portion of its order flow. This means that EAMs that would otherwise have a MORP qualifying business would be prohibited from participating in the program if certain segments of its business are not eligible for the program. The Exchange therefore proposes to increase the scope of MORP. In particular, the Exchange proposes to allow EAMs to opt in to MORP for specific sessions so that firms can appropriately segment their order flow such that sessions designated as MORP eligible can benefit from the program even though the firm may not qualify on a member-wide basis.
Currently, an EAM that is MORP eligible receives a rebate for all unsolicited Crossing Orders of $0.05 per originating contract side, provided that the member executes a minimum average daily volume (“ADV”) in unsolicited Crossing Orders of at least 30,000 originating contract sides. This rebate is increased to $0.07 per originating contract side, provided that the member executes a higher ADV in unsolicited Crossing Orders of 100,000 originating contract sides.
In addition, any EAM that qualifies for the MORP rebate by executing an ADV of 30,000 originating contract sides or more is also eligible for increased Facilitation and Solicitation break-up rebates
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange believes the proposed change to the MORP qualifications is reasonable and equitable because it is designed to make it easier for EAMs to participate in the program. Currently, an EAM that wishes to participate in MORP must be eligible to participate across the entire firm. Thus, firms that have business segments that are not MORP-eligible cannot participate with respect to those business segments that are. The Exchange believes that the proposed rule change will allow firms to participate in the program if they meet the requirements with respect to any segment of their order flow. This will encourage order routing firms to execute additional unsolicited Crossing Order volume on the Exchange, and will benefit all market participants on ISE by creating additional liquidity and increased opportunity to trade. In addition, the Exchange believes that the proposed change is not unfairly discriminatory as it would make it easier for firms to participate in the program, thus potentially sharing the
The Exchange believes the proposed increases to MORP rebates, including the rebate for unsolicited Crossing Orders, and the Facilitation and Solicitation break-up rebate, are reasonable and equitable because these changes are designed to incentivize additional participation in the program. Under MORP the Exchange currently provides enhanced rebates to EAMs that connect directly to the Exchange and provide their clients with order routing functionality that includes all U.S. options exchanges, including ISE. The Exchange proposes to increase the rebates to incentivize additional firms to participate in the program, and to encourage firms to send additional order flow to the Exchange in order to benefit from the increased rebates. The Exchange believes that the proposed rebates will be attractive to members to opt in to MORP, and are competitive with rebates provided on other options exchanges. In addition, the Exchange believes that the proposed rebates are not unfairly discriminatory as they apply to all EAMs that meet the program requirements and opt in to the program. Any EAM that participates in the program will be provided the increased rebates on an equal and non-discriminatory basis based on the order flow executed on the Exchange. While MORP is targeted towards unsolicited Crossing Order flow, the Exchange offers other incentive programs to promote and encourage growth in other business areas. For example, solicited Crossing Orders benefit from the QCC and Solicitation Rebate, which applies to all QCC and/or other solicited Crossing Orders, including solicited orders executed in the Solicitation, Facilitation or Price Improvement Mechanisms. The Exchange believes that MORP is appropriately tailored to the order flow that the Exchange is seeking to attract, and will benefit all market participants that trade on ISE by encouraging additional liquidity.
In accordance with Section 6(b)(8) of the Act,
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 27, 2017, NYSE MKT LLC (the “Exchange” or “NYSE MKT”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission is extending the 45-day time period for Commission action on the proposed rule change. The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider and take action on the Exchange's proposed rule change.
Accordingly, pursuant to Section 19(b)(2) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to (i) request the decommission of “Tick-Worse” functionality and (ii) amend Rule 713 (Priority of Quotes and Orders) relating to the priority of split price transactions.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to (i) decommission the “Tick-Worse” functionality and (ii) amend Rule 713 (Priority of Quotes and Orders) as it relates to the priority of split price transactions. The proposed changes are discussed below.
The Exchange currently provides market makers
Due to the lack of demand for the Tick-Worse feature, the Exchange proposes to decommission the use of this functionality as it migrates symbols to INET no later than in July 31, 2017.
The Exchange is proposing to delete ISE Rule 713(f), which relates to the priority of split price transactions, because this priority rule currently only applies in the context of the Tick-Worse functionality, as described above, which the Exchange proposes to decommission. The Exchange proposes to delete this rule no later than July 31, 2017, along with the decommissioning of the Tick-Worse functionality.
ISE Rule 713(f) provides that if a Member purchases (sells) one (1) or more options contracts of a particular series at a particular price, it shall at the next lower (higher) price at which there are Professional Orders or market maker quotes, have priority over such Professional Orders and market maker quotes in purchasing (selling) up to the equivalent number of options contracts of the same series that it purchased (sold) at the higher (lower) price, but only if the purchase (sale) so effected represents the opposite side of a transaction with the same offer (bid) as the earlier purchase (sale). Although the language of Rule 713(f) is more general, the Exchange's intent was to apply split price priority solely to the Tick-Worse functionality.
The Exchange represents that Tick-Worse has historically only ever applied in the context of the split price priority rule in ISE Rule 713(f). Furthermore, the Exchange has historically only ever awarded priority pursuant to ISE Rule 713(f) for split price transactions that occur in the Tick-Worse functionality, and the existing rule should have been clarified to more accurately reflect its current application. Nonetheless, the Exchange is now proposing to delete the rule text in its entirety along with decommissioning the Tick-Worse functionality, as proposed above.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
As noted above, the Exchange originally offered Tick-Worse as an optional feature to help market makers meet their continuous quoting obligations under the Exchange's rules. The Exchange believes that its proposal is consistent with the Act because it has found that the Tick-Worse feature is rarely used today
As discussed above, the Exchange originally offered Tick-Worse as an optional feature to help market makers meet their continuous quoting obligations under the Exchange's rules. The Exchange has found, however, that the Tick-Worse feature is rarely used today as almost all market makers use their own systems to send refreshed quotations when their displayed quotations are exhausted. The Exchange therefore believes that decommissioning Tick-Worse and providing advance notice to its members, is consistent with the Act because it eliminates any investor uncertainty related to the status of this functionality.
The Exchange also believes that its proposal to delete the split price priority rule in Rule 713(f) protects investors and the public interest because it removes rule text that became obsolete with the decommission of the Tick-Worse functionality. As described above, the split price priority rule only applies to the Tick-Worse functionality. Because the Rule is more general than its current, specific application, however, the Exchange believes that the continued presence of Rule 713(f) in its rules even after retiring the Tick-Worse functionality will be confusing to its members and investors. By removing obsolete rule text that only applies in the context of Tick-Worse, the Exchange is eliminating any potential for confusion about how its systems operate.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is not designed to have any competitive impact but rather request the decommission of a rarely-used functionality on the Exchange and relatedly, to remove the rule text that this functionality supports from the Exchange's rulebook, thereby reducing investor confusion and making the Exchange's rules easier to understand and navigate.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 6.80 to make permanent a program that allows transactions to take place at a price that is below $1 per option contract. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend Rule 6.80 to make permanent a program that allows transactions to take place at a price that is below $1 per option contract.
An “accommodation” or “cabinet” trade refers to trades in listed options on the Exchange that are worthless or not actively traded. Trading is generally conducted in accordance with Exchange Rules, except as provided in Exchange Rule 6.80, Accommodation Transactions (Cabinet Trades), which sets forth specific procedures for engaging in cabinet trades.
Rule 6.80 currently provides that cabinet transactions at a price of $1 per option contract to occur via open outcry in any options series open for trading on the Exchange, except option classes participating in the Penny Pilot Program.
The Exchange amended the cabinet procedures to allow transactions to take place in open outcry at a price of at least $0 but less than $1 per option contract. This amendment expires on July 5, 2017. These lower-priced transactions are permitted to be traded pursuant to the same procedures applicable to $1 cabinet trades, except that (i) bids and offers for opening transactions are permitted only to accommodate closing transactions, and (ii) transactions in option classes participating in the Penny Pilot Program are permitted. The Exchange believes that allowing a price of at least $0 but less than $1 better accommodates the closing of options positions in series that are worthless or not actively traded, particularly when there has been a significant move in the price of the underlying security, resulting in a large number of series being out-of-the-money. For example, a market participant might have a long position in a put series with a strike price of $30 and the underlying stock might be trading at $100. In such an instance, there is likely no market to close-out the position, even at the $1 cabinet price.
As with other accommodation liquidations under Rule 6.80, transactions at prices less than $1 are not disseminated to the public on the consolidated tape. In addition, as with other accommodation liquidations under Rule 6.80, the transactions are exempt from the Consolidated Options Audit Trail (“COATS”) requirements of Exchange Rule 6.67, Order Format and System Entry Requirements. However, the Exchange maintains quotation, order and transaction information for such transactions in the same format as the COATS data is maintained. In this regard, all transactions for less than $1 must be reported to the Exchange following the close of each business day.
The Exchange notes that while the level of liquidation trades is not meaningful, such trades serve an essential purpose in that they allow market participants to close out options positions that are worthless or not actively trading. To illustrate, in 2016, there were a total of 558 Cabinet trades. Of these, 50 trades comprising 47,106 contracts were executed at a price of $0.01, while the remaining 508 trades comprising 208,078 contracts were executed for a premium of less than $0.01. The Exchange believes this level of trading demonstrates the benefit of the current program to market participants.
In support of making the program permanent, the Exchange represents that there are no operational issues in processing and clearing Cabinet trades in penny and sub-penny increments. Each Cabinet trade is input manually into the clearing system, and is then submitted for settlement at the Options Clearing Corporation. Additionally, OTP Holders and OTP Firms have not raised any concerns with the processing of Cabinet trades.
The Exchange believes that this proposed rule change is consistent with Section 6(b)
The Exchange believes that approving the program on a permanent basis is also consistent with the Act. With respect to the level of liquidation trades transacted on the Exchange, the Exchange believes that the data gathered provides meaningful support to make the program permanent.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that approving the program on a permanent basis will not impact competition, as it will continue to facilitate OTP Holders' ability to close positions in worthless or not actively traded series.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 968NY to make permanent a program that allows transactions to take place at a price that is below $1 per option contract. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend Rule 968NY to make permanent a program that allows transactions to take place at a price that is below $1 per option contract.
An “accommodation” or “cabinet” trade refers to trades in listed options on the Exchange that are worthless and typically not actively traded. Trading is generally conducted in accordance with Exchange Rules, except as provided in Exchange Rule 968NY, Accommodation Transactions (Cabinet Trades), which sets forth specific procedures for engaging in cabinet trades.
Rule 968NY currently provides that cabinet transactions at a price of $1 per option contract to occur via open outcry in any options series open for trading on the Exchange, except option classes participating in the Penny Pilot Program.
The Exchange has amended the cabinet procedures to allow transactions to take place in open outcry at a price of at least $0 but less than $1 per option
As with other accommodation liquidations under Rule 968NY, transactions at prices less than $1 are not disseminated to the public on the consolidated tape. In addition, as with other accommodation liquidations under Rule 968NY, the transactions are exempt from the Consolidated Options Audit Trail (“COATS”) requirements of Exchange Rule 955NY, Order Format and System Entry Requirements. However, the Exchange maintains quotation, order and transaction information for such transactions in the same format as the COATS data is maintained. In this regard, all transactions for less than $1 must be reported to the Exchange following the close of each business day.
The Exchange notes that while the level of liquidation trades are not meaningful, such trades serve an essential purpose in that they allow market participants to close out options positions that are worthless or not actively trading. To illustrate, in 2016, there were a total of 222 Cabinet trades. Of these, 148 trades comprising 112,257 contracts were executed at a price of $0.01, while the remaining 74 trades comprising 165,868 contracts were executed for a premium of less than $0.01. The Exchange believes this level of trading demonstrates the benefit of the current program to market participants.
In support of making the program permanent, the Exchange represents that there are no operational issues in processing and clearing Cabinet trades in penny and sub-penny increments. Each Cabinet trade is input manually into the clearing system, and is then submitted for settlement at the Options Clearing Corporation. Additionally, ATP Holders have not raised any concerns with the processing of Cabinet trades.
The Exchange believes that this proposed rule change is consistent with Section 6(b)
The Exchange believes that approving the program on a permanent basis is also consistent with the Act. With respect to the level of liquidation trades transacted on the Exchange, the Exchange believes that the data gathered provides meaningful support to make the program permanent.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that approving the program on a permanent basis will not impact competition, as it will continue to facilitate ATP Holders the ability to close positions in worthless or not actively traded series.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
The Advisory Panel to the U.S. Section of the North Pacific Anadromous Fish Commission will meet on May 3, 2017.
The meeting will take place via teleconference on May 3, 2017, from 4 p.m. to 5 p.m. Eastern time.
Colin Brinkman, Office of Marine Conservation. Telephone (202) 647-1952, email address
In accordance with the requirements of the Federal Advisory Committee Act, notice is given that the Advisory Panel to the U.S. Section of the North Pacific Anadromous Fish Commission (NPAFC) will meet on the date and time noted above. The panel consists of members from the states of Alaska and Washington who represent the broad range of fishing and conservation interests in anadromous and ecologically related species in the North Pacific. Certain members also represent relevant state and regional authorities. The panel was established in 1992 to advise the U.S. Section of the NPAFC on research needs and priorities for anadromous species, such as salmon, and ecologically related species occurring in the high seas of the North Pacific Ocean. The upcoming Panel meeting will focus on a review of the agenda for the 2017 annual meeting of the NPAFC (May 15-19, 2017; Victoria, Canada). Background material is available from the point of contact noted above and by visiting
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Norfolk Southern Railway Company (NSR) has filed a verified notice of exemption under 49 CFR part 1152, subpart F—
NSR has certified that: (1) No local traffic has moved over the Line for at least two years; (2) no overhead traffic has moved over the Line for at least two years and overhead traffic, if there were any, could be rerouted over other lines; (3) no formal complaint filed by a user of rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line either is pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of complainant within the two-year period; and (4) the requirements at 49 CFR 1105.7(c) and 1105.8(c) (environmental and historic report), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this exemption will become effective on April 22, 2017, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues,
A copy of any petition filed with the Board should be sent to NSR's representative: William A. Mullins, Baker & Miller PLLC, 2401 Pennsylvania Ave. NW., Suite 300, Washington, DC 20037.
If the verified notice contains false or misleading information, the exemption is void ab initio.
NSR has filed a combined environmental and historic report that addresses the effects, if any, of the abandonment on the environment and historic resources. OEA will issue an environmental assessment (EA) by March 28, 2017. Interested persons may obtain a copy of the EA by writing to OEA (Room 1100, Surface Transportation Board, Washington, DC 20423-0001) or by calling OEA at (202) 245-0305. Assistance for the hearing impaired is available through the Federal Information Relay Service at (800) 877-8339. Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or interim trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), NSR shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the Line. If consummation has not been effected by NSR's filing of a notice of consummation by March 23, 2018, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Federal Aviation Administration, DOT.
Notice of record of decision.
The Federal Aviation Administration (FAA) announces its decision to adopt the Department of the Navy's (DoN) Environmental Assessment/Overseas Environmental Assessment (EA/OEA) for the Mariana Islands Range Complex Airspace. In accordance with the National Environmental Policy Act of 1969 (“NEPA”), the Council on Environmental Quality's (“CEQ”) regulations implementing NEPA, and other applicable authorities, including the Federal Aviation Administration (FAA) Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 8-2, and FAA Order JO 7400.2K, “Procedures for Handling Airspace Matters,” paragraph 32-2-3, the FAA has conducted an independent review and evaluation of the DoN's Final Mariana Islands Range Complex (MIRC) Airspace EA/OEA dated June 2013. As a cooperating agency with responsibility for approving special use airspace the FAA provided subject matter expertise and closely coordinated with the DoN during the environmental review process, including preparation of the Draft EA/OEA and the Final EA/OEA. Based on its independent review and evaluation, the FAA has determined the Final EA/OEA, including its supporting documentation, as incorporated by reference, and other supporting documentation incorporated by reference for FAA's Written Re-Evaluation and Adoption of Final EA/OEA, adequately assesses and discloses the environmental impacts of the for Mariana Islands Range Complex Airspace, and that adoption of the Final EA/OEA by the FAA is authorized by regulation. FAA included the Written Re-Evaluation as part of the Adoption and FONSI-ROD because the DoN's FONSI is more than three years old. Accordingly, the FAA adopts the Final EA/OEA, and takes full responsibility for the scope and content that addresses the proposed changes to Special Use Airspace for MIRC.
Paula Miller, Airspace Policy and Regulations Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-7378.
In December 2012, in accordance with the National Environmental Policy Act and its implementing regulations, the DoN released a Draft EA/OEA. The Draft EA/OEA presented the potential environmental consequences of the DoN's proposal to establish Special Use Airspace to support Navy training activities that involve the use of advanced weapons systems. The DoN is the proponent for the MIRC Airspace and is the lead agency for the preparation of the EA/OEA, and the DoN issued their FONSI on June 15, 2013. As a result of public, agency, and tribal comments during the 46-day public comment period from December 20, 2012 through February 4, 2013 on the Draft EA/OEA, and the FAA aeronautical review process, the DoN, FAA, other federal and state agencies, and tribal governments have consulted to mitigate concerns while continuing to meet national defense training requirements. The FAA is a cooperating agency responsible for approving Special Use Airspace as defined in 40 CFR 1508.5.
The FAA is establishing Restricted Area 7201A and Warning Areas 11, 12, and 13. The MIRC legal descriptions have been modified to identify the correct US Territory from the description in the Notice of Proposed Rulemaking published in the
The Written Re-evaluation, the Adoption, and FONSI-ROD for the changes to the MIRC Airspace constitutes a final order of the FAA Administrator and is subject to exclusive judicial review under 49 U.S.C. 46110 by the U.S. Circuit Court of Appeals for the District of Columbia or the U.S. Circuit Court of Appeals for the circuit in which the person contesting the decision resides or has its principal place of business. Any party having substantial interest in this order may apply for review of the decision by filing a petition for review in the appropriate U.S. Court of Appeals no later than 60 days after the order is issued in accordance with the provisions of 49 U.S.C. 46110.
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of regulations. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number involved and must be received on or before April 12, 2017.
You may send comments identified by docket number FAA-2016-7647 using any of the following methods:
•
•
•
•
Deana Stedman, ANM-113, Federal Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356, email
This notice is published pursuant to 14 CFR 11.85.
Federal Highway Administration (FHWA), DOT.
Notice of extension of nomination deadline.
The FHWA is announcing the extension of the deadline for nomination applications for the Motorcyclist Advisory Council (MAC) until April 15, 2017.
The deadline for nominations for MAC membership is extended to April 15, 2017.
All nomination materials should be emailed to
Mr. Michael Griffith, Office of Safety, (202) 366-9469 or
The FHWA published its notice establishing the MAC and soliciting nominations for
The U.S. Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the Community Development Financial Institutions Fund (CDFI Fund), U.S. Department of the Treasury, is soliciting comments concerning the Annual Certification and Data Collection Report Form.
Written comments must be received on or before May 22, 2017 to be assured of consideration.
Submit your comments via email to Tanya McInnis, Certification, Compliance Monitoring and Evaluation (CCME) Acting Program Manager, CDFI Fund, at
Tanya McInnis, Acting CCME Program Manager, CDFI Fund, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW., Washington, DC 20220. Other information regarding the CDFI Fund and its programs may be obtained through the CDFI Fund's Web site at
Pub. L. 104-13; 12 CFR 1805; 12 CFR 1806; 12 CFR 1807; 12 CFR 1808.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning Form 1099-S, Proceeds from Real Estate Transactions.
Written comments should be received on or before May 22, 2017 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Martha R. Brinson, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Request For Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning Form 1116, Foreign Tax Credit (Individual, Estate, or Trust).
Written comments should be received on or before May 22, 2017 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Sara Covington, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
On October 8, 2014, the former Deputy Assistant Administrator of the then-Office of Diversion Control, issued an Order to Show Cause to Wesley Pope, M.D. (hereinafter, Respondent), of Newcastle, Oklahoma. ALJ Ex. 1, at 1. The Show Cause Order proposed the denial of Respondent's application for a new Certificate of Registration as a practitioner in schedules II through V, on the ground that his registration would be “inconsistent with the public interest.”
As support for the proposed denial, the Government alleged that “[f]rom on or about August 25, 2011 through on or about May 9, 2012, [Respondent] issued controlled substance prescriptions to [patient] B.B. in violation of Federal and Oklahoma . . . law.”
Respondent requested a hearing on the allegations. The matter was then placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). Following pre-hearing procedures, the CALJ conducted a hearing on April 7-8, 2015 in Oklahoma City, Oklahoma. During the hearing, both parties submitted documentary evidence; the Government elicited the testimony of several witnesses and Respondent testified on his own behalf.
On July 24, 2015, the CALJ issued his Recommended Decision (cited as R.D.). Therein, the CALJ found that the allegations were sustained only with respect to five of the dates on which Respondent prescribed (and with respect to four of these dates, only sustained in part).
The Government filed Exceptions to the Recommended Decision and Respondent filed a Response to the Government's Exceptions. Thereafter, the record was forwarded to my Office for Final Agency Action.
Having considered the record in its entirety including the Recommended Decision, the Government's Exceptions, and Respondent's Response to the Government's Exceptions, I agree with the CALJ's findings and legal conclusion with respect to the first prescribing event (August 25, 2011). While I agree with the CALJ's legal conclusions that Respondent acted outside of the usual course of professional practice when he prescribed controlled substances during the third, fourth, tenth, eleventh, and twelfth prescribing events, I hold that several of the exceptions raised by the Government are well taken and that additional relevant evidence should be considered in review of the record. Based on my consideration of the record as a whole, I, as the ultimate fact-finder, conclude that a preponderance of the evidence supports the conclusions that Respondent knowingly diverted controlled substances by issuing prescriptions in violation of 21 CFR 1306.04(a) when he prescribed various schedule II controlled substances on 11 occasions, beginning on September 22, 2011 and ending on May 9, 2012.
I further find that Respondent's misconduct is egregious and establishes a
In its Exceptions, the Government raises multiple contentions, several of which warrant discussion prior to making factual findings. The first of these is that the CALJ erroneously concluded that the Oklahoma Medical Board's Standards “on which the Government relied were permissive rather than mandatory.” Exceptions, at 5. Indeed, in making his legal conclusions, the CALJ repeatedly declined to give weight to the Government Expert's testimony on material issues, reasoning that the Expert's testimony was premised on his misunderstanding that the Board's regulations, in particular its documentation and recordkeeping rules, were mandatory rather than permissive.
Second, the Government maintains that the CALJ erroneously held that the Government failed to provide adequate notice to Respondent of its intent to rely on the various aberrant drug tests as part of its proof that various prescriptions were issued in violation of 21 CFR 1306.04(a). With respect to this exception, the Government argues that not only did it provide adequate notice, the aberrant nature of the various urine drug screens (UDS) was litigated by consent. Exceptions, at 15-25. It also takes exception to the CALJ's finding
Throughout his Recommended Decision, the CALJ repeatedly declined to give weight to the Government Expert's testimony that Respondent failed to conduct a medically adequate evaluation of B.B.'s pain complaint and establish medical necessity to justify the prescribing of controlled substances. The basis of the CALJ's reasoning was that the deficiencies identified by the Expert “generally relate to a paucity of documented proof in the chart entries as to whether or how much various medical treatment considerations that he favors were considered by the Respondent in making his prescription decision.” R.D. at 35. Based on his conclusion that the provisions of the Oklahoma Board's rules applicable to a physician's documentation of his evaluation of a patient and recordkeeping are “permissive” and not mandatory, the CALJ reasoned that “Respondent's alleged lack of documentation . . . is likely not as fatal to the Respondent's adherence to the standard of care in Oklahoma as the Government expert claims.” R.D. 16. I disagree.
With respect to the evaluation of the patient, the Oklahoma Rule states:
A medical history and physical examination must be obtained, evaluated and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
The CALJ, however, cited no authority from either the Board or the Oklahoma courts definitively interpreting the word “should” as used in the context of these two provisions as “permissive.”
However, when the Board promulgated the current version of the rule in 2005, it simply noted that “[t]he rule is being updated based on recommendations from the Federation of State Medical Boards.” 22 Okla. Reg. 2096 (June 15, 2005);
Furthermore, although the word “should” is susceptible to different meanings, when used in the context of legal requirements, it generally does not connote “permission” but rather obligation or duty.
Moreover, reading the Board's documentation and recordkeeping provisions as permissive cannot be squared with the Oklahoma Medical Practice Act.
Thus, construing the Board's documentation and recordkeeping rules as permissive would be fundamentally inconsistent with the Medical Practice Act's provisions on documentation and recordkeeping, which are clearly mandatory.
Accordingly, the Board's Intractable Pain Rule's documentation and recordkeeping provisions are not
In its Policy Statement, the Board also stated that it “will judge the validity of the physician's treatment of the patient based on available documentation.”
Accordingly, I do not agree that the Government Expert's testimony as to the deficiencies in Respondent's evaluations of B.B. was based on the Expert's mistaken understanding of the scope of the Oklahoma Board's documentation and recordkeeping standards. Thus, while I fully agree with the CALJ that the Expert's “testimony predictably raised no issues regarding credibility,” I disagree with the CALJ's assertion that the Expert's “testimony was not without its own `red flags.' ” R.D. 18. I therefore find that this exception is well taken.
Throughout his Recommended Decision, the CALJ repeatedly declined to consider the Government's evidence that Respondent failed to address an aberrant urine drug screen which showed that his patient B.B. was not taking a controlled substance that had been prescribed to him.
At issue in footnote 28 of
While the Decision noted that the Government had not identified the specific subsection of 1306.04 which it alleged was violated, it did not hold that the “notice was deemed insufficient.” R.D. 66. Indeed, while the Decision rejected the Government's contention that the pharmacist acted outside of the usual course of professional practice in violation of 1306.04(a) and 1306.06 for lack of evidence, 80 FR at 29064, and further noted that 1306.04(c) “impose[s] duties only on the issuer of [a] prescription which has been issued to provide maintenance or detoxification purposes,”
Indeed, notwithstanding that the Government cited the wrong provision of the regulations, the respondent's principal did not dispute that her conduct in filling these prescriptions was a violation.
The CALJ further asserted that “[i]n
Apparently, the CALJ's assertion refers to the Agency's declination to find that the respondent's conduct in intercepting a pharmacist's phone calls (who questioned the validity of a prescription the respondent had created for herself by forging the signature of the purported prescriber) constituted actionable misconduct under factor five. 21 U.S.C. 823(f)(5). This factor provides for liability based on “such other conduct which may threaten public health and safety.”
Significantly, the Show Cause Order made no such allegation, and while the Government disclosed in its pre-hearing statement that it intended to elicit testimony from the pharmacist regarding his attempt to verify the prescription after it was rejected for payment by respondent's insurer, at no point in the proceedings did the Government rely on the evidence other than as proof that the “[r]espondent illegally obtained hydrocodone on eleven occasions.”
Thus, contrary to the CALJ's statement, the Government never relied on this conduct as a separate “violation of the public interest factors.” R.D. at 66. Nor could it have, as the public interest factors do not impose substantive rules of conduct but are simply “components of the public interest” that “shall be considered” in determining whether to grant an application for a registration.
The CALJ also held that the Government could not rely on this evidence under the doctrine of litigation by consent—even though Respondent never objected to the Expert's testimony that the June 1 (and other tests) were aberrant and that Respondent failed to properly address the aberrant results—asserting that the Government had the duty to “timely and affirmatively raise[] . . . this theory” and failed to do so.
Here, by contrast, the Government has taken exception to the CALJ's rulings that the issue has not been litigated by consent.
“The primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior.”
Accordingly, even where the Government fails to disclose an allegation in the Order to Show Cause, “an issue can be litigated if the Government otherwise timely notifies a [r]espondent of its intent to litigate the issue.”
To be sure, “[a]n agency may not base its decision upon an issue the parties tried inadvertently. Implied consent is not established merely because one party introduced evidence relevant to an unpleaded issue and the opposing party failed to object to its introduction. It must appear that the parties understood the evidence to be aimed at the unpleaded issue.”
Having reviewed the record, I find the Government's exception well taken and hold that the Government provided Respondent with adequate notice that both the aberrant nature of the June 1 drug test and his failure to address it would be at issue throughout the proceeding. Moreover, even if the Government failed to specifically reference the June 1 test by date in the Show Cause Order (and Pre-hearing Statements) with respect to several of the prescriptions, Respondent had adequate notice that it was at issue throughout the proceeding and indeed, had a full and fair opportunity to litigate the issue.
The Show Cause Order repeatedly provided notice that the aberrant nature of B.B.'s June 1 UDS and Respondent's failure to address it would be at issue in the proceeding. For example, paragraph 3 of the Show Cause order alleged that “[f]rom on or about
In the allegations regarding the August 25, 2011 prescriptions, the Show Cause Order provided a detailed recitation of the factual basis for the allegation that the June 1, 2011 UDS was aberrant and that this “should have indicated . . . that B.B. may have been misusing/abusing the alprazolam by consuming more than he had been prescribed, or diverting it.”
In setting forth the allegations with respect to the October 6 and 20 prescriptions, the Show Cause Order alleged that “[y]ou still did not address with B.B.
Likewise, in its Pre-hearing Statement, the Government provided notice that “Dr. Owen [its Expert] will testify that [Respondent] should have been aware from documentation in B.B.'s file of red flags that B.B. may have been abusing or diverting controlled substances prior to transferring his treatment to” Respondent (the period in which the June 1 UDS was obtained), as well as notice setting forth the factual basis as for why the June 1 UDS was aberrant. ALJ Ex. 5, at 10, 12-13. With respect to the September 22, 2011 prescriptions, the Pre-hearing Statement provided notice that the medical file shows that Respondent “never addressed with B.B. this now second aberrant UDS in an approximately three month period, despite noting in the record that [he] had `extensively reviewed' B.B.'s past medical history” and that Respondent “took no other steps to monitor B.B.'s controlled substance use, such as requiring him to take another UDS
Moreover, with respect to the October 6 prescriptions, the Pre-hearing Statement provided notice that “Dr. Owen will testify that on this visit [Respondent] again failed to address with B.B. the two aberrant UDSs,” and with respect to the October 20, 2011 prescriptions, “the record lacks documentation that . . . he confronted B.B.
Thus, the Show Cause Order's allegations and the Pre-Hearing Statement's disclosure of the expected testimony provided Respondent with more than adequate notice that the results of the June 1, 2011 UDS and his failure to address it would be at issue throughout the proceeding. And even if I concluded otherwise, the record is clear that the issue was litigated by consent.
Notably, during its direct examination of Dr. Owen regarding the September 22, 2011 prescriptions, the Government asked Dr. Owen the following questions:
Q. Would the aberrant urine drug test from June 1 have shown up in a review of the history?
A. Yes.
Q. Would the aberrant drug test from August 25, 2011, have shown up in the history?
A. Yes.
Q. And were those aberrant drug tests part of this medical file as you received it?
A. Yes, it [sic] was.
Q. What—how does [Respondent] address the aberrant drug tests in this 9/22 patient file note[]?
A. It's [sic] completely ignored.
Q. What steps should [Respondent] have taken regarding the aberrant drug screens?
A. He should have acknowledged their existence and then taken some corrective action.
. . . .
Q. Does it appear that [Respondent] took any safeguard regarding the potential for diversion or abuse with the aberrant drug screens?
A. No.
Tr. 132-33.
Notably, Respondent did not object to any of this testimony.
Indeed, Respondent's counsel raised the issue when, in Respondent's case-in-chief, she asked him: `Do you recall if you looked back at the previous drug tests?”
Subsequently, on its cross-examination of Respondent with respect to what he looked at in the chart when he took over B.B.'s care, the Government asked: “Did you see the June 1, 2011, UD[S], urine drug test?”
Thus, Respondent was clearly aware that his failure to address the June 1, 2011 drug test was at issue with respect to the entirety of his controlled substance prescribing to B.B. and in no sense was this “an incidental issue” in the case.
Based on the preponderance of the evidence, I make the following findings.
Respondent is a family practice physician licensed by the Oklahoma State Board of Medical Licensure and Supervision. RX 1. Respondent graduated from the University of Oklahoma (OU) College of Medicine in 1989. Tr. 231. Thereafter, he did an internship through the OU “Tulsa/Bartlesville program” and “the last two years of his residency” in family medicine at OU in Oklahoma City.
Respondent testified that upon completing his residency, he practiced family medicine and obstetrics for several years at several rural clinics.
Respondent testified that due to the expense of malpractice insurance for his OB/GYN activities, he stopped delivering babies and focused on family medicine.
Respondent testified that he did drug screens “every three months” and that any patient who received more than two Lortabs (hydrocodone with acetaminophen) a day would be subject to “the guidelines of our pain management contract and rules.”
Respondent came to the attention of the authorities on or about May 10, 2012, when police in Norman, Oklahoma found Respondent's patient B.B., a 27-year old male (RX 3, at 2), who was “semiconscious” and “appeared to be intoxicated” in a vehicle parked “in the center median of” Interstate-35. Tr. 18; RX 3, at 2. The police also found “several prescription bottles of opiate pain killers” which had been prescribed to B.B. by Respondent. RX 3, at 2-3; Tr. 18. With B.B.'s consent, the police searched his cell phone and found text messages that “indicated that [B.B.] was illegally buying and selling prescriptions drugs,” as well as messages between B.B. and Respondent related to B.B.'s “medical care, prescription dosages and prescriptions to be picked up by” B.B. RX 3, at 3. In addition, the police found “numerous sexually explicit messages” that had been exchanged between Respondent's phone and B.B.
In the meantime, the Chief Investigator, who was familiar with Respondent's background because the latter “was on probation at that time for an incident that involved sexual misconduct,” obtained a report from the Oklahoma Bureau of Narcotics Prescription Monitoring Program to “see any prescriptions that were prescribed by [Respondent] to” B.B.
After reviewing the PMP report, the Chief Investigator notified the Board's Executive Director of his findings,
On May 11, 2012, the DI and two Detectives interviewed B.B., who “confirmed that he was” Respondent's patient.
On that day, the Chief Investigator (accompanied by another Board Investigator), the DI and the lead Detective went to Respondent's clinic to interview him.
On September 13, 2012, the Board lifted Respondent's suspension.
Thereafter, a Diversion Investigator obtained a copy of B.B.'s patient file from the Board and provided it to Graves Owen, M.D., an expert in pain management, to review and determine whether Respondent lawfully issued the controlled substance prescriptions. Tr. 50-52, 55. The DI testified that he did not ask Dr. Owen to come to any specific conclusion and that Dr. Owen's compensation was not contingent on the conclusions he drew.
Dr. Owen obtained a Bachelor of Science in chemistry and biology from Texas State University in 1985 and a Doctor of Medicine from the University of Texas Health Science Center (Houston) in 1990.
Dr. Owen's work experience includes more than 16 years at the Texas Pain Rehabilitation Institute (Sept. 1995 through Nov. 2011), which is an interdisciplinary pain management clinic.
While Dr. Owen is licensed to practice medicine in Texas, he testified that he had reviewed Oklahoma's guidelines and policies.
The Government then asked Dr. Owen “what else is required?”
Subsequently, Dr. Owen explained that “there [are] three broad treatments in pain management: Interventional, rehabilitative, and pharmaceutical. So your treatment plan would list each of these categories if you're going to use elements of those categories in your treatment plan, and it would specifically define what your treatment plan is and how you tie it to your treatment goal.”
Subsequently, Dr. Owen testified that a treatment plan can involve more than one of these approaches and that it evolves over the course of treating the patient if the treatment goals are not being achieved.
Well, if it's interventional, you would talk about what intervention you're going to do. If it's rehabilitative, you'd talk about physical therapy, occupational therapy or psychotherapy. If it's pharmaceutical, you're going to talk about the specific pharmaceutical, its dose and the frequency that you're going to prescribe it and hopefully the indication it's being used for.
Asked whether the file for a patient being prescribed opioid controlled substances would contain anything else, Dr. Owen testified that you would “have an informed consent and a pain management agreement.”
As to why a physician treating a patient for pain would seek consultation with other specialists, Dr. Owen testified that “[t]hese are complex cases, and you can't be an expert of everything, and you may need help in narrowing your diagnosis or help in stabilizing comorbidities that are outside of your scope of practice.”
Asked by the Government if “these requirements . . . are . . . best practices,” Dr. Owen testified that “some of them can be best practices, but most of them are standard of care items.”
Well, I'm not a lawyer. I would say that the policies and guidelines that I was sent for Oklahoma say certain things about consultations, and the one that stood out is if somebody's a complex pain patient with psychological or psychiatric comorbidities, they should get consultations with a pain management physician with expertise in these complex cases.
Dr. Owen testified that “comorbid psychiatric conditions” include “depression, anxiety, maladaptive coping mechanisms, such as catastrophization, fear avoidance, disability conviction, and a sense of injustice,” which are “all built on a foundation of cognitive distortions.”
The CALJ then asked Dr. Owen if the reason it is important to refer a pain patient to a mental health expert is so that the patient's “subjective complaint[] of pain” can be “properly gauged?”
The CALJ then asked Dr. Owen if “ask[ing] the patient about activities of daily living” is “one of the tools that you use?”
Dr. Owen was then asked to describe “the steps that a practitioner would take to determine whether a patient is truly experiencing chronic pain?”
Well, there's no objective way to know if somebody [is] experiencing pain, so you take them for their word at it. But what you need to do is to make sure that you go through a process to ensure that they have exhausted all the medically reasonable treatments before you go to a high-risk, non-evidence-based treatment.
Dr. Owen further explained that “[h]igh-risk treatments are treatments that have a potential for bad outcomes, and there's evidence-based and non-evidence-based treatments. There's low-risk, medium-risk, and high-risk treatments, and you have to have some context for how you approach the problem.”
Asked whether it is “permissible to taken on a patient who's already on high-risk treatment and to continue them on high-risk treatment,” Dr. Owen testified that while a physician “can do that,” the physician must “adequately document the justification for skipping steps,”
Next, the CALJ asked Dr. Owen what, as a chronic pain specialist, he would look at to determine if a patient who was referred to him was being successfully treated with long-term opioid therapy.
The CALJ then asked Dr. Owen if there are “tests that are traditionally done in the office, such as . . . range of motion and other things . . . that have an objective sense to them?”
Next, the CALJ asked Dr. Owen if on taking over a long-term opioid therapy patient, it is “generally true that [the patient will be] continue[d] on the . . . regimen?”
Dr. Owen further testified that there is a difference between addiction and dependence.
Dr. Owen then explained that a physician “would use urine drug testing to see if [the patient] ha[s] all the drugs that were prescribed in [his] urine.”
While Dr. Owen acknowledged that the presence of suspicious behavior by a patient does not necessarily mean the patient is abusing or diverting controlled substances, it does require that the physician take “some type of corrective action.”
Dr. Owen disputed the CALJ's suggestion that the use of urine drug screens is “pretty controversial in the pain management field,” stating that “[i]t's a standard of care.”
Asked how a practitioner should respond to an aberrant drug test, Dr. Owen testified that “first you need to document the presence of the aberrant . . . test. You need to document your rationale for your corrective actions. And then you explain what the corrective action is going to be.”
Returning to the issue of what constitutes an adequate medical history, Dr. Owen testified that:
. . . it's a history that's appropriate for whatever the chief complaint is, for example, low back pain. It includes a who, what, when, why, where, and type of elements that you would do in most any kind of a journalism course.
So you'd say, how did you hurt yourself; where does it hurt; does the pain radiate down an extremity; if so, how far down; does it go past the knee; where does it end up; is there any numbness or weakness associated with it. And then you would talk about what treatments have you had or what diagnostics have you had.
And you'd gather as much of that information, and you'd ask . . . how's the pain affecting you physically and psychosocially. And that's part of the Oklahoma guidelines is that you assess the person functionally, physically and psychosocially.
Continuing, Dr. Owen explained that:
. . . if you don't do a proper history and a proper physical exam, if you don't look at all the pertinent previous medical records, you can't get an accurate diagnosis. And . . . you can't draw any accurate conclusions about what is the right treatment plan. And if you don't do accurate assessments, it results in potentially dangerous treatments that aren't reasonable or medically necessary.
Asked by the CALJ to explain what a pain management contract is, Dr. Owen testified that it's “a document informing the patient what the rules of the road are.”
On cross-examination, Dr. Owen was asked whether a prescriptive practice can “be within . . . legitimate medical practice and still be below the standard of care?”
On further cross-examination, Dr. Owen was asked whether the Oklahoma Guideline which addresses the need for consultation with an expert in the management of patients who have a history of substance abuse or a comorbid psychiatric disorder is mandatory as he had previously testified.
B.B.'s patient file reflects that from the date of his first visit on or about April 24, 2009 up until August 25, 2011, B.B. obtained narcotic prescriptions from Dr. Schoelen, Respondent's partner.
B.B. was not seen by either Dr. Schoelen or Respondent on this day. GX 3, at 49. However, he was required to provide a urine sample, the results of which were reported by the lab on August 29, 2011.
While the Government alleged in the Order to Show Cause that the prescriptions Respondent issued on this day were “invalid” and violated 21 CFR 1306.04(a) and made extensive factual allegations to support this conclusion, it did not elicit any testimony from its Expert as to why. Moreover, Respondent testified that this was “a nurse-only visit” and that he issued the prescriptions because “Dr. Schoelen works half [a] day” and while Schoelen had issued one of the prescriptions, “he had missed the fact that—or the nurses had missed and not written the other two medications for him.” Tr. 389. The CALJ found this testimony credible. R.D. at 31.
As the Government put forward no evidence to support the conclusion that it was outside of the usual course of professional practice for Respondent to cover for his partner, nor cites to any state rule prohibiting prescribing under this circumstance, I find that the allegation is unsupported by substantial evidence.
As noted above, the Government elicited no testimony from Dr. Owen as to whether Respondent's issuance of the prescriptions was below the standard of care or outside of the usual course of professional practice. Apparently, the Government relies on subsection 1 of the Board's chronic pain rule,
However, in 2014, the Board promulgated an exception to the requirement that “[t]he physician/patient relationship shall include a medically appropriate, timely-scheduled, face-to-face encounter with the patient,” which allows “providers covering the practice of another provider [to] approve refills of previously ordered medications if they have access to the medical file of the patient.” Okla. Admin. Code § 435:10-7-12(1). While this rule was not in effect when Respondent issued the prescriptions, it strains credulity to suggest that providing prescriptions under the circumstances of covering for a partner violated the standard of care two years earlier when Respondent issued the prescriptions. While the Government speculates that Dr. Schoelen “may not have issued B.B. these two prescriptions purposefully pending the results of the new UDS,” Exceptions at 46, and argues that Respondent was required to call Dr. Schoelen as a witness to corroborate his testimony, the Government ignores that it had the burden of proof on this issue.
On some date after August 25, 2011, the State Board suspended Dr. Schoelen's medical license and Respondent took over the treatment of B.B., who came for an office visit on September 22, 2011. Tr. 290; GX 3, at 48.
B.B.'s file also contains a Pain Management Treatment Plan, which includes a section bearing the caption: “Treatment Objective Evaluation.” GX 3, at 28. This form lists several questions, with boxes for documenting by date, various findings which included: “Has patient achieved treatment objective?”; “Patient completed . . . updated pain scale”; “Re-review benefits and risks of using medications”; “Consider referral to another physician for second opinion or further treatment options”; “Changes to Treatment Plan”; and the “[p]hysician's initials.”
On the form's second page, it asked “[w]hat side effects or symptoms are you having,” and directed B.B. to “[c]ircle the number that best describes your experience during the past week,” again using a 0 (“Barely Noticeable”) to 10 (“Severe Enough to Stop Medicine”) scale for 10 side effects and symptoms such as nausea, vomiting, constipation, lack of appetite, difficulty thinking and insomnia. And finally, the form directed B.B. to “[c]ircle the one number”—on a scale of 0 for “not [i]nterfer[ing]” to 10 for “[c]ompletely [i]nterfering”—which “describes how during the past week pain has interfered with” his “[g]eneral [a]ctivity,” “[m]ood,” “[n]ormal work,” “[s]leep,” “[e]njoyment of [l]ife,” “[a]bility to [c]oncentrate,” and “[r]elations with [o]ther [p]eople.”
Dr. Owen testified that because this was B.B.'s first visit with Respondent, Respondent should have “do[ne] a proper history and physical exam and review[ed] previous treatments and everything that typically is expected for a new patient evaluation.” Tr. 131. According to Dr. Owen, this included reviewing B.B.'s patient file which included the aberrant June 1 and August 25, 2011 drug tests.
With respect to the August 25 drug test, Dr. Owen testified that B.B. had previously received prescriptions for alprazolam, hydrocodone, Soma (carisoprodol) and oxymorphone.
Dr. Owen testified that Respondent “completely ignored” the aberrant drug screens and “should have acknowledged their existence and then taken some type of corrective action.”
Dr. Owen then testified that the patient record did not justify the prescribing of controlled substances as it did not “establish medical necessity for this type of treatment.”
For one, it's a superficial evaluation that doesn't adequately explain the chief complaint or what previous treatments have or have not been done. And there's no evaluation of pain or function, physical or psychosocial in the documentation. There's no evidence of a previous therapeutic benefit. There's no medical rationale for continuing with an ineffective treatment, so there's no justification to continue treatment with controlled substances.
On cross-examination, Dr. Owen was asked if he considered Respondent's ordering of an MRI at this visit to be “a safeguard.”
In response to a further question by the CALJ which posited whether an MRI would provide an objective basis such as “foraminal narrowing” or “spondylosis” for concluding that a patient “may be having a spine issue” and is not “making it up,” Dr. Owen explained that “foraminal stenosis or foraminal narrowing are common in asymptomatic people.”
Dr. Owen further noted that “almost all the exams” on B.B. “said it was negative straight leg raise” and that this is “the most sensitive physical finding for low back pain.”
Regarding B.B.'s September 22, 2011 visit and the prescriptions he issued, Respondent testified that the first thing he would do when entered the exam room is look at the Pain Management Treatment Plan (GX 3, at 28) after which he would “look[ ] at his previous notes.”
Asked with respect to the August 25 prescriptions if he “looked back at the previous drug tests,” Respondent answered: “I don't recall, but I doubt I did. . . . I wouldn't expect myself to.”
Respondent was then asked by his counsel if he looked back at the August 25 drug screen. Tr. 287. Respondent testified that he “would not” have discussed the results with B.B. because “[b]asically he was on all the medicines he was prescribed, and according to [the lab], if you're on one benzodiazepine, all the other benzodiazepines can appear positive within the drug screen.”
Respondent further testified that although he took over the care of B.B., he did not simply continue the same treatment that Dr. Schoelen provided.
Respondent also maintained that B.B.'s “reported pain and his objective” were consistent with the findings on physical examination.
As for why he ordered the MRI, Respondent testified that it was the “[s]tandard of care in Oklahoma,” and that while “[h]e had an X-ray done in 2009 that was consistent with his finding . . . [i]f you treat chronic pain . . . patients and [are] audited by the Board or your insurance company [and] you don't have an objective finding in the chart, such as X-rays and MRIs, you're quite . . . the outlier.”
On October 6, 2011, B.B. again saw Respondent. In the visit note, Respondent wrote: “Patient has been on the DURAGESIC 50 mcg and the OPANA. Now, he would like to try the Morphine. He is slowly trying to figure out the right regimen for him.” GX 3, at 47. Respondent again noted in the chart that “[p]ast medical history extensively reviewed and placed in chart.”
At the visit, Respondent prescribed 30 tablets of Morphine Sulfate ER15 mg B.I.D. (one tablet twice per day), for a 15-day supply. GX 5, at 25. Respondent also recommended that B.B. “[w]ear a corset if at all possible” for his hernia. GX 3, at 47.
Regarding the prescription, Dr. Owen testified (in the words of Government counsel) that it is not “normal practice . . . for patients to dictate the controlled substances they're prescribed.” Tr. 135. Asked “why not,” he explained that a physician must “safeguard the patient against addiction, and you need to do things that are medically necessary, not what patients want.”
Asked what steps Respondent should have taken, Dr. Owen testified that “just the fact that the aberrant urine drug tests were there means that you should get some consultations, because . . . this is a complex issue, and there's behaviors going on that you can't quite understand without a more thorough assessment by mental health providers or addictionologists.”
Here again, Dr. Owen testified that the medical record did not justify the prescribing of controlled substances.
Regarding this visit, Respondent testified that B.B. had “report[ed] that his objectives were only fair” and that “[h]is pain level had gone up to a 6 out of 10 on the Duragesic.”
As for the statement in the progress note that B.B. “would like to try the Morphine,” GX 3, at 47, Respondent testified that B.B. “did not believe the Duragesic was sufficient and that he wanted to try one of the other medicines that was on the formulary.” Tr. 296. Respondent testified that he did not believe this to be a “red flag” in B.B.'s case because he “had made it very clear to [B.B.] what our choices were” under the Medicaid formulary and “the majority of patients are very concerned [because] Duragesic and morphine are used for dying cancer patients, and why are we putting them on medications for dying.”
The CALJ, observing that “saying the patient requested morphine . . . is kind of a remarkable note,” asked Respondent how his conversation with B.B. went.
Respondent also testified that he had given B.B. a shot of Decadron, a steroid, which “sometimes” provides patients in “severe pain” with “significant relief” and is “a great indicator that [the patient's] pain was more inflammatory than other nature.”
B.B. again saw Respondent on October 20, 2011. GX 3, at 46. According to the progress note, B.B. reported that “his stress [was] up,” that he had “los[t] his father, and “he [was] having a lot of grief.”
As for the physical exam, Respondent noted that B.B. had “[l]ow back paraspinal and spinal tenderness” and a “[n]egative straight leg raise, but [that] lying down and sitting up cause him a lot of pain.”
With respect to the statement in the progress note that B.B. was having a lot of stress and grief, Dr. Owen testified that this “magnifies the perception of pain and disability” and that because there were previous “aberrant behaviors going on and now . . . another stressor in [B.B.'s] life,” this “increase[d] the risk” that B.B. would “use [the] drugs to chemically cope.” Tr. 139. Dr. Owen then explained that Respondent should have “sought psychological counseling for” B.B.
Dr. Owen also testified that Respondent's notation that “[n]onmedicinal pain-relieving modalities suggested” lacked sufficient detail before rhetorically asking: “What does that mean, nonmedicinal modalities suggested?”
Well, the purpose of documentation is for continuity of care. Not only continuity of care for this same provider from visit to visit but continuity of care should somebody else assume the care later on down the road or should you need to get a consultation, that the consultant can read your notes and understand what was happening with this patient at this point in time.
Regarding this visit, the CALJ asked Dr. Owen if Respondent's notation that “[n]egative straight leg raise, but lying down and sitting up causes him a lot of pain” had “any significance?”
Dr. Owen again testified that the medical record did not support the prescribing of controlled substances.
Respondent testified that the “most remarkable” thing in the October 20 progress note was that B.B.'s blood pressure had gone up and that B.B. was also “wanting to know about his MRI report.”
Continuing, Respondent testified that he diagnosed B.B. with acute grief and lumbar disc disease and that he increased his Morphine to two pills or 30 milligrams in the evening while keeping his Opana for breakthrough pain.
On October 21, 2011, the day after this visit, B.B. had an MRI done of his lumbar spine.
Regarding the MRI, Dr. Owen tested that it “did not show any specific problems that would be attributable for this kind of pain complaint[], nor was it significant to cause the perceived disability that this 26-year-old gentleman considers himself” to have. Tr. 207. And as he earlier testified in response to the CALJ's question as to whether an MRI would provide an objective basis such as “foraminal narrowing” or “spondylosis” for concluding that a patient “may be having a spine issue” and not “making it up,” Dr. Owen explained that “foraminal stenosis or foraminal narrowing are common in asymptomatic people.”
On November 18, 2011, Respondent wrote new prescriptions with the same dosing instructions for 90 Morphine Sulfate ER 15 mg and 120 Opana 10 mg; each of these was for a 30-day supply. GX 5, at 17, 21; GX 3, at 23. B.B. filled the prescriptions the same day. While B.B.'s file contains photocopies of the prescriptions, it contains no documentation of a visit with either Respondent or a nurse on this date.
Likewise, on December 15, 2011, Respondent wrote new prescriptions with the same dosing instructions for 90 Morphine Sulfate ER 15 mg and 120 Opana 10 mg, each of these being for a 30-day supply. GX 3, at 67, 90. Respondent filled these prescriptions the same day.
Dr. Owen testified that “[e]specially in the context of the previous aberrant urine drug testing and the lack of any clear medical necessity or therapeutic benefit,” Respondent “should have” seen B.B. in his office prior to prescribing the drugs on both dates. Tr. 142. Dr. Owen further testified that notwithstanding that at the October 20 visit, B.B. had reported that “his stress is up” and that “he [was] having a lot of grief,” there is no notation in B.B.'s file as to how B.B. was dealing with these issues.
After explaining that the aberrant drugs tests and mention of B.B.'s life stressors supported the need for psychological counselling and consultations with a psychologist or addictionologist, Dr. Owen was asked what risk was created by prescribing these drugs to B.B. without requiring an office visit.
On cross-examination, Dr. Owen was asked whether he was aware that under DEA's regulation which allows a physician to “issue multiple prescriptions authorizing the patient to receive . . . up to a 90-day supply of a schedule II controlled substance, provided [various] conditions are met,” “it was okay . . . to only see a patient once . . . every 90 days?”
Regarding these prescriptions, Respondent testified that he did not understand that he had to see B.B. “every 30 days” and that “[w]e saw him every 90 days.”
On January 19, 2012, B.B. again saw Respondent, who reported that he had gone to the emergency room “two weeks ago with right leg swelling” but that “[h]is ultrasound was negative.” GX 3, at 45. B.B. complained of “some calf pain” and that “[h]e still feels very tight.”
According to Respondent's exam notes, B.B. was “[a]lert and oriented and in no apparent distress.”
Respondent diagnosed B.B. with “lumbar disc disease,” “exposure to infectious disease,” and “[r]ight calf pain.”
At this visit, B.B. was required to provide a urine drug screen. While the results were not reported until January 31, 2012, the lab reported that morphine was “not detected” and that this result was “not expected with prescribed medications.” GX 3, at 97. Moreover, while the lab detected the presence of alpha-hydroxyalprazolam, a metabolite of alprazolam, the lab also detected the presence of nordiazepam, the metabolite of diazepam, as well as the presence of oxazepam, and temazepam.
Dr. Owen testified that while “oxazepam can be a metabolite of several other benzodiazepines,” this was an aberrant drug test because non-prescribed drugs were detected and prescribed drugs were not detected. Tr. 150-51. As for the drugs that were detected but were not prescribed, Dr. Owen testified that B.B. was either “getting [them] from the illicit . . . market or from a friend.”
Regarding this visit, Dr. Owen testified that when a patient reports having gone to the emergency room, he would get the record to find out both “what the problem was,” as well as if “any additional medication [was] prescribed.” Tr. 147. However, the patient file does not contain a note from the emergency room.
Regarding the prescriptions, Respondent testified that B.B. wanted refills and then testified as to what he had documented in the note.
Observing that the visit note “almost seems as if [B.B.] would be a person that's not in pain,” the CALJ asked: “doesn't it seem like an unremarkable set of . . . notes for such a high amount of painkillers?” Tr. 315. Respondent answered: “He just continued to have the same pain that he had before, so I didn't go into details on it.”
At this point, Respondent's attorney suggested that he had noted “his lumbar disc disease and “low back paraspinal tenderness” in the visit note, prompting Respondent to state: “[t]hat's correct. And he still had the negative straight leg raise.”
Moreover, when the CALJ asked if “[t]his note was more saying . . . that he's still maintaining an absence of at least an objective sign of radiculopathy,” Respondent answered: “[o]f radiculopathy, but not necessarily paraspinal or muscular-skeletal pain.” Tr. at 318-19. Upon further questioning by the CALJ as to his reason for noting the negative straight leg raise, Respondent agreed with the CALJ's suggestion that the reason for the note was to “more or less show that things [weren't] getting worse” and then added that “there was no change.”
Yet, at this visit, Respondent neither documented that B.B. had achieved his treatment objective nor indicated if he had completed an update pain scale on the Treatment Plan form.
According to the progress note for the January 27 visit, B.B. reported that he was “very anxious” about the price of the vaccine for HPV. GX 3, at 44. Respondent also documented that B.B.'s “[p]ast medical history [was] extensively reviewed and placed in chart and includes severe thoracic and lumbar pain.”
The CALJ also asked Respondent whether he thought the Jan. 27 visit note looked “very benign” if he was “really evaluating” the “efficacy of the pain [medication] regimen” as it only referred to B.B.'s “past history” of thoracic and lumbar pain.
The CALJ, explaining that the progress note did not “seem to discuss at all the underlying basis for the pain [medication] regimen” or the “activities of daily living or . . . function,” asked Respondent if “those [are] things that you would ordinarily include in there?”
Observing that the visit notes “don't tend to deal with activities of daily living or anything where you were
Subsequently, the CALJ asked Respondent how he knew “how the meds were doing?”
The CALJ then asked Respondent if he was not asking B.B. “questions about what activities he's doing or what's better or worse or what's causing him pain, then aren't you just depending on his subjective desire for more or less pain medicine?”
Well, I was talking to him about those things and what all he did in a day, and he was not able to work. He . . . didn't have a vehicle, I don't believe. I think that was a major issue for how he got his prescriptions or not. And so he basically was stuck in the house all day, trying to figure out how to stretch or how to do his exercises at home—he was pretty much homebound, taking care of his son.
On February 13, 2012, Respondent issued B.B. new prescriptions for both 120 Opana 10 and 90 Morphine Sulfate ER 15, with the same dosing instructions as the previous prescriptions. GX 5, at 3 & 23. As noted previously, the lab reported the results of the January 19, 2016 urine drug test on January 31, 2012, GX 3, at 97; and thus Respondent should have had the results by this date. Tr. 153. As explained previously, other than the undated notation on the Lab Report that B.B. was “counseled to only take what is prescribed,” the only documentation in the progress notes for this date (which is written at the bottom of the January 27, 2012 progress note) is the following: “Zpack, Prednisone 10 mg # 28, Phenergan.” GX 3, at 44.
Dr. Owen testified that there should have been an office visit “in light of the previous aberrant drug-taking behaviors and the lack of medical necessity [having been] established to treat with controlled substances.” Tr. 154. He further explained that Respondent “need[ed] to establish medical necessity and establish a therapeutic benefit, and now we have another aberrant drug test in late January.”
Moreover, Dr. Owen again found that the patient record did not justify the prescribing of controlled substances and further noted that the “medical necessity for the prescriptions ha[d] not been established in any of the previous evaluations.” Tr. 155. He further opined that the Opana and morphine prescriptions issued on this date lacked a legitimate medical purpose and were issued outside of the usual course of professional practice.
Respondent testified that he had reviewed the drug test results and had directed his staff to pull a PMP report.
[t]he red flag that I saw—the morphine said not detected, but the oxymorphone was positive, so that was explainable. The nordiazepam, the oxazepam, and then the Xanax, the lab always said that if . . . Xanax was positive, that they could all three be positive. The temazepam, in our practice, usually didn't show up, and temazepam is a sleeping pill called Restoril.
And so I wanted to pull the chart, and so Dr. Schoelen didn't mind his pain patients being on Restoril. I did, and so I wanted to make sure, has he been prescribed Restoril. I couldn't find it on the PMP, so I'm sure what was told was, if you have an old Restoril or some other doctor, I do consider that breaking our rules, and so you can't take it.
Notably, while the PMP report shows that B.B. had received a number of prescriptions for Ambien (zolpidem), it does not list any prescriptions for temazepam. GX 3, at 22-26. Nor do the progress notes during the period in which B.B. was being treated by Dr. Schoelen contain any indication that Schoelen had prescribed temazepam to B.B.
Asked by the CALJ why he did not find the non-detection of morphine to be “an anomaly,” Respondent asserted that this was because oxymorphone is a metabolite of the former.
It is true that meprobamate is a metabolite of carisoprodol—as noted by the lab itself on the reports.
However, as found above, B.B. had last obtained a morphine prescription on December 15, 2011, 35 days before the January 19 visit, and if taken as directed, B.B. would have run out of his
On March 13, 2012, Respondent issued B.B. new prescriptions for both 120 Opana 10 and 90 Morphine Sulfate ER 15, with the same dosing instructions as the previous prescriptions.
Dr. Owen testified that Respondent should have required an office before issuing these prescriptions, reiterating that the “medical necessity for” the prescriptions still had not been established. Tr. 156. Asked to again identify the deficiencies which led him to conclude that Respondent had not established medical necessity, Dr. Owen explained:
Reviewing all the pertinent previous medical records, including what previous treatments have been performed, an adequate history and physical exam, consultations as medically appropriate, establishing a clinically meaningful and objective therapeutic benefit, and addressing any aberrant drug-taking behaviors.
In his direct testimony, Respondent did not address his reasons for issuing the March 13 Opana and morphine prescriptions.
On April 12, 2012, B.B. saw Respondent for an office visit. GX 3, at 42. According to the visit note, B.B. “report[ed] his pain has been worse,” that “[h]e has run out of his medicines; he had them stolen,” and that “[h]e has done fairly well.”
In the visit note, Respondent wrote that B.B. “still has severe anxiety and depression” and has been “exposed to someone with HPV”; Respondent then wrote: “[h]e is also wanting to switch his medicines because he is having trouble finding the OPANA.” GX 3, at 42. Respondent also noted: “[p]ast medical history extensively reviewed and placed in chart.”
In his exam findings, Respondent noted “[l]ow back paraspinal and spinal tenderness,” “[n]egative straight leg raise,” and “[n]euro intact.”
Respondent further documented that he discussed the “[a]ddictive, dependence, and tolerance nature of the medicines, as well as alternatives.”
Respondent also required B.B. to undergo a urine drug screen. While the preliminary screen shows that B.B. tested positive for oxycodone (which had not been prescribed to him) and negative for opiates/morphine (which he had been prescribed), the line on the form for noting the oxycodone result includes the parenthetical “synthetic & semi-synthetic opiates” and the form contains no separate entry for oxymorphone, which is a semi-synthetic narcotic. GX 3, at 63. Notably, the Government produced no evidence as to whether a positive result for oxymorphone would show up as positive for oxycodone or as positive for “opiates/morphine.” Moreover, Dr. Owen acknowledged that there are reliability issues with this type of test and thus, “you would send it off for a confirmatory mass spectroscopy test.” Tr. 164. However, according to Dr. Owen, the results are still valid until the confirmation shows otherwise.
Respondent did send B.B.'s. urine sample to the lab for further testing. GX 3, at 96. According to the lab report, which was reported back to Respondent on April 17, 2012, B.B. tested positive for oxymorphone, which was expected based on Respondent's having prescribed Opana to him.
Dr. Owen testified that Respondent did not address the aberrant preliminary drug screen conducted on April 12 nor any of the previous aberrant drugs tests at this visit.
The Government also asked Dr. Owen if it was noteworthy that B.B. had told Respondent that his pain was worse, that he had run out of his medicines and had them stolen.
Well, one, his pain is worse, so why is it worse? Two is he's run out of his medications, and then he had them stolen. What is it? Did you run out of them because you self-escalated, or were they stolen and you ran out of them? It needs clarification. But either event, self-escalation or having them stolen, is a red flag.
Dr. Owen then noted that B.B.'s pain contract stated that “lost and stolen medications will not be replaced,”
Dr. Owen also found problematic the notations in the visit note that B.B. reported that “his pain has been worse” and that “[h]e has done fairly well.”
Dr. Owen further testified that Respondent “did not” address B.B.'s “ongoing stress and anxiety issues,” and that “[h]e did not” conduct a thorough patient history.
With respect to Respondent's notation that he had discussed “[a]ddictive dependency and tolerance nature of these medications as well as alternatives,”
Dr. Owen was also asked about entries in a PMP report in B.B.'s file which showed the controlled substance prescriptions he obtained and filled from April 12, 2011 through April 11, 2012. Tr. 170-72. The report showed that on March 14, 2012, B.B. had obtained and filled a prescription from another provider (R.H.) for 60 alprazolam 1 mg, which was a 30-day supply and that on April 6, 2012, he had obtained and filled another prescription from R.H. for 30 alprazolam 1 mg.
Dr. Owen testified that Respondent should have addressed the early refills because although he did “not prescrib[e] this drug, it is a reflection of B.B.'s ability to self-regulate his controlled substance use.”
Continuing, Dr. Owen reiterated his earlier testimony that the patient record was “not adequate” to establish “medical necessity” for prescribing the controlled substances on this date and that between September 22, 2011 (when he assumed the care of B.B.) and April 12, 2012, Respondent had not established medical necessity for the drugs.
Regarding the April 12 visit, Respondent testified that B.B. “said he perceived [his] treatment objective was fair” and that “[t]here's a `yes' this time instead of just fair.”
Respondent also testified that “[h]is pain had gone from a 7 in January to a 6.”
Respondent further testified that he had not replaced the stolen medication.
At this point, the CALJ interjected that he did not “understand this, because if a person says that my medicines were stolen, the medicines are going to be gone” and “they won't have medicines to keep taking them.”
In his testimony, Respondent agreed with the CALJ that he preferred prescribing extended release drugs, and that these formulations require a patient “to keep a certain amount in [his] system so that [he] would have relief from [his] pain” and be able “to engage in the [ ] activities of daily living.”
Respondent offered no explanation as to how a patient could forgo taking extended release medication to create “a stash” while still managing his pain. In any event, Respondent offered no evidence that he even asked B.B. when the purported theft had occurred, which drugs had been stolen, and when B.B. had last taken the drugs he prescribed.
As for why he changed B.B.'s medication, Respondent testified that “Opana was very difficult to get in some of the pharmacies” as some of the pharmacies “couldn't get it from their suppliers” and he had a policy of requiring patients to obtain their medications at a single pharmacy.
While Respondent acknowledged that “having chronic pain [can] lead to worse anxiety and depression” as well as that “uncontrolled anxiety or depression [can] lead [ ] to more pain,”
Continuing, the CALJ asked Respondent if “a mental health provider [is] prescribing controlled substances simultaneously with you, ordinarily will you consult with the mental health provider?”
We've become quite reliant on the PMPs now. Before the PMP, there was quite a bit of cross-talk, because you would get pharmacists [who] would call you and say, did you know that they're [sic] seeing so and so, or they're [sic] taking this, that or the other. And so there was much more of a need to try and get ahold [sic] of them. But we've become very reliant on the PMPs now to track that.
The CALJ then asked Respondent “if two practitioners are simultaneously providing controlled substances [to] the same patient, wouldn't the two practitioners talk to each other about [that] approach?”
This answer prompted the CALJ to ask: “but with a mental health practitioner, if that practitioner is also prescribing controlled substances, you wouldn't consult with them and—or ask anything about that patient?”
On April 25, 2012, Respondent provided B.B. with a prescription for 30 Roxicodone (oxycodone) 15 mg. GX 5, at 4. B.B.'s file contains no documentation that there was an office visit, and notwithstanding that this was a change in medication from what Respondent had prescribed at the previous visit, there is no notation in the progress notes as to why he changed the prescription.
According to Dr. Owen, when adding a new drug to a patient's regimen of pain medications, a physician “would have to establish medical necessity with some type of note, using sound medical rationale.” Tr. 175. Dr. Owen further testified that making such a notation is “a standard of care, and it's part of the documentation guidelines that are issued across every state for the most part.”
Regarding the Roxicodone prescription, Respondent asserted that he “was just doing a two-week trial, trying to figure out his dose, and at the time, most likely the patient didn't have any punches on his card left, and Roxicodone is much cheaper than Percocet, and it's the same medication.”
As for why he did not take any action with regard to the lab's finding that the April 12 drug test result was negative for morphine sulfate, Respondent asserted that the result was not aberrant.
Pursuant to 5 U.S.C. 556(e), I take official notice that morphine does not metabolize into oxymorphone.
On May 9, 2012, Respondent wrote B.B. a prescription for 60 Opana ER 20 mg. GX 3, at 93; GX 5, at 27. Respondent did not require an office visit, and he made no notations in the progress notes regarding the prescription.
Asked why he refilled the prescriptions,
Asked to provide his opinion as to Respondent's prescribing of controlled substances from September 2011 through May 9, 2012, Dr. Owen opined that Respondent did not adequately review B.B.'s medical history.
Respondent offered only vague testimony that he has taken “extreme CME [continuing medical education] . . . in hospice care and pain medicine” in 1995 and had done some “reading” on pain management. Tr. 235, 381. Respondent offered no further detail as to the subject matter of the CME course[s] he took.
Section 303(f) of the Controlled Substances Act (CSA) provides that “[t]he Attorney General may deny an application for [a practitioner's] registration . . . if the Attorney General determines that the issuance of such registration . . . would be inconsistent with the public interest.” 21 U.S.C. 823(f). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are . . . considered in the disjunctive.”
The Government has the burden of proving, by a preponderance of the evidence, that the requirements for denial of an application pursuant to 21 U.S.C. 823(f) are met. 21 CFR 1301.44(d). However, once the Government has made a
Having considered all of the factors, I find that the Government's evidence with respect to Factors Two and Four satisfies its
To be sure, the Agency's case law contains some older decisions which can be read as giving more than nominal weight in the public interest determination to a State Board's decision (not involving a recommendation to DEA) either restoring or maintaining a practitioner's state authority to dispense controlled substances.
Of note, these cases cannot be squared with the Agency's longstanding holding that “[t]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.”
As to factor three, I acknowledge that there is no evidence that Respondent has been convicted of an offense under either federal or Oklahoma law “relating to the manufacture, distribution or dispensing of controlled substances.” 21 U.S.C. 823(f)(3). However, there are a number of reasons why even a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one.
While I have considered factor five, I deem it unnecessary to make any findings.
Under a longstanding DEA regulation, a prescription for a controlled substance is not “effective” unless it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). Under the CSA, it is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to act “in the usual course of . . . professional practice” and to issue a prescription for a “legitimate medical purpose.”
As the Supreme Court has explained, “the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”
Both this Agency and the federal courts have held that “establishing a violation of the prescription requirement `requires proof that the practitioner's conduct went “beyond the bounds of any legitimate medical practice, including that which would constitute civil negligence.” ' ”
However, as the Agency has held in multiple cases, “the Agency's authority to deny an application [and] to revoke an existing registration . . . is not limited to those instances in which a practitioner intentionally diverts a controlled substance.”
“Accordingly, under the public interest standard, DEA has authority to consider those prescribing practices of a physician, which, while not rising to the level of intentional or knowing misconduct, nonetheless create a substantial risk of diversion.”
In March 2005, the Oklahoma Board of Medical Licensure and Supervision issued its Policy Statement on the “Use of Controlled Substances for the Treatment of Pain.” Okla. Bd. of Med. Lic. & Super.,
. . . .
. . . The Board will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. All such prescribing must be based on clear documentation of unrelieved pain. To be within the usual course of professional practice, a physician-patient relationship must exist and the prescribing should be based on a diagnosis and documentation of unrelieved pain. Compliance with applicable state and/or federal law is required.
The Board will judge the validity of the physician's treatment of the patient based on available documentation, rather than solely on the quantity and duration of medication administration. The goal is to control the patient's pain while effectively addressing other aspect of the patient's functioning, including physical, psychological, social and work-related factors.
Simultaneously with the issuance of its Policy Statement, the Board promulgated its regulation on the “[u]se of controlled substances for the management of chronic pain.” Okla. Admin. Code § 435:10-7-11. As the Board explained, its purpose was to adopt “criteria” to be used “when evaluating [a] physician's treatment of pain, including the use of controlled substances.”
With respect to the evaluation of the patient, the Rule states:
A medical history and physical examination must be obtained, evaluated and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
After providing the criteria for informed consent and agreement for treatment, which states,
The physician should periodically review the course of pain treatment and any new information about the etiology of the pain or the patient's state of health. Continuation or modification of controlled substances for pain management therapy depends on the physician's evaluation of progress toward treatment objectives. Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function or improved quality of life. Objective evidence of improved or diminished function should be monitored and information from family members or other caregivers should be considered in determining the patient's response to treatment. If the patient's progress is unsatisfactory, the physician should assess the appropriateness of continued uses of the current treatment plan and consider the use of other therapeutic modalities.
With respect to consultation, the Rule provides:
The physician should be willing to refer the patient, as necessary, for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those patients with pain who are at risk for medication misuse, abuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultations with or referral to an expert in the management of such patients.
And finally, with respect to medical records, the Rule states in relevant part that “[r]ecords should remain current” and that “[t]he physician should keep accurate and complete records.”
The CALJ rejected the bulk of the Government's case, finding the allegations proven only “in part” and only with respect to the prescriptions Respondent issued on October 6 and 20, 2011 (prescribing events 3 and 4), April 12 and 25, and May 9, 2012 (prescribing events 10, 11, and 12). Even then, however, the CALJ reasoned that “[t]he
I conclude, however, that the Government has proved additional violations of 21 CFR 1306.04(a) beyond those found by the CALJ, and I further conclude that the evidence does not simply reflect “inattention to detail” on Respondent's part—a finding which is legally insufficient to support the conclusion that he violated 21 CFR 1306.04(a)—but rather, that he knowingly diverted drugs to B.B. I am mindful of the various credibility findings made by the CALJ, particularly with respect to the testimony of Respondent, as well as his finding that “Dr. Owen's expert testimony predictably raised no issues regarding credibility” but that his “testimony was not without its own `red flags.' ” R.D. 18. For reasons explained earlier, I respectfully disagree with the CALJ's reasons for declining to give weight to much of Dr. Owen's testimony, including his conclusion that Dr. Owen's testimony was based upon a misunderstanding of the nature of the Oklahoma Board's Pain Management Regulations. And to the extent the CALJ declined to consider the evidence of various UDS results with respect to the specific prescribing events on the ground that the Government did not provide adequate notice, as explained above, I conclude that Respondent had constitutionally sufficient notice and understood that the UDS results were at issue throughout the proceeding.
The CALJ rejected the Government's allegation that the Duragesic and Opana prescriptions issued by Respondent on this date violated 21 CFR 1306.04(a) because they were issued outside of the usual course of professional practice and lacked a legitimate medical purpose.
I decline to adopt this ruling for multiple reasons. First, as several federal appeals courts have recognized, there is no material difference between the phrases “usual course of professional practice” and “legitimate medical purpose,” and thus the courts have sustained convictions for violating the regulation and 21 U.S.C. 841(a)(1), notwithstanding that an indictment charged the defendant “with dispensing of a controlled substance not in the usual course of professional practice” but did not allege that the dispensing lacked a legitimate medical purpose, as well as where the jury instructions only referenced the “usual course of professional practice” and did not require the jury to find that the defendant “dispensed without a legitimate medical purpose.”
Likewise, in
Furthermore, even if these were two distinct theories for proving a violation of 21 CFR 1306.04(a), the record supports a finding of litigation by consent. The Government did not “sporadically elicit testimony from its expert” on this issue, but rather, asked Dr. Owen whether each of the prescriptions lacked a legitimate medical purpose. Respondent did not object to any of these questions, and thus, it is clear that unlike the issue in
Dr. Owen further noted that Respondent documented that B.B. had a negative straight leg raise and that this is “the most sensitive physical finding for low back pain.”
Dr. Owen further testified that Respondent's patient file contained two aberrant drug tests, the June 1, 2011 test, which did not detect alprazolam even though B.B. was obtaining the drug every 30 days, and the August 25, 2011 test, which detected the presence of nordiazepam, oxazepam, and temazepam, which the lab reported as not expected based on the prescribed medications. Dr. Owen testified that Respondent “completely ignored” the aberrant drug screens and that he “should have acknowledged their existence and . . . taken some type of corrective action.”
The CALJ found uncontroverted Dr. Owen's testimony that B.B. was a new patient and thus, Respondent was required to have done everything typically expected of a physician in the evaluation of a new patient, including a proper history and physical, reviewing previous treatments, and reviewing his patient file. R.D. at 33-34. The CALJ further found uncontroverted Dr.
As for the aberrant drug tests, the CALJ asserted that “there is little doubt that the June 1 UDS is aberrant to the extent it shows that B.B. was not taking his alprazolam,” and that Dr. Owen's testimony that “failing to act on this aberrant UDS fell below the prevailing standard . . . stands unrebutted [on] the record.”
Accordingly, I find that the June 1 drug test was aberrant and that Respondent breached the standard of care when he failed to address the test with B.B. prior to issuing the September 22, 2011 prescriptions. The CALJ, however, also rejected the Government's contention that the drug test of August 25, 2011, which showed the presence of nordiazepam, oxazepam and temazepam when these drugs had not been prescribed to B.B. by either Dr. Schoelen or his mental health professional, was also aberrant and not properly considered and addressed by Respondent prior to prescribing to B.B. R.D. at 38. While Respondent testified that he did not remember if he reviewed this UDS prior to the September 22 visit or at any point, Tr. 397, in the visit note, Respondent stated that B.B.'s “[p]ast medical history was extensively reviewed.” GX 3, at 48. Moreover, Dr. Owen credibly testified as to the need to obtain “all . . . previous medical records pertaining to [the] chief complaint” and review them to determine what previous treatments had been tried and their results, as well as “to look for any previous aberrant behaviors.” Tr. 94. And Dr. Owen further explained that “if you don't look at all the pertinent previous medical records, you can't get an accurate diagnosis.”
In rejecting the Government's contention that the August 25 test was aberrant, the CALJ did not make a credibility finding as to Respondent's testimony that he did not remember whether he reviewed the UDS at the time he was treating B.B. Nor did he make an explicit finding as to whether Respondent reviewed the UDS.
Instead, the CALJ reasoned that “Respondent credibly testified that, based on his professional opinion and his conversations with personnel at the testing lab, a patient taking any benzodiazepine may test positive for any other benzodiazepine[,] [and] [t]hus, the Respondent
However, if, in fact, Respondent did not review the UDSs prior to prescribing (notwithstanding the notation that he “extensively reviewed” B.B.'s medical history), Dr. Owen's unrefuted testimony establishes that Respondent committed a gross breach of the standard of care in failing to do so. Of note, Respondent testified that Dr. Schoelen had instituted urine drug testing as a “safeguard” after Dr. Schoelen joined the American Academy of Pain Management and attended training, and that a drug test was done “every three months” on the clinic's “chronic pain patients.” Tr. 253-55. Thus, Respondent clearly knew that B.B. had been subjected to drug testing.
Moreover, if it is the case that Respondent did not review the August 25 drug test, then it is clear that Respondent's testimony as to what he was told by the lab was not offered to show his state of mind in failing to address the aberrant test result. Rather, it was offered to prove the truth of the matter asserted—that because of cross-reactions, “a patient taking any benzodiazepine may test positive for any other benzodiazepine.”
Thus, Respondent's testimony was hearsay which was uncorroborated by either the testimony of a lab employee, an expert in drug testing, or articles from scientific or medical journals. The CALJ did not, however, analyze the reliability of the hearsay statements recounted by Respondent.
Applying the
Notably, in his Response to the Government's Exceptions, Respondent does not maintain that this testimony was offered for the non-hearsay purpose of showing Respondent's state of mind when he failed to address the August 25 drug test with B.B. Response to Exceptions, at 4-6. Indeed, in his brief, Respondent argues only that “there is no evidence that the written test results provided by . . . the drug testing company . . . are unreliable and inadmissible or that the results themselves are unreliable.”
Moreover, even were I to consider Respondent's testimony on the issue of his state of mind—which would seem to require a finding that he did see the lab
Of consequence, B.B.'s January 19, 2012 drug test also detected the presence (in addition to that of alpha-hydroxyalprazolam, the metabolite of alprazolam) of nordiazepam, oxazepam, and temazepam. GX 3, at 97. Yet on this occasion, Respondent noted on the Lab Report that he had “counseled [B.B.] to only take what is prescribed.” GX 3, at 97. And in his testimony regarding the January 19 drug test results, Respondent stated that he made the notation because “[t]he nordiazepam, the oxazepam, and then the Xanax, the lab always said that if . . . Xanax [alprazolam] was positive, that they could all three be positive. The temazepam, in our practice usually didn't show up, and temazepam is [a] sleeping pill called Restoril.” Tr. 335;
Respondent offered no explanation for the inconsistency between his testimony regarding why he “would not consider” the August 25 drug test to be aberrant and his testimony as to why he deemed the January 19 drug test as aberrant, even though both tests reported the presence of the same four benzodiazepines, and in particular, temazepam. Most significantly, the CALJ did not address the inconsistency between Respondent's testimony regarding the August 25 and January 19 drug tests in making his credibility finding.
I conclude, however, that for the same reason that Respondent deemed the January 19 test to be aberrant, I reject his testimony that he does not believe the August 25 test was aberrant and find that it was. I further find that this was now the second aberrant drug test that B.B. had provided in the previous four months.
I am also unpersuaded by the CALJ's reasoning for rejecting Dr. Owen's testimony as to the adequacy of Respondent's evaluation of B.B. The CALJ reasoned that the deficiencies identified by Dr. Owen “generally relate to a paucity of documented proof in the chart entries” as to whether Respondent had adequately evaluated B.B.'s chief complaint, the treatments he had previously undergone, his physical and psychosocial function, and whether the prescribing of controlled substances provided a therapeutic benefit. R.D. at 35-36. As explained above, the CALJ declined to give weight to Dr. Owen's testimony based on the erroneous legal conclusion that the Board's documentation and recordkeeping standards are permissive and not mandatory. The CALJ apparently credited Respondent's testimony in finding that “B.B. reported pain, which was consistent with the findings of the exam the Respondent conducted on that date.”
As to Respondent's claim that B.B. had undergone physical therapy for some time, Respondent admitted that this was not documented in the patient file. Tr. 392. Indeed, a review of the progress notes prepared by Dr. Schoelen finds no mention of B.B.'s having been referred to physical therapy, but rather, mentions only Dr. Schoelen's recommendations of such modalities as gentle stretching, low back strengthening exercises, heat, and low back range of motion exercises.
Accordingly, I do not find credible Respondent's testimony that he did not have B.B. go to physical therapy because B.B. “had been on physical therapy monthly for quite some time and didn't feel that it was of any benefit at all.” Tr. 392. Here too, because Respondent's testimony is inconsistent with the evidence (and lack thereof), I decline to adopt the CALJ's apparent credibility finding as to this testimony. I further agree with Dr. Owen's assessment that Respondent failed to properly assess whether B.B. had undergone conservative treatments.
As explained above, Dr. Owen also provided extensive testimony as to the standard of care for evaluating the history of a patient's pain complaint and the effect of the pain on a patient's physical and psychosocial functioning. Tr. 116. In his testimony, Dr. Owen identified various questions that Respondent should have asked B.B. and for which Respondent's September 22 visit note contains no evidence that he did so.
Respondent's note for this visit is totally devoid of any documentation that he asked B.B. how he hurt himself; whether his pain radiated down his extremities and if so, how far down; if the pain went past his knee; if he had
Against this evidence, Respondent testified that B.B. reported pain which was consistent with the exam he conducted at this visit. Tr. 292. He also explained that he ordered an MRI because he “wanted to make sure that” the results were “consistent with his pain,” his physical exam, and “the fact that he was on a schedule II narcotic.”
While Respondent may have palpated B.B.'s lumbar region, he offered no testimony or other evidence refuting Dr. Owen's testimony that the straight leg raise test is “the most sensitive physical finding for low back pain,” and that “if you don't have a positive finding you don't have that diagnosis.”
As for Respondent's having changed B.B.'s medication from Lortab to Fentanyl patches, even long-acting schedule II medications are susceptible to abuse. Moreover, because Respondent performed only a superficial evaluation and did not establish a diagnosis and medical necessity to prescribe controlled substances, let alone two schedule II controlled substances, this evidence is entitled to no weight.
So too, the CALJ took issue with Dr. Owen's testimony regarding “Respondent's failure to make referral to other specialists.” R.D. 39. However, Dr. Owen's opinion that Respondent did not establish medical necessity for the September 22 prescriptions was based on Respondent's superficial evaluation of B.B.'s pain and function, Respondent's failure to exhaust conservative treatments, and the lack of evidence of a therapeutic benefit. Tr. 133-34. While Dr. Owen did suggest that based on the two aberrant drug tests, Respondent “could have sent” B.B. to an evaluation by an addictionologist or a psychiatrist/psychologist with experience in addiction medicine, he also testified that there was a further alternative step that Respondent could have taken: he could have been “much more careful and objective [as to] how [he] measure[d] a therapeutic benefit.”
I further hold that Respondent's issuance of the prescriptions for the fentanyl patches and Opana (oxymorphone) prescriptions was not merely malpractice. Rather, I conclude that the evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed these drugs to B.B. Here, not only did Respondent do a superficial evaluation as to B.B.'s purported pain complaint, his medical history, and the effect of the pain on his ability to function, he also performed a cursory examination which did not support his diagnosis,
Moreover, even were I to credit Respondent's testimony that he “doubt[ed]” that he reviewed the drug tests performed by Dr. Schoelen and “wouldn't expect [him]self to,” Tr. 283, the evidence shows that Respondent clearly knew that B.B. was a chronic pain patient who was on multiple narcotics and was subject to drug testing. Dr. Owen credibly testified as to the importance of reviewing a patient's medical records to determine if the patient has a history of aberrant behaviors,
Here again, Dr. Owen testified that the medical record did not justify the prescribing of controlled substances. Tr. 137. Dr. Owen then explained that Respondent's evaluation of B.B. was superficial in that there was no assessment of B.B.'s pain and his physical and psychosocial functioning. Dr. Owen thus concluded that once again, Respondent had not established medical necessity to prescribe controlled substances and thus, he opined that the prescriptions “were not” issued in the usual course of professional practice and “were not” for a legitimate medical purpose.
Explaining that “[t]he principal issue raised by Dr. Owen and noticed by the Government” with respect to these prescriptions “centers on” this notation, the CALJ found credible Respondent's testimony regarding B.B.'s request to try morphine, characterizing the notation as “a poorly-worded memorialization of a longer conversation wherein he got medication efficacy input from B.B. and outlined several medication options based on the existing Oklahoma Medicaid formulary.” R.D. 43. The CALJ then explained that “[t]he progress notes related to issues regarding the Respondent's evaluation and treatment of a suspected upper respiratory ailment are likewise more consistent with a conscientious practitioner than a pill mill operator.”
Next, while the CALJ rejected the Government's contention that the
As explained previously, with respect to those instances in which he found violations, the CALJ simply concluded that Respondent's actions were neglectful. However, even accepting the CALJ's credibility finding with respect to Respondent's testimony regarding B.B.'s request to try morphine, I find that the evidence still supports the conclusion that Respondent violated 21 CFR 1306.04(a) in issuing the prescriptions for both morphine ER and Opana (oxymorphone).
As explained in my discussion of the September 22nd prescriptions, I conclude that the August 25, 2011 UDS was anomalous. And as also discussed previously, I find that the Board's documentation and recordkeeping provisions are mandatory and thus, Dr. Owen's testimony should be given weight.
In refutation of Dr. Owen's testimony that Respondent's evaluation was inadequate, Respondent testified that B.B. reported that “his objectives were only fair” and that his pain level had increased to a six out of ten. Respondent further noted that he did “a full exam” but that “[t]he MRI was not back yet.” Tr. 295.
As the CALJ noted, Respondent “admitted that this part of the patient visit went very quickly, and that a patient may not remember the treatment goal when asked this.” R.D. 41 n.80. Indeed, after admitting that “that part would be very quick in my office,” Respondent added that “I wouldn't ask him what he was actually doing to achieve that.” Tr. 393. He also testified that he was not sure as to why, when the question was “has patient achieved treatment objective” and was, in essence, a yes or no question, and the patient may not even remember what his treatment objective was, B.B. would have answered “fair.”
Although Respondent maintained that he did a full physical exam, once again he found that B.B.'s straight leg raise was negative. As Dr. Owen testified, without a positive finding on this test, Respondent did not have a diagnosis for lumbar disc disease. And as for the Respondent's testimony that “the MRI results were not back yet,” B.B. had not even gone for the MRI as of this date.
Nor do I find persuasive the reasoning that Respondent's treatment of B.B.'s upper respiratory ailment was “more consistent” with the treatment provided by “a conscientious practitioner than a pill mill operator.” R.D. 43. Putting aside that there is no evidence as to how a conscientious practitioner would treat a patient who complains of a potential upper respiratory ailment, even patients who engage in the abuse or diversion of controlled substances may seek treatment for legitimate health conditions. So too, a physician may nonetheless divert controlled substances to some patients without being a pill mill operator. Thus, even assuming that Respondent properly evaluated and treated B.B. for this condition, this has no bearing on whether he properly evaluated B.B. to determine whether he had a legitimate pain condition which warranted the prescription of controlled substances.
Notably, B.B. returned for another office visit only two weeks later. GX 3, at 46. Yet the note for the visit contains no mention of the hernia.
In sum, because I agree with Dr. Owen that Respondent still had not established medical necessity for the prescriptions and had still failed to address the two aberrant drug tests, I conclude that the prescriptions lacked a legitimate medical purpose and that Respondent acted outside of the usual course of professional practice in issuing them. 21 CFR 1306.04(a).
At this visit, Respondent noted that B.B. reported that “his stress [was] up” and that he had “lo[st] his father” and was “having a lot of grief.” GX 3, at 46. He made similar physical exam findings as at the previous visit, again noting that B.B.'s straight leg raise was negative but that “lying down and sitting up cause him a lot of pain.”
Dr. Owen testified that B.B.'s having a lot of stress and grief would magnify B.B.'s “perception of pain and disability.” Tr. 139. He further explained that because of B.B.'s previous aberrant behaviors and the new stressors in B.B.'s life, he was at increased risk to “use [the] drugs to chemically cope” and that Respondent should have “sought psychological counselling for” him but did not do so.
Dr. Owen also took issue with Respondent's notation in the visit note that he suggested nonmedicinal modalities for two reasons.
As for Respondent's notations that the straight leg raise test was negative but that lying down and sitting up caused B.B. a lot of pain, Dr. Owen testified that these were not objective findings in a neurological sense in that B.B. could not “have a radiculopathy” absent a positive straight leg raise test.
The CALJ declined to give weight to much of Dr. Owen's testimony, reasoning that his “view of the level of documentation detail required in Oklahoma, as well as his description of
I do not read Dr. Owen's testimony as categorically stating that the Oklahoma regulation imposes a mandatory requirement of obtaining a consultation when a patient presents with a co-morbid psychiatric disorder. While Dr. Owen testified that one of the provisions in Oklahoma's “policies and guidelines . . . that stood out is if somebody's a complex pain patient with psychological or psychiatric comorbidities, they should get consultations with a pain management physician with expertise in these complex cases,” Tr. 101, he acknowledged that the Board's rule used the words “may require” but that a physician “should document why [he] deviate[s] from that recommendation.”
Thus, Dr. Owen's testimony is not fairly read as asserting that Oklahoma imposes a mandatory requirement of obtaining a consultation in all instances in which a patient presents with a comorbid psychiatric disorder. Moreover, even if I agreed with the CALJ's characterization of Dr. Owen's testimony on this issue, the Board's standard is nonetheless evidence that the standard of care may require referral or consultation depending on the circumstances presented by the patient, and there is ample evidence to support Dr. Owen's conclusion that Respondent breached the standard of care when he failed to even consult with B.B.'s mental health providers.
Dr. Owen testified that patients who present with comorbid psychiatric conditions present a heightened risk of abusing controlled substances because these conditions may magnify a patient's perception of pain and disability and aggravate a patient's experience of suffering,
To be sure, the evidence shows that B.B. was already seeing a mental health professional during this period. However, Respondent admitted that he never even consulted with the mental health professionals who were simultaneously prescribing controlled substances to B.B., whether in response to B.B.'s report of increased stress and grief at this visit, or at any point during the course of his prescribing to B.B.
When then asked if two practitioners who are simultaneously prescribing controlled substances to the same patient wouldn't “talk to each other about” their joint prescribing, Respondent initially answered “absolutely.”
While, when considered in isolation, Respondent's failure to consult with B.B.'s mental health providers would not establish a violation of 21 CFR 1306.04(a), Dr. Owen again explained that Respondent's evaluation was “inadequate” and did not support a finding of medical necessity to continue prescribing controlled substances.
As before, Respondent's failure to address the aberrant drug screens as well as Dr. Owen's testimony that the evaluation was inadequate, that prescribing controlled substances did not provide a therapeutic benefit, and that Respondent did not establish medical necessity to continue prescribing controlled substances, are sufficient to support a finding that Respondent violated 21 CFR 1306.04(a). Respondent's failure to consult with B.B.'s mental health providers given B.B.'s report of increased stress and grief provides additional support for this conclusion.
On both dates, Respondent issued B.B. prescriptions for 90 Morphine Sulfate ER 15 mg and 120 Opana 10 mg without requiring that B.B. appear for an office visit with him. Dr. Owen again found that Respondent should have seen B.B. prior to issuing the prescriptions and that Respondent still
Dr. Owen acknowledged that under a DEA regulation (21 CFR 1306.12(b)), a practitioner may issue multiple prescriptions for a schedule II drug to provide up to a 90-day supply of the drug based on only seeing the patient once every 90 days. However, Dr. Owen explained that a physician who does so must have “established medical necessity and legitimate therapeutic benefit . . . and [that] a patient doesn't have a high risk of abuse,” but that B.B. already had provided two aberrant drug screens before Respondent issued the prescriptions.
In refutation, Respondent offered only that after the October 20 visit, he “felt like [B.B.] could really go into the three-month” and that he did not understand that he had to see B.B. “every 30 days.”
The CALJ found the allegations “not sustained” with respect to both the November 18 and December 15 prescriptions. R.D. at 51. In the CALJ's view, although the June 1 UDS was aberrant, it was not adequately noticed with respect to these two prescribing events, and as for the August 25 UDS, “the record evidence [did] not support a finding that the . . . results [were] aberrant.”
I find, however that on both dates, Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the morphine and Opana prescriptions without requiring an office visit. As previously explained, the Show Cause Order provided Respondent with fair notice that the aberrant June 1 drug test would be at issue throughout this proceeding, including with respect to the prescriptions he issued on November 18 and December 15, 2011.
So too, for reasons explained previously, I reject the CALJ's interpretation of the documentation requirements imposed by the Oklahoma regulations. In any event, in his testimony regarding his evaluation of B.B., Respondent simply read aloud what he had documented in the visit notes and in the Treatment Objective Evaluation section of the Treatment Plan (GX 3, at 28) and never identified additional measures he took to evaluate B.B.'s pain and how it affected his ability to function.
As for the CALJ's reliance on the regulation which allows a practitioner to issue to a patient multiple schedule II prescriptions for up to a 90-day supply at one time, provided the practitioner meets certain conditions, the rationale underlying this provision does not provide a safe harbor to Respondent.
On January 19, 2012, B.B. again saw Respondent. B.B. reported that he had gone to the emergency room “two weeks ago with right leg swelling” but that “[h]is ultrasound was negative”; he complained of “some calf pain” and that “[h]e still feels very tight.” GX 3, at 45. Respondent also noted that B.B. “goes to a psychiatrist” and “reports severe lumbar disc disease.”
According to Respondent's exam notes, B.B. was “[a]lert and oriented and in no apparent distress.”
Respondent diagnosed B.B. with “lumbar disc disease,” “exposure to infectious disease,” and “[r]ight calf pain.”
Dr. Owen testified that when a patient reports having gone to the emergency room, he would get the record to find out both “what the problem was” as well as if “any additional medication [was] prescribed.” Tr. 147. B.B.'s file does not, however, contain a note from the emergency room.
In refutation of Dr. Owen's testimony, Respondent asserted that B.B. did not report anything other than his calf pain and his new conditions (apparently a reference to his exposure to someone with HPV).
While Respondent agreed that his visit notes were unremarkable given the high amount of narcotics he was prescribing and asserted he could have done a better job dictating his notes (which he attributed to seeing 40 to 45 patients a day and dictating the notes), he maintained that because B.B. “just continued to have the same pain that he had before . . . I didn't go into details on it.” Tr. 315. However, notwithstanding that he had not seen B.B. in three months, he did not document whether B.B. had achieved his treatment objective nor document a numeric pain rating. GX 3, at 28.
The CALJ rejected the Government's contention that the controlled substance prescriptions Respondent issued at this visit violated 21 CFR 1306.04(a). Again, the CALJ concluded that the Government did not provide adequate notice regarding its reliance on the June 1 UDS and that the record does not support a finding that the August 25 UDS result was aberrant. R.D. at 51. And again, the CALJ reasoned that Dr. Owen's view of the level of documentation required findings of therapeutic benefit and medical necessity, as well as his conclusion that Respondent did not adequately document B.B.'s visit to the emergency room and should have obtained the record of that visit, were “at odds with the requirements of the” Board's rules.
For reasons explained previously, I find that Respondent was provided adequate notice regarding the Government's reliance on the June 1 UDS and that the record supports a finding that the August 25 UDS was aberrant. As also explained previously, because I do not agree with the conclusion that Dr. Owen's understanding of the Oklahoma documentation requirement is “at odds” with the permissive nature of the State's regulations, R.D. 51, and agree with the CALJ's conclusion that Dr. Owen's testimony “predictably raised no issues regarding credibility,” I give weight to Dr. Owen's testimony that Respondent did not establish medical necessity to issue the prescriptions.
As for Dr. Owen's criticism of Respondent for failing to obtain the emergency room record, Respondent testified that he checked the PMP and found no evidence that B.B. had been prescribed controlled substances. Moreover, even if the standard of care does require a pain management physician to obtain an ER record for his patient, it not clear how quickly that record could have been obtained on the date of this visit. Nor is it clear why, if a physician has otherwise properly evaluated his patient, his failure to obtain an ER record on that date would preclude his issuance of controlled substance prescriptions.
However, Dr. Owen provided credible testimony that when Respondent issued the January 19 prescriptions, he still did not perform an adequate evaluation of B.B.'s pain complaint by doing a proper history and physical exam, nor determined whether there was a therapeutic benefit to justify the continued prescribing of controlled substances, nor addressed the previous aberrant drugs tests. Dr. Owen's testimony provides substantial evidence to conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he issued the prescriptions.
In discussing Respondent's testimony regarding the notes he made after B.B.'s January 27 office visit (on which occasion he did not prescribe controlled substances), the CALJ stated that “Respondent noted that B.B. was on Social Security disability, and objective data had confirmed that he had chronic pain.” R.D. at 50 (citing Tr. 324). However, Respondent did not identify what the “objective data” were.
The CALJ also found that in the Respondent's view, B.B. had not behaved in a way that set off alarms, and was stable on his medications.” R.D. at 50. However, as found previously, Respondent testified that he probably never even looked at the UDS results that were in B.B.'s chart and didn't expect that he would have done so. Yet Respondent also testified that Dr. Schoelen had instituted urine drug testing for the clinic's chronic pain patients and thus Respondent obviously knew that B.B.'s file likely contained UDS results. And the evidence also shows that Respondent did not conduct a drug test of B.B. at any of his first three visits and yet concluded that he only needed to see B.B. once every three months. Thus, to the extent Respondent claims that B.B's behavior did not set off
The CALJ apparently also credited Respondent's testimony to the effect that “[m]uch more went on in the office than what's written” in the visit notes and that he “definitely knew what was going on in [B.B's] life from each visit, and I just failed to dictate that.” Tr. 326. And the CALJ further asserted that “Respondent provided details to demonstrate that he knew his patient,” R.D. 50, and apparently credited Respondent's testimony that he “was talking to [B.B] about those things and what all he did in a day, and he was not able to work.” Tr. 327 (cited at R.D. 51).
Yet, on the occasion of the January 19 visit, during which he issued B.B. new prescriptions for morphine and oxymorphone, Respondent did not even document in the Treatment Objective Evaluation section on the Treatment Plan if B.B. was meeting his treatment objectives and did not obtain a pain rating. Of note, the former was typically documented with a handwritten one-word answer of either “yes” or “fair,” and the latter was documented with a handwritten notation of a number; thus neither of these inquiries required dictation at all.
Moreover, when asked by the CALJ how he knew how the meds he prescribed “were doing,” Respondent replied that his evaluation was “purely subjective, and if they were needing more or less pain meds.” Only after a further question as to whether he asked objective questions in assessing how B.B. was responding to the medications did Respondent maintain that he was aware of what B.B. did all day and that he had not returned to work.
Dr. Owen provided unrefuted testimony that “return[ing] to work” is “the gold standard for functionality in pain management.” Tr. 100. Given this, it is telling that Respondent never documented whether B.B. had returned to work in the progress notes he prepared for the various visits. Moreover, given that B.B.'s treatment objective was to return to work without pain and yet B.B. never returned to work during the course of Respondent's prescribing to him,
As for why he did so, Respondent testified that he would ask his patients if they were meeting their treatment objective and he would write down what the patient told him. Tr. 392. However, Respondent further testified that “[a]ctually that part [of the visit] would be very quick in my office. I wouldn't ask him what he was actually doing to achieve that.”
Respondent “absolutely” agreed with the CALJ that he would ask his patients “[h]ave you achieved your treatment objective?” only to then acknowledge that his patients “may not” remember what their treatment objective was. Tr. 394. And while this question appears to have been directed at assessing a patient's function, Respondent testified that the question was intended to elicit “[b]asically if they were satisfied with the care or the standard that they meet.”
Tellingly, at another point during his testimony on this issue, Respondent explained:
They [the patients] were very well trained by the time this was here. Whenever we walked in, they knew the questions before we asked them. You know, are you meeting your objective? What's your pain level? And do you wish to change? Do you think we should make a referral? We asked it every time, just like clockwork.
I disagree with the CALJ that “Respondent's testimony provides convincing evidence that he was engaged in
As noted previously, in its Policy Statement, the Board stated that it “will judge the validity of the physician's treatment of the patient
In concluding so, I am mindful that while the Board initially charged Respondent with “fail[ing] to maintain adequate medical records to support diagnosis . . . treatment or prescribed medications, in violation of 59 O.S. § 509(20),” RX 1, at 4, the Board ultimately entered into a settlement with him prior to hearing which did not include a finding that he violated this provision. There is, however, nothing unusual about prosecutors agreeing to enter settlement agreements in which they waive meritorious allegations and, as the voluntary settlement agreement offers no explanation as to why the Board did not rely on this specific allegation, I place no weight on the failure of the Board to find that Respondent violated the provision.
I am also mindful of the CALJ's criticism that Dr. Owen is not licensed to practice in Oklahoma and has never practiced there, as well as that Dr. Owen's “representation that the controlled substance prescribing standards in his home state of Texas are similar to, but less restrictive than Oklahoma, is flat out wrong,” and that this diminishes the weight to be given to his testimony. R.D. 89 (citing Tr. 87, 94, 105-06).
It is true that in several respects the Texas Board's standards are more restrictive than Oklahoma's, and thus, Dr. Owen's testimony that Texas's standards are less restrictive was erroneous. However, on the critical issues of the scope of the evaluation of the patient and the documentation required, as explained previously, I conclude that the Oklahoma Board's standards on these issues are mandatory. While the Texas Board uses even more emphatic language to express the mandatory nature of these requirements, I conclude that there is no material difference between the standards of Oklahoma and Texas.
Moreover, Dr. Owen provided additional evidence to support the view that the standards of medical practice require the documentation of considerably more information than found in B.B.'s progress notes. As he explained:
Notably, Respondent put on no evidence showing that Oklahoma's standard was materially different than what Dr. Owen testified to on the issue of the adequacy of the evaluation and required level of documentation.
Moreover, while States have the primary responsibility for the regulation of the medical profession, many of the profession's norms were created by the profession itself. Thus, on such issues as the adequacy of a clinical evaluation for a particular pain complaint and the necessary documentation to support the prescribing of controlled substances, the standard of medical practice would not seem to vary to any material degree between States, especially between States that border each other.
Finally, unlike Respondent, Dr. Owen is board certified in pain management, is a member of multiple pain management professional organizations, including the American Academy of Pain Medicine and the American Academy of Pain Management, has practiced pain management for more than sixteen years, serves as a peer reviewer on pain medicine for the Journal of the American Academy of Pain Medicine, and has made numerous presentations on pain-management. In light of his extensive professional credentials, I conclude that even though he has not practiced in Oklahoma, I find persuasive his testimony as to the inadequacy of Respondent's evaluations of B.B. and Respondent's failure to establish a medical necessity for the prescriptions. I thus conclude that the January 19, 2012 Morphine and Opana prescriptions lacked a legitimate medical purpose and that Respondent acted outside of the usual course of professional practice in issuing them. 21 CFR 1306.04(a).
On this date, Respondent issued B.B. new prescriptions for 120 Opana 10 and 90 Morphine Sulfate ER 15. Moreover, by this date, Respondent likely had the results of the January 19 UDS, which showed that Morphine Sulfate was not detected and that B.B. had tested positive for nordiazepam, oxazepam and temazepam (as well as alprazolam). On the lab report, Respondent wrote that B.B. was “counsel[led] to only take what is prescribed.” Respondent did not require that B.B. appear for an office visit.
Dr. Owen testified that Respondent should have required an office visit because of B.B.'s previous aberrant drug-taking behaviors and because Respondent still needed to establish that there was a medical necessity to prescribe controlled substances and a therapeutic benefit. Tr. 154. While Dr. Owen acknowledged Respondent's notation that he had counseled B.B., Dr. Owen testified that this was not an adequate safeguard to prevent abuse or diversion because this was B.B.'s third aberrant drug test.
In refutation, Respondent maintained that “the morphine said not detected, but the oxymorphone was positive, so that was explainable.”
The CALJ again rejected the Government's contention that Respondent violated 21 CFR 1306.04(a) when he issued the prescriptions, reasoning that “the record evidence does not support a finding that the August 25 or January 19 UDS results are aberrant.” R.D. at 54. While the CALJ again explained that “it is beyond argument that the June 1 UDS does present an anomaly, reliance on that event [was] not adequately notice by the Government in support” of its contentions regarding these prescriptions.
In addition, the CALJ found that Respondent “provided a thoughtful and reasoned explanation (based on his professional experience and knowledge of operating Tri-City) of why B.B. may have tested positive for temazepam despite not having been prescribed it.”
However, as explained above, even though the June 1 UDS was not specifically referenced in the Show Cause Order with respect to the February 13 prescriptions, the issues of the aberrant nature of the June 1 test (as well as the August 25 test) were litigated by consent. As for the CALJ's assertion that the record does not support a finding that the August 25 and January 19 UDS results were aberrant, Respondent's testimony and the notation he placed on the report of the January 19 test establish that both tests were aberrant in that B.B. was taking a medication which Respondent had not prescribed to him and which was not listed on the PMP reports, including one
As for the CALJ's assertion that the Government provided no evidence that Respondent's action in counseling B.B. to take only what he was prescribed fell below the standard of care, the CALJ's reasoning rests on the erroneous premise that this was B.B.'s first aberrant drug test. However, for reasons explained previously, it was his third aberrant test in less than eight months, and each of his last three tests produced an aberrational result.
In rejecting Dr. Owen's testimony that Respondent needed to obtain a consultation, the CALJ further asserted that Oklahoma's referral standard (which uses the language “may require”) is “permissive” and not “directive.” R.D. at 55. The provision is, however, more appropriately read as conferring a degree of discretion which must be exercised within the bounds of “sound clinical judgment,”
Thus, in contrast to the CALJ, I give weight to Dr. Owen's testimony that based on B.B.'s multiple aberrational tests, Respondent needed to obtain a consultation with a specialist in addiction. Moreover, as Respondent did not require an office visit, I also give weight to Dr. Owen's testimony that Respondent had still not established medical necessity to justify the continued prescribing of controlled substances. Accordingly, I conclude that the Opana and Morphine prescriptions lacked a legitimate medical purpose and that Respondent acted outside of the usual course of professional practice in issuing them. 21 CFR 1306.04(a).
On March 13, 2012, Respondent issued B.B. new prescriptions for both 120 Opana 10 and 90 Morphine Sulfate ER 15.
Dr. Owen testified that Respondent should have required an office visit before issuing these prescriptions, reiterating that Respondent still had not established “medical necessity for” prescribing controlled substances to B.B. Tr. 155. Asked to again identify the deficiencies which led him to conclude that Respondent had not established medical necessity, Dr. Owen explained:
Reviewing all the pertinent previous medical records, including what previous treatments have been performed, an adequate history and physical exam, consultations as medically appropriate, establishing a clinically meaningful and objective therapeutic benefit, and addressing any aberrant drug-taking behaviors.
In his direct testimony, Respondent did not address his reasons for issuing the March 13 Opana and morphine prescriptions.
Here again, the CALJ concluded that the Government's evidence was not sufficient to sustain the allegations that Respondent violated 21 CFR 1306.04(a) in issuing the prescriptions. According to the CALJ, “there [was] no persuasive evidence to support the conclusion that the absence of an office visit by B.B., standing alone, render[ed] this prescribing event below the prevailing medical standard in Oklahoma.” R.D. at 56. Again noting that under 21 CFR 1306.12(b), which allows for the issuance of multiple schedule II prescriptions to provide up to a 90-day supply provided certain conditions are met, the CALJ concluded that “without persuasive expert or state regulatory guidance, evidence [of] the failure to conduct an in-person office visit does not establish that this prescribing event fell below the standard of care required in Oklahoma.”
As for the CALJ's assertion that the UDS results were not adequately noticed, in the Show Cause Order, the Government alleged with respect to these prescriptions that Respondent “once again issued [B.B.] controlled substance prescriptions . . . without taking appropriate steps to monitor his controlled substances use despite the persistent red flags of abuse and diversion he previously presented.” ALJ Ex. 1, at 5 (¶ 3h). Even if this was not enough to provide Respondent with notice that the three UDSs would be at issue with respect to these prescriptions, Respondent did not object when the Government asked Dr. Owen: “[a]re there any aberrant drug-taking behaviors here?” and he answered: “[t]here has [sic] been three previous.” Tr. 158. I thus conclude that Respondent consented to the litigation of the issue.
As for the CALJ's assertion that there is no persuasive evidence that standing alone, the absence of an office visit rendered these prescriptions below the prevailing medical standard, the Respondent's prescribing without requiring an office visit does not stand alone. Rather, Dr. Owen credibly identified multiple deficiencies in Respondent's evaluation of B.B.'s pain complaint, including his failure to perform an adequate history and physical, his failure to properly evaluate how B.B.'s pain was effecting his ability to function, his failure to determine if the controlled substances were providing a therapeutic benefit and to try conservative treatments, and his failure to address the multiple instances of aberrant behavior. Of further note, Respondent offered no evidence refuting
On April 12, 2012, B.B. saw Respondent for an office visit. GX 3, at 42. According to the visit note, B.B. “report[ed] his pain has been worse,” that “[h]e has run out of his medicines; he had them stolen,” and that “[h]e has done fairly well.”
In the visit note, Respondent wrote that B.B. “still has severe anxiety and depression” and has been “exposed to someone with HPV”; Respondent then wrote: “[h]e is also wanting to switch his medicines because he is having trouble finding the OPANA.”
In his exam findings, Respondent noted “[l]ow back paraspinal and spinal tenderness,” “[n]egative straight leg raise,” and “[n]euro intact.”
Respondent further documented that he discussed the “[a]ddictive, dependence, and tolerance nature of the medicines, as well as alternatives.”
During this visit, Respondent also required B.B. to provide a UDS. The preliminary screening found that B.B. was negative for opiates and morphine. And according to the confirmatory testing done by the lab, which was reported back to Respondent on April 17, 2012, B.B. tested positive for oxymorphone, which was expected based on Respondent's having prescribed Opana to him.
Dr. Owen found it problematic that B.B. had told Respondent that his pain was worse, that he had run out of his medicines and had them stolen.
Well, one, his pain is worse, so why is it worse? Two is he's run out of his medications, and then he had them stolen. What is it? Did you run out of them because you self-escalated, or were they stolen and you ran out of them? It needs clarification. But either event, self-escalation or having them stolen, is a red flag.
Regarding B.B.'s report that his medications were stolen, Dr. Owen testified that because there had “been the aberrant urine drug tests before . . . this, there is [sic] enough aberrant behaviors that” Respondent needed “to get the person to an addictionologist or a psychologist, or just stop prescribing these controlled substances since there's no evidence they're helping this gentleman.”
Dr. Owen also found problematic the notations in the visit note that B.B. reported that “his pain has been was worse” and that “[h]e has done fairly well.”
Dr. Owen further testified that Respondent “did not” address B.B.'s “ongoing stress and anxiety issues” and that “[h]e did not” conduct a thorough patient history.
Dr. Owen reiterated his earlier testimony that the patient record was “not adequate” to establish “medical necessity” for prescribing the controlled substances on this date and that between September 22, 2011 (when he assumed the care of B.B.) and April 12, 2012, Respondent had never established medical necessity for prescribing controlled substances to B.B.
The CALJ sustained the Government's allegations only with respect to its contention that Respondent ignored the PMP data showing that B.B. was obtaining early refills of alprazolam and failed to take any action in response to this information, such as contacting the other prescribers or cautioning B.B. in response to this information. R.D. at 61-62. For reasons explained previously, the evidence does not support the contention that B.B. exhibited a pattern of obtaining early refills as of this visit. I also agree with the CALJ that the evidence does not support a finding that Respondent provided B.B. with an early refill of his pain medications.
However, for many of the same reasons previously discussed, the CALJ rejected the other evidence offered by the Government to prove that the prescriptions violated 21 CFR 1306.04(a). For example, the CALJ again reasoned that “the UDS results prior to the April 12 amino assay UDS” were not “adequately noticed by the Government . . . regarding this prescribing event [and] are unavailable to support its expert's opinion here.” R.D. at 60. And the CALJ further asserted that the Government could not rely on litigation by consent because it did “not timely and affirmatively raise[]” this theory.
From on or about August 25, 2011 through on or about May 9, 2012, you issued controlled substance[] prescriptions to B.B. in violation of Federal and Oklahoma state law. You were aware on each of the occasions that you issued controlled substance[] prescriptions to B.B. that he presented
ALJ Ex. 1, at 1 ¶ 3.
The CALJ also failed to give weight to Dr. Owen's testimony that Respondent should have either referred B.B. to a specialist in addiction or spoken with his mental health professional, asserting that the Government did “not establish[ ] that good medical practice in Oklahoma require[d] that.” R.D. at 60. However, Dr. Owen is board-certified in pain management, a member of multiple national professional societies which focus on pain medicine and is a peer reviewer on pain medicine for the Journal of Pain Management. As previously explained, while the Oklahoma referral provision does not categorically require that a physician refer a patient to a specialist in addiction or consult with other providers, it clearly contemplates that a physician will use sound clinical judgment in determining whether a referral or consultation is necessary. And as to whether Respondent exercised sound clinical judgment when he neither referred B.B. to an addictionologist nor consulted with his mental health providers, Respondent produced no evidence showing that the standard of care in Oklahoma is materially different from the standard in Texas or the standard that is generally recognized by pain management practitioners.
In rejecting the Government's evidence, the CALJ also explained that the Government did not establish that “good medical practice in Oklahoma require[d]” that Respondent “document[] in any specific level of detail the Respondent's discussion with B.B. about . . . [his] success on the treatment plan.” R.D. at 60. Yet the Board's Regulation directs that “[t]he physician should periodically review the course of pain treatment” and “[c]ontinuation or modification of controlled substances for pain management therapy depends on the physician's evaluation of progress toward treatment objectives. Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function or improved quality of life. Objective evidence of improved or diminished function should be monitored . . . ” Okla. Admin. Code § 435:10-7-11(4). Moreover, another provision of the regulation requires physicians to “keep accurate and complete records to include . . . follow-up evaluations . . . . [and] periodic reviews.”
Moreover, even if the Board's rule does not mandate “any specific level of detail,” Dr. Owen offered credible testimony as to why the standard of care clearly requires more documentation than that made by Respondent. As he explained, “the purpose of documentation is for continuity of care. Not only continuity of care for this same provider from visit to visit but continuity of care should somebody else assume the care later on down the road or should you need to get a consultation, that the consultant can read your notes and understand what was happening with this patient at this point in time.” Tr. 210.
Notably, while B.B.'s treatment objective was to return to work without pain, B.B. had not returned to work as of the April 12 visit (and never did during the course of Respondent's prescribing) and yet in the box for documenting whether he was meeting his treatment objective, Respondent wrote the words “fair” and “yes.” Yet at the hearing, Respondent did not recall why he wrote “yes,” just as he was “unsure” as to why he had written “fair” in the box at previous visits. As Respondent could not even explain why he made these entries, it is clear that no other physician who subsequently took over B.B.'s care could “understand what was happening with” B.B. at various points. So too, as Respondent could not explain the inconsistency between his having noted in B.B.'s progress note that “his pain was worse” while B.B. reported a decrease in his numeric pain rating and that “he has done fairly well,” I give weight to Dr. Owen's testimony that Respondent's notes fell below the standard of care.
Finally, the CALJ declined to give weight to Dr. Owen's testimony regarding Respondent's failure to address the aberrant immunoassay drug test result once again asserting that the Board's regulations “contain no specific directive to mandate such a notation.” R.D. at 61. However, as the CALJ noted, “Respondent did not address this issue in his testimony” and thus, there is no dispute that he took no action other than to send the specimen in for confirmatory testing. While it is true that Dr. Owen testified that the immunoassay test has reliability problems and thus, by sending the specimen to the lab for further testing “it could not be said that [Respondent] took no action,” what is notable is that Respondent offered no testimony that he ever asked B.B. which drugs had been purportedly stolen and when they had been stolen. Obviously, without determining and documenting what drugs had been stolen, Respondent could not evaluate whether the lab's finding (using GC-MS testing) that B.B. had tested negative for morphine was aberrational.
Moreover, even crediting Respondent's testimony regarding the notation that B.B. wanted to switch medications because he was having troubling finding immediate release Opana, his testimony regarding the limitations imposed by the Medicaid formulary, and his explanation for why he provided B.B. with Percocet, I still conclude that the Government has proved that Respondent violated 21 CFR 1306.04(a) when he issued the Opana 20 ER and Percocet 10 prescriptions at this visit. As Dr. Owen testified, Respondent still had not done a thorough patient history and evaluation of B.B.'s pain complaint; failed to properly address multiple instances of aberrant behavior including the three previous UDSs and the other red flags he presented (
Of further note, Respondent could not explain why he made the entries of “fair” and “yes” for whether B.B. was meeting his treatment objective, when he acknowledged that B.B.'s treatment objective was to return to work but never did so. And while he essentially agreed with Dr. Owen's testimony that a patient with depression and anxiety has a higher perception of pain and is at greater risk of self-escalating his use of controlled substances, he nonetheless maintained that while “[i]n every other field but mental health we do” consult with the patient's other practitioners, consulting with mental health practitioners who are “also prescribing controlled substances . . . [t]hat doesn't happen very often.” Tr. 410. I thus conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when, on this date, he issued the Opana and Percocet prescriptions to B.B. 21 CFR 1306.04(a).
On April 25, 2012, Respondent provided B.B. with a prescription for 30 Roxicodone (oxycodone) 15 mg. GX 5, at 4. B.B.'s file contains no documentation that there was an office visit, and notwithstanding that this was a change in medication from what Respondent had prescribed at the previous visit, there is no notation in the progress notes as to why he changed the prescription.
According to Dr. Owen, when adding a new drug to a patient's regimen of pain medications, a physician “would have to establish medical necessity with some type of note, using sound medical rationale.” Tr. 175. Dr. Owen further testified that making such a notation is “a standard of care, and it's part of the documentation guidelines that are issued across every state for the most part.”
Regarding the Roxicodone prescription, Respondent asserted that he “was just doing a two-week trial, trying to figure out his dose, and at the time, most likely the patient didn't have any punches on his card left, and Roxicodone is much cheaper than Percocet, and it's the same medication.”
As for the April 12 UDS lab report, which he had obtained prior to issuing the prescription and which found that morphine was not detected and that this result was not expected based on the prescribed medications, Respondent testified that in his opinion the result was not aberrant. Respondent did not explain whether this was based on his previous claim that the oxymorphone is a metabolite of morphine or because B.B. had reported that his medications were stolen. Tr. 364-66.
As Respondent offered no testimony that he asked B.B which of his drugs were stolen and was told that it was the morphine, B.B.'s claim of stolen drugs does not render the test non-aberrant. Moreover, the lab reports noted various instances in which the presence of various metabolites was consistent with prescribed medications and that the particular substances were metabolites of prescribed drugs but included no such notation with respect to oxymorphone and morphine. Finally, Respondent's testimony is contradicted by science and he offered no evidence which would support a finding that he had a good faith but mistaken belief that oxymorphone is a metabolite of morphine. Based on these reasons, I find that the April 12 UDS was aberrant and that Respondent knew it to be.
While the CALJ concluded that the Government could not rely on the four UDS reports, he nonetheless found that the evidence supported the Government's contention that Respondent acted outside of the usual course of professional practice in issuing the prescriptions. R.D. at 64. While the CALJ accepted Respondent's assertion that Percocet and Roxicodone are similar drugs in that they both contain oxycodone (although he noted that Roxicodone does not contain acetaminophen and contains only oxycodone),
While I agree with the CALJ that Respondent's testimony was unpersuasive, I also give weight to Dr. Owen's testimony that Respondent had not established medical necessity for prescribing controlled substances by demonstrating that conservative treatments had been tried and been unsuccessful and by establishing an “objective therapeutic benefit from the previous use of controlled substances.” Tr. 176. Moreover, Dr. Owen's testimony as to the other reasons why
On May 9, 2012, Respondent wrote B.B. a prescription for 60 Opana ER 20 mg. GX 3, at 93; GX 5, at 27. Respondent did not require an office visit, and he made no notations in the progress notes regarding the prescription.
Asked to provide his opinion as to Respondent's prescribing of controlled substances from September 2011 through May 9, 2012, Dr. Owen opined that Respondent did not adequately review B.B.'s medical history.
Asked why he refilled the prescriptions,
Moreover, at no point did the Government put in issue whether Respondent violated 21 CFR 1306.04(a) when he issued the Roxicodone prescription. The Government did not mention this prescription in the specific allegation it made in the Show Cause Order regarding the events of May 9, 2012,
The CALJ found that because he “had PMP data indicating that B.B. had previously engaged in a pattern of procuring early refills from multiple prescribers,” Respondent's issuance of the prescription was “a breach of [his] obligation as a registrant to guard against the diversion of controlled substances.” R.D. at 67-68. The CALJ thus concluded that Respondent acted outside of the course of professional practice in issuing the Opana prescription.
I am, however, left to wonder why the same reasoning did not apply to the multiple instances in which the CALJ asserted that the Government did not provide sufficient notice that it intended to rely on the various UDSs. Notably, paragraph 3 of the Show Cause Order alleged that:
[f]rom on or about August 25, 2011 through on or about May 9, 2012, you issued controlled substance[] prescriptions to B.B. in violation of Federal and Oklahoma state law. You were aware on each of the occasions that you issued controlled substance[] prescriptions to B.B. that he presented a high risk of abuse and/or diversion of controlled substances, as evidenced by the red flags documented in his patient file, such as aberrant urine drug tests. . . . You failed to address and, in fact, ignored these red flags, continuing to issue B.B. controlled substance prescriptions in the face of mounting evidence that he was misusing, abusing, and/or diverting the controlled substances you were prescribing.
ALJ Ex. 1, at 1.
While I agree with the CALJ that Respondent violated 21 CFR 1306.04(a) in issuing the prescription, I do so for reasons other than that B.B. had “engaged in a pattern of early refills.” As Respondent did not see B.B. on this date, I give weight to Dr. Owen's testimony that Respondent did not establish medical necessity for the prescription (or any of the prescriptions for that matter) for the reasons he explained throughout his testimony as well as for the other reasons discussed in this Decision.
* * *
In his Recommended Decision, the CALJ alleges that the Agency “has been engaged in a deliberate winnowing of the scope of Factor 2, to the extent that . . . it now largely mirrors the considerations found in Factor 4.” R.D. 77. He further asserts that the Agency's rejection of dicta which has appeared in various recommended decisions to the effect that Factor 2 “manifests Congress's acknowledgement that . . . the quantitative volume in which an applicant has engaged in the dispensing of controlled substances may be [a] significant factor” in the public interest determination,
Congress did not, however, define the term “experience” in the CSA, and as the Administrator has explained at length, the word has multiple meanings, none of which “compels the conclusion that Congress acknowledged that the quantitative volume of an applicant's dispensing may be a significant consideration under this factor, and certainly none [of these definitions] suggests that the Agency is required to count up the number of times an applicant or registrant has dispensed controlled substances,”
Notably, the CALJ does not cite to any of the sources typically invoked by the courts in cases which have held that a statute has a plain meaning.
As previously explained, Congress enacted the public interest standard to provide DEA with additional authority to address the diversion of controlled substances because prior to the 1984 amendment of section 823(f), the Agency's authority to deny an application or revoke a registration was limited to cases in which a practitioner: (1) Had materially falsified an application, (2) had been convicted of a State or Federal felony offense related to controlled substances, or (3) had his State license or registration suspended, revoked, or denied.
The Senate Report thus explained that “the bill would amend 21 U.S.C. 824(f) [sic] to expand the authority of the Attorney General to deny a practitioner's registration application.”
Indeed, as
As in past cases, the parties may continue to introduce evidence as to the extent of both a practitioner's lawful or unlawful dispensing activities. However, under Agency precedent, proof of a single act of intentional or knowing diversion remains sufficient to satisfy the Government's
The CALJ further alleges that on remand in
Not mentioned by the CALJ is that several years later, the exact same arguments were raised before the Eleventh Circuit by two different physicians and rejected without any discussion. In
So too, in
Again, the Eleventh Circuit denied the physician's petition for review, holding that “the record supports that the administrator considered all aspects of the evidence in light of the applicable statutory factors and . . . [her] decision was not arbitrary and capricious. . . . [w]e also agree with the administrator's conclusion that [the physician's] continued registration would be inconsistent with the public interest.”
The CALJ also dismisses the published decision of the Tenth Circuit in
The DEA must consider the totality of the experiences a physician has, including: the interaction reflected in each of the medical charts of patients that were seized by the DEA, the “thousands of other patients . . . [and] positive experience” with dispensing controlled substances and not merely the testimony of people trying to make a case against the physician.
The DEA, in fact, flat out disregarded the substantial experience Dr. MacKay has had with dispensing controlled substances. The law requires the DEA to consider evidence that reflects that the physician is not a danger to the public and delineates how the DEA must do so.
Brief of Petitioner, 13-14,
Notwithstanding that the Agency's decision was based entirely on the evidence with respect to two patients (K.R. and M.R.),
Despite Dr. MacKay's claim to the contrary, the Deputy Administrator considered the entire record, including the evidence in Dr. MacKay's favor. She determined, however, that none of Dr. MacKay's evidence negated the DEA's prima facie showing that Dr. MacKay had intentionally diverted drugs to K.D. and M.R. Indeed, she found that even if Dr. MacKay had provided proper medical care to all of his other patients, that fact would not overcome the government's evidence with regard to M.R. and K.D.
None of the evidence presented by Dr. MacKay undermines the evidence relating to M.R. and K.D. Although numerous patients and colleagues of Dr. MacKay related their positive experiences with him, none had any personal knowledge regarding his treatment of M.R. and K.D. Notably, Dr. MacKay's medical expert . . . failed to specifically discuss and justify Dr. MacKay's treatment of M.R. and K.D. As a result, none of Dr. MacKay's evidence contradicts the testimony and evidence presented by the DEA relating to the knowing diversion of drugs to these two patients.
The Court of Appeals then rejected MacKay's contention that the Deputy Administrator had misweighed the public interest factors. As the Court explained: “[i]n light of Dr. MacKay's misconduct relating to factors two and four, the government made a prima facie showing that [his] continued registration is inconsistent with the public interest.”
The CALJ further asserts that “to the extent that the ever-widening range of activity that the Agency considers `positive experience' is banned, Factor 2 analysis, in the majority of Agency cases, will largely consist of a reprise of evidence also considered under Factor 4.” R.D. 81. Continuing, the CALJ contends that “[t]he Government's ability to introduce alleged acts of malfeasance will warrant double consideration under Factor 2 and again under Factor 4, but respondents will remain unable to demonstrate that a transgression constituted an isolated occurrence when compared with even many years of compliant practice as a registrant.”
The CALJ is mistaken. As
Equally misplaced is the CALJ's assertion that the Government's evidence of unlawful prescribing will hence be given double consideration in the public interest determination.
As the Agency's decision on remand in
While the Agency has explained that proof of a single act of intentional or knowing diversion remains sufficient to satisfy the Government's
Thus, contrary to the CALJ's understanding, a respondent can still argue (as he/she always could) that his/her misconduct in knowingly or intentionally diverting controlled substances was “an isolated occurrence” or an “aberration” in his/her years of otherwise compliant professional practice. However, one cannot argue that his/her conduct was “an isolated occurrence” or “an aberration” without first acknowledging that he/she has engaged in unlawful conduct.
While Respondent put on no evidence as to the lawfulness of his controlled substance prescribing to patients other than B.B., I have assumed that every other prescription he has issued in the course of his professional career complied with 21 CFR 1306.04(a).
I therefore hold that the Government has established its
Where, as here,
Finally, the Agency has also held that “`[n]either
Even with respect to the violations which he found proven, the CALJ found that “one clear and consistent aspect of the record is the Respondent's almost dogged determination to accept no responsibility for his actions.” R.D. 92. This holds equally true with respect to each of the controlled substance prescriptions he issued in violation of 21 CFR 1306.04(a), as other than his meager acknowledgement that his documentation on certain progress notes could have been better, Respondent has not accepted responsibility for his misconduct with respect to any of the controlled substance prescriptions he unlawfully issued to B.B. beginning on September 22, 2011 and ending on May 9, 2012. And as explained above, the evidence supports the conclusion that Respondent was not merely neglectful, but that he engaged in knowing misconduct when he issued the prescriptions. As the Tenth Circuit has recognized, Respondent's failure to acknowledge his misconduct establishes that he is not prepared to remedy his unlawful prescribing practices.
So too, while the Agency's interest in specific deterrence is not triggered (because I deny his application), as found above, Respondent's misconduct is egregious and the Agency has a manifest interest in deterring similar misconduct by other practitioners. This interest would be compelling even if it was not the case that the nation was confronting an epidemic of opioid abuse. I therefore conclude that granting Respondent's application “would be inconsistent with the public interest.” 21 U.S.C. 823(f). Accordingly, I will deny his application.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Wesley Pope, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This Order is effective immediately.
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