| Page Range | 45955-46121 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 46045 - Office of General Counsel; Agency Information Collection Extension | |
| 82 FR 46043 - Sunshine Act Meeting Notice | |
| 82 FR 46087 - Extension of Agency Information Collection Activity Under OMB Review: Critical Facility Information of the Top 100 Most Critical Pipelines | |
| 82 FR 46091 - Proposed Extension of Information Collection; Training Plan Regulations and Certificate of Training [OMB Control No. 1219-0009] | |
| 82 FR 46063 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 82 FR 46052 - Notice of Receipt of Requests To Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations To Terminate Certain Uses-30-Day Comment Period | |
| 82 FR 46050 - Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations to Terminate Certain Uses-180-Day Comment Period | |
| 82 FR 46049 - Pesticide Product Registration; Receipt of Applications for New Uses | |
| 82 FR 46057 - Sunshine Act Meetings; Deletion of Items From Sunshine Act Meeting | |
| 82 FR 46056 - Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council | |
| 82 FR 46011 - Petition for Reconsideration of Action in Rulemaking Proceeding | |
| 82 FR 46056 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 82 FR 45990 - Significant New Use Rule on Certain Chemical Substances | |
| 82 FR 46042 - Agency Information Collection Activities: Comment Request | |
| 82 FR 46119 - Data Collection Available for Public Comments | |
| 82 FR 46002 - Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Georges Bank Cod Possession and Trip Limit Adjustment for the Common Pool Fishery | |
| 82 FR 45962 - Negotiated Noncompetitive Agreements for the Use of Sand, Gravel, and/or Shell Resources on the Outer Continental Shelf | |
| 82 FR 45984 - Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet; Brooklyn, NY | |
| 82 FR 46004 - Special Anchorage Areas; Passagassawakeag River, Belfast Bay, Belfast, Maine | |
| 82 FR 46007 - Security Zones; Port Canaveral Harbor, Cape Canaveral Air Force Station, FL | |
| 82 FR 46078 - M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use; International Council for Harmonisation; Guidance for Industry; Availability | |
| 82 FR 46114 - American Century ETF Trust and American Century Investment Management, Inc. | |
| 82 FR 46089 - Meeting of the NDCAC Executive Advisory Board | |
| 82 FR 46041 - Advisory Committee to the U.S. Section of the International Commission for the Conservation of Atlantic Tunas; Fall Meeting | |
| 82 FR 46083 - Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment; Request for Comments | |
| 82 FR 46090 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Evaluation of the Youth CareerConnect (YCC) Grant Program, New Collection | |
| 82 FR 46036 - Foreign-Trade Zone 214-Lenoir County, North Carolina; Application for Expansion of Subzone 214A; Consolidated Diesel Company; Enfield, North Carolina | |
| 82 FR 46036 - Foreign-Trade Zone (FTZ) 57-Charlotte, North Carolina, Authorization of Limited Production Activity; DNP Imagingcomm America Corporation (Coatings and Lamination on Semi-Completed Coated Paper), Concord, North Carolina | |
| 82 FR 46039 - Proposed Information Collection; Comment Request; Cooperative Game Fish Tagging Report | |
| 82 FR 46041 - Proposed Information Collection; Comment Request; Pacific Islands Region Vessel and Gear Identification Requirements | |
| 82 FR 46074 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting | |
| 82 FR 46036 - Certain Stainless Steel Sheet and Strip in Coils From Japan, the Republic of Korea, and Taiwan; Continuation of Antidumping Duty Orders and Countervailing Duty Order | |
| 82 FR 46000 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries | |
| 82 FR 46044 - Combined Notice of Filings | |
| 82 FR 46045 - Combined Notice of Filings | |
| 82 FR 46102 - Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Service Provider Licenses | |
| 82 FR 46075 - Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability | |
| 82 FR 46118 - Administrative Declaration of a Disaster for the State of California | |
| 82 FR 46119 - Interest Rates | |
| 82 FR 46118 - Data Collection Available for Public Comments | |
| 82 FR 46120 - Notice of Rights and Protections Available Under the Federal Antidiscrimination and Whistleblower Protection Laws | |
| 82 FR 45988 - Safety Zone, Blue Angels Air Show; St. Johns River, Jacksonville, FL | |
| 82 FR 46011 - Migratory Bird Hunting; Supplemental Proposals for Migratory Game Bird Hunting Regulations for the 2018-19 Hunting Season; Notice of Meetings | |
| 82 FR 46042 - Cash Payment Method Will No Longer Be Accepted | |
| 82 FR 46115 - Proposed Collection; Comment Request | |
| 82 FR 46071 - Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability | |
| 82 FR 46061 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 82 FR 46060 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 82 FR 46072 - Abbreviated New Drug Applications Submissions-Refuse-To-Receive Standards: Questions and Answers; Draft Guidance for Industry; Availability | |
| 82 FR 46065 - Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access; Public Workshop; Request for Comments | |
| 82 FR 45955 - Importation of Fresh Persimmons From New Zealand Into the United States | |
| 82 FR 46034 - Agenda and Notice of Public Meeting of the Delaware Advisory Committee | |
| 82 FR 46035 - Agenda and Notice of Public Meeting of the Delaware Advisory Committee | |
| 82 FR 45981 - Safety Zone; Patapsco River, Northwest and Inner Harbors; Baltimore, MD | |
| 82 FR 46064 - Agency Information Collection Activities; Public Comment Request; Proposed Extension With Changes of a Currently Approved Collection; Evidence-Based Falls Prevention Program | |
| 82 FR 46040 - Pacific Fishery Management Council; Public Meeting | |
| 82 FR 46079 - Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications | |
| 82 FR 46068 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
| 82 FR 46066 - Abbreviated New Drug Applications Submissions-Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability | |
| 82 FR 46070 - Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | |
| 82 FR 46069 - Request for Nominations for Voting Members on a Public Advisory Committee; the Tobacco Products Scientific Advisory Committee | |
| 82 FR 46058 - Notice to All Interested Parties of the Termination of the Receivership of 10286-Horizon Bank; Bradenton, Florida | |
| 82 FR 46076 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
| 82 FR 46081 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
| 82 FR 45980 - Drawbridge Operation Regulation; Willamette River, Portland, OR | |
| 82 FR 46035 - Submission for OMB Review; Comment Request | |
| 82 FR 46058 - FDIC Advisory Committee on Economic Inclusion (ComE-IN); Notice of Meeting | |
| 82 FR 45979 - Special Local Regulation; Cumberland River, Nashville, TN | |
| 82 FR 45977 - Special Local Regulation; Tennessee River, Chattanooga, TN | |
| 82 FR 46034 - Submission for OMB Review; Comment Request | |
| 82 FR 46111 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Order Granting Approval of a Proposed Rule Change To Adopt Rules Relating to Trading in Index Options | |
| 82 FR 46111 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Withdrawal of a Proposed Rule Change To Extend the Implementation Date for Certain Changes to the NYSE Arca Rule 5 and Rule 8 Series | |
| 82 FR 46106 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Shares of the GraniteShares Palladium Trust Under NYSE Arca Rule 8.201-E | |
| 82 FR 46103 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Withdrawal of a Proposed Rule Change To Extend the Implementation Date For Certain Changes to Exchange Rules 14.11 and 14.12 | |
| 82 FR 46039 - Open Meeting of the Information Security and Privacy Advisory Board | |
| 82 FR 46088 - Certain Wi-Fi Enabled Electronic Devices and Components Thereof; Institution of Investigation | |
| 82 FR 46103 - PREDEX and PREDEX Capital Management, LLC | |
| 82 FR 46120 - Advisory Board-Notice of Public Meetings | |
| 82 FR 46010 - Overweight Parcels | |
| 82 FR 46043 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual Progress Reporting Form for the American Indian Vocational Rehabilitation Services (AIVRS) Program | |
| 82 FR 46084 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings | |
| 82 FR 46085 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 82 FR 46087 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
| 82 FR 46085 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
| 82 FR 46085 - Center for Scientific Review; Notice of Closed Meetings | |
| 82 FR 46092 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 | |
| 82 FR 46116 - Wells Fargo Exchange-Traded Funds Trust, et al. | |
| 82 FR 46087 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings | |
| 82 FR 46093 - Astronomy and Astrophysics Advisory Committee; Notice of Meeting | |
| 82 FR 46058 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 82 FR 45995 - Air Plan Approval; South Carolina; Interstate Transport (Prongs 1 and 2) for the 2010 1-Hour NO2 | |
| 82 FR 46010 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Baltimore, Maryland Nonattainment Area | |
| 82 FR 45997 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Baltimore, Maryland Nonattainment Area | |
| 82 FR 45986 - Safety Zone; Roanoke River, Plymouth, NC | |
| 82 FR 45981 - Drawbridge Operation Regulation; Sacramento River, Sacramento, CA | |
| 82 FR 46089 - Hearings of the Judicial Conference Advisory Committee on the Federal Rules of Criminal Procedure | |
| 82 FR 45959 - Updated Statements of Legal Authority for the Export Administration Regulations | |
| 82 FR 45958 - Establishment of Class E Airspace; Hattiesburg, MS | |
| 82 FR 45957 - Establishment of Class E Airspace; Picayune, MS | |
| 82 FR 46016 - Fisheries of the Exclusive Economic Zone Off Alaska; Authorize Recreational Quota Entity To Participate in the Halibut IFQ Program | |
| 82 FR 46094 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information and Safeguards Information |
Animal and Plant Health Inspection Service
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Federal Energy Regulatory Commission
Western Area Power Administration
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Community Living Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Transportation Security Administration
Fish and Wildlife Service
Ocean Energy Management Bureau
Mine Safety and Health Administration
Federal Aviation Administration
Saint Lawrence Seaway Development Corporation
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.
Animal and Plant Health Inspection Service, USDA.
Final rule.
We are amending the regulations concerning the importation of fruits and vegetables to allow the importation of fresh persimmons from New Zealand into the United States. As a condition of entry, the persimmons must be produced in accordance with a systems approach that includes requirements for orchard certification, orchard pest control, post-harvest safeguards, fruit culling, traceback, sampling, and treatment with either hot water or modified atmosphere treatment. The persimmons will also have to be accompanied by a phytosanitary certificate with an additional declaration stating that they were produced under, and meet all the components of, the systems approach and were inspected and found to be free of quarantine pests in accordance with the requirements. This action allows the importation of fresh persimmons from New Zealand while continuing to protect against the introduction of plant pests into the United States.
Effective November 2, 2017.
Mr. David B. Lamb, Senior Regulatory Policy Specialist, IRM, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737-1231; (301) 851-2103.
The regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-79, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States.
On August 26, 2016, we published in the
We solicited comments concerning our proposal for 60 days ending October 25, 2016. We received two comments by that date, from a private citizen and the national plant protection organization (NPPO) of New Zealand. One commenter generally objected to the importation of all fruits and vegetables into the United States, but did not otherwise address any issues germane to the proposal. The other comment is discussed in greater detail below.
In paragraph (d)(3) of the proposal, we proposed to require that diseased or insect-infested fruit and fruit with surface pests be culled either before or during packing and removed from the packinghouse. We also proposed to require that the culling include any damaged or deformed fruit. The NPPO of New Zealand stated that the removal of deformed fruit is a grading concern rather than a phytosanitary issue.
We disagree. As explained in the proposed rule, deformed fruit is more susceptible to infestation, as is damaged fruit.
In paragraph (d)(4), we proposed to require that shipping containers be marked to identify the place of production and packinghouse from which the consignment of fruit originated. The NPPO of New Zealand asked for clarification of the term “final shipping container,” which we used in the preamble of the proposed rule. The NPPO stated that each individual packed unit of New Zealand persimmons will be marked to identify the place of production and packinghouse from which the packed unit of fruit originated.
Our use of the term “final shipping container” was intended to refer to the individually packed units of the consignment and not the container in which the individually packed units are shipped. We have amended the text of paragraph (d)(4) to clarify that.
In paragraph (e), we proposed to require that inspectors from the NPPO of New Zealand visually inspect a sample of fruit from each consignment at a rate jointly agreed upon by the Animal and Plant Health Inspection Service (APHIS) and the NPPO of New Zealand, and cut fruit to inspect for quarantine pests that are internal feeders. The NPPO of New Zealand stated that, because there are no quarantine pests that are internal feeders on persimmons in New Zealand, cutting of fruit is not necessary.
As described in the pest risk assessment, there are seven Lepidoptera pests of quarantine significance present in New Zealand that could be introduced into the United States through the importation of fresh persimmons. The larvae of some or all of these pests, which are classified as leafroller moths, may bore into the fruit and feed internally. Evidence of infestation, including entrance holes and frass, would easily be detected during visual inspection except for the extensive calyx on persimmon fruit. Therefore, we proposed to require fruit cutting as an addition to visual inspection. We agree that fruit cutting is not necessary as long as the area of the fruit under the calyx is thoroughly examined for the presence of internally
In paragraph (c)(2), we proposed to require that the NPPO of New Zealand or its approved designee visit and inspect the places of production monthly beginning at blossom drop and continuing until the end of the shipping season for quarantine pests. In paragraph (f), we also proposed that the persimmons be treated with hot water treatment or with modified atmosphere treatment by being packed in semi-permeable polymeric bags and stored at 0 °C for a minimum of 28 days. The NPPO of New Zealand stated that, because the persimmons will undergo a 28-day cold treatment prior to export, by the time persimmons are shipped, there will not be any persimmons in the place of production to inspect.
We agree with the commenter and are amending paragraph (c)(2) to state that inspection of places of production will continue until the end of the harvest season rather than the end of the shipping season.
Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.
This final rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. Further, because this rule is not significant, it is not a regulatory action under Executive Order 13771.
In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available on the
APHIS is amending the regulations in 7 CFR 319.56, to allow the importation of fresh persimmon fruit (
The wholesale value of the persimmon fruit for which New Zealand has requested import access will be about $90,000 initially. The value of future imports is forecast to reach about $330,000, or about 2 percent of the U.S. persimmon market.
The Small Business Administration's (SBA) small-entity standard for entities involved in fruit farming is $750,000 or less in annual receipts (NAICS 111339). It is probable that most or all U.S. persimmon producers are small businesses by the SBA standard. We expect any impact of the rule for these entities will be minimal, given New Zealand's expected small share of the U.S. persimmon market.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.
This final rule allows fresh persimmons to be imported into the United States from New Zealand. State and local laws and regulations regarding fresh persimmons imported under this rule will be preempted while the fruit is in foreign commerce. Fresh fruits are generally imported for immediate distribution and sale to the consuming public, and remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. No retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this final rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.
Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Rice, Vegetables.
Accordingly, we are amending 7 CFR Part 319 as follows:
7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Fresh persimmons (
(a)
(b)
(c)(1)
(2) The NPPO of New Zealand or its approved designee must visit and inspect the places of production monthly beginning at blossom drop and continuing until the end of the harvest season for quarantine pests. Appropriate pest controls must be applied in accordance with the operational workplan. If the NPPO of New Zealand finds that a place of production is not complying with the requirements of this section, no fruit from the place of production will be eligible for export to the United States until APHIS and the NPPO of New Zealand conduct an investigation and appropriate remedial actions have been implemented.
(d)(1)
(2) During the time the packinghouse is in use for exporting persimmons to the United States, the packinghouse may only accept persimmons from registered approved places of production and the fruit must be segregated from fruit intended for other markets.
(3) All diseased or insect-infested fruit and fruit with surface pests must be culled either before or during packing and removed from the packinghouse. Culling must also include any damaged or deformed fruit.
(4) Boxes or other containers in which the fruit is shipped must be marked to identify the place of production where the fruit originated and the packinghouse where it was packed.
(5) The NPPO of New Zealand must monitor packinghouse operations to verify that the packinghouses are complying with the requirements of the systems approach. If the NPPO of New Zealand finds that a packinghouse is not complying with the requirements of this section, no fruit from the packinghouse will be eligible for export to the United States until APHIS and the NPPO of New Zealand conduct an investigation and appropriate remedial actions have been implemented.
(e)
(f)
(1)
(2)
(g)
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace extending upward from 700 feet above the surface at Picayune, MS, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures (SIAPs) serving Highland Community Hospital Heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the heliport.
Effective 0901 UTC, December 7, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace extending upward from 700 feet above the surface at Highland Community Hospital Heliport, Picayune, MS, to support IFR operations under standard instrument approach procedures at the heliport.
The FAA published a notice of proposed rulemaking (NPRM in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
This action amends title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Highland Community Hospital Heliport, Picayune, MS. This action provides the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations at Highland Community Hospital Heliport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the FAA amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of the Highland Community Hospital Heliport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace extending upward from 700 feet above the surface at Forrest General Hospital Heliport, Hattiesburg, MS, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures (SIAPs) serving Forrest General Hospital Heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the heliport.
Effective 0901 UTC, December 7, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in
The FAA published a notice of proposed rulemaking (NPRM in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6 mile radius of Forrest General Hospital Heliport, Hattiesburg, MS. This action provides the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations at the Heliport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the FAA amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6-mile radius of Forrest General Hospital Heliport.
Bureau of Industry and Security, Commerce.
Final rule.
This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice continuing a national emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural, non-substantive rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
The rule is effective October 3, 2017.
Nancy Kook, Regulatory Policy Division, Bureau of Industry and Security, Telephone: (202) 482-2440.
The authority for all parts of the EAR (15 CFR parts 730-774) other than part 745 rests, in part, on Executive Order 13222 of August 17, 2001—National Emergency with Respect to Export Control Regulations, 66 FR 44025, 3
This rule is purely procedural and makes no changes other than to revise CFR authority paragraphs for the purpose of making the authority citations current. It does not change the text of any section of the EAR, nor does it alter any right, obligation or prohibition that applies to any person under the EAR.
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). This rule does not impose any regulatory burden on the public and is consistent with the goals of Executive Order 13563. 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 shall any person 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
3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.
4. The Department finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because they are unnecessary. This rule only updates legal authority citations. It clarifies information and is non-discretionary. This rule does not alter any right, obligation or prohibition that applies to any person under the EAR. Because these revisions are not substantive changes, it is unnecessary to provide notice and opportunity for public comment. In addition, the 30-day delay in effectiveness otherwise required by 5 U.S.C. 553(d) is not applicable because this rule is not a substantive rule. Because neither the Administrative Procedure Act nor any other law requires that notice of proposed rulemaking and an opportunity for public comment be given for this rule, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601
Administrative practice and procedure, Advisory committees, Exports, Reporting and recordkeeping requirements, Strategic and critical materials.
Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.
Administrative practice and procedure, Exports, Inventions and patents, Research, Science and technology.
Exports.
Exports, Terrorism.
Administrative practice and procedure, Reporting and recordkeeping requirements.
Exports, Reporting and recordkeeping requirements, Terrorism.
Exports, Reporting and recordkeeping requirements.
Agricultural commodities, Exports, Forests and forest products, Horses, Petroleum, Reporting and recordkeeping requirements.
Administrative practice and procedure, Exports, Penalties.
Boycotts, Exports, Reporting and recordkeeping requirements.
Administrative practice and procedure, Business and industry, Confidential business information, Exports, Reporting and recordkeeping requirements.
Administrative practice and procedure, Exports, Law enforcement, Penalties.
Administrative practice and procedure, Confidential business information, Exports, Law enforcement, Penalties.
Administrative practice and procedure, Exports, Reporting and recordkeeping requirements, Science and technology.
Accordingly, parts 730, 732, 734, 736, 738, 740, 742, 743, 744, 746, 748, 750, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772 and 774 of the EAR (15 CFR parts 730-774) are amended as follows:
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
Bureau of Ocean Energy Management, Interior.
Final rule.
This final rule establishes new regulations to address the use of Outer Continental Shelf (OCS) sand, gravel, and/or shell resources for shore protection, beach restoration, or coastal wetlands restoration projects by Federal, state, or local government agencies, and for use in construction projects authorized by or funded in whole or in part by the Federal Government. The final rule describes the negotiated noncompetitive agreement process for qualifying projects and codifies new and existing procedures.
This rule is effective December 4, 2017.
Deanna Meyer-Pietruszka, Chief, Office of Policy, Regulations, and Analysis, Bureau of Ocean Energy Management, at:
On March 22, 2016, the Bureau of Ocean Energy Management (BOEM) published in the
Congress amended the Outer Continental Shelf Lands Act, 43 U.S.C. 1331-1356 (OCSLA), in 1994 to authorize the Secretary of the Interior to negotiate noncompetitive agreements with any person for the use of OCS sand, gravel, and/or shell resources in a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, state, or local government agency, or in a construction project either authorized by, or funded in whole or in part by the Federal Government. See 43 U.S.C. 1337(k)(2). In negotiating an agreement for use of the OCS sand, gravel, and/or shell resources, OCSLA provides that “the Secretary may assess a fee based on an assessment of the value of the resources and the public interest served by promoting development of the resources.” However, the same provision of OCSLA also states that no fee will be assessed directly or indirectly against a Federal, state, or local government agency. See 43 U.S.C. 1337(k)(2)(B).
Generally, shore protection and beach and coastal wetlands restoration projects are initiated to rebuild eroding shoreline segments, such as beaches and dunes, barrier islands, and wetlands. In sensitive wetland areas, these projects are intended to forestall further erosion, restore habitat and/or to provide protection from hurricanes and storms. These projects are typically accomplished by placing sand, gravel, or shell resources directly on the beach, in open water areas that are the location of an eroded beach, and/or within breaches in the shoreline that compromise the integrity of the beach or barrier island system or its capacity to form, and subsequently maintain, a beach. Material may also be placed updrift from the beach, allowing longshore processes to redistribute the
OCSLA authorizes BOEM to enter into a negotiated noncompetitive agreement when the use of OCS sand, gravel, and/or shell resources is authorized for qualifying projects. This negotiated agreement may take the form of a lease or a Memorandum of Agreement (MOA), depending upon the type of applicant(s) requesting use of OCS sand, gravel, and/or shell resources. If a non-Federal entity requests the use of OCS sand, gravel, and/or shell resources, the negotiated noncompetitive agreement required by OCSLA would generally take the form of a lease. If a Federal agency requests the use of OCS sand, gravel, and/or shell resources, BOEM and the Federal agency, as well as their Federal, state, or local government agency counterparts on the project, would enter into an MOA. For example, when a Federal agency partially or wholly funds a non-Federal entity to conduct a project that is otherwise eligible for OCS sand, gravel, and/or shell resources, the negotiated noncompetitive agreement may take the form of a three-party MOA. As warranted, the Federal applicant(s) and BOEM would designate a lead agency and enter into a cooperating agency agreement for the environmental analysis and review of the proposed project. Likewise, if another Federal agency is not involved, BOEM would ensure that appropriate environmental analysis and review is completed. The negotiated noncompetitive agreement in each of these situations would describe the project and procedures that would be followed, and identify environmental and administrative requirements that must be met. As described in Section III below in response to a comment received, the requirements and processes for entering into a negotiated noncompetitive agreement are the same whether the agreement takes the form of a lease or a MOA. The only distinction is that which Congress provides in OCSLA that, when these projects involve Federal agencies, the Federal agency “shall enter into a Memorandum of Agreement with the Secretary. . . .” See 43 U.S.C. 1337(k)(2)(D).
BOEM and its predecessor agencies—the Minerals Management Service and the Bureau of Ocean Energy Management, Regulation and Enforcement—through the Marine Minerals Program, have been exercising statutory authority regarding OCS sand, gravel, and/or shell resources under OCSLA pursuant to written guidelines, without the benefit of implementing regulations. BOEM has negotiated over 50 noncompetitive agreements, providing for the use of more than 100 million cubic yards of OCS sand, gravel, and/or shell resources for shore protection, beach restoration, or coastal wetlands restoration projects undertaken by a Federal, state, or local government agency, and for federally authorized or funded construction projects. BOEM believes that promulgation of regulations at this time is advisable to provide additional clarity and certainty and to help ensure continuity of the Marine Minerals Program.
This section explains BOEM's authority for IC activities related to part 583. It explains the reasons the information is being collected and confirms the Office of Management and Budget (OMB) approval of the collection.
This section explains that the purpose of this rule is to refine and formally adopt procedures for entering into negotiated noncompetitive agreements for the use of OCS sand, gravel, and/or shell resources for shore protection; beach or coastal wetlands restoration by a Federal, state, or local government agency; or for construction projects authorized or funded, in whole or in part, by the Federal Government. This section explains that the rule applies exclusively to the negotiated noncompetitive use of sand, gravel, and/or shell resources on the OCS and does not apply to competitive leasing of minerals, including oil, gas, sulphur, geopressured-geothermal and associated resources, and all other minerals that are authorized by an Act of Congress to be produced from “public lands” as defined in section 103 of the Federal Land Policy and Management Act of 1976, as amended (FLPMA). (43 U.S.C. 1701
This section explains that in adopting these regulations, BOEM is operating under authority granted to the Secretary of the Interior by OCSLA.
This section defines many of the terms commonly used in the Marine Minerals Program and now used in this part, including “borrow area,” “placement area,” and “project.” This section also defines other terms for purposes of this part, including “agreement,” “amendment,” “applicant,” “BOEM,” “Federal agency,” “local government,” “modification,” “program,” and “Secretary.” This section also makes the definitions applicable to Part 550 of Title 30 of the CFR applicable to this part.
This section explains who is qualified to enter into an agreement with BOEM for the use of OCS sand, gravel, and/or shell resources, and explains the requirements to comply with the relevant debarment regulations.
This section sets out the kinds of decisions that would be subject to reconsideration, and the process available to an unsuccessful applicant or adversely affected party for obtaining reconsideration.
This section explains who is allowed to use OCS sand, gravel, and/or shell resources under these regulations, and explains that use authorizations are in the form of agreements that are negotiated on a case-by-case basis. It also explains that the agreements identify the location, type and volume of OCS sand, gravel, and/or shell resources allowed to be used under the agreement. In addition, it explains that an authorization to use OCS sand, gravel, and/or shell resources is not exclusive. BOEM has modified language in this section from the proposed rule by adding language stating that “terms and conditions and environmental stipulations” will be included in the list of the minimum contents of an agreement, and adding language to clarify the conditions under which more than one entity may use the same borrow area.
This section explains who may submit a request to BOEM to obtain an agreement for the use of OCS sand, gravel, and/or shell resources. It lists the information that the request must include, such as a detailed description of the proposed project and how it qualifies as a program or project eligible under OCSLA to receive OCS sand, gravel, and/or shell resources pursuant to a negotiated noncompetitive agreement; a description of borrow and placement areas; certain maps and data; other uses of the OCS and infrastructure in the borrow area that are known to the applicant; a description of the environmental evaluations that have been completed or are being prepared that cover the project, including both onshore and offshore components; a target date or date range when the resources will be needed; a description of the person or government entities that are undertaking the project and points of contact; a list of permits, licenses and authorization required for the project; a description of potential inconsistencies with state coastal zone management plans or other applicable state and local laws; and a statement explaining who authorized the project and how the project will be funded. Since issuance of the proposed rule, BOEM replaced the requirement that hard copy maps be provided with the request for a negotiated noncompetitive agreement in section 583.300(a)(2)(i); instead, the final rule requires digital (pdf) maps be provided. This modification in the final rule recognizes changes in technology and that most submissions are now made electronically.
This section lays out the factors that BOEM uses to determine whether a project qualifies for use of OCS sand, gravel, and/or shell resources under a negotiated noncompetitive agreement. The section enumerates the evaluation criteria, including: The project purpose; other uses of OCS sand, gravel, and/or shell resources that are currently or previously authorized from the same borrow area; the project funding source(s) and amounts; the proposed design and feasibility of the project; any potential environmental and safety risks associated with the project; other Federal interests located near or within the specified borrow area; comments received from potentially affected state or local governments, if any; the applicant's background and experience working on similar projects or activities; whether the project operations can be conducted in a manner that protects the environment and promotes orderly development of OCS mineral resources; whether activities can be conducted in a manner that does not pose a threat of serious harm or damage to, or waste of, any natural resources, any life, property, or the marine, coastal, or human environment; and whether the project is consistent with applicable statutes and their implementing regulations, which may include, but are not limited to, the Endangered Species Act (ESA) (16 U.S.C. 1531
This section explains the process that BOEM follows to evaluate a project that qualifies for the use of OCS sand, gravel, and/or shell resources to decide whether to enter into a negotiated noncompetitive agreement. It states that BOEM coordinates with relevant Federal agencies, states, and local governments, and any potentially affected federally recognized Indian tribes or Alaska Native corporations during this process. It also describes how BOEM evaluates the project and additional information provided under sections 583.300 and 583.305 to determine if the information is sufficient to conduct necessary technical and environmental reviews to comply with the requirements of applicable statutes and regulations, which may include, but are but not limited to: OCSLA (43 U.S.C. 1331
This section describes the steps BOEM takes once it has completed its technical, environmental and other evaluations. This section provides further that, once BOEM has completed its review of an application, BOEM will decide whether to enter into an agreement. This section provides that, if BOEM decides to enter into an agreement, BOEM will negotiate the terms of the agreement and prepare a draft agreement for the applicant's review and comment. The section also provides that, after BOEM considers the applicant's comments and suggestions, it may, at its discretion, finalize the agreement and send it to the applicant for signature. As provided in this section, once BOEM receives the agreement with the applicant's signature, BOEM will execute the agreement and distribute it to the parties to the agreement. Finally, this section describes the process BOEM would use when it decides not to approve an agreement.
This section describes the minimum information that an agreement is required to include, such as an agreement number assigned by BOEM; the purpose of, and authorities for, the agreement; the designated and delineated borrow area(s); the project description, including the timeframe within which the project is to be started and completed; the terms and conditions of the agreement, including any reporting requirements; all obligations of the parties; and the signatures of appropriate individuals authorized to bind the applicants and BOEM. In this final rule, in section 583.320(e), BOEM added “environmental mitigations and operating parameters” to the examples of terms and conditions that might be included in an agreement, to make clear that, if there are any environmental mitigations or operating parameters, that information must be included in negotiated noncompetitive agreements.
This section describes what determines the effective date of the agreement.
This section describes how BOEM would enforce the terms of an agreement and the consequences, including termination, for failure to comply with any applicable law or with the agreement terms. This section also provides that the failure to comply in a timely and satisfactory manner with any provision, term or condition of the agreement may delay or prevent BOEM's approval of future requests for use of OCS sand, gravel, and/or shell resources on the part of the parties to the agreement.
This section explains when an agreement terminates: (1) By a date specified in the agreement; (2) pursuant to 30 CFR 583.350; or (3) when parties to the agreement notify BOEM in writing that sufficient resources, up to the amount authorized in the agreement, have been removed to complete the project. This section also explains that, absent extraordinary circumstances, no agreement will have a term that is longer than five years from its effective date. Examples of extraordinary circumstances where a term longer than five years may be appropriate include a program of multiple individual projects to be carried out over multiple seasons, or where the Congressional authorization for a project calls for multiple phases. It is within BOEM's sole discretion to determine when extraordinary circumstances warrant a term longer than five years. Prior to the end of the term in an agreement, the parties would have the option to request an extension or modification to the terms of the agreement, as set forth in section 583.345.
This section explains that the applicant has the obligation to ensure that all contracts and transactions related to an agreement issued under this part comply with the suspension and debarment regulations at 2 CFR part 180 and 2 CFR part 1400.
This section explains how an applicant may seek to extend or modify an agreement and spells out the timeframes when this might be accomplished. It provides that BOEM is under no obligation to extend or modify an agreement and cannot be held liable for the consequences of the expiration of an agreement. If BOEM approves a modification, BOEM will prepare an amendment to the agreement and provide it for review by the parties to the agreement prior to execution of the amendment. If BOEM disapproves the request, BOEM will notify the parties to the agreement of the reasons in writing. Parties to the agreement may ask the BOEM Director for reconsideration in accordance with section 583.125.
This section explains the circumstances under which the Director will terminate an agreement after notice and an opportunity to be heard. The termination factors include fraud or misrepresentation. This section also explains the circumstances under which the Director may immediately suspend and subsequently terminate an agreement, including when there is noncompliance with the agreement; national security or defense reasons; or when the Director determines that: (1) There are situations in which continuing with the agreement would cause serious harm or damage to natural resources, life, property, the marine, coastal, or human environment, or significant historical or archaeological sites, structures or objects; (2) the threat of harm or damage will not disappear or decrease to an acceptable extent within a reasonable period of time; and (3) the advantages of termination outweigh the advantages of continuing the agreement. This section also explains the process for terminations and suspensions and explains that none of the parties to the agreement will be entitled to compensation as a result of expenses or lost revenues that may result from the termination.
The timelines for processing applications and requests vary based upon a number of factors, including, but not limited to, completion of necessary environmental analyses (
Because every project must be evaluated using a number of factors and project-specific information, BOEM determined that it is not possible to modify the rule as requested by the commenters. Providing specific weighting of criteria or providing an inflexible review deadline would be unnecessarily restrictive given the complexities of evaluating individual, site specific projects while complying with multiple statutes governing environmental review and consultation.
This final rule modified language in the proposed rule at section 583.130 to state “BOEM may allow other entities to use OCS sand, gravel, and/or shell resources from the same borrow area if these uses are determined by BOEM to be non-conflicting and do not exceed the availability of the OCS resource.”
Aside from identifying the type of resources included in an agreement, the regulation does not address quality. BOEM will not make representations as to any aspects of quality, other than the type, of any particular material utilized for qualified projects. It is the applicant's responsibility to assess the quality of the type of OCS sand, gravel, and/or shell resources in a borrow area as it relates to the suitability of these resources for the applicant's proposed use.
BOEM has determined, in its discretion under NEPA, it will either individually or programmatically evaluate the environmental impacts of projects as they are proposed, when there is sufficient information on the proposal to be evaluated, including but not limited to the timing, location, and resources that may be implicated. Without these types of project specific details, impacts could not be reasonably evaluated at a national programmatic level. NEPA requires, even in project specific analyses, that cumulative impacts from past, present, and reasonably foreseeable activities be considered. There is a similar requirement during ESA consultations to ensure cumulative impacts on listed species are considered.
BOEM examined a number of options for maximum terms for agreements, absent extraordinary circumstances. A longer maximum agreement term could serve as an incentive for agencies or authorities to seek authorizations for highly speculative projects far into the future that may be unlikely to be funded or that would change significantly in scope and require additional environmental analysis in the future. Therefore, BOEM selected five years as the maximum term for negotiated noncompetitive agreements, which considers the lead times needed for a project applicant to obtain an agreement and enter into related construction contracts. There must be some reasonable time limit within which BOEM expects the resources to be used and the project completed to fulfill the Bureau's statutory obligations and manage the resources responsibly for multiple stakeholders.
Congressional authorization is not the only available condition for demonstrating an extraordinary circumstance justifying a term longer than five years under section 585.335, or for obtaining a negotiated noncompetitive agreement extension under section 585.345. When referring to section 583.307, the preamble to the proposed rule reads: “Examples of extraordinary circumstances where an initial term longer than five years may be appropriate would include a program of multiple individual projects to be carried out over multiple seasons
E.O. 12866 provides that the Office of Information and Regulatory Affairs (OIRA), a part of the OMB, will review all significant rules. OIRA has determined that this rule is not significant.
(1) A regulatory impact analysis is not required. This rule formalizes existing policies and procedures that govern the use of OCS sand, gravel, and/or shell resources. The existing policies, procedures, consultations and monitoring requirements for the noncompetitive use of OCS sand, gravel, and/or shell resources are longstanding and have remained relatively consistent for two decades. This rule does not materially change the existing requirements for authorizing the use of OCS sand, gravel, and/or shell resources through leases or MOAs for shore protection, beach or wetlands restoration by a Federal, state or local government agency, or for construction projects authorized or funded, in whole or in part, by the Federal Government. The regulatory baseline is essentially the same as the rule. BOEM believes that any changes between the current BOEM process and this rule are immaterial and would not impose additional compliance obligations or costs upon the regulated entities.
Formalizing the existing conveyance process will provide certainty to the public entities requesting noncompetitive leases or MOAs for OCS sand, gravel, and/or shell resources. BOEM believes there is a benefit to the regulated entities in the form of regulatory certainty when Federal, state and local government agencies desire to use OCS sand, gravel, and/or shell resources for qualifying projects. Entities affected by this rulemaking had the opportunity to comment through the rulemaking process on the proposed provisions, which are consistent with current practices for the conveyance of sand, gravel, and/or shell resources.
(2) This rule does not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. It reflects the existing process developed over the life of the program in cooperation with other Federal agencies, including the U.S. Fish and Wildlife Service (FWS), National Marine Fisheries Service (NMFS) and U.S. Army Corps of Engineers, and state and local governments.
(3) This rule does not have an annual effect on the economy of $100 million or more and does not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities. This rule simply codifies BOEM's longstanding existing practice.
(4) This rule does not alter the budgetary effects of existing entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients.
(5) This rule does not raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.
E.O. 13563 reaffirms the principles of E.O. 12866, while calling for improvements in the nation's regulatory system to promote predictability; reduce uncertainty; and use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. BOEM has developed this rule in a manner consistent with these requirements.
This rule is not an E.O. 13771 regulatory action because it is not significant under E.O. 12866.
BOEM certifies this rule would not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601
The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small businesses about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the actions of BOEM enforcement activities, you may call 1-888-734-3247. You may comment to the Small Business Administration without fear of retaliation. Allegations of discrimination/retaliation filed with the Small Business Administration will be investigated for appropriate action.
This rule is not a major rule under the SBREFA (5 U.S.C. 804 (2)). This rule:
(a) Will not have an annual effect on the economy of $100 million or more;
(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and,
(c) Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
This rule would not impose an unfunded mandate on State, local, or tribal governments, or the private sector of more than $100 million per year. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1501
Under the criteria in E.O. 12630, this rule will not have significant takings implications. The rule is not a governmental action capable of interference with constitutionally protected property rights. A Takings Implication Assessment is not required.
Under the criteria in E.O. 13132, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. This rule does not substantially and directly affect the relationship between the Federal and state and local governments. To the extent that State and local governments have a role in OCS activities, this rule would not affect that role. A Federalism Assessment is not required.
This rule complies with the requirements of E.O. 12988. Specifically, this rule:
(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and,
(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
The U.S. Department of the Interior (DOI) strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. BOEM's Tribal Liaison Officer has certified that this regulation does not have tribal implications as defined in section 1(a) of E.O. 13175 and has determined that the regulation does not have substantial and direct effects on federally recognized tribes or any Alaska Native Corporation established pursuant to the Alaska Native Claims Settlement Act (ANCSA) (43 U.S.C. 1601
As it relates to any federally recognized Indian tribe, this rule merely formalizes existing policies and procedures that govern the use of OCS sand, gravel, and/or shell resources. The existing policies, procedures, consultations and monitoring requirements for the noncompetitive use of OCS sand, gravel, and/or shell resources are longstanding and have remained relatively consistent for two decades. If BOEM determines an individual project authorized under this part may have effects on federally recognized tribes or any Alaska Native Corporation, BOEM will initiate consultation as soon as possible consistent with E.O. 13175 and DOI tribal consultation policies. A tribe or Alaska Native Corporation may also request BOEM to initiate consultation pursuant to E.O. 13175.
This rule contains a collection of information request that was submitted to OMB for review and approval under 44 U.S.C. 3501
BOEM included a request for approval of a collection of information in the
The title of the IC request is “30 CFR 583, Negotiated Noncompetitive Agreements for the Use of Sand, Gravel, and Shell Resources on the OCS.” Respondents are other Federal, state, and local government agencies; corporations; and individual entities. Responses will primarily be required to obtain or retain a benefit. The frequency of response will vary depending on the requirement. BOEM will protect proprietary information according to 30 CFR 550.197, “Data and information to be made available to the public or for limited inspection,” the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations at 43 CFR part 2. BOEM will collect the information under this part to evaluate applications for leases/agreements to access sand, gravel, or shell resources on the OCS; to balance multiple uses of the OCS; and to monitor activities for environmental protection and safety.
In response to the proposed rule, BOEM received two comments that addressed aspects of the information collection for this rulemaking and are summarized below. One commenter suggested that the required information submitted with their permit application is duplicative of the information submitted in a Clean Water Act application. In cases where the information is duplicative in nature, BOEM will allow submission of the information in the Clean Water Act permit application to BOEM to comply with the filing requirements of this rule. However, BOEM did not change the burden hours for this requirement, because we do not have sufficient data to estimate how many parties seeking agreements will be able to use this means of reducing the burdens of the application process. This comment is addressed in more detail in the preamble of this final rule.
Another commenter focused on consultation with the fishing industry regarding renewable energy projects, which is outside the scope of this rulemaking. This commenter stated that the information request does not include any provision requiring consultation with the fishing industry or reporting requirements that would ensure a project is compatible with consideration of fishing rights. However, such outreach and coordination does occur through the NEPA, MSFCMA and other consultation processes.
The information collection burdens were not changed from the proposed rule. The following table provides a breakdown of the IC requirements and burdens in this part.
An agency may not conduct or sponsor, and you are not required to respond to, a collection of information unless it has a currently valid OMB control number. The public may comment, at any time, on the accuracy of the IC burden estimate in this rule and may submit any comments to the Information Collection Clearance Officer, Office of Policy, Regulation and Analysis; Bureau of Ocean Energy Management; VAM-BOEM DIR; 45600 Woodland Road, Sterling, Virginia 20166.
This rule does not constitute a major Federal action significantly affecting the quality of the human environment. BOEM has analyzed this rule under the criteria of the NEPA and DOI's NEPA implementing regulations at 43 CFR part 46. This rule meets the criteria set forth in 43 CFR 46.210(i) for a Departmental “categorical exclusion” in that this rule is “. . . of an administrative, financial, legal, technical, or procedural nature . . . .” BOEM has also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215.
In accordance with the IQA, DOI has issued guidance regarding the quality of information that it relies upon for regulatory decisions. This guidance is available at DOI's Web site at
Send your comments to the U.S. Department of the Interior, Bureau of Ocean Energy Management, Office of Policy, Regulation and Analysis, Attn: IQA Comments, 45600 Woodland Road, VAM-BOEM DIR, Sterling, Virginia 20166.
This rule is not a significant energy action under the definition in E.O. 13211. A Statement of Energy Effects is not required.
We are required by E.O. 12866, E.O. 12988, and the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever helpful.
Administrative practice and procedure, Beach restoration, Coastal wetlands restoration, Continental shelf, Federal lands, Gravel, Government contracts, Intergovernmental relations, Marine minerals, Marine minerals program, Noncompetitive agreements, Negotiated agreements, Outer Continental Shelf, Reporting and recordkeeping, Sand, Shell resources, and Shore protection.
For the reasons stated in the preamble, BOEM amends 30 CFR chapter V by adding 30 CFR part 583 to subchapter B to read as follows:
43 U.S.C. 1334.
The IC requirements contained in part 583 have been approved by OMB under 44 U.S.C. 3501 and assigned control number 1010-0191. The information is being collected to determine if the applicant for a negotiated noncompetitive agreement (agreement)
The regulations in this part provide procedures for entering into negotiated noncompetitive agreements for the use of OCS sand, gravel, and/or shell resources. The rules of this part apply exclusively to negotiated noncompetitive use of OCS sand, gravel, and/or shell resources and do not apply to competitive leasing of minerals, including oil, gas, sulphur, geopressured-geothermal and associated resources, and all other minerals that are authorized by an Act of Congress to be produced from “public lands” as defined in section 103 of the Federal Land Policy and Management Act of 1976, as amended (43 U.S.C. 1701
(a) Pursuant to authority granted by section 8(k) of the Outer Continental Shelf Lands Act (OSCLA), as amended (43 U.S.C. 1337(k)), the Secretary has authority to negotiate a noncompetitive agreement for the use of OCS sand, gravel, and/or shell resources:
(1) In a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, State, or local government agency; or
(2) In a construction project, other than a project described in paragraph (a)(1) of this section, that is funded in whole or in part by or authorized by the Federal Government.
(b) The Secretary has delegated authority to BOEM to administer the negotiated noncompetitive agreement provisions of OCSLA and prescribe the rules and regulations necessary to carry out those provisions.
The definitions at 30 CFR 550.105 apply to this part. In addition, when used in this part, the following terms will have the meaning given below:
(a) BOEM may enter into an agreement with any person proposing to use OCS sand, gravel, and/or shell resources for a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, state, or local government agency or in a construction project that is funded in whole or in part by or authorized by the Federal Government.
(b) To request an agreement under this part, the applicant must be:
(1) A Federal, state, or local government agency;
(2) A citizen or national of the United States;
(3) An alien lawfully admitted for permanent residence in the United States, as defined in the Immigration and Nationality Act, as amended (8 U.S.C. 1101(a)(20));
(4) A private or public corporation organized under the laws of the United States, or of any State or territory thereof; or
(5) An association of such citizens, nationals, resident aliens, or private or public corporations.
(c) When entering into an agreement under this part, all applicants are subject to the requirements of 2 CFR part 180 and 2 CFR part 1400.
(a) After being notified of disqualification or disapproval of an agreement or modification, an unsuccessful applicant, or adversely affected party to an agreement, may apply for reconsideration by the Director.
(1) All applications for reconsideration must be submitted to the Director within 15 days of being notified of disqualification or disapproval of an agreement or modification, and must be accompanied by a statement of reasons for the requested reconsideration, with one copy also submitted to the program office whose decision is the subject of the request for reconsideration.
(2) The Director will respond in writing within 30 days.
(b) No appeal rights are available under 30 CFR part 590 and 43 CFR part 4, subpart E.
Any use of OCS sand, gravel, and/or shell resources in an agreement will be negotiated on a case-by-case basis. The agreement will specify, at a minimum, who may use the OCS sand, gravel, and/or shell resources; the nature of the rights granted, including any terms and conditions and environmental stipulations; and the location, type, and
Any person may submit a written request to BOEM to obtain an agreement for the use of OCS sand, gravel, and/or shell resources for use in a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, state, or local government agency, or in a construction project that is funded in whole or in part by or authorized by the Federal Government.
(a) The written request must include:
(1) A detailed description of the proposed project for which the OCS sand, gravel, and/or shell resources will be used and how it qualifies as a program or project eligible under OCSLA to use OCS sand, gravel, or shell resources;
(2) A description of the proposed borrow area(s) and placement area(s), along with maps with geographic coordinates depicting the location of the desired borrow area(s), the OCS block number(s), OCS Planning Area(s), OCS Protraction Diagram Designation(s), and the placement area(s). These should include:
(i) A detailed set of digital (
(ii) Digital geo-referenced spatial and tabular data depicting the borrow area with features, such as geological sampling locations and any hard or live-bottom benthic habitat present;
(3) Any available geological and geophysical data used to select, design, and delineate the borrow area(s) and potential borrow areas considered but not selected for final design in digital format, geo-referenced where relevant. These may include:
(i) Sediment sampling (sediment cores and grab samples) data such as physical description sheets, photographs, core locations, and grain size analysis; and
(ii) Geophysical data such as subbottom profiler, marine magnetometer, and side-scan sonar data, and bathymetry including geo-referenced navigation survey tracklines, shotpoints, and/or timestamps;
(4) Any other uses of the OCS or infrastructure in the borrow area that are known to the applicant at the time of application submittal;
(5) A description of the environmental evaluations and corresponding documents that have been completed or are being prepared that cover all offshore and onshore components of the project, as applicable;
(6) A target date or date range when the OCS sand, gravel, and/or shell resources will be needed;
(7) A description of the person or government entities undertaking the project;
(8) A list of any permits, licenses or authorizations required for the project and their current status;
(9) A description of any potential inconsistencies with state coastal zone management plans and/or any other applicable state and local statutes, regulations or ordinances;
(10) The name, title, telephone number, mailing address and email address of any points of contact for any Federal agencies, state, or local governments, and contractor(s) with whom the applicant has contracted or intends to contract;
(11) A statement explaining who authorized the project and how the project is to be funded, indicating whether the project is federally funded, in whole or in part, and whether the project is authorized by the Federal Government; and
(12) For any other Federal, state, or local government agency identified in the application, the name, title, mailing address, telephone number, and email address of both a primary and a secondary point of contact for the agency.
(b) [Reserved]
BOEM will make a determination as to whether the project, as described in § 583.300, qualifies for a negotiated noncompetitive agreement for the use of OCS sand, gravel, and/or shell resources. Within 15 business days of receipt of the application, BOEM will determine if the application is complete or will request additional information. After it has determined the application is complete, BOEM will review the application and notify the applicant in writing whether the project qualifies for an agreement. In determining whether a project qualifies for an agreement, BOEM will consider, among other criteria, the following:
(a) The project purpose;
(b) Other uses of OCS sand, gravel, and/or shell resources from the same borrow area that are currently or were previously authorized by BOEM for other projects or programs, including the location, type and volume of such resources;
(c) The project funding source(s) and amounts;
(d) The proposed design and feasibility of the project;
(e) Any potential environmental and safety risks associated with the project;
(f) Other federal interests located near or within the specified borrow area;
(g) Comments received from potentially affected state or local governments, if any;
(h) The applicant's background and experience working on similar projects or activities;
(i) Whether the project operations can be conducted in a manner that protects the environment and promotes orderly development of OCS mineral resources;
(j) Whether activities can be conducted in a manner that does not pose a threat of serious harm or damage to, or waste of, any natural resource, any life (including fish and other aquatic life), property, or the marine, coastal, or human environment; and
(k) Whether the project is consistent with the requirements of applicable statutes and their implementing regulations, which may include, but are not limited to, the Endangered Species Act (ESA) (16 U.S.C. 1531
(a) Once BOEM has determined a project qualifies for an agreement, BOEM will begin the project evaluation process to decide whether to enter into a negotiated noncompetitive agreement.
(b) BOEM will coordinate with relevant Federal agencies, State, and local governments and any potentially affected federally recognized Indian
(c) BOEM will evaluate the project and additional information provided pursuant to §§ 583.300 and 583.305, to determine if the information is sufficient to conduct necessary technical and environmental reviews to comply with the requirements of applicable statutes and regulations, which may include, but are not limited to: OCSLA (43 U.S.C. 1331
(d) BOEM will not enter into a negotiated noncompetitive agreement with the applicant until the information requested for the evaluation has been provided and BOEM has evaluated it.
(a) Upon completion of the technical, environmental and other evaluations established in §§ 583.305 and 583.310, BOEM will decide whether to enter into a negotiated noncompetitive agreement with the applicant for use of OCS sand, gravel, or shell resources for its proposed project.
(b) If BOEM decides not to enter into such an agreement, BOEM will inform the applicant of its reasons for not doing so. An applicant may ask the BOEM Director for reconsideration of this decision, in accordance with § 583.125(a).
(c) If BOEM has decided to enter into a negotiated noncompetitive agreement with the applicant, BOEM will negotiate the terms and conditions of the agreement with the applicant and prepare a draft agreement for the applicant's review.
(d) After considering comments and suggestions from the applicant, BOEM, at its discretion, may finalize the agreement and distribute it to the applicant for signature.
(e) Upon receipt of the agreement with the applicant's signature, BOEM will execute the agreement. A copy of the executed agreement will be mailed to the parties.
Every agreement is negotiated on a case-by-case basis, but at a minimum, must include:
(a) An agreement number, as assigned by BOEM;
(b) The purpose of, and authorities for, the agreement;
(c) Designated and delineated borrow area(s);
(d) A project description, including the timeframe within which the project is to be started and completed;
(e) The terms and conditions of the agreement, including any reporting requirements, environmental mitigations, and operating parameters;
(f) All obligations of the parties; and
(g) The signatures of appropriate individuals authorized to bind the applicant and BOEM.
The agreement will become effective on the date when all parties to the agreement have signed it.
(a) Failure to comply with any applicable law or any provision, term, or condition of the agreement may result in the termination of the agreement, a referral to an appropriate Federal or State agency for enforcement, or both. Termination of the agreement for noncompliance will be in the sole discretion of the Director.
(b) The failure to comply in a timely and satisfactory manner with any provision, term or condition of the agreement may delay or prevent BOEM's approval of future requests for use of OCS sand, gravel, and/or shell resources on the part of the parties to the agreement.
(a) An agreement will terminate upon one of the following, whichever occurs first:
(1) The agreement expires by its own terms, unless the term is extended prior to expiration under § 583.345;
(2) The project is terminated, as set forth in § 583.350; or
(3) A party to the agreement notifies BOEM, in writing, that sufficient OCS sand, gravel, and/or shell resources, up to the amount authorized in the agreement, have been obtained to complete the project.
(b) Absent extraordinary circumstances, no agreement will be for a term longer than five years from its effective date.
The parties to an agreement must ensure that all contracts and transactions related to an agreement issued under this part comply with the suspension and debarment regulations in 2 CFR part 180 and 2 CFR part 1400.
(a) Unless otherwise provided for in the agreement, the parties to the agreement may submit to BOEM a written request to extend or modify an agreement. BOEM is under no obligation to extend or modify an agreement and cannot be held liable for the consequences of the expiration of an agreement. With the exception of paragraph (b) of this section, any such requests must be made at least 180 days before the term of the agreement expires. BOEM will respond to the request for modification within 30 days of receipt and request any necessary information and evaluations to comply with § 583.305. BOEM may approve the request, disapprove it, or approve it with modifications subject to the requirements of § 583.305.
(1) If BOEM approves a request to extend or modify an agreement, BOEM will draft an agreement modification for review by the parties to the agreement in the form of an amendment to the original agreement. The amendment will include:
(i) The agreement number, as assigned by BOEM;
(ii) The modification(s) agreed to;
(iii) Any additional mitigation required; and
(iv) The signatures of the parties to the agreement and BOEM.
(2) If BOEM disapproves a request to extend or modify an agreement, BOEM will inform the parties to the agreement of the reasons in writing. Parties to the agreement may ask the BOEM Director for reconsideration in accordance with § 583.125.
(b) By written request, for strictly minor modifications that do not change the substance of the project or the analyzed environmental effects of the project, including but not limited to, the change of a business address, the substitution of a different Federal, State or local government agency contact, or an extension of less than 30 days, parties to the agreement may memorialize the minor modification in a letter from BOEM to the parties indicating the request has been granted.
(a) The Director will terminate any agreement issued under this part upon proof that it was obtained by fraud or misrepresentation, after notice and an opportunity to be heard has been afforded to the parties of the agreement.
(b) The Director may immediately suspend and subsequently terminate any agreement issued under this part when:
(1) There is noncompliance with the agreement, pursuant to § 583.330 (a); or
(2) It is necessary for reasons of national security or defense; or
(3) The Director determines that:
(i) Continued activity under the agreement would cause serious harm or damage to natural resources; life (including human and wildlife); property; the marine, coastal, or human environment; or sites, structures, or objects of historical or archaeological significance;
(ii) The threat of harm or damage will not disappear or decrease to an acceptable extent within a reasonable period of time; and
(iii) The advantages of termination outweigh the advantages of continuing the agreement.
(c) The Director will immediately notify the parties to the agreement of the suspension or termination. The Director will also mail a letter to the parties to the agreement at their record post office address with notice of any suspension or termination and the cause for such action.
(d) In the event that BOEM terminates an agreement under this section, none of the parties to the agreement will be entitled to compensation as a result of expenses or lost revenues that may result from the termination.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a special local regulation for all navigable waters of the Tennessee River from mile marker (MM) 453.0 to MM 453.6. This action is necessary to provide for the safety of life on these navigable waters near Chattanooga, TN during the Swim the Suck marine event. Entry into, transiting through, or anchoring within this regulated area is prohibited unless authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.
This rule is effective from 9:15 a.m. through 9:45 a.m. on October 14, 2017.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this notice of enforcement, call Petty Officer Jonathan Braddy, Marine Safety Detachment Nashville, U.S. Coast Guard, telephone 615-736-5421, 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.
We must establish this special local regulation by October 14, 2017 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. The NPRM process would delay the establishment of the special local regulation until after the scheduled date of the marine event and jeopardize public safety.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), 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. 1233. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the Swim the Suck marine event from 9:15 a.m. through 9:45 a.m. on October 14, 2017 will present a safety concern for all navigable waters on the Tennessee River extending from mile marker (MM) 453.0 to MM 453.6. The purpose of this rulemaking is to ensure the safety of life and vessels on the navigable waters before, during, and after the scheduled event.
This rule establishes a special local regulation from 9:15 a.m. through 9:45 a.m. on October 14, 2017 for all navigable waters on the Tennessee River from MM 453.0 to MM 453.6. The duration of the special local regulation is intended to ensure the safety of life and vessels on these navigable waters before, during, and after the scheduled event. No vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative.
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, duration, and time-of-day of the regulated area. Vessel traffic will be able to safely navigate through the affected area before
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 regulated area 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 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 the establishment of a special local regulation lasting one half of an hour extending less than one mile that will prohibit entry on all navigable waters of the Tennessee River from MM 453.0 to MM 453.6. It is categorically excluded from further review under paragraph 35(a) of Figure 2-1 of the Commandant Instruction and a Record of Environmental Consideration was not necessary.
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) Persons or vessels desiring entry into or passage through the area must request permission from the COTP or a designated representative. U.S. Coast Guard Sector Ohio Valley may be contacted on VHF Channel 13 or 16 or by telephone at 1-800-253-7465.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a special local regulation for all navigable waters of the Cumberland River from mile marker (MM) 190.0 to MM 195.0. This action is necessary to provide for the safety of life on these navigable waters near Nashville, TN during the Music City Head Race. Entry into, transiting through, or anchoring within this regulated area is prohibited unless authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.
This rule is effective from 9 a.m. on October 6, 2017 through 7 p.m. on October 7, 2017.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this notice of enforcement, call Petty Officer Jonathan Braddy, Marine Safety Detachment Nashville, U.S. Coast Guard, telephone 615-736-5421, 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. This event is among the annual recurring events listed in 33 CFR 100.801, Table 1, line no. 65, between mile marker (MM) 190.0 to MM 195.0, as occuring on the last weekend in September. This year, the dates of the event have been changed by the event organizer to the first weekend in October.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), 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. 1233. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the Music City Head Race from 9 a.m. through 7 p.m. on October 6, 2017 and from 4 a.m. through 7 p.m. on October 7, 2017, will be a safety concern for all navigable waters on the Cumberland River extending from mile marker (MM) 190.0 to MM 195.0. The purpose of this rulemaking is to ensure the safety of life and vessels on these navigable waters before, during, and after the scheduled event.
This rule establishes a special local regulation from 9 a.m. through 7 p.m. on October 6, 2017 and from 4 a.m. through 7 p.m. on October 7, 2017 for all navigable waters on the Cumberland River from MM 190.0 to MM 195.0. The duration of the regulated area is intended to ensure the safety of life and vessels on these navigable waters before, during, and after the scheduled event. No vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative.
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, duration, and time-of-day of the special local regulation. Vessel traffic will be able to safely navigate through the affected area before and after the scheduled event. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the regulated area and the rule allows vessels to seek permission to enter the area.
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 regulated area 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
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 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 the establishment of a special local regulation lasting twenty-three hours over two days extending a limited distance of five miles that will prohibit entry on all navigable waters of the Cumberland River from MM 190.0 to MM 195.0. It is categorically excluded from further review under paragraph 35(a) of Figure 2-1 of the Commandant Instruction and a Record of Environmental Consideration was not necessary.
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) Persons or vessels desiring entry into or passage through the area must request permission from the COTP or a designated representative. U.S. Coast Guard Sector Ohio Valley may be contacted on VHF Channel 13 or 16 or by telephone at 1-800-253-7465.
(d)
Coast Guard, DHS.
Notice of temporary deviation from drawbridge regulation; cancellation.
The Coast Guard is canceling the temporary deviation concerning the Morrison Bridge across the Willamette River, mile 12.8, at Portland, Oregon. A temporary interim rule has been approved which grants the bridge owner, Multnomah County, an extension of time to replace the bridge decking. The temporary interim rule effectively replaces the temporary deviation.
The temporary deviation published on September 1, 2017 (82 FR 41520), is cancelled as of October 3, 2017.
The docket for this deviation, USCG-2017-0826, is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
On September 1, 2017, we published a temporary deviation entitled “Drawbridge Operation Regulation; Willamette River, Portland, OR” in the
While replacing the bridge decking, the bridge owner's construction crew experienced delays with both material deliveries and machining bolt hole tolerances. Therefore, more time was needed to complete the necessary tests and inspections. The subject temporary deviation was approved by mistake in an attempt to give the bridge owner more time to finish construction. After approval of the temporary deviation it was discovered that 180 days would not be enough time to complete construction. After we approved this temporary deviation, we approved a temporary interim rule in order to provide more time to finish the bridge construction. The temporary interim rule effectively replaces the temporary deviation. Therefore, we are cancelling this temporary deviation; docket number USCG-2017-0826 concerning the Morrison Bridge.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Tower Drawbridge across the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the community to participate in the Sacramento Century Challenge bicycle race. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.
This deviation is effective from 7 a.m. through 10 a.m. on October 7, 2017.
The docket for this deviation, USCG-2017-0918, is available at
If you have questions on this temporary deviation, call or email Carl T. Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516; email
The California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge over the Sacramento River, mile 59.0, at Sacramento, CA. The drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.
The drawspan will be secured in the closed-to-navigation position from 7 a.m. through 10 a.m. on October 7, 2017, to allow the community to participate in the Sacramento Century Challenge bicycle race. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised. Vessels able to pass through the bridge in the closed position may do so at anytime. In the event of an emergency the draw can open on signal if at least one hour notice is given to the bridge operator. There are no immediate alternate routes for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for certain waters of the Patapsco River, Northwest Harbor and Inner Harbor. This action is necessary to provide for the safety of life on the navigable waters at Baltimore, MD, during the movement of the historic sloop-of-war USS CONSTELLATION on October 26, 2017. If necessary, due to inclement weather, the event will be rescheduled for October 27, 2017. This action will prohibit persons and vessels from entering the safety zone unless authorized by the Captain of the Port Maryland—National Capital Region.
This rule is effective from 8 a.m. on October 26, 2017, through 1 p.m. on October 27, 2017.
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 Mr. Ronald L. Houck, at Sector Maryland—National Capital Region, Waterways Management Division, U.S. Coast Guard; telephone 410-576-2674, email
On September 15, 2017, Historic Ships in Baltimore of Baltimore, MD, notified the Coast Guard that from 9 a.m. to noon on October 26, 2017, it will be conducting a tow of the historic sloop-of-war USS CONSTELLATION in Baltimore, MD, from its berth at the Inner Harbor to a point on the Patapsco River near the Fort McHenry National Monument and Historic Shrine, and its return to its berth at the Inner Harbor.
This rule involves the USS CONSTELLATION “turn-around” cruise, an event that takes place in Baltimore, MD. A permanent safety zone for this rule, with an enforcement period from 2 p.m. through 7 p.m. local time annually on the Thursday before Memorial Day (observed), has been published and is detailed at Title 33 Code of Federal Regulations, section 165.512. However, due to a change in scheduling, the event this year is planned for October 26, 2017. If necessary, due to inclement weather, the event will be rescheduled for October 27, 2017. The event is scheduled to start at 9 a.m. and the event location remains unchanged.
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 due to the short time period between event planners notifying the Coast Guard of details concerning the event, on September 15, 2017, and publication of this safety zone. It is impracticable and contrary to the public interest to publish an NPRM to provide a notice and an opportunity for comment period because we must establish this safety zone by October 26, 2017 to ensure the safety of vessels and the navigable waters before, during, and after the scheduled event. Such hazards include vessels colliding, sinking or grounding, creating hazards to navigation, and threatening the marine environment.
Under 5 U.S.C. 553(d)(3), 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 COTP has determined that potential hazards associated with the USS CONSTELLATION “turn-around” cruise will be a safety concern for anyone on the Patapsco River, Northwest Harbor and Inner Harbor. The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.
This rule establishes a safety zone from 8 a.m. through 1 p.m. on October 26, 2017, and, if necessary due to inclement weather, from 8 a.m. through 1 p.m. on October 27, 2017. The safety zone will include all navigable waters within 200 yards ahead of and 100 yards outboard or aft of the historic sloop-of-war USS CONSTELLATION while operating in the Inner Harbor, the Northwest Harbor or the Patapsco River. This location is entirely within the Area of Responsibility of the COTP Maryland-National Capital Region, as set forth at 33 CFR 3.25-15.
This rule requires any unauthorized persons in the regulated area at the time this safety zone is in effect to immediately proceed out of the zone. Except for USS CONSTELLATION “turn-around” participants, and vessels at berth, mooring, or at anchor, this rule temporarily requires all vessels in the designated safety zone as defined by this rule to immediately depart the safety zone. Entry into this safety zone is prohibited, unless specifically authorized by the COTP Maryland—National Capital Region. Coast Guard personnel will be present to prevent the movement of unauthorized persons into the zone. Federal, state, and local agencies may assist the Coast Guard in the enforcement of this rule. The COTP Maryland—National Capital Region will issue Broadcast Notices to Mariners to further publicize the safety zone and notify the public of changes in the status of the zone. Such notices will continue until the event is complete. The regulatory text appears at the end of this document.
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, it 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, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone, which will impact a small designated area of the Patapsco River, Northwest Harbor and Inner Harbor for five hours during the weekday when vessel traffic is normally low. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 22A about the zone. Such notifications will be updated as necessary, to keep the maritime community informed of the status of the safety 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
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 safety zone lasting approximately five hours that will prohibit entry within 200 yards ahead of and 100 yards outboard or aft of the historic sloop-of-war USS CONSTELLATION. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration (REC) 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) With the exception of USS CONSTELLATION “turn-around” participants, and vessels at berth, mooring, or at anchor, entry into or remaining in this zone is prohibited, unless authorized by the Captain of the Port, Maryland—National Capital Region. All vessels underway within this safety zone at the time it is implemented shall depart the safety zone.
(3) Persons or vessels requiring entry into or passage through the moving safety zone must first request authorization from the Captain of the Port, Maryland—National Capital Region to seek permission to transit the area. The Captain of the Port, Maryland—National Capital Region can be contacted at telephone number (410) 576-2693 and on Marine Band Radio VHF Channel 16 (156.8 MHz). The Coast Guard vessels enforcing this section can be contacted on Marine Band Radio VHF Channel 16 (156.8 MHz). Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light, or other means, the person or vessel shall proceed as directed. If permission is granted, all persons or vessels must comply with the instructions of the Captain of the Port, Maryland—National
(4) The COTP Maryland—National Capital Region will notify the public of any changes in the status of this safety zone by Marine Safety Radio Broadcast on VHF-FM marine band radio channel 22A (157.1 MHZ).
(d)
(e)
Coast Guard, DHS.
Temporary interim rule and request for comments.
The Coast Guard is establishing a temporary safety zone on the navigable waters of Gerritsen Inlet surrounding the Belt Parkway Bridge. This action is necessary to provide for the safety of life on these navigable waters in Brooklyn, NY, during bridge replacement operations, both planned and unforeseen, until the new bridge is built and the existing bridge is removed. This regulation prohibits persons and vessels from being in the safety zone unless authorized by the Captain of the Port New York or a designated representative.
This rule is effective without actual notice from October 3, 2017 through December 31, 2018. For the purposes of enforcement, actual notice will be used from 12:01 a.m. on October 1, 2017 through October 3, 2017.
Comments and related material may be received by the Coast Guard during the effective period.
You may submit comments identified by docket number USCG-2017-0937 using the Federal eRulemaking Portal at
If you have questions on this rule, call or email Mr. Jeff Yunker, Coast Guard Sector New York, Waterways Management Division, telephone 718-354-4195, email
In a letter received by the Coast Guard on May 16, 2013 NYC DOT and their contractors outlined the first five phases of operations that require in-channel work in the construction and demolition of the Belt Parkway Bridge. On November 29, 2013, the Coast Guard published a NPRM titled “Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet, Brooklyn, NY” (78 FR 71546). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this bridge construction. During the comment period that ended December 20, 2013, we received no comments.
On May 12, 2014, the Coast Guard published a TIR and request for comments titled “Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet, Brooklyn, NY” (79 FR 26848). During the comment period that ended June 2, 2014, we received no comments.
On July 25, 2014 the Coast Guard published a correcting amendment titled “Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet, Brooklyn, NY” (79 FR 43255). There we corrected an inadvertent error included in one of the coordinates of the safety zone.
The NYC DOT has requested the USCG safety zone and the USCG bridge permit be extended until June 30, 2018, to complete all remaining contract operations in and over the channel, including, but not limited to, substructure concrete placements, steel erection, concrete bridge deck placements, installation of navigation lighting, channel clean up and final fathometric surveying. The Coast Guard is issuing this TIR with an effective date through December 31, 2018 in case of additional project delays due to unforeseen circumstances.
The Coast Guard is issuing this temporary interim 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), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking with respect to this rule because it is impracticable as it is necessary to protect the safety of both the construction crew and the waterway users operating in the vicinity of the bridge construction zone. A delay or cancellation of the currently ongoing bridge rehabilitation project in order to accommodate a full notice and comment period would delay necessary operations, result in increased costs, and delay the date when the bridge is expected to reopen for normal operations.
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 COTP has determined that potential hazards associated with the construction of the Belt Parkway replacement bridge over Gerritsen Inlet will be a safety concern for anyone within approximately 300 feet of the existing bridge. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during bridge construction.
As noted above, we received no comments on our NPRM published November 29, 2013 or on our TIR published May 12, 2014. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM or in the previous TIR except for the effective period.
This rule establishes a safety zone from 12:01 a.m. on October 1, 2017 through December 31, 2018. The safety zone will cover all navigable waters within approximately 300 feet of the existing Belt Parkway Bridge over Gerritsen Inlet. The duration of the zone is intended to ensure the safety of vessels and these navigable waters during bridge construction. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget, and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the fact that vessel traffic will only be restricted from this safety zone for limited durations and the safety zone covers only a small portion of the navigable waterway. The Coast Guard will notify the public whenever the safety zone is being enforced and whenever enforcement is suspended through Broadcast Notice to Mariners via VHF-FM marine channel 16, First Coast Guard District Local Notice to Mariners at
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 no comments 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 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 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 safety zone usually enforced for less than 1 hour that will prohibit entry within approximately 300 feet of the existing Belt Parkway Bridge over Gerritsen Inlet. It is categorically excluded from further review under paragraph 34(g) of
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 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 TIR as being available in the docket, and all public comments, will be in our online docket at
Marine safety, Navigation (water), Reporting and recordkeeping requirements, 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, 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(1) Designated Representative. A “designated representative” is any Coast Guard commissioned, warrant or petty officer of the U.S. Coast Guard who has been designated by the Captain of the Port Sector New York (COTP), to act on his or her behalf. The designated representative may be on an official patrol vessel or may be on shore and will communicate with vessels via VHF-FM radio or loudhailer. In addition, members of the Coast Guard Auxiliary may be present to inform vessel operators of this regulation.
(2) Official Patrol Vessels. Official patrol vessels may consist of any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement vessels assigned or approved by the COTP.
(c)
(1) This regulation is enforceable 24 hours a day from 12:01 a.m. on October 1, 2017 through December 31, 2018.
(2) Prior to commencing or suspending enforcement of this regulation, the COTP and designated on-scene patrol personnel will notify the public whenever the regulation is being enforced and whenever enforcement is lifted, to include dates and times. The means of notification will include, but are not limited to, Broadcast Notice to Mariners and Local Notice to Mariners, Marine Safety Information Bulletins, or other appropriate means.
(d)
(2) During periods of enforcement, all persons and vessels must comply with all orders and directions from the COTP or the COTP's designated representative.
(3) During periods of enforcement, upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light, or other means, the operator of the vessel must proceed as directed.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for one mile of navigable waters of the Roanoke River in Plymouth, North Carolina. This temporary safety zone is intended to restrict vessel traffic from a portion of the Roanoke River during the Virginia Outlaw Drag Boat Association End of the Year Showdown 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 safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP), North Carolina or a designated representative.
This rule is effective from 11 a.m. on October 7, 2017, through 6 p.m. on October 8, 2017.
To view documents mentioned in this preamble, go to
If you have questions on this rule, contact 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. The Coast Guard was not notified of the need for this rule until September 13, 2017. It is impracticable and contrary to the public interest to delay this action. Waiting for a comment period to run would inhibit the Coast Guards' ability to protect the public and participants from the dangers associated with the high speed boat race scheduled on October 7 and October 8, 2017.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary 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 COTP North Carolina has determined that potential hazards associated with the Virginia Outlaw Drag Boat Association End of the Year Showdown scheduled on October 7 and October 8, 2017, is a safety concern for mariners during the high speed boat race on the Roanoke River in Plymouth, 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 safety zone which will be enforced for portions of the day on October 7 and October 8, 2017, on the navigable waters of the Roanoke River in Plymouth, North Carolina. The safety zone will include all navigable waters from approximate positions: Latitude 35°52′25″ N., longitude 076°44′33″ W., then northwest to latitude 35°52′29″ N., longitude 076°44′37″ W., then southwest along the shoreline to latitude 35°52′00″ N., longitude 076°45′31″ W., then south to latitude 35°51′56″ N., longitude 076°45′30″ W., then northeast along the shoreline to the point of origin, on the Roanoke River, Plymouth, North Carolina. This safety zone will be established for the safety of mariners and participants during the high speed boat race. For safety reasons, no public spectators will be allowed to view the event from the waterway. Vessel traffic will be able to pass through the safety zone between race sets with permission. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP North Carolina or a designated representative.
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. 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, the 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 safety zone. The regulation enforcement period, approximately seven hours per day for two consecutive days, should not overly burden vessel traffic given its short duration. This safety zone will impact a one mile segment of the Roanoke River, Plymouth, NC. Additionally, the rule allows for vessel operators to request permission from the COTP North Carolina or the designated representative to enter and transit through the safety zone. The Coast Guard will issue a Broadcast Notice to Mariners to notify vessels in the region of the establishment of this 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 the precise number of small entities impacted is unknown, the Roanoke River has a low number of vessels transiting the area planned for the safety zone during the enforcement period. Although 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,
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 safety zone lasting 7 hours per day on two consecutive days that prohibits entry into a portion of Roanoke River, Plymouth, NC. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. 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) 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 vessels within this safety zone when this section becomes effective 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)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a safety zone on the waters of the St. Johns River in vicinity of Naval Air Station (NAS) Jacksonville, Florida during the Blue Angels Air Show. This rulemaking prohibits persons and vessels from being in the safety zone unless authorized by the Captain of the Port (COTP) Jacksonville or a designated representative.
This rule is effective from 8 a.m. on November 3, 2017 through 5 p.m. on November 5, 2017.
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 Allan Storm, Sector Jacksonville, Chief, Waterways Management Division, U.S. Coast Guard; telephone (904) 714-7616, email
On April 25, 2017, NAS Jacksonville submitted a marine event application to the Coast Guard for the Blue Angels Air Show that will take place from November 3, 2017 through November 5, 2017. The air show will consist of various flight demonstrations over the St. Johns River in vicinity of NAS Jacksonville. Over the years, there have been unfortunate instances of aircraft mishaps that involve crashing during performances at various air shows around the world. Occasionally, these incidents result in a wide area of scattered debris in the water that can damage property or cause significant injury or death to the public observing the air shows. The Captain of the Port (COTP) Jacksonville has determined that a safety zone is necessary to protect the general public from hazards associated with aerial flight demonstrations. In response, on August 1, 2017, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone, Blue Angels Air Show; St. Johns River, Jacksonville, FL (82 FR 35717). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this air show. During the comment period that ended August 31, 2017, we received no comments.
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP Jacksonville has determined that potential hazards associated with aerial flight demonstrations will be a safety concern for members of the public observing the event from the water. The purpose of the rule is to ensure the safety of vessels and persons on the navigable waters of the St. Johns River in vicinity of NAS Jacksonville, Florida.
As noted above, we received no comments on our NPRM published August 1, 2017. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.
This rule establishes a safety zone, from 8 a.m. to 5 p.m. on November 3, 2017 through November 5, 2017, on the waters of the St. Johns River in vicinity of NAS Jacksonville, Florida during the Blue Angels Air Show. The safety zone will encompass all waters within an area approximately three quarters of a mile parallel to the shoreline, and one mile out into the St. Johns River in Jacksonville, FL. The duration of the zone is intended to ensure the safety of the public and these navigable waters during the aerial flight demonstrations. No vessel or person is permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The Coast Guard will provide notice of the regulated area by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
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, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone which would impact a small designated area of the St. Johns River for nine hours on each of the three days the air show is occurring. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners 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 received no comments 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 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 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 safety zone that would prohibit persons and vessels from transiting through a one square mile regulated area during a three day air show lasting nine hours daily. 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) Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Jacksonville by telephone at (904) 714-7557, or a designated representative via VHF-FM radio on channel 16, to request authorization. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Jacksonville or a designated representative.
(3) The Coast Guard will provide notice of the regulated area through Broadcast Notice to Mariners via VHF-FM channel 16 or by on-scene designated representatives.
(d)
Environmental Protection Agency (EPA).
Final rule.
EPA is finalizing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes, which was the subject of premanufacture notice (PMN) P-11-482. This action requires persons who intend to manufacture (defined by statute to include import) or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use is unable to commence until EPA has conducted a
This final rule is effective November 2, 2017.
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2016-0207. All documents in the docket are listed in the docket index available at
You may be potentially affected by this action if you manufacture, process, or use the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482). 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, but are not limited to:
Manufacturers (including importers) or processors of the subject chemical substance (NAICS codes 325 and 324110),
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127, and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to a SNUR must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export the chemical substance that is the subject of a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
EPA is finalizing a SNUR for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482). This final action requires persons who intend to manufacture or process the chemical substance for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. In the
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III of this document. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. Persons who must report are described in § 721.5.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to
Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482), EPA considered relevant information about the toxicity of the chemical substance, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.
During review of the PMN P-11-482, the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes, EPA concluded that one or more of the criteria of concern established at § 721.170 were met. For additional discussion on this chemical substance, see Unit II. of this rule.
EPA is issuing this SNUR for a specific chemical substance which has undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:
• EPA will receive notice of any person's intent to manufacture or process a TSCA Chemical Substance Inventory (TSCA Inventory) listed chemical substance for the described significant new use before that activity begins.
• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.
• EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at
If uses begun after the proposed rule was published were considered ongoing rather than new, any person could defeat the SNUR by initiating the significant new use before the final rule was issued. Therefore, EPA designated the date of public release/web posting of the proposed rule, as the cutoff date for determining whether the new use is ongoing. Consult the
EPA recognizes that TSCA section 5 does not require developing any particular new information (
In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to
In the TSCA section 5(e) consent orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the
Any request by EPA for the triggered and pended testing described in the Consent Order was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substance. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.
The recommended tests specified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
• Human exposure and environmental release that may result from the significant new use of the chemical substances.
According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at
EPA evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substance during the development of the direct final rule. The Agency's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2016-0207.
EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the risk assessment documents included in the public docket. These information sources supply information relevant to whether a particular use would be a significant new use, based on relevant factors including those listed under TSCA section 5(a)(2).
The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this proposed significant new use rule, in Unit II and in the documents noted above. EPA recognizes, based on the available information, that there is variability and uncertainty in whether any particular significant new use would actually present an unreasonable risk. For precisely this reason, it is appropriate to secure a future notice and review process for these uses, at such time as they are known more definitely. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule.
This action establishes a SNUR for the chemical substance that is the subject of a PMN and a TSCA section 5(e) consent order. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review
According to the PRA, (44 U.S.C. 3501
EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.
The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601
1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost significantly more than $8,300.
A copy of that certification is available in the docket for this action.
This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit IX. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:
• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
• Submission of the SNUN would not cost any small entity significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this final rule. As such, EPA has determined that this final rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501
This action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).
This final rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This final rule does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this final rule.
This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks
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), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.
In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Reporting and recordkeeping requirements.
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
7 U.S.C. 135
15 U.S.C. 2604, 2607, and 2625(c).
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
Environmental Protection Agency.
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve a revision to the South Carolina State Implementation Plan (SIP), submitted by the South Carolina Department of Health and Environmental Control (DHEC), on December 7, 2016, addressing the Clean Air Act (CAA) interstate transport (prongs 1 and 2) infrastructure SIP requirements for the 2010 1-hour Nitrogen Dioxide (NO
This rule will be effective November 2, 2017.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2017-0045. All documents in the docket are listed on the
Andres Febres of the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Febres can be reached by telephone at (404) 562-8966 or via electronic mail at
By statute, SIPs meeting the requirements of sections 110(a)(1) and (2) of the CAA are to be submitted by states within three years after promulgation of a new or revised NAAQS to provide for the implementation, maintenance, and enforcement of the new or revised NAAQS. EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Sections 110(a)(1) and (2) require states to address basic SIP elements such as requirements for monitoring, basic program requirements, and legal authority that are designed to assure attainment and maintenance of the newly established or revised NAAQS. More specifically, section 110(a)(1) provides the procedural and timing requirements for infrastructure SIPs. Section 110(a)(2) lists specific elements that states must meet for the infrastructure SIP requirements related to a newly established or revised NAAQS. The contents of an infrastructure SIP submission may vary depending upon the data and analytical tools available to the state, as well as the provisions already contained in the state's implementation plan at the time in which the state develops and submits the submission for a new or revised NAAQS.
Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and 110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct components, commonly referred to as “prongs,” that must be addressed in infrastructure SIP submissions. The first two prongs, which are codified in section 110(a)(2)(D)(i)(I), are provisions that prohibit any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS in another state (prong 1) and from interfering with maintenance of the NAAQS in another state (prong 2). The third and fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit emissions activity in one state from interfering with measures required to prevent significant deterioration of air quality in another state (prong 3) and from interfering with measures to protect visibility in another state (prong 4). Section 110(a)(2)(D)(ii) requires SIPs
On January 22, 2010, EPA established a new 1-hour primary NAAQS for NO
States were required to submit infrastructure SIP submissions for the 2010 1-hour NO
In a notice of proposed rulemaking published August 15, 2017 (82 FR 38646), EPA proposed to approve South Carolina's December 7, 2016, SIP submission concluding that its SIP adequately addresses prong 1 and prong 2 requirements for the 2010 1-hour NO
The details of South Carolina's submission and the rationale for EPA's action are explained in the August 15, 2017, notice of proposed rulemaking. Comments on the proposed rulemaking were due on or before September 14, 2017. EPA did not receive any adverse comments on the proposed action.
As described above, EPA is taking final action to approve South Carolina's December 7, 2016, SIP revision addressing prongs 1 and 2 of CAA section 110(a)(2)(D)(i) for the 2010 1-hour NO
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);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this action for the state of South Carolina does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it does not have substantial direct effects on an Indian Tribe. The Catawba Indian Nation Reservation is located within the State of South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120, “all state and local environmental laws and regulations apply to the [Catawba Indian Nation] and Reservation and are fully enforceable by all relevant state and local agencies and authorities.” However, EPA has determined that this action does not have substantial direct effects on an Indian Tribe because it is not approving any specific rule, but rather determining that South Carolina's already approved SIP meets certain CAA requirements. EPA notes this action will not impose substantial direct costs on Tribal governments or preempt Tribal law.
The Congressional Review Act, 5 U.S.C. 801
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 December 4, 2017. 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
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve the 2011 base year inventory for the Baltimore, Maryland moderate nonattainment area for the 2008 8-hour ozone national ambient air quality standard (NAAQS). The State of Maryland submitted the emission inventory through the Maryland Department of the Environment (MDE) to meet the nonattainment requirements for moderate ozone nonattainment areas for the 2008 8-hour ozone NAAQS. EPA is approving the 2011 base year emissions inventory for the 2008 8-hour ozone NAAQS as a revision to the Maryland state implementation plan (SIP) in accordance with the requirements of the Clean Air Act (CAA).
This rule is effective on December 4, 2017 without further notice, unless EPA receives adverse written comment by November 2, 2017. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2017-0396 at
Gavin Huang, (215) 814-2042, or by email at
Ground level ozone is formed when nitrogen oxides (NO
On July 18, 1997, EPA promulgated a revised ozone NAAQS of 0.08 ppm, averaged over eight hours. 62 FR 38855. This 8-hour ozone NAAQS was determined to be more protective of public health than the previous 1979 1-hour ozone NAAQS. In 2008, EPA revised the 8-hour ozone NAAQS from 0.08 to 0.075 ppm.
On May 21, 2012, the Baltimore, Maryland area was designated as moderate nonattainment for the 2008 8-hour ozone NAAQS. 77 FR 30088. The designation of the Baltimore, Maryland area as moderate nonattainment was effective July 20, 2012. The Baltimore, Maryland nonattainment area is comprised of Anne Arundel County, Baltimore County, Baltimore City, Carroll County, Harford County, and Howard County. Under section 172(c)(3) of the CAA, Maryland is required to submit a comprehensive, accurate, and current inventory of actual emissions from all sources of the relevant pollutants in its moderate nonattainment area.
Under CAA section 172(c)(3), states are required to submit a comprehensive, accurate, and current account of actual emissions from all sources (point, nonpoint, nonroad, and onroad) in the nonattainment area. CAA section 182(a)(1) and (b) requires that areas designated as nonattainment and classified as moderate submit an inventory of all sources of ozone precursors no later than 2 years after the effective date of designation. EPA's guidance for emissions inventory development calls for actual emissions to be used in the base year inventory. The state must report annual emissions as well as “summer day emissions.” As defined in 40 CFR 51.900(v), “summer day emissions” means, “an average day's emissions for a typical summer work weekday. The state will select the particular month(s) in summer and the day(s) in the work week to be represented.”
On December 30, 2016, MDE submitted a formal revision (SIP #16-16) to its SIP. The SIP revision consists of the 2011 base year inventory for the Baltimore, Maryland nonattainment area for the 2008 8-hour ozone NAAQS. In accordance with EPA's requirements for ozone SIP planning, “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements,” MDE selected 2011 for its base year emissions inventory.
Table 1 summarizes the 2011 VOC and NO
Point sources are large, stationary, and identifiable sources of emissions that release pollutants into the atmosphere. For the 2011 inventory, point sources are defined as stationary commercial or industrial operations that emit more than 10 tpy of VOC or 25 tpy of NO
Quasi-point sources are sources that contain a wide variety of air emission sources, including traditional point sources, on-road mobile sources, off-road mobile sources, and area sources. For these sources, the emissions are totaled under a single point source and referred to as a “quasi-point source.” MDE identified three facilities that met these requirements which include the Aberdeen Proving Grounds, Baltimore Washington International Airport, and the Port of Baltimore.
Nonpoint sources, also known as area sources, are sources of pollution that are small and numerous and have not been inventoried as specific point or mobile sources. For example, these sources include residential heating emissions and emissions from consumer solvents. To inventory these sources, they are grouped so that emissions can be estimated collectively using one methodology. MDE calculated nonpoint emissions for the Baltimore, Maryland nonattainment area by multiplying emissions factors specific for each source category with some known indicator of collective activity for each source category, such as population or employment data.
Nonroad sources are mobile sources other than onroad vehicles, including aircraft, locomotives, construction and agricultural equipment, and marine vessels. Emissions from different source categories are calculated using various methodologies. The methodologies used for nonroad source emission estimates include EPA's National Mobile
Onroad or highway sources are vehicles, such as cars, trucks, and buses, which are operated on public roadways. These onroad emissions were estimated using EPA's Motor Vehicle Emission Simulator (MOVES) model, version 2010a, using appropriate activity levels, such as vehicle miles traveled (VMT) estimates developed from vehicle count data maintained by the State Highway Administration (SHA) of the Maryland Department of Transportation (MDOT).
M-A-R sources include marine vessels, airports, and railroad locomotives. M-A-R emissions were estimated using data from surveyed sources or state and federal reporting agencies.
EPA reviewed Maryland's 2011 base year emission inventory's results, procedures, and methodologies for the Baltimore, Maryland moderate nonattainment area and found them to meet the applicable requirements for approval under sections 110, 172(c)(3) and 182(a)(1) and (b) of the CAA. EPA's review and analysis is detailed in a Technical Support Document (TSD) prepared for this rulemaking. The TSD is available online at
EPA is approving the Maryland SIP revision which includes the 2011 base year inventory for the 2008 8-hour ozone NAAQS for the Baltimore, Maryland moderate nonattainment area because the inventory was prepared in accordance with requirements in sections 110, 172(c)(3) and 182(a)(1) and (b) of the CAA and its implementing regulations including 40 CFR 51.915. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of this issue of the
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
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 December 4, 2017. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this issue of the
This action approving Maryland's 2011 base year inventory for the 2008 8-hour ozone NAAQS for the Baltimore, Maryland moderate nonattainment area may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(e) * * *
(r) EPA approves as a revision to the Maryland state implementation plan the 2011 base year emissions inventory for the Baltimore, Maryland moderate nonattainment area for the 2008 8-hour ozone national ambient air quality standards submitted by the Maryland Department of the Environment on December 30, 2016. The 2011 base year emissions inventory includes emissions estimates that cover the general source categories of stationary point, quasi-point, area (nonpoint), nonroad mobile, onroad mobile, and Marine-Air-Rail (M-A-R). The inventory includes actual annual emissions and typical summer day emissions for the months of May through September for the ozone precursors, VOC and NO
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; inseason General category bluefin tuna quota transfer.
NMFS is transferring 156.4 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Reserve category to the General category for the remainder of the 2017 fishing year, to account for overharvests of the January, June through August, and September subquotas. This action is intended to preserve the opportunity for General category fishermen to participate in the October through November and December General category fisheries to the extent that transferrable quota is available and is based on consideration of the regulatory determination criteria regarding inseason adjustments and applies to Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels when fishing commercially for BFT.
The quota transfer is effective September 28, 2017 through December 31, 2017.
Sarah McLaughlin or Brad McHale, 978-281-9260.
Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
The base quota for the General category is 466.7 mt, as established in the 2015 BFT quota final rule (80 FR 52198, August 28, 2015). See § 635.27(a). Each of the General category time periods (January, June through August, September, October through November, and December) is allocated a “subquota” or portion of the annual General category quota. Although it is called the “January” subquota, the regulations allow the General category fishery under this quota to continue until the subquota is reached or March 31, whichever comes first. The subquotas for each time period are as follows: 24.7 mt for January; 233.3 mt for June through August; 123.7 mt for September; 60.7 mt for October through November; and 24.3 mt for December. Any unused General category quota rolls forward within the fishing year, which coincides with the calendar year, from one time period to the next, and is available for use in subsequent time periods. On December 19, 2016, NMFS published an inseason action transferring 16.3 mt of BFT quota from the December 2017 subquota to the
Under § 635.27(a)(9), NMFS has the authority to transfer quota among fishing categories or subcategories, after considering regulatory determination criteria at § 635.27(a)(8). NMFS has considered all of the relevant determination criteria and their applicability to the General category fishery. These considerations include, but are not limited to, the following:
NMFS considered the catches of the General category quota to date (including during the summer/fall and winter fisheries in the last several years), and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). Preliminary landings data as of September 22, 2017, indicate that the General category has landed 596 mt this year, which exceeds the overall General category quota of 506.7 mt. NMFS closed the General category fishery when the September subquota (123.7 mt) was met, effective September 17, 2017 (82 FR 43711, September 19, 2017). Without a quota transfer at this time, the October through November and December General category subquotas would not be available to General category participants because the entire General category quota of 506.7 mt has been reached and exceeded. Approximately 81 percent (717.3 mt) of the total of the BFT subquotas for all commercial categories (888.7 mt, as published in the 2015 BFT quota final rule) has been harvested as of September 22, 2017, however, and NMFS anticipates that some amount of quota may remain unused by the end of the year even with the transfer. Absent a transfer at this time, this segment of the fishery would have to remain closed if no adjustment is made, even though NMFS anticipates that commercial-sized BFT will be readily available to vessels fishing under the General category quota when the General category fishery is scheduled to reopen on October 1, 2017. Transferring 156.4 mt of BFT quota from the Reserve category would allow this segment of the fishery to continue fishing and would result in a total of 663.1 mt being available to the General category for the 2017 General category fishing season.
Regarding the projected ability of the vessels fishing under the particular category quota (here, the General category) to harvest the additional amount of BFT quota transferred before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS considered General category landings over the last several years and landings to date this year. Landings are highly variable and depend on access to commercial-sized BFT and fishing conditions, among other factors. A portion of the transferred quota covers overharvests in the category as prosecuted to date, and thus has already been harvested. For the remainder of the transferred quota, which make the remaining subquotas whole to the extent that transferrable quota is available, there is a high probability that the transferred quota will be harvested during the October through November and December time periods.
NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2017 landings and dead discards. In the last several years, total U.S. BFT landings have been below the total available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2017 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and NMFS anticipates having sufficient quota to do that.
Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by General category fishermen and provided by BFT dealers continue to provide NMFS with valuable data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT over the longest time-period allowable would support the collection of a broad range of data for these studies and for stock monitoring purposes.
This transfer would be consistent with the current U.S. quota, which was established and analyzed in the 2015 BFT quota final rule, and with objectives of the 2006 Consolidated HMS FMP and amendments. (§ 635.27(a)(8)(v) and (vi)). Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and Amendment 7, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)).
Based on the considerations above, NMFS is transferring all of the available 156.4 mt from the Reserve category to the General category with the objective of making the remaining subquotas whole. Therefore, NMFS adjusts the General category quota to 663.1 mt for the 2017 General category fishing season (
NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. General and HMS Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing
NMFS reminds General category participants that when the fishery reopens October 1, 2017, the BFT General category daily retention limit will be one large medium or giant BFT (measuring 73″ or greater) per vessel per day/trip.
The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:
The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Affording prior notice and opportunity for public comment to implement the quota transfer for the remainder of 2017 is impracticable and contrary to the public interest as such a delay would result in continued closure of the General category fishery (because the available quota has been met) and the need to re-open the fishery later in the October through November time period, rather than the fishery automatically re-opening on October 1. The delay would preclude the fishery from harvesting BFT that are available on the fishing grounds and that might otherwise become unavailable during a delay. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For these reasons, there also is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.
This action is being taken under § 635.27(a)(9) (Inseason adjustments) and is exempt from review under Executive Order 12866.
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; inseason adjustment.
This action decreases the possession and trip limits for Georges Bank cod for Northeast multispecies common pool vessels for the remainder of the 2017 fishing year, through April 30, 2018. Recent catch data reported through September 19, 2017, indicates that the common pool fishery has already caught 2.4 metric tons, or 65.7 percent, of the Trimester 2 Georges Bank cod Total Allowable Catch since the second trimester began on September 1, 2017. We project that, at its current trajectory, the common pool will catch its Trimester 2 TAC well before the end of the second trimester, and is also at risk of exceeding its annual 2017 quota. This possession and trip limit decrease is intended to prevent the common pool fishery from exceeding its allocation for this stock prior to the end of the fishing year.
This possession and trip limit decrease is effective September 28, 2017, through April 30, 2018.
Claire Fitz-Gerald, Fishery Management Specialist, (978) 281-9255.
The regulations at § 648.86(o) authorize the Regional Administrator to adjust the possession and trip limits for common pool vessels in order to help prevent the overharvest or underharvest of the common pool quotas.
Recent catch data reported through September 19, 2017, indicates that the common pool fishery has already caught 2.4 metric tons, or 65.7 percent, of the Trimester 2 Georges Bank (GB) cod Total Allowable Catch (TAC) since the second trimester began on September 1, 2017. The current GB cod possession and trip limit for GB cod is 250 pounds per DAS, and up to 500 pounds per trip. Under these possession limits, the common pool fishery caught its Trimester 1 TAC and triggered an area closure for GB cod on July 27, 2017. We project that, at its current trajectory, the common pool will catch its Trimester 2 TAC well before the end of the second trimester, and is also at risk of exceeding its annual 2017 quota. In the event that the common pool exceeds its 2017 quota, regulations require that the overage must be deducted from the following year's quota, which would have a negative economic impact on common pool vessels. Therefore, a decrease to the possession and trip limits is being implemented to help prevent the common pool fishery from exceeding its quota for the 2017 fishing year.
Effective September 28, 2017, the GB cod possession and trip limits are decreased to 25 lb (11.3 kg) per day and 50 lb (22.7 kg) per trip, as summarized in the table below. Common pool groundfish vessels that have declared their trip through the vessel monitoring system (VMS) or interactive voice response system, and crossed the VMS demarcation line prior to September 28, 2017, are not subject to the new possession and trip limits for that trip.
Weekly quota monitoring reports for the common pool fishery are on our Web site at:
This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.
The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3) to waive prior notice and the opportunity for public comment and the 30-day delayed effectiveness period because it would be impracticable and contrary to the public interest.
The regulations at § 648.86(o) authorize the Regional Administrator to adjust the Northeast multispecies possession and trip limits for common pool vessels in order to help prevent the overharvest or underharvest of the pertinent common pool quotas. The catch data used as the basis for this action only recently became available. The available analysis indicates that the common pool fishery has already achieved 65.7 percent of its second trimester GB cod TAC within the first three weeks of the trimester and if the GB cod possession and trip limits are not reduced immediately, the common pool fishery may exceed its quota for this stock. This action reduces the probability of the common pool fishery exceeding its quota for GB cod. Any overages of the common pool quota for this stock would undermine conservation objectives and trigger the implementation of accountability measures that would have negative economic impacts on the common pool vessels. The time necessary to provide for prior notice and comment, and a 30-day delay in effectiveness, would prevent NMFS from implementing the necessary possession and trip limit adjustment in a timely manner, which could undermine conservation objectives of the Northeast Multispecies Fishery Management Plan, and cause negative economic impacts to the common pool fishery.
16 U.S.C. 1801
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish two special anchorage areas in the Passagassawakeag River in the vicinity of Belfast, Maine. This proposed action is necessary to facilitate safe navigation in that area and provide safe and secure anchorages for vessels less than 20 meters in length. This action is intended to increase the safety of life and property in the Passagassawakeag River in the vicinity of Belfast, improve the safety of anchored vessels, and provide for the overall safe and efficient flow of vessel traffic and commerce. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before December 4, 2017.
You may submit comments identified by docket number USCG-2016-0989 in the Federal eRulemaking Portal
If you have questions about this proposed rulemaking, contact Mr. Craig Lapiejko, Waterways Management at Coast Guard First District, telephone (617) 223-8351, email
Beginning in the fall of 2008, the Town of Belfast, Maine (ME) Harbor Committee began to discuss the possibility of designating a special anchorage area in the waters off Belfast in the Passagassawakeag River due to the rise of commercial and recreational vessel traffic. Over the next several years the Belfast harbormaster had several discussions with the First Coast Guard District, Waterways Management Division, to understand the processes involved with creating a special anchorage area. In March 2016, the harbormaster submitted a draft proposal to the Belfast City Council and subsequently the town began talks with Coast Guard Sector Northern New England regarding establishment of a special anchorage area in Belfast.
The proposed special anchorage areas are intended to reduce the risk of vessel collisions and to promote safe and efficient travel in the navigable channel of the Passagassawakeag River to the mouth of Belfast Bay clearly defining the mooring fields historically used by the town. All proposed coordinates are North American Datum 1983 (NAD 83).
The rule is intended to reduce the risk of vessel collisions by creating two special anchorage areas in the Passagassawakeag River in the vicinity of the northeastern portion of Belfast, ME. The Coast Guard proposes this rulemaking under the authority established in 33 U.S.C. 471, 1221 through 1236, and 2071.
The proposed rule would create two special anchorage areas, referred to as special anchorage areas A and B in the Passagassawakeag River in the vicinity of Belfast, ME. Special anchorage area A is approximately 554,800 sq. yards and is on the north side of the river located between the mouth of the Goose River and Patterson Pt, downstream of the US RT 1 Bridge. Special anchorage area B is approximately 693,889 sq. yards and located along the southern shores of the river located between the Belfast Town docks to Belfast City Park.
Vessels less than 20 meters in length, when at anchor in these special anchorage areas, will not be required to sound signals or display anchorage lights or shapes when at anchor. Additionally, mariners using these anchorage areas are encouraged to contact local and state authorities, such as the local harbormaster, to ensure compliance with any additional applicable state and local laws. Such laws may involve, for example, compliance with direction from the local harbormaster when placing or using moorings within the anchorage.
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.
Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”
The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771.
We anticipate the economic impact of the proposed rule to not be significant. This proposed determination is based on the historic and current use of the area as well as the minimal impact this proposed rule would have on surface navigation. The potential impact would be minimized for the following reasons: 1) normal surface navigation will not be affected as these two areas in the Passagassawakeag River in the vicinity of the northeastern portion of Belfast has been historically used as a mooring field by the Town of Belfast; and 2) this proposed rule would simply permit eligible vessels in existing mooring areas to not to sound signals or exhibit anchor lights or shapes when at anchor there.
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 Passagassawakeag River in Belfast, ME may be small entities, for the reasons stated above in section IV.A, 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 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 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 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 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 the establishment of special anchorage areas. It appears that this action may be categorically excluded from further review under paragraph 34(f) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary Record of Environmental Consideration is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact 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
Anchorage grounds.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 110 as follows:
33 U.S.C. 471; 1221 through 1236, 2071; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(2)
All coordinates referenced use datum: NAD 83. All anchoring in the areas is under the supervision of the town of Belfast harbormaster or other such authority as may be designated by the authorities of the Town of Belfast, Maine. Mariners using these special anchorage areas are encouraged to contact local and state authorities, such as the local harbormaster, to ensure compliance with any additional applicable state and local laws.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to expand the geographical boundaries of a permanent security zone at Port Canaveral Harbor. This action is necessary to ensure the security of vessels, facilities, and the surrounding areas within this zone. This rule is intended to prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within the security zone unless authorized by the Captain of the Port (COTP) Jacksonville or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before November 3, 2017.
You may submit comments identified by docket number USCG-2017-0146 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Lieutenant Allan Storm, Sector Jacksonville, Waterways Management Division, U.S. Coast Guard; telephone (904) 714-7616, email
On October 3, 1988, the Coast Guard published a final rule creating a permanent security zone at Port Canaveral Harbor, Cape Canaveral,
The U.S. Navy requested to amend the current regulation in 33 CFR 165.705(b) to expand the geographical boundaries to include the northern and northeastern portion of the Middle Basin of Port Canaveral Harbor in order to ensure the safety and security of military assets and infrastructure along the entire CCAFS waterfront.
The COTP Jacksonville has determined it is necessary to expand the security zone to ensure the security of military assets and waterfront facilities from destruction, loss, or injury from sabotage or other subversive acts, accidents or other causes of a similar nature, while still allowing for safe navigation within the Middle Basin of Port Canaveral Harbor. The proposed expanded geographical boundaries would encompass the entire CCAFS waterfront in the middle basin, with a perpendicular boundary distance from the shore varying from approximately 120 feet to 665 feet. The purpose of the proposed rule is to ensure the security of vessels, facilities, and the surrounding areas within the security zone. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.
The Coast Guard proposes to expand the geographical boundaries of the current regulated area in 33 CFR 165.705(b) to include the navigable waters of the Port Canaveral Harbor's Middle Basin. The proposed amendment would redesignate § 165.705(b) to new § 165.705(a)(2) and would read as follows: “Security Zone B. Middle Basin, Port Canaveral Harbor, at Cape Canaveral Air Force Station, Brevard County, Florida. All waters within the following coordinates inside the Middle Basin: starting at Point 1 in position 28°24′54.49″ N., 80°36′39.13″ W.; thence south to Point 2 in position 28°24′53.27″ N., 80°36′39.15″ W.; thence east to Point 3 in position 28°24′53.25″ N., 80°36′30.41″ W.; thence south to Point 4 in position 28°24′50.51″ N., 80°36′30.41″ W.; thence southeast to Point 5 in position 28°24′38.15″ N., 80°36′17.18″ W.; thence east to Point 6 in position 28°24′38.16″ N., 80°36′ 14.92″ W.; thence northeast to Point 7 in position 28°24′39.36″ N., 80°36′13.37″ W.; thence following the land based perimeter boundary to the point of origin.”
The proposed rule would also make the following amendments: (1) Change the title of the existing regulation in 33 CFR 165.705 from “Port Canaveral Harbor, Cape Canaveral, Florida” to “Security Zones: Port Canaveral Harbor, Cape Canaveral Air Force Station, FL”; (2) add a new paragraph (c) and change the title to “(c) Regulations”; (3) redesignate existing paragraph (d) as new paragraph (c)(1) with minor non-substantive changes; (4) redesignate existing paragraph (c) as new paragraph (c)(2) with minor non-substantive changes; (5) and add a new paragraph (c)(3), which states: “Persons desiring to enter, transit through, anchor in, or remain within the security zone may request permission from the COTP Jacksonville by telephone at 904-714-7557, or a designated representative via VHF-FM radio on channel 16. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Jacksonville or the designated representative.” Lastly, we propose to add a new paragraph (b), entitled “Definitions” and propose a new definition for the term “designated representative.”
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 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”
The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See the OMB Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
The economic impact of this proposed rule is not significant. Although persons and vessels may not enter, transit through, anchor it, or remain within the security zone without authorization from the COTP Jacksonville or a designated representative, they may operate in the navigable water adjacent to the proposed security zone and the Federal channel.
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 security 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 a substantial number of small entities.
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,
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 E.O. 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 E.O. 13132.
Also, this proposed rule does not have tribal implications under E.O. 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 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 proposed rule would not result in such an expenditure, the Coast Guard discusses the effects of this rule elsewhere in this preamble.
We have analyzed this proposed 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 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. The proposed rule involves expanding the geographical boundaries of a permanent security zone that will prohibit entry within certain navigable waters of the Port Canaveral Harbor's Middle Basin.
Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary Record of Environmental Consideration (REC) 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
Public participation is essential to effective rulemaking, and the Coast Guard will consider all comments and related materials 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)
(1) Security Zone A. East (Trident) Basin, Port Canaveral Harbor, at Cape Canaveral Air Force Station, Brevard County, Florida. All waters of the East Basin north of latitude 28°24′36″ N.
(2) Security Zone B. Middle Basin, Port Canaveral Harbor, at Cape Canaveral Air Force Station, Brevard County, Florida. All waters within the following coordinates inside the Middle Basin: Starting at Point 1 in position 28°24′54.49″ N., 80°36′39.13″ W.; thence south to Point 2 in position 28°24′53.27″ N., 80°36′39.15″ W.; thence east to Point 3 in position 28°24′53.25″ N., 80°36′30.41″ W.; thence south to Point 4 in position 28°24′50.51″ N., 80°36′30.41″ W.; thence southeast to Point 5 in position 28°24′38.15″ N., 80°36′17.18″ W.; thence east to Point 6 in position 28°24′38.16″ N., 80°36′14.92″ W.; thence northeast to Point 7 in position 28°24′39.36″ N., 80°36′13.37″ W.; thence following the land based perimeter boundary to the point of origin. These coordinates are based on North American Datum 1983.
(b)
(c)
(1) The general regulations governing security zones found in 33 CFR 165.33 apply to the security zones described in paragraph (a) of this section.
(2) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the security zone unless authorized by the COTP Jacksonville or a designated representative.
(3) Persons desiring to enter, transit through, anchor in, or remain within the security zone may request permission from the COTP Jacksonville by telephone at 904-714-7557, or a designated representative via VHF-FM radio on channel 16. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Jacksonville or the designated representative.
Postal Service
Request for comments.
The Postal Service is contemplating amendment of the
Submit comments on or before November 2, 2017.
Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to
You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor North, Washington, DC 20260. These records are available for review on Monday through Friday, 9 a.m.-4 p.m., by calling 202-268-2906.
Direct questions or comments to Lizbeth J. Dobbins by email at
Overweight parcels should never be accepted for delivery into the postal network. On occasion an item, such as a returns parcel, gets into the Postal network and arrives at a destination plant or post office. It is unsafe to return the item back through the postal network so the receiving office contacts the customer and asks the customer to pick up the package. Sometimes the package is abandoned which creates another safety issue trying to dispose of the overweight item.
Part of the challenge is that we do not want overweight items at any time since these items cause numerous safety issues and we strongly discourage mailers from entering them into the postal system. We do not accept them at postal retail counters either and yet, these items still get into the postal system.
In order to discourage unsafe practices, the Postal Service is seeking input from the mailing community about how to prevent overweight packages from entering the postal system, and if they get into the postal system, the appropriate postage to be paid. The maximum weight for postage payment is 70 pounds.
One partial remedy would be to assess additional postage on overweight parcels discovered in the postal network. Thus, if a package weight is 75 pounds, and it arrives at the destination office, with postage calculated at 70 pounds, an additional 5 pounds worth of postage could be collected (70 plus 5). Or if the item is 80 pounds, postage would be collected on the additional 10 pounds. This would appear to provide the Postal Service with at least some degree of reimbursement for the extra service provided.
As a further deterrent, another possibility would be to charge not only additional postage, but an additional penalty fee (perhaps $20.00). Thus, for an 80 pound parcel the total amount due would include the postage payment for 70 pounds, a postage surcharge for the additional 10 pounds and a $20 penalty.
Since HAZMAT parcels have lower maximum weight limits, and overweight HAZMAT parcels may pose additional safety challenges, it would seem appropriate to provide an additional element of deterrence with regard to the mailing of such items. Thus, for example, if a 65-pound HAZMAT package exceeded the maximum weight limit of 25 pounds, the amount due might include not only the postage on the actual weight of the package, but an additional surcharge of $20.00 for each 10 pounds (or fraction thereof) in excess of the applicable weight limit.
We look forward to feedback on this important safety issue.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) proposes to approve, as a state implementation plan (SIP) revision, the 2011 base year inventory for the Baltimore, Maryland moderate nonattainment area for the 2008 8-hour ozone national ambient air quality standard (NAAQS) submitted by the State of Maryland through the Maryland Department of the Environment (MDE). In the Final Rules section of this issue
Comments must be received in writing by November 2, 2017.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2017-0396 at
Gavin Huang, (215) 814-2042, or by email at
For further information, please see the information provided in the direct final action, with the same title, that is located in the “Rules and Regulations” section of this issue of the
Federal Communications Commission.
Petition for Reconsideration.
A Petition for Reconsideration (Petition) has been filed in the Commission's rulemaking proceeding by Rick Chessen, on behalf of NCTA-The Internet & Television Association.
Oppositions to the Petition must be filed on or before October 18, 2017. Replies to an opposition must be filed on or before October 30, 2017.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Lyle Elder, Media Bureau, at (202) 418-2365 or email:
This is a summary of the Commission's document, Report No. 3081, released September 21, 2017. The full text of the Petition is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554. It also may be accessed online via the Commission's Electronic Comment Filing System at:
Fish and Wildlife Service, Interior.
Proposed rule; supplemental.
We, the U.S. Fish and Wildlife Service (Service), proposed in an earlier document this year to establish annual hunting regulations for certain migratory game birds for the 2018-19 hunting season. This supplement to that proposed rule provides the regulatory alternatives for the 2018-19 duck hunting seasons, announces the Service Migratory Bird Regulations Committee (SRC) and Flyway Council meetings, and provides Flyway Council recommendations resulting from their March meetings.
You may submit comments on the proposals by one of the following methods:
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Ron W. Kokel at: Division of Migratory Bird Management, U.S. Fish and Wildlife Service, Department of the Interior, MS: MB, 5275 Leesburg Pike, Falls Church, VA 22041; (703) 358-1714.
As part of DOI's retrospective regulatory review, 2 years ago we developed a schedule for migratory game bird hunting regulations that is more efficient and provides hunting season dates much earlier than was possible under the old process. The new process makes planning easier for the States and all parties interested in migratory bird hunting. Beginning in the summer of 2015, with the development of the 2016-17 hunting seasons, we started promulgating our annual migratory game bird hunting regulations using a new schedule that combines the previously used early- and late-season regulatory processes into a single process. We make decisions for harvest management based on predictions derived from long-term biological information and established harvest strategies and, therefore, can establish migratory bird hunting seasons much earlier than the system we used for many years. Under the new process, we develop proposed hunting season frameworks for a given year in the fall of the prior year. We then finalize those frameworks a few months later, thereby enabling the State agencies to select and publish their season dates in early summer. We provided a detailed overview of the new process in the August 3, 2017,
The SRC will meet October 17-18, 2017, to review information on the current status of migratory game birds, consider Flyway Council recommendations, and develop 2018-19 migratory game bird regulations recommendations for these species. In accordance with Departmental policy, these meetings are open to public observation. You may submit written comments to the Service on the matters discussed.
On August 3, 2017, we published a proposal to amend title 50 of the Code of Federal Regulations (CFR) at part 20 (82 FR 36308). The proposal provided a background and overview of the migratory bird hunting regulations process, and addressed the establishment of seasons, limits, and other regulations for hunting migratory game birds under §§ 20.101 through 20.107, 20.109, and 20.110 of subpart K. This document is the second in a series of proposed, supplemental, and final rules for migratory game bird hunting regulations. We will publish additional supplemental proposals for public comment in the
All sections of this and subsequent documents outlining hunting frameworks and guidelines are organized under the numbered headings set forth in the August 3, 2017, proposed rule (82 FR 36308). Later sections of this and subsequent documents will refer only to numbered items requiring attention. Therefore, it is important to note that we will omit those items requiring no attention, and remaining numbered items will be discontinuous, thereby making the list appear incomplete.
The regulatory alternatives for the 2018-19 duck hunting seasons are shown at the end of this document. We plan to publish proposed season frameworks in mid-December 2017. We plan to publish final season frameworks in late February 2018.
This proposed rulemaking describes recommended changes or specific preliminary proposals that vary from the 2017-18 regulations and issues requiring discussion, action, or the attention of the States or tribes. We will publish responses to all proposals and written comments when we develop final frameworks for the 2018-19 season. We seek additional information and comments on this supplemental proposed rule.
New proposals and modifications to previously described proposals are discussed below. Wherever possible, they are discussed under headings corresponding to the numbered items identified in the August 3, 2017, proposed rule (82 FR 36308). Only those categories requiring attention or for which we received Flyway Council recommendations are discussed below.
Duck harvest management categories are: (A) General Harvest Strategy; (B) Regulatory Alternatives, including specification of framework dates, season length, and bag limits; (C) Zones and Split Seasons; and (D) Special Seasons/Species Management.
Regarding the Mississippi Flyway Council recommendation to limit regulatory changes to one step per year, we recognize the longstanding interest by the Council to impose a one-step constraint on regulatory changes. We note that the Central and Mississippi Flyways have worked with Service staff during the past 3 years to revisit the AHM protocol for managing harvest of mid-continent mallards. This effort has included a discussion of appropriate management objectives, regulatory packages, and management of non-mallard stocks. These discussions are the appropriate venue to discuss what role, if any, a one-step constraint might play in management of waterfowl in the Central and Mississippi Flyways. Such discussions should include the potential impact of a one-step constraint on the
Thus, the regulatory alternatives proposed in the August 3, 2017,
Regarding the Central and Mississippi Flyway Councils' recommendation, we supported a change in the opening date to September 14 for the Texas South Dove Zone (82 FR 24794, May 30, 2017). However, we noted that the National Dove Harvest Strategy used to guide dove harvest management had language that did not allow the earlier date, and would need to be revised. Therefore, we delayed implementation of the earlier opening date until the 2018-19 season. We support the recommendations and the change made to the Harvest Strategy, which will allow the earlier framework date in the Texas South Dove Zone for the 2018-19 season.
The Department of the Interior's policy is, whenever practicable, to afford the public an opportunity to participate in the rulemaking process. Accordingly, we invite interested persons to submit written comments, suggestions, or recommendations regarding the proposed regulations. Before promulgation of final migratory game bird hunting regulations, we will take into consideration all comments we receive. Such comments, and any additional information we receive, may lead to final regulations that differ from these proposals.
You may submit your comments and materials concerning the proposed rule by one of the methods listed in
We will consider, but possibly may not respond in detail to, each comment. As in the past, we will summarize all comments we receive during the comment period and respond to them after the closing date in any final rules.
Based on our most current data, we are affirming our required determinations made in the August 3, 2017, proposed rule (82 FR 36308); see that document for descriptions of our actions to ensure compliance with the following statutes and Executive Orders:
• National Environmental Policy Act;
• Endangered Species Act;
• Regulatory Flexibility Act;
• Small Business Regulatory Enforcement Fairness Act;
• Paperwork Reduction Act;
• Unfunded Mandates Reform Act; and
• Executive Orders 12630, 12866, 12988, 13132, 13175, 13211, 13563, and 13771.
Exports, Hunting, Imports, Reporting and recordkeeping requirements, Transportation, Wildlife.
The rules that eventually will be promulgated for the 2018-19 hunting season are authorized under 16 U.S.C. 703-711, 16 U.S.C. 712, and 16 U.S.C. 742 a-j.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS issues a proposed rule that would authorize formation of a recreational quota entity (RQE) that could participate in the Pacific Halibut and Sablefish Individual Fishing Quota Program in International Pacific Halibut Commission Regulatory Areas 2C and 3A in the Gulf of Alaska. The RQE would be authorized to purchase and hold a limited amount of commercial halibut quota share that would yield additional pounds of recreational fishing quota on an annual basis to augment the amount of halibut available for harvest in the charter halibut fishery. The RQE would provide a mechanism for a compensated reallocation of a portion of commercial halibut quota share to the charter halibut fishery. This proposed rule is necessary to promote social and economic flexibility in the charter halibut fishery, and is intended to promote the goals and objectives of the Northern Pacific Halibut Act of 1982, and other applicable laws.
Submit comments on or before November 17, 2017.
You may submit comments on this document, identified by NOAA-NMFS-2016-0158, by any of the following methods:
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Electronic copies of the Environmental Assessment, Regulatory Impact Review (RIR), and the Initial Regulatory Flexibility Analysis (IRFA) (collectively, Analysis) prepared for this action are available from
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this rule may be submitted by mail to NMFS at the above address; by email to
Kurt Iverson, 907-586-7228,
The International Pacific Halibut Commission (IPHC) and NMFS manage fishing for Pacific halibut (
The Halibut Act, at sections 773c(a) and (b), provides the Secretary of Commerce with general responsibility to carry out the Convention and the Halibut Act. In adopting regulations that may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act, the Secretary of Commerce is directed to consult with the Secretary of the department in which the U.S. Coast Guard is operating, which is currently the Department of Homeland Security.
The Halibut Act, at section 773c(c), also provides the North Pacific Fishery Management Council (Council) with authority to develop regulations, including limited access regulations, that are in addition to, and not in conflict with, approved IPHC regulations. Regulations developed by the Council may be implemented by NMFS only after approval by the Secretary of Commerce. The Council has exercised this authority in the development of halibut fishery management measures, codified at 50 CFR parts 300.65, 300.66, and 300.67. The Council also developed the Individual Fishing Quota (IFQ) Program for the commercial halibut and sablefish fisheries, codified at 50 CFR part 679. Management of halibut in the IFQ Program is authorized under section 773 of the Halibut Act.
This proposed action would change halibut fishery management in IPHC Regulatory Areas 2C and 3A. These regulatory areas are referred to as “IFQ Regulatory Areas” throughout the IFQ Program regulations at 50 CFR part 679 and as “Commission Regulatory Areas” throughout the halibut management regulations at 50 CFR parts 300.65, 300.66, and 300.67. These terms are synonymous with “IPHC Regulatory Areas” and may be used interchangeably throughout this document. This preamble uses the term “Area 2C” and “Area 3A” to refer to IPHC Regulatory Areas 2C and 3A, respectively. Additional information on the action area is provided in Section 2.3 of the Analysis.
The harvest of halibut in Alaska occurs in three fisheries—the commercial, sport, and subsistence
Sport fishing activities for halibut in Areas 2C and 3A are subject to different regulations, depending on whether those activities are guided or unguided. Guided sport fishing (charter fishing) for halibut is subject to charter restrictions under Federal regulations that are generally more restrictive than the regulations for unguided anglers. Charter fishery regulations apply if a charter vessel guide is providing assistance, for compensation, to a person who is sport fishing, to take or attempt to take fish during any part of a charter vessel fishing trip. Unguided anglers typically use their own vessels and equipment, or they may rent a vessel and fish with no assistance from a guide.
Over the years, the Council and NMFS have developed specific management programs for the charter fishery to achieve allocation and conservation objectives. The Council and NMFS have developed these management programs with the intent of maintaining stability and economic viability in the charter fishery by establishing: (1) Limits on the number of charter vessel operators; (2) allocations of halibut to the charter fishery that vary with abundance; and (3) a process for determining annual charter angler harvest restrictions to limit charter fishery harvest to the established allocations.
The charter fisheries in Areas 2C and 3A are currently managed under the Charter Halibut Limited Access Program (CHLAP) and the Catch Sharing Plan (CSP). The CHLAP limits the number of operators in the charter fishery, while the CSP establishes annual allocations to the charter and commercial fisheries and describes a process for determining annual management measures to limit charter harvest to the allocations in each management area. The CHLAP and the CSP are summarized below and described in more detail in Section 4.4 of the Analysis.
The CHLAP and CSP were developed in response to increasing harvests in the charter fisheries in Areas 2C and 3A over the past 20 years. Until 2003, charter and unguided anglers were managed under the same two-halibut daily bag limit in all IPHC Regulatory Areas in Alaska. Since 2003, charter management measures have become more restrictive in Areas 2C and 3A, where most charter fishing occurs, as NMFS and the IPHC have sought to limit charter harvests to specific harvest limits. In 2003, NMFS implemented a final rule to establish a guideline harvest level (GHL) that identified target harvest limits for the charter fishery in Areas 2C and 3A (68 FR 47256, August 8, 2003). After the GHL was implemented, NMFS and the IPHC implemented a variety of additional management measures in Areas 2C and 3A in an effort to constrain charter fishery harvests to the harvest limits established by the GHL. Section 4.4.2.2 of the Analysis describes historical catch limits, regulations, and harvest in the charter fisheries in Areas 2C and 3A.
In Area 2C, charter anglers have only been allowed to harvest a bag limit of one halibut per person, per day since 2009. Implementation of a one-halibut daily bag limit was intended to keep charter fishery harvests to approximately the Area 2C GHL. In the years following implementation of the one-fish bag limit, additional restrictions were required to maintain harvest near the Area 2C GHL, including a prohibition on halibut harvest by charter captains and crew, limits on the maximum number of lines that could be deployed, maximum size limits, and beginning in 2012, a reverse slot limit that allows charter vessel anglers to retain halibut that are either below or above a specific size range. With the implementation of the CSP in 2014, charter fishery management became more restrictive in Area 2C to maintain charter fishery harvests within the Area 2C CSP allocations. In 2017, the charter fishery in Area 2C has a catch limit of 915,000 pounds and is managed under a one-fish daily bag limit with a reverse slot limit that allows retention of a halibut of 44 inches or less, or 80 inches or more, and a prohibition on the harvest of halibut by skippers or crew. Charter management measures for Area 2C are summarized in Table 4-10 of the Analysis.
In Area 3A, a two-fish daily bag limit with no size limits was maintained until the CSP went into effect in 2014. Since 2014, the Area 3A charter fishery has continued to be managed under a two-fish daily bag limit, but management measures have become increasingly restrictive each year to maintain charter fishery harvests within the CSP allocation. In 2017, the charter fishery in Area 3A has a catch limit of 1,890,000 pounds and is managed under a two-fish daily bag limit with a 28-inch maximum size limit on one fish; a 4-fish annual limit for each charter fishery angler; closures to charter fishing on Wednesdays throughout the year; closures to charter fishing during three specific Tuesdays in the summer; a limit of only one charter trip per day per vessel (and per charter halibut permit); and a prohibition on the harvest of halibut by skippers or crew. Charter management measures for Area 3A are summarized in Table 4-11 of the Analysis.
NMFS implemented the CHLAP in January 2010 (75 FR 554, January 5, 2010). The CHLAP established Federal charter halibut permits (CHPs) that are required for operators in the charter halibut fishery in Areas 2C and 3A. NMFS determined the eligibility of applicants and issued CHPs in 2010. CHPs were required for participation in the charter halibut fishery beginning in 2011. NMFS implemented the CHLAP, based on recommendations by the Council, to meet allocation objectives in the charter halibut fishery. Specifically, this program provides stability in the fishery by limiting the number of charter vessels that may participate in Areas 2C and 3A. The CHLAP also issues a limited number of permits to non-profit corporations representing specified rural communities and to U.S. military morale programs for service members.
Since implementation of the CHLAP, all vessel operators in Areas 2C and 3A with charter anglers on board must have an original, valid permit on board during every charter vessel fishing trip on which halibut are caught and retained. CHPs are endorsed for the appropriate IPHC Regulatory Area (Area 2C or Area 3A) and the maximum number of anglers that may catch and retain halibut on a charter vessel fishing trip, ranging from 4 to 38 anglers.
Complete regulations for the CHLAP are published at §§ 300.65, 300.66, and 300.67. Additional details on the development and rationale for the CHLAP can be found in the proposed
The CSP was implemented by NMFS in January 2014 (78 FR 75844, December 12, 2013). The CSP replaced the GHL that was in place from 2004 through 2013 for managing the charter fisheries in Areas 2C and 3A. The CSP establishes commercial IFQ and charter fishery allocations that vary proportionally with changing levels of annual halibut abundance and that are intended to balance the differing needs of the commercial IFQ and charter fisheries over a wide range of halibut abundance in Areas 2C and 3A. Under the CSP, the IPHC divides a combined catch limit for Areas 2C and 3A into separate annual catch limits for the commercial IFQ and charter halibut fisheries pursuant to the CSP's allocation formulas.
The CCLs for Areas 2C and 3A are specified by the IPHC during an iterative process that takes place each year. In late November of each year, the IPHC begins the process of assessing the halibut resource, and provides a preliminary estimate of exploitable biomass of halibut. The exploitable biomass is the amount of halibut that could be available for harvest by commercial, sport, and subsistence fisheries. The IPHC determines the exploitable biomass using a combination of harvest data from the commercial, sport, and subsistence fisheries, and information collected during scientific surveys and sampling of halibut bycatch in other fisheries. The IPHC calculates the Total Constant Exploitation Yield (CEY), or the target level for total removals (in net pounds) for each IPHC regulatory area, by multiplying the estimate of exploitable biomass by the harvest rate specified for that IPHC regulatory area. For Areas 2C and 3A, the IPHC subtracts estimates of other removals from the Total CEY. Other removals include unguided sport harvest, subsistence harvest, and bycatch of halibut in non-target commercial fisheries. In Areas 2C and 3A, the remaining CEY, after other removals are subtracted, is the Fishery CEY. For Areas 2C and 3A, the Fishery CEY is equal to the annual combined catch limit for the commercial IFQ fishery and the charter fishery. This process is depicted in Figure 4-1 of the Analysis.
A fixed percentage of the annual CCLs for Area 2C and 3A is allocated to the commercial IFQ and charter fisheries (for additional detail see Figures 4-3 and 4-4 in the Analysis). The fixed percentage allocation to each fishery varies with halibut abundance and differs between Areas 2C and 3A. Overall, the charter fishery's relative share of the CCL is higher when the CCL is lower, but lower when the CCL is higher. At current levels of abundance, the charter fishery is allocated approximately 18 percent of the CCLs for both Areas 2C and 3A, and the commercial IFQ fishery is allocated approximately 82 percent. The IPHC multiplies the CSP allocation percentages for Area 2C and 3A by the annual CCL in that area to calculate the commercial and charter halibut allocations in net pounds. Fishery-specific catch limits are calculated by deducting separate estimates of wastage (
Additional detail on the development and rationale for the CSP can be found in preamble for the CSP proposed rule (78 FR 39122, June 28, 2013), and in the final rule implementing the CSP (78 FR 75844, December 12, 2013).
The CSP also describes a public process by which the Council develops recommendations to the IPHC for charter angler harvest restrictions (annual management measures) that are intended to limit harvest to the annual charter fishery catch limit in Areas 2C and 3A. The process for setting annual management measures is described in more detail in Section 4.4.1.2.2 of the Analysis. Key elements of the process are summarized below.
Each year in October, the Council's Charter Halibut Management Committee (Charter Committee) reviews charter harvest in Areas 2C and 3A during the current year in relation to the charter catch limit. Staff from the Alaska Department of Fish and Game, Council, and NMFS provide an analysis to predict harvest for the upcoming year under a range of alternative management measures. Some of these measures may directly restrict the number or size of fish that may be retained (
In December of each year, the Council considers the recommendations of the Charter Committee, the analysis on projected charter harvests under a range of management measures, and any additional information. After considering public input, the Council selects management measures to recommend to the IPHC that are intended to keep charter harvest within the charter fishery allocation in Area 2C and Area 3A under a range of different CCLs that may be established by the IPHC.
At its annual meeting in January of each year, the IPHC allocates the CCL for Area 2C and Area 3A between the commercial IFQ fishery and the charter fishery for that year based on the CSP regulations at 50 CFR 300.65. The IPHC takes into account Council recommendations, any additional information available to the IPHC, and input from the public and IPHC staff. After considering this information and other information on the abundance of the halibut resource in Areas 2C and 3A, the IPHC adopts CCLs for Areas 2C and 3A and charter halibut management measures designed to keep charter harvest in Area 2C and Area 3A within the catch limits specified under the CSP for the adopted CCLs. Once accepted by the Secretary of State with the concurrence of the Secretary of Commerce, NMFS publishes in the
In 2014, as part of the CSP, NMFS implemented the Guided Angler Fish (GAF) Program to authorize limited annual transfers of commercial halibut IFQ as GAF to qualified CHP holders. The GAF Program provides additional harvest opportunities for charter anglers. Using GAF, qualified CHP holders may offer charter anglers the opportunity to retain halibut up to the limit for unguided anglers when charter management measures limit charter anglers to a more restrictive harvest limit. For example, if charter management regulations in Area 2C restrict charter anglers to a one-halibut daily bag limit, a charter angler could retain one halibut and use one GAF to retain a second halibut, bringing the retained amount to two halibut—the
In order to receive GAF, an IFQ holder and a CHP holder receiving GAF must submit an application to NMFS for review and approval. Guided Angler Fish transfers may be between separate IFQ and CHP holders, or a person holding both IFQ and a CHP can transfer their IFQ to himself or herself as GAF. Upon approval of the transfer application, NMFS issues a GAF permit to the holder of the CHP. Once the transfer is approved, the GAF permit holder may offer additional GAF harvest opportunities to anglers on board the vessel on which the operator's GAF permit and the assigned CHP are used.
NMFS issues GAF in whole numbers of halibut based on a conversion factor from IFQ pounds. Conversion factors are based on the average net weights of GAF harvested in the applicable IPHC Regulatory Area (Area 2C or 3A) during the previous year. Average weights are determined from data that charter vessel guides report directly to NMFS. For 2017, 74 pounds of IFQ yields one GAF in Area 2C, and 42 pounds of IFQ yields one GAF in Area 3A. Based on self-reported data, CHP holders have paid more than $5 per pound of IFQ transferred as GAF in Area 2C and 3A, making GAF quite expensive, especially in Area 2C (see Section 4.4.2.3 in the Analysis for additional detail). In part due to the high costs of leasing GAF, annual participation has been low, averaging about 48,000 pounds per year from 2014 through 2016.
Three restrictions on GAF transfers were implemented with the GAF Program. First, IFQ holders in Area 2C are limited to transferring up to 1,500 pounds or 10 percent, whichever is greater, of their initially-issued annual halibut IFQ for use as GAF. In Area 3A, IFQ holders may transfer up to 1,500 pounds or 15 percent, whichever is greater, of their initially-issued annual halibut IFQ for use as GAF. Second, no more than 400 GAF will be assigned during one year to a GAF permit assigned to a holder of a CHP that is endorsed for six or fewer anglers. Third, no more than a total of 600 GAF will be assigned during one year to a GAF permit assigned to a holder of a CHP endorsed for more than six anglers. The restrictions on transfers of GAF are intended to prevent a particular individual, corporation, or other entity from acquiring an excessive share of halibut fishing privileges as GAF.
NMFS' costs associated with management, data collection, and enforcement of the GAF Program are recoverable through IFQ Program Cost Recovery fees. The IFQ permit holder is responsible for paying IFQ Program Cost Recovery fees on all pounds of IFQ landed as GAF. The fee calculation is based on the standard price calculated by NMFS, aggregated to IPHC Regulatory Area 2C or 3A.
The commercial halibut and sablefish fisheries off Alaska are managed under the IFQ Program (November 9, 1993; 58 FR 59375). The IFQ Program was implemented in 1995. The commercial halibut fishery is also referred to as the “directed halibut fishery.” The IFQ Program limits access to the commercial directed halibut fishery to those persons holding halibut quota share (QS) in specific management areas. A more detailed description of QS allocation and management is provided in Section 4.5.1 of the Analysis and summarized here.
The IFQ Program assigned QS by IPHC Regulatory Area based on certain thresholds of historical participation in the commercial halibut fishery. NMFS initially issued QS to qualified participants beginning in 1994. Once QS was issued, NMFS allows QS to be transferred from initial recipients to individuals meeting specific eligibility requirements. The GAF Program does not authorize the transfer of QS from the commercial IFQ fishery for use in the charter fishery. QS provides individual harvesting privileges that are allocated on an annual basis through the issuance of IFQ permits.
An annual IFQ permit authorizes the holder to harvest a specified amount of halibut in a designated IPHC Regulatory Area. The specific amount of IFQ (in net pounds) is determined by the number of QS units held, the total number of QS units issued in a specific IPHC Regulatory Area, and the total amount of the halibut catch limit allocated by the IPHC in a particular year. If the abundance of halibut decreases over time, the catch limit will decrease and, subsequently, the number of pounds on a person's annual IFQ permit also will decrease. By providing an exclusive privilege to harvest a certain amount of the catch limit at the beginning of the season, and by extending the season over a longer period, the IFQ Program allows QS holders to determine where and when to fish, how much gear to deploy, and how much overall investment to make in harvesting.
The Council and NMFS developed the IFQ Program with several goals in mind. Particularly applicable to this proposed action, the IFQ Program was designed to preserve an owner-operated fleet and to limit consolidation of QS ownership. To accomplish these goals, the IFQ Program was designed to control transferability of QS through: (1) Limits on the amount of QS that can be owned or controlled by individuals and companies (QS transfer and use caps); (2) vessel size categories that limit the size of vessels that can use the annual allocations resulting from the QS; (3) restrictions on who can purchase catcher vessel QS; and (4) limitations on leasing certain categories of QS.
Halibut QS is designated as one of four QS categories (also called “vessel categories” or “size categories” of QS). The term “vessel class” is also sometimes used, but the term “category” will be used in this preamble to be consistent with the term used in regulation. These categories include A-category for freezer catcher-processor vessels; B-category for vessels greater than 60 ft length overall (LOA); C-category for vessels 36 ft to 60 ft LOA; and D-category for vessels 35 ft or less LOA. The term “catcher vessel QS” refers to QS that can be used to catch, but cannot be used to process, halibut at sea (
After implementation of the IFQ Program, the total amount of QS held by residents of small, coastal communities and the number of IFQ holders substantially declined. To alleviate the social and economic impacts of this consolidation on rural communities, the Council revised the IFQ Program in 2004 to allow a distinct set of remote coastal communities with few economic
NMFS determined that CQE eligibility applied to 46 Alaskan communities, based on certain criteria for size, accessibility, and historical participation in the halibut or sablefish fisheries. Eligible communities must establish a non-profit corporation to become a CQE. The non-profit corporation must submit an application to NMFS detailing its organization, structure, and proposed procedures for leasing IFQ to community residents (among other requirements). If NMFS approves the application, a CQE may form to represent that community and the CQE may obtain QS by transfer. Currently, 28 communities have formed non-profit corporations and have applied for and been approved to obtain QS by transfer. Of those 28 CQEs, 4 have purchased QS. Community Quota Entities may also apply to NMFS to be able to participate in the CHLAP by purchasing CHPs, and are authorized to receive Community Charter Halibut Permits which is similar to a CHP, but available only to CQEs. To date, 20 CQEs have applied for and been issued Community Charter Halibut Permits. Although CQE's may also receive CHPs by purchasing (
Although CQEs are subject to different constraints than individual QS holders in the IFQ Program, in some cases, the CQE is subject to the same limitations as individual permit holders in the IFQ Program. For example, each CQE is held to the same QS use caps (
Currently, the charter fishery is limited to harvesting its percentage of the Area 2C or 3A combined catch limit it is allocated under the CSP. Charter catch limits increase or decrease as total halibut abundance increases or decreases. When halibut abundance is relatively low, as it has been in recent years compared to abundance trends in the 1990s and 2000s, the charter allocations under the CSP are lower, resulting in more restrictive annual management measures.
The only way that charter operators can currently provide more opportunity to charter clients than the established management measures allow for in their area is through participation in the GAF Program by individual charter operators. Because of the current restrictions on charter harvests under the existing charter allocations under the CSP and the limited flexibility for charter operators to provide additional harvest opportunities to their clients, the charter fishery has expressed its desire to find a market-based mechanism to increase its overall allocation of the halibut resource.
Based on these concerns, in 2015, the Council initiated the analytic process to develop a “market-based mechanism” to allow a non-profit entity (similar to a CQE) to purchase and hold a limited amount of commercial halibut QS on behalf of charter anglers. The intent of the Council was to provide additional harvest opportunity and less restrictive annual harvest measures for charter anglers in times of low halibut abundance, while complying with total halibut removals under the catch limits established by the IPHC under the CSP. In initiating this effort, the Council sought to balance the objectives of participants in the charter fishery without undermining the goals of the IFQ Program or creating significant adverse impacts to other halibut sectors. A complete history of the development of this proposed action is described in Section 2.2 of the Analysis.
In December 2016, the Council recommended the implementation of an RQE Program. This proposed RQE Program would provide a mechanism for the charter fishery to compensate the commercial IFQ fishery for halibut QS purchased from the commercial sector to increase the charter annual catch limits. The halibut RFQ that would result from that QS would provide potentially greater harvest opportunities to the clients of charter operators within Areas 2C and 3A.
The Council and NMFS considered a no-action alternative to maintain the status quo (no RQE Program) and an alternative to authorize an RQE Program. The Council and NMFS also considered a broad range of elements and options to determine: The number of RQEs that could form; the amount and type of QS that could be purchased and held by the RQE; the process for setting annual management measures; how the RQE Program should interact with the GAF and CQE Programs; how the RQE could use funds, the organizational structure of the RQE; and the appropriate reporting requirements for the RQE. The specific elements and options recommended by the Council and proposed by NMFS are described below. The entire suite of elements and options considered, and the predicted effects of those elements and options (including the no-action alternative) are evaluated in detail in the Analysis.
The Council stated that the principal objective of this proposed rule is to promote social and economic flexibility in the charter fishery by authorizing the development of an entity that would be eligible to purchase and hold commercial halibut QS in Areas 2C and 3A, thereby providing additional harvest opportunities to charter anglers. This proposed rule is intended to promote long-term efficiency in the use of the halibut resource by allowing transfers of QS between commercial QS holders and the charter fishery, through an RQE, under a “willing buyer and willing seller” approach.
This proposed rule would allow an RQE to be established as an eligible entity to purchase halibut QS in Area 2C and Area 3A, with limitations, for use by the charter fishery as a whole. Using a structure similar to a CQE, the RQE would be an eligible participant in the IFQ Program and could purchase Area 2C and 3A halibut QS for use by all charter halibut anglers in the respective
Halibut QS held by the RQE would generate annual pounds of recreational fishing quota (RFQ), a type of annual harvest privilege similar to IFQ that would have special requirements that pertain only to the RQE. RFQ would be calculated in the same manner as IFQ. Under this proposed rule, the specific amount of RFQ (in net pounds) would be determined by the number of QS units held by the RQE as of October 1 of the preceding calendar year, the total number of halibut QS units issued in Area 2C or 3A as of January 15 of the year the IFQ or RFQ is issued, and the total amount of halibut allocated to the commercial IFQ fisheries in Areas 2C and 3A for that year.
Although the amount of RFQ would be calculated in the same way as IFQ, it would be subject to different requirements. The additional pounds of RFQ for each regulatory area would be combined with the charter catch limit determined under the CSP to calculate an adjusted charter catch limit for the year for Area 2C or 3A. Annual charter management measures for Areas 2C and 3A would be analyzed, recommended to the IPHC, and adopted for implementation based on the estimated adjusted charter catch limits. Recreational Fishing Quota held by the RQE would be available for harvest by all charter anglers aboard registered charter vessels of any size, regardless of the QS category from which that RFQ originated. Under this proposed rule, RFQ could not be transferred as GAF. Unless specified in this proposed rule, regulations that refer only to IFQ permit holders would not apply to the RQE. Likewise, unless specified in this proposed rule, regulations that refer only to IFQ would not apply to RFQ.
This proposed rule would not change the underlying allocations to the commercial IFQ fishery and charter fishery specified in the CSP, and would not change the total QS pool. Therefore, the QS holders in the commercial IFQ fishery who do not transfer QS to the RQE would receive the same amount of IFQ pounds issued for their QS units regardless of the amount of QS transferred to, and held by, the RQE.
The Council recommends and NMFS proposes to allow the establishment of an RQE as a qualified non‐profit entity registered under the laws of the State of Alaska and recognized as exempt from Federal income tax by the Internal Revenue Service (IRS) to purchase and hold halibut QS for use by the charter fishery. The QS held by an RQE could yield RFQ annually. This proposed rule would allow a single non-profit entity to form to represent and manage separate QS holdings for Areas 2C and 3A.
The Council and NMFS considered an option to allow formation of two RQEs, one to represent Area 2C and another in Area 3A, but ultimately decided that one RQE would provide administrative efficiencies for purchasing and managing commercial QS. The Council and NMFS initially considered allowing multiple RQEs within Area 2C and 3A, but recommended against that structure to avoid potential competition against each other to purchase QS, and to reduce potential administrative costs.
The structure of the RQE is proposed to be similar to non-profits established to hold QS under the CQE Program. The Council recommended and NMFS proposes that the RQE be a non-profit entity to help ensure it represents the interests of the charter operators, whereas a for-profit entity could result in increased costs. The Council has consistently recommended, and NMFS has consistently approved the use of non-profit entities for the purposes of holding QS in other limited access programs. The proposed RQE organizational structure is consistent with past practice. Also, a non-profit entity that is independent of the Federal or state governments could more quickly and more flexibly take advantage of favorable market conditions for purchasing QS than a program administered by the Federal or state governments. More information on the structure of the proposed RQE is provided in section 4.8.1.1 of the Analysis.
NMFS proposes new definitions in § 679.2 for “Recreational fishing quota (RFQ)” and “Recreational quota entity (RQE).”
The Council recommended establishment of a single RQE that is a qualified non-profit entity registered with the IRS to purchase and hold commercial halibut QS for use by the guided halibut sector.” To implement this recommendation, NMFS proposes requirements specifying that the RQE must be a qualified non-profit entity registered under the laws of the State of Alaska and recognized as exempt from Federal income tax by the IRS. Non-profit status is a state law concept and does not directly apply to Federal tax law. A non-profit organization may be eligible for certain benefits, such as state sales, property and income tax exemptions. Although most Federal tax-exempt organizations are non-profit organizations, being recognized as a non-profit organization at the state level does not automatically grant the organization exemption from Federal income tax. To qualify as exempt from Federal income tax, an organization must seek recognition of exemption from Federal income tax under section 501(a) of the Internal Revenue Code.
This proposed rule would establish specific requirements for an entity to be authorized as the RQE. To be approved as the entity eligible to purchase and hold halibut QS, the applicant wishing to become the RQE would be required to demonstrate it is a non-profit entity registered under the laws of the State of Alaska by submitting to NMFS the articles of incorporation and management organization information, including bylaws and a list of key personnel including, but not limited to, the board of directors, officers, representatives, and managers.
Articles of incorporation are public documents that must be filed with the state agency where the corporation becomes incorporated (
In addition to demonstrating it is a non-profit corporation recognized by the State of Alaska, the applicant wishing to become the RQE would be required to demonstrate it has been granted an exemption from Federal income tax by the IRS by submitting to NMFS the IRS acknowledgement of the entity's Federal tax exemption.
NMFS proposes to require the approved RQE to maintain its non-profit and tax-exempt status, as described above. If the approved RQE entity does not meet this requirement, NMFS would not issue the RFQ that would otherwise be issued to the RQE based on its QS holdings. In addition, NMFS would provide the approved RQE entity with an opportunity to reinstate its non-profit and/or tax-exempt status. If the approved RQE entity does not demonstrate to NMFS that it is a qualified non‐profit entity registered under the laws of the State of Alaska and recognized as exempt from federal income tax by the IRS by the established deadline, NMFS would issue an Initial Administrative Determination (IAD) to revoke the entity's status as the approved RQE and to require the entity to divest its QS holdings. The entity would have the opportunity to appeal the IAD through the National Appeals Office under the provisions established at 15 CFR part 906. The application and procedures for approving the application to become an RQE would be modeled after the application and process for CQEs. The applicant would complete the “Application for a Non-profit Corporation to be Designated as a Recreational Quota Entity (RQE)” and submit it to NMFS Alaska Region for review and approval. The application form would be available on the NMFS Alaska Region Web site at
NMFS proposes adding a new paragraph § 679.41(n) to describe the application process and eligibility requirements for a prospective RQE.
Under this proposed RQE Program, two-way transfers of QS would be allowed. Quota share acquired by the RQE could be transferred to an otherwise eligible participant in the commercial IFQ fishery. Because QS and the resulting IFQ used in the commercial IFQ fishery is subject to vessel categories and block designations on initially-issued QS—unlike the QS and resulting RFQ used by the RQE, which is exempt from such categories and designations—NMFS will track QS units, IFQ pounds, and vessel category and block designations that apply to ensure that original categories and designations for the commercial IFQ fishery are maintained during the transfer process.
The Council recommended and NMFS proposes two-way transfers because it is expected that there would be variability from year to year in the amount of QS the RQE would be interested in using as RFQ. For example, if halibut biomass increases, the RQE may hold QS that is not needed to yield RFQ to provide additional opportunities for participants in the charter fishery, and may decide to sell a portion of its QS to an eligible buyers in the commercial fishery sector.
NMFS proposes modifying § 679.42 to describe the QS transfer process for RQEs.
This proposed rule would establish area-specific annual limits on the amount of halibut QS that can transfer to an RQE. The intended effect of these transfer limits is to limit the amount of halibut QS that could be transferred from the commercial IFQ fishery and used as RFQ in the charter fishery each year, and to minimize any abrupt negative impacts that may occur to participants in the commercial IFQ fishery or to CQEs due to additional competition in the QS market that could occur with the entry of an RQE. Annual transfer limits would allow users in the commercial IFQ and charter fisheries time to adapt business plans and personal strategies to changes in the composition of the fisheries.
The Council recommended and NMFS proposes an annual transfer limit equivalent to 1 percent of the commercial QS units in Area 2C based on the 2015 pool of all QS categories (59,477,396 units). Based on the 2015 QS pool, the RQE would be limited to receiving by transfer a maximum of 594,774 units of Area 2C QS in a year. Even if the QS pool changes in future years, this proposed rule would fix the annual transfer limit in Area 2C at 594,774 QS units. This will clearly define the limit for fishery participants and prevent a change in the limit if there are future changes in the Area 2C or 3A QS pools. For example, in 2017, the QS:IFQ ratio is 14.1209 QS units per pound of IFQ, and the annual transfer limit would be 42,120 pounds of IFQ for Area 2C.
The Council recommended and NMFS proposes an annual transfer limit equivalent to 1.2 percent of the commercial QS pool in Area 3A based on the 2015 pool of all QS categories (184,893,008 units). For example, based on the 2015 QS pool, the RQE would be limited to receiving by transfer a maximum of 2,218,716 units of Area 3A QS in a year. Even if the QS pool changes in future years, this proposed rule would fix the annual transfer limit in Area 3A at 2,218,716 QS units. For example, in 2017, the QS:IFQ ratio is 23.8911QS units per pound of IFQ, and the annual transfer limit would be 92,868 pounds of IFQ for Area 3A.
For both Area 2C and 3A, the Council and NMFS considered annual transfer limits between 0.5 and 5 percent and determined that 1 percent for Area 2C and 1.2 percent for Area 3A were the appropriate annual transfer limits because they would allow the RQE to reach the cumulative use limits on QS holding (discussed in the next section) in 10 years if the RQE purchased the maximum amount of QS in each area in each year after the RQE Program is implemented. The Council indicated that limiting annual transfers at these proposed limits and allowing the RQE to reach its maximum QS holdings over as few as 10 years would balance the desire to provide adequate additional harvest opportunity to charter anglers, while at the same time mitigating the potentially disruptive impacts on the QS market with the entry of the RQE. Therefore, the proposed annual limits are equal to 1/10 of the cumulative holdings limits. Annual transfer limits are discussed in further detail in Section 4.8.1.2.2 of the Analysis.
NMFS proposes adding a new paragraph at § 679.42(f)(8) to describe the annual transfer limits on QS for RQEs.
The Council recommended and NMFS proposes a limit on the total
This rule proposes a limit on QS holdings for Area 3A of 12 percent of the 2015 entire commercial QS pool, including categories and blocks of QS units that the RQE would be prohibited from purchasing. Twelve percent of the 2015 commercial QS pool equates to 22,187,161 units.
As described in the previous section for annual transfer limits for the RQE, this proposed rule would fix the limits on total QS holdings by the RQE in regulations so that they are clearly defined for fishery participants and will not fluctuate if there are future changes in the Area 2C or 3A QS pools.
The Council and NMFS considered limits that ranged from 5 to 20 percent of the 2015 QS pools in each area. The Council recommended and NMFS proposes 10 percent and 12 percent limits in Areas 2C and 3A, respectively, to provide a balance between providing ample opportunity for additional harvest opportunity for the charter fishery, while seeking to alleviate potential adverse impacts to commercial halibut participants from increased competition in the QS market and higher QS prices that could occur if the RQE were provided a higher limit on QS holdings by the RQE. The limits on RQE holdings of QS are discussed in further detail in Section 4.8.1.2.3 of the Analysis.
NMFS proposes adding a new paragraph at § 679.42(f)(8) to describe the QS holding limits for the RQE.
As part of the RQE Program, the Council recommends and NMFS proposes to limit the total amount of GAF that could be used annually by CHP holders by limiting the amount of GAF that could be transferred to the charter fishery as RQE QS holdings increase.
Under existing regulations, a significant amount of GAF could be transferred to CHP holders each year. For example, based on 2015 data, if all QS holders transferred the maximum allowable amounts of IFQ as GAF to eligible CHP holders, 49.1 percent of the Area 2C IFQ and 35.5 percent of the Area 3A could potentially be transferred as GAF. However, actual participation in the GAF Program has been relatively low. From 2014 through 2016, less than 1.25 percent of Area 2C IFQ, and less than 0.2 percent of Area 3A IFQ have been transferred as GAF in any year. Based on the cost to transfer IFQ as GAF noted earlier in this preamble, NMFS considers it very unlikely that participation in the GAF Program will increase substantially and approach the maximum allowable transfer limits. Notwithstanding that unlikelihood, the Council determined and NMFS agrees that limiting the amount of GAF that could be transferred to the charter fishery as RQE QS holdings increase appropriately balances the objective of establishing an RQE to further increase harvest opportunity in the charter fishery while minimizing the negative impacts that may result in the commercial IFQ fishery from transfers of QS.
The Council recommended and NMFS proposes restricting GAF transfers so that in any year, the combined amount of RFQ and GAF transferred to CHP holders could not exceed a poundage equal to the maximum amount of pounds that could be issued as RFQ in Area 2C or 3A.
The following two examples describe how NMFS would administer this provision in Area 2C. Under this proposed rule, in Area 2C the RQE may hold a maximum of 10 percent of the 2015 Area 2C QS pool (5,947,740 units). These two examples use the 2017 QS:IFQ ratio for Area 2C (14.1209 QS units per pound of IFQ), and the 2017 conversion factor for IFQ to GAF for Area 2C (74 pounds of IFQ to yield one GAF). The first example assumes the RQE held the maximum amount of QS units (5,947,740 units) in Area 2C. Under this example, the RQE would be issued 421,201 pounds of RFQ (5,947,740 QS units/14.1209 QS:IFQ = 421,201 pounds), and NMFS would not approve any transfers of GAF to CHP holders in Area 2C during that calendar year because the combined amount of RFQ and GAF transferred by CHP holders would exceed the cumulative limit for RFQ and GAF in Area 2C (421,201 pounds). The second example assumes the RQE held 50 percent of the RQE's Area 2C cumulative QS limit (
The Council and NMFS considered options that would not have restricted transfers of GAF even if the RQE reached its cumulative use limit of QS. The Council recommended and NMFS proposes limiting the total amount of annual poundage that could be reallocated to the charter fishery as RFQ and GAF to the cumulative use limit on RQE holdings. This limit was chosen, as described in the previous section of the preamble, to balance the concerns of commercial fishery participants about the increased potential for reallocation to the charter fishery with the interests of charter operators to increase harvest opportunities. The limit on GAF transfers as RQE QS holdings increase is discussed in further detail in Section 4.8.1.2.4 of the Analysis.
NMFS proposes adding a new paragraph at § 300.65(c)(5)(ii)(D)(
The Council recommended and NMFS proposes limits on the amounts of QS the RQE could hold by vessel category in Areas 2C and 3A. The RQE would be limited to holding an amount equal to 10 percent of D-category QS and an amount equal to 10 percent of B-category QS, based on the 2015 QS pools, in Area 2C. Translated to QS units, this proposed rule would prohibit the RQE from holding more than 889,548 units of D-category QS, and more than 265,524 units of B-category QS in Area 2C (see Table 4-40 of the Analysis).
Under this proposed rule, the RQE would be prohibited from purchasing or holding D-category QS in Area 3A. The RQE could purchase any amount, up to the annual transfer and cumulative use limits of A-, B-, and C-category QS in Area 3A.
The Council and NMFS considered the current composition of the QS pools in Areas 2C and 3A, and the potential impact on specific QS categories when proposing these regulations. D-category QS cannot be fished on vessels greater than 35 ft LOA in Area 3A or 2C. Thus, the proposed limits on the RQE
In Area 2C, B- and C-category QS also provide entry-level opportunities. A total prohibition on acquisition of D-category QS in Area 2C could put market pressure on other parts of the Area 2C QS market that are important for entry and diversity. While C-category QS makes up about 79 percent of the total Area 2C QS pool, B-category QS represents a relatively small percentage (4.5 percent, as shown in Table 4-19 of the Analysis). Therefore, the Council recommended and NMFS proposes limiting RQE QS purchases in Area 2C to 10 percent of the B-category QS pool (based on the 2015 QS pool). Because restrictions on B-category QS transfers would limit the QS market opportunity for the RQE in Area 2C, the Council recommended and NMFS proposes some limited opportunity in the D-category market to relieve some of the potential market pressure on the remaining C-category QS (10 percent of the D-category QS pool in Area 2C). These provisions would ensure that most of the B- and D-category QS are used in the commercial IFQ fishery and are intended to balance entry-level opportunities and fleet diversity in the commercial IFQ fishery, with potential benefits to the charter fishery from transfers of QS to the RQE. The proposed vessel category restrictions are discussed in more detail in Section 4.8.1.2.5 of the Analysis.
NMFS proposes adding a new paragraph at § 679.42(f)(8) describing RQE use limits for specific vessel categories of QS.
In addition to vessel category restrictions for the RQE, the Council recommended and NMFS proposes limits on the size of QS blocks that the RQE could purchase. The RQE would be prohibited from purchasing blocks of QS by category that equate to 1,500 pounds or less (based on 2015 pounds). For Area 2C, this means that the RQE could not purchase blocked QS of 24,250 units or less. For Area 3A, the RQE would be prohibited from purchasing blocked QS of 35,620 units or less. The Council recommended and NMFS proposes these prohibitions to ensure that small and more affordable blocks of QS remain available for purchase by new entrants and small businesses in the commercial IFQ fishery. The prohibition on the transfer of small blocks of QS will have limited impact on the total available market of QS that the RQE could purchase. Block restrictions are discussed in more detail in Section 4.8.1.3 of the Analysis.
NMFS proposes to add a new paragraph at § 679.42(g)(1)(iii) to establish restrictions on the type and amount of blocked QS that the RQE can hold.
This proposed rule would also modify several regulations to facilitate the proper accounting of RFQ. This section describes the process that would be used annually to calculate the amount of RFQ and establish annual management measures.
On October 1 of each year, the RQE's QS holdings would be used as the basis for estimating the number of RFQ pounds to add to the charter allocation under the CSP for the following calendar year. This estimated combined allocation would be used to recommend the charter fishery management measures for the following year. The process and timeline for setting annual management measures would remain unchanged. Once the IPHC annual management measures are approved, typically in late February or early March, NMFS would issue pounds of RFQ to the RQE based on the number of QS units held by the RQE on October 1 of the previous year to augment the charter catch limit established under the CSP. The Council recommended and NMFS proposes establishing October 1 as the date for determining how many QS units would yield RFQ so that the Council's Charter Committee and the Council would be able to estimate the pounds of RFQ that the RQE would receive in the following year and be able to factor that amount into its recommendations for charter management measures in the following year.
The RFQ would not be issued to the RQE in the upcoming fishing year for any QS that the RQE received by transfer after October 1. If the RQE transfers QS that it holds on October 1 to a recipient in the commercial IFQ fishery after that date, NMFS would not issue IFQ to the commercial recipient for that QS in the following calendar year. This approach is similar to the method used in the commercial fishery to allow the transfer of QS but not the IFQ once that IFQ has been used. In this case, NMFS would consider that RFQ is effectively “used” if it is assigned to the charter allocation for the following calendar year. If the RQE receives QS by transfer after October 1, that QS would not result in the issuance of RFQ for the following calendar year. However, if the RQE subsequently transferred any QS received by transfer after October 1 that did not result in RFQ back to the commercial IFQ fishery, NMFS would issue IFQ to the commercial recipient for that QS.
In late November of each year, NMFS would estimate the pounds of RFQ that the QS units held by the RQE on October 1 would yield in the upcoming year based on the current year's QS:IFQ ratio and the IPHC's preliminary estimate of the possible combined catch limits in Areas 2C and 3A.
In December of each year, the Council would recommend a range of potential charter management measures for Areas 2C and 3A that would be expected to limit charter harvests in an area to the estimated charter catch limit plus the estimated supplemental pounds provided by the RFQ.
NMFS proposes revising § 679.40(c)(2) to clarify that NMFS would use the QS pool for the IFQ regulatory area, including Areas 2C and 3A, on record with the Alaska Region, NMFS, on January 15 of that year for purposes of calculating the amount of IFQ and RFQ for that regulatory area for that year. This proposed revision to move the date of record from January 31 to January 15 of each year would ensure that the IPHC would be able to determine the amount of IFQ and RFQ and the total allocations that would be assigned to the commercial IFQ and charter fisheries, respectively, when it adopts annual management measures at its annual meeting in late January.
NMFS also proposes revising § 300.65(c) to authorize the use of RFQ in the charter fishery, and to describe how and when QS holdings by the RQE would be calculated and added to the charter catch limit under the CSP.
The Council recommended and NMFS proposes a temporary redistribution of RFQ from the RQE to the commercial IFQ fishery if the RQE
The Council and the Analysis use the term “reallocate” to describe the temporary (1-year) redistribution of excess RFQ to the commercial IFQ fishery. NMFS notes that the term reallocate is often used in other regulations to describe a permanent transfer of harvest privileges from one group of participants to another. NMFS uses the term redistribute in this proposed rule to clarify for fishery participants and the public that the distribution of excess RFQ to commercial IFQ fishery participants is in effect for one year, and is not a permanent reallocation.
The Council recommended and NMFS proposes the following process for the temporary redistribution of RFQ (as IFQ) to the commercial IFQ fishery, in the event that the RQE has QS holdings in excess of the amount needed to provide charter anglers with harvest opportunities equal to those for unguided recreational anglers. Each January, the IPHC will recommend charter fishery management measures for Areas 2C and 3A that are expected to limit charter harvest to the adjusted charter catch limit for each area (the sum of the annual guided sport catch limit under the CSP and the estimated amount of RFQ from the RQE's QS holdings on October 1 of the previous year).
After the IPHC recommends charter fishery management measures, NMFS will determine if a redistribution of excess RFQ is necessary. If the IPHC has adopted charter fishery management measures that are equivalent to the unguided recreational management measures in either Area 2C or 3A (
Under this proposed rule, 50 percent of any RFQ in excess of the amount needed to achieve the unguided recreational management measures in either Area 2C or 3A would be redistributed as IFQ to all catcher vessel QS holders in the applicable area (Area 2C or Area 3A) who held not more than 32,333 QS units in Area 2C, and 47,469 QS units in Area 3A (
The Council's recommendation stated that 50 percent of excess RFQ should be redistributed “equally” to all qualified QS holders. During Council deliberations, NMFS staff and the Council clarified how NMFS would implement the Council's recommendation. NMFS proposes to implement this provision by dividing the amount of IFQ available for redistribution to qualified QS holders by the total amount of QS units held by all qualified QS holders. For example, if there were 50,000 pounds of excess RFQ to be redistributed as IFQ in Area 3A in calendar year 2025 among QS holders who held not more than 47,469 QS units in the year prior to the redistribution (2024), and in the year during which the redistribution occurs (2025), and the total sum of all QS held by those qualified QS holders was 500,000 units, then each of these qualified QS holders would receive an additional 1/10 of a pound of IFQ in 2025 for each QS unit held. NMFS does not issue IFQ in less than one pound increments, therefore NMFS would round the amount of redistributed IFQ to the nearest pound for each qualified QS holder. Section 4.8.1.3 of the Analysis provides additional information on the method NMFS would use to redistribute excess RFQ.
This proposed rule would require the QS holder to hold the QS in the year prior to the redistribution to meet the clear intent of the Council, as well as in the year that the redistribution occurs in order to ensure the proper administration of this provision. NMFS proposes this requirement to ensure that IFQ is issued to persons who hold the underlying QS eligible to receive the redistribution. If NMFS were to redistribute RFQ as IFQ only to QS holders that held QS in the year prior to the redistribution, it is possible that a person could hold QS in the year prior to the redistribution, subsequently transfer that QS before NMFS issues IFQ for the following year, and receive IFQ from the redistribution even though that person does not hold QS. Issuing IFQ to persons who do not currently hold QS would be contrary to the current functioning of the IFQ Program (
Under this proposed rule, the remaining 50 percent of RFQ in excess of the amount needed to achieve the unguided sport management measures in either Area 2C or 3A would be redistributed equally among all CQEs that held halibut QS in the applicable area (Area 2C or Area 3A) in the year prior to the redistribution as well as in the year that the redistribution occurs. If no CQE held QS in the applicable area (Area 2C or Area 3A) in the preceding year and in the year that the redistribution occurs, this 50 percent of the excess RFQ would not be redistributed in that area. In other words, the excess RFQ would be unfished or “left in the water” for conservation. The rationale for requiring the CQE to hold QS in the year prior to the redistribution, and in the year the redistribution occurs is the same as the rationale for the redistribution to catcher vessel QS holders described above. NMFS solicits comments from the public on whether excess RFQ should be redistributed to eligible catcher vessel QS holders and CQEs based on this proposed methodology.
The Council and NMFS considered options that would not have required a redistribution of RFQ as only IFQ, and alternative methods to redistribute RFQ as IFQ. The Council recommended and NMFS proposes the reallocation procedures in this rule to provide additional harvest opportunity among holders of small amounts of QS as well as to CQEs who hold QS on behalf of coastal community residents. Section 4.8.1.4 of the Analysis describes the options considered by the Council and NMFS and notes that based on the current levels of halibut abundance and the cumulative use limits in Area 2C and 3A, it is unlikely that the RQE could hold an amount of QS that would result in the need for redistribution of excess RFQ.
NMFS proposes to add regulations under § 679.40(c) to describe how excess RFQ would be redistributed.
The Magnuson-Stevens Act at section 304(d)(2)(A) requires that cost recovery fees be collected for the costs directly
NMFS calculates IFQ cost recovery fee assessments in November each year. To determine cost recovery fees for IFQ holders, NMFS uses data reported by Registered Buyers to compute annual standard ex-vessel IFQ prices by month and port (or, if confidential, by port group). NMFS publishes these standard prices in the
In years when the RQE holds QS and the RFQ is issued to augment the charter fishery's catch limit, the charter fishery would be effectively using all of this RFQ; therefore, the RQE would pay cost recovery fees on all of its RFQ. Since all annual RFQ issued to the RQE would be considered “used,” NMFS would levy the fee calculated for the RQE's annual RFQ pounds that are issued, rather than estimating RFQ harvest at each point of charter landings. The fee would be calculated using the standard price calculated for Area 2C or 3A and the RFQ held by the RQE. This is similar to the method used to apply an ex-vessel value for GAF. The IFQ cost recovery fee could be levied on the RQE each year the RQE holds QS, and the resulting RFQ is issued to augment the catch limit in the charter fishery. All holdings acquired by the RQE on October 1 of the prior year would be subject to the IFQ cost recovery fee.
For purposes of cost recovery, the RQE would pay fees on all resulting pounds of RFQ, even if the charter fishery's harvest was under its catch limit in Area 2C or 3A for that year. In December of each year, NMFS would (1) determine the standard prices and the cost recovery fee percentage; (2) announce the standard prices and the cost recovery fee percentage in the
Based on NMFS policy, only “incremental” costs,
NMFS proposes revising regulations throughout § 679.45 to incorporate the RQE into the IFQ Program cost recovery fee estimation and collection process.
Because all RFQ would be considered landed or used by the RQE in the year for which it is issued and the standard prices would be applied to pounds of RFQ, the RQE would not be required to complete the recordkeeping and reporting requirements described for the IFQ Program at § 679.5(1). The RQE would be exempt from submitting the IFQ Prior Notice of Landing, Product Transfer, IFQ Landing, IFQ Transshipment Authorization, and IFQ Departure reports.
The Council recommended and NMFS proposes that the RQE file an annual report with the Council by January 31 of each year that details the administrative activities and business operations of the RQE during the prior year for each year that it holds commercial QS. Although not specifically requested by the Council, NMFS proposes that the annual report also be submitted to NMFS for reasons described below.
The RQE would be required to include the following general information in its annual report: (1) Any changes to the bylaws, board of directors, or other key management personnel of the RQE during the preceding year; (2) amounts and descriptions of annual administrative expenses; (3) amounts and descriptions of funds spent on conservation, research, and promotion of the halibut resource and a summary of the results; and (4) amounts and descriptions of all other expenses. Additionally, the RQE would be required to submit the following information by regulatory area: (1) The total amount of halibut QS by vessel category and block held by the RQE at the start of the calendar year, on October 1, and at the end of the calendar year; (2) a list of all transfers (purchases, sales, and any other transfers) of halibut QS, including transaction prices if applicable; and (3) the number of CHPs and associated angler endorsements purchased and held by the RQE.
The Council did not specify what would happen if the RQE did not submit a timely and complete annual report. Section 679.41(c)(10)(ii) requires a CQE to submit a timely and complete annual report to NMFS before a transfer of QS will be approved or IFQ will be issued. NMFS proposes a similar requirement for the RQE at new paragraph § 679.41(c)(11)(i). If the RQE held QS in the previous year and has not submitted a timely and complete annual report by the January 31 deadline, NMFS would not approve a transfer of QS or issue RFQ until the report is submitted. To confirm receipt of the report, NMFS is proposing that the RQE submit the annual report to both the Council and NMFS. NMFS seeks public comment on whether these requirements, similar to those for CQEs, should apply to the RQE.
NMFS proposes adding § 679.5(v) to include the RQE annual report requirements.
NMFS proposes revisions throughout the IFQ regulations at 50 CFR part 679
NMFS proposes revisions throughout 50 CFR part 679 that refer to the IFQ permit that also pertain to the RQE to include the term “RFQ permit account.” NMFS proposes these revisions because the RQE would not be issued an IFQ fishing permit. Instead, NMFS proposes establishing an RFQ permit account for the RQE that would be used to administer RFQ as described in this proposed rule.
NMFS also proposes revisions throughout 50 CFR part 679 that refer to IFQ to include the term “RFQ” when the regulations refer to IFQ and RFQ.
These minor changes are shown in the proposed regulatory text.
This proposed rule would change several references within §§ 679.41 and 679.45 that describe the former procedure for appealing an IAD to the NOAA Fisheries' Alaska Office of Administrative Appeals. Those procedures were described at to § 679.43. NOAA Fisheries has centralized the appeals process in the National Appeals Office, which operates out of NOAA Fisheries' headquarters in Silver Spring, MD. The National Appeals Office is now charged with processing appeals that were filed with the Office of Administrative Appeals, Alaska Region. The procedure for appealing an IAD through the National Appeals Office is at 15 CFR part 906 (79 FR 7056, February 6, 2014). This proposed rule would update the regulations referring to appeals procedures for the IFQ Program to refer to 15 CFR part 906 instead of to § 679.43.
During the development of the RQE Program, the Council and NMFS considered, but did not propose regulations that would address RQE funding, limits on the use of RQE funds, and the purchase of CHPs by the RQE. This section of the preamble provides the public with a description of the overall intent of the Council regarding RQE funding and limits on the use of RQE funds, and notes that NMFS would regulate the purchase of CHPs by the RQE consistent with existing regulations.
The Council did not recommend and NMFS does not propose regulations that would define the specific type of incorporation (
The Council did not recommend and NMFS does not propose regulations regarding the use of funds obtained by the RQE. However, the Council did indicate how funds obtained by the RQE could be used to meet the objectives of the RQE Program. The Council indicated that it intended for the RQE to use funds primarily for the acquisition of commercial halibut QS; halibut conservation and research; promotion of the halibut resource; and administrative costs. NMFS notes that this proposed rule would require the RQE to submit an annual report describing its annual expenditures (described in a previous section of this preamble) to NMFS and the Council. Based on information received in this annual report, the Council could choose to initiate a subsequent action that would limit the use of funds held by the RQE in the future if the RQE's annual reports indicate that RQE funds are being used in a manner that is contrary to the Council's intent described above.
The Council did not specify limits on the acquisition of CHPs by the RQE; therefore, the RQE would be subject to regulations that apply to any other person, as defined at § 300.61, for purposes of purchasing and holding CHPs. Section 300.67(j) states that a person may not own, hold, or control more than five CHPs, with limited exceptions. The RQE would be authorized to purchase and hold up to five transferable CHPs in both regulatory areas combined. Any purchases or sales of CHPs by the RQE would be required to be reported in the RQE's annual report to the Council and NMFS.
Regulations governing the U.S. fisheries for Pacific halibut are developed by the IPHC, the Pacific Fishery Management Council, the North Pacific Fishery Management Council, and the Secretary of Commerce. Section 5 of the Halibut Act (16 U.S.C. 773c) allows the Regional Council having authority for a particular geographical area to develop regulations governing fishing for halibut in U.S. Convention waters as long as those regulations do not conflict with IPHC regulations. The Halibut Act, at sections 773c(a) and (b), provides the Secretary of Commerce with the general responsibility to carry out the Convention with the authority to, in consultation with the Secretary of the department in which the U.S. Coast Guard is operating, adopt such regulations as may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act. This proposed rule is consistent with the Halibut Act and other applicable laws.
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866.
An RIR was prepared to assess all costs and benefits of available regulatory alternatives. The RIR considers all quantitative and qualitative measures. A copy of this analysis is available from NMFS (see
An Initial Regulatory Flexibility Analysis (IRFA) was prepared for this action, as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. The IRFA describes the action; the reasons why this action is proposed; the objectives and legal basis for this proposed rule; the number and description of directly regulated small entities to which this proposed rule would apply; the recordkeeping, reporting, and other compliance requirements of this proposed rule; and the relevant Federal rules that may duplicate, overlap, or conflict with this proposed rule. The IRFA also describes significant alternatives to this proposed rule that would accomplish the stated objectives of the Magnuson-Stevens Act, and any other applicable statutes, and that would minimize any significant economic impact of this proposed rule on small entities. The description of the proposed action, its purpose, and the legal basis are explained in the preamble and are not repeated here. A summary of the IRFA follows. A copy of the IRFA is available from NMFS (see
The Small Business Administration (SBA) criteria for determining whether
For this proposed action, the pool of small, directly regulated entities would be limited to those entities that would be engaging in QS transfer (
NMFS considers commercial halibut fishing vessels as proxies for small entities because IFQ from more than one QS holder is often fished from the same vessel. NMFS estimates that 812 vessels across all IPHC regulatory areas landed halibut in 2014, the most recent year of complete data on the value of halibut landings by vessel. Of those, 11 vessels would be considered large entities because they showed revenues that exceeded the $11 million threshold. The remaining 801 vessels would be considered directly regulated small entities for this proposed rule. See Section 5.6 of the Analysis for more information.
This proposed action is expected to have distributional impacts to the identified directly regulated small entities. Transfers of QS would be voluntary among all the small, directly regulated entities identified in the IRFA. The preferred alternative is the only alternative considered that would give current halibut QS holders an additional opportunity to transfer their QS and the RQE an opportunity to form and obtain QS. As noted earlier in this preamble, the Council and NMFS considered the status quo and the preferred alternative. However, under the preferred alternative, the Council and NMFS considered a wide range of potential limitations on the amount and type of QS that could be held by the RQE. The wide variation in the options considered under the preferred alternative provided the Council and NMFS with a broad range of potential policy choices to minimize the adverse impacts.
Under the preferred alternative, the RQE representing the charter fishery would not be expected to participate in the IFQ Program (and purchase halibut QS) if it did not benefit the charter fishery as a whole. QS holders, including CQEs, would not be expected to engage in a QS transaction with the RQE if it did not benefit from that transfer. However, there is a potential for the RQE to affect the QS market by increasing competition in the market. This increased competition could limit the ability for persons in the commercial IFQ fishery to expand their QS holdings by increasing the market price of QS or limiting the amount of QS available to commercial QS holders and CQEs. This potential negative impact is considered in the Regulatory Impact Review (Section 4.8.2 of the Analysis). To mitigate the expected effects on the QS market, the Council recommended and NMFS proposes provisions to limit the amount and types of QS that could be acquired by the RQE, annually and cumulatively.
Specifically, the Council's preferred alternative (and this proposed rule) would create an annual transfer limitation of 1 percent of the QS in Area 2C and an annual transfer limitation of 1.2 percent of the QS in Area 3A. Cumulative use limits for the charter fishery are proposed to limit the combined amount of commercial QS held by RQE and transferred under GAF (10 percent in Area 2C and 12 percent in Area 3A). Proposed transfer limits include prohibiting the RQE from purchasing D-category QS in Area 3A and limiting it to holding 10 percent of D-category QS in Area 2C, and restricting purchase of B-category QS to no more than 10 percent in Area 2C and 10 percent of B-category QS in Area 2C. Block restrictions would prohibit the RQE from purchasing small blocks of QS. This proposed rule would seek to derive the greatest net benefit for small regulated entities by increasing market opportunities in the charter fishery while ameliorating adverse impacts that could occur for QS holders and CQEs in the commercial IFQ fishery if QS holdings by the RQE were not limited. Overall, the net benefits to directly regulated small entities are expected to be positive.
NMFS has not identified any duplication, overlap, or conflict between this proposed action and existing Federal rules.
The RFA requires a description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record. This proposed rule would require new information collections from an RQE. Under this proposed rule, a non-profit entity that wants to become an RQE would need to complete an application and submit it to NMFS for approval. This application would require submission of the entity's articles of incorporation, the corporate by-laws, a list of key personnel, including the Board of Directors, officers, representatives, and managers. NMFS would approve the first complete RQE application it receives.
If the RQE wants to receive or transfer halibut QS, it would need to use the “Application for Transfer QS To or From an RQE” available on the NMFS Alaska Region Web site at
This proposed rule contains collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). NMFS has submitted these requirements to OMB for approval under a temporary new information collection, to be merged after approval with OMB Control Number 0648-0272. Public reporting burden is estimated to average per response: 200 hours for Application for a Non-Profit Corporation to be Designated as a Recreational Quota Entity; 2 hours for Application for Transfer of QS To or From an RQE; 40 hours for RQE Annual Report; 1 minute for electronic submission of cost recovery fee; and 30 minutes for non-electronic fee submission for IFQ Permit Holder Fee Submission Form. Public comment is sought regarding: Whether these proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden statement; ways to enhance quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information, to NMFS (see
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to penalty for failure to comply with, a collection of information subject to the requirement of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at
Administrative practice and procedure, Antarctica, Canada, Exports, Fish, Fisheries, Fishing, Imports, Indians, Labeling, Marine resources, Reporting and recordkeeping requirements, Russian Federation, Transportation, Treaties, Wildlife.
Alaska, Fisheries, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, 50 CFR parts 300 and 679 are proposed to be amended as follows:
16 U.S.C. 773-773k.
(c) * * *
(1) * * *
(iii) Authorizes the use of Commission regulatory areas 2C and 3A RFQ resulting from halibut QS held by the RQE as authorized in part 679 to this title to supplement the annual guided sport catch limit in the corresponding area, pursuant to paragraph (c)(4) of this section.
(4) * * *
(i) The Commission regulatory areas 2C and 3A annual guided sport catch limits are determined by subtracting wastage from, and adding any pounds of RFQ held by an RQE for that area to, the allocations in Tables 3 and 4 of this subpart E, adopted by the Commission as annual management measures, and published in the
(iii) The amount of QS held by the RQE for Commission regulatory area 2C and 3A as of October 1 each year will be the basis for determining the amount of RFQ pounds that will be added to the annual guided sport catch limit for the corresponding area in the upcoming year.
(5) * * *
(ii) * * *
(D) * * *
(
(
(
(
16 U.S.C. 773
(d) * * *
(1) * * *
(iv)
(l) * * *
(7) * * *
(ii) * * *
(A)
(C)
(D)
(9) An annual report on RQE activities must be submitted to NMFS by the RQE as required at § 679.5(v).
(v)
(2)
(3)
(4)
(i) Any changes to the bylaws, board of directors, or other key management personnel of the RQE from the preceding year;
(ii) Amount and description of annual administrative expenses;
(iii) Amount and description of funds spent on conservation and research, including a summary of the results of those expenditures; and
(iv) Amount and description of all other expenses incurred by the RQE.
(5)
(i) The total amount of halibut QS by category and blocks held by the RQE at the start of the calendar year, on October 1, and at the end of the calendar year;
(ii) A list of all transfers (purchases or sales) of halibut QS, including the transaction price; and
(iii) A description of the number of charter halibut permits and number of angler endorsements purchased and held by the RQE.
(f) * * *
(3) * * *
(i) * * *
(C) Use fixed gear as defined in § 679.2 to retain halibut RFQ.
(b) Annual allocation of IFQ and RFQ. The Regional Administrator shall assign halibut or sablefish IFQs to each person, except the RQE, holding unrestricted QS halibut or sablefish, respectively, up to the limits prescribed in § 679.42(e) and (f). Each assigned IFQ will be specific to an IFQ regulatory area and vessel category, and will represent the maximum amount of halibut or sablefish that may be harvested from the specified IFQ regulatory area and by the person to whom it is assigned during the specified fishing year, unless the IFQ assignment is changed by the Regional Administrator within the fishing year because of an approved transfer or because all or part of the IFQ is sanctioned for violating rules of this part. The Regional Administrator shall assign RFQ to the RQE pursuant to paragraph (c)(4) of this section.
(c)
(2)
(4)
(ii)
(iii)
(A) Calculate the annual allocation of halibut RFQ to the RQE as specified in paragraph (c)(4)(ii) of this section;
(B) Determine the amount of RFQ needed to supplement the annual guided sport catch limit from the CSP in Area 2C and Area 3A (described in § 300.65(c)) to account for charter fishery harvests under the charter fishery management measures specified in the annual management measures and issue that amount of RFQ to the RFQ permit account.
(C) Calculate the amount of excess RFQ by subtracting the amount of RFQ issued as determined in paragraph (c)(4)(iii)(B) of this section from the annual calculation of RFQ halibut to the RQE as calculated in paragraph (c)(4)(iii)(A) of this section.
(iv)
(A) 50 percent to all catcher vessel QS holders in the applicable area who held not more than 32,333 QS units in Area 2C, and 47,469 QS units in Area 3A in the current calendar year and in the calendar year prior to the redistribution, in proportion to their QS holdings; and
(B) 50 percent divided equally among all CQEs that held halibut QS in the applicable IFQ regulatory area (Area 2C or Area 3A) in the current calendar year and in the calendar year prior to the redistribution. If no CQE held QS in the applicable IFQ regulatory area (Area 2C and Area 3A) in the current calendar year and in the calendar year prior to the redistribution, that RFQ will not be redistributed as IFQ and will not be available for use by any CQE, IFQ permit holder, or RQE in that calendar year.
(g) * * *
(2) * * *
(iii) The fish will not be calculated as part of the recreational harvest of halibut and will not be debited against the RFQ permit account or the annual guided sport catch limit as defined in § 300.61 of this title.
(h) * * *
(3)
(iii) All annual RFQ halibut issued to an RQE will be considered landed in the year for which it is issued.
(c) * * *
(11) If the person applying to receive or transfer QS is an RQE, the following determinations are required:
(i) The RQE applying to receive or transfer QS, has submitted the timely and complete annual report required by § 679.5(v);
(ii) The RQE applying to receive QS is eligible to hold QS on behalf of the charter halibut sector in IFQ regulatory area 2C or 3A; and
(iii) The RQE applying to receive QS has received notification of approval of eligibility to receive QS on behalf of the charter halibut sector in IFQ regulatory area 2C or 3A as described in paragraph (d)(1) of this section.
(d) * * *
(1)
(g) * * *
(1) Except as provided in paragraph (f), paragraph (g)(2), paragraph (l), or paragraph (n) of this section, only persons who are IFQ crew members, or who were initially issued QS assigned to vessel categories B, C, or D, and meet the eligibility requirements in this section, may receive by transfer QS assigned to vessel categories B, C, or D, or the IFQ resulting from it.
(9) For transfers of QS to an RQE, the RQE may only receive halibut QS that is assigned to IFQ regulatory area 2C or 3A.
(10) For transfers of QS from an RQE:
(i) Quota category and block designations at time of purchase by an RQE are retained if QS is transferred to an eligible QS holder for use in the IFQ program.
(ii) NMFS will not issue any IFQ from any QS transferred from an RQE to a QS holder for use in the IFQ program for a calendar year if that QS resulted in the issuance of RFQ to an RQE during that calendar year.
(11)
(ii) If the Regional Administrator determines the RQE approved by NMFS does not meet the requirement specified in in paragraph (n)(1)(i) of this section, NMFS will notify the RQE of the Regional Administrator's determination and specify that the RQE has 60 days to meet the requirement in paragraphs (n)(1)(i) of this section to maintain eligibility as the RQE authorized by NMFS.
(iii) If the RQE demonstrates to NMFS within 60 days of notification that it meets the requirement in paragraphs (n)(1)(i) of this section, NMFS will notify the RQE that it remains the authorized RQE.
(iv) If the RQE does not demonstrate to NMFS within 60 days of notification that it meets the requirement in paragraphs (n)(1)(i) of this section, NMFS will issue an initial administrative determination (IAD):
(A) Revoking authorization of the RQE;
(B) Disallowing the RQE from receiving any QS by transfer;
(C) Requiring the CQE to divest of any QS that it holds; and
(D) Withholding the issuance of RFQ based on any QS that the RQE holds.
(v) The RQE would have the opportunity to appeal the IAD through the National Appeals Office under the
(n)
(ii) The RQE will be a non-profit entity incorporated under the laws of the State of Alaska and recognized as exempt from federal income tax by the Internal Revenue Service; and
(iii) The RQE will submit an annual report to NMFS and the Council detailing RQE activities during the prior year according to § 679.5(v).
(2)
(i) The articles of incorporation under the laws of the State of Alaska for that non-profit entity;
(ii) Acknowledgement from the Internal Revenue Service that the non-profit entity is exempt from federal income tax under section 501(a) of the Internal Revenue Code;
(iii) Management organization information, including:
(A) The bylaws of the non-profit entity;
(B) A list of key personnel of the managing organization including, but not limited to, the RQE board of directors, officers, representatives, and any managers;
(C) A description of how the non-profit entity is qualified to manage QS on behalf of charter fishery participants and a demonstration that the non-profit entity has the management, technical expertise, and ability to manage QS and RFQ;
(D) The name of the non-profit organization, taxpayer ID number, NMFS person number, permanent business mailing addresses, name of contact persons and additional contact information of the managing personnel for the non-profit entity, resumes of management personnel, name and notarized signature of applicant, and Notary Public signature and date when commission expires;
(iv) A statement describing the procedures that will be used to determine the acquisition of funds to purchase QS.
(3)
(4)
(5)
(a) * * *
(2) * * *
(v) In IFQ regulatory areas 2C and 3A, RFQ held by an RQE may be harvested aboard charter vessels as defined at 50 CFR 300.61 of any size, regardless of the QS category from which that RFQ originated.
(f) * * *
(1) Unless the amount in excess of the following limits was received in the initial allocation of halibut QS, no person other than a CQE representing the community of Adak, AK, individually or collectively, or an RQE, may use more than:
(8)
(ii)
(iii)
(B) The RQE may not hold halibut QS in IFQ regulatory area 3A that is assigned to vessel category D.
(C) The RQE may not hold more than 265,524 units of halibut QS that is assigned to vessel category B in IFQ regulatory area 2C.
(g) * * *
(1) * * *
(iii) The RQE is limited to receiving:
(A) Transfers of halibut QS blocks of less than or equal to 24,250 quota share units in IFQ regulatory area 2C.
(B) Transfers of halibut QS blocks of less than or equal to 35,620 quota share units in IFQ regulatory area 3A.
(a) * * *
(1)
(2) * * *
(i)
(A) Each year, the Regional Administrator will issue each IFQ permit holder a summary of his or her IFQ equivalent pounds landed as IFQ and GAF and will issue an RQE a summary of its RFQ pounds issued as part of the IFQ Landing and Estimated Fee Liability page described at § 679.5(l)(7)(ii)(D).
(B) * * *
(
(D) An RQE may not challenge the standard ex-vessel value used to determine the fee liability for all RFQ issued to the RQE.
(3)
(ii) An RQE is responsible for collecting its own fees during the calendar year in which the RFQ is issued to the RQE.
(4) * * *
(i)
(b) * * *
(1)
(ii) An RQE must use the IFQ standard ex-vessel value derived by NMFS for all RFQ issued to the RQE.
(f) * * *
(2) After the expiration of the 30-day period, the Regional Administrator will evaluate any additional documentation submitted by an IFQ permit holder or RQE in support of its payment. If the Regional Administrator determines that the additional documentation does not meet the burden of proving the payment is correct, the Regional Administrator will send the IFQ permit holder or RQE an IAD indicating that the IFQ permit holder or RQE did not meet the burden of proof to change the IFQ fee liability as calculated by the Regional Administrator based upon the IFQ standard ex-vessel value. The IAD will set out the facts and indicate the deficiencies in the documentation submitted by the IFQ permit holder or RQE. An IFQ permit holder or RQE who receives an IAD may appeal the IAD, as described in paragraph (h) of this section.
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 November 2, 2017 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 20503. Commentors 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.
Commission on Civil Rights.
Announcement of briefing 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 briefing meeting of the Delaware Advisory Committee to the Commission will convene at 9:00 a.m. (EDT) on Wednesday, November 1, 2017 at Widener University Delaware Law School, 4601 Concord Pike, Wilmington DE 19803-0406. The purpose of the briefing is to hear from government officials, advocates, and others on Policing in Communities of Color and Implicit Bias in Delaware.
Wednesday, November 1, 2017 (EDT).
Widener University Delaware Law School, 4601 Concord Pike, Wilmington DE 19803-0406.
Ivy Delaviez at
If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at
Time will be set aside at the end of the briefing so that members of the public may address the Committee after the formal presentations have been completed. Persons interested in the issue are also invited to December 1, 2017. Written comments may be mailed to the Eastern Regional Office, U.S. Commissionon Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202)
Records and documents discussed during the meeting will be available for public viewing as they become available at
Commission on Civil Rights.
Announcement of monthly planning meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Delaware State Advisory Committee to the Commission will convene by conference call, on Monday, October 16 at 10:00 a.m. (EDT). The purpose of the meeting is to make preparations for a briefing meeting on Policing in Communities of Color and Implicit Bias in Delaware, including refining the agenda and list of the invited expert presenters. The briefing meeting is planned for November 1, 2017 at Widener University Delaware Law School, 4601 Concord Pike, Ruby R. Vale Moot Courtroom, Wilmington, DE 19803-0406. A public session will convene directly following the briefing in November.
Monday, October 16, 2017, at 10:00 a.m. (EDT) and Wednesday, November 1, 2017.
Ivy L. Davis, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-800-210-9006 and conference call ID: 4124362. Please be advised that before placing them into the conference call, the conference call operator may 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 telephone number herein.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-888-364-3109 and providing the operator with the toll-free conference call number: 1-800-210-9006 and conference call ID: 4124362.
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, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
On May 30, 2017, the Charlotte Regional Partnership, Inc., grantee of FTZ 57, submitted a notification of proposed production activity to the FTZ Board on behalf of DNP Imagingcomm America Corporation (DNP), within Subzone 57C, in Concord, North Carolina.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
An application has been submitted to the Foreign-Trade Zones Board (the Board) by the North Carolina Department of Transportation, grantee of FTZ 214, requesting an expansion of Subzone 214A on behalf of Consolidated Diesel Company (CDC). The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on September 26, 2017.
Subzone 214A was approved on May 8, 2000 (Board Order 1093, 65 FR 33294, May 23, 2000) and consists of the following sites:
In accordance with the Board's regulations, Kathleen Boyce of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is November 13, 2017. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to November 27, 2017.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via
For further information, contact Kathleen Boyce at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of determinations by the Department of Commerce (the Department) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) orders on certain stainless steel sheet and strip (SSSS) in coils from Japan, the Republic of Korea (Korea), and Taiwan, and the countervailing duty (CVD) order on SSSS in coils from Korea would likely lead to continuation or recurrence of dumping and countervailable subsidies and material injury to an industry in the United States, the Department is publishing notice of the continuation of the AD orders and the CVD order.
Applicable October 3, 2017.
Terre Keaton Stefanova, AD/CVD
On July 27, 1999, the Department published the AD orders on SSSS in coils from Japan, Korea, and Taiwan.
As a result of these sunset reviews, the Department found that revocation of the AD orders on SSSS in coils from Japan, Korea, and Taiwan would likely lead to continuation or recurrence of dumping, and that revocation of the CVD order would likely lead to continuation or recurrence of countervailable subsidies.
On September 26, 2017, pursuant to sections 751(c) and 752(a) of the Act, the ITC published its determination that revocation of the AD orders on SSSS in coils from Japan, Korea, and Taiwan and revocation of the CVD order on SSSS in coils from Korea would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.
The merchandise covered by these
The merchandise subject to these
Excluded from the scope of these
Razor blade steel is a flat-rolled product of stainless steel, not further worked than cold-rolled (cold-reduced), in coils, of a width of not more than 23 mm and a thickness of 0.266 mm or less, containing, by weight, 12.5 to 14.5 percent chromium, and certified at the time of entry to be used in the manufacture of razor blades.
Flapper valve steel is also excluded from the scope: This product is defined as stainless steel strip in coils containing, by weight, between 0.37 and 0.43 percent carbon, between 1.15 and 1.35 percent molybdenum, and between 0.20 and 0.80 percent manganese. This steel also contains, by weight, phosphorus of 0.025 percent or less, silicon of between 0.20 and 0.50 percent, and sulfur of 0.020 percent or less. The product is manufactured by means of vacuum arc re-melting, with inclusion controls for sulphide of no more than 0.04 percent and for oxide of no more than 0.05 percent. Flapper valve steel has a tensile strength of between 210 and 300 ksi, yield strength of between 170 and 270 ksi, plus or minus 8 ksi, and a hardness CRv) of between 460 and 590. Flapper valve steel is most commonly used to produce specialty flapper valves in compressors.
Suspension foil excluded from the scope is a specialty steel product used in the manufacture of suspension assemblies for computer disk drives. Suspension foil is described as 302/304
Certain stainless steel foil for automotive catalytic converters is also excluded from the scope. This stainless steel strip in coils is a specialty foil with a thickness of between 20 and 110 microns used to produce a metallic substrate with a honeycomb structure for use in automotive catalytic converters. The steel contains, by weight, carbon of no more than 0.030 percent, silicon of no more than 1.0 percent, manganese of no more than 1.0 percent, chromium of between 19 and 22 percent, aluminum of no less than 5.0 percent, phosphorus of no more than 0.045 percent, sulfur of no more than 0.03 percent, lanthanum of less than 0.002 or greater than 0.05 percent, and total rare earth elements of more than 0.06 percent, with the balance iron.
Permanent magnet iron-chromium-cobalt alloy stainless strip is also excluded from the scope. This ductile stainless steel strip contains, by weight, 26 to 30 percent chromium, and 7 to 10 percent cobalt, with the remainder of iron, in widths 228.6 mm or less, and a thickness between 0.127 and 1.270 mm. It exhibits magnetic remanence between 9,000 and 12,000 gauss, and a coercivity of between 50 and 300 oersteds. This product is most commonly used in electronic sensors and is currently available under proprietary trade names such as “Arnokrome III.”
Certain electrical resistance alloy steel is also excluded from the scope. This product is defined as a non-magnetic stainless steel manufactured to American Society of Testing and Materials (ASTM) specification B344 and containing, by weight, 36 percent nickel, 18 percent chromium, and 46 percent iron, and is most notable for its resistance to high temperature corrosion. It has a melting point of 1390 degrees Celsius and displays a creep rupture limit of 4 kilograms per square millimeter at 1000 degrees Celsius. This steel is most commonly used in the production of heating ribbons for circuit breakers and industrial furnaces, and in rheostats for railway locomotives. The product is currently available under proprietary trade names such as “Gilphy 36.”
Certain martensitic precipitation-hardenable stainless steel is also excluded from the scope. This high-strength, ductile stainless steel product is designated under the Unified Numbering System (UNS) as S45500-grade steel, and contains, by weight, 11 to 13 percent chromium, and 7 to 10 percent nickel. Carbon, manganese, silicon and molybdenum each comprise, by weight, 0.05 percent or less, with phosphorus and sulfur each comprising, by weight, 0.03 percent or less. This steel has copper, niobium, and titanium added to achieve aging, and will exhibit yield strengths as high as 1700 Mpa and ultimate tensile strengths as high as 1750 Mpa after aging, with elongation percentages of 3 percent or less in 50 mm. It is generally provided in thicknesses between 0.635 and 0.787 mm, and in widths of 25.4 mm. This product is most commonly used in the manufacture of television tubes and is currently available under proprietary trade names such as “Durphynox 17.”
Three specialty stainless steels typically used in certain industrial blades and surgical and medical instruments are also excluded from the scope. These include stainless steel strip in coils used in the production of textile cutting tools (
In addition, as a result of changed circumstances reviews,
• Stainless steel welding electrode strips that are manufactured in accordance with American Welding Society (AWS) specifications ANSIIAWS A5.9-93.
• Certain stainless steel used for razor blades, medical surgical blades, and industrial blades that are sold under proprietary names such as DSRIK7, DSRIKA, and DSRIK9.
• Certain stainless steel lithographic sheet that is made of 304-grade stainless steel.
• Certain nickel clad stainless steel sheet.
As a result of the determinations by the Department and the ITC that revocation of the AD orders and the CVD order would likely lead to continuation or recurrence of dumping and countervailable subsidies and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), the Department hereby orders the continuation of the AD orders on SSSS in coils from Japan, Korea, and Taiwan and the CVD order on SSSS in coils from Korea.
U.S. Customs and Border Protection will continue to collect AD and CVD cash deposits at the rates in effect at the
These five-year (sunset) reviews and this notice are in accordance with sections 751(c) of the Act and published pursuant to section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).
National Institute of Standards and Technology, Commerce.
Notice.
The Information Security and Privacy Advisory Board (ISPAB) will meet Wednesday, October 25, 2017 from 9:00 a.m. until 4:30 p.m., Eastern Time, Thursday, October 26, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, and Friday, October 27, 2017 from 9:00 a.m. until 12:00 p.m. Eastern Time. All sessions will be open to the public.
The meeting will be held on Wednesday, October 25, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, Thursday, October 26, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, and Friday, October 27, 2017 from 9:00 a.m. until 12:00 p.m. Eastern Time.
The meeting will be held at the Constitution Hall, American University, 4400 Massachusetts Ave. NW., Washington, DC 20016.
Matthew Scholl, Information Technology Laboratory, NIST, 100 Bureau Drive, Stop 8930, Gaithersburg, MD 20899-8930, Telephone: (301) 975-2941, Email address:
Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the Information Security and Privacy Advisory Board (ISPAB or Board) will meet Wednesday, October 25, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, Thursday, October 26, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, and Friday, October 27, 2017 from 9:00 a.m. until 12:00 p.m. Eastern Time. All sessions will be open to the public. The ISPAB is authorized by 15 U.S.C. 278g-4, as amended, and advises the National Institute of Standards and Technology (NIST), the Secretary of Homeland Security, and the Director of the Office of Management and Budget (OMB) on information security and privacy issues pertaining to Federal government information systems, including thorough review of proposed standards and guidelines developed by NIST. Details regarding the ISPAB's activities are available at
The agenda is expected to include the following items:
Note that agenda items may change without notice. The final agenda will be posted on the Web site indicated above. Seating will be available for the public and media. Pre-registration is not required to attend this meeting.
Speakers who wish to expand upon their oral statements, those who had wished to speak but could not be accommodated on the agenda, and those who were unable to attend in person are invited to submit written statements. In addition, written statements are invited and may be submitted to the ISPAB at any time. All written statements should be directed to the ISPAB Secretariat, Information Technology Laboratory, 100 Bureau Drive, Stop 8930, National Institute of Standards and Technology, Gaithersburg, MD 20899-8930.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before December 4, 2017.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Eric Orbesen, Southeast Fisheries Science Center, 75 Virginia Beach Dr., Miami, FL 33149, (305) 361-4253 or
This request is for extension of a current information collection.
The Cooperative Game Fish Tagging Program was initiated in 1971 as part of a comprehensive research program resulting from passage of Public Law 86-359, Study of Migratory Game Fish, and other legislative acts under which the National Marine Fisheries Service (NMFS) operates. The Cooperative Tagging Center attempts to determine the migration patterns of, and other biological information for, billfish, tunas, and swordfish. The fish tagging report is provided to the angler with the tags, and he/she fills out the card with the information when a fish is tagged and mails it to NMFS. Information on each species is used by NMFS to determine migratory patterns, distance traveled, stock boundaries, age, and growth. These data are necessary input for developing management criteria by regional fishery management councils, states, and NMFS.
Information is submitted by mail, and occasionally, international anglers scan the report cards and submit them via email to
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting (webinar).
The Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT) and Science and Statistical salmon subcommittee (SSC-Salmon) will hold a joint one-day methodology review meeting via webinar, which is open to the public.
The webinar meeting will be held on Tuesday, October 17, 2017, from 10 a.m. until 5 p.m. or until business for the day has been completed.
The meeting will be held via webinar. To attend the webinar (1) join the meeting by visiting this link
Ms. Robin Ehlke, Pacific Council; telephone: (503) 820-2410.
The purpose of the methodology review meeting is to discuss and review proposed changes to analytical methods used in salmon management. Results and recommendations from this methodology review meeting will be presented at the November 14-20, 2017, Council meeting in Costa Mesa, CA where the Council is scheduled to take final action on the proposals. At the September 2017 meeting, the Council adopted one topic for consideration at the methodology review meeting. The topic under review is:
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (503) 820-2411 at least 10 business days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
In preparation for the 2017 International Commission for the Conservation of Atlantic Tunas (ICCAT) meeting, the Advisory Committee to the U.S. Section to ICCAT is announcing the convening of its fall meeting.
The meeting will be held on October 17-18, 2017. There will be an open session on Tuesday, October 17, 2017, from 9 a.m. through approximately 12:30 p.m. The remainder of the meeting will be closed to the public and is expected to end by 1 p.m. on October 18. Interested members of the public may present their views during the public comment session on October 17, 2017.
The meeting will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Written comments should be sent via email to
Terra Lederhouse, Office of International Affairs and Seafood Inspection, 301-427-8360.
The Advisory Committee to the U.S. Section to ICCAT will meet October 17-18, 2017, first in an open session to consider management- and research-related information on stock status of Atlantic highly migratory species and then in a closed session to discuss sensitive matters. The open session will be from 9 a.m. through 12:30 p.m. on October 17, 2017, including an opportunity for public comment beginning at approximately 12 p.m. Comments may also be submitted in writing for the Advisory Committee's consideration. Interested members of the public can submit comments by mail or email; use of email is encouraged. All written comments must be received by October 13, 2017 (see
NMFS expects members of the public to conduct themselves appropriately at the open session of the Advisory Committee meeting. At the beginning of the public comment session, an explanation of the ground rules will be provided (
After the open session, the Advisory Committee will meet in closed session to discuss sensitive information relating to upcoming international negotiations regarding Atlantic highly migratory species conservation and management.
The meeting location is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Terra Lederhouse at (301) 427-8360 or
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before December 4, 2017.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Walter Ikehara, (808) 725-5175 or
This request is for extension of a currently approved information collection.
Regulations at 50 CFR 665.16 require that all U.S. vessels with Federal permits fishing for Western Pacific fishery management unit species display identification markings on the vessel and gear, as specified in 50 CFR 665 and 50 CFR 300. Vessels registered for use with a permit issued under Subparts B through E and Subparts G through I of 50 CFR 665, must display the vessel's official number on both sides of the deckhouse or hull, and on an appropriate weather deck. Vessels fishing for highly migratory species in the Western and Central Pacific Fisheries Commission (WCPFC) Convention Area must comply with the regulations at 50 CFR 300.217. These regulations require that vessels must display their international radio call sign on both sides of the deckhouse or hull, and on an appropriate weather deck, unless specifically exempted. Regulations at 50 CFR 300.35 require that vessels fishing under the South Pacific Tuna Treaty must display their international radio call sign on the hull, the deck, and on the sides of auxiliary equipment such as skiffs and helicopters. The numbers must be a specific size at specified locations. The display of the identifying numbers aids in fishery law enforcement.
Western Pacific fisheries regulations at 50 CFR 665.128, 665.228, 665.428, 665.628 and 665.804 require that certain fishing gear must be marked. In the pelagic longline fisheries, the vessel operator must ensure that the official number of the vessel is affixed to every longline buoy and float. In the coral reef ecosystem fisheries, the vessel number must be affixed to all fish and crab traps. The marking of gear links fishing
Third party disclosure
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
United States Patent and Trademark Office, Department of Commerce.
Notice.
The United States Patent and Trademark Office (USPTO) will no longer accept cash, including coins, as payment for products and services for which fees are required.
Matthew Lee, Director, Receipts Accounting Division, Office of Finance, by email at
Effective November 1, 2017, the USPTO will no longer accept cash, including coins, as payment for products and services for which fees are required. This change is being made to streamline the administrative fee collection process and is in accordance with the Department of the Treasury's policy on agencies adopting a no-cash policy. See
The USPTO's total net revenue for the last three fiscal years exceeded $3.0 billion each year, and the cash payment method collections averaged less than $14,000 each year. In fiscal year (FY) 2016, the cash payment method comprised less than $11,000, which represented less than 0.0004 percent of total net revenue collections. Furthermore, the USPTO processed over 4.95 million total fee transactions in FY 2016, and only 55 patent fees totaling under $5,000, and eleven trademark fees totally under $4,000, were paid by cash.
The only other fees collected by cash in FY 2016 were about $1,500 in copying fees. The current self-service copiers are to be discontinued as part of Office plans to enter a “No Cost” contract with a vendor who will keep all payments collected in exchange for providing this service. See
For the past three years, the overwhelming majority of fees have been paid to the USPTO using a payment method other than cash, and the costs of handling, safeguarding, auditing, transporting, and depositing of cash payments greatly outweigh the benefits of continuing to accept the cash payment method.
While the USPTO will no longer accept the cash payment method on or after November 1, 2017, payments will continue to be accepted in-person and by mail when made by check or money order, credit/debit card, or deposit account. Payment of fees attempted with cash will be refused and returned. More information about all accepted payment methods is available at
Bureau of Consumer Financial Protection.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for an existing information collection, titled, “Generic Information Collection Plan for Studies of Consumers using Controlled Trials in Field and Economic Laboratory Settings.”
Written comments are encouraged and must be received on or before December 4, 2017 to be assured of consideration.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
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Documentation prepared in support of this information collection request is available at
Wednesday, October 11, 2017, 10:00 a.m.-12:00 p.m.
Hearing Room 420, Bethesda Towers, 4330 East-West Highway, Bethesda, MD.
Commission Meeting—Open to the Public
Briefing Matters: (1) Revision to the Notice of Requirements (NOR) for Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates—Notice of Proposed Rulemaking; (2) Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates—Final Rule
A live webcast of the Meeting can be viewed at
Rockelle Hammond, Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814, (301) 504-7923.
Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before November 2, 2017.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact August Martin, 202-245-7410.
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
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Western Area Power Administration, Department of Energy.
Submission for Office of Management and Budget review; request for comments.
Western Area Power Administration (WAPA), an agency within the Department of Energy (DOE), submitted an extension to an existing Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review, comment, and approval, as required under the Paperwork Reduction Act of 1995. The ICR seeks a 3-year extension for WAPA's Applicant Profile Data form (APD), OMB Control No. 1910-5136. The ICR described below identifies the request, including the anticipated public burden. The ICR is necessary for the proper performance of WAPA's functions. WAPA markets a limited amount of Federal hydropower. Due to the high demand for WAPA's power, WAPA needs the ability to collect information under the ICR in order to evaluate who may receive an allocation of Federal power pursuant to specific marketing plans. This APD public process only determines the information WAPA will collect in its ICR. The actual allocation of Federal power will be conducted through a separate marketing plan process outside the scope of this APD process.
To ensure consideration, comments regarding this collection must be received on or before November 2, 2017. The Paperwork Reduction Act requires OMB to make a decision on the extension of the ICR within 60 days after this publication or receipt of the proposed collection of information, whichever is later. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, please advise the DOE Desk Officer at OMB of your intention to make a
Written comments should be sent to: The DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10102, 735 17th Street NW., Washington, DC 20503.
A copy of the comments should be sent to WAPA, attention Mr. Brent Osiek, Vice President of Power Marketing, Western Area Power Administration, 150 East Social Hall Avenue, Suite 300, Salt Lake City, UT 84111 or by email to
Requests for additional information or copies of the APD should be directed to Mr. Brent Osiek at the above address or by telephone at 801-524-5495. The APD is available on WAPA's Web page at
Reclamation Laws are a series of laws arising from the Desert Land Act of 1877 and include, but are not limited to: The Desert Land Act of 1877, Reclamation Act of 1902, Reclamation Project Act of 1939, and the Acts authorizing each individual project such as the Central Valley Project Authorizing Act of 1937.
WAPA is collecting—and will continue to collect—the data under its APD to properly perform its function of marketing a limited amount of Federal hydropower. The information WAPA collects is voluntary. Due to the high demand for WAPA's power and limited amount of available power, WAPA will use the information collected in the APD—and has used the information collected under the current OMB-approved control number—pursuant to its marketing plans, to determine an applicant's eligibility for an allocation of Federal power. As a result, the information WAPA collects under its APD is both necessary and useful.
WAPA notes the Paperwork Reduction Act
On May 18, 2017, in compliance with the Paperwork Reduction Act, WAPA published a notice in the
In May 2017, concurrent with the publication of the
WAPA received no comments.
WAPA submitted to OMB the request to extend WAPA's APD. The APD and responses to the APD will not be part of a system of records covered by the Privacy Act
A copy of the APD is available on WAPA's Web page at:
As part of this process, WAPA has identified the minimum amount of information WAPA needs for its regional offices to properly perform the power marketing functions of the agency. Due to the variations that may develop in each region, the regional office, through its marketing plan, may determine that it does not need to collect all of the information contained in the APD. As a result, WAPA will allow each region to use subsets of the form, where one region's APD may request less information than another region's APD. Also, to ensure equitable
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To avoid unnecessary duplication, only entities that desire a new WAPA allocation are required to submit an APD. As it relates to each component of the APD, there is no duplication. Section 1 is information WAPA needs to identify the applicant; whether the applicant is a statutorily-defined preference entity;
The information requested is the minimum amount of information needed to determine whether the applicant qualifies as a statutorily-defined preference entity and is ready, willing, and able to receive an allocation of Federal power under a marketing plan.
The collection uses plain, coherent, and unambiguous language that is understandable to the target audience. The terms in the collection are those used in the electric utility industry. WAPA does not market power to individual members of the public such as homeowners or shopkeepers. Preference entities are statutorily-designated potential customers who generally are involved in the power business. As a result, the language used in the application is understandable to the target audience.
The information collection is voluntary. WAPA will use the information to determine an allocation of Federal power under a marketing plan. As discussed above, there is no mandatory recordkeeping requirement on the applicant if it does not receive an allocation of Federal power. For those entities that receive a Federal power allocation, WAPA requires that they keep the information for 3 years after WAPA grants the power allocation and the applicant signs a Federal power contract. The 3-year record retention policy for such applicants allows WAPA sufficient time to administer the regional contract and to ensure the applicant provided factual information in its application. WAPA anticipates that a 3-year record retention policy will have little impact on most businesses in the power industry who will keep the APD as part of their normal business records. The procedure and process for the allocation of power shall be the subject matter of a separate marketing plan notice and is outside the scope of this process.
The APD identifies that there is no recordkeeping requirement for the respondent if it does not receive an allocation of Federal power. It also identifies that applicants who receive an allocation of Federal power must retain the records for 3 years.
WAPA has a limited amount of power available and WAPA's Administrator has discretion in allocating power under a marketing plan. WAPA will (a) use the information collected on the application, (b) not accept incomplete applications, and (c) work with respondents that require assistance in completing the application. No respondent is required to submit any information unless a valid OMB control number is displayed. No respondent is required to submit any information unless they desire a Federal power allocation under a marketing plan.
WAPA's regional power marketing offices will administer and evaluate the applications. Use and management of the collected information were factored into each office's functions and resource requirements. Historically, WAPA has requested the same relative information from applicants and effectively used WAPA resources to utilize and manage the information in its determinations. Each office will make a recommendation to WAPA's Administrator on which applicant(s) should be awarded a Federal power allocation based upon marketing plan requirements and the information contained in the APD. WAPA's Administrator has discretion in the final award of power allocations. The procedure and process for the allocation of power shall be the subject matter of a separate marketing plan notice and is outside the scope of this process.
Since the information collected is used to help determine whether an applicant may receive an allocation of Federal power, this section is not applicable.
The APD will be accessible for downloading via WAPA's Web page at
WAPA invites public comment on its request to extend its APD that WAPA submitted to OMB pursuant to the Paperwork Reduction Act of 1995. The Paperwork Reduction Act requires OMB to make a decision on the ICR within 60 days after this publication or receipt of the proposed collection of information, whichever is later.
Environmental Protection Agency (EPA).
Notice.
EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Comments must be received on or before November 2, 2017.
Submit your comments, identified by the Docket Identification (ID) Number and the File Symbol of interest as show in the body of this document, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Michael Goodis, 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).
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EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.
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7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by the registrants to voluntarily cancel their registrations and to amend their product registrations to terminate uses. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw their requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled and uses terminated only if such sale, distribution, or use is consistent with the terms as described in the final order.
Comments must be received on or before April 2, 2018.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2017-0467, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Christopher Green, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-0367; email address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
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This notice announces receipt by EPA of requests from registrants to cancel certain pesticide products and amend product registrations to terminate certain uses. The affected products and the registrants making the requests are identified in Tables 1-3 of this unit.
Unless a request is withdrawn by the registrant or if the Agency determines that there are substantive comments that warrant further review of this request, EPA intends to issue an order in the
Table 3 of this unit includes the names and addresses of record for the registrants of the products listed in Table 1 and Table 2 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in Table 1 and Table 2 of this unit.
Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Section 6(f)(1)(B) of FIFRA (7 U.S.C. 136d(f)(1)(B)) requires that before acting on a request for voluntary cancellation, EPA must provide a 30-day public comment period on the request for voluntary cancellation or use termination. In addition, FIFRA section 6(f)(1)(C) (7 U.S.C. 136d(f)(1)(C)) requires that EPA provide a 180-day comment period on a request for voluntary cancellation or termination of any minor agricultural use before granting the request, unless:
1. The registrants request a waiver of the comment period, or
2. The EPA Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment.
The registrants listed in Table 3 of Unit II have not requested that EPA waive the 180-day comment period. Accordingly, EPA will provide a 180-day comment period on the proposed requests.
Registrants who choose to withdraw a request for product cancellation or use termination should submit the withdrawal in writing to the person listed under
Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the action. If the requests for voluntary cancellation and amendment to terminate uses are granted, the Agency
In any order issued in response to these requests for cancellation of product registrations and for an amendment to terminate uses, EPA proposes to include the following provisions for the treatment of any existing stocks of the products listed in Tables 1 and 2 of Unit II.
The registrant has requested to the Agency via letter to distribute existing stocks for an 18-month period for products 53883-370.
For all other voluntary product cancellations identified in Table 1 of Unit II, registrants will be permitted to sell and distribute existing stocks of voluntarily canceled products for 1 year after the effective date of the cancellation, which will be the date of publication of the cancellation order in the
Once EPA has approved product labels reflecting the requested amendment to terminate the use identified in Table 2 of Unit II, registrants will be permitted to sell or distribute products under the previously approved labeling for a period of 18 months after the date of
Persons other than the registrant may sell, distribute, or use existing stocks of canceled products and products whose labels include the terminated use until supplies are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products and terminated use.
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by pesticide registrants to voluntarily cancel certain pesticide product registrations and to amend certain product registrations to terminate uses. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw their requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled and uses terminated only if such sale, distribution, or use is consistent with the terms as described in the final order.
Comments must be received on or before November 2, 2017.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2017-0466, by one of the following methods:
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Christopher Green, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-0367; email address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
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This notice announces receipt by EPA of requests from pesticide registrants to cancel certain pesticide products and amend product registrations to terminate certain uses. The affected products and the registrants making the requests are identified in Tables 1A-3 of this unit.
Unless a request is withdrawn by the registrant or if the Agency determines that there are substantive comments that warrant further review of this request, EPA intends to issue an order in the
Table 3 of this unit includes the names and addresses of record for the registrants of the products listed in Table 1A, Table 1B and Table 2 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in Table 1A, Table 1B and Table 2 of this unit.
Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Section 6(f)(1)(B) of FIFRA (7 U.S.C. 136d(f)(1)(B)) requires that before acting on a request for voluntary cancellation, EPA must provide a 30-day public comment period on the request for voluntary cancellation or use termination. In addition, FIFRA section 6(f)(1)(C) (7 U.S.C. 136d(f)(1)(C)) requires that EPA provide a 180-day comment period on a request for voluntary cancellation or termination of any minor agricultural use before granting the request, unless:
1. The registrants request a waiver of the comment period, or
2. The EPA Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment.
The registrants listed in Table 3 of Unit II have requested that EPA waive the 180-day comment period. Accordingly, EPA will provide a 30-day comment period on the proposed requests.
Registrants who choose to withdraw a request for product cancellation or use deletion should submit the withdrawal in writing to the person listed under
Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of
In any order issued in response to these requests for cancellation of product registrations and for amendments to terminate uses, EPA proposes to include the following provisions for the treatment of any existing stocks of the products listed in Tables 1A, 1B and 2 of Unit II.
The registrant has requested to the Agency via letter to sell existing stocks for an 18-month period for products 211-25, 211-32, 211-36, 211-62 and 34810-8.
As there are no risk concerns for these products, after December 31, 2020, the registrant will be prohibited from producing, selling, or distributing existing stocks of products containing Spirodiclofen.
The registrant has requested to the Agency via letter to manufacture and/or distribute existing stocks for a 24-month period starting the date of the request which was April 25, 2017 for products 47000-91 and 47000-95, and June 28, 2017 for product 47000-144.
For all other voluntary product cancellations identified in Table 1A of Unit II, registrants will be permitted to sell and distribute existing stocks of voluntarily canceled products for 1 year after the effective date of the cancellation, which will be the date of publication of the cancellation order in the
Once EPA has approved product labels reflecting the requested amendments to terminate uses identified in Table 2 of Unit II, registrants will be permitted to sell or distribute products under the previously approved labeling for a period of 18 months after the date of
Persons other than the registrant may sell, distribute, or use existing stocks of canceled products and products whose labels include the terminated uses until supplies are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products and terminated uses.
7 U.S.C. 136
Federal Communications Commission.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC or Commission) Communications Security, Reliability, and Interoperability Council (CSRIC) VI will hold its second meeting.
October 26, 2017.
Federal Communications Commission, Room TW-C305 (Commission Meeting Room), 445 12th Street SW., Washington, DC 20554.
Jeffery Goldthorp, Designated Federal Officer, (202) 418-1096 (voice) or
The meeting will be held on October 26, 2017, from 1:00 p.m. to 5:00 p.m. in the Commission Meeting Room of the Federal Communications Commission, Room TW-C305, 445 12th Street SW., Washington, DC 20554.
The CSRIC is a Federal Advisory Committee that will provide recommendations to the FCC to improve the security, reliability, and interoperability of communications systems. On March 19, 2017, the FCC, pursuant to the Federal Advisory Committee Act, renewed the charter for the CSRIC for a period of two years through March 18, 2019. The meeting on October 26, 2017, will be the second meeting of the CSRIC under the current charter. The FCC will attempt to accommodate as many attendees as possible; however, admittance will be limited to seating availability. The Commission will provide audio and/or video coverage of the meeting over the Internet from the FCC's Web page at
Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to
Written PRA comments should be submitted on or before December 4, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The following items have been deleted from the list of items scheduled for consideration at the Tuesday, September 26, 2017, Open Meeting and previously listed in the Commission's Notice of September 19, 2017.
Federal Deposit Insurance Corporation (FDIC).
Notice of open meeting.
In accordance with the Federal Advisory Committee Act, notice is hereby given of a meeting of the FDIC Advisory Committee on Economic Inclusion, which will be held in Washington, DC. The Advisory Committee will provide advice and recommendations on initiatives to expand access to banking services by underserved populations.
Wednesday, October 18, 2017, from 9:00 a.m. to 3:45 p.m.
The meeting will be held in the FDIC Board Room on the sixth floor of the FDIC Building located at 550 17th Street NW., Washington, DC.
Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Committee Management Officer of the FDIC, at (202) 898-7043.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Notifiable Diseases Surveillance System to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on December 22, 2016 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Evaluation of the National Tobacco Prevention and Control Public Education Campaign (OMB Control Number 0920-1083, Expiration 09/30/2017)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
In 2012, HHS/CDC launched Phase 1 of the National Tobacco Prevention and Control Public Education Campaign (The Campaign). The primary objectives of The Campaign are to encourage smokers to quit smoking and to encourage nonsmokers to communicate with smokers about the dangers of smoking. To evaluate “The Campaign,” CDC obtained OMB approval for information collections beginning in 2012 (OMB Control Number 0920-0923). CDC conducted baseline and follow-up surveys with both smokers and nonsmokers.
In 2013, CDC launched Phase 2 of “The Campaign” and conducted an additional survey with smokers and one additional survey with nonsmokers under OMB Control Number 0920-0923.
CDC recently completed collecting the information needed to evaluate Phase 3 of “The Campaign,” which launched in early 2014. The evaluation of The Campaign in 2014 consisted of a longitudinal cohort using four waves of online surveys involving smokers and three waves involving nonsmokers to assess their awareness of and reactions to the 2014 advertisements as related to The Campaign's objectives (see previously-approved information collection with OMB Control Number 0920-0923, expired 3/31/2017).
The final wave of this data collection effort also served as a pre-campaign baseline for Phase 4 of the campaign in 2015. The CDC subsequently aired Phase 5 of the campaign in 2016. To evaluate Phases 4 and 5, CDC fielded four additional waves of survey data collection. CDC fielded these data collections from September to November in 2015 and March to June, June to August, and November to December of 2016 (see previously approved information collection under OMB Control Number 0920-1083, expires 9/30/2017).
CDC has scheduled to launch new media activities for Phases 6 and 7 of “The Campaign” in early 2017 and early 2018, respectively. To support evaluation of “The Campaign” through Phases 6 and 7, CDC plans to field five new waves of information collection. CDC will field the surveys in English and Spanish and will occur during 2017 and 2018. Once enrolled in the first wave of data collection, researchers will re-contact all participants for follow-up at subsequent survey waves.
The sample for the data collection will originate from two sources: (1) An online longitudinal cohort of smokers and nonsmokers, sampled randomly from postal mailing addresses in the United States (address-based sample, or ABS); and (2) the existing GfK KnowledgePanel, an established long-term online panel of U.S. adults. The ABS-sourced longitudinal cohort will consist of smokers and nonsmokers who have not previously participated in any established online panels to reduce potential panel conditioning bias from previous participation. GfK will recruit the new cohort, utilizing similar recruitment methods that are used in the recruitment of KnowledgePanel. To support larger sample sizes that will allow for more in-depth subgroup analysis, which is a key objective for CDC, researchers will use the GfK KnowledgePanel in combination with the new ABS-sourced cohort. Researchers will conduct all online surveys, regardless of sample source, via the GfK KnowledgePanel Web portal for self-administered surveys.
Researchers will collect information through Web surveys (self-administered on computers in the respondent's home or in another convenient location). Researchers will collect information about smokers' and nonsmokers' awareness of and exposure to specific campaign advertisements; knowledge, attitudes, beliefs related to smoking and secondhand smoke; and other marketing exposure. The surveys will also measure behaviors related to smoking cessation (among the smokers in the sample) and behaviors related to nonsmokers' encouragement of smokers to quit smoking, recommendations of cessation services, and attitudes about other tobacco and nicotine products.
It is important to evaluate “The Campaign” in a context that assesses the dynamic nature of tobacco product marketing and uptake of various tobacco products, particularly since these may affect successful cessation rates. Survey instruments may be updated to include new or revised items on relevant topics, including cigars, noncombustible tobacco products, and other emerging trends in tobacco use.
Participation is voluntary and there are no costs to respondents other than their time. CDC estimates the total response burden at 37,170 hours over two years between August 2017 and February 2019. Thus, CDC estimates the total annualized burden hours at 18,585 for the combined English and Spanish versions of each survey.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Notifiable Diseases Surveillance System to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on January 17, 2017 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Assessment of the Market for Electronic Technology for Underground Coal Mining Safety and Health Applications—New—Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health, Office of Mine Safety and Health Research.
Underground coal mining in the U.S. is a relatively small industry (about 46,000 employees) that operates in a unique and hazardous work environment. The common presence of explosive gasses and other hazards creates special safety requirements for equipment, including safety and health protection technologies, used in underground coal mines.
The MINER Act of 2006 assigned the National Institute for Occupational Safety and Health (NIOSH) the responsibility to enhance development of new mine safety and health protection technology and technological applications and to expedite the commercial availability and implementation of such technology. As part of this study, NIOSH seeks to identify the barriers to commercial availability and implementation of such technology in U.S. mines.
Experience to date has shown that there are many issues that the U.S.
NIOSH has an understanding of some of these barriers, however, NIOSH is not an end user of these products. Thus, the goal of the study is to provide a complete perspective of the barriers from the point of view of the mine operators and technology innovators, in order to improve the efficacy of the contract and grant awards that NIOSH administers under the authority of the MINER Act.
The Federal Mine Safety & Health Act of 1977, Section 501 authorizes the collection of this data. A CDC contractor will collect the required data.
NIOSH will identify 200 stakeholder organizations for structured interviews and a workshop. Stakeholder organizations include those parties involved in the development, supply, use, and regulation of safety and health protection technologies relevant to underground coal mining. Because there is no nationally representative database of these stakeholder organizations, NIOSH will use web searches of supplier and mining company Web sites, online mining publications, trade association member directories, federal and state regulator Web sites, and university mining research and development programs to compile a list of 200 organizations. Representatives of NIOSH Office of Mining Safety and Health Research will also augment the search with their input.
From the 200 stakeholder organizations, 150 representatives will participate in structured interviews. CDC expects that a pre-call to each organization will require 15 minutes to complete and the structured interview will require 60 minutes to complete, including the time it may take respondents to look-up and retrieve needed information.
In addition, 30 stakeholder representatives will participate in the workshop. The burden table below reflects 15 hours of burden for each workshop group. This includes the in-person participation of 9 hours and 6 hours of travel time. A total of 10 respondents per year will participate in the workshop. The estimated annualized burden hours for the respondents' time to participate in this information collection are 217 hours.
CDC seeks a three-year OMB approval to collect information.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Notifiable Diseases Surveillance System to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 13, 2017 to obtain comments from the public and affected agencies. CDC received seven comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Assessing School-centered HIV/STD Prevention Efforts in a Local Education
HIV infections remain high among young men who have sex with men. The estimated number of new HIV infections increased between 2008 and 2010 both overall and among MSM ages 13 to 24. Sexual risk behaviors associated with HIV, other sexually transmitted disease (STD), and pregnancy often emerge in adolescence. The 2015 Youth Risk Behavior Surveillance System (YRBSS) data revealed 41.2% of U.S. high school students reported having had sex, and among those who had sex in the previous three months, only 56.9% reported having used a condom during last sexual intercourse. The data revealed high school students identifying as gay, lesbian, and bisexual and those reporting sexual contact with both males and females were more likely to engage in sexual risk-taking behaviors than heterosexual students.
Given the disproportionate risk for HIV among YMSM ages 13-24, it is important to find ways to reach the younger youth (
For this revised information collection project, CDC requests a one-year OMB approval. This CDC-funded information collection project is the third data collection to assess HIV and STD prevention efforts in one local education agency (LEA). CDC's cooperative agreement, under funding opportunity announcement PS13-1308:
This collection will provide data and reports for the LEA, and will allow the LEA to identify program areas that are working well and other areas that need improvement. The findings will allow CDC to determine the potential impact of currently recommended strategies and make changes to those recommendations if necessary.
The questionnaire covers demographics, HIV/STD risk behaviors, use of HIV/health services, experiences at school, including school connectedness, harassment and bullying, homophobia, support of LGBTQ students, sexual orientation, receipt of referral for HIV and STD prevention health services, and health education.
This data collection system involves administration of a paper-and-pencil questionnaire to seven high schools that are participating in the HIV/STD prevention project. This is the third and final data collection of a 4-year project that includes three data collections; previous data collections occurred in December 2014 and December 2016. Data collection points coincide with the approximate beginning, mid-way, and end points of the cooperative agreement.
We anticipate the final data collection will yield data from up to 16,500 high school students in grades 9 through 12 at the selected schools. Although some students may have completed the questionnaire in one or more of the previous years, this is not a longitudinal design and researchers will not track individual student responses across the years. Researchers will not collect personally identifiable information.
All students' parents will receive parental consent forms to provide them with an opportunity to opt their children out of the study. Each student will read verbal assent language that explains that he or she may choose not to complete the questionnaire or may skip any questions without penalty. Participation is voluntary.
The estimated burden per response ranges from 35-45 minutes due to the variability in skip patterns that may occur. Students will complete the questionnaire only once under this approval. Annualizing the collection over a one-year period results in an estimated annualized burden of 11,000 hours for respondents. There are no costs to respondents other than their time.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by December 4, 2017.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
William Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under 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 they conduct or sponsor. The term “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 requires federal agencies to publish a 60-day notice in the
1.
Forms CMS-21 and -21B provide CMS with the information necessary to issue quarterly grant awards, monitor current year expenditure levels, determine the allowability of state claims for reimbursement, develop Children's Health Insurance Program (CHIP) financial management information, provide for state reporting of waiver expenditures, and ensure that the federally established allotment is not exceeded. They are also necessary in the redistribution and reallocation of unspent funds over the federally mandated timeframes.
Form CMS-37 due dates are November 15, February 15, May 15 and August 15 of each fiscal year. While all submissions represent equally important components of the grant award cycle, the May and November submissions are particularly significant for budget formulation. The November submission introduces a new fiscal year to the budget cycle and serves as the basis for the formulation of the Medicaid portion of the President's Budget, which is presented to Congress in January. The February and August submissions are used primarily for budget execution in providing interim updates to our Office of Financial Management, the Department of Health and Human Services, the Office of Management and Budget, and Congress depending on the scheduling of the national budget review process in a given fiscal year. The submissions provide us with base information necessary to track current year obligations and expenditures in relation to the current year appropriation and to notify senior managers of any impending surpluses or deficits.
Form CMS-64 is used to issue quarterly grant awards, monitor current year expenditure levels, determine allowed state claims for reimbursement, develop Medicaid financial management information provide for state reporting of waiver expenditures, ensure that the federally-established limit is not exceeded for HCBS waivers, and to allow for the implementation of the Assignment of Rights and Part A and Part B Premium (
Administration for Community Living, HHS.
Notice.
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the
Submit written or electronic comments on the collection of information by December 4, 2017.
Submit electronic comments on the collection of information to
Shannon Skowronski at
Under 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 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 following collection of information, ACL invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility; (2) the accuracy of ACL's estimate of the burden of the proposed collection of information, 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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The Evidence-Based Falls Prevention Programs is a cooperative agreement financed through the Prevention and Public Health Fund (PPHF), most recently with FY 2017 PPHF funds. The statutory authority for cooperative agreements under the current program announcement is contained in the Public Health Service Act, 42 U.S.C. 300u-2 (Community Programs) and 300u-3 (Information Programs); and Consolidated and Further Continuing Appropriations Act, 2015, Pub. L. 113-235, Div. G., Title II, § 219(a); and the Patient Protection and Affordable Care Act, 42 U.S.C. 300u-11 (Prevention and Public Health Fund).
The Evidence-Based Falls Prevention Programs support a national resource center and award competitive grants to implement evidence-based community programs that have been proven to reduce the incidence of falls for older adults and adults with disabilities (including Tribal elders). The programs also identify sustainable funding mechanisms for these programs via the resource center, promote the importance of falls prevention strategies, and provide public education about the risks of falls and ways to prevent them.
OMB approval of the existing set of Falls Prevention data collection tools (OMB Control Number, 0985-0039) expires on 01/31/2018. This data collection continues to be necessary for monitoring program operations and outcomes. ACL/AoA proposes to use the following tools: (1) Semi-annual performance reports to monitor grantee progress; (2) a Host Organization Data form to record location of agencies that sponsor programs that will allow mapping of the delivery infrastructure; and (3) a set of tools used to collect information at each program completed by the program leaders (Program Information Cover Sheet and Attendance Log), a Participant Information Form completed by each participant, and a Post Program Survey to be completed by a random sample of participants. ACL/AoA intends to continue using an online data entry system for the program and participant survey data. In addition to non-substantive formatting edits, minor changes are being proposed to 2 of the 5 currently approved tools, as indicated below. All changes proposed are based on feedback from a focus group that included a sub-set of current grantees and consultation with subject-matter experts.
• On the Participant Information Form:
1. Additional chronic conditions have been added to the list of options
2. Question #11 (assessing the frequency and impact of falls) has been enhanced to include the location of the fall(s) and further assess impact
3. Two questions have been added (#15 and #16) to examine modifications made to home and activity level
• On the Post-Program Survey:
1. Question #2 (assessing the frequency and impact of falls) has been enhanced to include the location of the fall(s) and further assess impact
2. Questions #6 and #7 have been modified slightly—removing references to home modifications and activity level. Home modifications and activity level are now addressed in questions #8 and #9 instead.
The proposed Falls Prevention Data Collection Tools can be found at ACL's Web site at:
The total estimated burden is 4,345 hours per year. ACL/AoA estimates the burden of this collection of information as 288 hours for project staff, 1,435 hours for local agency staff, and 2,622 hours for individuals.
Food and Drug Administration, HHS.
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access.” The purpose of the public workshop is to provide an overview of current regulatory science initiatives related to generic topical dermatological drug products, solicit public input on scientific barriers that may limit patient access to such drug products, and discuss approaches to overcome/address any such barriers. FDA is seeking public input from a variety of stakeholders, including industry, academia, patient advocates, and professional associations.
The public workshop will be held on October 20, 2017, from 8:30 a.m. to 4:30 p.m., Eastern Standard Time. Submit either electronic or written comments on this public workshop by November 20, 2017. See the
The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public workshop 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 November 20, 2017. 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
Sam Raney, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4706, Silver Spring, MD 20993, 240-402-7967, email:
The conventional approach to establish bioequivalence (BE) for most topical dermatological generic drug products relies upon clinical endpoint BE studies. The risk of failing to demonstrate BE due to the relative insensitivity of these clinical endpoint studies, combined with their burden and length, may represent a barrier to generic drug development and may adversely impact patient access to some topical dermatological generic drug products. FDA is evaluating alternative BE approaches for topical dermatological generic drug products, using methods that are more efficient, and also more sensitive and reproducible. FDA believes that these BE approaches would benefit from public discussion.
This public workshop will focus on a discussion of current regulatory science initiatives intended to foster the development of topical dermatological generic drug products, examining alternative BE approaches that may be more efficient and less risky than traditional approaches. FDA is also interested in receiving public input about any barriers that may limit the use of such alternative BE approaches in the development of topical dermatological generic drug products. Public input is also sought about strategies to overcome these barriers.
Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by October 13, 2017, midnight, Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization.
If you need special accommodations due to a disability, please contact Sam Raney (see
If you have never attended a Connect Pro event before, test your connection at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA.” This draft guidance is intended to explain to applicants how
Submit either electronic or written comments on the draft guidance by December 4, 2017 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930,
FDA is announcing the availability of a draft guidance for industry entitled “ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA.” This guidance is intended to assist applicants preparing to submit amendments to ANDAs or PASs to FDA under section 505(j) of the FD&C Act (21 U.S.C. 355(j)) by explaining how the review goals established as part of GDUFA II apply to these submissions. In accordance with the “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022” (GDUFA II Commitment Letter, available at:
The GDUFA II Commitment Letter reflects significant changes in the classification of and review goals for amendments to ANDAs and PASs under the Generic Drug User Fee Amendments of 2012 (GDUFA I). Under GDUFA I, amendments were classified into a complex tier system based on the following factors:
• Whether the amendment was solicited (submitted in response to a complete response letter) or unsolicited (submitted on the applicant's own initiative).
• Whether the amendment was major or minor.
• The number of amendments submitted to the ANDA or PAS.
• Whether an inspection was necessary to support the information contained in the amendment.
GDUFA II simplified the amendment review goals and no longer subjects them to a tier system; however, review
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 “ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA.” 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 draft 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 314.96 have been approved under OMB control number 0910-0001.
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA or Agency) 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 the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The public meeting will be held on October 18, 2017, 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-2017-N-5891. The docket will close on October 17, 2017. Submit either electronic or written comments on this public meeting by October 17, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 17, 2017. The
Comments received on or before October 11, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. 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
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 Web site 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 Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
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 special accommodations due to a disability, please contact LaToya Bonner at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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.
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products.
FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Nominations received on or before December 4, 2017 will be given first consideration for membership on the Tobacco Products Scientific Advisory Committee. Nominations received after December 4, 2017 will be considered for nomination to the committee as later vacancies occur.
All nominations for membership should be sent electronically by logging into the FDA Advisory Nomination Portal:
Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site by using the following link:
FDA is requesting nomination for voting members on the Tobacco Products Scientific Advisory Committee.
The Tobacco Products Scientific Advisory Committee (the Committee) advises the Commissioner of Food and Drugs (the Commissioner) or designee in discharging responsibilities related to the regulation of tobacco products. The Committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information, and recommendations to the Commissioner.
The Committee consists of 12 members including the Chair. Members and the Chair are selected by the Commissioner or designee from among individuals knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. Almost all non-Federal members of this committee serve as Special Government Employees. The Committee includes nine technically qualified voting members, selected by the Commissioner or designee. The nine voting members include seven members who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty. The nine voting members also include one member who is an officer or employee of a State or local government or of the Federal Government, and one member who is a representative of the general public. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years.
Any interested person may nominate one or more qualified individuals for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that SPECTAZOLE (econazole nitrate) topical cream, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Nisha Shah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455.
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 versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the listed drug, which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
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, a drug is 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.
SPECTAZOLE (econazole nitrate) topical cream, 1%, is the subject of NDA 018751, held by Alvogen Malta Operations Ltd., and initially approved on December 23, 1982. SPECTAZOLE is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by
SPECTAZOLE (econazole nitrate) topical cream, 1%, is currently listed in
Lachman Consultant Services, Inc. submitted a citizen petition dated April 21, 2017 (Docket No. FDA-2017-P-2530), under 21 CFR 10.30, requesting that the Agency determine whether SPECTAZOLE (econazole nitrate) topical cream, 1%, was 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 SPECTAZOLE (econazole nitrate) topical cream, 1%, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that SPECTAZOLE (econazole nitrate) topical cream, 1%, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of SPECTAZOLE (econazole nitrate) topical cream, 1%, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list SPECTAZOLE (econazole nitrate) topical cream, 1%, 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. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also 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 “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” This draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. This draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II).
Submit either electronic or written comments on the draft guidance by December 4, 2017 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 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
Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930,
FDA is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” This draft guidance describes an enhanced pathway for discussions between FDA and an applicant (or prospective applicant) preparing to submit an ANDA for a complex product to FDA. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA.
This draft guidance reflects a unified approach to all formal meetings between FDA and ANDA applicants or prospective ANDA applicants for complex products. This draft guidance is intended to assist ANDA applicants and prospective ANDA applicants in generating and submitting to FDA a meeting request and the associated meeting package for these complex products, as defined in this guidance, to be submitted under section 505(j) of the FD&C Act (21 U.S.C 355(j)) and as contemplated in GDUFA II.
As part of the commitments FDA made in connection with GDUFA II, FDA agreed to develop a program to assist ANDA applicants and prospective ANDA applicants of complex products before the submission of an ANDA to FDA. As stated in the “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022” (GDUFA II Goals or Commitment Letter), this pre-ANDA program is intended to:
To facilitate development of complex products that may be submitted in an ANDA, FDA and industry agreed to a series of meetings between ANDA applicants and prospective ANDA applicants and FDA to discuss the proposed complex product and support submission of a high-quality, approvable ANDA.
In addition to developing a robust pre-ANDA program, FDA agreed to respond to requests for and conduct meetings related to the development of complex products submitted on or after October 1, 2017, within specific timeframes.
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 “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” 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 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 collection of information has been approved under OMB control number 0910-0797.
Persons with access to the internet may obtain the draft 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 “ANDA Submissions—Refuse-to-Receive Standards: Questions and Answers.” This draft guidance is intended to assist applicants preparing to submit abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs. This guidance provides answers to questions we have received from applicants regarding the guidance for industry, “ANDA Submissions—Refuse-to-Receive Standards” (RTR Standards guidance). The questions and answers address general issues about the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to Drug Master Files (DMFs), product quality, and bioequivalence (BE) and clinical reviews, and are intended to clarify the deficiencies that may cause FDA to refuse to receive (RTR) an ANDA.
Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the
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. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930,
FDA is announcing the availability of a draft guidance for industry entitled “ANDA Submissions—Refuse-to-Receive Standards: Questions and Answers.” This draft guidance is intended to assist applicants preparing to submit ANDAs and certain prior approval supplements (PASs) to ANDAs. This guidance provides answers to questions we have received from applicants regarding the guidance for industry, “ANDA Submissions—Refuse-to-Receive Standards” and the filing process, in general. The questions and answers address general issues about the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to DMFs, product quality, and BE and clinical reviews, and are intended to clarify the deficiencies that may cause FDA to RTR an ANDA. FDA evaluates each submitted ANDA individually to determine whether the Agency can receive it for review. When FDA decides to receive an ANDA, it means the Agency has made a threshold determination that the ANDA is a substantially complete application (
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 “ANDA Submissions—Refuse-to-Receive Standards.” 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 that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by November 2, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The United States exports a large volume and variety of foods in international trade. For certain food products, foreign governments may require assurances from the responsible authority of the country of origin of an imported food that the processor of the food is in compliance with applicable country of origin regulatory requirements. With regard to U.S. milk products, FDA is the competent U.S. food safety authority to provide this information to foreign governments. FDA provides the requested information about processors in the form of lists, which are provided to the foreign governments and posted online at
Currently, FDA provides Chile, China, and the European Union (EU) with a list of U.S. milk product manufacturers/processors that: (1) Have expressed interest in exporting their products to these countries; (2) are subject to FDA's jurisdiction; and (3) are not the subject of a pending enforcement action (
FDA has published guidance documents for these countries under the authority of section 701(h) of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)), which authorizes the Secretary of Health and Human Services (the Secretary) to develop guidance documents with public participation presenting the views of the Secretary on matters under the jurisdiction of FDA.
The guidance documents explain what information manufacturers/processors should submit to FDA to be considered for inclusion on the lists and what criteria FDA intends to use to determine eligibility for placement on the lists. The guidance documents also explain how FDA intends to update the list and communicate any new information to the government that requested the list. Finally, the guidance documents note that the information is provided voluntarily by manufacturers/processors with the understanding that it will be posted on FDA's external Web site and communicated to, and possibly further disseminated by, the government that requested the list; thus, FDA considers the information on the lists to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4).
Application for inclusion on each list is voluntary. However, some foreign governments may require inclusion on the list for acceptance of imported food. FDA recommends that U.S. manufacturers/processors that want to be placed on the export lists send FDA the following information: (1) Country to which the milk manufacturer/processor wants to export product; (2) type of milk product facility; (3) the Food Facility Registration Module number (the information collected by this module is approved under OMB control number 0910-0502); (4) name and address of the firm and the manufacturing plant; (5) name, telephone number, and email address of the contact person; (6) list of products divided into three categories: Presently shipped, ready to ship, and available for shipment in the next 3 years; (7) identities of Agencies that inspected the plant; (8) date of last inspection, plant number, and copy of last inspection notice; and (9) if other than an FDA inspection, copy of last inspection report.
We request that this information be updated every 2 years.
We use the information submitted by firms to determine their eligibility for placement on the export lists, which are published on our Web site. The purpose of the lists is to help foreign governments in their determinations of which U.S. milk product manufacturers and processors are eligible to export to their respective countries.
FDA has recently developed an electronic registry system (Form FDA 3972) that allows milk product manufacturers and processors to electronically send a request to FDA to be included on the export lists. Manufacturers and processors that prefer to submit a paper request in a format of their own choosing will still have the option to do so. Electronic Form FDA 3972 collects the same information as is currently collected via the existing paper-based process. Draft screenshots of Form FDA 3972 and instructions are available at
In the
FDA estimates the burden of this collection of information as follows:
FDA bases its estimate on the number of manufacturers/processors that have submitted new written requests, biennial updates, and occasional updates over the past 10 years. The estimate of the number of burden hours it will take a manufacturer/processor to gather the information needed to be placed on the list or update its information is based on FDA's experience with manufacturers/processors submitting similar requests. FDA believes that the information to be submitted will be readily available to manufacturers/processors. This collection is also incorporating information collected to maintain lists of eligible exporters of dairy products who wish to export to the EU from OMB control number 0910-0320, “Request for Information from U.S. Processors that Export to the European Community.”
FDA estimates that 2,000 firms will average 60 minutes (1 hour) to submit new requests for inclusion on the list, 2,000 firms will average 30 minutes (0.5 hour) to update their information every 2 years, and 200 firms will average 30 minutes (0.5 hour) to occasionally update their information in this system. We also believe that submission via the electronic registry system will not affect the burden estimates. An electronic registry will enhance the ability of firms to more efficiently request inclusion on export lists. FDA calculates, therefore, that the total burden for this collection is 3,100 hours ((2,000 × 1) plus (2,000 × 0.5) plus (200 × 0.5)).
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 “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) permits any person to submit to the FDA an abbreviated new drug application (ANDA) to seek approval to market a generic version of a previously approved drug product. This draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product (specifically glucagon, liraglutide, nesiritide, teriparatide, and teduglutide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin should be submitted as an ANDA rather than as new drug application (NDA).
Submit either electronic or written comments on the draft guidance by December 4, 2017 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Gail Schmerfeld, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1672, Silver Spring, MD 20993-0002, 301-796-9291.
FDA is announcing the availability of a draft guidance for industry entitled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.” In general, for FDA to approve an ANDA submitted under section 505(j) of the FD&C Act, an ANDA applicant must demonstrate, among other things, that the proposed generic drug has the “same” active ingredient(s) as and is bioequivalent to its reference listed drug, and that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the proposed generic drug are adequate to assure and preserve its identity, strength, quality, and purity (sections 505(j)(2)(A) and (4) (21 U.S.C. 355(j)(2)(A) and (4)) of the FD&C Act). If a person is seeking approval of a synthetic peptide drug product (specifically glucagon, liraglutide, nesiritide, teriparatide, or teduglutide) and intends to submit an application that refers to a previously approved peptide drug product of rDNA origin, if the active ingredient in the proposed synthetic peptide drug product can be shown to be the same as the active ingredient in the peptide drug product of rDNA origin, whether the application should be submitted as an ANDA under section 505(j) of the FD&C Act or as a new drug application under section 505(b) of the FD&C Act will depend largely on the impurity profile for the synthetic peptide drug product as compared to the impurity profile for the peptide drug product of rDNA origin. Differences in impurities, particularly peptide-related impurities, may affect the safety or effectiveness of a peptide drug product. This draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of rDNA origin should be submitted as an ANDA rather than an NDA.
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 the submission of ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin. 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.
This draft 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 collection of information required under 21 CFR part 314 for the submission of NDAs and ANDAs is approved under OMB control number 0910-0001, and the submission of controlled correspondence pertaining to ANDAs is approved under OMB control number 0910-0797.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The public meeting will be held on November 1, 2017, from 8 a.m. to 5 p.m.
FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4918. The docket will close on October 27, 2017. Submit either electronic or written comments on this public meeting by October 27, 2017. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 27, 2017. The
Comments received on or before October 17, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency.
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
Kalyani Bhatt, 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 Web site 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 Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
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 special accommodations due to a disability, please contact Kalyani Bhatt at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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 (GIF) entitled “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use.” The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance updates the Quality-related sections of the Granularity Document Annex, Module 2.3 Quality Overall Summary, and Module 3 Quality. The guidance is intended to provide recommendations on the organization of the common technical document (CTD)/eCTD and replaces the August 2001 FDA guidance for industry “M4: Organization of the CTD” and the October 2005 FDA guidance for industry “Granularity Document Annex to M4: Organization of the CTD.”
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 (CDER), 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically-based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the members of the ICH Association.
The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers.
The M4 guidance provides guidance on the organization of the CTD and eCTD for Modules 2 through 5 providing direction on the location and hierarchy of headings within modules, document pagination and segregation, section numbering within documents, and the formatting of the table of contents. The guidance updates the Quality-related sections of the Granularity Document Annex, Module 2.3 Quality Overall Summary, and Module 3 Quality. The guidance provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD v4 submissions, and includes “Appendices for eCTD v4 Submissions” to facilitate the implementation of the next major version of the eCTD. This guidance replaces both the August 2001 FDA GIF “M4: Organization of the CTD” and the October 2005 FDA GIF “Granularity Document Annex to M4: Organization of the CTD.” This merger reflects the 2002 addition of the Annex: Granularity Document into the “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use.”
There have been no updates or changes relative to Module 4 or Module 5.
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 the organization of the CTD for the registration of pharmaceuticals for human use. 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.
Persons with access to the internet may obtain the document at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is withdrawing approval of 7 new drug applications (NDAs) and 71 abbreviated new drug applications (ANDAs) from multiple
Withdrawal of approval is effective November 2, 2017.
Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.
The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications pursuant to the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective November 2, 2017. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on the date that this notice becomes effective (see
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA or Agency) announces a forthcoming public
The public meeting will be held on October 31, 2017, from 8 a.m. to 5 p.m.
FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4977. The docket will close on October 27, 2017. Submit either electronic or written comments on this public meeting by October 27, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 27, 2017. The
Comments received on or before October 17, 2017, will be provided to the committees. Comments received after that date will be taken into consideration by the Agency.
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
Kalyani Bhatt, 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 Web site 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 Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
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 special accommodations due to a disability, please contact Kalyani Bhatt at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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; request for comments.
The Food and Drug Administration (FDA or the Agency) is seeking public input on the design of the REMS Platform Standards Initiative, as well as methods and best practices for its construction. To facilitate this, FDA is making available the “REMS Platform Standards Initiative: Needs Assessment” (needs assessment), which summarizes a range of risk evaluation and mitigation strategies (REMS) activities that could be standardized and integrated into the health care system through the use of electronic data standards.
The comment period will be open indefinitely.
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
Adam Kroetsch, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993-0002, 301-796-3842,
On October 5, 2015, FDA launched the REMS Platform Standards Initiative (previously referred to as the “Common REMS Platform Initiative”), with the goal of developing and leveraging electronic health data standards, referred to as “REMS platform standards,” to further standardize certain activities associated with REMS with elements to assure safe use (ETASU), and integrate them into existing health care systems. (Information about the initiative can be found at:
(1) Does this needs assessment cover all of the REMS activities for which standards development would be beneficial?
(2) Which REMS activities should be given highest priority for standards development?
(3) What standards already exist that could be used to address the needs and facilitate the REMS activities described in the needs assessment?
(4) Where (if at all) do new standards need to be developed?
(5) What other opportunities exist to leverage health IT to facilitate the completion of REMS activities?
FDA hopes that the needs assessment will help identify areas where standards development projects to support REMS are already underway, as well as areas that are ripe for standards development, enabling interested stakeholders to engage further in this project.
The goal of the REMS Platform Standards Initiative is to leverage electronic health data standards to standardize certain activities in REMS with ETASU and integrate them into health IT systems. Under the initiative, FDA seeks to work with third-party standards development organizations to encourage the development of electronic data standards that may be used to facilitate communication between REMS and their participants. Once the standards are developed, FDA would maintain a list of REMS platform standards, encourage their use in REMS with ETASU, and encourage the development of tools that use these standards to integrate REMS into health care providers' existing systems.
This initiative was launched for a number of reasons. Stakeholders have requested a centralized method to enroll in and interact with REMS with ETASU and more fundamental standardization of REMS architecture. There is also a need for a comprehensive set of standards for REMS to help minimize REMS burden on the health care delivery system and integrate REMS into health IT systems.
The goal of the REMS Platform Standards Initiative is to give all stakeholders—including sponsors, data vendors, clinical decision support system developers (such as those for hospitals, private practices, etc.)—a “fixed target” for standardization and integration. If successful, this will clarify how sponsors can develop standardized REMS that are more easily integrated into the health care system and what health care providers must do to comply with those REMS. Ultimately, REMS that are more effectively standardized and integrated into the health care system should facilitate enhanced compliance and safer use of drugs that have REMS.
Persons with access to the Internet may obtain the needs assessment at
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.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following NHLBI Mentored Clinical and Basic Science Review Committee meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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.
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.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the NHLBI Mentored Patient-Oriented Research Review Committee meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Transportation Security Administration, DHS.
30-day Notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0050, abstracted below to OMB for an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. TSA published a
Send your comments by November 2, 2017. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to
Christina A. Walsh, TSA PRA Officer, Office of Information Technology (OIT), TSA-11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6011; telephone (571) 227-2062; email
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Consistent with the requirements of Executive Order (EO) 13771, Reducing Regulation and Controlling Regulatory Costs, and EO 13777, Enforcing the Regulatory Reform Agenda, TSA is also requesting comments on the extent to which this request for information could be modified to reduce the burden on respondents.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 29, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Sharp Corporation of Japan and Sharp Electronics Corporation of Montvale, New Jersey. Supplements to the complaint were filed on August 30, 2017 and September 21, 2017. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain Wi-Fi enabled electronic devices and components thereof by reason of infringement of certain claims of U.S. Patent No. 8,325,838 (“the '838 patent”) and U.S. Patent No. 8,279,809 (“the '809 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute.
The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2017).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after
(2) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), the presiding administrative law judge shall take evidence or other information and hear arguments from the parties and other interested persons with respect to the public interest in this investigation, as appropriate, and provide the Commission with findings of fact and a recommended determination on this issue, which shall be limited to the statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1);
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainants are:
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; and
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
Advisory Committee on the Federal Rules of Criminal Procedure, Judicial Conference of the United States.
Notice of cancellation of public hearing.
The following public hearing on proposed amendments to the Federal Rules of Criminal Procedure has been canceled: Criminal Rules Hearing on October 24, 2017, in Chicago, Illinois.
Rebecca A. Womeldorf, Rules Committee Secretary, Rules Committee Staff, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Announcement for this hearing was previously published in 82 FR 37610.
Justice Department.
Meeting notice.
The purpose of this notice is to announce the meeting of the Department of Justice's National Domestic Communications Assistance Center's (NDCAC) Executive Advisory Board (EAB). The meeting is being called to address the items identified in the Agenda detailed below. The NDCAC EAB is a federal advisory committee established pursuant to the Federal Advisory Committee Act (FACA).
The NDCAC EAB meeting is open to the public, subject to the registration requirements detailed below. The EAB will meet in open session from 9:00 a.m. until 1:00 p.m. on November 1, 2017.
The meeting will take place at 5000 Seminary Rd, Alexandria, VA 22311. Entry into the meeting room will begin at 8:00 a.m.
Inquiries may be addressed to Ms. Alice Bardney-Boose, Designated Federal Officer, National Domestic Communications Assistance Center, Department of Justice, by email at
Agenda: The meeting will be called to order at 9:00 a.m. by EAB Chairman Preston Grubbs. All EAB members will be introduced and EAB Chairman Grubbs will provide remarks. The EAB will receive an update presentation and hold a discussion on the National Domestic Communications Assistance Center; receive a status report from its Administrative sub-committee; review the EAB Charter; and discuss the process of filling the NDCAC Deputy Director position. Note: Agenda items are subject to change.
The purpose of the EAB is to provide advice and recommendations to the Attorney General or designee, and to the Director of the NDCAC that promote public safety and national security by advancing the NDCAC's core functions:
In accordance with the FACA, all comments shall be made available for public inspection. Commenters are not required to submit personally identifiable information (such as name, address, etc.). Nevertheless, if commenters submit personally identifiable information as part of the comments, but do not want it made available for public inspection, the phrase “Personally Identifiable Information” must be included in the first paragraph of the comment. Commenters must place all personally identifiable information not to be made available for public inspection in the first paragraph and identify what information is to be redacted. Privacy Act Statement: Comments are being collected pursuant to the FACA. Any personally identifiable information included voluntarily within comments, without a request for redaction, will be used for the limited purpose of making all documents available to the public pursuant to FACA requirements.
Online registration for the meeting must be completed on or before 5:00 p.m. (EST) October 17, 2017. Anyone requiring special accommodations should notify Ms. Bardney-Boose at least seven (7) days in advance of the meeting or indicate your requirements on the online registration form.
Office of the Assistant Secretary for Policy, Chief Evaluation Office, Department of Labor.
Notice of information collection; request for comment.
The Department of Labor (DOL), 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) [44 U.S.C. 3506(c)(2)(A)]. 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 is properly assessed.
Currently, the Department of Labor is soliciting comments concerning the collection of follow-up survey data about the Evaluation of the Youth CareerConnect (YCC) Grant Program [SGA/DFA PY-13-01]. A copy of the proposed Information Collection Request (ICR) can be obtained by contacting the office listed in the addressee section of this notice.
Written comments must be submitted to the office listed in the addressee's section below on or before December 4, 2017.
You may submit comments by either one of the following methods:
Contact Jessica Lohmann by email at
The evaluation will address three main research questions: (1) What was the impact of the YCC programs on students' short-term outcomes? (2) How were the YCC programs implemented? and (3) Did the effectiveness of YCC programs vary by student characteristics? The RCT and QED will estimate program effectiveness and will
This request is part of a larger study which has had other components approved under prior clearance numbers. The YCC Participant Tracking System (PTS) was approved on March 20, 2015 under OMB Control No 1291-0002. Data collection instruments used for the baseline portion of the RCT and the instruments used for the implementation study were approved on April 15, 2015 under OMB Control No 1291-0003.
This
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• 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.
• 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—for example, permitting electronic submission of responses.
Comments submitted in response to this request 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.
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to assure 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 Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Training Plan Regulations and Certificate of Training.
All comments must be received on or before December 4, 2017.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below.
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Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 813(h), authorizes MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811, authorizes the Secretary of Labor
The Mine Act, as amended, 30 U.S.C. 801
MSHA is soliciting comments concerning the proposed information collection related to Training Plan Regulations and Certificate of Training. MSHA is particularly interested in comments that:
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to 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 information collection request will be available on
The public may also examine publicly available documents at USDOL-Mine Safety and Health Administration, 201 12th South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.
Questions about the information collection requirements may be directed to the person listed in the
This request for collection of information contains provisions for Training Plan Regulations and Certificate of Training. MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request.
Comments submitted in response to this notice will be summarized and 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 Science Foundation.
Notice of permit applications received.
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Interested parties are invited to submit written data, comments, or views with respect to this permit application by November 2, 2017. This application may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Ave., Alexandria, Virginia 22331.
Nature McGinn, ACA Permit Officer, at the above address, at 703-292-8030, or
The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541, 45 CFR 671), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science
Nuclear Regulatory Commission.
License amendment request; opportunity to comment, request a hearing, and petition for leave to intervene; order imposing procedures.
The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of three amendment requests. The amendment requests are for Hope Creek Generating Station, R.E. Ginna Nuclear Power Plant, and Wolf Creek Generating Station. For each amendment request, the NRC proposes to determine that they involve no significant hazards consideration. Because the amendment requests contain sensitive unclassified non-safeguards information (SUNSI) and safeguards information (SGI), an order imposes procedures to obtain access to SUNSI and SGI for contention preparation.
Comments must be filed by November 2, 2017. A request for a hearing must be filed by December 4, 2017. Any potential party as defined in § 2.4 of title 10 of the
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Lynn Ronewicz, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1927, email:
Please refer to Docket ID NRC-2017-0192, facility name, unit number(s), plant docket number, application date, and subject when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2017-0192, facility name, unit number(s), plant docket number, application date, and subject in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the NRC is publishing this notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This notice includes notices of amendments containing SUNSI and/or SGI.
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of 10 CFR, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated, or (2) create the possibility of a new or different kind of accident from any accident previously evaluated, or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period if circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. If the Commission takes action prior to the expiration of either the comment period or the notice period, it will publish a notice of issuance in the
Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to establish when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective,
A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 60 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2), a State, local governmental body, or Federally-recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.
All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562; August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC Web site at
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
Further consideration of committed modifications has resulted in the conclusion that the modification to install overcurrent protection, Engineering Service Request (ESR) 12-0141 (
Operation of Ginna in accordance with the proposed amendment does not increase the probability or consequences of accidents previously evaluated. Engineering analyses, which may include engineering evaluations, probabilistic safety assessments, and fire modeling calculations, have been performed to demonstrate that the performance-based requirements of NFPA 805 have been satisfied with the elimination of fire-induced overcurrent protection. The proposed amendment does not affect accident initiators, nor does it alter design assumptions, conditions, or configurations of the facility that would increase the probability of accidents previously evaluated. Further, the changes to be made for fire hazard protection and mitigation do not adversely affect the ability of structures, systems, or components to perform their design functions for accident mitigation, nor do they affect the postulated initiators or assumed failure models for accidents described and evaluated in the UFSAR [Updated Final Safety Analysis Report]. Structures, systems, or components required to safely shutdown the reactor and to maintain it in a safe shutdown condition will remain capable of performing their design functions.
The proposed amendment will not affect the source term, containment isolation, or radiological release assumptions used in evaluating the radiological consequences of any accident previously evaluated, and equipment required to mitigate an accident remains capable of performing the assumed function(s). The applicable radiological dose criteria will continue to be met.
The combination of all the proposed modifications and data updates reduces the overall calculated delta risk relative to the previously submitted information even with the removal of the fire-induced overcurrent modifications. The net Core Damage Frequency (CDF) delta risk including the internal events offset is 4E-6. The net Large Early Release Frequency (LERF) delta risk including the internal events offset is less than 1E-7.
Based on the above discussion, it is concluded that the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any kind of accident previously evaluated?
Response: No.
The original purpose of the overcurrent protection modifications was to reduce the fire risk by protecting the EDGs from fire-induced overcurrent events allowing local recovery of the EDGs. Several alternative means will be made available to provide the power for decay heat removal, RCS inventory and reactivity control, as well as providing power to the vital battery chargers, long-term indication and control power, and breaker control in lieu of ESR-12-0141. Operation of Ginna in accordance with the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated. The proposed change does not alter the requirements or functions for systems required during accident conditions. Implementation of this change will not result in new or different accidents.
The proposed amendment does not introduce new or different accident initiators, nor does it alter design assumptions, conditions, or configurations of the facility in such a manner as to introduce new or different accident initiators. The proposed amendment does not adversely affect the ability of structures, systems, or components to perform their design function. Structures, systems, or components required to safely shutdown the reactor and maintain it in a safe shutdown condition remain capable of performing their design functions.
The requirements of NFPA 805 address only fire protection and the impacts of fire on the plant that have previously been evaluated. Thus, implementation of the proposed amendment would not create the possibility of a new or different kind of accident beyond those already analyzed in the UFSAR. No new accident scenarios, transient precursors, failure mechanisms, or limiting single failures will be introduced, and there will be no adverse effect or challenges imposed on any safety-related system as a result of the proposed amendment.
Based on the above discussion, it is concluded that the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in the margin of safety?
Response: No.
The purpose of the proposed amendment is to permit Ginna to adopt a new fire protection licensing basis which complies with the requirements in 10 CFR 50.48(a) and (c) and the guidance in Regulatory Guide 1.205, Revision 1. The NRC considers that NFPA 805 provides an acceptable methodology and performance criteria for licensees to identify fire protection systems and features that are an acceptable alternative to the 10 CFR 50, Appendix R required fire protection features (69 FR 33536; June 16,
The overall approach of NFPA 805 is consistent with the key principles for evaluating license basis changes, as described in Regulatory Guide 1.174, Revision 2, is consistent with the defense-in-depth philosophy, and maintains sufficient safety margins. Engineering analysis, which may include engineering evaluations, probabilistic safety assessments, and fire modeling calculations, have been performed to demonstrate that the performance-based methods do not result in a significant reduction in the margin of safety.
Operation of Ginna in accordance with the proposed amendment does not involve a significant reduction in the margin of safety. The proposed amendment does not alter the manner in which safety limits, limiting safety system settings, or limiting conditions for operation are determined. The safety analysis acceptance criteria are not affected by this change. The proposed amendment does not alter the manner in which safety limits, limiting safety system settings, or limiting conditions for operation are determined. The safety analysis acceptance criteria are not affected by this change. The proposed amendment does not adversely affect existing plant safety margins or the reliability of equipment assumed to mitigate accident sin the UFSAR. The proposed amendment does not adversely affect the ability of structures, systems, or components to perform their design function. Structures, systems, or components required to safely shut down the reactor and to maintain it in a safe shutdown condition remain capable of performing their design functions.
Based on the above discussion, it is concluded that the proposed amendment does not involve a significant reduction in the margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change will increase the Hope Creek Generating Station rated thermal power (RTP) from 3840 megawatts thermal (MWt) to 3902 MWt. The reviews and evaluations performed to support the proposed uprated power conditions included all structures, systems, and components that would be affected by the proposed changes. The reviews and evaluations determined that these structures, systems, and components are capable of performing their design function at the proposed uprated RTP of 3902 MWt. Accident mitigation systems will function as designed. The performance requirements for these systems have been evaluated and found acceptable. Thus, the proposed changes do not create any new accident initiators or increase the probability of an accident previously evaluated.
The primary loop components (
The current safety analyses were evaluated for operation at 3902 MWt. The results demonstrate that acceptance criteria for applicable analyses continue to be met at the uprated conditions. As such, applicable accident analyses continue to comply with the relevant event acceptance criteria. The analyses performed to assess the effects of mass and energy releases remain valid. Source terms used to assess radiological consequences have been determined to bound operation at the uprated power level.
Power level is an input assumption to equipment design and accident analyses, but is not a transient or accident initiator. Accident initiators are not affected by the power uprate, and plant safety barrier challenges are not created by the proposed change.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
No new accident scenarios, failure mechanisms, or single failures are introduced as a result of the proposed change. Structures, systems, and components previously required for transient mitigation remain capable of fulfilling their intended design functions. The proposed change has no adverse effect on any safety-related structures, systems, or components and does not challenge the performance or integrity of any safety-related system.
The proposed change does not adversely affect any current system interfaces or create any new interfaces that could result in an accident or malfunction of a different kind than previously evaluated. Plant operation at 3902 MWt does not create any new accident initiators or precursors. Credible malfunctions are bounded by the current accident analyses of record or recent evaluations demonstrating that applicable criteria are still met with the proposed change.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Do the proposed changes involve a significant reduction in a margin of safety?
Response: No.
The margins of safety associated with the power uprate are those pertaining to core thermal power. Analyses of the primary fission product barriers have concluded that relevant design criteria remain satisfied, both from the standpoint of primary fission product barrier integrity and compliance with the required acceptance criteria. As appropriate, evaluations have been performed using methods that have either been reviewed and approved by the Nuclear Regulatory Commission, or are in compliance with regulatory review guidance and standards.
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed addition of TS 3.7.20 creates a[n] LCO for the Class 1E Electrical Equipment A/C System that is required to support the TS Class 1E electrical equipment. The 30 day Completion Time to restore an inoperable Class 1E electrical equipment A/C train to OPERABLE status is consistent with the Control Room Air Conditioning System (CRACS) and is supported by a plant specific calculation. The Class 1E Electrical Equipment A/C Systems' actuation, operation, or failure is not an initiator to any accident previously evaluated. As a result, the probability of an accident previously evaluated is not significantly increased. Conversely, the proposed change provides a period of time to recover an unexpected loss of cooling capability with one OPERABLE Class 1E electrical equipment A/C train providing adequate area cooling for both trains of Class 1E electrical equipment during normal and accident conditions (with mitigating actions being required).
Overall protection system performance will remain within the bounds of the previously performed accident analyses since no hardware changes are proposed to the protection systems. The same Reactor Trip System (RTS) and Engineered Safety Feature Actuation System (ESFAS) instrumentation will continue to be used. The protection systems will continue to function in a manner consistent with the plant design basis. The proposed change will not adversely affect accident initiators or precursors nor adversely alter the design assumptions and conditions of the facility or the manner in which the plant is operated and maintained with respect to such initiators or precursors.
The proposed change will not alter or prevent the capability of structures, systems, and components (SSCs) to perform their intended functions for mitigating the consequences of an accident and meeting applicable acceptance limits.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
No new accident scenarios, transient precursors, failure mechanisms, or limiting single failures will be introduced as a result of this amendment. No new or different accidents result from addition of the proposed specification. The Class 1E electrical equipment A/C trains maintain the capability to perform their specified safety function. The proposed license amendment includes regulatory commitments to achieve the capability for one OPERABLE Class 1E electrical equipment A/C train to provide adequate cooling for both trains of electrical equipment during normal and accident conditions by design changes. [The planned modifications proposed by regulatory commitments will be implemented under the requirements of 10 CFR 50.59.]
The proposed amendment will not alter the design or performance of the 7300 Process Protection System, Nuclear Instrumentation System, Solid State Protection System, Balance of Plant Engineered Safety Features Actuation System, Main Steam and Feedwater Isolation System, or Load Shedder and Emergency Load Sequencers used in the plant protection systems.
The proposed change adds requirements in the TSs that were previously located in plant procedures. One OPERABLE Class 1E electrical equipment A/C train is capable of providing adequate area cooling for both trains of Class 1E electrical equipment during normal and accident conditions (with mitigating actions being required). The change does not have a detrimental impact on the manner in which plant equipment operates or responds to an actuation signal.
Therefore, the proposed change will not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed specification allows for a period of time in which one Class 1E electrical equipment A/C train is capable of providing adequate area cooling for both trains of Class 1E electrical equipment during normal and accident conditions (with mitigating actions being required). The proposed change does not impact accident offsite dose, containment pressure or temperature, Emergency Core Cooling System settings or Reactor Protection System settings, or any other parameter that could affect a margin of safety. The margin of safety is enhanced by periodically verifying the area room temperatures are maintained within limit while one Class 1E electrical equipment A/C train is inoperable and allowing a reasonable period to perform preventive and corrective maintenance thus increasing system reliability.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
A. This Order contains instructions regarding how potential parties to this proceeding may request access to documents containing sensitive unclassified information (including Sensitive Unclassified Non-Safeguards Information (SUNSI) and Safeguards Information (SGI)). Requirements for access to SGI are primarily set forth in 10 CFR parts 2 and 73. Nothing in this Order is intended to conflict with the SGI regulations.
B. Within 10 days after publication of this notice of hearing and opportunity to petition for leave to intervene, any potential party who believes access to SUNSI or SGI is necessary to respond to this notice may request access to SUNSI or SGI. A “potential party” is any person who intends to participate as a party by demonstrating standing and filing an admissible contention under 10 CFR 2.309. Requests for access to SUNSI or SGI submitted later than 10 days after publication will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.
C. The requestor shall submit a letter requesting permission to access SUNSI, SGI, or both to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Associate General Counsel for Hearings, Enforcement and Administration, Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The expedited delivery or courier mail address for both offices is: U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email address for the Office of the Secretary and the Office of the General Counsel are
(1) A description of the licensing action with a citation to this
(2) The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the action identified in C.(1);
(3) If the request is for SUNSI, the identity of the individual or entity requesting access to SUNSI and the requestor's basis for the need for the information in order to meaningfully participate in this adjudicatory proceeding. In particular, the request must explain why publicly-available versions of the information requested would not be sufficient to provide the basis and specificity for a proffered contention; and
(4) If the request is for SGI, the identity of each individual who would have access to SGI if the request is granted, including the identity of any expert, consultant, or assistant who will aid the requestor in evaluating the SGI. In addition, the request must contain the following information:
(a) A statement that explains each individual's “need to know” the SGI, as required by 10 CFR 73.2 and 10 CFR 73.22(b)(1). Consistent with the definition of “need to know” as stated in 10 CFR 73.2, the statement must explain:
(i) Specifically why the requestor believes that the information is necessary to enable the requestor to proffer and/or adjudicate a specific contention in this proceeding;
(ii) The technical competence (demonstrable knowledge, skill, training or education) of the requestor to effectively utilize the requested SGI to provide the basis and specificity for a proffered contention. The technical competence of a potential party or its counsel may be shown by reliance on a qualified expert, consultant, or assistant who satisfies these criteria.
(b) A completed Form SF-85, “Questionnaire for Non-Sensitive Positions,” for each individual who would have access to SGI. The completed Form SF-85 will be used by the Office of Administration to conduct the background check required for access to SGI, as required by 10 CFR part 2, subpart C, and 10 CFR 73.22(b)(2), to determine the requestor's trustworthiness and reliability. For security reasons, Form SF-85 can only be submitted electronically through the electronic questionnaire for investigations processing (e-QIP) Web site, a secure Web site that is owned and operated by the Office of Personnel Management. To obtain online access to the form, the requestor should contact the NRC's Office of Administration at 301-415-3710.
(c) A completed Form FD-258 (fingerprint card), signed in original ink, and submitted in accordance with 10 CFR 73.57(d). Copies of Form FD-258 may be obtained by writing the Office of Administrative Services, Mail Services Center, Mail Stop P1-37, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by email to
(d) A check or money order payable in the amount of $324.00
(e) If the requestor or any individual(s) who will have access to SGI believes they belong to one or more of the categories of individuals that are exempt from the criminal history records check and background check requirements in 10 CFR 73.59, the requestor should also provide a statement identifying which exemption the requestor is invoking and explaining the requestor's basis for believing that the exemption applies. While processing the request, the Office of Administration, Personnel Security Branch, will make a final determination whether the claimed exemption applies. Alternatively, the requestor may contact the Office of Administration for an evaluation of their exemption status prior to submitting their request. Persons who are exempt from the background check are not required to complete the SF-85 or Form FD-258; however, all other requirements for access to SGI, including the need to know, are still applicable.
Copies of documents and materials required by paragraphs C.(4)(b), (c), and (d) of this Order must be sent to the following address: U.S. Nuclear Regulatory Commission, ATTN: Personnel Security Branch, Mail Stop TWFN-03-B46M, 11555 Rockville Pike, Rockville, MD 20852.
These documents and materials should
D. To avoid delays in processing requests for access to SGI, the requestor should review all submitted materials for completeness and accuracy (including legibility) before submitting them to the NRC. The NRC will return incomplete packages to the sender without processing.
E. Based on an evaluation of the information submitted under paragraphs C.(3) or C.(4) above, as applicable, the
(1) There is a reasonable basis to believe the petitioner is likely to establish standing to participate in this NRC proceeding; and
(2) The requestor has established a legitimate need for access to SUNSI or need to know the SGI requested.
F. For requests for access to SUNSI, if the NRC staff determines that the requestor satisfies both E.(1) and E.(2) above, the NRC staff will notify the requestor in writing that access to SUNSI has been granted. The written notification will contain instructions on how the requestor may obtain copies of the requested documents, and any other conditions that may apply to access to those documents. These conditions may include, but are not limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order setting forth terms and conditions to prevent the unauthorized or inadvertent disclosure of SUNSI by each individual who will be granted access to SUNSI.
G. For requests for access to SGI, if the NRC staff determines that the requestor has satisfied both E.(1) and E.(2) above, the Office of Administration will then determine, based upon completion of the background check, whether the proposed recipient is trustworthy and reliable, as required for access to SGI by 10 CFR 73.22(b). If the Office of Administration determines that the individual or individuals are trustworthy and reliable, the NRC will promptly notify the requestor in writing. The notification will provide the names of approved individuals as well as the conditions under which the SGI will be provided. Those conditions may include, but are not limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order
H. Release and Storage of SGI. Prior to providing SGI to the requestor, the NRC staff will conduct (as necessary) an inspection to confirm that the recipient's information protection system is sufficient to satisfy the requirements of 10 CFR 73.22. Alternatively, recipients may opt to view SGI at an approved SGI storage location rather than establish their own SGI protection program to meet SGI protection requirements.
I. Filing of Contentions. Any contentions in these proceedings that are based upon the information received as a result of the request made for SUNSI or SGI must be filed by the requestor no later than 25 days after receipt of (or access to) that information. However, if more than 25 days remain between the petitioner's receipt of (or access to) the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI or SGI contentions by that later deadline.
J. Review of Denials of Access.
(1) If the request for access to SUNSI or SGI is denied by the NRC staff either after a determination on standing and requisite need, or after a determination on trustworthiness and reliability, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.
(2) Before the Office of Administration makes a final adverse determination regarding the trustworthiness and reliability of the proposed recipient(s) for access to SGI, the Office of Administration, in accordance with 10 CFR 2.336(f)(1)(iii), must provide the proposed recipient(s) any records that were considered in the trustworthiness and reliability determination, including those required to be provided under 10 CFR 73.57(e)(1), so that the proposed recipient(s) have an opportunity to correct or explain the record.
(3) The requestor may challenge the NRC staff's adverse determination with respect to access to SUNSI or with respect to standing or need to know for SGI by filing a challenge within 5 days of receipt of that determination with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer.
(4) The requestor may challenge the Office of Administration's final adverse determination with respect to trustworthiness and reliability for access to SGI by filing a request for review in accordance with 10 CFR 2.336(f)(1)(iv).
(5) Further appeals of decisions under this paragraph must be made pursuant to 10 CFR 2.311.
K. Review of Grants of Access. A party other than the requestor may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed within 5 days of the notification by the NRC staff of its grant of access and must be filed with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer.
If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by the Commission of orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311.
L. The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI or SGI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those petitioners who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. The attachment to this Order summarizes the general target schedule for processing and resolving requests under these procedures.
It is so ordered.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
NUREG; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued Revision 1 to NUREG-1556, Volume 18, “Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Service Provider Licenses,” which updates licensing guidance for service provider licenses. This document has been revised to include information on updated regulatory requirements, safety culture, security of radioactive materials, protection of sensitive information, and changes in regulatory policies and practices. The document is intended for use by applicants, licensees, and the NRC staff.
NUREG 1556, Volume 18, Revision 1 was published in August 2017.
Please refer to Docket ID NRC-2014-0124 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
This NUREG-1556 volume is also available on the NRC's public Web site at
Anthony McMurtray, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2746; email:
The NRC issued a revision to NUREG-1556, Volume 18, Revision 1, to provide guidance to existing materials service provider licensees and to applicants preparing an application for a materials service provider license. This NUREG volume also provides the NRC staff with criteria for evaluating these license applications. The purpose of this notice is to notify the public that the NUREG-1556 volume listed in this
The NRC published a notice of the availability of the draft report for comment version of NUREG-1556, Volume 18, Revision 1 in the
This NUREG volume is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found this NUREG revision to be a major rule as defined in the Congressional Review Act.
For the U.S. Nuclear Regulatory Commission.
On July 31, 2017, Bats BZX Exchange, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 18(a)(2), 18(c) and 18(i) of the Act, under sections 6(c) and 23(c)(3) of the Act for an exemption from rule 23c-3 under the Act, and for an order pursuant to section 17(d) of the Act and rule 17d-1 under the Act.
Applicants request an order to permit certain registered closed-end management investment companies to issue multiple classes of shares and to impose asset-based distribution and/or service fees and early withdrawal charges.
PREDEX (the “Initial Fund”), and PREDEX Capital Management, LLC (the “Adviser”).
The application was filed on May 5, 2017, and amended on August 14, 2017.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail.
Hearing requests should be received by the Commission by 5:30 p.m. on October 23, 2017, and should be accompanied by proof of service on the applicants, in the form of an affidavit, or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants: PREDEX, 17605 Wright Street, Suite 2, Omaha, NE 68130; Adviser, 18500 Von Karman Ave., Suite 350, Irvine, CA 92612.
Bruce R. MacNeil, Senior Counsel, at (202) 551-6817, or David J. Marcinkus, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. The Initial Fund is a Delaware statutory trust that is registered under the Act as a non-diversified, closed-end management investment company. The Initial Fund's primary investment objective is to seek consistent current income while secondarily seeking long-term capital appreciation with moderate volatility. The Initial Fund pursues its investment objectives by investing up to 95% of its total assets in real estate investment funds managed by institutional asset managers with expertise in managing portfolios of real estate and real estate related industry securities.
2. The Adviser, a Delaware limited liability company, is registered as an investment adviser under the Investment Advisers Act of 1940. The
3. The applicants seek an order to permit the Funds (as defined below) to issue multiple classes of shares, each having its own fee and expense structure and to impose early withdrawal charges and asset-based distribution and/or service fees with respect to certain classes.
4. Applicants request that the order also apply to any continuously-offered registered closed-end management investment company that has been previously organized or that may be organized in the future for which the Adviser, or any entity controlling, controlled by, or under common control with the Adviser, or any successor in interest to any such entity,
5. The Initial Fund is currently making a continuous public offering of its common shares. Applicants state that additional offerings by any Fund relying on the order may be on a private placement or public offering basis. Shares of the Funds are not expected to be listed on any securities exchange nor quoted on any quotation medium and the Funds do not expect there to be a secondary trading market for their shares.
6. If the requested relief is granted, the Initial Fund intends to redesignate its common shares as “Class I Shares” and to commence a continuous offering of two additional classes of shares (“Class A Shares” and “Class C Shares”), with each class having its own fee and expense structure and may also offer additional classes of shares in the future. Because of the different distribution fees, services, and any other class expenses that may be attributable to the Class A Shares, Class I Shares, and Class C Shares, the net income attributable to, and the dividends payable on, each class of shares may differ from each other.
7. Applicants state that, from time to time, the Initial Fund may create additional classes of shares, the terms of which may differ from Class A Shares, Class I Shares and Class C Shares in the following respects: (i) The amount of fees permitted by different distribution plans or different service fee arrangements; (ii) voting rights with respect to a distribution plan of a class; (iii) different class designations; (iv) the impact of any class expenses directly attributable to a particular class of shares allocated on a class basis as described in the application; (v) any differences in dividends and net asset value resulting from differences in fees under a distribution plan or in class expenses; (vi) any early withdrawal charge or other sales load structure; and (vii) exchange or conversion privileges of the classes as permitted under the Act.
8. Applicants state that the Initial Fund has adopted a fundamental policy to repurchase a specified percentage of its shares (no less than 5%) at net asset value on a quarterly basis. Such repurchase offers will be conducted pursuant to rule 23c-3 under the Act. Each of the other Funds will likewise adopt fundamental investment policies in compliance with rule 23c-3 and make quarterly repurchase offers to its shareholders, or provide periodic liquidity with respect to its shares pursuant to rule 13e-4 under the Exchange Act.
9. Applicants represent that any asset-based service and/or distribution fees for each class of shares of the Funds will comply with the provisions of FINRA Rule 2341 (“FINRA Sales Charge Rule”).
10. Each of the Funds will comply with any requirements that the Commission or FINRA may adopt regarding disclosure at the point of sale and in transaction confirmations about the costs and conflicts of interest arising out of the distribution of open-end investment company shares, and regarding prospectus disclosure of sales loads and revenue sharing arrangements, as if those requirements applied to the Fund. In addition, each Fund will contractually require that any distributor of the Fund's shares comply with such requirements in connection with the distribution of such Fund's shares.
11. Each Fund will allocate all expenses incurred by it among the various classes of shares based on the net assets of the Fund attributable to each class, except that the net asset value and expenses of each class will reflect the expenses associated with the distribution plan of that class, service fees, and any other incremental expenses of that class. Expenses of a Fund allocated to a particular class of shares will be borne on a pro rata basis by each outstanding share of that class. Applicants state that each Fund will comply with the provisions of rule 18f-3 under the Act as if it were an open-end investment company.
12. Applicants state that each Fund may impose an early withdrawal charge on shares submitted for repurchase that have been held less than a specified period and may waive the early withdrawal charge for certain categories of shareholders or transactions to be established from time to time. Applicants state that each Fund will apply the early withdrawal charge (and any waivers or scheduled variations of the early withdrawal charge) uniformly to all shareholders in a given class and consistently with the requirements of rule 22d-1 under the Act as if the Funds were open-end investment companies.
13. Each Fund operating as an interval fund pursuant to rule 23c-3 under the
1. Section 18(a)(2) of the Act provides that a closed-end investment company may not issue or sell a senior security that is a stock unless certain requirements are met. Applicants state that the creation of multiple classes of shares of the Funds may violate section 18(a)(2) because the Funds may not meet such requirements with respect to a class of shares that may be a senior security.
2. Section 18(c) of the Act provides, in relevant part, that a closed-end investment company may not issue or sell any senior security if, immediately thereafter, the company has outstanding more than one class of senior security. Applicants state that the creation of multiple classes of shares of the Funds may be prohibited by section 18(c), as a class may have priority over another class as to payment of dividends because shareholders of different classes would pay different fees and expenses.
3. Section 18(i) of the Act provides that each share of stock issued by a registered management investment company will be a voting stock and have equal voting rights with every other outstanding voting stock. Applicants state that multiple classes of shares of the Funds may violate section 18(i) of the Act because each class would be entitled to exclusive voting rights with respect to matters solely related to that class.
4. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction or any class or classes of persons, securities or transactions from any provision of the Act, or from any rule or regulation under the Act, if and to the extent such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicants request an exemption under section 6(c) from sections 18(a)(2), 18(c) and 18(i) to permit the Funds to issue multiple classes of shares.
5. Applicants submit that the proposed allocation of expenses relating to distribution and/or services and voting rights among multiple classes is equitable and will not discriminate against any group or class of shareholders. Applicants submit that the proposed arrangements would permit a Fund to facilitate the distribution of its shares and provide investors with a broader choice of shareholder services. Applicants assert that the proposed closed-end investment company multiple class structure does not raise the concerns underlying section 18 of the Act to any greater degree than open-end investment companies' multiple class structures that are permitted by rule 18f-3 under the Act. Applicants state that each Fund will comply with the provisions of rule 18f-3 as if it were an open-end investment company.
1. Section 23(c) of the Act provides, in relevant part, that no registered closed-end investment company shall purchase securities of which it is the issuer, except: (a) On a securities exchange or other open market; (b) pursuant to tenders, after reasonable opportunity to submit tenders given to all holders of securities of the class to be purchased; or (c) under other circumstances as the Commission may permit by rules and regulations or orders for the protection of investors.
2. Rule 23c-3 under the Act permits a registered closed-end investment company (an “interval fund”) to make repurchase offers of between five and twenty-five percent of its outstanding shares at net asset value at periodic intervals pursuant to a fundamental policy of the interval fund. Rule 23c-3(b)(1) under the Act permits an interval fund to deduct from repurchase proceeds only a repurchase fee, not to exceed two percent of the proceeds, that is paid to the interval fund and is reasonably intended to compensate the fund for expenses directly related to the repurchase. A Fund will not impose a repurchase fee on investors who purchase and tender their shares.
3. Section 23(c)(3) provides that the Commission may issue an order that would permit a closed-end investment company to repurchase its shares in circumstances in which the repurchase is made in a manner or on a basis that does not unfairly discriminate against any holders of the class or classes of securities to be purchased.
4. Applicants request relief under section 6(c), discussed above, and section 23(c)(3) from rule 23c-3 to the extent necessary for the Funds to impose early withdrawal charges on shares of the Funds submitted for repurchase that have been held for less than a specified period.
5. Applicants state that the early withdrawal charges they intend to impose are functionally similar to contingent deferred sales loads imposed by open-end investment companies under rule 6c-10 under the Act. Rule 6c-10 permits open-end investment companies to impose contingent deferred sales loads, subject to certain conditions. Applicants note that rule 6c-10 is grounded in policy considerations supporting the employment of contingent deferred sales loads where there are adequate safeguards for the investor and state that the same policy considerations support imposition of early withdrawal charges in the interval fund context. In addition, applicants state that early withdrawal charges may be necessary for the distributor to recover distribution costs. Applicants represent that any early withdrawal charge imposed by the Funds will comply with rule 6c-10 under the Act as if the rule were applicable to closed-end investment companies. The Funds will disclose early withdrawal charges in accordance with the requirements of Form N-1A concerning contingent deferred sales loads.
1. Section 17(d) of the Act and rule 17d-1 under the Act prohibit an affiliated person of a registered investment company, or an affiliated person of such person, acting as principal, from participating in or effecting any transaction in connection with any joint enterprise or joint arrangement in which the investment company participates unless the Commission issues an order permitting the transaction. In reviewing applications submitted under section 17(d) and rule 17d-1, the Commission considers whether the participation of the investment company in a joint
2. Rule 17d-3 under the Act provides an exemption from section 17(d) and rule 17d-1 to permit open-end investment companies to enter into distribution arrangements pursuant to rule 12b-1 under the Act. Applicants request an order under section 17(d) and rule 17d-1 under the Act to the extent necessary to permit the Fund to impose asset-based distribution and/or service fees. Applicants have agreed to comply with rules 12b-1 and 17d-3 as if those rules applied to closed-end investment companies, which they believe will resolve any concerns that might arise in connection with a Fund financing the distribution of its shares through asset-based distribution and/or service fees.
3. For the reasons stated above, applicants submit that the exemptions requested under section 6(c) are necessary and appropriate in the public interest and are consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicants further submit that the relief requested pursuant to section 23(c)(3) will be consistent with the protection of investors and will insure that applicants do not unfairly discriminate against any holders of the class of securities to be purchased. Finally, applicants state that the Funds' imposition of asset-based distribution and/or service fees is consistent with the provisions, policies and purposes of the Act and does not involve participation on a basis different from or less advantageous than that of other participants.
Applicants agree that any order granting the requested relief will be subject to the following condition:
Each Fund relying on the order will comply with the provisions of rules 6c-10, 12b-1, 17d-3, 18f-3, 22d-1, and, where applicable, 11a-3 under the Act, as amended from time to time, as if those rules applied to closed-end management investment companies, and will comply with the FINRA Sales Charge Rule, as amended from time to time, as if that rule applied to all closed-end management investment companies.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to list and trade shares of the GraniteShares Palladium Trust under NYSE Arca Equities Rule 8.201 [sic]. The proposed change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to list and trade shares (“Shares”) of the GraniteShares Palladium Trust (the “Trust”), under NYSE Arca Equities Rule 8.201.
The Trust will not be registered as an investment company under the Investment Company Act of 1940, as amended,
The Sponsor of the Trust is GraniteShares LLC, a Delaware limited liability company. The Bank of New York Mellon is the trustee of the Trust (the “Trustee”)
The Commission has previously approved listing on the Exchange under NYSE Arca Equities Rule 8.201 [sic] of other precious metals and palladium-based commodity trusts, including the ETFS Platinum Trust,
The Exchange represents that the Shares satisfy the requirements of NYSE Arca Equities Rule 8.201 [sic] and thereby qualify for listing on the Exchange.
The investment objective of the Trust will be for the Shares to reflect the performance of the price of palladium, less the expenses and liabilities of the Trust. The Trust will issue Shares which represent units of fractional undivided beneficial interest in and ownership of the Trust.
The Trust will not trade in palladium futures or options on any futures exchange or over the counter (“OTC”) transactions in forwards, options and other derivatives. The Trust will not hold or trade in commodity futures contracts, “commodity interests”, or any other instruments regulated by the Commodities Exchange Act. The Trust will take delivery of physical palladium that complies with the LPPM palladium delivery rules.
The Shares are intended to constitute a simple and cost-effective means of making an investment similar to an investment in palladium. Although the Shares are not the exact equivalent of an investment in palladium, they provide investors with an alternative that allows a level of participation in the palladium market through the securities market.
The global trade in palladium consists of OTC transactions in spot, forwards, and options and other derivatives, together with exchange-traded futures and options.
Most trading in physical palladium is conducted on the OTC market, predominantly in Zurich and London. The LPPM coordinates various OTC market activities, including clearing and vaulting, acts as the principal intermediary between physical palladium market participants and the relevant regulators, promotes good trading practices and develops standard market documentation. In addition, the LPPM promotes refining standards for the palladium market by maintaining the “London/Zurich Good Delivery List,” which are the lists of LPPM accredited melters and assayers of palladium.
The basis for settlement and delivery of a spot trade is payment (generally in US dollars) two business days after the trade date against delivery. Delivery of the palladium can either be by physical delivery or through the clearing systems to an unallocated account. The unit of trade in London and Zurich is the troy ounce, whose conversion between grams is: 1,000 grams is equivalent to 32.1507465 troy ounces, and one troy ounce is equivalent to 31.1034768 grams.
A good delivery palladium plate or ingot is acceptable for delivery in settlement of a transaction on the OTC market (a “Good Delivery Palladium Plate or Ingot”). A Good Delivery Palladium Plate or Ingot must contain between 32 and 192 troy ounces of palladium with a minimum fineness (or purity) of 999.5 parts per 1,000 (99.95%), be of good appearance, and be easy to handle and stack. A Good Delivery Palladium Plate or Ingot must also bear the stamp of one of the melters and assayers who are on the LPPM approved list. Unless otherwise specified, the palladium spot price always refers to the “Good Delivery Standards” set by the LPPM.
The Trust will create and redeem Shares on a continuous basis in one or more blocks of 15,000 Shares (a block of 15,000 Shares is called a “Basket”). As described below, the Trust will issue Shares in Baskets to certain authorized participants (“Authorized Participants”) on an ongoing basis. Baskets of Shares will only be issued or redeemed in exchange for an amount of palladium represented by the aggregate number of Shares redeemed. No Shares will be issued unless the Custodian has allocated to the Trust's account the corresponding amount of palladium. Initially, a Basket will require delivery of 1,500 fine ounces of palladium. The amount of palladium necessary for the creation of a Basket, or to be received upon redemption of a Basket, will decrease over the life of the Trust, due to the payment or accrual of fees and other expenses or liabilities payable by the Trust.
Baskets may be created or redeemed only by Authorized Participants. Orders must be placed by 3:59 p.m. Eastern Time (“E.T.”). The day on which a Trust receives a valid purchase or redemption order is the order date.
Each Authorized Participant must be a registered broker-dealer, a participant in Depository Trust Corporation (“DTC”), have entered into an agreement with the Trustee (the “Authorized Participant Agreement”) and have established a palladium unallocated account with the Custodian or a physical palladium clearing bank. The Authorized Participant Agreement provides the procedures for the creation and redemption of Baskets and for the delivery of palladium in connection with such creations or redemptions.
According to the Registration Statement, Authorized Participants may surrender Baskets of Shares in exchange for the corresponding Basket Amount announced by the Trustee. Upon surrender of such Shares and payment of the Trustee's applicable fee and of any expenses, taxes or charges (such as stamp taxes or stock transfer taxes or fees), the Trustee will deliver to the order of the redeeming Authorized Participant the amount of palladium corresponding to the redeemed Baskets. Shares can only be surrendered for redemption in Baskets of 15,000 Shares each.
Before surrendering Baskets of Shares for redemption, an Authorized Participant must deliver to the Trustee a written request indicating the number of Baskets it intends to redeem. The date the Trustee receives that order determines the Basket Amount to be
The redemption distribution from the Trust will consist of a credit to the redeeming Authorized Participant's unallocated account representing the amount of the palladium held by the Trust evidenced by the Shares being redeemed as of the date of the redemption order.
The NAV of the Trust will be calculated by subtracting the Trust's expenses and liabilities on any day from the value of the palladium owned by the Trust on that day; the NAV per Share will be obtained by dividing the NAV of the Trust on a given day by the number of Shares outstanding on that day. On each day on which the Exchange is open for regular trading, the Trustee will determine the NAV as promptly as practicable after 4:00 p.m. E.T. The Trustee will value the Trust's palladium based on the most recently announced LBMA Palladium Price PM or LBMA Palladium Price AM. If neither price is available for that day, the Trustee will value the Trust's palladium based on the most recently announced LBMA Palladium Price PM or LBMA Palladium Price AM. If the Sponsor determines that such price is inappropriate to use, the Sponsor will identify an alternate basis for evaluation to be employed by the Trustee. Further, the Sponsor may instruct the Trustee to use on an on-going basis a different publicly available price which the Sponsor determines to fairly represent the commercial value of the Trust's palladium.
The NAV per Share will be calculated by taking the current price of the Trust's total assets, subtracting any liabilities, and dividing by the total number of Shares outstanding. Authorized Participants will offer Shares at an offering price that will vary, depending on, among other factors, the price of palladium and the trading price of the Shares on the Exchange at the time of offer. Authorized Participants will not receive from the Trust, the Sponsor, the Trustee or any of their affiliates any fee or other compensation in connection with the offering of the Shares.
While the Trust seeks to reflect generally the performance of the price of palladium less the Trust's expenses and liabilities, Shares may trade at, above or below their NAV. The NAV of Shares will fluctuate with changes in the market value of the Trust's assets. The trading prices of Shares will fluctuate in accordance with changes in their NAV as well as market supply and demand. The amount of the discount or premium in the trading price relative to the NAV may be influenced by non-concurrent trading hours between the major palladium markets and the Exchange. While the Shares trade on the Exchange until 4:00 p.m. E.T., liquidity in the market for palladium may be reduced after the close of the major world palladium markets, including London, Zurich and COMEX. As a result, during this time, trading spreads, and the resulting premium or discount, on Shares may widen.
Currently, the Consolidated Tape Plan does not provide for dissemination of the spot price of a commodity such as palladium over the Consolidated Tape. However, there will be disseminated over the Consolidated Tape the last sale price for the Shares, as is the case for all equity securities traded on the Exchange (including exchange-traded funds). In addition, there is a considerable amount of information about palladium and palladium markets available on public Web sites and through professional and subscription services.
Investors may obtain palladium pricing information on a 24-hour basis based on the spot price for an ounce of palladium from various financial information service providers, such as Reuters and Bloomberg.
Reuters and Bloomberg provide at no charge on their Web sites delayed information regarding the spot price of palladium and last sale prices of palladium futures, as well as information about news and developments in the palladium market. Reuters and Bloomberg also offer a professional service to subscribers for a fee that provides information on palladium prices directly from market participants. ICAP plc provides an electronic trading platform called EBS for the trading of spot palladium, as well as a feed of real-time streaming prices, delivered as record-based digital data from the EBS platform to its customer's market data platform via Bloomberg or Reuters.
Complete real-time data for palladium futures and options prices traded on the COMEX are available by subscription from Reuters and Bloomberg. The NYMEX also provides delayed futures and options information on current and past trading sessions and market news free of charge on its Web site. There are a variety of other public Web sites providing information on palladium, ranging from those specializing in precious metals to sites maintained by major newspapers, such as The Wall Street Journal.
The intraday indicative value (“IIV”) per Share for the Shares will be disseminated by one or more major market data vendors at least every 15 seconds during the Core Trading Session. The IIV will be calculated based on the amount of palladium held by the Trust and a price of palladium derived from updated bids and offers indicative of the spot price of palladium.
The Web site for the Trust (
The Trust will be subject to the criteria in NYSE Arca Equities Rule 8.201(e) [sic] for initial and continued listing of the Shares.
A minimum of one Basket or 15,000 Shares will be required to be outstanding at the start of trading, which is equivalent to 1,500 fine ounces of palladium. The Exchange believes that the anticipated minimum number of Shares outstanding at the start of
The Exchange deems the Shares to be equity securities, thus rendering trading in the Trust subject to the Exchange's existing rules governing the trading of equity securities. Trading in the Shares on the Exchange will occur in accordance with NYSE Arca Equities Rule 7.34(a). The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in NYSE Arca Equities Rule 7.6, Commentary .03, the minimum price variation (“MPV”) for quoting and entry of orders in equity securities traded on the NYSE Arca Marketplace is $0.01, with the exception of securities that are priced less than $1.00 for which the MPV for order entry is $0.0001.
Further, NYSE Arca Equities Rule 8.201 [sic] sets forth certain restrictions on ETP Holders acting as registered Market Makers in the Shares to facilitate surveillance. Under NYSE Arca Equities Rule 8.201(g) [sic], an ETP Holder acting as a registered Market Maker in the Shares is required to provide the Exchange with information relating to its trading in the underlying palladium, related futures or options on futures, or any other related derivatives. Commentary .04 of NYSE Arca Equities Rule 6.3 requires an ETP Holder acting as a registered Market Maker, and its affiliates, in the Shares to establish, maintain and enforce written policies and procedures reasonably designed to prevent the misuse of any material nonpublic information with respect to such products, any components of the related products, any physical asset or commodity underlying the product, applicable currencies, underlying indexes, related futures or options on futures, and any related derivative instruments (including the Shares).
As a general matter, the Exchange has regulatory jurisdiction over its ETP Holders and their associated persons, which include any person or entity controlling an ETP Holder. A subsidiary or affiliate of an ETP Holder that does business only in commodities or futures contracts would not be subject to Exchange jurisdiction, but the Exchange could obtain information regarding the activities of such subsidiary or affiliate through surveillance sharing agreements with regulatory organizations of which such subsidiary or affiliate is a member.
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares. Trading on the Exchange in the Shares may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which conditions in the underlying palladium market have caused disruptions and/or lack of trading, or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. In addition, trading in Shares will be subject to trading halts caused by extraordinary market volatility pursuant to the Exchange's “circuit breaker” rule.
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances administered by the Exchange, as well as cross-market surveillances administered by the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares with other markets and other entities that are members of the ISG, and the Exchange or FINRA, on behalf of the Exchange, or both, may obtain trading information regarding trading in the Shares from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.
Also, pursuant to NYSE Arca Equities Rule 8.201(g) [sic], the Exchange is able to obtain information regarding trading in the Shares and the underlying palladium, palladium futures contracts, options on palladium futures, or any other palladium derivative, through ETP Holders acting as registered Market Makers, in connection with such ETP Holders' proprietary or customer trades through ETP Holders which they effect on any relevant market.
In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
All statements and representations made in this filing regarding (a) the description of the portfolio, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange listing rules specified in this rule filing shall constitute continued listing requirements for listing the Shares of the Trust on the Exchange.
The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Trust to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If the Trust is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under NYSE Arca Equities Rule 5.5(m).
Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. Specifically, the Information Bulletin will discuss the following: (1) The procedures for purchases and redemptions of Shares in Baskets (including noting that Shares are not individually redeemable); (2) NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts
In addition, the Information Bulletin will reference that the Trust is subject to various fees and expenses as will be described in the Registration Statement. The Information Bulletin will also reference the fact that there is no regulated source of last sale information regarding physical palladium, that the Commission has no jurisdiction over the trading of palladium as a physical commodity, and that the CFTC has regulatory jurisdiction over the trading of palladium futures contracts and options on palladium futures contracts.
The Information Bulletin will also discuss any relief, if granted, by the Commission or the staff from any rules under the Act.
The basis under the Act for this proposed rule change is the requirement under Section 6(b)(5)
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in NYSE Arca Equities Rule 8.201 [sic]. The Exchange has in place surveillance procedures that are adequate to properly monitor trading in the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws. The Exchange may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that there is a considerable amount of palladium price and palladium market information available on public Web sites and through professional and subscription services. Investors may obtain palladium pricing information on a 24-hour basis based on the spot price for an ounce of palladium from various financial information service providers. Delayed information regarding the spot price of palladium and last sale prices of palladium futures, as well as information about news and developments in the palladium market, are also available from financial information service providers. Information on palladium prices directly from market participants is also available from financial information service providers. An electronic trading platform called EBS for the trading of spot palladium, as well as a feed of real-time streaming prices, is also available from information service providers.
The NAV of the Trust will be published by the Sponsor on each day that the NYSE Arca is open for regular trading and will be posted on the Trust's Web site. The IIV relating to the Shares will be widely disseminated by one or more major market data vendors at least every 15 seconds during the Core Trading Session. The Trust's Web site will also provide the Trust's prospectus, as well as the two most recent reports to stockholders. In addition, information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Shares and may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement. In addition, as noted above, investors will have ready access to information regarding palladium pricing.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes the proposed rule change will enhance competition by accommodating Exchange trading of an additional exchange-traded product relating to physical palladium.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove 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 Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 3, 2017, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 9, 2017, Miami International Securities Exchange, LLC (“MIAX Options” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to adopt new Chapter 18 and amend certain rules in the MIAX Options rulebook. The purpose of the Exchange's proposal is to establish: (1) Trading rules enabling MIAX Options Members to trade index options on the Exchange and (2) generic listing standards and maintenance standards to permit the Exchange to list “broad-based” and “narrow-based” index options on the Exchange pursuant to Rule 19b-4(e) under the Act.
In accordance with the proposal, the Exchange will need to file additional proposed rule changes with the Commission when the Exchange identifies specific products, because the rules related to trading options in indices are product specific in many areas.
MIAX Options proposes to add new Chapter 18 to the Exchange rules and make conforming changes to certain existing Exchange rules.
The proposed rules also establish position limit and exercise limits for index options.
The Exchange also proposes to establish generic listing and maintenance standards in proposed Rule 1802 to enable the Exchange to list and trade new broad-based index options pursuant to Rule 19b-4(e) under the Act.
The Exchange further proposes to establish generic listing and maintenance standards in Proposed Rule 1802 to enable the Exchange to list and trade new narrow-based index options pursuant to Rule 19b-4(e) under the Act.
The Exchange represents that it has an adequate surveillance program in place for index options. The Exchange is a member of the Intermarket Surveillance Group (“ISG”), which is comprised of an international group of exchanges, market centers, and market regulators.
The Exchange will announce the implementation date of the proposed rule change by Regulatory Circular to be published no later than 90 days following the approval of the proposed rule change. The implementation date will be no later than 90 days following the issuance of the Regulatory Circular.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange and, in particular, with Section 6(b) of the Act.
The Commission's approval of the Exchange's proposed listing standards for broad-based and narrow-based index options will allow those index option products that satisfy the generic listing standards to begin trading pursuant to Rule 19b-4(e) under the Act, without the need for notice and comment and Commission approval. The Exchange's ability to rely on Rule 19b-4(e) under the Act for these products potentially reduces the time frame for listing and trading these securities, and thus enhances investors' opportunities.
The Commission believes that trading options on an index of securities (including a narrow-based index) permits investors to participate in the price movements of the index's underlying securities and allows investors holding positions in some or all of such securities to hedge the risks associated with their portfolios. The Commission further believes that trading options on an index provides investors with an important trading and hedging mechanism that is designed to reflect accurately the overall movement of the component stocks. In particular, the Commission believes that the proposed position and exercise limits should serve to minimize potential manipulation concerns.
In considering the proposed generic listing and maintenance standards for broad-based and narrow-based index options, the Commission notes that they are consistent with the listing and maintenance standards for broad-based and narrow-based index options that other exchanges
The Commission also finds the requirements that all securities comprising the index be an “NMS stock” as defined in Rule 600 of Regulation NMS under the Act,
The Commission further notes that the Exchange's rules that are applicable to broad-based and narrow-based index options, including provisions addressing sales practices, floor trading procedures, position and exercise limits, margin requirements, and trading halts and suspensions, will continue to apply to any broad-based or narrow-based index options listed pursuant to Rule 19b-4(e) under the Act.
As noted above,
For new derivative securities products based on securities from a foreign market, the SRO should have a comprehensive Intermarket Surveillance Agreement with the market for the securities underlying the new securities product.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and 12(d)(1)(B) of the Act. The requested order would permit (a) actively-managed series of certain open-end management investment companies (“Funds”) to issue shares redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Fund shares to occur at negotiated market prices rather than at net asset value (“NAV”); (c) certain Funds to pay redemption proceeds, under certain circumstances, more than seven days after the tender of shares for redemption; (d) certain affiliated persons of a Fund to deposit securities into, and receive securities from, the Fund in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the Funds (“Funds of Funds”) to acquire shares of the Funds; and (f) certain Funds (“Feeder Funds”) to create and redeem Creation Units in-kind in a master-feeder structure.
American Century ETF Trust (“Trust”), a Delaware statutory trust that will be registered under the Act as an open-end management investment company with multiple series, and American Century Investment Management, Inc. (“Initial Adviser”), a Delaware corporation registered as an investment adviser under the Investment Advisers Act of 1940.
The application was filed on June 30, 2017.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on October 24, 2017, and should be accompanied by proof of service on applicants, in the form of an affidavit, or for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants: Michael W. Mundt, Esq., Stradley Ronon Stevens & Young, LLP, 1250 Connecticut Avenue NW., Ste. 500, Washington, DC 20036; Mr. Charles A. Etherington, American Century Investment Management, Inc., 4500 Main Street, Kansas City, MO 64111.
Jean E. Minarick, Senior Counsel, at (202) 551-6811, or David J. Marcinkus, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. Applicants request an order that would allow Funds to operate as actively-managed exchange traded funds (“ETFs”).
2. Each Fund will consist of a portfolio of securities and other assets and investment positions (“Portfolio Instruments”). Each Fund will disclose on its Web site the identities and quantities of the Portfolio Instruments that will form the basis for the Fund's calculation of NAV at the end of the day.
3. Shares will be purchased and redeemed in Creation Units and generally on an in-kind basis. Except where the purchase or redemption will include cash under the limited circumstances specified in the
4. Because shares will not be individually redeemable, applicants request an exemption from section 5(a)(1) and section 2(a)(32) of the Act that would permit the Funds to register as open-end management investment companies and issue shares that are redeemable in Creation Units only.
5. Applicants also request an exemption from section 22(d) of the Act and rule 22c-1 under the Act as secondary market trading in shares will take place at negotiated prices, not at a current offering price described in a Fund's prospectus, and not at a price based on NAV. Applicants state that (a) secondary market trading in shares does not involve a Fund as a party and will not result in dilution of an investment in shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants represent that share market prices will be disciplined by arbitrage opportunities, which should prevent shares from trading at a material discount or premium from NAV.
6. With respect to Funds that hold non-U.S. Portfolio Instruments and that effect creations and redemptions of Creation Units in kind, applicants request relief from the requirement imposed by section 22(e) in order to allow such Funds to pay redemption proceeds within fifteen calendar days following the tender of Creation Units for redemption. Applicants assert that the requested relief would not be inconsistent with the spirit and intent of section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds.
7. Applicants request an exemption to permit Funds of Funds to acquire Fund shares beyond the limits of section 12(d)(1)(A) of the Act; and the Funds, and any principal underwriter for the Funds, and/or any broker or dealer registered under the Exchange Act, to sell shares to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act. The application's terms and conditions are designed to, among other things, help prevent any potential (i) undue influence over a Fund through control or voting power, or in connection with certain services, transactions, and underwritings, (ii) excessive layering of fees, and (iii) overly complex fund structures, which are the concerns underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
8. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act to permit a person who is an affiliated person, as defined in section 2(a)(3) of the Act (“Affiliated Person”), or an affiliated person of an Affiliated Person (“Second-Tier Affiliate”), of the Funds, solely by virtue of certain ownership interests, to effectuate purchases and redemptions in-kind. The deposit procedures for in-kind purchases of Creation Units and the redemption procedures for in-kind redemptions of Creation Units will be the same for all purchases and redemptions and Deposit Instruments and Redemption Instruments will be valued in the same manner as those Portfolio Instruments currently held by the Funds. Applicants also seek relief from the prohibitions on affiliated transactions in section 17(a) to permit a Fund to sell its shares to and redeem its shares from a Fund of Funds, and to engage in the accompanying in-kind transactions with the Fund of Funds.
9. Applicants also request relief to permit a Feeder Fund to acquire shares of another registered investment company managed by the Adviser having substantially the same investment objectives as the Feeder Fund (“Master Fund”) beyond the limitations in section 12(d)(1)(A) and permit the Master Fund, and any principal underwriter for the Master Fund, to sell shares of the Master Fund to the Feeder Fund beyond the limitations in section 12(d)(1)(B).
10. Section 6(c) of the Act permits the Commission to exempt any persons or transactions from any provision of the Act if such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors. Section 17(b) of the Act authorizes the Commission to grant an order permitting a transaction otherwise prohibited by section 17(a) if it finds that (a) the terms of the proposed transaction are fair and reasonable and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policies of each registered investment company involved; and (c) the proposed transaction is consistent with the general purposes of the Act.
For the Commission, by the Division of Investment Management, Under delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 17g-1, Form NRSRO and the Instructions to Form NRSRO contain certain recordkeeping and disclosure requirements for NRSROs. Currently,
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Background documentation for this information collection may be viewed at the following Web site:
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and 12(d)(1)(B) of the Act. The requested order would permit (a) index-based series of certain open-end management investment companies (“Funds”) to issue shares redeemable in large aggregations (“Creation Units”); (b) secondary market transactions in Fund shares to occur at negotiated market prices rather than at net asset value (“NAV”); (c) certain Funds to pay redemption proceeds, under certain circumstances, more than seven days after the tender of shares for redemption; (d) certain affiliated persons of a Fund to deposit securities into, and receive securities from, the Fund in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the Funds (“Funds of Funds”) to acquire shares of the Funds; (f) certain Funds (“Feeder Funds”) to create and redeem Creation Units in-kind in a master-feeder structure; and (g) certain Funds to issue Shares in less than Creation Unit size to investors participating in a distribution reinvestment program.
Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants: Devin F. Sullivan, Esq., Wells Fargo Funds Management, LLC, 45 Fremont Street, 26th Floor, San Francisco, CA 94105.
Laura L. Solomon, Senior Counsel, at (202) 551-6915, or Daniele Marchesani, Assistant Chief Counsel at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. Applicants request an order that would allow Funds to operate as index-based exchange traded funds (“ETFs”).
2. Each Fund will hold investment positions selected to correspond closely to the performance of an Underlying Index. In the case of Self-Indexing
3. Shares will be purchased and redeemed in Creation Units and generally on an in-kind basis, or issued in less than Creation Unit size to investors participating in a distribution reinvestment program. Except where the purchase or redemption will include cash under the limited circumstances specified in the application, purchasers will be required to purchase Creation Units by depositing specified instruments (“Deposit Instruments”), and shareholders redeeming their shares will receive specified instruments (“Redemption Instruments”). The Deposit Instruments and the Redemption Instruments will each correspond pro rata to the positions in the Fund's portfolio (including cash positions) except as specified in the application.
4. Because shares will not be individually redeemable, applicants request an exemption from Section 5(a)(1) and Section 2(a)(32) of the Act that would permit the Funds to register as open-end management investment companies and issue shares that are redeemable in Creation Units (other than pursuant to a dividend reinvestment program).
5. Applicants also request an exemption from section 22(d) of the Act and rule 22c-1 under the Act as secondary market trading in shares will take place at negotiated prices, not at a current offering price described in a Fund's prospectus, and not at a price based on NAV. Applicants state that (a) secondary market trading in shares does not involve a Fund as a party and will not result in dilution of an investment in shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants represent that share market prices will be disciplined by arbitrage opportunities, which should prevent shares from trading at a material discount or premium from NAV.
6. With respect to Funds that effect creations and redemptions of Creation Units in kind and that are based on certain Underlying Indexes that include foreign securities, applicants request relief from the requirement imposed by section 22(e) in order to allow such Funds to pay redemption proceeds within fifteen calendar days following the tender of Creation Units for redemption. Applicants assert that the requested relief would not be inconsistent with the spirit and intent of section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds.
7. Applicants request an exemption to permit Funds of Funds to acquire Fund shares beyond the limits of section 12(d)(1)(A) of the Act; and the Funds, and any principal underwriter for the Funds, and/or any broker or dealer registered under the Exchange Act, to sell shares to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act. The application's terms and conditions are designed to, among other things, help prevent any potential (i) undue influence over a Fund through control or voting power, or in connection with certain services, transactions, and underwritings, (ii) excessive layering of fees, and (iii) overly complex fund structures, which are the concerns underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
8. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act to permit persons that are Affiliated Persons, or Second Tier-Affiliates, of the Funds, solely by virtue of certain ownership interests, to effectuate purchases and redemptions in-kind. The deposit procedures for in-kind purchases of Creation Units and the redemption procedures for in-kind redemptions of Creation Units will be the same for all purchases and redemptions and Deposit Instrument and Redemption Instruments will be valued in the same manner as those investment positions currently held by the Funds. Applicants also seek relief from the prohibitions on affiliated transactions in section 17(a) to permit a Fund to sell its shares to and redeem its shares from a Fund of Funds, and to engage in the accompanying in-kind transactions with the Fund of Funds.
9. Applicants also request relief to permit a Feeder Fund to acquire shares of another registered investment company having substantially the same investment objectives as the Feeder Fund (“Master Fund”) beyond the limitations in section 12(d)(1)(A) and permit the Master Fund, and any principal underwriter for the Master Fund, to sell shares of the Master Fund to the Feeder Fund beyond the limitations in section 12(d)(1)(B).
10. Section 6(c) of the Act permits the Commission to exempt any persons or transactions from any provision of the Act if such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors. Section 17(b) of the Act authorizes the Commission to grant an order permitting a transaction otherwise prohibited by section 17(a) if it finds that (a) the terms of the proposed transaction are fair and reasonable and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policies of each registered investment company involved; and (c) the proposed transaction is consistent with the general purposes of the Act.
For the Commission, by the Division of Investment Management, under delegated authority.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of California dated 09/26/2017.
Issued on 09/26/2017.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 153265 and for economic injury is 153270.
The State which received an EIDL Declaration # is California.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of California dated 09/26/2017.
Issued on 09/26/2017.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 153285 and for economic injury is 153290.
The State which received an EIDL Declaration # is California.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, requires federal agencies to publish a notice in the
Submit comments on or before December 4, 2017.
Send all comments to Gina Beyer, Supervisory Administrative Specialist, Office of Disaster Assistance, Small Business Administration, 409 3rd Street, 6th Floor, Washington, DC 20416.
Gina Beyer, Supervisory Administrative
The Governor of the State U.S. territory or possession affected by a disaster submits this information collection to request that SBA issue a disaster declaration. The information identifies the time, place and nature of the incident and helps SBA to determine whether the regulatory criteria for a disaster declaration have been met, and disaster assistance can be made available to the affected region.
SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
60-Day notice and request for comments
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, requires federal agencies to publish a notice in the
Submit comments on or before December 4, 2017.
Send all comments to Susan Suckfiel, Supervisory Financial Analyst, Office of Financial Program Operations, Small Business Administration, 409 3rd Street, 6th Floor, Washington, DC 20416.
Susan Suckfiel, Supervisory Financial Analyst, Office of Financial Program Operations,
This information collection is provided by SBA lenders and borrowers to provide basic loan information and certifications regarding the disbursement of loan proceeds. SBA relies on this information during the guaranty purchase review process as a component in determining whether to honor a loan guaranty.
SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, requires federal agencies to publish a notice in the
Submit comments on or before December 4, 2017.
Send all comments to Lyn Womack, Chief, Fund Administration Branch Office of Investment, Small Business Administration, 409 3rd Street, 6th Floor, Washington, DC 20416.
Lyn Womack, Chief, Fund Administration Branch, Office of Investment,
Applicants for SBA-guaranteed commitment must complete these forms as part of the application process. SBA uses the information to make informed and proper credit decisions and to establish the SBIC's eligibility for leverage and need for funds.
SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
(1)
The Small Business Administration publishes an interest rate called the
Pursuant to 13 CFR 120.921(b), the maximum legal interest rate for any third party lender's commercial loan which funds any portion of the cost of a 504 project (see 13 CFR 120.801) shall be 6% over the New York Prime rate or, if that exceeds the maximum interest rate permitted by the constitution or laws of a given State, the maximum interest rate will be the rate permitted by the constitution or laws of the given State.
Saint Lawrence Seaway Development Corporation (SLSDC); DOT.
Notice of public meeting.
This notice announces the public meeting via conference call of the Saint Lawrence Seaway Development Corporation Advisory Board.
The public meeting will be held on (all times Central):
• Monday, October 30, 2017, from 2:00 p.m.-4:00 p.m.
The meeting will be held in person and via conference call at the Global Waters Center, 247 West Freshwater Way (Suite 529), Milwaukee, WI 53204.
Wayne Williams, Chief of Staff, Saint Lawrence Seaway Development Corporation, 1200 New Jersey Avenue SE., Washington, DC 20590; 202-366-0091
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463; 5 U.S.C. App. I), notice is hereby given of a meeting of the Advisory Board of the Saint Lawrence Seaway Development Corporation (SLSDC). The agenda for this meeting will be as follows:
Attendance at the meeting is open to the interested public but limited to the space available. With the approval of the Administrator, members of the public may present oral statements at the meeting. Persons wishing further information should contact the person listed in the
Office of the Secretary, Department of Transportation.
No FEAR Act Notice.
This Notice implements Title II of the Notification and Federal Employee Antidiscrimination and Retaliation Act of 2002 (No FEAR Act of 2002). It is the annual obligation for Federal agencies to notify all employees, former employees, and applicants for Federal employment of the rights and protections available to them under the Federal Anti-discrimination and Whistleblower Protection Laws.
Yvette Rivera, Associate Director of the Equity and Access Division (S-32), Departmental Office of Civil Rights, Office of the Secretary, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Room W78-306, Washington, DC 20590, 202-366-5131 or by email at
You may retrieve this document online through the Federal Document Management System at
On May 15, 2002, Congress enacted the “Notification and Federal Employee Antidiscrimination and Retaliation Act of 2002,” now recognized as the No FEAR Act (Pub. L. 107-174). One purpose of the Act is to “require that Federal agencies be accountable for violations of antidiscrimination and whistleblower protection laws.” (Pub. L. 107-174, Summary). In support of this purpose, Congress found that “agencies cannot be run effectively if those agencies practice or tolerate discrimination” (Pub. L. 107-174, Title I, General Provisions, section 101(1)). The Act also requires the United States Department of Transportation (USDOT) to provide this Notice to all USDOT employees, former USDOT employees, and applicants for USDOT employment. This Notice informs such individuals of the rights and protections available under Federal antidiscrimination and whistleblower protection laws.
A Federal agency cannot discriminate against an employee or applicant with respect to the terms, conditions, or privileges of employment because of race, color, religion, sex, national origin, age, disability, marital status, genetic information, or political affiliation. One or more of the following statutes prohibit discrimination on these bases: 5 U.S.C. 2302(b)(1), 29 U.S.C. 631, 29 U.S.C. 633a, 29 U.S.C. 206(d), 29 U.S.C. 791, 42 U.S.C. 2000e-16 and 2000ff.
If you believe you were a victim of unlawful discrimination on the bases of race, color, religion, sex, national origin, age, genetic information, and/or disability, you must contact an Equal Employment Opportunity (EEO) counselor within 45 calendar days of the alleged discriminatory action, or in the case of a personnel action, within 45 calendar days of the effective date of the action to try and resolve the matter informally. This must be done before filing a formal complaint of discrimination with USDOT (See,
If you are alleging discrimination based on marital status or political affiliation, you may file a written discrimination complaint with the U.S. Office of Special Counsel (OSC). Form OSC-11 is available online at the OSC Web site
If you are alleging compensation discrimination pursuant to the Equal Pay Act, and wish to pursue your allegations through the administrative process, you must contact an EEO counselor within 45 calendar days of the alleged discriminatory action as such complaints are processed under EEOC's regulations at 29 CFR part 1614. Alternatively, you may file a civil action in a court of competent jurisdiction within two years, or if the violation is willful, three years of the date of the alleged violation, regardless of whether you pursued any administrative complaint processing. The filing of a complaint or appeal pursuant to 29 CFR part 1614 shall not toll the time for filing a civil action.
A USDOT employee with authority to take, direct others to take, recommend, or approve any personnel action must not use that authority to take, or fail to take, or threaten to take, or fail to take a personnel action against an employee or applicant because of a disclosure of information by that individual that is reasonably believed to evidence violations of law, rule, or regulation; gross mismanagement; gross waste of funds; an abuse of authority; or a substantial and specific danger to public health or safety, unless the disclosure of such information is specifically prohibited by law and such information is specifically required by Executive Order to be kept secret in the interest of national defense or the conduct of foreign affairs.
Retaliation against a USDOT employee or applicant for making a protected disclosure is prohibited (5 U.S.C. 2302(b)(8)). If you believe you are a victim of whistleblower retaliation, you may file a written complaint with the U.S. Office of Special Counsel at 1730 M Street NW., Suite 218, Washington, DC 20036-4505 using Form OSC-11. Alternatively, you may file online through the OSC Web site at
Under existing laws, USDOT retains the right, where appropriate, to discipline a USDOT employee who engages in conduct that is inconsistent with Federal Antidiscrimination and Whistleblower Protection laws up to and including removal from Federal service. If OSC initiates an investigation under 5 U.S.C. 1214, USDOT must seek approval from the Special Counsel to discipline employees for, among other activities, engaging in prohibited retaliation (5 U.S.C. 1214). Nothing in the No FEAR Act alters existing laws, or permits an agency to take unfounded disciplinary action against a USDOT employee, or to violate the procedural rights of a USDOT employee accused of discrimination.
For more information regarding the No FEAR Act regulations, refer to 5 CFR part 724, as well as the appropriate office(s) within your agency (
Pursuant to section 205 of the No FEAR Act, neither the Act nor this notice creates, expands, or reduces any rights otherwise available to any employee, former employee, or applicant under the laws of the United States, including the provisions of law specified in 5 U.S.C. 2302(d).
| 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 |