Page Range | 6949-7106 | |
FR Document |
Page and Subject | |
---|---|
83 FR 7081 - Sunshine Act Meetings; National Science Board | |
83 FR 7039 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension | |
83 FR 7010 - Notice of Public Meeting of the Ohio Advisory Committee to the U.S. Commission on Civil Rights | |
83 FR 7012 - Notice of Public Meetings of the Kansas Advisory Committee. | |
83 FR 7010 - Notice of Public Meetings of the Arkansas Advisory Committee to the U.S. Commission on Civil Rights | |
83 FR 7015 - Procurement List; Additions | |
83 FR 7068 - Docket No. BOEM-2017-0078] | |
83 FR 7070 - Gulf of Mexico Outer Continental Shelf Oil and Gas Lease Sale 250; MMAA104000 | |
83 FR 6975 - Pendimethalin; Pesticide Tolerances | |
83 FR 7026 - Privacy Act of 1974; System of Records | |
83 FR 6981 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Hatheway & Patterson Superfund Site | |
83 FR 6959 - 2017 Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas | |
83 FR 7016 - Procurement List; Addition | |
83 FR 6996 - Air Plan Approval; Douglas, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plan | |
83 FR 7002 - Approval and Promulgation of State Implementation Plans; Alaska; Regional Haze Progress Report | |
83 FR 6957 - Special Local Regulation; Pamlico River, Washington, NC | |
83 FR 6994 - Safety Zone; Cape Fear River, Wilmington, NC | |
83 FR 6982 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska | |
83 FR 7106 - Voluntary Service National Advisory Committee, Notice of Meeting | |
83 FR 7083 - Advisory Committee on Reactor Safeguards; Notice of Meeting | |
83 FR 7039 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
83 FR 7080 - Request for Information on Improving the Military Selective Service Process and Increasing Participation in Military, National, and Public Service | |
83 FR 7014 - Fermi Research Alliance, et al.; Notice of Decision on Application for Duty-Free Entry of Scientific Instruments | |
83 FR 7009 - Codex Alimentarius Commission: Meeting of the Codex Committee on Residues of Veterinary Drugs in Food | |
83 FR 7008 - Submission for OMB Review; Comment Request | |
83 FR 7065 - Agency Information Collection Activities; Nonferrous Metals Surveys | |
83 FR 7022 - Privacy Act of 1974; System of Records | |
83 FR 7104 - Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Investment Securities | |
83 FR 6968 - Air Plan Approval; Connecticut; Nonattainment New Source Review Permit Requirements for the 2008 8-Hour Ozone Standard | |
83 FR 6972 - Air Plan Approval; New Hampshire; Rules for Open Burning and Incinerators | |
83 FR 7084 - New Postal Products | |
83 FR 7029 - Pine Creek Mine, LLC; Notice of Availability of Environmental Assessment | |
83 FR 7029 - Northwest Pipeline LLC; Notice of Availability of the Environmental Assessment for the Proposed North Seattle Lateral Upgrade Project | |
83 FR 7034 - California Public Utilities Commission, Transmission Agency of Northern California, Sacramento Municipal Utility District, M-S-R Public Power Agency, City of Santa Clara, California, State Water Contractors, Modesto Irrigation District, Northern California Power Agency v. Pacific Gas and Electric Company; Notice of Amended Complaint | |
83 FR 7042 - Determination of Regulatory Review Period for Purposes of Patent Extension; MOVANTIK | |
83 FR 7040 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
83 FR 7021 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Work Colleges Expenditure Report | |
83 FR 7025 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Work Colleges Application and Agreement | |
83 FR 7020 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Teacher Cancellation Low Income Directory | |
83 FR 6966 - Safety Zone; Pensacola Bay, Pensacola, FL | |
83 FR 7077 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Approval of a New Collection | |
83 FR 7048 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
83 FR 7043 - Submission of Content Necessary for Bioresearch Monitoring Inspection Planning for the Center of Drug Evaluation and Research; Availability | |
83 FR 6949 - Russian Sanctions: Addition of Certain Entities to the Entity List | |
83 FR 7064 - Announcement of Program for the Private Sector To Participate in Trade-Related Training of U.S. Customs and Border Protection and U.S. Immigration and Customs Enforcement Personnel | |
83 FR 7062 - Healthy Start Initiative: Eliminating Disparities in Perinatal Health Program Listening Session | |
83 FR 7058 - Pediatric Advisory Committee; Establishment of a Public Docket; Request for Comments; Amendment of Notice | |
83 FR 7051 - How To Prepare a Pre-Request for Designation; Guidance for Industry; Availability | |
83 FR 7059 - Determination of Regulatory Review Period for Purposes of Patent Extension; HYMOVIS | |
83 FR 6964 - Safety Zone; Santa Rosa Sound, Pensacola Beach, FL | |
83 FR 6956 - Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits | |
83 FR 7060 - Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability | |
83 FR 7050 - Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment; Guidance for Industry; Availability | |
83 FR 7056 - Migraine: Developing Drugs for Acute Treatment; Guidance for Industry; Availability | |
83 FR 7057 - Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy From Adults to Pediatric Patients 4 Years of Age and Older; Draft Guidance for Industry; Availability | |
83 FR 7047 - Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability | |
83 FR 7063 - Towing Safety Advisory Committee | |
83 FR 7078 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act | |
83 FR 7065 - Draft List of Critical Minerals | |
83 FR 7054 - Determination of Regulatory Review Period for Purposes of Patent Extension; COTELLIC | |
83 FR 6961 - Security Zone; Delaware River, Schuylkill River; Philadelphia, PA | |
83 FR 7079 - Agency Information Collection Activities: Proposed eCollection eComments Requested; Reinstatement, With Change, of a Previously Approved Collection: 2018 Census of State and Local Law Enforcement Agencies (CSLLEA) | |
83 FR 7052 - Pediatric Medical Device Development; Public Meeting; Request for Comments | |
83 FR 6986 - Proposal of Special Measure Against ABLV Bank, AS as a Financial Institution of Primary Money Laundering Concern | |
83 FR 6984 - Airworthiness Directives; The Boeing Company Airplanes | |
83 FR 7104 - Notice of Application for Approval To Discontinue or Modify a Railroad Signal System | |
83 FR 7103 - Petition for Waiver of Compliance | |
83 FR 7038 - Proposed Agency Information Collection Activities; Comment Request | |
83 FR 7077 - Plastic Decorative Ribbon From China; Determinations | |
83 FR 7076 - Notice of Receipt of Complaint; Solicitation of Comments; Relating to the Public Interest | |
83 FR 7031 - Notice of Commission Staff Attendance | |
83 FR 7032 - Black Bear Hydro Partners, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Terms and Conditions, and Prescriptions | |
83 FR 7030 - Midship Pipeline Company, LLC Notice of Availability of the Draft Environmental Impact Statement for the Proposed Midcontinent Supply Header Interstate Pipeline Project | |
83 FR 7086 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change Relating to Simplified Arbitration | |
83 FR 7096 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change, Security-Based Swap Submission or Advance Notice Relating to Amendments to the ICE Clear Europe CDS Clearing Stress Testing Policy (the “Stress Testing Policy”) | |
83 FR 7090 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the ICE Clear Europe Rules for the Transition of Trading in Certain F&O Contracts | |
83 FR 7084 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing of Proposed Rule Change To Adopt IM-8040-3 to Rule 8040 | |
83 FR 7036 - Agency Information Collection Activities: Submission for OMB Review; Comment Request (OMB No. 3064-0177) | |
83 FR 7092 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing of a Proposed Rule Change To Amend Rules Related to the Complex Order Book | |
83 FR 7035 - Availability of the Integrated Risk Information System (IRIS) Assessment Plan for Uranium; correction | |
83 FR 7011 - Notice of Public Meeting of the West Virginia Advisory Committee | |
83 FR 7012 - Notice of Public Meeting of the Indiana Advisory Committee To Hear Testimony Regarding Voting Rights in Indiana | |
83 FR 6970 - Approval and Revision of Air Quality Implementation Plans; State of New York; Regional Haze State and Federal Implementation Plans | |
83 FR 7034 - Allocations of Cross-State Air Pollution Rule Allowances From New Unit Set-Asides for 2017 Control Periods | |
83 FR 7018 - Arms Sales Notification | |
83 FR 7046 - Determination That LOTENSIN HCT (Benazepril Hydrochloride; Hydrochlorothiazide) Oral Tablets, 5 Milligrams and 6.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | |
83 FR 7017 - Defense Advisory Committee on Investigation Prosecution and Defense of Sexual Assault in the Armed Forces; Notice of Federal Advisory Committee Meeting | |
83 FR 7062 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
83 FR 7080 - Division of Longshore and Harbor Workers' Compensation Proposed Extension of Existing Collection; Comment Request | |
83 FR 7036 - Environmental Impact Statements; Notice of Availability | |
83 FR 7013 - Lightweight Thermal Paper From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016 | |
83 FR 7015 - Hot-Rolled Steel Products From Brazil: Rescission of 2016 Countervailing Duty Administrative Review | |
83 FR 7098 - Office of the Under Secretary of State for Public Diplomacy and Public Affairs Request for Proposal (RFP) for the Fundraising, Project Management, Design, Construction, Operation, Disassembly and Removal of a USA Pavilion at Expo 2020 Dubai | |
83 FR 7017 - Record of Decision for the Presidential Aircraft Recapitalization Program at Joint Base Andrews-Naval Air Facility Washington, Maryland Final Environmental Impact Statement |
Food Safety and Inspection Service
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Air Force Department
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
U.S. Immigration and Customs Enforcement
Geological Survey
Ocean Energy Management Bureau
Federal Bureau of Investigation
Justice Programs Office
Workers Compensation Programs Office
Federal Aviation Administration
Federal Railroad Administration
Comptroller of the Currency
Financial Crimes Enforcement Network
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.
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Bureau of Industry and Security, Commerce.
Final rule.
The Bureau of Industry and Security (BIS) with this final rule amends the Export Administration Regulations (EAR) by adding twenty-one entities to the Entity List. The twenty-one entities that are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. BIS is taking this action to ensure the efficacy of existing sanctions on the Russian Federation (Russia) for violating international law and fueling the conflict in eastern Ukraine. These entities will be listed on the Entity List under the destinations of Georgia, Poland and Russia.
This rule is effective February 16, 2018.
Chair, End-User Review Committee, Office of the Assistant Secretary, Export Administration, Bureau of Industry and Security, Department of Commerce, Phone: (202) 482-5991, Email:
The Entity List (Supplement No. 4 to Part 744 of the EAR) identifies entities and other persons reasonably believed to be involved in, or that pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy of the United States. The EAR imposes additional licensing requirements on, and limits the availability of most license exceptions for, exports, reexports, and transfers (in-country) to those persons or entities listed on the Entity List. The license review policy for each listed entity is identified in the License Review Policy column on the Entity List and the impact on the availability of license exceptions is described in the
The End-user Review Committee (ERC) is composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy, and where appropriate, the Treasury. The ERC makes decisions to add an entry to the Entity List by majority vote and to remove or modify an entry by unanimous vote. The Departments represented on the ERC have approved these changes to the Entity List.
This rule adds twenty-one entities to the Entity List. These twenty-one entities are being added on the basis of § 744.11 (License requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR. The twenty-one entities being added to the Entity List consist of one entity in Georgia, one entity in Poland and ninteteen entities in Russia.
Under § 744.11(b) (Criteria for revising the Entity List) of the EAR, persons for whom there is reasonable cause to believe, based on specific and articulable facts, have been involved, are involved, or pose a significant risk of being or becoming involved, in activities that are contrary to the national security or foreign policy interests of the United States and those acting on behalf of such persons may be added to the Entity List. The entities being added to the Entity List have been determined to be involved in activities that are contrary to the national security or foreign policy interests of the United States. Specifically, in this rule, BIS adds entities to the Entity List for violating international law and fueling the conflict in eastern Ukraine. These additions ensure the efficacy of existing sanctions on Russia. The particular additions to the Entity List and related authorities are described below.
Four entities are added based on activities that are described in Executive Order 13660 (79 FR 13493),
Executive Order 13660 blocks all property and interests in property that are in the United States, that come within the United States, or that are or come within the possession or control of any United States person (including any foreign branch) of any person determined by the Secretary of the Treasury, in consultation with the Secretary of State, to be responsible for or complicit in, or to have engaged in, directly or indirectly, misappropriation of state assets of Ukraine or of an economically significant entity in Ukraine, among other activities. Under Section 8 of the Order, all agencies of the United States Government are directed to take all appropriate measures within their authority to carry out the provisions of the Order.
The Department of the Treasury's Office of Foreign Assets Control (OFAC), pursuant to Executive Order 13660, has designated the following four entities as being within the scope of the Order: Doncoaltrade SP Z O O; Kompaniya Gaz-Alyans; Ugolnye Tekhnologii, OOO; and ZAO Vneshtorgservis. In conjunction with that designation, the Department of Commerce adds all four entities to the Entity List under this rule and imposes a license requirement for exports,
Two entities are added based on activities that are described in Executive Order 13661 (79 FR 15533),
Executive Order 13661 includes a directive that all property and interests in property that are in the United States, that hereafter come within the United States, or that are or thereafter come within the possession or control of any United States person (including any foreign branch) of the following persons are blocked and may not be transferred, paid, exported, withdrawn, or otherwise dealt in: Persons determined by the Secretary of the Treasury, in consultation with the Secretary of State to have either materially assisted, sponsored or provided financial, material or technological support for, or goods and services to or in support of a senior official of the government of the Russian Federation or operate in the defense or related materiel sector in Russia. Under Section 8 of the Order, all agencies of the United States Government are directed to take all appropriate measures within their authority to carry out the provisions of the Order.
The Department of the Treasury's OFAC, pursuant to Executive Order 13661, on behalf of the Secretary of Treasury, and in consultation with the Secretary of State, has designated the following two entities as being within the scope of the Order: Evro Polis Ltd. and Instar Lodzhistiks, OOO. BIS is also adding these entities to the Entity List pursuant to Executive Order 13661. The two entities added to the Entity List under Executive Order 13661 meet the criteria of Section 1, subparagraph B of the Executive Order 13661 because they operate in Russia's arms or related materiel sector. With respect to these two entities, BIS imposes a license requirement for exports, reexports, or transfers (in-country) of all items subject to the EAR to these entities. This license requirement implements an appropriate measure within the authority of the EAR to carry out the provisions of Executive Order 13661.
Twelve entities are added to the Entity List based on activities that are described in Executive Order 13662 (79 FR 16169),
Specifically, Executive Order 13662 expanded the scope to include sectors of the Russian economy as may be determined by the Secretary of the Treasury, in consultation with the Secretary of State, such as financial services, energy, metals and mining, engineering, and defense and related materiel. Under Section 8 of the Order, all agencies of the United States Government are directed to take all appropriate measures within their authority to carry out the provisions of the Order.
The Department of the Treasury's OFAC, pursuant to Executive Order 13662, on behalf of the Secretary of the Treasury, and in consultation with the Secretary of State, has designated the following twelve entities as operating in the energy sector of Russia and owned or controlled by, or have acted or purported to act for or on behalf of, directly or indirectly, a person whose property and interests are blocked pursuant to the Order: Kaliningradnefteprodukt OOO; Kinef OOO; Kirishiavtoservis OOO; Lengiproneftekhim OOO; Media-Invest OOO; Novgorodnefteprodukt OOO; Pskovnefteprodukt OOO; SNGB AO; SO Tvernefteprodukt OOO; Sovkhoz Chervishevski PAO; Strakhovove Obshchestvo Surgutneftegaz OOO; and Surgutmebel OOO. In conjunction with that designation, BIS adds all twelve of the entities to the Entity List under this rule and imposes a license requirement for exports, reexports, or transfers (in-country) of all items subject to the EAR to these blocked persons, when the exporter, reexporter or transferor knows that the item will be used directly or indirectly in exploration for, or production of, oil or gas in Russian deepwater (greater than 500 feet) or Arctic offshore locations or shale formations in Russia, or is unable to determine whether the item will be used in such projects. This license requirement implements an appropriate measure within the authority of BIS to carry out the provisions of Executive Order 13662.
Three entities are added based on activities that are described in Executive Order 13685 (79 FR 77357),
The Department of the Treasury's OFAC, pursuant to Executive Order 13685, on behalf of the Secretary of the Treasury and in consultation with the Secretary of State, has designated the following three entities as operating in the Crimea region of Ukraine: Limited Liability Company Foreign Economic Association Technopomexport; PJSC Power Machines; and VAD, AO. In conjunction with these designations, BIS adds all three of these entities to the Entity List under this rule and imposes a license requirement for exports, reexports, or transfers (in-country) of all items subject to the EAR to these blocked persons. This license requirement implements an appropriate measure within the authority of the EAR to carry out the provisions of Executive Order 13685.
For the twenty-one entities added to the Entity List based on activities that are described in Executive Order 13660, 13661, 13662 or 13685, BIS imposes a license requirement for all items subject to the EAR and a license review policy of presumption of denial. The license requirements apply to any transaction in which items subject to the EAR are to be exported, reexported, or transferred (in-country) to any of the entities or in which such entities act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the entities being added to the Entity List in this rule.
The acronym “a.k.a.” (also known as) is used in entries on the Entity List to help exporters, reexporters and transferors to better identify listed persons on the Entity List.
This final rule adds the following twenty-one entities to the Entity List:
Although the Export Administration Act of 1979 expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 15, 2017, 82 FR 39005 (August 16, 2017), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act of 1979, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.
2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to
3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.
4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public comment and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States. (
5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601
Exports, Reporting and recordkeeping requirements, Terrorism.
For the reasons stated in the preamble, the Bureau of Industry and Security amends part 744 of the Export Administration Regulations (15 CFR parts 730-774) as follows:
50 U.S.C. 4601
The additions read as follows:
Pension Benefit Guaranty Corporation.
Final rule.
This final rule amends the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans to prescribe interest assumptions under the regulation for valuation dates in March 2018. The interest assumptions are used for paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.
Effective March 1, 2018.
Daniel S. Liebman (
PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminated single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's website (
PBGC uses the interest assumptions in appendix B to part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in appendices B and C of the benefit payment regulation are the same.
The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for March 2018.
The March 2018 interest assumptions under the benefit payments regulation will be 0.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for February 2018, these assumptions are unchanged.
PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.
Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during March 2018, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.
PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.
Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).
Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.
In consideration of the foregoing, 29 CFR part 4022 is amended as follows:
29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.
Issued in Washington, DC, by
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a special local regulation on the navigable waters of the Pamlico River near Washington, North Carolina. This special local regulation is intended to restrict vessel traffic on the Pamlico River during a high-speed boat race. This action is intended to restrict vessel traffic movement in the regulated area to protect participants, spectators, and property from the hazards posed by high-speed boat races. Entry of vessels or persons into this special local regulation is prohibited unless specifically authorized by the Captain of the Port (COTP) North Carolina or a designated representative.
This rule is effective from 7 a.m. on February 23, 2018, through noon on February 24, 2018, with an alternate date of February 25, 2018 from 7 a.m. through noon.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer Matthew Tyson, Waterways Management Division, U.S. Coast Guard Sector North Carolina, Wilmington, NC; telephone: 910-772-2221, email:
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard was notified about the race on December 1, 2017 and there were multiple revisions over the following three weeks. It is impracticable and contrary to the public interest to delay this action. Waiting for a comment period to run would inhibit the Coast Guard's ability to protect the public and participants from the dangers associated with the high-speed boat race scheduled to start on February 23, 2018.
For the same reasons, the Coast Guard finds good cause to make this rule effective less than 30 days after publication, under 5 U.S.C. 553(d)(3). Immediate implementation is required to protect the public and participants from the dangers associated with these activities.
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The COTP North Carolina has determined that potential hazards associated with the Iconic Marine Group Kilo Race scheduled on February 23 and February 24, 2018, with an alternate date February 25, 2018, is a safety concern for mariners during the high-speed boat race on the Pamlico River near Washington, North Carolina. This rule is necessary to protect persons and vessels from the potential hazards associated with the high-speed boat race.
This rule establishes a special local regulation on a portion of the Pamlico River on February 23 and February 24, 2018, with an alternate date of February 25, 2018, in the event that weather or other factors do not allow the race to commence on the primary dates. The special local regulation will be enforced for approximately one hour between the hours of 7 a.m. and noon, when environmental conditions meet the requirements for the race. The exact times of enforcement will be broadcast locally over VHF-FM marine radio. The special local regulation will include all navigable waters of the Pamlico River near Washington, North Carolina, from approximate positions: Latitude 35°28′42″ N, longitude 076°59′14″ W, then northwest to latitude 35°29′53″ N, longitude 077°01′18″ W, then northwest along the shoreline to latitude 35°32′29″ N, longitude 077°03′47″ W, then northwest to latitude 35°32′34″ N, longitude 077°03′56″ W, then northeast to latitude 35°32′42″ N, longitude 077°03′50″ W, then southeast along the shoreline to latitude 35°29′06″ N, longitude 076°58′48″ W, then southwest back to the point of origin, a length of approximately six miles. The duration of this special local regulation is
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, and duration of the proposed special local regulation. Vessel traffic will not be allowed to enter or transit a portion of the Pamlico River on February 23 and February 24, 2018 with an alternate date of February 25, 2018 for approximately one hour on each day. The Coast Guard will issue a Local Notice to Mariners and transmit a Broadcast Notice to Mariners via VHF-FM marine channel 16 regarding the special local regulation. The specific enforcement times will be broadcast locally each day prior to the race on VHF-FM marine channel 16. This portion of the Pamlico River has been determined to be a low traffic area during this time of the year. This rule allows vessels to request permission to enter as a spectator or pass through the special local regulation.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the special local regulation may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a special local regulation lasting approximately one hour on three consecutive days that prohibits entry into a portion of the Pamlico River. It is categorically excluded from further review under paragraph L60 (a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(c)
(2) With the exception of participants and spectators, entry into or remaining in this special local regulation is prohibited unless authorized by the COTP North Carolina or the COTP North Carolina's Patrol Commander. All other vessels must depart the special local regulation immediately.
(3) To request permission to remain in, enter, or transit through the special local regulation, contact the COTP North Carolina or the COTP North Carolina's Patrol Commander through the Coast Guard Sector North Carolina Command Duty Officer, Wilmington, North Carolina, at telephone number 910-343-3882 or on VHF-FM marine band radio channel 13 (165.65 MHz) or channel 16 (156.8 MHz).
(d)
(e)
(f)
Coast Guard, DHS.
Notification of expired temporary rules issued.
This document provides notification of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the
This document lists temporary Coast Guard rules that became effective, primarily between October 2017 to December 2017, unless otherwise indicated, and were terminated before they could be published in the
Temporary rules listed in this document may be viewed online, under their respective docket numbers, using the Federal eRulemaking Portal at
For questions on this document contact Yeoman First Class David Hager, Office of Regulations and Administrative Law, telephone (202) 372-3862.
Coast Guard District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety and security needs within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations.
Timely publication of these rules in the
The following unpublished rules were placed in effect temporarily during the period between October 2017 to December 2017 unless otherwise indicated. To view copies of these rules, visit
Coast Guard, DHS.
Final rule.
The Coast Guard is establishing a permanent security zone within portions of the Delaware River, and Schuylkill River, for the protection of Very Important Persons (VIP) who arrive or depart from Philadelphia International Airport, Philadelphia, PA. This permanent rule will allow for the expedited enforcement of the security zone when short notice is received by the Coast Guard regarding such travel arrangements. The security zone will be enforced only during times of a protected VIP transit to or from the airport and will restrict vessel traffic while the zone is being enforced. Only vessels or people specifically authorized by the Captain of the Port, Delaware Bay, or designated representative, may enter or remain in the regulated area.
This rule is effective March 19, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rulemaking, call or email Petty Officer Amanda Boone, U.S. Coast Guard, Sector Delaware Bay, Waterways Management Division, Coast Guard; telephone (215) 271-4814, email
On occasion, protected VIPs will arrive or depart Philadelphia International Airport, Philadelphia, PA, which is located within the Coast Guard Sector Delaware Bay Captain of the Port (COTP) zone. These visits require the implementation of heightened security measures for protection of VIPs who may travel over or on portions of the Delaware River or Schuylkill River on their route to or from the airport. The purpose of this rulemaking is to protect the VIP and the public from destruction, loss, or injury from sabotage, subversive acts, or other malicious or potential terrorist acts. This rule will allow expedited enforcement of the security zone for protected VIPs traveling to or from Philadelphia International Airport when short notice is provided to the COTP.
On May 15, 2017, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Security Zone; Delaware River, Schuylkill River, Philadelphia, PA” (82 FR 22301). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this proposed permanent security zone. During the comment period that ended June 14, 2017, we received one comment.
The Coast Guard is establishing this rulemaking under authority in 33 U.S.C. 1231. The purpose of this rulemaking is to protect VIPs and the public from destruction, loss, or injury from sabotage, subversive acts, or other malicious or potential terrorist acts.
As noted above, we received one comment on our NPRM published May 15, 2017. The comment had seven questions regarding establishment of the permanent security zone.
1.
In the past, similar temporary security zones in this general area have been established in order to provide protection for traveling VIPs. The creation of security zones in this manner, by necessity, has limited opportunity to the public for advanced notification of establishment and enforcement procedures and intentions. While this rule does not provide the exact times and dates that the security zone will be enforced, the resulting public awareness better serves the maritime community and industry operating on this portion of the Delaware River by establishing a pre-determined location and guidelines in the event of activation. The establishment of this permanent security zone provides the best opportunity for public awareness and notification. This regulatory text has been amended to include this limitation.
2.
3.
4.
5.
6.
7.
We made four changes in the regulatory text of this rule from the proposed rule in the NPRM. First, we noted that the coordinates listed in paragraph (a), Location, use North American Datum 83. Second, we made stylistic changes to the format of the contents of paragraph (b), Definitions. Third, within paragraph (b), Definitions, we defined the meanings and intent of the term Very Important Person (VIP). Fourth, we have amended paragraph (d), Enforcement, to specifically state that the security zone can only be used in relation to the movement of VIPs to or from the Philadelphia International Airport.
This rule establishes a permanent security zone on all waters of the Delaware River in the vicinity of Philadelphia International airport, within an area bound to the west by a line drawn from the New Jersey shoreline at Thompson Point, latitude 39°50′37″ N, longitude 75°18′23″ W, thence northwest to the Pennsylvania shoreline at latitude 39°51′45″ N, longitude 75°18′46″ W; thence up river and bound shoreline to shoreline; bound to the east by a line drawn from the New Jersey shoreline at latitude 39°52′28″ N, longitude 75°11′14″ W, and thence northwest to the Pennsylvania shoreline near the eastern side of mouth to the Schuylkill River at latitude 39°53′05″ N, longitude 75°11′34″ W; the security zone extends north into the waters of Schuylkill River, bound from shoreline to shoreline, including the waters of Schuylkill River adjacent to the Navy Yard Reserve Basin Bridge, and terminates along a line drawn from latitude 39°54′04″ N, longitude 75°12′56″ W, thence eastward across the Schuylkill River to latitude 39°54′07″ N, longitude 75°12′48″ W, located approximately 500 yards northwest and parallel with the George C. Platt Memorial—Penrose Avenue lift-bridge. This security zone will be enforced with actual notice by the U.S. Coast Guard representatives on scene, as well as other methods listed in 33 CFR 165.7.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action is based on the security zone's size, location, and duration. Although the security zone area covers a large portion of the navigable waterways, mariners may request permission from COTP Coast Guard Sector Delaware Bay or the designated representative to transit or remain in the security zone. Furthermore, the duration of the security zone would not significantly impact vessels because of the small amount of time it takes for protected VIP to transit to or from the airport. Advance notifications will be made to the local
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received one comment from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the security zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a security zone generally lasting no more than 2 hours, which will restrict vessels from anchoring or transiting in portions of the Delaware River while protected VIPs arrive or depart from the Philadelphia International Airport. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) Only vessels or people specifically authorized by the Captain of the Port, Delaware Bay, or designated representative, may enter or remain in the regulated area. To request permission to enter or remain in the regulated area contact the COTP or the COTP's representative on VHF-FM channel 13 or 16. Vessel operators and persons within the security zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative. No person may swim upon or below the surface of the water of this security zone unless authorized by the COTP or his designated representative.
(3) Upon being hailed by an official patrol vessel or the designated representative, by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed. Failure to comply with lawful direction may result in expulsion from the regulated area, citation for failure to comply, or both.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for the navigable waters within a 500 yard radius of the Kokosing Cable Lay Barge on the Santa Rosa Sound, Pensacola Beach, FL. This temporary safety zone is necessary to provide for the safety of life and property on these navigable waters during a power cable laying project taking place on the waterway. Entry into or transiting in this zone is prohibited to all vessels, mariners, and persons unless specifically authorized by the Captain of the Port Sector Mobile (COTP) or a designated representative.
This rule is effective without actual notice from February 16, 2018 through March 30, 2018. For the purposes of enforcement, actual notice will be used from February 10, 2018 through February 16, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Kyle D. Berry, Sector Mobile, Waterways Management Division, U.S. Coast Guard; telephone 251-441-5940, email
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest. It is impracticable to publish an NPRM because we must establish this safety zone by February 10, 2018 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. It is also contrary to the public interest as it would delay the safety measures necessary to protect life and property from the possible hazards associated with the power cable laying project.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Mobile (COTP) has determined that potential hazards associated with the power cable laying project from February 10, 2018 through March 30, 2018 will be a safety concern for any vessels or persons in the vicinity of the Kokosing Cable Lay Barge located between positions 30°21′26.0″ N, 87°09′13.0″ W and 30°20′04.7″ N, 87°08′20.8″ W on the Santa Rosa Sound, Pensacola Beach, FL. This rule is needed to protect the public, mariners, and vessels from the potential hazards
This rule establishes a temporary safety zone encompassing all navigable waters within a 500 yard radius of the power cable laying project in the vicinity of the Kokosing Cable Lay Barge located between positions 30°21′26.0″ N, 87°09′13.0″ W and 30°20′04.7″ N, 87°08′20.8″ W from February 10, 2018 through March 30, 2018. The location and duration of this safety zone is intended to protect persons and vessels during the power cable laying project taking place on this navigable waterway. No person or vessel will be permitted to enter or transit within the safety zone, unless specifically authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Mobile. Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM channel 16 or by telephone at 251-441-5976. Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. Public notifications will be made to the local maritime community prior to the event through Broadcast Notice to Mariners (BNM).
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protectors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory determination is based on the size, location, and duration of the safety zone. This temporary safety zone will only restrict navigation in a 500 yard radius portion of the Santa Rosa Sound, in Pensacola Beach, FL for duration of the power cable laying project. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners (BNM) via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will prohibit entry within a 500 yard radius of the Kokosing Cable Lay Barge on the Santa Rosa Sound. It is categorically excluded from further
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) Entry into this zone is prohibited unless authorized by the Captain of the Port Sector Mobile (COTP) or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Mobile.
(3) Persons or vessels seeking to enter into or transit through the zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM channel 16 or by telephone at 251-441-5976.
(4) Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a safety zone for all navigable waters on Pensacola Bay within 500 yards of the construction of the new Pensacola Bay Bridge in Pensacola, FL. The purpose of the safety zone is to protect personnel, vessels, and the marine environment from potential hazards created by work performed during the construction of the new bridge located across the Pensacola Bay. This rulemaking restricts speed to an idle speed or slowest safe speed for all vessels, mariners, and persons unless specifically authorized by the Captain of the Port Sector Mobile (COTP) or a designated representative.
This rule is effective without actual notice from February 16, 2018 until December 31, 2020. For the purposes of enforcement, actual notice will be used from February 7, 2018 until February 16, 2018.
If you have questions about this rulemaking, call or email Lieutenant Kyle D. Berry, Sector Mobile, Waterways Management Division, U.S. Coast Guard; telephone 251-441-5940, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The construction of the Pensacola Bay Bridge has advanced to the phase requiring the presence of vessels, barges, and cranes that are now working in and around the main navigation channel and other areas frequently navigated by recreational vessels. Hazards associated with this phase of the construction include accidental falling debris, submerged objects, collision, allision, and other navigational hazards. It is impracticable to publish an NPRM because we must establish this safety zone immediately to prevent injury to persons and vessels and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), and for the reasons stated above, the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Mobile (COTP) has determined that potential hazards associated with the bridge work that is currently ongoing will be a safety concern for anyone within 500 yards of the construction of the new Pensacola Bay Bridge. This rule is needed to protect personnel, vessels, and the marine environment in the navigable
This rule establishes a temporary safety zone effective from February 7, 2018 until December 31, 2020 on Pensacola within 500 yards of the construction of the new Pensacola Bay Bridge in Pensacola, FL. The safety zone is needed to protect life and property from the hazards associated with the construction of the new bridge on Pensacola Bay. This rulemaking restricts speed to an idle speed or slowest safe speed for all vessels, mariners, and persons unless specifically authorized by the COTP or a designated representative. The duration of the zone is intended to ensure the safety of people and vessels on these navigable waters during the construction of the new bridge.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on size, location, and duration of the rulemaking. This safety zone will be in place within 500 yards of the construction of the new Pensacola Bay Bridge until the estimated completion of the bridge on December 31, 2020. Vessels are permitted to enter the safety zone, but must do so at idle or the slowest safe speed. Additionally, the Coast Guard will issue Broadcast Notices to Mariners via VHF-FM marine channel 16 about the regulation so that waterway users may plan accordingly for transits during this restriction.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of federal employees who enforce, or otherwise determine compliance with, federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under executive order 13132, federalism, if it has 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. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in executive order 13132.
Also, this rule does not have tribal implications under executive order 13175, consultation and coordination with Indian Tribal governments, because it does not have a substantial direct effect 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a state, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves safety zone within 500 yards of the construction of the new Pensacola Bay Bridge on Pensacola Bay, Pensacola, FL. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine Safety, Navigation (water), Reporting and Recordkeeping Requirements, Security Measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve the state implementation plan (SIP) revision submitted on March 9, 2017 by the Connecticut Department of Energy and Environmental Protection (CT DEEP) addressing the nonattainment new source review (NNSR) requirements for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS). The SIP revision addresses both of Connecticut's ozone nonattainment areas for the 2008 ozone NAAQS; the Greater Connecticut area and the Connecticut portion of the New York-N. New Jersey-Long Island, NY-NJ-CT area. The Connecticut portion of the New York-N. New Jersey-Long Island, NY-NJ-CT ozone nonattainment area consists of Fairfield, New Haven, and Middlesex counties. The Greater Connecticut nonattainment area includes the rest of the State. This action is being taken pursuant to the Clean Air Act (CAA or Act) and its implementing regulations.
This rule is effective on March 19, 2018.
EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2017-0150. All documents in the docket are listed on the
Donald Dahl, U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, Air Permits, Toxics, and Indoor Programs Unit, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912. Mr. Dahl's telephone number is (617) 918-1657; email address:
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
On August 14, 2017, EPA published a Notice of Proposed Rulemaking (NPR) (82 FR 37829) and Direct Final Rulemaking (DFRN) (82 FR 37819) proposing to approve and approving, respectively, Connecticut's demonstration that its nonattainment new source review regulations approved into the state implementation plan meet the requirements of the 2008 8-hour ozone standard. The demonstration was submitted on March 9, 2017 by the CT DEEP as a SIP revision. In the DFRN, EPA stated that if an adverse comment were to be submitted to EPA by September 13, 2017, the action would be withdrawn and not take effect, and a final rule would be issued based on the NPR. EPA received one adverse comment prior to the close of the comment period. Therefore, EPA withdrew the DFRN on October 13, 2017 (82 FR 47630). This action is a final rule based on the NPR. A detailed discussion of Connecticut's March 9, 2017 SIP revision and EPA's rationale for approving the SIP revision was provided in the DFRN and will not be restated here, except to the extent it is relevant to our response to the public comment we received.
EPA received one adverse comment on its August 14, 2017 (82 FR 37829) Notice of Proposed Rulemaking.
Connecticut's NNSR SIP also contains more stringent modification thresholds for VOC and NO
Connecticut's NNSR SIP is at least as stringent in all respects as compared to the OTR requirements contained in CAA section 184. By demonstrating that Connecticut's NNSR SIP meets the requirements for serious or severe nonattainment areas, the Connecticut SIP is shown to be as stringent, or in some instances, more stringent, than the requirements of section 184 of the CAA as it pertains to the NNSR permit program.
EPA is approving Connecticut's March 9, 2017, SIP revision addressing the NNSR requirements for the 2008 8-hour ozone NAAQS for both nonattainment areas in the State. The approval encompasses both the original designations under the 2008 8-hour ozone NAAQS of marginal and the subsequent reclassification of both nonattainment areas to moderate. The approval also includes the applicable NNSR provisions of Connecticut's regulations that satisfy the CAA's anti-backsliding requirements. That is, Connecticut's SIP retains the NNSR requirements applicable to serious and severe nonattainment areas (associated with the earlier, revoked 1-hour ozone standard), even though the two nonattainment areas in the State are now classified as moderate nonattainment areas for the 2008 ozone NAAQS. By demonstrating that Connecticut's SIP meets the NNSR requirements for serious and severe nonattainment areas, EPA has concluded that the State's submission fulfills the requirements of 40 CFR 51.1114, and meets the requirements of CAA sections 110, 182, and 184 as well as the minimum SIP requirements of 40 CFR 51.165.
Under the Clean Air Act, 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, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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 (Public Law 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 Clean Air Act; 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).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the Second Circuit by April 17, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(r)
Environmental Protection Agency.
Final rule.
The Environmental Protection Agency (EPA) is approving a source-specific revision to the New York State Implementation Plan (SIP). The SIP revision establishes Best Available Retrofit Technology (BART) emission limits for sulfur dioxide that are identical to those set by the EPA's Federal Implementation Plan (FIP) for the Roseton Generating Station, Units 1 and 2, which was promulgated in an action taken on August 28, 2012. The EPA finds that the SIP revision fulfills the requirements of the Clean Air Act and the EPA's Regional Haze Rule for Roseton Units 1 and 2. In conjunction with this approval, the EPA is withdrawing the FIP that addresses BART for Roseton Units 1 and 2.
This rule is effective on March 19, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R02-OAR-2017-0340. All documents in the docket are listed on the
Irene B. Nielson, Environmental Protection Agency, Air Programs Branch, 290 Broadway, New York, New York 10007-1866 at 212-637-3586 or by email at
Throughout this document, “we,” “us,” and “our” refer to the EPA.
The EPA is approving a source-specific State Implementation Plan (SIP) revision for Units 1 and 2 of the Roseton Generating Station submitted by the New York State Department of Environmental Conservation (NYSDEC) on April 18, 2017. The EPA is approving emission limits for sulfur dioxide (SO
In its submittal, the NYSDEC included the following BART emission limits for Roseton Units 1 and 2: 0.55 pounds of SO
During the public comment period, three interested parties submitted comments on the EPA's proposal. Two comments expressed support of this action. A third commenter expressed support for the benefits of reduced sulfur for public health and raised the following two additional comments.
The EPA has evaluated the Roseton SIP Revision and is determining that it meets the requirements of the CAA and the Regional Haze Rule. Therefore, the EPA is approving the BART emission limits and related administrative requirements (
At the time of the proposal, Roseton and Danskammer were the only two sources in New York State subject to the Regional Haze FIP (77 FR 51915). In a separate action, effective January 3, 2018, the EPA withdrew the FIP requirements for Danskammer after approving a source-specific SIP (82 FR 57126). In this action, the EPA is similarly approving a source-specific SIP for Roseton and withdrawing the FIP requirements for that facility. Upon the effective date of the
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of a single-source SIP revision, dated April 18, 2017, for Roseton Units 1 and 2 (Facility DEC ID 3334600075), including Title V permit conditions (permit ID 3-3346-00075/0008) that include BART emission limits for SO
Additional information about these statutes and Executive Orders can be found at
This action is exempt from review by the Office of Management and Budget (OMB) because it will result in the approval of a SIP submitted by the NYSDEC for Roseton Units 1 and 2. Approval of SIPs falls within a category of actions that is exempt from review by OMB. It was therefore not submitted to OMB for review.
This action is not an Executive Order 13771 regulatory action because this action falls within the category of actions that OMB has exempted from review. This action specifically is an approval of a SIP.
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act (PRA).
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This rule does not impose any requirements or create impacts on small entities as no small entities are subject to the requirements of this rule.
This action does not contain any unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Because this final rule has identical BART emission limits and related administrative requirements (
This action does not have federalism implications. It 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.
This action does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments. Thus, Executive Order 13175 does not apply to this rule.
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997). The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards. Therefore, the EPA is not considering the use of any voluntary consensus standards.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). As explained previously, the SIP revision being approved in this action includes identical BART emission limits and related administrative requirements (
This rule is exempt from the CRA because it is a rule of particular applicability.
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 17, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
42 U.S.C. 7401
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(d) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) revisions submitted by the State of New Hampshire on August 9, 2011 and July 23, 2013. These SIP revisions establish rules for open burning and establish emission standards and operating practices for incinerators and wood waste burners that are not regulated pursuant to Federal incinerator standards. We are also approving revisions to the definitions of “Incinerator” and “Wood Waste Burner,” submitted by the State on July 23, 2013 and October 26, 2016, respectively. This action is being taken in accordance with the Clean Air Act (CAA).
This rule is effective on March 19, 2018.
EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2017-0138. All documents in the docket are listed on the
Alison C. Simcox, Environmental Scientist, Air Quality Planning Unit, Air Programs Branch (Mail Code OEP05-02), U.S. Environmental Protection Agency, Region 1, 5 Post Office Square, Suite 100, Boston, Massachusetts, 02109-3912; (617) 918-1684;
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
On January 10, 2003, New Hampshire Department of Environmental Services (NH DES) submitted a SIP revision for Env-A 1000 (Prevention, Abatement and Control of Open Source Air Pollution). On August 9, 2011, NH DES submitted an updated version of this regulation. Because the 2011 submittal superseded the previous submission, the State withdrew the 2003 submittal on May 5, 2014. The withdrawal letter is included in the docket for this action.
On July 23, 2013, NH DES submitted Env-A 1900 (Incinerators and Wood Waste Burners) and Env-A 101.104 (definition of “Incinerator”) to EPA for approval. Env-A 1900 is not currently part of the federally-approved New Hampshire SIP. The definition of the term “Incinerator” is currently part of the New Hampshire SIP, but is codified at Env-A 101.59
A definition of “Wood Waste Burner” is currently part of the New Hampshire SIP, but is codified as Env-A 101.95 and explicitly excludes incinerators. On October 26, 2016, NH DES submitted a revision of the definition of “Wood Waste Burner” (Env-A 101.219) to EPA for approval. This revised definition does not exclude incinerators. The current SIP-approved version of the definition of “Wood Waste Burner” (Env-A 101.95) will be replaced by the new definition of that term (Env-A 101.219) as a result of this approval.
The version of Env-A 1900 (Incinerators and Wood Waste Burners) submitted by the State to EPA included an affirmative defense provision for malfunction, which is defined as a sudden and unavoidable breakdown of process or control equipment. On April 13, 2016, NH DES sent a letter to EPA withdrawing the affirmative defense provision in Env-A 1900 (
These SIP revisions establish rules for open burning and establish emission standards and operating practices for incinerators and wood waste burners that are not regulated pursuant to Federal incinerator standards. New Hampshire also submitted revisions to the definitions of “Incinerator” and “Wood Waste Burner” on July 23, 2013 and October 26, 2016, respectively.
On September 6, 2017, EPA published a Notice of Proposed Rulemaking (82 FR 42054) and Direct Final Rulemaking (DFRN) (82 FR 42037) proposing to approve and approving, respectively, the revisions submitted by New Hampshire on August 9, 2011, July 23, 2013, and October 26, 2016.
In the DFRN, EPA stated that if an adverse comment were to be submitted to EPA by October 6, 2017, the action would be withdrawn and not take effect, and a final rule would be issued based on the NPR. EPA received a comment that is not relevant to this SIP action, and one adverse comment that is relevant, before the close of the comment period. Therefore, EPA withdrew the DFRN on November 6, 2017 (82 FR 51349).
This action is a final rule based on the NPR. A detailed discussion of New Hampshire's August 9, 2011; July 23, 2013; and October 26, 2016, SIP revisions, and EPA's rationale for approving these were provided in the DFRN and will not be restated here, except to the extent relevant to our response to the public comments we received.
EPA received public comments from anonymous commenters on our September 6, 2017 NPR. All of the comments are contained in the docket for this final action. One commenter submitted a comment that is not relevant to this SIP action and, therefore, requires no response. One commenter submitted two comments that are adverse and are discussed below.
EPA is approving and incorporating two regulations into the New Hampshire SIP. The two regulations include revised Env-A 1000 (Prevention, Abatement and Control of Open Source Air Pollution) submitted by the State of New Hampshire on August 9, 2011, effective on May 1, 2011; and Env-A 1900 (Incinerators and Wood Waste Burners) submitted by the State on July 23, 2013, effective April 23, 2013, except for the withdrawn affirmative defense provision. The revised version of Env-A 1000 that we are approving into the SIP will replace the existing SIP-approved version of Env-A 1000.
In addition, EPA is approving a revised definition of “Incinerator” (Env-A 101.104), submitted by the State on July 23, 2013, effective April 23, 2013, which replaces the definition of “Incinerator” currently in the New Hampshire SIP (numbered Env-A 101.59). We are also approving a revised definition of “Wood Waste Burner” (Env-A 101.219), submitted by the State on October 26, 2016, effective January 14, 2005, which replaces the definition of “Wood Waste Burner” currently in the New Hampshire SIP (numbered Env-A 101.95). Thus, the SIP at Env-A 101.59 and at Env-A 101.95 will read “[reserved].”
New Hampshire organizes Env-A 101 (Definitions) alphabetically, and also assigns a codification number, in sequential order, to each defined term. Because the State's SIP submissions did not include the entirety of Env-A 101, and the State has added other definitions to Env-A 101 over time (not all of which are SIP-approved), our approval of the two definitions in this action will result in the numbered codification assigned to the defined terms being out of numerical sequence in the SIP. However, the two defined terms will still be in alphabetical order.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the New Hampshire Code of Administrative Rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through
Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.
Under the Clean Air Act, 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, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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 (Public Law 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 Clean Air Act; 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). The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revision and additions read as follows:
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation amends the tolerances for residues of pendimethalin in or on alfalfa, forage and alfalfa, hay. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective February 16, 2018. Objections and requests for hearings must be received on or before April 17, 2018, and must be filed in accordance with the instructions provided in 40 CFR part
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0247, is available at
Michael L. Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; 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).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0247 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 17, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0247, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pendimethalin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pendimethalin follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The target organ for pendimethalin is the thyroid. Thyroid toxicity in chronic and subchronic rat and mouse studies was manifested as alterations in thyroid hormones (decreased total T4 and T3,
There is no evidence that pendimethalin is a developmental, reproductive, neurotoxic, or immunotoxic chemical. There is no evidence of increased qualitative or quantitative susceptibility in the young. EPA classified pendimethalin as a “Group C”, possible human carcinogen based on a statistically significant increased trend and pair-wise comparison between the high-dose group and controls for thyroid follicular cell adenomas in male and female rats. A non-quantitative approach (
Specific information on the studies received and the nature of the adverse effects caused by pendimethalin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for pendimethalin used for human risk assessment is shown in Table 1 of this unit.
1.
i.
Such effects were identified for pendimethalin. In estimating acute dietary exposure, EPA Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA used tolerance-level residues, and 100 percent crop treated (PCT) for all commodities.
ii.
iii.
iv.
2.
Based on the Pesticide Root Zone Model Ground Water (PRZM GW) and
For acute dietary risk assessment, the water concentration value of 96.4 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 9.73 ppb was used to assess the contribution to drinking water.
3.
Pendimethalin is currently registered for the following uses that could result in residential exposures: Turf, home gardens, and ornamentals. EPA assessed residential exposure using the following assumptions:
• For handlers, it is assumed that residential use will result in short-term (1 to 30 days) duration dermal and inhalation exposures.
• Residential post-application exposure is also assumed to be short-term (1-30 days) in duration, resulting from the following exposure scenarios:
• Gardening: Adults (dermal) and children 6 < 11 years old (dermal);
• Physical activities on turf: Adults (dermal) and children 1-2 years old (dermal and incidental oral);
• Mowing turf: Adults (dermal) and children 11 < 16 years old (dermal); and
• Exposure to golf courses during golfing: Adults (dermal), children 11 < 16 years old (dermal), and children 6 < 11 years old (dermal).
EPA did not combine exposure resulting from adult handler and post-application exposure resulting from treated gardens, lawns, and/or golfing because the conservative assumptions and inputs within each estimated exposure scenario would result in an overestimate of adult exposure. EPA selected the most conservative adult residential scenario (adult dermal post-application exposure from gardening) as the contributing source of residential exposure to be combined with the dietary exposure for the aggregate assessment. The children's oral exposure is based on post-application hand-to-mouth exposures. To include exposure from object-to-mouth and soil ingestion in addition to hand-to-mouth would overestimate the potential for oral exposure. However, there is the potential for co-occurrence of dermal and oral exposure, since the toxicological effects from the dermal and oral routes of exposure are the same. As a result, the children's aggregate assessment combines post-application dermal and oral exposure along with dietary exposure from food and water. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found pendimethalin to share a common mechanism of toxicity with any other substances, and pendimethalin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pendimethalin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
1.
2.
3.
i. The toxicity database for pendimethalin is complete. Although a subchronic inhalation study was not available in the database, EPA determined that one is not needed at this time based on a weight-of-evidence analysis, considering the following: (1) All relevant hazard and exposure information, which indicates its low acute inhalation toxicity; (2) its physical/chemical properties, which indicate its low volatility; and (3) the use of an oral POD that results in a residential inhalation margin of exposure (MOE) more than 10X the level of concern (in the case of pendimethalin MOE = 30 based on thyroid POD).
ii. There is no indication that pendimethalin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that pendimethalin results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to pendimethalin in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pendimethalin.
EPA determines whether acute and chronic dietary pesticide exposures are
1.
2.
3.
Pendimethalin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pendimethalin.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 130 for adults and 92 for children 1-2 years old, the two population subgroups receiving the greatest combined dietary and non-dietary exposure. Because EPA's level of concern for pendimethalin is a MOE of 30 or below, these MOEs are not of concern.
4.
An intermediate-term adverse effect was identified; however, pendimethalin is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for pendimethalin.
5.
6.
Adequate enforcement methodology, gas chromatography with electron capture detection (GC/ECD), is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
There are currently no established Codex MRLs for the residues of pendimethalin on alfalfa hay, although Codex has established an MRL for residues of pendimethalin in alfalfa fodder (which is equivalent to the US commodity of alfalfa forage) at 4 ppm. Harmonization is not possible because use of the Codex MRL would result in residues of pendimethalin exceeding tolerances in the U.S. as a result of use in accordance with the approved label.
Therefore, tolerances are established for plant residues by measuring only the sum of pendimethalin, [
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The revisions read as follows:
(a)(1)
Environmental Protection Agency.
Final rule.
The Environmental Protection Agency (EPA) Region 1 announces the deletion of the Hatheway & Patterson Superfund Site (Site) located in Mansfield and Foxborough, Massachusetts, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the Commonwealth of Massachusetts, through the Massachusetts Department of Environmental Protection (MassDEP), have determined that all appropriate response actions under CERCLA, other than operation and maintenance, monitoring, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.
This action is effective February 16, 2018.
U.S. EPA Region 1, Superfund Records Center, 5 Post Office Square, Suite 100, Boston, MA 02109, Phone: 617-918-1440, Monday-Friday: 9:00 a.m.-5:00 p.m., Saturday and Sunday—Closed.
Kimberly White, Remedial Project Manager, U.S. Environmental Protection Agency, Region 1, OSRR07-1, Boston, MA 02109-3912, (617) 918-1752, email:
The site to be deleted from the NPL is: Hatheway & Patterson Superfund Site, Mansfield and Foxborough, Massachusetts. A notification of deletion for this Site was published in the
The closing date for comments on the notification of deletion was January 2, 2018. Six (6) public comments were received and three of the comments questioned whether EPA completed what is required under CERCLA and whether deletion of the Site was appropriate; the remaining three comments did not articulate a position on the proposed deletion. As a result of the comments, EPA published a notification of withdrawal of the direct final rule in the
After consideration of the comments received, EPA concluded that the deletion of the Site is still appropriate. Based on EPA's evaluation of the data, the remedy protects human health and the environment because remediation of the soil (soil removal and on-site consolidation) has been completed to cleanup levels that are considered protective for the anticipated future use of the property, there is no current use of on-site groundwater which is classified as non-potable, and institutional controls are in place. Operation and maintenance activities are on-going and will ensure that the consolidation area and associated components of the remedy (
EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. Deletion of a site from the NPL does not affect responsible party liability in the unlikely event that future conditions warrant further actions.
Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.
For reasons set out in the preamble, 40 CFR part 300 is amended as follows:
33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2018 Pacific cod total allowable catch apportioned to vessels using pot gear in the Central Regulatory Area of the GOA.
Effective 1200 hours, Alaska local time (A.l.t.), February 14, 2018, through 1200 hours, A.l.t., June 10, 2018.
Obren Davis, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.
The A season allowance of the 2018 Pacific cod total allowable catch (TAC) apportioned to vessels using pot gear in the Central Regulatory Area of the GOA is 1,075 metric tons (mt), as established by the final 2017 and 2018 harvest specifications for groundfish of the GOA (82 FR 12032, February 27, 2017) and inseason adjustment (82 FR 60327, December 20, 2017).
In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2018 Pacific cod TAC apportioned to vessels using pot gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 1,065 mt and is setting aside the remaining 10 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
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 757 airplanes. This proposed AD was prompted by reports of bolt rotation in the engine drag fitting joint and fasteners heads; an inspection of the fastener holes revealed that cracks were found in the skin on two airplanes. This proposed AD would require repetitive inspections for skin cracking and shim migration at the upper link drag fittings, diagonal brace cracking, and fastener looseness; and applicable on-condition actions. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by April 2, 2018.
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
Chandra Ramdoss, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5239; 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 reports indicating bolt rotation in the engine drag fitting joint and fasteners heads; an inspection of the fastener holes revealed that cracks were found in the skin on two airplanes. The bolt rotations have been reported on airplanes having between 1,889 and 21,073 total flight cycles, and between 6,000 and 56,008 total flight hours. Boeing analysis has found that the root cause of the crack is loss of clamp-up causing movement of the fastener in the hole and high peak stresses, galling of the hole, and early cracking of the skin. Loss of clamp-up is potentially caused by shim migration, cracked bolt heads, loss of torque, and other contributing factors. Discontinuation of cold working on the holes (line numbers 803 through 1050) is a contributing factor to very early cracking. This condition, if not corrected, could result in cracking in the wing upper skin and forward drag fittings, and lead to a compromised upper link and reduced structural integrity of the engine strut.
We reviewed Boeing Alert Requirements Bulletin 757-57A0073 RB, dated July 14, 2017. The service information describes procedures for repetitive detailed inspections for skin cracking and shim migration at the upper link drag fittings, repetitive general visual inspections for diagonal brace cracking and fastener looseness, and applicable on-condition actions. 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 accomplishment of the actions identified in the Boeing Alert
For information on the procedures and compliance times, see this service information at
The FAA worked in conjunction with industry, under the Airworthiness Directives Implementation Aviation Rulemaking Committee (AD ARC), to enhance the AD system. One enhancement is a process for annotating which steps in the service information are “required for compliance” (RC) with an AD. Boeing has implemented this RC concept into Boeing service bulletins.
In an effort to further improve the quality of ADs and AD-related Boeing service information, a joint process improvement initiative was worked between the FAA and Boeing. The initiative resulted in the development of a new process in which the service information more clearly identifies the actions needed to address the unsafe condition in the “Accomplishment Instructions.” The new process results in a Boeing Requirements Bulletin, which contains only the actions needed to address the unsafe condition (
We estimate that this proposed AD affects 606 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
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.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
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 April 2, 2018.
None.
This AD applies to The Boeing Company Model 757-200, -200PF, -200CB, and -300 series airplanes, certificated in any category, as identified in Boeing Alert Requirements Bulletin 757-57A0073 RB, dated July 14, 2017.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by bolt rotation in the engine drag fitting joint and fasteners heads; an inspection of the fastener holes revealed that cracks were found in the skin on two airplanes. We are issuing this AD to detect and correct cracking in the wing upper skin and forward drag fittings, which could lead to a compromised upper link and reduced structural integrity of the engine strut.
Comply with this AD within the compliance times specified, unless already done.
Except as required by paragraph (h) of this AD: At the applicable times specified in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 757-57A0073 RB,
Guidance for accomplishing the actions required by this AD can be found in Boeing Alert Service Bulletin 757-57A0073, dated July 14, 2017, which is referred to in Boeing Alert Requirements Bulletin 757-57A0073 RB, dated July 14, 2017.
(1) For purposes of determining compliance with the requirements of this AD: Where Boeing Alert Requirements Bulletin 757-57A0073 RB, dated July 14, 2017, uses the phrase “the original issue date of the requirements bulletin,” this AD requires using “the effective date of this AD.”
(2) Where Boeing Alert Requirements Bulletin 757-57A0073 RB, dated July 14, 2017, specifies contacting Boeing, this AD requires repair using a method approved in accordance with the procedures specified in paragraph (i) of this AD.
(1) The Manager, Los Angeles ACO Branch, 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 certification office, 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 Branch, 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.
(1) For more information about this AD, contact Chandra Ramdoss, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5239; 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
Financial Crimes Enforcement Network (FinCEN), Treasury.
Notice of proposed rulemaking.
FinCEN is issuing a notice of proposed rulemaking (NPRM), pursuant to Section 311 of the USA PATRIOT Act, to prohibit the opening or maintaining of a correspondent account in the United States for, or on behalf of, ABLV Bank, AS.
Written comments on the notice of proposed rulemaking must be submitted on or before April 17, 2018.
You may submit comments, identified by RIN-1506-AB39, by any of the following methods:
•
•
• Comments submitted in response to this NPRM will become a matter of public record. Therefore, you should submit only information that you wish to make publicly available.
•
The FinCEN Resource Center at (800) 949-2732.
On October 26, 2001, the President signed into law the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001, Public Law 107-56 (the USA PATRIOT Act). Title III of the USA PATRIOT Act amends the anti-money laundering (AML) provisions of the Bank Secrecy Act (BSA), codified at 12 U.S.C. 1829b, 12 U.S.C. 1951-1959, and 31 U.S.C. 5311-5314, 5316-5332, to promote the prevention, detection, and prosecution of international money laundering and the financing of terrorism. Regulations implementing the BSA appear at 31 CFR Chapter X. The authority of the Secretary of the Treasury (the Secretary) to administer the BSA and its implementing regulations has been delegated to FinCEN.
Section 311 of the USA PATRIOT Act (Section 311), codified at 31 U.S.C. 5318A, grants FinCEN the authority, upon finding that reasonable grounds exist for concluding that a jurisdiction outside of the United States, one or more financial institutions operating outside of the United States, one or more classes of transactions within or involving a jurisdiction outside of the United States, or one or more types of accounts is of primary money laundering concern, to require domestic financial institutions and domestic financial agencies to take certain “special measures.” The five special measures enumerated in Section 311 are prophylactic safeguards that defend the U.S. financial system from money laundering and terrorist financing. FinCEN may impose one or more of these special measures in order to protect the U.S. financial system from these threats. Special measures one through four, codified at 31 U.S.C. 5318A(b)(1)-(b)(4), impose additional recordkeeping, information collection, and reporting requirements on covered U.S. financial institutions. The fifth special measure, codified at 31 U.S.C. 5318A(b)(5), allows FinCEN to prohibit,
Before making a finding that reasonable grounds exist for concluding that a foreign financial institution is of primary money laundering concern, the Secretary is required to consult with both the Secretary of State and the Attorney General.
• The extent to which such a financial institution is used to facilitate or promote money laundering in or through the jurisdiction, including any money laundering activity by organized criminal groups, international terrorists, or entities involved in the proliferation of weapons of mass destruction (WMD) or missiles;
• The extent to which such a financial institution is used for legitimate business purposes in the jurisdiction; and
• The extent to which such action is sufficient to ensure that the purposes of Section 311 are fulfilled, and to guard against international money laundering and other financial crimes.
Upon finding that a foreign financial institution is of primary money laundering concern, the Secretary may require covered financial institutions to take one or more special measures. In selecting which special measure(s) to take, the Secretary “shall consult with the Chairman of the Board of Governors of the Federal Reserve System, any other appropriate Federal banking agency (as defined in Section 3 of the Federal Deposit Insurance Act), the Secretary of State, the Securities and Exchange Commission, the Commodity Futures Trading Commission, the National Credit Union Administration Board, and in the sole discretion of the Secretary, such other agencies and interested parties as the Secretary [of the Treasury] may find appropriate.”
In addition, in selecting which special measure(s) to take, the Secretary shall consider the following factors:
• Whether similar action has been or is being taken by other nations or multilateral groups;
• Whether the imposition of any particular special measure would create a significant competitive disadvantage, including any undue cost or burden associated with compliance, for financial institutions organized or licensed in the United States;
• The extent to which the action or the timing of the action would have a significant adverse systemic impact on the international payment, clearance, and settlement system, or on legitimate business activities involving the particular jurisdiction, institution, class of transactions, or type of account; and
• The effect of the action on United States national security and foreign policy.
This NPRM sets forth (i) FinCEN's finding that ABLV Bank, AS (ABLV), a commercial bank located in Riga, Latvia, is a foreign financial institution of primary money laundering concern pursuant to Section 311, and (ii) FinCEN's proposal of a prohibition under the fifth special measure on the opening or maintaining in the United States of a correspondent account for, or on behalf of, ABLV. As described more fully below,
Due to geography, linguistic profile, and a stable and developed banking system, Latvia serves as a financial bridge between the Commonwealth of Independent States (CIS),
According to Latvia's Financial Capital and Market Commission (FCMC), the primary banking regulator, non-resident banking services contribute between 0.8 and 1.5 percent to Latvia's gross domestic product (GDP). Non-resident deposits (NRDs) in Latvia are equal to roughly $13 billion. Latvian NRD banking activity transiting the U.S. financial system is estimated in recent years to have reached billions of dollars annually.
The Latvian banking system's reliance on NRD funds for capital exposes it to increased illicit finance risk. A 2014 report by the European Commission's Directorate General for Economic and Financial Affairs (ECFIN) singled out Latvia's reliance on NRD banking as a risk to Latvia's private sector, for a variety of reasons, including the fact that ensuring compliance with anti-money laundering rules may be more challenging for non-resident banks as verifying clients' background and business activities could prove difficult. Criminal groups and corrupt officials may use elaborate offshore services to hide true beneficiaries or create fraudulent business transactions.
In a positive development, since 2015, the FCMC has led significant efforts to reform Latvia's AML/CFT regulations and enforcement regime. However, as noted in the aforementioned 2014 ECFIN report, positive changes need to be consistently implemented jointly with the banks. The need to improve the institutional capacity remains a long-term challenge due to the complexities of investigating and prosecuting money laundering.
Established in 1993, ABLV Bank, AS (ABLV) is headquartered in Riga, Latvia. According to data provided by the Association of Latvian Commercial Banks, ABLV is the second largest bank in Latvia by assets, with the equivalent of roughly $4.6 billion as of March 31, 2017. ABLV is Latvia's largest NRD bank by assets. As further described below, the majority of ABLV's customers are high-risk shell companies registered outside of Latvia.
ABLV offers banking, investment, and advisory services. ABLV currently does not maintain correspondent accounts directly with U.S. banks, but instead accesses the U.S. financial system through nested U.S. dollar correspondent relationships with other foreign financial institutions. Those foreign financial institutions, in turn, hold direct U.S. correspondent accounts.
ABLV holds several subsidiary entities, including a subsidiary bank, ABLV Bank, Luxembourg, S.A., located in Luxembourg. The beneficial owners of ABLV are Ernests Bernis and Oleg Fils. Bernis holds 4.93 percent of shares in the bank directly, and 43.12 percent of shares indirectly via Cassandra Holding Company, SIA. Fils holds 43.13 percent of shares in ABLV indirectly through SIA “OF Holding.” Unspecified “other shareholders” own the remaining equity.
Based on information available to the agency, including both public and nonpublic reporting, and after performing the requisite interagency consultations and considering each of the factors discussed below, FinCEN finds that reasonable grounds exist for concluding that ABLV is a financial institution operating outside the United States of primary money laundering concern.
According to information available to FinCEN, ABLV executives, shareholders, and employees have institutionalized money laundering as a pillar of the bank's business practices. ABLV management orchestrates, and permits the bank and its employees to engage in, money laundering schemes. Management solicits the high-risk shell company activity that enables the bank and its customers to launder funds, maintains inadequate controls over high-risk shell company accounts, and is complicit in the circumvention of AML/CFT controls at the bank. As a result, multiple actors have exploited the bank in furtherance of illicit financial activity, including transactions for parties connected to U.S. and UN-designated entities, some of which are involved in North Korea's procurement or export of ballistic missiles. In addition, ABLV management seeks to obstruct enforcement of Latvian AML/CFT rules. Through 2017, ABLV executives and management have used bribery to influence Latvian officials when challenging enforcement actions and perceived threats to their high-risk business.
ABLV's business practices enable the provision of financial services to clients seeking to evade financial regulatory requirements. Bank executives and employees are complicit in their clients' illicit financial activities, including money laundering and the use of shell companies to conceal the true nature of illicit transactions and the identities of those responsible. ABLV is considered innovative and forward leaning in its approaches to circumventing financial regulations. The bank proactively pushes money laundering and regulatory circumvention schemes to its client base and ensures that fraudulent documentation produced to support financial schemes, some of which is produced by bank employees themselves, is of the highest quality.
In 2014, ABLV was involved in the theft of over $1 billion in assets from three Moldovan banks, BC Unibank S.A., Banca Sociala S.A., and Banca de Economii S.A., in which criminals took over the three Moldovan banks using a non-transparent ownership structure, partly financed by loans from offshore entities banking at ABLV. Separately, ABLV previously developed a scheme to assist customers in circumventing foreign currency controls, in which the bank disguised illegal currency trades as international trade transactions using fraudulent documentation and shell company accounts.
As referenced in Section III of this notice, Latvian NRD banks cater to offshore shell companies, and ABLV is Latvia's largest NRD bank. Offshore shell company business poses inherent money laundering risks because of its lack of transparency, and financial institutions must manage the risks associated with providing financial services to shell companies. As described in detail below, ABLV's continuing failure to implement adequate AML controls commensurate with this high risk has caused the bank to facilitate transactions for shell companies owned or controlled by illicit actors engaged in transnational organized criminal activity, corruption, and sanctions evasion. Oftentimes, these actors take advantage of ABLV's propensity to facilitate high-risk shell company business, using shell company accounts to obscure the transparency of their illicit activities.
ABLV does not mitigate these risks effectively. ABLV does not adequately conduct know-your-customer (KYC) checks or customer due diligence (CDD) on a number of its customers, does not collect or update supporting documentation from its customers to justify transactional activity, and uses fraudulent documentation in some of its CDD files. Furthermore, the bank has had deficiencies in its internal control system, including insufficient customer due diligence and monitoring of transactions.
In an example demonstrative of ABLV's failures to mitigate these risks, ABLV received a substantial amount of funds from a Russia-based bank in a manner consistent with an illicit transfer of assets. FinCEN assesses that ABLV should have known that the shell companies receiving the Russian bank-sourced funds in their ABLV accounts were related to the ultimate beneficial owners of the Russia-based bank. Such a pattern is a hallmark of asset-stripping. In addition, ABLV has facilitated public corruption through the provision of shell company accounts for corrupt CIS-based politically exposed persons (PEPs) and other corrupt actors. Through 2014, for example, Ukrainian tycoon Serhiy Kurchenko funneled billions of dollars through his ABLV shell company accounts. Treasury's Office of Foreign Assets Control (OFAC) designated Kurchenko in 2015, finding that he was responsible for, complicit in, or had engaged in, directly or indirectly, the misappropriation of state assets of Ukraine or of an economically significant entity in Ukraine. ABLV
ABLV's business practice of banking high-risk shell companies without appropriate risk mitigation policies and procedures has also caused the bank to facilitate transactions for parties connected to U.S.- and UN-designated Democratic People's Republic of Korea (DPRK or North Korea) entities. These designated entities include Foreign Trade Bank (FTB), Koryo Bank, Koryo Credit Development Bank, Korea Mining and Development Trading Corporation (KOMID), and Ocean Maritime Management Company (OMM), some of which are involved in North Korea's procurement or export of ballistic missiles. ABLV facilitated transactions related to North Korea after the bank's summer 2017 announcement of a North Korea “No Tolerance” policy.
Widely available public documents describe North Korean sanctioned entities' use of front and shell companies and financial representatives to evade international sanctions. As early as 2014, the UN Panel of Experts (UN POE) noted in its report that sanctioned North Korean entities used front companies to evade international sanctions by hiding the sources of funds. Subsequent UN POE reports expanded on these findings, highlighting specific examples and methodologies used by North Korea-related entities to evade sanctions. Since 2011, the Financial Action Task Force (FATF) has called upon its members and urged all countries to apply effective countermeasures to protect their financial systems from the money laundering, terrorist financing, and proliferation financing threat emanating from the DPRK. More recently, the FATF has highlighted the DPRK's frequent use of front companies, shell companies, and opaque ownership structures for the purpose of evading international sanctions.
FinCEN has found that the DPRK is a foreign jurisdiction of “primary money laundering concern.”
FinCEN assesses that the public nature of these reports, advisories, and actions should have provided ABLV the necessary guidance to apply appropriate due diligence to accounts and transactions that fit the typologies described in these public documents. However, ABLV's pursuit of high-risk shell company business and its failure to heed these public warnings and implement an appropriate risk-mitigating CDD and KYC program enabled certain customers to exploit ABLV's weaknesses to conduct transactions with parties connected to designated entities. Certain customers' counterparties have also been designated by OFAC, further demonstrating their links to the DPRK.
Ninety percent of ABLV's customers are high-risk per ABLV's own risk rating methodology and are primarily high-risk shell companies registered in secrecy jurisdictions. FinCEN assesses that, beginning in 2012 and continuing into 2017, ABLV conducted a high volume of transactions for shell companies registered outside of Latvia in offshore secrecy jurisdictions totaling tens of billions of dollars. FinCEN is aware that ABLV frequently fails to respond to other financial institutions' questions concerning the nature of the transactions that ABLV is processing. Multiple U.S. financial institutions have proactively closed ABLV's U.S. correspondent accounts. Nonetheless, ABLV's indirect correspondent activity with the U.S. financial system and its business model of facilitating non-transparent transactions for shell companies both continue.
While publicly stating that it is implementing plans to reform its AML/CFT compliance program, ABLV owners and executives have privately expressed an unwillingness to meaningfully alter ABLV's high-risk business practices. This fact, combined with ABLV's AML/CFT compliance issues to date raise serious concerns about the entity's commitment to implementing these plans. These concerns are further supported by the fact that ABLV management seeks to obstruct enforcement of Latvian AML/CFT rules and has used bribery to influence Latvian officials. Any institution that undermines enforcement actions through such corrupt acts presents a significant risk that it will continue practices which facilitate illicit activity.
As an NRD bank catering to non-Latvian customers, the majority of ABLV's customers are not based in Latvia and do not conduct business in Latvia outside of holding a bank account at ABLV. As described above, Latvia's NRD banking sector is a financial bridge between the CIS region's financial systems and the West. ABLV provides entities, typically controlled by CIS region-based actors, access to U.S. dollar, euro, pound sterling, and Swiss franc accounts, and ABLV's correspondent relationships enable its customers to transact with counterparties holding accounts at banks across the globe, including U.S. and EU financial institutions. Oftentimes, NRD customers are shell companies registered in corporate secrecy jurisdictions that are owned or controlled by parties in third jurisdictions, typically in the CIS region.
ABLV may be used for some legitimate purposes. However, the high number of shell company customers banking at ABLV, some of which are themselves engaged in money laundering or illicit activity, as described above, indicates that ABLV is extensively used for illicit purposes.
While it may carry certain risks or an additional AML/CFT compliance burden, non-resident banking is not inherently suspicious or illicit. For example, any non-Latvian entity banking in Latvia would maintain a “non-resident” account. Such non-Latvian clients may include lower-risk entities, such as publicly traded companies in the United States or other well-regulated jurisdictions. While such entities may be engaged in non-proximate banking, the customers' lines of business, ownership, and activity would be transparent, and the customers may be considered low-risk pursuant to the bank's internal policies and procedures and the relevant regulatory framework.
However, 90 percent of ABLV's customers are high-risk per ABLV's own risk rating methodology, and are primarily high-risk shell companies registered in secrecy jurisdictions, as discussed previously. FinCEN assesses that ABLV's shell company customers' involvement in a wide range of illicit and suspicious activity through ABLV indicates that ABLV does not properly control NRD accounts to ensure they are used primarily to conduct legitimate business
As noted above, FinCEN does not believe that ABLV, or its shareholders and executives, plan to meaningfully implement AML/CFT reforms. While publicly stating that it is implementing plans to reform its AML/CFT compliance program, ABLV owners and executives have privately expressed an unwillingness to meaningfully alter ABLV's high-risk business practices.
FinCEN assesses that ABLV is used to facilitate money laundering, illicit financial schemes and other illicit activity conducted by its customers and other illicit actors, including actors associated with transnational organized crime, North Korea's procurement or export of ballistic missiles, sanctions evasion, and large-scale corruption. Given the national security threat posed by such activity, FinCEN believes that imposing a prohibition under the fifth special measure would be sufficient and necessary to prevent ABLV from continuing to access the U.S. financial system. This action would guard against international money laundering activity and other financial crimes involving ABLV.
Although U.S. financial institutions have proactively closed direct U.S. correspondent relationships with ABLV, many U.S. financial institutions continue to process transactions for or on behalf of ABLV through indirect correspondent banking relationships. This action, if finalized, would sever ABLV's access to U.S. correspondent accounts, direct or otherwise.
After performing the requisite interagency consultations, considering the relevant factors, and making a finding that ABLV is a foreign financial institution of primary money laundering concern, FinCEN proposes a prohibition under the fifth special measure. A prohibition under the fifth special measure is the most effective and practical measure to safeguard the U.S. financial system from the illicit finance risks posed by ABLV.
Below is a discussion of the relevant factors FinCEN considered in proposing a prohibition under the fifth special measure with respect to ABLV.
FinCEN is not aware of an action by another nation or multilateral group that would prohibit or place conditions on ABLV's correspondent banking relationships. However, according to press reports, the National Bank of Ukraine issued an advisory on August 28, 2016 to Ukrainian banks warning that ABLV, among other foreign banks, was suspected of being related to risky financial operations, including laundering the revenues of criminal activities. In addition, the FCMC has conducted examinations of ABLV and issued a fine and reprimand of a board member in May of 2016. None of these actions, however, sufficiently protect the U.S. financial system from the illicit finance risk posed by ABLV.
While ABLV is a large bank among Latvian financial institutions, it is not large by international standards and is not a major participant in the international payment system. Therefore, FinCEN does not believe that imposing a prohibition under the fifth special measure would cause a significant competitive disadvantage or place an undue burden or cost on U.S. financial institutions.
The special due diligence obligations proposed in this rulemaking would not create undue costs or burden on U.S. financial institutions. U.S. financial institutions already generally have systems in place to screen transactions in order to identify and report suspicious activity and comply with the sanctions programs administered by OFAC. Institutions can modify these systems to detect transactions involving ABLV. ABLV does not currently hold U.S. correspondent bank accounts. While there may be some additional burden on U.S. financial institutions in conducting due diligence on foreign correspondent account holders and notifying them of the prohibition, FinCEN believes that any such burden will likely be minimal, and certainly not undue, given the threats posed by ABLV's facilitation of money laundering.
As noted previously, although ABLV is a large bank among Latvian financial institutions, it is not large by international standards, is not a major participant in the international payment system, and is not relied upon by the international banking community for clearance or settlement services. Thus, the imposition of a prohibition under the fifth special measure against ABLV will not have an adverse systemic impact on the international payment, clearance, and settlement system. FinCEN also considered the extent to which this action could have an impact on the legitimate business activities of ABLV and concludes that the need to protect the U.S. financial system from ABLV, a bank that facilitates illicit financial activity, strongly outweighs any such impact.
FinCEN notes that ABLV as of July 2017 maintained euro, Japanese yen, Hong Kong dollar, pound sterling, and Australian dollar correspondent accounts, according to a commercial database, and thus is not necessarily limited to U.S. dollar transactions in its international wire transfer activity. A prohibition on the opening or maintaining of U.S. correspondent accounts under the fifth special measure would not prevent ABLV from conducting legitimate business activities in foreign currencies as long as such activity does not involve a correspondent account maintained in the United States.
As described in detail above, financial activity that ABLV has conducted through the U.S. financial system has consisted largely of international funds transfers between shell entities registered in offshore secrecy jurisdictions. FinCEN assesses that this financial activity includes money laundering and other transactions conducted by a range of illicit actors that threaten the national security of the United States. Furthermore, ABLV's business practice of banking high-risk shell companies without adequate risk mitigation policies and procedures has caused the bank to facilitate transactions for entities linked to North Korea. Ensuring the effectiveness of the North Korea sanctions program is a top
Prohibiting covered financial institutions from maintaining a correspondent account for ABLV, and preventing ABLV's indirect access to a U.S. correspondent account, will enhance national security. The proposed action serves as a measure to prevent illicit actors from accessing the U.S. financial system. It will further the U.S. national security and foreign policy goals of thwarting sanctions evasion and preventing other illicit financial activity from transiting the U.S. financial system. The imposition of a prohibition under the fifth special measure would also complement the U.S. government's worldwide efforts to expose and disrupt international money laundering.
Under Section 311, special measures one through four enable FinCEN to impose additional recordkeeping, information collection, and information reporting requirements on covered financial institutions. The fifth special measure also enables FinCEN to impose conditions as an alternative to a prohibition on the opening or maintaining of correspondent accounts. FinCEN considered alternatives to a prohibition under the fifth special measure, including the imposition of one or more of the first four special measures, as well as imposing conditions on the opening or maintaining of correspondent accounts under the fifth special measure. For the reasons explained below, FinCEN believes that a prohibition under the fifth special measure would most effectively safeguard the U.S. financial system from the illicit finance risks posed by ABLV.
Given ABLV's apparent disregard of regulatory reform and enforcement measures, FinCEN does not believe that any condition, additional recordkeeping requirement, or reporting requirement would be an effective measure to safeguard the U.S. financial system. Such measures would not prevent ABLV from accessing directly or indirectly the correspondent accounts of U.S. financial institutions, thus leaving the U.S. financial system vulnerable to processing the types of illicit transfers that pose a national security and money laundering risk. In addition, no recordkeeping requirement or conditions on correspondent accounts would be sufficient to guard against the risks posed by a bank that processes transactions that are designed to obscure the transactions' true nature and are ultimately for the benefit of illicit actors or activity. Therefore, a prohibition under the fifth special measure is the only special measure that can adequately protect the U.S. financial system from the illicit financial risk posed by ABLV.
The proposed rule defines “ABLV” to mean all subsidiaries, branches, and offices of ABLV Bank, AS operating as a bank in any jurisdiction. As noted above, FinCEN is aware of one subsidiary bank, ABLV Bank, Luxembourg, S.A., located in Luxembourg.
The proposed rule defines “Correspondent account” to have the same meaning as the definition contained in 31 CFR 1010.605(c)(l)(ii). In the case of a U.S. depository institution, this broad definition includes most types of banking relationships between a U.S. depository institution and a foreign bank that are established to provide regular services, dealings, and other financial transactions, including a demand deposit, savings deposit, or other transaction or asset account, and a credit account or other extension of credit. FinCEN is using the same definition of “account” for purposes of this proposed rule as was established for depository institutions in the final rule implementing the provisions of Section 312 of the USA PATRIOT Act requiring enhanced due diligence for correspondent accounts maintained for certain foreign banks.
In the case of securities broker-dealers, futures commission merchants, introducing brokers-commodities, and investment companies that are open-end companies (“mutual funds”), FinCEN is also using the same definition of “account” for purposes of this proposed rule as was established for these entities in the final rule implementing the provisions of Section 312 of the USA PATRIOT Act requiring enhanced due diligence for correspondent accounts maintained for certain foreign banks.
The proposed rule defines “covered financial institution” with the same definition used in the final rule implementing the provisions of Section 312 of the USA PATRIOT Act, which in general includes the following:
An insured bank (as defined in section 3(h) of the Federal Deposit Insurance Act (12 U.S.C. 1813(h));
a commercial bank;
an agency or branch of a foreign bank in the United States;
a Federally insured credit union;
a savings association;
a corporation acting under section 25A of the Federal Reserve Act (12 U.S.C. 611);
a trust bank or trust company;
a broker or dealer in securities;
a futures commission merchant or an introducing broker-commodities; and
a mutual fund.
The proposed rule defines “foreign banking institution” to mean a bank organized under foreign law, or an agency, branch, or office located outside the United States of a bank. The term does not include an agent, agency, branch, or office within the United States of a bank organized under foreign law. This is consistent with the definition of “foreign bank” under 31 CFR 1010.100.
The proposed rule defines “subsidiary” to mean a company of which more than 50 percent of the voting stock or analogous equity interest is owned by another company.
Section 1010.661(b)(1) and (2) of this proposed rule would prohibit covered financial institutions from opening or maintaining in the United States a correspondent account for, or on behalf of, ABLV. It would also require covered financial institutions to take reasonable steps to not process a transaction for the correspondent account of a foreign banking institution in the United States if such a transaction involves ABLV. Such reasonable steps are described in 1010.661(b)(3), which sets forth the special due diligence requirements a covered financial institution would be required to take when it knows or has reason to believe that a transaction involves ABLV.
As a corollary to the prohibition set forth in section 1010.661(b)(1) and (2),
The purpose of the notice requirement is to aid cooperation with correspondent account holders in preventing transactions involving ABLV from accessing the U.S. financial system. FinCEN does not require or expect a covered financial institution to obtain a certification from any of its correspondent account holders that access will not be provided to comply with this notice requirement.
Methods of compliance with the notice requirement could include, for example, transmitting a notice by mail, fax, or email. The notice should be transmitted whenever a covered financial institution knows or has reason to believe that a foreign correspondent account holder provides services to ABLV.
Special due diligence also includes implementing risk-based procedures designed to identify any use of correspondent accounts to process transactions involving ABLV. A covered financial institution would be expected to apply an appropriate screening mechanism to identify a funds transfer order that on its face listed ABLV as the financial institution of the originator or beneficiary, or otherwise referenced ABLV in a manner detectable under the financial institution's normal screening mechanisms. An appropriate screening mechanism could be the mechanisms used by a covered financial institution to comply with various legal requirements, such as the commercially available software programs used to comply with the economic sanctions programs administered by OFAC.
Section 1010.661(b)(4) of the proposed rule would clarify that the proposed rule does not impose any reporting requirement upon any covered financial institution that is not otherwise required by applicable law or regulation. A covered financial institution must, however, document its compliance with the notification requirement described above.
FinCEN invites comments on all aspects of the proposed rule, including the following specific matters:
1. FinCEN's proposal of a prohibition under the fifth special measure under 31 U.S.C. 5318A(b), as opposed to special measures one through four or imposing conditions under the fifth special measure;
2. The form and scope of the notice to certain correspondent account holders that would be required under the rule; and
3. The appropriate scope of the due diligence requirements in this proposed rule.
When an agency issues a rulemaking proposal, the Regulatory Flexibility Act (RFA) requires the agency to “prepare and make available for public comment an initial regulatory flexibility analysis” that will “describe the impact of the proposed rule on small entities.” (5 U.S.C. 603(a)). Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the proposed rulemaking is not expected to have a significant economic impact on a substantial number of small entities.
For purposes of the RFA, both banks and credit unions are considered small entities if they have less than $550,000,000 in assets.
Broker-dealers are defined in 31 CFR 1010.100(h) as those broker-dealers required to register with the Securities and Exchange Commission (SEC). For the purposes of the RFA, FinCEN relies on the SEC's definition of small business as previously submitted to the Small Business Administration (SBA). The SEC has defined the term small entity to mean a broker or dealer that: (1) Had total capital (net worth plus subordinated liabilities) of less than $500,000 on the date in the prior fiscal year as of which its audited financial statements were prepared pursuant to Rule 17a-5(d) or, if not required to file such statements, a broker or dealer that had total capital (net worth plus subordinated debt) of less than $500,000 on the last business day of the preceding fiscal year (or in the time that it has been in business if shorter); and (2) is not affiliated with any person (other than a natural person) that is not a small business or small organization as defined in this release.
Futures commission merchants (FCMs) are defined in 31 CFR1010.100(x) as those FCMs that are registered or required to be registered as a FCM with the Commodity Futures Trading Commission (CFTC) under the Commodity Exchange Act (CEA), except persons who register pursuant to section 4f(a)(2) of the CEA, 7 U.S.C. 6f(a)(2). Because FinCEN and the CFTC regulate substantially the same population, for the purposes of the RFA, FinCEN relies on the CFTC's definition of small business as previously submitted to the SBA. In the CFTC's “Policy Statement and Establishment of Definitions of
For purposes of the RFA, an introducing broker-commodities dealer is considered small if it has less than $38,500,000 in gross receipts annually.
Mutual funds are defined in 31 CFR 1010.100(gg) as those investment companies that are open-end investment companies that are registered or are required to register with the SEC. For the purposes of the RFA, FinCEN relies on the SEC's definition of small business as previously submitted to the SBA. The SEC has defined the term “small entity” under the Investment Company Act to mean “an investment company that, together with other investment companies in the same group of related investment companies, has net assets of $50 million or less as of the end of its most recent fiscal year.”
As noted above, 80 percent of banks, 92.5 percent of credit unions, 17 percent of broker-dealers, 95 percent of introducing broker-commodities dealers, no FCMs, and seven percent of mutual funds are small entities.
The proposed prohibition under the fifth special measure would require covered financial institutions to provide a notification intended to aid cooperation from foreign correspondent account holders in preventing transactions involving ABLV from being processed by the U.S. financial system. FinCEN estimates that the burden on institutions providing this notice is one hour.
Covered financial institutions would also be required to take reasonable measures to detect use of their correspondent accounts to process transactions involving ABLV. All U.S. persons, including U.S. financial institutions, currently must comply with OFAC sanctions, and U.S. financial institutions have suspicious activity reporting requirements. The systems that U.S. financial institutions have in place to comply with these requirements can easily be modified to adapt to this proposed rule. Thus, the special due diligence that would be required under the proposed rule—
For these reasons, FinCEN certifies that the proposals contained in this rulemaking would not have a significant impact on a substantial number of small businesses.
FinCEN invites comments from members of the public who believe there would be a significant economic impact on small entities from the imposition of a prohibition under the fifth special measure regarding ABLV.
The collection of information contained in this proposed rule is being submitted to the Office of Management and Budget for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). Comments on the collection of information should be sent to the Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Office of Management and Budget, Paperwork Reduction Project (1506), Washington, DC 20503 (or by email to
The notification requirement in section 1010.661(b)(3)(i)(A) is intended to aid cooperation from correspondent account holders in denying ABLV access to the U.S. financial system. The information required to be maintained by that section would be used by federal agencies and certain self-regulatory organizations to verify compliance by covered financial institutions with the provisions of 31 CFR 1010.661. The collection of information would be mandatory.
FinCEN specifically invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the mission of FinCEN, including whether the information would have practical utility; (b) the accuracy of FinCEN's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information required to be maintained; (d) ways to minimize the burden of the required collection of information, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to report the information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number.
Executive Orders 12866 and 13563 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that the proposed rule is not a “significant regulatory action” for purposes of Executive Order 12866.
Administrative practice and procedure, banks and banking, brokers, counter money laundering, counter-terrorism, foreign banking.
For the reasons set forth in the preamble, part 1010, chapter X of title 31 of the Code of Federal Regulations, is proposed to be amended as follows:
2 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314, 5316- 5332; Title III, sec. 314 Pub. L. 107-56, 115 Stat. 307; sec. 701 Pub. L. 114-74, 129 Stat. 599.
(a)
(1)
(2)
(3)
(4)
(5)
(b)
(1)
(2)
(3)
(A) Notifying those foreign correspondent account holders that the covered financial institution knows or has reason to believe provide services to ABLV that such correspondents may not provide ABLV with access to the correspondent account maintained at the covered financial institution; and
(B) Taking reasonable steps to identify any use of its foreign correspondent accounts by ABLV, to the extent that such use can be determined from transactional records maintained in the covered financial institution's normal course of business.
(ii) A covered financial institution shall take a risk-based approach when deciding what, if any, other due diligence measures it reasonably must adopt to guard against the use of its foreign correspondent accounts to process transactions involving ABLV.
(iii) A covered financial institution that knows or has reason to believe that a foreign bank's correspondent account has been or is being used to process transactions involving ABLV shall take all appropriate steps to further investigate and prevent such access, including the notification of its correspondent account holder under paragraph (b)(3)(i)(A) of this section and, where necessary, termination of the correspondent account.
(4)
(ii) Nothing in paragraph (b) of this section shall require a covered financial institution to report any information not otherwise required to be reported by law or regulation.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a temporary safety zone on the navigable waters of the Cape Fear River in New Hanover County, North Carolina. This temporary safety zone is intended to restrict vessel traffic on the Cape Fear River while a vessel prepares for and actively off-loads two new Post-Panamax gantry cranes to the North Carolina State Port Authority in Wilmington, North Carolina. This action is intended to restrict vessel traffic on the Cape Fear River to protect mariners and vessels from the hazards associated with off-loading the two gantry cranes. Entry of vessels or persons into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) North Carolina or a designated representative. This proposed rule is a follow-up action to a proposed rule that can be found in docket number USCG-2017-0965. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before March 19, 2018.
You may submit comments identified by docket number USCG-2018-0024 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, contact Petty Officer Matthew Tyson, Waterways Management Division, U.S. Coast Guard Sector North Carolina, Wilmington, NC; telephone: 910-772-2221, email:
On August 22, 2017, the North Carolina State Port Authority notified the Coast Guard that they will be transporting two pre-assembled Post-Panamax gantry cranes up the Cape Fear River to the North Carolina State Port in Wilmington, North Carolina. The planned transit date is April 1, 2018 with alternate dates of March 29th, 30th, 31st, April 2nd, 3rd, or 4th, 2018. A proposed safety zone for the transit can be found in docket number USCG-2017-0965. Once the transit is complete a second safety zone is needed for the gantry cranes off-loading at the North Carolina State Port in Wilmington, North Carolina. The COTP North Carolina has determined that potential safety hazards associated with the gantry cranes off-loading would be a concern for anyone transiting the Cape Fear River.
The purpose of this rule is to protect persons, property, vessels, and the marine environment on the navigable waters on the Cape Fear River during the off load of the gantry cranes. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.
The COTP proposes to establish a safety zone on a portion of the Cape Fear River to be enforced during the preparation and active off-loading of two pre-assembled Post-Panamax gantry cranes at the North Carolina State Port in Wilmington, North Carolina for seven days, beginning once the transport vessel moors. As stated in the proposed safety zone found in docket number USCG-2017-0965, the vessel is scheduled to complete its transit on April 1, 2018. There will be alternate dates of March 29th, 30th, 31st, April 2nd, 3rd, or 4th, 2018 in case severe weather or other conditions prevent the safe transit of the vessel on April 1st. The safety zone will be enforced at various times once the vessel has been safely moored at North Carolina State Port in Wilmington, North Carolina and terminate upon completion of the crane off-load evolution. The safety zone will include all navigable waters of the Cape Fear River within 200 yards of the transport vessel while it is moored. The duration of this zone is intended to protect persons, property, vessels, and the marine environment on the navigable waters of the Cape Fear River during the off-load of the gantry cranes. No vessel or person will be permitted to enter the safety zone unless specifically authorized by the Captain of the Port North Carolina or a designated representative. No vessels greater than 40 feet in height will be allowed to transit the safety zone.
We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, and duration of the proposed safety zone. Vessel traffic will not be allowed to enter or transit a portion of the Cape Fear River beginning on April 1, 2018 with alternate dates of March 29th, 30th, 31st, April 2nd, 3rd, or 4th, 2018 for seven days. The Coast Guard will issue a Local Notice to Mariners and transmit a Broadcast Notice to Mariners via VHF-FM marine channel 16 regarding the safety zone. This portion of the Cape Fear River has been determined to be a high traffic area. This rule allows vessels to request specific authorization to pass through the safety zone as long as they are under the height restriction of 40 feet.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect 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. If you believe this proposed rule has
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a safety zone enforced at various times over a seven day period that would prohibit entry within 200 yards of a moored vessel. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) With the exception of participants, entry into or remaining in this safety zone is prohibited unless authorized by the COTP North Carolina or the COTP North Carolina's designated representative. All other vessels must depart the zone immediately.
(3) To request permission to remain in, enter, or transit through the safety zone, contact the COTP North Carolina or the COTP North Carolina's representative through the Coast Guard Sector North Carolina Command Duty Officer, Wilmington, North Carolina, at telephone number 910-343-3882, or on VHF-FM marine band radio channel 13 (165.65 MHz) or channel 16 (156.8 MHz).
(d)
(e)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve, as part of the State Implementation Plan (SIP) for the State of Arizona, the second 10-year maintenance plan for the Douglas maintenance area for the 1971 National Ambient Air Quality Standards (NAAQS or “standards”) for sulfur dioxide (SO
Any comments on this proposal must be received by March 19, 2018.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2017-0537 at
Ashley Graham, EPA Region IX, (415) 972-3877,
Throughout this document, the words “we,” “us,” or “our” refer to the EPA.
We are proposing to approve the second 10-year maintenance plan for the Douglas, Arizona SO
The NAAQS are health-based and welfare-based standards for certain ambient air pollutants. SO
In 1971 the EPA established both short- and long-term primary NAAQS for SO
In 2010 the EPA revised the primary SO
The Douglas maintenance area is located in southern Cochise County near the U.S.-Mexico border. On March 3, 1978, for lack of a State recommendation, we designated Cochise County as a primary SO
On the date of enactment of the 1990 CAA Amendments, SO
In 2006 we redesignated the Douglas area using the criteria for SO
During its operation, the Phelps Dodge Douglas Reduction Works Smelter (PDDRWS) was the largest point source in the Douglas SO
The remaining SO
Currently, no ambient SO
Section 175A of the CAA provides the general framework for maintenance plans. The initial 10-year maintenance plan must provide for maintenance of the NAAQS for at least 10 years after redesignation, including any additional control measures necessary to ensure such maintenance. In addition, maintenance plans are to contain contingency provisions necessary to assure the prompt correction of a violation of the NAAQS that occurs after redesignation. The contingency measures must include, at a minimum, a requirement that the state will implement all control measures contained in the nonattainment SIP prior to redesignation.
Section 175A(b) of the CAA requires states to submit a subsequent maintenance plan revision (“second 10-year maintenance plan”) eight years after redesignation. The Act requires only that this second 10-year maintenance plan maintain the applicable NAAQS for 10 years after the expiration of the first 10-year maintenance plan. Beyond these provisions, section 175A of the CAA does not define the content of a second 10-year maintenance plan.
Section 110 of the CAA requires states to make SIP revisions available for public review and comment and to hold a public hearing or provide the public the opportunity to request a public hearing. The Act requires the plan be adopted by the state and submitted to the EPA by the governor or his/her designee.
The primary guidance on maintenance plans and redesignation requests is a September 4, 1992 memorandum from John Calcagni, titled “Procedures for Processing Requests to Redesignate Areas to Attainment” (“Calcagni Memo”).
Guidance on SO
While the Seitz Memo primarily addresses redesignations, we find it is appropriate to apply the Seitz Memo to second 10-year maintenance plans for areas that were redesignated in accordance with the memo and continue to experience similar conditions to those at the time of redesignation.
Our historic redesignation policy for SO
(1) Emissions inventories representing actual emissions when violations occurred, current emissions, and emissions projected to the tenth year after redesignation; all three inventories should include estimates of emissions in, and within a 50-km buffer zone of, the nonattainment area boundaries;
(2) dispersion modeling showing that no SO
(3) evidence that if the retired source resumes operation, it would be considered a new source and be required to obtain a permit under the Prevention of Significant Deterioration (PSD) provisions of the CAA; and
(4) a commitment to resume monitoring before any major SO
On December 14, 2016, the ADEQ submitted to the EPA the “Maintenance Plan Renewal, 1971 Sulfur Dioxide National Ambient Air Quality Standards, Douglas Maintenance Area” (“2016 Douglas Second Maintenance Plan”). The State verified that it had adhered to its SIP adoption procedures in Appendix C to the 2016 Douglas Second Maintenance Plan, which includes the notice of public hearing, the agenda for the December 9, 2016 public hearing, the sign-in sheet, the public hearing officer certification and transcript of the hearing, and the State's responsiveness summary.
On June 14, 2017, the 2016 Douglas Second Maintenance Plan was deemed complete by operation of law.
As discussed above, the only major source of SO
The 2016 Douglas Second Maintenance Plan covers the second 10 years of the 20-year maintenance period, as required by section 175A(b) of the CAA. As discussed below, the State has addressed the requirements in the Seitz Memo for emissions inventories, modeling, permitting of major new sources, and agreement to commence monitoring if a new major source locates in the Douglas area. We provide more details on each requirement and how the 2016 Douglas Second Maintenance Plan meets each requirement in the following sections.
On December 14, 2001, the ADEQ submitted to the EPA the “Douglas Sulfur Dioxide State Implementation and Maintenance Plan” and request to redesignate the area to attainment (“2001 Douglas Maintenance Plan”). Following our request for additional information on emissions inventories and modeling, the ADEQ submitted a series of supplements to the EPA containing additional and revised technical information to support its redesignation request. The ADEQ's “Douglas Sulfur Dioxide Nonattainment Area State Implementation Plan, Emissions Inventory and Air Quality Dispersion Modeling Update, September 2005” (“2005 Supplement”) included emissions inventories for sources in, and within 50 km of, the Douglas maintenance area for 1985 when PDDRWS was operating and SO
In addition to reproducing emissions for 1985, the 2016 Douglas Second Maintenance Plan includes an emissions inventory representing current emissions for 2011 for sources in, and within 50 km of, the Douglas maintenance area. The ADEQ rolled the base 2011 inventory forward to generate an inventory for 2015, the final year of the first maintenance period, and similarly developed inventories for 2020, 2025, and 2030 to extend through the second 10-year maintenance period.
The emissions inventories in the 2016 Douglas Second Maintenance Plan (
Table 1 presents a summary of actual SO
Based on our review of the emissions inventories in the 2016 Douglas Second Maintenance Plan, including the supporting information in Appendix A, we conclude that the inventories are complete, accurate, and consistent with applicable CAA provisions and the Seitz Memo.
Past EPA policy memoranda on SO
For the 2005 Supplement to the 2001 Douglas Maintenance Plan, screening dispersion modeling was performed using the SCREEN3 model run with conservative assumptions about source parameters and meteorology. In the 2005 Supplement, the ADEQ identified seven existing stationary sources in, and within 50 km of, the Douglas nonattainment area. The modeling analysis for emissions projected to 2015 indicated that the impact of these sources would not exceed 61 percent and 64 percent of the 1971 annual and 24-hour SO
The Seitz Memo also requires a modeling analysis that shows that the retired point sources were the dominant sources contributing to high SO
For the 2016 Douglas Second Maintenance Plan, the ADEQ conducted a modeling analysis similar to the analysis for the 2005 Supplement. Five facilities for which SO
The ADEQ used the EPA-recommended AERSCREEN dispersion model (version 15181) to estimate the SO
One way that the ADEQ modeling was potentially not conservative was in its assumption of simple terrain. Terrain with elevations above stack height,
Section 172(c)(5) of the CAA requires New Source Review permits prior to the construction and operation of new major stationary sources and prior to major modifications at existing major stationary sources in nonattainment areas. However, in attainment areas, major sources and major modifications require PSD permits in accordance with section 165 of the CAA. The PSD program requires stationary sources to apply the best available control technology (BACT) and ensure that projects will not cause or contribute to a violation of a NAAQS or a maximum allowable increase.
The ADEQ has a PSD permitting program (
The ADEQ commits to resume monitoring before any major source of SO
As discussed above, section 175A of the CAA sets forth the statutory requirements for maintenance plans, and the Calcagni, Seitz, and Shaver memos cited above contain specific EPA guidance. The only maintenance plan element not covered by the Seitz Memo is the contingency provisions element. Section 175A(d) of the CAA requires that maintenance plans contain contingency provisions deemed necessary by the Administrator to assure that the state will promptly correct any violation of the standards that occurs after the redesignation of the area as an attainment area. The Calcagni Memo provides additional guidance, noting that although a state is not required to have fully-adopted contingency measures that will take effect without further action by the state for the maintenance plan to be approved, the maintenance plan should ensure that the contingency measures are adopted expeditiously once they are triggered. Specifically, the maintenance plan should clearly identify the measures to be adopted, include a schedule and procedure for adoption and implementation of the measures, and contain a specific time limit for action by the state. In addition, the state should identify specific indicators or triggers that will be used to determine when the contingency measures need to be implemented.
The 2016 Douglas Second Maintenance Plan includes the State's
Since there are no remaining sources of SO
Furthermore, the ADEQ anticipates no relaxation of any implemented control measures used to attain and maintain the NAAQS, and they commit to submit to us any changes to rules or emission limits applicable to SO
Upon review of the contingency plan summarized above, we find that the ADEQ has established a contingency plan for the Douglas area that satisfies the requirements of the CAA section 175A(d) and the Calcagni Memo.
Conformity is required under section 176(c) of the CAA to ensure that federal actions are consistent with (“conform to”) the purpose of the SIP. Conformity to the purpose of the SIP means that federal activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the relevant NAAQS or interim reductions and milestones. Conformity applies to areas that are designated nonattainment and to maintenance areas. The requirement to determine conformity applies to transportation plans, programs, and projects developed, funded, or approved under Title 23 U.S.C. and the Federal Transit Act (“transportation conformity”), and to other federally supported or funded projects (“general conformity”).
Transportation conformity applies to projects that require Federal Highway Administration or Federal Transit Administration funding. 40 CFR part 93 describes the requirements for federal actions related to transportation plans, programs, and projects to conform to the purposes of the SIP. Because the EPA does not consider SO
Section 176(c)(4) of the CAA establishes the framework for general conformity. Besides ensuring that federal actions not covered by the transportation conformity rule will not interfere with the SIP, the general conformity regulations encourage consultation between the federal agency and the state or local air pollution control agencies before and during the environmental review process; public notification of and access to federal agency conformity determinations; and air quality review of individual federal actions.
Section 176(c) of the CAA requires the states to revise their SIPs to establish criteria and procedures to ensure that federally supported or funded projects in nonattainment and maintenance areas “conform” to the air quality planning goals in the applicable SIP. State implementation plan revisions intended to meet the conformity requirements in section 176(c) are referred to as “conformity SIPs.” In 2005 Congress amended section 176(c), and under the amended conformity provisions, states are no longer required to submit conformity SIPs for general conformity, and the conformity SIP requirements for transportation conformity have been reduced to include only those relating to consultation, enforcement, and enforceability.
The EPA believes it is reasonable to interpret the conformity SIP requirements as not applying for purposes of a redesignation request under section 107(d)(3)(E)(v) because state conformity rules are still required after redesignation and federal conformity rules apply where state rules have not been approved.
Criteria for making determinations and provisions for general conformity are contained in A.A.C. R18-2-1438. Arizona has an approved general conformity SIP (64 FR 19916, April 23, 1999).
The ADEQ commits in the 2016 Douglas Second Maintenance Plan to review and comment, as appropriate, on any federal agency draft general conformity determination it receives consistent with 40 CFR 93.155 for any federal plans or actions in the Douglas area, although none are currently planned for the area.
The EPA is proposing to approve the Douglas second 10-year SO
We will accept comments from the public on this proposal for 30 days from the date of publication of this notice, and we will consider any relevant comments in taking final action on today's proposal.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• 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);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• 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
• 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 the 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).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur oxides.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Alaska Regional Haze State Implementation Plan (SIP), submitted by the State of Alaska on March 10, 2016. Alaska submitted its Regional Haze Progress Report (“progress report” or “report”) and a negative declaration stating that further revision of the existing regional haze SIP is not needed at this time. Alaska submitted both the progress report and the negative declaration in the form of implementation plan revisions as required by federal regulations. The progress report addresses the federal Regional Haze Rule (RHR) requirements under the Clean Air Act (CAA) to submit a report describing progress in achieving reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the state's existing plan addressing regional haze. We are also proposing to approve minor updates to the Enhanced Smoke Management Plan, Long-Term Strategy, and Commitment to Future 308 Plan Revision sections of the regional haze SIP, submitted concurrently with the progress report.
Comments must be received on or before March 19, 2018.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2016-0749 at
Jeff Hunt, Air Planning Unit, Office of Air and Waste (OAW-150), Environmental Protection Agency—Region 10, 1200 Sixth Ave., Seattle, WA 98101; telephone number: (206) 553-0256, email address:
Throughout this document whenever “we,” “us,” or “our” is used, it is intended to refer to the EPA.
Alaska submitted its initial regional haze SIP to the EPA on March 29, 2011, for the first regional haze planning period ending in 2018, which the EPA approved on February 14, 2013.
To facilitate a better understanding of Alaska's progress report as well as the EPA's evaluation of it, this section provides background on the regional haze program in Alaska.
The EPA has established a metric for determining visibility conditions at Class I areas referred to as the “deciview index,” which is measured in deciviews, as defined in 40 CFR 51.301. The deciview index is calculated using monitoring data collected from the Interagency Monitoring of Protected Visual Environments (IMPROVE) network monitors. Alaska has four Class I areas within its borders: Denali National Park and Preserve, Tuxedni National Wildlife Refuge, Simeonof Wilderness Area, and the Bering Sea Wilderness Area. In developing its initial regional haze SIP, Alaska determined, and the EPA in its approval agreed, that due to lack of proximity to other states, visibility in Alaska's Class I areas is not affected by emission
Under the RHR, a state's initial regional haze SIP must establish two RPGs for each of its Class I areas: One for the 20 percent least impaired days and one for the 20 percent most impaired days. The RPGs must provide for an improvement in visibility on the 20 percent most impaired days and ensure no degradation in visibility on the 20 percent least impaired days, as compared to visibility conditions during the baseline period. In establishing the RPGs, a state must consider the uniform rate of visibility improvement from the baseline to natural conditions in 2064 and the emission reductions measures needed to achieve it. Alaska set the RPGs for the Denali, Tuxedni, and Simeonof Class I areas. In setting the RPGs for these three Class I areas, Alaska used atmospheric air quality modeling based on projected emission reductions from control strategies in Alaska's regional haze SIP, as well as emission reductions expected to result from other federal, state and local air quality programs.
Alaska's fourth Class I area, the Bering Sea Wilderness Area, is extremely remote, with no IMPROVE monitoring site. Therefore, no RPG was established for this area in Alaska's regional haze SIP, and Alaska's progress report does not address visibility progress in this area.
Alaska relied on the Western Regional Air Partnership (WRAP) technical data and analyses in a report titled “Western Regional Air Partnership Regional Haze Rule Reasonable Progress Summary Report” (WRAP Report), dated June 28, 2013, included as an appendix in the progress report. The WRAP Report analyzes monitoring data collected in Alaska during the 2005-2009 period, and relies on emission data reported to the EPA's National Emissions Inventory (NEI) for 2008. Alaska then supplemented the information in the WRAP report with more current 2009-2013 visibility data for its Class I areas as part of the progress report adopted by the state in 2015.
This section describes the contents of Alaska's progress report and the EPA's evaluation of the report, as well as the EPA's evaluation of the determination of adequacy required by 40 CFR 51.308(h) and the requirement for state and Federal Land Manager coordination in 40 CFR 51.308(i).
In its progress report, Alaska provides a description of the control measures in the state's regional haze SIP that the state relied on to implement the regional haze program. According to the progress report, Alaska relied in its regional haze SIP upon, among other things, Best Available Retrofit Technology (BART) controls, its Prevention of Significant Deterioration/New Source Review permitting program, and its smoke management programs for agricultural and forestry burning to achieve the reasonable progress goals it established for its Class I areas. Alaska included a description of these programs in the progress report, which are summarized below.
Alaska's regional haze SIP imposed BART-level controls on one source, the Golden Valley Electric Association's (GVEA) Healy Power Plant, Unit 1. The Healy Power Plant consists of two power generating units. Unit 1 is a nominal 25 megawatt (MW) coal-fired electric generating unit. The EPA approved the state's BART determination for this unit when we approved the Alaska regional haze SIP. Alaska determined that BART for Unit 1 included installation of Selective Non Catalytic Reduction (SNCR) to reduce nitrogen oxide (NO
On November 19, 2012, the United States and GVEA entered into a consent decree that specifies conditions on Unit 1 and Unit 2 at the Healy Power Plant, separate from the BART-level controls required by Alaska's regional haze SIP.
Alaska's progress report states that a key regulatory program for addressing visibility impairment from new or modified industrial stationary sources is the state's Major New Source Review (NSR)/Prevention of Significant Deterioration (PSD) rule. According to Alaska, this rule protects visibility in Class I areas from impacts from new or modified major stationary sources. Alaska's regulations (18 AAC 50 Article 3) and the Alaska SIP require visibility impact assessments and mitigation of emissions from new and modified major stationary sources through protection of air quality related values (AQRVs). AQRVs are scenic and environmentally related values that may be adversely affected by a change in air quality, including visibility, odor, noise, vegetation, and soils. These visibility requirements were approved by the EPA into the Alaska SIP in 1983.
In its regional haze SIP, Alaska predicted that implementation of more
Additionally, On June 3, 2015, the Alaska Wildfire Coordinating Group approved a routine 5-year update to the Alaska ESMP, which ADEC submitted as a SIP revision along with the progress report. The 2015 revisions to the ESMP were generally minor in nature, such as updating the summary text to note the EPA's approval of the initial regional haze SIP and availability of additional electronic tools for submitting controlled burn applications developed since the original ESMP. The most substantive change to the ESMP was an update of Chapter 6.2 “Public Notification and Exposure Reduction” to reflect changes to Alaska's air quality episode and advisory regulations, which the EPA approved in a separate action on September 8, 2017 (82 FR 42457).
Alaska also submitted a minor update to the long-term strategy, with two sentences edited to reflect adoption of the revised ESMP in 2015. The EPA is proposing to approve this set of minor revisions to the SIP.
In addition to the evaluation of control measures, Alaska documented in the progress report the differences between the visibility conditions during the baseline period (2000-2004), the first progress period (2005-2009), and the most current five year averaging period (2009-2013) available at the time Alaska adopted the progress report in 2015. As part of our review, the EPA supplemented this information with current 2012-2016 data, as shown in Table 1.
Alaska's concluded that for the 20% most impaired days, five-year average visibility remained about the same at the Simeonof and Tuxedni
Regarding visibility monitoring, Alaska intends to continue relying on the IMPROVE network sites that represent the state's Class I areas for complying with the monitoring requirement in the RHR. As described in the progress report, the Tuxedni monitor discontinued operation in December 2014, when the property owner and site operator notified the U.S. Fish and Wildlife Service that he would no longer be able to service the site. The progress report also noted efforts by the U.S. National Park Service and U.S. Fish and Wildlife Service to establish a new site across the Cook Inlet, which they succeeded in doing roughly 3 miles south of the community of Ninilchik.
Alaska's progress report summarizes the emissions reductions attributable to anthropogenic sources and attributable to managing wildfire emissions. Regarding anthropogenic sources, the progress report summarizes reductions
Regarding the replacement of electric generating units, Alaska concludes that some of the reductions in NO
• Anchorage Municipal Light and Power's George Sullivan Plant Two's unit 1, a gas turbine generator rated for 480 million British thermal units (BTU)/hour, was put into limited operation as a reserve unit, resulting in reduced emissions from this unit.
• Chugach Electric Association's Beluga plant's units 3 and 5, both rated for 940 million BTU/hour, were put on reserve status, resulting in reduced emissions from these units.
• In 2014, Alaska Electricity and Energy Cooperative's Nikiski plant added a steamer unit to improve efficiency, reducing overall fuel requirements within the grid and thus reducing emissions from this plant.
Overall, Alaska concluded that NO
In addition, the progress report includes a discussion of control measures to attain and maintain the particulate matter national ambient air quality standards, such as wood smoke reduction programs for Eagle River, the Mendenhall Valley, and the Fairbanks North Star Borough. Current control measures in Fairbanks include an opacity limit and mandatory curtailment program for solid-fuel fired heating devices, emission standards for new wood-fired heating devices installed in the area, a requirement to burn only dry wood in wood heaters, a woodstove changeout program, a prohibition on open burning, and public education, among other requirements. Alaska noted in its progress report that these control measures could potentially reduce overall area source emissions inventories in the future.
In addition to reductions of emissions from anthropogenic sources, the progress report describes emissions reductions attributable to wildfire management. Specifically, the report states that in recent years, prescribed fires have reduced the emissions from the area burned by close to half of what they would have been if they had burned during a wildfire. According to the progress report, over the period of 2007 to 2013, hundreds of tons of PM
The progress report also contains an analysis tracking the change in statewide emissions between 2002 and 2008. The 2002 inventory was used in the development of the original Alaska regional haze SIP. At the time Alaska prepared the progress report, the 2008 inventory was the most recent year that complete emission inventories were available for the state. Alaska notes that the differences between the 2002 and 2008 inventories for some source categories do not accurately reflect a change in emissions, as a number of methodology changes and enhancements have occurred between the developments of the individual inventories, as described in more detail below. Summaries from the progress report are included in Tables 2 and 3. A more detailed description of each inventory is provided in section 3.2.1 of Appendix A to the progress report.
Regarding emissions inventories, Alaska made the following observations:
• Fire emission inventory estimates decreased. Note that these differences are not necessarily reflective of changes in monitored data, as the five-year baseline period is represented by a 2000-2004 average of fire emissions developed by the WRAP, and the five-year progress period is represented by fires that occurred in 2008.
• Point source inventories showed decreases for all species.
• Area source inventories showed increases in SO
• On-road mobile source inventory comparisons showed increases in SO
• Commercial marine sources showed large increases in NO
Alaska also notes that during high fire years, emissions from wildland fires can make up a significant portion of the state's overall emissions for some pollutants. Further, wildfire activity varies greatly from year to year, and unlike other emission sources, the locations vary from year to year. Alaska also notes that one contributing source of anthropogenic emissions not included in the emissions inventory is international anthropogenic emissions. According to the progress report, Alaska receives a significant amount of globally transported pollution, particularly from Asia and Russia. Continued industrial growth in these areas is likely to increase emissions of pollutants that contribute to regional haze in Alaska, although the extent of this contribution to haze in Alaska has not been determined due to lack of accurate international emission inventories.
In accordance with 40 CFR 51.308(h)(1), “If the state determines [at the time the five-year progress report is submitted] that the existing implementation plan requires no further substantive revision at this time in order to achieve established goals for visibility improvement and emissions reductions, the state must provide to the Administrator a negative declaration that further revision of the existing implementation plan is not needed at this time.” Within the progress report, the State of Alaska provided a negative declaration stating that further revision of the existing implementation plan is not needed. The basis for the state's negative declaration is the finding that visibility on the 20% most impaired days has improved, and 2018 RPGs attained, at all Alaska IMPROVE monitors, except for the Denali Headquarters monitor, which shows a slight decrease in visibility for the current period compared to the baseline due to smoke from wildfires in Alaska in 2009.
Accordingly, the EPA proposes to find that Alaska adequately addressed the requirements in 40 CFR 51.308(h) in its determination that the existing Alaska regional haze SIP requires no substantive revisions at this time to achieve the established RPGs for Alaska Class I areas. We note in particular that, based on the visibility conditions for the most recent five-year period (2012-2016), Alaska is meeting 2018 RPGs at all Alaska IMPROVE monitors.
In accordance with 40 CFR 51.308(i), the state must provide the Federal Land Managers (FLMs) with an opportunity for consultation, in person and at least 60 days prior to holding any public hearings on an implementation plan (or plan revision). The state must also include a description of how it addressed any comments provided by the FLMs. The State of Alaska provided an opportunity for FLM consultation at least 60 days prior to holding any public hearing on a draft progress report. This progress report was submitted to the FLMs on April 27, 2015, for review and comment. Comments were received from the FLMs on June 30, 2015. The FLM comments and state responses are presented in the progress report. In accordance with 40 CFR 51.308(i)(4), Alaska's progress report reaffirms the state' commitment to the regional haze SIP procedures for continuing consultation between the State of Alaska and FLMs on, among other things, the implementation of Alaska's regional haze SIP.
The EPA proposes to find that Alaska has addressed the requirements in 40 CFR 51.308(i) to provide the FLMs with an opportunity for consultation in person and at least 60 days prior to a public hearing on the progress report, included a description of how it addressed any comments from the FLMs, and provided a commitment for continuing consultation between the state and the FLMs. FLM comments and ADEC responses are provided in section E of the progress report.
Concurrent with the progress report, Alaska submitted an update to the
The EPA is proposing to approve the Alaska Regional Haze Progress Report submitted to the EPA on March 10, 2016, as meeting the applicable requirements of the CAA and RHR, as set forth in 40 CFR 51.308(g). The EPA proposes to find that the existing regional haze SIP is adequate to meet the state's visibility goals and requires no substantive revision at this time, as set forth in 40 CFR 51.308(h). We propose to find that Alaska fulfilled the requirements in 40 CFR 51.308(i) regarding state coordination with FLMs. Lastly, we propose to approve updates to the Enhanced Smoke Management Plan, Long-Term Strategy, and Commitment to Future 308 Plan Revision sections of the regional haze SIP, submitted concurrently with the Alaska Regional Haze Progress Report.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations.
• 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);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because actions such as SIP approvals are exempted under Executive Order 12866;
• 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 this rulemaking does not involve technical standards; and
• Does not provide the 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, this proposed action does not apply on any Indian reservation land or in any other area where the 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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Visibility, and Volatile organic compounds.
42 U.S.C. 7401
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (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 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.
Comments regarding this information collection received by March 19, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
These forms are used to safeguard the U.S. animal population from pests and diseases. If the information was collected less frequently or not collected, APHIS would be unable to process reagent orders or provide training that customer's desire.
Office of the Deputy Under Secretary for Food Safety, USDA.
Notice of public meeting and request for comments.
The Office of the Deputy Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA), are sponsoring a public meeting on April 4, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 24th Session of the Codex Alimentarius Commission's (Codex's) Committee on Residues of Veterinary Drugs in Foods (CCRVDF), taking place in Chicago, Illinois, April 23-27, 2018. The Deputy Under Secretary for Food Safety and the FDA recognize the importance of providing interested parties the opportunity to obtain background information on the 24th Session of the CCRVDF and to address items on the agenda.
The public meeting is scheduled for Wednesday, April 4, 2018, from 1:00 p.m. to 4:00 p.m.
The public meeting will take place at the USDA, Jamie L. Whitten Building, 1400 Independence Avenue SW, Room 107-A, Washington, DC 20250.
Documents related to the 24th Session of the CCRVDF will be accessible via the internet at the following address:
Brandi Robinson, U.S. Delegate to the 24th Session of the CCRVDF, invites U.S. interested parties to submit their comments electronically to the following email address:
If you wish to participate in the public meeting for the 24th Session of the CCRVDF by conference call, please use the following call-in-number:
The participant code will be posted on the following web page:
Attendees may register to attend the public meeting by emailing
Brandi Robinson, International Program Manager, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, FDA, 7500 Standish Place, HFV-100, Rockville, MD 20855, Telephone: (240) 402-0645, Email:
Kenneth Lowery, U.S. Codex Office, 1400 Independence Avenue SW, South Agriculture Building, Room 4861, Washington, DC 20250. Telephone: (202) 690-4042, Fax: (202) 720-3157, Email:
Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization and the World Health Organization (FAO/WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.
The CCRVDF is responsible for determining priorities for the consideration of residues of veterinary drugs in foods, recommending maximum levels of such substances, developing codes of practice as may be required, and considering methods of sampling and analysis for the determination of veterinary drug residues in foods.
The Committee is hosted by the United States.
The following items on the Agenda for the 24th Session of the CCRVDF will be discussed during the public meeting:
• Matters referred by the Codex Alimentarius Commission and other subsidiary bodies;
• Matters of interest arising from the FAO/WHO and from the 85th Meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA);
• Report of the World Organisation for Animal Health activities, including harmonization of technical requirements for registration of veterinary medicinal products (VICH);
• Draft Risk Management Recommendation for gentian violet;
• Proposed draft maximum residue limits (MRLs) for zilpaterol hydrochloride (cattle fat, kidney, liver, muscle)(81st JECFA) at Step 4;
• Proposed draft MRLs for amoxicillin (finfish fillet, muscle); ampicillin (finfish fillet, muscle); flumethrin (honey), lufenuron (salmon and trout fillet), monepantel (cattle fat, kidney, liver, muscle) (85th JECFA) at Step 3;
• Discussion paper on MRLs for groups of fish species;
• Discussion paper on edible offal tissues (possible definition and edible offal tissues of interest in international trade);
• Discussion paper on the revision of the criteria for the use of multi-residue analytical methods for the determination and identification of veterinary drugs in foods in Codex;
• Discussion paper on the evaluation of the rationale for the decline in new compounds to be included in the CCRVDF Priority List for evaluation by JECFA;
• Database on countries' need for MRLs;
• Draft priority list of veterinary drugs requiring evaluation or re-evaluation by JECFA; and
• Other business and future work.
Each issue listed will be fully described in documents distributed, or to be distributed, by the Secretariat before the Meeting. Members of the public may access or request copies of these documents (see
At the April 4, 2018, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to the U.S. Delegate for the 24th Session of the CCRVDF, Brandi Robinson (see
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email: Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410, Fax: (202) 690-7442, Email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
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 Ohio Advisory Committee (Committee) will hold a meeting via web conference on Friday March 2, 2018, from 11:30am-1:00 p.m. EST for the purpose of hearing public testimony on voting rights in the state.
The meeting will be held on Friday, March 2, 2018, at 11:30 a.m. EST.
Melissa Wojnaroski, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the above listed toll free number (audio only) and web access link (visual only). Please use
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 Regional Programs Unit 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 Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
This is the first in a series of public meetings the Committee will hold on this topic. Please consult the
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 Friday, March 9, 2018 at 12 p.m. Central time. The Committee will discuss approval of a project proposal to study civil rights and criminal justice in the state.
The meeting will take place on Friday, March 9, 2018 at 12 p.m. Central.
Melissa Wojnaroski, DFO, at
Members of the public can listen to these discussions. These meetings are available to the public through the above call in numbers. 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 1-800-877-8339 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 Regional Programs Unit, 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 Corrine Sanders at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
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 (FACA) that a meeting of the West Virginia Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EST) on Friday, March 2, 2018. The purpose of the meeting is to receive status reports from the Planning Workgroup on recommendations for examining the Committee's examination of the collateral consequences of felony convictions in WV and to make decisions, as needed.
Friday, March 2, 2018, at 12:00 p.m. EST.
Ivy Davis at
Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-877-604-9665 and conference call 5788080. 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.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-877-604-9665 and conference call 5788080.
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 Corrine Sanders at
Records and documents discussed during the meeting will be available for public viewing as they become available at
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 Kansas Advisory Committee (Committee) will hold a meeting on Monday, March 5, 2018 from 12-1:30 pm Central time. The Committee will hear testimony from policy experts in the state as part of their current study on civil rights and school funding.
The meeting will take place on Monday, March 5, 2018 at 12pm Central time, for a duration of 90 minutes.
Melissa Wojnaroski, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the above listed toll free number (audio only) and web access link (visual only). Please use both the call in number and the web access link in order to fully access 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 1-800-877-8339 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 Regional Programs Unit, 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 Corrine Sanders at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
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 Indiana Advisory Committee (Committee) will hold a meeting on Friday, March 2, 2018, from 9:00 a.m.-5:00 p.m. EST. The Committee will hear testimony regarding voting rights in the state.
The meeting will be held on Friday March 2, 2018, from 9:00 a.m.-5:00 p.m. EST.
Ivy Tech Community College Event Center, 2820 North Meridian Street in Indianapolis, IN, 46208.
Melissa Wojnaroski, DFO, at
This meeting is open to the public. Members of the public are invited to make statements during the open comment period beginning at 4:30 p.m. In addition, members of the public may 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 Regional Programs Unit, 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 and documents discussed during the meeting will be available for public viewing prior to and following the meeting at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On December 1, 2017, the Department of Commerce (Commerce) published in the
Applicable February 16, 2018.
Alex Rosen, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-7814.
On December 1, 2017, Commerce published the
The merchandise covered by this order includes certain lightweight thermal paper, which is thermal paper with a basis weight of 70 grams per square meter (g/m2) (with a tolerance of ±4.0 g/m2) or less; irrespective of dimensions;
Commerce preliminarily determined that none of the companies under review, Shenzhen Formers Printing Co., Ltd (Formers), Sailing International Ltd (Sailing), and Suzhou Xiandai Paper Production Co (Xiandai) demonstrated eligibility for separate rate status and, thus, found them to be part of the China-wide entity.
Commerce's policy regarding the conditional review of the China-wide entity applies to this administrative review.
Commerce has determined, and CBP shall assess, antidumping duties on all appropriate entries in this review, in accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1). Commerce intends to issue assessment instructions directly to CBP 15 days after publication in the
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For previously investigated or reviewed China and non-China exporters who are not under review in this segment of the proceeding but who have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (2) for all China exporters of subject merchandise that have not been found to be entitled to a separate rate, including Formers, Sailing and Xiandai, the cash deposit rate will be the China-wide rate of 115.29 percent; and (3) for all non-China exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the China exporter(s) that supplied that non-China exporter. These deposit requirements, when imposed, shall remain in effect until further notice.
Normally, Commerce discloses to interested parties the calculations performed in connection with the final results within five days of its public announcement, or if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). However, because Commerce determined that Formers, Sailing and Xiandai are part of the China-wide entity, to which the China-wide rate applies, there are no calculations to disclose.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement off antidumping duties prior to liquidation of the relevant entries during this period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/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 violation which is subject to sanction.
This notice of the final results of this antidumping duty administrative review is issued and published in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.213(h) and 19 CFR 351.221(b)(5).
This is a decision pursuant to Section 6(c) of the Educational, Scientific, and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, as amended by Pub. L. 106-36; 80 Stat. 897; 15 CFR part 301). Related records can be viewed between 8:30 a.m. and 5:00 p.m. in Room 3720, U.S. Department of Commerce, 14th and Constitution Ave, NW, Washington, DC.
Docket Number: 17-014. Applicant: Fermi Research Alliance, Batavia, IL 60510. Instrument: ICARUS T600 Detector. Manufacturer: The European Organization for Nuclear Research, Switzerland. Intended Use: See notice at 82 FR 57212, December 4, 2017. Comments: None received. Decision: Approved. We know of no instruments of equivalent scientific value to the foreign instruments described below, for such purposes as this is intended to be used, that was being manufactured in the United States at the time of order. Reasons: The instrument will be used to study the rate at which muon neutrinos, a type of elementary particle, change flavor to electron neutrinos as they travel the distance between three LArTPC detectors. This is the only instrument that meets the requirements for position and time resolution of particle trajectories.
Docket Number: 17-015. Applicant: New Mexico Institute of Mining and Technology, Socorro, NM 87801. Instrument: Unit Telescope Enclosure #1 (UTE1). Manufacturer: European Industrial Engineering (EIE) Group, Italy. Intended Use: See notice at 82 FR 57212, December 4, 2017. Comments: None received. Decision: Approved. We know of no instruments of equivalent scientific value to the foreign instruments described below, for such purposes as this is intended to be used, that was being manufactured in the United States at the time of order. Reasons: The instrument will be used to study star and planet formation, active galactic nuclei and stellar accretion and mass loss. Unique features of the instrument include access to all astronomical objects above 30 degrees in elevation, with an inner axis rotation angle between +40 degrees and −50 degrees, as well as thermal stability and protection from shock load and vibration.
Docket Number: 17-016. Applicant: Yale University, New Haven, CT 06520. Instrument: Mosquito crystal robot. Manufacturer: TTP Labtech, United Kingdom. Intended Use: See notice at 82 FR 57212-13, December 4, 2017. Comments: None received. Decision: Approved. We know of no instruments of equivalent scientific value to the foreign instruments described below, for such purposes as this is intended to be used, that was being manufactured in the United States at the time of order. Reasons: The instrument will be used to obtain crystals of the biological macromolecule with and without its binding partner(s). Unique features of the instrument include disposable tips, which are essential to avoid cross contamination.
Docket Number: 17-018. Applicant: Brookhaven National Laboratory, Upton, NY 11973. Instrument: Solid State Klystron Modulator. Manufacturer: Scandinova Systems AB, Sweden. Intended Use: See notice at 82 FR 57213, December 4, 2017. Comments: None received. Decision: Approved. We know of no instruments of equivalent scientific value to the foreign
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) is rescinding the administrative review of the countervailing duty order on hot-rolled steel products from Brazil for the period of review (POR) January 15, 2016, through December 31, 2016.
Ross Belliveau or William Miller, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4952 or (202) 482-3906, respectively.
On October 4, 2017, Commerce published in the
On December 7, 2017, Commerce published in the
Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if a party who requested the review withdraws the request within 90 days of the date of publication of notice of initiation of the requested review. As noted above, CSN withdrew its request for review by the 90-day deadline, and no other party requested an administrative review of this order. Therefore, we are rescinding the administrative review of the countervailing duty order on hot-rolled steel products from Brazil covering the period January 15, 2016, through December 31, 2016.
Commerce will instruct U.S. Customs and Border Protection (CBP) to assess countervailing duties on all appropriate entries. Countervailing duties shall be assessed at rates equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions directly to CBP 15 days after the date of publication of this notice in the
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/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 notice is issued and published in accordance with section 777(i)(1) of the Act and 19 CFR 351.213(d)(4).
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to the Procurement List.
This action adds products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 12/22/2017 (82 FR 245) and 1/12/2018 (83 FR 9), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and impact of the additions on the current or most recent contractors, the Committee has determined that the products listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or
2. The action will result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products proposed for addition to the Procurement List.
Accordingly, the following products are added to the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Addition to from the Procurement List.
This action adds a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 11/27/2017 (82 FR 226), the Committee for Purchase From People Who Are Blind or Severely Disabled published a notice of proposed addition to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agency to provide the service and impact of the addition on the current or most recent contractors, the Committee has determined that the service listed below is suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will provide the service to the Government.
2. The action will result in authorizing small entities to provide the service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service proposed for addition to the Procurement List.
Accordingly, the following service is added to the Procurement List:
Department of the Air Force, DOD.
Notice of availability of a Record of Decision.
The United States Air Force signed the Record of Decision for the Presidential Aircraft Recapitalization at Joint Base Andrews-Naval Air Facility Washington, Maryland (hereafter referred to as “the Program”) Final Environmental Impact Statement. The Air Force will construct and operate a two-bay Presidential Aircraft Recapitalization Hangar Complex (hereafter referred to as “the Hangar Complex”) facility on Joint Base Andrews at a location known as Alternative 4 to house two separately acquired Boeing 747-8 aircraft.
Mr. Michael Ackerman, (210) 925-2741, EIS Project Manager, AFCEC/CZN, 2261 Hughes Ave, Ste. 155, JBSA Lackland, TX 78326-9853.
On December 27, 2017 the United States Air Force signed the Record of Decision for the Presidential Aircraft Recapitalization. The Air Force decided to utilize the interim Taxiway C site for the Hazardous Cargo Pad during the Hangar complex construction but did not make a final decision for the Hazardous Cargo Pad and Explosive Ordnance Disposal Proficiency Range permanent siting. However, the Air Force identified Hazardous Cargo Pad and Explosive Ordnance Disposal Proficiency Range Southeast Option 1 or a variant thereof (
Air Force decisions documented in the Record of Decision were based on matters discussed in the Final Environmental Impact Statement, inputs from the public and regulatory agencies, and other relevant factors. The Final Environmental Impact Statement was made available to the public on October 17, 2017 through a notice of availability in the
This notice of availability is published pursuant to the regulations (40 CFR 1506.6 and 1502.14(e)) implementing the provisions of NEPA (42 U.S.C. 4321,
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 Defense Advisory Committee on Investigation Prosecution and Defense of Sexual Assault in the Armed Forces will take place. This meeting will be open to the public.
Friday, March 2, 2018, from 11:00 a.m. to 2:00 p.m.
One Liberty Center, 875 N. Randolph Street, Suite 150, Arlington, Virginia 22203.
Dwight Sullivan, 703-695-1055 (Voice),
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 and 102-3.150.
Defense Security Cooperation Agency, Department of Defense (DoD).
Arms sales notice.
The Department of Defense is publishing the unclassified text of an arms sales notification.
Pamela Young, (703) 697-9107,
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-77 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
Also included are seventeen (17) MK25 quad pack canisters, eight (8) MK783 shipping containers, spare and repair parts, support and test equipment, publications and technical documentation, training, U.S. Government/Contractor engineering, technical and logistics support services and technical assistance, and other related elements of logistical support.
(iv)
(v)
(vi)
(vii)
(viii)
*As defined in Section 47(6) of the Arms Export Control Act.
The Government of Finland has requested a possible sale of sixty-eight (68) Evolved SEASPARROW Missiles (ESSM) and one (1) ESSM inert operational missile. Also included are seventeen (17) MK25 quad pack canisters, eight (8) MK783 shipping containers, spare and repair parts, support and test equipment, publications and technical documentation, training, U.S. Government/Contractor engineering, technical and logistics support services and technical assistance, and other related elements of logistical support. The estimated total case value is $112.7 million.
This proposed sale will support the foreign policy and national security objectives of the United States by improving the security of a partner nation that has been, and continues to be, an important force for political stability and economic progress in Europe.
Finland intends to use the missiles on its new Squadron 2020 class Corvette ships. The missiles will provide enhanced capabilities in effective defense of critical sea lanes and improve Finland's capability to meet current and future threats of enemy anti-ship weapons. Finland has not purchased ESSM previously, but will have no difficulty incorporating this capability into its naval forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractors will be Raytheon Missile Systems (RMS) Tucson, AZ, for the missiles, and BAE Systems, Aberdeen, SD, for the missile canisters. The purchaser typically requests offsets. Any offset agreement will be defined in negotiations between the purchaser and the contractor.
Implementation of this proposed sale will require up to 12 U.S. Government personnel to travel to Finland providing support over a period of five years.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The Evolved SEASPARROW missiles (ESSM) includes the guidance section, warhead section, transition section, propulsion section, control section, and Thrust Vector Control (TVC) of which the guidance section and transition section are classified CONFIDENTIAL. Standard missile documentation will include:
2. The Evolved SEASPARROW Missile (ESSM) contains SENSITIVE technological information and/or RESTRICTED information in the missile guidance section. Certain operating frequencies and performance characteristics are classified SECRET because they could be used to develop tactics and/or countermeasures to reduce or defeat the missile effectiveness.
3. If a technologically advanced adversary were to obtain knowledge of specific hardware, the information could be used to develop countermeasures which might reduce weapons system effectiveness or be used in the development of a system with similar or advanced capabilities.
4. A determination has been made that Finland can provide substantially the same degree of protection for sensitive technology being released as the U.S. Government. This proposed sustainment program is necessary to the furtherance of the U.S. foreign policy and national security objectives outlined in the policy justification.
5. All defense articles and services listed on this transmittal are authorized for release and export to the Government of Finland.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before March 19, 2018.
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 Tammy Gay, 816-804-0848.
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.
The data collected for the development of the Teacher Cancellation Low Income Directory provides web-based access to a list of all elementary and secondary schools, and educational service agencies that serve a total enrollment of more than 30 percent low income students (as defined under Title I, Part A of the Elementary and Secondary Education Act of 1965, as amended). The Directory allows post-secondary institutions to determine whether or not a teacher, who received a Federal Perkins Loan, Direct Loan, or Federal Family Education Loan at their school, is eligible to receive loan cancellation or forgiveness or that a teacher who received a TEACH Grant is meeting the service obligation.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Interested persons are invited to submit comments on or before March 19, 2018.
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 Tammy Gay, 816-804-0848.
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.
Office of Management, Department of Education.
Notice of a Modified System of Records.
In accordance with the Privacy Act of 1974, as amended (Privacy Act) (5 U.S.C. 552a), the Department of Education (Department or ED) publishes this notice of a modified system of records entitled “Student Loan Repayment Benefits Case Files” (18-05-15). The system contains records related to employees and job candidates who are being considered for student loan repayment benefits under the Department's Human Capital Policy 537-1 entitled “Student Loan Repayment Program,” as well as individuals who have been approved for and are receiving such benefits.
The information maintained in the system of records entitled “Student Loan Repayment Benefits Case Files” consists of one or more of the following: Request letters from selecting officials or supervisors with supporting documentation; employees' and job candidates' names, home and work addresses, Social Security numbers, student loan account numbers, loan balances, repayment schedules, repayment histories, and repayment status; the loan holders' names, addresses, and telephone numbers; and a signed written service agreement in which an employee or job candidate agrees to complete a specified period of employment with ED. The information that will be maintained in the modified system of records will be collected through various sources, including directly from the individual to whom the information applies, officials of the Department, and official Department documents. The Department published a notice of a modified system of records in the
Submit your comments on this modified system of records notice on or before March 19, 2018
This modified system of records will become effective upon publication in the
Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at
Kimberly Ritter, Director, Office of Human Resources, Learning and Development Division. Telephone: (202) 453-5588.
If you use a telecommunications device for the deaf or a text telephone, you may call the Federal Relay Service at 1-800-877-8339.
The Student Loan Repayment Benefits Case Files (18-05-15) system of records was most recently published in the
You may also access documents of the Department published in the
For the reasons discussed in the preamble, the Acting Assistant Secretary for Management, U.S. Department of Education (Department or ED), publishes a notice of a modified system of records to read as follows:
Student Loan Repayment Benefits Case Files (18-05-15).
Unclassified.
Office of Human Resources, Learning and Development Division, Office of Management, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202-4573.
Director, Office of Human Resources, Learning and Development Division, Office of Management, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202-4573.
The Floyd D. Spence National Defense Authorization Act of Fiscal Year 2001 (Pub. L. 106-398), as amended (5 U.S.C. 5379), and implementing regulations at 5 CFR part 537.
These records are maintained to determine eligibility and benefits and to process requests to offer student loan repayment benefits to recruit highly qualified job candidates or to retain highly qualified Department employees under authority set forth at 5 U.S.C. 5379. The Department uses these records to prepare its reports for the Office of Personnel Management (OPM) as is required by 5 U.S.C. 5379 and 5 CFR 537.110. The Department will also refer information from this system to loan holders for collection activities in the case of any student loan default or delinquency that becomes known to the Department in the course of determining an employee's and job candidates' eligibility for student loan repayment benefits because of the Department's mission responsibilities for Federal student loan programs and its role in promoting their responsible use by student borrowers.
This system contains records on employees and job candidates (other than those outside of the Department who are currently employed in the Federal service) who are being considered for student loan repayment benefits under the Department's Human Capital Policy 537-1 entitled “Repayment of Federal Student Loans,” as well as employees who have been approved for and received such benefits and former employees who have been approved for and received such benefits before separating from the Department.
This system contains correspondence and other documents related to requests made by selecting officials or supervisors to offer student loan repayment benefits to recruit highly qualified job candidates or retain highly qualified employees. This system contains: (1) Request letters from selecting officials or supervisors with supporting documentation; (2) employees' and job candidates' names, home and work addresses, Social Security numbers, student loan account numbers, loan balances, repayment schedules, repayment histories, and repayment status; (3) the loan holders' names, addresses, and telephone numbers; and (4) a signed written service agreement in which an employee or job candidate agrees to complete a specified period of employment with ED.
Information in this system of records is obtained from the individual to whom the information pertains, officials of the Department, official Department documents, and from other individuals or entities from which data is obtained under routine uses set forth below.
The Department may disclose information contained in a record in this system of records under the routine uses listed in this system of records without the consent of the individual if the disclosure is compatible with the purposes for which the record was collected. These disclosures may be made on a case-by-case basis or, if the Department has complied with the computer matching requirements of the Privacy Act of 1974, as amended (Privacy Act) under a computer matching agreement.
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(a)
(i) The Department, or any component of the Department; or
(ii) Any Department employee in his or her official capacity; or
(iii) Any Department employee in his or her individual capacity if the Department of Justice (DOJ) has agreed or has been requested to provide or arrange for representation for the employee;
(iv) Any Department employee in his or her individual capacity where the Department requests representation for or has agreed to represent the employee; or
(v) The United States where the Department determines that the litigation is likely to affect the Department or any of its components.
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Records are maintained in hard copy in locked file cabinets and electronically on the SharePoint platform, which runs on the Department's network (EDUCATE).
Records are retrievable by the name of the individual.
All documents will be retained in accordance with the ED Records Schedule 235: Student Loan Repayment Benefit Case Files. Non-disputed service agreements—Temporary. Destroy/delete 3 years after date of approval or upon completion of service agreement, or allowance, whichever is later. Disputed service agreements—Temporary. Destroy/delete 6 years and 3 months after the dispute has been resolved, service agreement completed, or repayment, whichever is later. Disapproved requests—Temporary. Cut off after requested benefits are denied. Destroy/delete 3 years after cut off.
All physical access to the building where this system of records is maintained is controlled and monitored by security personnel who check each individual entering the building for an employee or visitor badge. Hard copy records are stored in locked metal filing cabinets, with access limited to personnel whose duties require access. Electronic records are stored on the SharePoint network, which runs on the Department's network (EDUCATE). The network complies with the security controls and procedures described in the Federal Information Security Management Act (FISMA), National Institute of Standards and Technology (NIST) Special Publications, and Federal Information Processing Standards (FIPS). Some specific security controls in place include:
Operating systems and infrastructure devices are hardened in accordance with NIST and Department guidance.
Intrusion Detection Systems are deployed at the Intranet and internet edges and are actively monitored by the Security Operations Center (SOC).
Vulnerability scans are conducted periodically to ensure supporting systems, and all applications are at the highest state of security and are patched accordingly.
This security system limits data access to Department and contract staff on a “need to know” basis, and controls individual users' ability to access and modify records within the system. Personal computers used to access the electronic records are password-protected, and passwords are changed periodically throughout the year.
If you wish to request access to your records, you should contact the system manager at the address listed above. You must provide necessary particulars such as your name, name of organization, subject matter, and any other identifying information requested by the Department while processing the request, to distinguish between individuals with the same name. You must comply with the Department's Privacy Act regulations at 34 CFR 5b.5, including proof of identity.
If you wish to request an amendment to your records, you should contact the system manager at the address listed above. Your request must meet the requirements of the Department's Privacy Act regulations at 34 CFR 5b.7.
If you wish to inquire whether a record exists regarding you in this system, you should contact the system manager at the address listed above. You must provide necessary particulars such as your name, name of organization, subject matter, and any other identifying information requested by the Department while processing the request, to distinguish between individuals with the same name. Your request must meet the requirements of the Department's Privacy Act regulations at 34 CFR 5b.5, including proof of identity.
None.
The System of Records entitled “Student Loan Repayments Benefits Case Files” (18-05-15) was first published in the
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Interested persons are invited to submit comments on or before March 19, 2018.
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 Tammy Gay, 816-804-0848.
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
Office of Management, Department of Education.
Notice of a modified system of records.
In accordance with the Privacy Act of 1974, as amended (Privacy Act), the Department of Education (Department) modifies in its inventory of system of records notices subject to the Privacy Act the system of records entitled “Departmental Parking Control Policy” (18-05-01). The Departmental Parking Control Policy contains individually identifying information provided by individuals who wish to use parking spaces on Department-managed and Department-controlled property and on property assigned to the Department by the General Services Administration or any other Federal agency.
Submit your comments on this modified system of records notice on or before March 19, 2018.
This modified system of records will become effective upon publication in the
Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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David Cogdill, Director, Logistics Services Division, Office of Management, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202.
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), you may call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
The Departmental Parking Control Policy (18-05-01) System of Records Notice was last published in the
For the reasons discussed in the preamble, the Acting Assistant Secretary for Management, U.S. Department of Education (Department), publishes a notice of a modified system of records to read as follows:
Parking Application Tracking System (PATS)(18-05-01).
Unclassified.
Logistics Services Division, Office of Management, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202.
Director, Logistics Services Division, Office of Management, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202.
The Federal Property and Administrative Services Act of 1949, as amended, 40 U.S.C. 101 et. seq., and 41 CFR 102-74.265-310 (Parking Facilities).
The information contained in this system is used to: (1) Provide standards for apportionment and assignment of parking spaces on property managed by the Department of Education (Department) and Department-controlled property, and on property assigned to the Department by the General Services Administration (GSA) or any other Federal agency, and (2) allocate and check parking spaces assigned to government vehicles, visitors, handicapped personnel, executive personnel, carpool and van pools, and others.
All Department employees and non-Department carpool members utilizing parking facilities.
This system includes the following information on all persons applying for a parking permit: Name, participant-generated four-digit number, office room number, Department email address, office phone number, principal office, complete home address, and automobile license number, make and model.
Information in this system is obtained from reports submitted by Department staff, Principal Offices and Regional Offices, GSA Federal Management circulars, Federal Property Management Regulations, and directly from individuals.
The Department may disclose information contained in a record in this system of records under the routine uses listed in this system of records without the consent of the individual if the disclosure is compatible with a purpose for which the record was collected. These disclosures are made on a case-by-case basis or, if the Department has complied with the computer matching requirements of the Privacy Act of 1974, as amended (Privacy Act), under a computer matching agreement.
(1)
(2)
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(i) The Department or any of its components.
(ii) Any Department employee in his or her official capacity.
(iii) Any Department employee in his or her individual capacity if the U.S. Department of Justice (DOJ) has been requested to or has agreed to provide or arrange for representation for the employee.
(iv) Any Department employee in his or her individual capacity where the Department has agreed to represent the employee.
(v) The United States where the Department determines that the litigation is likely to affect the Department or any of its components.
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Records are stored electronically, and the signage sheets are produced and kept in binders in file cabinets.
Records are retrieved by parking facility, parking criteria, and participant's name. Binders are stored alphabetically by parking facility.
ED Schedule 174: Credential Files for the Office of Management. Disposition instructions: TEMPORARY. Cut off after return to issuing office. Destroy/delete 3 months after cutoff.
All physical access to the Department site where this system of records is maintained, is controlled and monitored by security personnel who check each individual entering the building for his or her employee or visitor badge.
The computer system employed by the Department offers a high degree of resistance to tampering and circumvention. This security system limits data access to Department and contract staff on a “need to know” basis, and controls individual users' ability to access and alter records within the system. All users of this system of records are given a unique user ID with personal identifiers. All interactions by individual users with the system are recorded.
If you wish to access a record regarding you in this system of records, provide the system manager with necessary particulars of your name, participant-generated four-digit number, agency and office, and the location where Department parking is provided. Requesters should also reasonably specify the record contents sought. Your request must meet the requirements of the regulations at 34 CFR 5b.5, including proof of identity.
If you wish to request an amendment to your records, provide the system manager with necessary particulars of your name, participant-generated four-digit number, agency and office, and the location where the parking is provided. Contact the system manager at the address specified under NOTIFICATION PROCEDURES below, and reasonably identify the record and specify the information to be contested. Your request must meet the requirements of the regulations at 34 CFR 5b.7.
If you wish to determine whether a record exists regarding you in this system of records, provide the system manager with necessary particulars of your name, participant-generated four-digit number, agency and office, and the location where Department parking is provided. Your request must meet the requirements of the regulations at 34 CFR 5b.5, including proof of identity.
None.
The System of Records entitled “Departmental Parking Control Policy” (18-05-01) was last published in the
In accordance with the National Environmental Policy Act of 1969, and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47,897), the Office of Energy Projects has reviewed Pine Creek Mine, LLC's (PCM or applicant) application for a license to construct its proposed Pine Creek Mine Tunnel Hydroelectric Project (Pine Creek Mine or project), and has prepared an Environmental Assessment (EA). The proposed 1.5-megawatt (MW) project would be located largely inside the Pine Creek Mine tunnel and adjacent to Morgan Creek and Pine Creek in Inyo County, California. The project would occupy only subsurface federal lands managed the U.S. Forest Service.
The EA contains Commission staff's analysis of the potential environmental impacts of the proposed hydroelectric project. The EA concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
You may also register online at
Any comments and modified terms and conditions on the EA should be filed within 60 days from the date of this notice.
The Commission strongly encourages electronic filings. Please file comments using the Commission's eFiling system at
You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support. In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Please affix “Project No. 12532-006” to all comments.
Please contact Quinn Emmering (Commission Staff) by telephone at (202) 502-6382, or by email at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the North Seattle Lateral Upgrade Project, proposed by Northwest Pipeline LLC (Northwest) in the above-referenced docket. Northwest requests authorization to replace approximately 5.9 miles of 8-inch-diameter natural gas pipeline with 20-inch-diameter pipeline in Snohomish County, Washington. According to Northwest, the North Seattle Lateral Upgrade Project would increase service reliability and enable Northwest to provide an incremental 159,299 dekatherms per day of firm capacity to serve Puget Sound Energy.
The EA assesses the potential environmental effects of the construction and operation of the North Seattle Lateral Upgrade Project in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.
The proposed North Seattle Lateral Upgrade Project would consist of the following facilities:
• Replace 5.9-miles of 8-inch-diameter pipeline with 20-inch-diameter pipeline;
• rebuild the existing North Seattle/Everett meter station in order to accommodate the increased delivery capacity of the North Seattle Lateral;
• abandon and relocate approximately 0.1 mile of 16-inch-diameter pipeline;
• relocate an existing 8-inch pig launcher and a 20-inch pig receiver
• replace an existing 8-inch mainline valve with a 20-inch valve.
The FERC staff mailed copies of the EA to federal, state, and local government representatives and agencies; elected officials; Native American tribes; potentially affected landowners and other interested individuals and groups; and newspapers and libraries in the project area. In addition, the EA is available for public viewing on the FERC's website (
Any person wishing to comment on the EA may do so. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this project, it is important that we receive your comments in Washington, DC on or before March 13, 2018.
For your convenience, there are three methods you can use to file your comments to the Commission. In all instances, please reference the project docket number (CP17-441-000 and
(1) You can file your comments electronically using the eComment feature on the Commission's website (
(2) You can also file your comments electronically using the eFiling feature on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
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
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a draft environmental impact statement (EIS) for the Midcontinent Supply Header Interstate Pipeline Project, proposed by Midship Pipeline Company, LLC (Midship Pipeline) in the above-referenced docket. Midship Pipeline requests authorization to construct and operate approximately 233.6 miles of new pipeline, three compressor stations, a booster station, and accompanying facilities that would deliver an additional 1.44 billion standard cubic feet per day of year-round firm transportation capacity from Kingfisher County, Oklahoma to existing natural gas pipelines near Bennington, Oklahoma for transport to growing Gulf Coast and Southeast Markets.
The draft EIS assesses the potential environmental effects of the construction and operation of the project in accordance with the requirements of the National Environmental Policy Act. The FERC staff concludes that approval of the project would result in some adverse environmental impacts; however, these impacts would be reduced to less-than-significant levels with the implementation of Midship Pipeline's proposed mitigation and the additional measures recommended in the draft EIS.
The U.S. Environmental Protection Agency participated as a cooperating agency in the preparation of the EIS. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposal and participate in the National Environmental Policy Act analysis. The U.S. Environmental Protection Agency provided input to the conclusions and recommendations presented in the draft EIS.
The draft EIS addresses the potential environmental effects of the construction and operation of the following proposed project facilities in Oklahoma:
• 199.6 miles of new 36-inch-diameter natural gas pipeline in Kingfisher, Canadian, Grady, Garvin, Stephens, Carter, Johnston, and Bryan Counties;
• 20.4 miles of new 30-inch-diameter pipeline lateral in Kingfisher County;
• 13.6 miles of 16-inch-diameter pipeline lateral in Stephens, Carter, and Garvin Counties;
• three new compressor stations and one new booster station in Canadian, Garvin, Bryan, and Stephens Counties; and
• seven new receipt meters, two new receipt taps, four new delivery meters, and appurtenant facilities.
The FERC staff mailed copies of the draft EIS to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; and newspapers and libraries in the project area. Paper copy versions of this draft EIS were mailed to those specifically requesting them; all others received a CD version. In addition, the draft EIS is available for public viewing on the FERC's website (
Any person wishing to comment on the draft EIS may do so. To ensure consideration of your comments on the proposal in the final EIS, it is important that the Commission receive your comments on or before April 2, 2018.
For your convenience, there are four methods you can use to submit your comments to the Commission. The Commission will provide equal
(1) You can file your comments electronically using the eComment feature on the Commission's website (
(2) You can file your comments electronically by using the eFiling feature on the Commission's website (
(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 (CP17-458-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
4) In lieu of sending written or electronic comments, the Commission invites you to attend one of the public comment sessions its staff will conduct in the project area to receive comments on the draft EIS, scheduled as follows:
There will not be a formal presentation by Commission staff at any of the public comment sessions, although a format outline handout will be made available. Each comment sessions is scheduled from 4:00 p.m. to 8:00 p.m. (central time zone). If you wish to speak, the Commission staff will hand out numbers in the order of your arrival; distribution of numbers will be discontinued at 7:00 p.m. However, if no additional numbers have been handed out and all individuals who wish to provide comments have had an opportunity to do so, staff may conclude the session at 7:00 p.m.
The primary goal of the public comment sessions is to have you identify the specific environmental issues and concerns with the draft EIS. Individual verbal comments will be recorded on a one-on-one basis with a Court Reporter (with FERC staff or representative present) and become part of the public record for this proceeding. If a significant number of people are interested in providing verbal comments in the one-on-one settings, a time limit of 5 minutes may be implemented for each commentor. Transcripts of all comments from the sessions will be placed into the docket for the project, which are accessible for public viewing on the FERC's website (at
Commission staff will be available at each venue of the public sessions to answer questions about our environmental review process. It is important to note that written comments mailed to the Commission and those submitted electronically are reviewed by staff with the same scrutiny and consideration as the verbal comments given at the public sessions.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (Title 18 of the Code of Federal Regulations, Part 385.214).
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
In addition, the Commission offers a free service called eSubscription that 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
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of
The February 14, 2018 WestConnect Stakeholder Meeting will be held at: Pera Club, 1 E Continental Dr., Tempe, AZ 85281.
The April 11, 2018 Planning Management Committee Meeting will be held at: TSGT Offices, 1100 W 116th Ave., Westminster, CO 80234.
The above-referenced meetings will be available via web conference and teleconference.
The above-referenced meetings are open to stakeholders.
Further information may be found at
The discussions at the meetings described above may address matters at issue in the following proceeding: ER13-75,
For more information contact Nicole Cramer, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (202) 502-6775 or
Take notice that the following hydroelectric license application has been filed with the Commission and is available for public inspection.
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j. Deadline for filing motions to intervene and protests, comments, recommendations, terms and conditions, and 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 and protests, comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at
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. The existing Ellsworth Project consists of two developments (Graham Lake and Ellsworth) with a total installed capacity of 8.9 megawatts (MW). The project's average annual generation is 30,511 megawatt-hours. The power generated by the project is sold to the regional power pool administered by ISO New England, Inc.
The existing Graham Lake Development consists of: (1) A 630-foot-long, 58-foot-high dam that includes: (i) An 80-foot-long, 58-foot-high concrete spillway section with three 20-foot-wide, 22.5-foot-high spillway gates and one 8-foot-wide sluice gate used for downstream fish passage; and (ii) a 550-foot-long, 45-foot-high earthen embankment section with a concrete and sheet pile core wall; (2) an approximately 10,000-acre impoundment (Graham Lake) with a useable storage volume of 133,150 acre-feet at a normal maximum elevation of 104.2 National Geodetic Vertical Datum 1929 (NGVD); (3) a 720-foot-long, 58-foot-high concrete gravity flood control structure and a 65-foot-diameter, 55-foot-high stone-filled sheet pile retaining structure; (4) a 71-foot-long, 36.5-foot-high concrete wing wall; and (5) appurtenant facilities.
The existing Ellsworth Development consists of: (1) A 377-foot-long, 60-foot-high dam that includes: (i) A 102-foot-long, 60-foot-high concrete bulkhead section; and (ii) a 275-foot-long, 57-foot-high concrete overflow spillway with 1.7-foot-high flashboards; (2) an 85-foot-long, 71-foot-high concrete non-over flow wall at the west end of the bulkhead section; (3) a 26-foot-high abutment at the east end of the spillway; (4) a 90-acre impoundment (Lake Leonard) with a gross storage volume of 2,456 acre-feet at a normal maximum elevation of 66.7 feet NGVD; (5) generating facility No. 1 that includes: (i) a 15-foot-wide, 10-foot-high headgate with a 15-foot-wide, 12.5-foot-high trashrack; (ii) a 10-foot-diameter, 74-foot-long penstock; and (iii) a 26-foot-long, 28-foot-wide concrete and masonry powerhouse that is integral to the concrete non-overflow dam section and contains a single 2.5-MW turbine-generator unit; (6) generating facility No. 2 that includes: (i) an 88.4-foot-wide, 32-foot-high intake structure with two, 8-foot-wide, 15-foot-high headgates with 8-foot-wide, 14-foot-high trashracks, and one 12-foot-wide, 15-foot-high headgate with a 12-foot-wide, 14-foot-high trashrack; (ii) an 8-foot-diameter, 164-foot-long penstock, an 8-foot-diameter, 195-foot-long penstock, and a 12-foot-diameter, 225-foot-long penstock; and
The Ellsworth Project operates as a water storage facility and a peaking generation facility, depending on available inflows. Water is stored at the Graham Lake Development to reduce downstream flooding during periods of high flow, and is released during periods of low flow so that minimum flows can be maintained in the Union River below Graham Lake Dam. The ability to store and release water at the Graham Lake Development makes it possible for the Ellsworth Development to operate in a peaking mode during periods of high electric demand.
The existing license requires an instantaneous minimum flow release of 250 cubic feet per second (cfs), or inflow (whichever is less), downstream of each development from May 1 to June 30 each year. The minimum flow release from each development is reduced to 105 cfs from July 1 to April 30 each year. In addition to the minimum flows, the existing license requires Black Bear Hydro to maintain Graham Lake and Lake Leonard between elevations 93.4 and 104.2 feet NGVD and 65.7 and 66.7 feet NGVD, respectively. Black Bear Hydro proposes to continue the current licensed mode of operation, including minimum flow releases. Black Bear Hydro also proposes to install upstream eel passage facilities at the Graham Lake and Ellsworth Developments, construct a canoe portage trail at the Graham Lake Development, and improve angler access at the Graham Lake Development.
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 website at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of the Commission's 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,” “TERMS AND CONDITIONS,” or “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.
You may also register online at
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The application will be processed according to the following revised schedule. Revisions to the schedule may be made as appropriate.
Final amendments to the application must be filed with the Commission no later than the comment period listed in item j above.
p. A license applicant must file no later than 60 days following the date of issuance of this notice: (1) A copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.
Take notice that on February 7, 2018, pursuant to Rules 212 and 213 of the Rules of Practice and Procedure of Federal Energy Regulatory Commission (Commission), 18 CFR 385.212-.213 (2017), the California Public Utilities Commission, Transmission Agency of Northern California, Sacramento Municipal Utility District, M-S-R Public Power Agency, City of Santa Clara, California, doing business as Silicon Valley Power, State Water Contractors, Modesto Irrigation District, and Northern California Power Agency (collectively, the Californians or Complainants) submitted an amendment to its formal complaint, filed on September 29, 2017, against Pacific Gas and Electric Company (Respondent) to address a change in Commission policy on the evidentiary burden of complainants that occurred after the Californians submitted their September 29, 2017 complaint, as well as to account for tax law changes that took effect on January 1, 2018, all as more fully explained in its amended complaint.
Complainants certify that copies of the amended complaint were served upon each person designated on the official service list compiled by the Secretary in this proceeding.
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, 385.214 (2017). 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 Respondent's answer and all interventions, or protests, must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible online at
Environmental Protection Agency (EPA).
Notice of data availability.
The Environmental Protection Agency (EPA) is providing notice of the availability of data on emission allowance allocations to certain units under the Cross-State Air Pollution Rule (CSAPR) trading programs. EPA has completed calculations for the second round of allocations of allowances from the CSAPR new unit set-asides (NUSAs) for the 2017 control periods to new units and has posted spreadsheets containing the calculations on EPA's website. In addition to the eligible units identified in the previous notice regarding this round of 2017 NUSA allocations, EPA is allocating allowances to two newly affected units in Wisconsin that were not previously identified as eligible to receive such allocations. EPA has also completed calculations for allocations of the remaining 2017 NUSA allowances to existing units and has posted spreadsheets containing those calculations on EPA's website as well.
February 16, 2018.
Robert Miller at (202) 343-9077 or
Under each CSAPR trading program where EPA is responsible for determining emission allowance allocations, a portion of each state's emissions budget for the program for each control period is reserved in a NUSA (and in an additional Indian country NUSA in the case of states with Indian country within their borders) for allocation to certain units that would not otherwise receive allowance allocations. The procedures for identifying the eligible units for each control period and for allocating allowances from the NUSAs and Indian country NUSAs to these units are set forth in the CSAPR trading program regulations at 40 CFR 97.411(b) and 97.412 (NO
In a notice of data availability (NODA) published in the
EPA received one objection in response to the December 15, 2017 NODA. Madison Gas and Electric Company (MG&E) submitted an objection claiming that units U1 and U2 at the West Campus Cogeneration Facility (WCCF) in Madison, Wisconsin are eligible to receive second-round 2017 NUSA allocations because the units became newly affected units under the CSAPR trading programs as of January 1, 2017. As discussed below, based on the information provided by MG&E we agree that these units are eligible to receive second-round 2017 NUSA allocations and we have therefore included the units when calculating the allocations.
WCCF units U1 and U2 are fossil fuel-fired combustion turbines that began operating in 2005. According to MG&E, through 2015 the units qualified for an exemption from CSAPR applicability that is available to certain cogeneration units, but during 2016 the units no longer met the full set of qualifying conditions for the exemption. Applying the CSAPR definitions and applicability criteria, MG&E concluded that the units would become CSAPR-affected units as of January 1, 2017 and would be deemed to “commence commercial operation” for CSAPR purposes as of that same date.
Under the CSAPR regulations, a newly affected unit is treated as a “new” unit potentially eligible to receive first-round and/or second-round NUSA allocations. As relevant here, a newly affected unit is generally eligible to receive second-round NUSA allocations with respect to its reported emissions occurring on and after its monitor certification deadline in the calendar year in which the unit is deemed to have commenced commercial operation for CSAPR purposes and in the following calendar year.
The final unit-by-unit data and allowance allocation calculations are set forth in Excel spreadsheets titled “CSAPR_NUSA_2017_NOx_Annual_2nd_Round_Final_Data_New_Units”, “CSAPR_NUSA_2017_NOx_Ozone_Season_2nd_Round_Final_Data_New_Units”, “CSAPR_NUSA_2017_SO2_2nd_Round_Final_Data_New_Units”, “CSAPR_NUSA_2017_NOx_Annual_2nd_Round_Final_Data_Existing_Units”, “CSAPR_NUSA_2017_NOx_Ozone_Season_2nd_Round_Final_Data_Existing_Units”, and “CSAPR_NUSA_2017_SO2_2nd_Round_Final_Data_Existing_Units”, available on EPA's website at
EPA notes that an allocation or lack of allocation of allowances to a given unit does not constitute a determination that CSAPR does or does not apply to the unit. We also note that under 40 CFR 97.411(c), 97.511(c), 97.611(c), 97.711(c), and 97.811(c), allocations are subject to potential correction if a unit to which allowances have been allocated for a given control period is not actually an affected unit as of the start of that control period.
40 CFR 97.411(b), 97.511(b), 97.611(b), 97.711(b), and 97.811(b).
Environmental Protection Agency (EPA).
Notice of public comment period; Correction.
The Environmental Protection Agency (EPA) announced a 30-day public comment period in the
The 30-day public comment period began on January 31, 2018, and ends March 2, 2018. Comments must be received on or before March 2, 2018.
The IRIS Assessment Plan for Uranium, will be available via the internet on IRIS' website at
For information on the public comment period, contact the ORD Docket at the EPA Headquarters Docket Center; telephone: 202-566-1752; facsimile: 202-566-9744; or email:
For technical information on the draft IRIS Assessment Plan for Uranium, contact Dr. James Avery, NCEA; telephone: 202-564-1494; or email:
In the
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2017-0747 for uranium, by one of the following methods:
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The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is 202-566-1744. Deliveries are only accepted during the docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. If you provide comments by mail or hand delivery, please submit three copies of the comments. For attachments, provide an index, number pages consecutively
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, 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 the renewal of the existing information collection, as required by the Paperwork Reduction Act of 1995. On November 28, 2017, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. One comment was received and was generally supportive of the requirements in the rule but did not address the paperwork burden for this information collection. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.
Comments must be submitted on or before March 19, 2018.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
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All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Jennifer Jones, at the FDIC address above.
On November 28, 2017, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. One comment was received and was generally supportive of the requirements in the rule but did not address the paperwork burden for this information collection. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.
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There is no change to the FDIC's Part 360.6 affecting this information collection. The change in hourly burden and initial start-up costs are mostly attributed to the SEC's changes to Regulation AB in its September 24, 2014 final rule.
Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (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. All comments will become a matter of public record.
Board of Governors of the Federal Reserve System.
Notice, request for comment.
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the voluntary Policy Impact Survey (FR 3075 OMB No. 7100-00362).
Comments must be submitted on or before April 17, 2018.
You may submit comments, identified by FR 3075 by any of the following methods:
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All public comments are available from the Board's website at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, if approved. These documents will also be made available on the Federal Reserve Board's public website at:
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.
The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposal.
These surveys would be conducted on a voluntary basis. The confidentiality of information provided by respondents to the FR 3075 surveys will be determined on a case-by-case basis depending on the type of information provided for a particular survey. Depending upon the survey questions, confidential treatment may be warranted under exemptions 4, 6, and 8 of the Freedom of Information Act (5 U.S.C. 552(b)(4), (6), and (8)).
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 7, 2018.
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Federal Trade Commission (“FTC” or “Commission”).
Notice.
The information collection requirements described below will be submitted to the Office of Management and Budget (“OMB”) for review, as required by the Paperwork Reduction Act (“PRA”). The FTC intends to ask OMB to extend for an additional three years the current PRA clearance for the FTC's enforcement of the information collection requirements in its Fair Packaging and Labeling Act regulations (“FPLA Rules”). That clearance expires on April 30, 2018.
Comments must be filed by March 19, 2018.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Megan Gray, Attorney, Division of Enforcement, Bureau of Consumer Protection, (202) 326-3408,
On December 6, 2017, the FTC sought public comment on the information collection requirements associated with the FPLA Rules (December 6, 2017 Notice
As detailed in the December 6, 2017 Notice, the FTC estimates cumulative annual burden on affected entities to be 8,084,250 hours and $199,680,975 in labor costs. Commission staff believes that the FPLA Rules impose negligible capital or other non-labor costs, as the affected entities are likely to have the necessary supplies and/or equipment already (
You can file a comment online or on paper. For the FTC to consider your comment, we must receive it on or before March 19, 2018. Write “FPLA Rules, PRA Comment, P074200” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission website, at
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online, or to send them to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “FPLA Rules, PRA Comment, P074200” on your comment and on the envelope, and mail it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible FTC website at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before March 19, 2018. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see
Comments on the information collection requirements subject to review under the PRA should additionally be submitted to OMB. If sent by U.S. mail, they should be addressed to Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW, Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead can also be sent by email to
Agency for Healthcare Research and Quality, HHS.
Notice.
Through this Request for Information (RFI), the Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public, hospitals and other health care organizations, clinicians, quality improvement experts, researchers, and quality measure developers about current use of the AHRQ Quality Indicators (AHRQ QIs) for quality improvement efforts. AHRQ recognizes that the AHRQ QIs have been adopted for other uses, but for the purpose of this RFI, the Agency is specifically seeking information about quality improvement initiatives such as those that seek to: Improve clinical practice (
Comments on this notice must be received by the deadline on or before March 8, 2018.
Written comments should be submitted to: Maushami DeSoto, Ph.D., MHA, Health Scientist Administrator, Center for Delivery Organization and Markets, Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email at
Maushami DeSoto, Ph.D. MHA, Health Scientist Administrator, (301) 427-1546, or by emails at
The mission of AHRQ is to produce evidence to make health care safer; higher quality; and more accessible, equitable, and affordable. AHRQ works within the U.S. Department of Health and Human Services and with other public and private partners to make sure that the evidence is understood and used. The Agency fulfills this mission by supporting and conducting research; generating needed evidence; disseminating proven practices; creating and distributing training materials for health care systems and professionals; and developing measures and data used to track and improve performance. To learn more about the Agency, visit
Over the years, use of the AHRQ QIs has evolved. Originally developed to support quality improvement at the hospital and community levels, the AHRQ QIs now serve several additional purposes including: (1) Research; (2) needs assessments for planning at the local, state, and national levels; and (3) performance assessment by private and public value-based payment and consumer choice programs. In the current context, in which the purposes and methods of measurement continue to change rapidly, AHRQ is seeking updated information to inform its own planning and priority setting for future work in the area of measures for quality improvement. To do so, AHRQ must define evidence criteria that are specific to quality improvement and use those criteria to determine which AHRQ QIs work best for quality improvement and how they can be improved for that purpose.
As part of this effort, AHRQ is conducting a literature review and environmental scan to: (1) Document knowledge and evidence on the scientific acceptability of the AHRQ QIs for quality improvement; (2) document and synthesize information about the strengths and limitations of the AHRQ QIs; (3) identify areas of disagreement, if any, in the evidence; and (4) develop suggestions for refinement or improvement in the indicators, particularly those that make the AHRQ QIs more useful for quality improvement. As part of the environmental scan, AHRQ is issuing this RFI to obtain information from stakeholders who have not published their experiences using the AHRQ QIs or who wish to provide additional information beyond what they have published. AHRQ will review results from the literature review and environmental scan and release a summary report in December 2018.
Specific questions of interest to the Agency include, but are not limited to:
1. What type of organization do you represent?
2. How does your organization define quality improvement?
3. How does your organization use the AHRQ QIs for quality improvement? For example, do you use them for identifying patient safety problems, identifying quality improvement opportunities, and/or tracking performance over time?
4. Which specific AHRQ QIs does your organization use for quality improvement? Please include the number of each QI, for example, PQI 05, which can be found at the AHRQ QI website.
5. Have you stopped using an AHRQ QI for quality improvement? If yes, please identify it and explain why you stopped.
6. Of the AHRQ QIs you use now or used previously, which ones have been most valuable in improving quality?
a. What are the strengths of each measure you have used?
b. What are the weaknesses of each measure you have used?
7. What other methodological and/or data quality issues have you encountered when using AHRQ QIs for quality improvement that you haven't already mentioned?
8. Does your organization use measures other than the AHRQ QIs for quality improvement? If yes, which ones and what types of quality improvement initiatives does your organization use them for? How do they compare to the AHRQ QIs in terms of ease of use and impact on quality?
9. What changes and refinements to the AHRQ QIs would make them easier to use for quality improvement?
10. What changes and refinements to the AHRQ QIs would make them more effective for improving quality?
11. What resources would aid the uptake of the AHRQ QIs for quality improvement?
12. What improvements are needed to current AHRQ QI resources? These include resources available through the QI website such as tool kits, case studies, webinars, presentations, publication lists, video tutorials (WinQI and SASQI), measure technical specifications (IQI, PQI, PSI, PDI), TA support, FAQs, and software.
13. If you operate a community health center, which AHRQ QIs do you use for quality improvement in the community health center? Which other measures do you use for quality improvement in the community health center?
14. If you operate a hospital emergency department (ED), which AHRQ QIs do you use for quality improvement in the ED? Which other measures do you use for quality improvement in the ED?
15. How does your organization define quality improvement?
16. What types of quality improvement initiatives does your organization engage in?
17. Have you heard of the AHRQ QIs? If yes, what do you know about them?
18. What factors contribute to your organization's decision to not use the AHRQ QIs?
19. Has your organization used the AHRQ QIs in the past? If so, why is your organization no longer using them?
20. What measures does your organization use for quality improvement? What are some of the reasons/factors your organization uses these measures?
21. If you operate a community health center, which measures do you use for quality improvement?
22. If you operate a hospital emergency department (ED), which measures do you use for quality improvement?
23. If your organization is a community health center, which metrics do you use for quality improvement?
24. If your organization is an ED which metrics do you use for quality improvement and monitoring?
AHRQ is interested in all the questions listed above, but respondents are welcome to address as many or as few as they choose and to address additional areas of interest not listed. AHRQ will use the information it receives to assist in developing future initiatives. These initiatives may include, but are not limited to, developing research grant and contracting opportunities, investing in the creation of tools and training materials for health professionals and health care delivery organizations, developing quality improvement measures, and/or convening learning collaboratives.
Health care professionals and organizations are encouraged to respond to this RFI by submitting a written statement and supporting explanatory materials to the email or mailing address listed above by February 28, 2018. Supporting materials might include charters for quality and safety improvement committees, data use agreements for learning collaboratives, population health metrics and reports, or guidelines for the use of evidence-based practices. When responding to questions listed above, please clearly indicate the number of the question that is being addressed. AHRQ encourages respondents to include a description of their health care delivery organization at the beginning of their response to provide context for the information they provide.
This RFI is for planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of the Government to provide support for any ideas identified in response to it. AHRQ will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future solicitation(s) or policies. The information provided will be analyzed and may appear in reports. Respondents will not be identified in any published reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). The contents of all submissions will be made available to the public upon request. Materials submitted must be publicly available or can be made public.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MOVANTIK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (in the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 17, 2018. The
Submit electronic comments in the following way:
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• 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:
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• For written/paper comments submitted to the Dockets Management Staff, 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product MOVANTIK (naloxegol oxalate). MOVANTIK is indicated for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain. Subsequent to this approval, the USPTO received patent term restoration applications for MOVANTIK (U.S. Patent Nos. 7,662,365 and 7,786,133) from Nektar Therapeutics, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated October 30, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of MOVANTIK represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for MOVANTIK is 2,493 days. Of this time, 2,127 days occurred during the testing phase of the regulatory review period, while 366 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,020 days or 272 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions” along with the Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications (BIMO Technical Conformance Guide). The draft guidance and BIMO Technical Conformance Guide describe and provide specifications for the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA's Office of Regulatory Affairs (ORA) in the conduct of, bioresearch monitoring (BIMO) inspections. The draft guidance addresses major (
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 April 17, 2018.
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 Dockets Management Staff, 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 this 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
Jean Mulinde, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0768.
FDA is announcing the availability of: (1) A draft guidance for industry entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions” and (2) the BIMO Technical Conformance Guide. This draft guidance and the BIMO Technical Conformance Guide describe and provide specifications for the electronic submission of data and information in standardized formats, for submitting information used by CDER in the planning of, and by ORA in the conduct
To meet its review performance goals in accordance with CDER good review management principles and practices for products covered by the Prescription Drug User Fee Act, CDER generally initiates inspection planning early in the application review process (
This draft guidance and the associated technical conformance guide supersede the previously issued Summary Level Clinical Site Draft Guidance that published in the
In section 745A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k-1(a)), Congress granted explicit authorization to FDA to specify, in guidance, the electronic format for submissions under section 505(b), (i), or (j) of the FD&C Act (21 U.S.C. 355(b), (i), or (j)) and submissions under section 351(a) or (k) of the Public Health Service Act (42 U.S.C. 262(a) or (k)). Accordingly, to the extent that this guidance, when finalized, provides such requirements, as indicated by the use of the words
To comply with GGP regulations and make sure that regulated entities and the public understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard language explaining that guidance documents should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. FDA is not including this standard language in this draft guidance document because it is not an accurate description of this guidance. Insofar as this guidance specifies the format for electronic submissions pursuant to section 745A(a) of the FD&C Act, when finalized, it will have binding effect.
The draft guidance and the BIMO Technical Conformance Guide, when finalized, will represent the current thinking of FDA on standardized format for electronic submission of NDA and BLA content for the planning of BIMO inspections for CDER Submissions.
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the collection of information associated with this draft guidance and the associated technical conformance guide, FDA invites comments on the following topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The draft guidance and the Bioresearch Monitoring Technical Conformance Guide provide the electronic format and specifications for submission of data and information used by CDER in the planning of, and by ORA in the conduct of, BIMO inspections. Data and information described in the draft guidance comprises information required in parts 312, 314, or 601 (21 CFR parts 312, 314, or 601), including case histories (§ 312.62(b)), information regarding foreign clinical studies not conducted under an investigational new drug application (IND) (§ 312.120), and the clinical data section (§ 314.50(d)(5)) and case report forms and tabulations (§ 314.50(f)), or in part 601 (§ 601.2 Applications for biologics licenses; procedures for filing) in an NDA, BLA, or supplement. The draft guidance and the associated technical conformance guide describe the electronic format of clinical study-level information, subject-level data line listings by clinical site, and the summary-level clinical site dataset that are submitted from all major (
Based on CDER's data on the number of NDAs, BLAs, and NDA and BLA supplemental applications containing new clinical study reports that would be covered by the draft guidance, we estimate that each year approximately 75 applicants will submit for 125 original NDA or BLA applications and 152 supplemental applications containing new clinical study reports. We estimate that the submission of the clinical study-level information, subject-level data line listings by clinical site, and the summary-level clinical site dataset for each application would take approximately 40 hours to prepare. Initial preparation of the clinical study-level information, subject-level data line listings by clinical site, and the summary-level clinical site dataset could involve the development of new SOPs for some applicants. We estimate that 75 applicants would take approximately 20 hours to develop and subsequently 2 hours annually to maintain and update the SOP(s). The clinical study-level information, subject-level data line listings by clinical site, and the summary-level clinical site dataset submitted with each application would likely involve additional quality assurance procedures, which would add approximately 2 hours for each submission.
This draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in part 312 have been approved under OMB control number 0910-0014; the collections of information in part 314 have been approved under OMB control number 0910-0001; the collections of information in part 601 have been approved under OMB control number 0910-0338.
FDA estimates the burden of this collection of information as follows:
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 milligrams (mg) and 6.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for benazepril hydrochloride; hydrochlorothiazide oral tablets, 5 mg and 6.25 mg, if all other legal and regulatory requirements are met.
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, are the subject of NDA 020033, held by U.S. Pharmaceutical Holdings I, LLC, and initially approved on May 19, 1992. LOTENSIN HCT is indicated for the relief of symptoms of depression. LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, are currently listed in the “Discontinued Drug Product List” section of the Orange Book.
EAS Consulting Group, LLC submitted a citizen petition dated August 9, 2017 (Docket No. FDA-2017-P-4852), under 21 CFR 10.30, requesting that the Agency determine whether LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that these products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, from sale. We have also independently evaluated relevant literature and data for possible post-marketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
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 “Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of amyotrophic lateral sclerosis (ALS). Specifically, it addresses FDA's current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS. This guidance addresses the clinical development of drugs intended to treat the main neuromuscular aspects of ALS (
Submit either electronic or written comments on the draft guidance by April 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time 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 Dockets Management Staff, 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.”
•
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
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
Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-2250.
FDA is announcing the availability of a draft guidance for industry entitled “Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.” ALS is a progressive neurodegenerative disease that primarily affects motor neurons in the cerebral motor cortex, brainstem, and spinal cord, leading to loss of voluntary movement and difficulty in swallowing, speaking, and breathing. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of ALS. Specifically, it addresses FDA's current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS. This guidance addresses the clinical development of drugs intended to treat the main neuromuscular aspects of ALS (
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 treatment of ALS. 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 is not subject to Executive Order 12866.
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 part 312 have been approved under OMB control number 0910-0014, the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001, and the collections of information referred to in the guidance for industry entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees” (available at
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held on May 10, 2018, from 8 a.m. to 5 p.m.
Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. The conference center's telephone number is 240-645-4000. Answers to commonly asked questions about FDA Advisory Committee meetings may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0468. The docket will close on May 9, 2018. Submit either electronic or written comments on this public meeting by May 9, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 9, 2018. The
Comments received on or before April 26, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.
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 Dockets Management Staff, 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.”
•
LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email:
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact LaToya Bonner (see
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of X-linked Duchenne muscular dystrophy (DMD) and related dystrophinopathies. This guidance finalizes the draft guidance of the same name issued on June 10, 2015.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time 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 Dockets Management Staff, 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this 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-
Colleen Locicero, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4242, Silver Spring, MD 20993-0002, 301-796-1114.
FDA is announcing the availability of a guidance for industry entitled “Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment.” DMD and other dystrophinopathies result from genetic mutations in the dystrophin gene that decrease levels of dystrophin and/or cause dysfunction of the dystrophin protein, leading to muscle degeneration, including cardiac and respiratory muscles, and greatly decreased life expectancy. There remains a high-level unmet medical need for effective drug treatments for DMD and other dystrophinopathies. This guidance addresses FDA's current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of dystrophinopathies. This guidance finalizes the draft guidance of the same name issued June 10, 2015 (80 FR 32961). It reflects FDA's consideration of public comments on the draft guidance and makes minor clarifying changes.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on developing drugs for the treatment of DMD. 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 is not subject to Executive Order 12866.
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 guidance at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “How to Prepare a Pre-Request for Designation (Pre-RFD).” The purpose of this guidance is to explain the Pre-RFD process at the FDA Office of Combination Products (OCP), describe and help a sponsor understand the type of information that the sponsor should include in a Pre-RFD, and assist sponsors in obtaining a preliminary assessment from FDA through the Pre-RFD process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product's assignment to the appropriate Agency Center (Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER)) for premarket review and regulation.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time 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 Dockets Management Staff, 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.”
•
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for a single copies of this guidance entitled “How to Prepare a Pre-Request for Designation (Pre-RFD)” to the Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. See the
Leigh Hayes, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930.
Since its establishment on December 24, 2002, OCP has served as a resource for sponsors at various stages of development of their products. Sponsors often seek OCP feedback on whether their human medical product will be regulated as a drug, a device, a biologic, or a combination product, and which FDA medical product Agency Center (CDER, CBER, or CDRH) will regulate it, if it is a non-combination product, or will have the primary jurisdiction for the premarket review and regulation of the product, if it is a combination product.
There are two ways that a sponsor can receive such a feedback from OCP. One option is to submit an RFD to receive a formal, binding determination for the sponsor's product with respect to classification and/or center assignment that may be changed under conditions specified in section 563 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-2) and 21 CFR 3.9 in the regulations. The RFD process is codified in 21 CFR part 3, and OCP has issued a guidance about this process (see “How to Write a Request for Designation” at
Many sponsors seek to utilize a more flexible, approachable way to interact with OCP and the medical product Agency Centers, to obtain feedback from the Agency before submitting a marketing application to the Agency. Over time, these informal methods of obtaining feedback have become increasingly customary with sponsors, and for some, even preferable to the formal RFD process. Accordingly, FDA is enhancing the transparency and consistency of such interaction, which will now be called the “Pre-Request for Designation (Pre-RFD) Program.”
This guidance describes this structured process with clear recommendations for sponsors wishing to submit Pre-RFDs. It also provides the process for review of Pre-RFDs by FDA staff, the general timeframes for sponsors to receive feedback from OCP, and the process for scheduling teleconferences and meetings in relation to a Pre-RFD.
FDA carefully considered the comments received on the draft guidance, and, where appropriate, has revised the guidance to reflect such comments. FDA encourages stakeholders to contact OCP if they have additional questions.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on how to prepare a Pre-RFD. 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 is not subject to Executive Order 12866.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in this guidance regarding how to prepare a Pre-RFD have been approved under OMB control number 0910-0845.
Persons with access to the internet may obtain the document at
Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled “Pediatric Medical Device Development.” The purpose of the public meeting is to identify strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations. (The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients, for medical device purposes, as age 21 years or younger at the time of diagnosis or treatment and specifies categories of pediatric subpopulations.) Topics for discussion will include ways to improve research infrastructure and research networks to facilitate the conduct of clinical studies of pediatric devices, extrapolation, use of postmarket registries and data to increase pediatric medical device
The public meeting will be held on August 13 and August 14, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public meeting by September 14, 2018. See the
The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the Great Room), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 14, 2018. The
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 Dockets Management Staff, 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.”
•
Victoria Wagman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5562, Silver Spring, MD 20993, 301-796-6581,
For more than a decade, legislative changes and regulatory process improvements have been implemented to facilitate development of medical devices that serve the unique needs of pediatric populations. The FD&C Act defines pediatric patients, for medical device purposes, as age 21 years or younger at the time of diagnosis or treatment and specifies categories of pediatric subpopulations (see section 520(m)(6)(E) of the FD&C Act (21 U.S.C. 360j(m)(6)(E))). Nevertheless, children and those who care for them continue to have limited medical device options. FDA seeks to identify opportunities to support development and innovation of medical devices designed and labeled for children. Engaging in such opportunities will not only serve children and their families but optimize the medical device ecosystem for all. The Agency invites all stakeholders, including representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007, medical provider organizations, and organizations and individuals representing patients and consumers to collaborate with us in addressing this important public health issue (See Pub. L. 110-85; 42 U.S.C. 282 note).
FDA guidance documents entitled “Premarket Assessment of Pediatric Medical Devices,” “Providing Information about Pediatric Uses of Medical Devices,” and “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices,” provide background information regarding pediatric medical device development (Refs. 1 to 3).
As mandated by section 502(d) of the FDA Reauthorization Act of 2017 (FDARA), this FDA meeting on the development and labeling of pediatric medical devices is being convened with representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007, medical provider organizations, and organizations representing patients and consumers (see Pub. L. 110-85; 42 U.S.C. 282 note).
As directly outlined in FDARA, the meeting shall include consideration of ways to: (1) Improve research infrastructure and research networks to facilitate the conduct of clinical studies of devices for pediatric populations that would result in the approval or clearance, and labeling of medical devices for such populations; (2) appropriately use extrapolation under section 515A(b) of the FD&C Act (21 U.S.C. 360e-1(b)); (3) enhance the appropriate use of postmarket registries and data to increase pediatric medical device labeling; (4) increase FDA assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use; and (5) identify current barriers to pediatric device development and incentives to address such barriers.
A detailed agenda will be posted on the following website in advance of the workshop at
Registration is free, and in-person attendance is based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by August 6, 2018, 3 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public meeting.
If you need special accommodations due to a disability, please contact Peggy Roney at the Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, Silver Spring, MD 20993-0002, 301-796-5671,
If you have never attended a Connect Pro event before, test your connection at
The following references are on display at the Dockets Management Staff (see
1. FDA's guidance for Industry and FDA Staff: “Premarket Assessment of Pediatric Medical Devices,” available at
2. FDA's guidance for Industry and FDA Staff: “Providing Information about Pediatric Uses of Medical Devices,” available at
3. FDA's guidance for Industry and FDA Staff: “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices,” available at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 17, 2018. The
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 Dockets Management Staff, 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.”
•
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product COTELLIC (cobimetinib). COTELLIC is indicated for treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation,
FDA has determined that the applicable regulatory review period for COTELLIC is 3,219 days. Of this time, 2,884 days occurred during the testing phase of the regulatory review period, while 335 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,013 days or 676 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Migraine: Developing Drugs for Acute Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of prescription drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of prescription drugs for the acute treatment of migraine. This guidance finalizes the draft guidance of the same name issued October 22, 2014.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time 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 Dockets Management Staff, 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this 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
Eric Bastings, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4334, Silver Spring, MD 20993-0002, 301-796-1039.
FDA is announcing the availability of a guidance for industry entitled “Migraine: Developing Drugs for Acute Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of prescription drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of prescription drugs for the acute treatment of migraine, including trial population, trial design, dose selection, efficacy endpoints, and statistical considerations. The guidance also discusses safety considerations, pediatric studies, and labeling considerations.
This guidance finalizes the draft guidance of the same name issued October 22, 2014 (79 FR 63129). It reflects FDA's consideration of public comments on the draft guidance and makes minor clarifying changes.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on developing drugs for the acute treatment of migraine. 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 is not subject to Executive Order 12866.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 201, 312, and 314 have been approved under OMB control numbers 0910-0572, 0910-0014, and 0910-0001, respectively.
Persons with access to the internet may obtain the guidance at either
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 “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older.” The draft guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, it addresses FDA's thinking regarding clinical development programs that can support extrapolation of evidence of effectiveness in treatment of POS in adults to pediatric patients 4 years of age and older.
Submit either electronic or written comments on the draft guidance by April 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
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
Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-2250.
FDA is announcing the availability of a draft guidance for industry entitled “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older.” The draft guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of POS in pediatric patients. Specifically, it addresses FDA's thinking regarding clinical development programs that can support extrapolation of evidence of effectiveness in treatment of POS in adults to pediatric patients 4 years of age and older.
This draft guidance explains how efficacy can be extrapolated from adults to children when it is reasonable to assume that children, compared with adults, have a similar progression of disease, similar response of the disease to treatment, and similar exposure-response relationship.
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 “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy From Adults to Pediatric Patients 4 Years of Age and Older.” 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 is not subject to Executive Order 12866.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee (PAC). This meeting was announced in the
Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838,
In the
FDA will provide updates on the following topics without vote by the committee:
• Update regarding labeling change for inhaled corticosteroid long-acting β-2 agonists (ICS/LABAs);
• Safety labeling for gadolinium products;
• Overview of the FDA Adverse Event Reporting System (FAERS) and reports on reduced or lack of efficacy for certain generic drugs; and
• Generic drug approval process; and discussion on the differences in the approval process for brand name drugs versus generic drugs; exceptions.
On page 126, in the third column, the CDRH products portion of the document is changed to read as follows:
The PAC will meet to discuss the following products (listed by FDA Center):
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for HYMOVIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 17, 2018. The
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 Dockets Management Staff, 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the medical device HYMOVIS. HYMOVIS is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics. Subsequent to this approval, the USPTO received a patent term restoration application for HYMOVIS (U.S. Patent No. 7,863,256) from Fidia Farmaceutici S.p.A., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 26, 2016, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of HYMOVIS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for HYMOVIS is 1,845 days. Of this time, 1,665 days occurred during the testing phase of the regulatory review period, while 180 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 938 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
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 “Early Alzheimer's Disease: Developing Drugs for Treatment.” This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia. This guidance revises the draft guidance for industry entitled “Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease” issued February 8, 2013.
Submit either electronic or written comments on the draft guidance by May 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time 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 Dockets Management Staff, 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
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, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4339, Silver Spring, MD 20993-0002, 301-796-2250; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft guidance for industry entitled “Early Alzheimer's Disease: Developing Drugs for Treatment.” This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic AD that occur before the onset of overt dementia. This draft guidance revises the draft guidance for industry entitled “Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease” issued February 8, 2013 (78 FR 9396), and reflects FDA's consideration of public comments on the draft guidance. This revision addresses FDA's current thinking regarding the selection of patients with early AD for enrollment into clinical trials and the selection of endpoints for clinical trials in these populations.
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 treatment of early Alzheimer's disease. 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 draft guidance is not subject to Executive Order 12866.
Persons with access to the internet may obtain the draft guidance at
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice of meeting.
Listening Session: March 1, 2018, 1:00 p.m.-2:00 p.m. (EST). In addition, written comments will be accepted until March 16, 2018.
The meeting will be held virtually via webinar and phone. The meeting is open to the public. Please register to attend this meeting via the following link:
The purpose of the meeting is to solicit ideas for program development in the next grant cycle of HRSA's Healthy Start Initiative: Eliminating Disparities in Perinatal Health (Healthy Start) program, authorized by Section 330H of the Public Health Service Act (42 U.S.C. 254c-8), as amended by the Healthy Start Reauthorization Act of 2007 (Pub. L. 110-339).
HRSA's Healthy Start program currently supports 100 community-based projects across the nation where the infant mortality rate (IMR) was more than 1
The Listening Session will serve as a platform to engage and obtain feedback from the public on HRSA's strategic thinking and approaches for community-based infant mortality reduction programs. A final meeting agenda will be shared with registrants prior to the meeting.
The desired outcomes of the meeting are to:
(1) Share with the public an overview of HRSA's current Healthy Start program;
(2) Identify strategies and approaches that are important to implement at the community level, and scientifically known to reduce infant mortality, improve perinatal outcomes, and disparities therein, through input from experts, representatives of professional organizations, and the public at large; and
(3) Inform HRSA's strategies and approaches implemented through the HRSA's Healthy Start program.
Time will be provided for public comments. Each public comment is limited to 2 minutes. During the meeting, participants will have an opportunity to interact with presenters via phone and the chat function in the public comment section of the webinar system. Telephone lines and time to provide oral comments during the meeting are available on a first-come, first-served basis. Registered attendees for this meeting are encouraged to submit written comments prior to the meeting, no later than 5:00 p.m. ET on February 26, 2018.
If unable to attend the listening session, written comments will continue to be accepted via email to
Individuals who are submitting public comments or who have questions regarding the meeting should contact Benita Baker or CAPT Maria Benke, HRSA, Maternal and Child Health Bureau, telephone: (301) 443-8283, or email:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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.
U.S. Coast Guard, Department of Homeland Security.
Notice of Federal Advisory Committee meeting.
The Towing Safety Advisory Committee and its subcommittees will meet in Charleston, South Carolina to review and discuss recommendations from its subcommittees and to receive briefs on items listed in the agenda. All meetings will be open to the public.
All meetings will be held at the Charleston Marriott 170 Lockwood Boulevard, Charleston, South Carolina 29403;
For information on facilities or services for individuals with disabilities, or to request special assistance at the meetings, contact the individuals listed in the
Written comments must be submitted using the Federal eRulemaking Portal at
Commander Jose Perez, Designated Federal Officer of the Towing Safety Advisory Committee, Commandant (CG-OES-2), U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE, Stop 7509, Washington, DC 20593-7509; telephone 202-372-1410, fax 202-372-8382 or email
Notice of this meeting is in compliance with the
On March 20 and 21, 2018, from 8 a.m. to 5 p.m., the Towing Safety Advisory Committee and its subcommittees will meet to review, discuss, deliberate, and formulate recommendations, as appropriate, on the following tasks:
All current Towing Safety Advisory Committee tasks can be found at
A copy of all meeting documentation, including any draft final reports, will be available at
Public comments or questions will be taken throughout the meeting as the Committee discusses the issues and prior to deliberations and voting. There will also be a public comment period at the end of the meeting. Speakers are requested to limit their comments to 3 minutes. Please note that the public comment period may end before the period allotted, following the last call for comments. Please contact the individual listed in the
To receive automatic email notices of future Towing Safety Advisory Committee meetings in 2018, go to the online docket, USCG-2018-0050 (
U.S. Customs and Border Protection (CBP) and U.S. Immigration and Customs Enforcement (ICE), Department of Homeland Security.
General notice.
This document announces CBP's and ICE's process to solicit, evaluate, and select interested parties in the private sector to fulfill agency needs for instruction and related instructional materials for trade-related training, pursuant to section 104 of the Trade Facilitation and Trade Enforcement Act of 2015 (TFTEA).
Private sector parties interested in providing training to CBP or ICE personnel may submit a training proposal satisfying the criteria set forth below on or after February 16, 2018.
Private sector parties interested in submitting a request to provide trade-related training should submit proposals as indicated below:
CBP proposals should be submitted to
ICE proposals should be submitted to
Questions should be addressed to agency-designated personnel below:
On February 24, 2016, former President Barack Obama signed into law the Trade Facilitation and Trade Enforcement Act (TFTEA), (Pub. L. 114-125, 130 Stat. 122, Feb. 24, 2016) (19 U.S.C. 4301 note). Section 104 of the TFTEA directs the Commissioner of U.S. Customs and Border Protection (CBP) and the Director of U.S. Immigration and Customs Enforcement (ICE) to establish and carry out, on a fiscal year basis, trade-related educational seminars to: (1) Improve the ability of personnel of CBP to classify and appraise imported merchandise; (2) improve the trade enforcement efforts of CBP and ICE personnel; and (3) otherwise improve the ability and effectiveness of CBP and ICE personnel to facilitate legitimate international trade. Interested parties in the private sector that meet the guidelines and criteria set forth in this notice and are selected by CBP or ICE may provide instruction and related instructional materials at these seminars pursuant to section 104.
Topics upon which training may be conducted include tariff classification, customs valuation, country of origin (including procedures for identifying merchandise bearing mislabeled country of origin markings), proper assessment of AD/CVD, evasion of duties on imports of textiles, border enforcement of IPR, enforcement of child labor laws, and other topics as appropriate and useful as concerns the trade-related duties and missions of CBP and ICE.
Interested parties desiring to conduct training under this program will be selected based on: (1) The availability of CBP and ICE personnel for such training; (2) the relevance of the training to the topics specified in section 104; (3) the usefulness of the proposed training as concerns the trade-related duties and missions of CBP and ICE; (4) any existing or future need to train CBP and ICE personnel on identifying and detecting incorrect or false country of origin with respect to imported merchandise; and (5) the expertise and experience of the proposed private sector instructors in the subject matter of the proposed training.
Proposals for private sector training should be directed to either CBP or ICE, as appropriate, at the above addresses, and contain the following information and materials:
(1) Name, address, telephone number, and email address of the entity proposing the training;
(2) Type of business in which the entity is engaged;
(3) Topic for the proposed training;
(4) Outline of proposed curriculum and instructional materials;
(5) Name, address, telephone number, email address, and qualifications of the proposed private sector instructor(s) (including previous experience in conducting training on the proposed topic);
(6) Name of the ports or locations at which the training is proposed to be given (which may be conducted at a location provided by the entity proposing the training), as applicable, and the intended audience in CBP and/or ICE;
(7) Proposed dates for the training;
(8) Length of the training; and
(9) Any previous history of trade-related training provided to CBP and/or ICE.
An interested private sector party who submits a proposal to train CBP and/or ICE personnel will be notified whether the proposed training meets the guidelines in this notice and have been selected to conduct the training.
As provided for in section 104(d), the Commissioner of CBP will give due consideration to carrying out educational seminars under this program to improve the ability of CBP personnel to enforce specific AD/CVD orders if such training is proposed by a petitioner involved in the action underlying that order.
TFTEA does not provide for or authorize any compensation or reimbursement of costs and expenses for private sector parties who participate in training for CBP or ICE personnel under this program. Therefore, no compensation or payment will be made to any private sector parties selected to provide such training. Private sector parties selected to participate will be required to execute a gratuitous services agreement.
The procedures set forth herein create no private rights, benefits, or privileges for any person or party.
Please note that nothing in TFTEA or this notice precludes or limits CBP or ICE from soliciting private sector parties to participate in specific training programs considered useful to the missions of the agencies or from continuing any such current training programs with private sector parties.
U.S. Geological Survey, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the U.S. Geological Survey (USGS) is proposing to renew an information collection.
Interested persons are invited to submit comments on or before April 17, 2018.
Send your comments on the information collection request (ICR) by mail to the USGS, Information Collections Officer, 12201 Sunrise Valley Drive MS 159, Reston, VA 20192; or by email to
To request additional information about this ICR, contact Elizabeth Sangine by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary for USGS to perform its duties, including whether the information is useful; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, usefulness, and clarity of the information to be collected; and (4) how to minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. 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 may 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.
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 and current expiration date.
The authorities for this action are the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,
Office of the Secretary, Interior.
Notice.
The United States is heavily reliant on imports of certain mineral commodities that are vital to the Nation's security and economic prosperity. This dependency of the United States on foreign sources creates a strategic vulnerability for both its economy and military to adverse foreign government action, natural disaster, and other events that can disrupt supply of these key minerals. Pursuant to Executive Order 13817 issued on December 20, 2017, “A Federal Strategy To Ensure Secure and Reliable Supplies of Critical Minerals,” the Secretary of the Interior presents a draft list of 35 mineral commodities deemed critical under the definition provided in the Executive Order. Specifically, an analysis using multiple criteria identified 35 minerals or mineral material groups that are currently considered critical. These include: Aluminum (bauxite), antimony, arsenic, barite, beryllium, bismuth, cesium, chromium, cobalt, fluorspar, gallium, germanium, graphite (natural), hafnium, helium, indium, lithium, magnesium, manganese, niobium, platinum group metals, potash, rare earth elements group, rhenium, rubidium, scandium, strontium, tantalum, tellurium, tin, titanium, tungsten, uranium, vanadium, and zirconium. These commodities merit consideration in furthering the policy of the Federal Government to reduce the Nation's vulnerability for the security and prosperity of the United States. A summary report describing the methodologies and data sources used to develop the draft critical minerals list may be accessed at
To ensure consideration, written comments must be submitted before March 19, 2018.
You may submit written comments online at
Ryan Nichols, (202) 208-7250,
Executive Order 13817 of December 20, 2017 (82 FR 60835, December 26, 2017), section 2(b), directs the Secretary of the Interior, in coordination with the Secretary of Defense and in consultation with the heads of other relevant executive departments and agencies (agencies), to publish a list of critical minerals in the
A “critical mineral” as defined by the Executive Order is a mineral identified to be (i) a non-fuel mineral or mineral material essential to the economic and national security of the United States, (ii) the supply chain of which is vulnerable to disruption, and (iii) that serves an essential function in the manufacturing of a product, the absence of which would have significant consequences for the U.S. economy or national security.
The critical mineral screening methodology developed by the National Science and Technology Council Subcommittee on Critical and Strategic Mineral Supply Chains (CSMSC) in 2016 and updated in 2018, served as the starting point for the development of the draft list. The screening tool was designed to identify and prioritize minerals or mineral materials for in-depth study to evaluate risks to security of supply. Additional tools and sources of information used to produce the draft critical minerals list were as follows: (i) U.S. net import reliance statistics as published annually in the U.S. Geological Survey (USGS) Mineral Commodity Summaries; (ii) USGS Professional Paper 1802 “Critical Mineral Resources of the United States”; (iii) inputs from the Department of Defense; (iv) the National Defense Authorization Act for fiscal year 2018; (v) Department of Energy/Energy Information Administration uranium statistics in the 2016 Uranium Marketing Annual Report; and (vi) the judgment of subject matter experts of the USGS and other U.S. Government agencies, including representatives of other DOI Bureaus and members of the CSMSC Subcommittee.
The draft list of critical mineral commodities has been simplified through categorization. The rare earth elements include the lanthanides and yttrium. The platinum group elements include platinum, palladium, rhodium, ruthenium, and iridium.
Several of the materials on the draft list can only be recovered cost effectively as byproducts of other more common mineral commodities which may not meet the criteria for being included on the draft list. Tellurium, for example, is a byproduct of copper refining. Rhenium is a byproduct of molybdenum processing. Despite these codependences, neither copper nor molybdenum is among the materials designated as critical.
Mineral criticality is not static, but changes over time. This analysis represents a snapshot in time that should be reviewed and updated periodically using the most recently available data in order to accurately capture rapidly evolving technological developments and the consequent material demands.
This draft list is based on the definition of a “critical mineral” provided in Executive Order 13817. The U.S. Government and other organizations may also use other definitions and rely on other criteria to identify a material or mineral as “critical” or otherwise important. This draft list is not intended to replace related terms and definitions of materials that are deemed strategic, critical or otherwise important (
Please submit written comments on this draft list by March 19, 2018 to facilitate consideration. In particular, DOI is interested in comments addressing the following topics: The make-up of the draft list and the rationale associated with potential additions or subtractions to the draft list. 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.
E.O. 13817, 82 FR 60835 (December 26, 2017).
Bureau of Ocean Energy Management, Interior.
Notice of Availability of a Record of Decision.
The Bureau of Ocean Energy Management (BOEM) is announcing the availability of a Record of Decision for proposed Gulf of Mexico (GOM) region-wide oil and gas Lease Sale 250. This Record of Decision identifies BOEM's selected alternative for proposed Lease Sale 250, which is analyzed in the
The Record of Decision is available on BOEM's website at
For more information on the Record of Decision, you may contact Mr. Greg Kozlowski, Deputy Regional Supervisor, Office of Environment, by telephone at 504-736-2512 or by email at
In the 2018 GOM Supplemental EIS, BOEM evaluated five alternatives in regards to proposed Lease Sale 250. These alternatives are summarized below:
A total of 207 blocks within the CPA and 160 blocks in the WPA are affected by the Topographic Features Stipulation. There are currently no identified topographic features protected under this stipulation in the EPA. The Live Bottom Stipulation covers the pinnacle trend area of the CPA, affecting a total of 74 blocks. Under Alternative D, the number of blocks that would become unavailable for lease represents only a small percentage of the total number of blocks to be offered under Alternative A, B, or C (<4%, even if blocks subject to all three stipulations were excluded). Therefore, Alternative D could reduce offshore infrastructure and activities, but Alternative D also shifts the location of offshore infrastructure and activities farther from these sensitive zones and would not lead to a reduction in overall offshore infrastructure and activities.
The additional eight lease stipulations for proposed region-wide Lease Sale 250 are the Military Areas Stipulation; the Evacuation Stipulation; the Coordination Stipulation; the Blocks South of Baldwin County, Alabama, Stipulation; the Protected Species Stipulation; the United Nations Convention on the Law of the Sea Royalty Payment Stipulation; the Below Seabed Restrictions due to Rights-of-Use and Easement for Floating Production Facilities Stipulation; and the Stipulation on the Agreement between the United States of America and the
After careful consideration, BOEM has selected the preferred alternative (Alternative A) in the 2018 GOM Supplemental EIS for proposed Lease Sale 250. BOEM's selection of the preferred alternative meets the purpose and need for the proposed action, as identified in the 2018 GOM Supplemental EIS, and provides for orderly resource development with protection of the human, marine, and coastal environments while also ensuring that the public receives an equitable return for these resources and that free-market competition is maintained.
This Notice of Availability of a Record of Decision is published pursuant to the regulations (40 CFR part 1505) implementing the provisions of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321
Bureau of Ocean Energy Management, Interior.
Final Notice of Sale.
On Wednesday, March 21, 2018, the Bureau of Ocean Energy Management (BOEM) will open and publicly announce bids received for blocks offered in the Gulf of Mexico (GOM) Outer Continental Shelf (OCS) Region-wide Oil and Gas Lease Sale 250 (GOM Region-wide Sale 250), in accordance with the provisions of the Outer Continental Shelf Lands Act (OCSLA), as amended, and the implementing regulations issued pursuant thereto. The GOM Region-wide Sale 250 Final Notice of Sale (NOS) package contains information essential to potential bidders.
Public bid reading for GOM Region-wide Sale 250 will begin at 9:00 a.m. on Wednesday, March 21, 2018, at 1201 Elmwood Park Boulevard, New Orleans, Louisiana. All times referred to in this document are Central Standard Time, unless otherwise specified.
Public bid reading for GOM Region-wide Sale 250 will be held at 1201 Elmwood Park Boulevard, New Orleans, Louisiana. The venue will not be open to the general public, media, or industry. Instead, the bid opening will be available for public viewing on BOEM's website at
For more information on bid submission, see Section VII, “Bidding Instructions,” of this document.
Ann Glazner, Acting Regional Supervisor, Office of Leasing and Plans, 504-736-2607,
This Final NOS includes the following sections:
Whole and partial blocks that lie within the boundaries of the Flower Garden Banks National Marine Sanctuary (in the East and West Flower Garden Banks and the Stetson Bank), identified in the following list:
Blocks that are adjacent to or beyond the United States Exclusive Economic Zone in the area known as the northern portion of the Eastern Gap:
All whole and portions of blocks deferred by the Gulf of Mexico Energy Security Act of 2006, Public Law 109-432:
The following blocks, whose lease status is currently under appeal:
Each lease is issued pursuant to OCSLA, 43 U.S.C. 1331-1356, as amended, and is subject to OCSLA implementing regulations promulgated pursuant thereto in 30 CFR part 556, and other applicable statutes and regulations in existence upon the effective date of the lease, as well as those applicable statutes enacted and regulations promulgated thereafter, except to the extent that the after-enacted statutes and regulations explicitly conflict with an express provision of the lease. Each lease is also subject to amendments to statutes and regulations, including but not limited to OCSLA, that do not explicitly conflict with an express provision of the lease. The lessee expressly bears the risk that such new or amended statutes and regulations (
BOEM will use Form BOEM-2005 (February 2017) to convey leases resulting from this sale. This lease form may be viewed on BOEM's website at
The lease form will be amended to conform with the specific terms, conditions, and stipulations applicable to the individual lease. The terms, conditions, and stipulations applicable to this sale are set forth below.
Primary Terms are summarized in the following table:
(1) The primary term for a lease in water depths less than 400 meters issued as a result of this sale is 5 years. If the lessee spuds a well targeting hydrocarbons below 25,000 feet TVD SS within the first 5 years of the lease, then the lessee may earn an additional 3 years, resulting in an 8 year primary term. The lessee will earn the 8 year primary term when the well is drilled to a target below 25,000 feet TVD SS, or the lessee may earn the 8 year primary term in cases where the well targets, but does not reach, a depth below 25,000 feet TVD SS due to mechanical or safety reasons, where sufficient evidence is provided that it did not reach that target for reasons beyond the lessee's control.
In order to earn the 8 year extended primary term, the lessee is required to submit to the BOEM GOM Regional Supervisor for Leasing and Plans, as soon as practicable, but in any instance not more than 30 days after completion of the drilling operation, a letter providing the well number, spud date, information demonstrating a target below 25,000 TVD SS and whether that target was reached, and if applicable, any safety, mechanical, or other problems encountered that prevented the well from reaching a depth below 25,000 feet TVD SS. This letter must request confirmation that the lessee earned the 8 year primary term. The extended primary term is not effective unless and until the lessee receives confirmation from BOEM.
The BOEM GOM Regional Supervisor for Leasing and Plans will confirm in writing, within 30 days of receiving the lessee's letter, whether the lessee has earned the extended primary term and update BOEM records accordingly.
A lessee that has earned the 8 year primary term by spudding a well with a hydrocarbon target below 25,000 feet TVD SS during the standard 5 year primary term of the lease will not be granted a suspension for that same period under the regulations at 30 CFR 250.175 because the lease is not at risk of expiring.
(2) The primary term for a lease in water depths ranging from 400 to less than 800 meters issued as a result of this sale is 5 years. If the lessee spuds a well within the 5 year primary term of the lease, the lessee will earn an additional 3 years, resulting in an 8 year primary term.
In order to earn the 8 year primary term, the lessee is required to submit to the BOEM GOM Regional Supervisor for Leasing and Plans, as soon as practicable, but in no case more than 30 days after spudding a well, a letter providing the well number and spud date, and requesting confirmation that the lessee earned the 8 year extended primary term. Within 30 days of receipt of the request, the BOEM GOM Regional Supervisor for Leasing and Plans will provide written confirmation of whether the lessee has earned the extended primary term and update BOEM records accordingly.
(3) The standard primary term for a lease in water depths ranging from 800 to less than 1,600 meters issued as a result of this sale is 7 years. If the lessee spuds a well within the standard 7 year primary term, the lessee will earn an additional 3 years, resulting in a 10 year extended primary term.
In order to earn the 10 year primary term, the lessee is required to submit to
(4) The primary term for a lease in water depths 1,600 meters or greater issued as a result of this sale will be 10 years.
• $25.00 per acre or fraction thereof for blocks in water depths less than 400 meters; and
• $100.00 per acre or fraction thereof for blocks in water depths 400 meters or deeper.
BOEM will not accept a bonus bid unless it provides for a cash bonus in an amount equal to, or exceeding, the specified minimum bid of $25.00 per acre or fraction thereof for blocks in water depths less than 400 meters, and $100.00 per acre or fraction thereof for blocks in water depths 400 meters or deeper.
Annual rental rates are summarized in the following table:
Any lessee with a lease in less than 400 meters water depth who earns an 8 year primary term will pay an escalating rental rate as shown above. The rental rates after the fifth year for blocks in less than 400 meters water depth will become fixed and no longer escalate, if another well is spudded targeting hydrocarbons below 25,000 feet TVD SS after the fifth year of the lease, and BOEM concurs that such a well has been spudded. In this case, the rental rate will become fixed at the rental rate in effect during the lease year in which the additional well was spudded.
• 12.5 Percent for leases situated in water depths less than 200 meters; and
• 18.75 percent for leases situated in water depths of 200 meters and deeper.
• $7.00 Per acre or fraction thereof per year for blocks in water depths less than 200 meters; and
• $11.00 per acre or fraction thereof per year for blocks in water depths 200 meters or deeper.
The issuance of leases with Royalty Suspension Volumes (RSVs) or other forms of royalty relief is authorized under existing BOEM regulations at 30 CFR part 560. The specific details relating to eligibility and implementation of the various royalty relief programs, including those involving the use of RSVs, are codified in Bureau of Safety and Environmental Enforcement (BSEE) regulations at 30 CFR part 203.
In this sale, the only royalty relief program being offered that involves the provision of RSVs relates to the drilling of ultra-deep wells in water depths of less than 400 meters, as described in the following section.
Leases issued as a result of this sale may be eligible for RSV incentives on gas produced from ultra-deep wells pursuant to 30 CFR part 203. These regulations implement the requirements of the Energy Policy Act of 2005 (42 U.S.C. 13201
Consistent with the Record of Decision for the Final Programmatic Environmental Impact Statement for the 2017-2022 Five Year OCS Oil and Gas Leasing Program, Stipulation No. 5 (Topographic Features) and Stipulation No. 8 (Live Bottom) will apply to every lease sale in the GOM Program Area. One or more of the remaining eight stipulations may be applied to leases issued as a result of this sale. The detailed text of the following stipulations is contained in the “Lease Stipulations” section of the Final NOS package.
Information to Lessees (ITLs) provides detailed information on certain issues pertaining to specific oil and gas lease sales. The detailed text of the ITLs for this sale is contained in the “Information to Lessees” section of the Final NOS package.
The maps pertaining to this lease sale may be viewed on BOEM's website at
The lease terms and economic conditions associated with leases of certain blocks are shown on the map entitled, “Final, Gulf of Mexico Region-wide Oil and Gas Lease Sale 250, March 2018, Lease Terms and Economic Conditions.”
The lease stipulations and the blocks to which they apply are shown on the map entitled, “Final, Gulf of Mexico Region-wide Oil and Gas Lease Sale 250, March 2018, Stipulations and Deferred Blocks Map.”
Bids may be submitted in person or by mail at the address below in the “Mailed Bids” section. Bidders submitting their bid(s) in person are advised to email
For each block bid upon, a separate sealed bid must be submitted in a sealed envelope (as described below) and include the following:
• Total amount of the bid in whole dollars only;
• Sale number;
• Sale date;
• Each bidder's exact name;
• Each bidder's proportionate interest, stated as a percentage, using a maximum of five decimal places (
• Typed name and title, and signature of each bidder's authorized officer;
• Each bidder's qualification number;
• Map name and number or Official Protraction Diagram (OPD) name and number;
• Block number; and
• Statement acknowledging that the bidder(s) understand that this bid legally binds the bidder(s) to comply with all applicable regulations, including those requiring it to post a deposit in the amount of one-fifth of the bonus bid amount for any tract bid upon and make payment of the balance of the bonus bid upon BOEM's acceptance of high bids.
The information required on the bid(s) is specified in the document “Bid Form” contained in the Final NOS package. A blank bid form is provided in the Final NOS package for convenience and may be copied and completed with the necessary information described above.
Each bid must be submitted in a separate sealed envelope labeled as follows:
• “Sealed Bid for GOM Region-wide Sale 250, not to be opened until 9 a.m. Wednesday, March 21, 2018;”
• Map name and number or OPD name and number;
• Block number for block bid upon; and
• The exact name and qualification number of the submitting bidder only.
The Final NOS package includes a sample bid envelope for reference.
If bids are mailed, please address the envelope containing the sealed bid envelope(s) as follows: Attention: Leasing and Financial Responsibility Section, BOEM Gulf of Mexico Region, 1201 Elmwood Park Boulevard WS-266A, New Orleans, Louisiana 70123-2394. Contains Sealed Bids for GOM Region-wide Sale 250. Please Deliver to Mr. Greg Purvis, 2nd Floor, Immediately.
Bidders mailing bid(s) are advised to inform BOEM by email to
Bidders that are not currently an OCS oil and gas lease record title holder or designated operator, or those that ever have defaulted on a one-fifth bonus bid deposit, by Electronic Funds Transfer (EFT) or otherwise, must guarantee (secure) the payment of the one-fifth bonus bid deposit prior to bid submission using one of the following four methods:
• Provide a third-party guarantee;
• Amend an area-wide development bond via bond rider;
• Provide a letter of credit; or
• Provide a lump sum payment in advance via EFT.
For more information on EFT procedures, see Section X of this document entitled, “The Lease Sale.”
Prior to bidding, each bidder should file the Equal Opportunity Affirmative Action Representation Form BOEM-2032 (October 2011,
The GDIS is composed of three parts:
(1) The “Statement” page includes the company representatives' information and lists of blocks bid on that used proprietary data and those blocks bid on that did not use proprietary data;
(2) The “Table” listing the required data about each proprietary survey used (see below); and
(3) The “Maps” being the live trace maps for each proprietary survey that are identified in the GDIS statement and table.
Every bidder submitting a bid on a block in GOM Region-wide Sale 250, or participating as a joint bidder in such a bid, must submit at the time of bid submission all three parts of the GDIS. A bidder must submit the GDIS
The GDIS must be submitted in a separate and sealed envelope, and must identify all proprietary data; reprocessed speculative data, and/or any Controlled Source Electromagnetic surveys, Amplitude Versus Offset (AVO), Gravity, or Magnetic data; or other information used as part of the decision to bid or participate in a bid on the block. The bidder and joint bidder must also include a live trace map (
The GDIS statement must include the name, phone number, and full address of a contact person and an alternate who are both knowledgeable about the geophysical information and data listed and who are available for 30 days after the sale date. The GDIS statement also must include a list of all blocks bid upon that did not use proprietary or reprocessed pre- or post-stack geophysical data and information as part of the decision to bid or to participate as a joint bidder in the bid. The GDIS statement must be submitted even if no proprietary geophysical data and information were used in bid preparation for the block.
The GDIS table should have columns that clearly state:
• The sale number;
• The bidder company's name;
• The block area and block number bid on;
• The owner of the original data set (
• The industry's original name of the survey (
• The BOEM permit number for the survey;
• Whether the data set is a fast track version;
• Whether the data is speculative or proprietary;
• The data type (
• The Migration algorithm (
• The Live Proprietary Survey Coverage (
• The computer storage size, to the nearest gigabyte, of each seismic data and velocity volume used to evaluate the lease block;
• Who reprocessed the data and when the date of final reprocessing was completed (month and year);
• If data was previously sent to BOEM, list the sale and date of sale for which it was used; and
• Indicate if proprietary or Speculative AVO/AVA (PROP/SPEC) was used.
The computer storage size information will be used in estimating the reproduction costs for each data set, if applicable. The availability of reimbursement of production costs will be determined consistent with 30 CFR 551.13.
An example of the preferred format of the table is contained in the Final NOS package, and a blank digital version of the preferred table can be accessed on the GOM Region-wide Sale 250 web page at
The GDIS maps are live trace maps (
The data must be submitted to BOEM at the following address: Bureau of Ocean Energy Management, Resource Studies, GM 881A, 1201 Elmwood Park Blvd., New Orleans, LA 70123-2304.
BOEM recommends that bidders mark the submission's external envelope as “Deliver Immediately to DASPU.” BOEM also recommends that the data be submitted in an internal envelope, or otherwise marked, with the following designation: “Proprietary Geophysical Data Submitted Pursuant to GOM Region-wide Sale 250 and used during <Bidder Name's> evaluation of Block <Block Number>.”
In the event a person supplies any type of data to BOEM, that person must meet the following requirements to qualify for reimbursement:
(1) The person must be registered with the System for Award Management (SAM), formerly known as the Central Contractor Registration (CCR). CCR usernames will not work in SAM. A new SAM User Account is needed to register or update an entity's records. The website for registering is
(2) The persons must be enrolled in the Department of Treasury's Invoice Processing Platform (IPP) for electronic invoicing. The person must enroll in the IPP at
(3) The persons must have a current On-line Representations and Certifications Application at
The GDIS Information Table must be submitted digitally, preferably as an Excel spreadsheet, on a CD, DVD, or any USB external drive (formatted for Windows), along with the seismic data map(s). If bidders have any questions, please contact Ms. Dee Smith at (504) 736-2706, or Mr. John Johnson at (504) 736-2455.
Bidders should refer to Section X of this document, “The Lease Sale: Acceptance, Rejection, or Return of Bids,” regarding a bidder's failure to comply with the requirements of the Final NOS, including any failure to submit information as required in the Final NOS or Final NOS package.
BOEM requests that bidders provide this information in the suggested format prior to or at the time of bid submission. The suggested format is included in the Final NOS package. The form must not be enclosed inside the sealed bid envelope.
BOEM may require bidders to submit other documents in accordance with 30
On November 14, 2017, BOEM published the most recent List of Restricted Joint Bidders in the
All signatories executing documents on behalf of bidder(s) must execute the same in conformance with the BOEM qualification records. Bidders are advised that BOEM considers the signed bid to be a legally binding obligation on the part of the bidder(s) to comply with all applicable regulations, including that requiring payment of one-fifth of the bonus bid on all high bids. A statement to this effect is included on each bid form (see the document “Bid Form” contained in the Final NOS package).
BOEM warns bidders against violation of 18 U.S.C. 1860, prohibiting unlawful combination or intimidation of bidders.
Bids may be withdrawn only by written request delivered to BOEM prior to the Bid Submission Deadline. The withdrawal request must be on company letterhead and must contain the bidder's name, its BOEM qualification number, the map name/number, and the block number(s) of the bid(s) to be withdrawn. The withdrawal request must be executed in conformance with the BOEM qualification records. Signatories must be authorized to bind their respective legal business entity (
Minimum bonus bid calculations, including rounding, for all blocks will be shown in the document “List of Blocks Available for Leasing” included in the Final NOS package. The bonus bid amount must be stated in whole dollars. If the acreage of a block contains a decimal figure, then prior to calculating the minimum bonus bid, BOEM will round up to the next whole acre. The appropriate minimum rate per acre will then be applied to the whole (rounded up) acreage. If this calculation results in a fractional dollar amount, the minimum bonus bid will be rounded up to the next whole dollar amount. The bonus bid amount must be greater than or equal to the minimum bonus bid in whole dollars.
The Final NOS package includes instructions, samples, and/or the preferred format for the following items. BOEM strongly encourages bidders to use the recommended formats. If bidders use another format, they are responsible for including all the information specified for each item in the Final NOS package.
Sealed bids received in response to the Final NOS will be opened at the place, date, and hour specified under the
Each bidder submitting an apparent high bid must submit a bonus bid deposit to the Office of Natural Resources Revenue (ONRR) equal to one-fifth of the bonus bid amount for each such bid. A copy of the notification of the high bidder's one-fifth bonus bid amount may be obtained on the BOEM website at
BOEM requires bidders to use EFT procedures for payment of one-fifth bonus bid deposits for GOM Region-wide Sale 250 following the detailed instructions contained on the ONRR Payment Information web page at
The United States reserves the right to withdraw any block from this lease sale prior to issuance of a written acceptance of a bid for the block.
The United States reserves the right to reject any and all bids. No bid will be accepted, and no lease for any block will be awarded to any bidder, unless:
(1) The bidder has complied with all requirements of the Final NOS, including those set forth in the documents contained in the Final NOS package, and applicable regulations;
(2) The bid is the highest valid bid; and
(3) The amount of the bid has been determined to be adequate by the authorized officer.
Any bid submitted that does not conform to the requirements of the Final NOS and Final NOS package, OCSLA, or other applicable statute or regulation will be rejected and returned to the bidder. The U.S. Department of Justice and the Federal Trade Commission will review the results of the lease sale for antitrust issues prior to the acceptance of bids and issuance of leases.
To ensure that the U.S. Government receives a fair return for the conveyance of leases from this sale, high bids will be evaluated in accordance with BOEM's bid adequacy procedures, which are available at
BOEM requires each bidder awarded a lease to:
(1) Execute all copies of the lease (Form BOEM-2005 (February 2017), as amended);
(2) Pay by EFT the balance of the bonus bid amount and the first year's rental for each lease issued in accordance with the requirements of 30 CFR 218.155 and 556.520(a); and
(3) Satisfy the bonding requirements of 30 CFR part 556, subpart I, as amended. ONRR requests that only one transaction be used for payment of the balance of the bonus bid amount and the first year's rental. When ONRR receives such payment, the bidder awarded the lease may not request a refund of the balance bonus bid amount or first year's rental payment.
The BOEM Gulf of Mexico RD has the discretion to change any date, time, and/or location specified in the Final NOS package in the case of an event that the BOEM Gulf of Mexico RD deems may interfere with the carrying out of a fair and orderly lease sale process. Such events could include, but are not limited to, natural disasters (
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Tektronix,, Inc. on February 09, 2018. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain multi-domain test and measurement instruments. The complaint names as respondents: Rohde & Schwarz USA, Inc. of Columbia, MD; Rohde & Schwarz GmbH & Co. KG of Germany; and Rohde & Schwarz Vertriebs Gmbh of Germany. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) Identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) Identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) Indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) Explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3295) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
On the basis of the record
Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigations. The Commission will issue a final phase notice of scheduling, which will be published in the
On December 27, 2017, Berwick Offray LLC, Berwick, Pennsylvania filed petitions with the Commission and Commerce, alleging that an industry in the United States is materially injured or threatened with material injury by reason of subsidized imports of plastic decorative ribbon from China and LTFV imports of plastic decorative ribbon from China. Accordingly, effective December 27, 2017, the Commission, pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)), instituted countervailing duty investigation No. 701-TA-592 and antidumping duty investigation No. 731-TA-1400 (Preliminary).
Notice of the institution of the Commission's investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)). It completed and filed its determinations in these investigations on February 12, 2018. The views of the Commission are contained in USITC Publication 4763 (February 2018), entitled
By order of the Commission.
Laboratory Division Federal Bureau of Investigation Laboratory Division Survey of Forensic Science Services, Federal Bureau of Investigation, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Laboratory Division will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until March 19, 2018.
If you have comments, especially on the estimated public burden or associated
This process is conducted in accordance with 5 CFR 1320.10. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
On February 12, 2018, the Department of Justice lodged a proposed consent decree with the United States District Court for the Eastern District of Louisiana in the lawsuit titled
The United States and Louisiana Department of Environmental Quality filed this lawsuit under the Clean Air Act and Louisiana Environmental Quality Act. The complaint seeks injunctive relief and civil penalties based on violations of the Clean Air Act's New Source Review requirements, New Source Performance Standards, National Emissions Standards for Hazardous Air Pollutants, “Title V” program requirements and operating permits, and related Louisiana state implementation plan requirements. The alleged violations involve flares used at a chemical plant owned and operated by defendant Shell Chemical LP in Norco, Louisiana. The consent decree requires the defendant to perform injunctive relief, including operating a facility fenceline monitoring system, and pay $350,000 in civil penalties, with $262,500 to be paid to the United States and $87,500 to be paid to LDEQ.
The publication of this notice opens a period for public comment on the proposed consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the proposed consent decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $37.00 (25 cents per page reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits and signature pages, the cost is $26.75.
Bureau of Justice Statistics, Department of Justice.
30-Day Notice.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until March 19, 2018.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Shelley S. Hyland, Statistician, Law Enforcement Statistics Unit, Bureau of Justice Statistics, 810 Seventh Street NW, Washington, DC 20531 (email:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
(1)
(2)
(3)
(4)
The 2018 CSLLEA collection involves two phases. In the first phase, BJS will cognitively test the revised instrument with 48 agencies based on agency type (
Pending positive results from the first phase, in the second phase, BJS will conduct the main data collection. The 2018 CSLLEA is designed to collect general information on state, county, local and tribal law enforcement agencies. The survey asks about the level of government that operates the agency; total operating budget; full-time and part-time personnel counts for fully sworn officers, limited sworn officers and non-sworn employees; gender and primary job responsibility of full-time sworn officers; and the functions the agency performs on a regular or primary basis. Upon completion, the 2018 CSLLEA will serve as the sampling frame for future law enforcement surveys administered by BJS.
(5)
(6)
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance 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 (PRA95). 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 requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs (OWCP) is soliciting comments concerning the proposed collection: Notice of Payment (LS-208). A copy of the proposed information collection request can be obtained by contacting the office listed below in the address section of this Notice.
Written comments must be submitted to the office listed in the addresses section below on or before April 17, 2018.
You may submit comments by mail, delivery service, or by hand to Ms. Yoon Ferguson, U.S. Department of Labor, 200 Constitution Ave. NW, Room S-3323, Washington, DC 20210; by fax to (202) 354-9647; or by Email to
The Office of Workers' Compensation Programs administers the Longshore and Harbor Workers' Compensation Act. The Act provides benefits to workers' injured in maritime employment on the navigable waters of the United States or in an adjoining area customarily used by an employer in loading, unloading, repairing, or building a vessel. In addition, several acts extend the Longshore Act's coverage to certain other employees.
Under sections 914(b) & (c) of the Longshore Act, a self-insured employer or insurance carrier is required to pay compensation within 14 days after the employer has knowledge of the injury or death and immediately notify the district director of the payment. Under Section 914(g), the employer/carrier is required to issue notification of final payment of compensation. Form LS-208 has been designated as the proper form on which report of those payments is to be made.
The Department of Labor is particularly interested in comments which:
* 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,
The Department of Labor seeks the extension of approval of this information collection in order to carry out its responsibility to meet the statutory requirements to provide compensation or death benefits under the Act to workers covered by the Act.
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.
National Commission on Military, National, and Public Service.
Request for comments.
The National Commission on Military, National, and Public Service (the “Commission”) was created by Congress in the National Defense Authorization Act of Fiscal Year 2017 to “conduct a review of the military selective service process (commonly referred to as `the draft') ” and to consider methods to increase participation in military, national, and public service in order to address national security and other public service needs of the Nation. In connection with this effort, Congress has directed the Commission to seek written comments from the general public and interested parties on matters of the Commission's review. The Commission seeks to learn more about the general public's views on these topics, including what has encouraged or discouraged them to perform voluntary or paid services for their communities at all levels.
Comments are due by April 19, 2018.
You may submit comments, identified by Docket No. 05-2018-01, by any of the following methods:
•
•
•
All submissions received must include the docket number. If the Commission cannot read your comment due to technical difficulties and cannot contact you for clarification, the Commission may not be able to consider your comment. Late comments will be considered.
For general inquiries, submission process questions, or any additional information about this request for comments, please contact Rachel Rikleen, at (703) 571-3760 or by email at
The National Defense Authorization Act for Fiscal Year 2017, Public Law 114-328, 130 Stat. 2000 (2016), created the National Commission on Military, National, and Public Service (the “Commission”) to “conduct a review of the military selective service process (commonly referred to as `the draft')” and to “consider methods to increase participation in military, national, and public service in order to address national security and other public service needs of the Nation.” Public Law 114-328, Subtitle F, Section 551.
To this end, Congress has specifically directed the Commission to consider: “(1) the need for a military selective service process, including the continuing need for a mechanism to draft large numbers of replacement combat troops; (2) means by which to foster a greater attitude and ethos of service among United States youth, including an increased propensity for military service; (3) the feasibility and advisability of modifying the military selective service process in order to obtain for military, national, and public service individuals with skills (such as medical, dental, and nursing skills, language skills, cyber skills, and science, technology, engineering, and mathematics (STEM) skills) for which the Nation has a critical need, without regard to age or sex; and (4) the feasibility and advisability of including in the military selective service process, as so modified, an eligibility or entitlement for the receipt of one or more Federal benefits (such as educational benefits, subsidized or secured student loans, grants or hiring preferences) specified by the Commission for purposes of the review.”
The Commission's work is also guided by a series of principles issued by the President on April 3, 2017.
The Commission is required to provide the President and Congress a final report containing its findings and recommendations regarding these matters no later than March 2020. In preparing the report, the Commission must engage the American public, hearing directly from them about these topics. In particular, Congress has directed the Commission to seek written comments from the general public and interested parties on matters of the Commission's review within seven months of its establishment date, which means April 19, 2018. This notice and request for comments is intended to meet that statutory requirement.
The Commission is also receiving formal input from a number of Federal agencies. The Commission's enabling statute requires the Secretary of Defense to issue a preliminary report on the current and future need for a centralized registration system under the Military Selective Service Act, and the Comptroller General to perform a review of the procedures used by the Defense Department in evaluating the selective service requirements. Additionally, several Federal agencies are required under the Commission's enabling statute to offer to the Commission recommendations for the reform of the military selective service process and military, national, and public service in connection with that process.
The Commission will hold a series of public meetings on these topics as it prepares its report for Congress and the President. Information about those meetings will be made available on the Commission's website,
The Commission would welcome comments on any of the specific topics for which Congress has requested Commission input. These are set forth above under “Background.”
In addition, the Commission would welcome comments on any of the following specific topics:
(1) Is a military draft or draft contingency still a necessary component of U.S. national security?
(2) Are modifications to the selective service system needed?
(3) How can the United States increase participation in military, national, and public service by individuals with skills critical to address the national security and other public service needs of the nation?
(4) What are the barriers to participation in military, national, or public service?
(5) Does service have inherent value, and, if so, what is it?
(6) Is a mandatory service requirement for all Americans necessary, valuable, and feasible?
(7) How does the United States increase the propensity for Americans, particularly young Americans, to serve?
The National Science Board (NSB), pursuant to National Science Foundation (NSF) regulations (45 CFR part 614), the National Science Foundation Act, as amended, (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of the scheduling of meetings for the transaction of NSB business as follows:
Wednesday, February 21, 2018, from 8:15 a.m. to 5:15 p.m. and Thursday, February 22, 2018, from 8:30 a.m. to 2:00 p.m. EST.
These meetings will be held at the NSF headquarters, 2415 Eisenhower Avenue, Alexandria, VA 22314. Meetings are held in the boardroom on the 2nd floor. The public may observe public meetings held in the boardroom. All visitors must contact the Board Office (call 703-292-7000 or send an
Some of these meetings will be open to the public. Others will be closed to the public. See full description below.
The NSB Office contact is Brad Gutierrez,
Public meetings and public portions of meetings held in the 2nd floor boardroom will be webcast. To view these meetings, go to:
Please refer to the NSB website for additional information. You will find any updated meeting information and schedule updates (time, place, subject matter, or status of meeting) at
The NSB will continue its program to provide some flexibility around meeting times. After the first meeting of each day, actual meeting start and end times will be allowed to vary by no more than 15 minutes in either direction. As an example, if a 10:00 meeting finishes at 10:45, the meeting scheduled to begin at 11:00 may begin at 10:45 instead. Similarly, the 10:00 meeting may be allowed to run over by as much as 15 minutes if the Chair decides the extra time is warranted. The next meeting would start no later than 11:15. Arrive at the NSB boardroom or check the webcast 15 minutes before the scheduled start time of the meeting you wish to observe.
In accordance with the purposes of Sections 29 and 182b of the Atomic Energy Act (42 U.S.C. 2039, 2232b), the Advisory Committee on Reactor Safeguards (ACRS) will hold a meeting March 8-10, 2018, 11545 Rockville Pike, Rockville, Maryland 20852.
Procedures for the conduct of and participation in ACRS meetings were published in the
Thirty-five hard copies of each presentation or handout should be provided 30 minutes before the meeting. In addition, one electronic copy of each presentation should be emailed to the Cognizant ACRS Staff one day before meeting. If an electronic copy cannot be provided within this timeframe, presenters should provide the Cognizant ACRS Staff with a CD containing each presentation at least 30 minutes before the meeting.
In accordance with Subsection 10(d) of Public Law 92-463 and 5 U.S.C. 552b(c), certain portions of this meeting may be closed, as specifically noted above. Use of still, motion picture, and television cameras during the meeting may be limited to selected portions of the meeting as determined by the Chairman. Electronic recordings will be permitted only during the open portions of the meeting.
ACRS meeting agendas, meeting transcripts, and letter reports are
Video teleconferencing service is available for observing open sessions of ACRS meetings. Those wishing to use this service should contact Mr. Theron Brown, ACRS Audio Visual Technician (301-415-6702), between 7:30 a.m. and 3:45 p.m. (ET), at least 10 days before the meeting to ensure the availability of this service. Individuals or organizations requesting this service will be responsible for telephone line charges and for providing the equipment and facilities that they use to establish the video teleconferencing link. The availability of video teleconferencing services is not guaranteed.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
1.
This notice will be published in the
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to adopt IM-8040-3 to Rule 8040. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's internet website 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 these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to adopt IM-8040-3 to Rule 8040. Specifically, the Exchange is proposing that Directed Orders
Pursuant to Rule 8040(d), upon receipt of a Directed Order from an Order Flow Provider (“OFP”)
The Exchange notes that the proposed Auction Only designation is an optional designation that the submitting OFP may decide to utilize. The Exchange believes the proposed change will provide increased flexibility to OFPs when executing orders on the Exchange as well as provide execution certainty because the Directed Order will either execute via the PIP or be cancelled back. The Exchange further believes that the proposed designation will make the Directed Order process more attractive to Participants that are searching for liquidity
The Exchange will provide at least two weeks' notice to Participants via Circular prior to the launch of the proposed change. The Exchange anticipates launching in the second quarter of 2018.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
In particular, the Exchange believes the proposed rule change is designed to remove impediments to and perfect the mechanisms of a free and open market and a national market system by providing an additional tool and greater flexibility for Participants executing orders on the Exchange as well as providing execution certainty. The Exchange also believes the proposal will provide opportunity for Participants to achieve better handling of orders by providing Participants with this additional functionality. As a result, adopting this proposal to allow Directed Orders to be submitted with the Auction Only designation will promote just and equitable principles of trade and foster cooperation and coordination with persons engaged in facilitating transactions in securities.
As mentioned above, the EP is not notified that a Directed Order was submitted with the Auction Only designation and therefore there is no unfair advantage bestowed on the EP as a result of the proposal. As such, the proposal is designed to prevent fraudulent and manipulative acts and practices.
The Exchange believes that the proposal removes impediments to and perfects the mechanism of a free and open market by enhancing the Exchange's market by providing market participants the ability to send Directed Orders with an Auction Only designation to the Exchange. As such, BOX believes that the proposed change will increase flexibility to OFPs when executing orders on the Exchange.
The Exchange believes that the proposed Auction Only designation will provide OFPs with a valuable tool when executing orders on the Exchange. As such, the Exchange believes that the proposed change removes impediments to and perfects the mechanism of a free and open market because the proposed change further promotes competition among options exchanges. The Exchange believes that the proposed additional functionality for executing Directed Orders will protect investors and the public interest by providing OFPs with greater flexibility and opportunity for their orders on the Exchange. The Exchange believes this increased opportunity will lead to enhanced order flow to the Exchange, which in turn will benefit and protect investors and the public interest through the potential for greater volume of orders and executions on BOX. The Exchange believes that the proposed rule change is not designed to permit unfair discrimination between customers, issues, brokers, or dealers because the proposed additional tool for Directed Orders is open to all OFPs and is completely voluntary. As such, the Exchange believes the proposed change is consistent with the Act.
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 Act. On the contrary, the Exchange believes that the proposed feature to Directed Orders will enhance competition in the U.S. option markets by providing enhanced functionality thereby making the Exchange more competitive with other exchanges. Additionally, respecting intra-market competition, the additional feature for Directed Orders will be available to all OFPs that submit Directed Orders to the Exchange.
The Exchange has neither solicited nor received comments on the proposed rule change.
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.
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 Brent J. Fields, 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”)
FINRA is proposing to amend FINRA Rules 12600 and 12800 of the Code of Arbitration Procedure for Customer Disputes (“Customer Code”) and 13600 and 13800 of the Code of Arbitration Procedure for Industry Disputes (“Industry Code,” and together with the Customer Code, the “Codes”), to amend the hearing provisions to provide an additional hearing option for parties in arbitration with claims of $50,000 or less, excluding interest and expenses.
The text of the proposed rule change is available on FINRA's website at
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Codes provide two methods for administering arbitration cases with claims involving $50,000 or less, excluding interest and expenses. The default method is a decision by a single arbitrator based on the parties' pleadings and other materials submitted by the parties. The alternative method involves a full hearing with a single arbitrator. Under the Customer Code, a customer may request a hearing (regardless of whether the customer is a claimant or respondent),
FINRA believes that forum users with claims involving $50,000 or less would benefit by having an additional, intermediate form of adjudication that would provide them with an opportunity to argue their cases before an arbitrator in a shorter, limited telephonic hearing format. Therefore, FINRA is proposing to amend the Codes to include a Special Proceeding for Simplified Arbitration (“Special Proceeding”). The Special Proceeding would be limited to two hearing sessions, exclusive of prehearing conferences,
The suggestion to propose an intermediate form of adjudication originated from the FINRA Dispute Resolution Task Force (“Task Force”).
FINRA considered the Task Force's recommendations and questions in developing the format for an intermediate form of adjudication.
Option Two would be the new Special Proceeding subject to the regular provisions of the Code relating to prehearings and hearings, including all fee provisions, with several limiting conditions. The conditions are intended to ensure that the parties have an opportunity to present their case to an arbitrator in a convenient and cost effective manner without being subject to cross-examination by an opposing party.
Specifically:
• A Special Proceeding would be held by telephone unless the parties agree to another method of appearance;
• the claimants, collectively, would be limited to two hours to present their case and
• the respondents, collectively, would be limited to two hours to present their case and
• notwithstanding the abovementioned conditions, the arbitrator would have the discretion to cede his or her allotted time to the parties;
• in no event could a Special Proceeding exceed two hearing sessions, exclusive of prehearing conferences, to be completed in one day;
• the parties would not be permitted to question the opposing parties' witnesses;
• the Customer Code would provide that a customer could not call an opposing party, a current or former associated person of a member party, or a current or former employee of a member party as a witness, and members and associated persons could not call a customer of a member party as a witness; and
• the Industry Code would provide that members and associated persons could not call an opposing party as a witness.
Except for the two hearing session time limit for a Special Proceeding, FINRA would not impose any restrictions on the arbitrator's ability to ask the parties questions and has incorporated a substantial amount of time for arbitrator questions. Specifically, since FINRA would limit the parties' combined presentations to five hours, the arbitrator would have up to three hours to ask questions. In addition, under the proposed rule change FINRA would not prohibit the arbitrator from allowing parties additional time for their presentations or witness testimonies, so long as the hearing on the merits is completed within the two hearing session limit.
FINRA is further proposing to amend Rule 12800(a) to add clarity to the rule by explaining the customer's options earlier in the rule text. FINRA is proposing to amend the sentence in Rule 12800(c) that states that “[I]f no hearing is held, no initial prehearing conference or other prehearing
To add clarity on how arbitrators are paid in cases where the customer requests a hearing, FINRA is proposing to amend Rule 12800(f) to clarify that the regular provisions of the Code relating to arbitrator honoraria would apply in such cases. Since the Special Proceeding would be a new form of adjudication at the forum, FINRA intends to provide substantial training to arbitrators including, but not limited to, updating FINRA's written training materials for arbitrators, posting a Neutral Workshop video on the FINRA website for arbitrators to view on-demand, and including discussions about the Special Proceeding in FINRA's publication for arbitrators and mediators,
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
In addition, FINRA believes that the proposed rule change is consistent with the provisions of the Act because it would provide parties with claims of $50,000 or less with an additional, cost effective, hearing option for resolving disputes. FINRA believes that the proposed rule change would limit the potential costs of a hearing and provide parties with the opportunity to present their case without cross-examination from their opponents. The ability to present their case without cross-examination may benefit those who believe that a direct confrontation could intimidate their testimony. FINRA believes that the broader role of arbitrators for a Special Proceeding in asking questions of the parties would serve a similar function to cross-examination, such as gaining clarity on issues and assessing witness credibility, but within a potentially less intimidating environment.
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
As noted above, the Code currently provides two methods for administering arbitration cases with claims involving $50,000 or less, excluding interest and expenses. The default method is based exclusively on the parties' pleadings and other materials submitted by the parties, and the alternative method involves a full hearing. Although a full hearing provides the parties a more complete opportunity to present their cases to an arbitrator, for the reasons discussed above, the parties sometimes forego a full hearing. The proposal provides an additional method for administering these arbitration cases that would allow for oral testimony while limiting the costs of the proceedings.
The economic baseline for the proposal is the two current methods for administering arbitration cases with claims involving $50,000 or less. The proposal is expected to affect customers, either as claimant or respondent, with a claim involving $50,000 or less; industry parties, as claimant, with a claim involving $50,000 or less; and industry parties as respondents to these claims. The proposal is also expected to affect FINRA arbitrators.
The parties today that opt for a decision on the pleadings or for a full hearing face trade-offs between the two choices. A decision on the pleadings is dependent solely on the parties' pleadings and other submitted materials, and the cost to parties is generally limited to filing fees and the legal fees and expenses to submit the materials. On the other hand, a full hearing is dependent on the pleadings and submitted materials as well as oral testimony and arguments. In addition to filing fees and legal fees to submit the materials, parties can also incur arbitration hearing session fees, travel and lodging expenses, lost income, and other costs associated with the time spent at the hearings such as accommodations for dependent care. These costs increase with the number of hearings and are also dependent on the characteristics of the parties. For example, parties that live further away from the hearing site or that are less able to travel will incur higher travel costs than parties that live closer to the hearing site or that are more able to travel.
The costs of a full hearing are greater and more uncertain at the outset than the costs of a decision on the pleadings. Among other factors, parties selecting the arbitration format will weigh the potential benefits of providing testimony and arguments at a full hearing relative to its higher and more uncertain costs. The greater and more uncertain costs of a full hearing may cause parties to forego providing oral testimony and arguments and instead opt for a decision on the pleadings. Parties also may forego providing oral testimony and arguments to avoid cross-examination.
The parties not selecting the arbitration format may instead prefer a decision on the pleadings. A decision on the pleadings is likely to minimize their costs and prevents the potential influence of oral testimony on the award decision. Alternatively, in a full hearing, these parties are likely to incur greater costs and have exposure to the potential
For arbitration cases with close dates from January 2016 to December 2016, FINRA staff is able to identify 194 arbitration cases that had an amount of compensatory relief requested of less than or equal to $50,000 and were closed through a decision on the pleadings (154) or by hearing (40).
The Special Proceeding would provide a new third option for administering arbitration cases with claims involving $50,000 or less, and would not remove the ability of parties to choose either a decision on the pleadings or a full hearing. A primary benefit of this new third option is the increase in the ability of customers and intra-industry claimants to provide oral testimony but with fewer costs, including the provision of oral testimony without cross-examination, and with greater certainty of its length than in a full hearing. In general, a Special Proceeding would increase the number of options available to customers and intra-industry claimants in choosing the method which would provide the most benefits relative to its costs, and would therefore increase the overall net benefits of the forum to these parties.
A Special Proceeding would provide customers and intra-industry claimants the benefit of providing oral testimony to an arbitrator but subject to several conditions.
Parties to the Special Proceeding are expected to incur lower costs to participate in the forum than parties to a full hearing, particularly if the parties proceed by telephonic conference.
A Special Proceeding would also limit the number of hearings, and the arbitration fees, including hearing session fees, would be based on the current fee schedule.
The extent to which the benefits and costs associated with the forum increase or decrease for claims of $50,000 or less is dependent on what the parties would have chosen absent this new option. Customers and intra-industry claimants would have a greater ability to choose the method based on the trade-off between the potential value of providing oral testimony and arguments with a corresponding increase in forum costs.
The costs incurred by the parties not selecting the arbitration format could increase or decrease depending on the method that would have been chosen absent the new option. If the customer or intra-industry claimant would have chosen a decision on the pleadings, then the costs to these parties such as arbitration and hearing session fees would likely increase under a Special Proceeding. They would also have exposure to the potential influence of oral testimony and arguments on the award decision. A decision to conduct a Special Proceeding in lieu of a full hearing would potentially decrease the costs incurred by these parties through lower hearing session fees and lower costs to participate in the hearings. To the extent that the Special Proceeding increases the expected costs of parties not selecting the arbitration format to participate in the forum and their exposure to the potential influence of oral testimony, these parties could have additional impetus to consider settlement.
FINRA considered a range of alternatives during this process. The alternatives to the proposal include more or less restrictive limiting conditions for a Special Proceeding, and providing the new option to a broader range of claims such as those with higher dollar amounts. As discussed above, the Task Force recommended allowing parties with claims involving $50,000 or less to be able to appear in whatever manner they prefer: In person, by phone or by videoconference. FINRA determined that it is in the best interest of the parties to hold hearings by telephone because this method is the most expeditious and inexpensive format for hearings. As stated above, FINRA is proposing that parties can agree to other methods of appearance, including appearing in person or by videoconference. The Task Force also recommended a shorter time limit on
Written comments were neither solicited nor received.
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) of the Securities Exchange Act of 1934 (“Act”),
ICE Clear Europe proposes revising the ICE Clear Europe Rules (the “Clearing House Rules”)
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.
ICE Futures Europe has announced that certain F&O Contracts currently listed on that exchange and cleared at ICE Clear Europe will be removed from trading and that equivalent contracts will commence trading on the ICE Futures U.S., Inc. (“ICE Futures US”) exchange.
Specifically, ICE Clear Europe is adopting a new Part 23 of the Rules, which will apply to the announced transition as well as any future similar transitions. Part 23 will apply where the Clearing House identifies by Circular one or more F&O Contracts for which
New Rule 2303 provides that as of the relevant Transition Time, trading of the Transitioning Contract will transfer from the Exiting Market to the Receiving Market. New Rule 2304(a) provides that the Transitioning Contracts will be automatically redesignated such that they become Contracts under the Market Rules of the Receiving Market and are no longer Contracts under the Market Rules of the Exiting Market. Under the Rule, the redesignated Contracts remain in full force and effect as between the relevant Clearing Member and the Clearing House.
New Rule 2304(b) further addresses the situation where the Receiving Market is a U.S. designated contract market and the Exiting Market is not. In that case, in order to comply with relevant segregation requirements under Section 4d of the U.S. Commodity Exchange Act, Transitioning Contracts registered in the Non-DCM/Swap Customer Account of an FCM/BD Clearing Member will be automatically transferred to the DCM Customer Account of such FCM/BD Clearing Member; and FCM/BD Customer Collateral in respect of such open Transitioning Contracts will be held in the Clearing House DCM Segregated Account as FCM/BD U.S. Futures Customer Collateral under the Rules.
In connection with the announced transition between ICE Futures Europe and ICE Futures US, ICE Clear Europe will issue a Circular indicating the specific contracts that are to be Transitioning Contracts and the Transition Time for purposes of Part 23 of the Rules. ICE Clear Europe has attached as Exhibit 5 hereto the list of Transitioning Contracts. The Transition Time is expected to be on or about February 18, 2018.
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. The amendments solely are designed to facilitate the transition of the Transitioning Contracts from one Market to another, as requested by such markets. As a result, ICE Clear Europe does not believe the amendments would adversely affect Clearing Members, materially affect the cost of clearing, adversely affect access to clearing in F&O Contracts for Clearing Members or their customers, or otherwise adversely affect competition in clearing services. Accordingly, 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.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) 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.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2018-003 and should be submitted on or before March 9, 2018.
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 (the “Act”),
The Exchange proposes to amend its rules related to the Complex Order Book (“COB”).
(additions are
(a)-(b) No change.
(c) Complex Order Book:
(i) Routing of Complex Orders: The Exchange will determine which classes and which complex order origin types (
Complex orders not eligible to route to COB (either directly or from PAR to COB) will route via the order handling system pursuant to Rule 6.12.
(ii)-(iv) No change.
(d) No change.
. . . Interpretations and Policies:
.01-.12 No change.
The text of the proposed rule change is also available on the Exchange's website (
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 its rules related to the COB. Currently, Rule 6.53C(c)(i) states the Exchange may determine which classes and which complex order origin types (
The Exchange proposes to amend Rule 6.53C(c) to provide in a class in which the Exchange determines complex orders of Market-Makers and away market-makers are not eligible for entry into the COB, the Exchange may determine that Market-Makers and away market-makers may enter complex
Unlike the leg markets, in which market-makers provide liquidity through quotes, the COB has no market-maker quotes that indicate to customers the price at which liquidity providers are willing to trade against their orders.
Additionally, the Exchange believes it may be difficult for Market-Makers to respond to auctions, particularly when multiple auctions occur within a short amount of time, while managing risk related to the amount executed during those auctions. Market-makers have complicated risk modeling associated with their trading activity, which factors in the size, price, and frequency at which they trade with orders. In the leg markets, those risk models factor in market-makers' quotes. However, the Exchange understands Market-Makers have separate systems for quoting and for monitoring and responding to COAs, each of which has a different risk model and set of risk controls. For example, one server process submits quotes while another server process scans the market for opportunities, such as the presence of customer orders and auctions.
It is common for Market-Makers to set risk controls with respect to the COA monitoring and response system to not respond to too many COAs within a short timeframe. If multiple COAs in a strategy occur within a short amount of time, it is common for a Market-Maker's system to determine this to be a potential system issue of the submitting Trading Permit Holder or Exchange. To ensure a Market-Maker does not trade with potentially erroneous orders and protect the Market-Maker from erroneous transactions to ensure it does not become overexposed to risk, the Market-Maker's system that monitors COAs may stop responding to COAs in this situation pursuant to the Market-Maker's risk controls for that system (
Additionally, this may result in the Market-Maker missing opportunities to participate in legitimate auctions. However, it is common for market participants to enter multiple small orders into COAs that are not erroneous (
The Exchange believes the proposed rule change also permits it to maintain the protections in those classes gained from not having M and N complex orders otherwise resting in the COB by only permitting M and N complex orders to rest in the COB under certain circumstances for limited time periods. In classes in which there is significant open outcry trading, there is generally a large number of complex orders that execute in open outcry, and such orders are generally for significant quantity. There is a risk of orders in the COB interfering with this trading. For example, if a broker represents a large buy complex order on the floor, if there is a small sell order in the COB for that strategy at a better price, the broker must trade with that resting order first. While this affords price improvement for a small portion of the buy order, this first execution lengthens the time of execution for the entire order, which may ultimately harm the customer with respect to the overall price given the speed at which the market changes. Additionally, if there is a small buy order for that strategy in the COB at a better bid price, the floor broker would not be able to clear that order and would not be able to trade until that order is no longer resting on the book at a better
For the following examples, suppose the NBBO for the VIX October 14 call is 2.50 to 2.60, and the market for the VIX October 14 put is 1.50 to 1.60. Therefore, the NSM for a straddle
• At 10:00 a.m., a customer submits to the COB an order to buy 20 of the VIX October 14 straddle at $4.10 (there are no other customer orders resting in the COB to buy this strategy at any price).
• At 10:01 a.m., the customer order is still resting, and the COB receives a Market-Maker order to sell 50 of the VIX October 14 straddle at $4.12. The Market-Maker must cancel the order by 10:04 a.m.
• At 10:04 a.m., the Market-Maker cancels the order.
• At 10:04:30 a.m., the same customer order continues to rest on the COB, and the Market-Maker enters another order to sell the straddle at $4.11. The Market-Maker must cancel that order by 10:07:30 a.m.
• At 10:07 a.m., the Market-Maker cancels the order.
• At 10:31 a.m., a customer submits to the COB an order to buy 20 of the VIX October 14 straddle at $3.99 (there are no other customer orders resting in the COB to buy this strategy at any price).
• Market-Makers would not be permitted to enter opposing orders into the COB, because the customer order resting in the COB is priced outside of the NSM.
• At 10:35 a.m., the NSM changes from $4.00 to $4.20 to $3.90 to $4.10, and thus the resting customer order is now within the NSM.
• At 10:38 a.m., the COB receives a Market-Maker order to sell 50 of the straddle at $4.00.
• At 10:40 a.m., the customer cancels its resting order and submits a new order to buy 20 of the straddle at $4.00, which executes again the resting Market-Maker order.
• At 10:00:00:000 a.m., a customer submits an order to buy the VIX October 14 straddle, which initiates a COA (there was no other COA within the previous 1000 milliseconds), so Market-Makers may not submit an order into the COB.
• At 10:00:00:999 a.m., another customer submits an order to buy the VIX October 14 straddle, which initiates another COA. As this is the second COA within a one thousand millisecond interval, Market-Makers may submit orders to the COB.
• At 10:01:000 a.m., a Market-Maker submits to the COB an order to sell the VIX October 14 straddle at $4.12.
• The Market-Maker must cancel the order by 10:04:000 a.m.
The time period within which a Market-Maker must cancel its complex order pursuant to the proposed rule change provides the Market-Maker with sufficient time for the opposing customer to potentially re-price its order for execution against the Market-Maker's order or for the Market-Maker order to execute against an order following a COA, while also giving the Market-Maker sufficient time to manually cancel its unexecuted orders while managing all of its trading activity. A time period that is too short may discourage market-makers from entering orders under these circumstances, but a time period that is too long may eliminate the benefits of not permitting market-maker orders to rest in the COB (as discussed above). Additionally, requiring customer orders to be not outside the NSM for Market-Makers to submit orders to the COB prevents situations in which market participants may take advantage of this functionality. For example, a customer may rest an order in the COB that is far outside the NSM (and thus unlikely to execute) for long periods of time, which would then permit Market-Makers to rest orders in the COB for such long periods of time, because if a Market-Maker order on the COB does not trade, the Market-Maker could cancel it pursuant to the proposed rule change and then re-submit the order to the COB.
The Exchange's Regulatory Division will have surveillance in place to enforce the proposed rule change, which surveillance will monitor whether M and N orders have only been entered in the permitted circumstances described above, and whether any such unexecuted orders have been cancelled by the deadline imposed by the proposed rule change.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes the proposed rule change will add liquidity and increase customer execution opportunities at prices potentially better than the leg markets for resting priority customer complex orders and auctioned orders in classes in which the Exchange has determined M and N orders are otherwise not eligible for entry into the COB, while maintaining the protections in those classes gained from not having M and N complex orders otherwise resting in the COB,
Additionally, the Exchange believes it may be difficult for Market-Makers to respond to auctions, particularly when multiple auctions occur within a short amount of time, while managing risk related to amount executed during those auctions. Market-makers have complicated risk modeling associated with their trading activity, which factors in the size, price, and frequency at which they trade with orders. In the leg markets, those risk models factor in market-makers' quotes. However, the Exchange understands Market-Makers have separate systems for quoting and for monitoring and responding to COAs, each of which has a different risk model and set of risk controls. It is common for Market-Makers to set risk controls with respect to the COA monitoring and response system to not respond to too many COAs within a short timeframe. If multiple COAs in a strategy occur within a short amount of time, it is common for a Market-Maker's system to determine this to be a potential system issue of the submitting Trading Permit Holder or Exchange. To ensure a Market-Maker does not trade with potentially erroneous orders and protect the Market-Maker from erroneous transactions, the Market-Maker's system that monitors COAs may stop responding to COAs in this situation pursuant to the Market-Maker's risk controls for that system. This ultimately reduces auction liquidity and potential price improvement for COA orders. Allowing Market-Makers to enter orders on the COB when there are multiple auctions occurring in short periods of time permits Market-Makers to post their trading interest up to the total amount of contracts within a single strategy they desire to trade within their risk controls for orders (as an order on the COB may trade against various COA orders), which limits execution risk while permitting them to continue to provide liquidity to price improvement auctions.
Therefore, the proposed rule change will improve Market-Makers' ability to trade against orders auctioned in a short period of time while managing their risk and thus increase execution opportunities for these orders. M and N complex orders provide customers with additional information regarding prices at which there is interest in the strategies. Current rules permit the Exchange to allow M and N orders into the COB; the rule change merely provides the Exchange with flexibility to allow this if certain conditions exist. The time period within which a Market-Maker must cancel its complex order pursuant to the proposed rule change provides the Market-Maker with sufficient time for the opposing customer to potentially re-price its order for execution against the Market-Maker's order or for the Market-Maker order to execute against an order following a COA, while also giving the Market-Maker sufficient time to manually cancel its unexecuted orders while managing all of its trading activity. A time period that is too short may discourage market-makers from entering orders under these circumstances, as they may not have time to cancel the order in time while managing all their trading activity, but a time period that is too long may eliminate the benefits of not permitting market-maker orders to rest in the COB (as discussed above). Additionally, requiring customer orders to be not outside the NSM for Market-Makers to submit orders to the COB prevents situations in which market participants may take advantage of this functionality—for example, a customer may rest an order in the COB that is far outside the NSM (and thus unlikely to execute) for long periods of time, which would then permit Market-Makers to rest orders in the COB for such long periods of time, because if a Market-Maker order on the COB does not trade, the Market-Maker could cancel it pursuant to the proposed rule change and then re-submit the order to the COB.
The Exchange's Regulatory Division will have surveillance in place to enforce the proposed rule change, which surveillance will monitor whether M and N orders have only been entered in the permitted circumstances described above, and whether any such unexecuted orders have been cancelled by the deadline imposed by the proposed rule change.
Cboe Options 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. Current Rule 6.53C(c) permits the Exchange to determine M and N complex orders are not eligible to rest in the COB; the rule change merely provides the Exchange with flexibility to allow this if certain conditions exist. The proposed rule change permits Market-Makers to submit complex orders for entry into the COB, and cancel such orders if they remain unexecuted, in the same circumstances in those classes. If permitted, Market-Makers may enter complex orders for entry into the COB in their discretion; such order entry will not be required. Market-Makers may continue to enter opening only or immediate-or-cancel complex orders in those classes, or submit no complex orders in those classes, as they do today. Market-Makers have differing levels of resources, and some may determine to not expend resources to update systems to automatically recognize that conditions exist to permit them to rest orders in the COB. However, through discussions with Market-Makers, the Exchange understands any such system updates to require minimal expenditure. Additionally, it is possible for Market-Makers to manually observe the existence of conditions that would permit them to rest orders in the COB, and manually cancel them within the required timeframe. The proposed rule change does not require Market-Makers to submit orders to the COB if the conditions in the proposed rule change exist; such order submission would be voluntary and in Market-Makers' discretion. The proposed rule change provides all Market-Makers with the ability to submit orders to the COB in these circumstances.
The Exchange believes the proposed rule change will add liquidity and increase customer execution opportunities at prices potentially better than the leg markets for resting priority customer complex orders and auctioned orders in classes in which the Exchange has determined M and N orders are not otherwise eligible for entry into the COB. The proposed rule change will apply in the same manner to all Market-Makers in the classes in which the Exchange permits the proposed activity. The proposed rule change has no impact on intermarket competition, as it relates solely to orders that the Exchange permits to rest in its COB.
The Exchange neither solicited nor received comments on 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) of the Securities Exchange Act of 1934 (“Act”),
ICE Clear Europe proposes revising its Stress Testing Policy, among other matters, to recategorize certain CDS stress testing scenarios and make certain other enhancements and clarifications. These revisions do not involve any changes to the ICE Clear Europe Clearing Rules or Procedures.
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.
ICE Clear Europe proposes revising its Stress Testing Policy, among other matters, to recategorize certain CDS stress testing scenarios, address specific wrong way risk, introduce new forward looking credit event scenarios and make certain other enhancements and clarifications. These revisions do not involve any changes to the ICE Clear Europe Clearing Rules or Procedures.
ICE Clear Europe currently maintains a broad array of stress testing scenarios that are applied to portfolios of positions as part of its risk management practices for the CDS product category. As part of the existing policy, the Clearing House management regularly evaluates whether to retire certain scenarios or portfolios as outdated or otherwise inapplicable, and whether to add new scenarios or portfolios for testing purposes. ICE Clear Europe is not proposing to change the frequency of stress testing or of its regular reviews of stress testing scenarios, models and underlying parameters and assumptions.
The amendments generally reorganize the existing stress testing scenarios into two broad categories: Extreme but plausible market scenarios and extreme market scenarios. Extreme but plausible scenarios include both historical scenarios (such as those involving the 2008/2009 credit crisis, the Lehman Brothers default and discordant scenarios, where there are discordant moves among major indices) and hypothetical scenarios (such as
The treatment of extreme market scenarios, which generally apply certain of the base “extreme but plausible” scenarios but with higher magnitudes of spread widening or tightening, would be clarified to state in greater detail the approach used for scaling up such factors. In particular, the approach reflects the CDS market structure and the resulting asymmetric effects of spread widening versus tightening. The amendments also remove certain specific scenario tables from the policy as unnecessary given that they are reflected in the revised general description.
The Stress Testing Policy has also been amended to expressly address specific wrong-way risk in the calculation of hypothetical losses as part of stress testing. If a portfolio being stress tested presents specific wrong way risk (
The provisions of the Stress Testing Policy relating to the analysis of CDS guaranty fund adequacy are being revised to clarify that stress testing is conducted for both sold and bought credit protection, in order to test the main risk drivers of clearing member portfolios which would result in full depletion of the Guaranty Fund. With respect to hypothetical spread realizations, maximum levels would similarly be set to result in full depletion of the CDS guaranty fund.
The amendments also incorporate the overall Board risk appetite and limit framework, in a manner similar to other Clearing House policies. The amendments make various other drafting updates and clarifications, including updating references to relevant Clearing House personnel titles, management structures and governance policies. The amendments further address annual validation of models supporting the policy, routine review of the policy by Clearing House personnel, the CDS Risk Committee and Board Risk Committee, and procedures for escalation and notification of breaches of relevant thresholds.
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. The amendments will solely affect the method and factors utilized by ICE Clear Europe for purposes of CDS stress testing. ICE Clear Europe is not changing the Rules or Procedures, or the rights or obligations of Clearing Members. As a result, ICE Clear Europe does not believe the amendments would adversely affect Clearing Members, 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. Although revisions to stress testing could ultimately affect the required level of margin or guaranty fund contributions, any such changes would, in ICE Clear Europe's view, be appropriate in furtherance of the risk management of the Clearing House, consistent with the standards of the Act and regulations thereunder. 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 amendments have not been solicited or received by ICE Clear Europe. ICE Clear Europe will notify the Commission of any comments 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 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
• 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. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2018-001 and should be submitted on or before March 9, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Department of State.
Request for Proposals for the Design, Development, Installation, Operation, and Final Disposition of a U.S. Pavilion at Expo Dubai 2020.
The Expo Unit within the Office of the Under Secretary of State for Public Diplomacy and Public Affairs of the U.S. Department of State requests proposals from private U.S. individuals, firms, associations, educational institutions, and organizations (for profit and non-profit) for the fundraising, project management, design, construction, operation, and disassembly and removal of a USA Pavilion at Expo 2020 Dubai, in the United Arab Emirates (UAE) (
Submit proposals on or before April 17, 2018.
Matthew Asada, Dubai Expo 2020 Project Manager, at
Overall authority for Department of State support for U.S. participation in international expositions is contained in Section 102(a)(3) of the Mutual Educational and Cultural Exchange Act of 1961, as amended (22 U.S.C. 2452(a)(3)), also known as the Fulbright-Hays Act. The purpose of the Act is “to enable the Government of the United States to increase mutual understanding between the people of the United States and the people of other countries . . . to strengthen the ties which unite us with other nations by demonstrating the educational and cultural interests, developments, and achievements of the people of the United States and other nations . . . and thus to assist in the development of friendly, sympathetic and peaceful relations between the United States and the other countries of the world.” Pursuant to this authority, the Secretary of State has authorized the Under Secretary of State for Public Diplomacy and Public Affairs to provide for U.S. participation in international expositions abroad. The Expo Unit, in the Office of the Under Secretary for Public Diplomacy and Public Affairs, will represent the U.S. Government in dealings with the organizers of Expo 2020 Dubai and serve as the primary point of contact with the selected applicant.
Expo 2020 Dubai is a large-scale, universal exposition (also known as a World's Fair) registered by the Bureau of International Expositions (BIE). The BIE is an international treaty organization established to regulate certain international exhibitions. The United States rejoined the BIE on May 10, 2017. Invitations to world's fairs are extended from the host government to other governments.
The Government of the United Arab Emirates (UAE) has invited the United States to participate in Expo 2020 Dubai and, on October 19, 2017, the Secretary of State informed the UAE Government of the U.S. Government's intention to participate with an official USA Pavilion, contingent upon identification of a viable private sector partner and successful fundraising efforts. The Expo officially opens on October 20, 2020, and closes on April 10, 2021.
With a projected 25 million visitors, 70 percent of whom will come from outside of the UAE, Expo 2020 Dubai offers an excellent opportunity to inform and inspire foreign audiences—especially those residing in the Middle East, South Asia, and East Asia—about the United States, its people, values and foreign policies, and to promote U.S. economic and commercial interests. Expo 2020 Dubai is the first World's Fair hosted in the Middle East. U.S.
The theme of Expo 2020 Dubai is
The USA Pavilion at Expo 2020 Dubai will be an official representation of the United States; the Department must therefore ensure that the USA Pavilion is nonpolitical and nonpartisan in nature, of the highest possible quality, and balanced and representative of the diversity of American political, social, and cultural life. The USA Pavilion must maintain the highest level of scholarly integrity and meet the highest standards of artistic achievement and academic excellence. It should also be entertaining and interactive. The USA Pavilion will be used to promote U.S. commercial interests, U.S. foreign policy, as well as highlight outstanding U.S. cultural, scientific, technological, and artistic achievement.
Section 204 of Public Law 106-113 (22 U.S.C. 2452b) limits the support the Department of State may provide for U.S. participation in international expositions registered by the Bureau of International Expositions (BIE). This includes Expo 2020 Dubai. This Request for Proposals is intended to help identify a private U.S. individual, firm, association, or organization interested in, and capable of, providing a complete Pavilion/exhibit at Expo 2020 Dubai as a gift to the United States Government. The Department of State is not authorized to provide funding for the U.S. Pavilion at Expo 2020 Dubai.
Section 5 of Public Law 115-32 (22 U.S.C. 2452b note) prohibits Department of State employees from soliciting funds to pay expenses for a U.S. pavilion or other major exhibit at any exposition registered by the BIE.
Planning, budgeting, and operating a U.S. pavilion at a Bureau of International Expositions-recognized international exposition is a complicated, multi-year project. Cost for a representative USA Pavilion for Expo 2020 Dubai is estimated at 50-60 million USD and will be the sole responsibility of the selected organization.
The successful applicant will be responsible for all costs associated with the USA Pavilion including its fundraising, project management, design, construction, operation, and disassembly and removal of, as well as any claims arising from, the exhibit at the end of the Expo, as well as all support for the U.S. Commissioner General. The successful proposer will consult closely with and follow the guidance of Department officials and the U.S. Commissioner General with respect to Pavilion content, fundraising, and programming. The USA Pavilion shall be considered on loan to the U.S. Government. The aforementioned loan shall be treated as a gift to the U.S. Government. The U.S. Department of State is not authorized to provide federal funding for any aspect of the USA Pavilion at Expo 2020 Dubai.
The successful applicant must be able to demonstrate to the U.S. Department of State that it can raise the funds necessary to complete the project. Only after the applicant is able to secure sufficient seed funding, to be determined based on the successful applicant's proposed budget, and demonstrate viable future revenue streams will the U.S. Department of State sign a Memorandum of Agreement (MOA) with that applicant. The Department would subsequently sign a Participation Contract with the UAE's Bureau Expo Dubai 2020 (Expo Organizer).
For information regarding the guidelines for developing the exhibits, themes, and the design and construction of a pavilion, please refer to documents produced by the Expo 2020 Dubai Organizer, including the
The purpose of this request for proposal is to find a private sector partner who will serve as the U.S. Government's fundraiser and project manager for U.S. participation in Expo 2020. This entails three main tasks: (1) Raise all the funds needed to cover the costs of the USA Pavilion at Expo 2020 Dubai; (2) manage the USA Pavilion project; and (3) conduct all operations associated with the USA Pavilion.
As described above, the Department of State is prohibited from using its appropriated funds for the USA Pavilion at Expo 2020 Dubai and the Department's employees are prohibited from soliciting funds to pay for expenses of the USA Pavilion. Therefore, all funds for the establishment and operation of the USA Pavilion must come from other sources. It will be the responsibility of the selected entity to identify prospective sponsors, solicit the funds, and conclude sponsorship agreements. The Department must approve the selected entity's fundraising plan, process, and marketing materials.
Non-profit organizations must have nonprofit status with the IRS, or have applied for such status, at the time of application.
Once the nonprofit status of the selected proposer is confirmed, and if the proposer satisfies the U.S. citizenship requirements, the Department will issue a “Letter of Intent” to the selected organization authorizing it to proceed with fundraising to fund the USA Pavilion project. The letter will include guidelines on fundraising to be followed by the selected organization. Note that all prospective donors must be vetted by the Department of State pursuant to the Foreign Affairs Manual (2 FAM 962.1 Authority to Solicit and Accept Gift Funds
It is estimated that a representative USA pavilion will cost between 50 and 60 million USD, depending on final design, construction, and programming. The costs, described in greater detail below, include, but are not limited to:
• Design and construction of a building to house the exhibition and provide an appealing welcome on the exterior facade; provide exterior
• Design of the exhibition and development of the story line;
• Raising all necessary funds;
• Production of exhibits, audio-visual materials, films, DVDs, videos, posters and other promotional materials needed for the exhibit;
• Development and implementation of a media engagement and communications plan to promote and advertise the USA Pavilion to U.S. and foreign audiences, before and during Expo 2020;
• All administrative, personnel and exhibit costs, including salaries, benefits, staff housing expenses, contracting and supplier costs and consulting fees as well as funding associated with guides, escorts, and protocol gifts;
• Transport, travel, insurance, postage and shipping fees of all pavilion materials;
• Security, development and implementation of a security program for the USA Pavilion in consultation with the State Department and appropriate UAE authorities;
• Tear-down, including removal of exhibits, and return of the pavilion lot in the condition required by the Expo organizers; final disposition plan must be approved by the Expo Unit;
• Cultural and informational programs associated with the exhibition, including, but not limited to, production of U.S. National Day activities (each participating country has a national day celebration at some point during the six-month fair);
• Funding all expenses associated with the U.S. Commissioner General; and,
• Creation and staffing of facilities devoted to hosting VIPs visiting the USA Pavilion.
The selected organization would be responsible for all aspects of providing for U.S. participation in Expo 2020 Dubai. This includes, but is not limited to, (a) design, (b) construction and removal, (c) staffing, (d) programming, and (e) supporting the U.S. Commissioner General:
The pavilion will be the physical representation of the United States, and therefore should be worthy of representing our country and its people. The architecture and interior design of the USA Pavilion must reflect the theme of Expo 2020 Dubai,
The two main components to the design of the USA Pavilion are (i) architecture and (ii) interior design:
National pavilions are closely associated with their architecture. The design of the USA Pavilion should be spectacular, and worthy of carrying the name of the United States. The applicant should describe how they plan to create a design that is inspiring, while remaining cost-efficient. The successful applicant will be encouraged to hold a national design competition.
The concept for the pavilion structure should include an exhibition area, a live performance area, a VIP hospitality area, and administration/staff area. Food, beverage, and retail offerings can be considered, but are not required. The exhibition area is where the Expo's theme and sub-themes communicate American creativity, innovation and ingenuity to the visitors. Successful exhibits are those that communicate a message, are informative, but are also interactive and fun. The selected organization must also ensure that the exhibits are nonpolitical in nature and are of the highest possible quality. The VIP hospitality area should provide a reception space to support symposia, meetings, receptions, and delegations that advance economic and public diplomacy goals of the United States.
In designing the USA Pavilion, the selected entity is encouraged to translate the theme into an authentic portfolio of stories and perspectives that highlight the interconnections between the subthemes in a way that engages visitors of all ages. The selected entity will consult with the Department of State's Expo Unit for approval on all final designs, exhibit content, programmatic activities, and communications products.
In responding to this Request for Proposal, applicants should include a two-page Theme Statement that explains design, components and content of the USA Pavilion (per Annex) by the initial application due date. The submission should define the overall theme and the exhibits that will make up the pavilion, providing a general overview of the proposed strategy, thematic content, installations, events, and architectural expression of the pavilion. The selected organization will be required to develop a more detailed and final Theme Statement for approval by the Expo Unit followed by full design proposals for the USA Pavilion—Concept and Final—no later than June 30, 2019.
After the approval of the designs, and with necessary funding in hand, the selected entity will be responsible for constructing the USA Pavilion in Dubai in accordance with the specifications listed in the Organizer's
The selected entity is also responsible for the dismantling and removal of the USA Pavilion after conclusion of the Expo in April 2021.
The overall budget, including construction, must be reviewed by the Expo Unit before work can start, and the entity must consult with the Expo Unit before undertaking any changes in budget line items greater than $50,000. The implementing partner will be encouraged to establish an escrow account or obtain insurance to ensure that removal of the pavilion is completed.
Unlike other national pavilions that hire local workers to staff their pavilions, the U.S. pavilions have historically used American college students or recent graduates to staff the USA Pavilion as guides under a program called “Student Ambassadors.” For Dubai, applicants may also consider supplementing the Student Ambassador program with an additional cohort of alumni from U.S. Department of State exchange programs. Proposals must include a plan for funding, recruiting and managing student “ambassadors” and Department of State exchange alumni at the USA Pavilion. All Student Ambassadors, but not the exchange program alumni, must be U.S. citizens, from a diverse set of backgrounds and U.S. states, and ideally with two or more years of college-level Arabic language or area studies course work, or equivalent ability gained through family or residence in the Arab world. The selected organization is encouraged to
The selected organization will be responsible for all programming within the USA Pavilion. Proposals may include content and programming partnerships with a variety of community, educational, cultural, philanthropic, businesses, and non-profit organizations. Proposals are encouraged to identify potential linkages to existing State Department educational and cultural programs that could run concurrently with the USA Pavilion.
The selected organization will be responsible for supporting the U.S. Commissioner General, who will be appointed by the United States Government and serve as the official U.S. representative to Expo 2020. Details of this support will be specified in the Memorandum of Agreement (MOA).
The successful proposer will be responsible for full operation of the USA Pavilion. This will include, but not be limited to, such areas as protocol, public affairs, sponsorship fulfillment, cultural programming, student guide services, communications, operations, security, cleaning, and maintenance. Office space must be adequate for the proposed number of staff.
Applications may be submitted by U.S.-based individuals, firms, associations, and public and private organizations, or groups of such entities formed for this project. Non-profit organizations must meet the provisions described in Internal Revenue Code section 26 U.S.C. 501(c)(3). Non-profit organizations must have nonprofit status with the IRS, or have applied for such status, at the time of application.
Proposals should be no longer than thirty-five (35) pages (single-spaced, single-sided) and outline, in as much detail as possible, plans for providing a pavilion and exhibition for the U.S. Government at Expo 2020 Dubai.
1. Pavilion Theme Statement (2 pages max) explains design, components and content of the USA Pavilion in accordance with the Mobility sub-theme and the Expo 2020 Dubai Theme Guide.
2. Fundraising plan (3 pages)—How and when does the organization plan to reach the fundraising goals to cover the project? How does the organization plan to make use of sponsorship agreements to fund specific exhibits or the overall pavilion?
3. Project Management Plan (3 pages) that explains how the organization plans to accomplish all the tasks listed in the Project Management section. This plan should include specifics, including whether the organization plans to compete the different elements to sub-contractors, or if they plan to fulfill them in-house, and the process for each. This action plan should include the following sections:
a. Design of the USA Pavilion architecture and interior;
b. Construction procurement process; and
c. Disassembly and legacy (future use of the pavilion structure or exhibits).
4. Pavilion Designs (10 pages) A maximum of 5 conceptual designs of the proposed pavilion architecture and a maximum of 5 conceptual designs of the proposed interior fit-out.
5. Proposed Staffing Plan (3 pages) for management and staff before and during the expo, including envisioned Student Ambassador and Exchange Alumni programs. Provide biographic summaries of no more than one paragraph each of the architect, curator, designer, project manager, fundraiser, chief financial officer, and all other key personnel involved in the project.
6. Multi-year Operating Budget (4 pages) (narrative and chart in USD). A budget narrative should include an explanation of how the estimates were created (including but not limited to cost price analysis or past experience) for the major cost centers of the project. The operating budget should explain how early-stage operations of the project will be sustained prior to attaining major gifts and projected cash flow.
7. Track record (2 pages) of the organization's past fundraising and project management successes, a description of its resources, capabilities, key staff and their qualifications.
8. Timeline (3 pages) of the entire project.
9. Work Samples (5 pages) Submit up to 10 images of past architectural and design work.
• Adhere to the regulations and rules of Expo 2020 as stipulated by the Expo organizers (see participant guides), including restrictions and limitations related to construction;
• Consult closely with and follow the guidance of the U.S. Commissioner General, Expo Unit, and their designated representatives at the U.S. mission to the UAE;
• Operate in a transparent and financially responsible manner. This includes allowing the Commissioner General and Expo Unit insight into the budget and reporting on finances on a regular basis, with oversight of the Expo Unit, and seeking prior consultation before any expenditure or changes in budget line items greater than $50,000.
• Submit all contracts or sub-contracts contemplated to be awarded by the proposer to further the purposes of the USA pavilion that are in excess of $50,000 for review by the Expo Unit prior to their conclusion.
• Proposals should state clearly that all materials developed specifically for the project will be subject to prior review and approval by the Department.
• Proposals should state clearly that all fundraising plans, processes, and marketing materials will be subject to prior review and approval by the Department, including the need to have all potential donors vetted and approved by the Department.
Responses must be submitted electronically and in hard copy.
An electronic version of the proposal submission must be sent to
Proposal submissions must also be sent via a nationally recognized overnight delivery service (
Ten copies of the application should be sent to: U.S. Department of State, Ref.: Expo 2020 Dubai RFP, 2201 C Street NW, R/FO, Room 5932, Washington, DC 20520.
The Expo Unit will review all proposals for technical eligibility. Proposals will be deemed ineligible if they are not submitted by a U.S. citizen, U.S.-corporation, or U.S.-based organization and do not fully adhere to the General Regulations of the Expo 2020 Dubai and the guidelines stated herein.
Eligible proposals will be subject to compliance with Federal and Department regulations and guidelines. A panel of U.S. Government employees will review eligible proposals. Proposals may also be reviewed by the Office of the Legal Adviser or by other elements in the State Department and the U.S. Department of Commerce. The decision about which proposal demonstrates the greatest likelihood of achieving the goals of the project will be at the sole discretion of the Under Secretary of State for Public Diplomacy and Public Affairs.
Technically-eligible proposals will be reviewed and scored out of 100 points, according to the criteria stated below:
a. Architectural and Design Merit, including how the pavilion will educate and inform foreign audiences about the United States and its people and promote broad U.S. commercial interests, as well as how specifically it will address the theme and sub-themes of Expo 2020 Dubai.
a. Fundraising, including proposed plan, timeline, resources on hand, as well as potential to find and engage potential sponsors, manage sponsor relationships, and fulfill sponsorship agreements. The successful proposer must demonstrate to the Department that it can raise the funds necessary to complete the USA Pavilion project and has past fundraising success in completing time-bound, multi-year, multi-million dollar campaigns.
a. Design, Build, Remove, including plans to project manage the pavilion.
b. Operational Plan, including program management and operational staffing before and during the Expo 2020.
c. Expenditure, including summary and line-item budget.
a. Proposed Domestic and International Outreach in advance of and during the Expo to raise awareness of U.S. participation in Dubai Expo 2020 and amplify exhibit messages and partners.
b. Proposed Cultural Programming Events and programs that represent the diversity of America including potential linkages to existing State Department educational and cultural programs that could run parallel to or in conjunction with the USA Pavilion.
c. Virtual Presence and Engagement of the USA Pavilion before and during the Expo.
a. Program Management for design and build, and design and operation of temporary cultural and commercial exhibitions.
b. Architectural and Design Excellence, including quality and significance of the architects, curators, organizations, designs or services that the project will involve; record of professional activity and achievement by individuals/organizations involved; ability to monitor and measure the effectiveness and impact of the exhibition.
a. Strategic Partners and Legacy Use, including how the USA Pavilion fits in to the strategic plans of partners for their regional engagement and expansion and reflective of past regional experience.
b. Monitoring and Project Evaluation Plan, a plan to measure the impact of the proposed U.S. exhibition, and cultural and information programs.
Selection Notices: All applicants will receive a decision notification from the Expo Unit.
Project Launch and Construction & Participation Phases: There are two phases to the project. The first phase (Project Launch) will begin by the Department issuing a Letter of Intent to the selected proposer authorizing that entity to proceed with fundraising to complete the project. The letter will include guidelines on fundraising and will establish a deadline for completion of fundraising activities. The second phase (Construction & Participation) can begin once the successful proposer is able to demonstrate that all funding required for the project is available. A Memorandum of Agreement (MOA) between the successful proposer and the Department will be concluded and the Department will conclude a Participation Contract with the Expo organizing body.
The successful proposer must provide the Expo Unit with an electronic and hard copy original plus two copies of the following reports:
1. Program and financial reports every 45 (forty-five) calendar days after the signature of the Memorandum of Agreement.
2. Final program and financial reports no more than 90 (ninety) calendar days after the scheduled April 10, 2021, closing of Expo 2020 Dubai.
For questions about this announcement, contact
Please read the complete announcement before sending inquiries or submitting proposals. Once the RFP deadline for submission of proposals has passed, Expo Unit staff may not discuss this competition with applicants until the proposal review process has been completed.
The terms and conditions published in this Request for Proposals are binding and may only be modified in writing. Issuance of this RFP does not constitute an intention to agree to work with any private sector exhibitor at Expo 2020 Dubai. The Under Secretary for Public
Under part 211 of Title 49 Code of Federal Regulations (CFR), this provides the public notice that on January 29, 2018, the North County Transit District (NCTD) petitioned the Federal Railroad Administration (FRA) for an extension of its existing waiver of compliance from certain provisions of the Federal railroad safety regulations contained. FRA assigned the petition docket number FRA-2002-11809.
In its petition, NCTD seeks to extend the relief granted in its existing shared use waiver, which was originally granted by FRA's Railroad Safety Board (Board) on May 1, 2003; modified in 2006; and extended and modified in 2013. This shared use waiver applies to operation of the SPRINTER rail fixed guideway transit system between Oceanside, California, and Escondido, CA over the BNSF Railway's (BNSF) Escondido Subdivision. SPRINTER operates for 22 miles with temporal separation from the Pacific Sun Railroad which is contracted by BNSF. The exclusive passenger period is from 3:45 a.m. until 9:45 p.m. Sunday through Thursday, and 3:45 a.m. until 12:00 a.m. (midnight) Friday through Saturday.
NCTD continues to seek relief from 49 CFR part 210,
In its petition, NCTD states there have been no deficiencies with its operation since the last approval in 2013 and that NCTD, Pacific Sun Railroad, and the California Public Utilities Commission (CPUC) have continually interfaced with FRA Regional staff to monitor safety.
CPUC is the State Safety Oversight Agency (SSOA) providing equivalent safety oversight in accordance with the terms and conditions set forth in FTA regulations at T49 CFR part 659,
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by April 2, 2018 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Under part 235 of Title 49 of the Code of Federal Regulations (CFR) and 49 U.S.C. 20502(a), this provides the public notice that on January 21, 2018, Norfolk Southern Corporation (NS) petitioned the Federal Railroad Administration (FRA) seeking approval to discontinue or modify a signal system. FRA assigned the petition Docket Number FRA-2018-0015.
NS seeks to discontinue the existing signal location at milepost (MP) SC-127.5 on the Charleston District, Piedmont Division, at the west end of Andrews Yard, Columbia, SC. The existing positive signal, MP SC127.5, will be retired from service. A new crossover will be installed from the SC mainline to the yard track lead to allow trains to enter and exit the yard from multiple tracks. The existing westbound automatic signal located at MP SC-128.1 will become a positive signal and govern movements out of the yard per NS rules. The existing eastbound automatic signal at MP SC 128.0 will be removed from service.
NS states the reason for the proposed change is to increase efficiency of yard operations at the expanded west end of the yard and expedite train movements in and out of the yard.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by April 2, 2018 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal
In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and respondents are not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning the renewal of its information collection titled, “Investment Securities.” The OCC also is giving notice that it has sent the collection to OMB for review.
You should submit written comments by March 19, 2018.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0205, 400 7th Street SW, Suite 3E-218, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Additionally, please send a copy of your comments by mail to: OCC Desk Officer, 1557-0205, U.S. Office of Management and Budget, 725 17th Street NW, #10235, Washington, DC 20503 or by email to
Shaquita Merritt, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf or hearing impaired, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the OMB for each collection of information that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. The OCC requests that OMB extend its approval of this collection.
Under 12 CFR 1.7(b), a national bank may request OCC approval to extend the five-year holding period for securities held in satisfaction of debts previously contracted for up to an additional five years. In its request, the bank must provide a clearly convincing demonstration of why any additional holding period is needed. The OCC uses the information in the request to ensure, on a case-by-case basis, that the bank's purpose in retaining the securities is not speculative and that the bank's reasons for requesting the extension are adequate. The OCC also uses the information to evaluate the risks to the bank of extending the holding period, including potential effects on the bank's safety and soundness.
The comment related to 12 CFR 1.7(b). Twelve CFR 1.7(b) provides that a bank may hold securities in satisfaction of debts previously contracted for a period of five years and permits the OCC to extend the holding period up to an additional five years if the bank provides a clearly convincing demonstration as to why an additional holding period is needed.
The commenter stated that banks should rarely need to hold securities in satisfaction of debts previously contracted longer than five years. The commenter requested that the OCC conduct a retrospective analysis on the need, fairness, and appropriateness of the text in 12 CFR 1.7(b) that permits the OCC to extend the holding period beyond five years. The commenter stated that this retrospective analysis would enable the OCC to narrow the requirements for an extended holding period and to specify in 12 CFR 1.7(b) the rare and unusual reasons why banks may need more than five years to dispose of a security. The commenter further stated that 12 CFR 1.7(b) currently encourages banks to speculate on securities acquired in satisfaction of debts previously contracted.
In response to this comment, the OCC notes that the OCC cannot rescind regulations through the PRA renewal process. Moreover, as part of the OCC's ten-year regulatory review required under by section 222 of the Economic Growth and Regulatory Paperwork Reduction Act (“EGRPRA”), the OCC issued notices soliciting comments on all OCC regulations, including 12 CFR part 1.
Comments continue to be invited on:
(a) Whether the collection of information is necessary for the proper
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the annual meeting of the Department of Veterans Affairs Voluntary Service (VAVS) National Advisory Committee (NAC) will be held April 11-13, 2018, at the Tampa Hilton Downtown, 211 North Tampa Street, Tampa Florida. The meeting sessions are open to the public and are scheduled as follows:
The Committee, comprised of 51 national voluntary organizations, advises the Secretary, through the Office of the Under Secretary for Health, on the coordination and promotion of volunteer activities and strategic partnerships within VA facilities, in the community, and on matters related to volunteerism and charitable giving. The purposes of this meeting are: to provide for Committee review of volunteer policies and procedures; to accommodate full and open communications between organization representatives and the Voluntary Service Office and field staff; to provide educational opportunities geared towards improving volunteer programs with special emphasis on methods to recruit, retain, place, motivate, and recognize volunteers; and to provide Committee recommendations. The April 11, session will include a National Executive Committee Meeting, Health and Information Fair, and VAVS Representative and Deputy Representative training session. The April 12, business session will include welcoming remarks from local officials, and remarks by VA officials on new and ongoing VA initiatives and priorities. The recipients of the American Spirit Recruitment Awards, VAVS Award for Excellence, and the NAC male and female Volunteer of the Year awards will be recognized. Educational workshops will be held in the afternoon and will focus on building the Episodic Volunteer Workshop, S.A.V.E Training—Suicide Prevention, Voluntary Service System, new timekeeping system to track and manage volunteer hours, and a writing workshop. On April 13, the morning business session will include subcommittee reports, the Voluntary Service Report, NAC Chair Report, and remarks by VA officials on new and ongoing VA initiatives and priorities. The educational workshops will be repeated in the afternoon. No time will be allocated at this meeting for receiving oral presentations from the public. However, the public may submit written statements for the Committee's review to Ms. Sabrina C. Clark, Designated Federal Officer, Voluntary Service Office (10B2A), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC, 20420, or by email at
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |