| Page Range | 17477-17613 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 17536 - Request for Comments on Determining Whether a Claim Element Is Well-Understood, Routine, Conventional for Purposes of Subject Matter Eligibility | |
| 83 FR 17561 - Renewal of the Generalized System of Preferences (GSP) and Retroactive Application for Certain Liquidations and Reliquidations Under the GSP | |
| 83 FR 17590 - Announcement of Requirements for the Secretary of Transportation's RAISE (Recognizing Aviation and Aerospace Innovation in Science and Engineering) Awards | |
| 83 FR 17586 - Office of Commercial Space Transportation: Notice of Availability, Notice of Public Comment Period, Notice of Public Meeting, and Request for Comment on the Draft Programmatic Environmental Assessment for Front Range Airport Launch Site Operator License, Spaceport Colorado | |
| 83 FR 17587 - Membership in the National Parks Overflights Advisory Group | |
| 83 FR 17532 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting | |
| 83 FR 17534 - Pacific Fishery Management Council; Public Meeting | |
| 83 FR 17534 - South Atlantic Fishery Management Council; Public Meetings | |
| 83 FR 17535 - South Atlantic Fishery Management Council; Public Meetings | |
| 83 FR 17577 - Order Making Fiscal Year 2018 Annual Adjustments to Transaction Fee Rates | |
| 83 FR 17575 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Instituting Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Changes Related to ICEEU's Recovery and Wind-Down Plans | |
| 83 FR 17585 - Hennepin County Regional Railroad Authority-Acquisition Exemption-in Hennepin County, Minn | |
| 83 FR 17526 - Developing an Update to the National Space Weather Strategy | |
| 83 FR 17583 - Reporting and Recordkeeping Requirements Under OMB Review | |
| 83 FR 17552 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Shipbuilding and Ship Repair Facilities-Surface Coating (Renewal) | |
| 83 FR 17553 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Marine Tank Vessel Loading Operations (Renewal) | |
| 83 FR 17549 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Calciners and Dryers in Mineral Industries (Renewal) | |
| 83 FR 17583 - Information Collection; Subcontractor Past Performance Pilot Program | |
| 83 FR 17555 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 83 FR 17573 - Notice of Extension To Comment Period on the Request for Information on Improving the Military Selective Service Process and Increasing Participation in Military, National, and Public Service | |
| 83 FR 17535 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meeting | |
| 83 FR 17533 - South Atlantic Fishery Management Council; Public Hearings | |
| 83 FR 17554 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 83 FR 17513 - Safety and Security Zones; New York Marine Inspection and Captain of the Port Zone | |
| 83 FR 17539 - Procurement List; Additions and Deletions | |
| 83 FR 17538 - Procurement List; Proposed Additions and Deletions | |
| 83 FR 17493 - Safety Zone; Annual Events Requiring Safety Zones in the Captain of the Port Lake Michigan Zone-Rockets for Schools Rocket Launch, Sheboygan Harbor, Sheboygan, WI | |
| 83 FR 17498 - Bacillus subtilis | |
| 83 FR 17494 - Safety Zone; Annual Events Requiring Safety Zones in the Captain of the Port Lake Michigan Zone-Tulip Time Festival Fireworks | |
| 83 FR 17573 - Meeting of the Advisory Committee on Presidential Library-Foundation Partnerships | |
| 83 FR 17489 - Special Local Regulation; Pensacola Bay, Pensacola, FL | |
| 83 FR 17560 - Cooperative Research and Development Agreement: Safe Parameters for Ice Operations | |
| 83 FR 17496 - Bacillus Licheniformis | |
| 83 FR 17546 - Carolina Solar Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 83 FR 17548 - Notice of Effectiveness of Exempt Wholesale Generator Status | |
| 83 FR 17548 - Combined Notice of Filings #1 | |
| 83 FR 17521 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Longan From Taiwan | |
| 83 FR 17520 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Clementines from Spain | |
| 83 FR 17562 - Notice of Intent To Prepare an Environmental Impact Statement for the Coastal Plain Oil and Gas Leasing Program, Alaska | |
| 83 FR 17521 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Fresh Pitaya Fruit From Central America into the Continental United States | |
| 83 FR 17564 - Notice of Public Meeting, BLM Alaska Resource Advisory Council | |
| 83 FR 17563 - National Call for Nominations for Resource and Monument Advisory Councils | |
| 83 FR 17522 - Notice of Solicitation of Applications for the Repowering Assistance Program | |
| 83 FR 17585 - Notice of Change of Ownership of Permit Holder of Presidential Permit for Detroit River Crossing Pipeline Facilities on the Border of the United States and Canada | |
| 83 FR 17584 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Chaim Soutine: Flesh” Exhibition | |
| 83 FR 17585 - Notice of Determinations: Culturally Significant Objects Imported for Exhibition Determinations: “Renoir: Father and Son/Painting and Cinema” Exhibition | |
| 83 FR 17584 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “René Magritte: The Fifth Season” Exhibition | |
| 83 FR 17540 - Proposals by Non-Federal Interests, for Feasibility Studies and for Modifications to an Authorized Water Resources Development Project or Feasibility Study, for Inclusion in the Annual Report to Congress on Future Water Resources Development | |
| 83 FR 17541 - Intent To Prepare a Draft Environmental Impact Statement for the Dam Safety Modification Study Report for Center Hill Dam, DeKalb County, Tennessee | |
| 83 FR 17529 - Stainless Steel Bar From India: Final Results of Changed Circumstances Review and Reinstatement of Certain Companies in the Antidumping Duty Order | |
| 83 FR 17527 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016 | |
| 83 FR 17574 - New Postal Products | |
| 83 FR 17542 - Melvin R. Sampson Hatchery, Yakima Basin Coho Project | |
| 83 FR 17545 - Proposed Subsequent Arrangement | |
| 83 FR 17494 - Safety Zone for Fireworks Display; Patapsco River, Inner Harbor, Baltimore, MD | |
| 83 FR 17516 - Proposed Waiver-Migrant Education Program Consortium Incentive Grant Program | |
| 83 FR 17486 - Schedules of Controlled Substances: Placement of Butyryl Fentanyl and U-47700 Into Schedule I | |
| 83 FR 17525 - Notice of Public Meeting of the Alaska Advisory Committee | |
| 83 FR 17558 - National Advisory Committee on Children and Disasters Public Teleconference | |
| 83 FR 17488 - Service of Process; Production or Disclosure of Official Information in Response to Court Orders, Subpoenas, Notices of Depositions, Requests for Admissions, Interrogatories, or Similar Requests or Demands in Connection With Federal or State Litigation; Expert Testimony | |
| 83 FR 17567 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Permissible Equipment Testing | |
| 83 FR 17566 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Family and Medical Leave Act of 1993, as Amended | |
| 83 FR 17588 - Fifty-Seventh RTCA SC-224 Standards for Airport Security Access Control Systems Plenary | |
| 83 FR 17549 - Environmental Impact Statements; Notice of Availability | |
| 83 FR 17531 - Proposed Information Collection; Comment Request; National Minority Business Awards | |
| 83 FR 17532 - Proposed Information Collection; Comment Request; NIST Center for Neutron Research (NCNR) Information Management System Collection | |
| 83 FR 17549 - Notice of Request for Waiver; UGI Sunbury, LLC | |
| 83 FR 17547 - Notice of Application Ready for Environmental Analysis and Soliciting Comments, Recommendations, Terms and Conditions, and Prescriptions; Goodyear Lake Hydro, LLC | |
| 83 FR 17548 - Notice of Availability of Final Environmental Assessment; PacifiCorp | |
| 83 FR 17565 - Certain UV Curable Coatings for Optical Fibers, Coated Optical Fibers, and Products Containing Same; Notice of Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Extension of Target Date | |
| 83 FR 17509 - Rulemaking Petition: Former Candidates' Personal Use; Correction | |
| 83 FR 17557 - National Advisory Council on Nurse Education and Practice | |
| 83 FR 17525 - Agenda and Notice of Public Meeting of the New Jersey Advisory Committee | |
| 83 FR 17524 - Agenda and Notice of Public Meeting of the Delaware Advisory Committee | |
| 83 FR 17492 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Palm Beach, FL | |
| 83 FR 17492 - Drawbridge Operation Regulation; Willamette River, Portland, OR | |
| 83 FR 17493 - Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WA | |
| 83 FR 17518 - Overweight Items | |
| 83 FR 17568 - Underwriters Laboratories, Inc.: Applications for Expansion of Recognition and Proposed Modification To Update the Nationally Recognized Testing Laboratory (NRTL) Program's List of Appropriate Test Standards | |
| 83 FR 17571 - Modification to the List of Appropriate NRTL Program Test Standards and the Scopes of Recognition of Several NRTLs | |
| 83 FR 17574 - New Postal Product | |
| 83 FR 17556 - Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability | |
| 83 FR 17503 - Importation of Fresh Cape Gooseberry Fruit From Ecuador to the Continental United States | |
| 83 FR 17501 - Importation of Peppers From the Republic of Korea; Mesh Screening Size | |
| 83 FR 17506 - Almonds Grown in California; Adjusted Kernel Weight Computation | |
| 83 FR 17477 - Regulation Q; Regulatory Capital Rules; Correction | |
| 83 FR 17533 - Submission for OMB Review; Comment Request | |
| 83 FR 17588 - Petition for Exemption; Summary of Petition Received; Haverfield International Incorporated | |
| 83 FR 17559 - Government-Owned Inventions; Availability for Licensing | |
| 83 FR 17558 - Proposed Collection; 60-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form, National Institute of Mental Health | |
| 83 FR 17546 - DOE/NSF High Energy Physics Advisory Panel | |
| 83 FR 17566 - Notice of Lodging of Proposed Consent Decree | |
| 83 FR 17595 - Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period | |
| 83 FR 17481 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
| 83 FR 17483 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
| 83 FR 17589 - Notice of Final Federal Agency Actions on Proposed Highway in Washington | |
| 83 FR 17510 - Airworthiness Directives; Airbus Helicopters Deutschland GmbH Helicopters | |
| 83 FR 17480 - Revocation of Class E Airspace; Seven Springs, PA, and Amendment of Class E Airspace; Somerset, PA | |
| 83 FR 17512 - Proposed Amendment of Class E Airspace; New Castle, IN | |
| 83 FR 17478 - Airworthiness Directives; DG Flugzeugbau GmbH Gliders | |
| 83 FR 17550 - Notice of Availability of the Deepwater Horizon Oil Spill Louisiana Trustee Implementation Group Draft Restoration Plan and Environmental Assessment #4: Nutrient Reduction (Nonpoint Source) and Recreational Use |
Agricultural Marketing Service
Animal and Plant Health Inspection Service
Rural Business-Cooperative Service
International Trade Administration
Minority Business Development Agency
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Engineers Corps
Bonneville Power Administration
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Land Management Bureau
Drug Enforcement Administration
Occupational Safety and Health Administration
Federal Aviation Administration
Federal Highway Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Board of Governors of the Federal Reserve System.
Final rule; correcting amendments.
The Board of Governors of the Federal Reserve System (Board) published a final rule in the
This final rule is effective April 20, 2018.
Benjamin McDonough, Assistant General Counsel, (202) 452-2036, David Alexander, Counsel, (202) 452-2877, or Mark Buresh, Senior Attorney, (202) 452-5270, Legal Division, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551. For the hearing impaired, Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869.
The Board is correcting the unintended deletion of certain provisions of the regulatory capital rule originally published in the
Administrative practice and procedure, Banks, Banking, Holding companies, Reporting and recordkeeping requirements, Securities.
For the reasons set forth in the preamble, chapter II of title 12 of the Code of Federal Regulations is amended by making the following correcting amendments:
12 U.S.C. 248(a), 321-338a, 481-486, 1462a, 1467a, 1818, 1828, 1831n, 1831o, 1831p-l, 1831w, 1835, 1844(b), 1851, 3904, 3906-3909, 4808, 5365, 5368, 5371.
(a) * * *
(4) * * *
(iv)
(v)
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 2017-08-09 for DG Flugzeugbau GmbH Model DG-500MB gliders that are equipped with a Solo 2625 02 engine modified with a fuel injection system following the instructions of Solo Kleinmotoren GmbH Technische Mitteilung Nr. 4600-3 and identified as Solo 2625 02i. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as the potential of an in-flight shut-down and engine fire due to failure of the connecting stud for the two fuel injector mounts of the engine redundancy system on gliders equipped with a Solo 2625 02i engine. We are issuing this AD to add a model to the applicability and require actions to address the unsafe condition on these products.
This AD is effective May 25, 2018.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of May 26, 2017 (82 FR 18694, April 21, 2017).
You may examine the AD docket on the internet at
For service information identified in this AD, contact Solo Kleinmotoren GmbH, Postfach 600152, 71050 Sindelfingen, Germany; telephone: +49 703 1301-0; fax: +49 703 1301-136; email:
Jim Rutherford, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to DG Flugzeugbau GmbH Models DG-500MB and DG-1000M airplanes. That NPRM was published in the
The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. You may examine the MCAI on the internet at:
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed Solo Kleinmotoren GmbH issued Technische Mitteilung Nr. (English translation: Service Bulletin No.) 4600-5, Ausgabe 2 (English translation: Issue 2), dated December 12, 2014, approved for incorporation by reference on May 26, 2017 (82 FR 18694; April 21, 2017). The service information describes procedures for changing the fuel injector mounts for the engine redundancy system and securing of the connection of the lower to the upper engine mount. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We also reviewed Solo Kleinmotoren GmbH Technische Mitteilung Nr. (English translation: Service Bulletin No.) 4600-3, Ausgabe 3 (English translation: Issue 3), dated December 18, 2014, and the earlier versions. The service information describes procedures for modifying the engine Solo 2625 02 from the version with carburetors to the version with electronic engine management for fuel injection and ingnition.
We estimate that this AD will affect 6 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $67 per product.
Based on these figures, we estimate the cost of this AD on U.S. operators to be $912, or $152 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, and domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You may examine the AD docket on the internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) becomes effective May 25, 2018.
This AD replaces AD 2017-08-09, Amendment 39-18858 (82 FR 18694; April 21, 2017) (“AD 2017-08-09”).
This AD applies to DG Flugzeugbau GmbH DG-500MB and DG-1000M gliders, all serial numbers, certificated in any category, that are:
(1) Equipped with a Solo 2625 02 engine modified with a fuel injection system following the instructions of Solo Kleinmotoren GmbH Technische Mitteilung Nr. (English translation: Service Bulletin No.) 4600-3 and identified as Solo 2625 02i; or
(2) equipped with a Solo 2625 02i engine at manufacture.
Air Transport Association of America (ATA) Code 72: Engine.
This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and address an unsafe condition on an aviation product. The MCAI describes the unsafe condition as the potential of an in-flight shut-down and engine fire resulting in loss of control due to failure of the connecting stud for the two fuel injector mounts of the engine redundancy system on gliders equipped with a Solo 2625 02i engine. We are issuing this AD to prevent such failure that could lead to the potential of an in-flight shut-down and engine fire and result in loss of control.
Unless already done, do the following actions in paragraphs (f)(1) through (3) of this AD following Solo Kleinmotoren GmbH Technische Mitteilung Nr. (English translation: Service Bulletin No.), 4600-5, Ausgabe 2 (English translation: Issue 2), dated December 12, 2014.
(1)
(2)
(3)
This service information contains German to English translation. The EASA used the English translation in referencing the document. For enforceability purposes, we will refer to the Solo Kleinmotoren service information as it appears on the document.
This AD allows credit for modification of the engine redundancy system as required in paragraph (f)(1) of this AD if done before May 26, 2017 (the effective date of AD 2017-08-09) and allows credit for modification of the engine redundancy system as required in paragraph (f)(2) of this AD if done before May 25, 2018 (the effective date of this AD) following Solo Kleinmotoren GmbH Technische Mitteilung (English translation: Service Bulletin), Nr. 4600-5, Ausgabe 1 (English translation: Issue 1), dated November 24, 2014.
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI European Aviation Safety Agency (EASA) AD No.: 2014-0269, dated December 11, 2014, for related information. You may examine the MCAI on the internet at:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(3) The following service information was approved for IBR on May 26, 2017 (82 FR 18694; April 21, 2017).
(i) Solo Kleinmotoren GmbH Technische Mitteilung (English translation: Service Bulletin), Nr. 4600-5, Ausgabe 2 (English translation: Issue 2), dated December 12, 2014.
(ii) Reserved.
(4) For service information related to this AD, contact Solo Kleinmotoren GmbH, Postfach 600152, 71050 Sindelfingen, Germany; telephone: +49 703 1301-0; fax: +49 703 1301-136; email:
(5) You may view this service information at FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call 816-329-4148. In addition, you can access this service information on the internet at
(6) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
This action removes Class E airspace at Seven Springs, PA, as Seven Springs Borough Airport has been abandoned, and controlled airspace is no longer required. This action also removes reference to the Seven Springs, PA, Class E airspace area from the Somerset County Airport, Somerset, PA, description, and updates the geographic coordinates of Somerset County Airport to coincide with the FAA's aeronautical database. This action enhances the safety and management of controlled airspace within the national airspace system.
Effective 0901 UTC, July 19, 2018. 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, 1701 Columbia Avenue, College Park, GA 30337; 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 supports the removal of Class E airspace extending upward from 700 feet above the surface at Seven Springs Borough Airport, Seven Springs, PA, as the airport has closed, and amends the airspace at Somerset County Airport, Somerset, PA, in support of instrument flight rules operations.
The FAA published a notice of proposed rulemaking in the
Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.
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 removing Class E airspace extending upward from 700 feet or more above the surface at Seven Springs Borough Airport, Seven Springs, PA, as the airport has been abandoned. Therefore, the airspace is no longer necessary. Also, this action removes the words “excluding that portion that coincides with the Seven Springs, PA, Class E airspace area” from the regulatory text In Class E airspace extending upward from 700 feet above the surface for Somerset County Airport, Somerset, PA, and updates the geographic coordinates of Somerset County Airport, to be in concert with the FAA's aeronautical database.
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 Federal Aviation Administration 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 6.4-mile radius of Somerset County Airport, and within 3.1 miles each side of the 058° bearing from the Stoystown NDB extending from the 6.4-mile radius to 9.6 miles northeast of the NDB, and 4 miles each side of the 236° bearing from the Somerset County Airport extending from the 6.4-mile radius to 9.5 miles southwest of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the
This rule is effective April 20, 2018. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of April 20, 2018.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC, 20590-0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125), Telephone: (405) 954-4164.
This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C 553(d), good cause exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective April 20, 2018. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of April 20, 2018.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169, or
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420) Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125) telephone: (405) 954-4164.
This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air Traffic Control, Airports, Incorporation by reference, Navigation (Air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Drug Enforcement Administration, Department of Justice.
Final order.
With the issuance of this final order, the Administrator of the Drug Enforcement Administration maintains the placement of the substances butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylbutanamide) and U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide), including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, butyryl fentanyl and U-47700.
Effective April 20, 2018.
Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Section 201(d)(1) of the Controlled Substances Act (CSA) (21 U.S.C. 811(d)(1)) states that, if control of a substance is required “by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by section 201 (a) (21 U.S.C. 811 (a) or section 202(b) (21 U.S.C. 812(b)) of the Act and without regard to the procedures prescribed by section 201 (a) and (b) (21 U.S.C. 811(a) and (b).” If a substance is added to one of the schedules of the Single Convention on Narcotic Drugs (1961), then, in accordance with article 3, paragraph 7 of the Convention, as a signatory Member State, the United States is obligated to control the substance under its national drug control legislation, the CSA. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the Drug Enforcement Administration (DEA) (Administrator). 28 CFR 0.100.
On April 21, 2017, the Secretary-General of the United Nations advised the Secretary of State of the United States, that during the 60th session of the Commission on Narcotic Drugs, butyryl fentanyl and U-47700 were added to schedule I of the Single Convention on Narcotic Drugs, 1961. This letter was prompted by a decision at the 60th session of the Commission on Narcotic Drugs in March 2017 to schedule butyryl fentanyl and U-47700 under schedule I of the Single Convention on Narcotic Drugs. As a signatory Member State to the Single Convention on Narcotic Drugs, the United States is obligated to control butyryl fentanyl and U-47700 under its national drug control legislation, the CSA, in the schedule deemed most appropriate to carry out its international obligations. 21 U.S.C. 811(d)(1).
On May 12, 2016, and November 14, 2016, butyryl fentanyl and U-47700, respectively, were temporarily placed in schedule I of the CSA by the Administrator in order to avoid an imminent hazard to the public safety ((81 FR 29492-butyryl fentanyl) and (81 FR 79389-U-47700)). Butyryl fentanyl and U-47700 share a pharmacological profile similar to fentanyl, morphine, and other synthetic opioids. Law enforcement and public health reports demonstrate the illicit use and distribution of these substances, which are available on the internet. Both butyryl fentanyl and U-47700 are abused for their opioid-like effects. Evidence suggests the pattern of abuse of butyryl fentanyl and U-47700 parallels that of heroin and prescription opioid analgesics. Because both butyryl fentanyl and U-47700 can be obtained through illicit sources, information on their purity and potency is often unknown, thus posing significant adverse health risks to the users.
Similar to morphine and fentanyl, both butyryl fentanyl and U-47700 act as µ-opioid receptor agonists. Data obtained from preclinical studies (
Since 2014, butyryl fentanyl has been associated with numerous incidences of adverse health effects in humans. The DEA is aware of at least 40 confirmed fatalities associated with the misuse and/or abuse of butyryl fentanyl in the United States. Similarly, U-47700 has been associated with numerous cases of overdoses and overdose deaths.
The DEA is not aware of any claims or any medical or scientific literature suggesting that butyryl fentanyl and U-47700 have a currently accepted medical use in treatment in the United States. In addition, HHS advised the DEA, by letters dated January 13, 2016, and April 28, 2016, that there were no investigational new drug applications or approved new drug applications for butyryl fentanyl and U-47700.
By letters dated December 8, 2016, and March 1, 2017, the DEA requested that HHS conduct a scientific and medical evaluation of and a scheduling recommendation for butyryl fentanyl and U-47700, respectively. The DEA is not required under 21 U.S.C. 811(d)(1) to make any findings required by 21 U.S.C. 811(a) or 812(b), and is not required to follow the procedures prescribed by 21 U.S.C. 811(a) and (b). By letter dated November 1, 2017, the Acting Administrator advised HHS that the DEA no longer requires scientific and medical evaluations and scheduling recommendations for butyryl fentanyl and U-47700. Therefore, consistent with the framework of 21 U.S.C. 811(d), the DEA concludes that butyryl fentanyl and U-47700 have no currently accepted medical use in treatment in the United States and are most appropriately placed (as they have been since May 2016 and November 2016, respectively) in schedule I of the CSA. Further, while the DEA temporarily scheduled these substances under 21 CFR 1308.11(h), a subsection reserved for the temporary listing of substances subject to emergency scheduling, this order moves both substances to 21 CFR 1308.11(b). As explained above, since control is required under the Single Convention on Narcotic Drugs (1961), the DEA will not be initiating regular rulemaking proceedings to schedule these substances pursuant to 21 U.S.C. 811(a).
In order to meet the United States' obligations under the Single Convention on Narcotic Drugs (1961), and because butyryl fentanyl and U-47700 have no currently accepted medical use in treatment in the United States, the Administrator has determined that these substances should remain in schedule I of the CSA.
Butyryl fentanyl and U-47700 have been controlled as schedule I controlled substances since May 12, 2016, and November 14, 2016, respectively. With publication of this final order, butyryl fentanyl and U-47700 remain subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, engagement in research, and conduct of instructional activities with, and possession of schedule I controlled substances including the following:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
This action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB).
This action does not have federalism implications warranting the application of Executive Order 13132. This action does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications warranting the application of Executive Order 13175. The action does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
The CSA provides for an expedited scheduling action where control is required by the United States obligations under international treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is required pursuant to such international treaty, convention, or protocol, the Attorney General must issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings or procedures otherwise required for scheduling actions.
To the extent that 21 U.S.C. 811(d)(1) directs that if control is required by the United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, scheduling actions shall be issued by order (as compared to scheduling pursuant to 21 U.S.C. 811(a) by rule), the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this scheduling action. In the alternative, even if this action does constitute “rule making” under 5 U.S.C. 551(5), this action is exempt from the notice and comment requirements of 5 U.S.C. 553 pursuant to 21 U.S.C. 553(a)(1) as an action involving a foreign affairs function of the United States given that this action is being done in accordance with 21 U.S.C. 811(d)(1)'s requirement that the United States comply with its obligations under the specified international agreements.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA or any other law. As explained above, the CSA exempts this final order from notice and comment. Consequently, the RFA does not apply to this action.
This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
This action is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This order will not result in: “an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.” However, pursuant to the CRA, the DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, the DEA amends 21 CFR part 1308 as follows:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
The additions read as follows:
(b) * * *
Department of State.
Final rule.
The Department of State corrects erroneous citations and typographical errors within part 172 by correcting or removing them.
This rule is effective on May 21, 2018.
Alice Kottmyer, Attorney-Adviser, 202-647-2318,
Section 172 of Title 22, Code of Federal Regulations, describes procedures for the public to follow to request testimony or production of documents for litigation (so-called “
In this rulemaking, the Department is replacing the reference to Executive Order 12356 in the first sentence of § 172.1(e) to instead reference Executive Order 13526 (75 FR 707), the most recent executive order relating to classified national security information. Executive Order 12356 was revoked by Executive Order 12958, which in turn was revoked by Executive Order 13526.
The Department also corrects a typographical error in § 172.2(c) so that the first sentence references § 172.3(c) instead of § 173.3(c). Section 173.3(c) has no connection to service of process, whereas § 172.3(c) relates directly to service of process.
The Department deletes the following sentence in § 172.5(a): “Where documents or other materials are sought, the party should provide a description using the types of identifying information suggested in 22 CFR 171.10(a) and 171.31.” The two citations are not valid, and are likely artifacts from Part 172 as it existed in the past. The Department does not believe it is necessary to provide alternative citations. First, there are no analogs in the current regulation for the old §§ 171.10(a) or 171.31. Second, since the sentence immediately preceding the eliminated sentence calls
In § 172.5(c), the Department replaces the reference to “§ 172.2” to refer instead to § 172.4, which is the proper section about the Department officials designated to render such decisions.
The Department changes “Respectively” to “Respectfully” in § 172.6(a)(4), so that the sentence makes more sense and also conforms with the wording of § 172.6(b), which uses “respectfully” in a similar manner.
Finally, the Department corrects an office symbol in § 172.2.
The Department of State is publishing this rulemaking as a final rule, pursuant to 5 U.S.C. 553(b). This rulemaking is a rule of agency organization, procedure, or practice. The effective date of the rule is 30 days after publication, as provided in the Administrative Procedure Act.
The Department further finds that this is not a major rule; is not subject to the Unfunded Mandates Reform Act of 1995; will not have tribal implications as defined by Executive Order 13175; and will not have an impact on a substantial number of small entities under the Regulatory Flexibility Act. This rule is not an economically significant rule under Executive Order 12866, and the Department certifies that the benefits of this rulemaking outweigh any costs, which are minimal for the public. The Office of Information and Regulatory Affairs has designated this rule as “non-significant” as defined by Executive Order 12866. This rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.
The Department of State has reviewed this rule in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden. This rule will not have substantial direct effect on the states, on the relationships between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The rulemaking does not impose any new information collections subject to the Paperwork Reduction Act.
Administrative practice and procedure, Courts, Government employees.
For the reasons set forth in the preamble, 22 CFR part 172 is amended as follows:
5 U.S.C. 301; 8 U.S.C. 1202(f); 22 U.S.C. 2651a, 2664, 3926.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary special local regulation on Pensacola Bay in Pensacola, FL. This action is necessary to protect the persons participating in the Pensacola Triathlon marine event. This regulation restricts transit into, through, and within the regulated area unless authorized by the Captain of the Port Sector Mobile (COTP) or a designated representative.
This rule is effective from 4 a.m. through 10 a.m. April 29, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LT Kyle D. Berry, Sector Mobile, Waterways Management Division, U.S. Coast Guard; telephone 251-441-5940, email
On January 16, 2018, the Pensacola Triathlon notified the Coast Guard that it would be conducting the swim portion of the race in the vicinity of the Vince J. Whibbs Sr. Community Maritime Park in Pensacola, FL. In response, on March 6, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Special Local Regulation; Pensacola Bay, Pensacola, FL (83 FR 9454). There we stated why we issued the NPRM, and invited
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. 1233. The Captain of the Port Sector Mobile (COTP) has determined that potential hazards associated with the Pensacola Triathlon marine event on April 29, 2018 will be a safety concern for any vessels or persons within 300 yards of the Pensacola Triathlon. The purpose of this rule is to protect participants, spectators, and other persons and vessels during the Triathlon event on navigable waters.
As noted above, we received four comments on our NPRM published on March 6, 2018. Two of the four commenters supported the rulemaking. Another commenter opposed regulatory action generally without making remarks specific to this rulemaking, and the last comment was not related to the subject matter of this rulemaking at all. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.
This rule establishes temporary special local regulation from 4 a.m. through 10 a.m. on April 29, 2018. The regulated area will cover a 300 yard radius from position 30°24′16.4″ N, 87°12′55.2″ W in Pensacola Bay, Pensacola, FL. The duration of this special local regulation is intended to ensure the safety of vessels and persons before, during, and after the Pensacola Triathlon marine event. No vessel or person is permitted to enter the regulated area without obtaining permission from the COTP or a designated representative. A designated representative may be a Patrol Commander (PATCOM). The PATCOM may be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Patrol Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign “PATCOM”. All persons and vessels not registered with the sponsor as participants or official patrol vessels are considered spectators. The “official patrol vessels” consist of any Coast Guard, state, or local law enforcement and sponsor provided vessels assigned or approved by the COTP to patrol the regulated area.
Spectator vessels desiring to transit the regulated area may do so only with prior approval of the COTP or a designated representative and when so directed by that officer shall be operated at a minimum safe navigation speed in a manner that will not endanger participants in the regulated area or any other vessels. No spectator vessel shall anchor, block, loiter, or impede the through transit of participants or official patrol vessels in the regulated area during the effective dates and times, unless cleared for entry by or through an official patrol vessel. Any spectator vessel may anchor outside the regulated area, but may not anchor in, block, or loiter in a navigable channel. Spectator vessels may be moored to a waterfront facility within the regulated area in such a way that they shall not interfere with the progress of the event. Such mooring must be complete at least 30 minutes prior to the establishment of the regulated area and remain moored through the duration of the event.
The COTP or a designated representative may forbid and control the movement of all vessels in the regulated area. When hailed or signaled by an official patrol vessel, a vessel shall come to an immediate stop and comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.
The COTP or a designated representative may terminate the event or the operation of any vessel at any time it is deemed necessary for the protection of life or property. The COTP or a designated representative can terminate enforcement of the special local regulations at the conclusion of the event.
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.
This regulatory action determination is based on size, location, and duration of the special local regulation. The regulated area is a small area of Pensacola Bay extending in a 300 yard radius from position 30°24′16.4″ N, 87°12′55.2″ W, lasting only 6 hours on one day. Additionally, the Coast Guard will issue Broadcast Notices to Mariners (BNMs) via VHF-FM marine channel 16 about the regulation so that waterway users may plan accordingly for transits during this restriction. The rule also allows vessels to seek permission from the COTP or a designated representative to enter the regulated 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 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 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
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, 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 special local regulation on Pensacola Bay extending in a 300 yard radius from position 30°24′16.4″ N, 87°12′55.2″ W in Pensacola, FL. It is categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. 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
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; 33 CFR 1.05-1.
(a)
(b)
(c)
(2) All persons and vessels not registered with the sponsor as participants or official patrol vessels are considered spectators. The “official patrol vessels” consist of any Coast Guard, state, or local law enforcement and sponsor provided vessels assigned or approved by the COTP to patrol the regulated area.
(3) Spectator vessels desiring to transit the regulated area may do so only with prior approval of the COTP or a designated representative and when so directed by that officer will be operated at a minimum safe navigation speed in a manner which will not endanger participants in the regulated area or any other vessels.
(4) No spectator vessel shall anchor, block, loiter, or impede the through transit of participants or official patrol vessels in the regulated area during the effective dates and times, unless cleared for entry by or through an official patrol vessel.
(5) Any spectator vessel may anchor outside the regulated area, but may not anchor in, block, or loiter in a navigable channel. Spectator vessels may be moored to a waterfront facility within the regulated area in such a way that they shall not interfere with the progress of the event. Such mooring must be complete at least 30 minutes prior to the establishment of the regulated area and remain moored through the duration of the event.
(6) The COTP or a designated representative may forbid and control the movement of all vessels in the regulated area. When hailed or signaled by an official patrol vessel, a vessel shall come to an immediate stop and comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.
(7) The COTP or a designated representative may terminate the event or the operation of any vessel at any time it is deemed necessary for the protection of life or property.
(8) The COTP or a designated representative will terminate enforcement of the special local regulations at the conclusion of the event.
(d)
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Southern Boulevard (SR 700/80) Bridge across the Atlantic Intracoastal Waterway, mile 1024.7, at Palm Beach, FL. The deviation is necessary to accommodate the installation of a temporary lift bridge. This deviation allows the bridge to remain closed to navigation with openings when advanced notice is given during the temporary lift bridge installation.
This deviation is effective without actual notice from April 20, 2018 through 6 p.m. on April 30, 2018. For the purposes of enforcement, actual notice will be used from 7 a.m. on April 10, 2018, until April 20, 2018.
The docket for this deviation, USCG-2018-0342 is available at
If you have questions on this temporary deviation, call or email LT Ruth Sadowitz, U.S. Coast Guard Sector Miami, Waterways Management Division; telephone 305-535-4307, email
Johnson Bros. Corporation, on behalf of the bridge owner, Florida Department of Transportation, has requested a temporary deviation from the current operating regulation that governs the Southern Boulevard (SR 700/80) Bridge across the Atlantic Intracoastal Waterway, mile 1024.7, at Palm Beach, FL. The deviation is necessary to facilitate the installation of a temporary lift bridge adjacent to the existing bascule bridge, which will be used during the bridge replacement of the Southern Boulevard Bridge. The existing bridge is a double-leaf bascule bridge with a vertical clearance of 14 feet at mean high water in the closed to navigation position. The temporary lift bridge will have a vertical clearance of 14 feet in the closed position and 65 feet in the lifted position at mean high water.
The existing bridge operating regulation is set out in 33 CFR 117.261(w). Under this temporary deviation, the bridge will remain in the closed to navigation position from 7 a.m. on April 10, 2018 through 6 p.m. on April 16, 2018. From 6:01 p.m. on April 16, 2018 through 6 p.m. on April 30, 2018, both the existing bascule bridge and the temporary lift bridge will open with a four (4) hour advanced notice to the bridge tender. The vertical clearance will be reduced to 65 feet until the completion of the bridge replacement project.
The Atlantic Intracoastal Waterway is used by a variety of vessels including U.S. government vessels, small commercial vessels, recreational vessels and tugs and barge traffic. The Coast Guard has carefully considered the restrictions with waterway users in publishing this temporary deviation.
For the duration of the temporary lift bridge installation, 7 a.m. on April 10, 2018 through 6 p.m. on April 16, 2018, vessels will not be allowed to pass through the bridge for safety reasons. From 6:01 p.m. on April 16, 2018 through 6 p.m. on April 30, 2018, vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.
The Coast Guard will also inform the users of the waterways 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.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Broadway Bridge across the Willamette River, mile 11.7, at Portland, OR. The deviation is necessary to accommodate the Portland Race for the Roses event. This deviation allows the bridge to remain in the closed-to-navigation position to facilitate the safe movement of event participants across the bridge.
This deviation is effective from 5 a.m. to Noon on April 29, 2018.
The docket for this deviation, USCG-2018-0199, 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
Multnomah County, the bridge owner, requested the Broadway Bridge be allowed to remain in closed-to-navigation position to vessel traffic to facilitate the safe, uninterrupted roadway passage of participants in the Portland Race for the Roses event. The Broadway Bridge crosses the Willamette River at mile 11.7, and provides 90 feet of vertical clearance above Columbia River Datum 0.0 while in the closed-to-navigation position. This bridge operates in accordance with 33 CFR 117.897. This deviation allows the Broadway Bridge to not open to marine vessels from 5 a.m. to Noon (12 p.m.) on
Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. We requested objections from known river users, and no objections have been received. Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels 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.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Montlake Bridge across Lake Washington Ship Canal, mile 5.2, at Seattle, WA. The deviation is necessary to accommodate the University of Washington graduation ceremony. This deviation allows the bridge span to remain in the closed-to-navigation position.
This deviation is effective from 10:30 a.m. to 6:30 p.m. on June 9, 2018.
The docket for this deviation, USCG-2018-0294 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
The Washington Department of Transportation, the bridge owner, has requested a temporary deviation from the operating schedule for the Montlake Bridge across Lake Washington Ship Canal, at mile 5.2, at Seattle, WA. The deviation is necessary to accommodate event participates to cross the bridge safely. The Montlake Bridge is a double leaf bascule bridge; and in the closed-to-navigation position provides 30 feet of vertical clearance, and 46 feet of vertical clearance at the center 60 feet of the bridge; vertical clearance references to Mean Water Level of Lake Washington. To facilitate this event, the double bascule span is authorized to remain in the closed-to-navigation position from 10:30 a.m. to 2:30 p.m., and from 4:30 p.m. to 6:30 p.m. on June 9, 2018. The Coast Guard coordinated with the local mariners by requesting any objections via the Local Notice to Mariners.
The normal operating schedule for the Montlake Bridge operates in accordance with 33 CFR 117.1051(e). Waterway usage on the Lake Washington Ship Canal ranges from commercial tug and barge to small pleasure craft. Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open for emergencies. Lake Washington Ship Canal has no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels 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 designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone on the Sheboygan Harbor, near the Sheboygan South Pier in Sheboygan, WI for the Rockets for Schools Rocket Launch on May 12, 2018. This action is necessary and intended to ensure safety of life on navigable waterways before, during and after this event. During the aforementioned period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in the safety zone. No person or vessel may enter the safety zone while it is being enforced without permission of the Captain of the Port Lake Michigan or a designated representative.
The regulations in 33 CFR 165.929 will be enforced for safety zone (c)(3), Table 165.929, on May 12, 2018 from 8 a.m. to 5 p.m.
If you have questions about this notice of enforcement, call or email marine event coordinator MST1 Kaleena Carpino, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at (414) 747-7148, email
The Coast Guard will enforce the Rockets for School Rocket Launch Safety Zone listed as item (c)(3) in Table 165.929 of 33 CFR 165.929 on May 12, 2018 from 8 a.m. to 5 p.m. This action is being taken to provide for the safety of life on navigable waterways of the Sheboygan Harbor in Sheboygan, WI. This safety zone will encompass all waters of the Sheboygan Harbor within an arc of a circle with a 1500 yard radius from a center point launch position at 43°44.914′ N, 087°41.869′ W (NAD 83). As specified in 33 CFR 165.929, all vessels must obtain permission from the Captain of the Port Lake Michigan or a designated representative to enter, move within or exit the safety zone when it is enforced. Vessels or persons granted permission to enter the safety zone must
This notice of enforcement is issued under authority of 33 CFR 165.929; Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone, and 5 U.S.C. 552 (a). In addition to this publication in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone on Lake Macatawa in Holland, MI for the Tulip Time Festival Fireworks on May 12, 2018. This action is necessary and intended to ensure safety of life on navigable waters immediately prior to, during, and after the fireworks display. During the aforementioned period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in the safety zone. No person or vessel may enter the safety zone while it is being enforced without permission of the Captain of the Port Lake Michigan or a designated representative.
The regulations in 33 CFR 165.929 will be enforced for safety zone (c)(1), Table 165.929, from 9:45 p.m. until 10:30 p.m. on May 12, 2018.
If you have questions on this document, call or email MST1 Kaleena Carpino, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at (414) 747-7148, email
The Coast Guard will enforce the Tulip Time Festival Fireworks safety zone listed as item (c)(1) in Table 165.929 of 33 CFR 165.929. Section 165.929 lists many annual events requiring safety zones in the Captain of the Port Lake Michigan zone. This safety zone will encompass all waters of Lake Macatawa, within the arc of a circle with a 1000-foot radius from the fireworks launch site in approximate center position 42°47.496′ N, 086°07.348′ W (NAD 83). As specified in 33 CFR 165.929, all vessels must obtain permission from the Captain of the Port Lake Michigan or a designated representative to enter, move within, or exit the safety zone when it is enforced. Vessels and persons granted permission to enter the safety zone must obey all lawful orders or directions of the Captain of the Port Lake Michigan or a designated representative.
This document is issued under authority of 33 CFR 165.929, Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone, and 5 U.S.C. 552(a). In addition to this publication in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for certain waters of the Patapsco River. This action is necessary to provide for the safety of life on the navigable waters of the Inner Harbor at Baltimore, MD, during a fireworks display on April 21, 2018. If necessary, due to inclement weather, the event will be rescheduled to April 22, 2018. This action will prohibit persons and vessels from entering the safety zone unless authorized by the Captain of the Port Maryland-National Capital Region or a designated representative.
This rule is effective from 11 p.m. on April 21, 2018, through 1 a.m. on April 23, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Mr. Ronald Houck, Sector Maryland-National Capital Region Waterways Management Division, U.S. Coast Guard; telephone 410-576-2674, email
On December 15, 2017, the Baltimore Office of Promotion and The Arts notified the Coast Guard that from 11:59 p.m. on April 21, 2018, to 12:06 a.m. on April 22, 2018, or if necessary, due to inclement weather, from 11:59 p.m. on April 22, 2018 to 12:06 a.m. on April 23, 2018, it will be conducting a fireworks display launched from five floating platforms in the Inner Harbor, between Inner Harbor Pier 3 and Inner Harbor Pier 5, in Baltimore, MD. In response, on March 6, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Safety Zone for Fireworks Display; Patapsco River, Inner Harbor, Baltimore, MD” (83 FR 9456). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended April 5, 2018, we received three comments.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Baltimore (COTP) has determined that potential hazards associated with the fireworks to be used in this April 21, 2018, display will be a safety concern for anyone in the Inner Harbor near the five fireworks floating platforms. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.
As noted above, we received three comments on our NPRM published March 6, 2018. All three comments addressed issues not related to this rulemaking. Therefore, there are no substantive changes in the regulatory text of this rule from the proposed rule in the NPRM. We are making one small correction to a typographical error in paragraph (a)(2). The proposed text for this paragraph incorrectly crossed referenced paragraph (a) instead of paragraph (b), which is where the location of the zone is actually described.
This rule establishes a safety zone from 11 p.m. on April 21, 2018, until 1 a.m. on April 23, 2018. This rule will be enforced from 11 p.m. on April 21, 2018, until 1 a.m. on April 22, 2018, or 11 p.m. on April 22, 2018, until 1 a.m. on April 23, 2018, in the case of inclement weather on April 21st. The safety zone will cover all navigable waters of the Patapsco River, Inner Harbor, from shoreline to shoreline, within an area bounded on the east by longitude 076°36′12″ W, and bounded on the west by the Inner Harbor west bulkhead, located at Baltimore, MD. The duration of the zone is intended to ensure the safety of life on these navigable waters before, during, and after the scheduled 11:59 p.m. fireworks display. 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 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. Although this safety zone will restrict the entire width of the waterway, it will impact a small designated area of the Inner Harbor for two hours during the evening when vessel traffic is normally low. The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine band channel 16 to provide information about 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 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 Order13132.
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
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, 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 two hours that would prohibit vessel movement within the Inner Harbor at Baltimore, MD. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(1)
(2)
(b)
(c)
(1) All persons are required to comply with the general regulations governing safety zones found in 33 CFR 165.23.
(2) Entry into or remaining in this safety zone is prohibited unless authorized by the Coast Guard Captain of the Port Maryland-National Capital Region. All vessels underway within this safety zone at the time it is implemented are to depart the zone.
(3) Persons desiring to transit the area of the safety zone shall obtain authorization from the Captain of the Port Maryland-National Capital Region or designated representative. To request permission to transit the area, the Captain of the Port Maryland-National Capital Region and or designated representatives can be contacted at telephone number 410-576-2693 or on marine band radio VHF-FM channel 16 (156.8 MHz). The Coast Guard vessels enforcing this section can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz). Upon being hailed by a U.S. Coast Guard vessel, or other Federal, State, or local agency vessel, by siren, radio, flashing light, or other means, the operator of a vessel shall proceed as directed. If permission is granted to enter the safety zone, all persons and vessels shall comply with the instructions of the Captain of the Port Maryland-National Capital Region or designated representative and proceed as directed while within the zone.
(4)
(d)
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of
This regulation is effective April 20, 2018. Objections and requests for hearings must be received on or before June 19, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0185, is available at
Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0185 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 19, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0185, by one of the following methods:
•
•
•
In the
EPA added “in or on all food commodities” to align with the Agency's language and to more clearly define the petitioner's request.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”
EPA evaluated the available toxicity and exposure data on
Based upon its evaluation, EPA concludes that
Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of
EPA is establishing an exemption from a tolerance on all food commodities without any numerical limitation and thus an analytical method is not required for enforcement purposes.
This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemptions in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
An exemption from the requirement of a tolerance is established for residues of
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of
This regulation is effective April 20, 2018. Objections and requests for hearings must be received on or before June 19, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0186, is available at
Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0186 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 19, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0186, by one of the following methods:
•
•
•
In the
EPA added “for residues” and “in or on all food commodities” to align with the Agency's language and to more clearly define the petitioner's request.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”
EPA evaluated the available toxicity and exposure data on
Based upon its evaluation, EPA concludes that
Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of
EPA is establishing an exemption from a tolerance on all food commodities without any numerical limitation, and thus an analytical method is not required for enforcement purposes.
One comment on the Notice of Filing was received. That comment opposed allowing residues of this pesticide on food but provided no additional information to support a conclusion that the substance is unsafe. EPA evaluated the available information on
This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemptions in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
An exemption from the requirement of a tolerance is established for residues of
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to amend the regulations that allow the importation of peppers from the Republic of Korea to increase the mesh size of the screening over vent openings from 0.6 mm to 1.6 mm, and to require the use of colored sticky traps as an additional measure for pest monitoring. We have determined that, when used alongside other mitigations in the regulations, there is no additional pest risk related to the change in mesh size. This action would modify the conditions under which peppers from the Republic of Korea may be imported into the continental United States while continuing to protect against the introduction of quarantine pests.
We will consider all comments that we receive on or before June 19, 2018.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments that we receive on this docket may be viewed at
Ms. Carol Kreger, Regulatory Policy Specialist, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 851-2356, email:
The regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-82, 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 or dissemination of plant pests within the United States.
The regulations in § 319.56-42 allow the importation of peppers (
NPQS has requested that the Animal and Plant Health Inspection Service (APHIS) amend the regulations in § 319.56-42 to increase the mesh size of screenings that cover all openings, other than double doors, in greenhouse production facilities where peppers are grown for export to the continental United States. NPQS indicated that the 0.6 mm screens required under current regulations, while effective in preventing pests from entering the structures, lead to reduced air flow that can cause increased heat, humidity, and fungal issues that impact fruit quality.
As part of our evaluation of Korea's request, we prepared a commodity import evaluation document (CIED). The CIED documents our review of data from other APHIS-approved fruits and vegetables that are grown in pest exclusionary structures using the larger 1.6 mm screening size, in conjunction with additional pest survey and control measures, as they are produced and prepared for export to the United States and other countries. Copies of the CIED may be obtained from the person listed under
As noted in the CIED, fruits and vegetables approved by APHIS for importation into the United States that are grown in pest exclusionary structures with 1.6 mm screening to prevent the entry of pests include: Peppers from certain Central American countries, tomatoes from Chile, female squash flowers from Israel, eggplants from Israel, and tomatoes from the Republic of Korea. Additionally, the CIED notes that the Republic of Korea already exports peppers grown in pest exclusionary structures using 1.6 mm screening to countries such as Australia, Peru, and the Philippines. Based on our review of available evidence, the CIED concludes that the use of 1.6 mm screening in pest exclusionary structures, when combined with appropriate pest survey and control techniques including the use of sticky traps and insecticidal sprays, is adequate to manage pest risks associated with the importation of peppers to the continental United States from the Republic of Korea. Therefore, we propose to amend the regulations to change the size of the required mesh screening in greenhouses used to grow peppers bound for export to the continental United States from 0.6 mm to 1.6 mm, and to require that yellow and blue sticky traps, at a density agreed upon by APHIS and NPQS, be present in each greenhouse to monitor for levels of thrip activity. If such levels of activity are above the threshold agreed upon by APHIS and NPQS, exports from the greenhouse would be suspended until
This proposed 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. This proposed rule is not expected to be an Executive Order 13771 regulatory action because this proposed rule is not significant under Executive Order 12866.
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 by contacting the person listed under
The proposed rule would amend the import requirements for peppers (
Korea last exported peppers to the United States in 2008, when APHIS approved their import if grown in greenhouses with vents or openings (other than the self-closing doors) covered with 0.6 mm mesh screening to prevent the entry of pests into the greenhouse. However, this size of mesh reduces air flow, resulting in increased heat and fungal problems. The proposed rule would allow for a larger screen mesh size that APHIS has determined will not increase pest risks but would address the heat and fungal issues that currently constrain Korea's production of peppers for export to the United States.
Information on pepper exports by Korea are only available for an aggregated pepper category that includes the
U.S. imports of
Annual U.S. commercial production of bell peppers for 2014 and 2015 averaged 726,073 MT, and had a farmgate value of $731 million. Because U.S. export statistics include
The proposed rule would enable Korea to compete in the U.S. bell pepper market. However, given the established dominance of neighboring Mexico and Canada as foreign suppliers of peppers to the United States and Japan as the foreign buyer of peppers from Korea, the quantity of bell peppers imported from Korea by the United States, especially in the near-term, is expected to be limited. Imports that do take place would help meet the expanding U.S. demand for sweet bell peppers. It is unlikely the rule would have more than a modest impact on U.S. bell pepper producers or the U.S. bell pepper industry generally.
In the United States, there were 11,568 bell pepper farms in 2012, the latest year for which Census of Agriculture data are available. These farms are classified within NAICS 111219, Other Vegetable (except Potato) and Melon Farming, for which the Small Business Administration (SBA) small-entity standard is $750,000. The average value of production per farm for NAICS 111219 was approximately $63,600 in 2012, well below the SBA standard. Clearly, bell pepper growers are predominantly small entities, but as described, this proposed rule, if promulgated, will not have a significant economic impact on those growers.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.
This proposed rule would amend the screening and pest monitoring requirements in greenhouses in the Republic of Korea where peppers are grown in preparation for import to the continental United States. If this proposed rule is adopted, State and local laws and regulations regarding all varieties of
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 proposed 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 propose to amend 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.
The addition reads as follows:
(c) Yellow and blue sticky traps must be present in each greenhouse at a density agreed upon by APHIS and NPQS to monitor the population of thrips. When such monitoring indicates levels of thrip activity above the threshold agreed upon by APHIS and NPQS, exports from the greenhouse will be suspended until remedial measures are applied and APHIS and NPQS agree that the pest risk has been mitigated.
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to amend the fruits and vegetables regulations to allow the importation of fresh cape gooseberry fruit from Ecuador into the continental United States. As a condition of entry, fresh cape gooseberry fruit from Ecuador would be subject to a systems approach that would include requirements for establishment of pest-free places of production and the labeling of boxes prior to shipping. Fresh cape gooseberry fruit from non pest-free places of production would have to undergo approved cold treatment or irradiation. The fresh cape gooseberry fruit would also have to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the national plant protection organization of Ecuador certifying that the fruit has been produced in accordance with the systems approach. Fresh cape gooseberry fruit that does not meet the conditions of the systems approach would be allowed to be imported into the continental United States subject to treatment. This action would allow for the importation of fresh cape gooseberry fruit from Ecuador into the continental United States while continuing to provide protection against the introduction of plant pests.
We will consider all comments that we receive on or before June 19, 2018.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Ms. Claudia Ferguson, Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236; (301) 851-2352.
The regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-82, 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 or dissemination of plant pests within the United States.
The Animal and Plant Health Inspection Service (APHIS) received a request from the national plant protection organization (NPPO) of Ecuador to amend the regulations to allow the importation of commercially produced fresh cape gooseberry fruit (
The PRA, titled “Importation of Fresh Cape Gooseberry Fruit (
The PRA identifies
Based on the findings of the PRA, APHIS has determined that measures beyond standard port-of-entry inspection would mitigate the risks posed by this pest. These measures are listed in the RMD and are used as the basis for the requirements included in this proposed rule. We are therefore proposing to allow the importation of fresh cape gooseberry fruit from Ecuador into the continental United States if it is produced under a systems approach or subject to cold treatment or irradiation in accordance with the Plant Protection and Quarantine (PPQ) Treatment Manual
All fruit, regardless of whether it was produced under the systems approach or subject to treatment would have to be imported in commercial consignments only and subject to the requirements regarding registered production areas and phytosanitary certification detailed below.
These requirements would be added to the regulations as a new § 319.56-83.
We would require the NPPO of Ecuador to provide an operational workplan to APHIS that details the activities the NPPO will carry out to meet the requirements of this regulation, subject to APHIS' approval of the workplan. APHIS would be directly involved with the NPPO in monitoring and auditing implementation of the systems approach. An operational workplan is an agreement between APHIS officials of the NPPO of a foreign government, and, when necessary, foreign commercial entities that specifies in detail the phytosanitary measures that will be carried out to comply with our regulations regarding a specific commodity. Operational workplans apply only to the signatory parties and establish detailed procedures and guidance for the day-to-day operations of specific import/export programs. Operational workplans also establish how specific phytosanitary issues are dealt with in the exporting country and make clear who is responsible for dealing with those issues. The implementation of a systems approach typically requires an operational workplan to be developed.
Only commercial consignments of fresh cape gooseberry fruit from Ecuador would be allowed to be imported into the continental United States. Produce grown commercially is less likely to be infested with plant pests than noncommercial consignments. Noncommercial consignments are more prone to infestations because the commodity is often ripe to overripe, could be of a variety with unknown susceptibility to pests, and is often grown with little or no pest control. Commercial consignments, as defined in § 319.56-2, are consignments that an inspector identifies as having been imported for sale and distribution. Such identification is based on a variety of indicators, including, but not limited to: Quantity of produce, type of packaging, identification of grower or packinghouse on the packaging, and documents consigning the fruits or vegetables to a wholesaler or retailer.
Under this proposed rule, the production site where the fruit is grown would be required to be registered with the NPPO of Ecuador. Official identification of the production site would have to be marked on all field cartons and containers of harvested fresh cape gooseberry fruit. Registration of production sites with the NPPO of Ecuador and marking of field cartons and containers with identification that would need to be maintained until the fruit is released for entry into the continental United States would allow traceback to the production site if pest problems were found on fruit shipped to the United States. Problem production sites could then be suspended until further mitigation measures were taken to address the pest populations.
All openings to the outside of the packinghouse must be covered by screening or by some other barrier that prevents pests from entering. The packinghouse must have double doors at the entrance to the facility and at the interior entrance to the area where the fresh cape gooseberry fruit is packed.
Each consignment of fruit would have to be accompanied by a phytosanitary certificate issued by the NPPO of Ecuador that contains an additional declaration stating that the fruit in the consignment was produced in accordance with the requirements of § 319.56-83.
Requiring a phytosanitary certificate would ensure that the NPPO of Ecuador has certified that the fruit meets the conditions in the section for export to the United States.
As stated previously the risks presented by Medfly would be addressed either via compliance with an established systems approach or treatment in accordance with the PPQ Treatment Manual and 7 CFR part 305.
All places of production would have to be located within an area of low prevalence for Medfly. APHIS has reviewed and approved the methods used by the NPPO of Ecuador to survey for low pest prevalence and to recognize specific places of production as free of Medfly in the specified areas. Pest-free places of production within certified low pest prevalence areas have been effectively used in the past as an element of a systems approach to allow fruits to be safely imported into the United States, and we believe this measure can be successfully applied to the importation of fresh cape gooseberry fruit from Ecuador.
We would require the use of trapping to monitor the places of production within low prevalence areas as part of the systems approach to mitigate the risk posed by Medfly. The NPPO of Ecuador would be required to certify that places of production have effective fruit fly trapping programs and follow pest control guidelines. The NPPO of Ecuador or its approved designee
After the commodity is packed, the NPPO of Ecuador must visually inspect the fresh cape gooseberry fruit at a rate jointly approved by APHIS and the NPPO of Ecuador. Any fruit displaying evidence of pest presence must be cut open for further examination. External and internal inspection of a sample would ensure that pests at various life stages are detected. Any consignment that does not pass inspection may still be imported into the continental United States subject to treatment as described below.
Fresh cape gooseberry fruit that comes from a place of production that does not qualify as a pest free place of production in an area of low pest prevalence may still be exported to the continental United States subject to cold treatment or irradiation treatment in accordance with the PPQ Treatment Manual and 7 CFR part 305.
This proposed 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 subject to the requirements of Executive Order 13771. However, the Department considers this a deregulatory action for purposes of Executive Order 13771.
We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866, which 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, and equity). The economic analysis also examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available by contacting the person listed under
The United States does not produce fresh cape gooseberry fruit commercially. Small entities that would benefit from fresh cape gooseberry fruit imports from Ecuador would be importers, wholesalers, and other merchants who sell this fruit. While these industries are primarily comprised of small entities, APHIS expects any impacts of the rule for these businesses to be minor.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.
This proposed rule would allow fresh cape gooseberry fruit to be imported into the continental United States from Ecuador. If this proposed rule is adopted, State and local laws and regulations regarding fresh cape gooseberry fruit imported under this rule would be preempted while the fruit is in foreign commerce. Fresh fruit is generally imported for immediate distribution and sale to the consuming public and would 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. If this proposed rule is adopted, 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
APHIS is proposing to allow the importation of fresh cape gooseberry fruit from Ecuador into the continental United States under certain conditions designed to prevent the introduction of
We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology;
A copy of the information collection may be viewed on the
The Animal and Plant Health Inspection Service is committed to compliance with the EGovernment 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 proposed 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 propose to amend 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 cape gooseberry (
(a)
(2) The production site where the fruit is grown must be registered with the NPPO of Ecuador.
(3) Harvested fresh cape gooseberry fruit must be placed in field cartons or containers that are marked to show the official identification of the production site.
(4) All openings to the outside of the packinghouse where the fruit is packed must be covered by screening or by some other barrier that prevents pests from entering. The packinghouse must have double doors at the entrance to the facility and at the interior entrance to the area where the fresh cape gooseberry fruit is packed.
(5) Each consignment of fresh cape gooseberry fruit must be accompanied by a phytosanitary certificate issued by the NPPO of Ecuador that contains an additional declaration stating that the fruit in the consignment was produced in accordance with § 319.56-83.
(b)
(c) To be eligible for importation, the fresh cape gooseberry fruit must either be produced and shipped under the systems approach described in paragraph (d) of this section or treated in accordance with paragraph (e) of this section.
(d)
(1)
(2)
(ii) All fruit flies trapped must be reported to APHIS immediately. Capture of
(3)
(e)
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule would implement a recommendation from the Almond Board of California (Board) to
Comments must be received by May 21, 2018.
Interested persons are invited to submit written comments concerning this proposal. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or internet:
Andrea Ricci, Marketing Specialist, or Jeffrey Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This action, pursuant to 5 U.S.C. 553, proposes an amendment to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 981, as amended (7 CFR part 981), regulating the handling of almonds grown in California. Part 981 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Board locally administers the Order and is comprised of growers and handlers operating within California.
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposed rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's 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).
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This proposed rule invites comments on revisions to the adjusted kernel weight computation currently prescribed for almonds under the Order. This proposal would change the way adjusted kernel weight is expressed by requiring calculation of percentages for specified measurements to round the decimal to the nearest thousandth rather than the current hundredth. In addition, this proposed rule would allow adjustments to the calculated percentages for foreign material, excess moisture, or inedible kernels so that the sum of the percentages for the specified measurements would equal 100 percent. The Board unanimously recommended these changes at its December 4, 2017, meeting.
Section 981.42 provides authority for quality control regulations. Paragraph (a) of that section requires that each handler shall have the inspection agency determine the percentage of inedible kernels received by that handler and report such determination to the Board.
Section 981.442(a)(1) prescribes that each handler shall have a representative sample drawn from each lot of any variety of incoming almonds that the handler receives. Section 981.442(a)(3) prescribes that each such sample shall be analyzed by or under surveillance of the Federal-State Inspection Service (or, when specifically designated, the Federal Inspection Service) to determine the kernel content and the portion of inedible kernels in the sample. The inspection agency prepares a report showing, among other things, the total adjusted kernel weight. This report is submitted by the inspection agency to the Board and the handler.
Section 981.401(a) defines adjusted kernel weight. Section 981.401(b) provides examples of the computation that is used to determine adjusted kernel weight. This computation includes a calculation of percentages for specified measurements of edible kernels, inedible kernels, foreign material, and excess moisture. The table of examples contained in § 981.401(b) shows percentages rounded to the nearest tenth and the nearest hundredth decimal place. However, in practice, the calculated percentages are currently being rounded to the nearest hundredth decimal place.
Currently, the inspection agency utilizes a computer-based database program that computes and totals the percentages for the specified measurements. As part of the program's computation process, it automatically makes adjustments, when needed, so that the total of the percentages equals 100 percent. This program has been used for several years, and the industry is accustomed to receiving reports from the inspection agency that show the 100-percent summed total.
In early 2017, the USDA inspection service began testing a new web-based program that will replace the computer-based program described above. During this testing, USDA discovered that, due to the rounding method used by the new program, the sum of the percentages occasionally did not equal 100 percent. It was further determined during testing that having the new program round the decimal to the nearest thousandth, rather than the nearest hundredth as currently provided in the Order, would produce more accurate results.
The new program could also make automatic minor adjustments to the percentage computations for foreign material, excess moisture, or inedible kernels so that the sum of the percentages would always equal 100 percent. This allowance for automatic adjustments of these specified measurements aligns with industry practice that has existed for many years.
As a result of these test results, the Board determined that rounding the decimal to the nearest thousandth rather than the current hundredth would provide a more accurate computed percentage. In addition, allowing the program to make adjustments to the calculated percentages for foreign material, excess moisture, or inedible kernels would align the requirements under the Order with current industry practices, ensuring the continuance of longstanding reporting practices and transparency in the program.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 6,800 almond growers in the production area and approximately 100 almond handlers subject to regulation under the Order. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).
The National Agricultural Statistics Service (NASS) reported in its most recent (2012) Agricultural Census that there were 6,841 almond farms in the production area (California), of which 6,204 had bearing acres. The following computation provides an estimate of the proportion of agricultural producers (farms) and agricultural service firms (handlers) that would be considered small under the SBA definitions.
The NASS Census data indicates that out of the 6,204 California farms with bearing acres of almonds, 4,471 (72 percent) have fewer than 100 bearing acres.
For the almond industry's most recently reported crop year (2016), NASS reported an average yield of 2,280 pounds per acre and a season average grower price of $2.44 per pound. A 100-acre farm with an average yield of 2,280 pounds per acre would produce about 228,000 pounds of almonds. At $2.44 per pound, that farm's production would be valued at $556,320. The Census of Agriculture indicates that the majority of California's almond farms are smaller than 100 acres; therefore, it could be concluded that the majority of growers had annual receipts from the sale of almonds in 2016-17 of less than $556,320, which is below the SBA threshold of $750,000. Thus, over 70 percent of California's almond growers would be classified as small growers according to SBA's definition.
To estimate the proportion of almond handlers that would be considered small businesses, it was assumed that the unit value per shelled pound of almonds exported in a particular year could serve as a representative almond price at the handler level. A unit value for a commodity is the value of exports divided by the quantity. Data from the Global Agricultural Trade System database of USDA's Foreign Agricultural Service showed that the value of almond exports from August 2016 to July 2017 (combining shelled and inshell almonds) was $4.072 billion. The quantity of almond exports over that time period was 1.406 billion pounds, combining shelled exports and the shelled equivalent of inshell exports. Dividing the export value by the quantity yields a unit value of $2.90 per pound. Subtracting this figure from the NASS 2016 estimate of season average grower price per pound ($2.44) yields $0.46 per pound as a representative grower-handler margin. Applying the $2.90 representative handler price per pound to 2016-17 handler shipment quantities provided by the Board showed that approximately 40 percent of California's almond handlers shipped almonds valued under $7,500,000 during the 2016-17 crop year and would therefore be considered small handlers according to the SBA definition.
This proposed rule would revise the adjusted kernel weight computation in § 981.401 by requiring calculation of the percentages for specified measurements to round the decimal to the nearest thousandth rather than the current hundredth. In addition, this action would allow adjustments to the calculated percentages for foreign material, excess moisture, or inedible kernels so that the sum of the percentages for the specified measurements would equal 100 percent. Requiring rounding of the decimal to the nearest thousandth would provide for a more accurate computed percentage. In addition, allowing adjustments to the foreign material, excess moisture, or inedible kernel measurements would align the Order with current industry practices, ensuring the continuance of longstanding reporting practices and transparency in the program. Authority for this action is provided in § 981.42(a) of the Order. The Board recommended this action at a meeting on December 4, 2017.
It is not anticipated that this action would impose additional costs on handlers or growers, regardless of size. The proposed changes are intended to align provisions of the Order with current industry practices. This proposed rule is not expected to change handler inspection costs, as handlers are currently required to have all lots inspected to determine kernel content.
The Board considered alternatives to this action, including not changing the current computation procedures. Prior to this recommendation, the Board's Almond Quality, Food Safety and Services Committee (Committee) reviewed the program, surveyed handlers, and determined that not changing the computation procedures to align with current industry practices would cause disruption in the industry. Therefore, the Committee unanimously recommended this action to the Board at a meeting on November 16, 2017.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178 (Vegetable and Specialty Crops). No changes are necessary in those requirements as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large almond handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen
USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this proposed rule.
Further, the Board's meeting was widely publicized throughout the almond industry, and all interested persons were invited to attend the meeting and participate in Board deliberations. Like all Board meetings, the December 4, 2017, meeting was a public meeting, and all entities, both large and small, were able to express their views on this issue.
Also, the Board has a number of appointed committees to review certain issues and make recommendations to the Board. The Committee met on November 16, 2017, and discussed this issue in detail. That meeting was also a public meeting, and both large and small entities were able to participate and express their views.
Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
A 30-day comment period is provided to allow interested persons to respond to this proposal. All written comments timely received will be considered before a final determination is made on this matter.
Almonds, Marketing agreements, Nuts, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 981 is proposed to be amended as follows:
7 U.S.C. 601-674.
(b) * * *
(c)
Federal Election Commission.
Rulemaking Petition; Notification of Availability; Correction.
The Federal Election Commission published a Notification of Availability in the
Mr. Robert M. Knop, Assistant General Counsel, 1050 First Street NE, Washington, DC 20463, (202) 694-1650 or (800) 424-9530.
In the
All comments must be in writing. Commenters are encouraged to submit comments electronically via the Commission's website at
In the
The Commission seeks comments on the petition. The public may inspect the petition on the Commission's website at
On behalf of the Commission.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for various Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK117 and Model BO-105 helicopters. This proposed AD would require removing the swashplate bellows (bellows) and repetitively inspecting the swashplate assembly. This proposed AD is prompted by reports of loose and missing clamps installed on bellows. The proposed actions are intended to detect and prevent an unsafe condition on these products.
We must receive comments on this proposed AD by June 19, 2018.
You may send comments by any of the following methods:
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You may examine the AD docket on the internet at
For service information identified in this proposed rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.
Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.
We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.
EASA, which is the aviation authority for Germany, has issued AD No. 2016-0142, dated July 19, 2016, to correct an unsafe condition for Airbus Helicopters Model MBB-BK 117A-1, MBB-BK 117A-3, MBB-BK 117A-4, MBB-BK 117B-1, MBB-BK 117B-2, MBB-BK 117C-1, MBB-BK 117C-2, MBB-BK 117C-2e, BO-105A, BO-105C, BO-105D, BO105S, BO-105LS A-3 helicopters.
EASA advises of several reports of a lower clamp found missing from the bellows and damaging the swashplate bearing ring before becoming detached. EASA states an investigation showed that over-torqueing can damage the clamp, which may have caused the clamp to become loose and detach. According to EASA, this condition, if not detected and corrected, could lead to loss of a swashplate clamp, resulting in loss of helicopter control. A detached clamp could damage the swashplate and pitch link or strike the tail rotor. EASA states that its AD is considered interim action and a further AD to implement a terminating action will follow.
These helicopters have been approved by the aviation authority of Germany and are approved for operation in the United States. Pursuant to our bilateral agreement with Germany, EASA, its technical representative, has notified us of the unsafe condition described in its AD. We are proposing this AD because we evaluated all known relevant information and determined that an unsafe condition is likely to exist or develop on other products of the same type design.
We reviewed Airbus Helicopters Alert Service Bulletin (ASB) BO105-40A-107 for Model BO105 C-series, D-series and S-series helicopters; ASB BO105 LS-40A-12 for Model BO-105LS A-3 helicopters; ASB MBB-BK117-40A-115 for Model MBB-BK 117A-1, MBB-BK 117A-3, MBB-BK 117A-4, MBB-BK 117B-1, MBB-BK 117B-2, and MBB-BK 117C-1 helicopters; and ASB MBB-BK117 C-2-62A-007 for Model MBB-BK 117C-2 and MBB-BK 117C-2e helicopters. These ASBs are all Revision 4 and all dated May 23, 2016. We also
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This proposed AD would require a one-time inspection within 50 hours time-in-service (TIS) and repetitive inspections every 100 hours TIS and every 400 hours TIS, by following the instructions in the manufacturer's service bulletin. This proposed AD would also prohibit installing on any helicopter bellows P/N 105-10113.05, P/N 4619305044, and P/N 4638305043 and any gearbox that has these bellows installed.
The EASA AD requires compliance within different time intervals for some actions than what this proposed AD would require. The EASA AD allows a non-cumulative tolerance of 10 percent that may be applied to the compliance times, and this proposed AD would not. The EASA AD allows replacing the bellows clamps with cable ties before removing the bellows, and this proposed AD would not. This proposed AD would apply to Model MBB-BK 117D-2 helicopters while the EASA AD does not. The EASA AD applies to Model BO-105D helicopters, while this proposed AD would not.
We consider this proposed AD to be an interim action. The design approval holder is currently developing a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, we might consider additional rulemaking.
We estimate that this proposed AD would affect 286 helicopters of U.S. Registry and that labor costs would average $85 per work hour. Based on these estimates, we expect the following costs:
• Removing and inspecting the swashplate assembly would require 3 work-hours. No parts would be needed for a cost of $255 per helicopter and $72,930 for the U.S. fleet per inspection cycle.
• Repairing a scratched support tube would require 3 work-hours. No parts would be needed for a cost of $255 per helicopter.
• Replacing a corroded or damaged clamp would require 2 work-hours. Parts would cost $8 for a cost of $178 per helicopter.
• Replacing corroded ball bearings would require 4 work-hours. Parts would cost $3,000 for a cost of $3,340 per helicopter.
• Removing foreign objects from the outer deflection ring would require 2 work-hours. No parts would be needed for a cost of $170 per helicopter.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Airbus Helicopters Deutschland GmbH Model BO-105A, BO-105C, BO-105S, BO105LS A-3, MBB-BK 117A-1, MBB-BK 117A-3, MBB-BK 117A-4, MBB-BK 117B-1, MBB-BK 117B-2, MBB-BK 117C-1, MBB-BK 117C-2, and MBB-BK 117D-2 helicopters, certificated in any category.
Helicopters with an MBB-BK 117C-2e designation are Model MBB-BK 117C-2 helicopters.
This AD defines the unsafe condition as a loose bellows clamp. This condition can cause loss of the bellows, contact of the bellows with the main rotor blades, main rotor mast, and tail rotor, and subsequent loss of helicopter control.
We must receive comments by June 19, 2018.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
(1) Within 50 hours time-in-service (TIS):
(i) Remove the swashplate bellows (bellows) part number (P/N) 105-10113.05, P/N 4638305043, P/N 4619305044, or B623M20X2240 from the swashplate.
(ii) Inspect the swashplate by following the Accomplishment Instructions, paragraph 3.B.1.(h) through 3.B.1.(k) of Airbus Helicopters Alert Service Bulletin (ASB)
(2) Within 100 hours TIS after complying with the actions in paragraph (1) of this AD, and thereafter at intervals not to exceed 100 hours TIS, inspect the swashplate by following the Accomplishment Instructions, paragraph 3.B.2 of ASB BO105-40A-107, ASB BO105 LS 40A-12, ASB MBB-BK117-40A-115, ASB MBB-BK117 C-2-62A-007, or ASB MBB-BK117 D-2-62A-003, except you are not required to contact Airbus Helicopters customer support. If there is corrosion on a ball bearing, before further flight, replace the ball bearing.
(3) Within 400 hours TIS after complying with the actions in paragraph (1) of this AD, and thereafter at intervals not to exceed 400 hours TIS, inspect the swashplate by following the Accomplishment Instructions, paragraph 3.B.3 of ASB BO105-40A-107, ASB BO105 LS 40A-12, ASB MBB-BK117-40A-115, ASB MBB-BK117 C-2-62A-007, or ASB MBB-BK117 D-2-62A-003.
(4) Do not install a bellows P/N 105-10113.05, P/N 4619305044, or P/N 4638305043 or a gearbox with a bellows P/N 105-10113.05, P/N 4619305044, or P/N 4638305043 on any helicopter.
(1) The Manager, Safety Management Section, Rotorcraft Standards Branch, FAA, may approve AMOCs for this AD. Send your proposal to: Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2016-0142, dated July 19, 2016. You may view the EASA AD on the internet at
Joint Aircraft Service Component (JASC) Code: 6200, Main Rotor System.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend the Class E airspace extending upward from 700 feet above the surface at New Castle-Henry County Municipal Airport, New Castle, IN. The FAA is proposing this action as a result of an airspace review caused by the decommissioning of the Richmond VHF omnidirectional range (VOR) navigation aid as part of the VOR Minimum Operational Network (MON) Program. The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database.
Comments must be received on or before June 4, 2018.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2018-0290; Airspace Docket No. 18-AGL-9, at the beginning of your comments. You may also submit comments through the internet at
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.
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace extending upward from 700 feet above the surface at New Castle-Henry County Municipal Airport, New Castle, IN, to support instrument flight rule operations at this airport.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11B, 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
The FAA is proposing an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 by amending the Class E airspace extending upward from 700 feet above the surface to within a 6.4-mile radius (decreased from a 7-mile radius) at New Castle-Henry County Municipal Airport, New Castle, IN, and adding an extension 2.5 miles each side of the 267° bearing from the New Castle NDB extending from the 6.4-mile radius to 7.0 miles west of the NDB. The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database.
This action is necessary due to an airspace review caused by the decommissioning of the Richmond VOR as part of the VOR MON Program.
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 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of New Castle-Henry County Municipal Airport, and within 2.5 miles each side of the 267° bearing from the New Castle NDB extending from the 6.4-mile radius to 7.0 miles west of the New Castle NDB.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to modify the security zone surrounding the bridge between Liberty State Park and Ellis Island in order to increase navigational safety in New York Harbor. This security zone modification would allow certain vessels to transit underneath the bridge, reducing congestion in the adjacent Anchorage Channel. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before May 21, 2018.
You may submit comments identified by docket number USCG-2016-0799 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email MST1 Kristina Pundt, Waterways Management at U.S. Coast Guard Sector New York, telephone 718-354-4352, email
On November 27, 2002, the Coast Guard published a NPRM entitled, “Safety and Security Zones; New York Marine Inspection and Captain of the Port Zone” in the
On May 6, 2008, the Coast Guard published a NPRM entitled, “Safety and Security Zones; New York Marine Inspection Zone and Captain of the Port” in the
On November 3, 2016, the Coast Guard published an ANPRM entitled, “Safety and Security Zones; New York Marine Inspection and Captain of the Port Zone” in the
The purpose of this rulemaking is to modify the existing security zone to allow certain vessels to transit underneath the bridge between Liberty State Park and Ellis Island. This security zone modification will increase the navigational safety within New York Harbor by reducing congestion in the adjacent Anchorage Channel. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.
The COTP proposes to modify the existing security zone around Liberty Island and Ellis Island and the bridge between Ellis Island and Liberty State Park. This does not relinquish the COTP authority to enforce the full 150 yard security zone around the bridge. Rather, the modification would allow certain vessels to transit underneath the Ellis Island Bridge on weekends and Federally Observed Holidays, beginning on Memorial Day Weekend through October 1, between one hour after sunrise and one hour before sunset. Vessels making this transit (a) must be able to safely navigate underneath the bridge, (b) be human powered watercraft and (c) meet the horizontal and vertical navigational bridge clearances. The proposed regulatory text appears at the end of this document.
The Coast Guard developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below is a summary of our analyses based on a number of these statutes and Executive Orders and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the proposed modification and will allow greater access to a previously restricted area. Prior to the establishment of the security zone in 2003, small watercraft routinely transited underneath the Ellis Island Bridge. Since the enactment of the 2003 security zone, these craft have been diverted into the busy navigation channel east of Ellis Island. Although the current regulation allows vessels to transit under the Ellis Island Bridge with COTP permission, this modification grants standing COTP approval for certain vessels to transit underneath the bridge during specific time periods. Thus, this modification would lessen the regulatory burden on these vessels by allowing transit through the security zone without needing to seek prior COTP permission. Moreover, the Coast Guard would make the boating public aware of this modification through publication in the Local Notice to Mariners.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider
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 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 modification of a security zone surrounding the bridge between Liberty State Park and Ellis Island. Normally such actions are categorically excluded from further review under paragraph L60(b) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1
(a) * * *
(4)
(ii)
(A)
(B)
(C)
(D)
(E)
(iii)
Office of Elementary and Secondary Education, Department of Education.
Proposed waiver and extension of the project period.
The Secretary proposes to waive the requirement in the Education Department General Administrative Regulations that generally prohibits project period extensions involving the obligation of additional Federal funds. The proposed waiver and extension of the project period would enable the 34 grantees under the Migrant Education Program (MEP) Consortium Incentive Grant (CIG) Program that received awards in the fiscal year (FY) 2015 grant competition to continue to receive Federal funding for up to 24 additional months.
We must receive your comments on or before May 21, 2018.
Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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Jennifer Rodriguez. Telephone: (202) 453-6670 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
During and after the comment period, you may inspect all public comments about this proposed waiver and extension by accessing
The Department published a notice of final requirements for the MEP CIG program in the
The 2004 Notice established a project period of up to two years for grants awarded under the MEP CIG program. We subsequently published a notice of
The Department last awarded CIG program grants in FY 2015. Currently, 34 SEAs (out of a total of 46 SEAs that receive MEP formula grant program funds) participate in CIG program-funded consortia.
We are proposing to waive the requirement in 34 CFR 75.261(c)(2), which limits the extension of a project period if the extension involves the obligation of additional Federal funds. If finalized, this waiver would allow the 34 current CIG program grantees to continue to receive Federal funding for up to two additional years through FY 2019.
We are proposing to provide up to two years of additional funding to current CIG grantees for several reasons. The additional project years proposed by this waiver would allow grantees' work to continue as the Secretary considers changes to the priorities, structure, and duration of the CIG program.
Providing up to two additional years of funding would permit grantees to continue coordinating with one another and achieving the goals and objectives of their consortium applications. Based on the progress SEAs generally have made on consortium projects, we believe that current grantees could benefit from a fourth and fifth year in which to continue working on and implementing their CIG program projects.
Moreover, implementing this waiver and extension would ensure that the services provided by the current CIG program grantees continue uninterrupted as the Department supports States in their transition to implement requirements under the ESEA as amended by the Every Student Succeeds Act (ESSA). During this extension period, the activities of the current CIG program grantees would be modified through work plans, as necessary, to continue the implementation of consortium activities and to support States as they implement requirements under the ESSA.
For all of these reasons, we have concluded that it would be contrary to the public interest to have a lapse in the work of current CIG program grantees while the Secretary considers changes to the CIG program and while the Department implements the components of the ESSA as described above.
We intend to fund the extended project period for either one or two years by using the FY 2018 and, if necessary, FY 2019 funds that Congress appropriates under the current statutory authority. Funding for the extended project period would follow the two-tiered funding formula established by the 2004 Notice.
If this proposed waiver and extension becomes final—
(1) Current grantees will be authorized to receive continuation awards annually for up to two years.
(2) We would not announce a new competition or make new awards under the MEP CIG program in FY 2018 (if the project period is extended for one year) or in FY 2019 (if the project period is extended for two years).
(3) During the extension period, any activities carried out must be consistent with, or be a logical extension of, the scope, goals, and objectives of the grantee's approved application from the FY 2015 CIG program competition.
(4) Each grantee who receives a continuation award must also continue to comply with the requirements established in the program regulations, the 2004 and 2013 Notices, and the 2015 notice inviting applications for the MEP CIG program (80 FR 6502).
The proposed waiver of 34 CFR 75.261(c)(2) would not affect the applicability of the requirements in 34 CFR 75.253 (continuation of a multi-year project after the first budget period) to any current CIG program grantee that receives a continuation award as a result of the waiver.
We will announce the final waiver and extension, if any, in a document in the
For the 34 CIG program grantees that received awards in the FY 2015 competition, the Secretary proposes to waive the requirement in 34 CFR 75.261(c)(2) that prohibits extensions of project periods that involve the obligation of additional Federal funds.
The Secretary certifies that this proposed waiver and extension would not have a significant economic impact on a substantial number of small entities.
The entities that would be affected by this proposed waiver are:
(a) The FY 2015 grantees currently receiving Federal funds; and
(b) Entities not currently receiving Federal funds through the CIG program that would have been eligible to apply for an award in FY 2018 or in FY 2019 under the CIG program if the Department were to hold a competition in either year.
The Secretary certifies that the proposed waiver and extension would not have a significant economic impact on these entities because the proposed waiver and extension and the activities required to support the additional years of funding would not impose excessive regulatory burdens or require unnecessary Federal supervision. The proposed waiver and extension would impose minimal requirements to ensure the proper expenditure of program funds, including requirements that are standard for continuation awards. In addition, none of those entities are small entities; this program makes awards to SEAs.
This proposed waiver and extension does not contain any information collection requirements.
This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.
This document provides early notification of our specific plans and actions for this program.
You may also access documents of the Department published in the
Postal Service
Proposed rule.
The Postal Service recently published an advanced notice requesting comments on how the Postal Service should proceed to prevent overweight items from entering into the postal network. After considering the comments received, the Postal Service is now moving forward to propose amendment of the
Submit comments on or before May 21, 2018.
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.
Lizbeth Dobbins at (202) 268-3789 or Garry Rodriguez at (202) 268-7261.
On October 3, 2017, the Postal Service published an advanced notice requesting comments on how the Postal Service should proceed to prevent overweight items from entering into the postal network (82 FR 46010). The Postal Service received 18 responses and those suggestions have been incorporated into this proposed rule, as appropriate. The Postal Service now proposes to amend the DMM to add a penalty for attempting to enter nonmailable, overweight items into the mailstream. Implementation of this proposed rulemaking will require action by Postal Service management.
The Postal Service defines overweight items as anything over the Postal Service 70 pound maximum limit or the applicable maximum weight allowed for hazardous materials (see DMM 201.7.3). These overweight items are considered nonmailable and present a safety risk to employees.
Existing DMM section 601.1.3 provides that it is the mailer's responsibility to refrain from depositing nonmailable matter in the mail. A mailer's responsibilities include complying with applicable postal laws and regulations governing mailability. As such, the Postal Service reserves the right to refuse nonmailable items.
Overweight items should never be entered into the postal network. However, the Postal Service is noticing an increase in overweight items, such as items that are initially delivered using a private carrier, but are attempted to be returned using the Postal Service. It is unsafe to return the overweight item to the sender through the postal network. Occasionally, the item is abandoned which creates another safety issue when trying to dispose of the overweight item.
Most commenters identified that safety is an issue with overweight items and strongly supported the Postal Service position. Commenters recognized that heavier weight items require specialized equipment for lifting or at least two people to handle the item. In many locations neither specialized equipment nor enough people are available to move the heavy item.
Some commenters identified that it is nearly impossible to identify if an item is overweight unless a scale is used to validate weight. Since items are often picked up by postal personnel upon request or during the normal course of the delivery route and there are no scales inside delivery trucks, overweight packages may mistakenly enter into the postal network. It is impractical to place scales inside delivery vehicles to verify the weight of items. Postal personnel rely on mailer compliance with applicable postal laws and regulations governing mailability and preparation for mailing.
The Postal Service needs the full cooperation of its partners and customers to stop overweight items from entering into the postal network. Recently, other shipping companies adopted stronger practices to penalize those who fail to adhere to their maximum weight requirements.
As a result, the Postal Service is proposing to assess a penalty of $100.00 per item over the 70 pound maximum weight limit or the applicable maximum weight allowed for hazardous materials discovered in the postal network. Once the overweight item is identified, it would be secured and either the sender or receiver would be contacted to pick-up the item within 14 calendar days and notified of the assessed penalty. The penalty would be payable through any authorized retail payment method and must be paid prior to the release of the item. The Postal Service also proposes that the penalty and any amounts paid as purported postage and fees would not be refundable. Any overweight item not paid for and picked-up within the 14 calendar day timeframe would be considered abandoned and disposed of at the Postal Service's discretion.
Although exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), the Postal Service invites public comments on the following proposed revisions to
Administrative practice and procedure, Postal Service.
For the reasons stated in the preamble, the Postal Service proposes to amend 39 CFR part 111 as follows:
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
The maximum Postal Service weight limit is 70 pounds, lower weight limits may apply. Any item exceeding the 70 pound Postal Service maximum weight limit or the applicable maximum weight allowed for hazardous materials is nonmailable and if found in the postal network will be secured at the facility identifying the ineligible item for pick-up by the mailer or addressee. The Overweight penalty of $100.00 will be assessed and must be paid by any authorized retail payment method before release of the item.
Refunds are not made for the following:
i. For any amounts paid as purported postage and fees on overweight items that are nonmailable under 601.1.2.
We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.
Animal and Plant Health Inspection Service, USDA.
Revision to and extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of clementines from Spain.
We will consider all comments that we receive on or before June 19, 2018.
You may submit comments by either of the following methods:
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Supporting documents and any comments we receive on this docket may be viewed at
For information on the importation of clementines from Spain, contact Mr. Brendon Reardon, Assistant Director, PPQ Preclearance and Offshore Programs, PHP, PPQ, APHIS, 4700 River Road Unit 60, Riverdale, MD 20737; (301) 851-2223. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.
In accordance with § 319.56-34, clementines from Spain are subject to certain conditions before entering the United States to ensure that exotic plant pests, such as Mediterranean fruit fly, are not introduced into the United States. The regulations require the use of information collection activities, including trapping and control records, phytosanitary certificates, labeling, cold treatment data for consignments, trust fund agreements, grower registrations and agreements, Mediterranean fruit fly management program, cold treatment facility/carrier certifications, workplans, advance reservations for cold treatment port space, and emergency action notifications.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate 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) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Animal and Plant Health Inspection Service, USDA.
Revision to and extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of longan from Taiwan.
We will consider all comments that we receive on or before June 19, 2018.
You may submit comments by either of the following methods:
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Supporting documents and any comments we receive on this docket may be viewed at
For information on the importation of longan from Taiwan, contact Mr. Benjamin Kaczmarski, RCC Assistant Director, PHP, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737; (301) 851-2127. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.
Under these regulations, longan from Taiwan are subject to certain conditions before entering the United States to ensure that plant pests are not introduced into the United States. In addition, the fruit must be accompanied by a phytosanitary certificate stating that the fruit was inspected and found to be free of certain pests, and the individual cartons or boxes in which the longan are shipped must be stamped or printed with a statement prohibiting their importation into or distribution within the State of Florida. Lastly, under certain circumstances, an emergency action of notice may be required.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate 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) Evaluate the accuracy of our estimate of the burden of the collection of information including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Animal and Plant Health Inspection Service, USDA.
Revision to and extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of fresh pitaya fruit from Central America into the continental United States.
We will consider all comments that we receive on or before June 19, 2018.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For information on the importation of fresh pitaya fruit from Central America into the continental United States, contact Mr. Benjamin Kaczmarski, RCC Assistant Director, PHP, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737; (301) 851-2127. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.
Under these regulations, fresh pitaya from Central America may be imported into the continental United States under certain conditions, as listed in § 319.56-55, to prevent the introduction of plant pests into the United States. The regulations require information collection activities that include production site certification and registration, production site training program, review and maintenance of records, packinghouse registration, inspections and investigations, bilateral workplans, records of fruit fly detections and checking of traps, identification of places of production on shipping documents, box marking, phytosanitary certificates with additional declarations, and emergency action notifications.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate 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) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Rural Business-Cooperative Service, USDA.
Notice.
This Notice announces the solicitation of applications for up to $5 Million of available funding under the Repowering Assistance Program to encourage the use of renewable biomass as a replacement fuel source for fossil fuels used to provide process heat or power in the operation of eligible biorefineries. To be eligible for payments, biorefineries must have been in existence on or before June 18, 2008.
Applications will be accepted from April 20, 2018 through July 19, 2018. Applications received after July 19, 2018, regardless of their postmark, will not receive consideration. If the actual deadline falls on a weekend or a federally-observed holiday, the deadline is the next Federal business day.
Applications and forms may be obtained from:
• USDA, Rural Business-Cooperative Service, Energy Division, Attention: Repowering Assistance Program, 1400 Independence Avenue SW, STOP 3225, Washington, DC 20250-3225.
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For further information on this payment program, please contact Fred Petok, USDA, Rural Business-Cooperative Service, Energy Division, 1400 Independence Avenue SW, Room 6870, STOP 3225, Washington, DC 20250-3225. Telephone: 202-690-0784. Email:
The Agency encourages applications that will support recommendations made in the Rural Prosperity Task Force report to help improve life in rural America (
In accordance with the Paperwork Reduction Act of 1995, the information collection requirements associated with the Section 9004 Repowering Assistance Program, as covered in this Notice, have been approved by the Office of Management and Budget (OMB) under OMB Control Number 0570-0066.
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In accordance with 7 CFR 4288.10(a)(2), Corporations and entities with more than one biorefinery can submit an application for only one of their biorefineries. However, if a corporation or entity has multiple biorefineries located at the same location, the entity may submit an application that covers such biorefineries provided the heat and power used in the multiple biorefineries are centrally produced.
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The applicant must demonstrate that it has sufficient funds or has obtained commitments for sufficient funds to complete the repowering project, taking into account the amount of the payment request in the application.
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The Agency will evaluate projects based on the cost, cost-effectiveness, and capacity of projects to reduce fossil fuels used.
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For further information about this Notice, please contact Fred Petok, USDA, Rural Business—Cooperative Service, Energy Division, 1400 Independence Avenue SW, Room 6870, STOP 3225, Washington, DC 20250-3225. Telephone: 202-690-0784. Email:
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at
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USDA is an equal opportunity provider, employer, and lender.
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, May 21,
Monday, May 21, 2018, at 10:00 a.m. (EDT).
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 1-800-877-8339 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
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 New Jersey State Advisory Committee to the Commission will convene by conference call, on Friday, May 18, 2018 at 11:30 a.m. (EDT). The purpose of the meeting is select additional officers and discuss plans, including a date, for an in-person mini briefing on the several topics proposed by Committee members for a civil rights project. The Committee will determine whether to conduct the mini briefing meeting in June.
Friday, May 18, 2018, at 11:30 a.m. (EDT).
Ivy L. Davis, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-888-778-9069 and conference call ID: 6970676. 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 1-800-877-8339 and providing the operator with the toll-free conference call number:1-888-778-9069 and conference call ID: 6970676.
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
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Alaska Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Alaska Time) Thursday, May 10, 2018. The purpose of the meeting is for the Committee to discuss report writing schedule.
The meeting will be held on Thursday, May 10, 2018, at 12:00 p.m. AKT.
Ana Victoria Fortes (DFO) at
This meeting is available to the public through the following toll-free call-in number: 877-874-1563, conference ID number: 2785200. Any interested member of the public may call this number and listen to the meeting. 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. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
National Weather Service, National Oceanic and Atmospheric Administration, U.S. Department of Commerce.
Notice of request for information.
On behalf of the National Science and Technology Council (NSTC), Committee on Homeland and National Security, the National Weather Service (NWS) requests input from all interested parties on the development of an update to the National Space Weather Strategy (Strategy). Through this Request for Information (RFI), NWS seeks input from the public on ways to improve government coordination and on long-term guidance for Federal programs and activities to enhance national preparedness to space weather events, including geomagnetic disturbance (a natural source of electromagnetic pulse); promote American leadership in space weather research, technology, and innovation; and improve the safety and viability of human and robotic space activities. This RFI also seeks input on ways to enhance private sector engagement across these endeavors. The public input provided in response to this RFI will inform the NSTC as it works with Federal agencies and other stakeholders to develop the updated Strategy.
Responses are due by May 16, 2018.
You may submit comments by email to
Michael Bonadonna,
Space weather, a natural source of electromagnetic pulse (EMP), can disrupt, degrade, or damage infrastructure and technology systems, including the electric power grid. Space weather can also blackout air traffic control and high frequency communications systems. Beyond terrestrial systems, space weather can affect satellite systems, interfere with GPS service, endanger the lives of humans in space, and delay the launch of space missions. This makes preparing for space weather events critical to national security, infrastructure services, space missions, and technology innovations (such as autonomous vehicles) that rely on communications systems and GPS for positioning, navigation, and timing services.
Preparing the Nation for space weather events will contribute to addressing many priorities identified in the 2017 National Security Strategy (NSS). The NSS identifies the need for America to lead in research, technology, and inventions through collaborations with allies and partners, leveraging private capital and expertise, and rapidly fielding innovations. Additionally, the NSS calls for promoting American resilience through improving risk management, building a culture of preparedness, and improving planning. Space weather phenomena, including EMP, can disrupt or damage technology and critical infrastructure systems, challenging national resilience and necessitating new and innovative approaches to addressing this hazard.
The NSS identifies the need for the United States to maintain leadership and freedom of action in space, including advancing space as a priority domain, promoting space commerce, and maintaining the lead in exploration. In addition to the NSS, Space Policy Directive—1 (December 11, 2017) calls for the Nation to lead an innovative and sustainable program of exploration with commercial and international partners to enable human expansion across the solar system and to bring back to Earth new knowledge and opportunities. Robust space weather observing and forecasting capabilities are key to the safety and viability of human and robotic space activities.
NSTC has begun the process to update the Strategy, and is soliciting public input through this RFI to obtain recommendations from a wide range of stakeholders, including representatives from diverse industries, academia, and other relevant organizations and institutions. The public input provided in response to this RFI will inform the NSTC as it works with Federal agencies and other stakeholders to update the Strategy.
Through this RFI, NSTC seeks responses to the following questions to improve government coordination and provide long-term guidance for Federal programs and activities in support of national preparedness for space weather events, on Earth and in space; and, to promote American leadership in space weather research, technology, and innovation. Responses should clearly indicate which question is being addressed.
1. How can the Federal Government improve internal and external coordination and better inform the long-term guidance and direction for Federal programs and activities that support national preparedness for space weather events?
2. In priority order, how, where, and why should the Federal Government invest limited resources to enhance research, technology, and innovation to improve observations and understanding of space weather events? Please include near-term and long-term objectives for each investment.
3. In priority order, what activities should the Federal Government undertake to enhance national capabilities to prepare for, recover from, adapt to, or otherwise mitigate the effects of space weather events? Please include near-term and long-term objectives for each activity.
4. What innovative tools, platforms, or technologies are needed by the Federal Government and space weather research and development communities to advance the transition of research to operations for models and observations of space weather phenomena? Please include any barriers to implement the identified tools, platforms, or technologies.
5. In priority order, what opportunities exist to enhance U.S. operational space weather predictions, alerts, and services, for Earth, near-Earth, and deep space applications? Please include any barriers for implementation and utilization of these capabilities.
6. Are there regulatory or other barriers to commercial activities associated with space weather prediction, observation, or the transitioning of research to operations? Please list any, in priority order, and describe how the barrier(s) impedes activity.
7. Beyond regulation and grant programs, what can the federal government do to enable and advance the private sector role for capabilities, forecasting, modeling, mitigation, research, development, and observation in the space weather domain?
8. What opportunities exist for the United States to marshal the collective resources of like-minded nations and organizations to address the global hazard of space weather?
9. Is there any additional information related to enhancing national capabilities to address space weather events, not requested above, that you believe NSTC should consider?
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) continues to find that certain companies covered by this administrative review made sales of subject merchandise at less than normal value.
Applicable April 20, 2018.
Yang Jin Chun or Bryan Hansen, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5760 and (202) 482-3683, respectively.
On December 6, 2017, Commerce published the preliminary results of the administrative review of the antidumping duty order on diamond sawblades from China covering the period of review (POR) November 1, 2015, through October 31, 2016.
The merchandise subject to the order is diamond sawblades. The diamond sawblades subject to the order are currently classifiable under subheadings 8202 to 8206 of the Harmonized Tariff Schedule of the United States (HTSUS), and may also enter under subheading 6804.21.00. The HTSUS subheadings are provided for convenience and customs purposes. A full description of the scope of the order is contained in the Issues and Decision Memorandum.
All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in
We preliminarily found that Danyang City Ou Di Ma Tools Co., Ltd., Danyang Hantronic Import & Export Co., Ltd., Danyang Like Tools Manufacturing Co., Ltd., Danyang Tsunda Diamond Tools Co., Ltd., Jiangsu Huachang Tools Manufacturing Co., Ltd., Jiangsu Inter-China Group Corporation, Orient Gain International Limited, Qingdao Shinhan Diamond Industrial Co., Ltd., and Sino Tools Co., Ltd., which have been eligible for separate rates in previous segments of the proceeding and are subject to this review, did not have any reviewable entries of subject merchandise during the POR.
Commerce preliminarily determined that 20 respondents are eligible to receive separate rates in this review.
We made no revisions to the
As a result of this administrative review, we determine that the following weighted-average dumping margins exist for the period November 1, 2015, through October 31, 2016:
Pursuant to section
We intend to issue assessment instructions to CBP 15 days after the date of publication of the final results of review.
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date as provided by section 751(a)(2)(C) of the Act: (1) For subject merchandise exported by the companies listed above that have separate rates, the cash deposit rate will be the rate established in these final results of review for each exporter as listed above; (2) for previously investigated or reviewed Chinese and non-Chinese exporters not listed above that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the exporter-specific rate; (3) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be that for the China-wide entity; (4) for all non-Chinese exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Chinese exporter that supplied that non-Chinese exporter. These deposit requirements shall remain in effect until further notice.
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.
These final results of review are issued and published in accordance with sections 751(a)(1) and 777(i) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) has determined that certain producers/exporters of stainless steel bar (SS Bar) from India made sales of subject merchandise at less than normal value (NV) during the period of review (POR) July 1, 2015, through June 30, 2016. Accordingly, they are hereby reinstated in the antidumping order on SS Bar from India.
Applicable April 20, 2018.
Thomas Schauer, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-0410.
On October 18, 2017, Commerce published the preliminary results of this changed circumstances review and intent to reinstate Venus Wire Industries Pvt. Ltd. and its affiliates Precision Metals, Sieves Manufacturers (India) Pvt. Ltd., and Hindustan Inox Ltd. (collectively, the Venus Group), and Viraj Profìles Ltd. (Viraj) in the antidumping duty order on SS Bar from India.
On January 9, 2018, we received case briefs from the Venus Group and Viraj.
Commerce conducted this changed circumstances review in accordance with section 751(b)(1) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.216(d). For a full description of the methodology underlying our conclusions,
The merchandise subject to the order is SS bar. SS bar means articles of stainless steel in straight lengths that have been either hot-rolled, forged, turned, cold-drawn, cold-rolled or otherwise cold-finished, or ground, having a uniform solid cross section along their whole length in the shape of circles, segments of circles, ovals, rectangles (including squares), triangles, hexagons, octagons, or other convex polygons. SS bar includes cold-finished
Except as specified above, the term does not include stainless steel semi-finished products, cut-to-length flat-rolled products (
Imports of these products are currently classifiable under subheadings 7222.10.00, 7222.11.00, 7222.19.00, 7222.20.00, 7222.30.00 of the Harmonized Tariff Schedule (HTS). Although the HTS subheadings are provided for convenience and customs purposes, our written description of the scope of the order is dispositive.
In requesting revocation, pursuant to 19 CFR 353.25(b) (1996) and 19 CFR 353.25(a)(2)(iii) (1996),
In this case, because other exporters in India remain subject to the SS Bar order, the order remains in effect, and the Venus Group and/or Viraj may be reinstated in the order. Commerce conditionally granted the Venus Group and Viraj revocation based, in part, upon their agreement to immediate reinstatement in the antidumping duty order if Commerce were to find that the companies resumed dumping of SS Bar from India.
As discussed in the Issues and Decision Memorandum, we continue to find that the use of facts available is warranted in determining the dumping margin of the Venus Group and Viraj pursuant to section 776(a) of the Act. Further, we continue to find that the Venus Group and Viraj failed to cooperate to the best of their ability and, therefore, the use of facts available with an adverse inference is appropriate (AFA), pursuant to section 776(b) of the Act. We have assigned, as AFA, the rates below to the Venus Group and Viraj. Accordingly, we are reinstating the Venus Group and Viraj in the antidumping duty order on SS Bar from India.
All issues raised in the case and rebuttal briefs by parties to this changed circumstances review are addressed in the Issues and Decision Memorandum. A list of the issues which parties raised and to which we respond in the Issues and Decision Memorandum is attached to this notice as an Appendix.
Commerce determines that the following weighted-average dumping margins exist for the period July 1, 2015, through June 30, 2016:
Normally,
Because we established that SS bar from India produced and/or exported by the Venus Group and Viraj are being sold at less than NV, the Venus Group and Viraj are hereby reinstated in the antidumping duty order on SS Bar from India effective upon the publication of this notice in the
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing these results of review in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216.
Minority Business Development Agency, Department of 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 April 27, 2018.
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 Antavia Grimsley, Management Analyst, Minority Business Development Agency, U.S. Department of Commerce, Room 5063, 1401 Constitution Avenue NW, Washington, DC, 20230; telephone (202) 482-7458, and email:
The Minority Business Development Agency (MBDA) is the only federal agency created exclusively to foster the growth and global competitiveness of minority-owned businesses in the United States. For this purpose, a minority owned business must be owned or controlled by one of the following persons or group of persons: African American, American Indian, Alaska Native, Asian, Hispanic, Native Hawaiian, Pacific Islander, Asian Indian, and Hasidic Jew. MBDA provides management and technical assistance to large, medium, and small minority business enterprises through a network of business centers throughout the United States.
Since 1983, every president has issued a Presidential Proclamation designating one week as National Minority Enterprise Development (MED) Week. MBDA recognizes the role that minority entrepreneurs play in building the Nation's economy by honoring businesses that are making a significant contribution through the creation of jobs, products and services, in addition to supporting their local communities. The National Minority Business Awards Program is a key element of MED Week and celebrates the outstanding achievements of minority entrepreneurs. MBDA may make awards in the following categories: Minority Construction Firm of the Year, Minority Export Firm of the Year, Minority Manufacturing Firm of the Year, Minority Health Products and Services Firm of the Year, Minority Innovative Technology Firm of the Year, Minority Marketing and Communications Firm of the Year, Minority Professional Services Firm of the Year, Minority Veteran-Owned Firm of the Year, Minority “Under 30” Firm of the Year, and MBDA Minority Business Enterprise of the Year. In addition, MBDA may recognize trailblazers and champions through the Access to Capital Award, Advocate of the Year Award, Distinguished Supplier Diversity Award, Abe Venable Legacy Award for Lifetime Achievement, and Ronald H. Brown Leadership Awards. All awards will be presented at a ceremony during National MED Week. Nominations for these awards are open to the public. MBDA must collect two types of information: (a) Information identifying the nominee and nominator, and (b) information explaining why the nominee should be given the award. The information will be used to determine those applicants best meeting the preannounced evaluation criterion. Use of a nomination form standardizes and limits the information collected as part of the nomination process. This makes the competition fair and eases the burden on applicants and reviewers. Participation in the National Minority Business Awards competition is voluntary and the awards are strictly honorary.
The form may be submitted electronically or paper format.
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 Institute for Standards and Technology, 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 June 19, 2018.
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 Elizabeth Reinhart, NIST Management and Organization Office,
The NIST Center for Neutron Research (NCNR) Information Management System (IMS) is a public facing, web-based application to collect, manage and report operational data related to NCNR's role as a unique national user facility which was chartered to serve the nation's scientific community by providing unique experimental apparatus for scientific studies using neutron scattering. In order to fulfill that mission, NCNR established a complex business process to fairly distribute available scientific resources to prospective external users, outlined by the following steps:
• Registration of NCNR users
• Collection of scientific experiment proposals
• Regularly scheduled peer review of said proposals
• Merit-based award of available experimental resources
• Experiment date scheduling for selected projects (instrument scheduling)
• Collection and management of data required by the NCNR site access protocol
• Managing the Health Physics training of arriving scientists
• Coordination of administrative data
• Collection of data in support of related activities such as NCNR Summer School for facility users
• Management of the research results such as collected data, and subsequent publications
• Numerous reporting functions used to evaluate and manage the NCNR activities
Information will be collected electronically through the internet.
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; public meeting.
The Mid-Atlantic Fishery Management Council's (Council) Scientific and Statistical Committee (SSC) will hold a meeting.
The meeting will be held on Tuesday, May 8, 2018, from 10 a.m. through 5 p.m. and on Wednesday, May 9, 2018, from 8:30 a.m. to 12:30 p.m. See
The meeting will take place at the Admiral Fell Inn, 888 South Broadway, Baltimore, MD 21321; telephone: (410) 522-7380.
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The purpose of this meeting is to make multi-year ABC recommendations for Atlantic Mackerel based on the results of the recently completed benchmark stock assessment. A review the most recent survey and fishery data and the currently implemented 2019 ABC for Butterfish,
A detailed agenda and background documents will be made available on the Council's website (
These meetings are physically accessible to people with disabilities. Requests for sign language
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public hearings.
The South Atlantic Fishery Management Council (Council) will hold a series of public hearings pertaining to Vision Blueprint Regulatory Amendments 26 and 27 to the Snapper Grouper Fishery Management Plan for the South Atlantic Region. The amendments address recreational (Amendment 26) and commercial (Amendment 27) measures as identified in the Council's Vision Blueprint for the Snapper Grouper Fishery.
The public hearings will be held via listening stations and webinar on May 8, May 9, and May 10, 2018.
The hearings will be held via webinar. See
Kim Iverson, Public Information Officer, SAFMC; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843/769-4520; email:
The public hearings will be conducted via webinar with assigned listening stations. The public hearings will begin at 6 p.m. Registration for the webinars is required. Registration information will be posted on the Council's website at
1. Haddrell's Point Tackle, 885 Ben Sawyer Blvd., Mount Pleasant, SC 29464.
2. Southeast Regional Branch Library, 10599 Deerwood Park Blvd., Jacksonville, FL 32256.
3. NC Division of Marine Fisheries, Southern District Office, 127 Cardinal Drive Extension, Wilmington, NC 28405.
1. Cocoa Beach Public Library, 550 N. Brevard Ave., Cocoa Beach, FL 32931.
2. NC Division of Marine Fisheries, Central District Office, 5285 Hwy 70 West, Morehead City, NC 28557.
1. Murrells Inlet Community Center, 4462 Murrells Inlet Road, Murrells Inlet, SC 29576.
2. Marathon Government Center, BOCC, 2798 Overseas Highway, 2nd Floor, Marathon, FL 33050.
3. Hatteras Community Building, 57689 NC Hwy 12, Hatteras, NC 27943.
The draft regulatory amendment contains actions to address recreational measures as identified in the Council's Vision Blueprint for the Snapper Grouper Fishery. The amendment proposes modifying the species composition of recreational aggregates to better reflect how fishermen are currently fishing and allow more focused management measures (
The draft regulatory amendment contains actions to address commercial measures as identified in the Council's Vision Blueprint for the Snapper Grouper Fishery. The amendment addresses concerns over equitable access for commercial fishermen fishing in the snapper grouper fishery and proposes measures to help minimize discards. The regulatory amendment includes actions for split commercial seasons for blueline tilefish, snowy grouper, greater amberjack, and red porgy. The amendment also includes actions to modify the commercial trip limit for blueline tilefish, greater amberjack, red porgy, and vermilion snapper. Other measures include specifying a minimum size limit for almaco jack, implementing a trip limit for the Other Jacks complex, extending the seasonal closure for red grouper in federal waters off North Carolina and South Carolina, removing the minimum size limit for three deep-water snappers, and reducing the commercial minimum size limit for gray triggerfish off the east coast of Florida.
During the public hearings, Council staff will present an overview of each amendment and will be available for informal discussions and to answer questions via webinar. Area Council members will be present at each of the Listening Stations. Members of the public will have an opportunity to go on record to offer their comments for consideration by the Council.
These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
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).
In January 2011, the National Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries Service (NMFS) implemented a trawl rationalization program, a catch share program, for the Pacific coast groundfish fishery's trawl fleet. The program was developed through Amendment 20 to the Groundfish Fishery Management Plan (FMP), under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801
Several of the information collections have been merged into other information collections (OMB Control No. 0648-0620 and OMB Control No. 0648-0738) where they have a better fit, and thus the burden and cost for this collection has decreased.
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
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting webinar.
The South Atlantic Fishery Management Council (Council) will hold a public meeting of its Coral Advisory Panel.
The meeting will be held via webinar on May 9, 2018, from 1 p.m. until 5 p.m.
Kim Iverson, Public Information Officer, SAFMC; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email:
Agenda items for the Coral Advisory Panel include the following: An update on fishery plan amendments currently under review and those recently approved by the Council; an overview of Joint Coral Amendment 10, Golden Crab Amendment 10, and Shrimp Amendment 11 addressing allowable fishing areas, Vessel Monitoring Systems (VMS) for the golden crab fishery and transit provisions for shrimp trawlers; updates on coral disease in Florida and deepsea coral research; discussion of the Southeast Florida Coral Conservation Area; and a discussion of regulatory reform. Advisory panel members will provide recommendations as appropriate. They will also elect a new chair and vice-chair.
The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting (webinar).
The Pacific Fishery Management Council's (Pacific Council) Coastal Pelagic Species Management Team (CPSMT) will hold a meeting via webinar that is open to the public.
The webinar will be held Tuesday, May 8, 2018, from 1 p.m. to 4 p.m., or until business has been completed.
The meeting will be held via webinar. A public listening station is available at the Pacific Council office (address below). To attend the webinar, use this link:
Kerry Griffin, Pacific Council; telephone: (503) 820-2409.
The purpose of the meeting is for the CPSMT to develop materials, including a proposed purpose and need statement, to assist the Council in establishing the scope for a potential action to revise the Pacific sardine live bait provisions in the Coastal Pelagic Species Fishery Management Plan, when the Pacific sardine biomass is in an overfished condition. The Council established a process that includes scoping at the June 2018 meeting, adopting a range of alternatives at the September 2018 meeting, and final action at the November 2018 meeting.
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.
The public listening station is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The South Atlantic Fishery Management Council (Council) will hold a meeting of its Scientific and Statistical Committee (SSC) and Socio-Economic Panel (SEP) to review the seasonal autoregressive integrated moving average (SARIMA) model proposed for use by the Southeast Regional Office (SERO) staff to conduct management analyses. See
The SSC and SEP meeting will be held via webinar on Monday, May 7, 2018, from 10 a.m. to 12 p.m.
Mike Errigo; 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email:
This meeting is held to review the SARIMA model proposed for use in management analyses by SERO staff. The SSC decided at their October 24-26, 2017 meeting in Charleston, SC that the complexity of the SARIMA model made it less favorable as a management tool. They also determined that the method using the last 3 years of fishery data was likely more representative of the current fishery than using the entire time series, as was done in the SARIMA model. However, the SEP also reviewed the SARIMA model and concluded that in principle, the SARIMA model is superior to using average catch rates from the last 3 years. The SEP's recommendation was to present both models to the Council as both have pros and cons.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The South Atlantic Fishery Management Council (Council) will hold a meeting of its Spiny Lobster Advisory Panel.
The meeting will be held via webinar on May 7, 2018, from 1 p.m. until 4 p.m.
Kim Iverson, Public Information Officer, SAFMC; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email:
Agenda items for the Spiny Lobster Advisory Panel include the following: A review of Spiny Lobster Amendment 13 (gear requirements and cooperative management procedures), development of a Fishery Performance Report for spiny lobster, and a discussion of regulatory reform. Advisory panel members will provide recommendations as appropriate.
The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
United States Patent and Trademark Office, Commerce.
Request for comments.
The U.S. Court of Appeals for the Federal Circuit (Federal Circuit) recently issued a decision regarding the inquiry of whether a claim limitation represents well-understood, routine, conventional activities (or elements) to a skilled artisan in the relevant field. Specifically, the Federal Circuit found that whether a claim element, or combination of elements, represents well-understood, routine, conventional activities to a skilled artisan in the relevant field is a question of fact. The United States Patent and Trademark Office (USPTO) has implemented this decision in a memorandum recently issued to the Patent Examining Corps (the
Comments must be sent by electronic mail message over the internet addressed to:
Electronic comments submitted in plain text are preferred, but also may be submitted in ADOBE® portable document format or MICROSOFT WORD® format. Comments not submitted electronically should be submitted on paper in a format that facilitates convenient digital scanning into ADOBE® portable document format. The comments will be available for viewing via the USPTO's internet website (
Carolyn Kosowski, Senior Legal Advisor, at 571-272-7688 or Matthew Sked, Senior Legal Advisor, at 571-272-7627, both with the Office of Patent Legal Administration.
The USPTO recognizes that unless careful consideration is given to the particular contours of subject matter eligibility (35 U.S.C. 101), it could “swallow all of patent law.”
As set forth in MPEP § 2106.05(d)(I), an examiner should conclude that an element (or combination of elements) represents well-understood, routine, conventional activity only when the examiner can readily conclude that the element(s) is widely prevalent or in common use in the relevant industry. The
The question of whether additional elements represent well-understood, routine, conventional activity is distinct from patentability over the prior art under 35 U.S.C. 102 and 103. This is because a showing that additional elements are obvious under 35 U.S.C. 103, or even that they lack novelty under 35 U.S.C. 102, is not by itself sufficient to establish that the additional elements are well-understood, routine, conventional activities or elements to those in the relevant field.
1. A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s). A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a). A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with respect to describing such element.
2. A citation to one or more of the court decisions discussed in MPEP § 2106.05(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s).
3. A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s). An appropriate publication could include a book, manual, review article, or other source that describes the state of the art and discusses what is well-known and in common use in the relevant industry. It does not include all items that might otherwise qualify as a “printed publication” as used in 35 U.S.C. 102.
4. A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). This option should be used
The MPEP will be updated in due course to incorporate the changes put into effect the
As discussed previously, the
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to and deletions from the Procurement List.
The Committee is proposing to add a product and services to the Procurement List that will be furnished by the nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
For further information or to submit comments contact: Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the product and services listed below from the nonprofit agencies employing persons who are blind or have other severe disabilities.
The following product and services are proposed for addition to the Procurement List for production by the nonprofit agencies listed:
The following products and services are proposed for deletion from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and deletions from the Procurement List.
This action adds products to the Procurement List that will be furnished by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products and service from the Procurement List previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 3/16/2018 (83 FR 52), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of a qualified nonprofit agency to provide the products and impact of the addition on the current or most recent contractors, the Committee has determined that the products listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will furnish the products to the Government.
2. The action will result in authorizing a small entity to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products proposed for addition to the Procurement List.
Accordingly, the following products are added to the Procurement List:
On 3/2/2018 (83 FR 42), 3/9/2018 (83 FR 47), and 3/16/2018 (83 FR 52), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the products and service listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products and service deleted from the Procurement List.
Accordingly, the following products and service are deleted from the Procurement List:
1089 E. Ninth Street, Cleveland, OH
800 Dan Street, Akron, OH
U.S. Army Corps of Engineers, DoD.
Notice.
Section 7001 of Water Resources Reform and Development Act (WRRDA) 2014 requires that the Secretary of the Army annually submit to the Congress a report (Annual Report) that identifies feasibility reports, proposed feasibility studies submitted by non-Federal interests, and proposed modifications to an authorized water resources development project or feasibility study that meet certain criteria. The Annual Report is to be based, in part, upon requests for proposals submitted by non-Federal interests.
Proposals must be submitted online by August 20, 2018.
Submit proposals online at:
Send an email to the help desk at
Section 7001 of WRRDA 2014 requires the publication of a notice in the
Proposals by non-Federal interests must be entered online and require the following information:
1. The name of all non-Federal interests planning to act as the sponsor, including any non-Federal interest that has contributed to or is expected to contribute toward the non-Federal share of the proposed feasibility study or modification.
2. State if this proposal is for a feasibility study or a modification to an authorized USACE water resources development project or feasibility study and, if a modification, specify the authorized water resources development project or study that is proposed for modification.
3. State the specific project purpose(s) of the proposed study or modification.
4. Provide an estimate, to the extent practicable, of the total cost, and the Federal and non-Federal share of those costs, of the proposed study and, separately, an estimate of the cost of construction or modification.
5. Describe, to the extent applicable and practicable, an estimate of the anticipated monetary and non-monetary benefits of the proposal with regard to benefits to the protection of human life and property; improvement to transportation; the national economy; the environment; or the national security interests of the United States.
6. Describe if local support exists for the proposal.
7. State if the non-Federal interest has the financial ability to provide the required cost share, reference ER 1105-2-100.
8. Upload a letter or statement of support from each associated non-Federal interest.
All provided information may be included in the Annual Report to Congress on Future Water Resources Development. Therefore, information that is Confidential Business Information, information that should not be disclosed because of statutory restrictions, or other information that a non-Federal interest would not want to appear in the Annual Report should not be included.
1. Are related to the missions and authorities of the USACE;
Involves a proposed or existing USACE water resources project or effort whose primary purpose is flood and storm damage reduction, commercial navigation, or aquatic ecosystem restoration. Following long-standing USACE practice, related proposals such as for recreation, hydropower, or water supply, are eligible for inclusion if undertaken in conjunction with such a project or effort.
2. Require specific congressional authorization, including by an Act of Congress;
Comprise the following cases:
a.
• Signed Chief's Reports
• Non-Federal feasibility reports submitted to the Secretary of the Army under Section 203 of WRDA 1986, as amended, under Administration review,
• Ongoing feasibility studies that are expected to result in a Chief's Report, and
• Proposed modifications to environmental infrastructure projects that were authorized prior to the date of enactment of the Water Resources Development Act of 2016 (December 16, 2016) pursuant to Section 219 of WRDA 1992, as amended; and
• Proposed modifications to authorized water resources development projects requested by non-Federal interests through the Section 7001 of WRRDA 2014 process.
b.
• New feasibility studies proposed by non-Federal interests through the Section 7001 of WRRDA 2014 process will be evaluated by the USACE to determine whether or not there is existing study authority, and
• Proposed modifications to studies requested by non-Federal interests through the Section 7001 of WRRDA 2014 process will be evaluated by the USACE to determine whether or not there is existing study authority.
c. The following cases are NOT ELIGIBLE to be included in the Annual Report and will be included in the appendix for transparency:
• Proposals for modifications to non-Federal projects where USACE has provided previous technical assistance. Authorization to provide technical assistance does not provide authorization of a water resources development project.
• Proposals for construction of a new water resources development project that is not the subject of a currently authorized USACE project or a complete or ongoing feasibility study.
• Proposals that do not include a request for a potential future water resources development project through completed feasibility reports, proposed feasibility studies, and proposed modifications to authorized projects or studies.
3. Have not been congressionally authorized;
4. Have not been included in the Annual Report table of any previous
• If the proposal was included in the Annual Report table in a previous Report to Congress on Future Water Resources Development, then the proposal is not eligible to be included in the Annual Report table. If a proposal was previously included in an appendix it may be re-submitted.
5. If authorized, could be carried out by the USACE.
• Whether following the USACE Chief's Report process or Section 7001 of WRRDA 2014, a proposal for a project or a project modification would need a current decision document to provide updated information on the scope of the potential project and demonstrate a clear Federal interest. This determination would include an assessment of whether the proposal is:
Feasibility study proposals submitted by non-Federal interests are for the study only. If Congressional authorization of a feasibility study results from inclusion in the Annual Report, it is anticipated that such authorization would be for the study, not for construction. Once a decision document is completed in accordance with Executive Branch policies and procedures, the Secretary will determine whether to recommend the project for authorization.
All water resources development projects must meet certain requirements before proceeding to construction. These requirements include: (1) That the project is authorized for construction by Congress; (2) that the Secretary, or other appropriate official, has approved a current decision document; and, (3) that the funds for project construction have been appropriated and are available.
Section 902 of WRDA 1986 establishes a maximum authorized cost for projects (902 limit). A Post Authorization Change Report (PACR) is required to be completed to support potential modifications, updates to project costs, and an increase to the 902 limit. Authority to undertake a 902 study is inherent in the project authority, so no authority is required to proceed with the study. Since these PACRs support project modifications, they may be considered for inclusion in the Annual Report if a report's recommendation requires Congressional authorization.
The Secretary shall include in the Annual Report to Congress on Future Water Resources Development a certification stating that each feasibility report, proposed feasibility study, and proposed modification to an authorized water resources development project or feasibility study included in the Annual Report meets the criteria established in Section 7001 of WRRDA 2014.
Please contact the appropriate district office or use the contact information above for assistance in researching and identifying existing authorizations and existing USACE decision documents. Those proposals that do not meet the criteria will be included in an appendix table included in the Annual Report to Congress on Future Water Resources Development. Proposals in the appendix table will include a description of why those proposals did not meet the criteria.
U.S. Army Corps of Engineers, DoD.
Notice of Intent.
Pursuant to the National Environmental Policy Act (NEPA) of 1969, as amended, the U.S. Army Corps of Engineers, Nashville District (USACE) is preparing a draft Environmental Impact Statement (EIS) to support the Dam Safety Modification Study Report (DSMSR) for Center Hill Dam. The study would evaluate the main dam spillway gate operability, the saddle dam fuse plug operation, and spillway additions to the new Roller Compacted Concrete (RCC) berm structure at the saddle dam, all for the purpose of lowering risk at Center Hill Dam, DeKalb County, Tennessee.
Comments regarding the NOI must be received by USACE within 30 days of publication of the NOI on or before May 20, 2018.
USACE-Nashville District, 110 9th Avenue South, RM 405A, Nashville, Tennessee 37203-3817.
Please direct your comments to Joy Broach, Aquatic Biologist, (615) 736-7956; email:
1.
a. Replacement of the current gate machinery with hydraulic machinery that can operate under water;
b. Addition of equipment to the current spillway gates to keep them open if the operating machinery is underwater;
c. Modification of the spillway gates or gate machinery to allow operation from the top of the dam;
d. Relocation of the gate operating machinery to the road level, which would require raising or relocating Highway 96 which currently crosses over the dam;
e. Removal of the existing fuse plug at the saddle dam and installation of spillway additions on top of the newly constructed RCC Berm to discharge flood water down the valley;
f. Modification of the emergency operations plan in the water control manual that determines how to manage floods at Center Hill Dam; and
g. Other alternatives as identified by on-going engineering studies, the public, and agencies.
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Bonneville Power Administration (BPA), Department of Energy (DOE).
Record of Decision (ROD).
The Bonneville Power Administration (BPA) has decided to implement the Proposed Action as described in the Melvin R. Sampson Hatchery, Yakima Basin Coho Project Final Environmental Impact Statement (EIS) (DOE/EIS-0522, November 27, 2017). Under the Proposed Action, BPA will fund the construction and operation of the Melvin R. Sampson Hatchery (MRS Hatchery) in the Yakima Basin in central Washington. Operation of the MRS Hatchery will involve production of up to 700,000 coho salmon for release in the Yakima River and its subbasin, the Naches River. The hatchery will be owned and operated by the Confederated Tribes and Bands of the Yakama Nation (Yakama Nation) and will be constructed on land owned by the Yakama Nation northwest of Ellensburg in Kittitas County, Washington.
This ROD will be available to all interested parties and affected persons and agencies. It is being sent to all stakeholders who requested a copy. Copies of the Melvin R. Sampson Hatchery, Yakima Basin Coho Project Draft and Final EISs and additional copies of this ROD are available from BPA's Public Information Center, P.O. Box 3621, Portland, Oregon 97208. Copies of these documents may also be obtained by using BPA's nationwide toll-free document request line: 1-800-622-4520, or by accessing the project website at
Dave Goodman, Bonneville Power Administration—ECF-4, P.O. Box 3621, Portland, Oregon, 97208-3621; toll-free telephone number 1-800-622-4519; fax number 503-230-5699; or email
BPA is a federal agency that markets power generated from the federal hydroelectric facilities on the Columbia River and its tributaries. BPA's operations are governed by several statutes, including the Northwest Power Act. The Northwest Power Act directs BPA to protect, mitigate, and enhance fish and wildlife affected by the development and operation of those federal hydroelectric facilities. To assist in accomplishing this, the Northwest Power and Conservation Council (Council) makes recommendations to BPA concerning which fish and wildlife projects to fund. The Council gives deference to project proposals developed by state and tribal fishery managers and has a three-step process for reviewing artificial propagation project (
In addition, BPA, U.S. Army Corps of Engineers, and U.S. Bureau of Reclamation signed an agreement in 2008 with the Yakama Nation and other Tribes to work as partners to provide tangible survival benefits for salmon recovery. The 2008 Columbia Basin Fish Accords Memorandum of Agreement includes an agreement to fund the MRS Hatchery contingent on the favorable recommendation from the Council, completion of site-specific environmental review under the National Environmental Policy Act (NEPA), and compliance with other environmental laws.
To meet obligations under NEPA, BPA prepared an EIS in which the Washington Department of Ecology was a cooperating agency. Public scoping for the MRS Hatchery EIS was initiated with the publication of the Notice of Intent in the
In March 2017, BPA issued the draft EIS for public review and comment. Notice of Availability for the draft EIS was published in the
BPA received comments from nine entities on the draft EIS. After consideration of the comments, BPA issued the final EIS in November 2017. The final EIS responded to comments received on the draft EIS and made necessary corrections and revisions to the EIS text. As with the draft EIS, BPA distributed the final EIS to individuals, organizations, tribes, and agencies who had previously requested it, posted it on the BPA project website, and sent out letters announcing its availability to potentially interested parties. A Notice of Availability of the final EIS was published in the
The final EIS considered in detail the Proposed Action and the No Action Alternative. The final EIS also discussed other alternatives that were considered but eliminated from detailed study. The following summarizes the alternatives that were considered in detail in the EIS.
Under the Proposed Action, BPA will fund the Yakama Nation for the construction and operation of the MRS Hatchery. The Proposed Action will help transition the Yakama Nation's existing coho restoration program in which broodstock are collected out-of-basin and juveniles are reared out-of-basin, to a program that will use in-basin rearing (at the MRS Hatchery) and the use of out-of-basin broodstock will be phased out as natural-origin broodstock become available.
The Proposed Action will involve construction of a coho hatchery facility on eight acres at the former Holmes Ranch property. Facilities will include a hatchery building; adult holding and spawning ponds; a shop building; three employee houses; intake screens and a surface water pump station to provide Yakima River water via the existing New Cascade Canal diversion; stoplog supports to allow surface water to be diverted; one existing groundwater well and up to eight new wells; centralized degassing headbox for groundwater treatment and supply; site utilities, including pipes for water intake and discharge (outfall); a waste treatment pond; acclimation ponds and tanks; and site access roads.
Under the Proposed Action, the MRS Hatchery will produce and release up to 500,000 coho parr and up to 200,000 coho smolts as part of the overall coho reintroduction program. Per NMFS consultation (NWR-2011-06509; NMFS 2016a), the production of up to 200,000 smolts and 500,000 parr is authorized. Conversion to an all-smolt release (
Up to 1,000 coho adults, including natural- and hatchery-origin, will be collected at Roza Dam for broodstock for the proposed MRS Hatchery. Adults may also be collected at Prosser Dam as a backup source, and possibly in the future at the Cowiche or Wapatox Dams. The broodstock goal is to collect 1,000 fish that will be processed over a four month period.
Prior to release, smolts will be acclimated in ponds adjacent to tributaries in which they will be released to help encourage their return as adults to these locations. A number of existing ponds, including Jack Creek, Hundley, Boone, and Easton will be used to acclimate coho smolts from the MRS Hatchery. Mobile acclimation units will also be used for a small number of coho smolts in the basin. Juvenile coho propagated at the MRS Hatchery will be released into tributaries that are not currently subject to coho releases, with a goal of seeding more habitats throughout the basin.
Monitoring, research, and evaluation of the overall Yakima-Klickitat Fisheries Project (YKFP) coho reintroduction program is ongoing and would continue under the Proposed Action. Such activities would include coho spawning surveys, snorkel surveys, juvenile collection, and juvenile abundance surveys.
Construction under the Proposed Action will comply with applicable regulatory requirements, permits, and guidance for protection of the environment and human well-being and safety, and will incorporate Best Management Practices such as erosion and dust control, waste management, weed management, fire prevention, and work-hour and noise restrictions. The Proposed Action incorporates special measures such as retaining as much native vegetation as possible, landscaping with native plants, erecting buildings reflective of local character, shielding of facility lighting, and installing water reuse and treatment systems. Instream structures will meet applicable NOAA Fisheries and U.S. Fish and Wildlife Service fish passage design requirements, and construction will be managed to accommodate and reduce impacts on existing fish production and fish use of the affected waters.
Instream work will occur behind temporary cofferdams or other appropriate water diversions and comply with applicable regulations and permits. Solid waste management and hatchery effluent treatment and filtering systems will ensure that discharge will comply with applicable regulations and permit standards.
Under the No Action Alternative as described in the EIS, BPA would have not funded the construction and operation of the proposed MRS Hatchery. The Yakama Nation would have still expanded juvenile release and acclimation locations, but would have not converted to complete in-basin rearing. The Yakama Nation would have likely continued using a combination of artificial production and habitat improvements to meet natural production and harvest goals, including increasing coho spawning in tributaries, phasing out imported releases of coho in the Yakima Basin, and testing and monitoring new acclimation techniques.
Under the No Action Alternative, a portion of the juvenile coho released into the Yakima River as part of the overall YKFP coho reintroduction program would have continued to be reared out-of-basin. The release of out-of-basin juveniles would have expected to result in reduced survival and adult returns and would have not met the Yakama Nation's goal of providing a self-sustaining coho run throughout its historic range.
Following the issuance of the final EIS, BPA received comments from the U.S. Environmental Protection Agency (EPA) Region 10 in accordance with EPA responsibilities to review EISs under Section 309 of the Clean Air Act. The comments were received in a letter dated December 21, 2017 and in follow-up conversations with EPA staff. These comments can be viewed on-line at
Although NEPA does not require written responses to comments received on a final EIS, this section of the ROD summarizes and addresses the EPA comments received since issuance of the final EIS.
EPA's letter stated that the final EIS was responsive to their comments submitted on the draft EIS. EPA also further expanded on comments sent on the draft EIS and requested that BPA conduct additional quantitative analysis of water quality impacts due to hatchery effluent discharge. More specially, EPA requested that various parameters (ammonia nitrogen, dissolved oxygen, and phosphorous, total suspended solids [TSS], turbidity, and biochemical oxygen demand BOD) be considered in the effluent dilution calculations; that effluent dilution calculations be at the point of discharge into the side channel (which flows into the main channel of the Yakima River); that consideration be taken for effluent plumes in the Yakima River if lateral mixing is incomplete; and that BPA provide rationale that the analysis is considering worst-case conditions and rationale that the effluent discharge will achieve water quality standards.
In response to these comments, BPA continued to work with the Washington State Department of Ecology (Ecology), the entity responsible for regulating water quality in the State of Washington, conducted additional waste load calculations, and had further conversations and email exchanges with EPA.
As described in Sections 2.2.3.3, 3.5.1.4.2, 3.5.2.2.4, and 4.1.3.1.2 of the EIS, BPA and the Yakama Nation have worked with Ecology to ensure that the hatchery complies with National Pollutant Discharge Elimination System (NPDES) requirements. Per Washington State Administrative Code (WAC) 173-221A-100, all upland fin fish facilities require wastewater discharge permits requiring compliance with defined effluent standards, and must comply with the applicable Total Maximum Daily Loads (TMDLs). The TMDLs determine the amount of pollutants that a given waterbody, in this case it is the Yakima River, can receive and still meet or exceed water quality standards. The permit application submitted to Ecology described the hatchery design (size, number of fish, water sources and flow rates, dimensions and volumes of settling ponds, discharge points and receiving waters, solid waste disposal areas, and details about the water condition equipment) and the water quality characterization of the hatchery effluent. The technical memo supporting the permit application and the additional hatchery effluent discharge analysis may be viewed on BPA's project website at
The Yakima River 7Q10 flow rate (the lowest 7-day average flow occurring on average once every 10 years) is 1,891 cubic feet per second (cfs), while the volume of discharge from the hatchery will be 4 cfs, 0.002 percent of the river flow. As described in Section 3.5.2.2.4 of the EIS, the effluent limits for general NPDES permit treatment requirements include a net total suspended solids (TSS) maximum concentration of 5 milligrams per liter (mg/l); the calculated TSS concentrations in the hatchery effluent during peak fish feeding (worst case pollutant discharge conditions) is 0.73 mg/l— which is well under the requirements. This TSS limitation requirement is for the end-of-pipe effluent and does not require determinations of lateral mixing or dilution. The hatchery easily meets the TMDL load allocation that has been approved by EPA for the Yakima River.
The additional waste load calculations conducted at EPA's request found that waste load allocations for total ammonia nitrogen (TAN), dissolved oxygen (DO), and total phosphorous associated with hatchery discharge had no-to-minimal influence on the background concentrations (TAN changed background river levels by 0.002mg/l; DO had no change; total phosphorous changed by 0.0004 mg/l over background levels). As described above, the TSS levels would be well under the TMDL load allocation requirements, and because of the correlation of TSS and turbidity, Ecology determined that, based on the limitations associated with TSS, the
Regarding EPA's comment that the side channel dilution rates should be considered, the end-of-pipe effluent that would be discharged into the side channel would meet the water quality standards for the Yakima River, whether it is into the side channel or the main stem itself; dilution is not part of the criteria for meeting the effluent water quality standards. Therefore, BPA believes that further calculations of dilution rates are not necessary or relevant to water quality considerations.
The end-of-pipe effluent water quality also pertains to EPA's comment on whether there would be effluent plumes due to incomplete lateral mixing in the Yakima River. The hatchery operation at full capacity has to meet end-of-pipe discharge limitations that reduce the existing load present in the Yakima River. The WAC sets effluent limitation guidelines for the pollutant of concern to meet water quality standards at the end-of-pipe, not at some point downstream after a mixing zone or dilution factor are taken into consideration. Therefore, because the effluent itself would meet load requirements, there would be no plumes within the river due to the effluent and further consideration of lateral mixing is not necessary or relevant.
Ecology is poised to issue an NPDES permit for the hatchery and has stated that it is satisfied that the hatchery effluent would clearly meet all water quality criteria. As such, BPA believes it has a sufficient understanding of the impacts of the hatchery effluent on water quality, that the final EIS provides appropriate consideration and analyses of these impacts to meet the requirements of NEPA, and that the additional calculations do not alter the conclusions made in the final EIS about potential water quality impacts.
In making its decision to implement the Proposed Action, BPA has considered and balanced a variety of relevant factors. BPA considered how well the Proposed Action and the No Action Alternative would fit with BPA's statutory missions and relevant policies and procedures. BPA also considered the environmental impacts described in the final EIS, as well as public comments received throughout the NEPA process for the Project.
Another consideration was the extent to which each alternative under consideration would meet the following BPA purposes (
• Support efforts to mitigate for effects of the development and operation of the Federal Columbia River Power System on fish and wildlife in the mainstem Columbia River and its tributaries under the Northwest Power Act.
• Assist in carrying out commitments related to proposed hatchery actions that are contained in the 2008 Columbia Basin Fish Accords Memorandum of Agreement with the Yakama Nation and others.
• Implement BPA's Fish and Wildlife Implementation Plan EIS and Record of Decision policy direction, which calls for protecting weak stocks, while sustaining overall populations of fish for their economic and cultural value.
• Minimize harm to natural and human resources, including species listed under the Endangered Species Act.
After considering and balancing all of these factors, BPA has decided to fund the Melvin R. Sampson Hatchery, Yakima Basin Coho Project. The Proposed Action was recommended to BPA for funding by the Northwest Power and Conservation Council and is consistent with the Council's Columbia River Basin Fish and Wildlife Program. Providing funding for the construction of the Proposed Action will help mitigate for the effects of the FCRPS on fish and wildlife by restoring natural coho spawning in the Yakima Basin. In addition, the Proposed Action is consistent with commitments contained in the 2008 Columbia Basin Fish Accords, as well as with BPA's Fish and Wildlife Implementation Plan policy direction for protecting weak stocks, while sustaining overall populations of fish for their economic and cultural value.
In planning and designing the hatchery, BPA, the Yakama Nation, and other project designers worked to minimize environmental and social impacts through project design, consultation with regulatory entities, and development of mitigation measures. Impacts considered and fully disclosed in the final EIS, include disturbance of soils, vegetation removal, conversion of habitat, groundwater and surface water impacts on aquifers and floodplains, impacts of hatchery effluent discharge, impacts of hatchery construction and juvenile coho releases on species such as bull trout and steelhead, and visual changes associated with new structures.
All mitigation measures described in the final EIS and the project Biological Assessment with the U.S. Fish and Wildlife Service have been adopted. A complete list of these measures is presented in the project Mitigation Action Plan, available on the project website. All practicable means to avoid or minimize environmental harm are adopted.
Issued in Portland, Oregon, on April 10, 2018.
National Nuclear Security Administration, Department of Energy.
Proposed subsequent arrangement.
This document is being issued under the authority of the Atomic Energy Act of 1954, as amended. The Department is providing notice of a proposed subsequent arrangement under the Agreement between the Government of the United States of America and the Government of Australia Concerning Peaceful Uses of Nuclear Energy and the Agreement for Cooperation in the Peaceful Uses of Nuclear Energy between the United States of America and the European Atomic Energy Community (Euratom).
This subsequent arrangement will take effect no sooner than May 7, 2018 and after 15 days of continuous session of the Congress has elapsed, beginning the day after the date on which the reports required under section 131b.(1) of the Atomic Energy Act of 1954, as amended, are submitted to the House Foreign Affairs Committee and the Senate Foreign Relations Committee. The two time periods referred to above may run concurrently.
Mr. Sean Oehlbert, Office of Nonproliferation and Arms Control, National Nuclear Security Administration, Department of Energy. Telephone: 202-586-3806 or email:
This subsequent arrangement concerns the retransfer of 507,713 g of U.S.-obligated
In accordance with section 131 of the Atomic Energy Act of 1954, as amended, I have determined that this subsequent arrangement concerning the retransfer of U.S.-obligated special nuclear material for reprocessing will not be inimical to the common defense and security of the United States of America and made the judgment that it will not result in a significant increase in the risk of proliferation beyond that which exists now, or which existed at the time approval was requested.
For the Department of Energy.
Office of Science, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the DOE/NSF High Energy Physics Advisory Panel (HEPAP). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the
Monday, May 14, 2018, 8:30 a.m. to 6:00 p.m.; Tuesday, May 15, 2018, 8:30 a.m. to 4:00 p.m.
Hilton Washington DC North/Gaithersburg, 620 Perry Parkway, Gaithersburg, MD 20877.
John Kogut, Executive Secretary; High Energy Physics Advisory Panel (HEPAP); U.S. Department of Energy; Office of Science; SC-25/Germantown Building, 1000 Independence Avenue SW, Washington, DC 20585; Telephone: (301) 903-1298.
This is a supplemental notice in the above-referenced proceeding Carolina Solar Power, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is May 7, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
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e.
f.
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The Commission strongly encourages electronic filing. Please file comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted, and is ready for environmental analysis at this time.
l.
Goodyear Lake Hydro operates the project in a run-of-river mode. The project experiences substantial seasonal and annual variations in generation, and generates an annual average of 5,985 megawatt-hours. Goodyear Lake Hydro proposes to continue to operate the project in run-of-river mode.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
All filings must (1) bear in all capital letters the title COMMENTS, REPLY COMMENTS, RECOMMENDATIONS, TERMS AND CONDITIONS, or PRESCRIPTIONS; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. Each filing must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
You may also register online at
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o.
Take notice that during the month of March 2018, the status of the above-captioned entities as Exempt Wholesale Generators became effective by operation of the Commission's regulations. 18 CFR 366.7(a)(2017).
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
Take notice that the Commission received the following qualifying facility filings:
Description: Form 556 of Trustees of Princeton University [Plainsboro].
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:
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for new license for the Prospect No. 3 Hydroelectric Project, located on the South Fork Rogue River in Jackson County, Oregon, and has prepared a Final Environmental Assessment (FEA) for the project. The project currently occupies 32.4 acres of federal land managed by the U.S. Forest Service as part of the Rogue River-Siskiyou National Forest.
The FEA contains the staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the FEA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
You may also register online at
For further information, contact Dianne Rodman at (202) 502-6077.
Take notice that on April 13, 2018, UGI Sunbury, LLC, filed a request for waiver of the requirement to provide its certified public accountant certification statement for the 2017 FERC Form No. 2 on the basis of the calendar year ending December 31.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at
This filing is accessible on-line at
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Revision to the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR)—NSPS for Calciners and Dryers in Mineral Industries (Renewal), EPA ICR Number 0746.10, OMB Control Number 2060-0251—to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through April 30, 2018. Public comments were previously requested via the
Additional comments may be submitted on or before May 21, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0028, to: (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
Environmental Protection Agency (EPA).
Notice of availability; request for public comments.
In accordance with the Oil Pollution Act of 1990 (OPA) and the National Environmental Policy Act (NEPA), the Federal and State natural resource trustee agencies for the Louisiana Trustee Implementation Group (Louisiana TIG) prepared a Draft Restoration Plan and Environmental Assessment #4: Nutrient Reduction (Nonpoint Source) and Recreational Use (Draft RP/EA). The Draft RP/EA describes and proposes restoration project alternatives considered by the Louisiana TIG to improve water quality by reducing nutrients from nonpoint sources and to compensate for recreational use services lost as a result of the
The Louisiana TIG will consider public comments received on or before May 21, 2018.
Alternatively, you may request a CD of the Draft RP/EA (see
Once submitted, comments cannot be edited or withdrawn. The Louisiana TIG may publish any comment received on the document. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The Louisiana TIG will generally not consider comments or comment contents located outside of the primary submission (
On April 20, 2010, the mobile offshore drilling unit
The
• U.S. Environmental Protection Agency (EPA);
• U.S. Department of the Interior (DOI), as represented by the National Park Service, U.S. Fish and Wildlife Service, and Bureau of Land Management;
• National Oceanic and Atmospheric Administration (NOAA), on behalf of the U.S. Department of Commerce;
• U.S. Department of Agriculture (USDA);
• State of Louisiana Coastal Protection and Restoration Authority (CPRA), Oil Spill Coordinator's Office (LOSCO), Department of Environmental Quality (LDEQ), Department of Wildlife and Fisheries (LDWF), and Department of Natural Resources (LDNR);
• State of Mississippi Department of Environmental Quality;
• State of Alabama Department of Conservation and Natural Resources and Geological Survey of Alabama;
• State of Florida Department of Environmental Protection and Fish and Wildlife Conservation Commission; and
• State of Texas Parks and Wildlife Department, General Land Office, and Commission on Environmental Quality.
On April 4, 2016, the Trustees reached and finalized a settlement of their natural resource damage claims with BP in a Consent Decree approved by the United States District Court for the Eastern District of Louisiana. Pursuant to that Consent Decree, restoration projects in the Louisiana Restoration Area are now chosen and managed by the Louisiana TIG. The Louisiana TIG is composed of the following Trustees: CPRA, LOSCO, LDEQ, LDWF, LDNR, EPA, DOI, NOAA, USDA.
In a July 2017 notice posted at
The Draft RP/EA is being released in accordance with OPA, NRDA regulations found in the Code of Federal Regulations (CFR) at 15 CFR 990, and NEPA (42 U.S.C. 4321
For the Nutrient Reduction (Nonpoint Source) restoration type, the Draft RP/EA proposes the following preferred project alternatives:
For the Provide and Enhance Recreational Opportunities restoration type, the Draft RP/EA proposes the following preferred project alternatives:
The Draft RP/EA also evaluates a no action alternative. One or more alternatives may be selected for implementation by the Louisiana TIG. The proposed projects are intended to continue the process of using restoration funding to reduce nutrients (nonpoint sources) and restore recreational use services lost as a result of the
The public is encouraged to review and comment on the Draft RP/EA. A public meeting is scheduled to also help facilitate the public review and comment process. After the public comment period ends, the Louisiana TIG will consider the comments received before issuing a Final RP/EA. A summary of comments received and the Louisiana TIG's responses and any revisions to the document, as appropriate, will be included in the final document.
The documents comprising the Administrative Record for the Draft RP/EA can be viewed electronically at
The authority for this action is the Oil Pollution Act of 1990 (33 U.S.C. 2701
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR)—NESHAP for Shipbuilding and Ship Repair Facilities—Surface Coating, EPA ICR Number 1712.10, OMB Control Number 2060-0330, to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through April 30, 2018. Public comments were requested previously, via the
Additional comments may be submitted on or before May 21, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0056, to: (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online either at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR)—NESHAP for Marine Tank Vessel Loading Operations (Renewal), EPA ICR Number 1679.10, OMB Control Number 2060-0289—to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through April 30, 2018. Public comments were previously requested via the
Additional comments may be submitted on or before May 21, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2013-0324, to: (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP. Any owner/operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority. If there is no such delegated authority, the reports are sent directly to the EPA regional office.
Centers for Medicare & Medicaid Services.
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
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' website 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.
2.
Centers for Medicare & Medicaid Services, Department of Health and Human Services.
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 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by May 21, 2018.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
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' website address at website address at
1. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
2. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
The interim final rules also leave the accommodation process in place as an optional process for objecting entities who wish to use it voluntarily. To avoid contracting, arranging, paying, or referring for contraceptive coverage, an organization seeking to be treated as an eligible organization may self-certify (by using EBSA Form 700), prior to the beginning of the first plan year to which an accommodation is to apply, that it meets the definition of an eligible organization. The eligible organization must provide a copy of its self-certification to each health insurance issuer that would otherwise provide such coverage in connection with the health plan (for insured group health plans or student health insurance coverage). The issuer that receives the self-certification must provide separate payments for contraceptive services for plan participants and beneficiaries (or students and dependents). For a self-insured group health plan, the self-certification must be provided to its third party administrator. An eligible organization may alternatively submit a notification to HHS as an alternative to submitting the EBSA Form 700 to the eligible organization's health insurance issuer or third party administrator. A health insurance issuer or third party administrator providing or arranging payments for contraceptive services for participants and beneficiaries in plans (or student enrollees and covered dependents in student health insurance coverage) of eligible organizations must provide a written notice to such plan participants and beneficiaries (or such student enrollees and covered dependents) informing them of the availability of such payments.
Under the interim final regulations, eligible organizations can revoke at any time the accommodation process if
Final rules were published in the
Due to judicial decisions preliminarily enjoining the implementation of the 2017 interim final regulations, the information collection requirements are drafted to be applicable under whichever accommodation rules are in effect (for example, the 2017 interim final rules, or the 2015 final rules if the 2017 interim final rules continue to be enjoined). HHS will only implement the ICRs under regulations that are legally in effect at the time the ICRs are used.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.” The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question and answer (Q&A) guidance addresses questions about implementation of FDA's guidance “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients” (ICH Q7). The Q&A guidance is intended to clarify uncertainties due to the interpretation of certain sections of ICH Q7 and to help ensure that all active pharmaceutical ingredients (APIs) meet the standards for quality and purity they purport or are represented to possess.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, 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, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under ICH. FDA has participated in several ICH meetings designed to enhance harmonization, and FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies.
ICH was established 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 ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; FDA; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association also 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 ICH member and observer. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance.
A final draft of the guidance was submitted to the ICH Assembly and endorsed by the regulatory agencies in June 2015. The guidance provides clarification on the implementation of good manufacturing practices for APIs, as described in ICH Q7.
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 “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.” 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 guidance at
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice of Federal Advisory Committee meeting.
In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) will hold a public meeting.
Wednesday, May 16, 2018, from 11:00 a.m. to 4:00 p.m. ET.
This meeting is a teleconference and webinar. The conference call-in number is 1-800-619-2521 and the passcode is 9271697. The webinar link is
Anyone requesting information regarding the NACNEP meeting should contact CDR Antoine Smith, Designated Federal Official (DFO), Bureau of Health Workforce (BHW), HRSA, in one of three ways: (1) Send a request to the following address: CDR Antoine Smith, DFO, BHW, HRSA, 5600 Fishers Lane, Room 11N120, Rockville, Maryland 20857; (2) call 301-443-3726; or (3) send an email to
NACNEP provides advice and recommendations
During the May 16, 2018, meeting, NACNEP members will be oriented to the work of the Council and identify a topic for 2018. The NACNEP final agenda will be available on the NACNEP website three (3) days prior to the meeting at
Members of the public will have the opportunity to provide comments, which are part of the official Committee record. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written comments to the NACNEP should be sent to CDR Antoine Smith, DFO, using the contact information above, at least three (3) business days prior to the meeting.
Office of the Secretary, Department of Health and Human Services (HHS).
Notice.
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will hold a public teleconference on May 1, 2018.
The NACCD Teleconference is May 1, 2018, from 3:00 p.m. to 4:00 p.m. Eastern Standard Time EST.
We encourage members of the public to attend the teleconference. To register, send an email to
Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), and section 2811A of the Public Health Service Act (42 U.S.C. 300hh-10a), as added by section 103 of the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5), the HHS Secretary, in consultation with the Secretary of the U.S. Department of Homeland Security, established the NACCD. The purpose of the NACCD is to provide advice and consultation to the HHS Secretary with respect to the medical and public health needs of children in relation to disasters.
We encourage members of the public to provide written comments that are relevant to the NACCD Teleconference prior to May 1, 2018. Send written comments by email to
National Institutes of Health, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Mental Health (NIMH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Melba Rojas, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, Office of Science Policy, Planning and Communications, NIMH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Bethesda, Maryland 20892, call 301-443-4335, or email your request, including your mailing address, to
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the
OMB approval is requested for 3 years. There are no costs to respondents' other than their time. The total estimated annualized burden hours are 56.
National Institutes of Health, HHS.
Notice.
The invention listed below is owned by an agency of the U.S. Government and is available for licensing.
Dr. Amy Petrik, 240-627-3721;
Technology description follows.
An effective universal influenza vaccine would eliminate the uncertain and costly process of seasonal influenza vaccine development each year. Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) are developing immunogens which elicit neutralizing antibodies to the highly conserved stem region of the influenza viral protein hemagglutinin. By targeting this highly conserved region, which is nearly identical in various strains of influenza virus, these immunogens could train the immune system to defend against a wide variety of influenza strains including pandemic strains derived from animal reservoirs.
This vaccine candidate employs a protein nanoparticle platform to display portions of the highly conserved stem region of the group 1 hemagglutinin (HA) viral surface protein in its native, trimeric conformation. Animal studies have shown that the HA stem region trimers displayed on a nanoparticle are more immunogenic compared to HA stem region trimers alone. Immunization of mice and ferrets with an H1N1 nanoparticle HA stem immunogen conferred protection from a lethal dose of H5N1 virus.
NIAID is continuing development of these vaccine candidates through animal studies and moving toward clinical evaluation.
This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration.
Coast Guard, DHS.
Notice of intent; request for comments.
The Coast Guard is announcing its intent to enter into a Cooperative Research and Development Agreement (CRADA) with W.L. GORE and Associates Inc. (GORE) to conduct insulation value testing for the Coast Guard's Maritime Cold Weather Suit System (MCWSS) in the air instead of the water, which the system was designed for. While the Coast Guard is currently considering partnering with GORE, we are soliciting public comment on the possible nature of and participation of other parties in the proposed CRADA. In addition, the Coast Guard also invites other potential non-Federal participants, who have the interest and capability to bring similar contributions to this type of research, to consider submitting proposals for consideration in similar CRADAs.
Comments must be submitted to the online docket via
Synopses of proposals regarding future CRADAs must reach the Coast Guard (see
Submit comments online at
If you have questions on this notice or wish to submit proposals for future CRADAs, contact LT Ryan Huebner, Project Official, Surface Branch, U.S. Coast Guard Research and Development Center, 1 Chelsea Street, New London, CT 06320, telephone 860-271-2815, email
We request public comments on this notice. Although we do not plan to respond to comments in the
Comments should be marked with docket number USCG-2018-0185 and should provide a reason for each suggestion or recommendation. You should provide personal contact information so that we can contact you if we have questions regarding your comments; but please note that all comments will be posted to the online docket without change and that any personal information you include can be searchable online (see the
We encourage you to submit comments through the Federal eRulemaking Portal at
If desired, submit detailed proposals for future CRADAs directly to the Coast Guard (see
CRADAs are authorized under 15 U.S.C. 3710(a).
CRADAs are not procurement contracts. Care is taken to ensure that CRADAs are not used to circumvent the contracting process. CRADAs have a specific purpose and should not be confused with procurement contracts, grants, and other type of agreements.
Under the proposed CRADA, the R&D Center will collaborate with one non-Federal participant. Together, the R&D Center and the non-Federal participant will conduct thermo conductive tests on the Coast Guard's MWCSS in various environmental scenarios to determine the system's insulation properties to be used to create safe parameters for personnel wearing the MWCSS during Ice Rescue missions.
We anticipate that the Coast Guard's contributions under the proposed CRADA will include the following:
(1) Provide appropriate staff with pertinent expertise to take the lead in accomplishing the required tasks;
(2) Provide information regarding the ensemble items and parameters needed for creating the test plan;
(3) Provide all support resources, including travel, for Coast Guard staff that supports this CRADA;
(4) Obtain, transport and provide all of the ensemble items to be used during the testing;
(5) Provide personnel support to non-Federal participant to assist with setting up and execute testing in accordance with the agreed upon test plan;
(6) Work with non-Federal participant to develop a Final Report, which will document the methodologies, findings, conclusions, and recommendations of this CRADA work.
We anticipate that the non-Federal participants' contributions under the proposed CRADA will include the following:
(1) Provide appropriate staff with pertinent expertise to support the above mentioned tasks;
(2) Provide all necessary facility resources needed to conduct insulation value testing;
(3) Provide technical approach for the test plan;
(4) Lead the testing runs of the Coast Guard's MWCSS in accordance with the agreed upon test plan;
(5) Provide test data upon completion of testing.
The Coast Guard reserves the right to select for CRADA participants all, some,
(1) How well they communicate an understanding, of and ability to meet, the proposed CRADA's goal; and
(2) How well they address the following criteria:
(a) Technical capability to support the non-Federal party contributions described, and
(b) Resources available for supporting the non-Federal party contributions described.
Currently, the Coast Guard is considering GORE for participation in this CRADA. This consideration is based on the fact that GORE has demonstrated its technical ability and availability of appropriate facilities to effectively determine insulation properties of clothing. However, we do not wish to exclude other viable participants from this or future similar CRADAs.
This is a technology assessment effort. The goal of the Coast Guard for this CRADA is to determine the insulation properties of the Coast Guard's MWCSS in the air instead of the water which the system was designed for. Special consideration will be given to small business firms/consortia, and preference will be given to business units located in the U.S. This notice is issued under the authority of 5 U.S.C. 552(a).
U.S. Customs and Border Protection, Department of Homeland Security.
General notice.
The Generalized System of Preferences (GSP) is a renewable preferential trade program that allows the eligible products of designated beneficiary developing countries to enter the United States free of duty. The GSP program expired on December 31, 2017, but has been renewed through December 31, 2020, effective April 22, 2018, with retroactive effect between January 1, 2018, through April 21, 2018, by a provision in the Consolidated Appropriations Act, 2018.
This document provides notice to importers that U.S. Customs and Border Protection (CBP) will again accept claims for GSP duty-free treatment for merchandise entered, or withdrawn from warehouse, for consumption and that CBP will process refunds on duties paid, without interest, on GSP-eligible merchandise that was entered during the period that the GSP program was lapsed. Formal and informal entries that were filed electronically via the Automated Broker Interface (ABI) using Special Program Indicator (SPI) Code “A” as a prefix to the tariff number will be automatically processed by CBP and no further action by the filer is required to initiate the refund process. Non-ABI filers, and ABI filers that did not include SPI Code “A” on the entry, must timely submit a duty refund request to CBP. CBP will continue conducting verifications to ensure that GSP benefits are available to eligible entries only.
As of April 22, 2018, the filing of GSP-eligible entry summaries may be resumed without the payment of estimated duties, and CBP will initiate the automatic liquidation or reliquidation of formal and informal entries of GSP-eligible merchandise that was entered on or after January 1, 2018, through April 21, 2018, and filed via ABI with SPI Code “A” notated on the entry. Requests for refunds of GSP duties paid on eligible non-ABI entries, or eligible ABI entries filed without SPI Code “A,” must be filed with CBP no later than September 19, 2018.
Instructions for submitting a request to CBP to liquidate or reliquidate entries of GSP-eligible merchandise that was entered on or after January 1, 2018, through April 21, 2018 but without the SPI Code “A” are located at
General questions concerning this notice should be directed to Seth Mazze, Office of Trade, Trade Agreements Branch, 202-863-6567 or at
Section 501 of the Trade Act of 1974, as amended (19 U.S.C. 2461), authorizes the President to establish a Generalized System of Preferences (GSP) to provide duty-free treatment for eligible articles imported directly from designated beneficiary countries for specific time periods. Pursuant to 19 U.S.C. 2465, as amended by section 201(a) of Pub. L. 114-27, 129 Stat. 371, duty-free treatment under the GSP program expired on December 31, 2017.
On March 23, 2018, President Donald J. Trump signed the Consolidated Appropriations Act, 2018 (Pub. Law 115-141, 132 Stat. 348) (the Act). Section 501 of Title V of the Act pertains to the extension of duty-free treatment and the retroactive application for certain liquidations and reliquidations under the GSP. Section 501(b)(1) provides that GSP duty-free treatment will be applied to eligible articles from designated beneficiary countries that are entered, or withdrawn from warehouse, for consumption on or after April 22, 2018 through December 31, 2020. Section 501(b)(2) provides that for entries made on or after January 1, 2018 through April 21, 2018 (30th day after the date of enactment of the Act), to which duty-free treatment would have applied if GSP had been in effect during that time period (“covered entries”), any duty paid with respect to such entry will be refunded provided that a request for liquidation or reliquidation of that entry, containing sufficient information to enable U.S. Customs and Border Protection (CBP) to locate the entry or to reconstruct the entry if it cannot be located, is filed with CBP no later than September 19, 2018 (180 days after enactment of the Act). Section 501(b)(2)(C) provides that any amounts owed by the United States pursuant to section 501(b)(2)(A) will be paid
Field locations will not issue GSP refunds except as instructed to do so by CBP Headquarters. The processing of retroactive GSP duty refunds will be administered by CBP according to the terms set forth below.
As of April 22, 2018, filers may resume filing GSP-eligible entry summaries without the payment of estimated duties.
CBP will automatically liquidate or reliquidate formal and informal entries of GSP-eligible merchandise that were entered on or after January 1, 2018 through April 21, 2018, and filed electronically via the Automated Broker Interface (ABI) using Special Program Indicator (SPI) Code “A” as a prefix to the listed tariff number. Such entry filings will be treated as a conforming request for a liquidation or reliquidation pursuant to section 501(b)(2)(A) of the Act, and no further action by the filer is required to initiate a retroactive GSP duty refund. To avoid confusion, importers should not submit post-importation GSP claims on tariff items filed with the SPI “A” at entry summary. CBP expects to begin processing automatic refunds for these entries shortly after April 22, 2018.
CBP will not automatically process GSP duty refunds for formal covered entries that were not filed electronically via ABI, nor for formal and informal covered entries that were filed electronically via ABI with payment of estimated duties, but without inclusion of the SPI Code “A” as a prefix to the listed tariff number. In both situations, requests for liquidation or reliquidation of covered entries must be made no later than September 19, 2018, pursuant to the procedures set forth in
For merchandise that was imported via the mail, addressees must request liquidation or reliquidation of covered entries no later than September 19, 2018, pursuant to the procedures set forth in
For non-ABI informal entries and baggage declarations, travelers/importers must request liquidation or reliquidation of covered entries no later than September 19, 2018, pursuant to the procedures set forth in
Bureau of Land Management, Interior.
Notice of Intent.
In accordance with Section 20001 of the Tax Cuts and Jobs Act of 2017 (Tax Act), and the National Environmental Policy Act of 1969, (NEPA) as amended, and in a manner similar to the administration of lease sales under the Naval Petroleum Reserves Production Act of 1976, as amended, the Bureau of Land Management (BLM) Alaska State Office, Anchorage, Alaska, intends to prepare a Leasing Environmental Impact Statement (Leasing EIS) to implement an oil and gas leasing program within the area defined as the “Coastal Plain.”
This Notice initiates the public scoping process for the Leasing EIS. Comments on issues, impacts and potential alternatives to be analyzed may be submitted in writing until June 19, 2018. The BLM will hold public scoping meetings in Anchorage, Arctic Village, Fairbanks, Kaktovik and Utqiaġvik. The BLM may hold additional public scoping meetings in other communities if there is strong community interest. The dates, times, and locations of scoping meetings will be announced through local news media, newspapers, and the BLM website.
You may submit comments by any of the following methods:
•
•
•
Nicole Hayes, 907-271-4354; email
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The BLM is undertaking a Coastal Plain Oil and Gas Leasing EIS to implement the leasing program pursuant to the Tax Act (Pub. L. 115-97, Dec. 22, 2017). The Leasing EIS will serve to inform BLM's implementation of the Tax Act, including the requirement to hold not fewer than two lease sales area-wide. It may also inform post-lease activities, including seismic and drilling exploration, development, and transportation of oil and gas in and from the Coastal Plain. Specifically, the Leasing EIS will consider and analyze the potential environmental impacts of various leasing alternatives, including the areas to offer for sale, and the terms and conditions (
The purpose of the public scoping process is to determine the scope of issues to be addressed and to identify the significant issues related to implementing an oil and gas leasing program within the Coastal Plain. Information received during scoping will influence the development of the proposed action and alternatives and guide the environmental analysis.
The BLM will work collaboratively with interested parties to identify the management decisions best suited to local, regional, and national needs and concerns, as well as to develop a proposed action and alternatives consistent with the following criteria:
• The EIS will consider all Federal lands and waters within the area defined by Congress as the Coastal Plain;
• The EIS will address oil and gas leasing and will use scoping to identify issues, impacts and potential alternatives to be addressed;
• Under the Tax Act, not fewer than two lease sales, each to include not fewer than 400,000 acres area-wide of the areas with the highest potential of hydrocarbons, must occur by December 2024;
• The BLM will consider subsistence resources and users, as well as potential actions to minimize adverse impacts to subsistence in accordance with section 810 of the Alaska National Interest Lands Conservation Act (ANILCA); and
• The EIS will appropriately consider the surface management of the Coastal Plain.
Future on-the-ground actions requiring subsequent BLM approval, including proposed seismic and exploration plans or development proposals, would require subsequent NEPA analysis based on specific and detailed information about where and what kind of activity is proposed. Additional site-specific terms and conditions may be required by the Authorized Officer prior to authorizing any oil and gas activity.
Upon completion of a Record of Decision, the BLM intends to conduct lease sales in accordance with the Tax Act.
40 CFR 1501.7.
Bureau of Land Management, Interior.
Notice of call for nominations.
The purpose of this notice is to request public nominations for the Bureau of Land Management (BLM) Resource Advisory Councils (RAC) that have members whose terms are scheduled to expire. RACs provide advice and recommendations to the BLM on land use planning and management of the National System of Public Lands within their geographic areas.
All nominations must be received no later than June 4, 2018.
Nominations and completed applications for RACs should be sent to the appropriate BLM offices listed in the
Twinkle Thompson, BLM Communications, 1849 C Street NW, Room 5645, Washington, DC 20240, telephone: 202-208-7301; email:
The Federal Land Policy and Management Act (FLPMA) directs the Secretary of the Interior to involve the public in planning and issues related to management of lands administered by the BLM. Section 309 of FLPMA (43 U.S.C. 1739) directs the Secretary to establish 10- to 15-member citizen-based advisory councils that are consistent with the Federal Advisory Committee Act (FACA). As required by FACA, RAC membership must be balanced and representative of the various interests concerned with the management of the public lands. The rules governing RACs are found at 43 CFR subpart 1784 and include the following three membership categories:
Simultaneous with this notice, BLM State Offices will issue press releases providing additional information for submitting nominations, with specifics about the number and categories of member positions available for each RAC in the state.
Before including any address, phone number, email address, or other personal identifying information in the application, nominees should be aware this information may be made publicly available at any time. While the nominee can ask to withhold the personal identifying information from public review, BLM cannot guarantee that it will be able to do so.
Nominations and completed applications for RACs should be sent to the appropriate BLM offices listed below:
Lesli J. Ellis-Wouters, BLM Alaska State Office, 222 West 7th Street, Anchorage, AK 99513, 907-271-4418.
Amber Cargile, BLM Arizona State Office, One North Central Avenue, Suite 800, Phoenix, AZ 85004, 602-417-9214.
Steve Razo, BLM California Desert District, 22835 Calle San Juan De Los Lagos, Moreno Valley, CA 92553, 951-697-5217.
Serena Baker, BLM Central California District Office, 5152 Hillsdale Circle, El Dorado Hills, CA 95762, 916-941-3146.
Serena Baker, BLM Central California District Office, 5152 Hillsdale Circle, El Dorado Hills, CA 95762, 916-941-3146.
Jeff Fontana, BLM Northern California District Office, 2550 Riverside Drive Susanville, CA 96130, 530-252-5332.
Amber Iannella, BLM Rocky Mountain District Office, 3028 East Main Street, Cañon City, CO 81212, 719-269-8553.
David Boyd, BLM Northwest District Office, 2300 River Frontage Road, Silt, CO 81652, 970-876-9008.
Shannon Borders, BLM Southwest District Office, 2465 South Townsend Avenue, Montrose, CO 81401, 970-240-5399.
Michael Williamson, BLM Boise District Office, 3948 South Development Avenue, Boise, ID 83705, 208-384-3393.
Suzanne Endsley, BLM Coeur d'Alene District Office, 3815 Schreiber Way, Coeur d'Alene, ID 83815, 208-769-5004.
Sarah Wheeler, BLM Idaho Falls District Office, 1405 Hollipark Drive, Idaho Falls, ID 83401, 208-524-7550.
Heather Tiel-Nelson, BLM Twin Falls District Office, 2878 Addison Avenue East, Twin Falls, ID 83301, 208-736-2352.
Jonathan Moor, BLM North Central Montana District Office, 920 Northeast Main Street, Lewistown, MT 59457, 406-538-1943.
Mark Jacobsen, BLM Eastern Montana/Dakotas District Office, 111 Garryowen Road, Miles City, MT 59301, 406-233-2831.
Mark Jacobsen, BLM Eastern Montana/Dakotas District Office, 111 Garryowen Road, Miles City, MT 59301, 406-233-2831.
David Abrams, BLM Western Montana District Office, 106 North Parkmont, Butte, MT 59701, 406-533-7617.
Mark Matthews, BLM Socorro Field Office, 901 South Highway 85, Socorro, NM 87801, 575-838-1250.
Zachary Stone, BLM Farmington District Office, 6251 College Boulevard, Farmington, NM 87402, 505-564-7677.
Deborah Stevens, BLM Las Cruces District Office, 1800 Marquess Street, Las Cruces, NM 88005, 575-525-4421.
Glen Garnand, BLM Pecos District Office, 2909 West Second Street, Roswell, NM 88201, 575-627-0209.
Kirsten Cannon, Southern Nevada District Office, 4701 North Torrey Pines Drive, Las Vegas, NV 89130, 702-515-5057.
Kyle Hendrix, Battle Mountain District Office, 50 Bastian Road, Battle Mountain, NV 89820; 775-635-4054.
Lisa Ross, Carson City District Office, 5665 Morgan Mill Road, Carson City, NV 89701, 775-885-6107.
Megan Harper, BLM Coos Bay District Office, 1300 Airport Lane, North Bend, OR 97459, 541-751-4353.
Jeff Clark, BLM Spokane District Office, 1103 North Fancher Road, Spokane, WA 99212, 509-536-1297.
Lisa Clark, BLM Prineville District Office, 3050 NE 3rd Street, Prineville, OR 97754, 541-416-6864.
Jennifer Velez, BLM Northwest Oregon District Office, 1717 Fabry Road SE, Salem, OR 97306, 541-222-9241.
Marcia de Chadenedes, BLM San Juan Islands National Monument Office, P.O. Box 3, 37 Washburn Avenue, Lopez Island, Washington 98261, 360-468-3051.
Larisa Bogardus, BLM Lakeview District Office, 1301 S. G Street, Lakeview, OR 97630, 541-947-6237.
Christina Breslin, BLM Medford District Office, 3040 Biddle Road, Medford, OR 97504, 541-618-2371.
Tara Thissell, BLM Burns District Office, 28910 Highway 20 West, Hines, OR 97738, 541-573-4519.
Lola Bird, BLM Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, UT 84101, 801-539-4033.
Emmet Pruss, BLM Wyoming State Office, 5353 Yellowstone Road, P.O. Box 1828, Cheyenne, WY 82009, 307-775-6266.
43 CFR 1784.4-1
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act of 1976, and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Alaska Resource Advisory Council (RAC) will meet as indicated below.
The Alaska RAC will hold a public meeting on Wednesday, May 16, 2018, from 9 a.m. until 5 p.m., and Thursday, May 17, 2018, from 9 a.m. until 4 p.m. A public comment period will be held on Wednesday from noon to 1 p.m. and on Thursday, from 3 p.m. until 3:30 p.m.
The meeting will take place in the Minto Room at the Westmark Fairbanks Hotel & Conference Center, 813 Noble Street, Fairbanks, Alaska. The agenda will be posted online by May 1, 2018, at
Lesli Ellis-Wouters, Communications Director, BLM Alaska State Office, 222 W. 7th Avenue #13, Anchorage, AK 99513;
The 15-member BLM Alaska RAC was chartered to provide advice to the BLM and the Secretary of the Interior on a variety of planning and management issues associated with public land management in Alaska. All advisory council meetings are open to the public.
The agenda will include updates on the National Petroleum Reserve in Alaska (NPR-A), the Greater Mooses Tooth Unit 2 project and proposed Willow Development. There will be updates on current BLM Alaska planning efforts, such as the Road to Ambler Mining District Environmental Impact Statement and the Bering Sea-Western Interior and Central Yukon Resource Management Plans. Four BLM Alaska RAC subcommittees including Placer Mining, Recreation, Alaska Native Claims Settlement Act, and Areas of Critical Environmental Concern will give their reports.
A focus on cooperative management will explore partnership opportunities for the BLM with the State of Alaska, other Federal agencies, local and Tribal governments, and nongovernmental organizations. A session on Alaska subsistence will include Federal and State responsibilities for the Federal Subsistence Management Program. Ahtna, Inc., one of the 13 Alaska Native Regional Corporations established under the Alaska Native Claims Settlement Act, will give a presentation about cooperative subsistence management and effective collaboration between the native corporations and Federal and State agencies.
The RAC will hear Intertribal Coalition presentations from the Tanana Chiefs Conference, Kuskokwim Fish Intertribal Commission, and Ahtna Intertribal Resource Commission. Presentations on BLM Alaska's conservation science partnerships will explore Landscape Conservation Cooperatives (LCCs), including the Northwest Boreal LCC, Western Alaska LCC, Arctic LCC, and Aleutian Bering Sea Islands LCC.
During the public comment period, depending upon the number of people wishing to comment, time for individual oral comments may be limited. Please be prepared to submit written comments. If you have information to distribute to the RAC, please do so prior to the start of the meeting.
You can submit written comments by email to
43 CFR 1784.4-2.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission (the “Commission”) has determined to review in part the final initial determination (the “ID”) issued by the presiding administrative law judge (“ALJ”) on February 15, 2018, finding a violation of section 337 of the Tariff Act of 1930, as amended, in connection with certain asserted patents. The Commission has also determined to extend the target date for the completion of this investigation from June 18, 2018, to June 25, 2018.
Ron Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone 202-205-3427. Copies of non-confidential documents filed in connection with this investigation are or will be 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, Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
On December 5, 2016, the Commission instituted this investigation based on a complaint filed by DSM Desotech, Inc. of Elgin, IL; and DSM IP Assets B.V. of Heerlen, Netherlands (collectively, “DSM” or “Complainants”). 81 FR 87588-89 (Dec. 5, 2016). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), based upon the importation into the United States, the sale for importation, or the sale within the United States after importation of certain UV curable coatings for optical fibers, coated optical fibers, and products containing same by reason of infringement of one or more of claims 1-8, 10-15, and 18-22 of U.S. Patent No. 6,961,508 (“the '508 patent”); claims 1-10 and 13-15 of U.S. Patent No. 7,171,103 (“the '103 patent”); claims 2-4, 9, 11-12, and 15 of U.S. Patent No. 7,067,564 (“the '564 patent”); and claims 1-3, 9, 12, 16-18, 21, and 30 of U.S. Patent No. 7,706,659 (“the '659 patent”).
Prior to the evidentiary hearing, DSM withdrew its allegations as to certain patent claims.
On February 15, 2018, the ALJ issued the ID, which finds only MUV in violation of section 337, and only as to the '508 and '103 patents. The ALJ recommended that the Commission issue a limited exclusion order directed to MUV's infringing products. The ALJ also recommended a bond of forty percent of entered value during the Presidential review period.
On February 27-28, 2018, OUII, DSM, MUV, and OFS filed petitions for review of the ID, and on March 7-8, 2018, the parties filed responses to the petitions. On March 19, 2018, the private parties filed statements on the public interest. The Commission also received comments on the public interest from members of the public.
Having examined the record in this investigation, including the ID, the petitions for review, and the responses thereto, the Commission has determined to review the ID in part. In particular, the Commission has determined to review the following:
(1) Whether respondent OFS imports respondent MUV's accused KS1-043/048 coating.
(2) Whether claim 30 of '659 patent is invalid for lack of written description.
(3) Whether claims 1-8, 11, 15, and 18-19 of the '508 patent are invalid for lack of written description and enablement.
(4) Whether claim 21 of the '508 patent and claims 1-10 and 13-15 of the '103 patent are invalid for lack of written description and enablement.
(5) Whether the accused products infringe the '508, '103, and '659 patents.
(6) Whether the technical and economic prongs of the domestic industry requirement have been met for the '508, '103, and '659 patents.
The Commission has determined to not review the remainder of the ID. The Commission does not request any briefing at this time.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
In accordance with Departmental Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in
This proposed Consent Decree concerns a complaint filed by the United States against Defendant Mr. James Bult, pursuant to 33 U.S.C. 1311(a), 1319(b) and 1319(d), to obtain injunctive relief from and impose civil penalties against the Defendant for violating the Clean Water Act by discharging pollutants without a permit into waters of the United States. The proposed Consent Decree resolves these allegations by requiring the Defendant to restore the impacted areas, perform mitigation, and pay a civil penalty.
The Department of Justice will accept written comments relating to this proposed Consent Decree for thirty (30) days from the date of publication of this Notice. Please address comments to Mr. Kurt N. Lindland, Assistant United States Attorney for the United States Attorney's Office, Northern District of Illinois, and Mr. Scott A. Schachter, Assistant Section Chief for the United States Department of Justice, Environment and Natural Resources Division, Environmental Defense Section, Post Office Box 7611, Washington, DC 20044, and refer to
The proposed Consent Decree may be examined at the Clerk's Office, United States District Court for the Northern District of Illinois, Eastern Division, 219 South Dearborn Street, Chicago, IL 60604. In addition, the proposed Consent Decree may be examined electronically at
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Wage and Hour Division (WHD) sponsored information collection request (ICR) titled, “Family and Medical Leave Act of 1993, As Amended,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before May 21, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-WHD, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
This ICR seeks to extend PRA authority for the Family and Medical Leave Act of 1993, As Amended (FMLA) information collection. More specifically, this ICR is to obtain clearance for statutory notice and certification provisions that assist employees and employers in meeting their FMLA-required third-party notification obligations. The recordkeeping requirements covered by this ICR are necessary in order for the DOL to carry out its statutory obligation under FMLA section 106 (29 U.S.C. 2616) to investigate and ensure employer compliance. FMLA sections 106 and 404 authorize this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on May 31, 2018. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, “Permissible Equipment Testing,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before May 21, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov website at
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-MSHA, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
This ICR seeks to extend PRA authority for the Permissible Equipment Testing information collection requirements codified in regulations 30 CFR parts 6 through 36 that contain application, testing and inspection, and quality control procedures for the approval of mining equipment or explosives used in both underground and surface coal, metal, and nonmetal mines. Except for parts 6 and 7, the MSHA conducts most of the testing and evaluation of products for a fee paid by the applicant; although, some regulations require the manufacturer to pretest the product. Upon MSHA approval, the manufacturer must ensure the product continues to conform to the specifications and design evaluated and approved by the MSHA. In some instances, as part of the approval process, manufacturers are required to have a quality control or assurance plan. Federal Mine Safety and Health Act of
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on April 30, 2018. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA announces the applications of Underwriters Laboratories, Inc., for expansion of its scope of recognition as a Nationally Recognized Testing Laboratory and presents the Agency's preliminary finding to grant the applications. Additionally, OSHA proposes to add twenty-two test standards to the NRTL Program's List of Appropriate Test Standards.
Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before May 7, 2018.
Submit comments by any of the following methods:
Information regarding this notice is available from the following sources:
The Occupational Safety and Health Administration is providing notice that Underwriters Laboratories, Inc., (UL) is applying for expansion of its current recognition as a NRTL. UL requests the addition of twenty-seven additional test standards to its NRTL scope of recognition.
OSHA recognition of a NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition and is not a delegation or grant of government authority. Recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.
The Agency processes applications by a NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the
Each NRTL's scope of recognition includes: (1) The type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has (have) the technical capability to perform the product testing and product-certification activities for test standards within the NRTL's scope.
UL currently has fourteen facilities (sites) recognized by OSHA for product testing and certification, with its headquarters located at: Underwriters Laboratories, Inc. 333 Pfingsten Road, Northbrook, Illinois 60062. A complete list of UL sites recognized by OSHA is available at
UL submitted an application, dated May 31, 2017, (OSHA-2009-0025-0020), to expand its recognition to include the addition of 26 additional test standards to UL's scope of recognition. This application was updated on November 1, 2017 (OSHA-2009-0025-0021) to include an additional standard for a total of 27 standards. OSHA staff performed detailed analyses of the application packets and other pertinent information. OSHA did not perform any on-site reviews in relation to these applications.
OSHA preliminarily determined that one of the standards requested in UL's application, UL 2703, “Standard for Mounting Systems, Mounting Devices, Clamping/Retention Devices, and Ground Lugs for Use with Flat-Plate Photovoltaic Modules and Panels,” does not meet the requirements of 29 CFR 1910.7's for an appropriate test standard in OSHA's NRTL Program. This standard is not included on the NRTL Program's List of Appropriate Test Standards. The types of products covered by UL 2703 do not fit into any of the categories covered by OSHA's NRTL Program. Specifically, the standard covers mechanical mounting and support equipment for solar panels,
Periodically, OSHA will propose to add new test standards to the NRTL List of Appropriate Test Standards following an evaluation of the test standard document. To qualify as an appropriate test standard, the Agency evaluates the document to (1) verify it represents a product category for which OSHA requires certification by a NRTL, (2) verify the document represents an end product and not a component, and (3) verify the document defines safety test specifications (not installation or operational performance specifications).
In this notice, OSHA proposes to add twenty-two new test standards to the NRTL Program's List of Appropriate Test Standards. Table 2, lists the test standards that are new to the NRTL Program. OSHA preliminarily determined that these test standards are appropriate test standards and proposes to include them in the NRTL Program's List of Appropriate Test Standards. OSHA seeks public comment on this preliminary determination.
Because the mechanical equipment covered by UL 2703 does not fall within the type of equipment covered by OSHA's NRTL Program, OSHA preliminary determined that UL 2703 is not an appropriate test standard and does not propose to include it in the NRTL Program's List of Appropriate Test Standards. OSHA also seeks public comment on this preliminary determination.
UL submitted acceptable applications for expansion of its scope of recognition. OSHA's review of the application files and related material indicate that UL can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of the 26 appropriate test standards for NRTL testing and certification listed above. This preliminary finding does not constitute an interim or temporary approval of UL's applications.
OSHA welcomes public comment as to whether UL meets the requirements of 29 CFR 1910.7 for expansion of its recognition as a NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer time period. OSHA may deny a request for an extension if it is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, Occupational Safety and Health Administration, U.S. Department of Labor, listed in
OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, make a recommendation to the Assistant Secretary for Occupational Safety and Health on whether to grant UL's applications for expansion of its scope of recognition. The Assistant Secretary will make the final decision on granting the applications. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.
OSHA will publish a public notice of this final decision in the
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
Occupational Safety and Health Administration (OSHA), Labor.
Notice of final decisions.
In this notice, OSHA announces its final decision to: (1) Delete a test standard from the NRTL Program's list of appropriate test standards; and (2) update the scopes of recognition of several NRTLs.
OSHA's final decisions are effective on April 20, 2018.
Information regarding this notice is available from the following sources:
The NRTL Program recognizes organizations that provide product safety testing and certification services to manufacturers. These organizations perform testing and certification, for purposes of the Program, to U.S. consensus-based product safety test standards. The products covered by the Program consist of those items for which OSHA safety standards require “certification” by a NRTL. The requirements affect electrical products and 38 other types of products. OSHA does not develop or issue these test standards, but generally relies on standards development organizations (SDOs) which develop and maintain the standards using a method that provides input and consideration of views of industry groups, experts, users, consumers, governmental authorities, and others having broad experience in the safety field involved.
OSHA may propose to remove a test standard from the NRTL list of appropriate test standards based on an internal review in which Program staff review the NRTL list of appropriate test standards to determine if the test
Second, a document that focuses primarily on usage, installation, or maintenance requirements would also not be considered an appropriate test standard (CPL 1-0.3, App. D.IV.B). In some cases, however, a document may also provide safety test specifications in addition to usage, installation, and maintenance requirements. In such cases, the document would be retained as an appropriate test standard based on the safety test specifications.
Finally, a document may not be considered an appropriate test standard if the document covers products for which OSHA does not require testing and certification (CPL 1-0.3, App. D.IV.A).
Similarly, a document that covers electrical product components would not be considered an appropriate test standard. These documents apply to types of components that have limitation(s) or condition(s) on their use, in that they are not appropriate for use as end-use products. These documents also specify that these types of components are for use only as part of an end-use product. NRTLs, however, evaluate such components only in the context of evaluating whether end-use products requiring NRTL approval are safe for use in the workplace. Testing such components alone would not indicate that the end-use products containing the components are safe for use. Accordingly, as a matter of policy, OSHA considers that documents covering such components are not appropriate test standards under the NRTL Program. OSHA notes, however, that it is not proposing to delete from NRTLs' scopes of recognition any test standards covering end-use products that contain such components.
In this notice, OSHA announces its final decision to delete one test standard from the NRTL Program's list of appropriate test standards.
Table 1 lists the test standard that OSHA will delete from the NRTL Program's list of appropriate test standards, as well as an abbreviated rationale for OSHA's actions. For a full discussion of the rationale, see Section I of this notice.
In this notice, OSHA announces its final decision to update the scopes of recognition of several NRTLs. The tables in this section (Table 2 thru Table 4) list, for each affected NRTL, the test standard that OSHA is deleting from the scope of recognition of the NRTL.
OSHA will incorporate into its informational web pages the modifications OSHA is making to each NRTL's scope of recognition. These web pages detail the scope of recognition for each NRTL, including the test standards the NRTL may use to test and certify products under OSHA's NRTL Program. OSHA also will add, to its “Current List of Removed Test Standards” web page, this test standard that OSHA no longer recognizes or permits under the NRTL Program. Access to these web pages is available at
Pursuant to the authority in 29 CFR 1910.7, OSHA hereby modifies the NRTL List of Appropriate Test Standards and associated modification to the scope of recognition for the impacted NRTLs specified above.
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2)), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
National Commission on Military, National, and Public Service.
Notice; extension of comment period.
The National Commission on Military, National, and Public Service (the “Commission”) is extending the comment period for the notice, “Request for Information on Improving the Military Selective Service Process and Increasing Participation in Military, National, and Public Service.” In response to stakeholder requests, the Commission is extending the comment period until September 2018. Additionally, the contact information for the Commission has been updated.
The comment period announced in the notice that was published on February 16, 2018, is extended. Comments must now be received by the Commission on or before September 30, 2018.
You may submit comments, identified by Docket No. 05-2018-01, by any of the following methods:
•
•
•
For general inquiries, submission process questions, or any additional information about this request for comments, please contact Rachel Rikleen, at (703) 571-3760 or by email at
On February 16, 2018, the Commission published in the
Additionally, the Commission has new contact information. The addresses provided in the February
National Archives and Records Administration (NARA).
Notice of Advisory Committee meeting.
In accordance with the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), the National Archives and Records Administration (NARA) announces a meeting of the Advisory Committee on Presidential Library-Foundation Partnerships.
The meeting will be on Thursday, May 3, 2018, from 10 a.m. to 12 noon, EST.
National Archives Building at 700 Pennsylvania Avenue NW; Washington, DC; Room 105.
Denise LeBeck by phone at 301-837-3250 or by email at
The purpose of this meeting is to discuss the Presidential library program and topics related to public-private partnerships between Presidential libraries and Presidential foundations.
The meeting will be open to the public. However, due to space limitations and access procedures, you must submit the name and telephone number of individuals planning to attend to Denise LeBeck no later than Monday, May 1, 2018. We will provide additional instructions for gaining access. Meeting attendees may enter from Pennsylvania Avenue entrance and photo identification will be required. No visitor parking is available at the Archives building; however there are commercial parking lots and metered curb parking nearby.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
1.
This Notice will be published in the
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
1.
2.
This Notice will be published in the
On December 29, 2017, ICE Clear Europe Limited (“ICE Clear Europe”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
Institution of proceedings does not indicate that the Commission has reached any conclusions with respect to the proposed rule changes, nor does it mean that the Commission will ultimately disapprove the proposed rule changes. Rather, as discussed below, the Commission seeks additional input on the proposed rule changes and issues presented by the proposed rule changes.
As a “covered clearing agency,”
According to ICE Clear Europe, the Recovery Plan is based on, and intended to be consistent with, ICE Clear Europe's Rules and Procedures, as well as its existing risk management frameworks, policies, and procedures.
The Recovery Plan also addresses the roles and responsibility of ICE Clear Europe Board of Directors, management, and other personnel, including with respect to development, review and approval, testing and maintenance, and liaison with relevant regulatory authorities.
ICE Clear Europe stated that a wind-down may result from situations where neither the Recovery Plan nor application of its loss allocation rules have succeeded in stopping default losses or non-default losses incurred and, as a result, ICE Clear Europe cannot remain viable as a going concern.
As stated by ICE Clear Europe, any decision to wind down is expected to be considered over a period of months, involve consultation with members, potential alternative clearing houses, exchange, and regulators, and would need approval by the ICE Clear Europe Board of Directors.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Exchange Act to determine whether the proposed rule changes should be approved or disapproved.
Pursuant to Section 19(b)(2)(B) of the Exchange Act,
• Section 17A(b)(3)(F) of the Exchange Act, which requires that the rules of a clearing agency be designed to, among other things, promote the prompt and accurate clearance and settlement of securities transactions, assure the safeguarding of securities and funds which are in the custody or control of the clearing agency for which it is responsible, and, in general, to protect investors and the public interest;
• Rule 17Ad-22(e)(2) under the Exchange Act, which requires that a covered clearing agency establish, implement, maintain, and enforce written policies and procedures reasonably designed to provide for governance arrangements that are clear and transparent and support the public interest requirements in Section 17A of the Exchange Act applicable to clearing agencies, and the objectives of owners and participants;
• Rule 17Ad-22(e)(3)(ii) under the Exchange Act, which requires that covered clearing agencies, among other things, “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . maintain a sound risk management framework for comprehensively managing legal, credit, liquidity, operational, general business, investment, custody, and other risks that arise in or are borne by the covered clearing agency, which . . . includes plans for the recovery and orderly wind-down of the covered clearing agency necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses;” and
• Rules 17Ad-22(e)(15)(i)-(ii) under the Exchange Act,
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues raised by the proposed rule changes. In particular, the Commission invites the written views of interested persons concerning whether the proposed rule changes are inconsistent with Section 17A(b)(3)(F) of the Exchange Act
Although there do not appear to be any issues relevant to approval or disapproval that would be facilitated by an oral presentation of views, data, and arguments, the Commission will consider, pursuant to Rule 19b-4, any request for an opportunity to make an oral presentation.
Interested persons are invited to submit written data, views, and arguments regarding whether the proposed rule changes should be approved or disapproved on or before May 11, 2018. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal on or before May 25, 2018. 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.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.
All submissions should refer to File Number SR-ICEEU-2017-016 and SR-ICEEU-2017-017 and should be submitted on or before May 11, 2018. If comments are received, any rebuttal comments should be submitted on or before May 25, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Section 31 of the Securities Exchange Act of 1934 (“Exchange Act”) requires each national securities exchange and national securities association to pay transaction fees to the Commission.
Section 31 of the Exchange Act requires the Commission to annually adjust the fee rates applicable under Sections 31(b) and (c) to a uniform adjusted rate.
The Commission is required to publish notice of the new fee rates under Section 31 not later than 30 days after the date on which an Act making a regular appropriation for the applicable fiscal year is enacted.
The new fee rate is determined by (1) subtracting the sum of fees estimated to be collected prior to the effective date of the new fee rate
As noted above, the Consolidated Appropriations Act, 2018, includes total appropriations of $1,896,507,052 to the Commission for fiscal year 2018.
The uniform adjusted rate is computed by dividing the residual fees to be collected of $509,263,828 by the estimated aggregate dollar amount of covered sales for the remainder of fiscal year 2018 of $39,323,689,064,673; this results in a uniform adjusted rate for fiscal year 2018 of $13.00 per million.
Under Section 31(j)(4)(A) of the Exchange Act, the fiscal year 2018 annual adjustments to the fee rates applicable under Sections 31(b) and (c) of the Exchange Act shall take effect on the later of October 1, 2017, or 60 days after the date on which a regular appropriation to the Commission for fiscal year 2018 is enacted.
Accordingly, pursuant to Section 31 of the Exchange Act,
By the Commission.
This appendix provides the methodology for determining the annual adjustment to the fee rates applicable under Sections 31(b) and (c) of the Exchange Act for fiscal year 2018. Section 31 of the Exchange Act requires the fee rates to be adjusted so that it is reasonably likely that the Commission will collect aggregate fees equal to its regular appropriation for fiscal year 2018.
To make the adjustment, the Commission must project the aggregate dollar amount of covered sales of securities on the securities exchanges and certain over-the-counter (“OTC”) markets over the course of the year. The fee rate equals the ratio of the Commission's regular appropriation for fiscal year 2018 (less the sum of fees to be collected during fiscal year 2018 prior to the effective date of the new fee rate and aggregate assessments on security futures transactions during all of fiscal year 2018) to the estimated aggregate dollar amount of covered sales for the remainder of the fiscal year following the effective date of the new fee rate.
For 2018, the Commission has estimated the aggregate dollar amount of covered sales by projecting forward the trend established in the previous decade. More specifically, the dollar amount of covered sales was forecasted for months subsequent to February 2018, the last month for which the Commission has data on the dollar volume of covered sales.
The following sections describe this process in detail.
First, calculate the average daily dollar amount of covered sales (“ADS”) for each month in the sample (January 2008-February 2018). The monthly total dollar amount of covered sales (exchange plus certain OTC markets) is presented in column C of Table A.
Next, model the monthly change in the natural logarithm of ADS as a first order autoregressive process (“AR(1)”), including monthly indicator variables to control for seasonality.
Use the estimated AR(1) model to forecast the monthly change in the log level of ADS. These percent changes can then be applied to obtain forecasts of the total dollar volume of covered sales. The following is a more formal (mathematical) description of the procedure:
1. Begin with the monthly data for total dollar volume of covered sales (column C). The sample spans ten years, from January 2008—February 2018.
2. For each month
3. Estimate the AR(1) model
4. For the first month calculate the forecasted value of the log growth rate of ADS as
For the next month use the forecasted value of the log growth rate of the first month to calculate the forecast of the next month. This process iterates until a forecast is generated for all remaining months in the fiscal year. These data appear in column F.
5. Assuming that the regression error in the AR(1) model is normally distributed, the expected percentage change in average daily dollar volume from month to month
6. For instance, for March 2018, using the β
7. For April 2018, proceed in a similar fashion. Using the estimates for March 2018 along with the β
8. Repeat this procedure for subsequent months.
1. Use Table A to estimate fees collected for the period October 1, 2017 through May 21, 2018. The projected aggregate dollar amount of covered sales for this period is $60,052,034,517,716. Actual and projected fee collections at the current fee rate of $23.10 per million are $1,387,201,997.
2. Estimate the amount of assessments on security futures products collected from October 1, 2017 through September 30, 2018. First, calculate the average and the standard deviation of the change in log average daily sales, in column E, for the 120 months ending February 2018. The average is 0.003357 and the standard deviation is 0.114918. These are used to estimate an average growth rate in ADS using the formula
3. Subtract the amounts $1,387,201,997 and $41,227 from the target off-setting collection amount set by Congress of $1,896,507,052, leaving $509,263,838 to be collected on dollar volume for the period May 22, 2018 through September 30, 2018.
4. Use Table A to estimate dollar volume for the period May 22, 2018 through September 30, 2018. The estimate is $39,323,689,064,673. Finally, compute the fee rate required to produce the additional $509,263,838 in revenue. This rate is $509,263,828 divided by $39,323,689,064,673 or 0.00001295056.
5. Round the result to the seventh decimal point, yielding a rate of 0.0000130 (or $13.00 per million).
This table summarizes the estimates of the aggregate dollar amount of covered sales, by time period. The figures in this table can be used to determine the new fee rate.
Small Business Administration.
30-Day Notice.
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before May 21, 2018.
Comments should refer to the information collection by name and/or OMB Control Number and should be sent to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030
The requested information is submitted by small businesses or not-for-profit organizations who seek federal financial assistance (loans) to help in their recovery from declared disaster. SBA uses the information to determine the eligibility and creditworthiness of these loan applicants.
A copy of the Form OMB 83-1, supporting statement, and other documents submitted to OMB for review may be obtained from the Agency Clearance Officer.
Comments may be submitted 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.
Small Business Administration.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval for the collection of information described below from the Office of Management and Budget (OMB). The Paperwork Reduction Act (PRA) of 1995, requires federal agencies to publish a notice in the
Submit comments on or before: June 19, 2018.
Send all comments or request for a copy of the proposed forms to Donna Fudge, Office of Government Contracting and Business Development, 409 3rd Street SW, Washington, DC 20416.
Donna Fudge, Procurement Analyst, 202-205-6363,
The National Defense Authorization Act for Fiscal year 2017 (Pub. L. 114-328), Section 1822, added paragraph 8(d)(17) to the Small Business Act, 15 U.S.C. 637(d)(17), to provide that SBA shall implement a pilot program to establish past performance ratings for small business subcontractors. Under this program, a small business concern without a past performance rating as a prime contractor in the Past Performance Information Retrieval System (PPIRS) may request a past performance rating in the Contractor Performance Assessment Reporting System (CPARS), if the small business is a first tier subcontractor under a covered Federal Government contract requiring a subcontracting plan in accordance with FAR 19.702(a). Ratings of subcontractor performance can be requested on subcontracts that exceed the simplified acquisition threshold, or subcontracts for architecture-engineering services valued at $35,000 or more as provided in FAR 42.1502.
Past performance information is one indicator of an offeror's ability to successfully perform the contract and is often considered by agencies when making contract awards. Allowing small business concerns performing as first tier subcontractors to voluntarily request a past performance evaluation, in the same system used by the Federal Government to monitor or record contractor past performance for prime contract awards, provides an enhanced opportunity for more small businesses to fairly compete for Federal Government contracting opportunities.
(1) Application—In order to obtain a past performance rating, the small business concern will submit a request using SBA Form 2465. The information to be provided includes, but is not limited to, Subcontractor name and DUNS + 4 Number; subcontract number; completion date; total dollar value, and suggested rating for each factor. The small business concern will complete the applicable portion of the form and submit it, electronically, along with written evidence of the past performance factors to the appropriate official to the
(2) Determination—The appropriate official shall submit the small business concern's application electronically to the requiring agency's Office of Small Business Utilization (OSDBU) and the prime contractor for the covered contract for review. The Prime Contractor and OSDBU shall, within 30 calendar days after receipt of the application, electronically submit to the appropriate official a response regarding the application.
(3) Agreement on Rating—If the OSDBU and the prime contractor agree on a past performance rating, or if either the OSDBU or prime contractor fail to respond and the responding person agrees with the rating of the applicant small business concern, the appropriate official shall enter the agreed-upon past performance rating in CPARS.
(4) Disagreement on Rating—If the OSDBU and the prime contractor fail to respond within 30 calendar days or if they disagree about the rating, or if either the OSDBU or prime contractor fail to respond and the responding person disagrees with the applicant small business concern's suggested rating, the OSDBU or the prime contractor shall submit a notice contesting the application to the appropriate official.
(5) Procedure for Rating—The appropriate official, within 14 calendar days after receipt of a notice contesting the applicant small business concern suggested ratings, shall submit the notice to the applicant small business concern. The concern may submit comments, rebuttals, or additional information relating to its past performance within 14 calendar days after receipt of the notice. The appropriate official shall enter a rating in CPARS that is neither favorable nor unfavorable, together with the concern's initial application, OSDBU and prime contractor responses, and any additional information provided by the applicant concern. A copy of the information submitted shall be provided to the contracting officer (or designee of such officer) for the covered contract.
(6) Use of Information—A small business subcontractor may use a past performance rating in CPARS to establish its past performance for a potential prime contract award.
(7) Duration—The subcontractor past performance pilot program shall terminate three (3) years after the date on which the first applicant small business concern receives a past performance rating for performance as a first-tier subcontractor.
(1)
(2.)
SBA is requesting comments on this proposed collection of information, including: (1) Whether there are ways to enhance the quality, utility, and clarity of the information; (2) whether the burden estimates are accurate and based on valid assumptions and methodology; and (3) whether there are ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated techniques or other forms of information technology.
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Chaim Soutine: Flesh,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Jewish Museum, New York, New York, from on or about May 4, 2018, until on or about September 16, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “René Magritte: The Fifth Season,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the San Francisco Museum of Modern Art, San Francisco, California, from on or about May 19, 2018, until on or about October 28, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Renoir: Father and Son/Painting and Cinema,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Barnes Foundation, Philadelphia, Pennsylvania, from on or about May 6, 2018, until on or about September 3, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Department of State.
Notice.
Notice is hereby given of a change in ownership of cross-border liquid hydrocarbon pipeline facilities at the U.S.-Canada border near Detroit, Michigan (“Detroit River Crossing Facilities”) authorized under a Presidential permit issued to Kinder Morgan Cochin LLC (“KM Cochin”) on November 3, 2015. KM Cochin transferred the Detroit River Crossing Facilities to Kinder Morgan Utopia LLC (“KM Utopia”) on May 7, 2017 and notified the Department of this transfer on October 29, 2017. Consistent with the procedures set forth in Public Notice 10111, dated Sept. 7, 2017, the Department has reviewed that notification and has determined that the change in ownership does not affect the prior national interest determination that resulted in issuance of the Presidential permit issued to KM Cochin on November 3, 2015. That permit, therefore, remains valid and the Department recognizes KM Utopia as holder of that permit, subject to its terms and conditions.
Presidential Permit Coordinator, Energy Resources Bureau, Office of Policy Analysis and Public Diplomacy, United States Department of State, 2201 C St. NW, Suite 4422, Washington, DC 20520. Tel: 202-485-1522.
The Hennepin County Regional Railroad Authority (HCRRA), a Class III carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to acquire from Soo Line Railroad Company d/b/a Canadian Pacific (CP) a permanent, irrevocable, exclusive rail freight operating easement over the Bass Lake Spur, which extends from Milepost 435.06 in Hopkins, Hennepin County, Minn., to Milepost 428.38 in St. Louis Park, Hennepin County, Minn., a distance of approximately 6.7 miles (the Line).
HCRRA states that the Line includes a portion of the connecting track between the Bass Lake Spur and CP's Minneapolis, Northfield and Southern Spur in St. Louis Park. According to HCRRA, together with the Kenilworth Corridor,
HCRRA further states that, through the proposed transaction, HCRRA intends to acquire CP's common carrier rights and obligations with respect to the Line. Immediately following HCRRA's acquisition, according to HCRRA, CP intends to transfer the trackage and underlying real estate to the Metropolitan Council, subject to HCRRA's permanent and exclusive rail freight operating easement. HCRRA states that TCWR operates over the Line pursuant to overhead trackage rights granted by CP, which maintains the Line but does not operate on it. Upon consummation of the transaction, HCRRA states, CP will execute an agreement assigning to HCRRA its rights and responsibilities under the TCWR trackage rights agreement that pertain to the Line. HCRRA asserts that it will have permanent and adequate rights to ensure the provision of any required common carrier service on the Line, and neither HCRRA nor the Metropolitan Council will unreasonably interfere with or restrict TCWR's continued overhead operations.
According to HCRRA, it has negotiated an Easement Agreement with CP and the Metropolitan Council setting forth the parties' respective rights and obligations in connection with HCRRA's acquisition of the easement that will allow HCRRA to acquire and fulfill CP's common carrier rights and obligations
HCRRA certifies that its revenues from freight operations will not result in the creation of a Class I or Class II carrier. HCRRA also certifies that the proposed acquisition does not involve an interchange commitment or other limitation of future interchange with a third-party connecting carrier.
HCRRA states that the parties expect the transactions to be consummated in the second quarter of 2018. The earliest this transaction may be consummated is May 5, 2018 (30 days after the verified notice of exemption was filed).
According to HCRRA, its proposed acquisition of the Line is exempt from environmental reporting requirements under 49 CFR 1105.6(c)(1)(i) and from historic preservation reporting under 49 CFR 1105.8(b)(1).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than April 27, 2018 (at least seven days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36177, must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Charles A. Spitulnik, Kaplan Kirsch & Rockwell LLP, 1001 Connecticut Avenue NW, Suite 800, Washington, DC 20036.
Board decisions and notices are available on our website at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Federal Aviation Administration, DOT.
Notice of availability, notice of public comment period, notice of public meeting, and request for comment.
The FAA is announcing the availability of and requesting comments on the Draft Programmatic Environmental Assessment (PEA) for the Front Range Airport Launch Site Operator License, Spaceport Colorado. The FAA has prepared the Draft PEA to evaluate the potential environmental impacts of issuing a Launch Site Operator License to the Board of County Commissioners (the BOCC) of Adams County, Colorado to operate a commercial space launch site, called “Spaceport Colorado,” at the Front Range Airport (FTG), in Watkins, Colorado. The Launch Site Operator License would allow the BOCC to offer Spaceport Colorado to commercial launch providers to conduct launch operations of horizontal take-off and horizontal landing reusable launch vehicles (RLVs).
Comments must be received on or before May 25, 2018.
The FAA will hold a public meeting to solicit comments from the public concerning the content and analysis in the Draft PEA. The public meeting will be held on May 17, 2018 from 5:00 p.m. to 8:00 p.m. The public meeting will include an open house workshop from 5:00 p.m. to 6:00 p.m., an FAA presentation from 6:00 p.m. to 6:15 p.m., followed by a public comment period from 6:15 p.m. to 8:00 p.m., during which members of the public may provide up to a 3-minute statement. The FAA will transcribe oral comments. All comments received during the meeting and comment period, whether provided in writing or verbally, will be given equal weight and will be taken into consideration in the preparation of the Final PEA.
The FAA will hold the public meeting at the following location: Front Range Airport, Cafeteria, 5200 Front Range Parkway, Watkins, CO 80137.
Please submit comments or questions regarding the Draft PEA to Stacey Zee, Environmental Specialist, Federal Aviation Administration, c/o ICF, 9300 Lee Hwy, Fairfax, VA 22031. Comments may also be submitted by email to
Ms. Stacey M. Zee, Environmental Specialist, Federal Aviation Administration, 800 Independence Ave. SW, Suite 325, Washington, DC 20591; telephone (202) 267-9305; email
The FAA has prepared the Draft PEA in accordance with the National Environmental Policy Act of 1969 (NEPA; 42 United States Code 4321
An electronic version of the Draft PEA is available on the FAA Office of Commercial Space Transportation website at:
The FAA encourages all interested agencies, organizations, Native American tribes, and members of the public to submit comments concerning the analysis presented in the Draft PEA by May 25, 2018. Comments should be as specific as possible and address the analysis of potential environmental impacts. Reviewers should organize their participation so that it is meaningful and makes the agency aware of the viewer's interests and concerns using quotations and other specific references to the text of the Draft PEA and related documents. Matters that could have been raised with specificity during the comment period on the Draft PEA may not be considered if they are raised for the first time later in the
Before including your address, phone number, email address, or other personal identifying information in your comment, be advised that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold from the public review your personal identifying information, we cannot guarantee that we will be able to do so.
The FAA has prepared the Draft PEA to evaluate the potential environmental impacts of issuing a Launch Site Operator License to the BOCC of Adams County, Colorado to operate a commercial space launch site, called “Spaceport Colorado,” at FTG, in Watkins, Colorado. The successful completion of the environmental review process does not guarantee that the FAA Office of Commercial Space Transportation would issue a Launch Site Operator License to the BOCC. The project must also meet all FAA requirements of a Launch Site Operator License. Individual launch operators proposing to launch from the site would be required to obtain a separate launch operator license.
The CEQ Regulations for Implementing the Procedural Provisions of NEPA allow for federal agencies to prepare programmatic NEPA documents for broad federal actions (40 CFR 1502.4). Given that FTG does not have a commitment from a launch operator at this time, the analysis in this PEA uses a conceptual RLV and is based on broad assumptions regarding the location of related facilities and the surface movement of RLVs associated with operation of a horizontal RLV at FTG. The purpose of including these assumptions is to conservatively assess the potential environmental impacts of launch vehicle operations at FTG. This information does not necessarily reflect the exact launch vehicle(s) that would operate at FTG. Instead, it defines the scope (or bounds) of the analysis. If a prospective launch operator applies for a license to operate a launch vehicle at FTG, a separate environmental document, tiering off of this PEA, would be required to support the issuance of that Launch Operator License.
The Draft PEA considers the potential environmental impacts of the Proposed Action and No Action Alternative. The Proposed Action is for the FAA to issue a Launch Site Operator License to the BOCC that would allow the BOCC to offer the commercial space launch site, Spaceport Colorado, to commercial launch providers to conduct launch operations of horizontal take-off and horizontal landing reusable launch vehicles. The FAA would also conditionally approve the modified Airport Layout Plan showing the launch site boundary. Under the No Action Alternative, the FAA would not issue a Launch Site Operator License to the BOCC.
The Draft PEA evaluates the potential environmental impacts from the Proposed Action and No Action Alternative on air quality; biological resources (including fish, wildlife, and plants); climate; coastal resources; Department of Transportation Act, section 4(f); farmlands; hazardous materials, solid waste, and pollution prevention; historical, architectural, archaeological, and cultural resources; land use; natural resources and energy supply; noise and noise-compatible land use; socioeconomics, environmental justice, and children's environmental health and safety risks; visual effects (including light emissions); and water resources (including wetlands, floodplains, surface waters, groundwater, and wild and scenic rivers). Potential cumulative impacts are also addressed in the Draft PEA.
Federal Aviation Administration, Transportation.
Notice.
By
Persons interested in applying for the NPOAG openings representing air tour operator and Native American interests need to apply by June 15, 2018.
Keith Lusk, Special Programs Staff, Federal Aviation Administration, Western-Pacific Region Headquarters, 15000 Aviation Boulevard, Lawndale, CA 90261, telephone: (310) 725-3808, email:
The National Parks Air Tour Management Act of 2000 (the Act) was enacted on April 5, 2000, as Public Law 106-181, and subsequently amended in the FAA Modernization and Reform Act of 2012. The Act required the establishment of the advisory group within one year after its enactment. The NPOAG was established in March 2001. The advisory group is comprised of a balanced group of representatives of general aviation, commercial air tour operations, environmental concerns, and Native American tribes. The Administrator of the FAA and the Director of NPS (or their designees) serve as ex officio members of the group. Representatives of the Administrator and Director serve alternating one-year terms as chairman of the advisory group.
In accordance with the Act, the advisory group provides “advice, information, and recommendations to the Administrator and the Director—
(1) On the implementation of this title [the Act] and the amendments made by this title;
(2) On commonly accepted quiet aircraft technology for use in commercial air tour operations over a national park or tribal lands, which will receive preferential treatment in a given air tour management plan;
(3) On other measures that might be taken to accommodate the interests of visitors to national parks; and
(4) At the request of the Administrator and the Director, safety, environmental, and other issues related to commercial air tour operations over a national park or tribal lands.”
The current NPOAG is made up of one member representing general aviation, three members representing the commercial air tour industry, four members representing environmental concerns, and two members representing Native American interests.
Melissa Rudinger representing general aviation; Alan Stephen and Matt Zuccaro, representing commercial air tour operators with one opening; Les Blomberg, Rob Smith, John Eastman, and Dick Hingson representing environmental interests; and Martin Begaye representing Native American tribes with one opening. One NPOAG member representing air tour operator interests resigned in October 2017 and the 3-year membership term of Leigh Kuwanwisiwma expired on April 2, 2018.
No selections were made based on applications received after the October 31, 2017
The FAA and NPS invite persons interested in serving on the NPOAG to contact Mr. Keith Lusk (contact information is written above in
On August 13, 2014, the Office of Management and Budget issued revised guidance regarding the prohibition against appointing or not reappointing federally registered lobbyists to serve on advisory committees (79
Therefore, before appointing an applicant to serve on the NPOAG, the FAA and NPS will require the prospective candidate to certify that they are not a federally registered lobbyist.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Fifty Seventh RTCA SC-224 Standards for Airport Security Access Control Systems Plenary.
The FAA is issuing this notice to advise the public of a meeting of Fifty Seventh RTCA SC-224 Standards for Airport Security Access Control Systems Plenary.
The meeting will be held May 10, 2018 10:00 a.m.-1:00 p.m.
The meeting will be held at: RTCA Headquarters, 1150 18th Street NW, Suite 910, Washington, DC 20036.
Karan Hofmann at
Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Fifty Seventh RTCA SC-224 Standards for Airport Security Access Control Systems Plenary. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before April 30, 2018.
Send comments identified by docket number FAA-2018-0251 using any of the following methods:
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Keira Jones, (202) 267-9677, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of limitation on claims for judicial review of actions by FHWA.
This notice announces actions taken by the FHWA that are final. The action relates to the issuance of a Record of Decision for the Washington State Convention Center (WSCC) Addition in the City of Seattle, King County, State of Washington.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(
For FHWA, Lindsey Handel, Urban Transportation Engineer, Federal Highway Administration, 711 S Capitol Way, Suite 501, Olympia, WA 98501-1284, telephone: (360) 753-9550, or email:
Notice is hereby given that FHWA has taken final agency action(s) subject to 23 U.S.C. 139(
The proposed WSCC Addition would be a multi-level development of approximately 1.59 million square feet on a 3-block, 7.67-ac. site that is located northeast of the existing WSCC. This area includes five City rights-of-way that are proposed for full or subterranean vacation. The King County Site Work component of this project would occur prior to construction of the proposed WSCC Addition. Construction sequencing would enable King County Metro buses to continue to use CPS and operate in the Downtown Seattle Transit Tunnel until at least March 2019 or September 2019, depending upon the City of Seattle's permit approval process. It is proposed that the WSCC Addition be operational by 2021.
The actions by the Federal agencies, and the laws under which such actions were taken, are described in the Final Environmental Impact Statement/Record of Decision for the project approved on March 23, 2018, and in other documents in the project records. The Draft EIS, Final EIS/ROD, and other project records are available from FHWA and WSDOT at the addresses provided above and can be found at:
This notice applies to all Federal agency decisions that are final as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
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23 U.S.C. 139(
Office of the Secretary of Transportation, U.S. Department of Transportation.
Notice.
Pursuant to a recommendation by the Future of Aviation Advisory Committee, the Secretary of Transportation, through the Federal Aviation Administration (FAA), is announcing the fifth annual competition to recognize students with the ability to demonstrate unique, innovative thinking in aerospace science and engineering. There are two divisions within the competition: a high school division and a university division (both undergraduate and graduate). The Department of Transportation (DOT) intends to use the competition to incentivize students at high schools and universities to think creatively in developing innovative solutions to aviation and aerospace issues, and to share those innovations with the broader community.
Submissions accepted April 20, 2018 through midnight on June 1, 2018.
Patricia Watts, Ph.D., Federal Aviation Administration,
The following additional rules apply:
1. Candidates shall submit a project in the competition under the rules promulgated by the Department of Transportation (DOT);
2. Candidates shall agree to execute indemnifications and waivers of claims against the Federal government as provided in this Notice;
3. Candidates may not be a Federal entity or Federal employee acting within the scope of employment;
4. Candidates may not be an employee of the DOT, including but not limited to the FAA;
5. Candidates shall not be deemed ineligible because an individual used Federal facilities or consulted with Federal employees during a competition, if the facilities and employees are made available to all individuals participating in the competition on an equitable basis;
6. The competition is subject to all applicable Federal laws and regulations. Participation constitutes the Candidates' full and unconditional agreement to these rules and to the Secretary's decisions, which are final and binding in all matters related to this competition;
7. Submissions which in the Secretary's sole discretion are determined to be substantially similar to a prior submitted entry may be disqualified;
8. Submissions must be original, must be the work of the Candidates, and must not violate the rights of other parties. All submissions remain the property of the applicants. Each Candidate represents and warrants that s/he, or the team, is the sole author and owner of the submission, that the submission is wholly original, that it does not infringe any copyright or any other rights of any third party of which the Candidate is aware, and, if submitted in electronic form, is free of malware;
9. By submitting an entry, contestants and entrants agree to assume any and all risks and waive any claims against the Federal Government and its related entities (except in the case of willful misconduct) for any injury, death, damage, or loss of property, revenue or profits, whether direct, indirect, or consequential, arising from their participation in this contest, whether the injury, death, damage, or loss arises through negligence of otherwise;
10. The Secretary and the Secretary's designees have the right to request access to supporting materials from the Candidates;
11. The submissions cannot have been submitted in the same or substantially similar form in any previous Federally-sponsored promotion or Federally-sponsored contest, of any kind;
12. Each Candidate grants to the FAA, the DOT, as well as other Federal agencies with which it partners, the right to use names, likeness, application materials, photographs, voices, opinions, and/or hometown and state for the Department's promotional purposes in any media, in perpetuity, worldwide, without further payment or consideration; and
13. The FAA Administrator collects personal information from Candidates when they enter this competition. The information collected is subject to the Challenge Post privacy policy located at
Complete submission packages shall consist of the following elements:
1. Nomination letter from at least one teacher, advisor, faculty member, and others as appropriate. The nomination letter(s) must communicate accomplishments in the following areas:
Evidence of technical merit based upon teacher (parent or legal guardian in the case of home schooled applicants), advisor, or faculty nomination and evaluation of the submitted proposal, conducted research, written paper, results, and/or reports.
Evidence of professionalism and leadership may be in the form of, but not limited to:
2. An overall summary of the innovation, not to exceed one page, which includes a title of the project, a one paragraph synopsis, and a statement of the potential innovative impact the concept will have on the field of aviation or aerospace;
3. A copy of the student's academic transcript or certified grade report (as applicable);
4. A copy of the paper(s) and related materials describing the innovative concept written by the student(s) being nominated (no page limit).
The FAA may request additional information, including supporting documentation, more detailed contact information, releases of liability, and statements of authenticity to guarantee the originality of the work. Failure to respond in a timely manner may result in disqualification.
Electronic packages may be transmitted by email to
The submission period begins on April 20, 2018. Submissions must be sent by 11:59 p.m. Pacific daylight time on June 1, 2018. The timeliness of submissions will be determined by the postmark (if sent in hard copy) or time stamp of the recipient (if emailed). Competition administrators assume no responsibility for lost or untimely submissions for any reason.
The university level student(s) will attend the annual Outstanding Student of the Year Awards ceremony hosted by the University Transportation Centers—Council of Transportation Research Centers (CUTC). The DOT will honor the RAISE award recipient at this event conducted during the Transportation Research Board meetings each January in Washington, DC. Further details will be provided to the selectee(s).
Panel members will judge entries against other submissions from the same division or category based on the following criteria:
• Has the submission presented a clear understanding of the associated problems?
• Has the submission developed a logical and workable solution and approach to solving the problem/s?
• What are the most significant aspects of this concept?
• Has the submission clearly described the breadth of impact of the innovation?
• Is this concept new or a variation of an existing idea, and in what way(s)?
• How is this work unique?
• Was the concept developed independently or in cooperation with others?
• To what extent does this project have the potential to make a significant impact and/or contribution to the future of the aviation and aerospace environment?
• Who directly benefits from this work?
• Can this program or activity be implemented in a practical fashion?
• What are the costs anticipated to be incurred and saved by executing this concept?
• How has this individual/group measured the impact on the aviation environment?
• To what extent does the innovation result in measurable improvements?
• Can this effort be scaled?
• Is this work specific to one region, various regions, or to the entire nation?
All factors are important and will be given consideration, but the advisory panel will give the “technical merit” factor the most weight in the screening process. The Secretary of Transportation retains sole discretion to select the winning entrant.
• Federal grantees may not use Federal funds to develop COMPETES Act challenge applications.
• Federal contractors may not use Federal funds from a contract to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge submission.
15 U.S.C. 3719 (America COMPETES Act).
Department of Homeland Security; Department of Agriculture; Department of Energy; National Aeronautics and Space Administration; Department of Commerce; Consumer Product Safety Commission; Social Security Administration; Agency for International Development; Department of Housing and Urban Development; Department of Labor; Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; Department of Health and Human Services; National Science Foundation; and Department of Transportation.
Notice of proposed rulemaking.
In a final rule published on January 19, 2017, federal departments and agencies made revisions to the Federal Policy for the Protection of Human Subjects (hereafter the “2018 Requirements”). The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). The departments and agencies listed in this document have also published an interim final rule delaying the effective date and general compliance date for the 2018 Requirements for six months, to cover the time period of January 19, 2018 until July 19, 2018.
As per the interim final rule, the effective date of the 2018 Requirements is now July 19, 2018. The departments and agencies listed in this document propose delaying the general compliance date for the 2018 Requirements for an additional six months, for the time period of July 19, 2018 until January 21, 2019. This proposed rule is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements. This proposed rule, if finalized, would require regulated entities to continue to comply with the requirements of the current Federal Policy for the Protection of Human Subjects (hereafter the “pre-2018 Requirements”) until January 21, 2019.
This proposal also takes comment on whether to permit institutions to implement, for certain research studies, the following provisions in the 2018 Requirements during the period from July 19, 2018, until January 21, 2019, that the general compliance date is delayed. Those three provisions, intended to reduce burdens on regulated entities, are the 2018 Requirements' definition of “research,” which deems certain activities not to be research, the allowance for no annual continuing review of certain categories of research, and the elimination of the requirement that institutional review boards (IRBs) review grant applications related to the research. The way that this option is proposed, regulated entities would be required to comply with all pre-2018 Requirements during the period that the general compliance date is delayed, except for provisions substituted by the three burden-reducing provisions of the 2018 Requirements.
As described in section III, below, this flexibility is proposed only for studies for which an institution makes a choice to transition to comply with the 2018 Requirements, beginning on July 19, 2018. In order to clearly describe this proposed flexibility, including how it would impact institutions choosing to transition research to comply with the 2018 Requirements, this document proposes a redrafted transition provision.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 11:59 p.m. Eastern Standard Time on May 21, 2018.
You may submit comments, identified by docket ID number HHS-OPHS-2018-0007 by one of the following methods:
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○ Enter the following link into your web browser's address bar:
○ Click the blue “Comment Now!” button in the upper right hand corner and follow the instructions on how to submit a comment.
○ Alternatively, you can enter the docket ID number into the “search” box on the main page of the Federal eRulemaking Portal (
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• Comments received, including any personal information, will be posted without change to
Jerry Menikoff, M.D., J.D., Office for Human Research Protections (OHRP), Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240-453-6900 or 1-866-447-4777; facsimile: 301-402-2071; email
On September 8, 2015, HHS and 15 other federal departments and agencies published a notice of proposed rulemaking (NPRM) proposing revisions to each agency's codification of the Federal Policy for the Protection of Human Subjects, originally promulgated as a Common Rule in 1991. 80 FR 53931. On January 19, 2017, HHS and other federal departments and agencies published a final rule revising the Federal Policy for the Protection of Human Subjects. 82 FR 7149. The CPSC adopted the same regulatory changes, also with a scheduled effective date of January 19, 2018, in a separate final rule published on September 18, 2017. 82 FR 43459. For this reason, references in this document to the January 2017 final rule also extend to the CPSC's September 2017 final rule. The revised policy, reflected in both final rules, is hereafter referred to as the “2018 Requirements.” The 2018 Requirements were originally scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision at § __.114(b), for which the compliance date is January 20, 2020).
After publication of the 2018 Requirements, some representatives of the regulated community, including organizations representing recipients of federal human subjects research awards, expressed concern regarding the regulated community's ability to implement all of the 2018 Requirements by the scheduled general compliance date.
This NPRM proposes to delay the general compliance date of the 2018 Requirements by an additional six months, during the time period of July 19, 2018 to January 21, 2019.
We propose to delay the general compliance date of the 2018 Requirements for six months after the effective date of July 19, 2018 until January 21, 2019. Given the degree of complexity involved with implementing the revised rule, we believe the delay we are proposing in this action is both an appropriate action to take at this juncture, and a reasonable time period to allow the regulated community to be prepared for compliance with the 2018 Requirements and for HHS and the other Common Rule agencies to develop implementation guidance. The 2018 requirements include new exemptions, new IRB review procedures, and new provisions pertaining to informed consent, among other revisions, and guidance would be helpful to the regulated community in understanding and complying with these requirements. As described below, we propose to revise § __.101(l)(2) to specify that the general compliance date for the 2018 Requirements is January 21, 2019. We also propose to revise the dates in the transition provision at § __.101(l)(3),(4) and (5) to reflect this revised general compliance date.
As proposed, regulated entities would be required to comply with the pre-2018 Requirements prior to January 21, 2019, and the pre-2018 Requirements would be applied by the Common Rule departments and agencies during this period. To clarify, under this proposal, regulated entities would not be allowed, prior to January 21, 2019, to comply with all provisions of the 2018 Requirements in lieu of all provisions of the pre-2018 Requirements. As described below in section III, an exception would exist during the six-month period between July 19, 2018, and January 21, 2019, with respect to three specified burden-reducing provisions contained in the 2018 Requirements.
Research initiated (
Research initiated (
We do not propose delaying the compliance date for the cooperative research provision of the 2018 Requirements (§ _.114(b)), which will remain January 20, 2020.
This proposed rule also proposes to permit institutions, during the period from July 19, 2018, until January 21, 2019, that the general compliance date is proposed to be delayed, to take advantage of three provisions in the 2018 Requirements intended to minimize burdens on regulated entities (hereinafter “three burden-reducing 2018 Requirements”).
As under the January 2017 final rule, under this proposed rule, studies initiated prior to the general compliance date of the 2018 Requirements, would, as a default, remain subject to the pre-2018 Requirements for their duration unless and until a decision to transition to the 2018 Requirements (
The January 2017 final rule provided an option for institutions to transition ongoing studies from compliance with the pre-2018 Requirements to compliance with the 2018 Requirements for the studies' duration. This proposed rule would preserve that option, and proposes an additional flexibility for ongoing studies to transition to the 2018 Requirements if the decision to transition is documented prior to January 21, 2019, which would be the new general compliance date of the 2018 Requirements. Between July 19, 2018 and January 21, 2019, institutions that elect to transition studies to the 2018 Requirements would, after the decision to transition has been documented, be able to take advantage of the three burden-reducing 2018 Requirements. This option is available for ongoing studies, as well as for studies newly initiated after July 19, 2018.
This option is described in a proposed revision to § __.101(l). In order to clearly outline the operation of this proposed flexibility, we propose to redraft § __.101(l) to describe how the transition provision applies to research subject to the pre-2018 Requirements, research transitioned from the pre-2018 Requirements to the 2018 Requirements, and research subject to the 2018 Requirements. The revised § __.101(l) describes how the pre-2018 Requirements and the 2018 Requirements apply to research initiated (
As described, studies taking advantage of this option would be subject to the three burden-reducing 2018 Requirements instead of, or in addition to, the comparable provisions of the pre-2018 Requirements. The three burden-reducing 2018 Requirements are (1) the 2018 Requirements' definition of “research” at § __.102(l) (instead of § __.102(d) of the pre-2018 Requirements), which deems certain activities not to be research, (2) the elimination of the requirement that an IRB review the grant application related to the research at § __.103(d) of the 2018 Requirements (instead of § __.103(f) of the pre-2018 Requirements), and (3) the allowance for no annual continuing review of certain categories of research at § __.109(f)(1)(i) and (iii) of the 2018 Requirements (instead of § __.103(b), as related to the requirement for continuing review, and in addition to § __.109, of the pre-2018 Requirements).
Given that studies taking advantage of this flexibility would, if this proposal is adopted, temporarily be subject to the three burden-reducing 2018 Requirements, but not other provisions in the 2018 Requirements, we are clarifying our intended interpretations of these provisions during a transition period. First, the definition of “research” in the 2018 Requirements references a “public health authority,” a term defined in the 2018 Requirements, but not included in the pre-2018 Requirements. The reference to a “public health authority” in § __.102(l)(3) of the 2018 Requirements would be interpreted consistent with the definition of “public health authority” included in the 2018 Requirements (§ __.102(k)). Second, § __.103(d) of the 2018 Requirements refers to research “exempted under § __.104.” Because the exemptions that will be in place during any transition period are set forth in § __.101(b) of the pre-2018 Requirements, this reference to research “exempted under § __.104” would be interpreted, during this transition period and prior to the general compliance date of the 2018 Requirements, as a reference to research exempted under § __.101(b) of the pre-2018 Requirements. Third, the reference in § __.109(f)(1)(i) of the 2018 Requirements to research eligible for expedited review under § __.110 would be interpreted as a reference to that section in the pre-2018 Requirements. Moreover, the documentation requirements set forth in § __.115(a)(3) of the 2018 Requirements (documenting an IRB's rationale for conducting continuing review that would not otherwise be required under § __.109(f)(1) of the 2018 Requirements) would not be applicable during this transition period as proposed.
As proposed above, for institutions electing to transition a research study to compliance with the 2018 Requirements in order to take advantage of the three burden-reducing provisions, § __.103(d) of the 2018 Requirements would be substituted for § __.103(f) of the pre-2018 Requirements. Both sections address the requirement for certification of research supported by a Federal department or agency. In addition to removing the requirement that IRBs review grant applications or proposals, § __.103(d) of the 2018 Requirements reflects other minor wording changes necessary to accommodate the removal of the grant application or proposal review requirement or to provide additional clarifications.
Except for the three burden-reducing 2018 Requirements identified in proposed § __.101(l)(4)(i)(A), institutions that elect to transition a research study to comply with the 2018 Requirements and document that decision, at any time between July 19, 2018, and January 21, 2019, would be required to comply with the pre-2018 Requirements until January 21, 2019. This approach would afford institutions additional time before they are required to comply with all provisions of the 2018 Requirements, while enabling them to take advantage of the three burden-reducing 2018 Requirements more quickly. The option of applying the three burden-reducing 2018 Requirements would only be available for studies that institutions decided to transition to comply with the 2018 Requirements on or after July 19, 2018. If an institution so chooses to apply the three burden-reducing 2018 Requirements to certain research, those studies would be required to comply with all of the 2018 Requirements beginning on January 21, 2019.
An institution's decision about whether to transition a study to the 2018 requirements to take advantage of the three burden-reducing provisions might vary depending on the nature and progress of the study, including any elements of the study to be conducted on or after January 21, 2019. For example, studies planning to recruit some subjects on or after January 21, 2019 would have to meet the new requirements for obtaining the informed consent of those subjects. In contrast, for studies whose remaining activities
We considered stakeholder suggestions to extend this approach to other burden-reducing sections of the 2018 Requirements, such as the revised exemption categories. We do not propose adding the revised exemption categories to § __.101(l)(4)(i)(A) because implementation of these categories would involve significantly greater complications. For example, these categories use terms that are newly defined or for which revised definitions have been included in the 2018 Requirements, and permitting compliance with these categories without also selectively adopting revised definitions could be problematic. To minimize confusion, this proposed rule limits those provisions for which early adoption would be permitted to those that would minimize burdens without creating significant complexities. We also considered a delay to the effective and general compliance dates without proposing this additional option in the interim period. Such an approach would be simple to implement. We decided against proposing this alternative to be responsive to public comments received and in an effort to minimize burdens with respect to new provisions that will not be difficult to implement prior to the general compliance date of the 2018 Requirements.
As proposed for § __.101(l)(4)(ii), if the determination to transition previously initiated studies to the 2018 Requirements is not made until on or after January 21, 2019, such studies would not benefit from the additional flexibilities created for the period between July 19, 2018 and January 21, 2019. Such studies would be required to comply with the 2018 Requirements after the date of transition.
The regulatory provisions are not prescriptive regarding how an institution chooses to make its transition decisions. An institution may elect to transition research protocols to the 2018 Requirements on a protocol-by-protocol basis, or for a class of protocols (
We also propose a revision to § __.101(l)(4) regarding documentation of an institution's decision to transition research begun under the pre-2018 Requirements to the 2018 Requirements. This proposal is intended to offer institutions greater flexibility regarding who documents that decision. Under the January 19, 2017, final rule, if an institution determines that ongoing research will transition to comply with the 2018 Requirements, this determination must be documented by an IRB before the transition can take effect. We now propose that, to allow ease in implementing this documentation requirement, the documentation of an institution's transition determination may be performed either by an institution (through officials who have the authority to make such determinations on behalf of the institution) or an IRB. As proposed, this documentation must include the date of the transition determination. Records documenting the transition decision must be retained as per § __.115(b).
Once the institution makes the determination to transition the research to the revised rule and that determination is documented, the date of documentation will serve as the de facto compliance date as applied to the research. For a study that is transitioned in accordance with § __.101(l)(4)(i), between July 19, 2018, and January 20, 2019, one set of rules would apply until the general compliance date of the final rule and another would apply beginning on such general compliance date. As of the date the decision to transition is documented until January 20, 2019, the pre-2018 Requirements would be applicable, except that the three burden-reducing 2018 Requirements would apply instead of or in addition to the pre-2018 Requirements specified in § __.101(l)(4)(i)(A). Beginning on January 21, 2019, the 2018 Requirements would apply for the duration of the study.
As proposed, all studies that are transitioned in accordance with § __.101(l)(4)(ii) on or after January 21, 2019, and all studies that are newly initiated on and after January 21, 2019, would be required to follow all of the 2018 Requirements.
In summary, the proposed rule would create three options that would be available beginning July 19, 2018, that institutions may choose to follow for research studies initiated before January 21, 2019. The first option, and default, is to continue to follow all of the pre-2018 Requirements for the duration of the study. The second option is to choose to follow the pre-2018 Requirements, except for the three burden-reducing 2018 Requirements, until January 21, 2019, when all of 2018 Requirements would become applicable. The third option would be to follow the pre-2018 requirements until January 21, 2019, and at some point thereafter choose to follow all of the 2018 Requirements for the duration of the study.
We also solicit comments about the advisability of the alternative of delaying the effective date and general compliance date until January 21, 2019, but without the option to implement certain 2018 Requirements during that delay period.
In addition, we solicit comments on the desirability of the alternative of delaying the effective date and general compliance date beyond January 21, 2019. We do not believe the regulated community will require this additional time to come into compliance with the revised rule, but we are interested in receiving public comments on this alternative.
While we considered the alternative of proposing to amend the transition provision to permit institutions to voluntarily comply with the revised rule beginning on July 19, 2018, and not requiring compliance with the new rule until January 21, 2019 or later, we believe this approach could result in confusion regarding implementation of the revised Common Rule that could be minimized with the issuance of guidance from the Common Rule departments and agencies. By making the changes proposed above, we believe the Common Rule departments and agencies will be able to issue relevant guidance documents that will better enable the regulated community to comply with the revised rule.
We also solicit comments about the advisability of not making the changes proposed in this NPRM (
The legal authorities for the departments and agencies that are signatories to this action are as follows:
Department of Homeland Security, 5 U.S.C. 301; Public Law 107-296, sec. 102, 306(c); Public Law 108-458, sec. 8306. Department of Agriculture, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Energy, 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b). National Aeronautics and Space Administration, 5 U.S.C. 301; 42 U.S.C.
We have examined the effects of this proposed rule under Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017), the Paperwork Reduction Act of 1995 (Pub. L. 104-13), the Regulatory Flexibility Act, (Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism (August 4, 1999).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects; distributive impacts; and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. In accordance with the provisions of Executive Order 12866, this proposed rule was submitted to the Office of Management and Budget (OMB) for review, and has been determined to be a “significant” regulatory action. The designation, as regulatory or deregulatory under Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs, issued on January 30, 2017), of any final rule resulting from this notice of proposed rulemaking will be informed by comments received on the costs and cost savings of delaying the 2018 Requirements. Details on the preliminary estimated costs of this proposed rule can be found in the economic analysis below.
On January 19, 2017, HHS and 15 other federal departments and agencies published the 2018 Requirements designed to more thoroughly address the broader types of research conducted or otherwise supported by all of the Common Rule departments and agencies. In addition, the CPSC adopted the same regulatory changes on September 18, 2017.
This proposed rule, if finalized, would allow regulated entities to continue to comply with the pre-2018 requirements until January 21, 2019. As discussed above, this proposed rule also proposes to permit institutions, during the period between July 19, 2018, and January 21, 2019, to take advantage of three provisions in the 2018 Requirements intended to minimize burdens on regulated entities. Those three burden-reducing 2018 Requirements are (1) the 2018 Requirements' definition of “research,” which deems certain activities not to be research, (2) the allowance for no annual continuing review of certain categories of research, and (3) the elimination of the requirement that IRBs review grant applications related to the research. As described in section III above, this flexibility is proposed for studies for which an institution makes a choice to have those studies be subject to the 2018 Requirements.
The RIA for the 2018 Requirements described the benefits and costs of 16 broad categories of changes finalized. The RIA for this NPRM uses the information and calculations described in the preamble to the 2018 Requirements as a base for estimating benefits and costs of delaying the general implementation of the 2018 Requirements by six months. The time period for the analysis in this RIA is the six month period from July 2018 to January 2019.
Table 1 summarizes the quantified benefits and costs of delaying the general implementation of 2018 Requirements. Over the period of July 2018 to January 2019, annualized benefits of $6.4 million are estimated using a 3 percent discount rate; annualized benefits of $5.9 million are estimated using a 7 percent discount rate. Annualized costs of $37.2 million are estimated using a 3 percent discount rate; annualized costs of $34.4 million are estimated using a 7 percent discount rate. Note that all values are represented in millions of 2016 dollars, and 2016 is used as the frame of reference for discounting.
The estimated benefits and costs of delaying the general implementation date of the 2018 Requirements by six months are shown in Table 2 below. Note that the categorization shown below includes the same 16 categories used in the RIA of the 2018 Requirements.
We assume
Categories with different assumptions are described below:
We assume that even with the proposed six month delay, regulated entities and OHRP would still assume costs related to learning the new requirements and developing training materials. Thus, there are no effects estimated here.
We expect that some entities would experience cost savings as a result of this proposed rule, and some entities would experience costs as a result of this proposed rule, but we lack data to quantify these effects. We request comments which provide data that can be used to quantify these effects.
We assume that 50 percent of regulated entities will take advantage of the option proposed in this NPRM to implement three burden-reducing provisions of the 2018 Requirements early. We assume this because an institution's decision about whether to transition a study to the 2018 requirements to take advantage of the three burden-reducing provisions might vary depending on the nature and progress of the study, including any elements of the study to be conducted after January 21, 2019. For example, studies planning to recruit some subjects after January 21, 2019 would have to meet the new requirements for obtaining the informed consent of those subjects. In contrast, for studies whose remaining activities consist only of completing data analyses, the new requirements for informed consent would generally not be applicable. Therefore, we assume that there are situations where an institution would want to take advantage of the three burden-reducing provisions, and situations where an institution would not want to take advantage of this flexibility. We note that we intend to publish guidance on the carve-outs from the definition of research prior to July 2018, which may also impact an institution's decision to elect to implement the three burden-reducing provisions or not.
Thus, these entities will still obtain the benefits and costs described in the RIA for the 2018 Requirements, implying no effects of this rule for 50 percent of regulated entities. For the regulated entities that do not take advantage of these flexibilities, we assume that the foregone benefits (costs) of delaying implementation of these provisions are what would have been the benefits of implementing these provisions in January of 2018. Similarly, we assume that the benefits (cost-savings) associated with delaying the implementation of these provisions are what would have been the costs of implementing these provisions in July of 2018. We assume that these regulated entities account for 50 percent of the costs and benefits that would have been experienced in 2018 absent this delay.
We also assume that institutional staff at the IRB Administrative staff level
We request comment on our assumption that 50 percent of regulated entities will take advantage of the option proposed in this NPRM to implement three burden-reducing provisions of the 2018 Requirements early.
Some members of the regulated community have indicated that even though the 2018 Requirements yield cost savings, these institutions are still hesitant to transition ongoing research to the 2018 Requirements, largely because of the burden of making studies already in compliance with the pre-2018 requirements comply with the 2018 requirements. Also, some institutions seem inclined to make all of the transitions at once. This interconnectedness is key to some of the assumptions noted elsewhere in this analysis. For example, if the three burden-reducing provisions are considered on their own, a reasonable assumption would be that 100 percent of affected entities would realize the associated cost savings as soon as possible. The use, instead, of a 50 percent estimate reflects entities' possible inclinations to make all transitions at once. We request comment that would provide insight into entities' views regarding the interconnectedness of the 2018 Requirements' provisions and thus allow for refinement of the 50 percent estimate.
The 2018 Requirements include five new exemption categories, and modify all but one exemption that exist in the pre-2018 Requirements. We have received feedback from SACHRP that guidance will be useful for regulated entities to implement many of the exemption categories.
Because the guidance documents that would be helpful to assist regulated entities in implementing these 2018 Common Rule provisions have not yet been developed, we assume that 50 percent of the regulated entities would not have taken advantage of the expansion in exemptions during this six month-delay. For these entities, we assume that there are no benefits and costs of the proposed delay, because they would not have changed their operations. We assume that 50 percent of the regulated entities would have gone forward with using the new or expanded exemption categories under the 2018 Requirements; for these entities, there are costs of delaying the implementation of this provision during the six-month delay proposed in this NPRM.
We do not have data to support our assumption of what percent of regulated entities would have gone forward with the implementation of these provisions in the absence of additional guidance, and what percent would not have gone forward. We request comments on these assumptions and solicit data that can be used to quantify these effects.
This NPRM includes a primary alternative proposal of delaying the general effective and compliance date to January 2019.
Table 3 summarizes the quantified benefits and costs of the alternative proposal of delaying the general implementation of 2018 Requirements without the option to implement certain
This proposed rule contains collections of information that are subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), as amended (44 U.S.C. 3501-3520). A description of these provisions is given in this document with an estimate of the annual reporting and recordkeeping burden.
Section 101(l)(4)(i) would permit studies to transition to the 2018 Requirements between July 19, 2018 and January 21, 2019 (which would be the new general compliance date of the 2018 Requirements). Between July 19, 2018 and January 21, 2019, institutions that elect to transition studies to the 2018 Requirements would, after the decision to transition has been documented, be able to take advantage of the three burden-reducing 2018 Requirements.
This option is described in a proposed revision to § __.101(l)(4)(i). As described, studies taking advantage of this option would be subject to the three burden-reducing 2018 Requirements instead of, or in addition to, the comparable provisions of the pre-2018 Requirements. As discussed above, the three burden-reducing 2018 Requirements are (1) the 2018 Requirements' definition of “research” at § __.102(l) (instead of § __.102(d) of the pre-2018 Requirements), which deems certain activities not to be research, (2) the elimination of the requirement that an IRB review the grant application or proposal related to the research at § __.103(d) of the 2018 Requirements (instead of § __.103(f) of the pre-2018 Requirements), and (3) the allowance for no annual continuing review of certain categories of research at § __.109(f)(1)(i) and (iii) of the 2018 Requirements (instead of § __.103(b), as related to the requirement for continuing review, and in addition to § __.109 of the pre-2018 Requirements).
We estimate that approximately 92,084 protocols would take advantage of the voluntary election described in § __.101(l)(4)(i). We estimate that institutional staff would spend 5 minutes per protocol documenting that the study will be subject to the three burden-reducing 2018 Requirements during the time period of July 19, 2018 through January 21, 2019. We estimate that this provision includes 7,673 burden hours.
The Regulatory Flexibility Act (5 U.S.C. 601
If finalized, this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This proposed rule would not impose a regulatory burden for regulated small entities because it would delay the general compliance date of the 2018 Requirements, allowing the status quo to be retained for the period of delay, and also would allow regulated small entities to elect to implement the 2018 Requirements as scheduled if the entities so choose. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities. We request
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $148 million, using the most current (2016) implicit price deflator for the gross domestic product. We do not expect this rule to result in expenditures that will exceed this amount. This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on state and local governments or has federalism implications. We have determined that the proposed rule would not contain policies that would have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. The changes in the proposed rule represent the Federal Government regulating its own program. Accordingly, we conclude that the rule does not propose policies that have federalism implications as defined in Executive Order 13132 and, consequently, a federalism summary impact statement is not required.E:\FR\FM\A20ap2.024
For the reasons set forth in the preamble, the Federal Policy for the Protection of Human Subjects, as published in the
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § __.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § __.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Homeland Security proposes to further amend 6 CFR part 46 as published in the
5 U.S.C. 301; P.L. 107-296, sec. 102, 306(c); P.L. 108-458, sec. 8306.
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 46.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 46.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Agriculture proposes to further amend 7 CFR part 1c as published in the
5 U.S.C. 301; 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 1c.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 1c.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Energy proposes to further amend 10 CFR part 745 as published in the
5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 745.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 745.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, National Aeronautics and Space Administration proposes to further amend 14 CFR part 1230 as published in the
5 U.S.C. 301; 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 1230.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 1230.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Commerce proposes to further amend 15 CFR part 27 as published in the
5 U.S.C. 301; 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 27.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 27.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Consumer Product Safety Commission proposes to further amend 16 CFR part 1028 as published in the
5 U.S.C. 301; 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 1028.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 1028.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Social Security Administration proposes to further amend 20 CFR part 431 as published in the
5 U.S.C. 301; 42 U.S.C. 289(a).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 431.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 431.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Agency for International Development proposes to further amend 22 CFR part 225 as published in the
5 U.S.C. 301; 42 U.S.C. 300v-1(b), unless otherwise noted.
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 225.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Housing and Urban Development proposes to further amend 24 CFR part 60 as published in the
5 U.S.C. 301; 42 U.S.C. 300v-1(b) and 3535(d).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 60.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 60.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Labor proposes to further amend 29 CFR part 21 as published in the
5 U.S.C. 301; 29 U.S.C. 551.
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 21.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 21.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Dated: April 2, 2018.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Defense proposes to further amend 32 CFR part 219 as published in the
5 U.S.C. 301.
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 219.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 219.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Education proposes to further amend 34 CFR part 97 as published in the
5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474.
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 97.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 97.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Veterans Affairs proposes to further amend 38 CFR part 16 as published in the
5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 16.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 16.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Environmental Protection Agency proposes to further amend 40 CFR part 26 as published in the
5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 26.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 26.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Health and Human Services proposes to further amend 45 CFR part 46 as published in the
5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 46.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 46.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, National Science Foundation proposes to further amend 45 CFR part 690 as published in the
5 U.S.C. 301; 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 690.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 690.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, Department of Transportation proposes to further amend 49 CFR part 11 as published in the
5 U.S.C. 301; 42 U.S.C. 300v-1(b).
(l) * * *
(2) For purposes of this section, the
(3)
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 11.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 11.101(b) of the pre-2018 Requirements before January 21, 2019.
(4)
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(
(
(
(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.
(5)
(i) Research initially approved by an IRB on or after January 21, 2019,
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
| 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 |